THIN THEAUTHOR ATUNITATE US010071215B2

(12) United States Patent (10) Patent No.: US 10 ,071,215 B2

Bonutti (45) Date of Patent: * Sep . 11, 2018
(54 ) MEDICAL DEVICE SYSTEM INCLUDING 8/4263 (2013.01); A61B 8/445 ( 2013.01) ;
GUIDE ROD ILLUMINATION A61B 8 /461 (2013 .01); A61M 16 / 0411
(2014 .02 ); A61M 16 / 0434 ( 2013 . 01) ; A61M
( 71) Applicant: P Tech , LLC , Effingham , IL (US) 16 /0495 (2014 .02 ); A61M 16 /0497 (2013.01);
(72 ) Inventor: Peter M . Bonutti, Effingham , IL (US ) (Continued )
(58) Field of Classification Search
(73 ) Assignee : P Tech , LLC , Effingham , IL (US) CPC .. . A61B 5 / 06 ; A61M 16 /04 ; A61M 2025 /022
See application file for complete search history .
( * ) Notice : Subject to any disclaimer, the term of this
patent is extended or adjusted under 35 (56 ) References Cited
U . S .C . 154 (b ) by 0 days . U .S . PATENT DOCUMENTS
This patent is subject to a terminal dis 2 ,463, 149 A 3 /1949 Caine
claimer . 2 ,541,402 A 2 /1951 Caine
(21) Appl. No.: 14/553,094 (Continued )
(22 ) Filed : Nov . 25 , 2014 OTHER PUBLICATIONS
(65) Prior Publication Data Senyei et al., “ Magnetic Guidance of Drug -Carrying
Microspheres” , J. Appl. Phys. 49 (6 ):3578 -3582 (U .S .A . 1978).
US 2015 /0080763 A1 Mar. 19 , 2015 (Continued )
Related U .S . Application Data Primary Examiner — Jonathan Cwern
(63 ) Continuation of application No. 14 /256 ,629, filed on (74 ) Attorney, Agent, or Firm — Senniger Powers LLP
Apr. 18 , 2014 , which is a continuation of application
(Continued ) (57) ABSTRACT
(51) Int. Ci. A medical device system is provided . The medical device
system includes a positioning apparatus having a body
A61B 5 /06 ( 2006 .01) section and an upper section , the upper section slidably
A61M 16 /04 ( 2006 .01 ) coupled to the body section such that the upper section
(Continued ) slidably moves relative to the body section . The medical
(52 ) U .S . CI. device also includes a flexible guide rod extending through
CPC . ..... . A61M 16 / 0488 (2013 .01 ); A61B 1 /005 the positioning apparatus and configured to be inserted into
( 2013 .01) ; A61B 1 /00082 (2013 .01 ); A61B a passage of a respiratory system of a subject. The flexible
1 /00124 ( 2013 .01) ; A61B 1/015 ( 2013 .01) ; guide rod includes a visible light emitter configured to emit
A61B 1/ 0676 ( 2013 .01 ); A61B 1 /0684 visible light within the passage of the respiratory system and
(2013 .01) ; A61B 1/07 (2013 .01) ; A61B 5 /065 is visible outside the subject.
( 2013 . 01) ; A61B 8 /0841 (2013 .01); A61B 8 / 12
(2013.01); A61B 8/4254 (2013 .01); A61B 22 Claims, 14 Drawing Sheets

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 US 10 ,Page
071 ,2215 B2

Related U .S . Application Data 5 ,375, 596 A

5 ,386 ,828 A
12 / 1994 Twiss
2 / 1995 Owens
No. 13 /048, 163, filed on Mar. 15 , 2011 , which is a 5 ,425 ,367 A 6 / 1995 Shapiro
continuation of application No. 12 /431, 835 , filed on 5 , 437 ,273 A * 8 / 1995» Bates
Bates . ... .... ...... .. A61M 16 /0488
Apr. 29 , 2009, which is a continuation of application 128 /207. 14
5 , 469, 853 A 11/ 1995 Law
No. 10 / 990 ,870 , filed on Nov. 17 , 2004 , which is a 5 ,494, 035 A 2 / 1996 Leuthold
continuation of application No. 09/728 ,553 , filed on 5 ,540 ,691 A * 7 / 1996
9 / 1996
Elstrom et al. ................. 606 /64
Spencer
Dec. 2 , 2000 , now Pat. No. 6 ,820 ,614 . 5 ,558, 082 A
5 , 560, 351 A 10 / 1996 Gravenstein
5 ,582 , 165 A 12 / 1996 Bryan
(51) Int. CI. 5 ,617 , 857 A 4 / 1997 Chader
A61B 8 /08 ( 2006 . 01) 5 ,622 , 169 A 4 / 1997 Golden
A61B 8 / 12 ( 2006 .01) 5 ,622 , 170 A 4 / 1997 Schulz
A61B 8 / 00 (2006 .01) 5 ,638 ,819 A 6 / 1997 Manwaring
5 ,642, 730 A 7 /1997 Baran
AGIM 25 /01 ( 2006 .01) 5 ,694 , 929 A 12 / 1997 Christopher
A61B 1 /00 ( 2006 .01) 5 ,711 , 299 A 1/ 1998 Manwaring
A61B 1/005 ( 2006 .01) 5 ,729 , 129 A 3 /1998 Acker
A61B 1 /015 ( 2006 .01) 5 , 749 ,835 A 5 /1998 Glantz
A61B 1/06 (2006 .01) 5 ,762, 064 A 6 / 1998 Polvani
5 ,779 ,694 A 7 /1998 Howard
A61B 1/07 ( 2006 .01) 5 ,782, 765 A 7 / 1998 Jonkman
A61M 25 /09 ( 2006 .01 ) 5 ,785,051 A 7 / 1998 Lipscher
A61M 25 /02 ( 2006 .01 ) 5 ,817,057 A 10 / 1998 Berenstein
A61M 25 /00 ( 2006 . 01) 5 ,823 , 992 A 10 / 1998 Salmon
5 ,843 , 153 A 12/ 1998 Johnson
(52 ) U .S . CI. 5 ,879, 306 A * 3 / 1999 Fontenot et al. ........... 600 /473
CPC . .. A61M 25 /0102 (2013 .01) ; A61M 25 /0108 5 ,899 , 860 A 5 / 1999 Pfeiffer
( 2013 .01); A61M 25 /09 (2013 .01) ; A61M 5 ,906 ,579 A 5 / 1999 Vander Salm
2025 /0008 (2013 .01); A61M 2025 /022 5 ,913 , 820 A 6 / 1999 Bladen
5 ,944 ,023 A 8 /1999 Johnson
(2013 .01); A61M 2025/091 ( 2013 .01); ACIM 5 , 954 ,649 A 9/ 1999 Chia
2025/09008 (2013 .01); A61M 2205 /0272 5 ,996 ,582 A 12 / 1999 Turnbull
( 2013.01 ); A61M 2205 /587 (2013 .01) 6 ,014 ,580 A 1/2000 Blume
3 /2000 Century
6 ,041,775 A
( 56 ) References Cited 6 ,067, 985 A *5/ 2000 Islava ............ A61M 16 /0488
128 /200 . 26
U . S . PATENT DOCUMENTS 6 ,078 ,831 A 6 / 2000 Belef
6 ,081,741 A * 6 /2000 Hollis .... 600 /424
2 , 862,498 A 12 / 1958 Weekes 6 , 161,032 A 12/2000 Acker
3 , 314 ,431 A 4 / 1967 Taricco 6 , 161,537 A 12 /2000 Gravenstein
3 , 833 ,033 A 9 / 1974 Taricco 6 , 173, 199 B1 1/ 2001 Gabriel
3 ,996 ,939 A 12 / 1976 Sheridan 6, 175, 756 B1 1 /2001 Ferree
4 ,063, 561 A 12 / 1977 McKenna 6,188, 355 B1 2 /2001 Gilboa
4 , 173, 228 A 11/ 1979 Van Steenwyk 6 , 226, 543 B1 5 /2001 Gilboa
4 ,197 ,855 A 4 / 1980 Lewin 6 , 226 , 547 B1 5 /2001 Lockhart
4 ,244 , 362 A 1/ 1981 Anderson 6 ,233, 477 B1 5 /2001 Chia
4 ,431,005 A 2 / 1984 McCormick 6,246, 898 B1 6 / 2001 Vesely
6 , 298, 261 B1 10 / 2001 Rex
4 ,444, 185
4 ,445, 501
A * 4 / 1984 Shugar
A 5 / 1984 Bresier
.... 128/207.29 6 , 332,089 B1 12 / 2001 Acker
4 ,567, 882 A * 2 / 1986 Heller 600 / 249 6 ,349,720 B1 2 /2002 Clark
4 , 593,687 A 6 / 1986 Gray 6 ,380 ,732 B1 4 /2002 Gilboa
4 ,727, 872 A 3 / 1988 Hawk 6 ,432 ,041 B1 * 8/ 2002 Taniguchi ............ A61B 1/0055
4 ,793 ,327 A 12 / 1988 Frankel 600 /117
4 , 832,020 A 5 / 1989 Augustine 6 ,522, 909 B1 2 / 2003 Garibaldi
4 ,840 , 172 A 6 / 1989 Augustine 6 ,527, 761 B1 * 3 / 2003 Soltesz et al. ............... 604 /516
4 ,846 ,153 A 7 / 1989 Berci 6, 553, 993 B2 4 / 2003 Toti
4 , 865,586 A 9 / 1989 Hedberg 6 , 574 ,498 B1 6 / 2003 Gilboa
4 ,905 ,698 A 3 / 1990 Strohl 6 ,580, 938 B1 6 /2003 Acker
4 ,913 , 139 A 4 / 1990 Ballew 6 ,593, 884 B1 7 /2003 Gilboa
4 ,943, 770 A 7 / 1990 Ashley -Rollman 6, 615,155 B2 9 /2003 Gilboa
4 , 960, 122 A 10 / 1990 Mizus 6 ,672,308 B1 1 /2004 Gaspari
4 , 983, 165 A 1 / 1991 Loiterman 6 , 702,780
B1 3 / 2004 Gilboa
5 , 005,573 A 4 / 1991 Buchanan 6 , 711, 429
B1 3 / 2004 Gilboa
5 ,042,486 A 8 / 1991 Pfeiler 6, 820 , 614
B2 11/ 2004 Bonutti
5 ,099 ,845 A 3 / 1992 Besz 7 ,320 ,319
B2 1/2008 Bonutti
5 , 127 ,913 A 7 / 1992 Thomas 7 ,575 ,550
B1 8/ 2009 Govari
5 , 197 ,971 A 3 / 1993 Bonutti 2005 /0103333 Al 5 /2005 Bonutti
5 ,211 , 165 A 5 / 1993 Dumoulin 2009/02 16066 A1 8 / 2009 Bonutti
5 ,235, 970 A 8/ 1993 Augustine
5 ,257,636 A 11/ 1993 White OTHER PUBLICATIONS
5 ,259,371 A 11/ 1993 Tonrey
5 ,259, 377 A 11/ 1993 Schroeder Breyer et al., Ultrasonically Marked Catheter, a Method for Positive
5 , 263 ,478 A 11/ 1993 Davis
Echographic Catheter Position and Identification, Medical and
5 ,325, 873 A 7 / 1994 Hirschi
5 ,339, 805 A 8/ 1994 Parker Biological Engineering and Computing , May 1984 , pp . 268 -271.
5 , 353 ,787 A 10 / 1994 Price Final Office Action dated Oct. 19 , 2015 relating to U . S . Appl. No.
5 ,353, 807 A 10 / 1994 DeMarco 14 /256 ,629, 11 pages.
 US 10 ,Page
071 ,3215 B2

(56 ) References Cited

OTHER PUBLICATIONS
Non -Final Office Action dated Feb . 20 , 2015 relating to U .S. Appl.
No . 14 / 256 ,629 , 14 pages.
Final Office Action dated Jun. 23 , 2016 relating to U .S . Appl. No.
14 / 256 ,629 , 11 pages.
Non -Final Office Action dated Aug. 15 , 2016 relating to U .S . Appl.
No . 15 / 183 ,437 , 15 pages.
Final Office Action dated Nov. 1 , 2016 relating to U .S . Appl. No .
15 / 183 ,437 , 14 pages .
Non -Final Office Action dated May 25 , 2017 relating to U .S . Appl.
No . 14 /256 ,629, 10 pages.
Non -Final Office Action dated May 24 , 2017 relating to U .S . Appl.
No. 15 / 183 ,437 , 14 pages.
Final Office Action dated Jul. 28, 2017 relating to U .S . Appl . No.
14 / 256 ,629 ,
8 pages .
Final Office Action dated Aug. 1, 2017 relating to U .S . Appl. No.
15 / 183 , 437 , 11 pages.
* cited by examiner
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 US 10 ,071,215 B2
MEDICAL DEVICE SYSTEM INCLUDING emitter configured to emit light at the distal end portion of
GUIDE ROD ILLUMINATION the flexible guide rod wherein the visible light emitter is
configured to emit visible light within the passage of the
CROSS -REFERENCE TO RELATED respiratory system such that the emitted visible light trans
APPLICATION 5 mits through the subject and is visible outside the subject for
use in determining the location of the distal end portion of
This patent application is a continuation application of the flexible guide rod within the respiratory system ; and a
U . S. patent application Ser. No. 14 /256 ,629 , filed Apr. 18 , medical device slidably movable along the flexible guide rod
2014 , which is a continuation application of U .S . patent for positioning the medical device in the passage of the
application Ser. No. 13 /048 , 163, filed Mar. 15 , 2011 , appli- 10 respiratory system , the medical device including an elongate
cation is a continuation of U . S . patent application Ser. No. body having proximal and distal end portions, and a balloon
12 /431 , 835 , filed Apr. 29 , 2009, which is a continuation of at the distal end portion of the elongate body configured for
U .S . patent application Ser. No . 10 / 990 ,870 , filed Nov . 17 , selective expansion to apply a force against a portion of the
2004, which is a continuation of U . S . patent application Ser. respiratory system , wherein the medical device defines a
No. 09/ 728 , 553 , filed on Dec . 2 , 2000 , now U . S . Pat. No. 15 guide rod lumen extending along the elongate body of the
6 ,820 ,614 , the entirety of each of which is incorporated by medical device and configured for receiving the flexible
reference . guide rod therein , wherein the medical device defines an
inflation lumen extending along the elongate body of the
FIELD medical device in fluid communication with the balloon ,
20 wherein the medical device comprises a plurality of indicia
The present disclosure relates to a medical device system spaced apart from one another along the elongate body for
including guide rod illumination . use in determining a position of the medical device in the
respiratory system .
BACKGROUND In yet another embodiment, a method for positioning a
25 medical device system is provided . The method includes
Tracheal intubination has previously been utilized to inserting a flexible guide rod having a proximal portion and
provide an unobstructed air passage to a patient's lungs. a distal portion into a passage of a respiratory system of a
Tracheal intubination is frequently done under emergency subject, visually observing light output from a light output
circumstances which are not optimal. It has previously been component disposed at the distal portion of the flexible
recognized that is necessary to have a tracheal tube bend 30 guide rod when the light source is positioned within the
around the patient' s epiglottis and move from the patient' s passage of the respiratory system , and selectively expanding
pharynx into the larynx at the upper end of the patient' s a balloon at the distal end portion of the flexible guide rod
trachea rather than into the patient' s esophagus. However, it to apply a force against a portion of the respiratory system .
is difficult for a person inserting the tracheal tube to know It should be understood that any one of the features of the
where the leading end portion of the tracheal tube is located 35 present invention may be used separately or in combination
relative to the patient' s larynx . with other features of the invention . It' s believed that
Various methods and devices for assisting in tracheal various combinations of the features , other than those dis
intubination are disclosed in U .S . Pat. Nos. 4 ,832 ,020 ; closed herein , may advantageously be utilized and will be
4 ,865 ,586 ; 4 ,913 ,139 ; 5 ,353 ,787 ; 5 , 235 , 970 ; 5 ,560 , 351 ; and apparent to those skilled in the art from the description
5 ,694 , 929. 40 contained herein . In addition , it should be understood that
features of the present invention may be used for purposes
SUMMARY other than tracheal intubination .
In one embodiment, a medical device system is provided . BRIEF DESCRIPTION OF THE DRAWINGS
The medical device system includes a flexible guide rod 45
having a proximal end portion and a distal end portion , the The foregoing and other features of the present invention
flexible guide rod configured to be inserted into a passage of will become more apparent upon a consideration of the
a respiratory system of a subject, the flexible guide rod following description taken in connection with the accom
comprising a visible light emitter configured to emit light at panying drawings wherein :
the distal end portion of the flexible guide rod, wherein the 50 FIG . 1 is a fragmentary schematic illustration depicting
visible light emitter is configured to emit visible light within the use of a positioning apparatus to position a guide rod
the passage of the respiratory system such that the emitted relative to the mouth and trachea of a patient;
visible light transmits in the subject and is visible outside the FIG . 2 a fragmentary schematic illustration depicting the
subject for use in determining the location of the distal end manner in which a tracheal tube is moved along the guide
portion of the flexible guide rod within the respiratory 55 rod of FIG . 1 into the trachea of the patient;
system , and a medical device slidably movable along the FIG . 3 is a fragmentary schematic illustration , similar to
flexible guide rod to position the medical device in the FIG . 1, illustrating the manner in which a laryngoscope may
passage of the respiratory system , themedical device includ - be combined with the positioning apparatus;
ing an elongate body having proximal and distal end por- FIG . 4 is a fragmentary schematic illustration depicting
tions , and a balloon at the distal end portion of the elongate 60 the use of another embodiment of the positioning apparatus
body configured for selective expansion to apply a force to position a guide rod relative to the mouth and trachea of
against a portion of the respiratory system . a patient;
In another embodiment, a medical device system is pro - FIG . 5 is an enlarged schematic fragmentary sectional
vided . The medical device system includes a flexible guide view of a portion of the apparatus of FIG . 4 and illustrating
rod having a proximal end portion and a distal end portion , 65 the relationship between a guide rod and a guide tube ;
the flexible guide rod configured to be inserted into a FIG . 6 is an enlarged schematic fragmentary sectional
passage of a respiratory system of a subject; a visible light view of a portion of the apparatus of FIG . 4 and illustrating
 US 10 ,071,215 B2
the relationship between the guide tube , guide rod, and a FIG . 24 is a schematic illustration , generally similar to
guide member in the positioning apparatus; FIG . 23, illustrating another embodimentof the apparatus of
FIG . 7 is a schematic fragmentary sectional view illus- FIGS. 1 and 2 ;
trating a manner in which the positioning apparatus engages FIG . 25 is a fragmentary schematic illustration of a
a patient 's Adam 's apple and the manner in which a magnet 5 portion of a positioning apparatus having another embodi
is moved along the outside of the neck of the patient ; ment of the positioning section ;
FIG . 8 (on sheet 3 of the drawings) is an enlarged FIG . 26 is a fragmentary schematic illustration depicting
fragmentary schematic illustration of indicia on a portion of the relationship between the positioning section of FIG . 25
the guide rod of FIG . 4 ; and a patient' s Adam 's apple during use of the positioning
FIG . 9 is a fragmentary schematic illustration of the guide 10 apparatus ;
rod with the positioning apparatus and guide tube of FIG . 4 FIG . 27 is a fragmentary schematic illustration of a
removed after positioning of the guide rod relative to the portion of a positioning apparatus having another embodi
patient' s trachea ; ment of the positioning section ; and
FIG . 10 is a fragmentary schematic illustration , generally FIG . 28 is a fragmentary schematic illustration depicting
similar to FIG . 9, illustrating the manner in which a tracheal 15 the relationship between the positioning section of FIG . 27
tube is moved along the guide rod into the patient 's trachea ; and a patient' s Adam 's apple during use of the positioning
FIG . 11 is a fragmentary schematic illustration , generally apparatus .
similar to FIG . 4 , illustrating an embodiment of the appa
ratus in which the tracheal tube is used to guide movement DETAILED DESCRIPTION
of the guide rod; 20
FIG . 12 is a fragmentary schematic illustration , similar to General Description
FIG . 1, illustrating an embodiment of the positioning appa The present invention relates to a new and improved
ratus which transmits an image of body tissue adjacent to a method and apparatus for use in tracheal intubination or
leading end portion of the guide rod ; other medical procedures . A portion of a patient' s head 10
FIG . 13 is a fragmentary schematic illustration , generally 25 and respiratory system 11 has been illustrated schematically
similar to FIGS. 1 and 12 , of an embodiment of the invention in FIG . 1 . The schematicized illustration of the patient's
in which a detector on a leading end portion of a guide rod head 10 and respiratory system 11 includes a mouth 12
detects emitters disposed on the neck of the patient; which is connected with a throat 14 in a neck 16 of the
FIG . 14 is a fragmentary schematic illustration , depicting patient.
the manner in which a plurality of emitters are arranged in 30 A pharynx extends downward from a nasal cavity in the
an array around the Adams' s apple of the patient of FIG . 13 ; head 10 of the patient. The pharynx is connected with an
FIG . 15 is a fragmentary schematic illustration , generally esophagus 26 and a trachea 28 in the neck 16 of the patient.
similar to FIG . 13 , of an embodiment of the invention in The esophagus 26 extends from the pharynx to the stomach
which detectors on the neck of the patient detect an emitter of the patient. The trachea 28 extends from the pharynx to
on a leading end portion of the guide rod ; 35 the bronchial tubes and lungs of the patient.
FIG . 16 is a fragmentary schematic illustration , generally The trachea 28 (FIG . 1 ) has an upper end portion 30 which
similar to FIG . 14 , illustrating a manner in which a plurality is referred to as the larynx . Vocal cords or folds 32 havebeen
of detectors are positioned in an array around the Adam 's indicated schematically in FIG . 1 and are disposed in the
apple on the neck of the patient of FIG . 15 ; larynx 30 . The vocal cords 32 are adjacent to the Adam 's
FIG . 17 is an enlarged schematic fragmentary sectional 40 apple 34 of the patient. The Adam 's apple 34 is a laryngeal
view of the leading end portion of a guide rod on which a prominence formed by lamina of cartilage in the larynx .
detector and a plurality of expandable steering elements are Opening of a passage for air from the patient's mouth to
disposed ; the patient 's lungs may require insertion of a flexible tra
FIG . 18 is a plan view , taken generally along the line cheal tube 38 (FIG . 2 ). Movement of the flexible tracheal
18 - 18 of FIG . 17 , further illustrating the relationship of the 45 tube 38 from the patient's mouth 12 into the pharynx of the
expandable steering elements to the leading end portion of patient is relatively easily accomplished . However, directing
the guide rod; the tracheal tube 38 into the patient's trachea 28 may present
FIG . 19 is a schematic fragmentary sectional view of a difficulties. This is because the tracheal tube must extend
leading end portion of a guide rod on which an emitter and past the epiglottis into the larynx 30 at the upper end of the
a plurality of expandable steering elements are disposed ; 50 trachea 28 . The tracheal tube 38 must not enter the esopha
FIG . 20 is an enlarged schematic fragmentary sectional gus 26 rather than the trachea 28 . During movement of the
view of a leading end portion of a tracheal tube and leading end of the tracheal tube 38 through the larynx 30 , it
illustrating the manner in which a light source and light is desirable to have the tracheal tube near the central portion
conductor are disposed on the tracheal tube to facilitate of the laryngeal cavity in order to minimize irritation of the
visualization of tissue disposed adjacent to the leading end 55 vocal folds or cords 32 by the tracheal tube .
portion of the tracheal tube ; In accordance with one of the features of the present
FIG . 21 is an enlarged schematic fragmentary sectional invention , a flexible guide wire or rod 50 (FIG . 1 ) is utilized
view of a leading end portion of a tracheal tube and to guide movement of the flexible tracheal tube 38 (FIG . 2 )
illustrating a plurality of detectors which are disposed on the into the trachea 28 . The flexible guide rod 50 has a soft
leading end portion of tracheal tube ; 60 generally spherical leading end portion 52 . The leading end
FIG . 22 is an enlarged schematic fragmentary sectional portion 52 of the guide rod 50 is formed of a resiliently
view of a leading end portion of a tracheal tube illustrating compressible material which is readily deflected by engage
themanner in which a plurality of emitters and expandablem ent with the vocal cords or folds 32 and by engagement
steering elements are mounted on the leading end portion of with the surface of the trachea 28 . If desired , the leading end
the tracheal tube; 65 portion 52 of the guide rod 50 may be coated with a suitable
FIG . 23 is a schematic illustration depicting the position - lubricant to facilitate movement of the leading end portion
ing apparatus of FIGS . 1 and 2 ; between the vocal cords with minimum of irritation .
 US 10 ,071,215 B2
In accordance with another of the features of the inven configuration of the head 10 of the patient, and other factors.
tion , the guide wire 50 is initially positioned relative to the The distance which the guide rod 50 must be moved axially
patient' s trachea 28 with a positioning apparatus 56 (FIG . 1 ). into the patient's larynx 30 will vary as a function of
The positioning apparatus 56 engages the patient's Adam 's variations in the distance between the patient's mouth 12
apple 34 to locate the positioning apparatus relative to the 5 and the patient's Adam 's apple 34 . This is because the
trachea 28 of the patient . In addition , the positioning appa - patient 's Adam ' s apple 34 is located adjacent to the entrance
ratus 56 provides a measurement which is a function of the to the trachea 28 .
distance between the Adam 's apple 34 and the mouth 12 of The positioning apparatus 56 can be used to position
the patient. This measurement is utilized to determine the many different objects at desired locations in a patient's
distance through which the guide rod 50 is to be moved 10 body . For example , the guide rod 50 or a similar member
relative to the positioning apparatus 56 as the guide rod is could be inserted into a patient' s stomach or colon . The base
inserted into the trachea 28 . section 78 of the positioning apparatus would be positioned
Positioning Apparatus
The positioning apparatus 56 has been and will be in engagementwith an exterior surface on the patient's body
described herein in association with tracheal intubination . 15 at a location where the leading end portion 52 of the guide
However, it is contemplated that the positioning apparatus rod 50 is to be moved . The upper section 80 of the posi
56 will be used in association with many other medical tioning apparatus 56 would cooperate with the base section
procedures where accurate positioning of an object relative 78 and guide rod 50 to provide a clear indication of the
to body tissue is desired . The positioning apparatus may be location of the leading end portion 52 of the guide rod 50
used in association with endoscopic, arthroscopic or fiber 20 relative to the patient's body tissue, for example, the
optic surgical procedures . It is believed that the positioning patient's stomach or colon .
apparatus 56 will be used in conjunction with medical The base section 78 (FIG . 1 ) of the positioning apparatus
procedures where it is necessary to position an object at a 56 includes a tubular cylindrical body section 86 . The base
location in a patient's body where there is only limited section 78 also includes a positioning section 96 which
access . 25 engages the patient' s Adam ' s apple 34 and is supported by
The positioning apparatus 56 positions the guide rod 50 the body section 86 . The positioning section 96 engages the
relative to the patient's trachea 28 during insertion of the patient's Adam 's apple 34 . Although the illustrated posi
guide rod into the patient's trachea . In addition , the posi t ioning section 96 (FIG . 1 ) engages only a single location on
tioning apparatus 56 provides an indication of the distance the patient' s neck 16 , the positioning section could be
which the guide rod is to be moved into the patient' s trachea . 30 constructed so as to engage a plurality of locations on the
By using the positioning apparatus 56 , a person moving the patient' s neck . For example , it may be preferred to use a
guide rod 50 into the patient's trachea 28 can know where positioning section 96 having two positioning fingers dis
the leading end portion 52 of the guide rod is located relative posed on laterally opposite sides of the Adam ' s apple 34 .
to the trachea . It is contemplated that the positioning section 96 could
The flexible guide rod 50 may be formed of either 35 have many different constructions . It is believed that it may
polymeric material or metal. The illustrated polymeric guide be particularly advantageous to utilize a positioning section
rod 50 has a relatively small diameter and is readily 96 having the construction illustrated in FIGS. 25 and 26
deflected . The guide rod 50 has a circular cross sectional herein . Alternatively , the positioning section 96 may have
configuration . the construction illustrated in FIGS . 27 and 28 or FIGS. 4
The guide rod 50 is axially movable relative to the 40 and 7 herein if desired .
positioning apparatus 56 under the influence of force manu - Force may be manually applied against the positioning
ally applied to the portion of the guide rod disposed to the section 96 to straighten the trachea 28 of the patient . Thus ,
left ( as viewed in FIG . 1 ) of the positioning apparatus 56 . the patient' s trachea 28 may have a slight anterior bend
This force results in axial movement of the guide rod 50 when the patient' s head 10 is in the position illustrated in
relative to the positioning apparatus 56 . In addition , the 45 FIG . 1 . This slight bend can be eliminated by the manual
leading end 52 of the guide rod 50 may deflect body tissue application of minimal force to the positioning section 96 .
to clear a passage for the guide rod 50 . This force presses the positioning section 96 against the
As the guide rod 50 is moved axially relative to the patient' s neck .
positioning apparatus 56 , the guide rod may be resiliently Although it is preferred to use the patient' s Adam 's apple
deflected by engagement with the body tissue of the patient. 50 34 to locate the positioning apparatus 56 relative to the
As the guide rod 50 is manually pushed toward the right ( as patient 's trachea 28 , a different portion of the patient's body
viewed in FIG . 1 ), the leading end 52 of the guide rod moves could be used to locate the positioning apparatus relative to
toward the larynx 30 . the patient ' s trachea . For example , the patient' s shoulders
The positioning apparatus 56 is used to locate the leading could be used. Alternatively, bones in the patient 's neck 16
end portion 52 of the guide rod 50 as the guide rod moves 55 could be used to locate the positioning apparatus 56 relative
toward the larynx 30 . The positioning apparatus 56 includes to the patient's trachea 28 .However, it is believed that it will
a base section 78 and an arcuate upper section 80 (FIG . 1 ). be preferred to use the patient 's Adam 's apple 34 to locate
The base section 78 engages the patient' s Adam 's apple 34 the positioning apparatus 56 due to the close proximity of
to locate the positioning apparatus 56 relative to the patient's the patient's Adam 's apple to the upper end of the patient's
trachea 28 . The upper section 80 of the positioning apparatus 60 trachea 28 .
56 guides movement of the guide rod 50 during insertion of The arcuate upper section 80 of the positioning apparatus
the guide rod into the patient's trachea 28 . 56 includes an arcuate member 108 which is slidably
The base section 78 and upper section 80 of the position - connected with the body section 86 at a connection 110 . The
ing apparatus 56 cooperate to provide a measurementof the connection 110 is movable axially along the cylindrical body
distance between the patient's mouth 12 and the patient's 65 section 86 . The body section 86 is movable transversely to
Adam ' s apple 34 . This distance will vary from patient to the arcuate member 108 , in the manner indicated by the
patient depending upon the size of the patient, the specific arrows 112 in FIG . 1 . Suitable indicia, indicated by lines in
 US 10 ,071,215 B2
FIG . 1, may be provided on the arcuate member 108 to have moved through a desired distance into the patient's
indicate the position of the connection 110 relative to the trachea 28 and will be aligned with the patient 's Adam ' s
arcuate member. apple 34 .
The connection 110 may include a plurality of set screws When the positioning apparatus 56 is to be associated
(not shown ) having manually engagable flanges or arms. 5 with a different portion of a patient' s body, the indicia 124
One of the set screwsmay be tightened to preventmovement would be revised to correspond to the distance which the
between the body section 86 and the connection 110 . guide rod 50 is to be moved relative to the arcuate member
Another set screw may be tightened to prevent movement 108 to bring the leading end portion 52 of the guide rod into
between the arcuate member 108 and the connection 110 . alignment with the positioning section 96 or to a position
When the connection 110 has been moved to a desired 10 spaced a desired distance from the positioning section . It is
location along the body section 86 , a set screw in the contemplated that the positioning apparatus 56 maybe used
connection is tightened to hold the arcuate member 108 during endoscopic, arthroscopic , or fiber optic surgery at
against axial movement along to the cylindrical body section
86 . The arcuate member 108 is then moved transversely to many locations in a patient's body, for example during
the body section 86 . that is , in the direction of the arrows 15 surgery on joints in the patient' s body .
112 , to position a guide section 114 in alignment with the The positioning apparatus 56 may be used in association
patient's mouth 12 and trachea 28 . When the tubular guide with the delivery of medicants to relatively inaccessible
section 114 has been aligned with the patient's trachea 28 . locations in a patient' s body . For example, a medicant could
another set screw in the connection 110 is tightened to hold be connected with the leading end portion 52 of the guide
the arcuate member 108 against transverse movement rela - 20 rod 50 and released when the indicia 124 indicated that the
tive to the body section 86 . medicant has been moved to a desired position relative to the
The guide rod 50 extends through a cylindrical passage in positioning section 96 . The medicant may be released by
the guide section 114 . Therefore , transverse movement of activating a holder , disposed at the leading end portion 52 of
the arcuate member 108 relative to the body section 86 , that the guide rod . A Bowden cable or other actuator may extend
is, in the direction indicated by the arrows 112 positions the 25 through the guide rod to the medicant holder to operate the
guide rod 50 in alignment with the patient' s mouth 12 . The medicant holder from a closed condition to an open condi
guide rod
rod 50
50 isis axially
axially movable
movable 116
116 relative
relative toto the guide
the guide tion to release the medicant.
section 114 into the patient's mouth 12 and trachea 28 . Tracheal Intubination
In the illustrated embodiment of the invention , the dis Once the guide rod 50 has been moved through a desired
tance between the patient's Adam ' s apple 34 and the arcuate 30 distance
d
member 108 is indicated by indicia 124 ( FIG . 1 ). The indicia ratus 56 isintoseparated
the patient's trachea 28 , the positioning appa
from the guide rod 50 while the guide
124 is disposed on the cylindrical body section 86 of the
positioning apparatus 56 . The position of the connection 110 rod remains stationary relative to the patient's trachea. Thus ,
relative to the indicia 124 indicates the distance which the once the indicia 142 on the guide rod 50 indicates that the
leading end
arcuate member is spaced from the positioning section 96 . 35 through
leading portion 52 of the guide rod has been moved
The distance which the connection 110 is spaced from the aendesired distance into the patient's trachea 28 , axial
positioning section 96 is a function of the distance between movement of the guide rod 50 is interrupted . At this time,
the patient 's Adam 's apple 34 and the entrance to the one of the colored bands 142 on the guide rod 50 corre
patient's mouth 12 . sponding to the one of the colored bands 130 aligned with
In the illustrated embodiment of the invention , the indicia 40 the connection 110 , is aligned with the end surface 156 on
124 is formed by a plurality of colored bands 130. Each of the guide section 114 .
the bands 130 has a different color from the other bands. The guide section 114 is then slid axially outward , that is
Each of the bands 130 has the same axial extent. However, toward the left as viewed in FIG . 1, along the guide rod 50 .
the bands could have different axial extents if desired . During this sliding movement of the guide section 114 along
Rather than using the colored bands 130 as the indicia 124 , 45 the guide rod 50 , the guide rod is manually held against
numerical indicia could be provided .However, it is believed movement relative to the patient's mouth 12 and trachea 28 .
that it may be easier to read the different colored bands 130 The upper section 80 and base section 78 are separated from
than to read numerical indicia . the patient during movement of the guide section 114 along
Colored bands 142 are provided on the guide rod 50. The the guide rod 50 . As this occurs, the guide rod 50 is
colored bands 142 have different colors which correspond to 50 stationary relative to the patient.
the colors of the bands 130 on the cylindrical body section Once the upper section 80 has been separated from the
86 of the positioning apparatus 56 . The colored bands 142 on guide rod 50 , the tracheal tube 38 (FIG . 2 ) is slid along the
the guide rod 50 are spaced from the end portion 52 of the guide rod 50 into the patient' s trachea 28 . Thus , the end of
guide rod by the same distance which correspondingly the guide rod 50 remote from the patient' s mouth 12 and
colored bands 130 on the body section 86 are spaced from 55 trachea 28 is inserted into the tracheal tube 38 . As this is
the center of the Adam 's apple 34 . done, the guide rod 50 is manually held against movement
The bands 142 on the guide rod 50 cooperate with an end relative to the patient's mouth 12 and trachea 28 . The
portion 156 (FIG . 1 ) of the guide section 114 to indicate tracheal tube 38 is then moved axially along the guide rod
when the leading end portion 52 of the guide rod is in a 50 while the leading end portion 52 of the guide rod remains
desired position relative to the patient 's trachea 28 . Thus , 60 stationary in the patient' s trachea .
assuming that a red colored band 130 on the cylindrical body As the tracheal tube 38 is moved axially along the guide
section 86 of the positioning apparatus 56 is aligned with the rod 50, the guide rod directs the leading end portion of the
connection 110 , the red band on the guide rod 50 will be tracheal tube into the patient's larynx 30 and past the vocal
moved to a position in which it is adjacent to the guide cords 32 . The leading end of the tracheal tube 38 is centered
section 114 . When the guide rod 50 has been moved to a 65 in the space between the vocal cords and the entrance to the
position in which the red band is adjacent to the guide patient ' s trachea by the guide rod 50 . This minimizes
section 114 , the leading end portion 52 of the guide rod will irritation of the patient's vocal cords 32 . The tracheal tube 38
 US 10,071,215 B2
10
is moved along the guide rod 50 at least until the leading end the Adam 's apple 234 of the patient. The Adam 's apple 234
of the tracheal tube engages the leading end portion 52 of the is a laryngeal prominence formed by lamina of cartilage in
guide rod 50. the larynx .
It is contemplated that it may be desired to move the Opening of a passage for air from the patient' s mouth to
tracheal tube 38 further into the patient' s trachea 28 than the 5 the patient' s lungs may require insertion of a flexible tra
distance which the guide rod 50 is moved into the patient's cheal tube 238 ( FIG . 10 ). Movement of the flexible tracheal
trachea. If this is the case , the tracheal tube 38 is pushed tubethe238patient from the patient's mouth 212 into the pharynx 220
axially along the guide rod 50 past the leading end portion of is relatively easily accomplished . However,
portion 10 may present difficultiestube
52 of the guide rod . As this occurs, the leading end Creth directing the tracheal
.
238 into the patient' s trachea 228
This is because an anterior bend 240
52 of the guide rod 50 is compressed slightly and enters the must be formed in the tracheal tube 238 . The anterior bend
tracheal tube 38 . 240 extends around the epiglottis 242 into the larynx 230 at
Once the tracheal tube 38 has been moved to a desired
depth into the patient's trachea 28 , the guide rod 50 is bethe minimizedupper end of the trachea 228 . The anterior bend 240 can
by placing the patient in the orientation
removed from the tracheal tube (FIG . 7 ). The trachealcal tube
tube 1515 illustrated in FIGS . 1 and 2 .
38 then provides a passage for the conduction air, other During movement of the leading end of the tracheal tube
gases, and /or medication to the patient' s lungs . 238 through the larynx 230 , it is desirable to have the
Laryngoscope tracheal tube near the central portion of the laryngeal cavity
This contemplated that a laryngoscope 170 ( FIG . 3 ) in order to minimize irritation of the vocal folds or cords 232
maybe connected with the connection 110 which intercon - 20 by the tracheal tube. In accordance with a feature of the
nects the body section 86 and arcuate upper section 80 of the present invention , a flexible guide wire or rod 250 (FIGS. 4
positioning apparatus 56 . The laryngoscope 170 and body and 9 ) is utilized to guide movement of the flexible tracheal
section 86 are moveable relative to each other to enable the tube 238 (FIGS. 9 and 10 ) into the trachea 228. The flexible
laryngoscope to be positioned in the patient' s mouth 12 . As guide rod 250 ( FIG . 9 ) has a soft generally spherical leading
the laryngoscope 170 is inserted into the patient 's mouth 12 , 25 end portion 252 . The leading end portion 252 of the guide
the laryngoscope engages the patient' s tongue 276 . The rod 250 is formed of a resiliently compressible material
laryngoscope then holds the patients tongue in a desired which is readily deflected by engagement with the vocal
position in the mouth 12 of the patient. cords or folds 232 and by engagementwith the surface of the
The laryngoscope 170 is then inserted further into the trachea 228 . If desired , the leading end portion 252 of the
patient'smouth 12 to expose progressively deeper structures 30 guide rod 250 may be coated with a suitable lubricant to
within the oropharynx . The laryngoscope 170 could be facilitate movement of the leading end portion between the
advanced to facilitate visualization of the glottic opening in vocal cords with minimum of irritation .
a known manner. Although the laryngoscope may be pro - In accordance with another feature of the invention , the
vided as part of the positioning apparatus 56 , in themanner guide wire 250 is initially positioned relative to the patient's
illustrated in FIG . 3 , it is contemplated that the laryngoscope 35 trachea 228 with a positioning apparatus 256 (FIG . 4 ) . The
170 could be separate from the positioning apparatus if positioning apparatus 256 engages the patient's Adam ' s
desired . Regardless of whether the laryngoscope 170 is apple 234 to locate the positioning apparatus relative to the
formed as part of the positioning apparatus 56 or separate trachea 228 of the patient. In addition , the positioning
from the positioning apparatus, the laryngoscope is utilized apparatus 256 provides a measurement which is a function
in a known manner in management of the patient' s tongue 40 of the distance between the Adam 's apple 234 and themouth
and airway. 212 of the patient. This measurement is utilized to determine
Second Embodiment the distance through which the guide rod 250 is to be moved
A second embodiment of the invention is illustrated in relative to the positioning apparatus 256 as the guide rod is
FIGS. 4 through 10 . Since the embodiment of the invention inserted into the trachea 228 .
illustrated in FIGS. 4 - 10 is generally similar to embodiment 45 In accordance with still another feature of the present
of the invention illustrated in FIGS . 1 - 3 , similar terminology invention , a magnet 260 (FIG . 4 ) is utilized to attract the
will be utilized to refer to similar components . leading end portion 252 of the guide rod 250 and to steer the
A portion of a patient' s head 210 has been illustrated leading end portion of the guide rod into the patient' s trachea
schematically in FIG . 4 . The patient' s head includes a mouth 228. The magnet 260 is a permanent magnet formed of a
212 which is connected with a palate 211 , a throat 214 , and 50 strongly magnetizable material such as cobalt and neo
a neck 216 of the patient. Although the patient's head 210 dymium . Of course , other known magnetizable materials
has been schematically illustrated in an upright orientation having high saturation magnetization values, such as cerium ,
in FIG . 4 , it should be understood that the patient's head praseodymium , and/ or samarium with cobalt and/ or other
could be in a different orientation if desired . For example , materials , could be used . Alternatively, the magnet 260 may
the patient's head 210 could be in the orientation illustrated 55 be an electromagnet
in FIGS. 1 and 2 for the patient's head 10 . To enable the leading end portion 252 of the guide rod 250
Apharynx 220 extends downward from a nasal cavity 222 to be attracted by a magnetic field emanating from the
in the head 210 of the patient. The pharynx 220 is connected magnet 260, the leading end portion 252 of the guide rod
with an esophagus 226 and a trachea 228 in the neck 216 of contains ferrite particles. The ferrite particles may or may
the patient. The esophagus 226 extends from the pharynx 60 not bemagnetized . Or course , other known magnetizable or
220 to the stomach of the patient. The trachea 228 extends magnetic particles could be utilized . When a magnet is
from the pharynx to the bronchial tubes and lungs of the positioned on the leading end portion 252 of the guide rod
patient. 250 , the polarity of the leading end of the magnet on the
The trachea 228 (FIG . 4 ) has an upper end portion 230 guide rod is opposite from the polarity of the magnet 260 .
which is referred to as the larynx . Vocal cords or folds 232 65 As the guide rod 250 is moved downward (as viewed in
have been indicated schematically in FIG . 3 and are dis - FIG . 4 ) along the patient 's pharynx toward the larynx 230 ,
posed in the larynx 230 . The vocal cords 232 are adjacent to the leading end portion 252 of the guide rod enters the field
 US 10 ,071,215 B2
12
of the magnet 260. The field ofthe magnet 260 has sufficient addition , the positioning apparatus 256 provides an indica
strength to cause the guide rod 250 to deflect slightly toward tion of the distance which the guide rod is to be moved into
the right (as viewed in FIG . 4 ). As this occurs , the leading the patient' s trachea . By using the positioning apparatus
end portion 252 of the guide rod moves into the larynx 230 256 , a person moving the guide rod 250 into the patient's
at a location adjacent to the center of the larynx . This enables 5 trachea 228 can know where the leading end portion 252 of
the leading end portion 252 of the guide rod 250 to move the guide rod is located relative to the trachea .
between the vocal cords or folds 232 with a minimum of During movement of the guide rod 250 into the patient 's
irritation to the vocal cords. Although the magnet 260 is trachea , the guide rod is moved axially through a flexible ,
described herein as steering the leading end portion 252 of generally cylindrical, guide tube 264 (FIG . 5 ). The guide
the guide rod 250 into the trachea , it is contemplated that the 10 tube 264 is formed of a resilient polymeric material. The
magnet could be utilized to steer members atmany different guide tube 264 has a main section 266 and a leading end
locations in a patient's body. section 268. The leading end section 268 has a side wall 270
The magnet 260 may be an electromagnet. If themagnet which is thinner than a side wall 272 of the main section 266 .
260 is an electromagnet, the magnetmay be turned on and The side wall 270 is integrally molded as one piece with the
off , that is, energized and de - energized during steering of the 15 thicker side wall 272 . A generally cylindrical passage 274
leading end portion 252 of the guide 250 . If desired , the ( FIG . 5 ) extends axially through the guide tube 264 .
leading end portion 252 of the guide rod 250 could also be The thin walled leading end section 268 of the guide tube
formed by an electromagnet. If this was done , conductors for 264 is molded so as to naturally assume the arcuate con
connecting the leading end portion 252 of the guide 250 figuration illustrated in FIGS. 4 and 5 . This enables the end
would extend along the inside of the guide rod . By reversing 20 section 268 of the guide tube 264 to be positioned in the
the direction of current flow to either the electromagnet patient 's pharynx 220 (FIG . 4 ) with the end section forming
forming the magnet 260 or the electromagnet forming the a bend which extends around the upper end portion of the
leading end portion 252 of the guide rod 250, the two patient's epiglottis 242. Since the leading end section 268
electromagnets could be made to sequentially attract and has a relatively thin side wall (FIG . 5 ), the end section can
repel each other. 25 be easily deflected as it is moved into position in the
Steering of the leading end portion 252 of the guide rod patient's pharynx 220 . The thicker side wall 272 of themain
250 with the magnet 260 is facilitated by moving the magnet section 266 of the guide tube 264 is effective to support the
along the patient's neck 216 , in the manner indicated sche- leading end section 268 in the patient's pharynx 220 and to
matically in FIG . 7. The magnet 260 may be moved up and depress a tongue 76 in the mouth 212 of the patient (FIG . 1 ).
down along the patient' s neck . Themagnet 260 may also be 30 The guide rod 250 may be formed of either polymeric
moved sidewards relative to the patient' s neck . By moving material or metal. The illustrated polymeric guide rod 250
the magnet 260 relative to the patient's neck , a magnetic has a relatively small diameter and is readily deflected . The
field emanating from the magnet is effective to pull the guide rod 250 has a circular cross sectional configuration .
leading end portion 252 of the guide rod 250 in the desired The guide rod 250 extends axially through the guide tube
direction . 35 264 (FIG . 4 ). The guide rod 250 is axially movable relative
Although the use of the magnet 260 has been disclosed to the guide tube 264 under the influence of force manually
herein in association with the embodiment of the invention applied to the portion of the guide rod disposed to the right
illustrated in FIGS. 4 - 10, it is contemplated that the magnet (as viewed in FIG . 4 ) of the positioning apparatus 256 . This
260 could be used in association with other embodiments of force results in axial movement of the guide rod 250 along
the invention . For example , the magnet 260 could be used 40 the guide tube 264 .
with the embodiment of the invention illustrated in FIGS . 1 As the guide rod 250 is axially moved along the guide
and 2 . tube 264, the arcuate leading end section 268 of the guide
The magnet 260 may be used to steer devices other than tube 264 resiliently deflects the guide rod 250 to form the
the guide rod 250 . When the positioning apparatus 56 ( FIG . arcuate bend illustrated in FIG . 4 . As the guide rod 250 is
1 ) is to be associated with a portion of a patient' s body other 45 manually pushed toward the left (as viewed in FIG . 4 ), the
than the trachea , the magnet 260 (FIG . 4 ) could be used to leading end 252 of the guide rod moves downward (as
steer any one ofmany different devices to a desired location viewed in FIG . 4 ) toward the larynx 230 . As the leading end
in the patient's body. A positioning apparatus, similar to the 252 of the guide rod 250 moves downward (as viewed in
positioning apparatus 56 of FIG . 1 or the positioning appa - FIG . 4 ), tissues which may tend to block movement of the
ratus 256 of FIG . 4 , and a magnet , similar to themagnet 260 50 guide rod are pushed aside by the leading end of the guide
may be used during endoscopic , arthroscopic , or fiber optic rod . This clears a passage for the guide rod 250 .
surgery at many different locations in a patient' s body . Thus, The positioning apparatus 256 is used to locate the
the magnet 260 may be used to steer a guide rod being leading end portion 252 of the guide rod 250 as the guide rod
positioned relative to a joint by a positioning apparatus , moves along the guide tube 264. The positioning apparatus
similar to the positioning apparatus 56 of FIG . 1 and the 55 256 includes a base section 278 and an upper section 280
positioning apparatus 256 of FIG . 4 , during surgery at the (FIG . 4 ). The base section 278 engages the patient's Adam 's
joint. The magnet 260 may also be used to position medi- apple 234 to locate the positioning apparatus 256 relative to
cants at desired locations in the patient's body . Although it the patient's trachea 228 . The upper section 280 of the
is believed that the magnet 260 will be advantageously used positioning apparatus 256 holds the guide tube 264 which
in association with a positioning apparatus similar to the 60 guides movement of the guide rod 250 during insertion of
positioning apparatus 56 of FIG . 1 or the other positioning the guide rod into the patient 's trachea 228 .
apparatus 256 of FIG . 4 , the magnet may be used in The base section 278 and upper section 280 of the
situations where the positioning apparatus is not required . positioning apparatus 256 cooperate to provide a measure
Positioning Apparatus of FIGS. 4 - 10 ment of the distance between the patient ' s mouth 212 and
The positioning apparatus 256 (FIG . 4 ) positions the 65 the patient's Adam 's apple 234 . This distance will vary from
guide rod 250 relative to the patient's trachea 228 during patient to patient depending upon the size of the patient, the
insertion of the guide rod into the patient's trachea . In specific configuration of the head 210 of the patient, and
 US 10 ,071,215 B2
13 14
other factors . The distance which the guide rod 250 must be longitudinal central axis of the passage 292 and to the
moved axially relative to the guide tube 264 to move the longitudinal central axis of the support rod 298 . The guide
leading end portion 252 of the guide rod into the patient's tube 264 is slidable in the passage 318 .
larynx 230 will vary as a function of variations in the The guide tube 264 extends from the passage 318 into the
distance between the patient ' s mouth 212 and the patient' s 5 patient' s mouth 212 . Thus, the passage 318 in the upper
Adam ' s apple 234 . This is because the patient's Adam 's section 280 of the positioning apparatus 256 is axially
apple 234 is located adjacent to the entrance to the trachea aligned with the patient' s mouth 212 . Similarly, the passage
228 . 292 ( FIG . 4 ) in the end section 290 of the base section 278
The base section 278 of the positioning apparatus 256 of the positioning apparatus 256 is axially aligned with the
includes an upright tubular cylindricalbody section 286 . The 10 patient 's Adam 's apple 234. Therefore , the positioning appa
body section 286 has a cylindrical chamber 288. The cylin - ratus 256 can be utilized to measure the distance between the
drical upper section 280 of the positioning apparatus 256 is Adam 's apple 234 and the patient 's mouth 212 .
telescopically received in the chamber 288. The entrance through which the guide rod 250 must pass
In addition , the base section 278 includes an end section into the patient 's trachea 228 is adjacent to the Adam ' s apple
290 . The end section 290 extends perpendicular to the body 15 234 . Therefore , the distance through which the leading end
section 286 . The end section 290 has a cylindrical central portion 252 of the guide rod 250 must be moved relative to
passage 292 which extends perpendicular to and intersects the guide tube 264 (FIG . 4 ) to enter the patient's trachea 228 ,
the central axis of the chamber 288 . The body section 286 is a function of the distance between the patient's Adam 's
and the end section 290 are integrally molded as one piece apple 234 and the patient's mouth 212 . The positioning
of polymeric material. 20 apparatus 256 measures the distance between the patient' s
The base section 278 also includes a positioning section Adam 's apple 234 and the patient 's mouth by determining
296 which engages the patient's Adam 's apple 234 and is the position of the base section 278 and upper section 280 of
supported by the end section 290 . The positioning section the positioning apparatus relative to each other.
296 includes a cylindrical support rod 298 which extends In the illustrated embodiment of the invention , the dis
through the passage 292 and is connected with a locating 25 tance between the patient' s Adam 's apple 234 and the
portion 302 which engages the patient's Adam 's apple 234 . patient's mouth 212 is indicated by indicia 324 (FIG . 6 ). The
The locating portion 302 includes a generally hemispherical indicia 324 is disposed on the cylindrical rod portion 314 of
dome 304 and a resilient annular collar 306 which is the upper section 280 of the positioning apparatus 256 . The
connected to the rim of the dome 304 . The collar 306 rod portion 314 is telescopically received in the cylindrical
extends around the Adam 's apple 234 and engages upper 30 chamber 288 in the body section 286 of the positioning
and lower sides and left and right sides of the Adam 's apple apparatus 256 .
to center the dome 304 on the Adam ' s apple . The position of an annular upper end surface 328 on ( FIG .
If desired , the locating portion 302 could be constructed 6 ) the body section 286 relative to the indicia 324 indicates
to engage only two sides of the Adam 's apple 234 . For the distance which the rod portion 314 is extended from the
example , the left and right sides of the Adam ' s apple 234. It 35 body section 286 . The distance which the rod portion 314 is
is believed that it may be desired to form the locating portion extended from the body section 286 is a function of the
302 with the construction illustrated in FIGS. 25 and 26 distance between the patient's Adam 's apple 234 and the
herein . Alternatively, the locating portion 302 could be entrance to the patient' s mouth 212 .
constructed so as to engage only the central portion of the In the illustrated embodiment of the invention, the indicia
Adam ' s apple 234 . 40 324 is formed by a plurality of colored bands 330 , 332 , 334 ,
However, it is believed that it may be desired to form the 336 , 338 and 340 ( FIG . 6 ). Each of the bands 330 - 340 has
locating portion 302 so that it extends around the Adam 's a different color from the other bands . It should be under
apple 234 so as to locate the positioning section 296 relative stood that a lesser or greater number of colored bands
to the Adam 's apple. Force may be manually applied against 330 - 340 could be provided if desired . It should also be
the positioning section 296 to minimize the anterior bend 45 understood that although the bands 330 - 340 have the same
240 (FIG . 10 ) which must be formed in the tracheal tube axial extent, the bands could have different axial extents if
238 . The end section 290 is axially slidable along the support desired . Rather than using the colored bands 330 - 340 as the
rod 298 so that the body section 286 is disposed adjacent to indicia 324 , numerical indicia could be provided . However,
the chin 310 of the patient . it is believed that it may be easier to read the different
Although it is preferred to use the patient's Adam 's apple 50 colored bands 330 - 340 than to read numerical indicia .
234 to locate the positioning apparatus 256 relative to the Bands 342 , 344 , 346 , 348 , and 350 ( FIG . 8 ) are provided
patient' s trachea 228 , a different portion of the patient 's on the guide rod 250 . The colored bands 342 -350 have
body could be used to locate the positioning apparatus different colors which correspond to the colors of the bands
relative to the patient 's trachea . For example , the patient's 132 - 140 on the rod portion 314 (FIG . 6 ) of the positioning
shoulders could be used . Alternatively, bones in the patient's 55 apparatus 256 . It should be understood that although only
neck 216 could be used to locate the positioning apparatus the bands 342 - 350 having colors corresponding to the colors
256 relative to the patient's trachea 228 . However, it is of the bands 132 - 140 are illustrated , an additional band
believed that it will be preferred to use the patient' s Adam ' s having a color corresponding to the color of the band 330 in
apple 234 to locate the positioning apparatus 256 due to the FIG . 6 is provided on the guide rod 250 .
close proximity of the patient' s Adam ' s apple to the upper 60 The bands 342- 350 (FIG . 8 ) on the guide rod 250 coop
end of the patient's trachea 228 . erate with an annular end surface 356 (FIG . 4 ) on the guide
The upper section 280 of the positioning apparatus 256 tube 264 to indicate when the leading end portion 252 ofthe
includes a cylindrical rod portion 314 which is telescopically guide rod is in a desired position relative to the patient' s
received in the body section 286 of the positioning appara trachea 228 . Thus, assuming that the colored band 334 on
tus . An upper end section 316 has a cylindrical passage 318 65 the rod portion 314 of the positioning apparatus 256 is
through which the guide tube 264 extends. The passage 318 aligned with the end surface 328 on the body section 286 ( as
has a longitudinal central axis which extends parallel to the illustrated in FIG . 6 ), the band 344 (FIG . 8 ) on the guide rod
 US 10 ,071,215 B2
15 16
250 will be moved to a position in which it is partially patient 's trachea . Thus, once the indicia on the guide rod 250
covered by the guide tube 264 and projects outward from the indicates that the leading end portion 252 of the guide rod
end surface 356 (FIG . 4 ) for a distance corresponding to the has been moved through a desired distance into the patient' s
distance which the band 334 projects outward from the end trachea 228 , axial movement of the guide rod 250 is inter
surface 328 on the body section 286 ( FIG . 5 ) . The band 344 5 rupted . At this time, one of the colored bands 342 - 350 on the
has a color which is the same as the color of the band 334 . guide rod 250 corresponding to the one of the colored bands
When the guide rod 250 has been moved to a position in 330 - 340 aligned with the end surface 328 (FIG . 4 ) on the
which the band 344 is partially enclosed by the guide tube body section 286 of the positioning apparatus is aligned with
264 , the leading end portion 252 of the guide rod will have the end surface 356 (FIG . 4 ) on the guide tube 264 .
moved through a desired distance into the patient 's trachea 10 The guide tube 264 is then slid axially outward , that is
228, for example , a distance of approximately ten centime- toward the right as viewed in FIG . 4 , along the guide rod
ters. 250 . During this sliding movement of the guide tube 264
The bands 342 -350 ( FIG . 8 ) on the guide rod 250 are along the guide rod 250, the guide rod is manually held
spaced a predetermined distance from the end surface 356 against movement relative to the patient' s mouth 212 and
(FIG . 4 ) on the guide tube 264 when the leading end portion 15 trachea 228 . The positioning apparatus 256 is moved away
252 of the guide rod is disposed in abutting engagement with from the patient along with the guide tube 264 .
the leading end section 268 of the guide tube 264. During Once the guide tube 264 has been separated from the
movement of the indicia on the guide rod 250 from a guide rod 250 (FIG . 9 ), the tracheal tube 238 is slid along the
position spaced from the end surface 356 of the guide tube guide rod 250 into the patient's trachea 228 . Thus, the end
264 to a position in which the leading band on the guide rod 20 of the guide rod 250 remote from the patient's mouth 212
150 is adjacent to the end surface 356 , the leading end and trachea 228 is inserted into the tracheal tube 238 . As this
portion 252 of the guide rod 250 will have moved from the is done, the guide rod 250 is manually held against move
pharynx 220 of the patient and into the larynx 230 past the ment relative to the patient's mouth 212 and trachea 228 .
vocal cords 232 . The tracheal tube 238 is then moved axially along the guide
As the guide rod 250 continues to be manually pushed 25 rod 250 while the leading end portion 252 of the guide rod
into the guide tube 264, the leading end portion 252 of the remains stationary in the patient 's trachea . If desired , the
guide rod advances downward (as viewed in FIG . 4 ) in the magnet 260 may be utilized to attract the leading end portion
trachea 228 of the patient. Movement of the guide rod 250 252 of the guide rod 250 , in the manner illustrated in FIG .
into the trachea 228 of the patient is interrupted when the 9 , to facilitate maintaining of the leading end portion of the
band 344 having a color corresponding to the color of the 30 guide rod stationary in the patient 's trachea 228 .
band 334 (FIG . 6 ) has been partially covered by the guide As the tracheal tube 238 is moved axially along the guide
tube 264 . rod 250 , the guide rod directs the leading end portion of the
The magnet 260 is utilized to steer the guide rod 250 tracheal tube along a bend 360 (FIG . 9 ) formed in the guide
during movementof the leading end portion 252 of the guide rod . After the leading end portion of the tracheal tube 238
rod from the patient 's mouth 212 into the patient 's trachea 35 has moved around the bend 360 , the leading end portion of
228 . As the leading end portion 252 of the guide rod 250 is the tracheal tube enters the patient's larynx and moves past
moved downward along the inside of the patient's neck , the the vocal cords 232 . The leading end of the tracheal tube 238
magnet 260 is moved downward along the outside of the is centered in the space between the vocal cords and the
patient's neck . The magnetic field provided by the magnet entrance to the patient's trachea by the guide rod 250 . This
260 is effective to pull the leading end portion 252 down - 40 minimizes irritation of the patient' s vocal cords 232 . The
ward as the magnet moves downward . Eventually, the tracheal tube 238 is moved along the guide rod 250 at least
leading end portion 252 of the guide rod 250 and magnet 260 until the leading end of the tracheal tube engages the leading
will move downward from the entrance to the trachea 228 end portion 252 of the guide rod 250.
through a desired distance , for example a distance of It is contemplated that it may be desired to move the
approximately ten centimeters . Of course , the leading end 45 tracheal tube 238 further into the patient' s trachea than the
portion 252 of the guide rod 250 could be moved through a distance which the guide rod 250 is moved into the patient' s
different distance into the trachea 228 if desired . trachea . If this is the case , the tracheal tube 238 is pushed
It is contemplated that the distance between the patient's axially along the guide rod 250 past the leading end portion
Adam ' s apple 234 and the entrance to the patient 's mouth 252 of the guide rod. As this occurs , the leading end portion
212 will vary from patient to patient. However, the distance 50 252 of the guide rod 250 is compressed slightly and enters
which the leading end portion 252 of the guide rod 250 is the tracheal tube 238 .
moved into the patient's trachea 228 will remain constant at Once the tracheal tube 238 has been moved to a desired
a desired distance , for example , ten centimeters . This is depth into the patient's trachea 228 , the guide rod 250 is
because as the distance measured by the positioning appa - removed from the tracheal tube (FIG . 10 ). The tracheal tube
ratus 256 increases, the distance which the guide rod 250 is 55 238 then provides a passage for the conduction air, other
moved relative to the guide tube 264 increases. Conversely, gases, and /or medication to the patient 's lungs .
as the distance which is measured by the positioning appa - Method of Utilization
ratus 256 decreases , the distance which the guide rod 250 is When the tracheal tube 238 is to be inserted into a
moved relative to the guide tube 264 decreases . The distance patient 's trachea 228 , the guide rod 250 is first positioned
which is measured by the positioning apparatus 256 varies 60 relative to the guide tube 264 at a location spaced from the
as a function of the distance between the mouth 212 and patient. Atthis time, the leading end portion 252 of the guide
larynx 230 of the patient. rod 250 is disposed in abutting engagement with the leading
Tracheal Intubination end portion 268 of the guide tube 264. The upper section 280
Once the guide rod 250 has been moved through a desired of the positioning apparatus 256 is loosely positioned on the
distance into the patient's trachea 228 , the guide tube 264 65 guide tube 264 . The lower or base section 278 of the
and positioning apparatus 256 are separated from the guide positioning apparatus 256 is separate and spaced from the
rod 250 while the guide rod remains stationary relative to the upper section 280 of the positioning apparatus. A suitable
 US 10 ,071,215 B2
lubricantmay be applied to the leading end portion 252 of larynx 230 . As the guide rod 250 begins to move downward ,
the guide rod 250 and to the leading end portion 268 of the the bent leading end portion 268 of the guide tube 60 directs
guide tube 264 . the leading end portion 252 of the guide rod 80 downward
The guide tube 264 is then inserted into the patient's around the patient 's epiglottis 242 in a direction toward the
mouth 212 . As the guide tube 264 is inserted into the 5 entrance to the larynx 230 .
patient' s mouth , the leading end portion 268 of the guide It is contemplated that the resiliently deflectable guide rod
tube 264 and the leading end portion 252 of the guide rod 250 will initially be formed with a bend which is a continu
250 move from the patient's mouth into the pharynx 220 of ation of the bend in the leading end portion of the guide tube
the patient. As the leading end portion 268 of the guide tube 264 . Therefore , the natural resilience of the guide rod 250
264 moves into the pharynx 220 of the patient, the natural 10 will tend to cause the guide rod to bend rightward toward the
resilience of the material of the guide tube causes the guide patient 's Adam 's apple as the leading end portion 252 of the
tube to spring back to its initial or free configuration guide rod begins to move downward toward the larynx 230 .
illustrated in FIGS. 3 and 4 . As the leading end portion 252 of the guide rod 250
As the guide tube 264 and guide rod 250 are manually approaches the entrance to the larynx 230 , the field ema
moved together into the patient' s mouth 212 , the guide tube 15 nating from the magnet 260 attracts the leading end portion
bends itself around the upper (as viewed in FIG . 3 ) portion 252 of the guide rod 250. The magnetic attraction forces
of the patient's epiglottis 242. This results in the leading end applied to the leading end portion 252 of the guide rod 250
portion 252 of the guide rod 250 being pointed downward also promote rightward ( as viewed in FIG . 4 ) bending of the
(as viewed in FIG . 3 ) toward the lower end portion of the guide rod 250 toward the patient's Adam 's apple 234 . Thus ,
patient's pharynx 220 . A person initially inserting the guide 20 the combined effect of the magnet 260 and the natural
tube 264 and guide rod 250 into the patient 's mouth 212 can resilience of the preformed guide rod 250 urge the leading
visually ascertain when the guide tube and guide rod have end portions 52 of the guide rod 250 toward the entrance to
moved to the position illustrated in FIG . 3 the larynx 230 and away from the adjacent entrance to the
When the guide tube 264 and guide rod 250 have been esophagus 226 . This ensures that the leading end portion 252
positioned in this manner relative to the patient 's mouth 212 25 of the guide rod 250 enters the trachea 228 rather than the
and pharynx 220 , the positioning apparatus 256 is esophagus 226 . If desired , the magnet 260 could be posi
assembled . To assemble the positioning apparatus, the rod tioned above or on the patient' s Adam ' s apple 234 and then
portion 314 of the upper section 280 is telescopically moved downward as the guide rod 250 advances.
inserted into the chamber 288 in the body section 286 of the If desired , the flexible guide rod 250 could initially be
positioning apparatus . Contemporaneously therewith , the 30 formed with a straight configuration and only the magnet
locating portion 302 of the positioning apparatus 296 is 260 would steer the leading end portion 252 of the guide rod
moved into engagement with the patient's Adam 's apple into the entrance to the trachea 228 . Alternatively , the use of
234. The base section 278 and upper section 280 of the the magnet 260 could be eliminated and only the preformed
positioning apparatus 256 are moved axially along the guide configuration of the guide rod 250 would be used to direct
tube 264 and support rod 298 until the base section and 35 the leading end portion 252 of the guide rod into the entrance
upper section of the positioning apparatus 256 are adjacent to the trachea 228 . However, it is believed that it will be
to the patient's chin 310 (FIG . 4 ). At this time, the coincident preferred to use both the preformed configuration of the
central axes of the rod portion 314 and body section 286 of guide rod 250 and the magnet 260 to direct the leading end
the positioning apparatus 256 will extend perpendicular to portion 252 of the guide rod into the patient's trachea 228 .
the central axes of the guide tube 264 and support rod 298 . 40 The colored bands 342 -350 (FIG . 8 ) on the guide rod 250
The magnet 260 is then positioned immediately beneath cooperate with the end surface 356 (FIG . 4 ) of the guide tube
the patient' s Adam ' s apple 234 . This enables the magnetic 264 to provide an indication of the location of the leading
field from the magnet 260 to extend leftward and upward (as end portion 252 of the guide rod relative to the patient' s
viewed in FIG . 4 ) to the entrance to the patient's larynx 230 . Adam ' s apple 234 . As the leading end portion 252 of the
This results in the magnet 260 and positioning apparatus 256 45 guide rod 250 moves downward from the position shown in
being disposed in the orientation illustrated in FIG . 3 relative FIG . 3 toward the entrance to the larynx 230 , the indicia
to the patient. bands 342 - 350 willmove toward the end surface 356 of the
Once the positioning apparatus 256 , guide tube 264 and guide rod 250 . As the leading end portion 252 of the guide
guide rod 250 have been moved to the positions shown in rod 250 moves through the entrance to the larynx 230 , the
FIG . 3 relative to the patient' s head 210 , the person using the 50 indicia on the guide rod 250 will be approaching the end
positioning apparatus 256 visually determines the distance surface 356 of the guide tube 264.
between the patient's Adam 's apple 234 and the patient' s Continued axial movement of the guide rod 250 relative
mouth 212 . This is accomplished by viewing the indicia 324 to the stationary guide tube 264 moves the leading end
( FIG . 6 ) on the rod portion 314 of the positioning apparatus portion 252 of the guide rod to a position immediately above
256 . By determining which of the bands 330 -340 is aligned 55 the patient's vocal cords 232 . As this occurs, the leading end
with the end surface 328 on the body section 286 of the portion 252 of the guide rod 250 is strongly attracted by the
positioning apparatus 256 , the operator determines the dis - magnetic field emanating from the magnet 260 . Due to the
tance between the patient's Adam 's apple and the patient's approach of the indicia on the guide rod 250 toward the end
mouth . The distance which the guide rod 250 must bemoved surface 356 of the guide tube 264 , the operator realizes that
into the patient' s trachea 228 is a direct function of the 60 the leading end portion 252 of the guide rod 250 is adjacent
distance between the patient' s Adam ' s apple 234 and the to the magnet 260 and moves the magnet downward (as
patient's mouth 212 . viewed in FIG . 4 ) along the neck 216 of the patient as the
The operator then begins to manually apply force against guide rod 250 continues to be moved leftward through the
the rightward (as viewed in FIG . 4 ) portion of the guide rod stationary guide tube 264 . As the magnet 260 is manually
250 while holding the guide tube 264 against movement. 65 moved downward (as viewed in FIG . 4 ) with the leading end
This results in the leading end portion 252 of the guide rod portion 252 of the guide rod 250 , the magnet continues to
moving downward toward the entrance to the patient's attract the leading end portion of the guide rod .
 US 10 , 071,215 B2
19 20
One of the bands 330 -340 , having a particular color, for tracheal tube 238 and centering the leading end portion of
instance, red , on the rod portion 314 ( FIG . 6 ) will be the tracheal tube in the space between the vocal cords 232,
adjacent to the end surface 328 on the body section of the the tracheal tube can be moved into the patient's trachea 228
positioning apparatus 256 . When a correspondingly colored with a minimal amount of irritation to the vocal cords.
band, that is, when the red band 344 on the guide rod 250 5 As the tracheal tube 238 is moved through the patient's
( FIG . 8 ), is partially covered by the guide tube 264 and larynx 230 , the magnet 260 is disposed adjacent to the
extends axially outward from the end surface 356 , the leading end portion 252 of the guide rod 250. Therefore , the
operator will know that the leading end portion 252 of the leading end portion 252 of the guide rod 250 is attracted by
guide rod 250 will have moved past the vocal 232 to the the magnet 260 and tends to remain stationary in the
desired position relative to the patient's trachea . Insertion of 10 patient's trachea 228 . As the tracheal tube 238 is inserted
the guide rod 250 into the guide tube 264 is then interrupted .
After the guide rod 250 has been inserted for the desired into the patient' s trachea 228 , the leading end portion of the
tracheal tube 238 moves past the leading end portion 252 of
distance into the patient's trachea 228 , the guide tube 264 the guide rod 250. As this occurs, the leading end portion
and positioning apparatus 256 are separated from the guide
rod 250. During separation of the guide tube 264 and 15 252 of the guide rod 250 is slightly compressed and moves
positioning apparatus 256 from the guide rod 250, the guide into the tracheal tube 238 . Once the tracheal tube 238 has
rod is maintained stationary relative to a patient' s trachea moved to a desired position relative to the trachea 228 , the
228. In the illustrated embodiment of the invention , the guide rod 250 is withdrawn from the tracheal tube 238 while
guide tube 264 is merely moved rightward (as viewed in the tracheal tube is maintained stationary relative to the
FIG . 4 ) along the stationary guide rod 250 to disengage the 20 patient 's trachea .
guide tube and the positioning apparatus from the guide rod . In the embodiment of the invention illustrated in FIGS.
If desired , a slot could be provided in the guide tube 264 4 - 10 , the magnet 260 (FIG . 4 ) is utilized to attract the
to facilitate disengagement of the guide tube from the guide leading end portion 252 of the guide rod 250. However, it is
rod . A corresponding slot could be formed in the end section contemplated that the magnet 260 could be used for other
316 of the positioning apparatus 256 . The slots in the guide 25 purposes if desired . For example , the magnet 260 could be
tube 264 and end section 316 could be partially or fully used to position a suture anchor relative to body tissue .
blocked during insertion of the guide rod 250 into the guide When themagnet 260 is to be utilized to position a suture
tube 264. When the guide tube 264 is to be separated from anchor relative to body tissue , a leading end portion of the
the guide rod 250, that is after the guide rod has been suture anchor is formed of a magnetizable material, such a
inserted for the desired distance into the patient ' s trachea 30 ferrite . Alternatively , the leading end portion of the suture
228 , latch or closure members for the slots could be moved anchor could be formed of a magnetic material such as
to open positions and the guide tube 264 and apparatus 256 cobalt, neodymium , cerium , praseodymium , and/ or
moved out of engagement with the stationary guide rod 250 . samarium . If this was done , the magnet 260 would be
Once the guide tube 264 and positioning apparatus 256 oriented relative to the magnet on the suture anchor to have
have been disengaged from the guide rod 250, the guide rod 35 a pole of the magnet 260 of opposite polarity to the leading
is utilized to guide movement of the tracheal tube 238 into end of the suture anchor toward the suture anchor.
the patient's trachea 228 . The tracheal tube 238 has a The trailing end portion of the suture anchor may be
substantially larger diameter than the guide tube 264 to formed of a nonmagnetic material, such as a biodegradable
provide for a relatively large central opening through which polymer. The suture would extend through an opening in the
air or other gas may pass into the patient' s trachea 228 . 40 nonmagnetic material of the trailing end portion of the
When the tracheal tube 238 is to be moved into the suture anchor. Once the suture anchor had been moved to a
patient' s trachea 228 , the guide rod 250 is telescopically desired position relative to body tissue by attraction of the
inserted into the leading end of the tracheal tube . At this magnet 260 for the leading end portion of the suture anchor,
time, the right end ( as viewed in FIG . 4 ) of the guide rod 250 the leading end portion of the suture anchor may be sepa
will extend beyond the far right end of the tracheal tube 238 . 45 rated from the trailing end portion of the suture anchor. The
Therefore , the guide rod 250 can be manually grasped and leading end portion of the suture anchor could then be
the tracheal tube 238 moved axially along the guide rod removed from the patient 's body to eliminate the possibility
while the guide rod remains stationary relative to the of an undesired interaction in the future with a magnetic field
patient's trachea 228 . device , such as a magnetic resonance imaging device (MRI).
The tracheal tube 238 is moved leftward , in the manner 50 The suture would be held in place by the nonmagnetic
indicated by the arrow in FIG . 9 , along the stationary guide trailing end portion of the suture anchor
rod 250 into the patient' s mouth 212 . The tracheal tube 238 Embodiment of FIG . 11
is then moved around the bend 360 in the stationary guide In the embodiment of the invention illustrated in FIGS.
rod 250 and into the patient' s trachea 228 . Since the guide 4 - 10, a guide tube 264 is utilized to guide movement of the
rod 250 extends from the patient' s pharynx 220 into the 55 guide rod 250 as the guide rod is moved from the patient 's
trachea 228 , the guide rod 250 blocks movement of the pharynx 220 into the patient's trachea 228 . The guide tube
leading end portion of the tracheal tube 238 into the patient's 264 is then removed and a tracheal tube 238 is slid along the
esophagus 226 . The guide rod 250 acts as a track along guide rod 250 into the patient 's trachea. In the embodiment
which the tracheal tube 238 moves into the patient' s larynx of the invention illustrated in FIG . 11 , the tracheal tube is
230 and not into the adjacent esophagus 226 . 60 used to guide movement of the guide rod into the patient' s
As the leading end portion of the tracheal tube 238 trachea . This eliminates the need for a separate guide tube .
approaches and moves past the vocal cords 232 , the guide Since the embodiment of the invention illustrated in FIG . 11
rod 250 guides movement of the leading end portion of the is generally similar to the embodiment of the invention
tracheal tube in such a manner as to minimize irritation of illustrated in FIGS . 4 - 9 , similar numerals will be utilized to
the vocal cords . Thus, the guide rod 250 centers the leading 65 designate similar components , the suffix letter “ a ” being
end portion of the trachealtube 238 in the space between the associated being associated with the numerals of FIG . 11 to
vocal cords . By lubricating the leading end portion of the avoid confusion .
 US 10 ,071,215 B2
22
A patient's head 210a (FIG . 11 ) includes a mouth 212a 250a moves from the patient's pharynx 220a into the
which is connected with a throat 214a in a neck 216a of the patient's trachea 228a , the leading end portion of the guide
patient. A pharynx 220a is connected with an esophagus rod gently deflects body tissue. For example , the leading end
226a and a trachea 228a. A larynx 230a forms an upper end portion 252a of the guide rod 250a may gently engage and
portion of the trachea 228a and contains vocal cords 232a . 5 slightly deflect the patient's vocal cords or folds 32a .
An Adam 's apple 234a is formed by laminae of cartilage in A magnet 260a is initially positioned adjacent to the
the patient's larynx 230a . patient's Adam 's apple 234a, in the manner indicated in
A positioning apparatus 256a is utilized to position a dashed lines in FIG . 11 . Ferrite particles in the soft, resil
tracheal tube 238a and a guide rod or wire 250a during
insertion of the guide rod and during insertion of the tracheal 10 wire 250a are attractedleading
iently compressible end portion 252a of the guide
tube into the patient 's trachea 228a. The tracheal tube 238a causes the leading end portion magnet
by the 260a . This attraction
( FIG . 11 ) is flexible and is formed of a resilient polymeric to move into the open upper end portiontheofguide
252a of wire 250a
material. The tracheal tube 238a is initially formed with a rather than into the adjacent open upper end portion of228
the trachea
the
bend 380 in a leading end portion of the tracheal tube. When
the tracheal tube 238a is released or unrestrained, the natural 15 esophagus 226a . In addition , movement of the leading end
resilience of the tracheal tube causes the bend 380 to form portion 252a of the guide wire 250a into the open upper end
in the manner illustrated in FIG . 10 . However, the tracheal portion of the trachea 228 is promoted by the bend 380 in the
tube 238a is flexible so that the bend 380 is easily removed tracheal tube 238a . If desired , the magnet 260a could
from the tracheal tube by the application of a relatively small initially be positioned on or above the patient' s Adam 's
force or pressure against the leading end portion of the 20 apple 234a and moved downward from there .
tracheal tube. As the guide wire continues to be inserted into the tracheal
In the embodimentof the invention illustrated in FIG . 10 , tube 238a , the guide wire moves downward in the patient' s
the bend 380 in the tracheal tube 238a has a greater extent trachea 228a . At the same time, the magnet 260a is moved
than a corresponding bend in a leading end section 268 of downward along the outer side of the patient' s neck 216a .
the guide tube 264 (FIG . 4 ). If desired , the bend in the 25 The indicia (not shown ) on the guide rod 250a provides an
tracheal tube 238a ( FIG . 11 ) could be shortened so that the indication to an operator of the position of the leading end
leading end portion of the tracheal tube 238a has a configu - portion 252a of the guide rod . This enables the operator to
ration which corresponds to the configuration of the guide follow the leading end portion 252a of the guide rod 250a
tube 264 of FIG . 4 with the magnet 260a as the guide rod continues to be
The positioning apparatus 256a ( FIG . 11 ) includes a base 30 moved through the tracheal tube 238a into the patient' s
section 278a and an upper section 280a. A rod portion 314a trachea 228a.
of the upper section 280a is telescopically received in a Once the guide rod 250a has been moved for a desired
chamber 288a in the base section 278a . Indicia 324a on the distance into the trachea 228a , the guide rod 250a is held
rod portion 314a cooperates with a body section 286a of the stationary relative to the patient's trachea . The tracheal tube
base section 278a to provide a visual indication of the 35 238a is then moved axially toward the left ( as viewed in
distance between the patient ' s Adam ' s apple 234a and the FIG . 11 ) and downward into the patient' s trachea 228a .
patient's mouth 212a in the manner previously described in During this downward movement of the tracheal tube 238a ,
conjunction with the positioning apparatus of FIG . 4 . the guide rod 250a blocks sidewise movement of the leading
The base section 278a of the positioning apparatus 256a end of the tracheal tube so that the tracheal tube enters the
includes a positioning section 296a which engages the 40 larynx 230a rather than the adjacent open upper end of the
patient' s Adam 's apple 234a . The positioning section 296a esophagus 226a . As the tracheal tube 238a continues to be
includes a locating portion 302a which engages the patient's inserted into the trachea 228a , the leading end of the tracheal
Adam 's apple 234a . The locating portion 302a includes a tube 238a moves into engagement with the leading end
dome 304a and a soft annular collar 306a . Rather than using portion 252a of the guide rod 250a. The leading end portion
the collar 306a , it may be preferred to utilize a pair of 45 252a of the guide rod 250a is then compressed somewhatby
positioning fingers which engage the neck 216a of the the leading end portion of the tracheal tube 238a and moves
patient at laterally opposite sides of the Adam 's apple 234a. into the passage in the tracheal tube . The tracheal tube 238a
Indicia (not shown ) is provided on the guide rod 250 a to is then moved further into the trachea 228a .
indicate the position of the guide rod relative to a proximal After the tracheal tube 238a has been positioned relative
end of the tracheal tube 238a , that is , the right end as viewed 50 to the patient' s trachea , the guide rod 250a is withdrawn
in FIG . 11 . It should be understood that the tracheal tube from the tracheal tube while the tracheal tube remains
238a and the guide rod 250a extend toward the right from stationary relative to the patient 's trachea 228a . The posi
the fragmentary end portions illustrated in FIG . 11 . The tioning apparatus 256a is then separated from the tracheal
indicia on the guide rod 250a is formed by bands corree .- tube 238a .
sponding to the bands 342 - 350 of FIG . 8 . Rather than 55 Embodiment of FIG . 12
cooperating with the end 156 (FIG . 4 ) of a guide tube 264 , In the embodiment of the invention illustrated in FIG . 1 ,
the bands on the guide rod 250a (FIG . 11 ) cooperate with an a leading end portion 52 of the guide wire or rod 50 is
end (not shown ) of the tracheal tube 238a to indicate the inserted between the vocal cords or folds in the respiratory
position of the guide rod 250a relative to the tracheal tube system 11 of the patient. It' s contemplated thatmovement of
238a . 60 the leading end portion 52 of the guide rod 50 between the
When the guide rod 250a is to be moved from the vocal cords 32 to a desired depth in the patient's trachea 28
patient' s pharynx 220a into the patient' s trachea 228a, the may be facilitated by transmitting images of body tissue
guide rod is moved axially relative to the stationary tracheal adjacent to the leading end portion of the guide rod to a
tube 238a . As this occurs , a leading end portion 252a of the viewing location outside of the patient' s body . Since the
guide rod 250a moves downward ( as viewed in FIG . 11 ) past 65 embodiment of the invention illustrated in FIG . 12 is gen
the patient's vocal cords or folds 32a and into the patient' s erally similar in the embodiment invention illustrated in
trachea . As the leading end portion 252a of the guide rod FIGS. 1 and 2 , similar numerals will be utilized to designate
 US 10 ,071,215 B2
23 24
similar components , the suffix letter “ b ” being added to the As the tracheal tube is moved along the guide rod 50b into
numerals of FIG . 12 in order to avoid confusion . the patient' s respiratory system , in the manner previously
A positioning apparatus 56b is utilized to position a explained in conjunction with the embodiment invention
flexible guide rod 50b relative to the patient' s respiratory illustrated in FIG . 2 , body tissue immediately ahead of the
system 11b . The positioning apparatus 56b includes a body 5 leading end portion 52b of the stationary guide rod 50b is
section 86b and a base section 78b which is connected with illuminated and body tissue immediately ahead of the tra
a positioning section 96b . The positioning section 966 cheal tube is illuminated . Therefore, as the leading end
engages the patient' s Adam ' s apple 34b . An arcuate member portion of the tracheal tube approaches the vocal chords 32b ,
108b is connected with the base section 78b . The guide rod a surgeon or other viewer can easily determine the location
50b is moveable relative to a guide section 114b connected 10 of the leading end portion of the tracheal tube relative to the
with arcuate member 1086 . The construction and the manner vocal chords. As the leading end portion of the tracheal tube
of using the positioning apparatus 56b and guide rod 50b is approaches the leading end portion 52b of the guide rod , the
the same as was previously described in conjunction with
the embodiment invention illustrated in FIGS. 1 and 2 . image transmitted to the viewer will be of body tissue
ion 15
In accordance with a feature the embodiment invention 15 il illuminated by both light transmitted from the leading end
illustrated in FIG . 12 . light from a light source 400 is portion 52b of the guide rod and light transmitted from the
conducted through a fiber optic tube 402 to a leading end leading end portion of the tracheal tube.
portion 52b of the flexible guide rod 50b . The light trans - The leading end portion of the tracheal tube may be
mitted from the light source 400 through the fiber optic tube inserted into trachea 28b of a patient for greater distance
402 to the leading end portion 52b of the guide rod 50b is 20 than the distance which the guide rod 50b is inserted into the
directed from the leading end portion of the guide rod on to trachea. As the leading end portion of the tracheal tube
adjacent body tissue, in the manner indicated schematically moves past the leading end portion 52b of the guide rod 506 ,
at 404 in FIG . 12 . If desired , a plurality of fiber optic tubes illumination from the leading end portion of the guide rod
402 could be provided to conduct light from the light source 50b will be at least partially blocked from transmission back
400 to the leading end portion 52b of the guide rod . These 25 to the viewer through fiber optics in the tracheal tube.
fiber optic tubes could be bundled together or could be Therefore, the viewer will easily be able to determine when
spaced part at the leading end portion 52b of the guide rod the leading end portion of the tracheal tube has moved past
50b . the leading end portion of the guide rod 50b .
The light 404 which illuminates the body tissue immedi- Although the eye 410 of a viewer has been schematically
ately ahead of the leading end portion 52b of the guide rod 30 illustrated in FIG . 12 , it is contemplated that the image
50b is reflected from the body tissue and is transmitted transmitted through the fiber optic tube 408 may be dis
through a fiber optic tube 408 to the eye 410 of a viewer. played on a viewing screen . If this was done, the image
This results in the transmission of an image of the body transmitted through the fiber optic tube 408 would be
tissue adjacent to the leading end portion 52b of the guide transmitted to a computer and a viewing screen associated
rod 50b to the viewer to facilitate visualization , by the 35 with the computer would display an image of the body tissue
viewer, of the body tissue . If desired , a plurality of fiber immediately ahead of the leading end portion 52b of the
optic tubes 408 could be provided to conduct light from the guide rod 50b . As the tracheal tube is moved along the guide
leading end portion 52b of the guide rod to the eye 410 of rod into the patient' s respiratory system 11b , an image of
the viewer. These fiber optic tubes could be bundled together body tissue immediately ahead of the leading end portion of
or could be spaced apart at the leading end portion 52b of the 40 the tracheal tube may also be transmitted to the computer.
guide rod 506 . A second computer screen may be utilized to display an
By visualizing the body tissue immediately ahead of the image of the body tissue immediately ahead of the leading
leading end portion 52b of the guide rod 50b , the viewer can end portion of the tracheal tube. If this is done, the surgeon
determine the location of the leading end portion of the or other viewer would be able to see an image of body tissue
guide rod relative to the larynx 30b and vocal chords 32 of 45 immediately ahead the leading end portion 52b of the guide
a patient as the leading end portion of the guide rod moves rod 50b and an image of body tissue immediately ahead of
into the larynx and between the vocal chords. Since the light the leading end portion of the tracheal tube . When simulta
404 illuminates body tissue immediately ahead of the lead - neously viewing the two images on two separate screens or
ing end portion 52b of the guide rod 50b , the light enables on separate portions of a single screen , the surgeon or other
the viewer to continuously visualize where the leading end 50 viewer would be able to determine the positions of the
portion 52b of the guide rod 50b is located along the leading end portions of both the guide rod 50b and the
insertion path in the respiratory system 11b of the patient. tracheal tube relative to each other and to the respiratory
In the embodiment invention illustrated in FIG . 12 , the system 11b of a patient.
fiber optic tubes 402 and 408 extend through the guide rod Although it' s preferred to utilize the tracheal tube and it' s
50b to enable an image of body tissue immediately ahead of 55 associated illumination system in conjunction with the guide
the leading end portion 52b of the guide rod to be transmit rod 50b , the tracheal tube may be utilized by itself . Thus,
ted to a viewer. It is contemplated that movement of a fiber optic tubes which extend through the side wall of the
tracheal tube, corresponding to tracheal tube 38 of FIG . 2 , tracheal tube and correspond to the fiber optic tubes 402 and
along the guide rod 50b into the patient' s respiratory system 408 of FIG . 12 , would provide an image of the body tissue
11b will be facilitated by illuminating body tissue immedi- 60 immediately ahead of the leading end portion of the tracheal
ately ahead of the leading end portion of the tracheal tube . tube as the tracheal tube is moved into the patient's respi
Therefore, the side wall of the tracheal tube may beprovided ratory system 11b along an insertion path . The image
with fiber optic tubes which transmit light from a light transmitted from the leading end portion of the tracheal tube
source , such as a light source 400 , to a location immediately to the eye of the viewer or to a display screen would enable
ahead of the leading end portion of the tracheal tube and 65 a surgeon or other viewer to determine the location of the
transmit an image of illuminated body tissue immediately leading end portion of the tracheal tube relative to the
ahead of the leading end portion of tracheal tube to a viewer. patient's respiratory system 11b .
 US 10 ,071,215 B2
25 26
When the tracheal tube and it 's associated illumination 13 and 14 is generally similar to the embodiment invention
and image transmitting systems are utilized without guide illustrated in FIGS. 1 , 2 and 12 , similar numerals will be
rod 50b , the positioning apparatus 56b may be modified to utilized to identify similar components , the suffix letter “ c”
guide movement of the tracheal tube in much the same being associated with the numerals of FIGS . 13 and 14 to
manner as in which the positioning apparatus 56b is utilized 5 avoid confusion
to guide movement of the guide rod 50b . If this is done, A positioning apparatus 56c (FIG . 13 ) is utilized to
colored bands or other indicia could be provided on the position a flexible guide wire or rod 50c relative to a
tracheal tube to indicate the position of the tracheal tube in respiratory system 11c of a patient. The respiratory system
the samemanner as previously discussed in connection with 11c of the patient extends from the mouth 12c of head 10c
the guide rods 50 and 250. through a larynx 30c to a trachea 28c of the patient. The
It is contemplated that the positioning apparatus 56b may positioning
be used for purposes other than tracheal intubination . Thus , a patient to apparatus 56c engages an Adam 's apple 34c of
locate the guide rod 50c relative to the patient's
the positioning apparatus 56b may be used to position respiratory system 11c.
devices other than the guide rod 50b during endoscopic,
arthroscopic , or fiber optic surgery at any one of many 15 The positioning apparatus 56c has the same general
locations in a patient's body . A magnet, similar to the magnet construction and mode operation as the positioning appara
260 of FIGS. 4 and 7 may be used to steer a leading end tus 56 of FIGS. 1 and 2 . The positioning apparatus 56c
portion of the device being positioned in the patient's body. includes a base section 78c having a body section 86c which
The leading end portion of the device being positioned in the is pivotally connected with a positioning section 96c. The
patient's body may be located at a position adjacent to or 20 positioning section 96c engages an outer surface of the neck
spaced a desired distance from a positioning section , corre - of the patient adjacent to the Adam ' s apple 34c to locate the
sponding to the positioning section 96b , by the use of positioning apparatus 56c relative to the patient' s respiratory
suitable indicia , which may be similar to the indicia used in system 11c. If desired , the positioning apparatus 96c could
conjunction with the guide rods 50 and 250 . include a collar which would extend around the patient 's
When the positioning apparatus 50b is to be used to 25 Adam 's apple 34c in the matter previously described in
position a medicant or a device of any desired type at a conjunction with the embodiment invention illustrated in
selected location in a patient' s body , the positioning section FIG . 7 . Alternatively , the positioning apparatus 96c could
96b is positioned in engagement with a selected portion of include a pair of fingers which engage opposite lateral sides
the patient's body. The selected portion of the patient 's body of the patient's Adam 's apple .
may be a portion of the patient's body other than the Adam 's 30 An arcuate member 108c is connected with and is move
apple 34b . Although it is believed that it will probably be able relative to the body section 86c of the positioning
preferred to engage an exterior surface on the patient's body apparatus 56c at a connection 110c. A flexible guide rod 50c
with the positioning section 96b, the positioning section is axially slidable relative to a guide section 114c which is
could be placed in engagement with a surface disposed connected with the arcuate member 108c . The construction
within the patient' s body if desired 35 of the positioning apparatus 56c is the same as was previ
While the positioning section 96b is engaging the selected ously described in conjunction with the embodiment inven
portion of the patient's body, the guide rod 50b or a similar tion illustrated in FIGS. 1 and 2 .
elongated member is moved relative to the guide section In accordance with a feature of the embodiment invention
114b connected with the arcuate member 108b . The leading illustrated in FIG . 13 , a sensor assembly 420 is provided to
end portion 52b of the guide rod 50b or similar elongated 40 inform a surgeon or other user of the positioning apparatus
member is then moved into the patient' s body . The leading 560, of the position of the guide rod 50c relative to the
end portion 52b may be moved into the patient 's body patient 's respiratory system 11c . The sensor assembly 420
through a naturally occurring opening or through an incision includes an emitter portion 424 (FIG . 14 ) which provides an
formed in the patient ' s body. output and a detector portion 426 ( FIG . 13 ) which responds
The image transmitted through the guide rod or similar 45 to the output from the emitter portion 424 . In the embodi
elongated member 50b to the viewer will indicate when the ment of invention illustrated in FIGS. 13 and 14 , the emitter
leading end portion 52b has moved to a desired position in portion 424 is positioned on an outer side surface of the neck
the patient's body. Once the leading end portion 52b of the of the patient adjacent to the Adam 's apple 34c . The detector
guide rod or similar elongated member 50b has moved to the portion 426 is connected with a leading end portion 52c of
desired position relative to the patient 's body, any desired 50 a guide rod 50c . However, it should be understood that the
procedure may be performed in the patient's body. For emitter portion 424 could be connected with the guide rod
example , a surgical procedure could be conducted with one 50c and the detector portion 426 positioned adjacent to the
or more devices connected with the leading end portion 52b Adam 's apple 34c of the patient.
of the guide rod or similar elongated member. The position . In the illustrated embodiment invention, the emitter por
ing apparatus 56b may be used to position a therapeutic 55 tion 424 of the sensor assembly 420 includes a plurality of
agent or device at the desired position in the patient ' s body. emitters units 430 which are positioned an array which
Embodiment of FIGS. 13 and 14 extends around the Adam ' s apple 34c (FIG . 14 ) of the
In the embodiment invention illustrated in FIG . 12 , the patient. The emitter units 430 are secured to the neck of the
light source 400 and fiber optic tube 402 function as an patient by a suitable adhesive . The emitter units 430 may be
emitter which emits illumination 404 onto body tissue 60 positioned in any desired spatial relationship with the
immediately ahead of the leading end portion 52b of the patient' s Adam 's apple 34c .
guide rod 50b to facilitate visualization of the body tissue . Alternatively, the emitter units 430 may be connected
In the embodiment invention illustrated in FIGS . 13 and 14 , with the positioning section 96c . Thus, the positioning
a plurality of emitters are positioned adjacent to an outer side section 96c of the positioning apparatus 56c is provided with
surface of the patient's neck . A detector on a leading end 65 three fingers which engage the neck of the patient adjacent
portion of a guide rod is moved into the patient 's respiratory to the Adam 's apple 34c. Each of the emitter units 430 may
system . Since the embodiment invention illustrated in FIGS. be connected with one of the fingers of the positioning
 US 10 ,071,215 B2
27 28
section 96c. The positioning section 960 would accurately over leads 434 and 436 to a computer or micro processor
locate the emitter units 430 relative to the patient's Adam ' s 438 . The computer or micro processor has an output, indi
apple 34c. cated schematically at 440 , which can be viewed by a
In the embodimentof the invention illustrated in FIG . 13 , surgeon or other individual moving the guide rod 50c along
the positioning section 96c engages the Adam 's apple 34c 5 the insertion path into the patient' s respiratory system 11c .
and the emitter units are disposed in a generally circular The computer output may include a display having a
array which extends around the Adam 's apple 34c.However, schematic illustration of a typical patient's respiratory sys
it should be understood that the emitter units 430 could be tem . The positions of the emitter units 430 relative to the
connected with a collar, similar to the collar 306 of FIG . 7 . typical respiratory system and the position of the detector
The collar may be connected with the positioning section 10 portion 426 relative to the emitter units 430 would be
960 (FIG . 13 ). Alternatively, the collar could be separate indicated on the display. Thus, a display screen connected
from the positioning apparatus. with the computer 438 has an illustration representative of
Although it is preferred to utilize the positioning appara - the patient' s respiratory system 11c . A plurality of indicators
tus 56c in conjunction with the guide rod 50c , in the manner are provided on the display screen to indicate the positions
previously described in conjunction with the embodiment of 15 of the emitter units 430 relative to the schematic illustration
the invention illustrated in FIG . 1 , it is contemplated that the of the patient' s trachea . An indicator is provided to indicate
positioning apparatus 56c may be omitted and the guide rod the position of the leading end of the guide rod 50c relative
50c moved along an insertion path into the patient' s respi- to the schematic illustration of the patient ' s respiratory
ratory system without benefit of the assistance provided by system . The display screen has one illustration of the
the positioning apparatus. If this is done, the emitter units 20 patient' s respiratory system 11c as viewed in a medial plane
430 (FIG . 14 ) could be connected with a support structure and another illustration of the patient's respiratory system as
which holds the emitter units 430 in a fixed relationship viewed in a frontal plane. Indicators corresponding to the
relative to each other and facilitates positioning of the emitter units 430 and detector 426 are provided in both
emitter units relative to the patient's Adam 's apple 34c. For illustrations.
example , a positioning section having a plurality of fingers, 25 As the leading end portion 52c of the guide rod 50c moves
could be manually centered on the patient 's Adam 's apple along the insertion path into the patient' s respiratory system
34c to locate the emitter units 430 relative to the Adam 's 12c , the detector portion 426 of the sensor assembly 420
apple . Similarly, a collar, corresponding to the collar 306 of approaches the emitter portion 424 of the sensor assembly.
FIG . 7, could be provided on a circular or oval support As this occurs , the strength of the output from the detector
which would extend around the patient' s Adam ' s apple 34C 30 portion 426 through the leads 434 and 436 increases . As the
to locate the emitter units 430 relative to the patient's strength of the output from the detector portion 426
Adam 's apple . Regardless of the specific structure which is increases, the computer and the associated display indicates
utilized to position the emitter units 430 relative to each to an operator of the apparatus 56c that the leading end
other, this apparatus could be manually positioned relative to portion 52c of the guide rod 50c is approaching a junction
the patient's Adam 's apple 34c without being connected 35 between the patient's esophagus 26c and the pharynx .
with a positioning apparatus having a construction similar to If the guide rod continues movement along its intended
the construction of the positioning apparatus 56c. course of insertion , that is, into the patient's larynx 30c and
When the positioning apparatus 56c is to be utilized to not into the patient 's esophagus 26c, the strength of the
assist in the positioning of the guide rod 50c relative to the output signal provided by the detector portion 426 will
patient's respiratory system 11c , the positioning section 960 40 increase. However , if the leading end portion 52c of the
is positioned in engagement with the patient' s Adam 's apple guide rod 50c enters the patient 's esophagus 26c, the
34c. The emitter units 430 may be suitably mounted on the strength of the output signal from the detector portion 426
positioning section 96c. This would locate the emitter units will decrease . The decreasing strength of the signal from the
430 relative to the patient's Adam ' s apple 34c (FIG . 14 ). It detector portion 426 provides a clear indication to the
should be understood that the emitter units 430 could be 45 operator of the apparatus 56c that the leading end portion
mounted on a support other than the positioning section 960 52c of the guide rod 50c has deviated from its intended
if desired . Of course , the emitter units 430 may be secured cour
course .
directly to the neck of the patient by a suitable adhesive, as As the detector portion 426 of the sensor assembly 420
illustrated in FIG . 14 . When this is done , a support structure moves between the patient' s vocal chords 32c into align
interconnecting the emitter units 430 may be used to facili- 50 ment with the emitter portion 424 of the sensor assembly
tate positioning of the emitter units relative to the patient' s 420 , the strength of the signal transmitted to the computer
Adam ' s apple 34c. 438 will be maximized . As the guide rod 50c continues to be
The arcuate member 108c is then positioned axially along moved into the patient's trachea 28c along the insertion path ,
the body section 86c . When the arcuate member 108c has the strength of the signal transmitted through the leads 434
been moved to a desired position relative to the body section 55 and 436 to the computer 438 will decrease to indicate to the
86c, the connection 110c is secured to hold the arcuate operator of the apparatus 56c that the leading end portion
member against axialmovement along the body section . The 52c of the guide rod has moved past the patient's Adam 's
arcuate member 108c is then moved relative to the body apple 34C.
section 86c to position the guide section 114c and the Although it is believed that it will be preferred to display
leading end portion 52c of the guide rod 50c in alignment 60 the output of the computer 438 in association with one or
with the entrance to the patient' s mouth 11c . The guide rod more illustrations of the patient' s respiratory system 11c in
50c is then moved into the patient' s respiratory system 110 the manner previously mentioned , the computer output
along an insertion path . information could be transmitted in a different manner if
As the guide rod 50c is moved along the insertion path desired . For example , the computer 438 could have a light
into the patient's respiratory system 11c , the detector portion 65 display system which indicates how close the detector 426
426 of the sensor assembly 420 approaches the emitter units is to the emitter units 430. Similarly , the computer 438 could
430 . As this occurs, the detector portion provides an output have an audio output which indicates how close the detector
 US 10 , 071,215 B2
29 30
426 is to the emitter units. Of course, the computer could sive device is utilized to form the detector portion 426 of the
have an output which is a combination of a display screen , sensor assembly, the output from the detector portion will
lights and/or audio signals. vary as the distance between the leading end portion 52c of
Once the guide rod 50c has been moved to the desired the guide rod 50c and the magnets in the emitter units 430
position along the patient ' s respiratory system 11c, the 5 varies.
positioning apparatus 56c may be disconnected from the In the embodiment of the invention illustrated in FIGS . 13
guide rod 50c . A tracheal tube, corresponding to tracheal and 14 , the sensor assembly 420 is the type which responds
tube 38 of FIG . 2 , is then moved along the guide rod 50c into to a magnetic field . However , it is contemplated that the
the patient ' s trachea 28c. The manner in which the tracheal sensor assembly 420 could be constructed so as to respond
tube is moved along the guide rod 50c into the patient' s 10 to other types of emissions. For example , light sources could
trachea 28c is the same as was previously discussed in be utilized as the emitter units 430 and the detector portion
conjunction with the embodiment of the invention illustrated 436 may be a photo cell which responds to variations in the
in FIGS. 1 and 2 . A magnet, corresponding to the magnet amount of light received . Alternatively , the emitter units 430
260 of FIGS. 4 and 7 ,may be utilized to steer the leading end could be sources of radio frequency radiation and the
portion of the guide rod 50c . If desired , an electromagnet 15 detector portion 426 could be constructed so as to have an
which can be turned on and off may be utilized . output which varies as the distance between the detector
The tracheal tube which is utilized in association with the portion and the sources of radio frequency radiation varies .
guide rod 50c of FIG . 13 may have the same construction as If desired , the emitter units 430 could be ultrasonic trans
the tracheal tube 38 utilized with the guide rod 50 of FIG . ducers and the detector 426 could respond to ultrasonic
2 . Alternatively, the tracheal tube utilized with the guide rod 20 energy .
50c may have a second detector portion , having the same The sensor assembly 420 has been illustrated in FIGS. 13
construction as the detector portion 426 of the guide rod 50c . and 14 in association with the positioning apparatus 56c.
If the tracheal tube is provided with a second detector However, it should be understood that the sensor assembly
portion , the emitter portion 424 of the sensor assembly 420 420 could be utilized in association with the positioning
is maintained in position relative to the patient' s Adam 's 25 apparatus 256 of FIGS. 4 - 10 or the positioning apparatus
apple 34c. 256a of FIG . 11 . If this was done, the use of the magnet 260
By providing the tracheal tube with a second detector or 260a (FIGS. 4 , 7 and 11 ) may be eliminated to avoid
portion , and by maintaining the emitter portion 424 in interference with magnetic fields from the emitter units 430 .
position relative to the patient' s Adam 's apple 34c, the Of course , if the emitter units provided outputs which were
output from the second detector portion may be utilized to 30 not affected by the magnetic field from the magnets 260 and
locate the leading end portion of the tracheal tube as the 260a , the magnets 260 and 260a could still be utilized .
tracheal tube is moved along the guide rod 50c into the The positioning apparatus 56c and sensor assembly 420
patient' s respiratory system 11c . If this is done, leads, have been illustrated in association with a tracheal intubi
corresponding to the leads 434 and 436 would extend along nation procedure . It is contemplated that the positioning
the side wall of the tracheal tube from the second detector 35 apparatus 56c and / or sensor assembly 420 may be used in
portion to the computer 438 . The output from the computer association with other medical procedures if desired . For
438 would indicate the position of the leading end portion of example , the positioning apparatus 56c and/ or sensor assem
the tracheal tube relative to the emitter 424 . The output from bly 420 may be used in the performance of endoscopic ,
the second detector portion on the leading end portion of arthroscopic or fiber optic surgical procedures . The posi
tracheal tube would indicate the position of the leading end 40 tioning apparatus 56c and /or sensor assembly 420 may be
portion of the tracheal tube relative to the position of the used in association with surgery on joints or other portions
leading end portion of the guide rod 50c. of a patient 's body . The positioning apparatus 56c and/or
The output from the computer may be a display having the sensor assembly 420 may be used to deliver medicants to a
construction previously described in conjunction with the desired location in a patient's body Embodiments of FIGS.
guide rod 50c . Thus , a display screen connected with the 45 15 and 16
computer 438 has an illustration representative of the In the embodiment ofthe invention illustrated in FIGS. 13
patient's respiratory system 11c . A plurality of indicators are and 14 , the emitter portion 424 of the sensor assembly 420
provided on the display screen to indicate the positions of is disposed adjacent to the outer surface of the neck of the
the emitter units 430 relative to the patient' s trachea . An patient while the detector portion 426 of the sensor assembly
indicator is provided to indicate the position of the leading 50 is connected with the guide rod 50c. In the embodiment of
end of the tracheal tube relative to the patient' s respiratory the invention illustrated in FIGS . 15 and 16 , the detector
system . The display screen has one illustration of the portion of the sensor assembly is disposed adjacent to the
patient' s respiratory system llc as viewed in a medial plane outer surface of the patient 's neck and the emitter portion of
and another illustration of the patient' s respiratory system as the sensor assembly is connected with the leading end
viewed in a frontal plane . Indicators corresponding to the 55 portion of the guide rod . Since the embodiment of the
emitter units 430 and detector on the tracheal tube are invention illustrated FIGS . 15 and 16 is generally similar to
provided in both illustrations . the embodiment of the invention illustrated in FIGS. 1 , 2 , 13
In the embodiment of the invention illustrated in FIGS. 13 and 14 , similar numerals will be utilized to identify similar
and 14 , the emitter units 430 are magnets which emit a components, the suffix letter “ d ” being associated with the
magnetic field . The detector portion 426 is a magnetometer 60 numerals of FIGS. 15 and 16 to avoid confusion .
which responds to variations in the strength of a magnetic The positioning apparatus 56d is utilized to position a
field . Thus, the output from the detector portion 426 flexible guide rod 50d relative to a patient's respiratory
increases as the detector portion moves closer to the system 11d . The positioning apparatus 56d includes a base
patient' s Adam ' s apple 34c and the magnets forming the section 78d having a body section 86d and a positioning
emitter units 430 . The detector portion 436 may be Hall 65 section 96d . An arcuate member 108d is connected with the
effect device , magnetoresistor, or a galvanometer device . body section 86d at a connection 110d . When the arcuate
Regardless of what specific type of magnetic field respon - member 108d has been moved to a desired position along the
 US 10 ,071,215 B2
31 32
base section 86d , the connection 110d is actuated to hold the 420d relative to the patient's respiratory system and the
member 108d against axial movement along the body sec - position of the emitter portion 424d of the sensor assembly
tion 86d . When the guide section 114d has been moved into 420d relative to the patient's respiratory system . Since the
alignment with the patient's mouth 12d , the connection 110d emitter portion 424d is connected with the leading end
is again actuated to hold the arcuate member 108d against 5 portion 52d of the guide rod 50d , the display for the
movement relative to the base section 86d. computer 444 would indicate the position of the leading end
The guide section 114d cooperates with the flexible guide portion 52d of the guide rod relative to the patient's Adam 's
rod 50d to position the guide rod during movement of the apple 34d .
guide rod into the patient's respiratory system 11d along an Although it is believed that the use of a display screen
insertion path . The general construction and mode of opera - 10 may be preferred , the output 446 from the computer 444
tion of the positioning apparatus 56d is the same as was could take a different form if desired . For example , the
previously described in conjunction with the positioning computer could have an audio output. Alternatively , a dis
apparatus 56 of FIGS. 1 and 2 . play graph formed of a series of lights could provide a visual
In accordance with a feature of this embodiment of the
invention , a sensor assembly 420d is provided to sense when 15 output. As the emitter portion 424d approaches the sensor
the guide rod 50d has moved to a desired position relative tounits 440, the number of illuminated lights in the series of
the patient' s respiratory system 11d . The sensor assembly lights would increase . When the emitter portion 424d is
420d includes a detector portion 426d (FIG . 16 ) and an aligned with the center of the array of sensor units 440 and
emitter portion 424d (FIG . 15 ). the patient's Adam 's apple 34d , the entire series of lights
The sensor portion 426d of the sensor assembly 420d is 20 would be illuminated . Of course, the output 446 from the
positioned on the outer surface of a neck of a patient ( FIG . computer 444 could include both audio and visual outputs .
16 ) adjacent to the patient's Adam ' s apple 34d. The emitter In the embodiment of the invention illustrated in FIGS. 15
portion 424d is connected with a leading end portion 52d of and 16 , the emitter portion 424d of the sensor assembly 420d
the guide rod 50d ( FIG . 15 ). The sensor portion 426d ( FIG . is a magnet which emits a magnetic field . The sensor portion
16 ) is mounted directly on the patient ' s neck by a suitable 25 426d of the sensor assembly 420d has an outputwhich varies
adhesive . However, if desired , the sensor portion 426d could as a function of the strength of the magnetic field at the
be connected with the positioning section 96d of the posi- sensor units . Therefore , as the leading end portion 52d of the
tioning apparatus 56d . If this is done, when the positioning guide rod 50d approaches the patient's Adam 's apple 34d ,
section 96d of the positioning apparatus 56d is positioned in the strength of the magnetic field to the sensor units 440
engagement with the patient' s Adam ' s apple 34d, the sensor 30 increases and the output transmitted to the computer 444
portion 426 of the sensor assembly 420d would also posi increases .
tioned relative to the patient's Adam 's apple . However , if In the specific embodiment of the invention illustrated in
desired , the sensor portion 426d could be mounted on a FIG . 16 , the sensor units 440 are Hall effect devices .
support and positioned relative to the patient's Adam 's apple However, it is contemplated that other known devices which
34d independently of the positioning section 96d of the 35 respond to variations in a magnetic field may be utilized in
positioning apparatus 56d. place of the Hall effect devices which form the sensor units
The sensor portion 426d of the sensor assembly 420d 440 . For example , magnetoresistors could be utilized as the
includes a plurality of sensor units 440 which are disposed sensor units 440 in place of the Hall effect devices .
in an array around the patient' s Adam ' s apple 34d (FIG . 16 ) . Once the guide rod 50d has been positioned relative to the
The sensor units 440 have leads 442 which are connected 40 patient 's respiratory system 11d , the positioning apparatus
with a computer or micro processor 444 . The computer or 56d is disconnected from the guide rod 50d while the guide
micro processor 444 has an output, indicated schematically rod is maintained stationary relative to the patient' s respi
in 446 in FIG . 16 , which is indicative of the position of the ratory system 11d . A flexible tracheal tube, corresponding to
emitter portion 424d of the sensor assembly 420d relative to the tracheal tube 38 of FIG . 2 , is then moved along the guide
the position of the sensor portion 426d of the sensor assem - 45 rod 50d into the patient' s respiratory system 11d . The
bly . The emitter portion 424d of the sensor assembly 420d manner of insertion of the tracheal tube into the patient' s
is connected with the leading end portion 52d of the guide respiratory system 11d , by sliding the tracheal tube along the
rod 50d . guide rod 50d , is the same as was previously described in
During use of the positioning apparatus 56d, the leading conjunction with the embodimentof the invention illustrated
end portion 52d of the flexible guide rod 50d is aligned with 50 in FIG . 2 .
the mouth 12d of head 10d of the patient. The guide rod 50d It is contemplated that the sensor portion 426d of the
is then moved into the patient' s respiratory system 11d along sensor assembly 420d can be utilized in association with the
an insertion path . As the guide rod 50d is moved into the tracheal tube . Thus, the tracheal tube can be provided with
patient's respiratory system 11d , the emitter portion 424d of a second emitter portion having the same construction as the
the sensor assembly 420d approaches the sensor portion 55 emitter portion 424d . In the embodiment of the invention
426d of the sensor assembly 420d. As this occurs, the illustrated in FIGS . 15 and 16 , a magnet, which emits a
strength of the output from the sensor units 440 increases. magnetic field , would be mounted on a leading end portion
The increasing strength of the output from the sensor units of the tracheal tube.
440 results in a change in the output 446 from the computer As the tracheal tube having an emitter, is moved along the
444. The output 446 from the computer 444 may take the 60 guide rod 50d, the magnet on the leading end portion of the
form of a display which schematically indicates the position tracheal tube would have an effect on the sensor units 440 .
of the emitter portion 424d of the sensor assembly 420d The effect on the magnet on the sensor units 440 increases
relative to the sensor portion 426d of the sensor assembly. as the leading end portion of the tracheal tube approaches the
Thus, a display screen for the computer 444 may have a patient 's Adam 's apple 34d . It is contemplated that the
schematic illustration representative of a typical patient' s 65 tracheal tube may be inserted into the patient' s trachea 28d
respiratory system . The display screen would indicate the further than the guide rod 50d . If this is done, the output
position of the sensor portion 426d of the sensor assembly from the sensor units 440d diminishes in magnitude as the
 US 10 , 071,215 B2
33 34
leading end portion of the tracheal tube is moved down the Although the emitter portions 424 and 424d of the sensor
patient’s trachea past the sensor units. assemblies 420 and 420d have been described herein as
Although it is preferred to utilize the sensor assembly emitting magnetic fields, it is contemplated that the emitter
420d in association with the positioning apparatus 56d , the portions 424 and 424d could have outputs other than a
sensor assembly could be utilized separately from the posi- 5 magnetic field . For example , the emitter portions 424 and /or
tioning apparatus. For example , the sensor units 440 may be 424d (FIGS. 14 and 15 ) could be miniaturized radio fre
mounted in an array on a separate support structure . The
support structure would be positioned in an engagement quency devices . Thus , the emitter portions of the sensor
assemblies could be formed by radio signal transmitters
with the exterior of the patient's neck with the array of having miniaturized radio circuitry which provide a radio
sensor units 440 centered about the patient's Adam 's apple , 10 to frequency output signal. If a radio frequency transmitter is
in the manner illustrated schematically in FIG . 16 . utilized in the emitter portion 424 or 424d of the sensor
The guide rod 50d would then be moved along the assemblies, the sensor portion 426 or 426d would be a radio
patient' s respiratory system 11d without benefit of the
positioning apparatus 56d. As the guide rod 50d moves include frequency receiver. The radio frequency receiver could
along the patient's respiratory system 11d , the strength of the 15 signals. a The
receiving antenna which receives radio frequency
field of the antenna may be controlled by
magnetic field from the emitter portion 424d of the sensor
assembly 420d detected by the sensor units 440 would appropriate placement, orientation, and /or configuration of
increase. This would result in an increase in the output from the antenna.
the sensor units 440 to the computer 444 . The output 446 Alternatively , the emitter portions 424 and 424d could
from the computer 444 would indicate to the operator 20 emit ultrasonic energy . The sensor portion 426 or 426d
moving the guide rod 50d , the position of the guide rod would respond to ultrasonic energy.
along an insertion path into the patient' s respiratory system Embodiment of FIGS. 17 and 18
11d . In the embodimentof the invention illustrated in FIGS. 13
Once the guide rod 50d has been positioned in the and 14 , the sensor assembly 420 includes a detector portion
foregoing manner relative to the patient' s respiratory system 25 426 which is disposed on the leading end portion 52c of the
11d , without benefit of the positioning apparatus 56d , the guide rod 50c and responds to a magnetic field . The operator
tracheal tube would be moved along the guide rod into the of the positioning apparatus 56c is informed , by a display
patient' s respiratory system 11d . The tracheal tube could system connected with the computer 438 , of the position of
have the same construction and move in the samemanner as the leading end portion 52c of the guide rod 50c relative to
the tracheal tube 38 of FIG . 2 . 30 the patient' s respiratory system 11c . In the embodiment of
Alternatively , the tracheal tube could be provided with a the invention illustrated in FIG . 17 an 18 , the leading end
second emitter portion , corresponding to the emitter portion portion of the guide rod is steerable to enable the other
424d of the sensor assembly 420 . Thus, a magnet could be operator to alter the course ofmovement of the leading end
provided on the leading end portion of the tracheal tube . As portion of the guide rod to maintain the leading end portion
the leading end portion of the tracheal tube moves along the 35 of the guide rod on a desired insertion path into the patient 's
insertion path into the patient' s respiratory system 11d , the respiratory system . Since the embodiment of the invention
magnetic field detected by the sensor units 440 would illustrated in FIGS. 17 and 18 is generally similar in the
increase due to the magnet connected with the leading end embodiment of the invention illustrated in FIGS. 13 - 16 ,
portion of the tracheal tube approaching the magnet on the similar numerals will be utilized to designate similar com
leading end portion 52d of the guide rod 50d. 40 ponents, the suflix letter “ e ” being associated with the
It is also contemplated that the tracheal tube could be numerals of FIGS. 17 and 18 to avoid confusion .
positioned relative to the patient's respiratory system 11d The embodiment of the invention illustrated in FIGS. 17
without benefit of the guide rod 50d . The tracheal tube and 18 is utilized with a positioning apparatus having the
would be provided with an emitter corresponding to the same construction as the positioning apparatus of FIGS . 1 ,
emitter 424d . As tracheal tube is moved into the patient' s 45 2 , and 13 - 16 . However, the embodiment of the invention
respiratory system 11d without benefit of the guide rod 50d , illustrated in FIGS. 17 and 18 could be used with the
the output from the emitter connected to the leading end positioning apparatus 256 and /or 256a of FIGS. 4 - 11 if
portion of the tracheal tube would be detected by the sensor desired . The guide rod 50e of FIGS. 17 and 18 is provided
units 440 . The output from the sensor units 440 would with a steering apparatus 460 . The steering apparatus 460 is
indicate the position of the leading end portion of the 50 operable to change the course ofmovement of the leading
tracheal tube relative to the patient' s respiratory system 11d . end portion 52e ofthe flexible guide rod 50e as the guide rod
In the embodiment of the invention illustrated in FIGS. moves along the insertion path into the patient' s respiratory
13 - 16 , magnets have been utilized as emitter units . The system .
magnets which form the emitter portion 424 of the sensor The steering apparatus 460 applies force against body
assembly 420 are permanent magnets formed of a strongly 55 tissue in the patient's respiratory system to deflect the
magnetizable material such as cobalt or neodymium . Of leading end portion 52e of the flexible guide rod 50e away
course , other know magnetizable materials having saturation from an undesired course ofmovement. For example , when
magnetization values , such as cerium , praseodymium and or the leading end portion of the guide rod 50e is approaching
samarium with cobalt and / or other materials could be used . a junction between the patient's esophagus 26 (FIG . 1 ) and
Alternatively, the magnets in the emitter portion 424 ( FIG . 60 trachea 28 , the steering apparatus 460 (FIGS. 17 and 18 )
14 ) and 424d ( FIG . 15 ) could be electromagnets. may be activated to deflect the leading end portion 52e of the
The detector portion 426 (FIG . 13 ) and 426d (FIG . 16 ) of guide rod 50e away from the entrance to the patient' s
the sensor assemblies 420 and 420d may be any known esophagus. Similarly, when the leading end portion 52e of
device which respond to changes in the strength and/ or the guide rod 50e is approaching the larynx 30, the steering
direction of a magnet field . For example , the detector 65 apparatus 460 may be activated to align the leading end
portions 426 include one ormore Hall effect devices and /or portion 52e of the guide rod with an opening between vocal
one or more magnetoresistors. chords in the patient's larynx .
 US 10 ,071,215 B2
35 36
In the illustrated embodiment of the invention , the steer single annular recess which extends around the leading end
ing apparatus 460 includes a plurality of expandable ele - portion of the guide rod 50e . The contracted expandable
ments 464 , 466 and 468 ( FIG . 18 ) . Although three expand elements do not project outward from the outer side surface
able elements 464 - 468 have been illustrated as being of the guide rod 50e . Alternatively , the contracted expand
disposed in a circular array about the leading end portion 52e 5 able elements 464-468 could be contracted , under the influ
of the guide rod 50e, a greater or lesser number of expand ence of their own natural resilience , into tight abutting
able elements could be provided in association with the engagementwith the outer side surface of the guide rod 50e .
leading end portion of the guide rod if desired . It is contemplated that the conduits 472 , 474 and 476 and
The expandable elements 464, 466 and 468 are individu expandable elements 464, 466 and 468 may be formed in a
ally activatable so that one, two or all three of the expand- 10 manner similar to that disposed in U .S . patent application
able elements can be expanded . For example, just the
expandable element 464 (FIG . 18 ) may be expanded to Ser . No. 08 /470, 142 filed Jun. 6 , 1995 by Peter M . Bonutti
apply force against the leading end portion 52e of the guide et al. and entitled Method Of Using Expandable Cannula .
rod 50e to move the guide rod downward (as viewed in FIG . The disclosure of the aforementioned application Ser. No.
18 ) relative to a path ofmovement of the guide rod through 15 /470 ,142 is hereby incorporated herein in its entirety by
15 08
the patient's respiratory system . Alternatively, the expand this reference thereto . Alternatively , the expandable ele
able elements 466 and 468 may be expanded at the same ments 464, 466 and 468 could be formed in manners similar
time to deflect the leading end portion 52e of the guide rod to that disclosed in U .S . Pat. Nos. 3 ,833, 003 and/ or 5 , 197 ,
50e upward (as viewed in FIG . 18 ). It is believed that itmay 971.
be desired to center the leading end portion 52e of the guide 20 Although the illustrated expandable elements 464-468 are
rod 50e in a passage in the patient's respiratory system . expanded under the influence of fluid pressure , they could be
When this is to be done, all three expandable elements 464, expanded in a different manner if desired . For example ,
466 , and 468 would be expanded . mechanical actuators could be provided. The mechanical
In the illustrated embodiment of the invention , the actuators may be utilized to move members which are not
expandable elements 464, 466 and 468 are balloons or 25 balloons .
bladders which are expanded under the influence of fluid In order to enable an operator of the positioning apparatus
pressure , that is , under the influence of either a gas or a to determine the location of the leading end portion 52e of
liquid . To enable the expandable elements 464, 466 and 468 the guide rod 50e relative to the patient' s respiratory system ,
to be individually expanded , conduits 472 , 474 and 476 are a sensor assembly , similar to the sensor assembly 420 of
each connected in fluid communication with one of the 30 FIGS. 13 and 14 , is utilized in association with the steering
expandable elements 464, 466 or 468. For example , when apparatus 460 . In the embodiment of the invention illus
the expandable element 464 is to expanded , fluid under trated in FIG . 17 , the detector portion 426e of the sensor
pressure is connected through the conduit 472 to the expand assembly includes a detector 480 which responds to an
able element 464 . Similarly , when the expandable element output from an emitter portion of the sensor assembly. The
466 is to expanded , fluid under pressure is connected 35 detector 480 is enclosed by a soft dome or cap 482 which
through the conduit 474 to the expandable element 466 . forms part of the leading end portion 52e of the guide rod
Finally , when the expandable element 468 is to be expanded , 50e . The dome or cap 482 cushions engagement of the
fluid under pressure is connect through the conduit 476 to leading end portion 52e of the guide rod 50e with body
the expandable element 468 tissue along the patient's respiratory system . In addition , the
After one or more of the expandable element 464 - 468 40 dome 482 protects the detector portion 426e.
have been expanded to steer the leading end portion 52e of The detector 480 may be a Hall effect device which
the guide rod 50e , the expandable elements 464, 466 and /or cooperates with emitters , which are magnets, in the manner
468 are contracted . This may be accomplished by connect - described in conjunction with FIGS . 13 and 14 . Alterna
ing the conduits 472 , 474 and/ or 476 with a source of suction tively , the detector 480 may respond to radio frequency
or low pressure . The expandable elements 464 , 466 and 468 45 radiation . If desired , the detector 480 could be constructed
are contracted under the influence of their own natural so as to respond to ultrasonic energy . Rather than providing
resilience . If desired , springs could be provided in associa a detector 480 on the leading end portion 52e of the guide
tion with the expandable elements to contract the expand - rod 50e , an emitter could be provided in the manner
able elements 464- 468 . described in conjunction with FIGS . 15 and 16 .
The contracted expandable elements 464 , 466 and 468 are 50 The detector portion 426e ( FIG . 17 ) is connected with a
disposed in engagement with an outer side surface of the computer, similar to the computer 438 of FIG . 13 , by a lead
leading end portion 52e of the guide rod 50e . If desired , 486 ( FIG . 17 ). The output from the computer indicates to an
recesses could be provided in the leading end portion of the operator the position of the leading end portion 52e of the
guide rod 50e to receive each of the expandable elements guide rod 50e relative to the patient' s respiratory system .
464, 466 and 468 when the expandable elements are in their 55 The output of the computer will also indicate to the operator
contracted condition . when the leading end portion 52e of the guide rod 50e may
It is believed that it will be preferred to form the expand deviate from the intended course of insertion of the guide
able elements 464, 466 and 468 of a resiliently stretchable rod into the patient's respiratory system .
polymeric material so that the expandable elements can be When the output from the computer indicates that the
expanded , under the influence of fluid pressure , by stretch - 60 leading end portion of the guide rod may notmove along the
ing the material of the expandable elements . When the intended insertion path , the operator may initiate expansion
expandable elements are to be deflated , the resiliently of one or more of the expandable elements 464 -468 . The
stretched elastomeric material of the expandable elements expandable elements will apply force against the patient's
464 -468 will tend to force fluid out of the expandable body tissue and against the leading end portion 52e of the
elements and cause them to return to their contracted con - 65 guide rod 50e to deflect the guide rod in such a manner as
ditions . When the retracted , the expandable elements 464, to maintain the guide rod on its intended insertion path into
466 and 468 are disposed in either separate recesses or a the patient's respiratory system .
 US 10 ,071,215 B2
37 38
As was previously described in conjunction with the guide rod 50f. When the light source 490 is to be detected by
embodiments of the invention illustrated in FIGS. 13 - 16 , a the operator of the positioning apparatus , that is , when the
visual display system , illustrative of the patient' s respiratory operator is to function as the detector portion of the sensor
system , may be connected with the computer which receives assembly, it is believed that pulsing the light source will
the output from a sensor assembly 420 or 420d . By viewing 5 facilitate visual detection of the light source by the operator.
an illustration depicting the location and path ofmovement It should be understood that both photo electric detection
of the leading end portion 52e of the flexible guide rod 50e , apparatus and visual detection by the operator could be
an operator will know when to expand one or more of the utilized to locate the position of the leading end portion 52f
expandable elements 464, 466 and 468 .
It is contemplated that the steering apparatus 460 and 10 of the guide rod 50f as the guide rod is moved into the
patient' s respiratory system .
position sensing assembly may be used with devices for A steering apparatus 460F (FIG . 19) is connected with the
purposes other than tracheal intubination . For example, the leading end portion 52f of the guide rod 50f. The steering
steering apparatus 460 and position sensing assembly used
with the guide rod 50e of FIG . 17 could be used in apparatus 460f includes a plurality of expandable elements
association with a device which is used to position medicant 15 464f and 466f. Although only two expandable elements 464f
at a selected location in a patient's body. It is also contem and 466f have been illustrated schematically in FIG . 19, it
plated that the steering apparatus 460 and position sensing should be understood that a third expandable element,
assembly could be used in conjunction with endoscopic , corresponding to the expandable element 468 of FIG . 18 , is
arthroscopic , or fiber optic surgery. connected with the leading end portion 52f of the guide rod
Embodiment of FIG . 19 . 20 50f. The expandable elements are connected with a source of
In the embodiment of the invention illustrated in FIGS. 17 inflation fluid by conduits 472f, 474f and 476f.
and 18 , the steering apparatus 460 is disclosed in conjunc When one ormore of the expandable elements connected
tion with the guide rod 50e which is used with a sensor with the leading end portion 52f (FIG . 19 ) of the guide rod
assembly, corresponding with the sensor assembly 420 of 50f are to be expanded , fluid under pressure is conducted to
FIG . 13 , in which the detector portion is disposed on the 25 the expandable elements. For example , when the expandable
leading end portion 52e of the guide rod. In the embodiment element 464f is to be operated from a contracted condition
of the invention illustrated in FIG . 19 , the steering apparatus to an expanded condition , fluid under pressure , which may
is disposed in association with a guide rod having an emitter be either a gas or liquid , is conducted through the conduit
portion of a sensor assembly disposed on the leading end 472f to the expandable element 464f. As the expandable
portion of the guide rod in the manner illustrated in FIGS . 30 element 464f is operated from a contracted condition to an
15 and 16 . Since the embodiment of the invention illustrated expanded condition of the influence of fluid pressure , the
in FIG . 19 is generally similar to the embodiments of the expandable element applies force against the adjacent body
invention illustrated in FIG . 13 - 18 , similar numerals will be tissues in the patient 's respiratory system and applies force
utilized to designate similar components, the suffix letter “ f” against the leading end portion 52f of the guide rod 50f. The
being associated with the numerals of FIG . 19 in order to 35 force applied against the leading end portion 52f of the guide
avoid confusion. rod 50f deflects the leading end portion 52f of the guide rod
A guide rod 50f has a leading end portion 52f. The guide 50f downward ( as used in FIG . 19 ) to maintain the guide rod
rod 50f is used with a positioning apparatus similar to the on the intended path of insertion into the patient' s respira
positioning apparatus 56d of FIG . 15 . The flexible guide rod tory system . The output from the emitter portion 424f of the
50f (FIG . 19 ) is associated with a sensor assembly corre - 40 sensor assembly enables the operator to determine when it is
sponding to the sensor assembly 420d of FIG . 15 . Thus, the necessary to expand one ormore of the expandable elements
guide rod 50f has an emitter portion 424f (FIG . 19 ) which is and to determine which of the expandable elements to be
connected with the leading end portion 52f of the guide rod . expanded .
The output from the emitter portion 424f is detected by In the embodiment of the invention illustrated in FIG . 19 ,
suitable detectors disposed adjacent to the exterior surface of 45 the emitter on the leading end portion of the guide rod 50f
the patient' s neck and to the patient' s Adam ' s apple , in the is a light source 490 . However , a different type of emitter
manner illustrated schematically in FIG . 16 . could be provided if desired . For example , the emitter could
In the embodiment of the invention illustrated in FIG . 19 , be a magnet which cooperates with detectors in the manner
the emitter portion 424f includes a light source 490 . The previously described in conjunction with FIGS . 15 and 16 .
light source 490 is connected with source of electrical 50 Alternatively , the emitter could be a miniaturized radio
energy by a lead 492 . The light source 490 has been frequency transmitter.
illustrated schematically in FIG . 19 as being an incandescent Embodiment of FIG . 20
light source . However, itmay be preferred to provide a solid In the embodiment of the invention illustrated in FIGS . 13
state device as a light source 490 . For example , one or more through 19 , sensor assemblies have been illustrated as being
light emitting diodes could be disposed on the leading end 55 associated with a guide rod of a positioning apparatus. In the
portion 52f of the guide rod 50f to function as a light source . embodiment of the invention illustrated in FIG . 12 , fiber
It is contemplated that the electrical energy conducted optics are utilized in association with a light source to enable
over the lead 492 to the light source 490 may be varied as an operator to view images of body tissue immediately
the light source moves along the insertion path into the ahead of the leading end portion of a guide rod 50b . In the
patient's respiratory system . For example , if the light source 60 embodiment of the invention illustrated in FIG . 20 , a light
is pulsed from a maximum light emission level to a mini- source and fiber optics are associated with a tracheal tube to
mum light emission level, detection of the location of the enable an operator to view images of body tissue immedi
leading end portion 52f of the guide rod 50f may be ately ahead of a leading end portion of the tracheal tube
facilitated . during of insertion of the tracheal tube into a patient 's
The light source 490 may be detected by suitable photo 65 respiratory system . Since the embodiment of the invention
optic devices , such as photo cells or may be visually illustrated in FIG . 20 is generally similar to the embodiments
detected by the operator ofthe apparatus associated with the of the invention illustrated in FIGS. 1, 2 and 12 , similar
 US 10 ,071 , 215 B2
39 40
numerals will be utilized to designate similar components , the tracheal tube . Since images of body tissue immediately
the suffix letter “ g ” being associated with the numerals of ahead of the leading end portion of the tracheal tube are
FIG . 20 to avoid confusion . transmitted through the fiber optic tube 408g , an operator
A flexible tracheal tube 38g (FIG . 20 ) has a leading end who is positioning the tracheal tube relative to a patient' s
portion 500 . A light source 400g is disposed on the leading 5 respiratory system will be able to view images of the body
end portion 500 of the tracheal tube 38g. The light source tissue and , from these images, be able to determine when to
400g is connected with a source of electrical energy by leads activate one or more expandable elements of a steering
504 and 506 . When the tracheal tube 38g is moving along an apparatus connected with the leading end portion 500 of the
insertion path into a patient' s respiratory system , the light tracheal tube 38g.
source 400g illuminates body tissue immediately ahead of 10 Embodiment of FIG . 21
the leading end portion 500 of the tracheal tube 38g. In the embodiment of the invention illustrated in FIG . 20 ,
In the embodiment of the invention illustrated in FIG . 20, images of patient' s body tissue are transmitted from the
the light source 400g is mounted on the leading end portion leading end portion of the tracheal tube for viewing by an
of the tracheal tube 38g. However, it is contemplated that the operator who is inserting the tracheal tube into the respira
light source could be disposed at a location remote from the 15 tory system of a patient. In the embodiment of the invention
leading end portion 500 of the tracheal tube 38g and illustrated in FIG . 21, the tracheal tube is associated with a
illumination transmitted from the light source to the leading sensor assembly having the same construction as the sensor
end portion of the tracheal tube through a fiber optic tube, assembly 420 of FIGS. 13 and 14 . Since the embodiment of
corresponding to the fiber optic tube 402 of FIG . 12 . Of the invention illustrated in FIG . 21 is generally similar to the
course , a plurality of fiber optic tubes could be utilized if 20 embodiment of the invention illustrated in FIGS . 13 , 14 and
desired . 20 , similar numerals will be utilized to designate similar
The light source 400g has been illustrated schematically components , the suffix letter “ h ” being associated with the
in FIG . 20 as being an incandescent light source . However, numerals of FIG . 21 to avoid confusion .
it is contemplated that one ormore solid state devices, such A tracheal tube 38h (FIG . 21) has a leading end portion
as light emitting diodes, could form the light source 400g if 25 500h . A detector portion 426h is provided on the leading end
desired . A plurality of light sources 400g could be disposed portion 500h of the tracheal tube 38h . The detector portion
in a circular array on the leading end portion 500 of the 426h cooperates with an emitter portion of a sensor assem
tracheal tube 38g. bly having the same construction as the emitter portion 424
A prismatic lens 510 is also mounted on the leading end (FIG . 14 ) of the sensor assembly 420 .
portion 500 of the tracheal tube 38g . The lens 510 is 30 The tracheal tube 38h includes a plurality ofmagnetic flux
enclosed by a transparent dome 512 which is connected with sensor units 440h which respond to variations in a magnetic
the leading end portion 500 of the tracheal tube 38g . Light flux field in which the sensor units are exposed . In the
is transmitted from the lens 510 through a fiber optic tube illustrated embodiment of the invention , the sensor units
408g to the eye of a viewer or to a display unit associated 440h are Hall effect devices. However, the sensor units 440h
with a computer. The lens 510 is oriented so that images of 35 could be other known types of devices which respond to a
body tissue immediately ahead of the leading end portion magnetic flux field
500 of the tracheal tube 38g are transmitted through the fiber The sensors 440h are connected with a computer, similar
optic tube 408g . Although only a single light source 400g to the computer 438 of FIG . 13 , by a plurality of leads 442h .
and single lens 510 have been illustrated schematically in The computer to which the leads 442h are connected has a
FIG . 20 , it should be understood that a plurality of light 40 display unitwhich displays an image of a typical respiratory
sources and /or a plurality of lenses may be mounted on the system . The display indicates the position of the leading end
leading end portion 500 of the tracheal tube 38g. portion 500h of the tracheal tube 38h relative to the patient's
The flexible tracheal tube 38g may be utilized in asso - respiratory system
ciation with the positioning apparatus 56 of FIGS. 1 and 2 In addition , the computer display may also indicate the
or with the positioning apparatus 256 of FIG . 4 . Alterna - 45 position of a guide rod , corresponding to the guide rod 50c
tively, the tracheal tube 38g may be utilized by itself, that is of FIG . 13 , relative to the patient's respiratory system .
without a positioning apparatus . If the tracheal tube 38g is Therefore , the computer display shows the position of the
utilized with a positioning apparatus similar to the position leading end portion 500h of the tracheal tube 38h relative to
ing apparatus 56 or 256 , the tracheal tube may be moved the leading end portion 52c (FIG . 13 ) of the guide rod 50c .
along a guide rod similar to the guide rod 50 or the guide rod 50 Although the tracheal tube 38h may advantageously be
250 as the tracheal tube is moved into a patient' s respiratory utilized in association with a guide rod , similar to the guide
system . However, the tracheal tube may be moved along a rod 50c, it is contemplated that the tracheal tube 50h could
guide rod into a patient 's respiratory system without utiliz - be utilized by itself without an associated guide rod. Of
ing a positioning apparatus , similar to the positioning appa course , if the tracheal tube 38h was utilized by itself without
ratus 56 or 256 of FIGS . 1 and 4 . 55 a guide rod similar to the guide rod 50c of FIG . 13 , the
The tracheal tube 38g may be moved along an insertion output from the computer would indicated the position of the
path into a patient's respiratory system without benefit of a leading end portion 50h of the tracheal tube 38h relative to
guide rod . If desired , a steering apparatus, corresponding to the patient' s respiratory system and would not indicate the
the steering apparatus 460 and 460f of FIG . 17 - 19 , may be location of the guide rod .
associated with the leading end portion of the tracheal tube 60 It is contemplated that a steering apparatus similar to the
38g . Thus, expandable elements , corresponding to the steering apparatus 460 of FIG . 17 may be utilized with the
expandable elements 464, 466 and 468 of FIG . 18 may be tracheal tube 38h (FIG . 21 ). A plurality of expandable
connected with the leading end portion 500 of the tracheal elements, corresponding to the expandable elements 464,
tube 38g . The expandable elements connected with the 466 and 468 of FIG . 18 , would be connected with the
leading end portion 500 of the tracheal tube 38g may be 65 leading end portion 50h of the tracheal tube 38h . The
connected in fluid communication with a source of fluid cooperation between the Hall effect devices forming the
under pressure through conduits disposed in the side wall of sensor units 440h and the magnets of an associated detector
 US 10 ,071,215 B2
42
portion of a sensor assembly would enable an operator desired , the tracheal tube 38j could be inserted into a
inserting the tracheal tube 38h into a patient 's respiratory patient 's respiratory system without the benefit of a guide
system to determine when one or more of the expandable rod .
elements should be expanded to steer the leading end portion When the tracheal tube 38j is to be inserted into a patient's
500h of the tracheal tube 38h . 5 respiratory system , either with or without a guide rod , the
Embodiment of FIG . 22 light sources 490j are energized . Energization of the light
In the embodiment of the invention illustrated in FIG . 19 , sources 490j results in the emission of light which can be
a light source 490 and steering apparatus 460f is associated cent detected by photo cells or similar devices positioned adja
with the leading end portion 52f of a guide rod 50f. In the 10 cells tocould
the outside of the patient' s neck . If desired , the photo
be eliminated and an operator could visually
embodiment of the invention illustrated in FIG . 22 , a plu locate the leading end portion 50j of the tracheal tube 38j by
rality of light sources and a steering apparatus are associated viewing the illumination conducted through the patient's
with the leading end portion of a tracheal tube. Since the body tissues to the surface of the patient' s neck . It is
embodiment of the invention illustrated in FIG . 22 is gen contemplated that an operator will , in all probability , locate
erally similar to the embodiments of the invention illustrated 15 the leading end portion 500j of the tracheal tube 38j by a
in FIGS. 19 - 21 , similar numerals will be utilized to desig combination of the output from photo detectors and visually
nate similar components , the suffix letter “ j” being associ viewing the patient's neck . If desired , the light sources 490
ated with the numerals of FIG . 22 to avoid confusion . can be pulsed to provide a variation in the illumination from
A tracheal tube 38j has a leading end portion 500j. A the light sources to facilitate visual locating of the leading
plurality of light sources 490j are mounted on the leading 20 end portion of the tracheal tube 38j by an operator.
end portion 500j of the tracheal tube 38j. The light sources When the inflatable elements 464j and /or 466j are to be
490j are energized by electrical energy connected over leads operated from the expanded condition illustrated in FIG . 22
492j. Although the light sources 490 ; have been indicated to a contracted condition , the conduits 472 ; and 474 ; may be
schematically in FIG . 22 as being incandescent light exhausted to atmosphere . It is believed that it may be
sources , it is contemplated that solid state devices, such as 25 preferred to connect the conduits 472 ; and 474 ; with a source
light emitting diodes , could be utilized as the light sources of low pressure or suction so that fluid is drawn out of the
if desired . expandable elements .
The steering apparatus 460j is mounted on the leading end As the fluid pressure in the expandable elements 460j and
portion 500j of the tracheal tube 38j. The steering apparatus 466j is reduced , the natural resilience of the expandable
460j includes a plurality of expandable elements 464j andd 3030 elements causes them to contract tightly against the leading
end portion 500j of the tracheal tube 38j. If desired , a
466j. Although only two expandable elements 464 ; and 466j plurality of recesses may be provided in the leading end
have been illustrated schematically in FIG . 22 , it should be portion 500j of the tracheal tube 38j to receive the expand
understood that there are three expandable elements con able elements 464j and 466j. Of course , if additional
nected with the leading end portion 500j of the tracheal tube€ 35
, expandable elements are associated with the leading end
38j. The expandable elements are disposed in an array portion 500j of the tracheal tube 38j, additional recesses
around the end of the tracheal tube in much the samemanner would be provided to receive these expandable elements
as illustrated schematically in FIG . 18 in association with the when they are contracted .
guide rod 50e Various types of emitters and detectors have been illus
The expandable elements 464j and 466j are connected 40 trated in FIGS. 20 , 21 and 22 in association with the tracheal
with conduits 472 ; and 474 ;. The conduits 472 ; and 474j are tube 38 ;. It should be understood that any of the emitters or
formed in the side wall of the tracheal tube 38j in the manner detector systems previously described in association with a
indicated schematically in FIG . 22 . Of course , a third guide rod may be utilized in association with a tracheal tube .
conduit is provided to conduct fluid to and from a third For example , a radio frequency transmitter and a receiver
expandable element on the end portion 500j of the tracheal 45 may be utilized as the emitter portion and the sensor portion
tube 38 ;. It should be understood that the conduits 472 ; and of a sensor assembly which is utilized to detect the location
474j could be formed separately from the tracheal tube 38 ; of the leading end portion of a tracheal tube relative to a
if desired . patient's respiratory system .
When the steering apparatus 460j is to be utilized to Although it is believed that it will probably be preferred
change the course of movement of the leading end portion 50 to utilize a steering apparatus, similar to the steering appa
500 ; of the tracheal tube 38j relative to a patient 's respiratory ratus 460j in association with the tracheal tube, the steering
system , one or more of the expandable elements in the apparatus could be omitted if desired .
steering apparatus 460j is inflated under the influence of Positioning Apparatus — General — Mode of Operation
fluid pressure conducted through an associated conduit. For The general mode operation of the positioning apparatus
example , if the expandable element 464j is to be operated 55 56 of FIG . 1 is illustrated schematically in FIG . 23 . As was
from a contracted condition to the expanded condition previously explained, the positioning apparatus 56 includes
illustrated schematically in FIG . 22 , fluid pressure is con - an arcuate member 108 . The arcuate member 108 has a
nected through the conduit 472j. As the expandable element center of curvature indicated at 600 in FIG . 23 .
464; expands, forces are applied against tissue in the The body section 86 of the positioning apparatus 56 has
patient's respiratory system by the expandable element 464j. 60 a central axis which extends through the center 600 . The
At the same time, the expandable element 464j is effective positioning section 96 is connected with an end of the body
to apply force against the leading end portion 500j of the section 86 which is disposed closest to the center 600 of
tracheal tube 38j to deflect the tracheal tube downward (as curvature of the arcuate member 108. The indicia 124 ( FIG .
viewed in FIG . 22 1 ) on the body section 86 is effective to indicate the length
It is contemplated that the tracheal tube 38j may be 65 of the body section 86 .
utilized in association with a guide rod , such as the guide rod The guide rod 50 also has a central axis which extends
50f of FIG . 19 or the guide rod 50 of FIG . 1. However, if through the center 600 of curvature of the arcuate section
 US 10 ,071,215 B2
43 44
108. The indicia 142 (FIG . 1) on the guide rod 50 indicates the patient's neck . Since the embodiment of the invention
the distance from the leading end portion 52 of the guide rod illustrated in FIGS. 25 and 26 is generally similar to the
50 from the arcuate member 108. The guide rod 50 and body embodiments of the invention illustrated in FIGS. 1- 24 ,
section 86 of the positioning apparatus 56 are both radiuses similar numerals will be utilized to designate similar com
from the center 600 of curvature of the arcuate member. 5 ponents , the suffix letter " m " being associated with the
When the indicia 142 (FIG . 1) indicates that the guide rod numerals of FIGS . 25 and 26 to avoid confusion .
50 (FIG . 23 ) extends from the arcuate member 108 for the positioning apparatus 56m is utilized to position a guide
same distance as the body section 86 , the leading end portion rod 50m corresponding to the guide rod 50 of FIG . 1 , relative
52 of the guide rod 50 is aligned with the positioning to a patient 's trachea 28m during insertion of the guide rod
apparatus 96 . Since the positioning apparatus 96 is accu - 10 into the patient' s trachea . In addition , the positioning appa
rately located relative to the patient' s respiratory system 11 ratus 56m provides an indication of the distance which the
( FIG . 1 ) by engagement with the patient's Adam 's apple 34 , guide rod 50m is to be moved into the patient's trachea 28m .
the position of the leading end portion 52 of the guide rod The positioning apparatus 56m includes a base section 78m
relative to the patient' s larynx 30 is known when the leading which is connected with an arcuate upper section, corre
end portion 52 of the guide rod 50 is aligned with position - 15 sponding to the arcuate upper section 80 of FIG . 1 . The base
ing apparatus 96 . section 78m includes a tubular cylindrical body section 86m .
An alternative embodiment of the positioning apparatus The base section 78m also includes a positioning section
56 is illustrated in FIG . 24 . Since the embodiment of the 96m . The positioning section 96m locates the positioning
positioning apparatus illustrated in FIG . 24 is generally apparatus 56m relative to the patient's Adam 's apple 34m .
similar to the embodiment of the positioning apparatus 56 20 In accordance with a feature of the embodiment of the
illustrated in FIGS. 1 and 23 , similar numerals will be invention illustrated in FIGS . 25 and 26 , the positioning
utilized to indicate similar components , the suffix letter “ k ”
section 96 includes a pair of positioning fingers 622 and 624
being associated with the components of FIG . 24 to avoid which engage the neck 16m of the patient at locations
confusion. disposed on laterally opposite sides of the Adam 's apple
A positioning apparatus 56k includes a body section 86k. 25 34m . Thus, the positioning finger 622 is provided with a
A positioning section 96k is connected with an end portion relatively soft resilient spherical end portion 628 which is
of the body section 86k . The positioning section 96k engages pressed against the patient 's neck 16m at a location adjacent
the patient's Adam 's apple , in the manner previously to the left (as viewed in FIG . 26 ) side of the patient's Adam ' s
described in conjunction with the apparatus 56 of FIG . 1. apple . Similarly , the positioning finger 624 has a soft resil
In the embodiment of the invention illustrated in FIG . 24 , 30 ient spherical end portion 630 which is pressed against the
a member 108k is fixedly connected with the body section patient 's neck 16m at a location adjacent to the right (as
86k and extends at a known angle , indicated at 604 in FIG . viewed in FIG . 26 ) side of the patient' s Adam ' s apple 34m .
24 . A guide section 114k is disposed at an end of the member The positioning fingers 622 and 624 cooperate with the
108k opposite from the connection 606 with the body patient 's Adam 's apple 34m to locate the positioning section
section 86k . The guide rod section 114k guides movement of 35 96m laterally relative to the patient ' s Adam ' s apple 34m .
a guide rod 50k along a path which extends through a center In the embodiment of the positioning section 96m illus
600k. trated in FIGS. 25 and 26 , the positioning section is provided
The center 600k is disposed at the intersection of a with a straight center positioning finger 634 which is formed
longitudinal central axis of the body section 86k and a as a continuation of the tubular cylindrical body section 86m
longitudinal central axis of the guide rod 50k . An angle , 40 of the positioning apparatus 56m . Thus, the body section
indicated at610 in FIG . 24 , formed between the longitudinal 86m and center positioning finger 634 are integrally formed
central axis of the body section 86k and the guide rod 50k is as one piece. The center positioning finger 634 has a soft
known . The distance from the positioning section 96k to the resilient spherical end portion 636 which is pressed against
connection 606 between the body section 86k and member the patient's Adam 's apple 34m at the center of the patient's
108k is known. The angles 604 and 610 are known . The 45 Adam ' s apple .
length of the member 108 is also known . Therefore the Force may be applied against the body section 86m of the
distance which the guide rod 50k must extend from the guide positioning apparatus 56m and transmitted to the patient's
section 114k to have the leading end portion 52k of the guide neck 16m to straighten the trachea of the patient. Thus, a
rod aligned with the positioning section 96k can readily be slight bend in the trachea can be minimized by the manual
determined by trigonometric functions. 50 application of a relatively small force to the positioning
It should be understood that features of any one embodi- apparatus 56m . This force is transmitted through the end
ment of the invention may be used with features of other portions 628 and 630 of the positioning fingers 622 and 624
embodiments of the invention . For example, the positioning to the patient' s neck to straighten the patient 's neck . In
apparatus 256 of FIGS. 4 - 10 could have the same construc - addition , a portion of the force will be transmitted through
tion as the positioning apparatus 56 of FIGS. 1 - 3 . Similarly, 55 the center positioning finger 634 directly to the patient 's
the magnet 260 of FIG . 4 could be used with the embodi Adam 's apple 34m .
ment of the invention illustrated in FIGS. 1 - 3 . The sensor The position of the end portions 628 and 630 of the
assemblies 420 could be used with either the positioning positioning fingers 622 and 624 relative to the body section
apparatus 56 of FIG . 1 or the positioning apparatus 256 of 86m of the base section 78m of the positioning apparatus
FIGS . 4 - 10 . Other combinations of features of the invention 60 56m (FIG . 25 ) can be varied . Thus, the positioning fingers
will undoubtedly be utilized . 622 and 624 are fixedly connected to a slide block 640 which
Embodiment of FIGS. 25 and 26 is axially movable along the body section 86m . The body
In the embodiments of the invention illustrated in FIGS. section 86m extends through a cylindrical central opening in
1 - 24 , the positioning apparatus 56 has a positioning section the slide block 640. A set screw 642 (FIG . 25 ) having
96 which engages the patient's Adam 's apple 34 . In the 65 manually engagable wings or flanges can be tightened to
embodiment of the invention illustrated in FIGS . 25 and 26 , hold the positioning fingers 622 and 624 in a desired position
the positioning apparatus engages a plurality of locations on relative to the body section 86m of the positioning apparatus
 US 10 ,071,215 B2
45 46
56m . This enables the length of the center positioning finger (FIG . 28 ). The positioning section 96r is connected with an
634 to be adjusted . By adjusting the length of the center end of a body section 86r of the positioning apparatus 56r
finger 634, a relatively small amount of force can be by a universal pivot connection 652. The pivot connection
transmitted through the center finger 634 directly to the 652 allows the orientation of the base section 78r of the
patient' s Adam ' s apple 34m and substantially larger forces 5 positioning apparatus 56r to be changed in any direction
can be transmitted through the positioning fingers 622 and relative to the positioning section 96r. Thus, the body
624 to the patient 's neck 16m to locations disposed on section 86rof the positioning apparatus 56r can be raised or
opposite sides of the patient's Adam ' s apple 34m . lowered ( as viewed in FIG . 27 ) or pivoted to the left or right
It should be understood that the positioning section 96m (as viewed in FIG . 28
of FIGS. 25 and 26 can be utilized in any of the positioning 10 The positioning section 96r includes a plurality of posi
apparatus disclosed in FIGS. 1 through 24 herein . When the tioning fingers 622r , 624r and 634r. The positioning fingers
positioning section 96m is to be associated with the posi 622r, 624r and 634r are provided with soft resilient spheri
tioning apparatus 56c of FIG . 13 , the emitter units 430 ( FIG . cal end portions 628r, 630r, and 636r. Although the posi
14 ) could bemounted on or adjacent to the end portions 628 , tioning section 96r may be located in any one of many
630 and 636 (FIGS. 25 and 26 ) of the positioning fingers 15 different orientations relative to the patient's Adam 's apple
622, 624 and 634. Similarly, when the positioning section 34r, the position section 96r is illustrated in FIG . 28 with the
96m is utilized in association with the positioning apparatus end portions 628r and 630r disposed on laterally opposite
56d of FIGS. 15 and 16 , the sensor units 440 may be sides of the patient's Adam 's apple 34r . The end portion
disposed adjacent to and connected with the end portions 636r is disposed adjacent to the lower end portion of the
628 , 630 and 636 ( FIG . 25 ) of the positioning fingers 622 , 20 patient 's Adam ' s apple 34r . If desired , the orientation of the
624 and 634 . positioning section 96r could be rotated by 180 degrees from
It should be understood that the positioning apparatus the orientation illustrated in FIG . 28 . If this was done, the
56m (FIGS. 25 and 26 ) may be associated with guide rods end portion 636r on the positioning finger 634r would be
having the construction of the guide rod 50 of FIG . 1 , the disposed adjacent to the upper portion of the patient' s
guide rod 250 of FIGS . 4 and 8 , the guide rod 50e of FIGS. 25 Adam 's apple 34r. It is believed that it will probably be
17 and 18 , or the guide rod 50f of FIG . 19 . It should also be preferred to align the pivot connection 652 with the center
understood that the positioning apparatus 56m may be of the patient' s Adam 's apple 34r. However, if desired , the
associated with a tracheal tube having the construction of pivot connection 652 could be offset from the center of the
any one of the tracheal tubes 38 (FIG . 2), 238 (FIGS. 9 and patient's Adam 's apple 34 .
10 ), 38g ( FIG . 20), 38h ( FIG . 21 ) , or 38j (FIG . 22 ). 30 In the embodiments of the invention illustrated in FIGS.
Embodiment of FIGS . 27 and 28 25 - 28, the positioning sections 96m and 96r have been
In the embodiment of the invention illustrated in FIGS. 25 illustrated as having three positioning fingers . However, it is
and 26 , the positioning fingers 622 and 624 are fixedly contemplated that the positioning sections could have either
connected with the body section 86m of the positioning a greater number of positioning fingers or a lesser number of
apparatus 56m by the slide block 640 while the positioning 35 positioning fingers if desired . For example, the center posi
fingers 634 is integrally formed as one piece with the body tioning finger 634 of the embodiment of the invention
section 36m . In the embodiment of the invention illustrated illustrated in FIGS. 25 and 26 could be omitted . If this was
in FIGS . 27 and 28 , the positioning fingers are movable done, the positioning finger 622 would be positioned on one
relative to the body section of the positioning apparatus. side of the patient' s Adam 's apple 34m and the positioning
Since the embodiment of the invention illustrated in FIGS . 40 finger 624 would be positioned on the laterally opposite side
27 and 28 is generally similar to the embodiments of the of the patient' s Adam 's apple , in the manner illustrated in
invention illustrated in FIGS. 1 - 26 , similar numerals will be FIG . 26 , without engaging the central portion of the patient' s
utilized to designate similar components , the suffix letter “ r” Adam 's apple . Alternatively , the positioning section 96m or
being associated with the numerals of FIGS . 27 and 28 to 96r could be provided with four positioning fingers. If this
avoid confusion. 45 was done, two of the positioning fingers would be positioned
A positioning apparatus 56r positions a guide rod , corre - in engagement with the neck of the patient adjacent to one
sponding to the guide rod 50 of FIG . 1, relative to a patient 's side of the patient' s Adam ' s apple and the other two posi
trachea during insertion of the guide rod into the patient' s tioning fingers would be positioned in engagement with the
trachea . In addition , the positioning apparatus 56r provides patient 's neck on a laterally opposite side of the patient's
an indication of the distance which the guide rod is to be 50 Adam 's apple .
moved into the patient's trachea . Although only a portion of
the positioning apparatus 56r is illustrated in FIGS . 27 and CONCLUSION
28 , it should be understood that the positioning apparatus
may have the same general construction as the positioning An improved method and apparatus for use in tracheal
apparatus of any one of the embodiments illustrated in FIGS. 55 intubination or other medical procedures may include a
1 - 19 . positioning apparatus 56 , 256 . When the positioning appa
The positioning apparatus 56r includes a base section 78r ratus 56 , 256 is used for tracheal intubination , the position
which is connected with an arcuate upper section corre - ing apparatus is located relative to a patient' s trachea 28 , 228
sponding to the arcuate upper section 80 of FIG . 1 . The by engaging a portion of the patient's body, such as the
upper section of the positioning apparatus 56r guides move - 60 Adam 's apple 34 , 234 . A flexible guide rod 50 , 250 may be
ment of a guide rod , corresponding to the guide rod 50 of moved relative to the positioning apparatus until a leading
FIG . 1, during insertion of the guide rod into the patient's end portion 52 , 252 of the guide rod has moved into the
trachea . patient's trachea . A tracheal tube 38 , 238 is slid along the
In accordance with a feature of the present invention , a guide rod into the patient' s trachea .
positioning section 96r is connected with the base section 65 During movement of the guide rod 50 , 250 relative to the
78r. The positioning section 96r locates the positioning positioning apparatus 56 , 256 , the guide rod may be moved
apparatus 56r relative to the patient' s Adam ' s apple 34r through either a tubular guide member 264 or a tracheal tube
 US 10 ,071 , 215 B2
47 48
38 , 238 which extends through the patient's mouth into the It should be understood that any one of the features of the
patient' s pharynx . Before beginning to move the guide rod present invention may be used separately or in combination
50 , 250 , the distance which the guide rod is to be moved may with other features of the invention . It's believed that
advantageously determined . This may be done as a function various combinations of the features, other than those dis
of spacing between locations on the positioning apparatus 5 closed herein , may advantageously be utilized and will be
56 , 256 . If desired, indicia 124 , 324 may be provided on the apparent to those skilled in the art from the description
positioning apparatus 56 , 256 and cooperating indicia 142 contained herein . In addition , it should be understood that
342- 350 may be provided on the guide rod 50, 250. features of the present invention may be used for purposes
A magnet 260 may be utilized to attract a leading end other than tracheal intubination . From the above description
portion 252 of the guide rod 250 . The magnet 260 is 10 of the invention , those skilled in the art will perceive
disposed outside of the patient' s body and may be positioned improvements, changes and modifications . Such improve
adjacent to an anterior side of the trachea . Magnetic attrac ments , changes and modifications within the skill of the art
tion between themagnet 260 and the leading end portion 252 are intended to be covered by the appended claims.
of the guide rod deflects the guide rod . This steers the What is claimed is :
leading end portion of the guide rod 250 into the entrance to 15 1. A medical device system comprising :
the patient's trachea . A magnet may be used to steer a a positioning apparatus configured to enable the insertion
member relative to a patient's body tissue during perfor of a flexible guide rod into a passage of a respiratory
mance of operations other than tracheal intubination . system of a subject , the positioning apparatus having a
In order to locate the guide rod 50 , 250 and/or tracheal body section and an upper section , the body section
tube 38 , 238 relative to the patient' s trachea , an image of 20 having a cylindrical central passage , the upper section
body tissue adjacent to the leading end portion of the guide slidably coupled to the body section such that the upper
rod and / or tracheal tube may be transmitted to a location section slidably moves relative to the body section, and
outside of the patient's body (FIGS. 12 and 20 ). Movement the upper section having a cylindrical passage that
of the guide rod 50, 250 and/ or tracheal tube 38 , 238 into the enables the flexible guide rod to be positioned in and
patient' s trachea is interrupted when the image transmitted 25 extended through the upper section of the positioning
from the leading end portion of the guide rod or tracheal tube apparatus, wherein at least a portion of the cylindrical
indicates that the leading end portion of the guide rod or passage of the body section and a portion of the
tracheal tube has been moved to a desired position relative cylindrical passage of the upper section are parallel;
to the patient's trachea . the flexible guide rod having a proximal end portion and
It is believed that transmission of an image of body tissue 30 a distal end portion, the distal end portion of the flexible
adjacent to the leading end portion of the tracheal tube 38 , guide rod having a spherical leading end, the flexible
238 may advantageously be performed when the tracheal guide rod extending through the upper section of the
tube is utilized without benefit of the positioning apparatus positioning apparatus and configured to be inserted into
56 , 256 . However, the transmission of an image of body the passage of the respiratory system of the subject, and
tissue adjacent to the leading end portion of the tracheal tube 35 the flexible guide rod comprising a visible light emitter
38 , 238 may be performed when the positioning apparatus is configured to emit light at the distal end portion of the
used in association with the tracheal tube . Positioning of the flexible guide rod , wherein the visible light emitter is
guide rod 50 , 250 relative to the patient' s trachea may also configured to emit visible light within the passage of
be facilitated by the transmitting of images of body tissue the respiratory system such that the emitted visible light
adjacent to a leading end portion of the guide rod. 40 transmits in the subject and is visible outside the
Detectors and emitters 424 , 426 may be utilized to detect subject for use in determining the location of the distal
the position of the leading end portion of the guide rod 50 , end portion of the flexible guide rod within the respi
250 and / or the tracheal tube 38 , 238 relative to the patient' s ratory system ;
trachea . When this is done, an emitter 424 , such as a magnet a guide tube having a lumen through which the flexible
or a light source , may be connected with a leading end 45 guide rod is configured to be passed ;
portion 52, 252 of the guide rod 50, 250 and /or the tracheal a catheter positioned through the cylindrical passage in
tube 38 , 238 . One ormore detectors 426 may be provided on the slidable upper section of the positioning appara
the outside of the patient' s neck to detect the output from the tus and movable along the flexible guide rod to
emitter 424 when the guide rod 50 , 250 and / or the tracheal position the catheter in the passage of the respiratory
tube 38 , 238 are in a desired position relative to the patient' s 50 system , the catheter including an elongate body
trachea . Alternatively , a detector 426 may be connected with having proximal and distal end portions; and
the leading end portion of a guide rod 50, 250 and / or tracheal a balloon configured for selective expansion to apply a
tube 38 , 238 and one or more emitters 424 positioned force against a portion of the respiratory system ;
relative to the outside of the patient' s neck . The detector 426 wherein the upper section of the positioning apparatus
would provide an output indicating when the guide rod 50, 55 comprises a single piece of monolithic material that
250 and/ or tracheal tube 38 , 238 is moved to a desired extends seamlessly about the cylindrical passage of the
position relative to the patient' s trachea . upper section ;
During movement of the guide rod 50 , 250 and /or tracheal wherein the cylindrical passage of the upper section of the
tube 38 , 238 along the patient's respiratory system and into positioning apparatus has a length and the cylindrical
the patient' s trachea , force may be applied against the 60 central passage of the body section of the positioning
leading end portion 52 , 252 of the guide rod and /or tracheal apparatus has a length that is greater than the length of
tube to steer the leading end portion of the guide rod and /or the cylindrical passage of the upper section of the
tracheal tube. The application of force against the leading positioning apparatus ; and
end portion 52 , 252 of the guide rod 50 , 250 and/or tracheal wherein the body section of the positioning apparatus has
tube 38 , 238 may be accomplished by expanding an expand - 65 a length extending parallel to a longitudinal axis of the
able element 464 -468 connected with the guide rod 50 , 250 central cylindrical passage extending therethrough and
and /or the tracheal tube 38 , 238 . the upper section of the positioning apparatus has a
 US 10 ,071,215 B2
49 50
length extending parallel to the length of the body is visible outside the subject for use in determining the
section , wherein the length of the body section is location of the distal end portion of the flexible guide
greater than the length of the upper section . rod within the respiratory system ;
2 . The medical device system of claim 1, wherein the a guide tube having a lumen through which the flexible
catheter defines a guide rod lumen extending along the 5 guide rod is configured to be passed ;
elongate body of the catheter and configured for receiving a catheter positioned through the cylindrical passage in
the flexible guide rod therein . the slidable upper section of the positioning apparatus
3 . The medical device system of claim 2 , wherein the movable along the flexible guide rod for positioning the
guide rod lumen extends through the distal end portion of the catheter in the passage of the respiratory system , the
elongate body of the catheter 10 catheter including an elongate body having proximal
4 . The medical device system of claim 1 , wherein the and distal end portions; and
visible light emitter comprises a fiber optic tube extending a balloon configured for selective expansion to apply a
along the flexible guide rod . force against a portion of the respiratory system ,
5 . The medical device system of claim 4 , wherein the wherein the catheter defines a guide rod lumen extending
visible light emitter comprises a light source in communi- 15 along the elongate body of the catheter and configured
cation with the fiber optic tube . for receiving the flexible guide rod therein ,
6 . The medical device system of claim 5 , wherein the light wherein at least one of the catheter, guide tube, and guide
source comprises a light emitting diode . rod comprises a plurality of indicia spaced apart from
7 . The medical device system of claim 6 , wherein the one another along the elongate body for use in deter
flexible guide rod comprises an electrical lead configured to 20 mining a position of at least one of the catheter, guide
electrically connect the light source to a source of electrical tube, and guide rod in the respiratory system ;
energy . wherein the upper section of the positioning apparatus
8 . Themedical device system of claim 1 , wherein at least comprises a single piece of monolithic material that
one of the flexible guide rod and the guide tube has a bend. extends seamlessly about the cylindrical passage of the
9 . The medical device system of claim 1 , wherein at least 25 upper section ;
one of the guide rod , positioning apparatus, and catheter wherein the cylindrical passage of the upper section of the
comprises a plurality of indicia spaced apart from one positioning apparatus has a length and the cylindrical
another for use in determining a position of at least one of central passage of the body section of the positioning
the catheter and guide rod in the respiratory system . apparatus has a length that is greater than the length of
10 . The medical device system of claim 1, wherein both 30 the cylindrical passage of the upper section of the
the guide tube and the positioning apparatus contain at least positioning apparatus; and
one matching colored indicium . wherein the body section of the positioning apparatus has
11. The medical device system of claim 1 , wherein the a length extending parallel to a longitudinal axis of the
distal portion of the flexible guide rod is independently central cylindrical passage extending therethrough and
positionable with respect to the remainder of the flexible 35 the upper section of the positioning apparatus has a
guide rod . length extending parallel to the length of the body
12 . The medical device system of claim 1 , wherein the section , wherein the length of the body section is
catheter defines a suction lumen extending along the elon greater than the length of the upper section .
gate body of the catheter and configured for receiving a 14 . The medical device system of claim 13 , wherein the
suction conduit that provides at least one of a suction force 40 catheter defines a fluid lumen extending along the elongate
and a low pressure . body of the catheter.
13 . A medical device system comprising: 15 . The medical device system of claim 13 , wherein the
a positioning apparatus configured to enable the insertion visible light emitter comprises a fiber optic tube extending
of a flexible guide rod into a passage of a respiratory along the flexible guide rod .
system of a subject, the positioning apparatus having a 45 16 . The medical device system of claim 15 , wherein the
body section and an upper section , the body section visible light emitter comprises a light source in communi
having a cylindrical central passage , the upper section cation with the fiber optic tube.
slidably coupled to the body section such that the upper 17. The medical device system of claim 16 , wherein the
section slidably moves relative to the body section , and light source comprises a light emitting diode.
the upper section having a cylindrical passage that 50 18 . The medical device system of claim 17 , wherein the
enables the flexible guide rod to be positioned in and flexible guide rod comprises an electrical lead configured to
extended through the upper section of the positioning electrically connect the light source to a source of electrical
apparatus, wherein at least a portion of the cylindrical energy .
passage of the body section and a portion of the 19 . The medical device system of claim 13 , wherein at
cylindrical passage of the upper section are parallel ; 55 least one of the flexible guide rod and the guide tube has a
the flexible guide rod having a proximal end portion and bend .
a distal end portion , the distal end portion of the flexible 20 . The medical device system of claim 13 , wherein both
guide rod having a spherical leading end , and the the guide tube and the positioning apparatus contain at least
flexible guide rod extending through the upper section one matching colored indicium .
of the positioning apparatus and configured to be 60 21. A method for positioning a medical device , said
inserted into the passage of the respiratory system of method comprising :
the subject; providing a medical device system including a position
a visible light emitter configured to emit lightat the distal ing apparatus, a guide tube, a flexible guide rod, and a
end portion of the flexible guide rod wherein the visible balloon at a distal end portion of the flexible guide rod ,
light emitter is configured to emit visible light within 65 wherein the positioning apparatus is configured to
the passage of the respiratory system such that the enable the insertion of the guide tube , the flexible guide
emitted visible light transmits through the subject and rod , and the balloon into a passage of a respiratory
 US 10 ,071,215 B2
51 52
system of a subject, the positioning apparatus having a visually observing light output from a light output com
body section and an upper section , the body section ponent disposed at the distal portion of the flexible
having a cylindrical central passage , the upper section guide rod when the light source is positioned within the
slidably coupled to the body section such that the upper passage of the respiratory system ;
section slidably moves relative to the body section 55 holding the guide tube so that the distal end is located
generally at the first tube location ;
approximate the respiratory system of the subject, and while performing the step of holding the guide tube,
the upper section of the positioning apparatus having a advancing the balloon and the flexible guide rod rela
cylindrical passage that enables the flexible guide rod tive to the guide tube so that the balloon moves from
to be positioned in and extended through the upper the first balloon location relative to the distal end of the
section of the positioning apparatus, wherein at least a 10 guide tube to a second balloon location relative to the
portion of the cylindrical passage of the body section distal end of the guide tube ;
and a portion of the cylindrical passage of the upper selectively expanding the balloon after performing the
section are parallel; step of advancing the balloon relative to the guide tube
inserting the guide tube , the flexible guide rod , and the 15 to apply a force against a portion of the respiratory
balloon together into the subject' s body such that a system ; and
distal end of the flexible guide tube is located at a tube providing fluid into the respiratory system from a
first location adjacent a treatment portion of a respira source of fluid through a fluid lumen .
tory system of the subject's body and the balloon is further 22. The method of claim 21, wherein providing fluid
located at a first balloon location relative to the distal comprises providing fluid by a fluid pressure.
end of the flexible guide tube ; * * * *