US20050103333A1 - Medical device positioning system and method - Google Patents

Abstract

A tracheal tube positioning apparatus is located relative to a patient's trachea by engaging the patient's Adam's apple. Indicia on relatively movable sections of the positioning apparatus provides an indication of the distance between the patient's mouth and the patient's larynx. A flexible guide rod is moved through a distance corresponding to the distance between the patient's mouth and larynx, as determined by the positioning apparatus. A magnet is utilized to attract a leading end portion of the guide rod. A plurality of emitters may be disposed in an array around the patient's Adam's apple. Outputs from the emitters are detected by a detector connected with the guide rod and by a detector connected with the tracheal tube. Alternatively, a plurality of detectors may be disposed in an array around the patient's Adam's apple to detect the output from an emitter connected with the guide rod and by an emitter connected with the tracheal tube. Expandable elements may be connected with the guide rod and/or tracheal tube to steer movement along an insertion path.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a continuation of U.S. patent application Ser. No. 09/728,553, filed on Dec. 2, 2000, the entire contents of which are incorporated by reference.
FIELD OF THE INVENTION
• The present invention relates to a new and improved method and apparatus for use in tracheal intubination or other medical procedures
BACKGROUND OF THE INVENTION
• Tracheal intubination has previously been utilized to provide an unobstructed air passage to a patient's lungs. Tracheal intubination is frequently done under emergency circumstances which are not optimal. It has previously been recognized that is necessary to have a tracheal tube bend around the patient's epiglottis and move from the patient's pharynx into the larynx at the upper end of the patient's trachea rather than into the patient's esophagus. However, it is difficult for a person inserting the tracheal tube to know where the leading end portion of the tracheal tube is located relative to the patient's larynx.
• Various methods and devices for assisting in tracheal intubination are disclosed in U.S. Pat. Nos. 4,832,020; 4,865,586; 4,913,139; 5,353,787; 5,235,970; 5,560,351; and 5,694,929.
SUMMARY OF THE INVENTION
• An improved method and apparatus for use in tracheal intubination or other medical procedure may include a positioning apparatus. When the positioning apparatus is used for tracheal intubination, the positioning apparatus is located relative to a patient's trachea by engaging a portion of the patient's body, such as the Adam's apple. A flexible guide rod may be moved relative to the positioning apparatus until a leading end portion of the guide rod has moved into the patient's trachea. A tracheal tube is slid along the guide rod into the patient's trachea.
• During movement of the guide rod relative to the positioning apparatus, the guide rod may be moved through either a tubular guide member or a tracheal tube which extends through the patient's mouth into the patient's pharynx. Before beginning to move the guide rod, the distance which the guide rod is to be moved may advantageously determined. This may be done as a function of spacing between locations on the positioning apparatus. If desired, indicia may be provided on the positioning apparatus and cooperating indicia may be provided on the guide rod.
• A magnet may be utilized to attract a leading end portion of the guide rod. The magnet is disposed outside of the patient's body and may be positioned adjacent to an anterior side of the trachea. Magnetic attraction between the magnet and the leading end portion of the guide rod deflects the guide rod. This steers the leading end portion of the guide rod into the entrance to the patient's trachea. A magnet may be used to steer a member relative to a patient's body tissue during performance of operations other than tracheal intubination.
• In order to locate the guide rod and/or tracheal tube relative to the patient's trachea, an image of body tissue adjacent to the leading end portion of the guide rod and/or tracheal tube may be transmitted to a location outside of the patient's body. Movement of the guide rod and/or tracheal tube into the patient's trachea is interrupted when the image transmitted from the leading end portion of the guide rod or tracheal tube indicates that the leading end portion of the guide rod or tracheal tube has been moved to a desired position relative to the patient's trachea.
• It is believed that transmission of an image of body tissue adjacent to the leading end portion of the tracheal tube may advantageously be performed when the tracheal tube is utilized without benefit of the positioning apparatus. However, the transmission of an image of body tissue adjacent to the leading end portion of the tracheal tube may be performed when the positioning apparatus is used in association with the tracheal tube. Positioning of the guide rod relative to the patient's trachea may also be facilitated by the transmitting of images of body tissue adjacent to a leading end portion of the guide rod.
• Detectors and emitters may be utilized to detect the position of the leading end portion of the guide rod and/or the tracheal tube relative to the patient's trachea. When this is done, an emitter, such as a magnet or a light source, may be connected with a leading end portion of the guide rod and/or the tracheal tube. One or more detectors may be provided on the outside of the patient's neck to detect the output from the emitter when the guide rod and/or the tracheal tube are in a desired position relative to the patient's trachea. Alternatively, a detector may be connected with the leading end portion of a guide rod and/or tracheal tube and one or more emitters positioned relative to the outside of the patient's neck. The detector would provide an output indicating when the guide rod and/or tracheal tube is moved to a desired position relative to the patient's trachea.
• During movement of the guide rod and/or tracheal tube along the patient's respiratory system and into the patient's trachea, force may be applied against the leading end portion of the guide rod and/or tracheal tube to steer the leading end portion of the guide rod and/or tracheal tube. The application of force against the leading end portion of the guide rod and/or tracheal tube may be accomplished by expanding an expandable element connected with the guide rod and/or the tracheal tube.
• It should be understood that any one of the features of the present invention may be used separately or in combination with other features of the invention. It's believed that various combinations of the features, other than those disclosed herein, may advantageously be utilized and will be apparent to those skilled in the art from the description contained herein. In addition, it should be understood that features of the present invention may be used for purposes other than tracheal intubination.
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing and other features of the present invention will become more apparent upon a consideration of the following description taken in connection with the accompanying drawings wherein:
• FIG. 1 is a fragmentary schematic illustration depicting the use of a positioning apparatus to position a guide rod relative to the mouth and trachea of a patient;
• FIG. 2 a fragmentary schematic illustration depicting the manner in which a tracheal tube is moved along the guide rod ofFIG. 1 into the trachea of the patient;
• FIG. 3 is a fragmentary schematic illustration, similar toFIG. 1, illustrating the manner in which a laryngoscope may be combined with the positioning apparatus;
• FIG. 4 is a fragmentary schematic illustration depicting the use of another embodiment of the positioning apparatus to position a guide rod relative to the mouth and trachea of a patient;
• FIG. 5 is an enlarged schematic fragmentary sectional view of a portion of the apparatus ofFIG. 4 and illustrating the relationship between a guide rod and a guide tube;
• FIG. 6 is an enlarged schematic fragmentary sectional view of a portion of the apparatus ofFIG. 4 and illustrating the relationship between the guide tube, guide rod, and a guide member in the positioning apparatus;
• FIG. 7 is a schematic fragmentary sectional view illustrating a manner in which the positioning apparatus engages a patient's Adam's apple and the manner in which a magnet is moved along the outside of the neck of the patient;
• FIG. 8 (on sheet3 of the drawings) is an enlarged fragmentary schematic illustration of indicia on a portion of the guide rod ofFIG. 4;
• FIG. 9 is a fragmentary schematic illustration of the guide rod with the positioning apparatus and guide tube ofFIG. 4 removed after positioning of the guide rod relative to the patient's trachea;
• FIG. 10 is a fragmentary schematic illustration, generally similar toFIG. 9, illustrating the manner in which a tracheal tube is moved along the guide rod into the patient's trachea;
• FIG. 11 is a fragmentary schematic illustration, generally similar toFIG. 4, illustrating an embodiment of the apparatus in which the tracheal tube is used to guide movement of the guide rod;
• FIG. 12 is a fragmentary schematic illustration, similar toFIG. 1, illustrating an embodiment of the positioning apparatus which transmits an image of body tissue adjacent to a leading end portion of the guide rod;
• FIG. 13 is a fragmentary schematic illustration, generally similar toFIGS. 1 and 12, of an embodiment of the invention in which a detector on a leading end portion of a guide rod detects emitters disposed on the neck of the patient;
• FIG. 14 is a fragmentary schematic illustration, depicting the manner in which a plurality of emitters are arranged in an array around the Adams's apple of the patient ofFIG. 13;
• FIG. 15 is a fragmentary schematic illustration, generally similar toFIG. 13, of an embodiment of the invention in which detectors on the neck of the patient detect an emitter on a leading end portion of the guide rod;
• FIG. 16 is a fragmentary schematic illustration, generally similar toFIG. 14, illustrating a manner in which a plurality of detectors are positioned in an array around the Adam's apple on the neck of the patient ofFIG. 15;
• FIG. 17 is an enlarged schematic fragmentary sectional view of the leading end portion of a guide rod on which a detector and a plurality of expandable steering elements are disposed;
• FIG. 18 is a plan view, taken generally along the line18-18 ofFIG. 17, further illustrating the relationship of the expandable steering elements to the leading end portion of the guide rod;
• FIG. 19 is a schematic fragmentary sectional view of a leading end portion of a guide rod on which an emitter and a plurality of expandable steering elements are disposed;
• FIG. 20 is an enlarged schematic fragmentary sectional view of a leading end portion of a tracheal tube and illustrating the manner in which a light source and light conductor are disposed on the tracheal tube to facilitate visualization of tissue disposed adjacent to the leading end portion of the tracheal tube;
• FIG. 21 is an enlarged schematic fragmentary sectional view of a leading end portion of a tracheal tube and illustrating a plurality of detectors which are disposed on the leading end portion of tracheal tube;
• FIG. 22 is an enlarged schematic fragmentary sectional view of a leading end portion of a tracheal tube illustrating the manner in which a plurality of emitters and expandable steering elements are mounted on the leading end portion of the tracheal tube;
• FIG. 23 is a schematic illustration depicting the positioning apparatus ofFIGS. 1 and 2;
• FIG. 24 is a schematic illustration, generally similar toFIG. 23, illustrating another embodiment of the apparatus ofFIGS. 1 and 2;
• FIG. 25 is a fragmentary schematic illustration of a portion of a positioning apparatus having another embodiment of the positioning section;
• FIG. 26 is a fragmentary schematic illustration depicting the relationship between the positioning section ofFIG. 25 and a patient's Adam's apple during use of the positioning apparatus;
• FIG. 27 is a fragmentary schematic illustration of a portion of a positioning apparatus having another embodiment of the positioning section; and
• FIG. 28 is a fragmentary schematic illustration depicting the relationship between the positioning section ofFIG. 27 and a patient's Adam's apple during use of the positioning apparatus.
DETAILED DESCRIPTION OF THE INVENTION
• General Description
• The present invention relates to a new and improved method and apparatus for use in tracheal intubination or other medical procedures. A portion of a patient'shead10 andrespiratory system11 has been illustrated schematically inFIG. 1. The schematicized illustration of the patient'shead10 andrespiratory system11 includes amouth12 which is connected with athroat14 in aneck16 of the patient.
• A pharynx extends downward from a nasal cavity in thehead10 of the patient. The pharynx is connected with anesophagus26 and atrachea28 in theneck16 of the patient. Theesophagus26 extends from the pharynx to the stomach of the patient. Thetrachea28 extends from the pharynx to the bronchial tubes and lungs of the patient.
• The trachea28 (FIG. 1) has anupper end portion30 which is referred to as the larynx. Vocal cords or folds32 have been indicated schematically inFIG. 1 and are disposed in thelarynx30. Thevocal cords32 are adjacent to the Adam'sapple34 of the patient. The Adam'sapple34 is a laryngeal prominence formed by lamina of cartilage in the larynx.
• Opening of a passage for air from the patient's mouth to the patient's lungs may require insertion of a flexible tracheal tube38 (FIG. 2). Movement of the flexibletracheal tube38 from the patient'smouth12 into the pharynx of the patient is relatively easily accomplished. However, directing thetracheal tube38 into the patient'strachea28 may present difficulties. This is because the tracheal tube must extend past the epiglottis into thelarynx30 at the upper end of thetrachea28. Thetracheal tube38 must not enter theesophagus26 rather than thetrachea28. During movement of the leading end of thetracheal tube38 through thelarynx30, it is desirable to have the tracheal tube near the central portion of the laryngeal cavity in order to minimize irritation of the vocal folds orcords32 by the tracheal tube.
• In accordance with one of the features of the present invention, a flexible guide wire or rod50 (FIG. 1) is utilized to guide movement of the flexible tracheal tube38 (FIG. 2) into thetrachea28. Theflexible guide rod50 has a soft generally sphericalleading end portion52. Theleading end portion52 of theguide rod50 is formed of a resiliently compressible material which is readily deflected by engagement with the vocal cords or folds32 and by engagement with the surface of thetrachea28. If desired, theleading end portion52 of theguide rod50 may be coated with a suitable lubricant to facilitate movement of the leading end portion between the vocal cords with minimum of irritation.
• In accordance with another of the features of the invention, theguide wire50 is initially positioned relative to the patient'strachea28 with a positioning apparatus56 (FIG. 1). Thepositioning apparatus56 engages the patient's Adam'sapple34 to locate the positioning apparatus relative to thetrachea28 of the patient. In addition, thepositioning apparatus56 provides a measurement which is a function of the distance between the Adam'sapple34 and themouth12 of the patient. This measurement is utilized to determine the distance through which theguide rod50 is to be moved relative to thepositioning apparatus56 as the guide rod is inserted into thetrachea28.
• Positioning Apparatus
• Thepositioning apparatus56 has been and will be described herein in association with tracheal intubination. However, it is contemplated that thepositioning apparatus56 will be used in association with many other medical procedures where accurate positioning of an object relative to body tissue is desired. The positioning apparatus may be used in association with endoscopic, arthroscopic or fiber optic surgical procedures. It is believed that thepositioning apparatus56 will be used in conjunction with medical procedures where it is necessary to position an object at a location in a patient's body where there is only limited access.
• Thepositioning apparatus56 positions theguide rod50 relative to the patient'strachea28 during insertion of the guide rod into the patient's trachea. In addition, thepositioning apparatus56 provides an indication of the distance which the guide rod is to be moved into the patient's trachea. By using thepositioning apparatus56, a person moving theguide rod50 into the patient'strachea28 can know where theleading end portion52 of the guide rod is located relative to the trachea.
• Theflexible guide rod50 may be formed of either polymeric material or metal. The illustratedpolymeric guide rod50 has a relatively small diameter and is readily deflected. Theguide rod50 has a circular cross sectional configuration.
• Theguide rod50 is axially movable relative to thepositioning apparatus56 under the influence of force manually applied to the portion of the guide rod disposed to the left (as viewed inFIG. 1) of thepositioning apparatus56. This force results in axial movement of theguide rod50 relative to thepositioning apparatus56. In addition, the leadingend52 of theguide rod50 may deflect body tissue to clear a passage for theguide rod50.
• As theguide rod50 is moved axially relative to thepositioning apparatus56, the guide rod may be resiliently deflected by engagement with the body tissue of the patient. As theguide rod50 is manually pushed toward the right (as viewed inFIG. 1), the leadingend52 of the guide rod moves toward thelarynx30.
• Thepositioning apparatus56 is used to locate theleading end portion52 of theguide rod50 as the guide rod moves toward thelarynx30. Thepositioning apparatus56 includes abase section78 and an arcuate upper section80 (FIG. 1). Thebase section78 engages the patient's Adam'sapple34 to locate thepositioning apparatus56 relative to the patient'strachea28. Theupper section80 of thepositioning apparatus56 guides movement of theguide rod50 during insertion of the guide rod into the patient'strachea28.
• Thebase section78 andupper section80 of thepositioning apparatus56 cooperate to provide a measurement of the distance between the patient'smouth12 and the patient's Adam'sapple34. This distance will vary from patient to patient depending upon the size of the patient, the specific configuration of thehead10 of the patient, and other factors. The distance which theguide rod50 must be moved axially into the patient'slarynx30 will vary as a function of variations in the distance between the patient'smouth12 and the patient's Adam'sapple34. This is because the patient's Adam'sapple34 is located adjacent to the entrance to thetrachea28.
• Thepositioning apparatus56 can be used to position many different objects at desired locations in a patient's body. For example, theguide rod50 or a similar member could be inserted into a patient's stomach or colon. Thebase section78 of the positioning apparatus would be positioned in engagement with an exterior surface on the patient's body at a location where theleading end portion52 of theguide rod50 is to be moved. Theupper section80 of thepositioning apparatus56 would cooperate with thebase section78 and guiderod50 to provide a clear indication of the location of theleading end portion52 of theguide rod50 relative to the patient's body tissue, for example, the patient's stomach or colon.
• The base section78 (FIG. 1) of thepositioning apparatus56 includes a tubularcylindrical body section86. Thebase section78 also includes apositioning section96 which engages the patient's Adam'sapple34 and is supported by thebody section86. Thepositioning section96 engages the patient's Adam'sapple34. Although the illustrated positioning section96 (FIG. 1) engages only a single location on the patient'sneck16, the positioning section could be constructed so as to engage a plurality of locations on the patient's neck. For example, it may be preferred to use apositioning section96 having two positioning fingers disposed on laterally opposite sides of the Adam'sapple34.
• It is contemplated that thepositioning section96 could have many different constructions. It is believed that it may be particularly advantageous to utilize apositioning section96 having the construction illustrated inFIGS. 25 and 26 herein. Alternatively, thepositioning section96 may have the construction illustrated inFIGS. 27 and 28 orFIGS. 4 and 7 herein if desired.
• Force may be manually applied against thepositioning section96 to straighten thetrachea28 of the patient. Thus, the patient'strachea28 may have a slight anterior bend when the patient'shead10 is in the position illustrated inFIG. 1. This slight bend can be eliminated by the manual application of minimal force to thepositioning section96. This force presses thepositioning section96 against the patient's neck.
• Although it is preferred to use the patient's Adam'sapple34 to locate thepositioning apparatus56 relative to the patient'strachea28, a different portion of the patient's body could be used to locate the positioning apparatus relative to the patient's trachea. For example, the patient's shoulders could be used. Alternatively, bones in the patient'sneck16 could be used to locate thepositioning apparatus56 relative to the patient'strachea28. However, it is believed that it will be preferred to use the patient's Adam'sapple34 to locate thepositioning apparatus56 due to the close proximity of the patient's Adam's apple to the upper end of the patient'strachea28.
• The arcuateupper section80 of thepositioning apparatus56 includes anarcuate member108 which is slidably connected with thebody section86 at aconnection110. Theconnection110 is movable axially along thecylindrical body section86. Thebody section86 is movable transversely to thearcuate member108, in the manner indicated by thearrows112 inFIG. 1. Suitable indicia, indicated by lines inFIG. 1, may be provided on thearcuate member108 to indicate the position of theconnection110 relative to the arcuate member.
• Theconnection110 may include a plurality of set screws (not shown) having manually engagable flanges or arms. One of the set screws may be tightened to prevent movement between thebody section86 and theconnection110. Another set screw may be tightened to prevent movement between thearcuate member108 and theconnection110.
• When theconnection110 has been moved to a desired location along thebody section86, a set screw in the connection is tightened to hold thearcuate member108 against axial movement along to thecylindrical body section86. Thearcuate member108 is then moved transversely to thebody section86, that is, in the direction of thearrows112, to position aguide section114 in alignment with the patient'smouth12 andtrachea28. When thetubular guide section114 has been aligned with the patient'strachea28, another set screw in theconnection110 is tightened to hold thearcuate member108 against transverse movement relative to thebody section86.
• Theguide rod50 extends through a cylindrical passage in theguide section114. Therefore, transverse movement of thearcuate member108 relative to thebody section86, that is, in the direction indicated by thearrows112 positions theguide rod50 in alignment with the patient'smouth12. Theguide rod50 is axially movable relative to theguide section114 into the patient'smouth12 andtrachea28.
• In the illustrated embodiment of the invention, the distance between the patient's Adam'sapple34 and thearcuate member108 is indicated by indicia124 (FIG. 1). Theindicia124 is disposed on thecylindrical body section86 of thepositioning apparatus56. The position of theconnection110 relative to theindicia124 indicates the distance which the arcuate member is spaced from thepositioning section96. The distance which theconnection110 is spaced from thepositioning section96 is a function of the distance between the patient's Adam'sapple34 and the entrance to the patient'smouth12.
• In the illustrated embodiment of the invention, theindicia124 is formed by a plurality ofcolored bands130. Each of thebands130 has a different color from the other bands. Each of thebands130 has the same axial extent. However, the bands could have different axial extents if desired. Rather than using the coloredbands130 as theindicia124, numerical indicia could be provided. However, it is believed that it may be easier to read the differentcolored bands130 than to read numerical indicia.
• Colored bands142 are provided on theguide rod50. Thecolored bands142 have different colors which correspond to the colors of thebands130 on thecylindrical body section86 of thepositioning apparatus56. Thecolored bands142 on theguide rod50 are spaced from theend portion52 of the guide rod by the same distance which correspondingly coloredbands130 on thebody section86 are spaced from the center of the Adam'sapple34.
• Thebands142 on theguide rod50 cooperate with an end portion156 (FIG. 1) of theguide section114 to indicate when theleading end portion52 of the guide rod is in a desired position relative to the patient'strachea28. Thus, assuming that a redcolored band130 on thecylindrical body section86 of thepositioning apparatus56 is aligned with theconnection110, the red band on theguide rod50 will be moved to a position in which it is adjacent to theguide section114. When theguide rod50 has been moved to a position in which the red band is adjacent to theguide section114, theleading end portion52 of the guide rod will have moved through a desired distance into the patient'strachea28 and will be aligned with the patient's Adam'sapple34.
• When thepositioning apparatus56 is to be associated with a different portion of a patient's body, theindicia124 would be revised to correspond to the distance which theguide rod50 is to be moved relative to thearcuate member108 to bring theleading end portion52 of the guide rod into alignment with thepositioning section96 or to a position spaced a desired distance from the positioning section. It is contemplated that thepositioning apparatus56 maybe used during endoscopic, arthroscopic, or fiber optic surgery at many locations in a patient's body, for example during surgery on joints in the patient's body.
• Thepositioning apparatus56 may be used in association with the delivery of medicants to relatively inaccessible locations in a patient's body. For example, a medicant could be connected with theleading end portion52 of theguide rod50 and released when theindicia124 indicated that the medicant has been moved to a desired position relative to thepositioning section96. The medicant may be released by activating a holder, disposed at theleading end portion52 of the guide rod. A Bowden cable or other actuator may extend through the guide rod to the medicant holder to operate the medicant holder from a closed condition to an open condition to release the medicant.
• Tracheal Intubination
• Once theguide rod50 has been moved through a desired distance into the patient'strachea28, thepositioning apparatus56 is separated from theguide rod50 while the guide rod remains stationary relative to the patient's trachea. Thus, once theindicia142 on theguide rod50 indicates that theleading end portion52 of the guide rod has been moved through a desired distance into the patient'strachea28, axial movement of theguide rod50 is interrupted. At this time, one of thecolored bands142 on theguide rod50 corresponding to the one of thecolored bands130 aligned with theconnection110, is aligned with theend surface156 on theguide section114.
• Theguide section114 is then slid axially outward, that is toward the left as viewed inFIG. 1, along theguide rod50. During this sliding movement of theguide section114 along theguide rod50, the guide rod is manually held against movement relative to the patient'smouth12 andtrachea28. Theupper section80 andbase section78 are separated from the patient during movement of theguide section114 along theguide rod50. As this occurs, theguide rod50 is stationary relative to the patient.
• Once theupper section80 has been separated from theguide rod50, the tracheal tube38 (FIG. 2) is slid along theguide rod50 into the patient'strachea28. Thus, the end of theguide rod50 remote from the patient'smouth12 andtrachea28 is inserted into thetracheal tube38. As this is done, theguide rod50 is manually held against movement relative to the patient'smouth12 andtrachea28. Thetracheal tube38 is then moved axially along theguide rod50 while theleading end portion52 of the guide rod remains stationary in the patient's trachea.
• As thetracheal tube38 is moved axially along theguide rod50, the guide rod directs the leading end portion of the tracheal tube into the patient'slarynx30 and past thevocal cords32. The leading end of thetracheal tube38 is centered in the space between the vocal cords and the entrance to the patient's trachea by theguide rod50. This minimizes irritation of the patient'svocal cords32. Thetracheal tube38 is moved along theguide rod50 at least until the leading end of the tracheal tube engages theleading end portion52 of theguide rod50.
• It is contemplated that it may be desired to move thetracheal tube38 further into the patient'strachea28 than the distance which theguide rod50 is moved into the patient's trachea. If this is the case, thetracheal tube38 is pushed axially along theguide rod50 past theleading end portion52 of the guide rod. As this occurs, theleading end portion52 of theguide rod50 is compressed slightly and enters thetracheal tube38.
• Once thetracheal tube38 has been moved to a desired depth into the patient'strachea28, theguide rod50 is removed from the tracheal tube (FIG. 7). Thetracheal tube38 then provides a passage for the conduction air, other gases, and/or medication to the patient's lungs Laryngoscope.
• This contemplated that a laryngoscope170 (FIG. 3) maybe connected with theconnection110 which interconnects thebody section86 and arcuateupper section80 of thepositioning apparatus56. Thelaryngoscope170 andbody section86 are moveable relative to each other to enable the laryngoscope to be positioned in the patient'smouth12. As thelaryngoscope170 is inserted into the patient'smouth12, the laryngoscope engages the patient's tongue. The laryngoscope then holds the patients tongue in a desired position in themouth12 of the patient.
• Thelaryngoscope170 is then inserted further into the patient'smouth12 to expose progressively deeper structures within the oropharynx. Thelaryngoscope170 could be advanced to facilitate visualization of the glottic opening in a known manner. Although the laryngoscope may be provided as part of thepositioning apparatus56, in the manner illustrated inFIG. 3, it is contemplated that thelaryngoscope170 could be separate from the positioning apparatus if desired. Regardless of whether thelaryngoscope170 is formed as part of thepositioning apparatus56 or separate from the positioning apparatus, the laryngoscope is utilized in a known manner in management of the patient's tongue and airway.
Second Embodiment
• A second embodiment of the invention is illustrated inFIGS. 4 through 10. Since the embodiment of the invention illustrated inFIGS. 4-10 is generally similar to embodiment of the invention illustrated inFIGS. 1-3, similar terminology will be utilized to refer to similar components.
• A portion of a patient'shead210 has been illustrated schematically inFIG. 4. The patient's head includes amouth212 which is connected with athroat214 and aneck216 of the patient. Although the patient'shead210 has been schematically illustrated in an upright orientation inFIG. 4, it should be understood that the patient's head could be in a different orientation if desired. For example, the patient'shead210 could be in the orientation illustrated inFIGS. 1 and 2 for the patient'shead10.
• Apharynx220 extends downward from anasal cavity222 in thehead210 of the patient. Thepharynx220 is connected with anesophagus226 and atrachea228 in theneck216 of the patient. Theesophagus226 extends from thepharynx220 to the stomach of the patient. Thetrachea228 extends from the pharynx to the bronchial tubes and lungs of the patient.
• The trachea228 (FIG. 4) has anupper end portion230 which is referred to as the larynx. Vocal cords or folds232 have been indicated schematically inFIG. 3 and are disposed in thelarynx230. Thevocal cords232 are adjacent to the Adam'sapple234 of the patient. The Adam'sapple234 is a laryngeal prominence formed by lamina of cartilage in the larynx.
• Opening of a passage for air from the patient's mouth to the patient's lungs may require insertion of a flexible tracheal tube238 (FIG. 10). Movement of the flexibletracheal tube238 from the patient'smouth212 into thepharynx220 of the patient is relatively easily accomplished. However, directing thetracheal tube238 into the patient'strachea228 may present difficulties. This is because ananterior bend240 must be formed in thetracheal tube238. Theanterior bend240 extends around theepiglottis242 into thelarynx230 at the upper end of thetrachea228. Theanterior bend240 can be minimized by placing the patient in the orientation illustrated inFIGS. 1 and 2.
• During movement of the leading end of thetracheal tube238 through thelarynx230, it is desirable to have the tracheal tube near the central portion of the laryngeal cavity in order to minimize irritation of the vocal folds orcords232 by the tracheal tube. In accordance with a feature of the present invention, a flexible guide wire or rod250 (FIGS. 4 and 9) is utilized to guide movement of the flexible tracheal tube238 (FIGS. 9 and 10) into thetrachea228. The flexible guide rod250 (FIG. 9) has a soft generally sphericalleading end portion252. Theleading end portion252 of theguide rod250 is formed of a resiliently compressible material which is readily deflected by engagement with the vocal cords or folds232 and by engagement with the surface of thetrachea228. If desired, theleading end portion252 of theguide rod250 may be coated with a suitable lubricant to facilitate movement of the leading end portion between the vocal cords with minimum of irritation.
• In accordance with another feature of the invention, theguide wire250 is initially positioned relative to the patient'strachea228 with a positioning apparatus256 (FIG. 4). Thepositioning apparatus256 engages the patient's Adam'sapple234 to locate the positioning apparatus relative to thetrachea228 of the patient. In addition, thepositioning apparatus256 provides a measurement which is a function of the distance between the Adam'sapple234 and themouth212 of the patient. This measurement is utilized to determine the distance through which theguide rod250 is to be moved relative to thepositioning apparatus256 as the guide rod is inserted into thetrachea228.
• In accordance with still another feature of the present invention, a magnet260 (FIG. 4) is utilized to attract theleading end portion252 of theguide rod250 and to steer the leading end portion of the guide rod into the patient'strachea228. Themagnet260 is a permanent magnet formed of a strongly magnetizable material such as cobalt and neodymium. Of course, other known magnetizable materials having high saturation magnetization values, such as cerium, praseodymium, and/or samarium with cobalt and/or other materials, could be used. Alternatively, themagnet260 may be an electromagnet.
• To enable theleading end portion252 of theguide rod250 to be attracted by a magnetic field emanating from themagnet260, theleading end portion252 of the guide rod contains ferrite particles. The ferrite particles may or may not be magnetized. Or course, other known magnetizable or magnetic particles could be utilized. When a magnet is positioned on theleading end portion252 of theguide rod250, the polarity of the leading end of the magnet on the guide rod is opposite from the polarity of themagnet260.
• As theguide rod250 is moved downward (as viewed inFIG. 4) along the patient's pharynx toward thelarynx230, theleading end portion252 of the guide rod enters the field of themagnet260. The field of themagnet260 has sufficient strength to cause theguide rod250 to deflect slightly toward the right (as viewed inFIG. 4). As this occurs, theleading end portion252 of the guide rod moves into thelarynx230 at a location adjacent to the center of the larynx. This enables theleading end portion252 of theguide rod250 to move between the vocal cords or folds232 with a minimum of irritation to the vocal cords. Although themagnet260 is described herein as steering theleading end portion252 of theguide rod250 into the trachea, it is contemplated that the magnet could be utilized to steer members at many different locations in a patient's body.
• Themagnet260 may be an electromagnet. If themagnet260 is an electromagnet, the magnet may be turned on and off, that is, energized and de-energized during steering of theleading end portion252 of theguide250. If desired, theleading end portion252 of theguide rod250 could also be formed by an electromagnet. If this was done, conductors for connecting theleading end portion252 of theguide250 would extend along the inside of the guide rod. By reversing the direction of current flow to either the electromagnet forming themagnet260 or the electromagnet forming theleading end portion252 of theguide rod250, the two electromagnets could be made to sequentially attract and repel each other.
• Steering of theleading end portion252 of theguide rod250 with themagnet360 is facilitated by moving the magnet along the patient'sneck216, in the manner indicated schematically inFIG. 7. Themagnet360 may be moved up and down along the patient's neck. Themagnet360 may also be moved sidewards relative to the patient's neck. By moving themagnet360 relative to the patient's neck, a magnetic field emanating from the magnet is effective to pull theleading end portion252 of theguide rod250 in the desired direction.
• Although the use of themagnet260 has been disclosed herein in association with the embodiment of the invention illustrated inFIGS. 4-10, it is contemplated that themagnet260 could be used in association with other embodiments of the invention. For example, themagnet260 could be used with the embodiment of the invention illustrated inFIGS. 1 and 2.
• Themagnet260 may be used to steer devices other than theguide rod250. When the positioning apparatus56 (FIG. 1) is to be associated with a portion of a patient's body other than the trachea, the magnet260 (FIG. 4) could be used to steer any one of many different devices to a desired location in the patient's body. A positioning apparatus, similar to thepositioning apparatus56 ofFIG. 1 or thepositioning apparatus256 ofFIG. 4, and a magnet, similar to themagnet260 may be used during endoscopic, arthroscopic, or fiber optic surgery at many different locations in a patient's body. Thus, themagnet260 may be used to steer a guide rod being positioned relative to a joint by a positioning apparatus, similar to thepositioning apparatus56 ofFIG. 1 and thepositioning apparatus256 ofFIG. 4, during surgery at the joint. Themagnet260 may also be used to position medicants at desired locations in the patient's body. Although it is believed that themagnet260 will be advantageously used in association with a positioning apparatus similar to thepositioning apparatus56 ofFIG. 1 or theother positioning apparatus256 ofFIG. 4, the magnet may be used in situations where the positioning apparatus is not required.
• Positioning Apparatus ofFIGS. 4-10
• The positioning apparatus256 (FIG. 4) positions theguide rod250 relative to the patient'strachea228 during insertion of the guide rod into the patient's trachea. In addition, thepositioning apparatus256 provides an indication of the distance which the guide rod is to be moved into the patient's trachea. By using thepositioning apparatus256, a person moving theguide rod250 into the patient'strachea228 can know where theleading end portion252 of the guide rod is located relative to the trachea.
• During movement of theguide rod250 into the patient's trachea, the guide rod is moved axially through a flexible, generally cylindrical, guide tube264 (FIG. 5). Theguide tube264 is formed of a resilient polymeric material. Theguide tube264 has amain section266 and aleading end section268. Theleading end section268 has aside wall270 which is thinner than aside wall272 of themain section266. Theside wall270 is integrally molded as one piece with thethicker side wall272. A generally cylindrical passage274 (FIG. 5) extends axially through theguide tube264.
• The thin walledleading end section268 of theguide tube264 is molded so as to naturally assume the arcuate configuration illustrated inFIGS. 4 and 5. This enables theend section268 of theguide tube264 to be positioned in the patient's pharynx220 (FIG. 4) with the end section forming a bend which extends around the upper end portion of the patient'sepiglottis242. Since theleading end section268 has a relatively thin side wall (FIG. 5), the end section can be easily deflected as it is moved into position in the patient'spharynx220. Thethicker side wall272 of themain section266 of theguide tube264 is effective to support theleading end section268 in the patient'spharynx220 and to depress a tongue76 in themouth212 of the patient (FIG. 1).
• Theguide rod250 may be formed of either polymeric material or metal. The illustratedpolymeric guide rod250 has a relatively small diameter and is readily deflected. Theguide rod250 has a circular cross sectional configuration.
• Theguide rod250 extends axially through the guide tube264 (FIG. 4). Theguide rod250 is axially movable relative to theguide tube264 under the influence of force manually applied to the portion of the guide rod disposed to the right (as viewed inFIG. 4) of thepositioning apparatus256. This force results in axial movement of theguide rod250 along theguide tube264.
• As theguide rod250 is axially moved along theguide tube264, the arcuateleading end section268 of theguide tube264 resiliently deflects theguide rod250 to form the arcuate bend illustrated inFIG. 4. As theguide rod250 is manually pushed toward the left (as viewed inFIG. 4), the leadingend52 of the guide rod moves downward (as viewed inFIG. 4) toward thelarynx230. As theleading end252 of theguide rod250 moves downward (as viewed inFIG. 4), tissues which may tend to block movement of the guide rod are pushed aside by the leading end of the guide rod. This clears a passage for theguide rod250.
• Thepositioning apparatus256 is used to locate theleading end portion252 of theguide rod250 as the guide rod moves along theguide tube264. Thepositioning apparatus256 includes abase section278 and an upper section280 (FIG. 4). Thebase section278 engages the patient's Adam'sapple234 to locate thepositioning apparatus256 relative to the patient'strachea228. Theupper section280 of thepositioning apparatus256 holds theguide tube264 which guides movement of theguide rod250 during insertion of the guide rod into the patient'strachea228.
• Thebase section278 andupper section280 of thepositioning apparatus256 cooperate to provide a measurement of the distance between the patient'smouth212 and the patient's Adam'sapple234. This distance will vary from patient to patient depending upon the size of the patient, the specific configuration of thehead210 of the patient, and other factors. The distance which theguide rod250 must be moved axially relative to theguide tube264 to move theleading end portion252 of the guide rod into the patient'slarynx230 will vary as a function of variations in the distance between the patient'smouth212 and the patient's Adam'sapple234. This is because the patient's Adam'sapple234 is located adjacent to the entrance to thetrachea228.
• Thebase section278 of thepositioning apparatus256 includes an upright tubularcylindrical body section286. Thebody section286 has acylindrical chamber288. The cylindricalupper section280 of thepositioning apparatus256 is telescopically received in thechamber288.
• In addition, thebase section278 includes anend section290. Theend section290 extends perpendicular to thebody section286. Theend section290 has a cylindricalcentral passage292 which extends perpendicular to and intersects the central axis of thechamber288. Thebody section286 and theend section290 are integrally molded as one piece of polymeric material.
• Thebase section278 also includes apositioning section296 which engages the patient's Adam'sapple234 and is supported by theend section290. Thepositioning section296 includes acylindrical support rod298 which extends through thepassage292 and is connected with a locatingportion302 which engages the patient's Adam'sapple234. The locatingportion302 includes a generallyhemispherical dome304 and a resilientannular collar306 which is connected to the rim of thedome304. Thecollar306 extends around the Adam'sapple234 and engages upper and lower sides and left and right sides of the Adam's apple to center thedome304 on the Adam's apple.
• If desired, the locatingportion302 could be constructed to engage only two sides of the Adam'sapple234. For example, the left and right sides of the Adam'sapple234. It is believed that it may be desired to form the locatingportion302 with the construction illustrated inFIGS. 25 and 26 herein. Alternatively, the locatingportion302 could be constructed so as to engage only the central portion of the Adam'sapple234.
• However, it is believed that it may be desired to form the locatingportion302 so that it extends around the Adam'sapple234 so as to locate thepositioning section296 relative to the Adam's apple. Force may be manually applied against thepositioning section296 to minimize the anterior bend240 (FIG. 10) which must be formed in thetracheal tube238. Theend section290 is axially slidable along thesupport rod298 so that thebody section286 is disposed adjacent to thechin310 of the patient.
• Although it is preferred to use the patient's Adam'sapple234 to locate thepositioning apparatus256 relative to the patient'strachea228, a different portion of the patient's body could be used to locate the positioning apparatus relative to the patient's trachea. For example, the patient's shoulders could be used. Alternatively, bones in the patient'sneck216 could be used to locate thepositioning apparatus256 relative to the patient'strachea228. However, it is believed that it will be preferred to use the patient's Adam'sapple234 to locate thepositioning apparatus256 due to the close proximity of the patient's Adam's apple to the upper end of the patient'strachea228.
• Theupper section280 of thepositioning apparatus256 includes acylindrical rod portion314 which is telescopically received in thebody section286 of the positioning apparatus. Anupper end section316 has acylindrical passage318 through which theguide tube264 extends. Thepassage318 has a longitudinal central axis which extends parallel to the longitudinal central axis of thepassage292 and to the longitudinal central axis of thesupport rod298. Theguide tube264 is slidable in thepassage318.
• Theguide tube264 extends from thepassage318 into the patient'smouth212. Thus, thepassage318 in theupper section280 of thepositioning apparatus256 is axially aligned with the patient'smouth212. Similarly, the passage292 (FIG. 4) in theend section290 of thebase section278 of thepositioning apparatus256 is axially aligned with the patient's Adam'sapple234. Therefore, thepositioning apparatus256 can be utilized to measure the distance between the Adam'sapple234 and the patient'smouth212.
• The entrance through which theguide rod250 must pass into the patient'strachea228 is adjacent to the Adam'sapple234. Therefore, the distance through which theleading end portion252 of theguide rod250 must be moved relative to the guide tube264 (FIG. 4) to enter the patient'strachea228, is a function of the distance between the patient's Adam'sapple234 and the patient'smouth212. Thepositioning apparatus256 measures the distance between the patient's Adam'sapple234 and the patient's mouth by determining the position of thebase section278 andupper section280 of the positioning apparatus relative to each other.
• In the illustrated embodiment of the invention, the distance between the patient's Adam'sapple234 and the patient'smouth212 is indicated by indicia324 (FIG. 6). Theindicia324 is disposed on thecylindrical rod portion314 of theupper section280 of thepositioning apparatus256. Therod portion314 is telescopically received in thecylindrical chamber288 in thebody section286 of thepositioning apparatus256.
• The position of an annularupper end surface328 on (FIG. 6) thebody section286 relative to theindicia324 indicates the distance which therod portion314 is extended from thebody section286. The distance which therod portion314 is extended from thebody section286 is a function of the distance between the patient's Adam'sapple234 and the entrance to the patient'smouth212.
• In the illustrated embodiment of the invention, theindicia324 is formed by a plurality ofcolored bands330,332,334,336,338 and340 (FIG. 6). Each of the bands330-340 has a different color from the other bands. It should be understood that a lesser or greater number of colored bands330-340 could be provided if desired. It should also be understood that although the bands330-340 have the same axial extent, the bands could have different axial extents if desired. Rather than using the colored bands330-340 as theindicia324, numerical indicia could be provided. However, it is believed that it may be easier to read the different colored bands330-340 than to read numerical indicia.
• Bands342,344,346,348, and350 (FIG. 8) are provided on theguide rod250. The colored bands342-350 have different colors which correspond to the colors of the bands132-140 on the rod portion314 (FIG. 6) of thepositioning apparatus256. It should be understood that although only the bands342-350 having colors corresponding to the colors of the bands132-140 are illustrated, an additional band having a color corresponding to the color of theband330 inFIG. 6 is provided on theguide rod250.
• The bands342-350 (FIG. 8) on theguide rod250 cooperate with an annular end surface356 (FIG. 4) on theguide tube264 to indicate when theleading end portion252 of the guide rod is in a desired position relative to the patient'strachea228. Thus, assuming that thecolored band334 on therod portion314 of thepositioning apparatus256 is aligned with theend surface328 on the body section286 (as illustrated inFIG. 6), the band344 (FIG. 8) on theguide rod250 will be moved to a position in which it is partially covered by theguide tube264 and projects outward from the end surface356 (FIG. 4) for a distance corresponding to the distance which theband334 projects outward from theend surface328 on the body section286 (FIG. 5). Theband344 has a color which is the same as the color of theband334. When theguide rod250 has been moved to a position in which theband344 is partially enclosed by theguide tube264, theleading end portion252 of the guide rod will have moved through a desired distance into the patient'strachea228, for example, a distance of approximately ten centimeters.
• The bands342-350 (FIG. 8) on theguide rod250 are spaced a predetermined distance from the end surface356 (FIG. 4) on theguide tube264 when theleading end portion252 of the guide rod is disposed in abutting engagement with theleading end section268 of theguide tube264. During movement of the indicia on theguide rod250 from a position spaced from theend surface356 of theguide tube264 to a position in which the leading band on the guide rod150 is adjacent to theend surface356, theleading end portion252 of theguide rod250 will have moved from thepharynx220 of the patient and into thelarynx230 past thevocal cords232.
• As theguide rod250 continues to be manually pushed into theguide tube264, theleading end portion252 of the guide rod advances downward (as viewed inFIG. 4) in thetrachea228 of the patient. Movement of theguide rod250 into thetrachea228 of the patient is interrupted when theband344 having a color corresponding to the color of the band334 (FIG. 6) has been partially covered by theguide tube264.
• Themagnet260 is utilized to steer theguide rod250 during movement of theleading end portion252 of the guide rod from the patient'smouth212 into the patient'strachea228. As theleading end portion252 of theguide rod250 is moved downward along the inside of the patient's neck, themagnet360 is moved downward along the outside of the patient's neck. The magnetic field provided by themagnet360 is effective to pull theleading end portion252 downward as the magnet moves downward. Eventually, theleading end portion252 of theguide rod250 andmagnet260 will move downward from the entrance to thetrachea228 through a desired distance, for example a distance of approximately ten centimeters. Of course, theleading end portion252 of theguide rod250 could be moved through a different distance into thetrachea228 if desired.
• It is contemplated that the distance between the patient's Adam'sapple234 and the entrance to the patient'smouth212 will vary from patient to patient. However, the distance which theleading end portion252 of theguide rod250 is moved into the patient'strachea228 will remain constant at a desired distance, for example, ten centimeters. This is because as the distance measured by thepositioning apparatus256 increases, the distance which theguide rod250 is moved relative to theguide tube264 increases. Conversely, as the distance which is measured by thepositioning apparatus256 decreases, the distance which theguide rod250 is moved relative to theguide tube264 decreases. The distance which is measured by thepositioning apparatus256 varies as a function of the distance between themouth212 andlarynx230 of the patient.
• Tracheal Intubination
• Once theguide rod250 has been moved through a desired distance into the patient'strachea228, theguide tube264 andpositioning apparatus256 are separated from theguide rod250 while the guide rod remains stationary relative to the patient's trachea. Thus, once the indicia on theguide rod250 indicates that theleading end portion252 of the guide rod has been moved through a desired distance into the patient'strachea228, axial movement of theguide rod250 is interrupted. At this time, one of the colored bands342-350 on theguide rod250 corresponding to the one of the colored bands330-340 aligned with the end surface328 (FIG. 4) on thebody section286 of the positioning apparatus is aligned with the end surface356 (FIG. 4) on theguide tube264.
• Theguide tube264 is then slid axially outward, that is toward the right as viewed inFIG. 4, along theguide rod250. During this sliding movement of theguide tube264 along theguide rod250, the guide rod is manually held against movement relative to the patient'smouth212 andtrachea228. Thepositioning apparatus256 is moved away from the patient along with theguide tube264.
• Once theguide tube264 has been separated from the guide rod250 (FIG. 9), thetracheal tube238 is slid along theguide rod250 into the patient'strachea228. Thus, the end of theguide rod250 remote from the patient'smouth212 andtrachea228 is inserted into thetracheal tube238. As this is done, theguide rod250 is manually held against movement relative to the patient'smouth212 andtrachea228. Thetracheal tube238 is then moved axially along theguide rod250 while theleading end portion252 of the guide rod remains stationary in the patient's trachea. If desired, themagnet260 may be utilized to attract theleading end portion252 of theguide rod250, in the manner illustrated inFIG. 9, to facilitate maintaining of the leading end portion of the guide rod stationary in the patient'strachea228.
• As thetracheal tube238 is moved axially along theguide rod250, the guide rod directs the leading end portion of the tracheal tube along a bend360 (FIG. 9) formed in the guide rod. After the leading end portion of thetracheal tube238 has moved around thebend360, the leading end portion of the tracheal tube enters the patient's larynx and moves past thevocal cords232. The leading end of thetracheal tube238 is centered in the space between the vocal cords and the entrance to the patient's trachea by theguide rod250. This minimizes irritation of the patient'svocal cords232. Thetracheal tube238 is moved along theguide rod250 at least until the leading end of the tracheal tube engages theleading end portion252 of theguide rod250.
• It is contemplated that it may be desired to move thetracheal tube238 further into the patient's trachea than the distance which theguide rod250 is moved into the patient's trachea. If this is the case, thetracheal tube238 is pushed axially along theguide rod250 past theleading end portion252 of the guide rod. As this occurs, theleading end portion252 of theguide rod250 is compressed slightly and enters thetracheal tube238.
• Once thetracheal tube238 has been moved to a desired depth into the patient'strachea228, theguide rod250 is removed from the tracheal tube (FIG. 10). Thetracheal tube238 then provides a passage for the conduction air, other gases, and/or medication to the patient's lungs.
• Method of Utilization
• When thetracheal tube238 is to be inserted into a patient'strachea228, theguide rod250 is first positioned relative to theguide tube264 at a location spaced from the patient. At this time, theleading end portion252 of theguide rod250 is disposed in abutting engagement with theleading end portion268 of theguide tube264. Theupper section280 of thepositioning apparatus256 is loosely positioned on theguide tube264. The lower orbase section278 of thepositioning apparatus256 is separate and spaced from theupper section280 of the positioning apparatus. A suitable lubricant may be applied to theleading end portion252 of theguide rod250 and to theleading end portion268 of theguide tube264.
• Theguide tube264 is then inserted into the patient'smouth212. As theguide tube264 is inserted into the patient's mouth, theleading end portion268 of theguide tube264 and theleading end portion252 of theguide rod250 move from the patient's mouth into thepharynx220 of the patient. As theleading end portion268 of theguide tube264 moves into thepharynx220 of the patient, the natural resilience of the material of the guide tube causes the guide tube to spring back to its initial or free configuration illustrated inFIGS. 3 and 4.
• As theguide tube264 and guiderod250 are manually moved together into the patient'smouth212, the guide tube bends itself around the upper (as viewed inFIG. 3) portion of the patient'sepiglottis242. This results in theleading end portion252 of theguide rod250 being pointed downward (as viewed inFIG. 3) toward the lower end portion of the patient'spharynx220. A person initially inserting theguide tube264 and guiderod250 into the patient'smouth212 can visually ascertain when the guide tube and guide rod have moved to the position illustrated inFIG. 3.
• When theguide tube264 and guiderod250 have been positioned in this manner relative to the patient'smouth212 andpharynx220, thepositioning apparatus256 is assembled. To assemble the positioning apparatus, therod portion314 of theupper section280 is telescopically inserted into thechamber288 in thebody section286 of the positioning apparatus. Contemporaneously therewith, the locatingportion302 of thepositioning apparatus296 is moved into engagement with the patient's Adam'sapple234. Thebase section278 andupper section280 of thepositioning apparatus256 are moved axially along theguide tube264 andsupport rod298 until the base section and upper section of thepositioning apparatus256 are adjacent to the patient's chin310 (FIG. 4). At this time, the coincident central axes of therod portion314 andbody section286 of thepositioning apparatus256 will extend perpendicular to the central axes of theguide tube264 andsupport rod298.
• Themagnet260 is then positioned immediately beneath the patient's Adam'sapple234. This enables the magnetic field from themagnet260 to extend leftward and upward (as viewed inFIG. 4) to the entrance to the patient'slarynx230. This results in themagnet260 andpositioning apparatus256 being disposed in the orientation illustrated inFIG. 3 relative to the patient.
• Once thepositioning apparatus256,guide tube264 and guiderod250 have been moved to the positions shown inFIG. 3 relative to the patient'shead210, the person using thepositioning apparatus256 visually determines the distance between the patient's Adam'sapple234 and the patient'smouth212. This is accomplished by viewing the indicia324 (FIG. 6) on therod portion314 of thepositioning apparatus256. By determining which of the bands330-340 is aligned with theend surface328 on thebody section286 of thepositioning apparatus256, the operator determines the distance between the patient's Adam's apple and the patient's mouth. The distance which theguide rod250 must be moved into the patient'strachea228 is a direct function of the distance between the patient's Adam'sapple234 and the patient'smouth212.
• The operator then begins to manually apply force against the rightward (as viewed inFIG. 4) portion of theguide rod250 while holding theguide tube264 against movement. This results in theleading end portion252 of the guide rod moving downward toward the entrance to the patient'slarynx230. As theguide rod250 begins to move downward, the bentleading end portion268 of the guide tube60 directs theleading end portion252 of theguide rod80 downward around the patient'sepiglottis242 in a direction toward the entrance to thelarynx230.
• It is contemplated that the resilientlydeflectable guide rod250 will initially be formed with a bend which is a continuation of the bend in the leading end portion of theguide tube264. Therefore, the natural resilience of theguide rod250 will tend to cause the guide rod to bend rightward toward the patient's Adam's apple as theleading end portion252 of the guide rod begins to move downward toward thelarynx230.
• As theleading end portion252 of theguide rod250 approaches the entrance to thelarynx230, the field emanating from themagnet260 attracts theleading end portion252 of theguide rod250. The magnetic attraction forces applied to theleading end portion252 of theguide rod250 also promote rightward (as viewed inFIG. 4) bending of theguide rod250 toward the patient's Adam'sapple234. Thus, the combined effect of themagnet260 and the natural resilience of the preformedguide rod250 urge theleading end portions52 of theguide rod250 toward the entrance to thelarynx230 and away from the adjacent entrance to theesophagus226. This ensures that theleading end portion252 of theguide rod250 enters thetrachea228 rather than theesophagus226. If desired, themagnet260 could be positioned above or on the patient's Adam'sapple234 and then moved downward as theguide rod250 advances.
• If desired, theflexible guide rod250 could initially be formed with a straight configuration and only themagnet260 would steer theleading end portion252 of the guide rod into the entrance to thetrachea228. Alternatively, the use of themagnet260 could be eliminated and only the preformed configuration of theguide rod250 would be used to direct theleading end portion252 of the guide rod into the entrance to thetrachea228. However, it is believed that it will be preferred to use both the preformed configuration of theguide rod250 and themagnet260 to direct theleading end portion252 of the guide rod into the patient'strachea228.
• The colored bands342-350 (FIG. 8) on theguide rod250 cooperate with the end surface356 (FIG. 4) of theguide tube264 to provide an indication of the location of theleading end portion252 of the guide rod relative to the patient's Adam'sapple234. As theleading end portion252 of theguide rod250 moves downward from the position shown inFIG. 3 toward the entrance to thelarynx230, the indicia bands342-350 will move toward theend surface356 of theguide rod250. As theleading end portion252 of theguide rod250 moves through the entrance to thelarynx230, the indicia on theguide rod250 will be approaching theend surface356 of theguide tube264.
• Continued axial movement of theguide rod250 relative to thestationary guide tube264 moves theleading end portion252 of the guide rod to a position immediately above the patient'svocal cords232. As this occurs, theleading end portion252 of theguide rod250 is strongly attracted by the magnetic field emanating from themagnet260. Due to the approach of the indicia on theguide rod250 toward theend surface356 of theguide tube264, the operator realizes that theleading end portion252 of theguide rod250 is adjacent to themagnet260 and moves the magnet downward (as viewed inFIG. 4) along theneck216 of the patient as theguide rod250 continues to be moved leftward through thestationary guide tube264. As themagnet260 is manually moved downward (as viewed inFIG. 4) with theleading end portion252 of theguide rod250, the magnet continues to attract the leading end portion of the guide rod.
• One of the bands330-340, having a particular color, for instance, red, on the rod portion314 (FIG. 6) will be adjacent to theend surface328 on the body section of thepositioning apparatus256. When a correspondingly colored band, that is, when thered band344 on the guide rod250 (FIG. 8), is partially covered by theguide tube264 and extends axially outward from theend surface356, the operator will know that theleading end portion252 of theguide rod250 will have moved past the vocal232 to the desired position relative to the patient's trachea. Insertion of theguide rod250 into theguide tube264 is then interrupted.
• After theguide rod250 has been inserted for the desired distance into the patient'strachea228, theguide tube264 andpositioning apparatus256 are separated from theguide rod250. During separation of theguide tube264 andpositioning apparatus256 from theguide rod250, the guide rod is maintained stationary relative to a patient'strachea228. In the illustrated embodiment of the invention, theguide tube264 is merely moved rightward (as viewed in FIG.4) along thestationary guide rod250 to disengage the guide tube and the positioning apparatus from the guide rod.
• If desired, a slot could be provided in theguide tube264 to facilitate disengagement of the guide tube from the guide rod. A corresponding slot could be formed in theend section316 of thepositioning apparatus256. The slots in theguide tube264 andend section316 could be partially or fully blocked during insertion of theguide rod250 into theguide tube264. When theguide tube264 is to be separated from theguide rod250, that is after the guide rod has been inserted for the desired distance into the patient'strachea228, latch or closure members for the slots could be moved to open positions and theguide tube264 andapparatus256 moved out of engagement with thestationary guide rod250.
• Once theguide tube264 andpositioning apparatus256 have been disengaged from theguide rod250, the guide rod is utilized to guide movement of thetracheal tube238 into the patient'strachea228. Thetracheal tube238 has a substantially larger diameter than theguide tube264 to provide for a relatively large central opening through which air or other gas may pass into the patient'strachea228.
• When thetracheal tube238 is to be moved into the patient'strachea228, theguide rod250 is telescopically inserted into the leading end of the tracheal tube. At this time, the right end (as viewed inFIG. 4) of theguide rod250 will extend beyond the far right end of thetracheal tube238. Therefore, theguide rod250 can be manually grasped and thetracheal tube238 moved axially along the guide rod while the guide rod remains stationary relative to the patient'strachea228.
• Thetracheal tube238 is moved leftward, in the manner indicated by the arrow inFIG. 9, along thestationary guide rod250 into the patient'smouth212. Thetracheal tube238 is then moved around thebend360 in thestationary guide rod250 and into the patient'strachea228. Since theguide rod250 extends from the patient'spharynx220 into thetrachea228, theguide rod250 blocks movement of the leading end portion of thetracheal tube238 into the patient'sesophagus226. Theguide rod250 acts as a track along which thetracheal tube238 moves into the patient'slarynx230 and not into theadjacent esophagus226.
• As the leading end portion of thetracheal tube238 approaches and moves past thevocal cords232, theguide rod250 guides movement of the leading end portion of the tracheal tube in such a manner as to minimize irritation of the vocal cords. Thus, theguide rod250 centers the leading end portion of thetracheal tube238 in the space between the vocal cords. By lubricating the leading end portion of thetracheal tube238 and centering the leading end portion of the tracheal tube in the space between thevocal cords232, the tracheal tube can be moved into the patient'strachea228 with a minimal amount of irritation to the vocal cords.
• As thetracheal tube238 is moved through the patient'slarynx230, themagnet260 is disposed adjacent to theleading end portion252 of theguide rod250. Therefore, theleading end portion252 of theguide rod250 is attracted by themagnet260 and tends to remain stationary in the patient'strachea228. As thetracheal tube238 is inserted into the patient'strachea228, the leading end portion of thetracheal tube238 moves past theleading end portion252 of theguide rod250. As this occurs, theleading end portion252 of theguide rod250 is slightly compressed and moves into thetracheal tube238. Once thetracheal tube238 has moved to a desired position relative to thetrachea228, theguide rod250 is withdrawn from thetracheal tube238 while the tracheal tube is maintained stationary relative to the patient's trachea.
• In the embodiment of the invention illustrated inFIGS. 4-10, the magnet260 (FIG. 4) is utilized to attract theleading end portion252 of theguide rod250. However, it is contemplated that themagnet260 could be used for other purposes if desired. For example, themagnet260 could be used to position a suture anchor relative to body tissue.
• When themagnet260 is to be utilized to position a suture anchor relative to body tissue, a leading end portion of the suture anchor is formed of a magnetizable material, such a ferrite. Alternatively, the leading end portion of the suture anchor could be formed of a magnetic material such as cobalt, neodymium, cerium, praseodymium, and/or samarium. If this was done, themagnet260 would be oriented relative to the magnet on the suture anchor to have a pole of themagnet260 of opposite polarity to the leading end of the suture anchor toward the suture anchor.
• The trailing end portion of the suture anchor may be formed of a nonmagnetic material, such as a biodegradable polymer. The suture would extend through an opening in the nonmagnetic material of the trailing end portion of the suture anchor. Once the suture anchor had been moved to a desired position relative to body tissue by attraction of themagnet260 for the leading end portion of the suture anchor, the leading end portion of the suture anchor may be separated from the trailing end portion of the suture anchor. The leading end portion of the suture anchor could then be removed from the patient's body to eliminate the possibility of an undesired interaction in the future with a magnetic field device, such as a magnetic resonance imaging device (MRI). The suture would be held in place by the nonmagnetic trailing end portion of the suture anchor.
Embodiment of FIG.11
• In the embodiment of the invention illustrated inFIGS. 4-10, aguide tube264 is utilized to guide movement of theguide rod250 as the guide rod is moved from the patient'spharynx220 into the patient'strachea228. Theguide tube264 is then removed and atracheal tube238 is slid along theguide rod250 into the patient's trachea. In the embodiment of the invention illustrated inFIG. 11, the tracheal tube is used to guide movement of the guide rod into the patient's trachea. This eliminates the need for a separate guide tube. Since the embodiment of the invention illustrated inFIG. 11 is generally similar to the embodiment of the invention illustrated inFIGS. 4-9, similar numerals will be utilized to designate similar components, the suffix letter “a” being associated being associated with the numerals ofFIG. 11 to avoid confusion.
• A patient'shead210a(FIG. 11) includes amouth212awhich is connected with athroat214ain aneck216aof the patient. Apharynx220ais connected with anesophagus226aand atrachea228a. Alarynx230aforms an upper end portion of thetrachea228aand contains vocal cords232a. An Adam'sapple234ais formed by laminae of cartilage in the patient'slarynx230a.
• Apositioning apparatus256ais utilized to position atracheal tube238aand a guide rod orwire250aduring insertion of the guide rod and during insertion of the tracheal tube into the patient'strachea228a. Thetracheal tube238a(FIG. 11) is flexible and is formed of a resilient polymeric material. Thetracheal tube238ais initially formed with abend380 in a leading end portion of the tracheal tube. When thetracheal tube238ais released or unrestrained, the natural resilience of the tracheal tube causes thebend380 to form in the manner illustrated inFIG. 10. However, thetracheal tube238ais flexible so that thebend380 is easily removed from the tracheal tube by the application of a relatively small force or pressure against the leading end portion of the tracheal tube.
• In the embodiment of the invention illustrated inFIG. 10, thebend380 in thetracheal tube238ahas a greater extent than a corresponding bend in aleading end section268 of the guide tube264 (FIG. 4). If desired, the bend in thetracheal tube238a(FIG. 1) could be shortened so that the leading end portion of thetracheal tube238ahas a configuration which corresponds to the configuration of theguide tube264 ofFIG. 4.
• Thepositioning apparatus256a(FIG. 11) includes abase section278aand anupper section280a. Arod portion314aof theupper section280ais telescopically received in achamber288ain thebase section278a.Indicia324aon therod portion314acooperates with abody section286aof thebase section278ato provide a visual indication of the distance between the patient's Adam'sapple234aand the patient'smouth212ain the manner previously described in conjunction with the positioning apparatus ofFIG. 4.
• Thebase section278aof thepositioning apparatus256aincludes a positioning section96awhich engages the patient's Adam'sapple234a. The positioning section96aincludes a locatingportion302awhich engages the patient's Adam'sapple234a. The locatingportion302aincludes adome304aand a softannular collar306a. Rather than using thecollar306a, it may be preferred to utilize a pair of positioning fingers which engage theneck216aof the patient at laterally opposite sides of the Adam'sapple234a.
• Indicia (not shown) is provided on theguide rod250ato indicate the position of the guide rod relative to a proximal end of thetracheal tube238a, that is, the right end as viewed inFIG. 1. It should be understood that thetracheal tube238aand theguide rod250aextend toward the right from the fragmentary end portions illustrated inFIG. 1. The indicia on theguide rod250ais formed by bands corresponding to the bands342-350 ofFIG. 8. Rather than cooperating with the end156 (FIG. 4) of aguide tube264, the bands on theguide rod250a(FIG. 11) cooperate with an end (not shown) of thetracheal tube238ato indicate the position of theguide rod250arelative to thetracheal tube238a.
• When theguide rod250ais to be moved from the patient'spharynx220ainto the patient'strachea228a, the guide rod is moved axially relative to the stationarytracheal tube238a. As this occurs, aleading end portion252aof theguide rod250amoves downward (as viewed inFIG. 11) past the patient's vocal cords or folds32aand into the patient's trachea. As theleading end portion252aof theguide rod250amoves from the patient'spharynx220ainto the patient'strachea228a, the leading end portion of the guide rod gently deflects body tissue. For example, theleading end portion252aof theguide rod250amay gently engage and slightly deflect the patient's vocal cords or folds32a.
• Amagnet260ais initially positioned adjacent to the patient's Adam'sapple234a, in the manner indicated in dashed lines inFIG. 11. Ferrite particles in the soft, resiliently compressibleleading end portion252aof theguide wire250aare attracted by themagnet260a. This attraction causes theleading end portion252aof theguide wire250ato move into the open upper end portion of thetrachea228 rather than into the adjacent open upper end portion of theesophagus226a. In addition, movement of theleading end portion252aof theguide wire250ainto the open upper end portion of thetrachea228 is promoted by thebend380 in thetracheal tube238a. If desired, themagnet260acould initially be positioned on or above the patient's Adam'sapple234aand moved downward from there.
• As the guide wire continues to be inserted into thetracheal tube238a, the guide wire moves downward in the patient'strachea228a. At the same time, themagnet260ais moved downward along the outer side of the patient'sneck216a. The indicia (not shown) on theguide rod250aprovides an indication to an operator of the position of theleading end portion252aof the guide rod. This enables the operator to follow theleading end portion252aof theguide rod250awith themagnet260aas the guide rod continues to be moved through thetracheal tube238ainto the patient'strachea228a.
• Once theguide rod250ahas been moved for a desired distance into thetrachea228a, theguide rod250ais held stationary relative to the patient's trachea. Thetracheal tube238ais then moved axially toward the left (as viewed inFIG. 11) and downward into the patient'strachea228a. During this downward movement of thetracheal tube238a, theguide rod250ablocks sidewise movement of the leading end of the tracheal tube so that the tracheal tube enters thelarynx230arather than the adjacent open upper end of theesophagus226a. As thetracheal tube238acontinues to be inserted into thetrachea228a, the leading end of thetracheal tube238amoves into engagement with theleading end portion252aof theguide rod250a. Theleading end portion252aof theguide rod250ais then compressed somewhat by the leading end portion of thetracheal tube238aand moves into the passage in the tracheal tube. Thetracheal tube238ais then moved further into thetrachea228a.
• After thetracheal tube238ahas been positioned relative to the patient's trachea, theguide rod250ais withdrawn from the tracheal tube while the tracheal tube remains stationary relative to the patient'strachea228a. Thepositioning apparatus256ais then separated from thetracheal tube238a.
Embodiment of FIG.12
• In the embodiment of the invention illustrated inFIG. 1, aleading end portion52 of the guide wire orrod50 is inserted between the vocal cords or folds in therespiratory system11 of the patient. It's contemplated that movement of theleading end portion52 of theguide rod50 between thevocal cords32 to a desired depth in the patient'strachea28 may be facilitated by transmitting images of body tissue adjacent to the leading end portion of the guide rod to a viewing location outside of the patient's body. Since the embodiment of the invention illustrated inFIG. 12 is generally similar in the embodiment invention illustrated inFIGS. 1 and 2, similar numerals will be utilized to designate similar components, the suffix letter “b” being added to the numerals ofFIG. 12 in order to avoid confusion.
• Apositioning apparatus56bis utilized to position aflexible guide rod50brelative to the patient'srespiratory system11b. Thepositioning apparatus56bincludes abase section78bwhich is connected with apositioning section96b. Thepositioning section96bengages the patient's Adam'sapple34b. Anarcuate member108bis connected with thebase section78b. Theguide rod50bis moveable relative to aguide section114bconnected witharcuate member108b. The construction and the manner of using thepositioning apparatus56band guiderod50bis the same as was previously described in conjunction with the embodiment invention illustrated inFIGS. 1 and 2.
• In accordance with a feature the embodiment invention illustrated inFIG. 12, light from alight source400 is conducted through afiber optic tube402 to aleading end portion52bof theflexible guide rod50b. The light transmitted from thelight source400 through thefiber optic tube402 to theleading end portion52bof theguide rod50bis directed from the leading end portion of the guide rod on to adjacent body tissue, in the manner indicated schematically at404 inFIG. 12. If desired, a plurality of fiberoptic tubes402 could be provided to conduct light from thelight source400 to theleading end portion52bof the guide rod. These fiber optic tubes could be bundled together or could be spaced part at theleading end portion52bof theguide rod50b.
• The light404 which illuminates the body tissue immediately ahead of theleading end portion52bof theguide rod50bis reflected from the body tissue and is transmitted through afiber optic tube408 to theeye410 of a viewer. This results in the transmission of an image of the body tissue adjacent to theleading end portion52bof theguide rod50bto the viewer to facilitate visualization, by the viewer, of the body tissue. If desired, a plurality of fiberoptic tubes408 could be provided to conduct light from theleading end portion52bof the guide rod to theeye410 of the viewer. These fiber optic tubes could be bundled together or could be spaced apart at theleading end portion52bof theguide rod50b.
• By visualizing the body tissue immediately ahead of theleading end portion52bof theguide rod50b, the viewer can determine the location of the leading end portion of the guide rod relative to thelarynx30bandvocal chords32bof a patient as the leading end portion of the guide rod moves into the larynx and between the vocal chords. Since the light404 illuminates body tissue immediately ahead of theleading end portion52bof theguide rod50b, the light enables the viewer to continuously visualize where theleading end portion52bof theguide rod50bis located along the insertion path in therespiratory system11bof the patient.
• In the embodiment invention illustrated inFIG. 12, thefiber optic tubes402 and408 extend through theguide rod50bto enable an image of body tissue immediately ahead of theleading end portion52bof the guide rod to be transmitted to a viewer. It is contemplated that movement of a tracheal tube, corresponding totracheal tube38 ofFIG. 2, along theguide rod50binto the patient'srespiratory system11bwill be facilitated by illuminating body tissue immediately ahead of the leading end portion of the tracheal tube. Therefore, the side wall of the tracheal tube may be provided with fiber optic tubes which transmit light from a light source, such as alight source400, to a location immediately ahead of the leading end portion of the tracheal tube and transmit an image of illuminated body tissue immediately ahead of the leading end portion of tracheal tube to a viewer.
• As the tracheal tube is moved along theguide rod50binto the patient's respiratory system, in the manner previously explained in conjunction with the embodiment invention illustrated inFIG. 2, body tissue immediately ahead of theleading end portion52bof thestationary guide rod50bis illuminated and body tissue immediately ahead of the tracheal tube is illuminated. Therefore, as the leading end portion of the tracheal tube approaches thevocal chords32b, a surgeon or other viewer can easily determine the location of the leading end portion of the tracheal tube relative to the vocal chords. As the leading end portion of the tracheal tube approaches theleading end portion52bof the guide rod, the image transmitted to the viewer will be of body tissue illuminated by both light transmitted from theleading end portion52bof the guide rod and light transmitted from the leading end portion of the tracheal tube.
• The leading end portion of the tracheal tube may be inserted intotrachea28bof a patient for greater distance than the distance which theguide rod50bis inserted into the trachea. As the leading end portion of the tracheal tube moves past theleading end portion52bof theguide rod50b, illumination from the leading end portion of theguide rod50bwill be at least partially blocked from transmission back to the viewer through fiber optics in the tracheal tube. Therefore, the viewer will easily be able to determine when the leading end portion of the tracheal tube has moved past the leading end portion of theguide rod50b.
• Although theeye410 of a viewer has been schematically illustrated inFIG. 12, it is contemplated that the image transmitted through thefiber optic tube408 may be displayed on a viewing screen. If this was done, the image transmitted through thefiber optic tube408 would be transmitted to a computer and a viewing screen associated with the computer would display an image of the body tissue immediately ahead of theleading end portion52bof theguide rod50b. As the tracheal tube is moved along the guide rod into the patient'srespiratory system11b, an image of body tissue immediately ahead of the leading end portion of the tracheal tube may also be transmitted to the computer.
• A second computer screen may be utilized to display an image of the body tissue immediately ahead of the leading end portion of the tracheal tube. If this is done, the surgeon or other viewer would be able to see an image of body tissue immediately ahead theleading end portion52bof theguide rod50band an image of body tissue immediately ahead of the leading end portion of the tracheal tube. When simultaneously viewing the two images on two separate screens or on separate portions of a single screen, the surgeon or other viewer would be able to determine the positions of the leading end portions of both theguide rod50band the tracheal tube relative to each other and to therespiratory system11bof a patient.
• Although it's preferred to utilize the tracheal tube and it's associated illumination system in conjunction with theguide rod50b, the tracheal tube may be utilized by itself. Thus, fiber optic tubes which extend through the side wall of the tracheal tube and correspond to thefiber optic tubes402 and408 ofFIG. 12, would provide an image of the body tissue immediately ahead of the leading end portion of the tracheal tube as the tracheal tube is moved into the patient'srespiratory system11balong an insertion path. The image transmitted from the leading end portion of the tracheal tube to the eye of the viewer or to a display screen would enable a surgeon or other viewer to determine the location of the leading end portion of the tracheal tube relative to the patient'srespiratory system11b.
• When the tracheal tube and it's associated illumination and image transmitting systems are utilized withoutguide rod50b, thepositioning apparatus56bmay be modified to guide movement of the tracheal tube in much the same manner as in which thepositioning apparatus56bis utilized to guide movement of theguide rod50b. If this is done, colored bands or other indicia could be provided on the tracheal tube to indicate the position of the tracheal tube in the same manner as previously discussed in connection with theguide rods50 and250.
• It is contemplated that thepositioning apparatus56bmay be used for purposes other than tracheal intubination. Thus, thepositioning apparatus56bmay be used to position devices other than theguide rod50bduring endoscopic, arthroscopic, or fiber optic surgery at any one of many locations in a patient's body. A magnet, similar to themagnet260 ofFIGS. 4 and 7 may be used to steer a leading end portion of the device being positioned in the patient's body. The leading end portion of the device being positioned in the patient's body may be located at a position adjacent to or spaced a desired distance from a positioning section, corresponding to thepositioning section96b, by the use of suitable indicia, which may be similar to the indicia used in conjunction with theguide rods50 and250.
• When thepositioning apparatus50bis to be used to position a medicant or a device of any desired type at a selected location in a patient's body, thepositioning section96bis positioned in engagement with a selected portion of the patient's body. The selected portion of the patient's body may be a portion of the patient's body other than the Adam'sapple34b. Although it is believed that it will probably be preferred to engage an exterior surface on the patient's body with thepositioning section96b, the positioning section could be placed in engagement with a surface disposed within the patient's body if desired.
• While thepositioning section96bis engaging the selected portion of the patient's body, theguide rod50borasimilar elongated member is moved relative to theguide section114bconnected with thearcuate member108b. Theleading end portion52bof theguide rod50bor similar elongated member is then moved into the patient's body. Theleading end portion52bmay be moved into the patient's body through a naturally occurring opening or through an incision formed in the patient's body.
• The image transmitted through the guide rod or similarelongated member50bto the viewer will indicate when theleading end portion52bhas moved to a desired position in the patient's body. Once theleading end portion52bof the guide rod or similarelongated member50bhas moved to the desired position relative to the patient's body, any desired procedure may be performed in the patient's body. For example, a surgical procedure could be conducted with one or more devices connected with theleading end portion52bof the guide rod or similar elongated member. Thepositioning apparatus56bmay be used to position a therapeutic agent or device at the desired position in the patient's body.
Embodiment of FIGS.13 and14
• In the embodiment invention illustrated inFIG. 12, thelight source400 and fiberoptic tube402 function as an emitter which emitsillumination404 onto body tissue immediately ahead of theleading end portion52bof theguide rod50bto facilitate visualization of the body tissue. In the embodiment invention illustrated inFIGS. 13 and 14, a plurality of emitters are positioned adjacent to an outer side surface of the patient's neck. A detector on a leading end portion of a guide rod is moved into the patient's respiratory system. Since the embodiment invention illustrated inFIGS. 13 and 14 is generally similar to the embodiment invention illustrated inFIGS. 1, 2 and12, similar numerals will be utilized to identify similar components, the suffix letter “c” being associated with the numerals ofFIGS. 13 and 14 to avoid confusion.
• Apositioning apparatus56c(FIG. 13) is utilized to position a flexible guide wire orrod50crelative to arespiratory system11cof a patient. Therespiratory system11cof the patient extends from themouth12cthrough alarynx30cto atrachea28cof the patient. Thepositioning apparatus56cengages an Adam'sapple34cof a patient to locate theguide rod50crelative to the patient'srespiratory system11c.
• Thepositioning apparatus56chas the same general construction and mode operation as thepositioning apparatus56 ofFIGS. 1 and 2. Thepositioning apparatus56cincludes abase section78chaving abody section86cwhich is pivotally connected with apositioning section96c. Thepositioning section96cengages an outer surface of the neck of the patient adjacent to the Adam'sapple34cto locate thepositioning apparatus56crelative to the patient'srespiratory system11c. If desired, thepositioning apparatus96ccould include a collar which would extend around the patient's Adam'sapple34cin the matter previously described in conjunction with the embodiment invention illustrated inFIG. 7. Alternatively, thepositioning apparatus96ccould include a pair of fingers which engage opposite lateral sides of the patient's Adam's apple.
• Anarcuate member108cis connected with and is moveable relative to thebody section86cof thepositioning apparatus56cat aconnection110c. Aflexible guide rod50cis axially slidable relative to aguide section114cwhich is connected with thearcuate member108c. The construction of thepositioning apparatus56cis the same as was previously described in conjunction with the embodiment invention illustrated inFIGS. 1 and 2.
• In accordance with a feature of the embodiment invention illustrated inFIG. 13, asensor assembly420 is provided to inform a surgeon or other user of thepositioning apparatus56c, of the position of theguide rod50crelative to the patient'srespiratory system11c. Thesensor assembly420 includes an emitter portion424 (FIG. 14) which provides an output and a detector portion426 (FIG. 13) which responds to the output from theemitter portion424. In the embodiment of invention illustrated inFIGS. 13 and 14, theemitter portion424 is positioned on an outer side surface of the neck of the patient adjacent to the Adam'sapple34c. Thedetector portion426 is connected with aleading end portion52cof aguide rod50c. However, it should be understood that theemitter portion424 could be connected with theguide rod50cand thedetector portion426 positioned adjacent to the Adam'sapple34cof the patient.
• In the illustrated embodiment invention, theemitter portion424 of thesensor assembly420 includes a plurality ofemitters units430 which are positioned an array which extends around the Adam'sapple34c(FIG. 14) of the patient. Theemitter units430 are secured to the neck of the patient by a suitable adhesive. Theemitter units430 may be positioned in any desired spatial relationship with the patient's Adam'sapple34c.
• Alternatively, theemitter units430 may be connected with thepositioning section96c. Thus, thepositioning section96cof thepositioning apparatus56cis provided with three fingers which engage the neck of the patient adjacent to the Adam'sapple34c. Each of theemitter units430 may be connected with one of the fingers of thepositioning section96c. Thepositioning section96cwould accurately locate theemitter units430 relative to the patient's Adam'sapple34c.
• In the embodiment of the invention illustrated inFIG. 13, thepositioning section96cengages the Adam'sapple34cand the emitter units are disposed in a generally circular array which extends around the Adam'sapple34c. However, it should be understood that theemitter units430 could be connected with a collar, similar to thecollar306 ofFIG. 7. The collar may be connected with thepositioning section96c(FIG. 13). Alternatively, the collar could be separate from the positioning apparatus.
• Although it is preferred to utilize thepositioning apparatus56cin conjunction with theguide rod50c, in the manner previously described in conjunction with the embodiment of the invention illustrated inFIG. 1, it is contemplated that thepositioning apparatus56cmay be omitted and theguide rod50cmoved along an insertion path into the patient's respiratory system without benefit of the assistance provided by the positioning apparatus. If this is done, the emitter units430 (FIG. 14) could be connected with a support structure which holds theemitter units430 in a fixed relationship relative to each other and facilitates positioning of the emitter units relative to the patient's Adam'sapple34c. For example, a positioning section having a plurality of fingers, could be manually centered on the patient's Adam'sapple34cto locate theemitter units430 relative to the Adam's apple. Similarly, a collar, corresponding to thecollar306 ofFIG. 7, could be provided on a circular or oval support which would extend around the patient's Adam'sapple34cto locate theemitter units430 relative to the patient's Adam's apple. Regardless of the specific structure which is utilized to position theemitter units430 relative to each other, this apparatus could be manually positioned relative to the patient's Adam'sapple34cwithout being connected with a positioning apparatus having a construction similar to the construction of thepositioning apparatus56c.
• When thepositioning apparatus56cis to be utilized to assist in the positioning of theguide rod50crelative to the patient'srespiratory system11c, thepositioning section96cis positioned in engagement with the patient's Adam'sapple34c. Theemitter units430 may be suitably mounted on thepositioning section96c. This would locate theemitter units430 relative to the patient's Adam'sapple34c(FIG. 14). It should be understood that theemitter units430 could be mounted on a support other than thepositioning section96cif desired. Of course, theemitter units430 may be secured directly to the neck of the patient by a suitable adhesive, as illustrated inFIG. 14. When this is done, a support structure interconnecting theemitter units430 may be used to facilitate positioning of the emitter units relative to the patient's Adam'sapple34c.
• Thearcuate member108cis then positioned axially along thebody section86c. When thearcuate member108chas been moved to a desired position relative to thebody section86c, theconnection110cis secured to hold the arcuate member against axial movement along the body section. Thearcuate member108cis then moved relative to thebody section86cto position theguide section114cand theleading end portion52cof theguide rod50cin alignment with the entrance to the patient'smouth11c. Theguide rod50cis then moved into the patient'srespiratory system11calong an insertion path.
• As theguide rod50cis moved along the insertion path into the patient'srespiratory system11c, thedetector portion426 of thesensor assembly420 approaches theemitter units430. As this occurs, the detector portion provides an output overleads434 and436 to a computer ormicro processor438. The computer or micro processor has an output, indicated schematically at440, which can be viewed by a surgeon or other individual moving theguide rod50calong the insertion path into the patient'srespiratory system11c.
• The computer output may include a display having a schematic illustration of a typical patient's respiratory system. The positions of theemitter units430 relative to the typical respiratory system and the position of thedetector portion426 relative to theemitter units430 would be indicated on the display. Thus, a display screen connected with thecomputer438 has an illustration representative of the patient'srespiratory system11c. A plurality of indicators are provided on the display screen to indicate the positions of theemitter units430 relative to the schematic illustration of the patient's trachea. An indicator is provided to indicate the position of the leading end of theguide rod50crelative to the schematic illustration of the patient's respiratory system. The display screen has one illustration of the patient'srespiratory system11cas viewed in a medial plane and another illustration of the patient's respiratory system as viewed in a frontal plane. Indicators corresponding to theemitter units430 anddetector426 are provided in both illustrations.
• As theleading end portion52cof theguide rod50cmoves along the insertion path into the patient'srespiratory system12c, thedetector portion426 of thesensor assembly420 approaches theemitter portion424 of the sensor assembly. As this occurs, the strength of the output from thedetector portion426 through theleads434 and436 increases. As the strength of the output from thedetector portion426 increases, the computer and the associated display indicates to an operator of theapparatus56cthat theleading end portion52cof theguide rod50cis approaching a junction between the patient'sesophagus26cand the pharynx.
• If the guide rod continues movement along its intended course of insertion, that is, into the patient'slarynx30cand not into the patient'sesophagus26c, the strength of the output signal provided by thedetector portion426 will increase. However, if theleading end portion52cof theguide rod50centers the patient'sesophagus26c, the strength of the output signal from thedetector portion426 will decrease. The decreasing strength of the signal from thedetector portion426 provides a clear indication to the operator of theapparatus56cthat theleading end portion52cof theguide rod50chas deviated from its intended course.
• As thedetector portion426 of thesensor assembly420 moves between the patient'svocal chords32cinto alignment with theemitter portion424 of thesensor assembly420, the strength of the signal transmitted to thecomputer438 will be maximized. As theguide rod50ccontinues to be moved into the patient'strachea28calong the insertion path, the strength of the signal transmitted through theleads434 and436 to thecomputer438 will decrease to indicate to the operator of theapparatus56cthat theleading end portion52cof the guide rod has moved past the patient's Adam'sapple34c.
• Although it is believed that it will be preferred to display the output of thecomputer438 in association with one or more illustrations of the patient'srespiratory system11cin the manner previously mentioned, the computer output information could be transmitted in a different manner if desired. For example, thecomputer438 could have a light display system which indicates how close thedetector426 is to theemitter units430. Similarly, thecomputer438 could have an audio output which indicates how close thedetector426 is to the emitter units. Of course, the computer could have an output which is a combination of a display screen, lights and/or audio signals.
• Once theguide rod50chas been moved to the desired position along the patient'srespiratory system11c, thepositioning apparatus56cmay be disconnected from theguide rod50c. A tracheal tube, corresponding totracheal tube38 ofFIG. 2, is then moved along theguide rod50cinto the patient'strachea28c. The manner in which the tracheal tube is moved along theguide rod50cinto the patient'strachea28cis the same as was previously discussed in conjunction with the embodiment of the invention illustrated inFIGS. 1 and 2. A magnet, corresponding to themagnet260 ofFIGS. 4 and 7, may be utilized to steer the leading end portion of theguide rod50c. If desired, an electromagnet which can be turned on and off may be utilized.
• The tracheal tube which is utilized in association with theguide rod50cofFIG. 13 may have the same construction as thetracheal tube38 utilized with theguide rod50 ofFIG. 2. Alternatively, the tracheal tube utilized with theguide rod50cmay have a second detector portion, having the same construction as thedetector portion426 of theguide rod50c. If the tracheal tube is provided with a second detector portion, theemitter portion424 of thesensor assembly420 is maintained in position relative to the patient's Adam'sapple34c.
• By providing the tracheal tube with a second detector portion, and by maintaining theemitter portion424 in position relative to the patient's Adam'sapple34c, the output from the second detector portion may be utilized to locate the leading end portion of the tracheal tube as the tracheal tube is moved along theguide rod50cinto the patient'srespiratory system11c. If this is done, leads, corresponding to theleads434 and436 would extend along the side wall of the tracheal tube from the second detector portion to thecomputer438. The output from thecomputer438 would indicate the position of the leading end portion of the tracheal tube relative to theemitter424. The output from the second detector portion on the leading end portion of tracheal tube would indicate the position of the leading end portion of the tracheal tube relative to the position of the leading end portion of theguide rod50c.
• The output from the computer may be a display having the construction previously described in conjunction with theguide rod50c. Thus, a display screen connected with thecomputer438 has an illustration representative of the patient'srespiratory system11c. A plurality of indicators are provided on the display screen to indicate the positions of theemitter units430 relative to the patient's trachea. An indicator is provided to indicate the position of the leading end of the tracheal tube relative to the patient's respiratory system. The display screen has one illustration of the patient'srespiratory system11cas viewed in a medial plane and another illustration of the patient's respiratory system as viewed in a frontal plane. Indicators corresponding to theemitter units430 and detector on the tracheal tube are provided in both illustrations.
• In the embodiment of the invention illustrated inFIGS. 13 and 14, theemitter units430 are magnets which emit a magnetic field. Thedetector portion426 is a magnetometer which responds to variations in the strength of a magnetic field. Thus, the output from thedetector portion426 increases as the detector portion moves closer to the patient's Adam'sapple34cand the magnets forming theemitter units430. Thedetector portion436 may be Hall effect device, magnetoresistor, or a galvanometer device. Regardless of what specific type of magnetic field responsive device is utilized to form thedetector portion426 of the sensor assembly, the output from the detector portion will vary as the distance between theleading end portion52cof theguide rod50cand the magnets in theemitter units430 varies.
• In the embodiment of the invention illustrated inFIGS. 13 and 14, thesensor assembly420 is the type which responds to a magnetic field. However, it is contemplated that thesensor assembly420 could be constructed so as to respond to other types of emissions. For example, light sources could be utilized as theemitter units430 and thedetector portion436 may be a photo cell which responds to variations in the amount of light received. Alternatively, theemitter units430 could be sources of radio frequency radiation and thedetector portion426 could be constructed so as to have an output which varies as the distance between the detector portion and the sources of radio frequency radiation varies. If desired, theemitter units430 could be ultrasonic transducers and thedetector426 could respond to ultrasonic energy.
• Thesensor assembly420 has been illustrated inFIGS. 13 and 14 in association with thepositioning apparatus56c. However, it should be understood hat thesensor assembly420 could be utilized in association with thepositioning apparatus256 ofFIGS. 4-10 or thepositioning apparatus256aofFIG. 11. If this was done, the use of themagnet260 or260a(FIGS. 4, 7 and11) may be eliminated to avoid interference with magnetic fields from theemitter units430. Of course, if the emitter units provided outputs which were not affected by the magnetic field from themagnets260 and260a, themagnets260 and260acould still be utilized.
• Thepositioning apparatus56candsensor assembly420 have been illustrated in association with a tracheal intubination procedure. It is contemplated that thepositioning apparatus56cand/orsensor assembly420 may be used in association with other medical procedures if desired. For example, thepositioning apparatus56cand/orsensor assembly420 may be used in the performance of endoscopic, arthroscopic or fiber optic surgical procedures. Thepositioning apparatus56cand/orsensor assembly420 may be used in association with surgery on joints or other portions of a patient's body. Thepositioning apparatus56cand/orsensor assembly420 may be used to deliver medicants to a desired location in a patient's body.
Embodiments of FIGS.15 and16
• In the embodiment of the invention illustrated inFIGS. 13 and 14, theemitter portion424 of thesensor assembly420 is disposed adjacent to the outer surface of the neck of the patient while thedetector portion426 of the sensor assembly is connected with theguide rod50c. In the embodiment of the invention illustrated inFIGS. 15 and 16, the detector portion of the sensor assembly is disposed adjacent to the outer surface of the patient's neck and the emitter portion of the sensor assembly is connected with the leading end portion of the guide rod. Since the embodiment of the invention illustratedFIGS. 15 and 16 is generally similar to the embodiment of the invention illustrated inFIGS. 1, 2,13 and14, similar numerals will be utilized to identify similar components, the suffix letter “d” being associated with the numerals ofFIGS. 15 and 16 to avoid confusion.
• Thepositioning apparatus56dis utilized to position aflexible guide rod50drelative to a patient's respiratory system1d. Thepositioning apparatus56dincludes abase section78dhaving abody section86dand apositioning section96d. Anarcuate member108dis connected with thebody section86dat aconnection110d. When thearcuate member108dhas been moved to a desired position along thebase section86d, theconnection110dis actuated to hold themember108dagainst axial movement along thebody section86d. When theguide section114dhas been moved into alignment with the patient'smouth12d, theconnection110dis again actuated to hold thearcuate member108dagainst movement relative to thebase section86d.
• Theguide section114dcooperates with theflexible guide rod50dto position the guide rod during movement of the guide rod into the patient's respiratory system1dalong an insertion path. The general construction and mode of operation of thepositioning apparatus56dis the same as was previously described in conjunction with thepositioning apparatus56 ofFIGS. 1 and 2.
• In accordance with a feature of this embodiment of the invention, a sensor assembly420dis provided to sense when theguide rod50dhas moved to a desired position relative to the patient'srespiratory system11d. The sensor assembly420dincludes adetector portion426d(FIG. 16) and anemitter portion424d(FIG. 15).
• Thesensor portion426dof the sensor assembly420dis positioned on the outer surface of a neck of a patient (FIG. 16) adjacent to the patient's Adam'sapple34d. Theemitter portion424dis connected with aleading end portion52dof theguide rod50d(FIG. 15). Thesensor portion426d(FIG. 16) is mounted directly on the patient's neck by a suitable adhesive. However, if desired, thesensor portion426dcould be connected with thepositioning section96dof thepositioning apparatus56d. If this is done, when thepositioning section96dof thepositioning apparatus56dis positioned in engagement with the patient's Adam'sapple34d, thesensor portion426 of the sensor assembly420dwould also positioned relative to the patient's Adam's apple. However, if desired, thesensor portion426dcould be mounted on a support and positioned relative to the patient's Adam'sapple34dindependently of thepositioning section96dof thepositioning apparatus56d.
• Thesensor portion426dof the sensor assembly420dincludes a plurality ofsensor units440 which are disposed in an array around the patient's Adam'sapple34d(FIG. 16). Thesensor units440 haveleads442 which are connected with a computer ormicro processor444. The computer ormicro processor444 has an output, indicated schematically in446 inFIG. 16, which is indicative of the position of theemitter portion424dof the sensor assembly420drelative to the position of thesensor portion426dof the sensor assembly. Theemitter portion424dof the sensor assembly420dis connected with theleading end portion52dof theguide rod50d.
• During use of thepositioning apparatus56d, theleading end portion52dof theflexible guide rod50dis aligned with themouth12dof the patient. Theguide rod50dis then moved into the patient'srespiratory system11dalong an insertion path. As theguide rod50dis moved into the patient'srespiratory system11d, theemitter portion424dof the sensor assembly420dapproaches thesensor portion426dof the sensor assembly420d. As this occurs, the strength of the output from thesensor units440 increases.
• The increasing strength of the output from thesensor units440 results in a change in theoutput446 from thecomputer444. Theoutput446 from thecomputer444 may take the form of a display which schematically indicates the position of theemitter portion424dof the sensor assembly420drelative to thesensor portion426dof the sensor assembly. Thus, a display screen for thecomputer444 may have a schematic illustration representative of a typical patient's respiratory system. The display screen would indicate the position of thesensor portion426dof the sensor assembly420drelative to the patient's respiratory system and the position of theemitter portion424dof the sensor assembly420drelative to the patient's respiratory system. Since theemitter portion424dis connected with theleading end portion52dof theguide rod50d, the display for thecomputer444 would indicate the position of theleading end portion52dof the guide rod relative to the patient's Adam'sapple34d.
• Although it is believed that the use of a display screen may be preferred, theoutput446 from thecomputer444 could take a different form if desired. For example, the computer could have an audio output. Alternatively, a display graph formed of a series of lights could provide a visual output. As theemitter portion424dapproaches thesensor units440, the number of illuminated lights in the series of lights would increase. When theemitter portion424dis aligned with the center of the array ofsensor units440 and the patient's Adam'sapple34d, the entire series of lights would be illuminated. Of course, theoutput446 from thecomputer444 could include both audio and visual outputs.
• In the embodiment of the invention illustrated inFIGS. 15 and 16, theemitter portion424dof the sensor assembly420dis a magnet which emits a magnetic field. Thesensor portion426dof the sensor assembly420dhas an output which varies as a function of the strength of the magnetic field at the sensor units. Therefore, as theleading end portion52dof theguide rod50dapproaches the patient's Adam'sapple34d, the strength of the magnetic field to thesensor units440 increases and the output transmitted to thecomputer444 increases.
• In the specific embodiment of the invention illustrated inFIG. 16, thesensor units440 are Hall effect devices. However, it is contemplated that other known devices which respond to variations in a magnetic field may be utilized in place of the Hall effect devices which form thesensor units440. For example, magnetoresistors could be utilized as thesensor units440 in place of the Hall effect devices.
• Once theguide rod50dhas been positioned relative to the patient'srespiratory system11d, thepositioning apparatus56dis disconnected from theguide rod50dwhile the guide rod is maintained stationary relative to the patient'srespiratory system11d. A flexible tracheal tube, corresponding to thetracheal tube38 ofFIG. 2, is then moved along theguide rod50dinto the patient'srespiratory system11d. The manner of insertion of the tracheal tube into the patient's respiratory system1d, by sliding the tracheal tube along theguide rod50d, is the same as was previously described in conjunction with the embodiment of the invention illustrated inFIG. 2.
• It is contemplated that thesensor portion426dof the sensor assembly420dcan be utilized in association with the tracheal tube. Thus, the tracheal tube can be provided with a second emitter portion having the same construction as theemitter portion424d. In the embodiment of the invention illustrated inFIGS. 15 and 16, a magnet, which emits a magnetic field, would be mounted on a leading end portion of the tracheal tube.
• As the tracheal tube having an emitter, is moved along theguide rod50d, the magnet on the leading end portion of the tracheal tube would have an effect on thesensor units440. The effect on the magnet on thesensor units440 increases as the leading end portion of the tracheal tube approaches the patient's Adam'sapple34d. It is contemplated that the tracheal tube may be inserted into the patient'strachea28dfurther than theguide rod50d. If this is done, the output from the sensor units440ddiminishes in magnitude as the leading end portion of the tracheal tube is moved down the patient's trachea past the sensor units.
• Although it is preferred to utilize the sensor assembly420din association with thepositioning apparatus56d, the sensor assembly could be utilized separately from the positioning apparatus. For example, thesensor units440 may be mounted in an array on a separate support structure. The support structure would be positioned in an engagement with the exterior of the patient's neck with the array ofsensor units440 centered about the patient's Adam's apple, in the manner illustrated schematically inFIG. 16.
• Theguide rod50dwould then be moved along the patient'srespiratory system11dwithout benefit of thepositioning apparatus56d. As theguide rod50dmoves along the patient'srespiratory system11d, the strength of the magnetic field from theemitter portion424dof the sensor assembly420ddetected by thesensor units440 would increase. This would result in an increase in the output from thesensor units440 to thecomputer444. Theoutput446 from thecomputer444 would indicate to the operator moving theguide rod50d, the position of the guide rod along an insertion path into the patient'srespiratory system11d.
• Once theguide rod50dhas been positioned in the foregoing manner relative to the patient'srespiratory system11d, without benefit of thepositioning apparatus56d, the tracheal tube would be moved along the guide rod into the patient'srespiratory system11d. The tracheal tube could have the same construction and move in the same manner as thetracheal tube38 ofFIG. 2.
• Alternatively, the tracheal tube could be provided with a second emitter portion, corresponding to theemitter portion424dof thesensor assembly420. Thus, a magnet could be provided on the leading end portion of the tracheal tube. As the leading end portion of the tracheal tube moves along the insertion path into the patient'srespiratory system11d, the magnetic field detected by thesensor units440 would increase due to the magnet connected with the leading end portion of the tracheal tube approaching the magnet on theleading end portion52dof theguide rod50d.
• It is also contemplated that the tracheal tube could be positioned relative to the patient'srespiratory system11dwithout benefit of theguide rod50d. The tracheal tube would be provided with an emitter corresponding to theemitter424d. As tracheal tube is moved into the patient'srespiratory system11dwithout benefit of theguide rod50d, the output from the emitter connected to the leading end portion of the tracheal tube would be detected by thesensor units440. The output from thesensor units440 would indicate the position of the leading end portion of the tracheal tube relative to the patient'srespiratory system11d.
• In the embodiment of the invention illustrated inFIGS. 13-16, magnets have been utilized as emitter units. The magnets which form theemitter portion424 of thesensor assembly420 are permanent magnets formed of a strongly magnetizable material such as cobalt or neodymium. Of course, other know magnetizable materials having saturation magnetization values, such as cerium, praseodymium and or samarium with cobalt and/or other materials could be used. Alternatively, the magnets in the emitter portion424 (FIG. 14) and424d(FIG. 15) could be electromagnets.
• The detector portion426 (FIG. 13) and426d(FIG. 16) of thesensor assemblies420 and420dmay be any known device which respond to changes in the strength and/or direction of a magnet field. For example, thedetector portions426 include one or more Hall effect devices and/or one or more magnetoresistors.
• Although theemitter portions424 and424dof thesensor assemblies420 and420dhave been described herein as emitting magnetic fields, it is contemplated that theemitter portions424 and424dcould have outputs other than a magnetic field. For example, theemitter portions424 and/or424d(FIGS. 14 and 15) could be miniaturized radio frequency devices. Thus, the emitter portions of the sensor assemblies could be formed by radio signal transmitters having miniaturized radio circuitry which provide a radio frequency output signal. If a radio frequency transmitter is utilized in theemitter portion424 or424dof the sensor assemblies, thesensor portion426 or426dwould be a radio frequency receiver. The radio frequency receiver could include a receiving antenna which receives radio frequency signals. The field of the antenna may be controlled by appropriate placement, orientation, and/or configuration of the antenna.
• Alternatively, theemitter portions424 and424dcould emit ultrasonic energy. Thesensor portion426 or426dwould respond to ultrasonic energy.
Embodiment of FIGS.17 and18
• In the embodiment of the invention illustrated inFIGS. 13 and 14, thesensor assembly420 includes adetector portion426 which is disposed on theleading end portion52cof theguide rod50cand responds to a magnetic field. The operator of thepositioning apparatus56cis informed, by a display system connected with thecomputer438, of the position of theleading end portion52cof theguide rod50crelative to the patient'srespiratory system11c. In the embodiment of the invention illustrated in FIGS.17 an18, the leading end portion of the guide rod is steerable to enable the other operator to alter the course of movement of the leading end portion of the guide rod to maintain the leading end portion of the guide rod on a desired insertion path into the patient's respiratory system. Since the embodiment of the invention illustrated inFIGS. 17 and 18 is generally similar in the embodiment of the invention illustrated inFIGS. 13-16, similar numerals will be utilized to designate similar components, the suffix letter “e” being associated with the numerals ofFIGS. 17 and 18 to avoid confusion.
• The embodiment of the invention illustrated inFIGS. 17 and 18 is utilized with a positioning apparatus having the same construction as the positioning apparatus ofFIGS. 1, 2, and13-16. However, the embodiment of the invention illustrated inFIGS. 17 and 18 could be used with thepositioning apparatus256 and/or256aofFIGS. 4-11 if desired. Theguide rod50eofFIGS. 17 and 18 is provided with asteering apparatus460. Thesteering apparatus460 is operable to change the course of movement of theleading end portion52eof theflexible guide rod50eas the guide rod moves along the insertion path into the patient's respiratory system.
• Thesteering apparatus460 applies force against body tissue in the patient's respiratory system to deflect theleading end portion52eof theflexible guide rod50eaway from an undesired course of movement. For example, when the leading end portion of theguide rod50eis approaching a junction between the patient's esophagus26 (FIG. 1) andtrachea28, the steering apparatus460 (FIGS. 17 and 18) may be activated to deflect theleading end portion52eof theguide rod50eaway from the entrance to the patient's esophagus. Similarly, when theleading end portion52eof theguide rod50eis approaching thelarynx30, thesteering apparatus460 may be activated to align theleading end portion52eof the guide rod with an opening between vocal chords in the patient's larynx.
• In the illustrated embodiment of the invention, thesteering apparatus460 includes a plurality ofexpandable elements464,466 and468 (FIG. 18). Although three expandable elements464-468 have been illustrated as being disposed in a circular array about theleading end portion52eof theguide rod50e, a greater or lesser number of expandable elements could be provided in association with the leading end portion of the guide rod if desired.
• Theexpandable elements464,466 and468 are individually activatable so that one, two or all three of the expandable elements can be expanded. For example, just the expandable element464 (FIG. 18) may be expanded to apply force against theleading end portion52eof theguide rod50eto move the guide rod downward (as viewed inFIG. 18) relative to a path of movement of the guide rod through the patient's respiratory system. Alternatively, theexpandable elements466 and468 may be expanded at the same time to deflect theleading end portion52eof theguide rod50eupward (as viewed inFIG. 18). It is believed that it may be desired to center theleading end portion52eof theguide rod50ein a passage in the patient's respiratory system. When this is to be done, all threeexpandable elements464,466, and468 would be expanded.
• In the illustrated embodiment of the invention, theexpandable elements464,466 and468 are balloons or bladders which are expanded under the influence of fluid pressure, that is, under the influence of either a gas or a liquid. To enable theexpandable elements464,466 and468 to be individually expanded,conduits472,474 and476 are each connected in fluid communication with one of theexpandable elements464,466 or468. For example, when theexpandable element464 is to expanded, fluid under pressure is connected through theconduit472 to theexpandable element464. Similarly, when theexpandable element466 is to expanded, fluid under pressure is connected through theconduit474 to theexpandable element466. Finally, when theexpandable element468 is to be expanded, fluid under pressure is connect through theconduit476 to theexpandable element468.
• After one or more of the expandable element464-468 have been expanded to steer theleading end portion52eof theguide rod50e, theexpandable elements464,466 and/or468 are contracted. This may be accomplished by connecting theconduits472,474 and/or476 with a source of suction or low pressure. Theexpandable elements464,466 and468 are contracted under the influence of their own natural resilience. If desired, springs could be provided in association with the expandable elements to contract the expandable elements464-468.
• The contractedexpandable elements464,466 and468 are disposed in engagement with an outer side surface of theleading end portion52eof theguide rod50e. If desired, recesses could be provided in the leading end portion of theguide rod50eto receive each of theexpandable elements464,466 and468 when the expandable elements are in their contracted condition.
• It is believed that it will be preferred to form theexpandable elements464,466 and468 of a resiliently stretchable polymeric material so that the expandable elements can be expanded, under the influence of fluid pressure, by stretching the material of the expandable elements. When the expandable elements are to be deflated, the resiliently stretched elastomeric material of the expandable elements464-468 will tend to force fluid out of the expandable elements and cause them to return to their contracted conditions. When the retracted, theexpandable elements464,466 and468 are disposed in either separate recesses or a single annular recess which extends around the leading end portion of theguide rod50e. The contracted expandable elements do not project outward from the outer side surface of theguide rod50e. Alternatively, the contracted expandable elements464-468 could be contracted, under the influence of their own natural resilience, into tight abutting engagement with the outer side surface of theguide rod50e.
• It is contemplated that theconduits472,474 and476 andexpandable elements464,466 and468 may be formed in a manner similar to that disposed in U.S. patent application Ser. No. 08/470,142 filed Jun. 6, 1995 by Peter M. Bonutti et al. and entitled Method Of Using Expandable Cannula. The disclosure of the aforementioned application Ser. No. 08/470,142 is hereby incorporated herein in its entirety by this reference thereto. Alternatively, theexpandable elements464,466 and468 could be formed in manners similar to that disclosed in U.S. Pat. No. 3,833,003 and/or 5,197,971.
• Although the illustrated expandable elements464-468 are expanded under the influence of fluid pressure, they could be expanded in a different manner if desired. For example, mechanical actuators could be provided. The mechanical actuators may be utilized to move members which are not balloons.
• In order to enable an operator of the positioning apparatus to determine the location of theleading end portion52eof theguide rod50erelative to the patient's respiratory system, a sensor assembly, similar to thesensor assembly420 ofFIGS. 13 and 14, is utilized in association with thesteering apparatus460. In the embodiment of the invention illustrated inFIG. 17, thedetector portion426eof the sensor assembly includes adetector480 which responds to an output from an emitter portion of the sensor assembly. Thedetector480 is enclosed by a soft dome orcap482 which forms part of theleading end portion52eof theguide rod50e. The dome orcap482 cushions engagement of theleading end portion52eof theguide rod50ewith body tissue along the patient's respiratory system. In addition, thedome482 protects thedetector portion426e.
• Thedetector480 may be a Hall effect device which cooperates with emitters, which are magnets, in the manner described in conjunction withFIGS. 13 and 14. Alternatively, thedetector480 may respond to radio frequency radiation. If desired, thedetector480 could be constructed so as to respond to ultrasonic energy. Rather than providing adetector480 on theleading end portion52eof theguide rod50e, an emitter could be provided in the manner described in conjunction withFIGS. 15 and 16.
• Thedetector portion426e(FIG. 17) is connected with a computer, similar to thecomputer438 ofFIG. 13, by a lead486 (FIG. 17). The output from the computer indicates to an operator the position of theleading end portion52eof theguide rod50erelative to the patient's respiratory system. The output of the computer will also indicate to the operator when theleading end portion52eof theguide rod50emay deviate from the intended course of insertion of the guide rod into the patient's respiratory system.
• When the output from the computer indicates that the leading end portion of the guide rod may not move along the intended insertion path, the operator may initiate expansion of one or more of the expandable elements464-468. The expandable elements will apply force against the patient's body tissue and against theleading end portion52eof theguide rod50eto deflect the guide rod in such a manner as to maintain the guide rod on its intended insertion path into the patient's respiratory system.
• As was previously described in conjunction with the embodiments of the invention illustrated inFIGS. 13-16, a visual display system, illustrative of the patient's respiratory system, may be connected with the computer which receives the output from asensor assembly420 or420d. By viewing an illustration depicting the location and path of movement of theleading end portion52eof theflexible guide rod50e, an operator will know when to expand one or more of theexpandable elements464,466 and468.
• It is contemplated that thesteering apparatus460 and position sensing assembly may be used with devices for purposes other than tracheal intubination. For example, thesteering apparatus460 and position sensing assembly used with theguide rod50eofFIG. 17 could be used in association with a device which is used to position medicant at a selected location in a patient's body. It is also contemplated that thesteering apparatus460 and position sensing assembly could be used in conjunction with endoscopic, arthroscopic, or fiber optic surgery.
Embodiment of FIG.19
• In the embodiment of the invention illustrated inFIGS. 17 and 18, thesteering apparatus460 is disclosed in conjunction with theguide rod50ewhich is used with a sensor assembly, corresponding with thesensor assembly420 ofFIG. 13, in which the detector portion is disposed on theleading end portion52eof the guide rod. In the embodiment of the invention illustrated inFIG. 19, the steering apparatus is disposed in association with a guide rod having an emitter portion of a sensor assembly disposed on the leading end portion of the guide rod in the manner illustrated inFIGS. 15 and 16. Since the embodiment of the invention illustrated inFIG. 19 is generally similar to the embodiments of the invention illustrated inFIG. 13-18, similar numerals will be utilized to designate similar components, the suffix letter “f” being associated with the numerals ofFIG. 19 in order to avoid confusion.
• Aguide rod50fhas a leading end portion52f. Theguide rod50fis used with a positioning apparatus similar to thepositioning apparatus56dofFIG. 15. Theflexible guide rod50f(FIG. 19) is associated with a sensor assembly corresponding to the sensor assembly420dofFIG. 15. Thus, theguide rod50fhas anemitter portion424f(FIG. 19) which is connected with the leading end portion52fof the guide rod. The output from theemitter portion424fis detected by suitable detectors disposed adjacent to the exterior surface of the patient's neck and to the patient's Adam's apple, in the manner illustrated schematically inFIG. 16.
• In the embodiment of the invention illustrated inFIG. 19, theemitter portion424fincludes alight source490. Thelight source490 is connected with source of electrical energy by alead492. Thelight source490 has been illustrated schematically inFIG. 19 as being an incandescent light source. However, it may be preferred to provide a solid state device as alight source490. For example, one or more light emitting diodes could be disposed on the leading end portion52fof theguide rod50fto function as a light source.
• It is contemplated that the electrical energy conducted over thelead492 to thelight source490 may be varied as the light source moves along the insertion path into the patient's respiratory system. For example, if the light source is pulsed from a maximum light emission level to a minimum light emission level, detection of the location of the leading end portion52fof theguide rod50fmay be facilitated.
• Thelight source490 may be detected by suitable photo optic devices, such as photo cells or may be visually detected by the operator of the apparatus associated with theguide rod50f. When thelight source490 is to be detected by the operator of the positioning apparatus, that is, when the operator is to function as the detector portion of the sensor assembly, it is believed that pulsing the light source will facilitate visual detection of the light source by the operator. It should be understood that both photo electric detection apparatus and visual detection by the operator could be utilized to locate the position of the leading end portion52fof theguide rod50fas the guide rod is moved into the patient's respiratory system.
• Asteering apparatus460f(FIG. 19) is connected with the leading end portion52fof theguide rod50f. Thesteering apparatus460fincludes a plurality ofexpandable elements464fand466f. Although only twoexpandable elements464fand466fhave been illustrated schematically inFIG. 19, it should be understood that a third expandable element, corresponding to theexpandable element468 ofFIG. 18, is connected with the leading end portion52fof theguide rod50f. The expandable elements are connected with a source of inflation fluid byconduits472f,474fand476f.
• When one or more of the expandable elements connected with the leading end portion52f(FIG. 19) of theguide rod50fare to be expanded, fluid under pressure is conducted to the expandable elements. For example, when theexpandable element464fis to be operated from a contracted condition to an expanded condition, fluid under pressure, which may be either a gas or liquid, is conducted through theconduit472fto theexpandable element464f. As theexpandable element464fis operated from a contracted condition to an expanded condition of the influence of fluid pressure, the expandable element applies force against the adjacent body tissues in the patient's respiratory system and applies force against the leading end portion52fof theguide rod50f. The force applied against the leading end portion52fof theguide rod50fdeflects the leading end portion52fof theguide rod50fdownward (as used inFIG. 19) to maintain the guide rod on the intended path of insertion into the patient's respiratory system. The output from theemitter portion424fof the sensor assembly enables the operator to determine when it is necessary to expand one or more of the expandable elements and to determine which of the expandable elements to be expanded.
• In the embodiment of the invention illustrated inFIG. 19, the emitter on the leading end portion of theguide rod50fis alight source490. However, a different type of emitter could be provided if desired. For example, the emitter could be a magnet which cooperates with detectors in the manner previously described in conjunction withFIGS. 15 and 16. Alternatively, the emitter could be a miniaturized radio frequency transmitter.
Embodiment of FIG.20
• In the embodiment of the invention illustrated inFIGS. 13 through 19, sensor assemblies have been illustrated as being associated with a guide rod of a positioning apparatus. In the embodiment of the invention illustrated inFIG. 12, fiber optics are utilized in association with a light source to enable an operator to view images of body tissue immediately ahead of the leading end portion of aguide rod50b. In the embodiment of the invention illustrated inFIG. 20, a light source and fiber optics are associated with a tracheal tube to enable an operator to view images of body tissue immediately ahead of a leading end portion of the tracheal tube during of insertion of the tracheal tube into a patient's respiratory system. Since the embodiment of the invention illustrated inFIG. 20 is generally similar to the embodiments of the invention illustrated inFIGS. 1, 2 and12, similar numerals will be utilized to designate similar components, the suffix letter “g” being associated with the numerals ofFIG. 20 to avoid confusion.
• A flexible tracheal tube38g(FIG. 20) has aleading end portion500. Alight source400gis disposed on theleading end portion500 of the tracheal tube38g. Thelight source400gis connected with a source of electrical energy byleads504 and506. When the tracheal tube38gis moving along an insertion path into a patient's respiratory system, thelight source400gilluminates body tissue immediately ahead of theleading end portion500 of the tracheal tube38g.
• In the embodiment of the invention illustrated inFIG. 20, thelight source400gis mounted on the leading end portion of the tracheal tube38g. However, it is contemplated that the light source could be disposed at a location remote from theleading end portion500 of the tracheal tube38gand illumination transmitted from the light source to the leading end portion of the tracheal tube through a fiber optic tube, corresponding to thefiber optic tube402 ofFIG. 12. Of course, a plurality of fiber optic tubes could be utilized if desired.
• Thelight source400ghas been illustrated schematically inFIG. 20 as being an incandescent light source. However, it is contemplated that one or more solid state devices, such as light emitting diodes, could form thelight source400gif desired. A plurality oflight sources400gcould be disposed in a circular array on theleading end portion500 of the tracheal tube38g.
• Aprismatic lens510 is also mounted on theleading end portion500 of the tracheal tube38g. Thelens510 is enclosed by atransparent dome512 which is connected with theleading end portion500 of the tracheal tube38g. Light is transmitted from thelens510 through afiber optic tube408gto the eye of a viewer or to a display unit associated with a computer. Thelens510 is oriented so that images of body tissue immediately ahead of theleading end portion500 of the tracheal tube38gare transmitted through thefiber optic tube408g. Although only a singlelight source400gandsingle lens510 have been illustrated schematically inFIG. 20, it should be understood that a plurality of light sources and/or a plurality of lenses may be mounted on theleading end portion500 of the tracheal tube38g.
• The flexible tracheal tube38gmay be utilized in association with thepositioning apparatus56 ofFIGS. 1 and 2 or with thepositioning apparatus256 ofFIG. 4. Alternatively, the tracheal tube38gmay be utilized by itself, that is without a positioning apparatus. If the tracheal tube38gis utilized with a positioning apparatus similar to thepositioning apparatus56 or256, the tracheal tube may be moved along a guide rod similar to theguide rod50 or theguide rod250 as the tracheal tube is moved into a patient's respiratory system. However, the tracheal tube may be moved along a guide rod into a patient's respiratory system without utilizing a positioning apparatus, similar to thepositioning apparatus56 or256 ofFIGS. 1 and 4.
• The tracheal tube38gmay be moved along an insertion path into a patient's respiratory system without benefit of a guide rod. If desired, a steering apparatus, corresponding to thesteering apparatus460 and460fofFIG. 17-19, may be associated with the leading end portion of the tracheal tube38g. Thus, expandable elements, corresponding to theexpandable elements464,466 and468 ofFIG. 18 may be connected with theleading end portion500 of the tracheal tube38g. The expandable elements connected with theleading end portion500 of the tracheal tube38gmay be connected in fluid communication with a source of fluid under pressure through conduits disposed in the side wall of the tracheal tube. Since images of body tissue immediately ahead of the leading end portion of the tracheal tube are transmitted through thefiber optic tube408g, an operator who is positioning the tracheal tube relative to a patient's respiratory system will be able to view images of the body tissue and, from these images, be able to determine when to activate one or more expandable elements of a steering apparatus connected with theleading end portion500 of the tracheal tube38g.
Embodiment of FIG.21
• In the embodiment of the invention illustrated inFIG. 20, images of patient's body tissue are transmitted from the leading end portion of the tracheal tube for viewing by an operator who is inserting the tracheal tube into the respiratory system of a patient. In the embodiment of the invention illustrated inFIG. 21, the tracheal tube is associated with a sensor assembly having the same construction as thesensor assembly420 ofFIGS. 13 and 14. Since the embodiment of the invention illustrated inFIG. 21 is generally similar to the embodiment of the invention illustrated inFIGS. 13, 14 and20, similar numerals will be utilized to designate similar components, the suffix letter “h” being associated with the numerals ofFIG. 21 to avoid confusion.
• Atracheal tube38h(FIG. 21) has aleading end portion500h. Adetector portion426his provided on theleading end portion500hof thetracheal tube38h. Thedetector portion426hcooperates with an emitter portion of a sensor assembly having the same construction as the emitter portion424 (FIG. 14) of thesensor assembly420.
• Thetracheal tube38hincludes a plurality of magneticflux sensor units440hwhich respond to variations in a magnetic flux field in which the sensor units are exposed. In the illustrated embodiment of the invention, thesensor units440hare Hall effect devices. However, thesensor units440hcould be other known types of devices which respond to a magnetic flux field.
• Thesensors440hare connected with a computer, similar to thecomputer438 ofFIG. 13, by a plurality ofleads442h. The computer to which theleads442hare connected has a display unit which displays an image of a typical respiratory system. The display indicates the position of theleading end portion500hof thetracheal tube38hrelative to the patient's respiratory system.
• In addition, the computer display may also indicate the position of a guide rod, corresponding to theguide rod50cofFIG. 13, relative to the patient's respiratory system. Therefore, the computer display shows the position of theleading end portion500hof thetracheal tube38hrelative to theleading end portion52c(FIG. 13) of theguide rod50c. Although thetracheal tube38hmay advantageously be utilized in association with a guide rod, similar to theguide rod50c, it is contemplated that the tracheal tube50hcould be utilized by itself without an associated guide rod. Of course, if thetracheal tube38hwas utilized by itself without a guide rod similar to theguide rod50cofFIG. 13, the output from the computer would indicated the position of the leading end portion50hof thetracheal tube38hrelative to the patient's respiratory system and would not indicate the location of the guide rod.
• It is contemplated that a steering apparatus similar to thesteering apparatus460 ofFIG. 17 may be utilized with thetracheal tube38h(FIG. 21). A plurality of expandable elements, corresponding to theexpandable elements464,466 and468 ofFIG. 18, would be connected with the leading end portion50hof thetracheal tube38h. The cooperation between the Hall effect devices forming thesensor units440hand the magnets of an associated detector portion of a sensor assembly would enable an operator inserting thetracheal tube38hinto a patient's respiratory system to determine when one or more of the expandable elements should be expanded to steer theleading end portion500hof thetracheal tube38h.
Embodiment of FIG.22
• In the embodiment of the invention illustrated inFIG. 19, alight source490 andsteering apparatus460fis associated with the leading end portion52fof aguide rod50f. In the embodiment of the invention illustrated inFIG. 22, a plurality of light sources and a steering apparatus are associated with the leading end portion of a tracheal tube. Since the embodiment of the invention illustrated inFIG. 22 is generally similar to the embodiments of the invention illustrated inFIGS. 19-21, similar numerals will be utilized to designate similar components, the suffix letter “j” being associated with the numerals ofFIG. 22 to avoid confusion.
• Atracheal tube38jhas aleading end portion500j. A plurality oflight sources490jare mounted on theleading end portion500jof thetracheal tube38j. Thelight sources490jare energized by electrical energy connected over leads492j. Although thelight sources490jhave been indicated schematically inFIG. 22 as being incandescent light sources, it is contemplated that solid state devices, such as light emitting diodes, could be utilized as the light sources if desired.
• Thesteering apparatus460jis mounted on theleading end portion500jof thetracheal tube38j. Thesteering apparatus460jincludes a plurality ofexpandable elements464jand466j. Although only twoexpandable elements464jand466jhave been illustrated schematically inFIG. 22, it should be understood that there are three expandable elements connected with theleading end portion500jof thetracheal tube38j. The expandable elements are disposed in an array around the end of the tracheal tube in much the same manner as illustrated schematically inFIG. 18 in association with theguide rod50e.
• Theexpandable elements464jand466jare connected withconduits472jand474j. Theconduits472jand474jare formed in the side wall of thetracheal tube38jin the manner indicated schematically inFIG. 22. Of course, a third conduit is provided to conduct fluid to and from a third expandable element on theend portion500jof thetracheal tube38j. It should be understood that theconduits472jand474jcould be formed separately from thetracheal tube38jif desired.
• When thesteering apparatus460jis to be utilized to change the course of movement of theleading end portion500jof thetracheal tube38jrelative to a patient's respiratory system, one or more of the expandable elements in thesteering apparatus460jis inflated under the influence of fluid pressure conducted through an associated conduit. For example, if theexpandable element464jis to be operated from a contracted condition to the expanded condition illustrated schematically inFIG. 22, fluid pressure is connected through theconduit472j. As theexpandable element464jexpands, forces are applied against tissue in the patient's respiratory system by theexpandable element464j. At the same time, theexpandable element464jis effective to apply force against theleading end portion500jof thetracheal tube38jto deflect the tracheal tube downward (as viewed inFIG. 22.
• It is contemplated that thetracheal tube38jmay be utilized in association with a guide rod, such as theguide rod50fofFIG. 19 or theguide rod50 ofFIG. 1. However, if desired, thetracheal tube38jcould be inserted into a patient's respiratory system without the benefit of a guide rod.
• When thetracheal tube38jis to be inserted into a patient's respiratory system, either with or without a guide rod, thelight sources490jare energized. Energization of thelight sources490jresults in the emission of light which can be detected by photo cells or similar devices positioned adjacent to the outside of the patient's neck. If desired, the photo cells could be eliminated and an operator could visually locate the leading end portion50jof thetracheal tube38jby viewing the illumination conducted through the patient's body tissues to the surface of the patient's neck. It is contemplated that an operator will, in all probability, locate theleading end portion500jof thetracheal tube38jby a combination of the output from photo detectors and visually viewing the patient's neck. If desired, thelight sources490 can be pulsed to provide a variation in the illumination from the light sources to facilitate visual locating of the leading end portion of thetracheal tube38jby an operator.
• When theinflatable elements464jand/or466jare to be operated from the expanded condition illustrated inFIG. 22 to a contracted condition, theconduits472jand474jmay be exhausted to atmosphere. It is believed that it may be preferred to connect theconduits472jand474jwith a source of low pressure or suction so that fluid is drawn out of the expandable elements.
• As the fluid pressure in theexpandable elements460jand466jis reduced, the natural resilience of the expandable elements causes them to contract tightly against theleading end portion500jof thetracheal tube38j. If desired, a plurality of recesses may be provided in theleading end portion500jof thetracheal tube38jto receive theexpandable elements464jand466j. Of course, if additional expandable elements are associated with theleading end portion500jof thetracheal tube38j, additional recesses would be provided to receive these expandable elements when they are contracted.
• Various types of emitters and detectors have been illustrated inFIGS. 20, 21 and22 in association with thetracheal tube38j. It should be understood that any of the emitters or detector systems previously described in association with a guide rod may be utilized in association with a tracheal tube. For example, a radio frequency transmitter and a receiver may be utilized as the emitter portion and the sensor portion of a sensor assembly which is utilized to detect the location of the leading end portion of a tracheal tube relative to a patient's respiratory system.
• Although it is believed that it will probably be preferred to utilize a steering apparatus, similar to thesteering apparatus460jin association with the tracheal tube, the steering apparatus could be omitted if desired.
• Positioning Apparatus—General—Mode of Operation
• The general mode operation of thepositioning apparatus56 ofFIG. 1 is illustrated schematically inFIG. 23. As was previously explained, thepositioning apparatus56 includes anarcuate member108. Thearcuate member108 has a center of curvature indicated at600 inFIG. 23.
• Thebody section86 of thepositioning apparatus56 has a central axis which extends through thecenter600. Thepositioning section96 is connected with an end of thebody section86 which is disposed closest to thecenter600 of curvature of thearcuate member108. The indicia124 (FIG. 1) on thebody section86 is effective to indicate the length of thebody section86.
• Theguide rod50 also has a central axis which extends through thecenter600 of curvature of thearcuate section108. The indicia142 (FIG. 1) on theguide rod50 indicates the distance from theleading end portion52 of theguide rod50 from thearcuate member108. Theguide rod50 andbody section86 of thepositioning apparatus56 are both radiuses from thecenter600 of curvature of the arcuate member. When the indicia142 (FIG. 1) indicates that the guide rod50 (FIG. 23) extends from thearcuate member108 for the same distance as thebody section86, theleading end portion52 of theguide rod50 is aligned with thepositioning apparatus96. Since thepositioning apparatus96 is accurately located relative to the patient's respiratory system11 (FIG. 1) by engagement with the patient's Adam'sapple34, the position of theleading end portion52 of the guide rod relative to the patient'slarynx30 is known when theleading end portion52 of theguide rod50 is aligned withpositioning apparatus96.
• An alternative embodiment of thepositioning apparatus56 is illustrated inFIG. 24. Since the embodiment of the positioning apparatus illustrated inFIG. 24 is generally similar to the embodiment of thepositioning apparatus56 illustrated inFIGS. 1 and 23, similar numerals will be utilized to indicate similar components, the suffix letter “k” being associated with the components ofFIG. 24 to avoid confusion.
• Apositioning apparatus56kincludes abody section86k. Apositioning section96kis connected with an end portion of thebody section86k. Thepositioning section96kengages the patient's Adam's apple, in the manner previously described in conjunction with theapparatus56 ofFIG. 1.
• In the embodiment of the invention illustrated inFIG. 24, amember108kis fixedly connected with thebody section86 and extends at a known angle, indicated at604 inFIG. 24. Aguide section114kis disposed at an end of themember108kopposite from theconnection606 with thebody section86k. Theguide rod section114kguides movement of aguide rod50kalong a path which extends through acenter600k.
• Thecenter600kis disposed at the intersection of a longitudinal central axis of thebody section86kand a longitudinal central axis of theguide rod50k. An angle, indicated at610 inFIG. 24, formed between the longitudinal central axis of thebody section86kand theguide rod50kis known. The distance from thepositioning section96kto theconnection606 between thebody section86kandmember108kis known. Theangles604 and610 are known. The length of themember108 is also known. Therefore the distance which theguide rod50kmust extend from theguide section114kto have theleading end portion52kof the guide rod aligned with thepositioning section96kcan readily be determined by trigonometric functions.
• It should be understood that features of any one embodiment of the invention may be used with features of other embodiments of the invention. For example, thepositioning apparatus256 ofFIGS. 4-10 could have the same construction as thepositioning apparatus56 ofFIGS. 1-3. Similarly, themagnet260 ofFIG. 4 could be used with the embodiment of the invention illustrated inFIGS. 1-3. Thesensor assemblies420 could be used with either thepositioning apparatus56 ofFIG. 1 or thepositioning apparatus256 ofFIGS. 4-10. Other combinations of features of the invention will undoubtedly be utilized.
Embodiment of FIGS.25 and26
• In the embodiments of the invention illustrated inFIGS. 1-24, thepositioning apparatus56 has apositioning section96 which engages the patient's Adam'sapple34. In the embodiment of the invention illustrated inFIGS. 25 and 26, the positioning apparatus engages a plurality of locations on the patient's neck. Since the embodiment of the invention illustrated inFIGS. 25 and 26 is generally similar to the embodiments of the invention illustrated inFIGS. 1-24, similar numerals will be utilized to designate similar components, the suffix letter “m” being associated with the numerals ofFIGS. 25 and 26 to avoid confusion.
• Apositioning apparatus56mis utilized to position aguide rod50mcorresponding to theguide rod50 ofFIG. 1, relative to a patient'strachea28mduring insertion of the guide rod into the patient's trachea. In addition, thepositioning apparatus56mprovides an indication of the distance which theguide rod50mis to be moved into the patient'strachea28m. Thepositioning apparatus56mincludes abase section78mwhich is connected with an arcuate upper section, corresponding to the arcuateupper section80 ofFIG. 1. Thebase section78mincludes a tubularcylindrical body section86b. Thebase section78malso includes apositioning section96m. Thepositioning section96mlocates thepositioning apparatus56mrelative to the patient's Adam'sapple34m.
• In accordance with a feature of the embodiment of the invention illustrated inFIGS. 25 and 26, thepositioning section96 includes a pair ofpositioning fingers622 and624 which engage the neck16mof the patient at locations disposed on laterally opposite sides of the Adam'sapple34m. Thus, thepositioning finger622 is provided with a relatively soft resilientspherical end portion628 which is pressed against the patient's neck16mat a location adjacent to the left (as viewed inFIG. 26) side of the patient's Adam's apple. Similarly, thepositioning finger624 has a soft resilientspherical end portion630 which is pressed against the patient's neck16mat a location adjacent to the right (as viewed inFIG. 26) side of the patient's Adam'sapple34m. The positioningfingers622 and624 cooperate with the patient's Adam'sapple34mto locate thepositioning section96mlaterally relative to the patient's Adam'sapple34m.
• In the embodiment of thepositioning section96millustrated inFIGS. 25 and 26, the positioning section is provided with a straightcenter positioning finger634 which is formed as a continuation of the tubularcylindrical body section86mof thepositioning apparatus56m. Thus, thebody section86mandcenter positioning finger634 are integrally formed as one piece. Thecenter positioning finger634 has a soft resilientspherical end portion636 which is pressed against the patient's Adam'sapple34mat the center of the patient's Adam's apple.
• Force may be applied against thebody section86mof thepositioning apparatus56mand transmitted to the patient's neck16mto straighten the trachea of the patient. Thus, a slight bend in the trachea can be minimized by the manual application of a relatively small force to thepositioning apparatus56m. This force is transmitted through theend portions628 and630 of the positioningfingers622 and624 to the patient's neck to straighten the patient's neck. In addition, a portion of the force will be transmitted through thecenter positioning finger634 directly to the patient's Adam'sapple34m.
• The position of theend portions628 and630 of the positioningfingers622 and624 relative to thebody section86mof thebase section78mof thepositioning apparatus56m(FIG. 25) can be varied. Thus, the positioningfingers622 and624 are fixedly connected to aslide block640 which is axially movable along thebody section86m. Thebody section86mextends through a cylindrical central opening in theslide block640. A set screw642 (FIG. 25) having manually engagable wings or flanges can be tightened to hold thepositioning fingers622 and624 in a desired position relative to thebody section86mof thepositioning apparatus56m. This enables the length of thecenter positioning finger634 to be adjusted. By adjusting the length of thecenter finger634, a relatively small amount of force can be transmitted through thecenter finger634 directly to the patient's Adam'sapple34mand substantially larger forces can be transmitted through the positioningfingers622 and624 to the patient's neck16mto locations disposed on opposite sides of the patient's Adam'sapple34m.
• It should be understood that thepositioning section96mofFIGS. 25 and 26 can be utilized in any of the positioning apparatus disclosed inFIGS. 1 through 24 herein. When thepositioning section96mis to be associated with thepositioning apparatus56cofFIG. 13, the emitter units430 (FIG. 14) could be mounted on or adjacent to theend portions628,630 and636 (FIGS. 25 and 26) of the positioningfingers622,624 and634. Similarly, when thepositioning section96mis utilized in association with thepositioning apparatus56dofFIGS. 15 and 16, thesensor units440 may be disposed adjacent to and connected with theend portions628,630 and636 (FIG. 25) of the positioningfingers622,624 and634.
• It should be understood that thepositioning apparatus56m(FIGS. 25 and 26) may be associated with guide rods having the construction of theguide rod50 ofFIG. 1, theguide rod250 ofFIGS. 4 and 8, theguide rod50eofFIGS. 17 and 18, or theguide rod50fofFIG. 19. It should also be understood that thepositioning apparatus56mmay be associated with a tracheal tube having the construction of any one of the tracheal tubes38 (FIG. 2),238 (FIGS. 9 and 10),38g(FIG. 20),38h(FIG. 21), or38j(FIG. 22).
Embodiment of FIGS.27 and28
• In the embodiment of the invention illustrated inFIGS. 25 and 26, the positioningfingers622 and624 are fixedly connected with thebody section86mof thepositioning apparatus56mby theslide block640 while the positioningfingers634 is integrally formed as one piece with the body section36m. In the embodiment of the invention illustrated in FIGS.27 and28, the positioning fingers are movable relative to the body section of the positioning apparatus. Since the embodiment of the invention illustrated inFIGS. 27 and 28 is generally similar to the embodiments of the invention illustrated inFIGS. 1-26, similar numerals will be utilized to designate similar components, the suffix letter “r” being associated with the numerals ofFIGS. 27 and 28 to avoid confusion.
• Apositioning apparatus56rpositions a guide rod, corresponding to theguide rod50 ofFIG. 1, relative to a patient's trachea during insertion of the guide rod into the patient's trachea. In addition, thepositioning apparatus56rprovides an indication of the distance which the guide rod is to be moved into the patient's trachea. Although only a portion of thepositioning apparatus56ris illustrated inFIGS. 27 and 28, it should be understood that the positioning apparatus may have the same general construction as the positioning apparatus of any one of the embodiments illustrated inFIGS. 1-19.
• Thepositioning apparatus56rincludes abase section78rwhich is connected with an arcuate upper section corresponding to the arcuateupper section80 ofFIG. 1. The upper section of thepositioning apparatus56rguides movement of a guide rod, corresponding to theguide rod50 ofFIG. 1, during insertion of the guide rod into the patient's trachea.
• In accordance with a feature of the present invention, apositioning section96ris connected with thebase section78r. Thepositioning section96rlocates thepositioning apparatus56rrelative to the patient's Adam'sapple34r(FIG. 28). Thepositioning section96ris connected with an end of abody section86rof thepositioning apparatus56rby auniversal pivot connection652. Thepivot connection652 allows the orientation of thebase section78rof thepositioning apparatus56rto be changed in any direction relative to thepositioning section96r. Thus, thebody section86rof thepositioning apparatus56rcan be raised or lowered (as viewed inFIG. 27) or pivoted to the left or right (as viewed inFIG. 28.
• Thepositioning section96rincludes a plurality ofpositioning fingers622r,624rand634r. The positioningfingers622r,624rand634rare provided with soft resilientspherical end portions628r,630r, and636r. Although thepositioning section96rmay be located in any one of many different orientations relative to the patient's Adam'sapple34r, theposition section96ris illustrated inFIG. 28 with theend portions628rand630rdisposed on laterally opposite sides of the patient's Adam'sapple34r. Theend portion636ris disposed adjacent to the lower end portion of the patient's Adam'sapple34r. If desired, the orientation of thepositioning section96rcould be rotated by 180 degrees from the orientation illustrated inFIG. 28. If this was done, theend portion636ron thepositioning finger634rwould be disposed adjacent to the upper portion of the patient's Adam'sapple34r. It is believed that it will probably be preferred to align thepivot connection652 with the center of the patient's Adam'sapple34r. However, if desired, thepivot connection652 could be offset from the center of the patient's Adam'sapple34.
• In the embodiments of the invention illustrated inFIGS. 25-28, thepositioning sections96mand96rhave been illustrated as having three positioning fingers. However, it is contemplated that the positioning sections could have either a greater number of positioning fingers or a lesser number of positioning fingers if desired. For example, thecenter positioning finger634 of the embodiment of the invention illustrated inFIGS. 25 and 26 could be omitted. If this was done, thepositioning finger622 would be positioned on one side of the patient's Adam'sapple34mand thepositioning finger624 would be positioned on the laterally opposite side of the patient's Adam's apple, in the manner illustrated inFIG. 26, without engaging the central portion of the patient's Adam's apple. Alternatively, thepositioning section96mor96rcould be provided with four positioning fingers. If this was done, two of the positioning fingers would be positioned in engagement with the neck of the patient adjacent to one side of the patient's Adam's apple and the other two positioning fingers would be positioned in engagement with the patient's neck on a laterally opposite side of the patient's Adam's apple.
Conclusion
• An improved method and apparatus for use in tracheal intubination or other medical procedures may include apositioning apparatus56,256. When thepositioning apparatus56,256 is used for tracheal intubination, the positioning apparatus is located relative to a patient'strachea28,228 by engaging a portion of the patient's body, such as the Adam'sapple34,234. Aflexible guide rod50,250 may be moved relative to the positioning apparatus until aleading end portion52,252 of the guide rod has moved into the patient's trachea. Atracheal tube38,238 is slid along the guide rod into the patient's trachea.
• During movement of theguide rod50,250 relative to thepositioning apparatus56,256, the guide rod may be moved through either atubular guide member264 or atracheal tube38,238 which extends through the patient's mouth into the patient's pharynx. Before beginning to move theguide rod50,250, the distance which the guide rod is to be moved may advantageously determined. This may be done as a function of spacing between locations on thepositioning apparatus56,256. If desired,indicia124,324 may be provided on thepositioning apparatus56,256 and cooperatingindicia142,342-350 may be provided on theguide rod50,250.
• Amagnet260 may be utilized to attract aleading end portion252 of theguide rod250. Themagnet260 is disposed outside of the patient's body and may be positioned adjacent to an anterior side of the trachea. Magnetic attraction between themagnet260 and theleading end portion252 of the guide rod deflects the guide rod. This steers the leading end portion of theguide rod250 into the entrance to the patient's trachea. A magnet may be used to steer a member relative to a patient's body tissue during performance of operations other than tracheal intubination.
• In order to locate theguide rod50,250 and/ortracheal tube38,238 relative to the patient's trachea, an image of body tissue adjacent to the leading end portion of the guide rod and/or tracheal tube may be transmitted to a location outside of the patient's body (FIGS. 12 and 20). Movement of theguide rod50,250 and/ortracheal tube38,238 into the patient's trachea is interrupted when the image transmitted from the leading end portion of the guide rod or tracheal tube indicates that the leading end portion of the guide rod or tracheal tube has been moved to a desired position relative to the patient's trachea.
• It is believed that transmission of an image of body tissue adjacent to the leading end portion of thetracheal tube38,238 may advantageously be performed when the tracheal tube is utilized without benefit of thepositioning apparatus56,256. However, the transmission of an image of body tissue adjacent to the leading end portion of thetracheal tube38,238 may be performed when the positioning apparatus is used in association with the tracheal tube. Positioning of theguide rod50,250 relative to the patient's trachea may also be facilitated by the transmitting of images of body tissue adjacent to a leading end portion of the guide rod.
• Detectors andemitters424,426 may be utilized to detect the position of the leading end portion of theguide rod50,250 and/or thetracheal tube38,238 relative to the patient's trachea. When this is done, anemitter424, such as a magnet or a light source, may be connected with aleading end portion52,252 of theguide rod50,250 and/or thetracheal tube38,238. One ormore detectors426 may be provided on the outside of the patient's neck to detect the output from theemitter424 when theguide rod50,250 and/or thetracheal tube38,238 are in a desired position relative to the patient's trachea. Alternatively, adetector426 may be connected with the leading end portion of aguide rod50,250 and/ortracheal tube38,238 and one ormore emitters424 positioned relative to the outside of the patient's neck. Thedetector426 would provide an output indicating when theguide rod50,250 and/ortracheal tube38,238 is moved to a desired position relative to the patient's trachea.
• During movement of theguide rod50,250 and/ortracheal tube38,238 along the patient's respiratory system and into the patient's trachea, force may be applied against theleading end portion52,252 of the guide rod and/or tracheal tube to steer the leading end portion of the guide rod and/or tracheal tube. The application of force against theleading end portion52,252 of theguide rod50,250 and/ortracheal tube38,238 may be accomplished by expanding an expandable element464-468 connected with theguide rod50,250 and/or thetracheal tube38,238.
• It should be understood that any one of the features of the present invention may be used separately or in combination with other features of the invention. It's believed that various combinations of the features, other than those disclosed herein, may advantageously be utilized and will be apparent to those skilled in the art from the description contained herein. In addition, it should be understood that features of the present invention may be used for purposes other than tracheal intubination. From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications within the skill of the art are intended to be covered by the appended claims.

Claims (25)

1. A method of positioning a medical device in a body of a patient, comprising:

positioning a plurality of detectors in an array adjacent to an outer surface of a portion of the body of the patient;

moving the medical device along an insertion path in the body of the patient;

emitting an output at a leading end portion of the medical device as the medical device moves along the insertion path;

detecting the emitted output at the leading end portion of the medical device with the detectors of the plurality of detectors; and

determining the position of the leading end portion of the medical device along the insertion path as a function of the relationship of the emitted output detected by the detectors.

2. The method ofclaim 1, wherein the plurality of detectors extends in an array along the insertion path.

3. The method ofclaim 2, wherein the plurality of detectors extend in an array at least part way around the insertion path.

4. The method ofclaim 1, wherein the plurality of detectors are connected to a computer and wherein the computer determines the position of the leading end portion of the medical device along the insertion path as a function of the relationship of the emitted output detected by at least one of detectors of the plurality of detectors.

5. The method ofclaim 4, further including displaying on a display unit a position of a leading end portion of the medical device during movement of the medical device along the insertion path.

6. The method ofclaim 1, wherein emitting an output at a leading end portion of the medical device includes emitting an energy selected from the group consisting of magnetic, electromagnetic, radio frequency, ultrasonic, light energy, and combinations thereof.

7. The method ofclaim 1, further including providing a display unit illustrating a position of a leading end portion of the medical device.

8. The method ofclaim 1, wherein determining the position of the leading end portion of the medical device includes determining the position of the leading end portion of the medical device as a function of the relationship of the emitted output detected by one detector of the plurality of detectors to the emitted output detected by another detector of the plurality of detectors.

9. A method of positioning a medical device in a body of a patient, comprising:

positioning a plurality of emitters in an array adjacent to an outer surface of a portion of the body of the patient;

moving the medical device along an insertion path in the body of the patient, the medical device including a detector at a leading end portion;

emitting an output from the plurality of emitters as the medical device moves along the insertion path;

detecting the emitted output with the detector at the leading end portion of the medical device; and

determining the position of the leading end portion of the medical device along the insertion path as a function of the relationship of the emitted output detected by the detector.

10. The method ofclaim 9, wherein the plurality of emitters extends in an array along the insertion path.

11. The method ofclaim 10, wherein the plurality of emitters extend in an array at least part way around the insertion path.

12. The method ofclaim 9, wherein the detector is connected to a computer and wherein the computer determines the position of the leading end portion of the medical device along the insertion path as a function of the relationship of the emitted output detected by the detector.

13. The method ofclaim 12, further including displaying on a display unit a position of a leading end portion of the medical device during movement of the medical device along the insertion path.

14. The method ofclaim 9, wherein emitting an output from the plurality of emitters includes emitting an energy selected from the group consisting of magnetic, radio frequency, ultrasonic, light energy, and combinations thereof.

15. An apparatus for use in a medical procedure on a patient, comprising:

a medical device moveable along an insertion path into a body of the patient;

an emitter attached to a leading end portion of the medical device, the emitter providing an energy signal;

a plurality of detectors positionable on an outer surface of the body of the patient along the insertion path; and

a computer connected to the plurality of detectors, the computer determining the position of the leading end portion of the medical device along the insertion path as a function of the relationship of the energy signal detected by the detectors.

16. The apparatus ofclaim 15, wherein the plurality of detectors extend in an array at least part way around the insertion path.

17. The apparatus ofclaim 15, further comprising a display unit connected to the computer, wherein the display unit displays the position of the leading end portion of the medical device in the body of the patient.

18. The apparatus ofclaim 15, wherein the energy signal is selected from the group consisting of magnetic, electromagnetic, radio frequency, ultrasonic, light energy, and combinations thereof.

19. The apparatus ofclaim 15, further comprising a means for steering the medical device along the insertion path.

20. The apparatus ofclaim 15, further comprising a plurality of expandable elements connected about the leading end portion of the medical device, the expandable element being selectively expandable to direct the medical device along the insertion path.

21. The apparatus ofclaim 20, further comprising a fluid control system for selectively expanding the expandable elements.

22. The apparatus ofclaim 20, further comprising a mechanical control system for selectively expanding the expandable elements.

23. An apparatus for use in a medical procedure on a patient, comprising:

a medical device moveable along an insertion path into a body of the patient;

a plurality of emitters positionable on an outer surface of the body of the patient along the insertion path, each of the emitters providing an energy signal;

a detector attached to a leading end portion of the medical device, the detector configured to receive the energy signal from the emitters; and

a computer connected to the detector, the computer determining the position of the leading end portion of the medical device along the insertion path as a function of the relationship of the energy signals detected by the detector.

24. The apparatus ofclaim 23, wherein the plurality of emitters extend in an array at least part way around the insertion path.

25. The apparatus ofclaim 23, further comprising a display unit connected to the computer, wherein the display unit displays the position of the leading end portion of the medical device during movement of the medical device along the insertion path.

Images