Negative pressure therapy system with lock sheet for fixation

Abstract

The wound treatment system includes a negative pressure source and a dressing in pneumatic communication with the negative pressure source. The dressing includes a negative pressure therapy component configured to expose the anatomical structure to negative pressure in response to activation of the negative pressure source when the negative pressure therapy component is applied to the anatomical structure. The dressing also includes a immobilization component coupled to the negative pressure therapy system, the immobilization component configured to transition from a compliant state to a non-compliant state in response to activation of the negative pressure source.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 162,192, filed March 17, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Swelling associated with trauma or certain pathologies (e.g., lymphedema) can cause a variety of medical complications. For example, swelling can cause discomfort and pain, limit range of motion, or otherwise adversely affect a patient's quality of life. Swelling can also limit a healthcare provider's ability to medically image, view, and access the underlying tissue, or otherwise interfere with a patient's treatment, thus posing a hindrance to the patient's healing and recovery. In some circumstances, swelling can even result in more severe consequences, such as atrophy of the surrounding muscle tissue. For example, it would be advantageous to provide a system that can help reduce swelling at a tissue site by providing reduced pressure treatment to increase blood perfusion and lymph flow at the tissue site and reduce swelling at the tissue site. In some clinical scenarios, immobilization of a tissue site (e.g., of a joint) may also be desirable in coordination with reduced pressure treatment to improve patient outcomes. Coordinated or integrated treatment for both immobilization and swelling reduction can be difficult. Summary of the Invention

[0003] One implementation of the present disclosure is a wound treatment system. The wound treatment system includes a negative pressure source and a dressing in pneumatic communication with the negative pressure source. The dressing includes a negative pressure therapy component configured to expose the anatomical structure to negative pressure in response to activation of the negative pressure source when the negative pressure therapy component is applied to the anatomical structure. The dressing also includes a fixation component coupled to the negative pressure therapy system, the fixation component configured to transition from a compliant state to a non-compliant state in response to activation of the negative pressure source.

[0004] In some embodiments, the negative pressure therapy component comprises a manifold layer and an air impermeable layer configured to be sealed against the anatomical structure, defining an airtight volume between the air impermeable layer and the anatomical structure that contains the manifold layer.

[0005] In some embodiments, the immobilization component is further configured to transition from a non-compliant state to a compliant state in response to a release of negative pressure from the immobilization component. The immobilization component may be pneumatically communicable with a negative pressure source via a negative pressure therapy component. In some embodiments, the immobilization component is pneumatically communicable with a negative pressure source via a valve configured to close when a threshold amount of negative pressure is established within the immobilization component.

[0006] In some embodiments, the anatomical structure includes a joint of the patient, and the immobilization component is configured to substantially immobilize the joint when in a non-compliant state. The immobilization component may include an airtight chamber configured to be evacuated by activation of a negative pressure source, and a locking sheet disposed within the airtight chamber. In such embodiments, the locking sheet is flexible when the airtight chamber is not evacuated and interlocks to form a rigid structure when the airtight chamber is evacuated by activation of the negative pressure source.

[0007] Another implementation of the present disclosure is a wound treatment device. The wound treatment device includes a manifold layer having a patient-facing side and a non-patient-facing side, a first airtight chamber disposed along at least a portion of the non-patient-facing side of the airtight chamber, and a locking sheet disposed within the first airtight chamber. The locking sheet is configured to transition from a flexible state to a non-compliant state. The wound treatment device also includes a sealable layer coupled to the manifold layer and configured to define a second airtight chamber sealed to the patient and containing the manifold layer.

[0008] In some embodiments, the injury treatment system includes a valve configured to selectively place the first airtight chamber in fluid communication with the second airtight chamber.

[0009] In some embodiments, the lock sheet is flexible when the first airtight chamber is at atmospheric pressure, and the lock sheet is non-compliant when the first airtight chamber is suctioned to at least a threshold negative pressure. The threshold negative pressure may be -125 mmHg.

[0010] In some embodiments, the locking sheet includes a first sheet having protrusions arranged in a first pattern and a second sheet having recesses arranged in a first pattern. When the protrusions are disposed in the recesses, the first sheet is substantially prevented from sliding along the second sheet, thereby rendering the locking sheet inflexible. The protrusions may be configured to enter the recesses in response to establishment of a negative pressure in the airtight chamber and to exit the recesses in response to release of genitive pressure from the airtight chamber.

[0011] In some embodiments, the injury treatment device is configured to be applied to a patient's ankle. The manifold layer may have a first boot-like shape and the locking sheet may be less than coextensive with the manifold layer. For example, the locking sheet may be provided in a splint configuration configured to substantially immobilize the ankle when the locking sheet is in a non-compliant state and to allow the ankle to be inserted into the boot-like shaped manifold layer when the locking sheet is in a compliant state.

[0012] Another implementation of the present disclosure is a method of treating a joint injury, the method including applying a treatment device around a joint, sealing one or more edges of the treatment device to the joint to define a first airtight chamber containing a manifold layer, providing negative pressure therapy by venting air from the first airtight chamber to transmit negative pressure to the joint, and providing immobilization therapy by venting air from a second airtight chamber. The second airtight chamber contains a locking sheet configured to immobilize the joint in response to the second airtight chamber reaching at least a threshold negative pressure.

[0013] In some embodiments, venting air from the first and second airtight chambers is performed by operating a pump in fluid communication with both the first and second airtight chambers. In some embodiments, venting air from the second airtight chamber includes drawing air from the second airtight chamber through the first airtight chamber. In some embodiments, providing immobilization therapy includes closing a valve of the second airtight chamber when the second airtight chamber reaches a threshold negative pressure.

[0014] In some embodiments, the method also includes completing treatment of the injury by flowing air into the second airtight chamber to configure the lock sheet to transition from the non-compliant state to the compliant state, unsealing the first airtight chamber, and removing the treatment device articulation. The method may also include cleaning the treatment device for reuse.

[0015] Another implementation of the present disclosure is a wound treatment system including an airtight pouch, a negative pressure source pneumatically communicable with the airtight pouch and operable to establish a negative pressure within the airtight pouch, and a plurality of sheets disposed within the airtight pouch, each sheet having a thickness in the range of about 0.004" to 0.006". When the negative pressure source establishes a negative pressure within the airtight pouch, the plurality of sheets are configured to consolidate together to form a non-flexible block.

[0016] In some embodiments, the plurality of sheets has a combined thickness ranging from 0.125" to 0.25" inches. The plurality of sheets may include greater than 20 sheets. The plurality of sheets may include 10 to 80 sheets. The plurality of sheets may be made of paper. The plurality of sheets may include polyester. The plurality of sheets may include stone paper. In some embodiments, a first sheet of the plurality of sheets has a cut pattern configured to enhance conformability of the first sheet. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a storyboard-style diagram of providing immobilization therapy, according to an example embodiment. [Figure 2A] FIG. 2A is a storyboard-style diagram of the operation of a first embodiment of a lock sheet of an immobilization component of a wound treatment system, in accordance with an exemplary embodiment. [Figure 2B] FIG. 2B is a storyboard-style diagram of the operation of a second embodiment of a lock sheet of an immobilization component of a wound treatment system, in accordance with an exemplary embodiment. [Diagram 3] FIG. 3 is a diagram of an exemplary embodiment of a locking sheet of an immobilization component of a wound treatment system, according to an exemplary embodiment. [Figure 4] FIG. 4 is a block diagram of a wound treatment system, in accordance with an exemplary embodiment. [Diagram 5]FIG. 5 is a perspective view of one embodiment of a dressing of the wound treatment system of FIG. 4, according to an exemplary embodiment. [Figure 6] FIG. 6 is a perspective view of another embodiment of a dressing of the wound treatment system of FIG. 4, in accordance with an exemplary embodiment. [Figure 7] FIG. 7 is another perspective view of the dressing of FIG. 4 according to an exemplary embodiment. [Figure 8] FIG. 8 is a cutaway view of a dressing of a wound treatment system, according to an exemplary embodiment. [Figure 9] FIG. 9 is a block diagram of a lesion treatment showing a first exemplary airflow path, according to an exemplary embodiment. [Figure 10] FIG. 10 is a block diagram of a lesion treatment illustrating a second exemplary airflow path, according to an exemplary embodiment. [Figure 11] FIG. 11 is a block diagram of a lesion treatment illustrating a third exemplary airflow path, according to an exemplary embodiment. [Figure 12] FIG. 12 is a block diagram of a lesion treatment illustrating a fourth exemplary airflow path, according to an exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Before turning to the drawings, which show in detail certain example embodiments, it is to be understood that the disclosure is not limited to the details or methods set forth in the description or shown in the drawings, and that the terminology used herein is for the purpose of description only and should not be construed as limiting.

[0019] With general reference to the figures, an injury treatment system for applying negative pressure (e.g., partial vacuum) (relative to atmospheric pressure) to intact skin extending over or surrounding various types of treatment tissue sites (e.g., bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, etc.) and while immobilizing the tissue site is described, according to various embodiments. The application of negative pressure to the intact skin provided by the treatment system imparts a tensile (e.g., lifting) force to the intact skin, which reduces pressure at the treatment tissue site, thereby increasing perfusion of blood and other fluids (e.g., lymphatic flow, interstitial fluid) at the treatment tissue site. The reduced pressure at the treatment tissue site resulting from operation of the treatment system can advantageously reduce swelling at the tissue site. Meanwhile, immobilization can promote healing and prevent worsening of the injury.

[0020] The treatment system herein may be configured for use in both medical and non-medical environments and may be used to treat swelling resulting from a variety of different conditions. For example, the treatment system may be used by a patient in a home environment to treat swelling resulting from injury, excessive effort, underlying disease (e.g., lymphedema), and the like. As another example, the treatment system may also be used in a medical environment, such as to reduce swelling during pre- and / or post-operative care of a patient. For example, reducing swelling at a treatment site (e.g., caused by a fracture, edema, tissue sprain, tissue bruise, and the like) prior to surgery may advantageously facilitate access to underlying tissue at a target surgical site, reduce surgery time, and / or improve the outcome of a surgical treatment. Use of a treatment system according to any of the embodiments described herein prior to a surgical treatment may advantageously reduce the time required to reduce swelling at a target surgical site to an acceptable degree of swelling compared to the time required to reduce swelling using conventional methods of treating swelling. For example, use of the therapeutic system may reduce swelling to an acceptable level within 3 to 7 days of initiating treatment with the therapeutic system.

[0021] In addition to using the treatment system to reduce swelling, the reduced pressure therapy provided by the treatment system may also be advantageously used in the treatment of various other medical conditions or ailments. As one non-limiting example, the treatment system may be used for acute treatment of pain and / or inflammation (e.g., as a result of a sprain or other stress at a tissue site), such as for the treatment of ankle sprains of various severity. In yet other situations, the treatment system may be used to increase blood perfusion and / or lymph flow at the treated tissue site to minimize the effects of overuse (e.g., following athletic training or other strenuous activities). In some embodiments, the treatment system is reusable, washable, and configured to be intuitive for a user to self-apply without medical expertise.

[0022] 1, a storyboard style diagram of the operation of a wound treatment system 100 is shown, according to an exemplary embodiment. The wound treatment system 100 is shown as including a negative pressure source 102 (e.g., a pump), a tube 106, and an immobilization component 104. The immobilization component 104 is coupled to the negative pressure source 102 via the tube 106. The immobilization component 104 is configured to change from a compliant state to a non-compliant state in response to actuation of the negative pressure source 102.

[0023] In the illustrated example, the immobilization component 104 includes an airtight pouch 108. The airtight pouch 108 is substantially airtight except for a connection to the tube 106 such that the interior of the airtight pouch is in air communication with the negative pressure source 102 via the tube 106. The airtight pouch 108 may be made of a polyurethane drape material.

[0024] The immobilization component 104 also includes a locking sheet 110 disposed within the airtight pouch 108. When the airtight pouch is at about atmospheric pressure, the locking sheets 110 can move (e.g., slide) relative to one another within the airtight pouch, thereby allowing the immobilization component 104 to be flexible and conformable. Thus, the immobilization component 104 is in a flexible state when the airtight pouch is at about atmospheric pressure or above (e.g., above a threshold negative pressure). Figure 1 illustrates that while in a flexible state, the immobilization component 104 can be wrapped and / or conformed around a patient's anatomical features, for example, around a person's foot and ankle as shown in Figure 1.

[0025] Activation of the negative pressure source 102 is configured to reduce pressure within the airtight pouch 108 of the immobilization component 104, thereby establishing a negative pressure (relative to atmospheric pressure) within the immobilization component 104. For example, the negative pressure source 102 can draw air out of the airtight pouch 108 via the tube 106. A pressure difference between the surrounding environment and the interior of the immobilization component 104 causes the lock sheets 110 to press toward each other, increasing friction between the lock sheets 110 and substantially preventing the lock sheets 110 from moving relative to each other. Thus, the lock sheets 110 can be considered locked to each other. When locked to each other, the lock sheets 110 are inflexible, and each lock sheet 110 prevents another lock sheet 110 from bending. Thus, the immobilization component 104 is in a non-compliant state following activation of the negative pressure source 102 to establish a negative pressure in the immobilization component 104.

[0026] As shown in FIG. 1, the immobilization component 104 can thus be applied to a patient's anatomical structure in a desired configuration while in a flexible state, and then transitioned to a non-flexible state by activation of the negative pressure source 102. When applied in an appropriate configuration (e.g., a splint configuration), the immobilization component 104 can substantially immobilize a patient's joint (e.g., ankle, knee, elbow, wrist, shoulder) or other anatomical structure (e.g., foot, hand) while in a non-flexible state (i.e., while the immobilization component 104 is maintained at a negative pressure). Thus, the immobilization component 104 can provide the therapeutic benefits of a splint or cast while being easy to apply. In some embodiments, the same immobilization component 104 is suitable for application in a variety of splint configurations to provide medically preferred immobilization therapy to different joints and / or in a variety of possible situations.

[0027] In some embodiments, release of the negative pressure in the airtight pouch 108 of the immobilization component 104 (e.g., air flow into the airtight pouch 108) allows the lock sheets 110 to release from one another, returning the immobilization component 104 to a flexible state. In such embodiments, the immobilization component 104 can be repeatedly switched between a non-compliant state and a flexible state. This can allow for reuse of the immobilization component 104 for different injuries or different patients and adjustment of the immobilization therapy for a given injury over time.

[0028] 2A, a close-up cutaway view of one embodiment of an immobilization component 104 transitioning from a flexible state to a non-compliant state is shown, according to an exemplary embodiment. In particular, FIG. 2A shows a storyboard-style diagram of the immobilization component 104 in a flexible state in a first frame 200 and in a non-compliant state in a second frame 202 in an example where the immobilization component 104 includes two lock sheets 110.

[0029] As shown in the first frame 200, the immobilization component 104 includes lock sheets 110 (shown as first lock sheet 110a and second lock sheet 110b) disposed within an airtight pouch 108. The airtight pouch 108 is at substantially atmospheric pressure. When the airtight pouch 108 is at substantially atmospheric pressure, a space is provided between the first lock sheet 110a and the second lock sheet 110b to allow movement of the first lock sheet 110a relative to the second lock sheet 110b, including both horizontally and vertically in the perspective of FIG. 1. The first lock sheet 110a and the second lock sheet 110b are individually flexible such that when disposed as shown within the first frame 200, the lock sheets 110 allow the immobilization component 104 to flex, e.g., bend into a desired splinting configuration.

[0030] When the airtight pouch 108 is evacuated (e.g., brought to a negative pressure by activation of the negative pressure source 102), the immobilization component 104 transitions to a non-compliant state shown in the second frame 202. The pressure difference between the interior of the airtight pouch 108 and the exterior of the airtight pouch 108 compresses the airtight pouch 108 and forces the lock sheets 110 together. Thus, as shown in FIG. 1, the first lock sheet 110a contacts and is pressed against the second lock sheet 110b. The pressure difference can thereby create a large amount of friction between the first lock sheet 110a and the second lock sheet 110b while preventing the first lock sheet 110a from moving away from the second lock sheet 110b.

[0031] Surface textures or elements of the locking sheets 110 can help lock the locking sheets 110 in place relative to each other. In the example of FIG. 2A, the first locking sheet 110a is provided with a first protrusion 204 and the second locking sheet is provided with a second protrusion 206. In the example shown, when the immobilization component transitions to a non-compliant state, the first protrusion 204 moves into the recess between the second protrusions of the second locking sheet 110b and the second protrusion 206 moves into the recess between the first protrusions 204 of the first locking sheet 110a. The first protrusion 204 thereby connects with the second protrusion 206 such that the first locking sheet 110a is prevented from sliding along the second locking sheet 110b.

[0032] 2A shows an example including two rock sheets 110. In other embodiments, three or more (e.g., four, five, six, seven, eight, nine, etc.) rock sheets 110 are included. The rock sheets 110 may be made from paper (e.g., wood pulp-based materials), other organic materials, polyethylene materials, polymers, or some combination thereof. In some examples, the rock sheets 110 are configured as described in U.S. Patent No. 10,538,049, granted Jan. 21, 2020, the entire disclosure of which is incorporated herein by reference.

[0033] Referring now to FIG. 2B, FIG. 2B illustrates an exemplary embodiment in which multiple lock sheets 110 are included within the immobilization component 104. In the example of FIG. 2B, the lock sheets 110 are thin and substantially flat (e.g., without the protrusions of FIG. 2A). The number of lock sheets 110 may range from 10 to 80 sheets, for example, 20 to 40 sheets, or more than 20 sheets (e.g., 25, 50, 100, 200, etc.). As shown in FIG. 2B, 30 lock sheets 110 are included. Each sheet may have a thickness in the range of about 0.002" to 0.010", for example, about 0.004" to 0.006". When combined, the multiple lock sheets 110 may be combined to provide a total thickness of less than 0.25", for example, 0.125" to 0.25".

[0034] The rock sheets 110 may be made of paper, e.g., 30 lb paper. The paper provides conformability and flexibility for each rock sheet 110, while also providing a sufficient amount of friction between the sheets (e.g., due to the fibrous structure of the paper) and inflexibility of the combined sheets when the immobilization components are in a pressurized, inflexible state. The rock sheets 110 may also be made of polyester, e.g., polyethylene terephthalate, other plastics, or a paper-like material made of calcium carbonate (or other minerals) and a binder (known as stone paper). Such materials are waterproof and can be used in applications where moisture may reach the rock sheets 110.

[0035] 2B, when the airtight pouch 108 is at substantially atmospheric pressure (as shown in the first frame 250), the multiple locking sheets 110 are free to move and flex relative to one another. Each locking sheet 110 is flexible and conformable such that the immobilization component 104 is flexible and conformable at substantially atmospheric pressure.

[0036] When air is evacuated from the airtight pouch 108 and the airtight pouch 108 is brought to at least a threshold negative pressure (as shown in the second frame 252), the multiple lock sheets 110 are bound together by the pressure differential between the interior and exterior of the airtight pouch 108. The surface friction between the sheets 110 is sufficient to create an interlocking condition in which the sheets 110 cannot substantially move relative to each other. For example, in an example in which the sheets 110 are made of paper, the fibers of adjacent sheets 110 interact to provide a desired coefficient of friction between the sheets 110. Thus, the lock sheets 110 are formed as an inflexible and non-conforming substantially solid block of lock sheets 110, for example, having a total thickness of less than about 0.25", for example, between about 0.125" and 0.25". Thus, the lock sheets 110 interlock with each other to stiffen the immobilization component 104.

[0037] FIG. 3 shows a top view of a locking sheet 300 according to an exemplary embodiment. The locking sheet 300 can be an example of one of the locking sheets 110 of FIGS. 1-2B in an exemplary embodiment. As shown in FIG. 3, the locking sheet 300 is textured or scored to have a patterned surface that provides both increased flexibility of the locking sheet 300 when the immobilization component 104 is in a flexible state. For example, the locking sheet 300 can include a pattern that is cut into the locking sheet 300 using a rotary die.

[0038] In the illustrated example, the locking sheet 300 includes a triangular pattern formed by alternating recesses (slits, grooves, etc.) with non-recessed areas, non-recessed areas, etc. on the surface of the locking sheet 300. The recesses may provide areas of increased flexibility of the locking sheet 300. The recesses may be indentations in the locking sheet 300 or may extend all the way through the locking sheet 300. As shown in FIG. 3, the triangular patterns interlock and provide multiple linear recesses (e.g., recesses 302) that extend across the locking sheet 300 in three directions and form multiple triangular shapes (e.g., triangles 304) in the locking sheet 300, thereby providing the locking sheet 300 with a high degree of flexibility and conformability. In various embodiments, other geometric shapes (e.g., pentagons, hexagons, etc.) may be used. The interior of the triangular shapes (e.g., triangles 304) may be textured, for example, roughened or provided with alternating protrusions and recesses. Thereby, the locking sheet 300 may be configured to provide a large amount of friction when pressed against another example locking sheet 300. In examples where the locking sheet 300 includes a pattern of recesses (slots, grooves, etc.), such as in FIG. 3, a greater number of locking sheets may be used (e.g., greater than 30 sheets, 30-50 sheets) to achieve sufficient inflexibility in the inflexible state.

[0039] Referring now to Figure 4, a block diagram of a wound treatment system 400 is shown, according to an exemplary embodiment. The wound treatment system 400 is configured to provide integrated negative pressure and immobilization therapy to an injury site, such as a patient's joint. As described below, the wound treatment system 400 advantageously enables negative pressure and immobilization therapy via a shared negative pressure source. In Figure 4, the wound treatment system 400 is shown as including a negative pressure source 402 in pneumatic communication with a treatment device (dressing, therapy device, etc.) 404 (including a negative pressure therapy component 406 and an immobilization component 408) via a tube 410.

[0040] The negative pressure source 402 is configured to provide negative pressure to the treatment device 404, for example, by drawing air from the treatment device to the surrounding environment. For example, the negative pressure source 402 may include a pump. In some embodiments, the negative pressure source 402 includes a manually operated pump. In other embodiments, the negative pressure source 402 includes an electrically operated pump. In some such embodiments, the negative pressure source 402 includes one or more batteries (e.g., rechargeable batteries) that provide power to the electrically operated pump. In various embodiments, the negative pressure source 402 may include a sensor for determining the pressure at the treatment device 404 and a controller circuit for controlling the provision of negative pressure to the treatment device.

[0041] The treatment device 404 is shown as including a negative pressure therapy component 406 and an immobilization component 408. In the illustrated embodiment, the negative pressure therapy component 406 and the immobilization component 408 are integrated together (e.g., integrated, combined, fabricated together, etc.) to form the treatment device 404. In other embodiments, the negative pressure therapy component 406 and the immobilization component 408 may be provided separately (see, e.g., FIG. 1). The treatment device 404 is configured to be easily applied to a tissue site (e.g., a joint) and sealed over the tissue site while the pressure within the treatment device 404 is at approximately atmospheric pressure. The negative pressure source 402 can then be activated to create and maintain a negative pressure in the treatment device, e.g., above a threshold negative pressure. Once negative pressure is established, the treatment device 404 provides both negative pressure therapy to the tissue site (via the negative pressure therapy component 406) and immobilization of the tissue site (via the immobilization component 408).

[0042] The negative pressure therapy component 406 may include a reduced pressure layer (e.g., a manifold layer) and a drape layer, for example, as shown in and described in detail in FIG. 8. The drape layer is sealable over the tissue site to establish a substantially airtight volume over the tissue site that contains the reduced pressure layer. Adhesives (e.g., silicone adhesives), thermoplastic elastomer sealing rings, zippers, straps, or other attachments and sealing devices may be included to seal the negative pressure therapy over the tissue site.

[0043] The reduced pressure layer is configured to allow airflow and pressure transmission throughout a substantially airtight seal defined between the drape layer and the tissue site (when the negative pressure therapy component 406 is sealed over the tissue site). In some embodiments, the reduced pressure layer is made of an open-cell foam that may be configured to compress when negative pressure is established in the negative pressure therapy component 406. In other embodiments, the reduced pressure layer includes a macromesh or other foldable layer. For example, the reduced pressure layer may be structured with a stiffer outer portion and a softer (more compressible / foldable) inner portion such that the reduced pressure layer tends to collapse away from the tissue site. In some examples, the negative pressure therapy component 406 is configured as described in U.S. Provisional Patent Application No. 63 / 133,882, filed January 5, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0044] When negative pressure is established in the negative pressure therapy component 406 of the treatment device 404, the negative pressure exerts a tensile (e.g., lifting) force on the intact skin, which reduces pressure at the treatment tissue site, thereby increasing perfusion of blood and other fluids (e.g., lymphatic flow, interstitial fluid) at the treatment tissue site. Evidence suggests that this tensile or lifting force can promote swelling reduction, e.g., significantly reducing the amount of time required for a given amount of swelling to resolve, as compared to not providing negative pressure therapy. In some cases, swelling reduction with reduced pressure therapy provided by the negative pressure therapy component 406 is superior to traditional swelling management provided using compression wraps or compression therapy.

[0045] One aspect of the present disclosure is that reduced pressure therapy can be enhanced or complemented by simultaneous immobilization of tissue sites. For example, immobilization of bones of a joint relative to each other, referred to herein as joint immobilization (e.g., immobilization of the femur relative to the tibia, immobilization of the tibia or fibula relative to the bones of the foot, etc.), can protect the soft tissues of the joint from further damage or re-injury during the swelling reduction process. Immobilization therapy provides continued protection of the joint, as the patient's natural swelling response is reduced using negative pressure therapy. Therefore, it is advantageous to provide integrated and coordinated immobilization and negative pressure therapy.

[0046] Thus, the treatment device 404 includes an immobilization component 408. The immobilization component 408 may be configured substantially as described above with respect to the immobilization component 104 of FIGS. 1-3. In the example of FIG. 4, the immobilization component 408 is an integral part of the treatment device 404 and is coupled to and / or formed with the negative pressure therapy component 406. For example, the immobilization component 408 may be disposed outside of a drape layer of the negative pressure therapy component 406, as shown in FIGS. 5-8. In some embodiments, the immobilization component 408 is substantially coextensive with the negative pressure therapy component 406, thereby covering substantially the same tissue site as the negative pressure therapy component 406. In other embodiments, the immobilization component 408 is less than coextensive with the negative pressure therapy component 406 and is selectively provided in a preferred splint configuration to provide the desired immobilization to the joint, as shown in and described with reference to FIGS. 5-7, for example.

[0047] Referring now to FIG. 5, a first exemplary embodiment of a treatment device 404 applied to a patient's ankle is shown, according to an exemplary embodiment. In the illustrated example, the treatment device 404 is specifically designed for the treatment of ankle injuries or injuries to anatomical features near the ankle, such as ankle sprains or ankle fractures. As shown, the negative pressure therapy component 406 is provided in a boot or sock-like shape (e.g., with an open area) to fit the patient's foot, ankle, and lower leg. The negative pressure therapy component 406 may be formed in a ring-shaped configuration, or may be folded or wrapped around the ankle as shown in FIG. 5 to achieve the boot-like shape shown in FIG. 5. The negative pressure therapy component 406 covers substantially the entire affected anatomical area, thereby providing reduced pressure therapy at the ankle and surrounding tissues.

[0048] In Fig. 5, the immobilization component 408 is selectively positioned on only a portion of the negative pressure therapy component 406. In the example of Fig. 5, the immobilization component 408 extends across the top of the foot area, under the foot, around the heel, and along the Achilles tendon area to the mid-calf. The immobilization component 408 also includes a tab that extends from the lower calf toward the shin. The immobilization component 408 is thereby positioned to limit movement of the ankle in various directions without being overly cumbersome or uncomfortable for the patient.

[0049] 6-7 show another exemplary embodiment of a treatment device 404 applied to a patient's ankle. In FIG. 6-7, the immobilization component 408 is provided in a splint configuration in which the immobilization component 408 extends along the bottom of the patient's foot, around the heel, and up to the upper calf position. Thus, when activated, the immobilization component 408 prevents the patient from bending the foot downward (e.g., beyond 90 degrees), but may allow some upward movement. Various splint configurations of the immobilization component 408 are possible to provide clinically appropriate joint immobilization to promote healing and / or reduction of swelling.

[0050] In some cases, the presence of the immobilization component 408 at a given location can enhance the ability of the negative pressure therapy component 406 to exert a tensile force on the tissue at that location. For example, if the immobilization component 408 is stiff, the immobilization component 408 can provide a counter force to the reaction force pulling the tissue back into the reduced pressure layer. Thus, the immobilization component 408 may also be placed at locations where additional / targeted reduced pressure at a tissue site is desired.

[0051] While in Figures 5-7 the tubing 410 is shown as extending only to the negative pressure therapy component 406, Figures 5-7 show an example in which the immobilization component 408 can be in pneumatic communication with the tubing 410 and negative pressure source 402 via the negative pressure therapy component 406. Such an embodiment is shown in Figures 8-10, described below. In other embodiments, separate tubing extends directly to both the negative pressure therapy component 406 and the immobilization component 408, as shown in Figures 11-12 and described below.

[0052] 5-7 also show an example in which the immobilization component 408 is continuous. In other examples, multiple discontinuous portions of the immobilization component 408 may be provided on the negative pressure therapy component 406 to achieve a desired therapeutic effect.

[0053] 8, there is shown an enlarged cutaway view of an exemplary embodiment of a treatment device 404 applied onto intact skin at a tissue site, according to an exemplary embodiment. A negative pressure therapy component 406 abuts the intact skin and is disposed between the skin and an immobilization component 408.

[0054] The negative pressure therapy component 406 is shown as including a reduced pressure (manifold) layer, shown as foam 800. The foam 800 is an open cell foam that allows air flow such that air pressure is substantially uniform throughout the foam 800. The foam 800 is disposed within a substantially airtight volume 802 defined by intact skin and a drape layer 804 of the negative pressure therapy component 406. The drape layer 804 is sealed to the skin at an interface 806 of the drape layer 804, for example, with an adhesive, an elastomeric ring, or other seal. In some cases, for example, in a variation of the example of FIGS. 5-7, the drape layer 804, foam 800, and substantially airtight volume 802 are formed in an annular structure such that a seal can be provided only at the open end of the annular structure.

[0055] The intermediate portion 810 of the drape 804 defines the substantially airtight volume 802 of the negative pressure therapy component 406 and is part of the substantially airtight pouch 812 of the immobilization component 408. Thus, the interior volume 814 of the airtight pouch 812 of the immobilization component 408 is separated from the airtight volume 802 of the negative pressure therapy component 406 by the intermediate portion 810 of the drape 804.

[0056] The drape 804 and the airtight pouch 812 can be formed of the same material for ease of manufacturing, such as to facilitate heat sealing or ultrasonic welding of the drape 804 and the airtight pouch 812. For example, the drape 804 and the airtight pouch 812 can be formed of an impermeable polyurethane material that is configured to be flexible but non-stretchable under the range of forces experienced by the treatment device 404 during normal use.

[0057] 8, the immobilization component 408 includes a locking sheet 110 disposed within an airtight pouch 812. In the illustrated example, four locking sheets 110 are provided. The locking sheets are positioned to be substantially parallel to the intact skin to which the treatment device 404 is applied and to a middle portion 810 of the drape 804 that defines the interface between the negative pressure therapy component 406 and the immobilization component 408.

[0058] 8, the treatment device 404 is also shown as including a one-way valve 816 (e.g., a one-way baffle) disposed on the intermediate portion 810 of the drape 804, the valve 816 being capable of communicating with both the interior volume 814 of the airtight pouch 812 of the immobilization component 408 and the airtight volume 802 of the negative pressure therapy component 406. The one-way valve 816 is configured to allow air to flow out of the airtight pouch 812, across the intermediate portion 810 of the drape 804, and into the airtight volume 802, while preventing air flow in the opposite direction. The air flow can be induced by actuation of a negative pressure source 402 connected to the airtight volume 802 of the negative pressure therapy component 406 via a tube 410. Thus, in the embodiment of FIG. 8, the negative pressure source 402 operates to draw negative pressure within the airtight pouch 812 of the immobilization component 408 by drawing air into the tube 410 through the valve 816 and via the negative pressure therapy component 406, for example, via the foam 800 or other manifold or reduced pressure layer.

[0059] The movement of air out of the airtight pouch 812 transitions the immobilization component 408 from a compliant to a non-compliant state, as described above with reference to Figures 1-3. Specifically, when the airtight pouch 812 reaches at least a threshold negative pressure, the locking sheets 110 are forced together into a rigid, immobilized state. By preventing airflow back into the airtight pouch 812, the one-way valve 816 causes the immobilization component 408 to remain in a non-compliant state, regardless of pressure fluctuations in the negative pressure therapy component 406. This may advantageously protect a joint or other tissue site by maintaining immobilization of the joint, even if pressure is lost elsewhere in the injury treatment system.

[0060] In some embodiments, the valve 816 is configured to permanently seal in response to the pressure within the airtight pouch 812 of the immobilization component 408 reaching a threshold amount of negative pressure, for example, a value in the range of about -75 mmHg to about -150 mmHg (e.g., -125 mmHg). In such embodiments, the treatment device 404 may be a single-use device. In other embodiments, the one-way valve 816 may be selectively opened by a user to allow air to flow back into the airtight pouch 812, thereby transitioning the immobilization component back to a flexible state. In other embodiments, a separate user-selectable valve is provided on the airtight pouch 812 to allow the user to selectively release the negative pressure and transition to a flexible state. Such an embodiment may allow for easy removal of the treatment device 404 from the patient and reuse of the treatment device 404.

[0061] 9-12, various embodiments of a wound treatment system 400 having different airflow paths are shown, according to an exemplary embodiment. In particular, the schematic diagrams of FIGS. 9-12 show the elements of the wound treatment system 400 (i.e., the negative pressure source 402, the negative pressure therapy component 406, and the immobilization component 408) connected together via the tubing 110 in various ways that provide different airflow paths through the elements of the wound treatment system 400. Thus, in different embodiments, various airflow paths are shown that allow the treatment device 404 to be drawn down to a negative pressure.

[0062] For example, Figure 9 illustrates a schematic of an airflow path consistent with the embodiment of Figure 8. As shown in Figure 9, air flows out of the immobilization component 408, across the valve 816, through the negative pressure therapy component 406, and to the negative pressure source 402. The elements are connected in series along the airflow path.

[0063] As a next example, Figure 10 illustrates generally a variation of the embodiment of Figures 8-9 in which the valve 816 is omitted. In such an embodiment, air may flow freely between the negative pressure therapy component and the immobilization component 408. For example, with reference to Figure 8, the middle portion 810 of the drape 804 may be omitted or perforated to allow pressure to be transmitted in either direction between the negative pressure therapy component 406 and the immobilization component 408.

[0064] As another example, Figure 11 illustrates generally one embodiment of the wound treatment system 100 in which the negative pressure therapy component 406 and the immobilization component 408 are independently (i.e., in parallel) connected to the negative pressure source 402. In some such embodiments, the negative pressure source 402 operates to simultaneously draw air from both the negative pressure therapy component 406 and the immobilization component 408. In other variations of the embodiment of Figure 11, the negative pressure source 402 functions to independently and selectively draw air from either the negative pressure therapy component 406 or the immobilization component 408, but not necessarily both simultaneously. In some such embodiments, the negative pressure source 402 includes two independent pumps.

[0065] As yet another example, FIG. 12 illustrates an embodiment in which the tube 410 extending from the negative pressure source 402 splits at a junction 1206 into a first portion 1202 that extends to the negative pressure therapy component 406 and a second portion 1204 that extends to the immobilization component 408. As shown, the junction 1206 is external to both the negative pressure source 402 and the treatment device 404. Thus, the junction 1206 is accessible and visible to a user of the injury treatment system 400. In some embodiments, the junction 1206 includes a valve that can selectively close an airflow path to or from the immobilization component 408. The valve can also be located elsewhere along the second portion 1204 of the tube between the junction 1206 and the immobilization component 408. In such an embodiment, the negative pressure source 402 can be operated with the valve open to transition the immobilization component 408 from a compliant to a non-compliant state, and then closed to maintain the immobilization component 408 in the non-compliant state. To transition back to the compliant state, the valve can be reopened and air can be allowed to flow into the immobilization component 408. Thus, the injury treatment system 400 can be adapted for repeated adjustment, removal, and reuse.

[0066] The above examples include tubing 410. In other examples, tubing 410 is omitted, for example, with negative pressure source 402 attached directly to treatment device 404. Many such variations are within the scope of this disclosure.

[0067] Configuration of an Exemplary Embodiment As used herein, the terms "about," "approximately," "substantially," and similar terms are intended to have broad meanings consistent with common accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. Those of ordinary skill in the art reviewing this disclosure will understand that these terms are intended to enable the description of certain features as described and claimed without limiting the scope of those features to the precise numerical ranges provided. Thus, these terms should be interpreted as indicating that insubstantial or insignificant modifications or variations of the subject matter as described and claimed are considered to be within the scope of the present disclosure as set forth in the appended claims.

[0068] It should be noted that when used herein to describe various embodiments, the term "exemplary" and variations thereof (e.g., "exemplary") are intended to indicate that such embodiments are possible examples, representations, or illustrations of possible embodiments (such terms are not intended to imply that such embodiments are necessarily particular or best examples).

[0069] As used herein, the term "coupled" and variations of the term "coupled" refer to the direct or indirect connection of two members to one another. Such connections may be static (e.g., permanent or fixed) or movable (e.g., removable or releasable). Such connections may be achieved by two members being directly coupled to one another, two members being coupled to one another using a separate intervening member and any additional intermediate members coupled to one another, or two members being coupled to one another using an intervening member integrally formed with one of the two members as a single, integrated body. When a variation of "coupled" or "coupled" is modified by an additional term (e.g., directly coupled), the general definition of "coupled" provided above is modified by the ordinary meaning of the additional term (e.g., "directly coupled" means the connection of two members without a separate intervening member), resulting in a narrower definition than the general definition of "coupled" provided above. Such connections may be mechanical, electrical, or fluid.

[0070] As used herein, the term "or" is used in the inclusive sense of the term "or" (rather than the exclusive sense of the term "or"), and thus, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless otherwise indicated, a conjunction such as the phrase "at least one of X, Y, and Z" is understood to convey that the elements are either X, Y, Z, X and Y, X and Z, Y and Z, or X, Y, and Z (i.e., any combination of X, Y, and Z). Thus, unless otherwise indicated, such conjunctions are not generally intended to imply that an embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0071] References to the location of elements herein (e.g., "top," "bottom," "upper," "lower") are used merely to describe the orientation of the various elements in the figures. It should be noted that the orientation of the various elements may differ according to other exemplary embodiments, and such variations are intended to be encompassed by the present disclosure.

Claims

1. 1. A wound treatment system comprising: A negative pressure source; A dressing in pneumatic communication with the negative pressure source, the dressing comprising: a negative pressure therapy component configured to expose an anatomical structure to negative pressure in response to actuation of the negative pressure source when the negative pressure therapy component is applied to the anatomical structure; an immobilization component coupled to the negative pressure therapy system, the immobilization component configured to transition from a compliant state to a non-compliant state in response to the activation of the negative pressure source; A dressing comprising: An injury treatment system comprising:

2. 2. The wound treatment system of claim 1, wherein the negative pressure therapy component comprises a manifold layer and an air impermeable layer configured to be sealed against the anatomical structure, defining an airtight volume between the air impermeable layer and the anatomical structure to house the manifold layer.

3. The injury treatment system of claim 1 , wherein the immobilization component is further configured to transition from the non-compliant state to the compliant state in response to release of negative pressure from the immobilization component.

4. The wound treatment system of claim 1 , wherein the immobilization component is pneumatically communicable with the negative pressure source via the negative pressure therapy component.

5. 5. The injury treatment system of claim 4, wherein the immobilization component is pneumatically communicable with the negative pressure source via a valve configured to close when a threshold amount of negative pressure is established within the immobilization component.

6. The immobilization component comprises: an airtight chamber configured to be evacuated by said activation of said negative pressure source; A lock sheet disposed in the airtight chamber, the lock sheet being flexible when the airtight chamber is not evacuated; the locking sheets interlock to form a rigid structure when the airtight chamber is evacuated by the operation of the negative pressure source. Rock sheet and The injury treatment system of claim 1 , comprising:

7. a manifold layer having a patient-facing side and a non-patient-facing side; a first airtight chamber disposed along at least a portion of the non-patient-facing side of the airtight chamber; a lock sheet disposed within the first airtight chamber, the lock sheet configured to transition from a flexible state to a non-flexible state; a sealable layer coupled to the manifold layer and configured to define a second airtight chamber sealed to a patient and containing the manifold layer; An injury treatment device comprising:

8. 8. The injury treatment device of claim 7, comprising a valve configured to selectively place the first airtight chamber in fluid communication with the second airtight chamber.

9. When the first airtight chamber is at atmospheric pressure, the lock sheet is flexible; The injury treatment device of claim 7 , wherein the locking sheet is non-compliant when the first airtight chamber is suctioned to at least a threshold negative pressure.

10. The injury treatment device of claim 9, wherein the threshold negative pressure is -125 mmHg.

11. The lock sheet is a first sheet having protrusions arranged in a first pattern; a second sheet having recesses arranged in the first pattern; Equipped with 8. The injury treatment device of claim 7, wherein when the protrusion is disposed within the recess, the first sheet is substantially prevented from sliding along the second sheet, thereby rendering the locking sheet inflexible.

12. 12. The injury treatment device of claim 11, wherein the protrusion is configured to enter the recess in response to establishment of a negative pressure in the first airtight chamber and to exit the recess in response to release of the negative pressure from the first airtight chamber.

13. A device configured to be applied to the ankle, the manifold layer has a first boot shape; the lock sheet is less than coextensive with the manifold layer; The injury treatment device of claim 7.

14. 14. The injury treatment device of claim 13, wherein the locking sheet is provided in a splint configuration configured to substantially immobilize the ankle when the locking sheet is in the non-compliant state and to allow the ankle to be inserted into the boot-shaped manifold layer when the locking sheet is in the compliant state.

15. Airtight pouches and a negative pressure source pneumatically communicable with the airtight pouch and operable to establish a negative pressure within the airtight pouch; a plurality of sheets disposed within the airtight pouch, each sheet having a thickness in the range of about 0.004" to 0.006"; Equipped with when the negative pressure source establishes the negative pressure within the airtight pouch, the plurality of sheets are configured to consolidate together to form a non-flexible block. Damage treatment system.

16. 16. The wound treatment system of claim 15, wherein the plurality of sheets have a combined thickness ranging from 0.125" to 0.25" inches.

17. The wound treatment system of claim 15, wherein the plurality of sheets comprises between 10 and 80 sheets.

18. 16. The wound treatment system of claim 15, wherein the plurality of sheets comprises one or more of paper, stone paper, or polyester.

19. 16. The wound treatment system of claim 15, wherein a first sheet of the plurality of sheets has a cut pattern configured to enhance conformability of the first sheet.

Images