Soft Robotic Intubation Device

Abstract

The soft robotic intubation device comprises a compliant body. Upon placement in an opening on the body and subsequent application of pressure on the compliant body, the compliant body forms (i) a primary segment extending to the dorsal larynx, (ii) a secondary segment extending from the first segment into the trachea, and (iii) at least one patency from the first segment to the second segment, providing a pathway from the opening on the body to the trachea through which ventilation can be provided, either through the patency itself or an endotracheal tube advanced through the patency. The compliant body can comprise walls defining distinct first and second patencies. Pressurization of the first patency forms the primary and secondary segments. Pressurization of the second patency opens a pathway from the opening on the body to the trachea.

Description

[Technical field]

[0001] (cross reference) This PCT application claims priority to U.S. Provisional Application No. 63 / 399,597, filed August 19, 2022, U.S. Provisional Application No. 63 / 306,805, filed February 4, 2022, and U.S. Provisional Application No. 63 / 246,135, filed September 20, 2021, each of which is incorporated herein by reference in its entirety.

[0002] (Technical field) The present disclosure relates to medical devices, and more particularly, to devices and methods for performing endotracheal intubation. [Background technology]

[0003] Tracheal intubation or intubation is the placement of a flexible tube into the trachea (windpipe) to serve as a conduit for maintaining an open airway or administering certain medications. It is frequently performed in seriously injured, ill or anesthetized patients to facilitate ventilation of the lungs (including mechanical ventilation) and to reduce the risk of asphyxiation due to airway obstruction.

[0004] The most widely used route is orotracheal, in which an endotracheal tube is passed through the mouth and into the trachea. Intubation is usually facilitated by using a conventional laryngoscope, a flexible fiberoptic bronchoscope, or a visual laryngoscope to identify the vocal cords and pass the tube between the vocal cords and into the trachea (instead of into the esophagus). After the trachea is intubated, a balloon cuff is typically inflated just above the distal end of the tube to help secure the tube in place, prevent leakage of respiratory gases, and prevent the tracheobronchial tree from receiving undesirable material such as stomach acid.

[0005] Due to its invasive and uncomfortable nature, intubation is typically performed after administration of general anesthesia, but in emergency situations, it may also be performed without anesthesia. Tracheal intubation is associated with a variety of complications, such as broken teeth or laceration of the tissues of the upper airway. Possibly fatal complications include pulmonary aspiration of gastric contents, which can result in severe and sometimes fatal chemical aspiration pneumonia, or unrecognized intubation of the esophagus, which can lead to potentially fatal oxygen deprivation. Due to these risks, there is an ongoing need for improved devices for intubation that do not suffer from the shortcomings of the current state of the art. Summary of the Invention [Means for solving the problem]

[0006] Aspects of the present disclosure provide a device for intubation of a subject. An exemplary device may include a compliant body and is configured to form, upon placement in an opening on a subject's body and subsequent application of pressure on the compliant body, (i) a primary segment configured to extend to the back of the subject's laryngopharynx, (ii) a secondary segment configured to extend from the first segment into the subject's trachea, and (iii) at least one patency from the first segment to the second segment to provide a pathway from the opening on the subject's body to the subject's trachea. The opening on the body may be the subject's nostril or mouth.

[0007] In some embodiments, the compliant body comprises one or more walls defining a first patency and a separate second patency. The first patency allows pressurization of the compliant body to form a primary and secondary segment. The second patency extends from the primary segment into the secondary segment to provide a pathway from an opening on the subject's body to the subject's trachea. The first patency and the second patency may be configured to be pressurized by different pressurized flows. The second patency may be configured to directly provide ventilation for the subject through the pathway provided therefrom. Alternatively, an endotracheal tube may be advanced through the second patency to provide ventilation for the subject.

[0008] The device may further include an introducer coupled to the compliant body and configured for at least partial placement into an opening on the subject's body. The introducer may include one or more of a first access port or a second access port, the first access port being open to a first patency and the second access port being open to a second patency. The introducer may include a third access port, for example, for cuff inflation.

[0009] A portion of the one or more walls defining the second patency may be supported by one or more rigid elements. The one or more rigid elements may comprise a plurality of discontinuous rigid elements. The one or more rigid elements may comprise a spring. The one or more rigid elements may comprise at least one continuous elongated rigid element.

[0010] The second patency can be disposed at least partially within the first patency. The first patency and the second patency can be at least partially coaxial.

[0011] In some embodiments, the device further comprises a cuff coupled to the secondary segment and configured to protect the patency of at least one. The cuff may be at least partially rigid. The cuff may be expandable or inflatable, for example, with a pressure source independent of the separate pressure sources for the primary and secondary segments. The cuff may be coupled to a distal portion of the secondary segment.

[0012] In some embodiments, the device further comprises an introducer coupled to the compliant body and configured for at least partial placement and fixation within an orifice on the subject's body. The introducer may be configured to connect with one or more nostrils of the subject. The introducer may be configured to connect with the oropharynx of the subject. The introducer may be configured to connect with the mouth of the subject and may comprise a mouthpiece. The device may further comprise a bite block removably coupled to the mouthpiece. The bite block may be configured to at least partially accommodate the dentition of the subject.

[0013] In some embodiments, the device further comprises a storage compartment coupled to the compliant body and configured to house the compliant body prior to being pressurized. The compliant body may extend at least partially out of the storage compartment in response to pressurization. The device may further comprise an introducer coupled to the compliant body and the storage compartment, the introducer configured for at least partial placement and fixation within an opening on the subject's body. The storage compartment may comprise an access port to allow pressurization of the compliant body and to allow ventilation and / or cuff inflation.

[0014] In some embodiments, the primary segment comprises a first subsegment and one or more lateral subsegments, the one or more lateral subsegments being partially closed to fluid communication with the primary subsegment.

[0015] In some embodiments, the primary segment has a non-circular cross-section such that as the primary segment is pressurized, the primary segment is oriented in a preferred direction relative to the trachea. The primary segment comprises a first sub-segment and one or more lateral sub-segments, where the one or more lateral sub-segments may provide the non-circular cross-section in combination with the primary sub-segment. The one or more lateral sub-segments may be partially closed against fluid communication with the primary sub-segment. One or more rigid elements may be coupled to a portion of one or more walls in the first segment to provide the non-circular cross-section.

[0016] In some embodiments, the device further comprises at least one shifting element configured to shift surrounding tissue of the subject to facilitate advancement of the secondary segment into the trachea.

[0017] In some embodiments, the device further comprises at least one shifting element configured to shift the subject's epiglottis and facilitate advancement of the secondary segment into the trachea. The at least one shifting element may comprise at least one lifting element configured to extend laterally from the primary segment as the primary segment is pressurized. The at least one lifting element may be configured to extend laterally from an anterior side of the primary segment. The at least one lifting element may comprise one or more rigid scales. The at least one lifting element may comprise an inflatable member in fluid communication with the primary segment. The at least one shifting element may comprise a flexible shim configured to slide posteriorly of the epiglottis upon advancement into the laryngopharynx. The flexible shim may be configured to extend from the primary segment in response to pressurization thereof.

[0018] In some embodiments, the compliant body is configured to form a tertiary segment into a first piriform sinus of the subject upon placement in an opening on the body and subsequent application of pressure on the compliant body to facilitate advancement of the secondary segment into the trachea. The tertiary segment may be configured to extend from the primary segment into the first piriform sinus of the subject to elevate the epiglottis of the subject and facilitate advancement of the secondary segment into the trachea. The tertiary segment may be configured to extend from the primary segment into the first piriform sinus of the subject. The secondary segment may be configured to extend from the second segment into the trachea of ​​the subject. The compliant body may be configured to form a quaternary segment into a second piriform sinus of the subject upon placement in the mouth and subsequent application of pressure on the compliant body to form a quaternary segment configured to extend into a second piriform sinus of the subject. The quaternary segment may be configured to extend from the primary segment into the second piriform sinus to elevate the epiglottis of the subject and facilitate advancement of the secondary segment into the trachea.

[0019] In some embodiments, one or more of the primary or secondary segments are configured to evert in response to pressure.

[0020] In some embodiments, the secondary segment has a smaller cross-sectional area than the primary segment.

[0021] In some embodiments, the primary segment has a predetermined shape configured to position the secondary segment and orient it towards the trachea.

[0022] In some embodiments, the primary and secondary segments are integrally formed.

[0023] In some embodiments, the compliant body is made from a thin, flexible material, such as a thin film polymer.

[0024] In some embodiments, at least a portion of the compliant body is supported by one or more rigid elements.

[0025] Aspects of the present disclosure provide a method for intubation of a subject. In an exemplary method, a compliant body may be placed into an opening on a subject's body, the compliant body may be pressurized through at least one patency thereof such that a primary segment of the compliant body extends everted into the dorsal larynx of the subject, a secondary segment of the compliant body then extends everted from the primary segment into the trachea of ​​the subject, and ventilation from the opening on the body to the trachea may be provided via the pressurized compliant body. The opening on the body may be the subject's nostril or mouth.

[0026] In some embodiments, the at least one patency comprises a first patency and a second patency separate. The compliant body may comprise one or more walls defining the first patency and the second patency. Pressurization through the first patency may define a primary and secondary segment. The second patency may provide ventilation. The second patency may provide ventilation for the subject directly therethrough. The first patency and the second patency may be pressurized by different pressurized flows.

[0027] In some embodiments, patency of the second segment is maintained using a cuff coupled to a distal portion of the secondary segment. The cuff may be at least partially rigid. The cuff may be expanded, such as by inflating the cuff with a pressure source that is independent of the separate pressure sources for the primary and secondary segments.

[0028] In some embodiments, the primary segment can be oriented in a preferred orientation relative to the trachea as the primary segment is pressurized. Orienting the primary segment can include pressurizing a sub-segment lateral to the primary segment that extends laterally from the first sub-segment.

[0029] In some embodiments, the epiglottis may be shifted to facilitate extension of the secondary segment into the trachea. The epiglottis may be shifted by extending at least one lifting element laterally from the primary segment as the primary segment is pressurized. The epiglottis may be shifted by inflating at least one lifting element as the primary segment is pressurized. The epiglottis may be shifted by extending a flexible shim from the primary segment in response to pressurization such that the flexible shim slides posteriorly of the epiglottis.

[0030] In some embodiments, compressing the compliant body through its at least one patency extends a tertiary segment of the compliant body into at least one piriform sinus of the subject. The tertiary segment may extend from the primary segment into a first piriform sinus of the subject, lifting the epiglottis of the subject and facilitating advancement of the secondary segment into the trachea. The tertiary segment may extend from the primary segment into a first piriform sinus of the subject, and the secondary segment extends from the primary segment into the trachea of ​​the subject. The compliant body, upon placement in an opening on the body and subsequent compression of the compliant body, may form a quaternary segment extending into a second piriform sinus of the subject. The quaternary segment may extend from the primary segment into a second piriform sinus of the subject, lifting the epiglottis of the subject and facilitating advancement of the secondary segment into the trachea.

[0031] In some embodiments, the at least one patency directly provides ventilation for the subject therethrough. Providing ventilation via the at least one patency can include advancing an endotracheal tube through the at least one patency and providing ventilation through the endotracheal tube.

[0032] In some embodiments, the compliant body is retracted from the trachea and bodily opening, such as by applying negative pressure to the compliant body.

[0033] Additional aspects and advantages of the present disclosure will be readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Thus, the drawings and description are to be regarded as illustrative in nature, and not as restrictive. [Brief description of the drawings]

[0034] 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 present disclosure are utilized, and the accompanying drawings (also referred to herein as "Figure" and "FIG"), as follows:

[0035] [Figure 1A] 1A-1C depict an embodiment of an intubation device of the present disclosure at progressive stages during an intubation procedure. [Figure 1B] 1A-1C depict an embodiment of an intubation device of the present disclosure at progressive stages during an intubation procedure. [Figure 1C] 1A-1C depict an embodiment of an intubation device of the present disclosure at progressive stages during an intubation procedure.

[0036] [Diagram 2] 2A-2B depict embodiments of the intubation device of the present disclosure having a single-wall or double-wall configuration.

[0037] [Diagram 3] 3A-3B depict embodiments of an intubation device of the present disclosure having either an internal or external cuff.

[0038] [Figure 4-1]4A-4D depict embodiments of an intubation device of the present disclosure having an expandable cuff, which is either a rigid or inflatable cuff. [Figure 4-2] 4A-4D depict embodiments of an intubation device of the present disclosure having an expandable cuff, which is either a rigid or inflatable cuff.

[0039] [Figure 5-1] 5A-5E depict embodiments of the presently disclosed intubation device having at least one patency supporting rigid element during incremental stages of deployment. [Figure 5-2] 5A-5E depict embodiments of the presently disclosed intubation device having at least one patency supporting rigid element during incremental stages of deployment. [Figure 5-3] 5A-5E depict embodiments of the presently disclosed intubation device having at least one patency supporting rigid element during incremental stages of deployment.

[0040] [Figure 6] FIG. 6 depicts an embodiment of an intubation device of the present disclosure having an elongated rigid element.

[0041] [Figure 7] 7A-7D depict an embodiment of an intubation device of the present disclosure having a mouthpiece, a containment compartment, a primary segment, a secondary segment, a cuff, a first access port, and a second access port in progressive stages of deployment.

[0042] [Figure 8-1] 8A-8D depict an embodiment of an intubation device of the present disclosure in which the compliant body of the intubation device has one or more sub-segments. [Figure 8-2] 8A-8D depict an embodiment of an intubation device of the present disclosure in which the compliant body of the intubation device has one or more sub-segments.

[0043] [Figure 9] FIG. 9 depicts an embodiment of an intubation device of the present disclosure in which the compliant body of the intubation device has one or more rigid elements to provide a non-circular cross-section.

[0044] [Figure 10] 10A-10B depict a device assisted intubation device having a rigid blade coupled to an intubation device of the present disclosure according to some embodiments.

[0045] [Figure 11-1] 11A-11E depict a device assisted intubation device having a shim coupled to an intubation device of the present disclosure according to some embodiments. [Figure 11-2] 11A-11E depict a device assisted intubation device having a shim coupled to an intubation device of the present disclosure according to some embodiments. [Figure 11-3] 11A-11E depict a device assisted intubation device having a shim coupled to an intubation device of the present disclosure according to some embodiments.

[0046] [Figure 12] FIG. 12 depicts a device assisted intubation device having a stylet coupled to an intubation device of the present disclosure according to some embodiments.

[0047] [Figure 13-1] 13A-13G depict a midline epiglottis stabilization device having a lifting element coupled to a compliant body of an intubation device according to some embodiments. [Figure 13-2] 13A-13G depict a midline epiglottis stabilization device having a lifting element coupled to a compliant body of an intubation device according to some embodiments. [Figure 13-3] 13A-13G depict a midline epiglottis stabilization device having a lifting element coupled to a compliant body of an intubation device according to some embodiments. [Figure 13-4] 13A-13G depict a midline epiglottis stabilization device having a lifting element coupled to a compliant body of an intubation device according to some embodiments.

[0048] [Figure 14] 14A-14C depict various embodiments of shims for an intubation device.

[0049] [Figure 15] 15A-15D depict an embodiment of an intubation device of the present disclosure in an incremental state during advancement of a compliant body behind a hollow shim.

[0050] [Figure 16] FIG. 16 depicts an embodiment of an intubation device of the present disclosure having a rigid support coupled to a solid flexible shim.

[0051] [Figure 17] FIG. 17 depicts an asymmetric piriform sinus-utilizing epiglottis stabilizing device having a tertiary segment configured to enter a first piriform sinus of a patient according to some embodiments.

[0052] [Figure 18] 18A-18B depict a symmetric piriform sinus-utilizing epiglottis stabilization device having a tertiary segment configured to enter a first piriform sinus of a patient and a quaternary segment configured to enter a second piriform sinus of a patient in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] The following detailed description makes reference to the accompanying drawings, which form a part of this specification. In the figures, similar symbols typically identify similar components unless the context indicates otherwise. The illustrative embodiments described in the detailed description, figures, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the scope of the subject matter presented herein. It will be readily understood that aspects of the present disclosure, generally as described herein and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are expressly contemplated herein.

[0054] Although certain embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, and modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple separate operations in sequence in a manner that may be helpful in understanding an embodiment, however, the order of description should not be construed to imply that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components.

[0055] For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other aspects or advantages as may be taught or suggested herein.

[0056] In general, the present disclosure provides devices and methods for intubating a patient. In some embodiments, the present disclosure provides an intubation device comprising a compliant body that can be placed in an opening on a patient's body and pressurized. In some embodiments, pressurization of the compliant body causes a primary segment of the compliant body to extend to the back of the laryngopharynx. In some embodiments, pressurization of the compliant body causes a secondary segment to extend from the primary segment into the patient's trachea. In some embodiments, pressurization of the compliant body forms at least one patency from the first segment to the second segment, providing a pathway from the opening on the patient's body to the trachea. The compliant body can serve as a pathway through which a semi-rigid breathing tube (e.g., an endotracheal tube) can be threaded to initiate artificial ventilation. The overall length of the compliant body can be pre-determined to match different physiologies, for example, depending on the size, age, or measured physical characteristics of the patient. In some embodiments, the compliant body is disposable, avoiding problems associated with cleaning and reusing medical devices, such as, for example, hospital-acquired infections.

[0057] An embodiment of an intubation device 100 is illustrated in Figures 1A-1C at various stages during an intubation procedure: Figure 1A shows intubation device 100 inserted into a patient's mouth.

[0058] In some embodiments, the intubation device 100 comprises a compliant body and is configured for at least partial placement in the patient's mouth. The compliant body may further comprise a primary segment 106 configured to extend to the back of the patient's larynx, as shown in FIG. 1B. The compliant body may further comprise a secondary segment 108 configured to extend from the primary segment 106 into the patient's trachea, as shown in FIG. 1C. In some embodiments, the secondary segment 108 is a bifurcated segment that is redirected forward to cause the secondary segment 108 to extend into the trachea. The compliant body may be formed from a biocompatible plastic. In some embodiments, the primary segment 106 and the secondary segment 108 are made from a polymeric material. In some embodiments, the polymeric material is a thin polymeric material. In some embodiments, at a given pressure, the compliant body has a lower resistance to eversion than to radial stretching, such that the compliant body will lengthen instead of bulge outward when pressurized. Generally, the diameter and length of both the primary segment 106 and the secondary segment 108 can be predetermined according to the physiology type or measured physical characteristics of the patient being intubated, e.g., age, sex, physical measurements of throat structures, etc. In practice, a practitioner can select an intubation device 100 that is appropriately sized based on the patient's physiology.

[0059] In some embodiments, the compliant body has at least one patency from the primary segment 106 to the secondary segment 108. The at least one patency is configured to provide a pathway from the patient's mouth to the trachea.

[0060] The intubation device 100 can be a single-walled device or a double-walled device. Figures 2A-2B depict the intubation device 100 of the present disclosure having a single-walled or double-walled configuration. In some embodiments, the intubation device 100 is a single-walled device, whereby there is no separation of fluids (e.g., air or gas). In some embodiments, the intubation device 100 is a double-walled device, where the compliant body comprises one or more walls 203 that define a first patency 201 and a second separate patency 202. In some embodiments, the first patency 201 and the second separate patency 202 provide separate chambers that separate the inflation fluid and the ventilation fluid. In some embodiments, separating the inflation fluid and the ventilation fluid allows the intubation device 100 to employ a higher pressure for inflation than would typically be used for ventilation, without exposing the patient's lungs to the higher pressure. In some embodiments, the first patency 201 allows for pressurization of the compliant body and formation of the primary segment 106 and the secondary segment 108. In some embodiments, the second separate patency 202 extends from the primary segment 106 into the secondary segment 108 and provides a pathway from the patient's mouth to the trachea. In some embodiments, the second separate patency 202 resides at least partially within the first patency 201. In some embodiments, the first patency 201 and the second separate patency 202 are at least partially coaxial.

[0061] In some embodiments, the intubation device 100 further comprises a cuff coupled to the secondary segment 108, the cuff configured to protect the second separate patency 202. In some embodiments, the cuff is positioned at a distal end of the secondary segment 108 (i.e., the end of the intubation device 100 furthest from the user). FIGS. 3A-3B depict embodiments of the presently disclosed intubation device 100 having either an internal or external cuff 301. In some embodiments, the cuff is an external cuff such that it is attached to a surface of the secondary segment 108. In some embodiments, the cuff is an internal cuff such that it is disposed within one or more walls 203 of the compliant body. In some embodiments, the cuff is an expandable element. In some embodiments, the cuff expands radially outward toward the tracheal wall to create a pressure seal (i.e., the expanded volume of the cuff is greater than the tracheal volume). In some embodiments, the cuff is fabricated from a biocompatible material to create an optimal seal with the surrounding tissue. 4A-4D depict an intubation device 100 of the present disclosure having an expandable cuff, either a rigid cuff 401 or an inflatable cuff 402. In some embodiments, the intubation device 100 comprises a rigid cuff 401. In some embodiments, the rigid cuff 401 is actuated by inflation of the secondary segments 108 via a pass-through connection at the cuff tip and a rigid connection at the cuff base, whereby eversion of the secondary segments 108 causes contraction of the rigid cuff 401 and radial outward expansion of the cuff body, urging the cuff tip and cuff base together, similar to an arterial stent. In some embodiments, the rigid cuff 401 comprises a locking mechanism for locking the rigid cuff 401 in the actuated state. In some embodiments, the locking mechanism is released by a release wire. In some embodiments, the release wire re-inverts the intubation device 100 until the device is removed from the patient.

[0062] In some embodiments, the cuff is inflatable. In some embodiments, the inflatable cuff 402 is inflated using the same pressure source as the primary segment 106 and the secondary segment 108. In some embodiments, the distal end of the secondary segment 108 is provided with a wider portion such that upon pressurization (i.e., inflation and eversion), the wider portion blocks the trachea. In a single-wall intubation device, positive end-expiratory pressure may be employed to ensure continued isolation from the esophagus. In a double-wall intubation device, the inflation fluid and the ventilation fluid are separated by one or more walls 203, whereby positive end-expiratory pressure is not required. In some embodiments, the inflatable cuff 402 is inflated using a pressure source independent of the pressure sources for the primary segment 106 and the secondary segment 108. In some embodiments, the inflatable cuff 402 is a pneumatic cuff attached to the distal end of the secondary segment 108. In some embodiments, the pneumatic cuff is inflated using a cuff inflation line similar to that of an endotracheal tube. In some embodiments, the pneumatic cuff is actuated by a soft valve fabricated into the intubation device 100. In some embodiments, the secondary segment 108 is reinforced to protect the patency of the at least one opening from the patient's mouth to the trachea (i.e., to prevent collapse of the at least one opening). In some embodiments, the secondary segment 108 is reinforced at the location of the cuff.

[0063] 5A-5E depict an embodiment of the intubation device 100 of the present disclosure having a rigid element 501 that supports at least one patency in incremental stages of deployment. In some embodiments, a portion of one or more walls 203 that define the second distinct patency 202 is supported by one or more rigid elements. In some embodiments, the one or more rigid elements comprise a plurality of discontinuous rigid elements. In some embodiments, the plurality of discontinuous rigid elements comprise an assembly of appropriately spaced small sections of tubing. In some embodiments, the one or more rigid elements comprise a spring. In some embodiments, a thin film of polymer or the like is wrapped or press-fitted around the spring. In some embodiments, the one or more rigid elements comprise at least one continuous elongated rigid element. FIG. 6 depicts an embodiment of the intubation device 100 of the present disclosure having an elongated rigid element 601. In some embodiments, the rigid element provides a better scaffold for deployment, whereby the rigid element sequences the expansion of the compliant body. In some embodiments, the elongated rigid element 601 allows for the passage of a rigid ventilation tube (such as an endotracheal tube) through at least one patency. In some embodiments, the rigid ventilation tube is attached to the distal end of the secondary segment 108, and the expansion acts as a pulling force as the secondary segment 108 everts, allowing for automatic delivery of the rigid ventilation tube. In some embodiments, a biocompatible self-hardening material is injected into the compliant body of the intubation device 100, which allows the intubation device 100 to harden inside the body, creating a rigid ventilation tube of its own.

[0064] In some embodiments, the intubation device 100 further comprises an introducer 104 removably coupled to the compliant body, whereby after deployment of the compliant body, the introducer 104 may be separated from the compliant body. In some embodiments, the introducer 104 comprises one or more of a first access port 116 or a second access port 118, where the first access port 116 is open to a first patency 201 in the compliant body and the second access port 118 is open to a second patency 202 in the compliant body. The one or more of the first access port 116 or the second access port 118 are configured to allow fluid / pressure transfer into the compliant body of the intubation device 100 to evert and expand the compliant body. In some embodiments, the first patency 201 and the second patency 202 may be pressurized by different pressure flows or devices. In some embodiments, the second patency 202 is configured to provide ventilation to the patient through a pathway created therethrough. In some embodiments, the introducer 104 includes a passageway through which a semi-rigid breathing tube may be passed down through the second separate patency 202 to the trachea. Coupling to the introducer 104 for inflation is compatible with existing medical technology, e.g., a luer lock.

[0065] 7A-7D depict an embodiment of the intubation device 100 of the present disclosure having a mouthpiece, a storage compartment 701, a primary segment 106, a secondary segment 108, a cuff, a first access port 116, and a second access port 118 in progressive stages of deployment. In some embodiments, the introducer 104 is a mouthpiece. In some embodiments, the mouthpiece is formed from a biocompatible plastic or hard rubber compound. In some embodiments, the mouthpiece has the general anatomy of the human face and mouth. In some embodiments, the mouthpiece is employed either externally or internally to the patient's mouth. The mouthpiece may further include a protrusion for depressing the tongue and a bite block, which may be removably coupled to the mouthpiece such that the mouthpiece may be removed upon deployment of the compliant body. In some embodiments, the bite block comprises a hollow body, as shown in FIG. 7A-7D, to allow passage of the compliant body therethrough. The hollow bite block allows the compliant body to be stored from the front to the back. In some embodiments, the bite block has a recess into which teeth can fit to hold the intubation device 100 inside the mouth, and the recess can set a standard "zero" point reference from which the extension of the intubation device 100 can be determined. In some embodiments, the bite block is flattened so that when the compliant body is deployed, the bite block is placed between the patient's molars to protect the compliant body from twisting due to biting. Preferred materials for the mouthpiece include medical grade silicone, polyurethane, or polyethylene. The mouthpiece can be sized according to anatomical characteristics. The mouthpiece can house mechanical components (e.g., buttons) that allow actuation and indicators to show if it is being used. In some embodiments, the mouthpiece can connect to and / or include a pressure reservoir, an actuation mechanism to initiate intubation, and mechanical and electrical elements to actuate and control the intubation device 100.

[0066] In some embodiments, the intubation device 100 further comprises a storage compartment 701 coupled to the compliant body and configured to house the compliant body prior to being pressurized. In some embodiments, the compliant body extends at least partially out of the storage compartment 701 in response to pressurization. In some embodiments, the introducer 104 is coupled to the storage compartment 701. In some embodiments, the storage compartment 701 comprises an access port that allows pressurization of the compliant body. In some embodiments, the storage compartment 701 may be transparent, allowing a user to visualize when the reinforced segments are fully deployed.

[0067] In some embodiments, the cross-sectional area of ​​the primary segment 106 is such that when pressurized, the primary segment 106 fills the oral cavity and oropharynx, lifts the mandible, and protrudes it forward and downward. A fluid (e.g., air or gas) is delivered through the first access port 116 with sufficient pressure to inflate and invert the primary segment 106 at a slow rate until it reaches the back of the laryngopharynx. Once the primary segment 106 reaches the laryngopharynx, the secondary segment 108 can be actuated or pressurized. The primary segment 106 can be shaped into a pre-determined non-linear shape (when extended) and have additional features to introduce specific pressure points to protrude the mandible, lift the epiglottis, and expose the trachea. Methods for shaping materials and creating stiffness in specific sections can be found in U.S. Patent Publication No. US2019 / 0217908 by Hawkes et al., incorporated herein by reference.

[0068] 8A-8D depict a compliant body of intubation device 100 having one or more subsegments. In some embodiments, intubation device 100 may include one or more subsegments configured to provide a non-circular cross-section to the compliant body or to center primary segment 106 relative to the patient's anatomy. In some embodiments, the non-circular cross-section is flattened. In some embodiments, primary segment 106 includes first subsegment 801 and one or more lateral subsegments 802 configured to provide a non-circular cross-section in combination with first subsegment 801, as shown in FIGS. 8A-8B. In some embodiments, the one or more subsegments provide a non-circular cross-section and are configured to prevent wrinkling, rotation, and yaw of primary segment 106. In some embodiments, primary segment 106 includes first subsegment 801 and one or more lateral subsegments 802 configured to center primary segment 106, as shown in FIGS. 8C-8D. In some embodiments, the one or more subsegments configured to center the primary segment 106 have a cross-sectional width greater than the width of the patient's anatomy, such that upon pressurization, the primary segment 106 distributes the volume of fluid (i.e., air or gas) between the one or more subsegments (i.e., centered relative to the patient's anatomy) to achieve the lowest energy. In some embodiments, one or more side subsegments 802 are partially closed to fluid communication with the main subsegment 801. In some embodiments, the one or more subsegments may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more subsegments, however many may be required to achieve the desired effect.

[0069] FIG. 9 depicts a compliant body of intubation device 100 having one or more rigid elements 901 to provide a non-circular cross-section. In some embodiments, intubation device 100 may include one or more rigid elements 901 coupled to a portion of one or more walls 203 in primary segment 106 to provide a non-circular cross-section. In some embodiments, the one or more rigid elements are configured to provide a non-circular cross-section and prevent wrinkling and rotation of primary segment 106. As shown in FIG. 9, the one or more rigid elements enable primary segment 106 to have a wide and flat cross-section. In some embodiments, the one or more rigid elements may be symmetrically positioned, whereby one or more rigid elements are positioned oppositely on one or more walls 203 of primary segment 106. In some embodiments, the one or more rigid elements may be asymmetric. In some embodiments, the one or more rigid elements 901 enable inversion and eversion of the compliant body.

[0070] In some embodiments, the intubation device 100 extends beyond the vestibular folds to the trachea. In some embodiments, the distal end of the compliant body 102 terminates with at least one patency or with a temporarily sealed distal tip that can be broken or pierced, such that after pressurization (i.e., eversion) of the compliant body 102, the compliant body 102 provides at least one patency configured to provide a pathway from the patient's mouth to the trachea. In some embodiments, the distal tip comprises a perforated seal. In some embodiments, the distal tip is elastic. In some embodiments, the perforated or elastic distal tip can be broken using a breathing tube. In some embodiments, the perforated or elastic distal tip provides feedback to the practitioner when the breathing tube breaks the distal tip of the compliant body 102.

[0071] In some embodiments, the intubation device 100 is intended to be introduced through a nasal opening. In some embodiments, the intubation device 100 is introduced through either or both of the nostrils. In some embodiments, the introducer 104 directs the primary segment 106 inferiorly between the hard palate and the inferior turbinate. In some embodiments, the primary segment 106 includes a shifting element. In some embodiments, the primary segment 106 includes a shifting element to elevate the epiglottis and allow expansion of the primary segment 106 into the pharynx and access the trachea therethrough. In some embodiments, the primary body 106 has a predetermined shape configured to position the secondary segment 108 and direct the secondary segment 108 toward the trachea.

[0072] In some embodiments, the compliant body of intubation device 100 is inverted from the distal tip to proximal (i.e., the end of intubation device 100 closest to the user) and stored within a storage compartment 701 of intubation device 100. In some embodiments, intubation device 100 is sterilized and packaged for single use, and the packaging bag and device may include markings to ensure proper use by the practitioner.

[0073] In some embodiments, the intubation device is a device-assisted intubation device that requires the healthcare provider to manipulate the tissue of the airway to allow passage of the intubation device. For example, a conventional laryngoscope coupled to the intubation device can be used to lift the epiglottis, allowing passage of the intubation device. In some embodiments, the intubation device is a mid-epiglottis stabilization device that autonomously manipulates the tissue of the airway to allow passage of the intubation device. In some embodiments, the intubation device is a piriform fossa-based epiglottis stabilization device that takes advantage of the fact that the human body retains a natural opening in the airway, even when the body is sedated or in a supine position. For example, the piriform fossa is a natural opening through which air can pass, but the surrounding tissue would otherwise be collapsed on the pharyngeal wall. The piriform fossa-based epiglottis stabilization device is designed to pass around the tissue of the airway, such as the epiglottis.

[0074] (Device-assisted intubation device) The intubation device of the present disclosure may be a device-assisted intubation device. In some embodiments, the device-assisted intubation device requires manual manipulation of the tissue of the airway to allow passage of the intubation device. In some embodiments, the device-assisted intubation device is an epiglottis lifting device. FIGS. 10A-10B depict a device-assisted intubation device comprising a rigid blade 1001 coupled to an intubation device 100. In some embodiments, the intubation device 100 is attached to the superior side of a rigid blade 1001, such as a laryngoscope blade designed to lift the soft palate from the epiglottic vallecula, as in traditional laryngoscopy. After using the rigid blade 1001 to manipulate the airway tissue, the healthcare provider can pressurize the compliant body 102 of the intubation device 100, causing the compliant body 102 to extend behind the rigid blade 1001 past the epiglottis. In some embodiments, the compliant body 102 further comprises an endotracheal tube (not shown) configured to extend from the compliant body 102 upon pressurization of the compliant body 102. In some embodiments, the intubation device 100 is detached from the rigid blade 1001, allowing the rigid blade 1001 to be removed.

[0075] In some embodiments, the device-assisted intubation device is an epiglottis shimming device. In some embodiments, the flexible shim has a high aspect ratio. In some embodiments, the flexible shim has an aspect ratio of 10:1 or higher. In some embodiments, the flexible shim has low stiffness. In some embodiments, the flexible shim is a low friction element that allows the shim to be manipulated without encountering significant resistance from surrounding tissue. In some embodiments, the flexible shim is attached to the superior side of a rigid blade, such as a laryngoscope blade, and the flexible shim is manually advanced into the hypopharynx. FIGS. 11A-11E depict a shim coupled to an intubation device 100. In some embodiments, the shim is a solid flexible shim 1101, as shown in FIGS. 11A-11B. In some embodiments, the shim is an encased extruded metal wire or hollow shim 1102, as shown in FIGS. 11C-11E. In some embodiments, the hollow shim 1102 reduces friction and allows the secondary segment 108 of the compliant body 102 to expand within the hollow section of the hollow shim 1102, increasing reliability across the anatomy.

[0076] In some embodiments, the hollow shim 1102 or the solid flexible shim 1101 slides behind the epiglottis. Once past the epiglottis, the intubation device 100 attached to the superior side of the hollow shim 1102 or the solid flexible shim 1101 is pressurized, causing the compliant body to extend behind the solid flexible shim 1101, thereby passing through the epiglottis without eversion (or lifting). FIG. 11E depicts the compliant body of the intubation device 100 deployed behind the hollow shim 1102. In some embodiments, the compliant body further comprises an endotracheal tube (not shown) configured to extend from the compliant body upon pressurization of the compliant body. In some embodiments, the intubation device 100 is detached from the solid flexible shim 1101 or hollow shim 1102, allowing the solid flexible shim 1101 or hollow shim 1102 to be removed.

[0077] Another embodiment of a device-assisted intubation device includes a stylet 1201 having an attached intubation device 100, as shown in FIG. 12. In some embodiments, the semi-rigid stylet 1201 is advanced near the laryngeal inlet to stabilize the epiglottis. After the epiglottis stabilizes, the compliant body 102 is pressurized. In some embodiments, the compliant body 102 further comprises an endotracheal tube (not shown) configured to extend from the compliant body 102 upon pressurization of the compliant body 102.

[0078] The device-assisted intubation device may further include any of the features of any embodiment of the present disclosure, for example, device-assisted intubation device embodiments may be combined with mid-epiglottis stabilization devices and piriform sinus-assisted epiglottis stabilization device embodiments.

[0079] (mid-epiglottis stabilization device) The intubation device of the present disclosure may be a midline epiglottis stabilizing intubation device. In some embodiments, the midline epiglottis stabilizing device autonomously manipulates tissue of the airway to allow passage of the intubation device. In some embodiments, the midline epiglottis stabilizing device is an epiglottis lifting device. In some embodiments, the intubation device 100 further comprises at least one shifting element configured to manipulate (e.g., shift, lift, compress, redirect) a portion of the patient's anatomy. In some embodiments, the intubation device 100 further comprises at least one shifting element configured to shift the patient's epiglottis and facilitate advancement of the secondary segment 108 into the trachea. In some embodiments, the intubation device 100 further comprises at least one shifting element configured to shift the tongue to allow advancement of the primary segment 106. In some embodiments, the at least one shifting element is attached to a lateral side of the primary segment 106. In some embodiments, the at least one shifting element comprises at least one lifting element configured to extend laterally from the primary segment 106 as the primary segment 106 is pressurized. In some embodiments, at least one lifting element is configured to extend laterally from an anterior or superior side of the primary segment 106 .

[0080] 13A-13G depict the intubation device 100 with at least one lifting element. In some embodiments, the at least one lifting element is attached to the sagittal plane of the intubation device 100. In some embodiments, the at least one lifting element is configured to lift the soft palate and epiglottis from the pharyngeal wall, allowing expansion of the primary segment 106 and the secondary segment 108. In some embodiments, the at least one lifting element comprises one or more semi-rigid scales 1301 protruding from a surface of the primary segment 106, as shown in FIG. 13A-13D. In some embodiments, the semi-rigid scales 1301 may be continuously attached to the primary segment 106, as shown in FIG. 13D. In some embodiments, the semi-rigid scales 1301 may be joined together, as shown in FIG. 13A-13B. In some embodiments, the semi-rigid scales 1301 skim the surrounding tissue. In some embodiments, the semi-rigid scales 1301 burrow under the surrounding tissue. In some embodiments, the semi-rigid scales 1301 may deploy sequentially such that the leading semi-ridge scales grip the surrounding tissue before everting and reversing slightly. In some embodiments, at least one lifting element comprises an expandable member 1302 in fluid communication with the primary segment 106, as shown in Figs. 13E-13F. In some embodiments, the expandable member 1302 deploys and expands at low pressure. In some embodiments, the expandable member 1302 is any shape required to achieve the desired effect, i.e., to lift a portion of the patient's anatomy. Figs. 13E-13G show the expandable member 1302 having a "pillow", "wedge", and "pyramid" shape, respectively. In some embodiments, the expandable member 1302 is configured to lift the patient's tongue and allow passage of the primary segment to expand behind the expandable member 1302. In some embodiments, the expandable member 1302 may be an origami-like structure that comprises one or more features that deploy and expand sequentially.In some embodiments, the expandable member 1302 may be inverted within the primary segment 106 prior to deployment and inflation, such that when pressurized, the expandable member 1302 everts to create the desired effect.

[0081] In some embodiments, when the compliant body is pressurized, the at least one lifting element is deployed to the oropharynx just proximal to the vallecula. As pressure is applied, the at least one lifting element expands but the extension of the primary segment 106 stops, lifting tissue from the pharyngeal wall and exposing an overview of the hypopharynx. When the at least one lifting element is fully expanded, the primary segment 106 continues to extend through the opening created by the at least one lifting duct.

[0082] In some embodiments, the mid-epiglottis stabilization device is an epiglottis shimming device. In some embodiments, the at least one shifting element comprises a flexible shim configured to slide behind the epiglottis upon advancement into the laryngopharynx. In some embodiments, the shim has a high aspect ratio. In some embodiments, the shim has an aspect ratio of 10:1 or higher. In some embodiments, the shim has low stiffness. In some embodiments, the shim is a low friction element that allows the shim to be manipulated without encountering significant resistance from surrounding tissue. FIGS. 14A-14C depict various embodiments of the shim. In some embodiments, the shim is a solid flexible shim 1101. In some embodiments, the shim is an encased extruded metal wire or hollow shim 1102. In some embodiments, the hollow shim 1102 reduces friction and allows the compliant body secondary segment 108 to expand within the hollow section of the hollow shim 1102, increasing reliability across the anatomy. In some embodiments, the solid flexible shim 1101 or hollow shim 1102 is attached to a compliant body, more specifically to the primary segment 106, such that the solid flexible shim 1101 or hollow shim 1102 is advanced (i.e., extended) in response to pressurization of the compliant body. In some embodiments, the solid flexible shim 1101 or hollow shim 1102 slides behind the epiglottis. Once past the epiglottis, the intubation device 100 coupled to the solid flexible shim 1101 or hollow shim 1102 is pressurized, causing the compliant body to extend behind the solid flexible shim 1101 or hollow shim 1102, thereby passing through the epiglottis without eversion (or lifting). 15A-15D depict embodiments of the presently disclosed intubation device in a progressive state during advancement of the compliant body behind the hollow shim 1102. In some embodiments, the introducer 104 datums away from the pharyngeal wall, thereby fixing the angle 104 of the introducer 104 relative to the posterior wall of the pharynx. Upon compression of the compliant body, the hollow shim 1102 advances forward.The application of pressure causes the compliant body to expand behind the hollow shim 1102 .

[0083] In some embodiments, the flexible shim 1101 or hollow shim 1102 is reinforced to provide rotational control of the intubation device 100. In some embodiments, the intubation device includes a rigid vertebra running the length of the compliant body and coupled to the shim to provide orientation control of the flexible shim 1101 or hollow shim 1102 as the compliant body is expanded. Figure 16 depicts an embodiment of an intubation device of the present disclosure having a rigid vertebra 1601 coupled to the flexible shim 1101.

[0084] The midline epiglottis stabilization device may further include any of the features of any embodiment of the present disclosure, for example, an embodiment of a device-assisted intubation device may be combined with an embodiment of a device-assisted intubation device and an embodiment of a piriform sinus-utilizing epiglottis stabilization device.

[0085] (Epiglottis stabilization device utilizing the pyriform sinus) The intubation device of the present disclosure may be a piriform fossa-based epiglottis stabilizing device. In some embodiments, the piriform fossa-based epiglottis stabilizing device is an autonomous device. In some embodiments, the piriform fossa-based epiglottis stabilizing device is an asymmetric device, whereby the compliant body, upon placement in the mouth and subsequent application of pressure on the compliant body, forms a tertiary segment configured to extend into the first piriform sinus (pyriform sinus) of the patient to facilitate advancement of the second segment 108 into the trachea. In some embodiments, the asymmetric piriform fossa-based epiglottis stabilizing device is counterbalanced to one side of the patient's anatomy and configured to allow the primary segment 106 and the secondary segment 108 to expand inwardly toward the epiglottis and trachea. In some embodiments, the introducer or storage compartment 701 exhibits a piriform orientation to allow for consistent performance of the intubation device 100.

[0086] 17 depicts an asymmetric piriform sinus-utilizing epiglottis stabilizing device having a tertiary segment 1701 configured to enter a first piriform sinus of a patient. In some embodiments, the tertiary segment 1701 is configured to extend from the primary segment 106 into the first piriform sinus of a patient to elevate the base of the patient's epiglottis and facilitate advancement of the secondary segment 108 into the trachea. In some embodiments, the tertiary segment 1701 redirects the compliant body to allow the primary segment 106 to pass under the epiglottis. In some embodiments, the tertiary segment 1701 is configured to extend from the primary segment 106 into the first piriform sinus of a patient and the secondary segment 108 is configured to extend from the primary segment 106 into the trachea of ​​a patient.

[0087] In some embodiments, the piriform fossa-utilized epiglottis stabilization device is a symmetrical stabilization device, whereby the compliant body is configured to form, upon placement in the mouth and subsequent application of pressure on the compliant body, a tertiary segment configured to extend from the primary segment 106 into a first piriform sinus (pyriform sinus) of the patient and a quaternary segment configured to extend from the primary segment 106 into a second piriform sinus of the patient. FIGS. 18A-18B depict a symmetrical piriform fossa-utilized epiglottis stabilization device having a tertiary segment 1701 configured to enter a first piriform sinus of the patient and a quaternary segment 1801 configured to enter a second piriform sinus of the patient. In some embodiments, the tertiary segment 1701 is configured to extend from the primary segment 106. In some embodiments, the quaternary segment 1801 is configured to extend from the primary segment 106. In some embodiments, the tertiary segment 1701 and the quaternary segment 1801 are elevated at the base of the patient's epiglottis to facilitate advancement of the secondary segment 108 into the trachea.

[0088] In some embodiments, the cross-sectional area of ​​the tertiary segment 1701 and the quaternary segment 1801 is less than the cross-sectional area of ​​the primary segment 106. In general, the diameter and length of both the tertiary segment 1701 and the quaternary segment 1801 can be predetermined according to the physiology type or measured physical characteristics of the patient being intubated, e.g., age, sex, physical measurements of throat structures, etc. In practice, a practitioner can select an intubation device 100 that is appropriately sized based on the patient's physiology.

[0089] The piriform fossa-enabled epiglottis stabilization device may further include any of the features of any of the embodiments of the present disclosure, for example, embodiments of the piriform fossa-enabled epiglottis stabilization device may be combined with embodiments of the midline epiglottis stabilization device and the device-assisted intubation device.

[0090] (How to use) In some embodiments, the present disclosure provides a method of intubating a patient and placing a compliant body into an opening on the patient's body (e.g., as shown in FIG. 1A). In some embodiments, the method further includes pressurizing the compliant body through one or more of its patencies such that a primary segment 106 of the compliant body abducts and extends into the dorsal larynx of the patient (e.g., as shown in FIG. 1B) and a secondary segment 108 of the compliant body then abducts and extends from the primary segment 106 into the patient's trachea (e.g., as shown in FIG. 1C). In some embodiments, the method further includes providing ventilation from the opening on the body to the trachea via the pressurized compliant body.

[0091] In some embodiments, the at least one patency comprises a first patency 201 and a separate second patency 202, the compliant body comprises one or more walls 203 that define the first and second patencies 202, pressurization through the first patency 201 defines the primary segment 106 and the secondary segment 108, and the second patency 202 provides ventilation. In some embodiments, the second patency 202 provides ventilation for the patient directly therethrough.

[0092] In some embodiments, the step of providing ventilation via the separate second patency 202 includes advancing an endotracheal tube through the second patency 202 and providing ventilation through the endotracheal tube. In some embodiments, the first and second patencies 202 are configured to be pressurized by different pressurized flows.

[0093] In some embodiments, the method further includes maintaining patency of the second segment 108 with a cuff coupled to a distal portion of the secondary segment 108. In some embodiments, the cuff is at least partially rigid. In some embodiments, the cuff includes expanding the cuff. In some embodiments, expanding the cuff includes inflating the cuff. In some embodiments, the cuff is inflated with a pressure source that is independent of separate pressure sources for the primary segment 106 and the secondary segment 108.

[0094] In some embodiments, the method further includes orienting the primary segment 106 in a preferred orientation relative to the trachea as the primary segment 106 is pressurized. In some embodiments, orienting the primary segment 106 includes pressurizing a lateral sub-segment 802 of the primary segment 106 extending laterally from the first sub-segment 801.

[0095] In some embodiments, the method further includes shifting the epiglottis to facilitate extension of the secondary segment 108 into the trachea. In some embodiments, shifting the epiglottis includes extending at least one lifting element laterally from the primary segment 106 as the primary segment 106 is pressurized. In some embodiments, shifting the epiglottis includes inflating the at least one lifting element as the primary segment 106 is pressurized. In some embodiments, shifting the epiglottis includes extending a flexible shim 1101 from the primary segment 106 in response to pressurization such that the flexible shim 1101 slides posteriorly of the epiglottis.

[0096] In some embodiments, pressurizing the compliant body through its at least one patency extends the tertiary segment 1701 of the compliant body into at least one piriform sinus of the patient. In some embodiments, the tertiary segment 1701 extends from the primary segment 106 into a first piriform sinus of the patient to elevate the epiglottis of the patient and facilitate advancement of the secondary segment 108 into the trachea. In some embodiments, the tertiary segment 1701 extends from the primary segment 106 into a first piriform sinus of the patient and the secondary segment 108 extends from the primary segment 106 into the trachea of ​​the patient.

[0097] In some embodiments, the compliant body forms a quaternary segment 1801 that extends into the second piriform sinus of the patient upon placement in the bodily opening and subsequent application of pressure on the compliant body. In some embodiments, the quaternary segment 1801 extends from the primary segment 106 into the second piriform sinus to elevate the patient's epiglottis and facilitate advancement of the secondary segment 108 into the trachea.

[0098] In some embodiments, at least one patency provides ventilation for the patient directly therethrough.

[0099] In some embodiments, the step of providing ventilation via the at least one patency includes advancing an endotracheal tube through the at least one patency and providing ventilation through the endotracheal tube.

[0100] In some embodiments, the method further comprises retracting the compliant body from the trachea and the bodily opening, hi some embodiments, retracting the compliant body comprises applying a negative pressure to the compliant body.

[0101] In some embodiments, the bodily orifice is the patient's mouth, hi some embodiments, the bodily orifice is the patient's nostril.

[0102] While the above steps describe a method of intubating a patient according to many embodiments, one of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps may be completed in different orders. Steps may be added or omitted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as is beneficial or advantageous. ***

[0103] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will be apparent to those skilled in the art without departing from the scope of the present disclosure. It is understood that various alternatives to the embodiments of the present disclosure described herein may be adopted without departing from the scope of the present invention. Thus, the scope of the present invention is to be defined solely by the appended claims and the scope of equivalents thereof.

Claims

1. 1. A device for intubation of a subject, the device comprising a compliant body, the compliant body, upon placement into an opening on a body of a subject and subsequent application of pressure to the compliant body, (i) a primary segment configured to extend to a posterior surface of the subject's laryngopharynx; (ii) a secondary segment configured to extend from the first segment into the trachea of ​​the subject; (iii) at least one patency from the first segment to the second segment; configured to form The at least one patency provides a pathway from an opening on the subject's body to the trachea of ​​the subject.

2. the compliant body comprises one or more walls defining a first patency and a second patency; 10. The device of claim 1, wherein the first patency allows compression of the compliant body to form the primary and secondary segments, and the second patency extends from the primary segment into the secondary segment to provide the pathway from an opening on the body of the subject to the trachea of ​​the subject.

3. The device of claim 2 , wherein the first and second patencies are configured to be pressurized by different pressurized flows.

4. 3. The device of claim 2, further comprising an introducer coupled to the compliant body and configured for at least partial placement into an opening on the body of the subject, the introducer comprising one or more of a first access port or a second access port, the first access port being open to the first patency and the second access port being open to the second patency.

5. The device of claim 2 , wherein the second patency is configured to directly provide ventilation for the subject through the pathway provided therefrom.

6. The device of claim 2 , wherein the second patency is disposed at least partially within the first patency.

7. The device of claim 2 , wherein the first and second patencies are at least partially coaxial.

8. The device of claim 1 , further comprising a cuff coupled to the secondary segment and configured to protect the patency of the at least one segment.

9. The device of claim 8 , wherein the cuff is coupled to a distal portion of the secondary segment.

10. 10. The device of claim 1, further comprising an introducer coupled to the compliant body and storage compartment, the introducer configured for at least partial placement and fixation within an opening on the body of the subject.

11. The device of claim 1 , wherein the primary segment comprises a first subsegment and one or more lateral subsegments, the one or more lateral subsegments being partially closed to fluid communication with the primary subsegment.

12. 10. The device of claim 1, wherein the primary segment has a non-circular cross-section such that the primary segment orients in a preferred direction relative to the trachea as the primary segment is pressurized.

13. 10. The device of claim 1, further comprising at least one shifting element configured to shift surrounding tissue of the subject to facilitate advancement of the secondary segment into the trachea.

14. 10. The device of claim 1, further comprising at least one shifting element configured to shift the subject's epiglottis and facilitate advancement of the secondary segment into the trachea.

15. 15. The device of claim 14, wherein the at least one shifting element comprises a flexible shim configured to slide posterior to the epiglottis upon advancement into the laryngopharynx.

16. The device of claim 1 , wherein the bodily opening is the subject's mouth.

17. The device of claim 1 , wherein one or more of the primary or secondary segments are configured to evertate in response to the application of pressure.

18. The device of claim 1 , wherein the secondary segment has a smaller cross-sectional area than the primary segment.

19. The device of claim 1 , wherein the primary segment has a predetermined shape configured to position the secondary segment and orient the secondary segment toward the trachea.

20. The device of claim 1 , wherein the primary and secondary segments are integrally formed.

21. A device according to any preceding claim, wherein at least a portion of the compliant body is supported by one or more rigid elements.

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