NECK COLLAR FOR TREATMENT OF SLEEP APNEA

A collar for prevention of sleep apnea is disclosed. An illustrative collar includes upper and lower portions to provide a comfortable and generally air-sealed interface to the upper neck and jaw, and lower neck and chest, respectively, of the patient. In between, an intermediate section defines a chamber over the anterior neck to which negative pressure is applied, drawing tissue forward and away from the patient's airway, improving air flow for the patient and preventing sleep apnea.

BACKGROUND

Millions of people suffer from obstructive sleep apnea (OSA). OSA is a condition where the upper airway collapses during sleep and significantly limits or obstructs air entry into the lungs. The mainstay of treatment for OSA is continuous positive airway pressure (CPAP). This works by applying positive air pressure to the upper airway which consists of the nasal passages, mouth, nasopharynx, oropharynx, and hypopharynx. CPAP pressure opens the upper airway, allowing the sleeper to breathe easily without intermittent obstruction and interruption of airflow into the lungs.

CPAP pressure is delivered via a mask applied over the nose (nasal mask) or over the nose and mouth (full face mask) with air pressure tubing running from the mask to a CPAP machine. A good mask seal is desirable as high leak rates from air escaping around the sides of the mask are uncomfortable and may disrupt sleep. High leak rates may also cause CPAP treatment to be ineffective.

Some sleepers find using a mask at night uncomfortable and so have difficulty sleeping with one. Further, some sleepers will easily fall asleep using a CPAP mask only to discover that sometime during the night it has come off or that they have removed it surreptitiously. These problems clearly make CPAP therapy less effective than it otherwise might be. Depending on how compliance is defined and the duration of study, compliance rates may be as low as 50% or less.

Oral appliances for sleep apnea are known as well. Such products pull the lower jaw forward during sleep to prevent airway obstruction. However, teeth may shift over time, causing changes to bite and various dental problems. Some patients may experience headaches or other physical discomfort as the oral appliance holds the jaw in an unnatural position. Again, depending on how compliance is defined and the duration of study, compliance rates may be as low as 50% or less.

Obstructive sleep apnea is associated with a number of health difficulties including ranging from daytime drowsiness to increased blood pressure. Thus there remains a need to provide additional therapies that may supplant or supplement those which are already known.

Overview

The present inventors have recognized, among other things, that a problem to be solved is the desired for still further alternative treatments for sleep apnea. In an example, a collar is provided that is desired to maintain an open airway for the patient. In an example, negative pressure is applied via the collar to pull soft tissue away from the center of the throat, allowing for better breathing. Such negative pressure may be applied via an external apparatus such as a pump.

In some examples, the physical structure of the collar may aid in keeping the patient's jaw from dropping inferior and posterior relative to the chest, helping to avoid pharyngeal obstruction involving the tongue and soft palate. Such structural support, when combined with the positive atmospheric pressure seen by the nasopharynx, may also keep the soft palate in contact with the tongue, helping to keep both tongue and soft palate from obstructing the airway.

A first illustrative and non-limiting example takes the form of a collar for the treatment of sleep apnea comprising: a first end having a portion made of a soft, flexible material to provide a seal against the skin of the patient near the chin; a second end having a portion made of a soft, flexible material to provide a seal against the skin of the patient near the base of the neck; and a body between the first and second ends, the body having an inner wall for defining a chamber about the neck of the patient and at least one air channel associated with a first port in the inner wall.

Additionally or alternatively, the first and second ends may be configured such that the chamber is generally airtight to facilitate application of negative pressure to the neck of the patient to pull soft tissue away from the center of the throat, allowing the patient to breath.

Additionally or alternatively, at least one of the first or second ends may be made of silicone or a soft gel to facilitate patient comfort and a seal against the skin of the patient.

Additionally or alternatively, the body may comprise an inner layer of relatively more rigid material to maintain the chamber.

Additionally or alternatively, the first end may be configured to push open the soft palate by limiting movement of the jaw of the patient.

Additionally or alternatively, the body may include a back portion having a line of separation allowing the collar to be removed from and/or applied to the neck of a patient, and a front portion in which the first port is located.

Additionally or alternatively, the collar may further comprise a vent and a pressure sensor, the vent coupled to the air channel to allow release of pressure therein, wherein the pressure sensor is adapted to sense pressure in the chamber and/or air channel and open the vent to prevent over-pressurization.

Additionally or alternatively, the collar may further comprise a leak valve coupled to the inner wall and adapted to limit pressurization of the chamber.

Additionally or alternatively, the body may comprise a coiled support structure to allow longitudinal flexibility between the first and second ends, and lateral support to maintain the chamber.

Additionally or alternatively, the body may comprise a plurality of support structures in the form of rings, the rings being interrupted at the location of the line of separation.

Another example takes the form of system comprising a collar as in any of the preceding examples and an external vacuum motor coupled by a tube to a second port of the air channel.

Another example takes the form of a collar as in any of the preceding examples, further comprising a vacuum motor coupled to a second port of the air channel for applying a vacuum to the chamber.

A second illustrative non-limiting example takes the form of a method of treating a patient having a breathing disorder comprising: applying a collar to the patient's neck; and applying negative air pressure to the patient's neck via the collar.

In this second example, the breathing disorder may be obstructive sleep apnea.

A third illustrative non-limiting example takes the form of a method of treating a patient comprising making a collar to prevent sleep apnea by: obtaining one or more images of a region of the patient including the neck; and making a collar for treating sleep apnea using the obtained images to construct a collar having an upper end to provide an airtight and comfortable seal at the upper neck and/or jaw of the patient and a lower end to provide an airtight and comfortable seal at the base of the neck of the patient, with an intermediate section therebetween defining a chamber for applying negative pressure to the patient's anterior neck.

DETAILED DESCRIPTION

FIG. 1is a sagittal section view of the head and neck of a human patient. Certain anatomy of interest is highlighted for the patient10. The upper airway12can be seen extending up from the neck to the sinus cavity14and also through the mouth between the hard palate16and soft palate18, and tongue20. As the anatomy progresses inferiorly into the neck the esophagus22and trachea24divide, with the trachea24more anterior of the two.

FIG. 2is an axial section of a human neck at about the C4 vertebrae, with an illustrative device shown about the neck in order to illustrate the operation thereof. The neck50comprises the bony vertebral structure shown at52which defines the spinal column54. Anteriorly of the bony vertebral structure52is the trachea60, anterior of the esophagus64, with the thyroid gland62.

For some patients, excess tissue (typically fat) in the neck and or jaw region places pressure on the neck in certain positions, squeezing the trachea60and ultimately leading to certain forms of sleep apnea. Ordinary CPAP systems are designed to increase the air pressure within the trachea60(and other airways) in order to overcome the forces that cause sleep apnea, keeping the airway open. Some embodiments of the present invention, at least in part, avoid sleep apnea using a reversed approach.

As shown inFIG. 2, a device70may take the form of a neck collar that goes around the patient's neck. An anterior portion72of the device70is resilient, and is shaped to create a small cavity74over a portion of the anterior neck of the patient. Vacuum pressure is created in the cavity74to apply forces as shown at76that counteract the pressures that would otherwise close the airway60.

FIG. 3is a side view of an illustrative device on a patient. The patient100is shown with neck102, jawline104, base of the skull106, and upper chest108. About the patient's neck102is an illustrative device in the form of a collar110, which may be a neck collar similar in some respects to a cervical collar used for immobilizing the neck of a trauma patient, but with more flexibility and additional features discussed herein.

The collar110is configured for an air tight, or substantially air tight, seal against the patient's body at upper and lower ends thereof. A vacuum motor, which may be integral to the collar110or may be externally provided, causes negative pressure immediately around the neck and jaw, pulling the soft tissue away from the center of the throat to improve breathing, with a particular eye toward preventing the hypopneas and blood oxygen reductions associated with clinically significant sleep apnea. As noted above, the operation is the opposite of CPAP, which applies positive pressure inside the respiratory system of a patient, by applying negative pressure to areas of the patient that are linked to ease of breathing. In addition to the negative pressure, the collar110may support improved breathing by supporting the soft palette under the chin. The phrase “applying negative pressure” includes, in some examples, generating suction that pulls soft tissue.

The concept runs counter to the discussions of US PG Patent Application Publication No. 2007/0221231, which suggests that an adhesive may be used to pull on the neck. Use of adhesive, chronically, may become uncomfortable to the patient and may create points of strain and irritation at the edges thereof. Non-contact, negative air pressure is provided instead with some embodiments of the present invention. While adhesive may be used in some examples to aid in the creation of a seal, it is not the primary driver in affecting the soft tissue in the neck region in those embodiments that use adhesive.

Other prior devices have focused primarily on structural support, such as US PG Patent Application Publications No. 2003/0056785, and 2007/0256694 and/or a combination with electrical therapy and structural support as in US PG Patent Application Publication No. 2011/0230702. In some examples, an adhesive, such as a replaceable strip or strips of material permanently or temporarily coupled via adhesive, Velcro or snaps to the inside of the collar and having an adhesive such as that on tapes or bandages for application to the skin, may be used to aid in securing air-tightness or otherwise securing the collar on the patient. In other examples, no adhesive or strips/tape is used. Replaceable foam or gel pads, for example, may be provided at the upper and lower ends of the collar to achieve an air tight or mostly air tight seal.

Turning back again toFIG. 3, the collar110is placed over the neck of the patient, with the first or upper end112thereof extending generally over the jaw104of the patient with a flexible and elastic portion shown at116. The upper end112extends as well to approximately the lower margin of the cranium generally at106.

The second or lower end114of the collar110may generally reside near the upper chest of the patient. The lower end114may, for example, track the clavicle from the manubrium (or a location above the manubrium such as nearer the Adams Apple) generally to the lateral edge of the neck and then back to the top of the trapezius muscle group. The lower end114may, as shown, extend generally low along the back of the neck to a position about level with the Ti vertebra, though in other examples the lower end114may angle upward on the back of the patient to about the vertical middle of the neck (i.e., about C4 or C5, or higher or lower).

The upper end112and lower end114may be more pliable and softer than other regions of the collar110. For example, a multilayer structure may be provided at the upper and/or lower ends112,114with an outer layer of elastic material designed to achieve a hold, such as a stretchy fabric with elastic and inelastic fibers, while an inner layer is made of a gel material to provide a soft interface to the skin, optionally with foam, felt or other soft fabric on the inner layer to achieve an even softer interface.

Intermediately on the illustrative device, an anterior portion118has an inner wall that defines a chamber120to which negative pressure can be applied to preferentially draw tissue away from the center of the throat of the patient, making breathing easier. Though not shown, an air channel or channels may be provided as well on the body of the collar110to provide access to the chamber120for purposes of applying a vacuum or negative pressure thereto, as well as, optionally, to provide venting to prevent overpressure or to provide a slow air passage in the air chamber to avoid accumulation of sweat, for example, during sleep.

Two structures are shown at130,132that may be used throughout or for a portion of the collar110to achieve a semi-rigid structure. In the example shown, a square wave pattern is made of a first resilient material, such as a relative hard plastic or metal, with a softer material coating thereon. In a relaxed state, the pattern takes the form shown at130. When negative pressure is applied to one side, as shown at132, the horizontal parts of the pattern are pulled into tension, bringing the vertical parts into closer spacing, making the structure rigid in the vertical direction, while also limiting compression horizontally. The result, in an example, is that the collar section using such a structure (which may be understood as a set of outer circles and inner circles joined together with horizontal segments) becomes stiffer under the negative pressure influence. Such a support structure may be used, but is not necessary to the working of the invention.

FIG. 4is a rear view of an illustrative device with partial cut-away.FIG. 4shows another example of a collar200. A line of separation is shown at202which can be used to allow a patient to apply and remove the collar200without having to slide it over the head. To this end, straps are shown as at204,206which may be, for example, Velcro straps to secure the halves of the device on either side of the line of separation202to one another. Other securing mechanisms such as a buckle, a clip or locking mechanism, snaps, buttons, a releasable zip-line or ratchet, or adhesive strips may be used instead. In one example, the straps204,206are adjustable to allow the collar fit more closely or more loosely, to match patient comfort. Rather than a strap which extends across, the straps204,206may instead comprise a strap and buckle combination.

The internal structure of this example200includes a plurality of reinforcement bands212, separated by areas of soft material, as indicated in the cutout at210. For example, the bands212may be metal or stiff, resilient plastic, to provide structure to the collar200, with the soft material214provided to make the collar200less stiff than it would otherwise be.

In one example, the line of separation may integrate mating pieces, such as pins and holes, to ensure alignment thereof to prevent over-tightening of the collar200on the patient's neck, which could lead to discomfort, impairment of blood flow, or even asphyxiation. In an example, the collar200is designed to contact the patient only at the upper end, lower end, and rear portions thereof, without contact to the front side of the neck. In other examples, the collar200may have a defined area or chamber on the front of the patient's neck, specifically over the trachea, where the chamber (FIG. 3) is defined.

FIG. 5is a side view of an illustrative system on a patient. In this example, patient300has a collar310on his/her neck, with an upper first portion320, an intermediate section330, and a lower second portion340. The upper portion320is elastic and stretchy, with a soft inner wall adapted to be placed and held against the skin of the patient while providing a seal about the chin322of the patient. The lower portion340is elastic and stretchy, with a soft inner wall adapted to be placed and held against the skin of the patient while providing a seal about the base of the neck of the patient.

The intermediate portion330is stiffer and more resilient than the upper portion320and lower portion340. This stiffness and resilience allows the intermediate portion to define a chamber about the front of the neck, as shown at334. An air channel332is also provided into the chamber334. In this example, the air channel332couples to a port that is adapted to receive a tube352from an external air pump350. The air pump350applies negative pressure to the chamber334via the tube352, port, and air channel332. The negative pressure is used to apply negative pressure on the anterior neck, easing any restriction of the airway due to pressures from the patient's neck tissue, protecting the airway and reducing obstructions that can cause sleep apnea.

In general, known CPAP devices may provide in the range of 30-40 liters per minute of air flow to maintain the patient's internal airway at an elevated pressure to “blow open” the airway and avoid apnea/obstructions. In the present invention, it is anticipated that a good sealing system would only require a few milliliters of air flow per minute to maintain a negative pressure. Depending on the extent and strength of seal, as well as whether some amount of air flow is desired, the negative air pressure may yield a flow rate of up to one liter per minute or less. In other examples, the air flow may be in the range of less than 100 milliliters per minute, or less than 10 milliliters per minute, or in the range of 2-3 milliliters per minute. Total pressure may vary as desired and as is comfortable for a given patient. In an example, the negative pressure may be in the range of 7-12 millimeters water (approximately 70 to 120 Pa). In another example, the total negative pressure is in the range of 5-20 millimeters water (approximately 50 to 200 Pa). Higher or lesser negative pressures may be applied as desired and/or tolerated by the patient. The numeric ranges of this paragraph are merely illustrative; other ranges may also be in the scope of the present invention, and other measures may be used.

If desired, a pressure sensor may be provided to monitor pressure inside the chamber, and if further desired, a pressure release valve may be provided as a way of achieving emergency release (that is a manually actuated valve). In another example, a pressure valve is provided to bleed a small amount of air into the chamber to control maximum pressure while also allowing air circulation which may improve comfort. A wide variety of suitable pumps that can provide quiet and reliable operation are commercially available such as through Rena Aquatics.

InFIG. 5, the vacuum is applied using an external air pump350. Such a pump may be battery powered or powered using a plug-in to a wall outlet, as desired. An illustrative pump350may include circuitry to receive a signal from the collar (such as from a sensor associated with the collar) to detect one or more of pressure, moisture, humidity, temperature, or any other desirable feature (such as using an optical interface to such as a pulse oximeter to determine whether blood flow beneath the collar is pulsatile which would indicate that the pressure applied is not so high as to interfere with such blood flow) to determine whether the pressure beneath the collar is adequate and/or in a desired range. In some examples, a minimum air flow within the collar may be desired for comfort, or airflow within a general range, and pressure, humidity and temperature may be useful, all together or individually, to keep air flow at a desired level. Control circuitry, including for example a microcontroller or state machine, may be provided including machine or computer readable media, which may be non-transitory, containing instructions to monitor pressure or air flow and control the vacuum pump in accordance with preset parameters. A user interface may be provided on pump350, such as with a screen or analog or digital output, and/or the pump350may include wireless communication circuitry such as a Bluetooth™ antenna and/or chip (or any other suitable communication media and circuitry, such as using the Medradio band or other RF), to allow the user300to control the pump350with a user controller, which may be implemented on a smartphone for example, having its own communication circuitry or used in association with a plug-in controller or dongle.

FIG. 6is a side view of an illustrative integrated device on a patient, in this example, the pump is integrated in the collar. Specifically, patient400has a collar410having an upper portion410over the chin414, with an intermediate portion416defining an air chamber418having a port418coupled to an air channel420that is fluidly connected to an integrated pump422having an exit port424to allow air to be pumped out of the chamber418, maintaining negative air pressure on the anterior neck to improve and reduce airway constriction. The pump422may be as above in terms of the pressure and air flow provided. The pump422is shown mounted in the intermediate portion of the collar410, with the lower portion426provided as above. The pump422may instead be on the upper portion412or lower portion426, if desired. The pump422may be battery powered, using replaceable or rechargeable batteries, if desired.

An illustrative pump422may include circuitry to receive a signal from the collar (such as from a sensor associated with the collar) to detect one or more of pressure, moisture/humidity, temperature, or any other desirable feature (such as using an optical interface to such as a pulse oximeter to determine whether blood flow beneath the collar is pulsatile which would indicate that the pressure applied is not so high as to interfere with such blood flow) to determine whether the pressure beneath the collar is adequate and/or in a desired range. In some examples, a minimum air flow within the collar may be desired for comfort, or airflow within a general range, and pressure, humidity and temperature may be useful, all together or individually, to keep air flow at a desired level. Control circuitry, including for example a microcontroller or state machine, may be provided including machine or computer readable media, which may be non-transitory, containing instructions to monitor pressure or air flow and control the vacuum pump in accordance with preset parameters. A user interface may be provided on pump422, such as with a screen or analog or digital output, and/or the pump422may include wireless communication circuitry such as a Bluetooth™ antenna and/or chip (or any other suitable communication media and circuitry, such as using the Medradio band or other RF), to allow the user400to control the pump422with a user controller, which may be implemented on a smartphone for example, having its own communication circuitry or used in association with a plug-in controller or dongle.

As may be appreciated by the skilled artisan, the upper end412of the collar410abuts and, in the example shown, encircles a portion of the jaw at414. The more rigid intermediate portion416may physically improve airway management by preventing the jaw from dropping down in the region of the neck and constricting airflow. The soft palate may be supported by the upper end412of the collar410, for example, as an adjunct to the vacuum that is provided at chamber418. Such structural support, when combined with the positive atmospheric pressure seen by the nasopharynx, may also keep the soft palate in contact with the tongue, helping to keep both tongue and soft palate from obstructing the airway.

In an example, the collars as shown above may be manufactured by obtaining an image of the patient's neck, preferably with sufficient views to obtain a 360 degree view thereof with surface contours, to allow a collar to be manufactured by additive processes such as by 3D printing the collar. During such 3D printing, different areas of the device may be formed using different materials to achieve softer portions and harder or more rigid portions. In other examples, the rigid structure, such as bands shown above, may be formed separately and added to a 3D printed soft structure, where the softer structure is specifically configured for a given patient. In another example, the intermediate portion (FIGS. 5-6) may be a stock item or may come in a handful of sizes, while the upper and lower portions may be 3D printed or otherwise tailored to the given patient to account for the wide variety of jawlines and upper thorax structures of the patient population. In still other examples, the collar may come in a range of sizes and shapes for particular patients, where pre-use imaging may or may not be used to select a collar for a given patient.

FIG. 7is a side view of an illustrative device construction. Here, a plurality of interlocking rings are provided up and down on the device, which would allow for movement in the vertical direction as well as some twisting motion, while providing rigidity to offer a chamber that can apply negative pressure on the anterior neck. In the example, the collar internal structure is shown at500, with a cutout at502where the structure would interact with the skull (to avoid rubbing over bony tissue), with a first portion extending along the jawline as indicated at504. Interlocking rings are provided at510,520,530,540, having joints as shown below inFIGS. 8A-8B. The interlocking rings as shown would be covered on at least the interior side thereof with an inner lining adapted for comfort and sealing properties, such as using silicone at the tissue interface and a non-latex rubber or elastomer or other flexible, biocompatible polymer, for example, to define the hermetically sealed chamber as well as tissue interface surfaces.

FIGS. 8A-8Bshow a partial section view of a joint between layers of the embodiment ofFIG. 7. In an example shown atFIG. 8A, a first ring550couples to a second ring554at a joint defined by hooked portions552,556, that interact to provide a secure yet flexible attachment thereof. In an example shown atFIG. 8B, a single piece structure560with a joint formed by imparting a set of curves as shown at562between a first ring564and a second ring566.

FIGS. 9-10show a medial slice of each of two illustrative examples. As shown inFIG. 9, the collar600has an upper portion with jaw interface at602, and a chest/base interface at604. The overall structure has a thin, relatively strong or rigid core layer shown at610, with soft outer layer630and soft inner layer620. The core layer610may be of a rigid plastic to maintain overall shape of the collar600. The inner and outer layers may be any suitable material or may even have more than one layer of material using, for example, a non-latex rubber or a soft polymer, or even silicone and/or silicone gel.

As shown inFIG. 10, another alternative collar700has an upper portion with jaw interface at702, and a chest/base interface at704. The overall structure has a thin, relatively strong or rigid core layer shown at710, with soft outer layer730and soft inner layer720. The core layer710may be of a rigid plastic to maintain overall shape of the collar700. The inner and outer layers may be any suitable material or may even have more than one layer of material using, for example, a non-latex rubber or a soft polymer, or even silicone and/or silicone gel.

Further inFIG. 10, an additional inner layer is provided on the tissue contacting back side, as shown at740. This layer may be a replaceable component that is adapted to contact the back of the patient's neck. Over time, the tissue interface may become soiled and therefore can be removed and replaced to ensure continued comfort and to, for example, avoid smells and discoloration that can be caused by sweat and oils generated during use. A leak valve is shown at750, and may be used as described above to allow a small amount of air leakage into the chamber defined by the collar700, and a port is shown at760to allow a tube that in turn attaches to an air pump to be attached, in order to apply a vacuum to the chamber defined by the anterior portion of the collar. The air pump may be as in any of the above preceding embodiments.

The device may further include a grid or piece of spongy material770to allow the vacuum to be applied in a dispersed manner, preventing the patient's skin (which may be loose for some older or obese patients) from being sucked into the vacuum port. Element770may also be a replaceable component of the collar.

FIG. 11is a side view of another illustrative device. The collar800is placed on the neck802of a patient. As can be seen, the device has a posteriorly placed inflow valve at810to allow controlled air flow indicated at812into the interior of the collar800, while a pump820draws air out as shown at822. As noted above, such a construction allows air to circulate, possibly improving comfort. Air circulation may be constant or periodic such as in response to sensed pressure conditions, humidity, or at elapsed time intervals, as desired. A foam, gel, or otherwise soft interface is provided at the upper end830, as well as at the lower end840, of the collar, to provide comfort and a semi-airtight, or fully hermetic, seal at the upper and lower ends of the collar800.

An illustrative valve810and/or pump820may include circuitry to receive a signal from the collar (such as from a sensor associated with the collar) to detect one or more of pressure, moisture/humidity, temperature, or any other desirable feature (such as using an optical interface to such as a pulse oximeter to determine whether blood flow beneath the collar is pulsatile which would indicate that the pressure applied is not so high as to interfere with such blood flow) to determine whether the pressure beneath the collar is adequate and/or in a desired range. For the more integrated example ofFIG. 11, having the valve810and pump820as part of the collar itself, such sensors may be in or on the valve and/or pump820. The valve810and pump820may be electrically connected (via one or more wires, for example) or may communicate using a wireless protocol (such as Bluetooth™ Low Energy), or may operate independently. In some examples, a minimum air flow within the collar may be desired for comfort, or airflow within a general range, and pressure, humidity and temperature may be useful, all together or individually, to keep air flow at a desired level. Control circuitry, including for example a microcontroller or state machine, may be provided including machine or computer readable media, which may be non-transitory, containing instructions to monitor pressure or air flow and control the vacuum pump in accordance with preset parameters, in one, the other, or both of the valve810and/or pump820. The valve810and/or pump820may include wireless communication circuitry such as a Bluetooth™ antenna and/or chip (or any other suitable communication media and circuitry, such as using the Medradio band or other RF), to allow the user to control the valve810and/or pump820with a user controller, which may be implemented on a smartphone for example, having its own communication circuitry or used in association with a plug-in controller or dongle. Alternatively, a button or buttons may be provided on the collar800and/or the valve810and/or pump820to activate or change parameters, such as the degree of negative pressure applied by the system.

While the system is discussed herein primarily in the context of a device to treat sleep apnea, an acute trauma device may also be realized using similar principals. While tailoring to a particular patient by the use of imaging and additive manufacturing, or casting and molding processes discussed below may not be feasible for an acute case, the application of a collar about the neck of a patient as disclosed herein may be useful to help maintain an open airway in the event a breathing tube, for whatever reasons, cannot be used, is unavailable, or is contraindicated.

In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description.