Medical use soft robots

Abstract

Provided herein are systems and platforms that enable tracheal intubation with improved ease and reduced risk of patient harm

Description

MEDICAL USE SOFT ROBOTSCROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 413832, filed October 6, 2022, U.S. Provisional Application No. 63 / 437893, filed January 9, 2023, and U.S. Provisional Application No. 63 / 582035, filed September 12, 2023, which are hereby incorporated by reference in their entirety herein.BACKGROUND

[0002] The present disclosure generally relates to medical devices, systems, and methods, and in particular those suitable for facilitating procedures such as endoscopy and tracheal intubation.

[0003] Endoscopy is a procedure used in medicine to look inside the body. The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes are inserted directly into the organ, which can require a high degree of practitioner expertise and involve risk of patient harm.

[0004] Tracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer fluids. Intubation similarly can require a high degree of practitioner expertise and involve risk of patient harm.

[0005] Hence, improved devices, systems, and methods to facilitate such procedures, reducing the degree of practitioner expertise required and reducing the risk of patient harm, are desired.SUMMARY

[0006] An aspect of the present disclosure provides an exemplary tracheal intubation device , comprising an anterior tracheal access mechanism (ATAM) comprising: a posterior shim comprising a first tine and a second tine; and an anterior shim comprising: a first portion coupled to the first tine; a second portion coupled to the second tine; and a first bridge connecting the first portion and the second portion, wherein the first bridge is offset from the posterior shim.

[0007] In some embodiments, the device further comprises a primary vine robot that is shaped and sized to extend through a patient’s larynx when fully actuated. In some embodiments, the first tine and the second tine extend in an actuation direction of the primary vine robot. In some embodiments, the ATAM is shaped and sized to lift the epiglottis of a patient anteriorly when the primary vine robot is fully actuated. In some embodiments, the ATAM is removably coupled to an everting end of the primary vine robot. In some embodiments, the ATAM is rotatably andremovably coupled to the everting end of the vine robot. In some embodiments, the vine robot comprises a camera.

[0008] In some embodiments, the ATAM further comprises a first tine cover surrounding at least a distal portion of the first tine, a second tine cover surrounding at least a distal portion of the second tine, or both. In some embodiments, the first tine cover, the second tine cover, or both comprise a coating. In some embodiments, the first tine cover, the second tine cover, or both are formed of a material having a modulus of elasticity less than the modulus of elasticity of the material of the posterior shim.

[0009] In some embodiments, a distal portion of the first portion of the anterior shim, a distal portion of the second portion of the anterior shim, or both, comprise a rounded nub.

[0010] In some embodiments, the first portion of the anterior shim comprises a primary first segment and a secondary first segment noncolinear to the primary first segment; the second portion of the anterior shim comprises a primary second segment and a secondary second segment noncolinear to the primary second segment; or both.

[0011] In some embodiments, the anterior shim further comprises a second bridge connecting the first portion and the second portion at a point proximal to the first bridge. In some embodiments, the anterior shim further comprises a cantilever extending distally from the second bridge, hi some embodiments, the cantilever comprises a first cantilever portion and a second cantilever portion having a thickness less than a thickness of the first cantilever portion.

[0012] In some embodiments, the ATAM further comprises a webbing extending from at least two of the first portion, the second portion, and the first bridge.

[0013] In some embodiments, the first tine, the second tine, or both comprise a first flexible portion and a second flexible portion coupled to the distal terminus and the proximal terminus of the first flexible portion. In some embodiments, a mesial portion of the first flexible portion and a mesial portion of the second flexible portion are biased to separate. In some embodiments, the posterior shim further comprises an inflatable chamber between the first flexible portion and the second flexible portion of the first tine, the second tine, or both. In some embodiments, the posterior shim further comprises an inflatable chamber coupled to the first tine, the second tine, or both.

[0014] Another aspect of the present disclosure provides an exemplary tracheal intubation system comprising any of the tracheal intubation device described herein and an introducer device configured to accept said tracheal intubation device and to eject at least a portion of the tracheal intubation device into the mouth of the patient distal to the epiglottis.

[0015] In some embodiments, the introducer device comprises: an introducer comprising: a first slot sized to slidably receive the first tine of the posterior shim; a second slot sized to slidably receive the second tine of the posterior shim; and a channel between the first slot and the second slot sized to slidably receive the first bridge; and a plunger comprising: a first portion sized to slide within the first slot; a second portion sized to slide within the second slot; and an arcuate portion between the first portion and the second portion sized to slide within the channel of the introducer.

[0016] In some embodiments, the introducer system further comprises a disconnect configured to separate the introducer system from the vine robot.

[0017] In some embodiments, the introducer device comprises: a tubular body configured to receive the tracheal intubation device, wherein a distal end of the tubular body is angled with respect to a elongate axis of the tubular body; an ovular surface coplanar to the distal end and extending outwards from the elongate axis, wherein the ovular surface comprises a flap configured to, in a collapsed state, cover at least a portion of the distal end of the tubular body and, in an expanded state, extend perpendicular to the ovular surface. In some embodiments, an outer rim of the ovular surface has a greater thickness than the remainder of the ovular surface.

[0018] Another aspect of the present disclosure provides an exemplary method of intubating a patient comprising: (a) inserting the system herein into the mouth of the patient to the pharyngeal wall of the patient; (b) advancing the plunger distally toward the patient to eject the AT AM; (c) advancing the primary vine robot distally between the first bridge and the posterior shim of the AT AM; (d) disconnecting the ATAM from the primary vine robot; and (e) removing the AT AM and the introducer from the patient’s mouth.

[0019] In some embodiments, the primary vine robot remains within the patient after step (e).

[0020] In some embodiments, the first bridge contacts the vallecula of the patient, the hyoepiglottic ligament of the patient, the glossoepiglottic folds of the patient, or any combination thereof after step (b). In some embodiments, during advancement, pressure applied by the first bridge lifts the epiglottis anteriorly, hi some embodiments, the lifting of the epiglottitis anteriorly facilitates directing of the primary vine robot toward the trachea when being actuated.

[0021] Another aspect of the present disclosure provides an exemplary soft vine endoscopy robot, comprising a primary tube body having a sealed first end and a second end opposite the first end, wherein the first end is within a mesial portion of the primary tube body, and wherein the mesial portion comprises two or more stiffened portions, wherein adjacent stiffened portions are separated by a segment of the primary tube body. In some embodiments, the two or more stiffened portions are arranged from the first end to the second end. In some embodiments, thetwo or more stiffened portions are radially aligned about the primary tube body. In some embodiments, the two or more stiffened portions are radially arrayed about the primary tube body. In some embodiments, when inflated, the primary tube body has two non-colinear sections that intersect at one of the two or more stiffened portions. In some embodiments, the two or more stiffened portions have a thickness greater than the rest of the primary tube body. In some embodiments, the two or more stiffened portions have a modulus of elasticity less than the rest of the primary tube body. In some embodiments, the two or more stiffened portions comprises a stop coupled to the primary tube body.

[0022] In some embodiments, the robot comprises two or more stops, wherein the two or more stops are interconnected by a tendon. In some embodiments, the tendon has a constant length. In some embodiments, the tendon has an actuatable length. In some embodiments, the primary tube body comprises a plurality of segments separated from one another by the two or more stiffened portions. In some embodiments, the primary tube body, when inflated, is configured to have a plurality of segment lengths and angles between segments that match lengths and curvatures of a predefined bodily lumen.

[0023] In some embodiments, the robot further comprises an annular chassis having a cavity, wherein the primary tube body extends from the first end, through the cavity, around an outer surface of the annular chassis and to the mesial portion of the primary tube body.

[0024] In some embodiments, the chassis comprises one or more camera sensors. In some embodiments, the robot further comprises a camera body comprising: a proximal portion; a distal portion comprising one or more camera sensors, wherein the distal portion has an outer diameter greater than an inner diameter of the annular chassis; and a mesial portion between the distal portion and the proximal portion, wherein the mesial portion is sized to fit within the cavity of the annular chassis.

[0025] Another aspect of the present disclosure provides an exemplary method of forming a soft vine endoscopy robot, the method comprising: receiving an anatomical measurement comprising a length of a first portion, a length of a second portion, and an angle between the first portion and the second portion; stiffening a portion of a primary tube body based on the length of the first portion, the length of the second portion, the angle between the first portion and the second portion, or any combination thereof, wherein the primary tube body has a first end, a second end, and a channel therethrough; and inserting the first end through the channel at the second end. In some embodiments, stiffening the portion of the primary tube comprises heating the portion of the primary tube. In some embodiments, stiffening the portion of the primary tube comprises attaching a stop to the portion of the primary tube, wherein the stop is coupled to a tendon.

[0026] Another aspect of the present disclosure provides an exemplary a soft vine endoscopy robot, comprising: a primary tube body having a sealed first end, wherein the first end is within a mesial portion of the primary tube body; and a secondary tube body attached to an outer surface of the primary tube body, wherein the primary tube body and the secondary tube body are parallel or concentric. In some embodiments, inflating the tube body from the second end translates a distal end of the primary tube body distally relative to the sealed end. In some embodiments, inflating the secondary tube body bends the primary tube body about an attachment arc between the primary tube body and the secondary tube body.

[0027] Another aspect of the present disclosure provides an exemplary soft vine endoscopy robot, comprising: an endoscope connector comprising an endoscope fastener configured to fasten to an endoscope, a converging-diverging hole, and an inflation port; and a primary tube body having a first end coupled and sealed to an outer surface of the endoscope connector and a sealed second end that passes through the converging- diverging hole. In some embodiments, inflating the primary tube body through the inflation port extends a distal surface of the primary tube body away from the endoscope connector. In some embodiments, maintaining a set pressure within the primary tube body seals a mesial portion of the primary tube body against the converging-diverging hole.

[0028] Another aspect of the present disclosure provides an exemplary soft vine endoscopy robot, comprising: a primary tube body having a sealed first end, wherein the first end is within a mesial portion of the tube body; a retractor coupled to the first end of the primary tube body; and a motor configured to drive the retractor to collapse at least a portion of the primary tube body. In some embodiments, the retractor comprises a spool. In some embodiments, the retractor comprises a pulley.

[0029] Another aspect of the present disclosure provides an exemplary method of intubating a patient, the method comprising: inserting a vine robot in an unactuated position into the patient’s mouth, wherein the vine robot comprises a primary tube body having a sealed first end and a second end, wherein the fust end is within a mesial portion of the tube body; applying fluid pressure into the primary tube body to gradually evert and extend the primary tube body into the back of the laryngopharynx of the patient and into the trachea of the patient to provide a lumen from a mouthpiece to the trachea; and providing air or oxygen through the lumen into the trachea.

[0030] Another aspect of the present disclosure provides an exemplary method of accessing a cavity of a patient with a medical tool, the method comprising: inserting a vine robot in an unactuated position into the patient’s mouth, wherein the vine robot comprises a primary tubebody having a sealed first end and a second end, wherein the first end is within a mesial portion of the tube body; applying fluid pressure into the primary tube body to gradually evert and extend the primary tube body into the cavity of the patient to form a lumen into the cavity of the patient; and accessing the cavity of the patient through the lumen.BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0032] FIG. 1 shows a side view of tines of a tracheal intubation device, per one or more embodiments herein;

[0033] FIG. 2 shows a perspective view of anterior and posterior tine layers of a tracheal intubation device (e.g., the device of FIG. 1), per one or more embodiments herein;

[0034] FIG. 3 shows a perspective view of overlapping shims of a tracheal intubation device (e.g., the device of FIG. 1), per one or more embodiments herein;

[0035] FIG. 4 shows a first perspective view of an active-pinning shim of a tracheal intubation device (e.g., the device of FIG. 1), per one or more embodiments herein;

[0036] FIG. 5 shows a second perspective view of an active-pinning shim of a tracheal intubation device (e.g., the device of FIG. 1), per one or more embodiments herein;

[0037] FIG. 6A shows an exemplary section view map of a human airway;

[0038] FIG. 6B shows a schematic of a vine robot having stiffened portions, per one or more embodiments herein;

[0039] FIG. 7 A shows a schematic illustration of an exemplary first step in a point-controlled method of navigating a vine robot through a lumen and around an obstacle;

[0040] FIG. 7B shows a schematic illustration of an exemplary second step in a point-controlled method of navigating a vine robot through a lumen and around an obstacle;

[0041] FIG. 7C shows a schematic illustration of an exemplary third step in a point-controlled method of navigating a vine robot through a lumen and around an obstacle;

[0042] FIG. 7D shows a schematic illustration of an exemplary fourth step in a point-controlled method of navigating a vine robot through a lumen and around an obstacle;

[0043] FIG. 7E shows a schematic illustration of an exemplary fifth step in a point-controlled method of navigating a vine robot through a lumen and around an obstacle;

[0044] FIG. 7F shows a schematic illustration of an exemplary sixth step in a point-controlled method of navigating a vine robot through a tumen and around an obstacle;

[0045] FIG. 8 shows a section view of a tube body comprising a plurality of segments separated from one another by the two or more stiffened portions, per one or more embodiments herein;

[0046] FIG. 9 shows a section view illustration of a tube body comprising a first non-colinear section that intersects the tube body, per one or more embodiments herein;

[0047] FIG. 10A shows a side section view of a vine robot having an annular chassis, per one or more embodiments herein;

[0048] FIG. 10B shows a front section view illustration of a vine robot having an annular chassis, per one or more embodiments herein;

[0049] FIG. 11 shows a cross-sectioned side-view illustration of a vine robot having an annular chassis and a camera body, per one or more embodiments herein;

[0050] FIG. 12A shows a side-view illustration of an expanded vine robot comprising an endoscope connector, per one or more embodiments herein;

[0051] FIG. 12B shows a side-view illustration of a collapsed vine robot comprising an endoscope connector, per one or more embodiments herein;

[0052] FIG. 13 shows a cross-sectioned side-view illustration of a vine robot having a roller retraction mechanism, per one or more embodiments herein;

[0053] FIG. 14 shows a cross-sectioned side-view illustration of a vine robot having a reel retraction mechanism;

[0054] FIG. ISA shows a side-view illustration of a multi- walled vine robot, per one or more embodiments herein;

[0055] FIG. 15B shows a front- view illustration of an annular multi-walled vine robot, per one or more embodiments herein;

[0056] FIG. 15C shows a detailed side-view illustration of a reinforced multi-walled vine robot, per one or more embodiments herein;

[0057] FIG. 15D shows a front-view illustration of a radial multi-walled vine robot, per one or more embodiments herein;

[0058] FIG. 16A shows a front- left perspective view illustration of an exemplary orotracheal intubation introducer, per one or more embodiments herein;

[0059] FIG. 16B shows a side view illustration of an exemplary orotracheal intubation introducer, per one or more embodiments herein;

[0060] FIG. 16C shows a front view illustration of an exemplary orotracheal intubation introducer, per one or more embodiments herein;

[0061] FIG. 17A shows a first perspective view of an exemplary introducer with shims, per one or more embodiments herein;

[0062] FIG. 17B shows a second perspective view of an exemplary introducer with shims (e.g., the introducer of FIG. 17A), per one or more embodiments herein;

[0063] FIG. 17C shows a third perspective view n of an exemplary introducer with shims (e.g., the introducer of FIG. 17A), per one or more embodiments herein;

[0064] FIG. ISA shows a first perspective view of an exemplary introducer with a wedge, per one or more embodiments herein;

[0065] FIG. 18B shows a second perspective view of an exemplary introducer with a wedge (e.g., the introducer of FIG. ISA), per one or more embodiments herein;

[0066] FIG. 18C shows a third perspective view of an exemplary introducer with a wedge (e.g., the introducer of FIG. ISA), per one or more embodiments herein;

[0067] FIG. 1SD shows a third perspective view of an exemplary introducer with a wedge (e.g., the introducer of FIG. ISA), per one or more embodiments herein;

[0068] FIG. 19A shows a first perspective view of an exemplary introducer with a vallecula stop, per one or more embodiments herein;

[0069] FIG. 19B shows a second perspective view of an exemplary introducer with a vallecula stop (e.g., the introducer of FIG. 19A), per one or more embodiments herein;

[0070] FIG. 19C shows a third perspective view of an exemplary introducer with a vallecula stop (e.g., the introducer of FIG. 19A), per one or more embodiments herein;

[0071] FIG. 20A shows a first side view illustration of an exemplary toroidal vine robot, per one or more embodiments herein;

[0072] FIG. 20B shows a second side view illustration of an exemplary toroidal vine robot (e.g., the vine robot of FIG. 20A), per one or more embodiments herein;

[0073] FIG. 20C shows a third perspective view illustration of an exemplary toroidal vine robot (e.g., the vine robot of FIG. 20A), per one or more embodiments herein;

[0074] FIG. 21A shows a first perspective view of a commercial Endotracheal Tube (ETT) sheathed in an exemplary toroidal vine robot, per one or more embodiments herein;

[0075] FIG. 21B shows a second perspective view of a commercial ETT sheathed in an exemplary toroidal vine robot (e.g., the ETT of FIG. 21A), per one or more embodiments herein;

[0076] FIG. 22A shows a first illustration, in perspective view, of an exemplary introducer for delivering a posterior TAM, per one or more embodiments herein;

[0077] FIG. 22B shows a second illustration, in top view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0078] FIG. 22C shows a third illustration, in side view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0079] FIG. 22D shows a fourth illustration, in top view, an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0080] FIG. 22E shows a fifth illustration, in top view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0081] FIG. 23A shows a sixth illustration, in perspective view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0082] FIG. 23B shows a seventh illustration, in perspective view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0083] FIG. 23C shows an eighth illustration, in perspective view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0084] FIG. 23D shows a ninth illustration, in side view, of an exemplary introducer for delivering a posterior Tracheal Access Mechanism (TAM) (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0085] FIG. 24 shows a tenth illustration, in top view, of an exemplary introducer for delivering a posterior TAM (e.g., the introducer of FIG. 22A), per one or more embodiments herein;

[0086] FIG. 25A shows a first illustration, in perspective view, of an exemplary introducer for delivering an anterior TAM, per one or more embodiments herein;

[0087] FIG. 25B shows a second illustration, in perspective view, of an exemplary introducer for delivering an anterior TAM (e.g., the introducer of FIG. 25A), per one or more embodiments herein;

[0088] FIG. 25C shows a third illustration, in perspective view, of an exemplary introducer for delivering an anterior TAM (e.g., the introducer of FIG. 25A), per one or more embodiments herein;

[0089] FIG. 26A shows a first illustration, in perspective view, of an exemplary multibody introducer, per one or more embodiments herein;

[0090] FIG. 26B shows a second illustration, in perspective view, of an exemplary multibody introducer (e.g., the introducer of FIG. 26A), per one or more embodiments herein;

[0091] FIG. 27 shows additional illustrations, in perspective view, of an exemplary multibody introducer, per one or more embodiments herein;

[0092] FIG. 28A shows a first illustration, in perspective view, of an exemplary introducer with a flap, per one or more embodiments herein;

[0093] FIG. 28B shows a second illustration, in perspective view, of an exemplary introducer with a flap (e.g., the introducer of FIG. 28 A), per one or more embodiments herein;

[0094] FIG. 28C shows a third illustration, in perspective view, of an exemplary introducer with a flap (e.g., the introducer of FIG. 28A), per one or more embodiments herein;

[0095] FIG. 29A shows a first illustration, in perspective view, of an exemplary introducer with a deployable flap, per one or more embodiments herein;

[0096] FIG. 29B shows a second illustration, in perspective view, of an exemplary introducer with a deployable flap (e.g., the introducer of FIG. 29A), per one or more embodiments herein;

[0097] FIG. 29C shows a third illustration, in perspective view, of an exemplary introducer with a deployable flap (e.g., the introducer of FIG. 29A), per one or more embodiments herein;

[0098] FIG. 30A shows a side view of an exemplary introducer with a low contact-angle flap, one or more embodiments herein;

[0099] FIG. 30B shows a side view of an exemplary introducer with a medium contact-angle flap, one or more embodiments herein;

[0100] FIG. 30C shows a side perspective view of an exemplary introducer with a high contactangle flap, one or more embodiments herein;

[0101] FIG. 30D shows a side perspective view of an exemplary introducer with a higher contact-angle flap, one or more embodiments herein;

[0102] FIG. 31 shows a side perspective view of an exemplary Anterior Tracheal Access Mechanism (aTAM), per one or more embodiments herein;

[0103] FIG. 32 shows an illustration, in side view, perspective view, and front view, of an exemplary Anterior Shim (AShim), per one or more embodiments herein;

[0104] FIG. 33A shows a side perspective view of an exemplary aTAM trap door in a disengaged position, per one or more embodiments herein;

[0105] FIG. 33B shows a side perspective view of an exemplary aTAM trap door (e.g., the aTAM trap door of FIG. 33 A) in an engaged position, per one or more embodiments herein;

[0106] FIG. 34 A shows a perspective view of an exemplary aTAM trap door and an epiglottis in a disengaged position, per one or more embodiments herein;

[0107] FIG. 34B shows a perspective view of an exemplary aTAM trap door (e.g., the aTAM trap door of FIG. 34A)and an epiglottis in an engaged position, per one or more embodiments herein;

[0108] FIG. 35 shows a side view of an exemplary AShim having a noncolinear primary first segment and secondary first segment, per one or more embodiments herein;

[0109] FIG. 36A shows a side perspective view of an exemplary one-point bridge of an AShim, per one or more embodiments herein;

[0110] FIG. 36B shows a side perspective view of an exemplary two-point bridge of an AShim, per one or more embodiments herein;

[0111] FIG. 36C shows a top perspective view of an exemplary three-point bridge of an AShim, per one or more embodiments herein;

[0112] FIG. 37 shows an a side perspective view of an exemplary AShim having a webbing, per one or more embodiments herein;

[0113] FIG. 38 shows side and side perspective views of an exemplary vine robot with a nub, per one or more embodiments herein;

[0114] FIG. 39 shows side views of an exemplary vine robot with a nub being redirected around the epiglottis, per one or more embodiments herein;

[0115] FIG. 40 shows side perspective views of an exemplary cable-actuated vine ETT, per one or more embodiments herein;

[0116] FIG. 41A shows a side perspective view of an exemplary passively controlled AShim in a deactivated configuration, per one or more embodiments herein;

[0117] FIG. 41B shows a side perspective view of an exemplary passively controlled AShim in an activated configuration, per one or more embodiments herein;

[0118] FIG. 42A shows a side perspective view of an exemplary actively controlled AShim in a deactivated configuration, per one or more embodiments herein;

[0119] FIG. 42B shows a side perspective view of an exemplary passively controlled AShim in an activated configuration, per one or more embodiments herein;

[0120] FIG. 43 shows side perspective views of an exemplary aTAM with a retractor, per one or more embodiments herein;

[0121] FIG. 44, shows side and side perspective views of an exemplary plunger disconnect be attached to a plunger, per one or more embodiments herein;

[0122] FIG. 45 shows side views of an exemplary automatic ETT deployment, per one or more embodiments herein;

[0123] FIG. 46 shows side and side perspective views of a laryngoscope with an exemplary vine robot, per one or more embodiments herein;

[0124] FIG. 47 shows section view diagrams of an exemplary method for intubating a patient, per one or more embodiments herein;

[0125] FIG. 48 shows side view illustrations of an exemplary toroidal vine robot transmitting an ETT, per one or more embodiments herein.DETAILED DESCRIPTION

[0126] Provided herein are novel airway management devices, systems, and methods that facilitate and autonomously perform endotracheal intubation using a vine robot. In some embodiments, the devices herein exploit knowledge of a patient’s anatomy to establish tissue conditions which enable vine robot endotracheal intubation. In some embodiments, the systems herein comprise an introducer comprising a user-interfacing enclosure designed to facilitate the correct placement of the device and vine robot during intubation. In some embodiments, the devices herein comprise a Tracheal Access Mechanism (TAM) that locates a patient’s airway, establishes requisite tissue conditions, and places the vine robot in the proper initial position. The devices, systems, and methods herein are configured to perform airway management, diagnostic and therapeutic endoscopy (across the human body), and general autonomous endoluminal access. In some embodiments, the devices and methods herein employ introducers, sliding shims (advanced both automatically and manually), self-locating features, and Endotracheal Tube (ETT) advancement mechanisms for tracheal intubation. In some embodiments, the vine robot navigates a patient’s airway without the need for a visualization system, wherein its self-expanding soft geometry provides a sealed and direct airway for ventilation. In other embodiments, the devices and systems herein can be employed with steering, image guidance (e.g. guided in real time by imaging studies including CT, ultrasound, or MRI), or designed to follow a predetermined path through the body to the target (e.g. designed using pre-procedure imaging studies to follow a path to the target), hi some embodiments, the vine robot herein is composed of metals, plastics, or both. The devices and systems herein may employ multiple concentric pathways or lumens for instrumentation.

[0127] In some embodiments, the everting growth technology of the vine robots herein are employed for surgical resection of tumors throughout the body, including in the lung periphery, pleural space, or in the trachea or bronchi, including partial lobectomies and wedge or segmental lung resection, and in the gastrointestinal or reproductive tracts. Additionally, the vine robotsherein can be used in mediastinoscopy and / or be coupled with video-assisted thoracoscopic surgery (VATS) technology for partial lung resection, lung biopsies, pleural biopsies, or any combination thereof. The vine robots herein can be coupled with existing robotic technology (e.g., DaVinci platforms) for robotic surgery throughout the body (e.g., the thorax, pleural space, lung, abdomen, head, neck, and bladder). The vine robots herein can be employed with any current endoscopy procedure such as colonoscopies, laryngoscopies, and bronchoscopies. The vine robots herein can be used to transport a camera or biopsy / surgical instruments within a patient.

[0128] Vine robots suitable for use with the various embodiments described herein, as well as accessory devices suitable for such vine robots and their uses, are further described in U.S. Patent Application No. 17 / 632,335, filed February 2, 2022 and entitled “Vine robot tracheal intubation device” and PCT Application No. PCT / US2022 / 044162, filed September 20, 2022 and entitled “Soft Robot Intubation Device”, which are incorporated herein by reference.Airway Management

[0129] Disclosed in this document are systems, devices, and methods to pin an epiglottis of a patient (e.g., epiglottis defeat) during soft robotic intubation. Pinning the epiglottis of a patient anteriorly to facilitate the passage of an intubating vine robot can be achieved by the devices and systems herein though manual epiglottis defeat, wherein a tool is progressed using human action, or autonomous epiglottis defeat configuration, wherein a tool is progressed through soft robotic actuation).

[0130] FIGS. 1-3 show exemplary shims 200 for insertion of a vine robot 100. As shown, the shim 200 may comprise a first tine 211, a second tine 212, and a rail 220. In some embodiments, passive pinning stabilizes the epiglottis without the requirement for subsequent action. In one example, the shim 200 effectively pins the epiglottis during deployment. Per FIG. 1, the rail 220 may be parallel to the shim tines 211 212 and can be slightly narrower than an outer diameter of the vine robot 100. In some embodiments, the rail 220 aids in pinning the epiglottis, wherein once the shim 200 defeats the epiglottis, the rails 220 maintain contact with the tongue and the epiglottis, allowing the vine robot 100 to ride along a posterior surface of the shim 200. In some embodiments, with a slight anterior valence, this vine robot 100 is capable of passing through the tines 211 212 to intubate at the appropriate depth. In some embodiments, the first tine 211 and the second tine 212 enable individual contact of the shim 200 with a patient’s variable posterior pharyngeal wall anatomy. In some embodiments, a separation between the first tine 211 and the second tine 212 forms a cavity through which the vine robot 100 can pass to access the trachea.

[0131] In some embodiments, per FIG. 2, the first tine 211 comprises a first anterior tine layer 211 A and a first posterior tine layer 21 IB and the second tine 212 comprises a second anterior tine layer 212A and a second posterior tine layer 212B. In some embodiments, driving the shim 200 posteriorly to the epiglottis displaces the anterior shims 211 A 212A from the posterior shims 21 IB 212B. In some embodiments, the anterior shims 211A 212A and the posterior shims 21 IB 212B are flexible. In some embodiments, the anterior shims 211A 212A and the posterior shims 21 IB 212B are separated by a spring layer 230. In some embodiments, the spring layer 230 comprises foam, a spring, a flexure, or any combination thereof. In some embodiments, ejecting the shim 200 from an introducer 300 allows the spring layer 230 to separate the anterior shims 211 A 212A and the posterior shims 21 IB 212B, wherein the first anterior tine layer 211A and the second anterior tine layer 212A hold the tongue and epiglottis in place.

[0132] In another example per FIG. 3, the shim 200 may comprise a plurality of overlapping flaps 240. In some embodiments, when the shim 200 is inserted into the mouth of a patient, the flaps 240 are configured contact the back of the tongue and epiglottis after epiglottis defeat. In some embodiments, the flaps 240 have a geometry and are formed of a material configured to minimize traction against the patient’s tissue. Once in position, the vine robot 100 may be deployed between a portion of the flaps 240 not held in place by the weight of the tissue to enter the trachea.

[0133] In some embodiments, per FIGS. 4-5, the shim 200 can be configured for active pinning of the epiglottis after epiglottis defeat. As shown, the shim 200 comprises an inflatable pinning body 250, which lift the shim tines 211 A 21 IB 212A 212B to actively pin the epiglottis. In some embodiments, once the inflatable pinning body 250 is filled, a channel 213 is formed between the tines 211 212 through which the vine robot may pass. In some embodiments, inflatable pinning body 250 has a greater height than width. In some embodiments, the inflatable pinning body 250 translates the first anterior tine layer 211 A, the first posterior tine layer 21 IB, the second anterior tine layer 212A, the second posterior tine layer 212B, or any combination thereof.Endoscopy

[0134] Endoscopy in humans is generally performed by guiding, by a medical practitioner, a rigid scope with both a camera and a working channel through a lumen of the human body. The vine robots herein enable and improve diagnostic and therapeutic methods in endoscopic applications such as, for example, laryngoscopy, bronchoscopy, gastroscopy, enteroscopy, colonoscopy, cystoscopy, gynecological endoscopy, and vascular endoscopy.

[0135] In some embodiments, the vine robots 100 herein progress by add material to its proximal patient-side tip, which enables a vine robot 100 with built-in navigation features to alter its path as it grows. FIG. 6A shows an exemplary map of a human airway. In some embodiments, a lumen of the human body comprises, for example, an airway, a vascular system, biliary system, a hepatobiliary tract. In some embodiments, the vine robots herein are shaped to follow a specific path having a starting point 601 and an end point 602 through the human body lumen per relevant measurements of the lumen. In some embodiments, per FIG. 6B, when dimensions of the lumen are known, segment lengths 11, 12, 13, 14, 15 and angles 01, 02, 03, 04, 05 can be discerned by, for example, 3D imaging. The vine robot 100 may include features according to these lengths and angles, which when inverted, can be deployed through the lumen. In some embodiments, the devices herein further comprise a working channel, a camera, or both. In some embodiments, the vine robot 100, when inflated, is configured to have a plurality of segment lengths and angles between segments that match lengths and curvatures of a predefined bodily lumen. In some embodiments, per FIGS. 7A-7F show exemplary steps in a point-controlled method of navigating a vine robot through a lumen and around an obstacle.

[0136] In some embodiments, provided herein is a soft vine endoscopy robot 100, comprising a primary tube body 110 having a sealed first end 111 and a second end 112 opposite the first end 111. In some embodiments, the first end 111 is within a mesial portion 130 of the tube body 110.

[0137] In some embodiments, per FIGS. 8-9, the tube body 110 comprises a plurality of segments separated from one another by the two or more stiffened portions 801. In some embodiments, the primary tube body 110 comprises two or more stiffened portions 801. In some embodiments, adjacent stiffened portions 801 are separated by a segment of the primary tube body 110. In some embodiments, the two or more stiffened portions are arranged from the first end to the second end. In some embodiments, the two or more stiffened portions 801 are radially aligned about the tube body 110. In some embodiments, the two or more stiffened portions 801 are radially arrayed about the tube body 110. In some embodiments, the two or more stiffened portions 801 have a thickness greater than the rest of the tube body 110. In some embodiments, the two or more stiffened portions 801 have a modulus of elasticity less than the rest of the tube body 110.

[0138] In some embodiments, per FIG. 8, the two or more stiffened portions comprises a stop coupled to the tube body. In some embodiments, the stiffened portions 801 comprise a stop wherein two or more stops are interconnected by a tendon 802. In some embodiments, the tendon 802 has a constant length. In some embodiments, the tendon 802 has an actuatable length. In some embodiments, actuation of the tendon 802 and / or pneumatic actuation of the primary tubebody 110 can be used to control the relative lengths of sides the vine robot 100 to form a constant curve or buckle the body to produce a point curvature. In some embodiments, pneumatic actuation employs pneumatic artificial muscles, inverse pneumatic artificial muscles, or both (e.g., a McKibben actuator).

[0139] In some embodiments, when inflated, the tube body 110 has two non-colinear sections 910 920 that intersect at one of the two or more stiffened portions 801. In some embodiments, per FIG. 9, the tube body 110 comprises a first non-colinear section 910 that intersects the tube body 110 at a first stiffened portion 801 and a second non-colinear section 920 that intersects the tube body 110 at a second stiffened portion 801. In some embodiments, inflating the first nonlinear section 910 bends the tube body 110 at an angle (9) towards the first non-linear section 910. In some embodiments, inflating the second non-linear section 920 bends the tube body 110 at an angle towards the second non-linear section 920.Visualization

[0140] As the vine robot herein employs tip-based material addition, per FIGS. 10-11, a sensor 1001 may be coupled to the tip, within its body, or both for visualization.

[0141] In some embodiments, per FIGS. 10A-10B, the vine robot 100 further comprises an annular chassis 1010 having a cavity 1011. In some embodiments, per FIG. 10B, the vine robot 100 extends from its first end 110, through the cavity 1011, around an outer surface of the annular chassis 1010 and to the second end 120. In some embodiments, the sensor 1001 comprises a camera sensor an ultrasound sensor, or both.

[0142] In some embodiments, per FIG. 11, the vine robot 1000 further comprises a camera body 1020 comprising the sensor 1001. In some embodiments, camera body 1020 comprises a distal portion 1021 comprising one or more sensors 1001, a proximal portion 1023 having an outer diameter greater than an inner diameter of the annular chassis 1010, and a mesial portion 1022 (not shown) between the distal portion 1021 and the proximal portion 1023. In some embodiments, the mesial portion 1022 is sized to fit within the cavity 1011 of the annular chassis 1010.

[0143] In some embodiments, the vine robot 100 herein employs two or more sensors 1001 for visualization. In some embodiments, the two or more sensors 1001 are arrayed along the vine robot 100, which when evert, capture location-based sensor data to map in a discrete fashion. In some embodiments, the sensors 1001 are connected to a base station in a wireless or wired fashion.

[0144] In some embodiments, the tip-based material addition of the vine robot 100 covers the sensor 1001 with a clean film barrier during translation of the vine robot 100. In some embodiments, tip-directed friction force produced through this tail passage through the center of the annular chassis 1010 self-rightens of the annular chassis 1010 and the sensor 1001.

[0145] Such a sensor can be used to increase the efficacy of any endoscopic tool. As such, in some embodiments, per FIGS. 12A-12B, the vine robot 100 comprises an endoscope connector 1200. In some embodiments, the endoscope connector 1200 comprises an endoscope fastener configured to fasten to an endoscope. In some embodiments, the endoscope connector 1200 comprises a converging-diverging hole 1201, and an inflation port 1202. In some embodiments, a first end 111 of the primary tube body 110 is coupled and sealed to an outer surface of the endoscope connector 1200. In some embodiments, a sealed second end 112 of the primary tube body 110 passes through the converging-diverging hole 1201. In some embodiments, inflating the primary tube body 110 through the inflation port 1202, from an uninflated state per FIG. 12B to an inflated state per FIG. 12A, extends a distal surface of the primary tube body 110 away from the endoscope connector 1200. In some embodiments, maintaining a set pressure within the primary tube body 110 seals a mesial portion of the primary tube body 110 against the converging-diverging hole 1202.

[0146] In some embodiments, the vine robots herein can integrate with existing robotic technologies to facilitate multi-modal functionality. Additionally, the vine robots herein can couple to existing cameras, robotic devices, or biopsy technology to deliver an intervention to, for example, an endobronchial tumor or target via a simple connector and everting tool channel assembly. In some embodiments, the vine robot is coupled to an ion robotic-assisted bronchoscopy platform (e.g., Intuitive) for lung biopsies. In another embodiment, the vine robot is coupled to a Monarch robotic-assisted bronchoscopy platform (e.g., Auris)Retraction

[0147] In some embodiments, the tube body of the vine robot can be retracted for removal from a patient. In some embodiments, per FIGS. 13-14, retraction is tip-based. In some embodiments, per FIG. 13, one or more rollers 1301 driven by a motor 1302 collect the tube body 110. In some embodiments, the one or more rollers 1301 collect the tube body 110 into a housing 1303. In some embodiments, the one or more rollers 1301, the motor 1302, or both are contained within the housing 1302. In some embodiments, per FIG. 13, the tube body 110 is collected on a reel 1304. In some embodiments, the reel 1304 is driven by a motor 1302. In some embodiments, the reel 1304, the motor 1302, or both are within a housing 1303.Tool Channels

[0148] In some embodiments, multi-walled everting vine robots with multiple channels therebetween easily couple with an endoscope. If one channel is desired, a double-walled device can be incorporated. If multiple channels are desired, the second wall can be internally segmented to facilitate more channels, or additional double-walled devices of smaller diameter can be deployed within the original device (as a nested deployment).

[0149] FIGS. 15A-15D show exemplary multi-walled vine robots 1500. In some embodiments, per FIGS. 15A-15B, the multi-walled vine robot 1500 comprises an outer tube body 1510, a middle tube body 1520, and an inner tube body 1530, wherein the inner tube body 1530 is within a middle channel 1502 by the middle tube body 1520, and wherein the middle tube body 1520 is within an outer channel 1501 of the outer tube body 1510. In some embodiments, per FIG. 15C, an inner channel 1503 of the inner tube body 1530 comprises a reinforcement 1540. In some embodiments, per FIGS. L5A-15C, the outer channel 1501, the middle channel 1502, and the inner channel 1503 are concentric. In some embodiments, per FIGD. 15D, the outer channel 1501, the middle channel 1502, and the inner channel 1503 are radially arrayed.Introducer

[0150] Introducers provided herein enable blind intubation on patients with wide variations in anatomy. In some embodiments, the introducers are configured to be naturally introduced to an anatomical position, such as a laryngeal mask airway (LMA), to reduce a length between the anatomical position and an intubation position. In some embodiments, per FIGS. 16A-16C, an orotracheal intubation introducer 1600 reliably locates the oropharyngeal wall. Alternatively introducers can be used for nasotracheal intubation to aid in the location of, for example, the inferior turbinates.

[0151] Per FIGS. 17A-17C, the introducers 1600 herein may comprise a shim 1701 1702 to prevent a blind device from strafing the pharyngeal wall as it advances through the oropharynx and into the upper airway. In the example shown, the introducer 1600 may comprise a first shim 1701 and a second shim 1702 to prevent contact of the introducer with the C spine to enable deflection into the upper airway. In some embodiments, the introducer 1600 is advanced manually. In other embodiments, the introducer 1600 is advanced automatically using, for example, a motor an electronic actuator, a magnetic field generator, pneumatics, or hydraulics. The shims 1701 1702 maybe integral to the introducer 1600 (e.g., for an LMA-type introducer design), or disparate from the introducer 1600. The shims 1701 1702 may comprise a passive lifting mechanism (e.g., a foam or spring), an active lifting mechanism (i.e., pneumatics), or both, tolift the anatomy once in place. In some embodiments, the introducer 1600 comprise a ramp or staircase to displace the anatomy to different levels through advancement as desired. In some embodiments, per FIGS. 17B-17C, respectively, the introducer 1600 herein comprises flap 1703 and a rail 1704, to pin the epiglottis in place. In some embodiments, per FIG. 17A, the introducer comprises a camera or fiber optic bundle 1703 to visualize the placement of the shims 1701 1702 and tissue state during operation.

[0152] In some embodiments, the shims 1701 1702 of the introducer 1600 are configured to stop insertion once an operative anatomical position is reached. Per FIGS. 18A-18D, the introducer may comprise a wedge 1801 at a leading edge of the shim assembly to locate the glottis and arytenoids. FIGS. 19A-19C show a shim with a vallecula stop 1901 1902 to prevent the shim from advancing past the vallecula and / or glottic opening. In some embodiments, per FIG. 19A, the vallecula stop 1901 is separated from the shim, wherein per FIGS. 19B-19C, the vallecula stop 1902 is integrated into the shims 1701 1702. In some embodiments, the vallecula stop 1902 comprises a force-limiting advancement mechanism (e.g., a spring or a flexure) to minimize trauma to the anatomy. Such introducers 1600 could alternatively be configured for application to other areas of the body (e.g., the urethra, the bladder, the main stem bronchi, or the bronchioles).

[0153] In some embodiments, once the introducer is advanced and the vine robot is placed, an Endotracheal Tube (ETT) is passed through the vine robot for successful tracheal intubation. In some embodiments, per FIGS. 20A-20C, the ETT 2000 is sheathed within the vine robot 100. In some embodiments, per FIG. 20B and 48, the vine robot is a toroidal vine robot 3000, wherein a constant volume of fluid is maintained therein. In some embodiments, the fluid comprises air, water, oil, or any combination thereof. In some embodiments, the toroidal vine robot 3000 is coupled to the ETT 2000. In some embodiments, the toroidal vine robot 3000 is disparate from the ETT 2000. In some embodiments, pull-tendons may be incorporated to guide this assembly under direct visualization or routed through to the base of the introducer for provider control. FIGS. 21A-21B show a commercial ETT sheathed in a toroidal vine robot 3000.

[0154] In some embodiments, the introducer serves as a primary user interfaces in operating an Endotracheal tube (ETT). In some embodiments, the introducer delivers the tracheal access mechanism (TAM) and the ETT to correct position and orientation in the patient’s anatomy, to enable soft robotic intubation and / or serve as a hub for the deployment of other sub-assemblies.

[0155] FIGS. 22A-24 show exemplary introducers for delivering a posterior TAM (pTAM). In some embodiments, per FIGS. 22D-24, the introducer 2200 comprises a tubular body 2210 and an ovular surface 2220. In some embodiments, the tubular body 2210 is configured to receive thetracheal intubation device. In some embodiments, a distal end 2211 of the tubular body 2210 is angled with respect to a tubular axis or elongate axis 2212 of the tubular body 2210. In some embodiments, the ovular surface 2220 is coplanar to the distal end 2211 of the tubular body 2210 and extends outwards from the tubular axis or elongate axis 2212. In some embodiments, an outer rim 2221 of the ovular surface 2220 has a greater thickness than the remainder of the ovular surface 2220. In some embodiments, the ovular surface 2220 comprises a flap 2222 configured to, in a collapsed state per FIG. 23C, cover at least a portion of the distal end 2211 of the tubular body 2210. In some embodiments, the flap 2222 configured to, in an expanded state per FIGS. 23A-23B, in an expanded state, extend perpendicular to the ovular surface 2220. In some embodiments, the flap 2222 configured to, in the expanded state, extend within at least 20 degrees of perpendicular from the ovular surface 2220.

[0156] FIGS. 25A-25C show exemplary introducers 2500 for delivering an anterior TAM (aTAM). In some embodiments, Per FIG. 25A, the introducer 2500 comprises a vine channel 2501 to house the vine robot, and a vine robot attachment feature 2502. The open vine channel 2501 allows for easy separation from vine robot during removal. In some embodiments, per FIG. 25B, the introducer 2500 comprises an anterior shim 2503.

[0157] In some embodiments, the introducers 2500 herein employ tissue interaction to properly advance the TAM to the hypopharynx. In some embodiments, the introducers 2500 herein include a continuous connection between the TAM and the advancement feature. In some embodiments, the unibody introducers 2500 herein employ manual advancement. In some embodiments, the introducers 2500 s herein require fewer delivery steps. In some embodiments, the introducers 2500 herein enable the ETT to be stored integrally or detachably.

[0158] FIGS. 26A-27 show an exemplary multibody introducer 2600 configured to deliver an aTAM with various anatomical datum features. As shown, the introducer 2600 comprises a first datum 712 722 which stops against the oropharynx of the patient. As shown, the introducer 2600 comprises a second datum 721 that, when inserted into the mouth of the patient, rests to seat against their incisors to limit device tilt. A distance between a first point 713 and a second point 723 of the introducer 2600 is configured to self-center into the oropharynx as it slopes posteriorly. In some embodiments, the first point 713 and the second point 723 are rounded to reduce resistance against tissue folds. In some embodiments, per FIG 26, the introducer 2600 comprises an anterior slot 730 configured to separate from the vine robot while preventing compression the uvula when placed in the back of the patient’s oropharynx. Per FIGS. 26B and 27, a third datum 731 is configured to contact the tongue of the patient while minimizing tongue entrainment as the introducer 2600 is passed through the oral cavity.

[0159] In some embodiments, once the introducer 2600 is appropriately oriented in the patient’s oral cavity the practitioner may deploy the tracheal access mechanism by translating a plunger 740 distally towards the patient. In some embodiments, the plunger 740 and the anterior slot 730 are configured to interact and slide smoothly relatively to each other. In some embodiments, the introducer 2600 comprises a plunger disconnect 741 that removable couples to the plunger by, for example, a snap fit or a clip.

[0160] In some embodiments, upon completion of intubation the introducer 2600 may be removed from the patient, leaving the endotracheal tube in place. In some embodiments, per FIG. 27, the introducer comprises a retraction feature 741 configured to prevent tissue snags and damage. In some embodiments, per FIG. 27, the introducer 2600 is formed of a first part 750 and a second part 760 that are adjoined.Tissue Management Features

[0161] Tongues vary in volume, durometer, lubricity and topology. The variation in these factors makes the anterior surface of the oropharynx difficult for strafing the AShim and TAM against. Once the TAM Is seated in the airway against appropriate anatomical structures, the epiglottis and arytenoids must be managed to maintain a patent growth channel.

[0162] In some embodiments, per FIGS. 28A-28C, the introducer comprises a flap 2800 that prevents tongue entrapment throughout the operation of the ETT. The introducer flap (Figure 4) is a feature of the introducer to manage this tongue tissue, moving it away from the posterior surface of the pharynx as the TAM is deployed. The introducer flap is sufficiently lengthened to allow for smooth deployment of the TAM over the tongue tissue as it transitions to anterior oropharyngeal tissue.

[0163] In some embodiments, the flap 2800 comprises a first portion 2801 and a second portion 2802 having a modulus of elasticity than the first portion. In some embodiments, the flap creates 2800 forms a boundary surface that prevents the tongue from getting caught and pushed into the pharynx while the introducer advances to the oropharynx.

[0164] The trap door may be deployed or actuated by pneumatics, stored elastic energy or via contact with the everting vine robot. FIGS. 29A-29C show an exemplary inserter deployable flap 2800. The primary method is by contact with the everting vine robot. The vine robot everts under pressure on the flap 2800, from a closed position in FIG. 28A, lifting the flap 2800 to an open position, per FIG. 28A, that engages the epiglottis. In some embodiments, the flap 2800 comprises a first portion 2801 and a second portion 2802, wherein the first portion 2801 is more rigid than the second portion 2802.

[0165] FIGS. 30A-30D show introducers with flaps with increasing contact angles. In some embodiments, if the flap has an insufficient rigidity or too great of a contact angle, displacement waves may propagation effect throughout. Such waves may push the epiglottis inferiorly, increasing the risk of the epiglottis down-folding and closing off the glottic structures. As such, the flaps herein decrease wave propagation and increase the lifting force at its distal tip of the trap door. The rigid flap may be made of a metal, a plastic, an elastomer, or any combination thereof.

[0166] Another area to datum against the tissue is via the upper esophageal sphincter / cricopharyngeus, which is posterior to the previously identified anatomy exploited via the aTAM. In this approach, pTAM devices slide behind the epiglottis, arytenoids, and larynx to seat in the hypopharynx. Similar features such as those required for aTAMs may be incorporated into pTAMs with appropriate modifications to address the different datuming mechanisms.Tracheal Access Mechanisms

[0167] In some embodiments, the systems herein employ a tracheal access mechanism (TAM) to actively manipulate the state of tissue in the airway, maintain a patent growth channel for intubation, and place the vine robot within a set distance from the vocal cords. Tracheal access can be produced via airway tissue management feature provide an anatomical stop that resists motion at particular points along the airway. The TAM may be translated manually by the user, autonomously translated under power, or both. In some embodiments, the TAM strafes the pharyngeal wall as it advances into the airway without guidance by visualization. In some embodiments, the TAM herein comprise posterior and / or anterior contacting components that contact the arresting structures of the anatomy and are designed to avoid entrainment of the tongue. In some embodiments, the posterior and / or anterior contacting components are arrested upon contact with anatomical features, including but not limited to, the vallecula, the glottis, the hypopharynx, the cricopharyngeus, and the upper esophageal sphincter.

[0168] In some embodiments, an anterior TAM (aTAM) provided herein comprises of a posterior shim (PShim) and anterior shim (AShim). In some embodiments, the aTAM is advanced by a plunger of an introducer. In some embodiments, the aTAM is configured to guarantee proper strafing of the pharyngeal wall throughout its deployment.

[0169] In some embodiments, per FIG. 31, the PShim 3120 of the aTAM 3100 comprises a flexible tip 3121 to provide constant force against the posterior pharyngeal tissue as the AShim 3110 strafes the anterior tissue. In some embodiments, the flexible tips 3121 stabilize the aTAM 3100 during deployment. In some embodiments, the flexible tips 3121 are configured to providea lubricious and safe contacting surface to strafe the posterior tissue with minimal resistance from the tissue, especially in cases wherein, for example, curvature of the cervical spine varies naturally in healthy physiology and may be exaggerated due to pathological causes (e.g. kyphosis). The flexible tips 3121 may be shaped to follow the curvature of the cervical spine, improving placement of the aTAM 3100 in the preponderance of human anatomies.

[0170] In some embodiments, the AShim 3110 datums against a combination of tissues for placement of the aTAM 3100 in a vallecula state or a glottic state. In the vallecula state, the AShim 3110 datums against the vallecula broadly, including but not limited to the hyoepiglottic ligament and the glossoepiglottic folds, which assists in lifting the epiglottis anteriorly when pressure is applied. The applied force profile may e=be self-centering. In the glottic state, the AShim contacts the cartilaginous structures of the anterior glottis, including but not limited to, the epiglottis, the pharyngoepiglottic folds, and the underlying thyroid cartilage.

[0171] In some embodiments, per FIG 32, the AShim 3110 comprises a rounded nub 3112, a first bridge 3113, or both to establish the optimal tissue condition and increase the probability of entering the vallecula state.

[0172] In some embodiments, per FIGS. 31 and 33A-34B, the aTAM 3100 comprises a trap door 3130 to enable the PShim 3120 to slip past and lift the epiglottis out of the way when deploying the ETT. hi some embodiments, the trap door 3130 is configured for minimal contact with the arytenoids of the patient. In some embodiments, the flexible tips 3121 of the PShim 3120 retain the trap door 3130 while the aTAM 3100 advances from the introducer. In some embodiments, the trap door 3130 deploys during ETT eversion to sandwich the epiglottis anteriorly, leaving a clear growth path of the ETT into the trachea. In some embodiments, the trap door 3130 is actively actuated by an inflating body affixed to its posterior surface.

[0173] FIGS. 33A-33B show a flexible trap door 3130 in a disengaged and an engaged position, respectively. In some embodiments, the trap door 3130 comprises a pin joint that pivots rather than lifts as the vine robot grows beneath. In some embodiments, in an initial, posterior position, per FIG. 34A, the trap door 3310 translates anteriorly across the pharynx, lifting the epiglottis up to the AShim 3110 where it is entrained per FIG. 34B,

[0174] In some embodiments, the AShim 3110 comprises a primary first segment 3114 and a secondary first segment 3115 noncolinear to the primary first segment 3114. In some embodiments, per FIG. 35, the noncolinear primary first segment 3114 and secondary first segment 3115, right, provides a vine robot growth cavity 3400 not formed when the primary first segment 3114 and the secondary first segment 3115 are colinear, left.

[0175] FIGS. 36A-36C show exemplary bridges 3113 of an AShim 3110. In some embodiments, the bridge 3113 secures the ETT during deployment of the TAM and facilitate detachment when the introducer is removed. In one embodiment, per FIG. 36A, the bridge 3113 couples to the vine robot 100 via a one-point attachment, which offers the minimum necessary retention force to secure the vine robot 100 as it is placed by the TAM in the anatomy. In another embodiment, per FIG. 36B, the bridge 3113 couples to the vine robot 100 via a two-point attachment, which provides greater lateral stability in the deflated state while increasing the retention force in the inflated state. In yet another embodiment, per FIG. 36C, the bridge 3113 couples to the vine robot 100 via a three-point attachment with improved lateral stability.

[0176] In some embodiments, per FIG. 37, the AShim 3110 comprises an AShim webbing 3112 that forms a boundary surface to constrain the growth path of the vine robot and prevent overshooting of the glottis. In some embodiments, the AShim webbing 3112 forms a volume for the vine robot to safely occupy, while allowing anterior growth of an overtube. Anterior growth allows the vine robot to circumvent the arytenoids, which are located posteriorly.

[0177] In some embodiments, per FIG. 38, as the vine robot grows anteriorly from an initial position of the AShim bridge, a nub 3801 in the vine robot inflates under the trap door to deploy the trap door. Additionally, in some embodiments, the nub 3801 ensures the overtube everts over the arytenoids and into the glottis.

[0178] Per FIG. 39, the nub redirects growth into the base of the epiglottis in the event that the overtube is redirected posteriorly due to tissue interactions. In some embodiments, the nub also helps to dislodge the vine overtube from the petiole in the event that the everting overtube is caught on this anatomical feature of the larynx. While the nub provides passive direction of the vine robot, the vine robot may additionally comprise an active (e.g., inflatable) nub.

[0179] In some embodiments, per FIGS. 41A-41B, the AShim is passively controlled. In some embodiments, per FIGS. 42A-72B, the AShim is actively controlled via a routed cable to the tip from the base of the introducer, such that tension in the pull-cable corresponds to angle change in the AShim. hi some embodiments, per FIG. 43, the aTAM comprise a retractor 4300 which provides geometry for the tissue to slide over, preventing snags or damage to the tissue during removal. In some embodiments, per FIG. 44, the plunger disconnect may be attached to the plunger by either a snap fit, twist-off, clip, or other mechanical means.ETT Direction Control

[0180] FIG. 40 shows a cable-actuated vine ETT direction control, where a cable 4001 is routed on the anterior surface of the vine robot 100 through to the proximal base of the introducer wherethe user can apply tension to the cable 4001 to shorten it. In some embodiments, shortening the cable 4001 redirects the growth of the vine ETT. In some embodiments, the cable 4001 is added to a posterior surface of the vine robot 10, such that both directions may be controlled. The cable 4001 can be properly tensioned to return to the nominal direction when no additional forces are applied.

[0181] While the vine ETT can be deployed manually, FIG. 45 shows an exemplary automatic ETT deployment for increased deployment force. As shown, a spring 4501 provides an advancement force relative to the 4502.

[0182] A laryngoscope with a vine robot is shown in FIG. 46, which can enable visualization of the airway, manual manipulation of the tissues to create a patent airway, and placement of the vine robot in an advantageous position prior to an intubation attempt. Once the vine robot is under the epiglottis, the everting mechanism of the overtube replaces the need for a skilled and dexterous user in placing the ETT. The laryngoscope may have visualization (camera, fiber optics or mirrors). The vine robot may be manually inflated via syringe, pre-inflated, or be inflated via a pressure vessel stored in the device handle. The vine robot can grow or retract by manually translating the ETT from the proximal end. The growth angle is manually controlled by cables that are actuated by an interface in the handle of the device.Methods of Intubating a Patient

[0183] FIG. 47 shows diagrams of an exemplary method for intubating a patient. As shown, the tracheal intubation system is inserted into the mouth of the patient to the pharyngeal wall; the plunger is advanced distally toward the patient to eject the ATAM, the primary vine robot is advanced distally between the first bridge and the posterior shim of the ATAM, the ATAM is disconnected from the primary vine robot, and the ATAM and the introducer are removed from the patient’s mouth.Terms and Definitions

[0184] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0185] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and / or” unless otherwise stated.

[0186] As used herein, the term “about” in some cases refers to an amount that is approximately the stated amount.

[0187] As used herein, the term “about” refers to an amount that is near the stated amount by 10%, 5%, or 1 %, including increments therein.

[0188] As used herein, the term “about” in reference to a percentage refers to an amount that is greater or less the stated percentage by 10%, 5%, or 1%, including increments therein.

[0189] As used herein, the phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.

[0190] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the scope of the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A tracheal intubation device, comprising: an anterior tracheal access mechanism (ATAM) comprising:(a) a posterior shim comprising a first tine and a second tine; and(b) an anterior shim comprising:(i) a first portion coupled to the first tine;(ii) a second portion coupled to the second tine; and(iii) a first bridge connecting the first portion and the second portion, wherein the first bridge is offset from the posterior shim.

2. The device of claim 1, further comprising a primary vine robot that is shaped and sized to extend through a patient’s larynx when fully actuated.

3. The device of claim 2, wherein the first tine and the second tine extend in an actuation direction of the primary vine robot.

4. The device of claim 2 or 3, wherein the ATAM is shaped and sized to lift the epiglottis of a patient anteriorly when the primary vine robot is fully actuated.

5. The device of any one of claims 2-4, wherein the ATAM is removably coupled to an everting end of the primary vine robot.

6. The device of claim 5, wherein the ATAM is rotatably and removably coupled to the everting end of the vine robot.

7. The device of claim 5, wherein the vine robot comprises a camera.

8. The device of any one of claims 1-6, wherein the ATAM further comprises a first tine cover surrounding at least a distal portion of the first tine, a second tine cover surrounding at least a distal portion of the second tine, or both.

9. The device of claim 8, wherein the first tine cover, the second tine cover, or both comprise a coating.

10. The device of claim 8 or 9, wherein the first tine cover, the second tine cover, or both are formed of a material having a modulus of elasticity less than the modulus of elasticity of the material of the posterior shim.

11. The device of any one of claims 1-10, wherein a distal portion of the first portion of the anterior shim, a distal portion of the second portion of the anterior shim, or both, comprise a rounded nub.

12. The device of any one of claims 1-11, wherein:(a) the first portion of the anterior shim comprises a primary first segment and a secondary first segment noncolinear to the primary first segment;(b) the second portion of the anterior shim comprises a primary second segment and a secondary second segment noncolinear to the primary second segment; or(c) both.

13. The device of any one of claims 1-12, wherein the anterior shim further comprises a second bridge connecting the first portion and the second portion at a point proximal to the first bridge.

14. The device of claim 13, wherein the anterior shim further comprises a cantilever extending distally from the second bridge.

15. The device of claim 14, wherein the cantilever comprises a first cantilever portion and a second cantilever portion having a thickness less than a thickness of the first cantilever portion.

16. The device of any one of claims 1-15, wherein the ATAM further comprises a webbing extending from at least two of the first portion, the second portion, and the first bridge.

17. The device of any one of claims 1-16, wherein the first tine, the second tine, or both comprise a first flexible portion and a second flexible portion coupled to the distal terminus and the proximal terminus of the first flexible portion,18. The device of claim 17, wherein a mesial portion of the first flexible portion and a mesial portion of the second flexible portion are biased to separate.

19. The device of claim 17 or 18, wherein the posterior shim further comprises an inflatable chamber between the first flexible portion and the second flexible portion of the first tine, the second tine, or both.

20. The device of any one of claims 1-19, wherein the posterior shim further comprises an inflatable chamber coupled to the first tine, the second tine, or both.

21. A tracheal intubation system comprising:(a) the tracheal intubation device of any one of claims 2-20; and(b) an introducer device configured to accept the tracheal intubation device and to eject at least a portion of the tracheal intubation device into the mouth of the patient distal to the epiglottis.

22. The system of claim 21, wherein the introducer device comprises:(a) an introducer comprising:(i) a first slot sized to slidably receive the first tine of the posterior shim;(ii) a second slot sized to slidably receive the second tine of the posterior shim; and(iii) a channel between the first slot and the second slot sized to slidably receive the first bridge; and(b) a plunger comprising:(D a first portion sized to slide within the first slot;(ii) a second portion sized to slide within the second slot; and(iii) an arcuate portion between the first portion and the second portion sized to slide within the channel of the introducer.

23. The system of claim 21 , wherein the introducer system further comprises a disconnect configured to separate the introducer system from the vine robot.

24. The system of claim 21, wherein the introducer device comprises:(a) a tubular body configured to receive the tracheal intubation device, wherein a distal end of the tubular body is angled with respect to an elongate axis of the tubular body;(b) an ovular surface coplanar to the distal end and extending outwards from the elongate axis, wherein the ovular surface comprises a flap configured to, in a collapsed state, cover at least a portion of the distal end of the tubular body and, in an expanded state, extend perpendicular to the ovular surface.

25. The system of claim 24, wherein an outer rim of the ovular surface has a greater thickness than the remainder of the ovular surface.

26. A method of intubating a patient comprising:(a) inserting the system of any one of claims 21- 23 into the mouth of the patient to the pharyngeal wall of the patient;(b) advancing the plunger distally toward the patient to eject the AT AM;(c) advancing the primary vine robot distally between the first bridge and the posterior shim of the ATAM;(d) disconnecting the ATAM from the primary vine robot; and(e) removing the ATAM and the introducer from the patient’s mouth.

27. The method of claim 26, wherein the primary vine robot remains within the patient after step (e).

28. The method of claim 26 or 27, wherein the first bridge contacts the vallecula of the patient, the hyoepiglottic ligament of the patient, the glossoepiglottic folds of the patient, or any combination thereof after step (b).

29. The method of claim 28, wherein, during advancement, pressure applied by the first bridge lifts the epiglottis anteriorly.

30. The method of claim 29, wherein the lifting of the epiglottitis anteriorly facilitates directing of the primary vine robot toward the trachea when being actuated.

31. A soft vine endoscopy robot, comprising a primary tube body having a sealed first end and a second end opposite the first end, wherein the first end is within a mesial portion of the primary tube body, and wherein the mesial portion comprises two or more stiffened portions, wherein adjacent stiffened portions are separated by a segment of the primary tube body.

32. The robot of claim 31 , wherein the two or more stiffened portions are arranged from the first end to the second end.

33. The robot of claim 31 , wherein the two or more stiffened portions are radially aligned about the primary tube body.

34. The robot of claim 31 , wherein the two or more stiffened portions are radially arrayed about the primary tube body.

35. The robot of any one of claims 31-34, wherein inflating the primary tube body from the second end translates a distal end of the primary tube body distally relative to the sealed end;36. The robot of any one of claims 31-35, wherein, when inflated, the primary tube body has two non-colinear sections that intersect at one of the two or more stiffened portions.

37. The robot of any one of claims 31-36, wherein the two or more stiffened portions have a thickness greater than the rest of the primary tube body.

38. The robot of any one of claims 31-37, wherein the two or more stiffened portions have a modulus of elasticity less than the rest of the primary tube body.

39. The robot of any one of claims 31-38, wherein the two or more stiffened portions comprises a stop coupled to the primary tube body.

40. The robot of claim 39, comprising two or more stops, wherein the two or more stops are interconnected by a tendon.

41. The robot of claim 40, wherein the tendon has a constant length.

42. The robot of claim 40, wherein the tendon has an actuatable length.

43. The robot of any one of claims 31-42, wherein the primary tube body comprises a plurality of segments separated from one another by the two or more stiffened portions.

44. The robot of claim 43, wherein the primary tube body, when inflated, is configured to have a plurality of segment lengths and angles between segments that match lengths and curvatures of a predefined bodily lumen.

45. The robot of any one of claims 31-44 further comprising an annular chassis having a cavity, wherein the primary tube body extends from the first end, through the cavity, around an outer surface of the annular chassis and to the mesial portion of the primary tube body.

46. The robot of claim 45, wherein the chassis comprises one or more camera sensors.

47. The robot of claim 45 or 46, further comprising a camera body comprising:(a) a proximal portion;(b) a distal portion comprising one or more camera sensors, wherein the distal portion has an outer diameter greater than an inner diameter of the annular chassis; and(c) a mesial portion between the distal portion and the proximal portion, wherein the mesial portion is sized to fit within the cavity of the annular chassis.

48. A method of forming a soft vine endoscopy robot, the method comprising:(a) receiving an anatomical measurement comprising a length of a first portion, a length of a second portion, and an angle between the first portion and the second portion;(b) stiffening a portion of a primary tube body based on the length of the first portion, the length of the second portion, the angle between the first portion and the second portion, or any combination thereof, wherein the primary tube body has a first end, a second end, and a channel therethrough; and(c) inserting the first end through the channel at the second end.

49. The method of claim 48, wherein stiffening the portion of the primary tube comprises heating the portion of the primary tube.

50. The method of claim 48, wherein stiffening the portion of the primary tube comprises attaching a stop to the portion of the primary tube, wherein the stop is coupled to a tendon.

51. A soft vine endoscopy robot, comprising:(a) a primary tube body having a sealed first end, wherein the first end is within a mesial portion of the tube body; and(b) a secondary tube body attached to an outer surface of the primary tube body, wherein the primary tube body and the secondary tube body are parallel or concentric.

52. The robot of claim 51 , wherein inflating the tube body from the second end translates a distal end of the primary tube body distally relative to the sealed end.

53. The robot of claim 51 or 52, wherein inflating the secondary tube body bends the primary tube body about an attachment arc between the primary tube body and the secondary tube body.

54. A soft vine endoscopy robot, comprising:(a) an endoscope connector comprising an endoscope fastener configured to fasten to an endoscope, a converging-diverging hole, and an inflation port; and(b) a primary tube body having a first end coupled and sealed to an outer surface of the endoscope connector and a sealed second end that passes through the converging-diverging hole.

55. The robot of claim 54, wherein inflating the primary tube body through the inflation port extends a distal surface of the primary tube body away from the endoscope connector.

56. The robot of claim 54 or 55, wherein maintaining a set pressure within the primary tube body seals a mesial portion of the primary tube body against the converging-diverging hole.

57. A soft vine endoscopy robot, comprising:(a) a primary tube body having a sealed first end, wherein the first end is within a mesial portion of the tube body;(b) a retractor coupled to the first end of the primary tube body; and(c) a motor configured to drive the retractor to collapse at least a portion of the primary tube body.

58. The robot of claim 57, wherein the retractor comprises a spool.

59. The robot of claim 57 or 58, wherein the retractor comprises a pulley.

60. A method of intubating a patient, the method comprising:(a) inserting a vine robot in an unactuated position into the patient’s mouth, wherein the vine robot comprises a primary tube body having a sealed first end and a second end, wherein the first end is within a mesial portion of the tube body;(b) applying fluid pressure into the primary tube body to gradually evert and extend the primary tube body into the back of the laryngopharynx of the patient and into the trachea of the patient to provide a lumen from a mouthpiece to the trachea; and(c) providing air or oxygen through the lumen into the trachea.

61. A method of accessing a cavity of a patient with a medical tool, the method comprising:(a) inserting a vine robot in an unactuated position into the patient’s mouth, wherein the vine robot comprises a primary tube body having a sealed first end and a second end, wherein the first end is within a mesial portion of the tube body;(b) applying fluid pressure into the primary tube body to gradually evert and extend the primary tube body into the cavity of the patient to form a lumen into the cavity of the patient; and(c) accessing the cavity of the patient through the lumen.

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