The present application claims priority from U.S. provisional patent application No. 61/319,835 filed on 31/2010, No. 61/261,739 filed on 16/11/2009, and No. 61/169,446 filed on 14/4/2009 and is incorporated by reference in its entirety. This application is also incorporated by reference in its entirety in U.S. patent No. 6,142,144 filed on 1/4/1998 and in its provisional patent application No. 60/074,355 filed on 10/2/1998 and 60/067,205 filed on 7/12/1997; U.S. patent No. 6,543,447 filed on 6/12/2000 and U.S. patent application No. 09/704,507 filed on 2/11/2007 and No. 09/060,891 filed on 15/4/1998; and U.S. patent No. 6,655,377 filed on 30/1/2003 and U.S. patent application No. 09/732,129 filed on 6/12/2000 and 09/704,507 filed on 2/11/2000, and U.S. provisional patent application No. 60/352,283 filed on 30/1/2002; 60/223,330 filed on 8/7/2000; 60/168,711 filed on 6.12.1999; 60/074,355, filed on 10.2.1998, and 60/067,205, filed on 1.12.1997. All patents and patent applications are incorporated by reference in their entirety.
Drawings
Preferred and alternative examples of the present invention are described in detail below with reference to the attached drawing figures, wherein:
FIG. 1 depicts a general side view of a video laryngoscope system 10 having a single use (single use) transparent sterilizable sheath configured to receive a video wand stabilized by side posts of a detachable video wand that are engageable with side securing tabs of the sheath;
FIG. 2 depicts the detachable video wand during insertion into the sterilizable sheath, with the side posts of the wand slidably engaging the side securing tabs and shown passing halfway through the angled surfaces of the side securing tabs of the sheath;
FIG. 3 depicts the completed insertion motion of the video rod into the sheath, wherein the side posts of the rod have passed the angled surfaces of the tabs and are retained in the rounded apexes of the female V-shaped brackets and the inward slopes of the side securing tabs;
FIG. 4 depicts an enlarged view of the rod side post and sheath side fixation tabs shown in FIG. 3;
FIG. 5 depicts the open end of the sheath with the video wand fully engaged and secured within the V-shaped cradle of the sheath;
FIG. 6 depicts a general side view of a video laryngoscope system 50 having a single use transparent sterilizable sheath configured to receive a detachable video wand stabilized with side rails and rearward lips of the video wand engaged with an inside support and rearward locking tabs, respectively, of the sheath;
fig. 7 depicts a generally rear perspective view of a video laryngoscope system 50 showing a sheath blank with the medial support located on the wall of the rod handle chamber continuous with the sheath edge on which the locking tabs are mounted to engage the ledge and lip of the rod handle, respectively.
FIG. 8 depicts a rear perspective view of the removable video wand of FIG. 6 during insertion into the sterilizable sheath;
FIG. 9 depicts a side perspective view of the removable video wand of FIG. 6 during insertion into the sterilizable sheath;
FIG. 10 depicts a rear perspective view of the detachable video wand of FIG. 6 inserted and secured into a sterilizable sheath;
FIG. 11 depicts a side perspective view of a portion of the removable video wand of FIG. 6 inserted and secured into a sterilizable sheath;
fig. 12A-G depict structural plan and cross-sectional views of one embodiment of the sheath depicted in fig. 1.
Fig. 13A-G depict structural plan and cross-sectional views of another embodiment of the sheath depicted in fig. 1.
Fig. 14A-E depict structural plan and cross-sectional views of one embodiment of the sheath depicted in fig. 6.
Fig. 15A-E depict plan and cross-sectional views of another embodiment of the sheath depicted in fig. 6.
16A-D depict a series of general side and perspective views of a video laryngoscope system 100 having a single use non-transparent sterilizable sheath configured to receive a detachable video wand stabilized with side posts of the detachable video wand engageable with opposing side securing tabs located along the edges of a V-shaped bracket of an alternative embodiment of the sheath depicted in FIG. 1;
fig. 17A-C depict a series of general perspective and partial cross-sectional views of a sheath in a video laryngoscope system 200 having a non-transparent sheath as an alternative embodiment to the transparent sheath depicted in fig. 1;
18A-C depict a general side perspective view of a video laryngoscope system 300 having a single use non-transparent sterilizable sheath configured to receive a removable video wand stabilized with side rails and rearward lips of the video wand engaged with the medial support and lateral locking tabs, respectively, of an alternative embodiment of the sheath depicted in FIG. 6;
fig. 19A-C depict a general side perspective view of a video laryngoscope system 400 having a single use non-transparent sterilizable sheath configured to receive a detachable video wand stabilized with side posts of the detachable video wand that are engageable with side securing tabs of the sheath as an alternative embodiment to the transparent sheath shown in fig. 1;
20A-B depict the placement and advancement of a laryngoscope within the mouth of a patient;
FIG. 21 depicts the engagement of the epiglottis vallecula by the tip of the laryngoscope to move the epiglottis upwardly to expose the glottic space;
FIG. 22 depicts lifting the epiglottis directly from the tip of the laryngoscope to move the epiglottis upwardly to expose the glottic space;
FIG. 23 depicts a stylet adjacent to the ETT;
figures 24A and B depict placement of a stylet in the oropharynx of a patient via an ETT;
FIG. 25 depicts a patient cross-section showing a side view of the ETT/stylet in position to pass through the glottic gap;
26-29 illustrate the use of the laryngoscope system and device embodiments to deliver ETT into a patient; and
fig. 30 depicts a flow chart of a method of positioning an ETT within an airway of a patient using system and apparatus embodiments.
Detailed Description
Several embodiments of video-based intubation laryngoscopes and systems that allow examination of the upper airway and intubation are described. The system utilizes a video laryngoscope embodiment configured to view the patient's glottis, reposition the patient's epiglottis, view the glottis gap, and transmit video images of the patient's upper airway anatomy including the glottis and/or glottis gap and surrounding areas to a video monitor viewable by a laryngoscope user. An endotracheal tube (ETT) is placed in the patient's mouth and its position relative to the patient's GA is noted from the image presented on the video monitor. Based on the video images displayed on the monitor, the ETT is advanced into the trachea through the patient's glottic gap via a secondary stylet located within the cavity of the ETT.
Embodiments of the laryngoscope include a substantially transparent housing or sheath intended for disposable use, into which a video wand is inserted. The video wand includes a camera and a light source and is brought distally against an optical window located on the rear side of the laryngoscope blade. The images obtained from the video wand are transmitted to a video monitor that can be viewed by the laryngoscope user. The blades are used to reposition the epiglottis to expose the glottic space by engaging the patient's epiglottis vallecula or alternatively lifting the epiglottis directly. The ETT loaded with the stylet is inserted into the port under direct vision and advanced until the tip of the ETT appears at or near the distal portion of the laryngoscope blade in the video monitor image and proximate the glottic gap. The monitor is viewed and the ETT is then advanced through the glottic gap into the patient's trachea while the stylet is removed.
Improved intubation speed and accuracy is achieved by the particular configuration because a non-occluded, real-time or "live" view is immediately obtained on the visual display monitor. The aiming assistance provided by the arrangement of the laryngoscope allows the video laryngoscope to be repositioned in real time just prior to advancing the ETT from the video laryngoscope through the glottic gap to optimally align the tip of the ETT with the glottic gap. Video laryngoscopes provide a clear, direct image of the larynx, vocal cords, and laryngeal region on a display monitor and provide a way to control the trajectory of the ETT towards and through the glottic gap.
The laryngoscope includes a handle, a blade configured to engage the epiglottis to expose the glottic space visualized by the camera, and a distally directed illumination unit located behind the laryngoscope blade. The video-based laryngoscope embodiments can be manufactured from materials that allow for sterilization and re-use, or alternatively, can be configured as a disposable portion that includes a removable camera and illumination member housed in the internal chamber. The removable camera and lighting member unit is sufficiently enclosed within the chamber to prevent moisture or fluids from reaching the internal optics and electronics of the camera and lighting member. In yet another embodiment, a disposable laryngoscope adapter or sheath can be removably secured to a laryngoscope equipped with a non-removable camera to provide a clean sterile surface, which allows for the re-use of video-based laryngoscopes without having to undergo washing or decontamination procedures.
The exemplary embodiments described below include a device having a laryngoscope housing or sheath configured to removably receive a camera unit. The laryngoscope sheath has a handle and a blade with an internal chamber that starts from the handle and terminates in an optically transparent window on the back side of the blade pointing distally. The chamber is configured to receive an insertable camera unit and secure the camera unit in the interior chamber. The camera unit includes a camera and a light source that illuminates an anatomical region within a field of view of a lens.
A retention snap ring or tab located on an inner wall of the chamber proximate the handle portion removably engages against a surface of the camera such that a lens portion of the camera unit can be positioned against an inner side of the optically transparent window. The chamber is designed to receive a camera unit and to place the lens of the camera unit against or against the inside of the window by engaging the retention clip with surface features or structures of the camera unit. In another exemplary embodiment of the camera laryngoscope, the housing or sheath may be made transparent, translucent or opaque to the non-window portions thereof (e.g., the handle, blade and internal chamber). In still other embodiments, the window is also the lens of the focusing camera. In some embodiments, the retention snap ring is configured, for example by tapering or by being eccentrically positioned relative to the mating handle components, to press the distal ends of the video wand and the camera against the window, thereby minimizing the presence of air and/or moisture in the space between the camera and the window. The air gap and accompanying moisture can cause fogging of the camera. In addition, if the window is also a focus lens, the positioning of the camera relative to the lens is important for image quality.
The laryngoscope sheath or sheath may be constructed of materials for single use and thus disposable, or may be manufactured of materials that are amenable to cleaning, decontamination and/or sterilization and thus reusable or configured for multiple use with other insertable video laryngoscopes that are configured to be removably secured by locking tabs located in the interior portion of the disposable sheath.
A video laryngoscope, secured within a transparent or non-transparent disposable sheath, may be inserted into the patient's mouth to provide clear camera viewing through the optically transparent port of the transparent or non-transparent disposable sheath to allow for endotracheal procedures to be performed. Transparent or non-transparent disposable sheaths are sterilizable and may be used only once for a given patient. The rod-shaped video laryngoscope is configured to be removably detachable from the disposable sheath after removal from the patient and reinserted into another sterile disposable sheath for insertion into another patient. Alternatively, the reusable sheath undergoes a high level of sterilization after the clinical examination is complete. In other embodiments, the intended disposable use of the sheath may be achieved as follows: the retention clip or tab is constructed in a frangible arrangement whereby upon removal or disassembly of an inserted video wand from the inner chamber of the sheath, the frangible tab breaks to become unable to secure the video wand within the chamber of the sheath.
The described embodiments include a reusable video laryngoscope insertable into a transparent or non-transparent disposable sheath having a transparent optically transparent viewing window in contact with a camera lens. The reusable video laryngoscope is configured to be removably secured by locking tabs located in the transparent or non-transparent disposable sheath with complementarily shaped posts and ledges of the video laryngoscope. A video laryngoscope, secured in a transparent or non-transparent disposable sheath, may be inserted into the patient's mouth to provide clear camera viewing through an optically transparent window port of the transparent or non-transparent disposable sheath, thereby allowing endotracheal procedures to be performed. Transparent or non-transparent disposable sheaths are pre-sterilized and may be used only once for a given patient. The rod-shaped video laryngoscope is configured to be removably detachable from the disposable sheath and removed from the patient and reinserted into another sterile disposable sheath for insertion into another patient. The reusable video laryngoscope blade can then undergo a high level of disinfection after a series of clinical examinations are completed.
Other embodiments described herein include a video laryngoscope system having a video laryngoscope having a handle and a see-through sheath having a blade with an optically transparent window, a chamber configured to receive the handle and a camera, and a locking tab configured to engage at least one surface of the laryngoscope handle. This configuration allows a video laryngoscope to be inserted into the chamber of the sheath or holder (stat) such that the video laryngoscope fits in the chamber and the locking tab attachably engages with the at least one surface to slidably bring the camera into contact with the optically transparent window. Other embodiments allow the at least one locking tab to include an abutting tapered ledge engageable with a surface of the at least one surface of the laryngoscope handle. A rod-shaped video laryngoscope is removably detachable from a disposable sheath after use and can be easily inserted into another sterile disposable sheath for application to different patients.
The camera of the video wand may comprise a CCD or CMOS configuration that may be placed near an angled point near the midpoint of the disposable sheath blade to provide advantageous positioning of the camera at a distance from the glottic opening to allow a degree of perspective and wide angle viewing.
Fig. 1 depicts a general side view and partial perspective view of a video laryngoscope 10, the video laryngoscope 10 having a sterilizable sheath 12 configured to receive a detachable video wand 30 that can be internally disposed and detachably secured within the sterilizable sheath 12. Video wand 30 includes a non-flexible handle 33, a flexible cable 34 extending from handle 33, and a camera and illumination member 35 extending from cable 34 and located at the distal end of video wand 30. A power and video cable 38, which may be connected to an analog or digital video monitor 610 shown below in fig. 24A and 26, extends from the proximal side of the handle 33. Video wand 30 is intended for multiple uses with each individual sterilizable sheath 12, where each individual sheath 12 is intended for a single use event in a patient. Sterilizable sheath 12 may be transparent or opaque and includes a sheath handle 13 defining a chamber 24 that is similarly shaped and slightly larger than video wand 30. Sheath 12 includes two concave V-shaped cradles 18 having rounded apexes 20. The V-shaped brackets 18 are arranged diametrically opposite each other, as shown in fig. 5 below. Side securing or locking tabs 22 are located between the rounded apex 20 and the opening of the V-shaped bracket 18. The locking tabs 22 reside on the inner surface of the sterilizable sheath 12.
Sheath 12 has a proximal end with a chamber 24 that is open for receiving a video wand 30. The front portion includes a proximal blade portion 14 and a distal blade portion 16. The distal blade portion terminates in a distal tip 19, which distal tip 19 is used to lift the epiglottis or to engage the epiglottis vallecula V of the patient to lift the epiglottis EPI, thereby exposing the glottic gap GA. Window 17 is located on the rear side of sheath 12 and camera and illumination member 35 of video wand 30 terminates in video window 17 and points distally when inserted.
The V-shaped bracket 18 is convex and includes a rounded apex 20. In the enlarged illustration, the locking tab 22 is shown to include two abutting wedge surfaces 22A and 22B. The wedge surface 22A faces the opening portion of the V-shaped bracket 18, and the wedge surface 22B faces the rounded apex 20 of the V-shaped bracket 18. The video wand 30 includes a wand handle 33, a cable 34, a camera 35, a generally circular side post 36 on the opposite side of the wand handle 33, and a conduit 38 that carries optical information signals between the camera and illumination member 35 and a display device, such as a TV or computer monitor depicted in fig. 24A and 26 below. The side posts 36 are removably engaged with the locking tabs 22 to secure the video wand 30 within the sheath 12 and allow for its convenient removal after a laryngoscope procedure in a patient is performed.
Although sterilizable sheath 12 is intended for disposable use and is packaged for disposable use and discarded after removably attaching video wand 30 from transparent sheath 12, in a reusable embodiment, sterilizable sheath 12 may be cleaned and decontaminated to destroy pathogenic microorganisms or autoclaved or subjected to other sterilization processes to destroy pathogenic and non-pathogenic microorganisms. The re-sterilization process may include an autoclave sterilization process, a mixture of autoclave and acid or other chemical fumes, a gamma irradiation process, and a chemical sterilization process, such as ethylene oxide sterilization. In other cases, sterilizable sheath 12 may be subjected to a dry heat-based, wet heat-based, or chemical-based decontamination process to destroy pathogenic microorganisms.
Fig. 2 depicts the removable video wand 30 during insertion into the opening 24 of the sterilizable sheath 12, wherein the side posts 36 of the wand slidably engage the side fixation tabs 22 and are shown passing halfway through the inclined surfaces of the wedges 22A of the side fixation tabs 22. The camera and illumination means 35 are shown partially transferred to the optically transparent video window 17 and not yet abutting it.
Fig. 3 depicts the completed insertion motion of the video wand 30 into the chamber 24 of the sheath 12, wherein the side posts 36 of the wand have passed the angled surfaces or wedges 22A and 22B of the tabs 22 and are retained within the rounded apex of the female V-shaped bracket 18 and the inward slope 22B of the side securing tabs or locks 22. The camera 35 is in close proximity to the optical window 17.
Fig. 4 depicts an enlarged view of the rod side post 36 and sheath side fixation tab 22 depicted in fig. 3. Where the side posts 36 engage the smaller wedge surface 22B and rounded apex 20 of the bracket 18 to securely hold the video stick 30 residing in the holder or sheath 12 while the laryngoscope procedure is being performed.
Fig. 5 depicts sheath chamber 24 with video wand 30 fully engaged and secured within V-shaped cradle 18 of sheath 12. The locking tab 22 is fully engaged with the post 36 of the video wand 30.
Fig. 6 depicts a general side view of a video laryngoscope system 50 having a single use sterilizable sheath 52 configured to receive a detachable video wand 70 with a camera 55 and to be stabilized with side rails 76 and rearward lips 78 of the video wand engaged with medial supports 72 and rearward locking tabs 80, respectively, of the sheath 52.
Fig. 7 depicts a generally rear perspective view of the video laryngoscope system 50 showing the chamber 44 with the medial support 72 located on the wall of the rod handle chamber 53 continuous with the sheath edge 79 on which the rearward locking tab 80 is mounted, thereby engaging the ledge 76 and lip 78, respectively, of the rod handle 73.
Fig. 8 depicts a rear perspective view of the removable video wand 70 of fig. 6 during insertion of the sterilizable sheath 52. Where the locking tabs 80 have not yet contactably engaged the proximal lip 78 of the bar 70.
Fig. 9 depicts a side perspective view of the removable video wand 70 of fig. 6 during insertion of the sterilizable sheath 52. Where the locking tabs 80 have not yet engaged the proximal lip 78 of the bar 70. Similarly, the rails 76 of the rod 30 have not yet contactably engaged the side supports 72 of the sheath 52. In this side view, the ledge 76 of the rod 30 is shown as having a curved shape complementary to the side support 72 of the sheath 52 in that the side support 72 has a central cup-shaped recess 74 that receives a convex hemisphere or centering pin 77 extending from the side support 72 of the rod 70.
Fig. 10 depicts a rear perspective view of the removable video wand 70 of fig. 6 inserted and secured into the sterilizable sheath 52. Where tabs 80 of sheath 52 flex around to securely hold against edge or lip 78 of rod 70.
FIG. 11 depicts a side perspective view of a portion of the removable video wand 70 of FIG. 6 inserted and secured into the sterilizable sheath 52. Where the tabs 80 of the sheath 52 flex around to firmly hold against the edge 78 of the rod 70 and the side supports 72 of the sheath 52 engage the ledge or lip 76 of the rod 70 and the surface of the centering pin 77.
Fig. 12A-G depict plan and cross-sectional views of the structure of embodiment 12A of sheath 12 depicted in fig. 1. Top, bottom, left, right, perspective, front, and cross-sectional views are depicted to illustrate the dimensional differences of the distal blade portion 16A for a given sheath handle 13 configuration. Sheath 12A includes a chamber 24 in which a video wand 30 occupies. Handle 13 is overmolded to proximal blade portion 14 and distal blade portion 16 with a sealed closure. Sheath 12A is manufactured to be substantially free of flash, protruding gate vestige, scratches, spots, bubbles or weld lines in the region of window 17. Sheath 12A is also substantially free of fingerprints, grease, dirt, or other contaminants. Particular embodiments of sheath 12A may comprise a plastic material that is virgin plastic, i.e., not reground or recycled plastic, and the plastic molding process complies with the Sabic/GEPLASTIC PROCESSING Guide for LEXAN HPS1 (the Sabic/GE plastics Processing Guide for LEXAN HPS 1) without the use of a mold release agent. The dimensions 28mm, 22.7mm, 19.6mm, 8.0mm, 38.1mm, 15mm and 2mm depicted in fig. 12D are exemplary. Similarly, the dimensions 119.7mm, 22.7mm, 31.5mm, 8.6mm, and 4.17mm depicted in fig. 12G are exemplary.
Fig. 13A-G depict structural plan and cross-sectional views of another embodiment 12B of the sheath 12 shown in fig. 1. Top, bottom, left, right, perspective, front, and cross-sectional views are shown to show the differences in the size of the distal blade section 16B for a given handle 13 configuration. Sheath 12B includes a chamber 24 in which the video wand occupies. The manufacturing process of sheath 12B is substantially the same as that of sheath 12A of fig. 12A-G. The dimensions depicted in these figures are exemplary.
Fig. 14A-E depict plan and cross-sectional views of the construction of the embodiment 52A of the sheath 52 depicted in fig. 6. Top, bottom, left, right, perspective and front views are depicted to illustrate the differences in size of the tongue blade 56A for a given handle 53 configuration. Sheath 52A includes a chamber 44 in which a video wand 70 occupies. The handle 53 is ultrasonically welded to the proximal blade portion 14 and the distal blade portion 16 with the seals closed. Sheath 52A is manufactured to be substantially free of flash, protruding gate vestige, scratches, spots, bubbles or ultrasonic weld lines in the region of window 57. Sheath 52A is also substantially free of fingerprints, grease, dirt, or other contaminants. Particular embodiments of sheath 52A may comprise a plastic material that is virgin plastic, i.e., not reground or recycled plastic, and the plastic molding process complies with Chevron Phillips plastic processing Guide for K-Resin SBC KRO3 (Chevron Phillips plastic processing Guide for K-Resin SBC KRO 3). Other particular embodiments of the sheath 52A may be manufactured without the use of a release agent. Brackets 61, 62 span flange 59 and secure the flange to the lip below optical window 57. The dimensions depicted in these figures are exemplary.
Fig. 15A-E depict structural plan and cross-sectional views of another embodiment 52B of the sheath 52 shown in fig. 6. Top, bottom, left, right, perspective, and front views are depicted to illustrate the differences in size of the distal blade portion 56B for a given handle 53 configuration. Sheath 52B includes a chamber 44 in which a video wand 70 occupies. The manufacturing process of the sheath 52B is substantially the same as that of the sheath 52A of fig. 14A-E. The dimensions depicted in these figures are exemplary.
Fig. 16A-D depict a series of general side and perspective views of a video laryngoscope system 100 having a single use non-transparent sterilizable sheath configured to receive a detachable video wand stabilized with side posts of the video wand engageable with opposing side securing tabs 190 positioned to extend from the edges of the V-shaped bracket 18C of the alternative embodiment of the sheath 12 depicted in fig. 1. The light source 40 and camera lens 41 are shown as part of the camera and illumination member 35.
Fig. 17A-C show a series of general perspective and partial cross-sectional views of a sheath in a video laryngoscope system 200 having a non-transparent sheath as an alternative embodiment to the transparent sheath depicted in fig. 1. The engagement of the post 36 in the rounded apex and wedge surface 22B of the V-shaped bracket 18C is shown in cross-sectional view in fig. 17C.
Fig. 18A-C depict a general side perspective view of a video laryngoscope system 300 having a single use non-transparent sterilizable sheath configured to receive a removable video wand 70 stabilized with side rails and rearward lips of the video wand engaged with the medial support and lateral locking tabs 80A on the edge 79, respectively, of an alternative embodiment of the sheath depicted in fig. 6. The lateral locking tabs 80A are at approximately 90 degrees to the rearward locking tabs 80 depicted in the sheath 52 of fig. 6. The laryngoscope sheath 300 includes a chamber 44 in which the video wand 70 occupies. The light source 40 and camera lens 41 are shown as part of a camera 55.
Fig. 19A-C depict a general side perspective view of a video laryngoscope system 400 having a single use non-transparent sterilizable sheath 52 as an alternative embodiment of the transparent sheath 12 shown in fig. 1, the non-transparent sheath 52 configured to receive a removable video wand stabilized with its side posts engageable with the side supports 72 and secured in place by engaging the tabs 80 of the sheath 52. Chamber 44 is shown as being occupied therein by a video wand 70.
Fig. 20A-B depict laryngoscope 50 placement and advancement in a patient's mouth, with a video wand 70 removably placed therein and secured within the sheath 52. Other laryngoscope sheath-video wand embodiments may similarly be inserted and advanced in the patient's mouth, including laryngoscopes 10, 50, 52A, 52B, 100, 200, 300 and 400. The laryngoscopes 5-400 can be positioned within the patient to engage the epiglottis valleculae V via the respective distal tips of the sheaths 10-53 to thereby elevate the epiglottis EPI and thereby expose the glottic gap GA by squeezing the respective tips into the epiglottis valleculae V. Alternatively, the anterior surfaces of the distal blade sections 16, 16B, 56B, and 58 may directly elevate the epiglottis EPI to expose the glottic gap GA to the lens field of view of the camera and illumination member 35.
Fig. 21 and 22 below depict side perspective views of a laryngoscope 10 inserted into the body of a patient shown in cross-section, with the glottic gap GA exposed by engaging the epiglottis vallecula V to invert the epiglottis EPI or to lift the epiglottis EPI directly. The front of the laryngoscope sheath 12 contacts the surface of the tongue TN. The esophageal ESO is seen below the trachea T.
Fig. 21 depicts the engagement of the epiglottis vallecula V by the distal tip 19 of the sheath 10 of the laryngoscope 12 equipped with a video wand 30 to move the epiglottis EPI upward to expose the glottic gap GA. Epiglottis EPI usually blocks the glottic gap GA. The tip 19 presses against the epiglottis vallecula V to tension the hyoid-epiglottis ligament (not shown), thereby pulling the epiglottis upward and exposing the glottic gap GA for passage through the ETT512 shown in fig. 23 via operation of the stylet 500 described in fig. 25-27 below. The glottis gap and other anatomical regions are illuminated by the camera and light source of the light source member 35 (dashed lines).
Fig. 22 depicts the epiglottis being lifted directly by the tip or ridge 19 of the laryngoscope sheath 12 to move the epiglottis EPI upward to expose the glottic gap GA. The laryngoscope sheath 12 is equipped with a video wand 30 in place. Camera and illumination means 35 illuminates (in phantom) the glottic gap GA region for viewing and passage through an endotracheal tube ("ETT") 512 placed within trachea T.
Fig. 23 depicts a stylet 500 adjacent to an ETT 512. The ETT512 includes a hose connector 514, a tip aperture 516, a side aperture 518, a gas inflatable balloon or cuff 520, and a gas port 525 configured to receive a syringe (not shown) to deliver gas or air through an air conduit 527 hydraulically connected with the cuff 520. The side hole 518 is also called "Murphy's Eye". The ETT512 is shown to obtain a curvature that tends to follow the trajectory to the glottic gap GA by conforming to the curved shape of the stylet 500. The stylet 500 includes a handle 502, a rigid shaft 504 extending from the handle and having a linear portion, and a curved distal region 506 terminating in a bulbous end 508. The spherical end 508 is routed through the inner chamber of the ETT512 and is placed near the tip aperture 516 or adjacent the sepia 518.
Fig. 24A and B depict the placement and advancement of an ETT via a stylet in the upper airway of a patient using the sheath and laryngoscope embodiment 50 depicted in fig. 6 and 10, with the video wand 70 secured within the sheath 52 by tabs 80 engaging with the proximal lip 78 of the video wand 70, which is more readily seen in fig. 24B below.
Fig. 24A depicts the deployment of a laryngoscope system 600 against a patient. The laryngoscope system 600 includes a sheath placed within the patient's upper airway and a laryngoscope embodiment 50 for sending images from the video wand 70 to the monitor 610 via the power supply and video cable 38. The monitor 610 includes a monitor control panel 624 to adjust the images presented thereon. The ETT512 loaded with the stylet 500 is placed adjacent to the laryngoscope 50 and inserted into the patient's mouth under direct vision by the laryngoscope user.
Fig. 24B depicts the advancement of the ETT512 within the oropharynx of the patient under direct vision of the user of the laryngoscope 50. The curved region 506 of the stylet 500 is shown occupying the interior chamber of the ETT512, with the stylet bulbous end 508 adjacent the tip aperture 516. The fixed tabs 80 of the sheath 52 engage against the proximal lip 78 of the video wand 52.
Fig. 25 depicts a cross-sectional view of the upper airway of a patient in which the ETT512 of the loading stylet 500 is shown advanced into the upper airway adjacent the blade portion 56 of the laryngoscope 50. The ETT512 and proximal leaf contact the patient's tongue TN. The tip 58 of the laryngoscope 50 is shown directly lifting the epiglottis EPI of the patient to expose the glottic gap GA. The light beam (dashed line) emitted from camera 55 illuminates the glottic gap GA, adjacent vocal cords VC, trachea 10 and the immediately surrounding area, and their images are transmitted to monitor 610 when ETT512 is subsequently advanced sufficiently into the camera field of view, as shown in fig. 26 below. The stylet 500 is advanced within the upper airway to place the ETT within the camera field of view and in front of the acoustic gate gap GA. The esophageal ESO is below the trachea T. The front of the laryngoscope sheath 52 contacts the surface of the tongue TN.
Fig. 26-29 depict screenshots of an intubation procedure to place the ETT512 within the tracheal T. Screenshots are captured by the camera 55 and transmitted to the display of the monitor 610 and viewed by the laryngoscope user to advance and place the ETT512 into the trachea T.
Fig. 26 depicts a first monitor view 630 showing ETT512 positioned in front of glottic gap GA for entry into trachea T beyond vocal cords VC. Flange 59 is at the upper left side in the camera field of view and ETT512 is at the lower right side of the camera field of view as shown in first monitor image 630. The bulbous end 508 is shown adjacent to the murphy's eye 518. The location of the vocal cords VC, trachea T and arytenoid muscles AR is depicted.
Fig. 27 depicts a second monitor view 632 showing the ETT512 advancing toward the glottic gap GA and just entering the glottic gap GA, with the bulbous end 508 of the stylet 500 retracting (see motion arrows) at approximately the same time. The cuff 520 is advanced into the larynx and the bulbous end 508 previously adjacent the tip aperture 516 is now moving proximally towards the user, while the tip aperture 516 is seen moving distally and has just entered the glottic gap GA.
Figure 28 depicts a third monitor view 634 showing ETT512 advancing through glottic gap GA, and cuff 520 now entering glottic gap GA.
Fig. 29 depicts a fourth monitor view 636 that shows cuff 520 of ETT512 advancing through glottic gap GA and into trachea T. The cuff 520 may now be inflated and secured against the tracheal wall by injecting air via a syringe connected to the air port 525 and delivering the injected air to the cuff 520 via the air conduit 527, as shown in figure 23 above.
The system 600 may be used for endotracheal intubation, laser-based surgical and biopsy procedures, and passing ancillary equipment. The algorithms described below utilize the laryngoscope 10, but may be suitably modified to utilize the laryngoscopes 10, 50, 12A, 12B, 52A, 52B, 100, 200, 300 and 400. The intubation procedure may be adapted to place a single or double lumen catheter. A similar procedure may be used, for example, to remove foreign matter from the airway. Other laryngoscope procedures include guiding flexible laryngoscopes, bougies or bronchoscopes, and guiding otolaryngologists such as operating jet ventilators or performing biopsies and/or laser treatments for patients.
These algorithms can be used to allow passage and control of many tools useful for procedures and procedures in and around the airways, such as simultaneously visualizing and guiding surgical laser operating systems, electrosurgical operating sticks, surgical biopsy instruments, surgical suction devices, jet ventilation systems for transoceanic ventilation during laryngeal and airway surgery, dual lumen endotracheal tubes commonly used for lung isolation during surgical procedures on thoracic structures, flexible bronchoscopes and gastroscopes, intubation bougie devices, transesophageal echo probes, and nasogastric tubes.
Fig. 30 depicts an intubation method 700 of endotracheal intubation using a single lumen catheter loaded with the ETT512 of the auxiliary stylet 500, wherein the epiglottis EPI is flipped up by either direct lifting or by engaging the epiglottic valley V. Beginning at process block 704, the single lumen ETT512 is lubricated and the stylet 500 is inserted into the lumen of the ETT512 such that the bulbous end 508 of the stylet is positioned proximate to the tip aperture 516 or adjacent to the side aperture or Murphy's eye 518. At process block 708, the laryngoscope 10 is grasped by the left hand of the user and placed in the patient's mouth by direct vision or direct viewing by the user. Epiglottic translocation can then be performed by two alternative procedures. At process block 718, the epiglottis EPI is lifted with the tip 19 to expose the glottic gap GA. The location of the vocal cords VC is noted by the user viewing the images presented on the monitor 610. Alternatively, at process block 720, the epiglottis EPI is flipped up or displaced upward by squeezing the tip 19 against the patient's epiglottis valley V. The location of the glottic gap GA and vocal cords VC are similarly noted by the user viewing the images presented on the monitor 610. At process block 722, the stylet 500 loaded with the ETT512 is inserted into the port under direct vision and advanced adjacent to the laryngoscope until the tip of the single lumen ETT512 is visible on the monitor 610. At process block 724, with the laryngoscope 10 held in place, the single lumen ETT512 advances into the camera field of view as presented in the monitor 610. Thereafter, at process block 728, with the laryngoscope 10 held in place, the single lumen ETT512 is advanced distally toward the glottic gap GA and through the glottic gap GA, beyond the vocal cords VC, while the bulbous end 508 of the stylet 500 is retracted proximally toward the user. ETT512 is advanced distally sufficiently so that cuff 520 is beyond vocal cords VC and is placed in trachea T. Thereafter, the algorithm 700 is completed by holding the advanced single lumen ETT512 in place, and the laryngoscope 10 is removed. The algorithm 700 may similarly be used in the system 600 by utilizing the laryngoscopes 50, 12A, 12B, 52A, 52B, 100, 200, 300 and 400.
The above embodiments comprise a video-based sheath laryngoscope apparatus 10, 50, 12A, 12B, 52A, 52B, 100, 200, 300 and 400 substantially similar to that described aboveThe video may use an ENT laryngoscope. A transparent and translucent sheath or holder for use in a laryngoscope system allows tongue lifting and can be configured to provide an HDTV video bronchoscope that withstands rigorous disinfection procedures, an illumination source, and an aid delivered using free hands via an open channel or around the body of the sheath.
The video-available ENT laryngoscope has several advantages over existing devices: the single use of sterile sheaths solves the problem of BSE and Adult CJV in those jurisdictions where regulations require disposable components, as none of the components in direct contact with the patient are reused. The shape and size of the disposable sheath of the system embodiments described above allows anatomical features to be accessed with less force, thereby reducing potential trauma to the patient. This design allows the ENT surgeon to use a variety of different configurations based on the needs of the procedure being performed, the available equipment, and personal preferences. Disposable clear or transparent plastic sheaths may be adapted to the various embodiments described herein to provide efficient performance of an inter-patient laryngoscope procedure.
Other embodiments provide jet ventilation channels or conduits in disposable sheaths such that jet ventilation can be precisely targeted within about 3-4mm of the conduit. This makes it sure that a stable aim is established by the attending anaesthetist. This stable targeting allows the direction of the venting of positive pressure to be easily observed to ensure that high pressure gas does not enter the tissue, but instead entrains air to ventilate the trachea and minimize pressure build-up.
Laryngoscope systems provide video-enabled laryngoscopes that deliver visual confirmation of airway anatomy during airway procedures. Alternative embodiments provide a disposable housing assembly to protect a video device and provide a disposable housing assemblyA disposable option. The disposable design strategy provides effective coverage for video systems. The electronic package may be completely recessed for cleaning and have all of the features of a conventional video laryngoscope system so that its use in a surgical classroom does not require additional training procedures. The disposable housing assembly may be configured to have structural strength and durability to withstand sterilization procedures.
The usefulness of the disposable housing or sheath option is that it offers the possibility of having many blade options suitable for different applications and clinical tasks. Ranges include obese, young children, short stature, normal adults, training designs, and neonatal designs. Thus with one master unit the housing size can be selected to suit the clinical situation.
Other embodiments may include one or more channels into the throat region, which may have multiple support channels sometimes dedicated to different functions. The electronics assembly may include rigid or flexible leads to a camera having a heated lens, a Light Emitting Diode (LED) light emitting array, and a Charge Coupled Device (CCD) or Complementary Metal Oxide Semiconductor (CMOS) digital camera for real-time video monitoring of the airway for intubation and diagnosis.
While the preferred embodiments of the invention have been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. Accordingly, the scope of the invention is not limited by the disclosure of the preferred embodiments. Rather, the invention should be determined entirely by reference to the claims that follow.