Devices and methods for opening airways

Abstract

The present invention provides devices and methods for forming and / or maintaining a seal between a pump element and a vacuum chamber. The vacuum chamber device is configured to conform to a subject's skin at an external location that generally corresponds to the subject's internal soft tissue, for example, associated with the anterior triangle of the neck. The sealing device includes structural elements designed to optimize ease of use for the user while providing optimal sealing of the device components, which is accomplished by mechanisms that avoid excessive force during assembly and disassembly, while maintaining the chamber device's geometric integrity and airtight seal during operation of the device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 263,328, filed October 29, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] The following description of the background of the invention is provided merely to aid the reader in understanding the invention and is not admitted to describe or constitute prior art to the invention.

[0003] US Patent Nos. 5,343,878, 7,182,082, 7,762,263, 9,655,766, 10,780,017, and 10,874,577 describe various devices that are intended to utilize the application of external negative pressure to the outer surface of a patient's neck. The therapeutic appliance is provided having a surface configured to surround the outer area of ​​the neck, typically covering a portion of the upper airway. In certain embodiments, these appliances can provide a chamber body (e.g., a hollow space filled with air molecules) between the inner surface of the chamber body and the throat. The therapeutic appliance is operably connected to an air pump configured to generate a partial vacuum within the chamber body. Application of therapeutic levels of negative pressure to the chamber body can induce movement of the upper airway and relieve symptoms such as airway obstruction, e.g., snoring, sleep apnea, and complete or partial collapse of the airway.

[0004] In these "negative pressure" treatment devices and methods, it can be difficult to achieve a suitable fit between the elements of the device for an airtight seal that is also amenable to easy assembly and disassembly. For example, consider the fit between the chamber body of the treatment instrument and the air pump (designed to create and maintain a negative pressure differential relative to atmospheric pressure at a desired location on the patient). This is especially true for devices that are intended to be worn for extended periods of time each day, for example, and require frequent disassembly and assembly of parts for cleaning. Thus, the success of these negative pressure treatments is optimized by the device's ability to conform (bend, flex, flow, etc.) to various anatomical features (i.e., device compliance) through various movements, while also providing structural elements that support the elements of the device and allow the user to easily assemble and disassemble without compromising the leak-free seal of the device and device components during use. Ease of assembly and disassembly of the elements of the device, a comfortable interface between the device and the user to maximize user compliance with treatment, and a leak-tight seal of the device and its components should accommodate movement into different sleep positions without loss of the seal between the elements of the device and without loss of the seal between the device and the user. Summary of the Invention

[0005] The object of the present invention is to provide a sealing system for attaching an air pump element to a treatment device having a seal chamber body intended to be attached and sealed to an external tissue of a patient, such as the face, neck, areas around wounds, etc., the seal chamber body having a sealable aperture to which the air pump element is attached. The treatment device is particularly suitable for forming a seal chamber body configured to apply negative pressure to an external tissue of an individual to perform a targeted treatment. In doing so, the external negative pressure applied to the skin affects the underlying tissue, such as the tongue and other tissues around the upper airway of the neck. The treatment device of the present invention is preferably configured to be a fully body worn system.

[0006] In a first aspect, the present invention provides therapeutic devices configured to apply negative pressure to skin tissue of an individual. These therapeutic devices include: A chamber body, (i) a skin interface around a chamber body configured to provide a skin-contacting surface with an individual, wherein when the skin interface is in contact with the individual, the chamber body defines an exterior surface facing the ambient environment, an interior side facing the skin tissue, and an enclosed interior volume overlying the skin tissue enclosed by the chamber body; (ii) an aperture through the chamber body; (iii) a sealing interface around the aperture, a lip seal having a resilient sealing lip protruding toward the interior of the chamber body; a first recess rearward of the resilient seal lip relative to the aperture; a first backing support rearward of the first recess relative to the aperture; a second recess rearward of the backing support relative to the aperture; a second backing support rearward of the second recess relative to the aperture; a chamber body comprising: a seal interface; and wherein the lip seal and the first and second backing supports are configured as integral components of the chamber body; an air pump configured for insertion into the aperture from an exterior surface of the chamber body, the air pump having a first color interface surface, the air pump being operatively connected to the chamber body when inserted into the aperture, the air pump removing air from the seal space when energized, the air pump forming an airtight seal with the chamber body by biasing a resilient sealing lip into a first recess, the first color interface surface being accessible from an interior of the chamber body; a rigid or substantially rigid retainer collar comprising a continuous peripheral region configured for insertion into the second recess and a second collar interface surface configured for cooperative engagement with the first collar interface surface from within an interior surface of the chamber body, wherein insertion of the peripheral region into the second recess and engagement of the first and second collar interface surfaces reversibly retains the air pump and the retainer collar to the chamber body; Equipped with.

[0007] In certain embodiments, the therapeutic device of the present invention is configured and arranged to generate a negative pressure area on tissues of the anterior triangle of the neck, for example, for the purpose of treating conditions such as sleep apnea, snoring, or airway obstruction. Such devices may be referred to as negative airway pressure (NEP) therapeutic devices to distinguish them from positive airway pressure (PAP) therapeutic devices. In these embodiments, the therapeutic device may be configured such that the skin interface approximately conforms to a continuous contact area of ​​an individual defined by a first location approximately corresponding to a first gonion on one side of the individual's mandibular body, a second location approximately corresponding to the individual's mental prominence, a third location approximately corresponding to a second gonion on the other side of the individual's mandibular body, and a fourth location approximately corresponding to the individual's thyroid cartilage. Alternatively, such a therapeutic device may be in the form of a continuous collar as disclosed in U.S. Pat. No. 1,078,017 B2, which is hereby incorporated by reference.

[0008] In other embodiments, the treatment device of the present invention is configured and arranged to generate a negative pressure region on the wound. Such a device may be referred to as a negative pressure wound therapy (NPWT) device. See, for example, WO2013175306, WO2016174048, WO2017153357, WO2018060417, WO2019129581, and WO2020187971. Each of these documents is hereby incorporated by reference.

[0009] In certain embodiments, the lip seal is positioned at or very near the exterior surface of the chamber body. In a most preferred embodiment, the resilient seal lip contacts the air pump when the air pump is mounted within the aperture, but does not contact the retainer collar when the peripheral area is mounted within the second recess. In certain embodiments, the distal end of the resilient seal lip includes a rounded edge at the point of contact with the air pump.

[0010] In certain embodiments, the first and second collar interface surfaces cooperate to provide a reversible locking mechanism for orienting the air pump relative to the retainer collar. By way of example, the first and second collar interface surfaces may be in the form of a cooperating twist coupling, such as by providing a first bayonet connector on the air pump and a second corresponding second bayonet connector on the retainer collar. When one bayonet connector is rotated relative to the other, a pin on one bayonet connector engages a corresponding slot on the other bayonet connector, acting as a stopper and lock until the pin is pushed out of the slot.

[0011] In preferred embodiments, the second recess extends between the first and second backing supports at least to, and more preferably beyond, the bending moment of the resilient seal lip, In these embodiments, installation of the retainer collar preferably causes the continuous peripheral region to insert into the second recess until the second recess is fully occupied by the continuous peripheral region.

[0012] In certain embodiments, the air pump and / or the retainer collar comprise mounting points that engage with receiving points on the chamber body to both secure the pump module to the chamber body and lock it in a particular orientation. By way of example only, the retainer collar can be provided with posts, tabs, or other similar structural features that are configured to insert into corresponding slots on the interior side of the chamber body. The retainer collar can be held to the collar by a frictional component of the interaction between the structural features and the corresponding slots. The air pump can then be inserted into the aperture and attached to the retainer collar using a mechanism (e.g., a bayonet mount) that restricts the air pump to a particular reversibly locked orientation on the retainer collar upon rotation of the air pump. A skilled technician will appreciate that this arrangement can be reversed, with structural features provided on the chamber body that engage corresponding slots on the retainer collar. Alternatively, structural features can be provided on the air pump and corresponding slots provided on the exterior surface of the chamber body. This description is by way of example only, and those skilled in the art can readily identify similar means for securing the pump module to the chamber body in a particular orientation.

[0013] In one embodiment, the retainer collar includes mounting points that engage with receiving points on the chamber body to secure the air pump to the chamber body, while the air pump and retainer collar include thread and groove elements to allow a twist coupling between the air pump and the retainer collar that reversibly stops and locks relative to the chamber body, and does so without a specific end orientation of the air pump.

[0014] In another embodiment, the retainer collar includes mounting points that engage with receiving points on the chamber body to secure the air pump to the chamber body, while the air pump and retainer collar include mechanical (e.g., detents or cams) or magnetic means to resist or prevent insertion and / or rotation of the air pump into a reversibly locked orientation relative to the retainer collar.

[0015] The term "rigid" as used herein means, for rubber, plastics, and other non-metallic materials that are hardness tested in accordance with ASTM D-2240, a Shore D hardness of at least 75 in accordance with ASTM D-2240, and for other materials, a hardness value in accordance with standard methods that provides protection to the user equivalent to the Shore D hardness described herein. The term "substantially rigid" as used herein means, for rubber, plastics, and other non-metallic materials that are hardness tested in accordance with ASTM D-2240, a Shore D hardness of at least 60 in accordance with ASTM D-2240, and for other materials, a hardness value in accordance with standard methods that provides protection to the user equivalent to the Shore D hardness described herein. Thus, the term "substantially rigid" would include, for example, a Shore D hardness of at least 65 in accordance with ASTM D-2240, for rubber, plastics, and other non-metallic materials that are hardness tested in accordance with ASTM D-2240.

[0016] Such rigid or substantially rigid materials may include, for example, polymeric materials such as polypropylene, polyethylene, polybutylene terephthalate, acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), and ABS / PC alloys. Desirable properties of rigid or substantially rigid materials include, for example, one or more of hardness, toughness, low density (i.e., lightweight), and inertness (such as to minimize skin irritation, rashes, and the like). As a result, the rigid or substantially rigid material(s) may include, for example, at least one of metal, natural or synthetic rubber compounds with reinforcing fibers (such as Kevlar® pulp), or Kevlar®. The rigid or substantially rigid material(s) may incorporate advances in the field of nanotechnology. In one embodiment, the cage member 102 includes a substantially rigid material, thermoplastic polyurethane ("TPU").

[0017] As used herein, the terms "external region" and "external surface" of an individual refer to a portion of the external skin surface. Tissues targeted for negative pressure treatment may be tissues underlying this external surface, including the upper airway and associated tissues, wounds on the external surface, etc. In various embodiments, the treatment device is configured to provide optimized fitting parameters, such as seal, comfort, and localized device compliance, throughout all anatomical points selected to conform to the target body site.

[0018] Any type of air pump may be used in the present invention as long as the pump is capable of achieving a therapeutic level of vacuum. Preferred therapeutic vacuum levels range from about 7.6 cm H2O to about 61 cm H2O, preferably from about 20 to about 45 cm H2O. In certain embodiments, the air pump includes a piezoelectric material configured to provide a vibratory pumping motion. The vibratory pumping motion preferably operates at a frequency greater than 500 Hz, and most preferably at a frequency greater than 20,000 Hz, i.e., a frequency above the frequency range of most human hearing. In certain embodiments, the vacuum source may be variably used to maintain a therapeutic level of vacuum within a specified range rather than a single value.

[0019] In certain embodiments, the treatment device includes one or more venting elements configured to provide a controlled airflow within the chamber body when the chamber body is fitted to an individual and a therapeutic level of negative pressure is applied within the chamber body. The airflow is preferably between about 10 mL / min and about 200 mL / min, most preferably between about 20 mL / min and about 100 mL / min, and even more preferably between about 40 mL / min and about 80 mL / min. In one embodiment, the venting element can include an aperture and, optionally, a filter element within the aperture, the filter element comprising a pore size of about 0.25 μm or less, such as a pore size of about 0.1 μm. The aperture can be provided as a feature of the chamber body itself or can be a feature of the air pump. The filter element can be configured as a replaceable element. The level of airflow can be maintained at a constant value. Alternatively, the level of airflow can be variable.

[0020] In various embodiments, the venting element may include a critical orifice in either the chamber or the air pump, or both, that allows for a flow rate of approximately 10-60 mL / min, more preferably 30-50 mL / min, at a target negative pressure value of 30 cm H2O. In certain embodiments, the level of airflow is tied to a therapeutic level of vacuum, i.e., higher vacuum levels may be accompanied by higher airflow levels, due to the pressure differential between the atmospheric side of the venting element and the interior of the chamber body.

[0021] For purposes of this application, the terms "about" and / or "approximately" refer to + / - 10%, more preferably + / - 5%, and most preferably + / - 1% of any given value. [Brief description of the drawings]

[0022] [Figure 1]FIG. 1 is an exploded view of an exemplary embodiment of the device, including a chamber body 100, a chamber body inner surface 103, a chamber body outer surface 105 facing the ambient air, a skin interface surface 107 designed to contact the periphery of a user's treatment site, a lip seal element 109, a sealable aperture 110, a retaining element fixation recess 111, an air pump element 120, a pump element sealing surface 123, a pump element bayonet mechanism 125, a rigid or substantially rigid retainer collar 130 (with chamber body support mechanism(s) 133, a retaining element mounting point mechanism 135 in the form of a post, and a continuous peripheral region 137 providing a lip seal reinforcement element). [Diagram 2] FIG. 1 is a rear view of an exemplary embodiment of a chamber body 100, showing an inner surface 103 of the chamber body, an outer surface 105 of the chamber body that faces the ambient air, a skin interface 107 designed to contact the periphery of a user's treatment site, a lip seal element 109, a recess 111 configured to receive a retaining element mounting point post 135, a channel 113 configured to receive and engage a retainer collar, and a sealable aperture element 110. [Diagram 3] FIG. 1 is a front view and exemplary embodiment of a device including a chamber body 100, an outer surface 105 of the chamber body that faces the ambient air, a lip seal element 109, a sealable aperture 110, and a recess 111 configured to receive a retaining element mounting point post 135. [Figure 4] FIG. 1 is a rear view of an exemplary embodiment of the retainer collar 130, including the chamber body support feature(s) 133, the mounting points 135, and the bayonet feature 139, which includes the bayonet stop 140. The rear of the retainer collar is the side of the retainer collar that is distal to the aperture and air pump. [Diagram 5]FIG. 1 is a front view of an exemplary embodiment of a retainer collar 130 including chamber body support feature(s) 133, mounting points 135, cylindrical perimeter region 137, and bayonet feature 139 including bayonet stop 140. The front side of the retainer collar is the side of the retainer collar proximal to the aperture and air pump. [Figure 6] FIG. 1 is a rear view of an exemplary embodiment of an air pump 120 including a pump housing, a sealing surface 123 on the housing, and a bayonet mechanism 125 including a bayonet detent 127. [Figure 7] 1 is a cross-sectional view of an exemplary embodiment showing the chamber body 100, the relative position of the sealable aperture 110, the inner surface 103 of the chamber body, the outer surface of the chamber body facing the ambient air 105, the lip seal element 109 including the resilient sealing lip of the lip seal, the first recess 117 rearward of the resilient sealing lip, the first backing support 157, the second recess 113 (shown filled by a continuous peripheral region of the retainer collar), the second backing support 159, the lip seal contact surface 115, the apex 119 of the first recess, and the retainer collar 130 including the continuous peripheral region 137 inserted into the second recess. [Figure 8] 8 is a cross-sectional view of an exemplary embodiment similar to FIG. 7, in which an air pump 120 is installed in the aperture 110 of the chamber body 100. [Figure 9] 1 is an exemplary embodiment of the present invention showing a horizontal cross section of a chamber body 100, an inner surface 103 of the chamber body, an outer surface 105 of the chamber body facing the ambient air, a surface 107 designed to contact the periphery of a user's treatment site, a lip seal element 109, a sealable aperture 110, a recess 111 configured to receive a retention element mounting point post 135, and a second recess 113. [Figure 10]An exemplary embodiment of the present invention showing a horizontal cross section of a chamber body 100, an inner surface 103 of the chamber body, an outer surface 105 of the chamber body facing the ambient air, a lip seal element 109, a sealable aperture 110, a recess 111 configured to receive a retaining element mounting point post 135, a first recess 117, and a first backing support 157 and a second backing support 159 defining a second recess 113. [Figure 11a] 1 is an exemplary embodiment of the invention, showing a horizontal cross section (without air pump 120) of chamber body 100, including chamber body inner surface 103, chamber body outer surface 105 facing the ambient air, and sealable aperture 110. Also shown is detail 215, further showing resilient sealing lip 109 of the lip seal, retaining element 137, lip seal contact surface 115, first recess 117, first recess apex 119, retainer collar 130, first backing support 157 and second backing support 159 that define second recess 113. [Figure 11b] 1 is an exemplary embodiment of a close-up view of detail 215 showing a horizontal cross section of chamber body 100 (without air pump 120 installed) including retainer collar 130. Also shown is width dimension 140 of second recess (described below), radius point 141 of lip seal contact surface, distance dimension 143 that second recess 113 (and thus continuous peripheral region 137 of retainer collar 130) terminates at radius 150 and extends beyond apex 119 of lip seal 109 having apex radius 153, width dimension 145 of first recess measured from apex of lip seal radius to pump contact point on lip seal 109, width dimension 149 of resilient sealing lip 109 of lip seal, angle 151 of lip seal 109 in uncompressed state (i.e., prior to insertion of air pump 120), and first backing support 157 and second backing support 159 that define second recess 113. [Figure 12] An exemplary embodiment of the present invention shown in FIG. 11b shows a horizontal cross section of the chamber body 100 with the air pump 120 installed through the sealable aperture, illustrating the compressed dimension 155 of the lip seal when the pump housing is installed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The present invention and its various features and advantageous details will be more fully described with reference to the non-limiting embodiments shown in the accompanying drawings and detailed in the following description. It should be noted that the features shown in the drawings are not necessarily drawn to scale. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the present invention. The examples used herein are merely intended to facilitate an understanding of how the present invention may be implemented and further to enable those skilled in the art to implement the present invention. Thus, the examples should not be construed as limiting the scope of the present invention. In the drawings, like reference numerals indicate corresponding parts throughout the several views.

[0024] In the present invention, an air pump connection seal system is designed for a negative pressure therapy device that maximizes ease of use (i.e., assembly and disassembly) and sealing efficiency, ultimately optimizing device effectiveness and user compliance. Although described below as being used to open the upper airway when placed on a subject's neck on a surface that generally corresponds to the subject's upper airway, the exemplary application of this technology is not meant to be limiting.

[0025] An exemplary treatment device of the present invention comprises a chamber body, a skin interface that integrates with the edge of the chamber body along the circumferential direction of the skin interface to form an airtight joint between the skin interface and the chamber body, and an air pump element attached to the chamber body through a sealable aperture in the chamber body. The chamber body thus forms an air-filled dome / chamber of the treatment device. The chamber body is preferably flexible to accommodate the contours of various anatomical locations. Non-limiting examples of materials suitable for constructing the chamber body include plastics, metals, and elastic materials such as silicone, rubber, or urethane.

[0026] The contact surface of the skin interface may have an adhesive, foam, or other soft material located thereon. These elements are configured to minimize pressure variation along the individual's skin and maintain a substantially uniform contact pressure throughout all contact points of the treatment device on the patient. "Minimal pressure variation" means that the pressure at any point between the contact surface of the skin interface and the patient's tissue varies by no more than about 20%, preferably no more than about 10% or no more than about 5% from the average pressure across the entire contact surface. As used herein, the outer contact surface is the surface of the skin interface of the treatment device that contacts the individual's skin, forming the contact surface and sealing surface of the treatment device.

[0027] In the exemplary embodiment described herein, the skin interface is configured to conform to the contours of the treatment device, which itself is configured to generally conform to the individual from a first position that generally corresponds to a first gonion on one side of the individual's mandibular body, to a second position that corresponds to the individual's mental process, to a third position that corresponds to a second gonion on the other side of the individual's mandibular body, and to a fourth position that corresponds to the individual's thyroid cartilage, and then back to the first position that corresponds to the first gonion. As used herein, "gonion" refers to the approximate anatomical location of the mandibular angle on either side of an individual's mandible. As used herein, "mental prominence" refers to the approximate anatomical location of the prominence of the chin, the center of which may be depressed, but the sides are elevated to form the mental tubercle. As used herein, "thyroid cartilage" refers to the approximate anatomical location of the large cartilage of the human larynx.

[0028] The term "seal" as used in this context does not necessarily mean that a perfect seal is formed between the therapeutic device and the contact surface of an individual. Rather, "seal" refers to the portion of the device that engages with the wearer and maintains a therapeutic level of vacuum. Some leakage in the seal may be tolerated as long as the desired negative pressure can be achieved and maintained. Preferred operating vacuum levels range from 7.6 cm to about 61 cm of water. Preferred forces applied to the tissues of the user's neck to assist in opening the upper airway range from about 0.5 kilograms to about 6.68 kilograms. As used herein, the terms "about" and "approximately" refer to any value + / - 10% of that value.

[0029] The dome / chamber surrounded by the chamber body provides a finite volume that is evacuated by an air pump to achieve the desired therapeutic level of partial vacuum. Once created, the partial vacuum decays at a constant rate, thereby providing a controlled level of air leakage from air leaking past seals into the chamber body and / or through mechanisms integrated into the dome or air pump. In certain embodiments, the chamber body is 0.5-12 in. 3 Preferably, the leakage is 0.005 to 0.5 in. 3 / min (0.082 to 8.194 mL / min) or less, and most preferably about 0.01 to 0.1 in 3 / min (0.164 to 1.639 mL / min).

[0030] The treatment device may include one or more venting elements. As used herein, a venting element is an aperture through the treatment device that provides airflow into the chamber body when the chamber body is fitted to an individual and a therapeutic level of negative pressure is applied within the chamber body. The aperture(s) may be at any suitable location on the device. In some embodiments, the aperture(s) may be located at the top of the chamber body near positions 1 and 3 on the individual. In another embodiment, the aperture(s) may be located within an air pump. The venting element(s) may simply be a fixed critical orifice, in which case an airflow of about 10 mL / min to about 60 mL / min is achieved when the chamber body is fitted to an individual and a therapeutic level of negative pressure is applied. Alternatively, the venting element may be an aperture into which a filter element can be inserted to create a filtered airflow, in which case an airflow of about 10 mL / min to about 60 mL / min is achieved when the chamber body is fitted to an individual and a therapeutic level of negative pressure is applied. The filter element is a replaceable element and may include a pore size of about 0.25 μm to 0.1 μm, and when the chamber body is fitted to an individual and a therapeutic level of negative pressure is applied, an air flow of about 10 mL / min to about 60 mL / min is achieved. In certain preferred embodiments, the air flow is about 30 mL / min to about 50 mL / min.

[0031] In certain embodiments, the chamber body may include features that help further prevent localized collapse, bottoming out, and force transmission from one area to another of the treatment device. These may be assisted by structural elements of a seal system for connecting the air pump to the chamber, such as the chamber body support feature 133 shown in FIG. 1. In the absence of localized points of flexibility, a rigid chamber body may create situations where, when subjected to force, external pressure creates high contact pressure points, such as rolling onto a pillow or the like, causing a bottoming event on the device. Or, even more so, a rigid chamber body may create situations where external pressure on one side of the device creates a force transmission to the other side of the device. Such an event may result in discomfort, dislodgment of the device, or both.

[0032] The chamber body is operatively connected to an air pump to generate a therapeutic level of negative pressure within the chamber body. The air pump can be of any type suitable for generating a therapeutic level of negative pressure, such as a positive displacement pump, an impulse pump, a velocity pump, etc., which may include a manual squeeze valve, a rotary pump, a lobe pump, a vibratory pump, etc. In certain embodiments, the air pump includes a piezoelectric material configured to provide a vibratory pumping action, the vibratory pumping motion operating at a frequency greater than 500 Hz.

[0033] The air pump may be a separate component connected to the chamber body via a hose or tube, or may be configured integrally with the chamber body. The air pump may be connected to the chamber body in any suitable manner, for example, the air pump may be external to the chamber body and connected via a hose or tube, for example, fixed to the bedside or battery-powered and wearable by the patient. In certain wearable aspects, the air pump is configured to be integrated with the chamber body. For example, the air pump may be configured to be inserted into a sealable aperture in the chamber body, where the air pump fits snugly into the sealable aperture to form a seal. As used herein, a sealable aperture is an opening through an element of the device that can be closed or sealed from one side or the other by another element of the device to form an air-tight or water-tight seal.

[0034] The seal between the air pump and the sealable aperture of the chamber body comprises a lip seal. A lip seal, as used herein, is a sealing feature comprising a resilient sealing lip that extends into the sealable aperture at an angle, such that when the air pump element is inserted into the sealable aperture, the lip seal contacts the air pump housing. Compression of this lip seal during insertion creates an airtight seal between the air pump and the chamber body. The lip seal feature can be an integral, single, or separate part of the air pump, the chamber body, or both. In certain embodiments, the lip seal is provided as a component of the air pump. However, in a preferred embodiment, the lip seal is an integral feature on the inner periphery of the sealable aperture of the chamber body.

[0035] The properties of the seal formed by this compression of the lip seal can be influenced and optimized by several factors. These properties are influenced by the choice of material and the durometer, length, thickness, taper, contact radius of the lip seal element, as well as the amount of interference between the pump and the lip seal, as described below. For example, a tighter or looser fit can be achieved by decreasing or increasing the clearance between the air pump housing and the sealable aperture, and / or by increasing or decreasing the durometer of the lip seal element, respectively. Other factors that can help optimize the seal between the features of the device can also include increasing or decreasing the length of the resilient seal lip and / or the length of the portion of the resilient seal lip that actually contacts the air pump. Increasing or decreasing the thickness of the lip seal element can also help to stiffen or soften the bending moment of the lip seal element, respectively.

[0036] In preferred embodiments of the invention, the sealing mechanism of the device is optimized to allow for ease of multiple assembly / disassembly events, which may include insertion and / or removal of the air pump into the sealable aperture, and in some embodiments, rotation of the air pump in the sealable aperture when assembled and locked into a functional orientation. The dimensions of the device mechanism and the durometer of the flexible sealing elements should accommodate assembly / disassembly events over the life of the device, thereby providing sufficient sealing of the device components. These dimensions allow for no leakage between device components and the application of therapeutic levels of pressure during treatment, while not being so tight or constricting as to impede the user's ability to assemble or disassemble the device components.

[0037] The lip seal design shown in the figures is optimized to provide a reliable seal that resists leakage caused by movement and flexing of the chamber body while allowing for easy assembly / disassembly. Friction between the lip seal and air pump elements is optimized and minimized to allow for easy rotation of the pump during assembly / disassembly while also preventing the retainer collar from dislodging within the chamber during assembly. A locking mechanism such as a bayonet mount to the internal retainer collar is preferably used to secure the pump, not only ensuring proper positioning between the lip seal elements and the pump contact surfaces but also preventing over-tightening of the connection.

[0038] Since the chamber body is typically made of a flexible material, the reinforcing structure may be provided as a retaining element to both secure the air pump to the flexible chamber body and also provide structural support to support the chamber itself and / or isolate the aperture from movement that occurs within the flexible chamber during use. As used herein, a retaining element is defined as a rigid element designed to engage and secure the air pump element within the aperture of the chamber body. Engagement may be achieved by friction, a snap fitting, a rotatable fitting such as a bayonet fitting, or the like.

[0039] In certain embodiments, the flexible chamber body of the pressure containment structure can be mechanically supported by structure(s) that can be formed as separate element(s) including one or more structural members shaped to generally fit within the interior of the pressure containment structure, thereby preventing collapse of the flexible chamber body. The structural elements can also be integrated into a releasably securable retaining element.

[0040] 1-6, in a preferred embodiment of the device, the device comprises a chamber body 100 defining an interior volume and having an inner surface 103 facing the skin surface and an outer surface 105 facing the ambient air. The chamber body comprises a skin-interfacing surface 107 designed to contact the perimeter of a treatment site on a user, a lip seal mechanism 109, an aperture 110 configured to receive an air pump, a recess 111 (described below), and a retention element channel 113.

[0041] The device further comprises a pump element 120 including a first collar interface surface 123, shown in the figures as including a first bayonet connector 125, and a retainer collar 130 including chamber body support feature(s) 133, mounting points 135, a continuous peripheral region 137 which forms a lip seal reinforcement element in use, and a second bayonet connector 139.

[0042] The device is assembled by inserting the pump element 120 into the aperture 110 of the chamber body 100 and securing the pump element to the chamber body from inside the chamber body by engagement with the retainer collar 130. The retainer collar includes a mounting point 135 that fits into a retainer element securing recess 111 in the chamber body. The fit between the retainer element securing recess 111 and the mounting point 135 is preferably tight enough to overcome the force of inserting the air pump element 120 into the chamber body 100, such that the retainer collar 130 remains integral to the flexible chamber body 100 during assembly. However, the fit between the retainer element securing recess 111 and the mounting point 135 also allows for quick and easy removal of the retainer collar 130 upon inversion of the flexible chamber body 100 when the air pump element 120 is removed.

[0043] A locking and / or orientation mechanism may be provided, for example, so that the air pump 120 is aligned with the bayonet feature 139 (FIGS. 4 and 5) of the retainer collar, inserted into the sealable aperture 110 and retainer collar 130, and rotated until the bayonet feature 125 of the air pump reaches the bayonet stop feature 140 (FIGS. 4 and 5) of the retainer collar. The sealing surface 123 of the air pump mates with the lip seal 109 of the chamber body 100 to form an airtight seal.

[0044] In certain embodiments, the lip seal mechanism 109 may further substantially isolate the seal mechanism from structural loads generated by the chamber body during use by one or more structural members. These structural members may be integrated, separate, or unitary. For example, in FIG. 8, the sealable aperture 110 of the chamber body 100 comprises a resilient sealing lip 109 of the lip seal and a first recess 117 into which the lip seal element can be deflected by the insertion of the air pump element 120, the recess comprising an apex 119. The lip seal element 109 may be thin at the pump housing contact point 115 / 123, and then gradually increase in thickness as the lip seal element reaches the apex of the first recess 119. The first recess 117 is backed by a first backing support 157, a second recess 113 configured to receive the continuous peripheral region 137 of the retainer collar 130 as a supporting structural element, and a second backing support 159. Thus, the first backing support 157 and the second backing support 159 define the second recess 113 .

[0045] The retainer collar may be in the form of a releasably securable rigid or semi-rigid retaining element that is configured to be secured within the flexible chamber body and provide rigidity properties to the aperture, thereby serving to maintain the shape of the aperture and the lip seal mechanism. For example, as seen in Figures 5, 7, 8, 11, and 12, the retainer collar 130 includes an annular continuous peripheral region 137 that inserts into the second recess 113 of the chamber body 100. To operate properly, the inner diameter of the retainer collar must fit snugly against the outer diameter of the second channel 113. The protrusion provided by the peripheral region 137 has an insertion depth dimension 143 that extends at least to the location of the maximum bending moment on the resilient sealing lip 109 of the lip seal, and more preferably extends beyond the bending moment of the lip seal, as shown in Figure 11b.

[0046] Engagement and proper sealing between the inner diameter of the releasably securable retainer collar 130 and the inner diameter of the retaining element channel 11,3 isolates the aperture 110 from movement of the flexible chamber body 100, thereby preventing the seal from being broken during use of the device.

[0047] In a preferred embodiment of the present invention as seen in FIG. 11b, the flexible chamber body 100 may be formed from a molded silicone rubber Shore A durometer of about 20-60, more preferably about 30-40, and may have a retention element channel with a width dimension 140 that is about 1.03 millimeters wide, the retention element channel with a radius 150 at its apex of about 0.52 millimeters, the lip seal feature 109 with a length dimension 147 that is about 1.77 millimeters and a width dimension 149 that is about 0.60 millimeters thick, and the first recess apex extends outwardly from the retention element channel when the pump is not installed. 12, with a radial dimension 153 of approximately 0.4 millimeters, a pump housing contact seal surface dimension 141 with a radius of approximately 0.12 millimeters, with an angular dimension 151 from the surface to the sealable aperture of approximately 60 degrees, and when the pump housing is inserted into the sealable aperture of FIG. 12, the lip seal mechanism 109 contacts the sealing surface of the air pump 115 and biases inwardly toward the retainer collar 130 with a compressed dimension 155 of approximately 0.37 millimeters, thereby forming a seal between the air pump 120 and the lip seal element 109 to prevent air flow therethrough when a therapeutic level of negative pressure is applied within the chamber.

[0048] In certain aspects of the invention, one or more protrusions, tabs, and / or recesses are present on the chamber body, skin interface, and / or air pump element of the treatment device, which provide one or more guidance mechanism(s) that ensure proper orientation of, or fit between, one or more device elements. The tongues, tabs, and / or recesses can be utilized as part of a sensor system to determine various parameters associated with the use of the treatment device. These parameters can include, but are not limited to, compatibility of a particular air pump element with a treatment device element (e.g., serving as a recognition mechanism) and correct placement of the air pump element within the aperture of the chamber body. For example, one or more of these protrusions, tabs, or recesses can be located on the chamber body as a guide mechanism for the air pump element, such that the air pump element or recess on the chamber body will receive a protrusion or tab element on the chamber body or air pump element only when the air pump element is inserted into the sealable aperture in the correct orientation. This list is not meant to be limiting.

[0049] "User compliance" as used herein refers to a patient's adherence to prescribed usage of a therapeutic device, for example, usage of the device throughout a sleep cycle.

[0050] "Device compliance" as used herein refers to the ability of a device, or elements of a device, to accommodate variations in the device, such as bending, twisting, compression, and / or expansion, in response to application and use of the device, including anatomical variations in the patient.

[0051] Aspects of the device may be made of rigid or substantially rigid materials. A skilled artisan will appreciate that numerous polymers may be used, including thermoplastics, some thermoset plastics, and elastomers. Thermoplastic materials become flowing liquids when heated and solids when cooled, so the materials can often withstand multiple heating / cooling cycles without losing mechanical properties. Thermoset materials are made from prepolymers that react and irreversibly harden into a solid polymer network. Elastomers are viscoelastic materials that exhibit both elastic and viscous properties and may be either thermoplastic or thermoset. Common thermoplastics include PMMA, cyclic olefin copolymers, ethylene vinyl acetate, polyacrylates, polyaryletherketones, polybutadienes, polycarbonates, polyesters, polyetherimides, polysulfones, nylons, polyethylenes, and polystyrenes. Common thermosets include polyesters, polyurethanes, duroplasts, epoxy resins, and polyimides. This list is not meant to be limiting. Functional fillers such as talc and carbon fibers may be included to improve the stiffness, operating temperature, and shrinkage of the part.

[0052] Aspects of the device may be formed using several methods known to those skilled in the art, including, but not limited to, injection molding, machining, etching, 3D printing, etc. In a preferred embodiment, the base of the test device is injection molding, which is a process of molding thermoplastic and thermosetting materials into molded products of complex shapes at high production rates and with good dimensional accuracy. The process usually involves injecting a metered amount of heated and plasticized material under high pressure into a relatively cool mold, in which the plastic material solidifies. Resin pellets are fed through a heated screw and barrel under high pressure. The liquefied material travels through a runner system into the mold. The mold cavity determines the external shape of the product, while the core determines the internal shape. When the material enters the cooled cavity, it begins to replasticize, returning to a solid state and the configuration of the finished part. The machine then ejects the finished part or product.

[0053] Those skilled in the art will appreciate that the conception underlying the present disclosure may be readily utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.

[0054] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The examples provided herein are representative of preferred embodiments and are not intended to limit the scope of the invention.

[0055] It will be readily apparent to those skilled in the art that various substitutions and modifications can be made to the invention disclosed herein without departing from the spirit or scope of the invention.

[0056] All patents and publications mentioned in this specification are indicative of the level of those skilled in the art to which this invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

[0057] The invention illustratively described herein may suitably be practiced in the absence of any element or elements, limitation or limitations not specifically disclosed herein. Thus, for example, in each example herein, any of the terms "comprising", "consisting essentially of" and "consisting of" may be replaced with any of the other two terms. The terms and expressions employed are used as terms of description, not of limitation, and in the use of such terms and expressions, there is no intention to exclude equivalents of any of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention as claimed. Thus, although the present invention has been specifically disclosed by preferred embodiments and optional features, it should be understood that those skilled in the art may make modifications and variations of the concepts disclosed herein, and such modifications and variations are deemed to be within the scope of the invention as defined by the appended claims.

[0058] Other embodiments are within the scope of the following claims.

Claims

1. 1. A negative pressure therapy device, comprising: A chamber body, (i) a skin interface around the chamber body, the skin interface configured to provide a skin-contacting surface with an individual, wherein when the skin interface is in contact with the individual, the chamber body defines an exterior surface facing the ambient environment, an interior surface facing skin tissue, and an enclosed interior volume overlying the skin tissue, the interior volume being enclosed by the chamber body; (ii) an aperture through the chamber body; (iii) a sealing interface around the aperture, the sealing interface comprising: a lip seal having a resilient sealing lip protruding toward the interior of the chamber body; a first recess rearward of the resilient sealing lip relative to the aperture; a first backing support rearward of the first recess relative to the aperture; a second recess in the backing support rearwardly of the aperture; a second backing support rearward of the second recess relative to the aperture; Equipped with the lip seal and the first and second backing supports are configured as integral components of the chamber body. a seal interface; a chamber body comprising: an air pump configured to be inserted into the aperture from an exterior surface of the chamber body, the air pump having a first color interface surface, wherein when inserted into the aperture, the air pump is operably connected to the chamber body and, when energized, removes air from the seal space, the air pump biasing the resilient sealing lip into the first recess to form an airtight seal with the chamber body, the first color interface surface being accessible from the interior of the chamber body; a rigid or substantially rigid retainer collar including a continuous peripheral region configured for insertion into the second recess and a second collar interface surface configured to cooperatively engage the first collar interface surface from within an interior surface of the chamber body, wherein insertion of the peripheral region into the second recess and engagement of the first and second collar interface surfaces reversibly retains the air pump and the retainer collar to the chamber body; A negative pressure therapy device comprising:

2. 10. The negative pressure treatment device of claim 1, wherein the negative pressure treatment device is constructed and arranged to treat sleep apnea, snoring, or airway obstruction.

3. The negative pressure treatment device of claim 1 , wherein the negative pressure treatment device is constructed and arranged to treat a wound.

4. The negative pressure therapy device of claim 1 , wherein the lip seal is positioned at or very close to the outer surface of the chamber body.

5. 5. The negative pressure therapy device of claim 4, wherein the resilient sealing lip contacts the air pump when the air pump is installed within the aperture, but does not contact the retainer collar.

6. 6. The negative pressure therapy device of claim 5, wherein the first collar interface surface and the second collar interface surface cooperate to provide a reversible locking mechanism that orients the air pump relative to the retainer collar.

7. The negative pressure therapy device of claim 6 , wherein the first collar interface surface and the second collar interface surface provide a cooperating twist coupling.

8. 7. The negative pressure therapy device of claim 6, wherein the first collar interface surface and the second collar interface surface provide a cooperating bayonet mount.

9. 7. The negative pressure treatment device of claim 6, wherein the second recess extends between the first backing support and the second backing support at least to the point of maximum bending moment of the resilient sealing lip.

10. 10. The negative pressure treatment device of claim 9, wherein the continuous circumferential region is configured to be inserted into the second recess until the second recess is fully occupied by the continuous circumferential region.

11. 11. The negative pressure treatment device of claim 10, wherein the air pump and / or the retainer collar have mounting points configured to engage with receiving points on the chamber body and secure the pump module to the chamber body in a specific orientation.

12. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 10. The negative pressure therapy device of claim 1, comprising:

13. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 3. The negative pressure therapy device of claim 2, comprising:

14. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 4. The negative pressure therapy device of claim 3, comprising:

15. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 5. The negative pressure therapy device of claim 4, comprising:

16. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 6. The negative pressure therapy device of claim 5, comprising:

17. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 7. The negative pressure therapy device of claim 6, comprising:

18. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 8. The negative pressure therapy device of claim 7, comprising:

19. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 9. The negative pressure therapy device of claim 8, comprising:

20. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 10. The negative pressure therapy device of claim 9, comprising:

21. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 11. The negative pressure therapy device of claim 10, comprising:

22. The negative pressure treatment device for use in a method for providing negative pressure treatment to an external surface of an individual, the method comprising: fitting the negative pressure treatment device to the exterior surface to enclose an interior volume overlying skin tissue surrounded by a chamber body; evacuating air from the interior volume by energizing an air pump; 12. The negative pressure therapy device of claim 11, comprising:

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