Supraglottic airway support devices

Abstract

Supraglottic airway support devices are provided. Aspects of the present invention include supraglottic airway support devices comprising a support substrate configured to interface with a subject's head and a supraglottic airway interface integrated with the support substrate and configured to hold a supraglottic airway in a fixed position relative to the subject's head. Also provided are methods of stabilizing an artificial airway in a subject.

Description

[0001] SUPRAGLOTTIC AIRWAY SUPPORT DEVICES

[0002] CROSS-REFERENCE TO RELATED APPLICATION

[0003] This application claims the benefit of United States Provisional Patent Application Serial No. 63 / 715,887, filed November 4, 2025, the disclosure of which is incorporated herein by reference in its entirety.

[0004] INTRODUCTION

[0005] Supraglottic airways (SGAs) are ventilation devices used in patients under general anesthesia, who are not at risk of aspiration. They are blindly inserted deep in the patient’s throat and lie above the vocal cords. In comparison to endotracheal tubes (ETTs), the other most common ventilation device used for general anesthesia cases, SGAs have the advantage of being less invasive, faster to place and remove, require fewer drugs to place and cause less hemodynamic changes to the patient. SGAs, however, are more easily displaced as compared to ETTs. Current methods to secure SGAs (e.g., using tape to secure the SGA to the patient’s face) do not allow the SGA to be secured tightly and safely enough to allow a patient to be placed in a prone position. Hence, SGAs are avoided in general anesthesia cases where it would not be possible to readjust the SGA if displaced mid-case, such as if the patient is in a prone, lateral, or sitting position or if the patient’s head is rotated away from the anesthesiologist.

[0006] SUMMARY

[0007] Supraglottic airway (SGA) support devices are provided herein. SGA support devices provide a safe and efficient way to secure a supraglottic airway (SGA) in position after anesthesia induction, such that it remains firmly in place. The ability to hold an SGA in a fixed position relative to the subject’s head will allow for considerable increase in the use of SGAs in general anesthesia cases, since there are many general anesthesia cases in prone, lateral or sitting positions currently being done with endotracheal tubes (ETTs) that can potentially be done with SGAs.

[0008] An ETT (see, e.g., ETT 199 in FIG. 1A) is a tube with a cuffed balloon that is placed between the vocal cords and the trachea to supply oxygen and inhaled anesthetic agents to the lungs. To place the ETT in the correct position (see, e.g., FIG. 1 B), the vocal cords of the patient 102 must be visualized clearly. This is done by means of laryngoscopy, a procedure in which a blade is inserted deep in the throat of the patient to expose the larynx and allow placement of the ETT through the vocal cords under visualization. Patients are paralyzed prior to the placement of the ETT to prevent the vocal cords from spasming and contracting as the ETT passes through them. As laryngoscopy is a stimulating and painful procedure, most patients receive an IV analgesic in preparation for laryngoscopy. ETTs provide a secure airway because once in position, the cuffed balloon in the trachea below the vocal cords helps to hold the ETT tightly in position, with less likelihood of displacement. Accordingly, general anesthesia procedures performed in non-supine patient positions such as prone, lateral, or sitting or where the patient’s head is turned away from the anesthesiologist, are usually done using an ETT because ETTs are less likely to be displaced upon going from supine to final position (e.g., prone, lateral, or sitting position), making it a safer option.

[0009] However, there are a wide variety of prone, lateral or sitting surgical cases, which, besides the limitation of prone, lateral or sitting positioning, are ideal for SGA. These are generally short elective surgical cases that do not require paralysis (or paralysis may even be contraindicated) for prolonged periods and most importantly are being performed on patients that do not have aspiration risk factors. In contrast to an ETT, an SGA is a tube connected to an elliptically-shaped mask with a cuff that can be inflated (see, e.g., SGA 212 in FIG. 2A). SGAs rest above the vocal cords in the hypopharynx of the patient 202 and seal the glottic opening to allow ventilation (see, e.g., FIG. 2B). SGAs are blindly placed deep in the throat, without laryngoscopy. Accordingly, SGAs do not require a paralytic. In fact, paralytic agents are usually avoided to allow spontaneous breathing, which is safer in SGA cases since it minimizes the theoretical risk of aspiration associated with positive pressure ventilation in an unprotected airway. However, a change in patient position can cause the SGA to be displaced, resulting in a gas leak and poor ventilation. To prevent SGA displacement, current practice generally only uses SGAs in cases where the patient will remain supine or will require minimal position change post induction of anesthesia.

[0010] The SGA support devices of the present invention allow the SGA to be tightly secured to the patient’s face and minimize the chances of displacement upon position change, all the time ensuring facial protection thereby allowing SGAs to be used in cases with significant position changes post induction of anesthesia, such as prone, lateral, or sitting patient general anesthesia cases. Advantages of using SGAs include increased patient safety (e.g., less invasive, less hemodynamic instability, fewer drug side effects), time savings (e.g., shorter operating room times and recovery times) and significant cost savings (e.g., fewer drugs used, shorter time spent in the operating room and in recovery).

[0011] Supraglottic airway support devices are provided. Aspects of the present invention include supraglottic airway support devices comprising a support substrate configured to interface with a subject’s head and a supraglottic airway interface integrated with the support substrate and configured to hold a supraglottic airway in a fixed position relative to the subject’s head. Also provided are methods of stabilizing an artificial airway in a subject.

[0012] BRIEF DESCRIPTION OF THE FIGURES

[0013] The invention may be best understood from the following detailed description when read in conjunction with the accompanying drawings. Included in the drawings are the following figures:

[0014] FIGS. 1A-1 B depict an example of an endotracheal tube (ETT) (FIG. 1 A) and the position of the ETT when it is inserted into the subject’s airway (FIG. 1 B). FIGS. 2A-2B depict an example of a supraglottic airway (SGA) (FIG. 2A) and the position of the SGA when it is inserted into the subject’s airway (FIG. 2B).

[0015] FIGS. 3A-3D depict a supraglottic airway support device according to some embodiments of the disclosure. The device comprises two extension arms that pivot relative to the rail. A front view (FIG. 3A), side view (FIG. 3B), close-up view (FIG. 3C) and close-up side view (FIG. 3D) of the supraglottic airway support device are depicted.

[0016] FIGS. 4A-4D depict a supraglottic airway support device according to some embodiments of the disclosure. The device comprises two extension arms that slide along a rail. A front view (FIG. 4A), side view (FIG. 4B), close-up view (FIG. 4C) and close-up side view (FIG. 4D) of the supraglottic airway support device are depicted.

[0017] FIGS. 5A-5E depict a supraglottic airway support device according to some embodiments of the disclosure. FIGS. 5A-5C show an embodiment of the device that includes a chin support and FIGS. 5D and 5E show an embodiment of the device that does not include a chin support. A front view (FIG. 5A), closeup views (FIGS. 5B and 5C), front view (FIG. 5D) and close-up side view (FIG. 5E) of the supraglottic airway support device are depicted.

[0018] FIGS. 6A-6F depict a supraglottic airway support device according to some embodiments of the disclosure. FIG. 6A shows an embodiment of the device that includes a chin support and chin pad. FIGS. 6B-6D show an embodiment of the device that includes a chin pad, and FIGS. 6E-6F show an embodiment of the device that does not include a chin pad. A front view of the device on a subject (FIG. 6A), front views of the device alone (FIGS. 6B and 6E), side views of the device alone (FIGS. 6C and 6F) and a back view of the device (FIG. 6D) are depicted.

[0019] FIG. 7 depicts a subject in a prone position. DETAILED DESCRIPTION

[0020] Supraglottic airway support devices are provided. Aspects of the present invention include supraglottic airway support devices comprising a support substrate configured to interface with a subject’s head and a supraglottic airway interface integrated with the support substrate and configured to hold a supraglottic airway in a fixed position relative to the subject’s head. Also provided are methods of stabilizing an artificial airway in a subject.

[0021] Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0022] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0023] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.

[0024] All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0025] It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0026] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

[0027] While the system and method may be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 U.S.C. § 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 U.S.C. § 112 are to be accorded full statutory equivalents under 35 U.S.C. § 1 12.

[0028] SUPRAGLOTTIC AIRWAY SUPPORT DEVICES

[0029] As discussed above, aspects of the present disclosure include supraglottic airway support devices. In particular, the present disclosure includes a supraglottic airway (SGA) support device comprising a support substrate configured to interface with a subject’s head and a supraglottic airway interface integrated with the support substrate and configured to hold a supraglottic airway in a fixed position relative to the subject’s head.

[0030] By support substrate, it is meant any substrate that is integrated with the SGA interface to hold the SGA in a fixed position relative to the subject’s head. Support substrates include, but are not limited to, bands, hoods, hats, adhesives, masks and combinations thereof.

[0031] In some embodiments, the support substrate comprises a band. In some embodiments, the support substrate comprises one or more bands (e.g., one band, two bands, three bands, four bands, etc.) including, e.g., two or more bands, three or more bands or four or more bands. In some embodiments, the band wraps around the subject’s head. In some embodiments, the band wraps around the back of the subject’s head. In some embodiments, the band is adjustable. In some embodiments, the band includes a pad (i.e. , the band is a padded band). The band may be made of any suitable material including, but not limited to, plastic, silicone, elastic, fabric, metal and combinations thereof. In some embodiments, the band is an elastic band. In some embodiments, the band is a non-elastic band.

[0032] In some embodiments, the support substrate comprises a band with facial supports. By facial support, it is meant a support that secures the support substrate to the subject’s face. In some embodiments, the facial supports comprise silicone gel pads that secure the support substrate to subject’s face. In some embodiments, the silicone gel pads adhere to the face (e.g., cheeks) of the subject. Such silicone gel pads may further serve to protect the face (e.g., cheeks) from pressure injuries, e.g., pressure injuries that may result from wearing the device or pressure injuries that may occur during surgery (e.g., surgery wherein the subject is in a prone position). In some embodiments, the support substrate comprises a band with two or more facial supports (e.g., two facial supports, three facial supports, four facial supports, etc.). In embodiments wherein there are two facial supports, a first facial support may be present on the left side of the subject’s face and a second facial support may be present on the right side of the subject’s face. In some embodiments, the facial supports are cheek supports. By cheek support, it is meant a support that secures the support substrate to the subject’s cheek.

[0033] By supraglottic airway (SGA) interface, it is meant the portion of the SGA support device that interfaces with the SGA. As discussed above, the SGA interface is integrated with the support substrate and the SGA interface is configured to hold the SGA in a fixed position relative to the subject’s head. In certain embodiments, the SGA interface is configured to hold the SGA outside of the subject’s mouth. In other words, the SGA interface contacts a portion of the SGA that is outside of the subject’s mouth.

[0034] In some embodiments, the SGA interface comprises a chin pad. In some embodiments, the chin pad comprises a silicone gel pad. In some embodiments, the silicone gel pad adheres to the chin of the subject. Such silicone gel pads may protect the face (e.g., chin) from pressure injuries, e.g., pressure injuries that may result from wearing the device or pressure injuries that may occur during surgery (e.g., surgery wherein the subject is in a prone position). In certain cases, the chin pad is in contact with other portions (e.g., one or more extension arms) of the SGA interface. In certain cases, the chin pad is directly connected (e.g., via an adhesive) to the other portions of the SGA interface. In certain cases, the chin pad is directly connected to the first extension arm. In certain cases, the chin pad is directly connected to the second extension arm. In certain cases, the chin pad is directly connected to the first and the second extension arms. By directly connected, it is meant the chin pad can either be permanently or temporarily connected to other portions of the SGA interface (e.g., the first extension arm, the second extension arm or the first and the second extension arms). In certain cases, the chin pad is not directly connected to other portions of the SGA interface.

[0035] In some embodiments, the SGA interface comprises a rail. In some embodiments, the rail is integrated with the support substrate. In some embodiments, the rail is connected to the facial supports (e.g., cheek supports). In some embodiments, the rail is connected to the band. In some embodiments, the rail is configured such that the rail can be positioned above the subject’s upper lip (e.g., the rail is positioned between the subject’s nose and upper lip). In some embodiments, the rail comprises a pad. The pad may include any convenient material including, but not limited to, silicone gel, material and foam. The pad (e.g., silicone gel pad) may secure the rail to the subject’s face. Such silicone gel pads may further serve to protect the face (e.g., the portion of the face between the subject’s nose and upper lip) from pressure injuries that may occur during surgery (e.g., surgery wherein the subject is in a prone position).

[0036] In certain aspects, the SGA interface comprises a first extension arm. In some embodiments, the rail is connected to a first extension arm. In some embodiments, the first extension arm is connected to the rail via a first attachment. The first attachment may be any suitable attachment including, but not limited to, a stationary attachment, a slide attachment or a pivot attachment. By stationary attachment, it is meant an attachment wherein the first extension arm does not move relative to the rail. By slide attachment, it is meant an attachment wherein the first extension arm slides, or is capable of sliding along the rail (e.g., as in a ratchet attachment, in which a ratchet can be adjusted to hold an extension arm in place or allow an extension arm to slide along the rail). By pivot attachment, it is meant an attachment wherein the first extension arm pivots relative to the rail, e.g., where a cylindrical pin is used to attach the arm to the rail, such that the arm can rotate around the longitudinal axis of the pin. In some embodiments, the first attachment is a stationary attachment. In some embodiments, the first attachment is a slide attachment. In some embodiments, the first attachment is a pivot attachment. In certain embodiments, the rail is connected to a first end of the first extension arm (e.g., via a first attachment, wherein the first attachment may be any of the attachment types discussed above).

[0037] In some embodiments, the first extension arm includes a first extension arm feature. By “first extension arm feature” it is meant a feature that is configured to be attached to a connector piece. In other words, the connector piece can be attached to the first extension arm via the first extension arm feature. In some embodiments, the connector piece reversibly attaches to the first extension arm feature. First extension arm features may be any convenient feature capable of being attached (e.g., reversibly attached) to a connector piece including, but not limited to, a peg, a snap and a hole. In some embodiments, the first extension arm feature is a peg. In some embodiments, the arm includes one or more first extension arm features (e.g., one first extension arm feature, two first extension arm features, three first extension arm features, four first extension arm features, five first extension arm features, six first extension arm features, seven first extension arm features, eight first extension arm features, nine first extension arm features, ten first extension arm features, 11 first extension arm features, 12 first extension arm features, 13 first extension arm features, 14 first extension arm features, 15 first extension arm features, 16 first extension arm features, 17 first extension arm features, 18 first extension arm features, 19 first extension arm features, 20 first extension arm features) including, but not limited to, two or more first extension arm features, three or more first extension arm features, four or more first extension arm features, five or more first extension arm features, six or more first extension arm features, seven or more first extension arm features, eight or more first extension arm features, nine or more first extension arm features, ten or more first extension arm features, 11 or more first extension arm features, 12 or more first extension arm features, 13 or more first extension arm features, 14 or more first extension arm features, 15 or more first extension arm features, 16 or more first extension arm features, 17 or more first extension arm features, 18 or more first extension arm features, 19 or more first extension arm features and 20 or more first extension arm features. In some embodiments, the first extension arm includes one first extension arm feature (e.g., one peg). In some embodiments, the first extension arm includes two first extension arm features (e.g., two pegs). In some embodiments, the first extension arm includes three first extension arm features (e.g., three pegs). In some embodiments, the first extension arm includes four first extension arm features (e.g., four pegs). In some embodiments, the first extension arm includes five first extension arm features (e.g., five pegs).

[0038] In some embodiments, the first extension arm includes an auxiliary arm. By auxiliary arm, it is meant an arm that is connected to (e.g., branches off from) the first extension arm. In some embodiments, the auxiliary arm is not directly connected to the rail. In some embodiments, the auxiliary arm is a flexible auxiliary arm. In other words, the auxiliary arm is not rigid.

[0039] In some embodiments, the first extension arm is connected (e.g., directly connected) to the auxiliary arm via an auxiliary attachment. The auxiliary attachment may be any suitable attachment including, but not limited to, a stationary attachment, a slide attachment or a pivot attachment. By stationary attachment, it is meant an attachment where the point at which the auxiliary arm is attached to the first extension arm does not move relative to the first extension arm. By slide attachment, it is meant an attachment wherein the auxiliary arm slides, or is capable of sliding, along the first extension arm. By pivot attachment, it is meant an attachment wherein the auxiliary arm pivots relative to the first extension arm at the pivot attachment point. In some embodiments, the auxiliary attachment is a stationary attachment. In some embodiments, the auxiliary attachment is a slide attachment. In some embodiments, the auxiliary attachment is a pivot attachment. In certain embodiments, the first extension arm is connected to a first end of the auxiliary arm (e.g., via an auxiliary attachment, wherein the auxiliary attachment may be any of the attachment types discussed above).

[0040] In some embodiments, the first extension arm and the auxiliary arm are connected via a connector piece. By connector piece, it is meant any piece that is capable of connecting two arms (e.g., the first extension arm and the auxiliary arm). In some embodiments the connector piece is flexible. In other words, the connector piece is not rigid. In other embodiments the connector piece is rigid.

[0041] In some embodiments, the auxiliary arm includes an auxiliary arm feature. By “auxiliary arm feature” it is meant a feature that is configured to be attached to a connector piece. In other words, the connector piece can be attached to the auxiliary arm via the auxiliary arm feature. In some embodiments, the connector piece reversibly attaches to the auxiliary arm feature. Auxiliary arm features may be any convenient feature capable of being attached (e.g., reversibly attached) to a connector piece including, but not limited to, a peg, a snap and a hole. In some embodiments, the auxiliary arm feature is a peg. In some embodiments, the arm includes one or more auxiliary arm features (e.g., one auxiliary arm feature, two auxiliary arm features, three auxiliary arm features, four auxiliary arm features, five auxiliary arm features, six auxiliary arm features, seven auxiliary arm features, eight auxiliary arm features, nine auxiliary arm features, ten auxiliary arm features, 11 auxiliary arm features, 12 auxiliary arm features, 13 auxiliary arm features, 14 auxiliary arm features, 15 auxiliary arm features, 16 auxiliary arm features, 17 auxiliary arm features, 18 auxiliary arm features, 19 auxiliary arm features, 20 auxiliary arm features) including, but not limited to, two or more auxiliary arm features, three or more auxiliary arm features, four or more auxiliary arm features, five or more auxiliary arm features, six or more auxiliary arm features, seven or more auxiliary arm features, eight or more auxiliary arm features, nine or more auxiliary arm features, ten or more auxiliary arm features, 11 or more auxiliary arm features, 12 or more auxiliary arm features, 13 or more auxiliary arm features, 14 or more auxiliary arm features, 15 or more auxiliary arm features, 16 or more auxiliary arm features, 17 or more auxiliary arm features, 18 or more auxiliary arm features, 19 or more auxiliary arm features and 20 or more auxiliary arm features. In some embodiments, the auxiliary arm includes one auxiliary arm feature (e.g., two peg). In some embodiments, the auxiliary arm includes two auxiliary arm features (e.g., two pegs). In some embodiments, the auxiliary arm includes three auxiliary arm features (e.g., three pegs). In some embodiments, the auxiliary arm includes four auxiliary arm features (e.g., four pegs). In some embodiments, the auxiliary arm includes five auxiliary arm features (e.g., five pegs).

[0042] In some cases, the connector piece stabilizes the positions of the first extension arm and the auxiliary arm such that the first extension arm and the auxiliary arm do not move relative to each other. In certain embodiments, the first extension arm and a second end of the auxiliary arm (e.g., the end of the auxiliary arm that is positioned opposite from the first end of the auxiliary arm that is connected to the first extension arm) are connected via a connector piece. In other words, the first extension arm and the auxiliary arm are connected via a connector piece on an opposite end of the auxiliary arm from the auxiliary attachment. In some embodiments, the connector piece is attached to the first extension arm via a first extension arm feature (e.g., a peg) and the auxiliary arm via a first auxiliary arm feature (e.g., a peg). In certain embodiments, the first extension arm, the auxiliary arm and the connector piece form a closed ring around the SGA, i.e. , such elements enclose or incircle the SGA, e.g., an outer surface of the SGA. The first extension arm, the auxiliary arm and the connector piece may form a closed ring around the SGA, such that the SGA is held firmly in place (e.g., the SGA is held in a fixed position). In some cases, the size of the closed ring formed by the first extension arm, auxiliary arm and connector piece is adjustable, e.g., adjustable to accommodate SGAs of different sizes. In embodiments, the first extension arm, the auxiliary arm and the connector piece circumferentially engage the SGA, such as a tube of the SGA, such that the SGA is firmly attached to the SGA support device and, e.g., prevented from being dislodged from the patient or rotated relative to the patient.

[0043] In some embodiments, the connector piece includes one or more connector piece features (e.g., one connector piece feature, two connector piece features, three connector piece features, four connector piece features, five connector piece features, six connector piece features, seven connector piece features, eight connector piece features, nine connector piece features, ten connector piece features, 11 connector piece features, 12 connector piece features, 13 connector piece features, 14 connector piece features, 15 connector piece features, 16 connector piece features, 17 connector piece features, 18 connector piece features, 19 connector piece features, 20 connector piece features) including, but not limited to, two or more connector piece features, three or more connector piece features, four or more connector piece features, five or more connector piece features, six or more connector piece features, seven or more connector piece features, eight or more connector piece features, nine or more connector piece features, ten or more connector piece features, 11 or more connector piece features, 12 or more connector piece features, 13 or more connector piece features, 14 or more connector piece features, 15 or more connector piece features, 16 or more connector piece features, 17 or more connector piece features, 18 or more connector piece features, 19 or more connector piece features and 20 or more connector piece features. In some embodiments, the connector piece includes two to ten connector piece features including, but not limited to, two to eight connector piece features, three to seven connector piece features and four to six connector piece features.

[0044] Connector piece features may be any convenient feature capable of being attached (e.g., reversibly attached) to a first extension arm including, but not limited to, a peg, a snap and a hole. In some embodiments, the connector piece feature is a hole. In some cases, a connector piece feature of the connector piece attaches to a first extension arm feature of the first extension arm. In such cases, the first extension arm feature may be a peg and the connector piece feature may be a hole. In some cases, a connector piece feature of the connector piece attaches to an auxiliary arm feature of the auxiliary arm. In such cases, the auxiliary arm feature may be a peg and the connector piece feature may be a hole. In some cases, a first connector piece feature of the connector piece attaches to an auxiliary arm feature of the auxiliary arm and a second connector piece feature of the connector piece attaches to a first extension arm feature of the first extension arm. In such cases, the auxiliary arm feature may be a peg, the first extension arm feature may be a peg and the connector piece feature may be a hole.

[0045] In certain aspects, the SGA interface comprises a second extension arm. In some embodiments, the rail is further connected to a second extension arm. In other words, the rail is connected to a first extension arm and a second extension arm. In certain embodiments, wherein the rail is connected to a first extension arm and a second extension arm, the first extension arm does not comprise an auxiliary arm. In some embodiments, the second extension arm is connected to the rail via a second attachment. The second attachment may be any suitable attachment including, but not limited to, a stationary attachment, a slide attachment or a pivot attachment. By stationary attachment, it is meant an attachment wherein the second extension arm does not move relative to the rail. By slide attachment, it is meant an attachment wherein the second extension arm slides, or is capable of sliding, along the rail. By pivot attachment, it is meant an attachment wherein the second extension arm pivots relative to the rail. In some embodiments, the second attachment is a stationary attachment. In some embodiments, the second attachment is a slide attachment. In some embodiments, the second attachment is a pivot attachment. In certain embodiments, the rail is connected to a first end of the second extension arm (e.g., via a second attachment, wherein the second attachment may be any of the attachment types discussed above). In certain embodiments, the rail is connected to a first end the first extension arm and a first end of the second extension arm.

[0046] In some embodiments, the second extension arm includes a second extension arm feature. By “second extension arm feature” it is meant a feature that is configured to be attached to a connector piece. In other words, the connector piece can be attached to the second extension arm via the second extension arm feature. In some embodiments, the connector piece reversibly attaches to the second extension arm feature. Second extension arm features may be any convenient feature capable of being attached (e.g., reversibly attached) to a connector piece including, but not limited to, a peg, a snap and a hole. In some embodiments, the second extension arm feature is a peg. In some embodiments, the arm includes one or more second extension arm features (e.g., one second extension arm feature, two second extension arm features, three second extension arm features, four second extension arm features, five second extension arm features, six second extension arm features, seven second extension arm features, eight second extension arm features, nine second extension arm features, ten second extension arm features, 11 second extension arm features, 12 second extension arm features, 13 second extension arm features, 14 second extension arm features, 15 second extension arm features, 16 second extension arm features, 17 second extension arm features, 18 second extension arm features, 19 second extension arm features, 20 second extension arm features) including, but not limited to, two or more second extension arm features, three or more second extension arm features, four or more second extension arm features, five or more second extension arm features, six or more second extension arm features, seven or more second extension arm features, eight or more second extension arm features, nine or more second extension arm features, ten or more second extension arm features, 11 or more second extension arm features, 12 or more second extension arm features, 13 or more second extension arm features, 14 or more second extension arm features, 15 or more second extension arm features, 16 or more second extension arm features, 17 or more second extension arm features, 18 or more second extension arm features, 19 or more second extension arm features and 20 or more second extension arm features. In some embodiments, the second extension arm includes one second extension arm feature (e.g., one peg). In some embodiments, the second extension arm includes two second extension arm features (e.g., two pegs). In some embodiments, the second extension arm includes three second extension arm features (e.g., three pegs). In some embodiments, the second extension arm includes four second extension arm features (e.g., four pegs). In some embodiments, the second extension arm includes five second extension arm features (e.g., five pegs).

[0047] In some embodiments, the first extension arm and the second extension arm are connected via a connector piece (e.g., a piece that is capable of connecting the first extension arm and the second extension arm). Such a connector piece stabilizes the positions of the first extension arm and the second extension arm such that the first extension arm and the second extension arm do not move relative to each other. In certain embodiments, a second end of the first extension arm and a second end of the second extension arm (e.g., the ends of the first and second extension arms that are opposite from the first ends of the first and second extension arms that are connected to the rail) are connected via a connector piece. In other words, the first extension arm and the second extension arm are connected via a connector piece on an opposite end of the extension arms relative to the rail. In certain embodiments, the rail, the first extension arm, the second extension arm and the connector piece form a closed ring around the SGA.

[0048] In some cases, a connector piece feature of the connector piece attaches to a second extension arm feature of the second extension arm. In such cases, the second extension arm feature may be a peg and the connector piece feature may be a hole. In some cases, a first connector piece feature of the connector piece attaches to a second extension arm feature of the second extension arm and a second connector piece feature of the connector piece attaches to a first extension arm feature of the first extension arm. In such cases, the second extension arm feature may be a peg, the first extension arm feature may be a peg and the connector piece feature may be a hole.

[0049] In some embodiments, the first extension arm is configured to be in contact with the chin pad. In some embodiments, the second extension arm is configured to be in contact with the chin pad. In some embodiments, the first extension arm and the second extension arm are configured to be in contact with the chin pad. In some embodiments, the auxiliary arm is configured to not be in contact with the chin pad. In some embodiments, the first extension arm and / or the second extension arm comprise an adhesive that grips the SGA. In some embodiments, the adhesive is present on an inner surface (i.e. , a surface facing the SGA) of the first extension arm and / or the second extension arm. In some embodiments, the adhesive contacts the SGA.

[0050] In certain embodiments, the SGA support device further comprises an anchor piece that connects the SGA interface to the SGA. The anchor piece may be any suitable piece capable of connecting the SGA interface to the SGA including, but not limited to, a zip tie, a clamp, a string, a cord, a band or the like. Zip ties may be made of any material, e.g., a plastic zip tie. In some embodiments, the anchor piece is a zip tie. In some embodiments, the anchor piece is a plastic zip tie. In some embodiments, the anchor piece is a clamp. In some embodiments, the anchor piece connects the SGA interface to the SGA via the first extension arm and the second extension arm. In some embodiments, the first extension arm and the second extension arm comprise holes such that the anchor piece can be threaded through. In some embodiments, the anchor piece connects the SGA interface to the SGA via the first extension arm and the auxiliary arm. In some embodiments, the first extension arm and the auxiliary arm comprise holes such that the anchor piece can be threaded therethrough.

[0051] In certain aspects, the SGA support device comprises a chin support. The chin support secures the device relative to the subject’s chin. In some embodiments, the chin support comprises a chin support band or strap placed underneath the subject’s chin. The chin support band may be made of any suitable material including, but not limited to, plastic, silicone, elastic, fabric, metal and combinations thereof. In some embodiments, the chin support band comprises a silicone gel pad. In such embodiments, the silicone gel pad is located on a surface of the chin support band facing the subject’s chin. In some embodiments, the silicone gel pad contacts the subject’s chin (e.g., the underside of the chin). Such silicone gel pads may further serve to protect a region underneath the chin from pressure injuries that may occur during surgery (e.g., surgery wherein the subject is in a prone position). In some embodiments, the silicone gel pad extends the entire length of the chin support band. In some embodiments, the silicone gel pad is present in only a portion of the chin support band (e.g., only the portion of the chin support band that contacts the subject’s chin). The chin support may be directly connected to the facial supports or band of the support substrate. In some embodiments, the chin support band is adjustable. In some embodiments, the chin support band is non-adjustable.

[0052] Materials

[0053] SGA support devices of the present disclosure may include any convenient material. Materials of interest include biocompatible materials, e.g., compatible with contact with human skin, e.g., that minimize the risk of injury to human skin as a result of prolonged contact and / or application of pressure. Materials include, but are not limited to, thermoplastic polyurethane (TPU), polyethylene terephthalate glycol (PETG), polypropylene (PP), polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), carbon fiber, nylon, high-impact polystyrene (HIPS), polycarbonate (PC), polyether ether ketone (PEEK), polyetherimide (PEI), thermoplastic elastomer (TPE), thermoplastic copolyester (TPC), silicone, fabric, foam and combinations thereof.

[0054] In some embodiments, the SGA support device or any component of the SGA support device (e.g., SGA interface, facial support, chin support, rail, first extension arm, auxiliary arm, connector piece, second extension arm, anchor piece, chin support) includes of one or more of: thermoplastic polyurethane (TPU), polyethylene terephthalate glycol (PETG), polypropylene (PP), polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), carbon fiber, nylon, high-impact polystyrene (HIPS), polycarbonate (PC), polyether ether ketone (PEEK), polyetherimide (PEI), thermoplastic elastomer (TPE), thermoplastic copolyester (TPC) and silicone. In some embodiments, the SGA support device or any component of the SGA support device (e.g., SGA interface, facial support, chin support, rail, first extension arm, auxiliary arm, connector piece, second extension arm, anchor piece, chin support) is made of one or more of: thermoplastic polyurethane (TPU), polyethylene terephthalate glycol (PETG) and polypropylene (PP). In some cases, the SGA interface is made of a single material. In some cases, the SGA interface and the one or more facial supports are made of a single material. In some cases, the SGA interface is made of two or more materials (e.g., two materials, three materials, four materials, five materials) including, but not limited to, three or more materials, four three or more materials and five three or more materials. In some cases, the SGA interface and the one or more facial supports are made of two or more materials (e.g., two materials, three materials, four materials, five materials) including, but not limited to, three or more materials, four three or more materials and five three or more materials.

[0055] Position

[0056] Aspects of the present SGA support devices include devices configured to hold an SGA in a fixed position relative to the subject’s head while the subject is in a particular position. Such positions include positions that are relevant for surgery, including, but not limited to, supine positions, prone positions, lateral positions and sitting positions. In some embodiments, the SGA interface of the devices disclosed herein are further configured to hold the supraglottic airway in a fixed position relative to the subject’s head, wherein the subject is in a prone position, a lateral position or a sitting position. In some embodiments, the subject is in a prone position (see, e.g., subject 702 in FIG. 7). In some embodiments, the subject is in a lateral position. In some embodiments the subject is in a sitting position. In some embodiments, the subject is on an operating table, wherein the operating table is positioned (e.g., rotated) such that an end of the operating table in contact with the subject’s head is turned away from an anesthesiologist, such that the patient’s head is inaccessible to the anesthesiologist. In certain embodiments, the SGA interface of the devices disclosed herein is further configured to hold the supraglottic airway in a fixed position relative to the subject’s head, wherein the subject is moved between different positions during surgery. For example, the subject is moved from a prone position, a lateral position or a sitting position to another position (or vice versa). In certain embodiments, the SGA interface is further configured to maintain a seal between the SGA and the subject. By maintain a seal between the SGA and the subject, it is meant that the SGA interface is configured to hold the SGA in such a way that allows for continuous ventilation. In certain embodiments, the SGA interface is further configured to maintain a seal between the SGA and the subject’s trachea. In certain embodiments, the SGA interface is further configured to hold the SGA in a fixed position such that the subject can respire wherein the subject is in a prone position.

[0057] Devices of embodiments of the invention find use in a variety of different types of subjects. The terms “subject,” “individual,” and “patient” are used interchangeably to refer to the subject being assessed. Subjects may be any mammal, including, but not limited to, humans, primates, etc. In some embodiments, the subject is a human. Subjects include mammals (e.g., humans) of any age, including adolescents and adults. In some embodiments, the subject is a human, wherein the human is an adult human. The subject may be of any body type or body size.

[0058] Supraglottic airways (SGAs)

[0059] Supraglottic airways (SGAs) support ventilation in patients receiving general anesthesia. SGAs rest in the hypopharynx above the vocal cords. The present SGA support devices are compatible with a wide range of SGAs. Such SGAs include, but are not limited to, a laryngeal mask airway (LMA®), an AirQ® SGA, or an l-gel® SGA. Types of laryngeal mask airways include, but are not limited to, LMA® Classic™, a LMA® Protector™, a LMA® Guardian™, a LMA® Unique™, a LMA® ProSeal™, a LMA® Supreme™, a LMA® Flexible™ and LMA® Fastrach™.

[0060] Further SGAs which find use in the present devices are described in US Patent No. 10702665, US Patent No. 10806880, US Patent No. 5623921 , US Patent No. 6792948, US Patent No. 9027559, US Patent No. 7383736, US Patent No. 8033176, US Patent No. 9265904, US Patent No. 9498591 and US Patent No. 7493901 , the disclosures of which are herein incorporated by reference.

[0061] Procedures

[0062] In certain embodiments, the SGA support devices disclosed herein are compatible with a procedure wherein the subject is in a prone, lateral or sitting position. Procedures include surgical and non-surgical procedures. In certain embodiments, the SGA support devices disclosed herein are compatible with a procedure wherein the subject is moved to or from a prone position. Procedures wherein the subject is in a prone position include, but are not limited to, perianal procedures, spine procedures, urological procedures, plastic procedures, dermatological procedures, vascular procedures, interventional radiology procedures or combinations thereof. Examples of perianal procedures include, but are not limited to, a hemorrhoidectomy, pilonidal cyst-related surgery, a fistula surgery, anal stenosis and anal fissure surgery. Examples of spine procedures include, but are not limited to, a microdiscectomy, a laminectomy, a discectomy, a fusion, a single level spinal decompression and fusion or a two- level spinal decompression and fusion. Examples of urological procedures include, but are not limited to, percutaneous nephrolithotomy and urethral diverticula / reconstruction. Examples of plastic procedures include, but are not limited to, mass excisions (e.g., excisions on the posterior surface of the neck, trunk and / or legs), skin lesion surgery, scar-related surgery, burn-related surgery and liposuction. Examples of dermatological procedures include, but are not limited to, melanoma excisions. Examples of vascular procedures include, but are not limited to, sacral ulcer surgery, popliteal fossa surgery and spinal access. Examples of interventional radiology procedures include, but are not limited to, ablation of a renal trunk tumor.

[0063] In certain embodiments, SGA support devices disclosed herein are compatible with head support systems. Head support systems support the subject’s head during surgery such that the incidences of pressure related injury are reduced. In some embodiments, the head support system is a prone head support system (i.e., the head support system supports the subject’s head wherein the subject is in a prone position). In some embodiments, the prone head support system is a ProneView® helmet.

[0064] METHODS OF STABILIZING AN ARTIFICIAL AIRWAY

[0065] Also provided are methods of stabilizing an artificial airway in a subject, the method comprising placing a supraglottic airway in a subject, placing a supraglottic airway support device on the supraglottic airway and the subject, wherein the supraglottic airway support device comprises a support substrate configured to interface with the subject’s head and a supraglottic airway interface integrated with the support substrate and configured to hold the supraglottic airway in a fixed position relative to the subject’s head. Suitable supraglottic airway support devices include those disclosed herein. In some embodiments, placing a supraglottic airway support device comprises configuring the support substrate to interface with the subject’s head and configuring the supraglottic airway interface to interface with the supraglottic airway. In some embodiments, configuring the supraglottic airway interface comprises configuring the supraglottic airway interface to hold the supraglottic airway in a fixed position relative to the subject’s head. In certain embodiments of the methods disclosed herein, the subject is in a prone position.

[0066] UTILITY

[0067] The subject devices and methods find use in a variety of applications where it is desirable to hold a supraglottic airway in a fixed position relative to the subject’s head. In some embodiments, the devices and methods described herein find use in medical procedures (e.g., surgical procedures), wherein the subject is in a prone position, a lateral position or a sitting position, wherein the subject’s head is turned, or wherein the subject is moved during the surgery to or from a prone position, a lateral position or a sitting position.

[0068] In addition, the subject devices and methods find use in improving the safety of using supraglottic airways during surgical procedures, particularly in cases wherein supraglottic airways are not currently used due to safety constraints (e.g., general anesthesia cases wherein the subject is in a prone position). As supraglottic airways (SGAs) are easier to place and faster to position than the current standard for prone cases (i.e. , endotracheal tubes (ETTs)), the subject devices will provide for more time efficient and safer procedures, e.g., insofar as the subject devices enable the use of SGAs in connection with procedures that would otherwise entail use of an ETT. Further, SGAs require fewer drugs to be administered and do not require laryngoscopy, and thus are associated with fewer side-effects and lower costs.

[0069] The following is offered by way of illustration and not by way of limitation.

[0070] EXPERIMENTAL

[0071] Example 1:

[0072] FIGS. 3A-3B depict a front view (FIG. 3A) and a side view (FIG. 3B) of supraglottic airway (SGA) support device 300 comprising a support substrate 304 configured to interface with a subject’s head 302. The SGA support device 300 further comprises an SGA interface 310 integrated with the support substrate 304, wherein the SGA interface 310 is configured to hold an SGA 312 in a fixed position relative to the subject’s head 302. The support substrate 304 comprises a band 306 with facial supports 308. The band 306 wraps around the subject’s head 302. As shown in FIGS. 3A-3B, the facial supports may be two cheek supports (e.g., one cheek support on each of the subject’s two cheeks). Facial supports 308 comprise silicone gel pads 314 that secure the support substrate 304 to the subject’s face.

[0073] FIGS. 3C-3D depict a front view (FIG. 3C) and a side view (FIG. 3D) of the SGA interface 310. The SGA interface 310 comprises a rail 356 that is integrated with the support substrate (e.g., rail 356 is connected to the facial supports 308 of the support substrate). The rail 356 comprises a silicone gel pad 358 and is positioned above the subject’s upper lip. The rail 356 is connected to a first end of a first extension arm 352 at a first attachment 360. The rail 356 is further connected to a first end of a second extension arm 354 at a second attachment 362. As shown in FIGS. 3C-3D, the first attachment 360 is a pivot attachment that allows the first extension arm 352 to pivot relative to the rail 356, and the second attachment 362 is a pivot attachment that allows the second extension arm 354 to pivot relative to the rail 356. At a second end of the first extension arm 352 and a second end of the second extension arm 354 (i.e., opposite of the pivot attachments), the first extension arm 352 and the second extension arm 354 are connected via a connector piece 368. The second end of the first extension arm 352 and the second end of the second extension arm 354 are in contact with a chin pad 350 (e.g., a silicone gel pad). Adhesive 364 is present on an inner surface of the extension arms (e.g., the surface of the extension arms that face the SGA) to grip the SGA 312. Anchor piece 366 (e.g., a zip tie as depicted in FIGS. 3C-3D) further grips the SGA 312 by connecting the SGA 312 to the first extension arm 352 and the second extension arm 354.

[0074] Example 2:

[0075] FIGS. 4A-4B depict a front view (FIG. 4A) and a side view (FIG. 4B) of supraglottic airway (SGA) support device 400 comprising a support substrate 404 configured to interface with a subject’s head 402. The SGA support device 400 further comprises an SGA interface 410 integrated with the support substrate 404, wherein the SGA interface 410 is configured to hold an SGA 412 in a fixed position relative to the subject’s head 402. The support substrate 404 comprises a band 406 with facial supports 408. The band 406 wraps around the subject’s head 402. As shown in FIGS. 4A-4B, the facial supports may be two cheek supports (e.g., one cheek support on each of the subject’s two cheeks). Facial supports 408 comprise silicone gel pads 414 that secure the support substrate 404 to the subject’s face.

[0076] FIGS. 4C-4D depict a front view (FIG. 4C) and a side view (FIG. 4D) of the SGA interface 410. The SGA interface 410 comprises a rail 456 that is integrated with the support substrate (e.g., rail 456 is connected to the facial supports 408 of the support substrate). The rail 456 comprises a silicone gel pad 458 and is positioned above the subject’s upper lip. The rail 456 is connected to a first end of a first extension arm 452 at a first attachment 460. The rail 456 is further connected to a first end of a second extension arm 454 at a second attachment 462. As shown in FIGS. 4C-4D, the first attachment 460 is a slide attachment that allows the first extension arm 452 to slide along the rail 456, and the second attachment 462 is a slide attachment that allows the second extension arm 454 to slide along the rail 456. Such slide attachments comprise a ratchet mechanism for fixing and adjusting the position of the first extension arm 452 and the second extension arm 454 on the rail 456. At a second end of the first extension arm 452 and a second end of the second extension arm 454 (i.e. , opposite of the adapter attachments), the first extension arm 452 and the second extension arm 454 are connected via a connector piece 468. The second end of the first extension arm 452 and the second end of the second extension arm 454 are in contact with a chin pad 450 (e.g., a silicone gel pad). Adhesive 464 is present on an inner surface of the extension arms (e.g., the surface of the extension arms that face the SGA) to grip the SGA 412. Anchor piece 466 (e.g., a zip tie as depicted in FIGS. 4C-4D) further grips the SGA 412 by connecting the SGA 412 to the first extension arm 452 and the second extension arm 454.

[0077] Example 3:

[0078] FIG. 5A depicts a front view of a supraglottic airway (SGA) support device 500 comprising a support substrate 504 configured to interface with a subject’s head 502. The SGA support device 500 further comprises an SGA interface 510 integrated with the support substrate 504, wherein the SGA interface 510 is configured to hold an SGA 512 in a fixed position relative to the subject’s head 502. The support substrate 504 comprises a band 506 with facial supports 508. The band 506 wraps around the subject’s head 502. As shown in FIG. 5A, the facial supports may be two cheek supports (e.g., one cheek support on each of the subject’s two cheeks). Facial supports 508 comprise silicone gel pads 514 that secure the support substrate 504 to the subject’s face. Support substrate 504 further comprises a chin support 516. Chin support 516 comprises a silicone gel pad 518.

[0079] FIGS. 5B-5C depict a first side view (FIG. 5B) and a second side view (FIG. 5C) of the SGA interface 510. The SGA interface 510 comprises a rail 556 that is integrated with the support substrate (e.g., rail 556 is connected to the facial supports 508 of the support substrate). The rail 556 comprises a silicone gel pad 558 and is positioned above the subject’s upper lip. The rail 556 is connected to a first end of a first extension arm 552 via a first attachment 560 (e.g., a stationary attachment). The first extension arm 552 further comprises an auxiliary arm 570. The first extension arm is connected to a first end of the auxiliary arm 570 via an auxiliary attachment 572. As shown in FIGS. 5B-5C, the auxiliary attachment 572 is a pivot attachment such that the auxiliary arm 570 can pivot relative to the first extension arm 552. The first extension arm 552 and a second end of the auxiliary arm 570 are connected via a connector piece 568, such that the SGA 512 is held in a fixed position. The second end of the first extension arm 552 is in contact with a chin pad 550 (e.g., a silicone gel pad). The support substrate further comprises a chin support 516. Chin support 516 comprises a silicone gel pad 518.

[0080] FIGS. 5D-5E depict the same SGA support device as FIGS. 5A-5C, except without the chin support 516. FIG. 5D shows a front view of the SGA support device without the chin support and FIG. 5E shows a side view of the SGA interface.

[0081] Example 4:

[0082] FIG. 6A depicts a front view of a supraglottic airway (SGA) support device 600 including a support substrate 604 configured to interface with a subject’s head 602. The SGA support device 600 further includes a SGA interface 610 integrated with the support substrate 604, where the SGA interface 610 is configured to hold a SGA (not pictured) in a fixed position relative to the subject’s head 602. The support substrate 604 includes a band 606 with facial supports 608. The band 606 wraps around the subject’s head 602. As shown in FIG. 6A, the facial supports may be two cheek supports (e.g., one cheek support on each of the subject’s two cheeks). Facial supports 608 include silicone gel pads 614 that secure the support substrate 604 to the subject’s face. Support substrate 604 further includes a chin support 616. Chin support 616 comprises a silicone gel pad 618.

[0083] FIG. 6B depicts a front view of the SGA interface 610 of the SGA support device. The SGA interface 610 includes a rail 656 that is integrated with the support substrate (e.g., rail 656 is connected to the facial supports 608 of the support substrate). The rail 656 is connected to a first end of a first extension arm 652 via a first attachment 660 (e.g., a stationary attachment). The first extension arm 652 further includes an auxiliary arm 670 (e.g., a flexible auxiliary arm). The first extension arm 652 is fixedly connected to a first end of the auxiliary arm 670. The first extension arm 652 and a second end of the auxiliary arm 670 are connected via a connector piece 668. The first extension arm 652 includes one or more first extension arm features 680A, 680B, 680C (e.g., three first extension arm features) that can each be attached to the connector piece 668 via a connector piece feature 682, where connector piece feature is a hole configured to engage one of first extension arm features 680A, 680B, 680C. In some cases, the first extension arm feature is a peg (e.g., peg 680A) and connector piece feature is a hole (e.g., hole 682 as depicted in FIG. 6B). The closed ring formed by the first extension arm 652, the auxiliary arm 670 and the connector piece 668 is configured to circumferentially engage the SGA and thereby hold the SGA in a fixed position. Multiple first extension arm features 680A, 680B, 680C and connector piece features 682 are provided in order to accommodate different sized SGAs. The second end of the first extension arm 652 is in contact with a chin pad 650 (e.g., a silicone gel pad).

[0084] FIGS. 6C-6D depict a side view and a back view, respectively, of the SGA support device described in FIG. 6B. A similar SGA support device is depicted in FIGS. 6E-6F, except without the chin pad 550. FIG. 6E shows a front view and FIG. 6F shows a side view of the SGA interface. The below items disclose various aspects of the invention. Each of the aspects described below can be combined with other aspects and embodiments disclosed elsewhere herein, including the claims, where the combinations are clearly compatible. Certain aspects include:

[0085] Aspect 1 . A supraglottic airway support device, the device comprising: a support substrate configured to interface with a subject’s head, and a supraglottic airway interface integrated with the support substrate and configured to hold a supraglottic airway in a fixed position relative to the subject’s head.

[0086] Aspect 2. The device of Aspect 1 , wherein the support substrate comprises a band with facial supports.

[0087] Aspect 3. The device of Aspect 2, wherein the band wraps around the subject’s head.

[0088] Aspect 4. The device of Aspects 2 or 3, wherein the band is an elastic band.

[0089] Aspect 5. The device of any one of Aspects 2-4, wherein the facial supports comprise silicone gel pads that secure the support substrate to subject’s face.

[0090] Aspect 6. The device of any one of Aspects 2-5, wherein facial supports are cheek supports.

[0091] Aspect 7. The device of any of the previous Aspects, wherein the supraglottic airway interface is configured to hold the supraglottic airway outside of the subject’s mouth.

[0092] Aspect 8. The device of any of the previous Aspects, wherein the supraglottic airway interface comprises a chin pad.

[0093] Aspect 9. The device of Aspect 8, wherein the chin pad comprises a silicone gel pad.

[0094] Aspect 10. The device of any of the previous Aspects, wherein the supraglottic airway interface comprises a rail.

[0095] Aspect 11 . The device of Aspect 10, wherein the rail is integrated with the support substrate. Aspect 12. The device of Aspects 10 or 11 , wherein the rail is configured such that rail is positioned above the subject’s upper lip.

[0096] Aspect 13. The device of any of one of Aspects 10-12, wherein the rail comprises a silicone gel pad.

[0097] Aspect 14. The device of any one of Aspects 10-13, wherein the rail is connected to a first extension arm.

[0098] Aspect 15. The device of Aspect 14, wherein the rail is connected to the first extension arm via a first attachment.

[0099] Aspect 16. The device of Aspect 15, wherein the first attachment is a stationary attachment, a slide attachment or a pivot attachment.

[0100] Aspect 17. The device of Aspect 16, wherein the first attachment is a stationary attachment.

[0101] Aspect 18. The device of Aspect 16, wherein the first attachment is a slide attachment.

[0102] Aspect 19. The device of Aspect 16, wherein the first attachment is a pivot attachment.

[0103] Aspect 20. The device of any one of Aspects 14-19, wherein the rail is connected to a first end of the first extension arm.

[0104] Aspect 21 . The device of any one of Aspects 14-20, wherein the first extension arm comprises an auxiliary arm.

[0105] Aspect 22. The device of Aspect 21 , wherein the first extension arm is connected to the auxiliary arm via an auxiliary attachment.

[0106] Aspect 23. The device of Aspect 22, wherein the auxiliary attachment is a stationary attachment, a slide attachment or a pivot attachment.

[0107] Aspect 24. The device of Aspect 23, wherein the auxiliary attachment is a pivot attachment.

[0108] Aspect 25. The device of any of Aspects 21 -24, wherein the first extension arm and the auxiliary arm are connected via a connector piece.

[0109] Aspect 26. The device of any one of Aspects 14-25, wherein the first extension arm is in contact with the chin pad. Aspect 27. The device of any one of Aspects 14-26, wherein the rail is further connected to a second extension arm.

[0110] Aspect 28. The device of Aspect 27, wherein the rail is connected to the second extension arm via a second attachment.

[0111] Aspect 29. The device of Aspect 28, wherein the second attachment is a stationary attachment, a slide attachment or a pivot attachment.

[0112] Aspect 30. The device of Aspect 29, wherein the second attachment is a stationary attachment.

[0113] Aspect 31 . The device of Aspect 29, wherein the second attachment is a slide attachment.

[0114] Aspect 32. The device of Aspect 29, wherein the second attachment is a pivot attachment.

[0115] Aspect 33. The device of any one of Aspects 27-32, wherein the rail is connected to a first end of the second extension arm.

[0116] Aspect 34. The device of any one of Aspects 27-33, wherein the first extension arm and the second extension arm are connected via a connector piece.

[0117] Aspect 35. The device of any one of Aspects 27-34, wherein the second extension arm is in contact with the chin pad.

[0118] Aspect 36. The device of any one of Aspects 27-35, wherein the first extension arm and the second extension arm comprise an adhesive that grips that supraglottic airway.

[0119] Aspect 37. The device of any one of Aspects 27-36, wherein the device further comprises an anchor piece that connects the supraglottic airway interface to the supraglottic airway.

[0120] Aspect 38. The device of Aspect 37, wherein the anchor piece is a zip tie.

[0121] Aspect 39. The device of Aspect 38, wherein the zip tie is a plastic zip tie.

[0122] Aspect 40. The device of Aspect 37, wherein the anchor piece is a clamp. Aspect 41 . The device of any one of Aspects 37-40, wherein the anchor piece connects the supraglottic airway interface to the supraglottic airway via the first extension arm and the second extension arm.

[0123] Aspect 42. The device of Aspect 41 , wherein the first extension arm and the second extension arm comprise holes such that the anchor piece can be threaded therethrough.

[0124] Aspect 43. The device of any of the previous Aspects, wherein the support substrate further comprises a chin support.

[0125] Aspect 44. The device of Aspect 43, wherein the chin support comprises a chin support band placed underneath the subject’s chin.

[0126] Aspect 45. The device of Aspect 44, wherein the chin support band is adjustable.

[0127] Aspect 46. The device of Aspects 44 or 45, wherein the chin support band comprises a silicone gel pad.

[0128] Aspect 47. The device of any of the previous Aspects, wherein the supraglottic airway interface is further configured to hold the supraglottic airway in a fixed position relative to the subject’s head, wherein the subject is in a prone position, a lateral position or a sitting position.

[0129] Aspect 48. The device of Aspect 47, wherein the subject is in a prone position.

[0130] Aspect 49. The device of Aspect 47, wherein the subject is moved between a prone position, a lateral position or a sitting position to another position.

[0131] Aspect 50. The device of any of the previous Aspects, wherein the supraglottic airway interface is further configured to maintain a seal between the supraglottic airway and the subject.

[0132] Aspect 51 . The device of any of the previous Aspects, wherein the supraglottic airway interface is further configured to maintain a seal between the supraglottic airway and the subject’s trachea. Aspect 52. The device of Aspect 48, wherein the supraglottic airway interface is further configured to hold the supraglottic airway in a fixed position such that the subject can respire wherein the subject is in a prone position.

[0133] Aspect 53. The device of any of the previous Aspects, wherein the supraglottic airway is an LMA®, AirQ® or an l-gel®.

[0134] Aspect 54. The device of Aspect 53, wherein the LMA® is a LMA® Classic™, a LMA® Protector™, a LMA® Guardian™, a LMA® Unique™, a LMA® ProSeal™, a LMA® Supreme™, a LMA® Flexible™ or a LMA® Fastrach™.

[0135] Aspect 55. The device of any of the previous Aspects, wherein the device is compatible with a head support system.

[0136] Aspect 56. The device of Aspect 55, wherein the head support system is a prone head support system.

[0137] Aspect 57. The device of Aspect 56, wherein the prone head support system is a ProneView® helmet.

[0138] Aspect 58. The device of Aspect 48, wherein the device is compatible with a surgery wherein the subject is in a prone position.

[0139] Aspect 59. The device of Aspect 58, wherein the surgery is a perianal procedure, a spine procedure, a plastic procedure, or a combination thereof.

[0140] Aspect 60. The device of Aspect 59, wherein the perianal procedure is a hemorrhoidectomy, pilonidal cyst or an anal fissure.

[0141] Aspect 61 . The device of Aspect 59, wherein the spine procedure is a microdiscectomy or a single level spinal decompression and fusion.

[0142] Aspect 62. The device of Aspect 59, wherein the plastic procedure is a melanoma excision or liposuction.

[0143] Aspect 63. A method of stabilizing an artificial airway in a subject, the method comprising: placing a supraglottic airway in a subject; placing a supraglottic airway support device on the supraglottic airway and the subject, wherein the supraglottic airway support device comprises: a support substrate configured to interface with the subject’s head; and a supraglottic airway interface integrated with the support substrate and configured to hold the supraglottic airway in a fixed position relative to the subject’s head.

[0144] Aspect 64. The method of Aspect 63, wherein placing the supraglottic airway support device comprises: configuring the support substrate to interface with the subject’s head; and configuring the supraglottic airway interface to interface with the supraglottic airway.

[0145] Aspect 65. The method of Aspect 64, wherein configuring the supraglottic airway interface comprises: configuring the supraglottic airway interface to hold the supraglottic airway in a fixed position relative to the subject’s head.

[0146] Aspect 66. The method of any one of Aspects 63 to 65, wherein the subject is in a prone position.

[0147] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[0148] Accordingly, the preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[0149] The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims. In the claims, 35 U.S.C. § 1 12(f) or 35 U.S.C. § 112(6) is expressly defined as being invoked for a limitation in the claim only when the exact phrase “means for” or the exact phrase “step for” is recited at the beginning of such limitation in the claim; if such exact phrase is not used in a limitation in the claim, then 35 U.S.C. § 1 12(f) or 35 U.S.C. § 1 12(6) is not invoked.

Claims

What is claimed is:1 . A supraglottic airway support device, the device comprising: a support substrate configured to interface with a subject’s head, and a supraglottic airway interface integrated with the support substrate and configured to hold a supraglottic airway in a fixed position relative to the subject’s head.

2. The device of claim 1 , wherein the support substrate comprises a band with facial supports.

3. The device of claim 2, wherein the band wraps around the subject’s head.

4. The device of claims 2 or 3, wherein the band is an elastic band.

5. The device of any one of claims 2-4, wherein the facial supports comprise silicone gel pads that secure the support substrate to subject’s face.

6. The device of any one of claims 2-5, wherein facial supports are cheek supports.

7. The device of any of the previous claims, wherein the supraglottic airway interface is configured to hold the supraglottic airway outside of the subject’s mouth.

8. The device of any of the previous claims, wherein the supraglottic airway interface comprises a chin pad.

9. The device of claim 8, wherein the chin pad comprises a silicone gel pad.

10. The device of any of the previous claims, wherein the supraglottic airway interface comprises a rail.11 . The device of claim 10, wherein the rail is integrated with the support substrate.

12. The device of claims 10 or 11 , wherein the rail is configured such that rail is positioned above the subject’s upper lip.

13. The device of any of one of claims 10-12, wherein the rail comprises a silicone gel pad.

14. The device of any one of claims 10-13, wherein the rail is connected to a first extension arm.

15. The device of claim 14, wherein the rail is connected to the first extension arm via a first attachment.

16. The device of claim 15, wherein the first attachment is a stationary attachment, a slide attachment or a pivot attachment.

17. The device of claim 16, wherein the first attachment is a stationary attachment.

18. The device of claim 16, wherein the first attachment is a slide attachment.

19. The device of claim 16, wherein the first attachment is a pivot attachment.

20. The device of any one of claims 14-19, wherein the rail is connected to a first end of the first extension arm.21 . The device of any one of claims 14-20, wherein the first extension arm comprises an auxiliary arm.

22. The device of claim 21 , wherein the first extension arm is connected to the auxiliary arm via an auxiliary attachment.

23. The device of claim 22, wherein the auxiliary attachment is a stationary attachment, a slide attachment or a pivot attachment.

24. The device of claim 23, wherein the auxiliary attachment is a pivot attachment.

25. The device of any of claims 21 -24, wherein the first extension arm and the auxiliary arm are connected via a connector piece.

26. The device of any one of claims 14-25, wherein the first extension arm is in contact with the chin pad.

27. The device of any one of claims 14-26, wherein the rail is further connected to a second extension arm.

28. The device of claim 27, wherein the rail is connected to the second extension arm via a second attachment.

29. The device of claim 28, wherein the second attachment is a stationary attachment, a slide attachment or a pivot attachment.

30. The device of claim 29, wherein the second attachment is a stationary attachment.31 . The device of claim 29, wherein the second attachment is a slide attachment.

32. The device of claim 29, wherein the second attachment is a pivot attachment.

33. The device of any one of claims 27-32, wherein the rail is connected to a first end of the second extension arm.

34. The device of any one of claims 27-33, wherein the first extension arm and the second extension arm are connected via a connector piece.

35. The device of any one of claims 27-34, wherein the second extension arm is in contact with the chin pad.

36. The device of any one of claims 27-35, wherein the first extension arm and the second extension arm comprise an adhesive that grips that supraglottic airway.

37. The device of any one of claims 27-36, wherein the device further comprises an anchor piece that connects the supraglottic airway interface to the supraglottic airway.

38. The device of claim 37, wherein the anchor piece is a zip tie.

39. The device of claim 38, wherein the zip tie is a plastic zip tie.

40. The device of claim 37, wherein the anchor piece is a clamp.41 . The device of any one of claims 37-40, wherein the anchor piece connects the supraglottic airway interface to the supraglottic airway via the first extension arm and the second extension arm.

42. The device of claim 41 , wherein the first extension arm and the second extension arm comprise holes such that the anchor piece can be threaded therethrough.

43. The device of any of the previous claims, wherein the support substrate further comprises a chin support.

44. The device of claim 43, wherein the chin support comprises a chin support band placed underneath the subject’s chin.

45. The device of claim 44, wherein the chin support band is adjustable.

46. The device of claims 44 or 45, wherein the chin support band comprises a silicone gel pad.

47. The device of any of the previous claims, wherein the supraglottic airway interface is further configured to hold the supraglottic airway in a fixed position relative to the subject’s head, wherein the subject is in a prone position, a lateral position or a sitting position.

48. The device of claim 47, wherein the subject is in a prone position.

49. The device of claim 47, wherein the subject is moved between a prone position, a lateral position or a sitting position to another position.

50. The device of any of the previous claims, wherein the supraglottic airway interface is further configured to maintain a seal between the supraglottic airway and the subject.51 . The device of any of the previous claims, wherein the supraglottic airway interface is further configured to maintain a seal between the supraglottic airway and the subject’s trachea.

52. The device of claim 48, wherein the supraglottic airway interface is further configured to hold the supraglottic airway in a fixed position such that the subject can respire wherein the subject is in a prone position.

53. The device of any of the previous claims, wherein the supraglottic airway is an LMA®, AirQ® or an l-gel®.

54. The device of claim 53, wherein the LMA® is a LMA® Classic™, a LMA® Protector™, a LMA® Guardian™, a LMA® Unique™, a LMA® ProSeal™, a LMA® Supreme™, a LMA® Flexible™ or a LMA® Fastrach™.

55. The device of any of the previous claims, wherein the device is compatible with a head support system.

56. The device of claim 55, wherein the head support system is a prone head support system.

57. The device of claim 56, wherein the prone head support system is a ProneView® helmet.

58. The device of claim 48, wherein the device is compatible with a surgery wherein the subject is in a prone position.

59. The device of claim 58, wherein the surgery is a perianal procedure, a spine procedure, a plastic procedure, or a combination thereof.

60. The device of claim 59, wherein the perianal procedure is a hemorrhoidectomy, pilonidal cyst or an anal fissure.61 . The device of claim 59, wherein the spine procedure is a microdiscectomy or a single level spinal decompression and fusion.

62. The device of claim 59, wherein the plastic procedure is a melanoma excision or liposuction.

63. A method of stabilizing an artificial airway in a subject, the method comprising: placing a supraglottic airway in a subject; placing a supraglottic airway support device on the supraglottic airway and the subject, wherein the supraglottic airway support device comprises: a support substrate configured to interface with the subject’s head; and a supraglottic airway interface integrated with the support substrate and configured to hold the supraglottic airway in a fixed position relative to the subject’s head.

64. The method of claim 63, wherein placing the supraglottic airway support device comprises: configuring the support substrate to interface with the subject’s head; and configuring the supraglottic airway interface to interface with the supraglottic airway.

65. The method of claim 64, wherein configuring the supraglottic airway interface comprises: configuring the supraglottic airway interface to hold the supraglottic airway in a fixed position relative to the subject’s head.

66. The method of any one of claims 63 to 65, wherein the subject is in a prone position.

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