RELATED APPLICATION DATA

[0001] The present application claims benefit of co-pending U.S. provisional application Serial No. 62/676,945, filed May 26, 2018, the entire disclosure of which is expressly incorporated by reference herein.

FIELD OF THE INVENTION

[0002] The present invention relates generally to devices, systems, and methods for preventing, reducing, and/or otherwise managing swelling, e.g., about an ankle and/or foot of a subject.

BACKGROUND

[0003] Ankle and foot injuries are common, e.g., from fractures, sprains, and the like, and often result in localized swelling. To treat such swelling, an injured person may elevate the injured foot and use a compress, icepack, or other device to manually apply pressure to the injury. However, such devices generally require the person to hold the device against the desired region to apply pressure or remain stationary to allow the weight of the compress to apply pressure. Alternatively, an icepack or compress may be secured to the person’s extremity, e.g., using tape or a sleeve wrapped around the extremity, to apply pressure, but such devices may loosen over time, thereby providing only a constant or slowly declining pressure to the injured region. Further, such devices may be difficult to use when the injury requires a cast, splint, or wrap placed on a foot for an extended time.

[0004] Accordingly, devices and methods for reducing and/or managing swelling would be useful.

SUMMARY

[0005] The present application is directed to devices, systems, and methods for preventing, reducing, and/or otherwise managing swelling, e.g., about an ankle and/or foot of a patient or other subject, which may result from injuries, such as fractures, sprains, and/or other trauma.

[0006] In accordance with an exemplary embodiment, a system is provided for preventing, reducing, or managing swelling of a subject’s extremity that includes an insert comprising a base configured for placement against a target region of a subject’s extremity and one or more expandable elements on the base; an actuator coupled to the one or more expandable elements; and a controller communicating with the actuator for selectively expanding and contracting the one or more expandable elements to apply variable pressure to the extremity.

[0007] In accordance with another embodiment, a method is provided for preventing, reducing, or managing swelling of a subject’s extremity that includes placing an insert comprising one or more expandable elements against a target region of the subject’s extremity; and selectively expanding and contracting the one or more expandable elements to apply variable pressure to the target region.

[0008] In an exemplary embodiment, the system may include an insert including a bladder, base plate, and insole that may be installed inside a leg cast or splint on the plantar aspect of the foot in a patient who has sustained a lower extremity injury. The insert, once inserted, may be connected via tubing to an air pump unit or other actuator, which, in one embodiment, may include a power source, air pump, reservoir, valve, and controller. The bladder may be pressurized, e.g., in predetermined cycle or pattern via the air pump unit or actuator, to apply pressure to the plantar aspect of the foot, which may reduce swelling of the ankle and lower leg.

[0009] Other aspects and features including the need for and use of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features and design elements of the drawings are not to-scale. On the contrary, the dimensions of the various features and design elements are arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures.

[0011] FIG. 1 is a perspective view of an exemplary system for preventing or reducing swelling.

[0012] FIG. 2 is an exploded view of an exemplary insert that may be included in the system of FIG. 1. [0013] FIG. 3 is a schematic showing an exemplary pump or controller unit that may be included in the system of FIG. 1.

[0014] FIG. 4 is a cross-section of a subject’s lower extremity in a cast or splint, showing an exemplary insert placed within the cast or splint.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0015] Before the exemplary embodiments are described, it is to be understood that the invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0016] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither, or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0017] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0018] It must be noted that as used herein and in the appended claims, the singular forms“a,”“an,” and“the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to“a compound” includes a plurality of such compounds and reference to“the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0019] In general, the devices and systems herein include a component to generate pressure and a component to exert pressure, wherein these components may be separate or integrated together. Although the devices and systems may be particularly suited for preventing or reducing post-traumatic acute ankle swelling of an injured patient or subject, the devices and systems may be used for any suitable applications, clinical or otherwise, e.g., prevent or decrease any suitable lower extremity swelling.

[0020] Turning to the drawings, FIG. 1 shows an example of a system 8 for preventing, reducing, and/or otherwise managing swelling, e.g., of a subject’s ankle, foot, or other extremity. Generally, the system 8 includes an insert 100 including one or more expandable elements, and a pump unit or other controller unit 300 for controlling operation of the expandable element(s), e.g., to expand and/or contract the expandable element(s) in a desired manner, e.g., according to a predetermined cycle or pattern, to apply variable pressure to the extremity.

[0021] FIG. 2 shows an example of an insert 100 including a bladder 110, a base plate 120, and an insole 130, which may be included in the system 8. The components of the insert 100 may be assembled together, e.g., permanently bonded, fused, or otherwise attached together to provide an integral insert 100 that may be reusable, disposable, or recyclable. Optionally, an outer sleeve or covering may be provided around the insert 100, e.g., to seal the components, provide a desired finish, absorb fluids, and the like.

[0022] For example, the insole 130 may provide a base layer for the insert 100, e.g., that may be sized, shaped, and/or otherwise configured to be installed inside a cast or splint 10, e.g., as shown in FIG. 4, or otherwise support the bladder 110 and/or other expandable elements (not shown). In an exemplary embodiment, the insole 130 may have a shape similar to an insole for a shoe, i.e., shaped to be positioned against a plantar aspect of a foot, e.g., extending at least partially between a heel and toes of the foot. In this manner, the insole 13 may function to house or nest the bladder 110 and/or align the bladder 110, e.g., relative to a target location on the subject’s foot or other extremity to apply localized pressure, as described elsewhere herein.

[0023] The insole 130 may be formed from flexible or semi-rigid material, e.g., rubber, foam, elastomeric material, fabric, and the like, that may at least partially conform to the anatomy contacted by the insole 130 during use. In the example shown, the insole 130 includes an upper or first surface l30a including a recess 131 for receiving the bladder 110 and/or base plate 120, and a lower or second surface l30b opposite the first surface l30a. Optionally, one or both the first surface l30a and the second surface l30b may include one or more features for securing the insole 130 relative to the subject, e.g., a tacky adhesive, gripping texture, and the like, to allow the first surface 130a to be removably secured to the subject’s skin and/or to allow the second surface 130b to be removably or permanently secured within a cast, splint, walking boot, shoe, and the like.

[0024] The recess 131 may be shaped and/or sized to receive the base plate 120 and bladder 110 therein, which may have corresponding shapes to fix the base plate 120 and bladder 110 relative to the insole 130, e.g., to provide a uniform upper surface (before inflation of the bladder 110). The base plate 120 and/or bladder 110 may be substantially permanently or removably received within the recess 131, e.g., secured by one or more of an interference fit, bonding with adhesive, sonic welding, fusing, and the like.

[0025] The base plate 120 may be a substantially planar member formed from rigid or semi-rigid material, e.g., metal, wood, plastic, composite material, and the like, which is configured to direct expansion of the bladder 110 upwardly (above the plane of the upper surface l30a), e.g., to direct pressure unidirectionally upwardly against tissue contacted by the bladder 110, and away from the lower surface 130b, e.g., to prevent expansion downwardly and/or minimize risk of damaging a cast, splint, or other device within which the insole 100 is placed. The base plate 120 may be fixed to a lower surface of the recess 131, e.g., permanently attached by one or more of bonding with adhesive, sonic welding, fusing, and the like. Alternatively, the recess 131 may extend entirely through the insole 130 and the base plate 120 may be attached, e.g., flush with the lower surface l30b to partially enclose the recess 131.

[0026] The bladder 110 may be an enclosed flexible body, e.g., formed from elastic or inelastic material, e.g., elastomeric material, flexible plastics, and the like. The bladder 110 may include one or more ports 111 (one shown) for delivering fluid into the interior of the bladder 110 and/or removing fluid from the interior during use. Alternatively, the bladder 110 may be formed from one or more panels of different materials, e.g., a rigid or semi-rigid first panel to define a lower surface of the bladder 110 (which may allow the base plate 120 to be omitted), and a semi-rigid or flexible second panel to define an upper surface of the bladder 110 adjacent the upper surface l30a of the insole 130. Optionally, the bladder 110 and/or base plate 120 may be provided without the insole 130.

[0027] In another alternative, if the insole 130 is formed from non-gas-permeable or nonporous material, the bladder may include a single panel of flexible material attached across the recess 131 (not shown), e.g., within the plane of the upper surface 130a of the insole 130 such that an enclosed region is defined within the recess 131 of the insole 130. Optionally, in this alternative, the recess 131 may extend entirely through the insole 130 and the base plate may be attached, e.g., flush with the lower surface l30b such that the bladder panel and base plate substantially enclose the recess to define a fluid-tight compartment.

[0028] The port 111 may include a nipple that may be received in a corresponding passage 132 in the insole 130 that extends from the recess 131, e.g., to an outer edge of the insole 130. The nipple 11, the outer edge, or the passage 132 of the insole 130 may include a connector (not shown) for coupling to a first end 200a of a length of tubing 200 the insole 130, e.g., as shown in FIG. 1, such that a lumen of the tubing 200 communicates with the interior of the bladder 110. The first end 200a of the tubing 200 may be removably or permanently attached to the connector, e.g., by one or more of an interference fit, bonding with adhesive, sonic welding, fusing, and the like. Alternatively, the first end of the tubing 200 may be received within the passage 132 and secured to the insole 130, e.g., by one or more of an interference fit, bonding with adhesive, sonic welding, fusing, and the like.

[0029] The tubing 200 may be formed from flexible material having sufficient length to extend from the insert 100, e.g., when placed within a cast, splint, walking boot, shoe, and the like, to allow a second end 200b of the tubing 200 to be coupled to the controller unit 300, e.g., as shown in FIG. 1. In exemplary embodiments, the tubing 200 may be formed from rubber, polyurethane, PVC, nylon, polyethylene, polypropylene, fluoropolymers, latex, silicone, thermoplastic rubber, Viton, and the like. The tubing 200 may have any desired size, shape, and/or length. In exemplary embodiments, the tubing 200 size may range from a cross-sectional area less than 1 cm ² to a cross-sectional area larger than 25 cm ² to provide a lumen sized for facilitating fluid flow through the tubing 200 during operation of the system 8. The tubing 200 may have any cross-sectional shape, e.g., circular, ovular, ellipsoid, square, rectangular, and the like. The length of the tubing 200 may range from the minimum length to connect the insert 100 with the controller unit 300 to a length greater than one meter (1 m).

[0030] Although a bladder 110 including a single interior region is shown in FIG. 2, it will be appreciated that the insert 100 may be provided with multiple expandable regions, compartments, or chambers. For example, a single bladder may be provided that includes two or more interior chambers and respective ports (not shown), to allow fluid to delivered into and/or removed from the chambers independently of one another. Alternatively, multiple bladders may be provided, e.g., within separate recesses in the insole, e.g., spaced apart along a length of the insole, or multiple bladders may be provided within a single recess, e.g., arranged in a desired manner. In a further alternative, multiple bladders, fluid chambers, or compartments may be provided that communicate with one another, e.g., such that fluid may be directed from one chamber or compartment to another via one or more passages communicating between them to expand and/or contract the chambers

sequentially. In these embodiments, the insert may be able to apply pressure to the subject’s extremity simultaneously, sequentially, or in another timing pattern. For example, multiple bladders may be expanded and/or contracted in a coordinated fashion to apply rolling, gradient, other dynamic or static pressure, as described elsewhere herein.

[0031] In another alternative, one or more other expandable elements may be provided on the insole 130 instead of a bladder. For example, other flexible containers or chambers may be provided into which fluid or other compressible substance may be delivered and/or removed to apply pressure in a desired manner. In exemplary

embodiments, the compressible substance may be air or any other compressible fluid or substance that may yield to external pressure.

[0032] In yet another alternative, a mechanically actuatable structure (not shown) may be provided within the recess 131 of the insole 130 shown in FIG. 2, and a membrane (also not shown) may be attached over the recess 131, e.g., flush with the upper surface 13 a, such that actuation of the structure causes the membrane to expand or deflect upwardly away from the upper surface l30a of the insole 130. Such pressure transmission with or without a bladder may be achieved through a variety of mechanisms, e.g., contraction, deformation, bowing, or an equivalent action of any material suitable for this purpose and may be performed by a stepper motor, cable system, rollers, or other mechanical actuator.

[0033] Turning to FIG. 3, an exemplary embodiment of a controller unit 300 is shown that provides a pump to deliver pressurized air or other fluid at targeted levels and/or intervals to the insert 100, i.e., for controlling expansion and/or contraction of the bladder 110 (and/or other expandable elements) of the insert 100 in a desired manner, as described elsewhere herein. As shown, the controller unit 300 includes a power source 310, an air pump, 320, a reservoir 330, a valve, and a controller or processing unit 350 contained within a housing 360. The housing 360 and internal components may be sufficiently small and/or light that a user may carry the housing 360 when moving. Optionally, the housing 360 may include one or more handles (not shown) to facilitate carrying the controller unit 300 and/or the housing 360 may include one or more straps, hooks, or other features to allow the controller unit 300 to be secured to a belt, shoulder strap, or other structure worn, attached to, or carried by the user (also not shown). For example, the housing 360 may be placed in a satchel that may be carried over the user’s shoulder, may be secured to the user’s belt, strapped to the user’s leg, and the like (not shown).

[0034] The power source 310 may be a battery and/or a connector for coupling to an external power source (not shown) and may provide electricity to operate other components of the controller unit 300, e.g., the pump 320, valve 340, and controller 350. Thus, the power source 310 may allow the controller unit 300 to be portable for patient ambulation or to be plugged into a wall or other external power source during periods of sedentary use.

[0035] The pump 320 may be configured to pressurize the reservoir 330 to a predetermined pressure and maintain this pressure during use. For example, the pump 320 may be coupled to a high pressure canister within the housing 360, e.g., filled with gas, such as air, carbon dioxide, nitrogen, and the like, or other compressible fluid, or to an external source of fluid, such as an external canister, e.g., coupled to the pump 320 by a pressure regulator (not shown) set to the predetermined pressure. Alternatively, the pump 320 may be configured to draw ambient air into the housing 360, e.g., via one or more inlets in the housing 360, for delivery into the reservoir 330. The controller 350 may control operation of the pump 320, e.g., activating the pump 320 when pressure within the reservoir 330 falls below a predetermined minimum pressure, and deactivating the pump 320 when the reservoir attains a desired maximum pressure.

[0036] The reservoir 330 may include stored pressurized fluid provided by the pump 320 via delivery line 322. For example, the reservoir 330 may include one or more ports 331 communicating with an internal chamber, e.g., a first port communicating with the delivery line 322 and a second port communicating with the valve 340. Optionally, the reservoir 330 may include a pressure vent 332 to allow venting of excess pressure within the internal chamber.

[0037] The valve 340 may be a three-way valve to selectively direct fluid flow from the reservoir 330 to the bladder 110 and from the bladder 110 to exhaust to the environment via tubing 200. In an exemplary embodiment, the valve 340 may be a solenoid valve to allow electrical control of fluid flow. For example, the controller 350 may selectively direct the valve 340 between a delivery position, creating a flow path from the reservoir 330 to the bladder 110 to inflate or expand the bladder 110, and an exhaust position, creating a flow path from the bladder 110 to the environment to deflate or contract the bladder 110. As described elsewhere herein, the controller 350 may alternate the valve 340 between the delivery and exhaust positions at a predetermined cycle or pattern, e.g., to provide variable pressure to the subject’s extremity.

[0038] In an alternative embodiment, the reservoir 330 may be omitted, and the pump 320 may communicate directly with the valve 340. In this alternative, the controller 350 may activate the pump 320 during delivery of fluid to the bladder 110 and deactivate the pump 320 during venting of fluid from the bladder 110.

[0039] Alternatively, if the insert includes multiple bladders or compartments, the controller unit 300 may include a plurality of valves for controlling delivery of air or other fluid from a reservoir and/or pump to respective bladders or compartments, e.g., alternately, sequentially, or according to any desired cycle or pattern. In another alternative, the insert may include multiple bladders or compartments connected together as a closed system, e.g., in which fluid may be directed between bladders or chambers in a desired manner by a controller. Alteration of pressure and/or volume in any number of compartments resulting in the alteration of pressure and/or volume in any number of the other compartments may be used to apply pressure to the subject’s extremity. Any external or internal mechanism for effecting, directing, or regulating the flow of fluid between compartments within such a closed system may be used, including but not limited to spring-actuated plungers, valves, or other suitable mechanical actuator.

[0040] Optionally, the controller unit 300 and/or insert 100 may include one or more pressure sensors, sensing elements, and/or control elements to enable auto-regulation of pressure delivery based on one or more of the following aspects: weight or load on the insert; elevation of the subject’s foot in physical relation to the subject’s heart; internal (blood) and/or external (atmospheric) pressures; circadian rhythms; sleep cycles; activity cycles; and/or any other physiological metrics.

[0041] In another option, a fluid source and controller may be provided on an insert rather than a separate controller unit. For example, a reservoir or source of fluid may be provided in the insole of the insert, e.g., an integral reservoir formed within the insole (if formed from nonporous material) or an internal container (not shown), and a controller may selectively activate a pump, piston, or other mechanism to direct fluid from the reservoir into the bladder and/or to direct fluid from the bladder into the reservoir (or into and out of multiple bladders or chambers), thereby omitting external tubing. Alternatively, the components of the insert and controller unit may be incorporated into a wearable device, e.g., a boot-like unit, that may at least partially receive the subject’s foot and/or extremity to allow pressure to be applied to the extremity.

[0042] Turning to FIG. 4, exemplary methods will now be described for using the devices and systems herein to apply pressure to a subject’s extremity, e.g., to the plantar arch of a subject’s foot. In one embodiment, the system may be used for reducing post- traumatic swelling about the ankle of a subject’s leg L after providing a soft cotton overwrap 10 on the lower extremity. As shown in FIG. 4, the insert 100 may then be placed such that upper surface 130a of the insole 130 is oriented up towards the subject’s foot F and the bladder 110 is positioned adjacent to the plantar arch P of the foot F.

[0043] Optionally, the insole 130 may be trimmed at the toe and/or heel ends to improve patient fit, e.g., to allow a single size insert 100 to be used with patients having different size feet. Alternatively, the insert 100 may be produced in multiple specified or custom sizes to improve patient fit. If tubing 200 is not already connected to the insert 100, a first end 200a of the tubing 200 may be connected to the passage 132 of the insole 130 or the port 111 of the bladder 110 (e.g., as shown in FIG. 1).

[0044] In customary fashion, a rigid or semi-rigid structure, which may include a splint 14 made of plaster or any other material or materials and/or an elastic bandage 12, is applied to the lower extremity L. The structure application step may include fracture reduction. The second end 200b of the tubing 200 may be coupled to the controller unit 300, thereby coupling the reservoir 330 and pump 320 to the bladder 110, e.g., via valve 340 and tubing 200. These connections may be realized within the structure, external to the structure, or any combination thereof. In one embodiment, the controller unit 300 may be affixed to the outside of the splint 14 and turned on any time after the plaster or other material has hardened.

[0045] For example, the controller unit 300 may be activated continuously or may be selectively activated and deactivated by the patient and/or their caregiver. Once activated, the insert 100 may then apply intermittent pulsatile force to the arch P of the foot F via the bladder 110. With the bladder 110 closely applied to the undersurface of the foot F near the plantar arch P, selective pressurization and expansion of the bladder 110 transmits pressure to the foot F, which may increase blood flow and thereby reduce swelling.

[0046] Alternatively, the inserts herein may be inserted or otherwise placed in other devices, e.g., a rigid or semi-rigid structure, such as a cast, splint, walking boot, or shoe and/or other wearable devices, shoes, socks, and the like. The associated tubing may extend from the device and may be connected to a controller unit, which may be carried or secured to the patient, as described elsewhere herein. In another alternative, an insert may be positioned and/or affixed to a subject’s body without an independent holding apparatus, e.g., using an adhesive on the insert, using one or more straps, and the like.

[0047] In addition to preventing, reducing and/or managing swelling about the ankle or foot, the devices, systems, and methods herein may be useful for treating other locations and/or conditions. For example, the devices may be used for reducing swelling in lymphedema or any other acute or chronic swelling conditions.

[0048] Further, in describing representative embodiments, the specification may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims.

[0049] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.