CN111343949A

CN111343949A - Wound treatment devices with scar modulating properties and related methods

Info

Publication number: CN111343949A
Application number: CN201880049874.2A
Authority: CN
Inventors: 林正纶
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-07-29
Filing date: 2018-07-26
Publication date: 2020-06-26
Also published as: CN110944608B; CN111050711B; CN111050711A; CN110944608A; WO2019027807A1; WO2019027809A1; WO2019027806A1; CN110996866A; CN110958866B; WO2019027808A1; WO2019027810A1; CN110996866B; CN110958866A

Abstract

Disclosed herein is a wound treatment apparatus that, in various inventive aspects, may include a distal layer in contact with a wound bed, the distal layer being constructed of silicone and a channel provided in the distal layer to communicate between a distal side and a proximal side of the distal layer through the distal layer. In various aspects of the invention, a pad may be engaged with the proximal side of the distal layer to absorb exudate from the wound bed through the passageway past the distal layer. In various aspects of the invention, a variety of materials, including drugs, may be delivered through the channel to the wound bed through the distal layer. In various aspects of the invention, structural members may be included to secure the distal layer and pad to the skin surface. Related methods of using wound therapy devices are disclosed herein.

Description

Wound treatment devices with scar modulating properties and related methods

Cross reference to related patent

This application claims priority from the following patent applications: us patent application No. 15/663,708 filed on 29.7.7.2017, us patent application No. 15/663,709 filed on 29.7.7.7.7. 15/663,710 filed on 29.7.7.2017, us patent application No. 15/663,713 filed on 29.7.7.2017, and us patent application No. 15/663,714 filed on 29.7.7.2017. All priority-claims patent applications are hereby incorporated by reference in their entirety as if fully set forth herein.

Background

Technical Field

The present disclosure relates to medical devices, and more particularly, to devices for wound therapy and related compositions and methods of use.

Background

Wounds afflict hundreds of millions of people worldwide. Wounds are often traumatic, with cuts in the united states exceeding 7100 million. Many wounds heal with scars that can be prominent, thereby creating a shame, affecting aesthetics, and reducing self-esteem. Hypertrophic scars, such as keloids, may limit a person's mobility due to the thickness and limited nature of the scar tissue.

For the incision to heal better and faster, and without visible or minimally visible scar formation, there must be a number of important factors, including adequate blood flow and oxygen, no infection, proper moisture balance, even apposition (alignment) of the wound edges, with uniform tension dispersion across the wound area. The creation of a typical ugly "rail-type" scar is often caused by the local pulling force exerted by the suture, which may be further exacerbated by some degree of dehiscence of the wound (separation of the wound edges). Silicone in sheet form has been applied to completely or long healing wound scars, including keloids, to induce collagen reorganization with the therapeutic goal of creating a less pronounced scar. Silicone sheets are barriers to exudate transfer and, therefore, are not suitable for use during actual wound healing by conventional means.

Similarly, while various dressings applied to wounds during the healing process, including bandages, coverings, compresses, and the like, are referred to as comprising silicone, the reference to "silicone" refers to the presence of a silicone adhesive (rather than, for example, an acrylic) for securing the dressing to the skin surface. The silicone in these dressings does not come into direct contact with the wound because the silicone adhesive is easily peeled off the skin. These dressings take weeks or more to work and may not be effective in reducing scarring

Accordingly, there is a need for improved wound treatment devices and associated methods that can, for example, reduce scarring while protecting the wound during the healing process.

Disclosure of Invention

These and other needs and disadvantages are met and overcome by the wound treatment devices and associated methods of use and compositions thereof disclosed herein. Additional modifications and advantages may be recognized by those skilled in the art upon studying the disclosure.

At times, the wound treatment apparatus disclosed herein may include a distal layer in contact with the wound bed, the distal layer being constructed of silicone, the passageway disposed in the distal layer passing between a distal side of the distal layer and a proximal side of the distal layer to communicate between the distal side and the proximal side. At times, the pad may cooperate with the proximal side of the distal layer to absorb exudate from the wound bed through the passageway past the distal layer. At times, a variety of materials, including drugs, may be delivered to the wound bed through the distal layer via the channels. At times, structural members may be included to secure the distal layer and pad to the skin surface.

Methods of using wound therapy devices are disclosed herein. At times, the method of use may include the steps of: the distal side of the distal layer of the wound therapy device is brought into contact with the wound bed, and the distal layer comprising silicone comprises a passageway through the distal layer between the distal side and the proximal side of the distal layer. The use method can comprise the following steps: the exudate is removed from the wound bed by passing the exudate from the distal side of the distal layer to the proximal side of the distal layer. The use method can comprise the following steps: scar formation is mitigated by contacting the wound bed with a silicone-containing distal layer throughout the healing process of the wound bed.

The summary is presented to provide a basic understanding of some aspects of the devices and methods disclosed herein, as a prelude to the detailed description that follows. Thus, this summary is not intended to identify key elements or to delineate the scope of the devices, methods, and combinations disclosed herein.

Drawings

Fig. 1A illustrates a perspective view of an exemplary implementation of a wound treatment apparatus.

FIG. 1B illustrates a cross-sectional view of section 1A-1A of an exemplary implementation of the wound treatment apparatus of FIG. 1A;

FIG. 1C illustrates another perspective view of an exemplary implementation of the wound treatment apparatus of FIG. 1A;

FIG. 2 illustrates a perspective view of a portion of an exemplary implementation of the wound treatment apparatus of FIG. 1A;

fig. 3 illustrates a perspective view of a second exemplary implementation of a wound treatment apparatus in an exploded view relationship to a wound bed and skin surface:

FIG. 4 illustrates a perspective view of at least a portion of a third exemplary implementation of a wound treatment apparatus;

FIG. 5 illustrates a perspective view of at least a portion of a fourth exemplary implementation of a wound treatment apparatus;

fig. 6A illustrates a plan view of at least a portion of a fifth exemplary implementation of a wound treatment apparatus;

FIG. 6B illustrates a cross-sectional view of a portion of the exemplary implementation of the wound treatment apparatus of FIG. 6A;

FIG. 7A illustrates a cross-sectional view of a sixth exemplary implementation of a wound treatment apparatus;

FIG. 7B illustrates a cross-sectional view of a seventh exemplary implementation of a wound treatment apparatus;

FIG. 8 illustrates a perspective view of at least a portion of an eighth exemplary implementation of a wound treatment apparatus;

the illustrations are exemplary only, with the illustrated embodiments selected herein for convenience of explanation. The elements shown in the figures, such as numbers, positions, relationships, and dimensions, constitute various implementations described herein, and similarly, the dimensions and proportions are consistent with the particular force, weight, strength, flow, and similar requirements explained herein, or readily understood by one of ordinary skill in the art in view of this disclosure. Wherever possible, the same reference numbers are used in different drawings to refer to the same or like elements. Furthermore, when the terms "top," "bottom," "right," "left," "front," "rear," "first," "second," "inner," "outer," and similar terms are used, they should be understood with reference to the orientation of the embodiments as shown in the drawings and utilized to facilitate the description thereof. Relative terms used herein, such as substantially, approximately, substantially, may refer to engineering, manufacturing, or scientific tolerances, such as, for example, ± 0.1%, ± 1%, ± 2.5%, ± 5%, or other such tolerances, as would be readily understood by one of ordinary skill in the art after studying this disclosure.

Detailed Description

A wound treatment device is disclosed herein. Sometimes, the wound treatment device includes a distal layer that contacts the wound bed, the distal layer being at least partially constructed of silicone, typically in sheet form. Wound beds can be in a variety of healing states, ranging from new wound beds to nearly healed wound beds. Sometimes, the distal layer includes a passageway between the distal side of the distal layer (which may contact the wound bed) and the proximal side of the distal layer. At times, the pad may cooperate with the channel on the proximal side of the distal layer to absorb exudate flowing through the channel from the wound bed or to transport material through the channel to the wound bed.

At times, the wound treatment apparatus includes a structural member that physically cooperates with the distal layer and the pad (if present), and the structural member can be adhered to the skin surface surrounding the wound bed by an adhesive layer disposed on the structural member to maintain the distal layer in contact with the wound bed. The structural member may protect the wound bed, distal layer and pad (when present). At times, the structural member may hold the distal layer and the pad to one another.

Methods of using wound therapy devices are disclosed herein. At some point, the method of use includes the steps of: contacting a distal side of a distal layer with the non-healing wound bed, the distal layer comprising silicone including a passageway through the distal layer between the distal side and a proximal side of the distal layer, and the steps of: exudate is removed from the wound bed by transporting the exudate from the distal side of the distal layer to the proximal side of the distal layer. A method of using a wound treatment apparatus may comprise the steps of: scar formation is regulated during the healing process of the entire wound bed by at least partially exposing the wound bed to a distal layer comprising silicone and channels. A method of using a wound treatment apparatus may comprise the steps of: the wound interface, including the distal layer, the pad and the structural member, at times, is intermittently replaced throughout the wound bed healing process. A method of using a wound treatment apparatus may comprise the steps of: during the wound bed healing process, the distal layer is intermittently replaced.

The silicone, as referred to herein, including silicones, polysiloxanes, silicone-like materials, and combinations thereof, can be generally solid. The silicone resin may have the formula [ R2SiO ] n, where R is an organic radical. The silicone may include, for example, silicone polymers having an average molecular weight in excess of 100,000 (e.g., between about 100,000 and about 10,000,000). Examples include, but are not limited to, cross-linked silicones (e.g., cross-linked polydimethylsiloxane or derivatives of polydimethylsiloxane), copolymers such as stearyl methyl-dimethicone copolymer, polysiloxane-11 (a cross-linked silicone rubber resulting from the reaction of a vinyl-terminated silicone and a (dimethylhydro) silicone resin in the presence of a cyclomethicone), cetearyl dimethicone/vinyl dimethicone crosspolymer (copolymer of cetearyl dimethicone cross-linked with vinyl dimethicone), dimethicone/phenyl vinyl dimethicone crosspolymer (copolymer of dimethicone cross-linked with phenyl vinyl dimethicone)/vinyl dimethicone crosspolymer (copolymer of dimethicone cross-linked with vinyl dimethicone).

Reference herein to fluids includes liquids, gases and combinations thereof. Sometimes, reference herein to a material includes solids, liquids and gases, and the material may include one or more drugs. Exudate as referred to herein includes, for example, proteinaceous fluids exuded from the wound bed, as well as various plasma, blood and cellular components, and other fluids that may be exuded from the wound bed. Exudate may also include other liquids, such as sweat from the skin surface surrounding the wound bed, other liquids that may be present on or near the wound bed skin surface. Exudate, as referred to herein, may include gases (such as CO2) and water vapor emanating from the skin surface.

The term "fluid-tight" or related terms, as used herein, at times, refers to having sufficient leak-resistance to permit the creation of a pressure p in an enclosed space that may be above or below ambient pressure, by insufflation or negative pressure suction_ambPressure p of₀. At any timeThe term "fluid-tight" refers to having sufficient leak resistance to adequately retain fluids, including gases and liquids, within an enclosed space. At times, "fluid-tight" means having sufficient resistance to leakage to maintain a pressure p within the enclosed space₀Above or below ambient pressure p_amb。

Wound bed, as referred to herein, refers to a local breach of the outer surface of normal skin, for example, caused by trauma (e.g., abrasion, avulsion, laceration, puncture, incision, chemical or thermal injury) or microbial infection. The wound bed may include varying degrees of subcutaneous tissue and structural exposure, as well as possible infection and tissue changes. The wound bed represents an unhealed wound. In contrast, a healed wound refers to a skin surface that was previously wounded but where the local gap is now completely sealed and covered by a varying amount of epidermal and scar tissue.

The terms distal and proximal, as used herein, are relative and not necessarily terms of absolute position as defined from the perspective of a caregiver (including physicians, nurses and technicians) treating a patient with a wound treatment device. The distal portion of the wound therapy device may face the patient and the proximal portion of the wound therapy device may face the physician. For example, when deployed, a distal portion of the wound treatment apparatus may be closer to the patient and a proximal portion of the wound treatment apparatus may be closer to the caregiver. As another example, the distal surface in the multi-layer wound interface is closer to the wound bed, but not necessarily the layer in contact with or closest to the wound bed.

Fig. 1A, 1B, 1C illustrate an exemplary wound treatment apparatus 100. As shown in fig. 1A and 1B, wound treatment apparatus 100 includes a wound interface 115 secured to skin surface 111 to cover a wound bed 113. Wound interface 115 includes structural member 120, pad 170, distal layer 180, and adhesive 190, wound interface 115 being secured to skin surface 111 by adhesive 190.

Fig. 1B illustrates cross-section 1B-1B of fig. 1A, with wound interface 115 shown separately from wound bed 113 and skin surface 111 for clarity of illustration, but it should be understood that wound interface 115 is actually secured to skin surface 111. In this embodiment, when the wound interface is secured to the skin surface 111, the distal side 182 of the distal layer 180 is in contact with the wound bed 113, and the adhesive 190 contacts the skin surface 111 outside of the wound boundary 112 of the wound bed 113, such that there is no contact between the adhesive 190 and the wound bed 113.

As shown in fig. 1B, the pad 170 is interposed between the structural member 120 and the distal layer 180, with the distal side 172 of the pad 170 being biased toward engagement with the proximal side 184 of the distal layer 180, and the proximal side 174 of the pad 170 facing the distal side 122 of the structural member 120. Pad 170 is biased into engagement with distal layer 180 to form composite structure 150, as shown in FIG. 1C. In certain embodiments, the proximal side 174 of the pad 170 may be secured to the distal side 122 of the structural member 120, and in certain embodiments, the proximal side 174 of the pad 170 may be disposed substantially at the distal side 122 of the structural member 120, but connected to the structural member 120 by connection to the distal layer 180, the pad 170 not being directly connected to the structural member 120. In this embodiment, the structural member 120, the pad 170, and the distal layer 180 are attached to one another in a variety of ways, and the composite structure 150 is secured to the structural member 120 in a variety of ways, as will be readily appreciated by one of ordinary skill in the art in view of this disclosure.

The structural member 120 may, for example, be formed of a polyurethane layer, fabric, polyethylene, polyvinyl chloride, or latex, and the structural member 120 may be attached to the skin surface 111 adjacent the wound bed 113. In certain embodiments, the structural member 120 and the adhesive 190 have a suitable Moisture Vapor Transmission Rate (MVTR), allowing O₂，CO₂And water vapor from the distal side 122 to the proximal side 124, such that the underlying layer of the skin surface 111 may breathe, generally to exclude unwanted elements such as bacteria or water, to protect the wound bed 113 from external contamination. Although denoted as "breathable" with respect to evaporation, structural member 120 and adhesive 190 may be fluid-tight as defined herein such that wound interface 115 is closed and may be used for pressure therapy. The adhesive 190 may, for example, be formed of a silicone-based adhesive, acrylic, hydrocolloid, or other suitable medical adhesive. As the silicone-based adhesive 190 may have lower tack than an acrylic adhesive and thus may be used in weak or sensitive applicationsOn the skin surface 111, for example for use in neonates and elderly, to avoid damaging the skin surface 111 during removal of the wound interface 115.

In this embodiment, because distal layer 180 is formed at least in part from silicone 135, distal layer 180 may not adhere to wound bed 113 (e.g., by adhering granulation tissue in wound bed 113 to distal side 182 of distal layer 180. in addition to this non-adhesive property, silicone 135 of distal layer 180 may regulate the expression of two obstructive growth factors in wound bed 113, fibroblast growth factor β (FGF β) and tumor growth factor β (TGF β), TGF β may stimulate fibroblast synthesis of collagen and fibronectin, FGF β may normalize collagen synthesis in wound bed 113 and may increase the level of collagen breakdown.

Because silicone 135 has a high coefficient of friction, when the wound bed 113 is formed as a linear wound (including incisions that risk cracking), distal layer 180 may help fit the two sides of the linear wound together, thereby reducing the likelihood of causing significant wide scarring for a secondary purpose. In other certain embodiments, the distal layer 180 may provide additional benefits to the wound bed 113 when the distal layer 180 is in contact with the wound bed 113. The inclusion of a texture, such as texture 864 (see fig. 8), on the distal side 182 of the distal layer 180 may increase the coefficient of friction of the distal side 182 of the distal layer 180.

As shown in fig. 1B, the distal layer 180 includes a channel 160, the channel 160 extending between a distal side 182 and a proximal side 184 of the distal layer 180 for fluid communication between the distal side 182 and the proximal side 184 of the distal layer 180. For example, exudate 118 exuded by wound bed 113 may be transported from a distal side 182 of distal layer 180, through channel 160, to a proximal side 184 of distal layer 180, e.g., drawn toward pad 170 by capillary action. Pad 170 then absorbs exudate 118 from wound bed 113, transmitted through channels 160, through distal layer 180. Thus, pad 170 prevents exudate 118 from accumulating on wound bed 113 or skin surface 111, preventing prolonged contact with exudate 118 resulting in maceration. As shown in fig. 1B, material 116, such as air, oxygen, and medication 176, may pass from the pad 170 through the channel 160 from the proximal side 184 of the distal layer 180 to the distal side 182 of the distal layer 180 to the wound bed 113. The material 116 may be transported to the wound bed 113 through the channels 160 using a variety of transport mechanisms, such as fluid flow, capillary action, and diffusion.

The size, number, distribution of the distal layer and size of the pore size of channels 160 may be varied, for example, during different stages of wound bed 113 healing, to optimize the transfer of exudate 118 from wound bed 113. For example, when the wound bed 113 is formed as an acute wound, exudate 118 from the wound bed 113 may be thin (less viscous) and, therefore, the channels 160 may be relatively small. As another example, when the wound bed 113 is formed as a chronic wound, exudate 118 from the wound bed 113 may be more viscous and, therefore, the channels 160 may be larger or more numerous.

The pad 170 may be at least partially formed of, for example, polyvinyl alcohol, polyurethane foam with polyethylene glycol (PEG) that may enhance absorption and transmission characteristics, gauze, a fiber-like material such as carboxymethyl cellulose water-based fibers (Aquacel) or knitted synthetic fibers such as polypropylene and polyamide or a combination of both, with hydrophobic polypropylene fibers being primarily near the distal side 172 and hydrophilic polyamide fibers being primarily at the proximal side 174 to direct exudate 118 from the wound bed 113. Elastomeric fibers such as polyester-polyurea (e.g., spandex or lycra) may additionally be incorporated into the pad 170 to impart stretchability and conformability to the pad 170.

Pad 170 may include a variety of materials 116, materials 116 including drugs 176, e.g., antibiotics, analgesics such as local anesthetics, COX-2 inhibitors and non-steroidal 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 wound 113 by passage 160 through distal layer 180. pad 170 may include a variety of indicators 178, e.g., fluorescent dyes, to indicate pH under UV light to indicate the health of the wound of bed 113, structural members may be made at least in part of transparent or translucent materials to allow viewing of the indicators.the materials forming pad 170 may be adjusted to accommodate these indicators or deliver drugs 176 to wound bed 113. pad 170 may, e.g., include multiple layers of different materials, or each of the multiple layers may include a combination of multiple drugs 176 or a combination of indicators 178.

In some embodiments, drug 178 as a liquid formulation may be pre-formed into a containment device, proximate to or attached to layer 170, for release by puncturing, removing or opening a barrier in the containment device prior to application of wound interface 115 to wound bed 113. Alternatively, such a separate containment device may be added to layer 170 or connected to layer 170 by a syringe or via an optional injection port or air inlet prior to application of wound interface 115.

As shown in FIG. 1C, when the structural member 120 is secured to the skin surface 111, the perimeter 153 of the composite structure 150 is offset from the edge 123 of the structural member 120 by a length 155 to prevent exposure of the composite structure 150. In other embodiments, length 155 may be omitted such that perimeter 153 is aligned with edge 123. Perimeter 153 of composite structure 150 may be offset from adhesive 190 by length 157. Length 157 may be selected to avoid connection between wound bed 113 and adhesive 190 when wound interface 115 is secured to skin surface 111 and distal layer 180 contacts wound bed 113.

As shown in fig. 1C, the distal layer 180 and the pad 170 of the wound therapy device 100 are coextensive with each other at the structure 150, although this need not be the case in other embodiments. The structural member 120 is depicted as being primarily rectangular in shape with the structure 150 disposed in the middle, the structure 150 being depicted as having a rectangular shape. The structure 150 may be disposed at various locations on the structural member 120, the structure 150 and the structural member 120 may have a variety of other geometric shapes, such as square, circular, oval, and the shapes of the structural member 120 and the structure 150 may or may not be similar to each other in some embodiments. Such other geometries and arrangements may have equivalent lengths, e.g.,

lengths

155, 157, between structures, such as structure 150, and edges, such as

edges

123, 193, may be suitable. For clarity of explanation, fig. 1C, as well as other figures illustrating wound treatment apparatus 100, do not depict a release film layer that may be included in certain embodiments of wound treatment apparatus 100, as will be readily recognized by those of ordinary skill in the art in view of this disclosure.

Fig. 2 illustrates a distal layer 180 of an exemplary wound treatment apparatus 100, including a channel 160 disposed on the distal layer 180, the channel 160 passing through the distal layer 180 between a distal side 182 and a proximal side 184. Exudate 118 may be transported between distal side 182 and proximal side 184 of distal layer 180 through channel 160, and material 116 may be transported between proximal side 184 and distal side 182 of distal layer 180 through channel 160. The channel 160 in the exemplary wound treatment apparatus 100 is geometrically depicted as a circle, defined as a cylinder between the proximal side 184 and the distal side 182. In certain embodiments, the channels, such as channel 160, may have different shapes and sizes and may be distributed in regular and irregular patterns.

The thickness 187 of distal layer 180 may vary depending on the type of wound bed 113 to which wound interface 115 is applied and the degree of exudation. In certain embodiments, the thickness 187 may be in a range of about 0.1mm to about 2 mm. In certain embodiments, the thickness 187 may range from about 0.2mm to about 1 mm. The distal side 182 may be flat or may include a variety of textures, such as texture 864, which may 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 prone to stretching and deformation. In certain embodiments, the size of the channels 160 in the distal layer 180 may generally range from about 250 microns to 2500 microns or equivalent in diameter, or from about 500 microns (#35 mesh) to about 1000 microns (#18 mesh), or equivalent. In certain embodiments, per cm²The number of channels 160 in the distal layer 180 may be about 25/cm²To about 200/cm²Within the range of (1).

As shown in fig. 3, wound therapy device 200 includes wound interface 215 including structural member 220, pad 270, and distal layer 280. Structural member 220, pad 270, and distal layer 280 are oval-shaped, as shown, pad 270 is disposed between distal layer 280 and structural member 220. A border 223 of offset length 255 extends along the distal 222 perimeter of structural member 220 to enclose a pad 270 connected to a distal layer 280. An adhesive (such as

adhesive

190, 690, 790) disposed on at least a portion of the boundary 223 may secure the wound interface 215 to the skin surface 211 surrounding the wound bed 213. In certain embodiments of wound interface 215, structural member 220 may be fluid-tight, with the adhesive sealingly securing wound interface 215 to skin surface 211 about wound bed 213 to enclose pad 270 and distal layer 280, thereby forming a fluid-tight enclosed space 217 above wound bed 213, i.e., wound interface 215 secured to skin surface 211 is enclosed. In this embodiment, a port may be provided on the wound interface 215 for fluid communication with the enclosed space 217 through the structural member 220.

As shown in fig. 3, the channel 260 passes between a distal side 282 and a proximal side 284 of the distal layer 280. In this embodiment, distal layer 280 is formed at least in part from silicone 235. The channel 260, depicted as a square or star burst shape as shown, disposed on the distal layer 280, the channel 260 allows for the transfer of exudate 218, material 216, or exudate 218 and material 216 between the distal 282 and proximal 284 of the distal layer 280.

As shown in fig. 3, a window 227 formed of a transparent or translucent material is disposed between the proximal 224 and distal 222 sides of the structural member 220. For example, the window 227 may be formed from a polypropylene or polyethylene film that remains sealed to the linear bore in the structural member 220. A user may view at least a portion of pad 270, for example, to determine a degree of saturation of pad 270 with exudate (e.g., exudate 218). As another example, an indicator, such as indicator 178, may be included in pad 270, which indicator may be viewed through window 227, which indicates the pH of pad 270, and thus the condition of wound bed 213.

Fig. 4 illustrates the distal layer 380 and pad 370 of an exemplary wound therapy device 300. In this embodiment, pad 370 conforms in shape to distal layer 380, wherein both pad 370 and distal layer 380 are circular. As shown, the pad 370 has a distal side 372 and a proximal side 374, the distal side 372 of the pad 370 being secured to the proximal side 384 of the distal layer 380. In this embodiment, the distal layer 380 is formed at least in part from silicone 335, and the pad 370 may be formed from a material similar to the pad 170 of the example wound therapy device 100. In this embodiment, the channel 360 disposed on the distal layer 380 passes between the distal 382 and proximal 384 sides of the distal layer 380. As shown in fig. 4, the channel 360 is in the shape of a Z-shaped slit. It is noted that as shown in fig. 4, channels 360 located within the boundary 385 decrease in size and increase in density within the central region of the distal layer 380 when the channels 360 are regularly sized and distributed outside the boundary 385.

Fig. 5 illustrates that the distal layer 480 of the example wound therapy device 400 is formed at least in part from silicone 435, the distal layer 480 including a channel 460, the channel 460 passing between a distal side 482 and a proximal side 484 of the distal layer 480 to allow transfer of material 416 and exudate 418 between the distal side 482 and the proximal side 484. In fig. 5, distal layer 480 is in the shape of an elongated rectangle; the passage 460 is formed in a star burst shape, passing between a distal side 482 and a proximal side 484 of the distal layer 480.

Fig. 6A, 6B illustrate an exemplary wound treatment apparatus 500 including a distal layer 580 (formed at least in part from silicone 535) and a pad 570. As shown in fig. 6A, the distal layer 580 is formed on the distal side 572 of the pad 570, the distal layer 580 not occluding the entire distal side 572 of the pad 570. The distal layer 580 may be formed during the manufacture of the pad 570, for example, by rolling, spraying, or otherwise applying a layer of silicone material having a pattern 587 on the distal side 572 of the pad 570. A variety of forms, masks, window screens, and other ways may be used to form pattern 587.

In certain embodiments, the silicone material may be, for example, a silicone gel, which may comprise one or more of polysiloxane, silica, and a carrier formed from a volatile solvent. An example of a silicone gel is a dispersion of polysiloxane-11 in phenyltrimethicone as a carrier. After the silicone gel is applied to the distal side 572 of the pad 570, the carrier, e.g., phenyl trimethicone, disappears, leaving the silicone 535 on the distal side 572 of the pad 570 as the distal layer 580 with the pattern 587. The combined pad 570 and distal layer 580 may then be die cut and then assembled on the distal side of a structural member (such as

structural members

120, 620, 720).

Fig. 6A illustrates a distal side 582 of the distal layer 580. As shown in the detail of fig. 6A, the distal layer 580 is formed at least in part from silicone 535 having a pattern 587, and the pad 570 may be formed from a material similar to the pad 170 of the exemplary wound therapy device 100. Although the pattern 587 is shown generally as a regular rectangular geometric shape, in certain embodiments, the pattern 587 may have a variety of shapes, combinations of regularity and irregularity, and size distributions. The pattern 587 of the distal layer 580 forms occlusive regions 533 and channels 560 between the occlusive regions 533, the channels 560 exposing the distal side 572 of the pad 570, allowing exudate 518 or material 516 to travel between the distal side 582 of the distal layer 580 and the proximal side 584 of the distal layer 580, as well as the distal side 572 of the pad 570, as shown in fig. 6A, 6B. In certain embodiments, the thickness 589 of the distal layer 580 may be in a range from about 200 microns to about 1000 microns. The diameter of the channels 560 may range from about 50 microns (#270 mesh) to about 1000 microns (#18 mesh) in diameter or equivalent diameter, or from about 100 microns (#140 mesh) to about 750 microns (about #22 mesh) in diameter or equivalent diameter. In some embodiments, the number of channels 560 per square centimeter may generally be about 45/cm²To about 2500/cm²Within the range of (1).

For purposes of clarity of illustration, the wound interface 615 of the exemplary wound therapy device 600 illustrated in fig. 7A is shown separately from the wound bed 613 and the skin surface 611. In this embodiment, wound bed 613 comprises a skin graft. Wound interface 615 includes a distal layer 680 and a pad 670 (in cooperation with structural member 620), pad 670 being interposed between distal layer 680 and structural member 620. In this embodiment, the distal layer 680 is at least partially formed of silicone 635. In this embodiment, adhesive 690 disposed on structural member 620 may secure structural member 620 and wound interface 615 to skin surface 611 to bias distal layer 680 toward connection with wound bed 613. As shown, exudate 618 may be transferred from wound bed 613 to pad 670 through channels 660 in the distal layer, and material 616 may be transferred from pad 670 to wound bed 613 through channels 660.

Shear force F shown in FIG. 7A_sIn the form of a force acting tangentially on the wound interface 615 of the wound therapy device 600. Shear force F_sCan result from a variety of compressive forces having tangential force components on wound interface 615, as may occur during donning of wound interface 615, such as due to an object colliding, interacting with clothing or bedding, and the like.

In the embodiment of fig. 7A, wound interface 615 includes a spacer 640 having an envelope-like structure disposed between an adhesive 690 and a pad 670, adhesive 690 being disposed on distal side 622 of structural member 620. In some embodiments, spacer 640 may be located between structural member 620 and adhesive 690. Spacer 640 includes a distal layer 642 and a proximal layer 644 forming a space 646 between distal layer 642 and proximal layer 644 as shown. Spacer 640 may be a film formed of a low coefficient of friction material 625, such as polyethylene or polypropylene, for slidable connection of proximal layer 644 to distal layer 642. The slidable connection of proximal layer 644 and distal layer 642 in spacer 640 may be at least partially diverted to shear force F_sTo reduce the shear force F_sTo the distal layer 680, thereby reducing the force transmitted to the wound bed 613. Proximal side 624 of structural member 620 may be formed of a low coefficient of friction material 625 to reduce shear forces F_sFor example, to allow sliding movement between the proximal side 624 and objects contacting the proximal side 624. Thus, for reducing the shearing force F_sThe shear force reducing means transferred to the wound bed 613 can include a spacer 640 having a proximal layer 644 and a distal layer 642 with a space 646 therebetween, and the shear force reducing means can include a proximal side 624 of the structural member 620 formed from a low-coefficient of friction material 625.

At the beginning, the skin graft has no vascular connections. After a period of time, new blood vessel twigs begin to appear, starting fromThe wound bed faces the skin graft and eventually establishes the blood flow and viability of the graft. The viability of the skin graft is compromised if the wound bed 613 comprising the skin graft is sheared during the formation of the blood vessel. Thus, the spacer 640 and the low coefficient of friction 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 force F transmitted to the wound bed 613_sOr corresponding deflection shear force F_sTo avoid shear forces F_sDamage to the wound bed 613.

Fig. 7B illustrates a wound interface 715 of an exemplary wound treatment apparatus 600, including a pad 770 interposed between a distal layer 780 and a structural member 720. For purposes of clarity of explanation, wound interface 715 is depicted as being illustrated separately from wound bed 713 and skin surface 711. Distal layer 780 is at least partially formed of silicone 735, and distal layer 780 includes channels 760 for transmitting exudates 718 and material 716 through channels 760. As shown, the layer 744 is interposed between the adhesive layer 790 and the proximal side 774 of the pad 770, and the space 746 is located between the layer 744 and the proximal side 774 of the pad 770. Layer 744 may be a film formed of a low coefficient of friction material 725, such as polyethylene or polypropylene, to facilitate a slidable connection between layer 744 and the proximal side 774 of pad 770, reducing the shear force F applied to the structural member proximal side 724_sTo the distal layer 780. As shown, the layer 744 prevents at least a portion of the pad 770 from adhering to the structural member 720 via the adhesive 790, and slidably couples the layer 744 with the proximal side 774 of the pad 770 to permit movement between a portion of the structural member 720 and the pad 770 to at least partially deflect the shear force F applied to the proximal side 724 of the structural member 720_s. This can reduce the shear force F_sDelivery to wound bed 713. In certain embodiments, for example, the adhesive 790 may be omitted from the portion of the structural member 790 proximate the proximal side 774 of the pad 770, and the layer 744 may be omitted such that at least a portion of the proximal side 774 of the pad 770 is slidably connected to the structural member 720 to allow movement between a portion of the structural member 720 and the pad 770, which may cause a shear force F applied to the proximal side 724 of the structural member 720_sAt least partially deflected. Therefore, for reducing shearShear force F_sA method of reducing shear forces delivered to the wound bed 713 may include: for example, layer 744 with space 746.

Fig. 8 illustrates a distal layer 880 of the exemplary wound treatment apparatus 800, the distal layer 880 being at least partially formed of silicone 835. As shown in fig. 8,

channels

860a, 860b, 860e, 860d, 860e, 860f pass between distal side 882 and proximal side 884, respectively, having a square, rectangular, star, circular, slit, and fish-mouth geometry, and may be disposed on distal layer 880 in a variety of channel patterns. The exudate 818 or material 816 may communicate through

passages

860a, 860b, 860c, 860d, 860e, 860f between the distal side 882 and the proximal side 884. The geometry of the channels, e.g.,

channels

860a, 860b, 860e, 860d, 860e, 860f, and the mode of the channels may be selected to maintain the channels open during use, allowing exudate 818 or material 816 to be transported through the channels. For example, a channel that is Z-shaped (e.g., channel 360 in fig. 4) may be more likely to remain functionally useful than a simple slit, as the Z-shape may allow more multidirectional stretching of the distal layer. Fishmouth-shaped channels, such as channel 860f, may also exhibit increased patency.

Fig. 8 illustrates a texture 864 on the distal surface 882 of the distal layer 880, which may be a micro or macro surface texture in the form of, for example, bumps, dimples, ridges, and combinations thereof. When biased toward wound bed connectivity, such as

wound beds

113, 213, 613, 713, texture 864 may induce micro-deformation and pressure points that may accelerate wound healing by stimulating cell mitosis, differentiation, and angiogenesis.

As shown herein, in certain embodiments, a wound treatment device may include a distal layer, such as

distal layer

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 certain embodiments, the wound treatment device may include a distal layer, such as

distal layer

380, 580, and a pad, such as

pad

370, 570, as shown in

wound treatment devices

300, 500. In certain embodiments, the wound treatment device may include a distal layer, such as distal layer 480, as shown in wound treatment device 400.

In various exemplary methods of operation, for example, a 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 be in contact with a wound bed (e.g., wound

bed

113, 213, 613), e.g., applied immediately after an injury and before scarring. The distal layer is formed at least in part from silicone (e.g.,

silicone

135, 235, 335, 435, 535, 635, 735, 835), can provide an early self-balancing effect, and balances collagen, fibronectin, and collagenase levels to promote healing and reduce scar formation, which can eliminate the long-term need for altering excessive scarring after scarring.

In one exemplary method of operation, for example, the non-healing wound bed is in contact with a distal layer, the distal layer being at least partially formed of silicone, the distal layer may be used substantially on its own, and the pad (e.g.,

pad

170, 270, 370, 470, 570, 670, 770) and structural member (e.g.,

structural member

120, 200, 620, 720) may be omitted.

In another exemplary method of operation, the wound bed is in contact with the distal layer, which is attached to the pad, and the structural member is omitted. In such an exemplary method of operation, the pad absorbs exudate (e.g.,

exudate

118, 218, 418, 518, 618, 818) transported from the wound bed to the pad through the passages of the distal layer (e.g.,

passages

160, 260, 360, 460, 560, 660, 760, 860a, 860b, 860c, 860d, 860e, 860 f). Materials (e.g.,

materials

116, 216, 416, 516, 616, 816) may be delivered to the wound bed through the channel.

In a third exemplary method of operation, the wound bed is in contact with a distal layer, which is attached 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, the structural member may protect the wound bed.

In methods of operation involving a pad, when an indication is made, for example, that the pad is at least partially saturated with exudate, the distal layer and pad may be removed and then discarded. In some operations, a wound interface, such as

wound interface

115, 215, 615, 715, may be removed and replaced with another wound interface, which may or may not be similar to the removed wound interface. During the treatment process of the wound bed, for example, when the amount of exudate exuded by the wound bed is reduced or multiple medications, such as medication 176, are delivered to the wound bed, different wound interfaces may be used.

The plurality of methods of operation may include: the drug is delivered from the pad to the wound bed through the distal layer. The plurality of methods of operation may include: contacting the wound bed with a texture (e.g., texture 864) disposed distal to the distal layer may accelerate healing of the wound bed or may assist in apposition of the wound bed. The plurality of methods of operation may include: the pad is viewed through a window (such as window 227) disposed on the structural member. The plurality of methods of operation may include: viewing an indicator (e.g., indicator 178) included in the pad, and viewing the indicator through the window. The plurality of methods of operation may include: reducing shear forces F transmitted to the wound bed through the wound interface_s. The plurality of methods of operation may include: removing exudate or fluids from the wound interface via one or more ports disposed at the wound interface, and may include: fluid is input to the wound interface through one or more ports disposed in the wound interface.

The foregoing discussion, in conjunction with the accompanying drawings, discloses and describes various exemplary embodiments. These embodiments are not meant to limit the scope of coverage, but rather, to facilitate an understanding of the language used in the specification and claims. Having studied the disclosure and the illustrative implementations herein, one of ordinary skill in the art will readily recognize various changes, modifications, and alterations that may be made without departing from the spirit and scope of the invention as defined by the following claims.

Claims

1. A wound treatment apparatus comprising:

a distal layer in contact with the wound bed, the distal layer comprised of silicone; and the combination of (a) and (b),

a channel disposed in the distal layer, through a distal side of the distal layer and a proximal side of the distal layer, to communicate between the distal side and the proximal side.

2. The apparatus of claim 1, further comprising:

a pad disposed on the proximal side of the distal layer cooperating 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.

3. The device of claim 2, the pad comprising a hydrophobic material and a hydrophilic material, the hydrophobic material cooperating with the proximal side of the distal layer to remove the exudate from the proximal side of the distal layer, the hydrophilic material in fluid cooperation with the hydrophobic material to absorb the exudate from the hydrophobic material.

4. The apparatus of claim 1, further comprising:

a pad containing a drug, the pad disposed on the proximal side of the distal layer, cooperating with the channel to deliver the drug through the channel to the wound bed.

5. The apparatus of claim 1, further comprising:

a structural member connected with the distal layer, the structural member being adhesively securable to a skin surface surrounding the wound bed to maintain the distal layer in contact with the wound bed.

6. The apparatus of claim 5, further comprising:

a pad disposed on the proximal side of the distal layer in fluid communication with the channel, the structural member being adjacent to a proximal side of the pad.

7. The apparatus of claim 5, further comprising:

a window disposed on the structural member that allows viewing through the structural member when the structural member is secured to the skin surface.

8. The apparatus of claim 5, further comprising:

at least one layer of a low coefficient of friction membrane between the structural member and the distal layer to deflect at least a portion of a shear force externally applied to the structural member.

9. A wound treatment apparatus comprising:

a pad; and

a distal layer formed as a coating of silicone material on a distal surface of the pad, a portion of the distal surface of the pad being non-occlusive, exudate from a wound bed being transported into the pad through the non-occlusive portion of the distal surface of the pad.

10. The apparatus of claim 9, further comprising:

a structural member connected with the pad, the structural member being adhesively securable to a skin surface surrounding the wound bed to maintain a distal side of the distal layer in contact with the wound bed.

11. The device of claim 9, wherein the silicone material comprises a combination of one or more polysiloxanes and a carrier.

12. A method of using a wound treatment apparatus, comprising the steps of:

contacting a distal side of a distal layer of the wound therapy device with a wound bed, the distal layer comprising silicone and having a channel passing between the distal side of the distal layer and the proximal side of the distal layer; and

removing exudate from the wound bed by transmitting the exudate from the distal side of the distal layer to the proximal side of the distal layer.

13. The method of claim 12, wherein the wound bed is in a stage of non-healing.

14. The method of use of claim 12, further comprising the steps of:

fitting a pad to the distal side of the distal layer, absorbing the exudate into the pad.

15. The method of use of claim 12, further comprising the steps of:

delivering material to the wound bed by passing the material from the proximal side of the distal layer to the distal side of the distal layer.

16. The method of use of claim 15, wherein the material comprises a drug.

17. The method of use of claim 12, further comprising the steps of:

securing contact of the distal layer with the wound bed using a structural member adhered to the skin surface surrounding the wound bed, the structural member mechanically cooperating with the distal layer.

18. The method of use of claim 17, further comprising the steps of:

forming the distal layer by selectively applying a silicone gel to the distal side of the pad.

19. The method of use of claim 12, further comprising the steps of:

intermittently replacing the wound therapy device throughout the healing process of the wound bed.

20. The method of use of claim 12, further comprising the steps of:

reducing scar formation by contacting the wound bed with the distal layer comprising silicone throughout the healing process of the wound bed.