Wound treatment devices and related methods with scar-modifying properties

Abstract

This invention discloses a wound treatment device. In various aspects of the invention, the wound treatment device may include a distal layer in contact with a wound bed, the distal layer being made of silicone resin, and a channel disposed in the distal layer passing through the distal and proximal sides of the distal layer to connect the distal and proximal sides. In various aspects of the invention, a pad may engage with the proximal side of the distal layer to absorb exudate from the wound bed passing through the channel through the distal layer. In various aspects of the invention, various materials, including medications, may be delivered to the wound bed through the channel via the distal layer. In various aspects of the invention, structural members may be included to secure the distal layer and the pad to the skin surface. This invention also discloses methods for using the wound treatment device.

Description

[0001] This application is a divisional application of patent application No. 201880049874.2 entitled "Wound Treatment Device and Related Method with Scar Modification Properties". The original application corresponds to international application PCT / US2018 / 043962, with a filing date of July 26, 2018, and a priority date of July 29, 2017.

[0002] Cross-referencing of related patents This application claims priority to the following U.S. patent applications: No. 15 / 663,708, filed July 29, 2017; No. 15 / 663,709, filed July 29, 2017; No. 15 / 663,710, filed July 29, 2017; No. 15 / 663,713, filed July 29, 2017; and No. 15 / 663,714, filed July 29, 2017. All of these claimed priority patent applications are incorporated herein by reference in their entirety and form part of this application. Technical Field

[0003] This disclosure relates to medical devices, and in particular, to apparatus for wound treatment and related components and methods of use. Background Technology

[0004] Wounds afflict hundreds of millions of people worldwide. Wounds are often traumatic, with over 71 million incisions in the United States alone. Many wounds leave prominent scars, causing shame, affecting appearance, and lowering self-esteem. Due to the thickness and restrictive nature of scar tissue, hypertrophic scars such as keloids can limit a person's mobility.

[0005] For incisions to heal better and faster, and to result in minimal or no visible scarring, several important factors must be present, including adequate blood flow and oxygenation, absence of infection, proper moisture balance, and even alignment (or alignment) of the wound edges with uniform tension distribution throughout the wound area. The typical unsightly "railroad track" scar is often caused by the localized tension exerted by sutures, which can be further exacerbated by some degree of wound dehiscence (separation of wound edges). Silicone sheets have been applied to fully healed or long-healed wound scars, including keloids, to induce collagen remodeling, with the goal of producing less noticeable scarring. Silicone sheets act as a barrier to exudate transfer and are therefore not suitable for use during actual wound healing by conventional methods.

[0006] Similarly, although many dressings used in the wound healing process, including bandages, coverings, pressure pads, etc., claim to contain silicone, the term "silicone" refers to the presence of a silicone adhesive (not, for example, an acrylic) used to hold the dressing to the skin surface. Because silicone adhesives are easily peeled off the skin, the silicone in these dressings does not come into direct contact with the wound. These dressings take weeks or longer to work and may not be effective in reducing scarring.

[0007] Therefore, there is a need to improve wound treatment devices and methods, such as reducing scarring while protecting the wound during the healing process. Summary of the Invention

[0008] These and other needs and disadvantages can be met and overcome by the wound treatment device and related methods of use disclosed herein, and its composition. Other improvements and advantages may be recognized by those skilled in the art upon studying this disclosure.

[0009] In some cases, the wound treatment device disclosed herein may include a distal layer in contact with the wound bed, the distal layer being made of silicone resin, with a channel disposed in the distal layer passing through the distal and proximal sides of the distal layer to connect the distal and proximal sides. In some cases, a pad may engage with the proximal side of the distal layer to absorb exudate from the wound bed that passes through the channel into the distal layer. In some cases, various materials, including medications, may be delivered to the wound bed via the channel through the distal layer. In some cases, structural members may be included to secure the distal layer and the pad to the skin surface.

[0010] This document discloses methods of using a wound treatment device. In some cases, the method of use may include the step of: contacting the distal side of a distal layer of the wound treatment device with a wound bed, the silicone-containing distal layer including a channel passing through the distal and proximal sides of the distal layer. The method of use may include the step of: removing exudate from the wound bed by transferring exudate from the distal side of the distal layer to the proximal side of the distal layer. The method of use may include the step of: reducing scar formation throughout the healing process of the wound bed by contacting the wound bed with the silicone-containing distal layer.

[0011] The overview presented herein is intended to provide a basic understanding of some aspects of the apparatuses and methods disclosed herein, serving as an introduction to the detailed descriptions that follow. Therefore, this overview is not intended to identify key elements of the apparatuses, methods, and combinations disclosed herein or to describe their scope. Attached Figure Description

[0012] Figure 1A The diagram illustrates a perspective view of an exemplary implementation of the wound treatment device; Figure 1B Diagram explains Figure 1A A cross-sectional view of section 1A-1A of an exemplary embodiment of the wound treatment device; Figure 1C Diagram explains Figure 1A Another perspective view of an exemplary implementation of the wound treatment device; Figure 2 Diagram explains Figure 1A A perspective view of a portion of an exemplary embodiment of a wound treatment device; Figure 3 The diagram illustrates a perspective view of a second exemplary embodiment of the wound treatment device, wherein the wound treatment device is in an exploded view relationship with the wound bed and the skin surface; Figure 4 The diagram illustrates a perspective view of at least a portion of a third exemplary embodiment of the wound treatment device; Figure 5 The diagram illustrates a perspective view of at least a portion of a fourth exemplary embodiment of the wound treatment device; Figure 6A The diagram illustrates a plan view of at least a portion of a fifth exemplary embodiment of the wound treatment device; Figure 6B Diagram explains Figure 6A A cross-sectional view of a portion of an exemplary embodiment of a wound treatment device; Figure 7A The diagram illustrates a cross-sectional view of a sixth exemplary embodiment of the wound treatment device; Figure 7B The diagram illustrates a cross-sectional view of a seventh exemplary embodiment of the wound treatment device; Figure 8 The diagram illustrates a perspective view of at least a portion of an eighth exemplary embodiment of the wound treatment device.

[0013] The illustrations are merely exemplary, and the embodiments chosen herein for ease of explanation. Elements shown in the illustrations, such as numbers, positions, relationships, and dimensions, constitute the different embodiments described herein; similarly, dimensions and proportions conform to the specific forces, weights, strengths, flow rates, and similar requirements explained herein, or are readily understood by one of ordinary skill in the art upon studying this disclosure. Where used in different illustrations, the same numbers indicate the same or similar elements. Furthermore, when the terms “top,” “bottom,” “right,” “left,” “front,” “rear,” “first,” “second,” “inner,” “outer,” and similar terms are used, these terms should be understood in reference to the directions of the embodiments shown in the accompanying drawings, and used to aid in their description. Relative terms used herein, such as generally, approximately, approximately, substantially, may denote engineering, manufacturing, or scientific tolerances, such as ±0.1%, ±1%, ±2.5%, ±5%, or other such tolerances, and are readily understood by one of ordinary skill in the art upon studying this disclosure. Detailed Implementation

[0014] This article discloses a wound treatment device. Sometimes, the wound treatment device includes a distal layer that contacts the wound bed, the distal layer being at least partially composed of silicone resin, typically in sheet form. The wound bed can be in various healing states, ranging from a new wound bed to a nearly healed wound bed. Sometimes, the distal layer includes a channel passing through the distal side of the distal layer (potentially contacting the wound bed) and the proximal side of the distal layer. Sometimes, the pad can cooperate with the channel on the proximal side of the distal layer to absorb exudate flowing from the wound bed through the channel, or to transport material to the wound bed through the channel.

[0015] In some cases, wound treatment devices include structural members that physically cooperate with a distal layer and a pad (if present). The structural members can adhere to the skin surface surrounding the wound bed via an adhesive layer disposed on them, maintaining contact between the distal layer and the wound bed. The structural members protect the wound bed, the distal layer, and the pad (when the pad is present). In other cases, the structural members can hold the distal layer and the pad together.

[0016] This article discloses methods of using a wound treatment device. Sometimes, the method includes the steps of: contacting the distal side of a distal layer with an unhealed wound bed, the distal layer comprising silicone including a channel passing through the distal and proximal sides of the distal layer; and removing exudate from the wound bed by transporting exudate from the distal side of the distal layer to the proximal side of the distal layer. The method of using the wound treatment device may include the step of: modulating scar formation throughout the wound bed healing process by at least partially exposing the wound bed to the distal layer comprising silicone and the channel. The method of using the wound treatment device may include the step of: intermittently replacing the wound interface, which sometimes includes the distal layer, the pad, and structural members, throughout the wound bed healing process. The method of using the wound treatment device may include the step of: intermittently replacing the distal layer during the wound bed healing process.

[0017] The term "silicone" as used herein includes siloxanes, various polysiloxanes, silicone-like materials, and various combinations thereof, and can generally be solid. Silicone resins can have the chemical formula [R₂SiO]ₙ, where R is an organic group. Silicone resins may include, for example, silicone polymers with an average molecular weight exceeding 100,000 (e.g., between about 100,000 and about 10,000,000). Examples include, but are not limited to, crosslinked siloxanes (e.g., crosslinked polydimethylsiloxane or polydimethylsiloxane derivatives), copolymers such as stearyl methyl-dimethylsiloxane copolymers, polysiloxane-11 (a crosslinked silicone rubber produced by reacting a vinyl-terminated siloxane and a (dimethyl hydrogenated) silicone resin in the presence of cyclomethicone oil), cetearyl polydimethylsiloxane / vinyl polydimethylsiloxane crosslinked polymers (copolymers of cetearyl polydimethylsiloxane crosslinked with vinyl dimethyl polysiloxane), polydimethylsiloxane / phenyl vinyl polydimethylsiloxane crosslinked polymers (copolymers of dimethyl polysiloxane crosslinked with phenyl vinyl dimethylsiloxane) / vinyl polydimethylsiloxane crosslinked polymers (copolymers of dimethyl polysiloxane crosslinked with vinyl dimethylsiloxane).

[0018] Fluids as referred to herein include liquids, gases, and combinations thereof. In some cases, materials as referred to herein include solids, liquids, and gases, and materials may include one or more pharmaceuticals. Exudates as referred to herein include, for example, proteinaceous fluids oozing from the wound bed, as well as various plasma, blood, and cellular components, and other fluids that may ooze from the wound bed. Exudates may also include other fluids, such as sweat from the skin surface surrounding the wound bed, and other fluids that may be present on or near the wound bed. Exudates as referred to herein may include gases (such as CO2) and water vapor emanating from the skin surface.

[0019] In some cases, the term "leak-proof" or related terms used in this article refer to having sufficient resistance to leakage to allow for the generation of pressures within a confined space that may be higher or lower than ambient pressure through air injection or negative pressure suction. p amb pressure p 0 Sometimes, the term "leak-proof fluid" refers to having sufficient resistance to leakage to adequately retain fluids, including gases and liquids, within a closed space. Other times, it refers to having sufficient resistance to leakage to maintain pressure within a closed space. p 0 Higher or lower than environmental pressure p amb .

[0020] The wound bed, as referred to in this article, is a localized gap in the normal outer surface of the skin, caused by trauma (e.g., abrasion, avulsion, tear, puncture, cut, chemical or thermal injury) or microbial infection. A wound bed may include varying degrees of exposure of subcutaneous tissue and structures, as well as possible infection and tissue changes. A wound bed represents an unhealed wound. Conversely, a healed wound refers to a previously injured but localized gap in the skin that is now completely sealed and covered by varying amounts of epidermis and scar tissue.

[0021] The terms distal and proximal used in this article are relative and not necessarily terms of absolute location defined from the perspective of caregivers (including physicians, nurses, and technicians) treating a patient with a wound treatment device. The distal portion of a wound treatment device may face the patient, and the proximal portion may face the physician. For example, when arranged, the distal portion of the wound treatment device may be closer to the patient, and the proximal portion may be closer to the caregiver. As another example, in a multi-layered wound interface, the distal surface is closer to the wound bed, but not necessarily the layer in contact with or closest to the wound bed.

[0022] The present invention is further illustrated by the following embodiments and combinations thereof.

[0023] Implementation Scheme 1. A wound treatment device, comprising: The distal layer, which contacts the wound bed, is made of silicone resin; and, A channel is disposed in the distal layer, passing through the distal side of the distal layer and the proximal side of the distal layer, to connect the distal side and the proximal side.

[0024] Implementation Scheme 2. The apparatus according to Implementation Scheme 1 further comprises: A pad, disposed on the proximal side of the distal layer, cooperates with the channel to absorb exudate flowing from the wound bed, the exudate being transported through the channel from the distal side of the distal layer to the proximal side of the distal layer.

[0025] Implementation Scheme 3. The apparatus according to Implementation Scheme 2, wherein the pad comprises a hydrophobic material and a hydrophilic material, the hydrophobic material fluidly cooperating with the proximal side of the distal layer to remove the exudate from the proximal side of the distal layer, and the hydrophilic material fluidly cooperating with the hydrophobic material to absorb the exudate from the hydrophobic material.

[0026] Implementation Scheme 4. The apparatus according to Implementation Scheme 1 further comprises: A pad containing medication is disposed on the proximal side of the distal layer and cooperates with the channel to deliver the medication to the wound bed through the channel.

[0027] Implementation Scheme 5. The apparatus according to Implementation Scheme 1 further comprises: A structural member connected to the distal layer, the structural member being adhesively fixed to the skin surface surrounding the wound bed to maintain contact between the distal layer and the wound bed.

[0028] Implementation Scheme 6. The apparatus according to Implementation Scheme 5 further comprises: A pad, the pad being disposed on the proximal side of the distal layer and in fluid communication with the channel, the structural member being adjacent to the proximal side of the pad.

[0029] Implementation Scheme 7. The apparatus according to claim 5, further comprising: A window is provided on the structural member, allowing observation through the structural member when the structural member is fixed to the skin surface.

[0030] Implementation Scheme 8. The apparatus according to Implementation Scheme 5 further comprises: At least one low-friction coefficient film is provided between the structural member and the distal layer to deflect at least a portion of the shear force applied to the structural member from the outside.

[0031] Implementation Scheme 9. A wound treatment device, comprising: pad; and The distal layer is formed as a silicone material coating on the distal surface of the pad, a portion of which is non-occlusive, allowing exudate from the wound bed to be transported into the pad through the non-occlusive portion of the distal surface of the pad.

[0032] Implementation Scheme 10. The apparatus according to Implementation Scheme 9 further comprises: A structural member connected to the pad, the structural member being adhesively fixed to the skin surface surrounding the wound bed to maintain contact between the distal side of the distal layer and the wound bed.

[0033] Implementation Scheme 11. The apparatus according to Implementation Scheme 9, wherein the silicone resin material comprises a combination of one or more polysiloxanes and a carrier.

[0034] Implementation Scheme 12. A method of using a wound treatment device, comprising the following steps: The distal side of the distal layer of the wound treatment device contacts the wound bed, the distal layer comprising silicone resin and having a channel passing through the space between the distal side and the proximal side of the distal layer; and The exudate is removed by transferring the exudate from the wound bed from the distal side of the distal layer to the proximal side of the distal layer.

[0035] Implementation Scheme 13. According to the method described in Implementation Scheme 12, the wound bed is in a non-healing stage.

[0036] Implementation Scheme 14. The method of use described in Implementation Scheme 12 further includes the following steps: The pad is fitted to the distal side of the distal layer to absorb the exudate into the pad.

[0037] Implementation Scheme 15. The method of use described in Implementation Scheme 12 further includes the following steps: The material is delivered to the wound bed by transferring the material from the proximal side of the distal layer to the distal side of the distal layer.

[0038] Implementation Scheme 16. The method of use according to Implementation Scheme 15, wherein the material comprises a drug.

[0039] Implementation Scheme 17. The method of use described in Implementation Scheme 12 further includes the following steps: Using structural members that adhere to the skin surface around the wound bed, the contact between the distal layer and the wound bed is secured, and the structural members engage with the distal layer mechanically.

[0040] Implementation Scheme 18. The method of use described in Implementation Scheme 17 further includes the following steps: The distal layer is formed by selectively coating the distal side of the pad with silicone gel.

[0041] Implementation Scheme 19. The method of use according to Implementation Scheme 12 further includes the following steps: The wound treatment device is replaced intermittently throughout the healing process of the wound bed.

[0042] Implementation Scheme 20. The method of use according to Implementation Scheme 12 further includes the following steps: Scar formation is reduced by using the distal layer, which contains silicone, to contact the wound bed throughout the healing process.

[0043] Figure 1A Figures 1B and 1C illustrate an exemplary wound treatment device 100. (As shown...) Figure 1A and 1B As shown, the wound treatment device 100 includes a wound interface 115 fixed to the skin surface 111 to cover the wound bed 113. The wound interface 115 includes a structural member 120, a pad 170, a distal layer 180, and an adhesive 190, and the wound interface 115 is fixed to the skin surface 111 by the adhesive 190.

[0044] Figure 1B Diagram explains Figure 1A The cross-section 1B-1B is shown separately from the wound bed 113 and the skin surface 111 for clarity, but it should be understood that the wound interface 115 is actually fixed to the skin surface 111. In this embodiment, when the wound interface is fixed to the skin surface 111, the distal side 182 of the distal layer 180 contacts the wound bed 113, and the adhesive 190 contacts the skin surface 111 outside the wound boundary 112 of the wound bed 113, such that there is no contact between the adhesive 190 and the wound bed 113.

[0045] like Figure 1B As shown, a pad 170 is inserted between structural member 120 and distal layer 180. The distal side 172 of the pad 170 is biasedly connected to the proximal side 184 of the distal layer 180, with the proximal side 174 of the pad 170 facing the distal side 122 of the structural member 120. The biased connection between the pad 170 and the distal layer 180 forms a composite structure 150, as shown. Figure 1CAs shown. In some embodiments, the proximal side 174 of the pad 170 may be fixed to the distal side 122 of the structural member 120. In other embodiments, the proximal side 174 of the pad 170 may be generally disposed on the distal side 122 of the structural member 120, but connected to the structural member 120 through a connection with the distal layer 180, and the pad 170 is not directly connected to the structural member 120. In this embodiment, the structural member 120, the pad 170, and the distal layer 180 are interconnected in various ways, and the composite structure 150 is fixed to the structural member 120 in various ways, as will be readily recognized by those skilled in the art who have studied this disclosure.

[0046] Structural member 120 may be formed, for example, from a polyurethane layer, fabric, polyethylene, polyvinyl chloride, or latex, and may be adhered to the skin surface 111 near the wound bed 113. In some embodiments, structural member 120 and adhesive 190 have a suitable water vapor transfer rate (MVTR) to allow O2, CO2, and water vapor to be transported from distal 122 to proximal 124, enabling the underlying layer of skin surface 111 to breathe, generally to expel unwanted elements such as bacteria or water, to protect the wound bed 113 from external contamination. Although referred to as “breathable” in terms of evaporation, structural member 120 and adhesive 190 may be fluid-proof as defined herein, such that the wound interface 115 is sealed and can be used for pressure therapy. Adhesive 190 may be formed, for example, from a silicone-based adhesive, acrylic, hydrocolloid, or other suitable medical adhesive. As a silicone-based adhesive 190, it can have lower tack than acrylic adhesives, and therefore can be used on delicate or sensitive skin surfaces 111, such as in newborns and the elderly, to avoid damaging the skin surface 111 during the removal of the wound interface 115.

[0047] In this embodiment, because the distal layer 180 is at least partially formed of silicone resin 135, the distal layer 180 can be non-adhesive to the wound bed 113 (e.g., by adhering granulation tissue in the wound bed 113 to the distal side 182 of the distal layer 180). In addition to this non-adhesive property, the silicone resin 135 of the distal layer 180 modulates the expression of two growth inhibitory factors in the wound bed 113, fibroblast growth factor β (FGFβ) and tumor growth factor β (TGFβ). TGFβ stimulates fibroblasts to synthesize collagen and fibronectin. FGFβ normalizes collagen synthesis in the wound bed 113 and increases the level of collagen breakdown. The distal layer 180 thus restores the self-balance between fibroblast formation and fibroblast breakdown in the wound bed 113. The distal layer 180 increases hydration of the stratum corneum, thereby contributing to promoting fibroblast generation and reducing collagen production in the wound bed 113. As the wound bed 113 heals, the reversal of this excessive collagen formation may result in a softer and flatter scar. The silicone 135 of the distal layer 180 may also reduce symptoms of itching and discomfort associated with the wound bed 113 as the wound bed 113 heals.

[0048] Because silicone 135 has a high coefficient of friction, when the wound bed 113 is formed as a linear wound (including incisions with a risk of dehiscence), the distal layer 180 can help to bring the two sides of the linear wound together, thereby reducing the likelihood of resulting in a noticeable, wide scar by a secondary purpose. In some other embodiments, the distal layer 180 can provide additional benefits to the wound bed 113 when it comes into contact with the wound bed 113. Texture, such as texture 864 (see...) Figure 8 It is contained on the distal side 182 of the distal layer 180, which can increase the friction coefficient of the distal side 182 of the distal layer 180.

[0049] like Figure 1B As shown, the distal layer 180 includes a channel 160 extending between the distal side 182 and proximal side 184 of the distal layer 180 for fluid transport between these two sides. For example, exudate 118 from the wound bed 113 can be transported from the distal side 182 of the distal layer 180 through the channel 160 to the proximal side 184 of the distal layer 180, for example, by capillary action towards the pad 170. The pad 170 then absorbs the exudate 118 transported from the wound bed 113 through the channel 160 and across the distal layer 180. Therefore, the pad 170 prevents exudate 118 from accumulating on the wound bed 113 or the skin surface 111, preventing maceration due to prolonged contact with the exudate 118. Figure 1BAs shown, material 116, such as air, oxygen, and drug 176, can be delivered from pad 170 through channel 160, from proximal 184 of distal layer 180 to distal 182 of distal layer 180, to wound bed 113. Material 116 can be delivered to wound bed 113 through channel 160 using various transport mechanisms, such as fluid flow, capillary action, and diffusion.

[0050] The size, number, distribution in the distal layer, and pore size of the channels 160 can be varied, for example, during different stages of wound bed healing, to optimize the transfer of exudate 118 from the wound bed 113. For instance, when the wound bed 113 forms an acute wound, the exudate 118 from the wound bed 113 may be thinner (less viscous), and therefore, the channels 160 may be relatively small. As another example, when the wound bed 113 forms a chronic wound, the exudate 118 from the wound bed 113 may be more viscous, and therefore, the channels 160 may be larger or more.

[0051] The pad 170 may be at least partially composed of, for example, polyvinyl alcohol, polyurethane foam, polyurethane foam with polyethylene glycol (PEG) having enhanced absorption and transport properties, gauze, fibrous materials such as carboxymethyl sodium cellulose aqueous fibers (Aquacel), or knitted synthetic fibers such as polypropylene and polyamide, or a combination of both, wherein the hydrophobic polypropylene fibers are predominantly located near the distal side 172, and the hydrophilic polyamide fibers are predominantly located on the proximal side 174, to guide exudate 118 out of the wound bed 113. Elastic fibers such as polyester-polyurea (e.g., Spandex or Lycra) may be additionally incorporated into the pad 170 to impart stretchability and conformability to the pad 170.

[0052] The pad 170 may include various materials 116, including drugs 176, such as antibiotics, analgesics like local anesthetics, COX-2 inhibitors and nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, antimicrobial chitosan or silver compounds, bioactive factors such as the TGF-β family, collagen synthesis inhibitors; cytokines, various formulations of the placenta, including placental matrix powder, etc., for delivery to the wound 113 via channels 160 through the distal layer 180. The pad 170 may include various indicators 178, such as fluorescent dyes, to indicate pH under UV light, thereby indicating the health of the wound bed 113. The structural components may be at least partially made of transparent or translucent materials to allow viewing of the indicators. The materials forming the pad 170 may be adjusted to accommodate these indicators or deliver drugs 176 to the wound bed 113. The pad 170 may, for example, comprise multiple layers formed of different materials, or each layer of the multiple layers may include a combination of various drugs 176 or a combination of indicators 178.

[0053] In some embodiments, prior to application of the wound interface 115 to the wound bed 113, the drug 178, as a liquid formulation, may be pre-formed into a container device, close to or attached to the layer 170, and released by puncturing, removing, or opening the separator in the container device. Alternatively, prior to application of the wound interface 115, such a separate container device may be added to or attached to the layer 170 via a syringe or via an optional injection port or air inlet.

[0054] like Figure 1C As shown, when structural member 120 is secured to skin surface 111, the perimeter 153 of composite structure 150 is offset by a length 155 from the edge 123 of structural member 120 to prevent composite structure 150 from being exposed. In other embodiments, the length 155 can be ignored, so that perimeter 153 is aligned with edge 123. Perimeter 153 of composite structure 150 can be offset by a length 157 from adhesive 190. When wound interface 115 is secured to skin surface 111 and distal layer 180 contacts wound bed 113, length 157 can be selected to avoid connection between wound bed 113 and adhesive 190.

[0055] like Figure 1C As shown, the distal layer 180 and pad 170 of the wound treatment device 100 extend together at structure 150, but this is not required in other embodiments. Structural member 120 is depicted as primarily rectangular in shape, with structure 150 arranged in the middle, also depicted as having a rectangular shape. Structure 150 can be configured at different locations on structural member 120, and both structure 150 and structural member 120 can have a variety of other geometries, such as square, circular, elliptical. The shapes of structural member 120 and structure 150 can be similar to each other, or in some embodiments, dissimilar. Thus, other geometries and arrangements may be suitable between structures such as structure 150 and edges such as edges 123, 193, having equivalent lengths, such as lengths 155, 157. For clarity, Figure 1C The release film layer that may be included in certain embodiments of the wound treatment device 100, as well as other accompanying drawings illustrating the wound treatment device 100, will be readily recognized by those skilled in the art who study this disclosure.

[0056] Figure 2The diagram illustrates the distal layer 180 of an exemplary wound treatment device 100, including a channel 160 disposed on the distal layer 180, which passes through the distal layer 180 between a distal side 182 and a proximal side 184. Exudate 118 can be transported between the distal side 182 and the proximal side 184 of the distal layer 180 through the channel 160, and material 116 can be transported between the proximal side 184 and the distal side 182 of the distal layer 180 through the channel 160. The channel 160 in the exemplary wound treatment device 100 is geometrically depicted as circular and defined as cylindrical between the proximal side 184 and the distal side 182. In some embodiments, the channels, such as channel 160, may have different shapes and sizes and may be distributed in regular and irregular patterns.

[0057] The thickness 187 of the distal layer 180 can vary depending on the type and degree of exudation of the wound bed 113 to which the wound interface 115 is applied. In some embodiments, the thickness 187 can range from about 0.1 mm to about 2 mm. In some embodiments, the thickness 187 can range from about 0.2 mm to about 1 mm. The distal layer 182 can be flat or can include various textures, such as texture 864, which can be based on the type of wound bed 113 to which the wound interface 115 is applied. As the thickness 187 increases, the distal layer 180 may become less easily stretched and deformed. In some embodiments, the dimensions of the channels 160 in the distal layer 180 can typically range in diameter from about 250 micrometers to 2500 micrometers or equivalent, or from about 500 micrometers (#35 mesh) to about 1000 micrometers (#18 mesh) or equivalent. In some embodiments, per cm 2 The number of channels 160 in the distal layer 180 can be approximately 25 / cm. 2 Approximately 200 pieces / cm 2 Within the range.

[0058] like Figure 3As shown, the wound treatment device 200 includes a wound interface 215, which includes a structural member 220, a pad 270, and a distal layer 280. The structural member 220, pad 270, and distal layer 280 are elliptical, as shown, with the pad 270 disposed between the distal layer 280 and the structural member 220. A boundary 223 with an offset length 255 extends along the peripheral periphery of the distal side 222 of the structural member 220 to surround the pad 270 connected to the distal layer 280. An adhesive (such as adhesives 190, 690, 790) disposed on at least a portion of the boundary 223 can secure the wound interface 215 to the skin surface 211 surrounding the wound bed 213. In some embodiments of the wound interface 215, the structural member 220 may be fluid-proof. An adhesive seals the wound interface 215 to the skin surface 211 surrounding the wound bed 213, enclosing the pad 270 and the distal layer 280, thereby forming a fluid-proof closed space 217 on the wound bed 213; that is, the wound interface 215 fixed to the skin surface 211 is closed. In this embodiment, a port may be provided on the wound interface 215 for fluid communication with the closed space 217 via the structural member 220.

[0059] like Figure 3 As shown, channel 260 passes between the distal side 282 and the proximal side 284 of distal layer 280. In this embodiment, distal layer 280 is at least partially formed of silicone resin 235. Channel 260 disposed on distal layer 280, as shown, is depicted as a square or starburst shape, and channel 260 allows the transport of exudate 218, material 216, or exudate 218 and material 216 between distal side 282 and proximal side 284 of distal layer 280.

[0060] like Figure 3 As shown, a window 227, formed of a transparent or translucent material, is arranged between the proximal side 224 and the distal side 222 of the structural member 220. For example, the window 227 may be formed of a polypropylene or polyethylene film, which remains sealed to a linear pore within the structural member 220. A user can view at least a portion of the pad 270, for example, to determine the saturation level of the pad 270 by observing exudate (e.g., exudate 218). As another example, an indicator, such as indicator 178, may be included in the pad 270 and can be viewed through the window 227. The indicator indicates the pH value of the pad 270, and thus indicates the condition of the wound bed 213.

[0061] Figure 4The diagram illustrates the distal layer 380 and pad 370 of an exemplary wound treatment device 300. In this embodiment, the pad 370 is shaped similarly to the distal layer 380, wherein both the pad 370 and the distal layer 380 are circular. As shown, the pad 370 has a distal side 372 and a proximal side 374, with the distal side 372 of the pad 370 attached to the proximal side 384 of the distal layer 380. In this embodiment, the distal layer 380 is at least partially formed of silicone resin 335, and the pad 370 may be formed of a material similar to the pad 170 of the exemplary wound treatment device 100. In this embodiment, a channel 360 disposed on the distal layer 380 passes between the distal side 382 and the proximal side 384 of the distal layer 380. Figure 4 As shown, the 360° channel is a Z-shaped slit. It should be noted that, as... Figure 4 As shown, when the channels 360 are regularly sized and distributed outside the boundary 385, the channels 360 located inside the boundary 385 have a smaller size and increased density in the central region of the distal layer 380.

[0062] Figure 5 The illustration shows that the distal layer 480 of the exemplary wound treatment device 400 is at least partially formed of silicone resin 435. The distal layer 480 includes a channel 460 that passes between a distal side 482 and a proximal side 484 of the distal layer 480 to allow the transfer of material 416 and exudate 418 between the distal side 482 and the proximal side 484. Figure 5 In the middle, the distal layer 480 is a long rectangular shape; the channel 460 is formed into a starburst shape and passes between the distal layer 482 and the proximal layer 484 of the distal layer 480.

[0063] Figure 6A Figure 6B illustrates an exemplary wound treatment device 500, including a distal layer 580 (at least partially formed of silicone resin 535) and a pad 570. Figure 6A As shown, the distal layer 580 is formed on the distal side 572 of the pad 570, and the distal layer 580 does not block the entire distal side 572 of the pad 570. The distal layer 580 can be formed during the manufacture of the pad 570, for example, by rolling, spraying, or otherwise applying a layer of silicone material having pattern 587 onto the distal side 572 of the pad 570. A variety of stencils, masks, screens, and other methods can be used to form pattern 587.

[0064] In some embodiments, the silicone material may be, for example, a silicone gel, comprising one or more polysiloxanes, silica, and a carrier formed from a volatile solvent. An example of a silicone gel is a dispersion of polysiloxane-11 with phenyltrimethylpolysiloxane as the carrier. After the silicone gel is applied to the distal side 572 of the pad 570, the carrier, such as phenyltrimethylpolysiloxane, disappears, leaving silicone 535 on the distal side 572 of the pad 570 as a distal layer 580 having pattern 587. The combined pad 570 and distal layer 580 can then be die-cut and assembled onto the distal side of structural members (such as structural members 120, 620, 720).

[0065] Figure 6A The diagram illustrates distal layer 582 of distal layer 580. (See diagram for example.) Figure 6A As shown in the details, the distal layer 580 is at least partially formed of silicone resin 535 having pattern 587, and the pad 570 may be formed of a material similar to the pad 170 of the exemplary wound treatment device 100. Although pattern 587 is generally shown as a regular rectangular geometry, in some embodiments, pattern 587 may have a variety of shapes, combinations of regularity and irregularity, and size distributions. Pattern 587 of the distal layer 580 forms an occlusion region 533 and a channel 560 between the occlusion regions 533, the channel 560 exposing the distal side 572 of the pad 570, allowing exudate 518 or material 516 to be transported between the distal side 582 and the proximal side 584 of the distal layer 580, and between the distal side 572 of the pad 570, as... Figure 6A As shown in Figure 6B. In some embodiments, the thickness 589 of the distal layer 580 can range from about 200 micrometers to about 1000 micrometers. The diameter of the channel 560 can range from about 50 micrometers (#270 mesh) to about 1000 micrometers (#18 mesh) or equivalent diameter, or from about 100 micrometers (#140 mesh) to about 750 micrometers (about #22 mesh) or equivalent diameter. In some embodiments, the number of channels 560 per square centimeter can typically be about 45 / cm². 2 Approximately 2500 / cm 2 Within the range.

[0066] For the purpose of clarification, Figure 7AThe exemplary wound treatment device 600 illustrated in the diagram shows a wound interface 615 separate from the wound bed 613 and the skin surface 611. In this embodiment, the wound bed 613 includes a skin graft. The wound interface 615 includes a distal layer 680 and a pad 670 (cooperating with a structural member 620), with the pad 670 inserted between the distal layer 680 and the structural member 620. In this embodiment, the distal layer 680 is at least partially formed of silicone resin 635. In this embodiment, an adhesive 690 disposed on the structural member 620 can fix the structural member 620 and the wound interface 615 to the skin surface 611, thereby biasing the distal layer 680 toward the wound bed 613. As shown, exudate 618 can be transferred from the wound bed 613 to the pad 670 through channels 660 in the distal layer, and material 616 can be transferred from the pad 670 to the wound bed 613 through channels 660.

[0067] Figure 7A The shear force shown in the figure F s This manifests as a tangential force acting on the wound interface 615 of the wound treatment device 600. Shear force. F s It can be generated by various clamping forces with tangential components on the wound interface 615, such as those that may occur during the wearing of the wound interface 615, for example, due to collision with an object, interaction with clothing or bedding, etc.

[0068] exist Figure 7A In one embodiment, the wound interface 615 includes a spacer 640 having an envelope-like structure, disposed between an adhesive 690 and a pad 670, the adhesive 690 being disposed on the distal side 622 of the structural member 620. In some embodiments, the spacer 640 may be located between the structural member 620 and the adhesive 690. The spacer 640 includes a distal layer 642 and a proximal layer 644, forming a space 646 between the distal layer 642 and the proximal layer 644, as shown. The spacer 640 may be a film formed of a low-friction coefficient material 625, such as polyethylene or polypropylene, for a slidable connection between the proximal layer 644 and the distal layer 642. The slidable connection between the proximal layer 644 and the distal layer 642 in the spacer 640 can at least partially deflect shear forces. F s To reduce shear force F s The force transmitted to the distal layer 680 is reduced, thereby decreasing the force transmitted to the wound bed 613. The proximal side 624 of the structural member 620 can be formed of a low-friction coefficient material 625 to reduce shear forces. F s For example, to allow sliding between the proximal side 624 and the object in contact with the proximal side 624. Therefore, it is used to reduce shear forces.F s The shear force reduction method transmitted to the wound bed 613 may include a spacer 640 having a proximal layer 644 and a distal layer 642, with a space 646 in the middle of the spacer 640, and the shear force reduction method may include a proximal 624 of a structural member 620 formed of a low coefficient of friction material 625.

[0069] Initially, the skin graft has no vascular connection. After a period of time, new vascular branches begin to appear, extending from the wound bed towards the skin graft, eventually establishing blood flow and viability in the graft. If the wound bed 613, containing the skin graft, is sheared during vascularization, the viability of the skin graft is threatened. Therefore, the spacer 640 and the low-friction coefficient material 625 in the proximal side 624 of the structural member 620 can protect the wound bed 613 containing the skin graft by reducing the shear forces transmitted to the wound bed 613. F s or corresponding deflection shear force F s To avoid shear force F s Damage to the wound bed 613.

[0070] Figure 7B The illustration depicts a wound interface 715 of an exemplary wound treatment device 600, including a pad 770 inserted between a distal layer 780 and a structural member 720. For clarity, the wound interface 715 is depicted separately from the wound bed 713 and the skin surface 711. The distal layer 780 is at least partially formed of silicone resin 735 and includes channels 760 for transporting exudate 718 and material 716. As shown, a layer 744 is inserted between an adhesive layer 790 and the proximal side 774 of the pad 770, with a space 746 between the layer 744 and the proximal side 774 of the pad 770. The layer 744 may be a thin film formed of a low-friction material 725, such as polyethylene or polypropylene, to facilitate a slidable connection between the layer 744 and the proximal side 774 of the pad 770, reducing shear forces applied to the proximal side 724 of the structural member. F s The force is transferred to the distal layer 780. As shown, layer 744 prevents at least a portion of the pad 770 from adhering to the structural member 720 by adhesive 790, and slidably connects layer 744 to the proximal side 774 of the pad 770 to allow movement between a portion of the structural member 720 and the pad 770, thereby at least partially deflecting the shear force applied to the proximal side 724 of the structural member 720. F s This can reduce shear force. F sTransfer to wound bed 713. In some embodiments, for example, adhesive 790 may be omitted from a portion of structural member 790 near the proximal side 774 of pad 770, and layer 744 may be omitted, such that at least a portion of the proximal side 774 of pad 770 is slidably attached to structural member 720 to allow movement between a portion of structural member 720 and pad 770, which may reduce shear force applied to the proximal side 724 of structural member 720. F s At least partially deflected. Therefore, used to reduce shear force. F s Methods for reducing shear force transmitted to wound bed 713 may include, for example, a layer 744 having space 746.

[0071] Figure 8 The diagram illustrates the distal layer 880 of an exemplary wound treatment device 800, which is at least partially formed of silicone resin 835. Figure 8 As shown, channels 860a, 860b, 860c, 860d, 860e, and 860f pass between the distal layer 882 and the proximal layer 884, and have geometries of square, rectangular, star-shaped, circular, slit, and fish-mouth shapes, respectively, and can be arranged in various channel patterns on the distal layer 880. Exudate 818 or material 816 can communicate through channels 860a, 860b, 860c, 860d, 860e, and 860f between the distal layer 882 and the proximal layer 884. The channel geometry, such as channels 860a, 860b, 860c, 860d, 860e, and 860f, and the channel pattern can be selected to maintain the channel open during use, allowing exudate 818 or material 816 to be transported through the channel. For example, a Z-shaped channel (e.g., Figure 4 Channel 360 (in the design) is likely to retain its functional use more than a simple slit because the Z-shape allows for stretching in more directions in the distal layer. Fish-mouth shaped channels, such as channel 860f, may also exhibit enhanced patency.

[0072] Figure 8 The diagram illustrates the texture 864 on the distal surface 882 of the distal layer 880, which can be a microscopic or macroscopic surface texture, manifested as, for example, ridges, pits, ridges, and combinations thereof. When biased toward the wound bed junctions, such as wound beds 113, 213, 613, 713, the texture 864 can induce microdeformations and pressure points, which can accelerate wound healing by stimulating cell mitosis, differentiation, and angiogenesis.

[0073] As shown herein, in some embodiments, the wound treatment device may include a distal layer, such as distal layers 180, 280, 680, 780, a pad, such as pad 170, 270, 670, 770, and a structural member, such as structural member 120, 220, 620, 720, as shown in wound treatment devices 100, 200, 600, 700. In some embodiments, the wound treatment device may include a distal layer, such as distal layers 380, 580, and a pad, such as pad 370, 570, as shown in wound treatment devices 300, 500. In some embodiments, the wound treatment device may include a distal layer, such as distal layer 480, as shown in wound treatment device 400.

[0074] In various exemplary methods of operation, for example, the distal layer (e.g., distal layer 180, 280, 380, 480, 580, 680, 780, 880) of a wound treatment device (e.g., wound treatment device 100, 200) may come into contact with a wound bed (e.g., wound bed 113, 213, 613), for example, immediately after injury and before scar formation. The distal layer, at least partially formed of silicone (e.g., silicone 135, 235, 335, 435, 535, 635, 735, 835), can provide an early self-balancing effect and balance collagen, fibronectin, and collagenase levels to promote healing and reduce scar formation, which can eliminate the long-term need for altering excessive scarring after scar formation.

[0075] In one exemplary method of operation, for example, an unhealed wound bed is contacted with a distal layer, which is at least partially formed of silicone resin. The distal layer can be used essentially alone, and pads (e.g., pads 170, 270, 370, 470, 570, 670, 770) and structural members (e.g., structural members 120, 200, 620, 720) can be omitted.

[0076] In another exemplary method of operation, the wound bed is in contact with the distal layer, which is connected to the pad, and structural members are omitted. In such an exemplary method of operation, the pad absorbs exudate (e.g., exudates 118, 218, 418, 518, 618, 818) transported from the wound bed to the pad through channels in the distal layer (e.g., channels 160, 260, 360, 460, 560, 660, 760, 860a, 860b, 860c, 860d, 860e, 860f). Materials (e.g., materials 116, 216, 416, 516, 616, 816) can be transported to the wound bed through the channels.

[0077] In a third exemplary method of operation, the wound bed is in contact with a distal layer, the distal layer is connected to a pad, and a structural member is applied to a covering structure (such as structure 150, which includes a combination of a distal layer and a pad). The structural member may protect the pad, the distal layer, or a combination of the pad and the distal layer, and may protect the wound bed.

[0078] In procedures involving pads, when it is indicated, for example, that the pad is at least partially saturated with exudate, the distal layer and pad can be removed and then discarded. In some procedures, wound interfaces, such as wound interfaces 115, 215, 615, and 715, can be removed and replaced with another wound interface, which may be similar to or dissimilar to the removed wound interface. Different wound interfaces may be used during wound bed management, for example, when the amount of exudate from the wound bed decreases or when multiple medications, such as medication 176, are delivered to the wound bed.

[0079] Multiple methods of operation may include: delivering medication from the pad to the wound bed through the distal layer. Multiple methods of operation may include: bringing the wound bed into contact with a texture (e.g., texture 864) disposed distal to the distal layer, which may accelerate wound bed healing or facilitate lateral placement of the wound bed. Multiple methods of operation may include: observing the pad through a window (such as window 227) disposed on the structural member. Multiple methods of operation may include: observing an indicator (e.g., indicator 178) included in the pad, and observing the indicator through a window. Multiple methods of operation may include: reducing shear forces transmitted to the wound bed through the wound interface. F s Various operational methods may include: removing exudate or fluid from the wound interface via one or more ports provided at the wound interface, and may include: introducing fluid into the wound interface via one or more ports provided at the wound interface.

[0080] The foregoing discussion, together with the accompanying drawings, has disclosed and described a variety of exemplary embodiments. These embodiments are not intended to limit the scope of coverage, but rather, on the contrary, to aid in understanding the language used in this specification and claims. After studying this disclosure and the exemplary implementations herein, those skilled in the art will readily recognize various changes, modifications, and variations, which do not depart from the spirit and scope of the invention as defined in the following claims.

Claims

1. A wound treatment device, comprising: pad; and The distal layer is formed as a silicone material coating only on the distal surface of the pad, a portion of the distal surface of the pad being non-occlusive, allowing exudate from the wound bed to be transported into the pad through the non-occlusive portion of the distal surface of the pad. The non-blocked portion forms a channel in the silicone resin that passes only between the distal side of the distal layer and the proximal side of the distal layer.

2. The apparatus according to claim 1, further comprising: A structural member connected to the pad, the structural member being adhesively fixed to the skin surface surrounding the wound bed to maintain contact between the distal side of the distal layer and the wound bed.

3. The apparatus of claim 1, wherein the silicone material comprises a combination of one or more polysiloxanes and a carrier.

4. The device according to claim 2, wherein the structural components are at least partially made of a material selected from transparent and translucent materials.

5. The apparatus according to claim 2, further comprising: A membrane between the structural member and the distal layer deflects at least a portion of the shear force applied to the structural member from the outside.

6. The device according to claim 2, wherein the structural member forms a closed space on the wound bed when it is bonded and fixed to the skin surface surrounding the wound bed.

7. The apparatus of claim 2, wherein the structural members allow the passage of O2, CO2 and water vapor.

8. The apparatus according to claim 2, further comprising: Adhesives applied to structural components.

9. The apparatus according to claim 1, further comprising: The medication is placed inside the pad.

10. The device of claim 1, wherein the pad comprises a combination of a hydrophobic material and a hydrophilic material.

11. The device of claim 10, wherein the distal side of the pad contains more hydrophobic material than hydrophilic material, and the proximal side of the pad contains more hydrophilic material than hydrophobic material.

12. The apparatus of claim 1, wherein the diameter of the channel ranges from 50 micrometers to 1000 micrometers.

13. The apparatus according to claim 1, wherein the number of channels per square centimeter is 45 / cm. 2 Up to 2500 / cm 2 .

14. The device of claim 13, wherein the channel density is different in different portions of the distal layer.

15. The device of claim 1, wherein the thickness of the distal layer ranges from 200 micrometers to 1000 micrometers.

16. The apparatus of claim 1, wherein the silicone resin material comprises polysiloxane.

17. The apparatus of claim 1, wherein the silicone material comprises a polysiloxane dispersed in a solvent.

18. The apparatus of claim 1, wherein the silicone resin material comprises materials with a molecular weight between 10 and 10. 5 Up to 10 7 Silicone polymer.

19. The apparatus of claim 1, wherein the combined pad and distal layer are die-cut.

20. The device of claim 1, wherein the distal layer is formed by spraying a silicone material onto the distal surface of the pad.

Images