Decompression therapy treatment system

Abstract

To provide a decompression therapy for reducing swelling by increasing perfusion of the blood and lymph flow at a tissue site.SOLUTION: A treatment system 10 includes a dressing 100 having a decompression layer and an occlusive layer 110 that secures the dressing about a treatment site and defines a treatment chamber within which the decompression layer is positioned. Operation of an air displacement device 200 fluidly coupled to the chamber causes the decompression layer to compress away from the tissue site, resulting in a pulling force being imparted onto the treatment site. This decompression of the tissue site increases the perfusion of blood and other fluids, and advantageously may reduce swelling at the treatment site. To increase the degree of lifting of the treatment site, the decompression layer is advantageously constructed to exhibit a parallel plate effect during use of the treatment system. For example, the decompression layer is constructed having a center of stiffness located closer to an outwardly-facing surface of the decompression layer than a tissue-facing surface of the decompression layer.SELECTED DRAWING: Figure 1

Description

Background Art

[0004]

[0001] Cross - reference to related applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 929,215, filed November 1, 2019, and U.S. Provisional Patent Application No. 62 / 955,534, filed December 31, 2019, which are hereby incorporated by reference in their entirety.

[0002] Swelling associated with trauma or certain pathologies (e.g., lymphedema) can cause various medical complications. For example, swelling can cause discomfort and pain, can limit the range of motion, or otherwise negatively impact the patient's quality of life. Swelling can also limit the ability of a healthcare provider to medically image, visualize, and access underlying tissues, or otherwise interfere with the patient's treatment, thus posing an impediment to the patient's healing and recovery. In some situations, swelling can even result in more severe outcomes such as atrophy of the surrounding muscle tissue.

[0003] It would be advantageous to provide a durable, reusable treatment system that can be easily applied to a tissue site, can be cleaned (or otherwise sterilized) between uses, and can reliably operate repeatedly to provide a decompression therapy that increases blood perfusion and lymphatic flow at the tissue site to reduce swelling.

Summary of the Invention

[0005] In some embodiments, the occlusion layer extends at least 360 degrees around the limb (or other anatomical structure) defining the tissue site when sealed to the patient, and the decompression layer compresses radially outward during the operation of the vacuum source. In other embodiments, the occlusion layer extends less than 360 degrees around the limb (or other anatomical structure) defining the tissue site when sealed to the patient, and the decompression layer compresses upward during the operation of the vacuum source.

[0006] In some embodiments, the vacuum layer is formed from a macromesh material (e.g., a macromesh cloth). The macromesh material optionally includes an upper layer, a lower layer, and a plurality of filaments extending between the upper and lower layers and connecting them. The filaments are flexible such that the distance between the upper and lower layers before the operation of the vacuum source is greater than the distance between the upper and lower layers during the operation of the vacuum source.

[0007] In various embodiments, the upper layer extends substantially continuously with respect to the lower layer. The upper layer has at least one of higher rigidity and higher density than the lower layer.

[0008] The macromesh material optionally further includes a first intermediate layer disposed between the upper and lower layers. The first intermediate layer has at least one of higher rigidity and higher density than the lower layer. In some embodiments, the first intermediate layer is formed from the same material as the upper layer. Multiple filaments extend between the first intermediate layer and at least one of the lower and upper layers.

[0009] The macromesh material optionally further includes a second intermediate layer disposed between the upper layer and the first intermediate layer. The second intermediate layer has at least one of lower stiffness and lower density than the first intermediate layer.

[0010] In other embodiments, the macromesh material optionally further includes a second intermediate layer disposed between the lower layer and the first intermediate layer. The second intermediate layer has at least one of lower stiffness and lower density than the first intermediate layer. In various embodiments, the second intermediate layer is formed from the same material as the lower layer.

[0011] The center of mass of the decompression layer may be located at a height along the decompression layer, closer to the top surface of the decompression layer than to the bottom surface.

[0012] An optional interface layer is located beneath the underside of the decompression layer. The interface layer comes into contact with the skin surrounding the tissue site during sealing of the occlusion layer to the patient. The interface layer may include a nonwoven breathable fabric. The interface layer may be a separate structure provided independently of the decompression layer. The interface layer is optionally selectively releasable attached to at least one of the decompression layer and the occlusion layer. In some embodiments, the interface layer is attached to the decompression layer along its underside.

[0013] In some embodiments, the occlusion layer and the decompression layer are attached to each other to define an annular structure including at least a first open end. The annular structure is sized for attachment to one of the patient's knee, ankle, leg, arm, or hand. In some embodiments, the annular structure optionally further defines a sleeve-like structure including a second open end.

[0014] According to one embodiment of the present disclosure, a device for increasing at least one of hemoperfusion and lymphatic flow at a tissue site includes a circumferentially extending occlusion layer, a decompression layer, and a connector. The occlusion layer is configured to seal to the patient around the tissue site to define a substantially airtight chamber. The decompression layer has a lower surface configured to be positioned in close proximity to the tissue site within the chamber defined by the occlusion layer. The connector is configured to fluidly couple the chamber to a vacuum source. When the vacuum source is operating, the decompression layer is configured to compress away from the tissue site.

[0015] The closure layer optionally includes either a boot-shaped or hand-shaped configuration. The shape and size of the decompression layer may be the same as that of the closure layer. The size of the decompression layer is smaller than that of the closure layer so that the decompression layer is concentric with the closure layer. In some embodiments, the closure layer includes at least one of a zipper and a gusset.

[0016] In some embodiments, the reduced pressure layer includes a first mesh layer perpendicularly offset from a second mesh layer by a flexible layer. The first mesh layer is located opposite the occlusion layer, and the second mesh layer is located opposite the tissue site. The second mesh layer may move radially outward toward the first mesh layer during the operation of the vacuum source. The first mesh layer may have a higher density than the second mesh layer.

[0017] According to one embodiment of the present disclosure, a method for providing decompression therapy includes attaching a dressing in close proximity to intact skin extending over a treatment site. The dressing includes an occlusion layer configured to define a substantially airtight chamber between the patient's skin and the underside of the occlusion layer, and a compressible decompression layer including a plurality of fluid channels extending through it. An air displacement device fluidically coupled to the chamber operates to expel air from the chamber. The expulsion of air from the chamber compresses the decompression layer away from the tissue site. The compression of the decompression layer away from the tissue site is configured to pull the intact skin outward relative to the treatment site.

[0018] The decompression layer optionally includes a first mesh layer facing the occlusion layer and a second mesh layer facing the treatment site. The second layer is configured to move relative to the first layer in the direction opposite to the treatment site when air is discharged from the chamber. In some embodiments, the first layer has at least one of a higher density and / or higher rigidity than the second layer.

[0019] An optional interface layer may be attached in close proximity to intact skin extending over the treatment site. In some embodiments, the occlusion layer and decompression layer are attached to the patient's skin after the interface layer has been attached to the patient. The occlusion layer may be attached to the patient after the decompression layer has been attached to the patient.

[0020] The treatment site is optional and corresponds to at least one of the following: a fracture, sprain, or bruise in the limb. Exhausting air from the chamber reduces swelling at the treatment site from a first degree of swelling to a second degree of swelling. In some embodiments, the treatment site is treated surgically after the reduction in swelling at the treatment site from a first degree of swelling to a second degree or less. The reduction in swelling from the first degree to the second degree occurs 3–7 days after the initial operation of the exhaust device for expelling air from the chamber. [Brief explanation of the drawing]

[0021] [Figure 1] A side view of a vacuum therapy system showing a partial cross-sectional view of a dressing of the vacuum therapy system according to an exemplary embodiment.

[0022] [Figure 2] A cross-sectional view taken along line 2-2 of FIG. 1.

[0023] [Figure 3] An exploded perspective view of a dressing of a vacuum therapy system according to an exemplary embodiment. [[ID=十七]]

[0024] [Figure 4A] A schematic view of crushing of a vacuum layer of a dressing of a vacuum therapy system according to an exemplary embodiment.

[0025] [Figure 4B] A schematic view of crushing of a vacuum layer of a dressing of a vacuum therapy system according to an exemplary embodiment.

[0026] [[ID=三十一]] [Figure 5] A perspective view of a material forming a vacuum layer of a dressing of a vacuum therapy system according to an exemplary embodiment. <000##0097>

[0027] [Figure 6A] A cross-sectional view of a vacuum layer according to an exemplary embodiment. [Figure 6B] A cross-sectional view of a vacuum layer according to an exemplary embodiment. [Figure 6C] A cross-sectional view of a vacuum layer according to an exemplary embodiment. [Figure 6D] A cross-sectional view of a vacuum layer according to an exemplary embodiment. [Figure 6E] A cross-sectional view of a vacuum layer according to an exemplary embodiment. [Figure 6F] A cross-sectional view of a vacuum layer according to an exemplary embodiment.

[0028] [Figure 7]This table shows a comparison of the performance of the exemplary decompression layers shown in Figures 6A to 6E and the performance of a mesh foam-based decompression layer during use of a decompression therapy system according to an exemplary embodiment.

[0029] [Figure 8A] This is a perspective view of a dressing for a decompression therapy system according to an exemplary embodiment.

[0030] [Figure 8B] This is a perspective view of the dressing shown in Figure 8A, attached to a patient, according to an exemplary embodiment.

[0031] [Figure 8C] This is a perspective view of the dressing shown in Figure 8A, attached to a patient, according to an exemplary embodiment.

[0032] [Figure 9A] This is a perspective view of a dressing for a decompression therapy system according to an exemplary embodiment.

[0033] [Figure 9B] This is a perspective view of the dressing shown in Figure 9A, attached to a patient, according to one exemplary embodiment.

[0034] [Figure 10] This is a perspective view of a dressing for a decompression therapy system according to an exemplary embodiment.

[0035] [Figure 11A] This is an exploded perspective view of a dressing for a decompression therapy system according to an exemplary embodiment.

[0036] [Figure 11B] This is a perspective view of the dressing shown in Figure 11A, attached to a patient, according to one exemplary embodiment. [Modes for carrying out the invention]

[0037] Before referring to the drawings that illustrate an exemplary embodiment in detail, please understand that this disclosure is not limited to the details or methods described or shown in the description or drawings. Also, please understand that the terms used herein are for illustrative purposes only and should not be construed as limiting.

[0038] Generally with reference to the figures, various embodiments of decompression therapy treatment systems for applying vacuum 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.) are described. The application of vacuum to intact skin provided by the treatment system imparts a tensile (e.g., lifting) force to the intact skin, which depressurizes the treatment tissue site, thereby increasing blood perfusion and the perfusion of other fluids (e.g., lymphatic flow) in the treatment tissue site.

[0039] The decompression of the treated tissue site resulting from the operation of the treatment system can be advantageously used to reduce swelling in the tissue site. The treatment system is configured for use in both medical and non-medical settings and can be used to treat swelling resulting from a variety of different conditions. For example, the treatment system can be used by a patient in a home setting to treat swelling resulting from injury, overuse, or an underlying medical condition (e.g., lymphedema).

[0040] In further embodiments, the treatment system may also be used in medical settings, for example, to reduce swelling during the patient's preoperative and / or postoperative care. For example, reducing swelling at the treatment site before surgery (e.g., caused by fracture, edema, tissue sprain, tissue contusion, etc.) may advantageously facilitate access to underlying tissue at the target surgical site, reduce surgical time, and / or improve the outcome of the surgical treatment. The use of the treatment system according to any of the embodiments described herein prior to surgical treatment may advantageously reduce the time required to reduce swelling at the target surgical site to an acceptable degree compared to the time required to reduce swelling using conventional methods for treating swelling. For example, the use of the treatment system may reduce swelling to an acceptable degree within 3 to 7 days from the start of treatment using the treatment system.

[0041] In addition to the use of the treatment system to reduce swelling, the decompression therapy provided by the treatment system may also be advantageously used in the treatment of various other medical conditions or diseases. As one non-limiting example, the treatment system may be used for the acute treatment of pain and / or inflammation (e.g., resulting from a sprain or other stress on a tissue site). In yet another situation, the treatment system may be used to increase blood perfusion and / or lymphatic flow at the treatment tissue site to minimize the effects of overuse (e.g., after athletic training or other strenuous activity).

[0042] Referring to Figure 1, the treatment system 10 generally comprises a dressing 100 configured to be attached to the patient at a location surrounding the tissue site to be treated, and an exhaust device 200 (e.g., a vacuum source, a negative pressure pump, etc.) configured to provide a negative pressure source to a treatment chamber defined between the dressing 100 and the tissue site to be treated. When the exhaust device 200 is in operation, the treatment chamber defined between the patient's intact skin and the dressing 100 functions as a decompression chamber, and in the decompression chamber, when air is expelled from the treatment chamber, the skin and underlying tissues are subjected to an outward tensile (e.g., uplift) force (representatively shown by the arrows in Figure 2). An optional controller coupled to either or both the dressing 100 and the exhaust device 200 can be used to control the application of decompression therapy to the treatment site using the treatment system 10.

[0043] As shown by the embodiment of the treatment system 10 in Figure 1, the dressing 100 and the exhaust device 200 are optionally provided as separate components located far apart from each other. In such embodiments, the exhaust device 200 is fluidically and sealedly coupled to the treatment chamber via an external tube 205. An optional connector port 90, sealed and mounted around an opening 111 extending through the dressing 100, can facilitate fluid connection between the treatment chamber and the exhaust device 200. In other embodiments (e.g., embodiments in which the dressing 100 is configured to wrap around the patient), other connector port structures and / or configurations may be used to seal and engage and fluidly couple the exhaust device 200 and the dressing 100. As shown in Figure 11B, in yet another embodiment, the exhaust device 200 is optionally integrated within a module 300, which is fixedly or detachably mounted to the dressing 100 to define an integrated, self-contained, one-piece treatment system 10.

[0044] In addition to the use of the treatment system 10 as a standalone decompression therapy device, in various embodiments the treatment system 10 may be used in conjunction with one or more additional treatment systems (and optionally integrated within one or more additional treatment systems). For example, while the treatment system 10 is described as being used to apply tensile force to intact skin surrounding a treatment tissue site, in some embodiments the treatment system 10 may be used to apply tensile force to a wound. In some such embodiments the treatment system 10 may optionally be applied on top of a wound dressing of a negative pressure wound closure system ("Negative Pressure Wound Therapy (NPWT)" system) (or integrated within a wound dressing of an NPWT system). In yet other embodiments the treatment system 10 may be used in conjunction with various other treatment systems, such as a thermal treatment system or a system configured to treat fractures.

[0045] dressing Referring to Figure 3, the dressing 100 generally comprises a flexible occlusion layer 110 and a compressible decompression layer 120 (e.g., a manifolding layer, a macromesh layer, a compressible layer, a collapsible layer, etc.) containing multiple fluid channels extending through it. The occlusion layer 110 is configured to be attached to the patient (e.g., using an optional sealing member) to define a treatment chamber surrounding the tissue site to be treated. When the dressing 100 is attached to the patient, the decompression layer 120 is positioned within the treatment chamber and extends along the tissue site to be treated. An optional interface layer 130 extends between the patient's skin and the decompression layer 120.

[0046] During the operation of the treatment system 10, the expulsion of air from the treatment chamber at the start of the exhaust device 200 causes the occlusion layer 110 and the decompression layer 120 to be drawn toward the intact skin surrounding the treatment tissue site. Once the vacuum applied by the exhaust device 200 has removed most of the air from the treatment chamber, the continued application of negative pressure to the treatment chamber causes the compressible decompression layer 120 to collapse (e.g., compress) toward itself. This continued application of negative pressure to the treatment chamber and the collapse of the decompression layer 120 pulls toward the intact skin at the treatment tissue site outward (e.g., as indicated by the arrows in Figure 2), thereby stimulating hemoperfusion and lymphatic flow in the subcutaneous portion of the treatment tissue site.

[0047] A. Occlusion layer The occlusion layer 110 is configured to seal to the patient's skin so as to surround (e.g., enclose, extend upward, cover, etc.) the site of treatment. For example, in some embodiments, the occlusion layer 110 is defined by a sleeve-like structure, a boot-like structure, or other annular structure, and / or by a sheet-like or tape-like structure configured to wrap around an anatomical structure, the occlusion layer 110 extends about 360 degrees around the patient's limb, limb, or other anatomical structure (i.e., encircles it), or extends more than 360 degrees (i.e., the occlusion layer 110 wraps around itself). In other embodiments (e.g., during treatment of the knee, shoulder, elbow, etc.), the occlusion layer 110 is optionally defined by a sheet-like structure that extends less than 360 degrees (e.g., less than 180 degrees) around the patient's anatomical structure.

[0048] During the operation of the exhaust device 200, the sealed attachment between the occlusion layer 110 and the patient's skin forms a sealed decompression therapy chamber, through which negative pressure is transmitted to the treatment tissue site. An opening 111 is optionally defined through the occlusion layer 110, through which the therapy chamber is fluidically coupled to the exhaust device 200 of the therapy system 10. Alternatively, the therapy chamber is fluidly coupled to a vacuum source via a connector interposed between the patient's skin and the underside of the occlusion layer 110.

[0049] The occlusion layer 110 may be formed from a variety of materials capable of maintaining a desired vacuum within the treatment chamber during use of the treatment system 10. Optionally, the occlusion layer 110 is formed from a material having a high MVTR to allow moisture (e.g., sweat) to evaporate from the treatment tissue site during use of the treatment system 10. The material selected for the occlusion layer 110 is also advantageously strong and elastic enough to allow the occlusion layer 110 to withstand prolonged use of the treatment system 10. In embodiments where the occlusion layer 110 is reusable, the material forming the occlusion layer 110 is also optionally durable enough to allow the occlusion layer 110 to be cleaned (e.g., washed) between uses.

[0050] As shown in Figure 3, in some embodiments, the occlusion layer 110 is provided as a separate component of the dressing 100, integrated with other components (e.g., a decompression layer 120, an interface layer 130, etc.) during the application of the dressing 100 to the patient. In some such embodiments, the occlusion layer 110 is optionally provided with adhesive along its underside (the occlusion layer 110 is integrated with the sealing member). Such a peel-and-place arrangement allows the dressing 100 to be quickly wrapped (or otherwise attached) to the patient's anatomical structure (e.g., foot, leg, arm, etc.), enabling rapid application of the dressing 100 to the patient. Referring to representative embodiments in Figures 8A, 9A, and 10, in other embodiments, the occlusion layer 110 is alternatively detachably or permanently integrated with the decompression layer 120.

[0051] Non-limiting examples of materials that may be used for the occlusion layer 110 include, but are not limited to, polyurethane films (e.g., ESTANE 5714F), other polymer films including, but not limited to, polyalkoxyalkyl acrylates and methacrylates (e.g., the polymer films described in, for example, UK Patent Application Publication No. 1280631(A), filed November 22, 2002, the entire disclosure of which is incorporated herein by reference), laminated fabrics (e.g., polyurethane laminates, foamed polytetrafluoroethylene laminates, etc.), polymer-coated fabrics, and fabrics made from various synthetic fibers.

[0052] B. Decompression layer The depressurization layer 120 (e.g., manifold layer, macromesh layer, compressible layer, collapsible layer, etc.) is configured to impart tensile or lifting force to the skin at the treatment tissue site. The depressurization layer 120 is formed from a material that contains (or defines) a plurality of fluid channels (e.g., pathways, passages, pores, etc.) through which fluid channels pass. The fluid channels of the depressurization layer 120 enable the sustained transmission of negative pressure to the treatment tissue site (e.g., manifolding) during the operation of the treatment system 10. Some or all of the fluid channels are optionally interconnected to improve the distribution of fluid (e.g., air) supplied to or removed from the treatment tissue site. The depressurization layer 120 is formed from a compressible material that is stiff enough to provide an airflow through the fluid channels at a negative pressure of at least up to approximately 150 mmHg.

[0053] Referring to Figure 2, when air is discharged from the treatment chamber during the operation of the treatment system 10, the greater rigidity of the skin / muscle / bone beneath the treatment tissue site compared to the rigidity of the dressing 100 causes the occlusion layer 110 to be attracted to the outward-facing surfaces 125 of the decompression layer 120 (e.g., the top, outer, or opposite side of the tissue site), and also to the tissue-facing surfaces 127 of the decompression layer 120 (e.g., the bottom or inner surface) toward and toward the skin at the treatment tissue site (directly or indirectly via an optional interface layer 130). Once the air is substantially discharged from the treatment chamber, the continued application of vacuum to the treatment chamber results in the collapse of the compressible decompression layer 120.

[0054] The direction in which the decompression layer 120 collapses (e.g., compresses) (i.e., outward / inward, upward / downward, away from / towards the tissue, radially, vertically, etc.) varies depending on the construction of the decompression layer 120. A decompression layer 120 formed from a single layer of material with uniform density collapses in response to a vacuum, as shown by the arrows in Figure 4A. Such a decompression layer 120, having a rigid center located closer to the tissue-facing surface 127 than to the outward-facing surface 125 of the decompression layer 120, compresses so that the outward-facing surface 125 of the decompression layer 120 is attracted toward the tissue-facing surface 127 of the decompression layer 120.

[0055] Figure 4B shows that the vacuum layer 120, which includes an outer portion formed from a rigid material (i.e., the portion of the vacuum layer 120 adjacent to the outward-facing surface 125 facing away from the tissue site) and an inner portion formed from a softer material (i.e., the portion of the vacuum layer 120 adjacent to the tissue-facing surface 127), collapses in response to a vacuum. In contrast to the typical vacuum layer 120 shown in Figure 4A, the vacuum layer 120 shown in Figure 4B, defined by a rigid center located closer to the outward-facing surface 125 than to the tissue-facing surface 127 of the vacuum layer 120, experiences a parallel plate effect when subjected to a vacuum during use of the treatment system 10. As indicated by the arrows in Figure 4B, this arrangement, in which the softer inner half of the decompression layer 120 is sandwiched between two harder structures (i.e., the skin / muscle / bone beneath the treatment tissue site and the relatively harder outer half of the decompression layer 120), results in the tissue-facing surface 127 of the decompression layer 120 being pulled toward the outward-facing surface 125 of the decompression layer 120 when it is compressed. The tensile force applied to the skin at the treatment tissue site as a result of such outward compression of the decompression layer 120 is effective in improving lymphatic and hemoperfusion at the treatment tissue site.

[0056] Taking into account the parallel plate effect on lymphatic and hemoperfusion at the tissue site, the decompression layer 120 is advantageously constructed such that the rigidity center of the decompression layer 120 is located closer to the outward-facing surface 125 than to the tissue-facing surface 127 of the decompression layer 120. The decompression layer 120 is also advantageously constructed from a material that is flexible enough to allow the decompression layer 120 to adhere to the patient and the dressing 100 to allow a range of motion of the body part to which it is attached during use of the treatment system 10.

[0057] The depressurization layer 120 is also advantageously formed to have sufficient structural integrity and elasticity to withstand repeated application of negative pressure to the depressurization layer 120 over the course of the operation of the treatment system 10 (e.g., for a period of up to one week or more). To facilitate the reuse of the treatment system 10 in the same patient or another patient, the depressurization layer 120 is additionally, optionally, constructed to have durability that allows the depressurization layer 120 to be cleaned between uses.

[0058] Referring to Figure 5, an exemplary embodiment illustrates the construction of a flexible, elastic, and durable decompression layer 120 configured to impart increased tensile force to the skin at a tissue treatment site. In the embodiment of the decompression layer 120 shown in Figure 5, the decompression layer 120 is defined by a macromesh material comprising a lower layer 123, an upper layer 121, and an intermediate layer 122. When integrating the decompression layer 120 into the tissue treatment system 10, the lower surface of the lower layer 123 defines the tissue-facing surface 127 of the decompression layer 120 (e.g., the lower surface, the inner surface, the radially inward-extending surface, etc.), and the upper surface of the upper layer 121 defines the outward-facing surface 125 of the decompression layer 120 (e.g., the upper surface, the outer surface, the radially outward-extending surface, etc.). The upper layer 121 and the lower layer 123 are offset perpendicularly from each other and interconnected via an intermediate layer 122 (e.g., a connector layer).

[0059] The upper layer 121 and lower layer 123 that define the macromesh material forming the vacuum layer 120 can be defined by a variety of different materials. To provide the vacuum layer 120 with desired elasticity and durability, one or both of the upper layer 121 and the lower layer 123 are formed from a woven material. The woven material can be defined by a variety of different weave or nonwoven patterns, weight, density, fiber, stiffness, etc., depending on the desired properties of the vacuum layer 120. According to various embodiments, one or both of the upper layer 121 and the lower layer 123 are formed from a polymer or nylon material (e.g., polymer or nylon mesh).

[0060] To provide the vacuum layer 120 with a desired offset rigidity center (i.e., a rigidity center located near the outward-facing surface 125 of the vacuum layer 120), the upper layer 121 is formed from a different material than the lower layer 123, has a different construction than the lower layer 123, or otherwise differs from the lower layer 123. For example, the upper layer 121 is formed from a material having greater rigidity than the material used for the lower layer 123. The material selected for the upper layer 121 and / or the lower layer 123 may optionally include a coating (e.g., an antimicrobial coating, a hydrophobic coating, etc.) to provide the vacuum layer 120 with additional desired features.

[0061] The intermediate layer 122 can be formed from a variety of different materials. As shown in Figure 5, according to various embodiments, the intermediate layer 122 is formed from a plurality of filament fibers 129 that are durable, elastic, and flexible (e.g., crushable, deflectable, bendable, compressible, etc.) allowing the decompression layer 120 to be crushed (e.g., compressed, or otherwise reduce the distance between the upper layer 121 and the lower layer 123) one or more times during use of the treatment system 10. The filament fibers 129 forming the intermediate layer 122 can be defined by various yarn types (e.g., monofilament, multifilament, spun, etc.), diameter, length, material, weight, denier, density, stiffness, etc. The selection and arrangement of the filament fibers 129 can vary based on desired characteristics of the manifold layer. For example, the length and density of the filament fibers 129 forming the intermediate layer 122 can vary based on the desired stiffness of the decompression layer 120.

[0062] The effects of changing various properties of the arrangement of the two-layer decompression layer 120 shown in Figure 5 on the tensile force applied to the skin during the operation of the treatment system 10 will be explained with reference to Figures 6A to 6F and Figure 7. Non-limiting properties of embodiments of the decompression layer 120 shown in Figures 6A to 6E are provided in the table in Figure 7.

[0063] Generally, a vacuum layer 120 including a macromesh configuration, as typically shown in the embodiment of Figure 5, is defined by greater rigidity than a vacuum layer 120 formed from a single layer of uniformly dense mesh foam material. Therefore, as shown in the table of Figure 7, even if the two-layer vacuum layer 120 is defined by a rigid center located at the center (or substantially at the center) of the vacuum layer 120 (as shown in the embodiments of Figures 6A and 6B, for example), the structure of the two-layer vacuum layer 120 provides improved blood perfusion and lymphatic flow at the treatment tissue site compared to a vacuum layer formed from a single layer of uniformly dense mesh foam material.

[0064] For example, as shown in the table in Figure 7, in one embodiment, an embodiment of the decompression layer 120, such as the one shown in Figure 6A, which includes a macromesh configuration having an upper layer 121 and a lower layer 123 that are high density and / or high rigidity (for example, formed from a polyester material having about 3.4 denier), can increase the degree of perfusion and flow at the treatment tissue site by about 10.5% compared to a decompression layer formed from a single layer of uniformly dense mesh foam material. Also, as shown in the table in Figure 7, in one embodiment, an embodiment of the decompression layer 120, such as the one shown in Figure 6B, which includes a macromesh configuration having an upper layer 121 and a lower layer 123 that are low density and / or low rigidity (for example, formed from a polyester material having about 1.5 denier), can increase the degree of perfusion and flow at the treatment tissue site by about 7.7% compared to a decompression layer formed from a single layer of uniformly dense mesh foam material.

[0065] As summarized in the table in Figure 7, and as shown by the performance comparison of the examples of the vacuum layers 120 in Figures 6A and 6B, increasing the density (and stiffness) of the material used to form substantially similar upper and lower layers 121 and 123 of the vacuum layer 120, for example, as shown in the embodiment of Figure 6A, provides increased tensile strength compared to embodiments of a two-layer vacuum layer 120 having upper and lower layers 121 and 123, respectively, formed from materials of lower density (and lower stiffness), for example, as typically shown in the embodiment of Figure 6B.

[0066] As shown in the table in Figure 7, a two-layer decompression layer 120 arrangement, such as that typically shown in Figure 6C, which includes an upper layer 121 formed from a material with higher density (and higher stiffness) and a lower layer 123 formed from a material with lower density (and lower stiffness), and is therefore defined by a stiffness center located near the outward-facing surface 125 of the decompression layer 120, imparts increased tensile force to the treatment tissue site compared to a decompression layer 120 formed having both an upper layer 121 and a lower layer 123 made from materials of the same density (and the same stiffness), such as the embodiments of the decompression layer in Figures 6A and 6B. For example, compared to the foam of the embodiment of the depressurization layer 120 in Figure 6A (formed from a high-density / high-rigidity upper layer 121 and a lower layer 123), which shows a 10.5% improvement, and the foam of the embodiment of the depressurization layer 120 in Figure 6B (formed from a low-density / low-rigidity upper layer 121 and a lower layer 123), which shows a 7.7% improvement, the embodiment of the depressurization layer having a high-density and / or high-rigidity upper layer 121 and a low-density and / or low-rigidity lower layer 123 (for example, the embodiment in Figure 6C) exhibits a 24.6% improvement in perfusion and flow compared to a depressurization layer formed from a single layer of uniform-density mesh foam material.

[0067] As shown in Figure 7, the embodiment of the vacuum layer 120 in Figure 6D is formed from a high-density (and high-rigidity) material, similar to the material used for the lower layer 123 and upper layer 121 of the embodiment of the vacuum layer 120 in Figure 6C, and the lower layer 123 of the vacuum layer 120 is also formed from a low-density (and lower-rigidity) material. However, while the embodiment of the vacuum layer 120 in Figure 6C includes a continuously extending upper layer 121, the upper layer 121 of the embodiment of the vacuum layer 120 in Figure 6D is instead defined by strips of high-density (and high-rigidity) material, and the strips are separated from each other by portions of an intermediate layer 122 along which the upper layer 121 does not extend.

[0068] As a result of the configuration of the interrupted upper layer 121 in the embodiment of the decompression layer 120 in Figure 6D, the rigid center of the decompression layer 120 in Figure 6D is located closer to the tissue-facing surface 127 than to the outward-facing surface 125 of the decompression layer 120. As shown in Figure 7, the effect of the rigid center of the decompression layer 120 in Figure 6D being located closer to the tissue-facing surface 127 of the decompression layer 120 is that the embodiment of the decompression layer 120 in Figure 6D imparts even less tensile force to the skin at the treatment tissue site than a single-layer mesh foam-based decompression layer of uniform density. Therefore, as shown in the table in Figure 7, the arrangement of the decompression layer, such as the arrangement in Figure 6D, can result in a 16.1% reduction in perfusion and flow at the treatment tissue site compared to a decompression layer formed from a single-layer mesh foam material of uniform density.

[0069] The tensile force imparted to the skin by the decompression layer 120 can be further enhanced by constructing the decompression layer 120 to maximize the distance of the rigidity center from the tissue-facing surface 127 of the decompression layer 120. As described with reference to Figure 6C, one such option for maximizing this distance is to increase the rigidity of the upper layer 121 of the decompression layer 120 relative to the rigidity of the lower layer 123 of the decompression layer 120. As shown by embodiments in Figure 7, 6E and 6F, an additional option for increasing the tensile force imparted to the skin during use of the treatment system 10 is to increase the thickness of the decompression layer 120 (i.e., the distance between the outward-facing surface 125 and the tissue-facing surface 127).

[0070] As typically shown by embodiments in Figures 6E and 6F, an increase in the thickness of the vacuum layer 120 can be achieved by incorporating one or more additional fabric layers 128 (similar to the upper layer 121 or lower layer 123) into the structure of the vacuum layer 120. As shown in Figures 6E and 6F, these additional one or more layers 128 can be integrated into the structure of the vacuum layer 120 via one or more additional intermediate layers 122. To maximize the tensile force imparted to the skin by the vacuum layer 120, the additional fabric layers 128 are advantageously integrated into the vacuum layer 120 in such a manner that the rigidity center of the vacuum layer 120 is maintained near the outward-facing surface 125. For example, as shown by embodiment in Figure 6E, the vacuum layer 120 may include the vacuum layer 120 of Figure 6A (bonded or otherwise attached along the outward-facing surface 125 of the vacuum layer 120 of Figure 6B). As shown in Table 7, the configuration of such a multilayer vacuum layer 120 as shown in the embodiment of Figure 6E can provide a 51.2% increase in perfusion and flow at the treatment tissue site compared to a vacuum layer formed from a single layer of uniformly dense mesh foam material.

[0071] C.Interfacial layer An optional interface layer 130 (i.e., a skin contact layer) is positioned adjacent to the patient's skin when the dressing 100 is applied to the patient. The interface layer 130 may be incorporated into the dressing 100 for various reasons and may be defined by various different characteristics. For example, the interface layer 130 may be configured to reduce discomfort and irritation during use of the treatment system 10, provide cooling, absorb liquid from the skin, function as an antimicrobial barrier, and create friction between the decompression layer 120 and the skin to improve the lifting force applied to the skin by the decompression layer 120.

[0072] The material forming the interface layer 130 may be selected based on desired characteristics of the interface layer 130. Generally, the optional interface layer 130 is constructed from a lightweight, thin material that does not obstruct the flow between the skin and the decompression layer 120 and does not irritate the skin. As shown in Figure 11A, in some embodiments, the interface layer 130 may include a woven fabric or other porous material, such as a nonwoven breathable cloth. As shown in Figure 3, in other embodiments, the interface layer 130 may be formed from a occluding material that includes a plurality of perforations or holes formed through it. The interface layer 130 is also optionally formed to be durable and elastic enough to allow for reuse of the interface layer 130.

[0073] The interface layer 130 can be integrated within the dressing 100 in various configurations. In some embodiments, the interface layer 130 is provided separately from the decompression layer 120 as a whole. In some such embodiments, the interface layer 130 can be provided as a sock or sleeve that slides over and around the treatment tissue site (e.g., the patient's leg or arm). Once positioned as desired, the components of the decompression layer 120 and the occlusion layer 110 of the dressing 100 are attached to the patient. Such a separated configuration is advantageous because it allows the user to ensure that the interface layer 130 is stretched and smoothly laid along the skin before attaching the remaining components of the dressing 100, thus minimizing the risk of pinching resulting from wrinkles along the interface layer 130 during use of the treatment system 10.

[0074] Alternatively, the interface layer 130 is partially or entirely attached along the tissue-facing surface 127 of the decompression layer 120, as shown in the embodiment of Figure 8A, for example. In some embodiments, the interface layer 130 is removably attached to the decompression layer 120, allowing the interface layer 130 to be removed as desired (for example, to clean the interface layer 130 before reuse of the treatment system 10). In other embodiments, the interface layer 130 is instead fixedly attached to the entire or partial (e.g., peripheral) underside of the decompression layer 120 (e.g., by thermal bonding, via adhesive, via ultrasonic welding, etc.). Such fixed attachment of the interface layer 130 and the decompression layer 120 can advantageously minimize the presence of loose areas between the interface layer 130 and the decompression layer 120, which can reduce the generation of bumps and bubbles, thereby minimizing the risk of pinching during operation of the treatment system 10.

[0075] D. Sealing member The sealing member of the dressing 100 is used to provide a sealed (e.g., liquid-tight) attachment between the occlusion layer 110 and the underlying surface (e.g., skin, a section of the occlusion layer 110 wrapped around the patient, an optional interface layer 130, etc.), the sealed attachment allowing a vacuum to be generated and maintained within the treatment chamber surrounding the tissue treatment site. Advantageously, the sealing member is structured to be robust enough to maintain a desired negative pressure within the treatment chamber continuously or intermittently over the lifespan of the treatment system 10. Advantageously, the sealing member is self-adhesive and can provide a liquid-tight attachment to a variety of different surfaces, including, for example, skin, an optionally included interface layer 130, a decompression layer 120, the occlusion layer 110, etc. In embodiments where the sealing member is reusable, the sealing member is advantageously sterilizable. Alternatively, the sealing member may be replaceable (e.g., removable) so that a new sealing member can be used with each subsequent use of the treatment system 10.

[0076] The sealing member can be defined by a variety of sealing structures or combinations of various sealing structures. As shown in Figure 9B, the sealing member may optionally include separate components (or more) provided separately from the other components of the dressing 100. For example, the sealing member may include a tape-like or film-like structure 141 (e.g., a thermoplastic elastomer gel strip, a silicone / acrylic trilaminate film, etc.) applied along the entire or outer circumference of the upper layer of the occlusion layer 110 to secure the dressing 100 to the patient. In other embodiments, the sealing member may optionally or additionally include a wiper seal 143 (see, for example, Figure 1), an adhesive (e.g., an acrylic or silicone adhesive), or other sealing structures (e.g., a gasket) provided along (e.g., integrally) the entire or periphery of the lower surface of the occlusion layer 110, or disposed between the entire or periphery of the lower surface of the occlusion layer 110.

[0077] In various embodiments, the sealing attachment provided by the sealing member may be reinforced and / or concealed by a hook-and-pile fastener, adhesive bandage, cast protector, or other structure located on top of the dressing 100 after the dressing 100 has been attached to the patient.

[0078] Dressing composition The size, shape, and configuration of the dressing 100 may vary depending on various factors, including, for example, the site of the tissue being treated, the patient being treated, and the duration of the treatment being provided. Additional features of the dressing 100, which may vary depending on the desired use of the treatment system 10, include, for example, the degree to which the dressing 100 can be tailored to a particular treatment site, the extent to which the dressing 100 can be attached to the patient, the incorporation of features that facilitate the attachment of the dressing 100 to the patient, and the degree of integration of the components of the dressing 100.

[0079] As shown in Figures 9A and 10, according to various embodiments, the dressing 100 defines a closed annular structure configured to extend at least 360 degrees circumferentially around a limb or the entirety of another limb. When attached, the dressing 100 partially or completely encloses the limb.

[0080] In some embodiments, the annular dressing 100 is defined by a sleeve-like structure having a generally tubular shape, extending between a first open end and a second open end. In other embodiments, the sleeve-like annular dressing 100 extends between the first open end and the second open end and has a shape, size and form for attachment around a particular limb of a patient. Referring, for example, to Figures 9A and 10, in some embodiments, the dressing 100 defines an open-toe boot structure configured to receive a foot. In other embodiments, the annular dressing 100 defines a receptive portion configured to receive a portion (or all) of a user's limb (e.g., hand, foot, stump, etc.). The receptive portion is accessible through a single open end defined by the annular dressing 100. The receptive portion defined by the annular dressing 100 may generally have a cylindrical shape, or optionally, it may define a structure having a shape, size and form for receiving a specific limb of a patient. For example, the dressing 100 may include a glove or mitten structure for receiving a patient's hand, or a sock or closed-toe boot structure for receiving a patient's foot. Such customization of the dressing 100 to a specific tissue site for treatment may, advantageously, facilitate the airtight attachment of the dressing 100 to the tissue site for treatment. The annularly extending dressing 100 may optionally include folds and / or other joint features configured to allow at least partial flexion or movement during treatment using the therapy system.

[0081] In embodiments where the dressing 100 is defined by an annularly extending structure having one or two open ends, and the annularly extending structure is configured to enclose or otherwise surround a portion of the patient, the dressing 100 may be formed from a material that allows the dressing 100 to stretch during application of the dressing 100 around the patient. Alternatively or additionally, the dressing 100 optionally includes one or more features configured to facilitate application of the dressing 100 around the patient. For example, as shown in Figure 10, the dressing 100 optionally includes a slit that extends partially or entirely along the length of the slit. Mating engagement elements 151 (e.g., mating zipper teeth, hook and pile, etc.) are optionally provided along the length of each edge defining the slit to allow the edges to selectively connect and disconnect from each other. In some such embodiments, one or both of the edges optionally include a plurality of similar or identical engaging elements spaced generally parallel to one another at one or more locations spaced inward from the edge, thereby allowing the diameter of the dressing 100 to be adjusted as needed.

[0082] As an alternative to (or in addition to) constructing the dressing 100 from a material that provides the degree of elongation and / or inclusion of the slit, as typically shown in Figures 9A and 9B, the dressing 100 includes, in some embodiments, a gusset 153 which can be released (or taken in) via the tightening of an annularly extending strap 155 (e.g., a fitted hook-and-pile strap) to increase (or decrease) the dimensions of the opening of the dressing 100. In yet other embodiments, the components of the annular dressing 100 are optionally, additionally (or alternatively), formed from an elastic material that allows the dressing 100 to stretch and expand to facilitate the insertion of a limb or other limb into the opening of the dressing 100 during attachment of the dressing 100 to a patient.

[0083] According to other embodiments, the dressing 100 may be defined by a flexible sheet-like structure. The sheet-like dressing 100 may be provided in a range of shapes and sizes. As representatively shown by the embodiment in Figure 3, in some embodiments, the sheet-like dressing 100 optionally has a shape and size for application to a specific treatment site.

[0084] As shown in Figures 8A and 8B, in some embodiments, the sheet-like dressing 100 can be wrapped around a treatment site to substantially (e.g., entirely) surround a portion of the patient (e.g., a calf, wrist, ankle, etc.). For example, the sheet-like dressing 100 may be configured to wrap around a patient's limb or quadriplegia about 360 degrees or more. Alternatively, as shown in Figures 11A and 11B, in other embodiments, the sheet-like structure defining the dressing 100 is attached to the patient as a patch, in which case the outer periphery of the sheet-like dressing 100 surrounds the treatment site but does not surround the patient's limb or quadriplegia where the treatment site is located (for example, when the dressing 100 is applied over a knee or shoulder, the dressing 100 may extend less than 360 degrees around the limb or quadriplegia). In some such embodiments (and / or in other embodiments of the dressing 100), the dressing 100 is optionally provided with a thin, semi-rigid, flexible (e.g., bendable, shape-forming, etc.) reinforcing layer, which allows the sheet dressing 100 to be fitted to match the shape of the treatment tissue site to which the dressing 100 is attached, thereby facilitating the application of the dressing 100 to the patient. As shown in Figures 11A and 11B, the sheet dressing 100 optionally includes folds and / or other joint features 103 configured to allow at least partial flexion or movement during treatment using the therapy system.

[0085] In further embodiments, the dressing 100 may be provided as a flexible tape that can be wrapped around the treatment site or attached to the top of the treatment site as one or more strips. Such arrangements of the tape-like dressing 100 may provide the user with the ability to customize the attachment of the treatment system 10 for various different treatment sites and various different patients. In some embodiments, an adhesive is optionally provided along the outer circumference of the tape-like structure to facilitate the attachment of the dressing 100 to the patient. In such embodiments, the application of the tape-like structure such that adjacent sections of the tape (e.g., adjacent wraps or adjacent strips) overlap may allow the dressing 100 to be attached to the patient without requiring additional sealing of the dressing 100 to the patient. Alternatively, an additional sealing layer (e.g., an occlusion layer 110) may be attached to the patient so as to surround the tape-like dressing 100 applied to the patient.

[0086] The various configurations and features of the dressing 100 described above may apply to all or only some of the components of the dressing 100. For example, as typically shown by the embodiment in Figure 1, in some embodiments the occlusion layer 110 and the interface layer 130 may be defined by annular structures configured to slide over the patient's foot, and the decompression layer 120 may include a tape-like structure that can be wrapped around the occlusion layer 110 before the occlusion layer 110 is attached.

[0087] Configuration of an exemplary embodiment When used herein, the terms “about,” “approximately,” “substantially,” and similar terms are intended to have a broad meaning in accordance with the generally accepted usage by those skilled in the art in which the subject matter of this disclosure pertains. Those skilled in the art reviewing this disclosure will understand that these terms are intended to enable the description of certain features described and claimed without limiting the scope of those features to the exact numerical range provided. Accordingly, these terms should be interpreted as indicating that a non-substantial or insignificant modification or alteration of the subject matter described and claimed is considered to fall within the scope of this disclosure as set forth in the appended claims.

[0088] When used herein to describe various embodiments, the terms “exemplary” and variations thereof are intended to indicate that such embodiments are possible examples, representations, or illustrations of possible embodiments (and such terms are not intended to imply that such embodiments are necessarily special or best examples).

[0089] As used herein, the term “joined” and its variations mean connecting two members directly or indirectly to one another. Such connections may be stationary (e.g., permanent or fixed) or movable (e.g., detachable or detachable). Such connections may be achieved by the two members being directly joined to one another, by the two members being joined to one another using a separate intervening member and any additional intermediate member joined to one another, or by the two members being joined to one another using an intervening member integrally formed with one of the two members as a single aggregate body. Where “joined” or its variations are modified by an additional term (e.g., directly joined), the general definition of “joined” provided above is modified by the ordinary meaning of the additional term (e.g., “directly joined” means the connection of two members without a separate intervening member), resulting in a narrower definition than the general definition of “joined” provided above. Such connections may be mechanical, electrical, or fluid.

[0090] When used herein, the term "or" is used in its inclusive sense (rather than its exclusive sense), and for this reason, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless otherwise specified, conjunctions such as the phrase "at least one of X, Y, and Z" are understood to convey that the elements are any of X, Y, and 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 mean that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z, respectively.

[0091] References to the position of elements in this specification (e.g., “top,” “bottom,” “up,” “down”) are used simply to describe the orientation of various elements in the figures. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and such variations are intended to be included in this disclosure.

Claims

1. A depressurization layer for use in a device that applies lifting force to a tissue site, A lower surface configured to face the aforementioned tissue area; An upper surface configured to face the opposite side of the tissue area; A macromesh material comprising one or more channels through which a macromesh material is defined, and including an upper layer adjacent to the upper surface, a lower layer adjacent to the lower surface, and a plurality of filaments extending between the upper layer and the lower layer and connecting the upper layer and the lower layer, wherein the upper layer has higher rigidity than the lower layer, such that the reduced pressure layer is compressed in a direction away from the tissue when exposed to a vacuum. A depressurized layer equipped with a vacuum layer.

2. The vacuum layer according to claim 1, wherein the filament is flexible such that the distance between the upper layer and the lower layer before exposure to vacuum is greater than the distance between the upper layer and the lower layer while exposed to vacuum.

3. The vacuum layer according to claim 1, wherein the macromesh material further includes a first intermediate layer disposed between the upper layer and the lower layer in the plurality of filaments, the first intermediate layer having higher rigidity than the lower layer.

4. The vacuum layer according to claim 3, wherein the first intermediate layer comprises the same material as the upper layer.

5. The vacuum layer according to claim 3, wherein the plurality of filaments extend between the first intermediate layer and at least one of the lower layer and the upper layer.

6. The vacuum layer according to claim 3, wherein the macromesh material further includes a second intermediate layer disposed between the upper layer and the first intermediate layer in the plurality of filaments, and the second intermediate layer has lower rigidity than the first intermediate layer.

7. The vacuum layer according to claim 3, wherein the macromesh material further includes a second intermediate layer disposed between the lower layer and the first intermediate layer in the plurality of filaments, and the second intermediate layer has lower rigidity than the first intermediate layer.

8. The vacuum layer according to claim 7, wherein the second intermediate layer comprises the same material as the lower layer.

9. The vacuum layer according to claim 1, further comprising an interface layer configured to be located below the lower surface in order to contact the skin surrounding the tissue area.

10. The vacuum layer according to claim 1, wherein the vacuum layer is configured to be disposed within a sealed chamber in close proximity to the tissue site.

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