Negative pressure treatment system for thermoformable splints

Abstract

A kit (1500) for negative pressure and immobilization therapy includes a negative pressure dressing (100) configured to define a sealed volume between the patient's skin and the negative pressure dressing when applied to a patient, a pump (200) configured to be placed in pneumatic communication with the negative pressure dressing and operable to evacuate air from the sealed volume, and a thermoformable splint (900). The thermoformable splint includes a plurality of flexible tubes formed from a first material and bonded together to form a web, and a second material disposed within the flexible tubes, the second material having a lower softening or melting point than the first material.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority to U.S. Provisional Application No. 63 / 132,343, filed December 30, 2020, the entire content of which is incorporated herein by reference.

Background Art

[0002] Swelling associated with trauma or a pathology (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 affect a 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 a patient's treatment, thus posing an impediment to the patient's healing and recovery. In certain situations, swelling can even result in more severe consequences, such as atrophy of surrounding muscle tissue. For example, it would be advantageous to provide a system that can help reduce swelling at a tissue site, for example, by providing a decompression treatment to increase blood perfusion and lymphatic flow at the tissue site and reduce swelling at the tissue site. In some clinical scenarios, immobilization of a tissue site (e.g., a joint) may also be desirable in cooperation with decompression treatment to improve patient outcomes. Coordinated treatment for both immobilization and swelling reduction can be difficult.

Summary of the Invention

[0003] One implementation of the present disclosure is a sub - child. The sub - child includes a plurality of flexible tubes formed of a first material. The plurality of flexible tubes are joined to each other to form a web. The sub - child also includes a second material disposed within the flexible tubes and having a lower softening point than the first material. The web is compliant when the second material exceeds the softening point of the second material and rigid when the second material is below the softening point of the second material.

[0004] Another embodiment of the present disclosure is a first thermoplastic polymer, and the second material is a second thermoplastic polymer. In some embodiments, the second material includes polycaprolactone.

[0005] In some embodiments, the splint also includes a backing layer bonded to the web. The splint may also include a connecting feature that is bonded to the splint. The connecting feature is configured to bond the splint to the dressing.

[0006] In some embodiments, the web includes spacer segments between adjacent tubes of a plurality of flexible tubes. The flexible tubes may be in two or more planes. In some embodiments, the flexible tubes may be aligned in a common plane. In some embodiments, the cross-section of each flexible tube has a non-circular shape. Adjacent tubes of a plurality of flexible tubes may be periodically joined to each other in joining regions, with spaces between adjacent tubes of the plurality of flexible tubes between the joining regions.

[0007] Another embodiment of the present disclosure is a kit for negative pressure and immobilization therapy. The kit includes a negative pressure dressing configured to define a sealed volume between the patient's skin and the negative pressure dressing when applied to a patient; a pump configured to be in air communication with the negative pressure dressing and operable to expel air from the sealed volume; and a thermoformable splint. The thermoformable splint includes a plurality of flexible tubes formed from a first material and bonded together to form a web; and a second material disposed within the flexible tubes and having a lower softening or melting point than the first material.

[0008] In some embodiments, adjacent tubes within a web of multiple flexible tubes are periodically joined to each other in joining regions and spaced apart from each other in the joining regions. A thermoformable splint may include spacer segments that join adjacent tubes among the multiple flexible tubes to form a web.

[0009] In some embodiments, the negative pressure dressing includes a mounting feature configured to selectively bond a thermoformable splint to the negative pressure dressing. The thermoformable splint may include a connecting layer configured to bond to a web and to the mounting feature of the negative pressure dressing.

[0010] In some embodiments, the negative pressure dressing is molded to be applied to the patient's ankle. In such embodiments, the thermoformable splint is heated to a moldable state to facilitate the application of the thermoformable splint onto the negative pressure dressing at the patient's ankle, and then cooled to a rigid state to provide immobilization of the patient's ankle when the thermoformable splint is applied onto the negative pressure dressing at the patient's ankle.

[0011] Another embodiment of the present disclosure is a method for providing negative pressure and immobilization therapy to promote joint healing. The method includes sealing a negative pressure dressing over intact skin, operating a pump coupled to the negative pressure dressing to establish negative pressure between the negative pressure dressing and the intact skin, heating a thermoformable splint to at least the softening point of the material contained within the flexible tube of the thermoformable splint, fitting the thermoformable splint to a desired splint configuration on the dressing, and curing the thermoformable splint to the desired splint configuration as it cools to ambient temperature.

[0012] In some embodiments, fitting a thermoformable splint to a desired splint configuration includes spiraling the thermoformable splint around and along the dressing. In some embodiments, fitting a thermoformable splint to a desired splint configuration includes applying the thermoformable splint according to a rear splint approach. In some embodiments, fitting a thermoformable splint to a desired splint configuration includes applying the thermoformable splint according to a saddle splint approach.

[0013] In some embodiments, curing a thermoformable splint into a desired splint configuration includes bonding the thermoformable splint to a dressing in the desired splint configuration. Bonding a thermoformable splint to a dressing in the desired splint configuration may include applying the attachment features of the dressing to the connecting layer of the thermoformable splint. Curing a thermoformable splint into a desired splint configuration also includes the possibility that holding the splint in the desired splint configuration can also be achieved by wrapping it in an elastic bandage wrap such as ACE® Wrap or 3M® Coban® Wrap.

[0014] In some embodiments, the method also includes heating at least a portion of the thermoformable splint and bending the thermoformable splint in the dressing to separate it from the dressing.

[0015] Another implementation of the present disclosure is a therapeutic system. The therapeutic system includes a casting tape. The casting tape includes a net comprising an extruded elastomer and a tip provided on the outer surface of the net. The tip is formed of polycaprolactone. The tip is configured to bond together to form a substantially rigid structure when the casting tape is heated, wrapped around a tissue site so as to overlap the casting tape, and cooled.

[0016] In some embodiments, the treatment system includes a negative pressure dressing configured to define a sealed volume between the patient's skin and the negative pressure dressing when applied to the patient, and a pump configured to be in air communication with the negative pressure dressing and operable to expel air from the sealed volume. A casting tape is configured to be applied onto the negative pressure dressing.

[0017] In some embodiments, the net includes a plurality of straight sections and a plurality of corrugated sections. Each corrugated section is periodically and alternately connected to two adjacent straight sections of the plurality of straight sections. The tips may be provided along at least a subset of the plurality of straight sections.

[0018] In some embodiments, the casting tape has a thickness of about 1 millimeter. The tips may be spaced about 1 millimeter apart. The tips are configured to bond together when heated above a threshold temperature to melt or soften. In some embodiments, the tips contain polycaprolactone. In some embodiments, the tips may contain a lubricating material mixed with polycaprolactone. The casting tape may have a lubricant coating. In some embodiments, the casting tape contains a water-activated lubricant. [Brief explanation of the drawing]

[0019] [Figure 1] Figure 1 is a side view of a decompression therapy system, showing a partial cross-sectional view of the dressing of the decompression therapy system according to an exemplary embodiment. [Figure 2] Figure 2 is a cross-sectional view taken along line 2-2 in Figure 1. [Figure 3] Figure 3 is an exploded perspective view of a dressing for a decompression therapy system according to an exemplary embodiment. [Figure 4A] Figure 4A is a schematic diagram of the collapse of the decompression layer of a dressing in a decompression therapy system according to an exemplary embodiment. [Figure 4B] Figure 4B is a schematic diagram of the collapse of the decompression layer of a dressing in a decompression therapy system according to an exemplary embodiment. [Figure 5] Figure 5 is a perspective view of the material forming the decompression layer of a dressing for a decompression therapy system, according to an exemplary embodiment. [Figure 6A] Figure 6A is a cross-sectional view of a depressurized layer according to an exemplary embodiment. [Figure 6B] Figure 6B is a cross-sectional view of a depressurized layer according to an exemplary embodiment. [Figure 6C] Figure 6C is a cross-sectional view of a depressurized layer according to an exemplary embodiment. [Figure 6D] Figure 6D is a cross-sectional view of a depressurized layer according to an exemplary embodiment. [Figure 6E]FIG. 6E is a cross-sectional view of a reduced pressure layer according to an exemplary embodiment. [Figure 6F] FIG. 6F is a cross-sectional view of a reduced pressure layer according to an exemplary embodiment. [Figure 7] FIG. 7 is a table showing a comparison of the performance of the exemplary reduced pressure layer of FIGS. 6A-6E and the performance of a reticulated foam-based reduced pressure layer during use of a reduced pressure therapy system according to an exemplary embodiment. [Figure 8A] FIG. 8A is a perspective view of a dressing of a reduced pressure therapy system according to an exemplary embodiment. [Figure 8B] FIG. 8B is a perspective view of the dressing of FIG. 8A attached to a patient according to an exemplary embodiment. [Figure 8C] FIG. 8C is a perspective view of the dressing of FIG. 8A attached to a patient according to an exemplary embodiment. [Figure 9] FIG. 9 is a perspective view of a first application of a thermoformable adjunct applied onto a negative pressure dressing according to an exemplary embodiment. [Figure 10] FIG. 10 is a perspective view of a second application of a thermoformable adjunct applied onto a negative pressure dressing according to an exemplary embodiment. [Figure 11] FIG. 11 is a perspective view of a third application of a thermoformable adjunct applied onto a negative pressure dressing according to an exemplary embodiment. [Figure 12] FIG. 12 is a perspective view of a fourth application of a thermoformable adjunct applied onto a negative pressure dressing according to an exemplary embodiment. [Figure 13] FIG. 13 is a perspective view of a fifth application of a thermoformable adjunct applied onto a negative pressure dressing according to an exemplary embodiment. [Figure 14] FIG. 14 is a perspective view of a sixth application of a thermoformable adjunct applied onto a negative pressure dressing according to an exemplary embodiment. [Figure 15] FIG. 15 is a view of a negative pressure and immobilization kit according to an exemplary embodiment. [Figure 16]Figure 16 is a schematic cross-sectional view of a first co-extruded polymer article that can be incorporated into a thermoformable splint, according to an exemplary embodiment. [Figure 17] Figure 17 is a schematic cross-sectional view of a second co-extruded polymer article that can be incorporated into a thermoformable splint, according to an exemplary embodiment. [Figure 18] Figure 18 is a schematic cross-sectional view of a third co-extruded polymer article that can be included in a thermoformable splint, according to an exemplary embodiment. [Figure 19] Figure 19 is a schematic cross-sectional view of a fourth co-extruded polymer article that can be incorporated into a thermoformable splint, according to an exemplary embodiment. [Figure 20] Figure 20 is a schematic cross-sectional view of a fifth co-extruded polymer article that can be included in a thermoformable splint, according to an exemplary embodiment. [Figure 21] Figure 21 is a flowchart of a process for manufacturing a thermoformable splint according to an exemplary embodiment. [Figure 22] Figure 22 is a flowchart of the process for applying a negative pressure dressing and a thermoformable splint according to an exemplary embodiment. [Figure 23] Figure 23 is a flowchart of a process for adjusting or removing a thermoformable splint from a joint and / or negative pressure dressing, according to an exemplary embodiment. [Figure 24] Figure 24 is a perspective view of a roll of casting tape according to an exemplary embodiment. [Figure 25] Figure 25 is a perspective view of the casting tape from Figure 24 applied to a patient's joint using a negative pressure dressing, according to an exemplary embodiment. [Figure 26] Figure 26 is an enlarged perspective view of the casting tape of Figure 24 according to an exemplary embodiment. [Modes for carrying out the invention]

[0020] 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.

[0021] Generally with reference to the figures, various embodiments of decompression therapy systems for applying a vacuum (e.g., negative pressure 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.) 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 the perfusion of blood and other fluids (e.g., lymphatic flow, interstitial fluid) in the treatment tissue site.

[0022] 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).

[0023] 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.

[0024] 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). In some embodiments, the treatment system is configured to be reusable, washable, and intuitive for the user to self-apply without medical expertise.

[0025] 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.

[0026] 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, may 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. In some embodiments, 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.

[0027] 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 into 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. The vacuum (tensile force) may be applied continuously or intermittently. In some such embodiments the treatment system 10 may optionally be applied on top of (or integrated into) a wound dressing of a negative pressure wound closure system ("Negative Pressure Wound Therapy (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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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 water vapor transmission rate (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.

[0033] 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. In various embodiments, the occlusion layer 110 is alternatively detachably or permanently integrated with the decompression layer 120. The adhesive may be pattern-coated in separate islands of any shape to further improve the MVTR, but at the periphery or boundary, the adhesive is preferably continuous to form a good seal.

[0034] Non-limiting examples of materials that can be used for the occlusion layer 110 include, but are not limited to, polyurethane films (e.g., ESTANE 5714F), other polymer films such as polyalkoxyalkyl acrylates and methacrylates (e.g., those described in UK Patent Application No. 1280631A filed November 22, 2002, the entire disclosure of which is incorporated herein by reference), plasticized PVC, silicone, block copolymer elastomers (e.g., block copolymer elastomers available under trade name KRATON), polyolefins (including metallocene polyolefins), polyamides (e.g., polyester block amides available under trade name PEBAX), and elastomer polyesters (including elastomer polyesters available under trade name HYTREL). Thermosetting elastomers such as ethylene propylene diene monomer (EPDM), butyl rubber, nitrile rubber, natural rubber, neoprene, laminated fabrics (e.g., polyurethane laminates, stretched polytetrafluoroethylene laminates, etc.), polymer-coated fabrics, and fabrics made from various synthetic fibers may also be suitable. The fabric may be knitted, woven, or nonwoven. Examples of nonwoven fabrics include spunbond, water-entangled, spunlace, blown microfiber, and laminates thereof.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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 to allow a range of motion of the body part to which the dressing 100 is attached during use of the treatment system 10.

[0040] 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.

[0041] 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).

[0042] 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 such as polyester or a nylon material (e.g., polymer or nylon mesh).

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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 (three-dimensional knit) 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 site by about 10.5% compared to a decompression layer formed from a single layer of uniform density 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 site by about 7.7% compared to a decompression layer formed from a single layer of uniform density mesh foam material.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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).

[0053] 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.

[0054] 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.

[0055] 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. In some embodiments, the interface layer 130 may include, for example, 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.

[0056] 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.

[0057] 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.

[0058] 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.), which allows 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. In some embodiments, 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 may be 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.

[0059] The sealing member can be defined by a variety of sealing structures or combinations of various sealing structures. The sealing member may optionally include separate components provided separately from 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 periphery 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 one or more sealing cuffs (see, for example, Figure 1). In other embodiments, the sealing member may include an adhesive (e.g., an acrylic or silicone adhesive) provided along the entire or peripheral periphery of the lower surface of the occlusion layer 110 (e.g., integrated) or placed on it.

[0060] 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.

[0061] 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.

[0062] As shown in Figures 3 and 8A-8C, in some embodiments, the sheet dressing 100 can be wrapped around a tissue site to substantially (e.g., entirely) surround a portion of the patient (e.g., a calf, wrist, ankle, etc.). For example, the sheet dressing 100 may be configured to wrap around a patient's limb or quadruple about 360 degrees or more. For example, the sheet dressing 100 may be formed to be below and behind the patient's foot and ankle, and then wrapped forward to encircle the ankle. A first portion of the sheet dressing 100 (e.g., extending around the inside of the ankle) may overlap with a second portion of the sheet dressing 100 (e.g., extending around the outside of the ankle), as shown in Figure 8C. Adhesive boundaries or separate sealing strips may be provided to allow the dressing 100 to seal itself to form a closed annular structure around the ankle or other tissue site. Advantageously, the dressing 100, as configured in Figures 8A to 8C, can be applied to the ankle with minimal interference to the tissue site, without the need to pull, slide, or constrict the tissue site through, for example, a sleeve or other annular structure. In some embodiments, the sheet-like dressing 100 may be optionally molded and sized for application to specific treatment sites (e.g., particularly the ankle, particularly the wrist, particularly the knee, particularly the shoulder, etc.) and may be provided in different sizes for patients of different sizes.

[0063] In other embodiments, the dressing 100 may be provided as a flexible tape that can be wrapped around a treatment site or attached to 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.

[0064] In yet another embodiment, the dressing 100 defines a closed annular structure configured to extend at least 360 degrees circumferentially around an entire limb or another limb. For example, the annular dressing can be defined by a sleeve-like structure having a generally tubular shape extending between a first open end and a second open end. In some embodiments, the sleeve-like annular dressing 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.

[0065] Thermoformable splint for use with negative pressure therapy systems As described above, negative pressure therapy may be advantageous in reducing swelling and improving the healing of sprains, fractures, or other injuries to joints. In some cases, it may be clinically desirable to immobilize the injured joint to promote healing and reduce the risk of worsening the injury. One aspect of this disclosure is the determination that a treatment system or kit that integrates both joint immobilization and negative pressure therapy features is advantageous for treating joint injuries. Figures 9 to 23 generally relate to the use of a thermoformable splint, for example, comprising an extruded polymer web or net, together with a negative pressure therapy dressing, in order to provide both joint immobilization and negative pressure therapy.

[0066] A general reference to Figures 9–23 illustrates various features of a treatment system including thermoformable splints and negative pressure treatment systems. In particular, Figures 9–14 show various applications of negative pressure dressings and thermoformable splints to injured joints; Figure 15 shows a treatment kit including thermoformable splints and negative pressure treatment components; Figures 16–20 show various embodiments of extruded polymer articles (webs, nets, tube assemblies) that can be used in thermoformable splints for use with negative pressure treatment components; Figure 21 shows a process for manufacturing thermoformable splints; and Figures 22–23 show a process for providing treatment using negative pressure and immobilization treatment systems according to various exemplary embodiments. These drawings and their various advantages are described in detail below.

[0067] A. Application of thermoformable splints Referring here to Figures 9 to 14, perspective views of various applications of the negative pressure therapy dressing 100 and thermoformable splint 900 to a patient's ankle according to exemplary embodiments are shown. In the illustrated examples, the dressing 100 is configured as described above, for example with reference to Figures 8A to 8C. In other embodiments, various other embodiments of the negative pressure therapy dressing can be used. In yet another embodiment, the thermoformable splint can be applied to the joint with or without a non-NPT dressing. Furthermore, in the illustrated examples, the dressing 100 is applied to substantially cover the patient's ankle region, i.e., from the patient's forefoot or midfoot to the middle or upper part of the patient's calf. In other embodiments, the present disclosure can be adapted for use when applying negative pressure and immobilization therapy to other joints or body parts (e.g., knees, ankles, wrists, elbows, shoulders, ribs, fingers, hands, toes, feet, limbs, neck). Figures 9 to 14 show thermoformable splints applicable to various desired splint configurations (application, form, approach, etc.).

[0068] As will be described in detail below, the splint 900 is configured to be moldable (flexible, conformable, pliable, etc.) in a first temperature range and substantially rigid (substantially inflexible, substantially non-pliable) in a second lower temperature range. The second temperature range may be below normal body temperature and / or ambient temperature experienced under normal circumstances (e.g., below 120°F, below 60°C, preferably below 50°C, more preferably below 40°C, and most preferably below 30°C) so that the splint 900 remains in the second temperature range (and is therefore rigid) during normal wear by the patient or storage of the splint 900. The splint 900 can be heated to the first temperature range to make it moldable, in which state the splint 900 can be molded (bent, conformable) into a desired shape. In embodiments of this specification, the splint 900 is a flexible sheet or tape-like member that can be bent and adapted while substantially maintaining its thickness and continuous structure, which may be advantageous over the use of freely reformable plaster or putty that can be molded to any dimensions. Figures 9 to 14 show various desired shapes of the splint 900 in various embodiments while in a rigid state for immobilizing the patient's ankle joint.

[0069] Figure 9 shows a first application of the dressing 100 and thermoformable splint 900 to the ankle according to an exemplary embodiment. The splint 900 is applied over the dressing 100 so that the dressing 100 separates the splint 900 from the patient's skin. In the example of Figure 9, a posterior splint approach (configuration) is used. The splint 900 is positioned on the bottom side of the dressing 100 (i.e., the distal end of the patient's leg, the sole of the patient's foot) and is bent upward so as to extend along the posterior side of the ankle (i.e., to cover the patient's Achilles tendon). The splint 900 extends only partially upward over the posterior side of the patient's lower limb, for example, so that the dressing 100 extends further upward over the posterior side of the patient's lower limb than the splint 900 (e.g., about twice as far upward). This forms the splint 900 in a roughly L-shape. The splint 900 may also be molded to fit the dressing 100, so that the splint 900 partially extends along the outer and inner sides of the ankle region, for example, partially covering the underside of the patient's foot.

[0070] The splint 900 can be attached to the dressing 100 and / or the patient's ankle in such a way that it substantially prevents the ankle from moving relative to the splint 900 when the splint 900 is rigid. For example, the splint 900 may be held in place relative to the dressing 100 and the ankle by a feature of the dressing 900, such as a loop, strap, cord, clip, hook and loop material, or other fastener. As another example, the splint 900 can be fixed in place using a separate strap or adhesive tape. As yet another example, the splint 900 can be closely conformed to the anatomical structure of the dressing 100 and the patient, so that the shape of the splint relative to the shape of the dressing 100 and the ankle (e.g., foot, leg, bony prominence) prevents the rigid splint from moving relative to the ankle, as an effect of the splint 900 wrapping at least partially around the outer and inner sides of the patient's foot, as shown in Figure 9. Therefore, once the splint 900 has cooled and become a rigid structure, and is held in place relative to the patient's ankle, the splint 900 substantially immobilizes the patient's ankle.

[0071] Referring now to Figure 10, a second application of the splint 900 and dressing 100 is shown. In the example in Figure 10, a posterior splint approach is used. Compared to the example in Figure 9 described above, the splint 900 extends further up the posterior side of the patient's lower limb, for example, to a point slightly below the upper edge of the dressing 100. The splint 900 used in the example in Figure 10 is longer than that used in the example in Figure 9.

[0072] Next, referring to Figure 11, a third application of the splint 900 and dressing 100 is shown. Figure 11 is a posterior perspective view of the ankle, showing the posterior side of the lower limb of a patient to whom the dressing 100 and splint 900 have been applied. Figure 11 shows how the splint 900 can extend along the anterior and distal end of the patient's leg and, for example, can wrap at least partially around the lateral and medial sides of the patient's foot to help secure the splint 900 in place relative to the patient's ankle. Compared to the example in Figure 10, in Figure 11 a longer splint 900 is used, and the splint 900 extends over the dressing 100 in the direction of the patient's leg. Thus, Figure 10 shows that in some embodiments the splint 900 can be applied so that in some parts the splint 900 overlaps the dressing 100 and in other parts the splint 900 wraps along the patient's skin. Note: The inventors should consider presenting a three-part system comprising a splint, a pad which may or may not be pre-applied to the splint, and a dressing.

[0073] Referring now to Figure 12, a fourth application of the splint 900 and dressing 100 according to an exemplary embodiment is shown. Figure 12 shows the splint 900 applied using a cruciate or X-shaped splint approach. The splint 900 is shown extending from the posterior side of the patient's lower limb, around the outside of the ankle, across the top of the patient's foot, downward around the inside of the foot, across the bottom of the foot, upward around the outside of the foot, crossing (overlapping) across the top of the patient's foot, and upward around the inside of the ankle to the posterior side of the patient's lower limb. Thus, the splint 900 is formed to wrap around the dressing 100 and the bottom, top, and posterior of the patient's ankle. In the cruciate application of Figure 12, once cooled to a rigid state, the splint 900 is configured to substantially immobilize the ankle joint and hold itself in a substantially fixed position relative to the ankle.

[0074] Referring here to Figure 13, a combined saddle splint and posterior splint approach is used. As shown in Figure 13, splint 900 is used in combination with a second splint 1300. The second splint 1300 can be configured substantially the same as splint 900. In some cases, the second splint 1300 is of a different size than splint 900 (e.g., longer, narrower). As shown in Figure 13, splint 900 is applied in a posterior splint approach as shown in and described with reference to Figure 10. The second splint 1300 is shown formed as a saddle splint, and the second splint extends downward along the outside of the lower limb, passing under the patient's heel, and extending upward along the inside of the lower limb. In the illustrated example, the second splint 1300 extends around the first splint such that the first splint 900 is between the second splint 1300 and the dressing 100 at the patient's heel. In other embodiments, the second splint 1300 is initially applied such that it is located between the first splint 900 and the dressing 100. In other embodiments, an integrated splint having, for example, a cross shape or a T shape is provided, thereby allowing both a rear-type splint and a saddle-type splint to be provided using a single continuous splint.

[0075] Referring now to Figure 14, a fifth application of the splint 900 and dressing 100 is shown. In the example of Figure 14, the splint 900 is spirally wrapped around the dressing 100 and the ankle while the ankle is in a preferred position for fixation. As shown, the splint 900 wraps around the dressing 100 four times, extending along the dressing 100, to form a spiral or helical shape. For example, the splint 900 is shown to wrap twice around the foot and then extending to wrap twice around the lower limb. In other exemplary applications, the splint 900 may include a different number of turns around the dressing 100 and the patient's anatomical structure. In some embodiments, the dressing 100 includes spirally arranged markings or attachment features around the dressing 100 to guide the caregiver when applying the dressing in a spiral arrangement. In the helical application shown in Figure 14, the splint 900 is configured to hold itself in place relative to the dressing 100 and the patient's ankle, while remaining rigid.

[0076] Figures 11-14 show various exemplary applications of the splint 900 on the dressing 100 to provide immobilization and negative pressure therapy to a patient's ankle. In various cases, depending on clinical needs, caregiver preferences, and / or patient preferences, the same splint 900 can be used in various applications, such as those shown in Figures 11-14. In other embodiments, the splint 900 has a circumferential design so that it can receive the patient's ankle and the dressing 100 and self-fix to the area around the patient's ankle. For example, in some embodiments, the splint 900 may have a shape similar to the shape of the dressing 100 shown in Figure 8. In another example, the splint 900 may be molded as a sleeve or sock.

[0077] The dressing 100 and splint 900 can provide complementary features to facilitate treatment. For example, the dressing 100 can itself provide resistance to joint mobility when pulled by negative pressure. The dressing 100 can also be provided with attachment features to facilitate the application of the dressing 100 and splint 900 around the joint. Furthermore, when positioned between the splint 900 and the joint, the dressing 100 can provide cushioning and a comfortable patient interface material to provide a comfortable interaction between the patient and the splint 900. On the other hand, the immobilization of the joint by the splint 900 helps reduce the possibility of leakage occurring through the dressing 100 due to bending and extending of the joint while the dressing 100 is worn by the patient, thereby improving negative pressure treatment applied to the joint using the dressing 100.

[0078] B. Therapeutic kits for negative pressure and immobilization treatment Referring here to Figure 15, a schematic diagram of a treatment kit 1500 for negative pressure and immobilization therapy is shown. The treatment kit 1500 may include various reusable and / or disposable components of a negative pressure and immobilization therapy system. In Figure 15, the treatment kit 1500 is shown to include a dressing 100, a connector port 90, a tube 205, a pump 200, and a splint 900.

[0079] The dressing 100, connector port 90, tubing 205, and pump (air discharge device, negative pressure source) 200 can be configured as described above with reference to Figures 1 to 8C. In various embodiments, the dressing 100, connector port 90, tubing 205, and pump 200 can be distributed as separate, isolated components, pre-coupled and distributed together, or as some combination thereof. For example, as shown, the dressing 100 can be provided separately from the connector port 90, tubing 205, and pump 200, and the connector port 90 and tubing 205 are shown pre-coupled to each other. When applying the dressing, the connector port 90 can be coupled to the dressing 100, and the tubing 205 can be connected to the pump 200 to set up a treatment kit 1500 for use when providing treatment to a patient. The dressing 100 is shown to include mounting features 1502 (e.g., the hook side or loop side of a hook-and-loop fastener) configured to facilitate the attachment of the splint 900 to the dressing 100.

[0080] Kit 1500 is shown as including one splint 900. In other embodiments, multiple splints 900 are included. The splint 900 is configured to be applied as shown in Figures 9 to 14, or in various other applications in various examples.

[0081] As shown in Figure 15, the splint 900 is composed of multiple layers, indicated as a thermoplastic tubular structure 1504, a connecting layer 1506, and a backing layer 1508. The thermoplastic tubular structure 1504 is configured to be easily moldable (flexible, conformable) at temperatures above a first temperature and substantially rigid at temperatures below a second temperature, while the connecting layer 1506 and the backing layer 1508 are bonded to the thermoplastic tubular structure 1504 to facilitate handling of the splint 900. The first temperature and / or the second temperature can be considered as the softening point or melting point of the material contained within the thermoplastic tubular structure 1504.

[0082] The thermoplastic tubular structure 1504 is made of thermoplastic tubes joined together in a net-like or web-like manner, as shown in Figures 16 to 20, for example, and described below with reference to them. The thermoplastic tubes can be made from a first thermoplastic material that maintains its tubular shape below a third temperature significantly higher than a first temperature. The net or web of the thermoplastic tube can be flexible, including below the first and / or second temperature. The thermoplastic tubes can be made from high-melting-point thermoplastic elastomers such as Estane polyurethane, Hytrel elastomer polyester, Kraton block copolymer, etc. The tubes can be filled with low-melting-point polymers such as CAPA polycaprolactone.

[0083] The thermoplastic tube holds (e.g., accommodates, substantially fills) a second thermoplastic material. The second thermoplastic material can melt or partially melt at a temperature higher than the second temperature and higher than the first temperature, so that the second thermoplastic material becomes soft or liquid and is therefore freely moldable within the thermoplastic tube at temperatures higher than the first temperature. The second thermoplastic material can harden into a rigid structure at temperatures below the second temperature, while being partially flexible (e.g., mold-resistant) between the first and second temperatures. The softening or melting point of the tube net or web is higher than the softening or melting point of the second thermoplastic material used to fill the tube. Thus, the tube net or web (and the first thermoplastic material) defines the structure for the thermoplastic tubular structure 1504, while the second thermoplastic material within the tube net or web determines whether the thermoplastic tubular structure 1504 is flexible or rigid at a given time.

[0084] A suitable thermoplastic polymer for use as a second thermoplastic material within a net or web is a polymer that softens or melts at a temperature that can be comfortably tolerated by the patient and / or technician during the application of the splint, but is unlikely to be encountered during normal wear of the splint or during transport and storage of the material. This temperature (referred to herein as the “first temperature”) may be about 90°C in some embodiments. In other embodiments, the first temperature is about 75°C, about 60°C, or about 60°C to about 75°C. Suitable thermoplastic polymers include polyurethanes (particularly polyurethanes based on semicrystalline polyester polyols), polyethylene, ethylene vinyl acetate, cis and trans polyisoprene, and polyesters such as polycaprolactone. In the embodiments shown, the thermoplastic polymer used to fill the tubular structure is a semicrystalline polyester, e.g., polycaprolactone and a blend of polycaprolactone. These polymers may optionally contain one or more fillers. Fillers can improve heat transfer and / or improve the crystallization rate by nucleation. The polymer may also contain one or more pigments or colorants.

[0085] This structure can be advantageous for several reasons. Firstly, while the thermoplastic tubular structure 1504 is flexible and moldable at temperatures higher than the first temperature, the tubular web or net maintains the overall shape (e.g., a sheet-like shape) by limiting the degrees of freedom at which the thermoplastic tubular structure 104 can be molded, thereby enabling a high degree of flexibility without compromising the overall structure to facilitate application. Secondly, the thermoplastic tubular structure 1504 can provide a large surface area from which the internal (second) thermoplastic material can absorb or release heat, thereby reducing the time required to heat the thermoplastic tubular structure 1504 above the first temperature (i.e., to a state where it can be molded by the application of a heat source), and the time required for the thermoplastic tubular structure 1504 to cool below the softening point of the second thermoplastic material (e.g., by losing heat to the ambient air). Various other advantages are also provided.

[0086] In the embodiment shown in Figure 15, the connecting layer 1506 is bonded to the thermoplastic tubular structure 1504. The connecting layer 1506 is configured to provide bonding of the splint 900 to the dressing 100 and / or to other parts of the splint 900 (for example, when applied circumferentially around a patient structure). For example, the connecting layer 1506 may be configured to interact with the attachment feature 1502 of the dressing 100. As an example, the connecting layer 1506 may include the "hook" side of a hook-and-loop fastener, while the attachment feature 1502 of the dressing includes the "loop" side, thereby allowing the connecting layer 1506 to be selectively and detachably bonded to the attachment feature 1502. Snaps, buckles, clips, loops, adhesives, zippers, etc., can be used in various embodiments for the connecting layer 1506 and the attachment feature 1502. The connecting layer 1506 of the splint 900 and the mounting feature 1502 of the dressing 100 can thereby interact to hold the splint 900 on the dressing 100 while it is in a moldable state, thereby allowing the splint 900 to cool to a rigid state in the fixed position where it is applied. In some embodiments, the connecting layer 1506 includes a pad configured to provide a comfortable interface between the thermoplastic tubular structure 1504 and the dressing 100 and / or the patient. The pad may also be provided as a separate component in the kit 1500.

[0087] In some embodiments, the kit includes additional components. For example, the kit may include a heat source configured to heat the splint 900 to prepare it for application. In some embodiments, the heat source is a chemical heat source configured to undergo an exothermic reaction that releases enough thermal energy to heat the splint 900 to a moldable state. In some embodiments, the heat source is an electric heater, for example, a hair dryer-type device including an electric heating coil and a fan positioned to blow air over the splint 900 across the electric heating coil. In other embodiments, the kit includes a steamer device configured to heat water into steam and direct the steam towards the splint 900 to heat the splint 900. In other embodiments, the kit includes an infrared light source or other device for irradiating the splint 900 with light energy that can raise the temperature of the splint 900. In some such embodiments, the splint 900 may include a material selected for its ability to absorb infrared radiation. In other embodiments, the kit includes instructions on how to properly heat the splint 900 in a microwave oven or other oven (e.g., “cooking” time, power level). In some such embodiments, the splint 900 may include a material selected for its ability to absorb microwave radiation. Selectively, this material may include a microwave susceptor or be placed on a microwave susceptor package.

[0088] Therefore, Kit 1500 includes various components that can be used together and interoperable to provide negative pressure and immobilization therapy. In some embodiments, the components of Kit 1500 are reusable for application to multiple patients or to the same patient at different times. In other embodiments, one or more components of Kit 1500 are disposable and can be replaced after each use. Kit 1500 may include one or more components that may be user-friendly, for example, a first splint 900 and a second splint 1300 to enable the application shown in Figure 13.

[0089] In alternative embodiments, the splint 900 is integrated with the dressing 100, for example, permanently bonded to the closure layer of the dressing 100. In some cases, the splint is positioned below the closure layer, for example, between the closure layer 110 and the vacuum layer 120 shown in Figure 3. The entire dressing 100 can then be heated to allow the splint 900 to be molded. The splint 900 may have the same extent as the vacuum layer 120, or it may be selectively molded to provide a desired fixing effect while allowing flexibility of the dressing in other areas. Various such embodiments are included within the scope of this disclosure.

[0090] C. Tubular web structure for thermoformable splints Referring to Figures 16 to 20 in general, several embodiments of tube nets or webs that can constitute the thermoplastic tubular structure 1504 are shown. In some embodiments of the thermoplastic tubular structure 1504, one of the nets or webs shown in Figures 16 to 20 is used. In other embodiments, two or more nets or webs are laminated or otherwise joined for the thermoplastic tubular structure 1504.

[0091] Referring here to Figure 16, the exemplary web 1600 includes an array of separate polymer tubes 1602. Spacer segments 1612 are located between adjacent polymer tubes 1602. These spacer segments are formed simultaneously with the tubes and welded to the tubes to form a continuous web. The spacer segments provide uniform arrangement and spacing of the tubes. Regions 1613 are formed between adjacent tubes. In some embodiments, the regions 1613 above and below the spacer segments may be filled with a thermally conductive material (i.e., a material having a thermal conductivity of at least 0.5 watts / meter Kelvin). The spacer segments 1612 may allow a large portion of the tube periphery to be in contact with the thermally conductive material. In some embodiments, the portion of the tube periphery accessible for heat transfer is approximately 60 percent of the periphery, and in some cases, more than 80 percent. The polymer tubes 1602 may be hollow polymer tubes (i.e., a hollow core 1616 with a sheath 1614 surrounding the hollow core). The hollow core 1616 can be filled with a thermoplastic polymer (i.e., the second thermoplastic polymer described above). As shown in Figure 16, the web 1600 can be a continuous web. As shown in the exemplary web 1600 in Figure 16, the polymer tubes 1602 are in the same plane.

[0092] Referring to Figure 17, the exemplary web 1700 includes an array of separate polymer tubes 1702. Space segments 1712 are located between adjacent polymer tubes 1702. These spacer segments are formed simultaneously with the tubes and welded to the tubes to form a continuous web. The spacer segments provide uniform arrangement and spacing of the tubes. Regions 1713 are formed between adjacent tubes. In some embodiments, the regions 1713 above and below the connecting spacer segments may be filled with a thermally conductive material (i.e., a material having a thermal conductivity of at least 0.5 watts / meter Kelvin). The spacer segments 1712 allow a large portion of the tube's periphery to be in contact with the thermally conductive material. In some embodiments, the portion of the tube's periphery accessible for heat transfer is approximately 60 percent of the periphery, and in some cases, more than 80 percent. The polymer tubes 1702 may be hollow polymer tubes (i.e., a hollow core 1716 with a sheath 1714 surrounding the hollow core). The hollow core 1716 can be filled with a thermoplastic polymer (i.e., the second thermoplastic polymer described above). As shown in Figure 17, the web 1700 can be a continuous web. As shown in the exemplary web 1700 of Figure 17, the polymer tube 1702 lies in two planes. In some other embodiments, the polymer tube 1702 can lies in more than two planes.

[0093] Referring to Figure 18, the exemplary web 1800 includes a first array of separate polymer tubes 1802 and a second array of separate polymer tubes 1822. In some embodiments, the separate polymer tubes 1802 and 1822 are alternately spaced apart. For example, one polymer tube 1822 lies between two polymer tubes 1802. Space segments 1812 are located between adjacent polymer tubes 1802 and 1822. These spacer segments are formed simultaneously with the tubes and welded to the tubes to form a continuous web. The spacer segments provide uniform arrangement and spacing of the tubes.

[0094] A region 1813 is formed between adjacent tubes. In some embodiments, the regions 1813 above and below the connecting spacer segment may be filled with a thermally conductive material (i.e., a material having a thermal conductivity of at least 0.5 watts / meter Kelvin). The spacer segment 1812 allows a large portion of the tube's circumference to be in contact with the thermally conductive material. In some embodiments, the portion of the tube's outer circumference accessible for heat transfer is approximately 60 percent of the circumference, and in some cases, more than 80 percent. The polymer tubes 1802 and 1822 can be hollow polymer tubes (i.e., hollow cores 1816 or 1826 with sheaths 1814 or 1824 surrounding the hollow core). The hollow core 1816 can be filled with a thermoplastic polymer (i.e., the second thermoplastic polymer described above). As shown in Figure 18, the web 1800 can be a continuous web. As shown in the exemplary web 1800 in Figure 18, the cross-sections of the polymer tubes 1802 and 1832 have different shapes. In some other embodiments, the cross-sections of polymer tubes 1802 and 1832 may have the same shape.

[0095] Embodiments of the web described herein can be manufactured by a method comprising providing an extrusion die including a plurality of shims arranged adjacent to each other, which together define at least a first cavity, a second cavity, and a third cavity, and a distribution surface, wherein the distribution surface has an array of alternating distribution orifices, and the plurality of shims comprises a plurality of repeating arrangements of shims. The repeating arrangement may include shims that provide a fluid passage between the second cavity and the second plurality of orifices, and shims that provide a fluid passage between the first cavity and the first plurality of enclosed polygonal orifices, and also provide a third passage that extends from the third cavity to the third plurality of orifices located within the enclosed polygonal orifice region. The method may also include distributing a first polymer tube from the first distribution orifice while simultaneously distributing a spacer segment from the second distribution orifice, and providing an open air passage for the third cavity and the third distribution orifice. In some embodiments, the third passage is filled with air or gas and contains no other material. In some embodiments, a filling material (e.g., fluid) is distributed from the third distribution orifice.

[0096] Embodiments of the web described herein can be manufactured, for example, by a method including providing an extrusion die comprising an array of orifices arranged in close proximity to one another such that material dispensed from the orifices exits the orifices and welds together, wherein a first die cavity is connected to a plurality of enclosed polygonal orifices, a second die cavity is connected to a plurality of spacer orifices, and a third cavity is connected to a third plurality of orifices located within the enclosed polygonal orifice region. The method also includes dispensing a first polymer tube from the first dispensing orifice while simultaneously dispensing a spacer segment from the second dispensing orifice, and providing an open air passage for the third cavity and the third dispensing orifice. In some embodiments, the first and second dispensing orifices are collinear. In some embodiments, the first dispensing orifices are collinear, and the second dispensing orifice is also collinear but offset from the first dispensing orifice and not collinear with the first dispensing orifice.

[0097] In some embodiments, the extrusion die is used to manufacture the web described herein and includes a pair of end blocks for supporting a plurality of shims. In these embodiments, it may be convenient that one or all of the shims each have one or more through holes for the passage of connectors between the pair of end blocks. Bolts placed in such through holes are one convenient method for assembling the shims to the end blocks, but those skilled in the art may recognize other alternatives for assembling the extrusion die. In some embodiments, at least one end block has an inlet port for introducing fluid material into one or both of the cavities. In some embodiments, the shims are assembled according to a plan that provides a repeating array of various types of shims. The repeating array may have a varying number of shims per repeat.

[0098] Exemplary passage cross-sectional shapes include square and rectangular shapes. For example, the shapes of the passages within a repeating array of shims may be the same or different. For example, in some embodiments, a shim providing a passage between a first cavity and a first distribution orifice may have flow limiting properties compared to a shim providing a conduit between a second cavity and a second distribution orifice. For example, the widths of the distal openings within a repeating array of shims may be the same or different. For example, the portion of the distal opening provided by a shim providing a conduit between a first cavity and a first distribution orifice may be narrower than the portion of the distal opening provided by a shim providing a conduit between a second cavity and a second distribution orifice.

[0099] In some embodiments, the assembled shims (conveniently bolted between end blocks) also include a manifold body for supporting the shims. The manifold body has at least one (or more (e.g., two, three, four, or more)) manifolds within it, and the manifolds have outlets. An expansion seal (e.g., made of copper or an alloy thereof) is positioned to seal the manifold body and the shims, thereby the expansion seal defining a portion of at least one of the cavities (in some embodiments, a portion of both the first and second cavities), and the expansion seal allows a conduit between the manifold and the cavity.

[0100] Typically, the length of the passage between the cavity and the distribution orifice is a maximum of 5 mm. Sometimes, the first array of fluid passages has a greater flow limit than the second array of fluid passages.

[0101] In some embodiments, with respect to the extrusion die, each of the distribution orifices of the first and second arrays has a cross-sectional area, and each of the distribution orifices of the first array has a different area from that of the second array. Shims for the die may have a thickness in the range of 50 micrometers to 125 micrometers, but thicknesses outside this range may also be useful. Typically, the fluid passage has a thickness in the range of 50 micrometers to 750 micrometers and a length of less than 5 mm (generally, a smaller length is preferred for gradually decreasing passage thicknesses of 30), but thicknesses and lengths outside these ranges may also be useful. For fluid passages of large diameter, several shims of smaller thicknesses may be stacked together, or a single shim of the desired passage width may be used.

[0102] The shims are compressed tightly to prevent gaps between them and polymer leakage. For example, 12 mm (0.5 inch) diameter bolts are typically used and tightened to their recommended torque rating at the extrusion temperature. Also, the shims are aligned to provide uniform extrusion from the extrusion orifice, as misalignment can lead to the tube being extruded from the die at an angle that hinders the desired bonding of the net. Alignment keys can be cut into the shims to aid in alignment. A vibrating table may also be useful to provide smooth surface alignment of the extrusion tip.

[0103] Further details regarding shims, dies, methods, etc., for use with the thermoformable splints and negative pressure treatment kits described herein, for manufacturing the web designs described with reference to Figures 16-18, are described in detail in U.S. Provisional Patent Application No. 62 / 885,523, filed August 12, 2019, the disclosure thereof being incorporated herein by reference in its entirety.

[0104] Referring to Figure 19, the exemplary net 1900 includes an array 1901 of polymer strands 1902. The polymer strands 1902 are periodically joined to one another in bonding regions 1905 throughout the array 1901, with spaces 1903 between adjacent strands (i.e., between bonding regions, the bonded strands for each bonding region are separated). As shown, at least some of the spaces 1903 are filled with a thermally conductive material (i.e., a material having a thermal conductivity of at least 0.5 watts / meter Kelvin) 1904. At least several (i.e., at least two) strands 1902 are hollow polymer strands (i.e., hollow cores 1906 with a sheath 1907 surrounding the hollow core). The hollow cores 1906 can be filled with a thermoplastic polymer (i.e., the second thermoplastic polymer described above). The strands 1902 do not substantially cross each other (i.e., at least 50 percent of them do not cross each other). The net 1900 includes an opening 1903. In some embodiments, the opening 1903 is at least one of a hexagon or a rhombus.

[0105] In the example in Figure 19, a bond is formed when two adjacent molten polymer strands collide with each other. The adjacent strands are extruded at alternating speeds so that the adjacent molten strands collide sequentially to form a bond, and then separate to form a net opening. The strands are extruded in the same direction, and therefore these bonds are parallel bonds, all formed in the same direction. The bonds are shown to be in the same plane and not intersecting each other. For a given strand, on one side there is a first strand that is intermittently bonded, and on the opposite side there is a second strand that is also intermittently bonded. The bonded region is a continuum of the two strands, and therefore the bonded region includes the sum of the two adjacent strands. Typically, the strands continue without being cut and can continue continuously through the bonded region.

[0106] Embodiments of a net, such as net 1900 in Figure 19, can be manufactured by a method that includes providing an extrusion die comprising a plurality of adjacently arranged shims that together define at least a first cavity, a second cavity, and a third cavity, and a distribution surface having an array of alternating distribution orifices. The plurality of shims may comprise a plurality of repeating arrangements of shims. The repeating arrangement may include shims that provide a fluid passage between the first cavity and the first plurality of orifices, shims that provide a second passage extending from the second cavity to a second plurality of enclosed polygonal orifices, and shims that provide a third passage extending from the third cavity to a third plurality of orifices located within the polygonal region enclosed by the second plurality of orifices. The method may include distributing a first polymer strand from the first distribution orifice at a first strand velocity, while simultaneously distributing a second polymer strand from the second distribution orifice at a second strand velocity. In some embodiments, the first strand velocity is at least twice the second strand velocity (in some embodiments, in the range of 2 to 6 times, or even 2 to 4 times) to provide a net. In some embodiments, the third passage is filled with air and contains no material. In some embodiments, the method includes distributing a filler material (e.g., a fluid) from the third distribution orifice.

[0107] In some embodiments, a net such as net 1900 in Figure 19 can be manufactured by a method that includes, for example, providing an extrusion die comprising a plurality of shims arranged adjacent to one another. The shims together define at least a first cavity, a second cavity, and a third cavity, as well as a distribution surface. The distribution surface has an array of alternating distribution orifices, and the plurality of shims comprises a plurality of repeating arrangements of shims. The repeating arrangement may include shims that provide a fluid passage between the first cavity and the first plurality of orifices, shims that provide a second passage extending from the second cavity to a second plurality of enclosed polygonal orifices, and shims that provide a third passage extending from the third cavity to a third plurality of orifices located within the polygonal region enclosed by the second plurality of orifices. This method may include distributing a first polymer strand from a first distribution orifice at a first strand velocity, simultaneously distributing a second polymer strand from a second distribution orifice at a second strand velocity, and distributing the fluid from a third distribution orifice. In some embodiments, the first strand velocity is at least twice (in some embodiments, in the range of 2 to 6 times, or even 2 to 4 times) the second strand velocity in order to provide a net.

[0108] In some embodiments, the shims include a plurality of at least one repeating arrays of shims, each containing shims that provide passages between the first and second cavities and the first distribution orifice. In some of these embodiments, there are additional shims that provide passages between the first and / or second cavities and / or a third (or more) cavities and the second distribution orifice. Typically, not all shims of the die described herein have passages, and some may be spacer shims that do not provide passages between any cavities and distribution orifices. In some embodiments, there are repeating arrays that further include at least one spacer shim. The number of shims providing passages to the first distribution orifice may be equal to or equal to the number of shims providing passages to the second distribution orifice.

[0109] In some embodiments, the first and second distribution orifices are collinear. In some embodiments, the first and second distribution orifices are collinear, but offset from the first distribution orifice and are not collinear with it.

[0110] In some embodiments, the extrusion die described herein includes a pair of end blocks for supporting a plurality of shims. In these embodiments, it may be convenient that one or all of the shims each have one or more through holes for the passage of connectors between the pair of end blocks. Bolts placed in such through holes are one convenient method for assembling the shims to the end blocks, and other alternative means for assembling the extrusion die are also possible. In some embodiments, at least one end block has an inlet port for introducing fluid material into one or both of the cavities.

[0111] In some embodiments, the shims are assembled according to a plan that provides a repeating array of various types of shims. The repeating array can have a varying number of shims per repeat. For example, a repeating array of 27 shims can provide a net having single-material strands positioned alternately with core / sheath strands.

[0112] Exemplary passage cross-sectional shapes include square and rectangular shapes. For example, the shapes of the passages within a repeating array of shims may be the same or different. For example, in some embodiments, a shim providing a passage between a first cavity and a first distribution orifice may have flow limiting properties compared to a shim providing a conduit between a second cavity and a second distribution orifice. For example, the widths of the distal openings within a repeating array of shims may be the same or different. For example, the portion of the distal opening provided by a shim providing a conduit between a first cavity and a first distribution orifice may be narrower than the portion of the distal opening provided by a shim providing a conduit between a second cavity and a second distribution orifice.

[0113] In some embodiments, the assembled shim (conveniently bolted between end blocks) further includes a manifold body for supporting the shim. The manifold body has at least one (or more (e.g., two, three, four, or more)) manifolds therein, and the manifolds have outlets. An expansion seal (e.g., made of copper or an alloy thereof) is positioned to seal the manifold body and the shim, so that the expansion seal defines a portion of at least one of the cavities (in some embodiments, a portion of both the first and second cavities), and the expansion seal allows a conduit between the manifold and the cavity.

[0114] In some embodiments, with respect to the extrusion die described herein and relating to the embodiment shown in Figure 19, each of the first and second arrays of distribution orifices has a width, and each of the first and second arrays of distribution orifices is separated by up to twice the width of the respective distribution orifice. Typically, the length of the passage between the cavity and the distribution orifice is up to 5 mm. Sometimes, the first array of fluid passages has a greater flow limit than the second array of fluid passages.

[0115] In some embodiments, for an extrusion die described herein and associated with the embodiment in Figure 19, each of the distribution orifices in the first and second arrays has a cross-sectional area, and each of the distribution orifices in the first array has a different area from that of the second array. Typically, the spacing between orifices is up to twice the width of the orifices. The spacing between orifices is greater than the diameter of the strands obtained after extrusion. This diameter is commonly called the die swell. This spacing between orifices is greater than the diameter of the strands obtained after extrusion, which leads to the strands repeatedly colliding with each other to form a repeating bond of a net. If the spacing between orifices is too large, the strands will not collide with each other and will not form a net.

[0116] Shims for dies described herein and relating to the embodiments shown in Figure 19 typically have thicknesses in the range of 50 to 125 micrometers, although thicknesses outside this range may also be useful. Typically, fluid passages have thicknesses in the range of 50 to 750 micrometers and lengths of less than 5 mm (generally, smaller lengths are preferred for passages with gradually decreasing thickness), but thicknesses and lengths outside these ranges may also be useful. For fluid passages with large diameters, several shims of smaller thicknesses may be stacked together, or a single shim of the desired passage width may be used.

[0117] The shims are tightly compressed to prevent gaps between them and polymer leakage. For example, 12 mm (0.5 inch) diameter bolts are typically used and tightened to their recommended torque rating at the extrusion temperature. Also, the shims are aligned to provide uniform extrusion from the extrusion orifice, as misalignment can lead to the strands being extruded from the die at an angle that hinders the desired bonding of the net. Alignment keys can be cut into the shims to aid in alignment. A vibrating table may also be useful to provide smooth surface alignment of the extrusion tip.

[0118] Further details, such as shims, dies, and methods for manufacturing the net design described with reference to Figure 19, for use with the thermoformable splint and negative pressure treatment kit described herein, are described in detail in U.S. Provisional Patent Application No. 62 / 808620 filed February 21, 2020, and PCT Application No. IB2020 / 051315 filed February 12, 2020, the entirety of which disclosures are incorporated herein by reference.

[0119] Referring to Figure 20, the exemplary web 2000 includes an array of separate polymer tubes 102. The polymer tubes 2002 can be hollow polymer tubes (i.e., hollow cores 116 with a sheath 114 surrounding the hollow core). In some embodiments, the hollow cross-sectional area of ​​the tubes having a hollow cross-sectional area is greater than 50%, 60%, 70%, or 80% of the area between the top and bottom surfaces of the web. Adjacent polymer tubes 2002 are connected at a bonding region 2018. The length L of the bonding region 2018 is greater than 5% of the average diameter of the polymer tubes 2002. Generally, the length L of the bonding region, when the bonding length is longer, forms a more linear tubular opening of adjacent connected tubes.

[0120] A linear shape with rounded corners, such as a rectangular circle, results in a hollow cross-sectional area with a larger portion of the area between the top and bottom surfaces of the web compared to a circular shape joined to each other only at the contact points. A short joining length L creates a tubular shape that is more elliptical. These rectangular circles can also be extruded onto a flat quenching surface to form a flat top or bottom segment of a rectangular circle. A linear rectangular circle allows for a larger contact area with respect to the top and bottom planes than a circular tube. This larger contact area can be useful for heat transport between the top or bottom surface and the cooling medium within the tube.

[0121] In some embodiments, the bonding region has a length L ranging from 0.1 mm to 5 mm. In some embodiments, the thickness T2 of the bonding region is substantially uniform along its length. As shown in the exemplary web 2000 in Figure 1, the cross-sections of the polymer tubes 2002 have the same shape. In some other embodiments, the cross-sections of the polymer tubes 2002 can have different shapes. The cross-section of the polymer tube 2002 can be any suitable shape, for example, a rectangular circle. The polymer tube 2002 has a tube wall thickness T1 ranging from 0.025 mm to 0.25 mm. Adjacent polymer tubes have a first bonding point 2020 and a second bonding point 2021, where the bonding points have radii greater than 0.1T1, 0.2T1, 0.3T1, 0.4T1, or 0.5T1. These bonding points represent the beginning and end of the bonding region between adjacent tubes. Thus, they are the start and end points of the bonding line, indicated as length L in Figure 1. The bonding points with the adjacent tube walls form radii at the ends of the bonding length. A joint with a radius provides resistance to crack propagation between tubes. In some embodiments, the strength of the joint or weld between tubes is greater than the strength of the tube wall T1.

[0122] As shown in Figure 20, the web 2000 can be a continuous web. As shown in the exemplary web 2000 in Figure 1, the polymer tubes 2002 are in the same plane. Figure 1 shows the individual tube widths W1 and individual tube heights H1. The rectangular circular tubes have flat surfaces on the top and bottom of the web. The dimensions W2 and t shown in Figure 1 can be used to determine the contact area of ​​the rectangular circular tubular web. The surface contact area as a percentage can be calculated by comparing the dimensions W1 to W2 shown in Figure 1. In some embodiments, the contact area of ​​the top and bottom surfaces of the rectangular circular web 30 can be up to 10%, up to 25%, 50%, or even up to 95% of the flat surface area of ​​the top or bottom surface. In some embodiments, the web described herein has a height H1 of up to 5,000 (in some embodiments, up to 2,000, 1,000, 500, or even up to 100; 100-5,000, 100-2,000, 100-1,000, or even 100-500) micrometers. In some embodiments, the polymer tube has an average cross-sectional diameter in the range of 0.1-5 mm. In some embodiments, the thickness T2 is twice the thickness T1. In some embodiments, the thickness T1 is uniform around the outer circumference of the tube. In some embodiments, the thickness T1 is varied to assist in the formation of a desired tubular shape. In some embodiments, at least 25 percent (in some embodiments, at least 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or even 100) of the hollow polymer tubes each have a hollow cross-sectional area of ​​0.1 to 10 (in some embodiments, in the range of 0.1 to 2, or even 0.1 to 5) mm².

[0123] In some embodiments, the polymer includes filler materials (e.g., aluminum oxide, aluminum nitride, aluminum trihydrate, boron nitride, aluminum, copper, graphite, graphene, magnesium oxide, zinc oxide) to provide thermal conductivity. In some embodiments, the array of polymer tubes exhibits at least one of elliptical or rectangular circular cross-section openings. In some embodiments, the polymer tubes have a down-web direction, e.g., the t-direction as shown in Figure 20, and a cross-web direction. The polymer tubes are shown as extending substantially in the down-web direction.

[0124] The web thereby provides a coated core of a second thermoplastic polymer that may be fluid or solid depending on the temperature. In some embodiments, at least some of the tubes of the web described herein are filled with a thermally conductive material (i.e., a material having a thermal conductivity of at least 0.5 watts / meter Kelvin). Exemplary thermally conductive materials include functional particles (e.g., aluminum oxide, aluminum nitride, aluminum trihydrate, boron nitride, aluminum, copper, 25 graphite, graphene, magnesium oxide, zinc oxide) for providing desired thermal properties to the articles described herein. Additional information that may be useful in the fabrication and use of the tubes described herein when combined with this disclosure can be found in International Publication No. 2020 / 003065(A1) (Ausen et al.), the disclosure of which is incorporated herein by reference.

[0125] Embodiments of the web described herein with reference to Figure 20 can be manufactured, for example, by a method comprising providing an extrusion die comprising a plurality of shims arranged adjacent to one another. The shims together define at least a first cavity, a second cavity, and a third cavity. The extrusion die may also include a distribution surface, the distribution surface having an array of alternating distribution orifices. The plurality of shims comprises a plurality of repeating arrangements of shims, the repeating arrangements of which provide a fluid passage between the first cavity and the first plurality of enclosed polygonal orifices, and also include shims that provide a second passage extending from the second cavity to a second plurality of orifices located within the enclosed polygonal orifice region. The method may also include distributing a first polymer tube from the first distribution orifice and providing an open air passage for the second cavity and the second distribution orifice.

[0126] In some embodiments, the second passage is filled with air or gas and contains no other material. In some embodiments, the method includes distributing a filler material (e.g., a fluid) from the second distribution orifice.

[0127] Embodiments of the web described herein with reference to Figure 20 can be manufactured, for example, using a method that includes providing an extrusion die comprising an array of orifices arranged in close proximity to one another such that material dispensed from the orifices exits the orifices and welds together. Adjacent orifice regions may be substantially parallel to one another. The first die cavity may be connected to a plurality of enclosed polygonal orifices, and the second cavity may be connected to a second plurality of orifices arranged within the enclosed polygonal orifice region. The method may also include dispensing a first polymer tube from the first dispensing orifice and providing an open air passage for the second cavity and the second dispensing orifice.

[0128] In some embodiments, the first and second distribution orifices are collinear. In some embodiments, the first distribution orifice is collinear, and the second distribution orifice is also collinear, but offset from the first distribution orifice and not collinear with the first distribution orifice. In some embodiments, the orifice thickness is uniform around the orifice shape. In some embodiments, the orifice thickness differs on different sides of the orifice shape. In some embodiments, the extrusion die described herein includes a pair of end blocks for supporting a plurality of shims. In these embodiments, it may be convenient that one or all of the shims each have one or more through holes for the passage of a connector between the pair of end blocks. Bolts placed in such through holes are one convenient method for assembling the shims to the end blocks, but those skilled in the art may recognize other alternatives for assembling the extrusion die. In some embodiments, at least one end block has an inlet port for introducing fluid material into one or both of the cavities.

[0129] In some embodiments, the shims are assembled according to a plan that provides a repeating array of various types of shims. The repeating array may have a varying number of shims per repeat. Exemplary passage cross-sectional shapes include square and rectangular shapes. For example, the shapes of the passages in a repeating array of shims may be the same or different. For example, in some embodiments, a shim providing a passage between a first cavity and a first distribution orifice may have flow limiting compared to a shim providing a conduit between a second cavity and a second distribution orifice. For example, the widths of the distal openings in a repeating array of shims may be the same or different. For example, the portion of the distal opening provided by a shim providing a conduit between a first cavity and a first distribution orifice may be narrower than the portion of the distal opening provided by a shim providing a conduit between a second cavity and a second distribution orifice.

[0130] In some embodiments, the assembled shim (conveniently bolted between end blocks) further includes a manifold body for supporting the shim. The manifold body has at least one (or more (e.g., two, three, four, or more)) manifolds within it, and the manifolds have outlets. An expansion seal (e.g., made of copper or an alloy thereof) is positioned to seal the manifold body and the shim, thereby the expansion seal defining a portion of at least one of the cavities (in some embodiments, a portion of both the first and second cavities), and the expansion seal allows a conduit between the manifold and the cavity. Typically, the length of the passage between the cavity and the distribution orifice is up to 5 mm.

[0131] Sometimes, the first array of fluid passages has a greater flow limit than the second array of fluid passages. Shims for dies described herein with reference to Figure 20 typically have thicknesses in the range of 50 to 125 micrometers, although thicknesses outside this range may also be useful. Typically, fluid passages have thicknesses in the range of 50 to 750 micrometers and lengths of less than 5 mm (generally, smaller lengths are preferred for passages with gradually decreasing thickness), but thicknesses and lengths outside these ranges may also be useful. For fluid passages with large diameters, several shims of smaller thicknesses may be stacked together, or a single shim of the desired passage width may be used.

[0132] The shims are compressed tightly to prevent gaps between them and polymer leakage. For example, 12 mm (0.5 inch) diameter bolts are typically used and tightened to their recommended torque rating at the extrusion temperature. Also, the shims are aligned to provide uniform extrusion from the extrusion orifice, as misalignment can lead to the tube being extruded from the die at an angle that hinders the desired bonding of the net. Alignment keys can be cut into the shims to aid in alignment. A vibrating table may also be useful to provide smooth surface alignment of the extrusion tip.

[0133] Further details regarding shims, dies, methods, etc., for use with the thermoformable splints and negative pressure treatment kits described herein, for manufacturing the web designs described with reference to Figure 20, are described in detail in U.S. Provisional Patent Application No. 63 / 035970, filed June 8, 2020, the disclosure thereof being incorporated herein in its entirety by reference.

[0134] D. Method for fabricating and using a negative pressure treatment system having a thermoformable splint. Referring now to Figure 21, a flowchart of process 2100 for manufacturing a thermoformable splint 900 according to an exemplary embodiment is shown.

[0135] In step 2102, a tubular web or net is extruded. The tubular web or net may be the web 1600, web 1700, web 1800, net 1900, or web 2000 described above with reference to Figures 16-20. The extrusion process may also be carried out as described above with reference to Figures 16-20. This can result in a tubular web or net that forms multiple interconnected hollow tubes and is substantially flexible and conformable. The tubular web or net may be sized and formed to a desired final size and shape for the splint 900, for example, substantially rectangular, or substantially larger (for example, formed into a substantially continuous sheet or in sections larger than the final size and shape for the splint 900).

[0136] In step 2104, the hollow tubes of the tubular web or net are at least partially filled with a thermoplastic polymer different from the material used to make the tubular web or net. For example, the tubular web or net can be formed using a first thermoplastic polymer, and the tubes of the tubular web or net can be at least partially filled using a second thermoplastic polymer. Step 2104 can be formed with a second thermoplastic polymer that has a melting point higher than the second thermoplastic polymer, so that the second thermoplastic polymer is liquid and therefore flows through the tubes to fill them. The tubular web or net has a melting point higher than the polymer inserted therein to facilitate this process. In other embodiments of step 2104, the tubular web or net is filled with polymer as it is extruded so that the two materials are formed together during the extrusion process in order to at least partially fill the tubes with the thermoplastic polymer.

[0137] In step 2106, the filled tubular web is cut to an appropriate size. This may include sealing one or more open ends of the tubular web or net to accommodate the second thermoplastic polymer inside the tube. In some embodiments, step 2106 includes joining multiple sections of the tubular web together, for example, facing each other, to create a multilayer tubular web. This allows for the production of a thermoplastic tubular structure 1504.

[0138] In step 2108, the backing material (e.g., backing layer 1508), operational features, connection features (e.g., connection layer 1506), or other additional components of the splint 900 in various embodiments are bonded to a filled tube (i.e., thermoplastic tubular structure 1504). In some embodiments, as shown in Figure 15, the backing material is bonded to one side of the thermoplastic tubular structure 1504, and the connection layer 1506 is bonded to the opposite side of the thermoplastic tubular structure 1504. In other embodiments, the backing material, operational features, connection features, etc., are formed as a sleeve, and in step 2108, the thermoplastic tubular structure 1504 is inserted into the sleeve (e.g., sealed within the sleeve). In other embodiments, the thermoplastic tubular structure 1504 is incorporated into the splint device, for example, to replace a metal stay found in conventional splint devices. In yet another embodiment, step 2108 is omitted, and the splint 900 consists only of the thermoplastic tubular structure 1504.

[0139] Referring here to Figure 22, a flowchart of process 2200 for using kit 1500 is shown according to an exemplary embodiment. Process 2200 facilitates the provision of negative pressure therapy and joint immobilization therapy to the patient.

[0140] In step 2202, the negative pressure dressing is applied to the patient's joint. For example, the dressing 100 may be applied around the patient's ankle or other joint. The dressing 100 may be sealed to the patient's skin to provide a substantially airtight volume between the dressing 100 and the skin, as described elsewhere in this specification. Step 2202 may also include connecting the negative pressure dressing to a negative pressure source. For example, the dressing 100 may be connected to a connecting pad 90 and a tube 205, the tube 205 then connected to a pump 200 to pneumatically communicate the sealed volume between the dressing 100 and the skin with the negative pressure source.

[0141] In step 2204, the negative pressure source is actuated to establish negative pressure in the dressing. For example, air can be pumped from the dressing 100 by the pump 200 to expose the patient's joint to negative pressure. Thereby, negative pressure treatment of the joint is started in step 2024.

[0142] In step 2206, the sub-component is heated to at least a first temperature. For example, the sub-component can be placed in hot water, heated in an oven, heated in a microwave, or exposed to thermal energy by other means. The first temperature can, for example, correspond to the melting point of the thermoplastic polymer contained in the tube of the tubular structure of the sub-component. In various embodiments, the first temperature can be within the range of about 75°C to about 90°C. As a result of step 2206, the sub-component is in a formable state.

[0143] In step 2208, the sub-component is adapted to the negative pressure dressing and the joint in a desired sub-component form. For example, the sub-component can be applied to any of the various uses shown in FIGS. 9 - 14 and described above with reference thereto. Thus, step 2208 can include wrapping the sub-component around the joint and bending the sub-component to conform to the joint and the dressing. The sub-component can be applied such that the surface of the sub-component abuts the dressing and there is substantially no gap between the sub-component and the dressing.

[0144] In step 2210, the heated splint (i.e., the moldable state after step 2206) is held in the desired splint shape. For example, an integrated attachment feature of the connecting layer of the dressing and / or splint can be used to keep the heated splint in place. In another embodiment, a separate wrap (e.g., a flexible bandage) or tape (e.g., exercise tape) can be wrapped around the splint to secure it to the dressing and joint while the splint is still heated / mold. The dressing can provide a thermal barrier between the splint and the patient's skin to protect the patient from discomfort that may be caused by heat radiating from the splint.

[0145] In step 2212, the splint is cooled and hardened. By holding the splint as in step 2210, the splint hardens into the desired splint shape, i.e., as applied in step 2208. Step 2212 includes allowing the splint to gradually lose heat to the surrounding environment. Step 2212 may also include rapidly cooling the splint by applying ice or other cooling element to it. In step 2212, the splint may be cooled to a second temperature below the first temperature, and may become rigid as the thermoplastic polymer in the tubes of the splint's tubular web or net cools to a solid state. The splint may remain rigid below the second temperature, for example, below about 50°C or 60°C. Once the splint becomes rigid, the joint can be substantially fixed.

[0146] In step 2214, the negative pressure source operates to provide negative pressure therapy while the splint remains rigid to provide joint fixation. Under normal conditions, the splint is only exposed to a temperature lower than the second temperature and well below the first temperature, such as ambient air temperature, ground temperature, etc. Thereafter, the splint is maintained indefinitely in its rigidity. Thus, process 2200 provides the initiation and continuation of negative pressure and fixation therapy to the patient's joint.

[0147] Referring now to Figure 23, a process 2300 for adjusting or terminating immobilization treatment is shown according to an exemplary embodiment. Process 2300 may follow process 2200 in Figure 22.

[0148] In step 2302, the splint is heated to at least a second temperature. To heat the splint while it is already attached to the patient's joint, the splint may be exposed to a heating pad, massaged with a hot towel, exposed to hot air from a hairdryer or other electric air heating device, or supplied with thermal energy in a targeted manner to avoid overheating of the patient's skin. When the splint is heated above the second temperature, it becomes at least partially flexible and bendable, but it may not be as fully moldable and conformable as when the splint is heated above a first higher temperature, as in step 2206 of process 2200. As a result of step 2302, the splint may be sufficiently moldable to be adjusted or removed from the dressing and joint. In some embodiments, step 2302 includes setting heat to a particular section of the splint that is a critical area where adjustment is desired or flexibility would facilitate the removal of the dressing. Such a distinct area may be heated above the second or first temperature.

[0149] In some cases, in step 2304, the splint is reshaped to adjust and stabilize its functionality based on changes in swelling or other clinical adjustments. That is, the joint may gradually change, for example, by decreasing in size due to swelling reduction enhanced by negative pressure therapy. As another example, the degree or type of fixation that the clinician deems beneficial may gradually change. Thus, in step 2304, the splint may be adjusted to adjust the fixation without interrupting negative pressure therapy.

[0150] In step 2306, following the adjustment of the heated splint, the splint is cooled in the adjusted form and becomes rigid in the adjusted form. This provides an adjusted fixation treatment. This adjustability may be advantageous for healing.

[0151] In other cases, in step 2308, the splint is bent from the desired splint shape and removed from its fit with the dressing and joint. This may include bending at one or more key points of the splint, for example, at points where the splint wraps around a joint to allow the joint to be removed from the joint. In step 2310, the splint can be removed from the negative pressure dressing and joint. This may include separating the mounting features of the dressing from the splint, and / or separating the connecting features of the splint from the dressing, and / or removing any separate mounting tapes or wraps that may have been used to help secure the splint in place.

[0152] This allows the splint to be removed from the dressing. The immobilization treatment may be terminated at this point, but the dressing 100 and the provision of negative pressure may be limited to a lesser extent (which may be therapeutically sufficient in some cases at some treatment points) the movement of the joint without the splint. In some cases, the process 2300 also includes releasing the negative pressure and removing the dressing from the joint.

[0153] In step 2312, the splint is washed and stored for reuse. For example, the splint may be washed with hot (e.g., boiling or near-boiling) water to clean and disinfect it, and the splint may be heated to a highly moldable form so that it can be folded, rolled up, or otherwise made into a relatively small form for storage. The splint can then be stored for reuse. In some embodiments, for example, if the dressing is applied to completely intact skin, the dressing and / or other elements of kit 1500 are also washed and stored for reuse in step 2312.

[0154] Thermally activated casting tape Referring here to Figure 24, an exemplary embodiment of the casting tape 2400 is shown. The casting tape 2400 is flexible for application to a patient and is configured to form a rigid cast or splint by forming self-adhesive and rigid bonds between layers of the casting tape 2400. The casting tape 2400 can be thermally activated by heating the casting tape 2400 (e.g., in hot water) to make the casting tape 2400 flexible, allowing the casting tape 2400 to be wrapped around and laminated around a patient's joint, forming connections between adjacent layers of the casting tape 2400, and / or providing the casting tape 2400 with structural changes that enable it to provide joint fixation.

[0155] Figure 24 shows that the casting tape 2400 can be distributed as a roll. In some embodiments, the roll contains an amount of material relevant to a single application, so that the caregiver uses the entire roll of casting tape 2400 when fixing a joint. In other embodiments, the roll of casting tape 2400 may contain enough casting tape 2400 for multiple applications. The casting tape 2400 can be unwound and cut to the desired length during or before application to the patient.

[0156] Referring here to Figure 25, an exemplary application of the casting tape 2400 to a patient's joint according to one exemplary embodiment is shown. As shown in Figure 25, the casting tape 2400 is applied on and around the negative pressure dressing 100 to fix the patient's ankle. In particular, the casting tape 2400 can be heated and wrapped in multiple layers around the patient's ankle, for example, in a helical manner up and down along the patient's ankle and in different directions around the patient's ankle. The casting tape 2400 can also be applied in different directions to coincide with ankle taping approaches used with conventional sports medicine materials (e.g., adhesive exercise tapes), as is well known to caregivers. The casting tape 2400 can be applied such that several layers of the casting tape 2400 cover important areas for joint fixation, while one or more layers of the casting tape 2400 provide other areas where lower stiffness is desired. Figure 25 shows one of many possible applications of the casting tape 2400 to a patient's joint.

[0157] The casting tape 2400 can be applied by heating it. While at the elevated temperature (e.g., above a threshold temperature), the casting tape 2400 is flexible and conformable, and can be wrapped around joints and molded into, for example, the arrangement shown in Figure 25. The elevated temperature can also activate the casting tape 2400 to form bonds and connections between adjacent layers of the casting tape 2400 that are in contact with each other. For example, the casting tape 2400 may contain exposed polycaprolactone (PCL), as shown in and described in detail with reference to Figure 26. In such an example, when heated above a threshold temperature, the exposed PCL in one layer of the casting tape 2400 can bond, combine, mix, etc., with the exposed PCL in another layer of the casting tape 2400. When the casting tape 2400 is cooled (for example, to room temperature, below the threshold temperature), the combined / mixed PCL of adjacent layers of the casting tape 2400 hardens and bonds the adjacent layers together. This self-adhesion allows the casting tape 2400 to be held in place against the joint or other anatomical structure to which it is applied. In addition, the cooling and hardening of the adjacent layers of PCL of the casting tape 2400 can provide the overall structure of the casting tape 2400 with a substantially rigid form that can substantially fix the patient's joint.

[0158] Referring now to FIG. 26, an enlarged perspective view of a segment of a casting tape 2400 according to an exemplary embodiment is shown. As shown in FIG. 26, the casting tape 2400 includes a net 2600 formed of a first material and a tip portion 2602 formed of a second material. The net 2600 is shown as being formed from alternating straight portions 2604 and wavy portions 2606 that extend in a common direction along the length of the casting tape 2400. The wavy portions 2606 are periodically connected to the straight portions 2604 such that the wavy portions 2606 and the straight portions are joined together to form the net 2600. For example, as shown in FIG. 26, each wavy portion 2606 is alternately and repeatedly connected to two adjacent straight portions 2604. A gap (opening, channel, space, etc.) is defined between the wavy portion 2606 and the straight portion 2604. In some embodiments, the material is extruded to form the net 2600. For example, the net 2600 can be formed of an elastomer. Thus, the net 2600 can be flexible, stretchable, and conformable. The net 2600 is also porous and breathable.

[0159] The net 2600 can have various structures. In some embodiments, for example, the net 2600 is formed in accordance with the teachings of U.S. Patent No. 10,501,877 and / or U.S. Patent No. 10,265,653, both of which are hereby incorporated by reference in their entirety into this specification. For example, the net shown in FIG. 2 of U.S. Patent No. 10,501,877 can be combined with the ribbon and strand configuration shown in FIG. 5 of U.S. Patent No. 10,265,653 to provide greater strength to the net 2600.

[0160] The net 2600 also includes a tip 2602 formed from a polymer such as polycaprolactone (PCL) having a lower melting point than the net polymer. The tip 2602 is positioned on the outer surface of the net 2600 such that the tip 2602 is exposed. In the illustrated example, the tip 2602 extends along a straight section 2604 of the net 2600 and can extend along the entire length of the casting tape 2400. Each straight section 2604 corresponds to two tip 2602 on the opposing edges of the straight section 2604, i.e., on the opposing sides of the net 2600. The tip 2602 can be co-extruded together with the net 2600 so that the net 2600 and the tip 2602 are formed together to produce the casting tape 2400.

[0161] The casting tape 2400 can be provided in various dimensions in various embodiments. For example, the thickness of the casting tape 2400 may be about 1 millimeter or less. The leading portions 2602 may be spaced about 1 millimeter apart, and the straight portions 2604 may be spaced about 1 millimeter apart. The width of the leading portions and the straight portions 2604 may be about one-third of a millimeter. The corrugated portions 2606 can be sized accordingly. Any number of corrugated portions 2606 and straight portions 2604 can be provided to give the casting tape 2400 a desired overall width. For example, the width may be 4 to 20 centimeters in various embodiments.

[0162] The tip portion 2602 has a lower melting or softening point than the net 2600. At room temperature (e.g., below about 40°C), the tip portion 2602 can be at least partially rigid and, in some embodiments, may be foamed. When heated above a threshold temperature (e.g., above 40°C, above 50°C, above 60°C), the tip portion 2602 softens or melts, while the net 2600 substantially maintains its material properties (i.e., does not soften or melt unless at much higher temperatures). Thus, when the casting tape 2400 is heated above a threshold temperature, the casting tape 2400 can be easily wrapped around a patient's joint in a desired cast or splint configuration, fitted, and molded.

[0163] Furthermore, when the casting tape 2400 is layered on top of itself at this higher temperature, the leading edge 2602 of the first layer of the casting tape 2400 comes into contact with the leading edge 2602 of the second layer of the casting tape 2400. The contacting leading edge 2602 is soft or molten and can therefore be combined or mixed to be reformed as an integrated portion of the PCL material of the leading edge 2602. Depending on the arrangement of the casting tape 2400, the contacting leading edges 2602 can form a grid or other cross pattern of leading edges 2602 that intersect and combine with each other.

[0164] When the casting tape 2400 is cooled (for example, by exposure to ice or other cooling sources, returning to room temperature through heat loss to the ambient air), the reformed and combined pattern or PCL material of the tip 2602 hardens, forming a substantially rigid structure. The rigid structure is highly customizable, as the casting tape 2400 can be applied to a wide variety of uses as desired by caregivers. The tip 2602 can also be reformed while soft to at least partially fill the gap between the corrugated portion 2606 and the straight portion 2604 of the net 2600, which can increase the rigidity of the casting tape 2400 as the PCL material hardens.

[0165] When in the roll configuration shown in Figure 24, the cast tape 2400 can be heated to a threshold temperature, e.g., 65°C, to melt the PCL and facilitate unwinding. To facilitate unwinding of the cast tape 2400, the cast tape 2400 can be configured such that interlayer PCL bonds are formed only after the layers are applied and pressure is applied to form the cast on the patient's limb. Thus, in some embodiments, the structure of the cast tape 2400 limits the amount of exposed PCL and reduces or eliminates overlap between PCL when wound up, for example, as in Figure 24. As another example, a lubricant may be included in the PCL tip portion 2602. As yet another example, the lubricant is distributed on one or more surfaces of the cast tape 2400, for example, between the layers of the roll shown in Figure 24. The lubricant may be activated by water so that the lubricant is released by heating the cast tape 2400 in a hot water bath above the melting point of the PCL (e.g., 65°C), facilitating the movement of the layers of the cast tape 2400 relative to each other. For example, thermoplastic polyvinyl alcohol (e.g., Mowiflex TC232) can be added directly to the PCL in an amount of 5-30% by weight, preferably 10-20% by weight, to function as a lubricant. This can be achieved by dry blending pellets of CAPA 6800 PCL and Mowiflex TC232 before extrusion to form the cast tape 2400. Other water-soluble or dispersible polymers and surfactants, as well as combinations thereof, may also be useful. Various combinations of these approaches are within the scope of this application.

[0166] The casting tape 2400 thereby provides self-adhesive fixation of the joint. The casting tape 2400 is also adapted to be applied over a negative pressure wound dressing 100, for example, as shown in Figure 25. The casting tape 2400 offers a high degree of customizability in application, allowing the casting tape 2400 to be adapted to the features of the dressing 100 without compromising the effectiveness of fixation. For example, the casting tape 2400 can be applied so as not to obstruct the path for connecting pads and tubes to extend from the negative pressure dressing 100 to a negative pressure source (e.g., a pump). As another example, the negative pressure wound dressing 100 may have a PCL area on its outer surface so that the tip 2602 can fuse with the PCL of the dressing 100 to adhere to the dressing 100. In accordance with the other embodiments described above, various structures can be provided on the dressing 100 to facilitate the connection between the dressing 100 and the casting tape 2400.

[0167] The casting tape 2400 can be removed by cutting it from the joint using scissors, a blade, a competition tape cutter tool, etc. The casting tape 2400 can also be removed by reheating it above a threshold temperature, thereby softening or melting the PCL material and releasing the self-adhesion between the layers of the casting tape 2400. The casting tape 2400 can then be removed from the patient. Thus, the casting tape 2400 provides a fixation treatment that can be easily applied to and removed from a joint, and may be desired to promote wound healing.

[0168] 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.

[0169] When used herein to describe various embodiments, the terms “exemplary” and its variation (e.g., “case-like”) 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 special or best examples).

[0170] 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.

[0171] 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.

[0172] 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. Note 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. It is a splint, A plurality of flexible tubes formed from a first material comprising a first thermoplastic polymer, wherein the plurality of flexible tubes are bonded together to form a web, The system comprises a second material comprising a second thermoplastic polymer disposed within the flexible tube and having a lower thermal softening point than the first material, The web is flexible when the second material is heated to a temperature higher than the thermal softening point of the second material. A splint in which the web is rigid when the temperature of the second material is below the thermal softening point of the second material.

2. The splint according to claim 1, wherein the second material comprises polycaprolactone.

3. The splint according to claim 1, further comprising a backing layer bonded to the web.

4. The splint according to claim 1, further comprising a connecting layer coupled to the splint, wherein the connecting layer is configured to bond the splint to the dressing.

5. The splint according to claim 1, wherein the web further comprises spacer segments containing a thermally conductive material between adjacent tubes among the plurality of flexible tubes.

6. The splint according to claim 1, wherein the flexible tube lies in two or more planes.

7. The splint according to claim 1, wherein the flexible tubes are aligned in a common plane.

8. The splint according to claim 1, wherein each cross-section of the flexible tube has a non-circular shape.

9. The splint according to claim 1, wherein adjacent tubes among the plurality of flexible tubes are periodically joined to each other in a joining region, and the space between adjacent tubes among the plurality of flexible tubes is located between the joining regions.

10. A kit for negative pressure and fixation therapy, A negative pressure dressing configured to define a sealed volume between the patient's skin and the negative pressure dressing when applied to the patient, A pump configured to be positioned in air communication with the negative pressure dressing and capable of discharging air from the sealed volume, A thermoformable splint is provided, and the thermoformable splint is A plurality of flexible tubes formed from a first thermoplastic polymer and bonded together to form a web, A kit for negative pressure and fixation therapy, comprising: a second thermoplastic polymer disposed within the flexible tube and having a lower softening or melting point than the first thermoplastic polymer.

11. The kit according to claim 10, wherein adjacent tubes within the web of the plurality of flexible tubes are periodically joined to each other in joining regions and are spaced apart from the joining regions.

12. The kit according to claim 10, wherein the thermoformable splint further includes spacer segments that join adjacent tubes of the plurality of flexible tubes to form the web, and the spacer segments include a thermally conductive material.

13. The kit according to claim 10, wherein the negative pressure dressing comprises a mounting feature configured to selectively bond the thermoformable splint to the negative pressure dressing.

14. The kit according to claim 13, wherein the thermoformable splint comprises a connecting layer configured to be bonded to the web and to the mounting feature portion of the negative pressure dressing.

15. The negative pressure dressing is molded to be applied to the patient's ankle. The thermoformable splint is configured to be heated to a formable state in order to facilitate the application of the thermoformable splint onto the negative pressure dressing on the patient's ankle. The thermoformable splint is configured to cool to a rigid state to provide fixation of the patient's ankle when the thermoformable splint is applied to the patient's ankle on the negative pressure dressing. The kit according to claim 10.

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