Tension type skin treatment device and method

Abstract

Devices, kits, and methods described herein may include a dressing that is pre-tensioned and stored for a period of time, and then applied to the skin of a subject.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 317,839, filed on March 8, 2022, entitled “STRAINED SKIN TREATMENT DEVICES AND METHODS,” the entire contents of which are incorporated herein by reference for all purposes.

[0003] This application is related to U.S. application serial number 13 / 552,521 filed on July 18, 2012, the entire contents of which are incorporated herein by reference. Background Art

[0004] Scar formation in response to skin injury is part of the natural wound healing process. Wound healing is a long and ongoing process, although it is generally considered to occur in stages. This process begins immediately after injury, with an inflammatory phase. During this phase, which usually lasts two days to a week (depending on the wound), damaged tissue and foreign matter are removed from the wound. The proliferative phase occurs after the inflammatory phase and is characterized by fibroblast proliferation and the production of collagen and proteoglycans. It is during the proliferative phase that the extracellular matrix is ​​synthesized to provide structural integrity to the wound. Depending on the nature of the wound, the hyperplastic phase usually lasts about four days to several weeks, and hypertrophic scars are usually formed during this phase. The last stage is called the remodeling phase. During the remodeling phase, the previously constructed and randomly organized matrix is ​​remodeled into a highly cross-linked and arranged / aligned organized structure to increase mechanical strength.

[0005] Although the histological features that characterize hypertrophic scars have been well documented, the underlying pathophysiology is unclear. Hypertrophic scars are a side effect of excessive wound healing and often result in an overproduction of cells, collagen, and proteoglycans. Typically, these scars are raised and characterized by a random distribution of tissue bundles. The appearance (i.e., size, shape, and color) of these scars varies depending on the body part where they form and the underlying ethnicity of the person affected. Hypertrophic scars are very common and may occur after any full-thickness skin injury. Recently, it was shown in U.S. Patent Application Publication No. 2006 / 0037091 (U.S. Patent Application Serial No. 11 / 135,992, entitled "Method for Producing Hypertrophic Scarring Animal Model for Identification of Agents for Prevention and Treatment of Human Hypertrophic Scarring", filed May 24, 2005, incorporated herein by reference in its entirety) that mechanical stress can increase hypertrophic scars in a mouse model.

[0006] Keloids are generally characterized as tumors consisting of a highly proliferative mass that arises in the dermis and adjacent subcutaneous tissue of susceptible individuals, most often following trauma. Keloids are generally more severe than hypertrophic scars because they tend to invade into normal adjacent tissue, whereas hypertrophic scars tend to remain confined within the original scar borders. Summary of the invention

[0007] The devices, kits and methods described herein can be used for skin treatments where it is desired to manipulate or change the intrinsic or endogenous stresses within the skin and / or control or manipulate the effects of exogenous stresses on the skin. Such treatments may include, but are not limited to, wound treatment or therapy, amelioration or prevention of scars and / or keloids and / or treatment of wound dehiscence. According to the devices, kits and methods described herein, the device can be attached to or coupled to one or more layers of skin or tissue of a subject.

[0008] In one variation, a skin treatment device is provided, comprising: a dressing comprising a pre-tensioned elastic member coupled to a strain retention structure, wherein the strain retention structure is configured to maintain the elastic member in a tensioned configuration, and wherein the pre-tensioned elastic member is configured to maintain at least a desired amount of tension for a predetermined time period after an initial strain period. In some variations, the initial strain period is greater than about 24 hours, or greater than about one week. In other variations, the predetermined time period may be at least twelve weeks, at least 24 weeks, or at least 52 weeks. The elastic member may exhibit less than about 5%, less than about 15%, or less than about 25% force loss during the predetermined time period. In some variations, the elastic member may exhibit at least about 25% or 35% force loss, 40% force loss, 45% or more force loss during the initial time period. In some examples, the elastic member may exhibit a greater force loss percentage during the initial time period than during the predetermined time period.

[0009] In another embodiment, a skin treatment device assembly is provided that includes: a dressing including an elastic member; a support structure that is configured to be removably connected to a pre-tensioned dressing and configured to maintain the pre-tensioned dressing in a tensioned configuration; a tensioning element that is configured to pre-tension the dressing, wherein the tensioning element is configured to be removably connected to the support structure; a releasable locking element that is configured to maintain the pre-tensioned dressing in a strain-retaining engagement with the support structure; and a release mechanism that is configured to release the dressing from the support structure.

[0010] In another embodiment, a skin treatment device assembly is provided that includes: a dressing including an elastic member; a tensioning element configured to be connected to the dressing to pre-tension the dressing and to be separated from the dressing; and a support structure configured to be removably connected to the dressing to maintain the dressing in a pre-tensioned configuration after the dressing is separated from the tensioning element.

[0011] In still another variation, a method of manufacturing a dressing is provided, comprising: tensioning the dressing a predetermined amount using a tensioning element; connecting the dressing in a tensioned configuration to a removable strain retention element in a releasable locking engagement to form a pre-tensioned assembly including the dressing and the strain retention element; and removing the tensioning element from the pre-tensioned assembly.

[0012] In another variation, a method of making a pre-tensioned dressing is provided, comprising: tensioning the dressing to an initial tension amount greater than a desired tension amount required when the dressing is applied to the skin of a subject; and coupling the tensioned dressing to a removable strain retention device, and recommending a time of use of the dressing during a time period in which the tension amount is predicted to decrease by a desired reduction amount. The desired reduction amount may be a reduction of about 25%, 35%, 40%, 45% or more from the initial tension. The desired reduction amount may be a reduction of less than 25% from the initial tension.

[0013] In one variation, a skin treatment device is provided that includes a pre-tensioned polymer structure and an untensioned adhesive layer attached to the pre-tensioned polymer structure. The skin treatment device may also include a release liner attached to the untensioned adhesive layer. The pre-tensioned polymer structure and the untensioned adhesive layer may be located within a sealed package. The sealed package may be a sterile sealed package.

[0014] In another variation, a method of manufacturing a skin treatment device is provided, comprising: tensioning an elastic polymer structure with a removable tensioning structure; and applying an untensioned adhesive layer to a surface of the elastic polymer structure and removing the tensioning structure. The method may also include attaching a release liner to the untensioned adhesive layer. The method may also include packaging the elastic polymer structure and the untensioned adhesive layer in a sealed packaging structure, and optionally sterilizing the sealed packaging structure.

[0015] In one variation, a skin treatment device is provided that includes a pre-strained polymer structure, an adhesive layer attached to the pre-strained polymer structure, and an unstrained release liner attached to the adhesive layer.

[0016] In another variation, a method of making a skin treatment device is provided, comprising: tensioning an elastic polymer structure; applying an adhesive layer to a surface of the elastic polymer structure; and applying a release liner to the adhesive layer after tensioning the elastic polymer structure.

[0017] In one embodiment, a tensioned treatment device is provided, comprising a tensioned elastic dressing, an adhesive layer on a surface of the elastic dressing, a support structure comprising a polymer coated paperboard having a Taber stiffness of at least 160, two or more attachment structures between the tensioned elastic dressing and the support structure, the attachment structures comprising flexible non-elastic strips, wherein the attachment structures are adhered to the dressing by a high shear adhesive and are thermally bonded to the polymer coating of the paperboard, wherein the width of the thermal bond area is in the range of 0.10" to 0.25". The length of the thermal bond area may be greater than or equal to the length of the adhesive bond between the attachment structure and the dressing.

[0018] In another embodiment, a method of manufacturing a tensioned treatment device is provided, comprising: attaching a device carrier to a precursor dressing assembly; removing a manufacturing pad from the precursor dressing assembly; heat-staking a first region of the dressing to a first region of a support structure; tensioning the dressing and heat-staking a second region of the dressing in a tensioned configuration to a second region of the support structure; and applying an adhesive pad. The dressing may also include first and second attachment structures. The method may also include: attaching a tensioning element to the dressing; and pulling the tensioning element in a direction away from the first region of the dressing to tension the dressing. The method may also include: raising the tensioning element before pulling the tensioning element; and lowering the tensioning element after pulling the tensioning element. Attachment of the tensioning element to the dressing may be performed after heat-staking the first region. Heat-staking the first and second regions of the dressing may be performed on / inside the first and second attachment structures. The first and second attachment structures may each include two rows of perforations spaced apart from each other. The heat staking of the first and second regions can be performed outside the two rows of perforations on the respective attachment structure / transversely to the two rows of perforations on the respective attachment structure.

[0019] In another embodiment, a manufacturing assembly is provided, comprising: a conveying assembly for moving a plurality of components along a moving path; a first clamping assembly configured to reversibly clamp a first side of a subset of the plurality of components together; a first hot melt assembly configured to hot melt the subset of the plurality of components together near the first side of the subset of the plurality of components; a tensioning assembly, comprising a second clamping assembly configured to reversibly clamp a second side of the subset of the plurality of components together, a first separation assembly configured to reversibly displace the second clamping assembly, and a second assembly configured to reversibly displace the tensioning assembly in a direction away from the first clamping assembly; and a second hot melt assembly configured to hot melt the subset of the plurality of components together near the second side of the subset of the plurality of components. The first clamping assembly and the second clamping assembly may be configured to clamp in a first direction. The first separation assembly may be configured to lift the second clamping assembly in a second direction opposite to the first direction. The second separation assembly may be configured to displace the tensioning assembly in a third direction orthogonal to the first direction. The assembly may also include a third clamping assembly configured to reversibly clamp the subset of the plurality of components together, wherein the third clamping assembly is located between the first clamping assembly and the second clamping assembly. The third clamping assembly may be located between the first clamping assembly and the second hot melt assembly. The assembly may also include a cutting assembly configured to cut the subset of the plurality of components. The cutting assembly may be configured to cut the subset of the plurality of components near the second side of the subset of the plurality of components.

[0020] In still another embodiment, a tensioning assembly or subassembly is provided, comprising: a first clamping assembly configured to reversibly clamp a second side of a subset consisting of multiple components together; a first separation assembly configured to reversibly shift the second clamping assembly; a second assembly configured to reversibly shift the tensioning assembly in a direction away from the first clamping assembly; and a first hot melt assembly configured to hot melt the subset consisting of the multiple components together near the second side of the subset consisting of the multiple components. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1A is a perspective view of a dressing and a support structure in a first position.

[0022] Figure 1B It is in pre-tensioned configuration Figure 1A Top perspective view of the dressing and support structure.

[0023] Figure 1C It is in pre-tensioned configuration Figure 1A Bottom perspective view of the dressing and support structure.

[0024] Figure 2A is a perspective view of a dressing and a support structure in a first position.

[0025] Figure 2B It is in pre-tensioned configuration Figure 2A Top perspective view of the dressing and support structure.

[0026] Figure 3A is a top perspective view of the dressing assembly, support structure, and tensioning device in a relatively untensioned configuration.

[0027] Figure 3B is a top perspective view of the dressing assembly, support structure, and tensioning device in a pre-tensioned configuration.

[0028] Figure 3C yes Figure 3B Schematic side view of a dressing assembly, support structure, and tensioning device.

[0029] Figure 3D yes Figure 3C An enlarged schematic side cross-sectional view of a dressing assembly, support structure, and tensioning device.

[0030] Figure 3E yes Figure 3D An enlarged, schematic, detailed side view of a portion of a dressing and support structure.

[0031] Figure 3F is a schematic side view of a dressing assembly and support structure in a pre-tensioned configuration.

[0032] Figure 3G yes Figure 3F A. Magnified side view of the dressing assembly and support structure of Section A.

[0033] Figure 3H yes Figure 3F B. An enlarged side view of the dressing assembly and support structure of Section B.

[0034] Fig. 3I is a top perspective view of the pre-tensioning assembly including the remaining elements of the dressing assembly and the support structure.

[0035] Figure 4 is a perspective view of a plurality of pre-tensioned dressings on a support element.

[0036] Figure 5 A pre-tensioned dressing and support structure are illustrated.

[0037] Figure 6 The percent loss of force over time for an elastic dressing material as described in Example 1 is shown.

[0038] Figure 7 is a graphical representation of the percent loss of force over time of a pre-tensioned elastic material component of a dressing.

[0039] Figure 8 is a schematic diagram of the variation of the tension of the pre-tensioned elastic material component of the dressing over time.

[0040] Fig. 9 The percent loss of force over time for the elastic dressing material described in Example II is shown.

[0041] Fig. 10A is a top view of the pretensioning assembly.

[0042] Fig. 10B yes Fig. 10A Cross-sectional view along line AA.

[0043] Fig.11A is a flow chart illustrating a process and its sub-processes for manufacturing a pre-tensioned dressing.

[0044] Fig. 11B is a flow chart illustrating a process for removing a manufacturing liner.

[0045] Fig. 11C is a flow chart illustrating a process for securing a dressing to a support structure.

[0046] Fig.11D is a flow chart illustrating a process of tensioning a dressing and securing the dressing to a support structure in a tensioned configuration.

[0047] Fig.11Eis a flow chart illustrating a process for removing a tensioning element.

[0048] Fig.11F is a flow chart showing the application of an adhesive backing.

[0049] Fig. 12A is a top perspective view of a roll of dressing pre-assembly.

[0050] Fig. 12B yes Fig. 12A Top view of the dressing pre-assembly.

[0051] Fig.13 is a top perspective view of the manufacturing unit.

[0052] Fig.14 yes Fig.13 A top perspective view of one level of a manufacturing unit.

[0053] Fig.15A yes Fig.14 Side view of the manufactured assembly in the first step.

[0054] Fig. 15B yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0055] Fig. 15C yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0056] Fig.15D yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0057] Fig.15E yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0058] Fig.15F yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0059] Figure 15G yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0060] Fig.15H yes Fig.15A Side view of the fabricated assembly in subsequent steps.

[0061] Fig.16A yes Fig.13 Schematic diagram of the top of the dressing assembly during and after one stage of manufacturing the assembly.

[0062] Fig. 16B yes Fig.13A top schematic diagram of a dressing assembly before, during, and after one stage of manufacturing assembly.

[0063] Fig. 16C yes Fig.13 A top schematic diagram of a dressing assembly before, during, and after one stage of manufacturing assembly.

[0064] Fig.16D yes Fig.13 A top schematic diagram of a dressing assembly before, during, and after one stage of manufacturing assembly.

[0065] Fig.16E yes Fig.13 A top schematic diagram of a dressing assembly before, during, and after one stage of manufacturing assembly. DETAILED DESCRIPTION

[0066] According to the devices, kits and methods described herein, a skin treatment device, a skin device, a wound treatment device, a scar or keloid treatment device, a scar or keloid improvement or prevention device, a bandage or dressing (hereinafter referred to as a "dressing", "skin device" or "skin treatment device") can be provided that can be applied to, attached to or connected to one or more layers of the skin or tissue of a subject.

[0067] The present invention describes a device that can be used to improve scar and / or keloid formation at the skin or wound site. The scar can be any type of scar, such as a normal scar, a hypertrophic scar, etc. Generally, the device can be configured to be removably fixed to the skin surface near the wound.

[0068] In addition to improving scarring, other uses of such skin treatment devices may include, but are not limited to, or may not include without limitation: for example, treating skin-related conditions such as acne, blemishes, rosacea, warts, rashes (including but not limited to erythematous, macular, papular and / or bullous conditions), psoriasis, skin irritation / sensitivity, allodynia, telangiectasia, port wine stains and other arteriovenous malformations, and atopic dermatitis; treating or improving existing scars, wrinkles, stretch marks, loose or sagging skin, or other skin abnormalities; lifting, fixing, holding, mobilizing skin for various purposes, such as during pre-operative preparation, during surgical procedures such as as a low-profile tissue retractor to stabilize blood vessels during needle or catheter insertion, post-operatively, for pre-treatment before or after surgery or preconditioning the skin (e.g., pretreating or preconditioning the skin prior to wound incision, body reshaping, mastectomy skin expansion, cosmetic skin treatment, resurfacing, or scar repair, whether superficial or subdermal, whether or not using energy forms such as microwaves, radiofrequency ablation, high-intensity focused ultrasound, laser, infrared, incoherent light), during weight loss, or for cosmetic purposes; treating and / or closing skin injuries (e.g., incisions, wounds, chronic wounds, bedsores, ulcers (including venous stasis ulcers)), preventing or reducing the incidence of wound dehiscence, preventing or reducing the healing and / or relief of diabetic skin or wound diseases, burns; as an occlusive or negative pressure wound dressing; protecting an incision or wound, such as preventing dehiscence or opening, protecting the umbilicus of a newborn after cutting the umbilical cord. Such treatment may include the use of drugs or other therapeutic agents that can be applied to the skin using such a device. Agents may include, but are not limited to, antibiotics, antifungal agents, immunomodulators including corticosteroids, and non-steroidal immunomodulators. The reagent can be provided in any of a variety of dosage forms, including but not limited to powders, gels, lotions, creams, pastes, suspensions, etc. The device can also be used for drug delivery to the skin or through the skin, such as by stretching the skin and applying the drug to the skin. The different configurations of the device can adapt to the size or geometry of different body parts. The treatment can be applied to the area of ​​any shape (e.g., straight line, curve, star), size or depth, and one or more areas of the body, including but not limited to the scalp, forehead, face (e.g., nose, eyelids, cheeks, lips, chin), ears, neck, shoulders, upper arms, lower arms, palms, backs of hands, fingers, nail beds, armpits, chests, nipples, areolas, backs, abdomens, inguinal regions, buttocks, perineum regions, labia, penis, scrotum, thighs, calves, plantar surfaces, dorsal surfaces of feet, and / or toes. This device may also be referred to as "dressing", "skin device" or "skin treatment device" in this article.

[0069] Reducing exogenous and / or endogenous stress near the wound can improve the formation of scars, hypertrophic scars or keloids. The mechanical environment of the injury may be an important factor in the tissue's response to injury. The mechanical environment includes exogenous stress (i.e., physiological stress, including stress transferred to the wound by muscle action or physical movement of the body) and endogenous stress (i.e., dermal stress derived from the physical properties of the skin itself, including stress caused by skin expansion or contraction at the wound site). The devices, dressings, kits and methods described herein can control or adjust the mechanical environment of the skin, including but not limited to the mechanical environment of the wound. The devices, dressings, kits and methods described herein can also control or adjust the mechanical environment to improve the formation of scars and / or keloids. The mechanical environment of the skin may include stress, strain or any combination of stress and strain. The control of the mechanical environment of the wound may be active or passive, dynamic (e.g., by applying oscillating stress) or static. The stress and strain acting on the wound may involve skin layers, such as the outer stratum corneum, epidermis and dermis, and the connective tissue layers below, such as subcutaneous fat. The devices and methods described herein can protect a wound from its mechanical environment. The term "protection" means to include the reduction of stress experienced by the wound and the provision of a physical barrier to prevent contact, contaminants, etc. The devices and methods described herein can protect a wound by reducing endogenous and / or exogenous stresses to the wound and surrounding tissue. Therefore, the devices and methods described herein can reduce the stress experienced by the wound and surrounding tissue to a level lower than that experienced by normal skin and tissue. Reducing exogenous and / or endogenous stress near the wound can improve the formation of scars, hypertrophic scars, or keloids.

[0070] The external mechanical environment of cells can trigger biological responses inside cells and change cell behavior. Cells can use integrins (an integral membrane protein in the plasma membrane) and intracellular pathways to sense and respond to changes in their mechanical environment. Intracellular pathways are initiated by receptors attached to the cell membrane and the cell membrane that can sense mechanical forces. For example, mechanical forces can induce the secretion of cytokines, chemokines, growth factors, and other biologically active compounds, thereby increasing or triggering inflammatory responses. Such secretions can act on the cells that secrete them (intracrine), on the cells that secrete them (autocrine), on the cells surrounding the cells that secrete them (paracrine), or at a location far from the point of secretion (endocrine). Intracrine disturbances can alter cell signaling, which in turn can alter cell behavior and biology, including the recruitment of cells at the wound site, the proliferation of cells at the wound site, and the death of cells at the wound site. In addition, the extracellular matrix may also be affected.

[0071] As mentioned above, the wound healing process can be divided into three stages: the early inflammatory stage, the proliferation stage, and the remodeling stage. The inflammatory stage occurs immediately after injury and usually lasts about two days to a week. Blood coagulation is to stop blood loss and release factors to attract cells that can remove debris, bacteria, and damaged tissue from the wound. In addition, factors are released to initiate the proliferation stage of wound healing. In the proliferation stage, which lasts about 4 days to several weeks, fibroblasts grow and build new extracellular matrix by secreting collagen and proteoglycans. At the end of the proliferation stage, fibroblasts can further contract the wound. In the remodeling stage, randomly oriented collagen is organized and cross-linked along the skin tension lines. Cells that are no longer needed can undergo apoptosis. The remodeling stage may last for weeks or months, or indefinitely after injury. About 6-8 weeks after injury, scars usually reach about 75-80% of the breaking strength of normal skin. In general, scars usually have a triangular cross-section. That is, scars are usually the smallest in volume near the surface of the skin (i.e., the stratum corneum and epidermis), and their volume increases as they enter the deeper layers of the dermis.

[0072] There are three common possible outcomes to the wound healing process. First, a normal scar may result. Second, a pathological increase in scarring may result, such as the formation of a hypertrophic scar or a keloid. Third, the wound may not heal completely and become a chronic wound or ulcer. The devices, kits, and methods described herein can improve the formation of any type of scar. In addition, the devices, kits, and methods described herein can be applied to various wound sizes and different skin thicknesses, for example, the devices can be configured for different areas of the body. In addition, the devices, kits, and methods described herein can be applied to improve scarring in any type of skin (e.g., body part, age, race, or condition).

[0073] Without wishing to be bound by any particular theory, we believe that mechanical strain applied to a wound or incision early in the proliferative phase of the wound healing process may inhibit apoptosis, leading to a significant accumulation of cells and matrix, and thus increasing scar formation or the production of hypertrophic scars. Given the potential similarities between hypertrophic scars and keloids in terms of excessive matrix formation, we believe that the devices and methods described herein may also be used to prevent and treat keloids by alleviating or neutralizing at least some of the strain that may be applied to a wound or incision. The tensile strain may be exogenous and / or endogenous strain, and may include, but is not limited to, strain from intrinsic tension found in normal intact skin tissue.

[0074] The devices, kits and methods described herein can be used to treat subjects at skin sites ("skin treatment devices"), including but not limited to wound treatment or the treatment, improvement or prevention of scars and / or keloids, by manipulating the mechanical or physical properties of the skin or protecting the skin from pressure, and / or by controllably applying pressure or tension to the epidermal and dermal tissue layers at or near the skin site, i.e. at or near the wound or treatment site of the subject's skin. According to variations, manipulating the mechanical or physical properties can thereby adjust the tensile or compressive stress at the skin site. The stress at the skin site can be reduced to below the level borne by normal skin and tissue. The stress at the skin site can be increased to a level higher than that borne by normal skin and tissue. Stress or strain can be applied to the surrounding tissue in one, two or more directions to control the endogenous or exogenous stress at the skin site in one, two or more directions. According to variations, the devices and methods described herein can reduce or otherwise control the stress experienced by the skin and / or wound and surrounding tissue in order to treat the subject. The device can also help prevent or reduce the occurrence of wound dehiscence.

[0075] The devices, kits and methods described herein can be used to treat skin and / or improve or prevent scars and / or keloids by creating and / or maintaining a predetermined strain and / or a predetermined minimum or maximum strain in an elastic skin treatment device or dressing, and then securing the elastic skin treatment device or dressing to the skin surface using a skin attachment mechanism (e.g., a skin adhesive) to transfer a generally planar (e.g., compressive) force from the device or dressing to the skin surface. As used herein, "pre-strained," "pre-tensioned," or "pre-tensioned" refers to tensioning the device before applying the device to a subject.

[0076] The devices, kits, and methods herein may include a support, packaging, and / or applicator configured to maintain a pre-tensioned dressing in a tensioned configuration for a period of time after the dressing is strained and before application to the skin of a subject. The devices and methods herein may include methods of making such a pre-tensioned dressing.

[0077] According to one variation, the pre-tensioned and strain-protective dressing assembly may be stored for a period of time after being strained and prior to use. In some variations, the dressing may be configured to maintain a predictable and / or desired amount of tension for a predetermined period of time after initial strain. In some variations, the dressing may be configured to lose a predetermined maximum and / or minimum amount of tension (measured in the direction of tensile strain of the dressing) within one or more time periods.

[0078] The desired moment for applying the dressing to the subject may be when the dressing in the pre-tensioned and strain protected configuration has a desired tension characteristic or tension range. Such a desired range may be selected to provide adequate modulation of the force on the skin for treating the skin while avoiding or minimizing damaging irritation to the skin. As described herein, for a given dressing, different levels of stress or strain may be applied to the skin at different locations and / or on different subjects. In addition, different levels of force relief may be required for different individuals or different locations on the subject's skin. Therefore, different ranges of dressing force characteristics may be suitable for different skin treatment applications.

[0079] The desired force range can be selected based on determination of the force characteristics desired to be applied for a particular subject, skin portion, and / or for a particular skin treatment purpose. Such a desired force can be high enough to provide therapeutic mechanical conditioning of the skin while being low enough to prevent significant skin irritation.

[0080] The force characteristics of a pre-tensioned dressing may vary over time. An initial strain may be applied to the dressing, wherein the elastic material or other structure of the dressing has an initial tension characteristic. After pre-tensioning, the dressing may be maintained in a tensioned configuration at a particular strain level for an initial period of time. During the initial period of time, the force characteristics of the elastic material may weaken, decay, or show a loss of force. After the initial predetermined period of time, the force characteristics of the elastic material may reach, decrease, or decay to a desired force level and / or range of force levels. At least for a subsequent period of time, the force characteristics of the dressing elastic material may be within a desired range. In some variations, the dressing material may have an elastic modulus in the range of about 1 MPa to about 15 MPa, sometimes in the range of about 1.5 MPa to about 6 MPa, other times in the range of about 2 MPa to about 5 MPa, in the range of about 3 MPa to about 4 MPa, or in the range of about 3.5 MPa to 5 MPa, while having a peak load per width of less than 3 N / mm, sometimes less than about 2.5 N / mm, sometimes less than 2 N / mm, sometimes less than 1 N / mm, sometimes less than about 0.75 N / mm, other times less than about 0.6 N / mm or less than about 0.5 N / mm up to 0.6 strain. The peak load per width at a strain of at least about 0.35 N / mm, sometimes at least about 0.5 N / mm, other times at least about 0.6 N / mm, 0.7 N / mm, 0.8 N / mm, 0.9 N / mm, or 1 N / mm. The material can be selected such that it is capable of maintaining an engineering stress of at least about 200 kPa, 250 kPa, 300 kPa, 400 kPa or 500 kPa, 1000 kPa, 1500 kPa, 2000 kPa, 2500 kPa, 3000 kPa or more at a constant engineering strain of 20% for at least 8 hours with a change or decrease in engineering stress of less than 10% or 5%.

[0081] According to one variation, for example, the initial force or strain characteristics of the dressing may be selected such that a desired range of force values ​​occurs over a period of time with a decreasing percentage loss of force and over a longer period of time.

[0082] The initial strain and / or force level of the dressing may be selected so that the use time falls within a desired time range or period based on the percentage force loss of the dressing over time.

[0083] According to various variations, the dressing may initially produce strain or overstress to provide an initial force per unit width greater than the desired range when applied to the skin. According to variations, the initial strain per width of the dressing and the resulting initial force may be selected based on the desired final and resulting force characteristics and / or the desired time range of the dressing use. This initial strain level may be, for example, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 100% or more. According to variations, the initial force is greater than the desired force range. This initial force level may be, for example, about 25% or up to 25% higher, about 35% or up to 35% higher, about 50% or up to 50% higher, about 75% or up to 75% higher, or more than the force desired when the dressing is applied. This initial force level can be, but is not limited to, for example, in the range of 2 lbs / inch to 5 lbs / inch, in the range of 1.54 lbs / inch to 3.85 lbs / inch, in the range of 1.33 lbs / inch to 3.33 lbs / inch, or in the range of 0.85 lbs / inch to 2.20 lbs / inch.

[0084] According to variations, the dressing can be configured to initially generate strain or tensile stress to a desired strain or force level and remain in the tensioned configuration for an initial time range. According to variations, the initial time range can be, for example, 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more before application. According to variations, in a pre-conditioned state of the material prior to final assembly or manufacture, the initial time range can be 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more. This pre-conditioned state can be to strain the material at a constant strain, or to strain the material at different strain levels.

[0085] Then, according to some variations, the dressing can be configured to maintain a desired minimum final force or force range for a duration of a subsequent predetermined time range after the initial time range. In the subsequent time range, the device can be applied to the subject's skin for treatment. The range of such desired force can be from about 0.5 lbf / inch to 1.0 lbf / inch, 1.0 lbf / inch to 2.5 lbf / inch, or from about 1.6 lbf / inch to 2.1 lbf / inch. During the subsequent time period, the force loss can be up to 3%, up to 5%, up to 8%, up to 10%, up to 15%, up to 20%, up to 25% or more. The duration of the subsequent time period can be, for example, 2 months or longer, 3 months or longer, 6 months or longer, 12 months or longer, 36 months or longer, or 48 months or longer.

[0086] The pre-tensioned dressing may then be coupled to the strain-retaining element during an initial time period. The strain-retaining element may remain on the dressing for a portion of said subsequent time period until it is used.

[0087] According to one variation, for example, an average initial force or strain characteristic of a dressing pre-tensioned at the time of manufacture may be provided (the average may include or may comprise, for example, an average for each manufacturing batch, or a specified average within a given tolerance level) such that a desired range of average force values ​​occurs over a time period, with a reduced percentage of average force loss over that time period and occurring over a longer time period. In other variations, pre-tensioning begins at the point of use. In other variations, a portion of pre-tensioning is performed at the time of manufacture, while additional straining or strain relief is performed at the time of use. After pre-tensioning, the dressing may be packaged, sealed, and sterilized for future use.

[0088] The initial average strain and / or force level of the dressing may be selected so that the use time falls within a desired time range or period based on the average percent force loss of the dressing over time.

[0089] According to various variations, the dressing may initially produce strain or overstress to provide an initial force per unit width greater than the desired range when applied to the skin. According to variations, the average initial strain per width of the dressing and the resulting initial force may be selected based on the desired final and resulting force characteristics and / or the desired time range of the dressing use. This average initial strain level may be, for example, less than 20%, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 100% or more. According to variations, the average initial force is greater than the desired force range. This average initial force level may be, for example, about 25% higher or up to 25%, about 35% higher or up to 35%, about 50% higher or up to 50%, about 75% higher or up to 75%, or more than the force desired when the dressing is applied. This average initial force level can be, but is not limited to, for example, in the range of 2 lbs / inch to 5 lbs / inch, in the range of 1.54 lbs / inch to 3.85 lbs / inch, in the range of 1.33 lbs / inch to 3.33 lbs / inch, or in the range of 0.85 lbs / inch to 2.20 lbs / inch.

[0090] According to variations, the dressing may be configured to initially generate strain or tensile stress to a desired average strain or force level and remain in the tensioned configuration within an initial time range. According to variations, the initial time range may be, for example, 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more before application. According to variations, in a pre-conditioned state of the material prior to final assembly or manufacture, the initial time range may be 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more. This pre-conditioned state may be to strain the material at a constant average strain, or to strain the material at different average strain levels.

[0091] Then, according to some variations, the dressing can be configured to maintain a desired minimum average final force or average force range for a duration of a subsequent predetermined time range after the initial time range. In the subsequent time range, the device can be applied to the subject's skin for treatment. This desired average force range can be from about 0.5 lbf / inch to 1.0 lbf / inch, 1.31 lbf / inch to 1.41 lbf / inch. During the subsequent time period, the average force loss can be up to 3%, up to 5%, up to 8%, up to 10%, up to 15%, up to 20%, up to 25% or more. The duration of the subsequent time period can be, for example, 2 months or longer, 3 months or longer, 6 months or longer, 12 months or longer, 36 months or longer, or 48 months or longer.

[0092] During an initial period of time during one or more manufacturing steps, the pre-tensioned dressing may be coupled to the strain-retaining element. The strain-retaining element may remain on the dressing for a period of time during said subsequent period of time during manufacturing or in shipping or storage until it is used.

[0093] Example I below shows the percent change in force per unit width of selected pre-tensioned dressings after a period of time while maintaining a constant strain under test conditions.

[0094] Embodiment 1:

[0095] In this example, five (5) dressings were strained at 40% and five dressings were strained at 60%. The dressings were made from MED82-5010-10 from NUSILTECHNOLOGY LLC (Carpinteria, CA). The maximum number of particles per piece in the sample that was less than or equal to 0.020" was 5, and the number of surface gels and / or bubbles per piece that was not greater than 0.020" was 5. The sample was initially 8" (±0.02") X 1" (±1"), with a thickness of 0.010". The sample had a hardness value of approximately 50 (Shore A), a tensile strength of approximately 1,450 psi, an elongation of approximately 1000%, and a specific gravity of approximately 1.16. Six inch (6") center gauge marks were added. The gauge length of the 40% strain sample increased to 8.4 inches when strained. The gauge length of the 60% strain sample increased to 9.6 inches when strained. The sample is attached to a sample fixture or clamp in a tensioned configuration with a locking rod between the sample fixtures. The sample fixture is made of acrylic (PMMA) and coated with non-slip tape. When testing, the ends of the sample fixture are attached to the clamps of a tensile tester Chatillon model TCD225, 50LBF load cell. The measurement is then performed after releasing the locking rod. During the test, the sample is stored in the test laboratory at the laboratory ambient temperature. The tension of the dressing is measured at different time intervals. Figure 6 The percentage loss of force over time for each dressing is shown. The initial average post-strain loss after one hour at 60% strain was about 30%, and the initial average post-strain loss after one hour at 40% strain was about 25%. After the initial post-strain loss, unexpectedly, the additional loss after the initial loss decreased at a slower rate and averaged about 15% over a 2-year period (average total loss of 45%).

[0096] In various other embodiments, the maximum number of particles per sheet can be 1, 5, 10, 20 or 25 or more, with a maximum dimension of 0.01", 0.02", 0.040", 0.050", 0.07", or 0.1", and the maximum number of surface gels and / or bubbles can be 1, 5, 10, 20 or 25 or more, with a maximum dimension of 0.01", 0.02", 0.040", 0.050", 0.07", or 0.1". In various other variations, the durometer value of the dressing material can be about Shore A15 to about 90, sometimes about Shore A35 to 75, and other times about Shore A50 to 60, or Shore A50 to 75.

[0097] Example II below illustrates the percent change in force per unit width of selected pre-tensioned dressings after a period of time while maintaining a constant strain under test conditions.

[0098] Example II:

[0099] In this example, 10 dressing films were strained to 45%. The dressing films were made from polyurethane from 3M (St. Paul, MN). The samples were initially 8" (±0.02") X 1" (±1") with a thickness of 0.002". The tensile strength of the samples was approximately 2.2 lbs / inch and the elongation was approximately 300%. Six inch (6") center gauge marks were added. When tensioned, the gauge length of the 45% strain sample increased to 8.7". The samples were attached to a sample fixture or clamp in a tensioned configuration with a locking rod between the sample fixtures. The sample fixtures were made of acrylic (PMMA) and coated with non-slip tape. During testing, the ends of the sample fixtures were attached to the clamps of a tensile tester Chatillon model TCD225, 50LBF load cell. The measurements were then taken after the locking rods were released. During testing, the samples were stored in the test laboratory at ambient laboratory temperature. The tension of the dressing was measured at different time intervals.

[0100] Fig. 9 The percent loss of force over time for each dressing is shown. At 45% strain, the initial average post-strain loss after one day was about 33%. After the initial post-strain loss, unexpectedly, the rate of additional loss after the initial loss was slower and averaged about 12% over 13 days (average total loss of 45%).

[0101] Figure 7 is a graphical representation of the percent loss of force over time of an elastic material of a dressing that is tensioned a predetermined amount and maintained in the tensioned configuration over time. Figure 7 , the dressing and / or dressing material is maintained under constant strain for a period of time. The initial strain can be selected to provide different force loss percentage values ​​at a specific time. The force loss percentage value and the force value may be different due to different initial strain levels and different materials. The curve diagram of a specific dressing material can be determined, for example, as described in Example 1. For a specific material or dressing, as the force loss percentage increases, the force value decreases, and / or for a large number of materials or dressings manufactured with substantially the same pre-tensioning amount, as the average force loss value increases, the force value decreases. At time T0, the material is tightened. During the initial time range T0 to T1, the speed at which the percentage force loss of the material occurs is faster than in subsequent time periods or time ranges (e.g., from T1 to T3, from T1 to T2, and / or from T2 to T3). Time ranges T1 to T3, T1 to T2, and / or T2 to T3 represent exemplary time ranges, which can be selected or not selected based on the required force characteristics of the dressing, the required time of use characteristics, and / or the required force loss rate. For example, a dressing may be pre-strained during manufacture and then stored or shipped for a later use within a specified time frame (eg, T1 to T2, T2 to T3, and / or T1 to T3).

[0102] Figure 8 is a schematic diagram of the forces over time of an elastic material of a dressing that is stretched a predetermined amount and maintained in the stretched configuration over time. Figure 8 , the dressing and / or dressing material is kept under constant strain for a period of time. The initial strain can be selected to provide different force values ​​at a specific time. The force value and the force loss percentage value may be different due to different initial strain levels and different materials. The curve diagram of a specific dressing material can be determined, for example, as described in Example 1. For a specific material or dressing, as the force loss percentage increases, the force value decreases, and / or for a large number of materials or dressings manufactured with substantially the same pre-tensioning amount, as the average force loss value increases, the force value decreases. At time T0, the material is tightened. In the initial time range of T0 to TA, the material loses force at a faster speed than it in a subsequent time period or time range (e.g., from TA to TC, from TA to TB and / or from TB to TC). The time range T0 to TA, TA to TB and / or TB to TC represents an exemplary time range, which can be selected or not selected based on the force characteristics required for the dressing, the required use time of the characteristics and / or the required force loss rate. For example, a dressing may be pre-strained at the time of manufacture and then stored or shipped for a later use within a specified time frame (eg, TA to TB, TB to TC, and / or TB to TC).

[0103] According to some variants, the elastic means may be tensioned at different strain values ​​during pre-treatment.

[0104] Variations of the support devices, strain protection structures, or packages herein may or may not be used as applicators, wherein one or more elements of the package may be used to position and / or apply the dressing to the skin of a subject. Variations of the applicator device with the dressing attached may be pre-tensioned at the time of manufacture and releasably secured in the pre-tensioned configuration using a lock or limiter (e.g., a locking rod or a flexible limiter or band) attached to the applicator. Examples of applicators that can be used with a lock or limiter include those described in co-pending U.S. Patent Publication No. US2011 / 152,738, entitled “Devices and Methods For Dressing Applicators,” the entire contents of which are incorporated herein by reference.

[0105] The devices, kits or methods described herein may include supports, packages, applicators and / or other devices that can: hold, retain or support a pre-tensioned dressing; can be used to prepare a dressing for application; can be used to deliver, orient or apply a dressing; can be used to maintain a dressing in a stressed or tensioned configuration; can be used to stress or strain a dressing; can be used to stress or strain a dressing to a desired degree or within a window of a desired amount of strain, degree of strain or percentage of strain; and / or can be used during or after application of a dressing to provide additional treatment to the skin, wound, incision and / or other treatment location, such as applying pressure to a wound, incision or other treatment location. According to variations, the support device, package or applicator is configured to provide support for the dressing prior to and / or while the dressing is applied to a subject. The dressing support structure described herein may include a structure that directly or indirectly interfaces / interfaces with, supports and / or couples to the back side of the dressing to be applied to the subject. The dressing support may optionally include structure that interfaces / supports and / or couples directly or indirectly with the front side of the dressing to be applied to the subject.

[0106] The support structure may also include, at least in part, a material or structure that is harder or less flexible than the dressing to be applied to the subject. The support structure may include elements or sections that allow flexibility relative to adjacent elements or sections. Such materials may include, for example, plastics (e.g., PVC or acrylic) or cardboard. The elements or sections may be laminates of materials, such as solid bleached sulfate cardboard, with a layer of flexible material between the cardboard layers, such as polysiloxane, polyurethane, low-density polyethylene, rubber materials, or transfer adhesives with or without carriers. The material may also be metal. Such a support structure may be composed of a single substrate, a laminate, or multiple elements that are coupled to each other and / or to the dressing. According to some variations, the support, packaging, or applicator is more rigid or more capable of supporting the dressing in at least one direction, while being flexible in at least one direction, so as to be more conformable / compliantly applied to the curved or shaped skin surface of the subject, or to allow the dressing to be bent or shaped when applied. According to some variations, the support, package or applicator may include segments of relatively more rigid material flexibly coupled to adjacent segments to provide flexibility, thereby allowing the package / applicator and / or dressing to be formed while providing sufficient support for the dressing during application. According to some variations, the segments are coupled to adjacent segments by a flexible material (e.g., a composite of a low density polyethylene (LDPE) material or an adhesive and a thinner, more flexible substrate). Alternatively, the segments may be formed into a structure by manufacturing a substrate having cutouts, slits, grooves, notches or other openings or having a varying substrate thickness at different locations.

[0107] Support, packaging, applicator and / or its elements may have straight, curved or other different profiles to contact directly or indirectly with the body of the subject. Support, packaging device, applicator and / or its elements may be selected or configured to closely match the part of the subject's body contour to which the skin treatment device is to be attached. Support, packaging device, applicator or its elements may be selected or configured to have a profile that is ideal for a specific body position or profile to be placed on the subject's skin for the skin treatment device. Support, packaging device, applicator and / or its elements or sections may be curved, curvilinear, flexible, bendable, ductile, deformable, formable or removable to provide an alternative shape or profile of the attached dressing. They may be relatively curvilinear, curvilinear, pliable, ductile, bendable, deformable, formable or removable in at least one direction, and more rigid in another direction.

[0108] Many wound dressings have a backing, adhesive pad and / or packaging that is removed before applying the wound dressing. Many existing dressings can be difficult to handle when oriented and applied, and have a tendency to fold and adhere to themselves. According to some variations, the backing, support packaging and / or applicator can provide structural support or stability for the dressing when or after releasing the adhesive pad. The packaging and / or applicator can also provide structural support or stability for the dressing when the dressing is oriented and / or applied to the subject's skin. According to some variations, the assembly can be configured to avoid the dressing from folding or bending to the extent that the adhesive on the dressing sticks to itself. The packaging or applicator is configured to orient the device and / or apply the device to the subject's skin with one hand. For example, in some cases, particularly when using longer or larger dressings, the packaging or applicator provides structural support for the dressing so that the user can effectively hold, manipulate and / or apply the prepared dressing with one hand. According to a variation, the applicator and / or packaging can have sufficient support or rigidity to maintain the shape of the dressing, thereby making it easy to manipulate. According to a variation, the applicator may be sufficiently wider and / or sufficiently longer than the dressing, or have a sufficiently larger area, so that it can provide sterile application and / or single-handed application. According to a variation, a support structure is provided for the dressing. According to a variation, a margin is provided as part of the support structure between the dressing or dressing adhesive and one or more edge portions of the support structure. Such margin provides a supported edge or area to grasp or manipulate the dressing or its carrier without necessarily or resulting in a high probability of contact with the adhesive.

[0109] The support, packaging assembly and / or applicator device may include a tension-maintaining structure configured to help maintain the dressing in a pre-tensioned configuration.After a period of time in which the pre-tensioning device is coupled to the support, packaging or applicator, a certain acceptable level of strain may decrease.

[0110] According to one variation, the tension retention structure may include a first attachment portion configured to releasably attach to the dressing and a second attachment portion configured to releasably attach to the dressing, wherein the tension retention structure may be configured to maintain a previously applied separation force between the first attachment portion and the second attachment portion to maintain strain in the dressing attached to the first and second attachment portions. The elastic dressing may be configured to releasably attach to the first and second attachment portions of the dressing and packaging assembly and may include the attachment structure or may be integral with the attachment structure of the packaging device, applicator, or tensioning member.

[0111] Various attachment mechanisms, coupling mechanisms, locking mechanisms, latching mechanisms, or detent mechanisms may be used to hold the dressing and / or package, applicator, or tensioner in various configurations, including, but not limited to, various pre-tensioned or tensioned configurations. By coupling, attaching, or locking the package, applicator, tensioner, or dressing in a tensioned position, a predetermined strain and / or force characteristic for a given dressing may be achieved. The predetermined amount of strain may be based on the desired strain or force characteristic that the dressing will apply to the skin after application. After application to the skin, the strain may relax by a certain amount or percentage.

[0112] The support, packaging device and / or applicator, or the dressing or dressing assembly may include any attachment structure for attaching or coupling the support, packaging and / or applicator to the dressing or dressing assembly. The attachment feature or structure of the dressing device may be integral with the attachment structure of the support, packaging, applicator and / or its elements or include any attachment structure or structure corresponding to the attachment structure. Such releasable attachment structures may include, but are not limited to, attachment tabs, adhesives, pouches and tabs, hook and loop mechanisms, hooks, corner bars, adhesives, pins, drawstrings, towel bar configurations, sliding pins, friction locks, cam locks, vacuum or suction devices, snap connectors, carpet tacks, press-fit connections or other connections, cuttable, tearable or otherwise severable structures that allow the dressing to be removed from the support, packaging and / or applicator.

[0113] According to some variations, the package and / or applicator provides a release mechanism to separate the applied dressing from the support, package and / or applicator after the dressing is applied to the skin. The release mechanism may be configured to facilitate separation, release, removal or detachment of the attachment structure attaching the dressing to the support, package, applicator or its parts, including but not limited to the separation device and method described herein. The dressing release device may include, for example, a high-viscosity removable adhesive, such as a pressure-sensitive adhesive. For example, a polysiloxane dressing may have an acrylic pressure-sensitive adhesive that will not be permanently bonded to the polysiloxane. The dressing release device may include, for example, a tear strip, one or more perforated or pre-folded areas, a cutting member or a tearable material. The release mechanism may also include, but is not limited to, pivoting, rolling, shaking or sliding features associated with or connected to the attachment structure. They may be self-releasing latches or spring members. They may be actuated when the pressure member is applied to the skin treatment device before removing the applicator. They may be manually actuated. These mechanisms may include, for example, levers, latches, locking members, spring members, or other mechanisms such as cutters or pull cords, or other structures or features to facilitate tearing, cutting or separation of attached structures or elements.

[0114] According to some variations, an applicator can be further used to help reduce bleeding, for example, by allowing the use of a supporting structure to apply compression force to help reduce bleeding when or after the device is applied. One or more hemostatic agents or coagulants can be applied to the dressing, or otherwise integrated with the dressing to help reduce bleeding. Potential reagents include chitosan, calcium-loaded zeolites, microfibrillar collagen, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, coagulation factors (e.g., II, VII, VII, X, XIII, VonWillebrand factor), procoagulants (e.g., propyl gallate), antifibrinolytic agents (e.g., ε-aminocaproic acid), etc. In some variations, the reagent can be freeze-dried and integrated into the dressing, and activated / activated when in contact with blood or other fluids. In some further variations, before the dressing is used for a subject, an activator can be applied to the dressing or treatment site. Still in other embodiments, the hemostatic agent can be applied to the wound separately and directly before applying the dressing, or the hemostatic agent can be applied to the wound separately and directly through a catheter or tube after applying the dressing. The device may also include one or more other activators / active agents, which can be any suitable activators that help in some aspects of the wound healing process. For example, the activator can be a drug compound, a protein (e.g., a growth factor), a vitamin (e.g., vitamin E), or a combination thereof. Other examples of such drugs may include, but are not limited to, various antibiotics (including, but not limited to, cephalosporins, bacteriocins (bactitracin), polymyxin B sulfate (polyxyxin B sulfate), neomycin, polysporin), antibacterial agents (e.g., iodine solution, silver sulfadiazine, chlorhexidine), antifungal agents (e.g., nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (e.g., vascular endothelial growth factor (VEGF)) and other therapeutic agents (e.g., botulinum toxin). Of course, the device may include more than one drug or agent, and the device may deliver one or more drugs or agents.

[0115] In some variations, a dressing is provided that includes an elastic member, such as an elastic sheet structure (e.g., including polysiloxane polyurethane, TPE (thermoplastic elastomer), synthetic rubber or copolyester material), the elastic sheet structure including an upper surface, a lower surface, a first edge and a second edge opposite to the first edge, and one or more adhesive regions. The dressing may also include a first release liner releasably attached to one or more adhesive regions. The adhesive region may include a pressure-sensitive adhesive. The dressing may be tapered or otherwise formed to reduce skin tension at the edge. The dressing may have an improved, reduced amount or no adhesive near its edge to reduce skin tension at the edge. Some portions of the dressing may be strain-free / untightened, thereby reducing the strain of certain areas of the skin to which the dressing is applied. In some specific examples, one or more non-strained regions are found between the edge and the strained region of the dressing. In some further examples, the non-strained region is limited to the region, and the non-strained region is not found to exist between the strained regions of a single dressing in use during application or use. In other examples, the unstrained region is limited to an area along an edge of the dressing that intersects the strain axis of the strain region, but is not limited to an area along an edge of the dressing that is generally parallel to the strain axis.

[0116] The elastic material of the dressing may include a single layer of material or multiple layers of the same or different materials. The material may have any one of a variety of configurations, including solid, foam, mesh or braided configurations. The elastic material may be a biocompatible polymer, such as polysiloxane, polyurethane, TPE (thermoplastic elastomer), synthetic rubber or copolyester material. The thickness of the polymer sheet (such as a polymer sheet or a shape memory polymer sheet) may be selected so that the dressing has enough load-bearing capacity to obtain the desired recoverable strain and prevent the dressing from producing an undesirable creep amount over time. In some variations, the thickness across the dressing is uneven, such as the thickness across the dressing may vary to change hardness, load-bearing capacity or recovery strain in a selected direction and / or position. The thickness of the elastic material of the exemplary dressing may be in the range of about 50 microns to 1 mm or more, in the range of about 100 microns to about 500 microns, in the range of about 120 microns to about 300 microns, or in some variations in the range of about 200 microns to about 260 microns. An exemplary dressing may have an edge thickness of about 500 microns or less, 400 microns or less, or about 300 microns or less, with a lower risk of skin separation due to inadvertent lifting when accidentally rubbed against clothing or objects. In some variations, the dressing may taper near the edge to reduce thickness. The tapered edge may also improve the peak tension acting on the skin tissue near the adhesive edge of the dressing. This may or may not reduce the risk of skin blistering or other skin damage associated with tension. In other variations, the edge of the dressing may be thicker than the middle of the dressing. It is assumed that in some configurations, a thicker dressing edge may provide a relative inward movement of the peak tension position acting near the edge of the dressing compared to a dressing of uniform thickness. When the dressing is applied to the skin, the elastic material may have a load per width of at least 0.35 Newtons per millimeter, or a load per width of at least 0.25 Newtons per millimeter, or a load per width of at least 0.10 Newtons per millimeter. When the dressing is applied to the skin, the elastic material may have a load per width of no more than about 2 Newtons per millimeter, about 1 Newton per millimeter, about 0.7 Newtons per millimeter, or no more than about 0.5 Newtons per millimeter. The system elastic material may have a load per width that does not decrease from 0% to 60% engineering strain, a load per width curve that increases linearly from 0% to 60% engineering strain, or a load per width curve that does not bulge from 0% to 60% engineering strain. The elastic material may include an adhesive configured to maintain a substantially constant stress in the range of 200 kPa to about 500 kPa for at least 8 hours when strained to an engineering strain of about 20% to 30% and attached to a surface. The dressing may include an adhesive on the elastic material configured to maintain a substantially constant stress in the range of 200 kPa to about 400 kPa for at least 8 hours when strained to an engineering strain of about 20% to 30% and attached to a surface.The substantially constant stress may vary by less than 10% over at least 8 hours, or by less than 5% over at least 8 hours.

[0117] Although the dressing may have a generally rectangular configuration with a size of about 160 mm to about 50 mm, in other variations, the dressing may have various lengths and widths and may include various other shapes. In addition, for example, the corners of the dressing may be square or rounded. The length and / or width of the exemplary dressing may be in the range of about 5 mm to about 1 m or more, in some variations about 20 mm to about 500 mm, in other variations about 30 mm to about 50 mm, and in yet other variations about 50 mm to about 100 mm. In some variations, the ratio of the maximum dimension of the dressing (e.g., its length) to the orthogonal dimension (e.g., width) orthogonal to the maximum dimension (excluding the minimum dimension of the dressing (e.g., thickness)) may be in the range of about 1:1, about 2:1, about 3:1, about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, or about 10:1 or more. In some variations, the strain axis of the dressing in use can be oriented relative to the maximum dimension or relative to an orthogonal dimension of the maximum dimension. In some variations, the final compressive stress and strain applied by the elastic material on the skin may be the result of a dynamic balance between the tensile stress in the skin and the elastic material of the dressing. The elastic material and the adhesive area can be configured to be applied to the skin location so that when the dressing is stretched to a specific tension and then adhered to the skin site, the tensile stress in the dressing is transmitted to the skin site to compress the tissue directly below the dressing along the tangential axis of the skin surface, and the stress and strain applied to the skin site have a net or synthetic orientation or axis, which is also approximately tangential or coplanar with the outer surface of the elastic material and / or the skin site, with an axis similar to the orientation or axis of the tensile stress in the dressing. The tension in the dressing will relax to a tension level that is balanced with the increased tension in the skin near the dressing. Applying the dressing to the skin location may include placing the dressing without overlapping or wrapping around itself, such as where only adjacent areas of the dressing are interconnected, and where non-adjacent areas of the dressing are not interconnected. For example, the actual amount of stress and strain applied to the skin can vary depending on the specific person, skin location, thickness of the skin layer (e.g., epidermis, dermis, or underlying connective tissue) or various mechanical properties and / or the extent of pre-existing scars. In some further variations, the skin treatment dressing can be selected or configured for specific body locations, such as the scalp, forehead, cheeks, neck, upper back, lower back, abdominal area, upper trunk (including but not limited to breast folds), shoulders, upper arms, lower arms, palm areas, back of hands, fingers, thighs, calves, insteps or soles of feet and / or toes. Where applicable, some body regions can be further divided into front, back, middle, side, proximal and / or distal regions, such as arms and legs.

[0118] The dressing may be configured to apply skin strains ranging from about 10% or less to about 60% or more, in other configurations, from about 15% to about 50%, and in other configurations, from about 20% to about 30% or about 40%. In order to achieve the desired degree of skin strain, the dressing may be configured to withstand elastic tensile strains ranging from about 20% to about 80% or more, sometimes from about 30% to about 60%, and other times from about 40% to about 50% or about 60%. The dressing may include any of a variety of elastic materials, including but not limited to polysiloxanes, styrene block copolymers, natural rubber, fluoroelastomers, perfluoroelastomers, polyether block amides, thermoplastic elastomers, thermoplastic polyurethanes, polyisoprene, polybutadiene, and the like. The material of the exemplary dressing may have a Shore A hardness ranging from about 20 to about 90, from about 30 to about 80, or from about 50 to about 80. An exemplary dressing is comprised of MED 82-5010-05 (MED 4050) from NUSIL TECHNOLOGY LLC (Carpinteria, CA). Other examples of suitable materials are described in U.S. Patent Application No. 11 / 888,978, which was previously incorporated herein by reference in its entirety. Other exemplary materials include DUPONT TM LIVEO TM QP1-60 polysiloxane elastomer (DuPont; Wilmington, Germany) or LAIMEISI polysiloxane elastomer (Shenzhen Laimeisi Polysiloxane Industrial Co., Ltd.; Shenzhen, China).

[0119] When the dressing is applied to a skin site and allowed to at least partially recover to its basic configuration, the recovery level or equilibrium level of strain in the dressing may be in the range of about 10% or less to about 60% or more, about 15% to about 50% in other configurations, and about 20% to about 30% or about 40% in other configurations. The ratio between the initial engineering tensile strain applied to the dressing before recovery and the engineering compressive strain generated in the skin can vary depending on the skin type and location, but in some examples, it can be about 2:1. In other examples, the ratio can be in the range of about 4:1 to about 5:4, about 3:1 to about 5:3, or about 5:2 to about 2:1. These skin strain characteristics can be determined relative to a reference position (e.g., an anatomical position) of the body or body part to facilitate reproducible measurements. A particular degree of strain can be characterized as an engineering strain or a true strain, but can be calculated or converted from other types of strains based on or without other types of strains (e.g., strain can be based on a 45% engineering strain converted to a true strain).

[0120] In some further variations, one or more properties of the elastic material may correspond to various features on the material stress / strain curve. For example, the engineering and true stress / strain curves of a specific example of a dressing include a material that exhibits an engineering stress of about 1.2 MPa at about 60% engineering strain during the initial strain time period. In other examples, the engineering stress during the initial strain time period can be in the range of about 900 KPa to about 2.5 MPa, about 1 MPa to about 2.2 MPa, about 1 MPa to about 2 MPa, about 1.1 MPa to about 1.8 MPa, about 1.1 MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When the dressing is unloaded or relieved of stress, the material can be configured to have an engineering stress of about 380 KPa at about 40% engineering strain, but in other examples, the engineering stress during the time period when the material is unloaded to about 40% strain can be in the range of about 300 KPa to about 700 KPa, about 325 KPa to about 600 KPa, about 350 KPa to about 500 KPa, or about 375 KPa to about 425 KPa. When the material is unloaded to about 30% engineering strain, the material exhibits an engineering stress of about 300 KPa, but in other examples, when the material is unloaded to about 30% strain, the engineering stress can be in the range of about 250 KPa to about 500 KPa, about 275 KPa to about 450 KPa, about 300 KPa to about 400 KPa, or about 325 KPa to about 375 KPa. When unloaded to an engineering strain of about 20%, the material may have an engineering stress of about 100 KPa, but in other examples, the unloaded engineering stress at about 20% may be in the range of about 50 KPa to about 200 KPa, about 75 KPa to about 150 KPa, or about 100 KPa to about 125 KPa. According to some variations, the thickness of the material may be greater or less due to certain factors, and the engineering stress may be similarly considered, i.e., for example, the engineering stress increases as the material becomes thinner. In some examples, the material may be configured to achieve at least a specific range or level of engineering stress at each of the above-specified engineering strain levels, but in other examples, the material may be configured to have a lower level of maximum engineering strain during the initial strain time period, such as up to about 30% or about 40%, or to have a higher maximum engineering strain and a higher engineering stress during the initial strain time period, such as an engineering strain greater than 60%.

[0121] In some examples, certain portions of the stress / strain curve may have a particular morphology. For example, for a particular level of maximum strain at the initial strain, the load curve is typically linear on the corresponding true stress / strain curve. In examples using the dressings described herein, the load curve had a substantially linear configuration until approximately 45% of the true strain. In other examples, the configuration may be linear along only a portion of the load curve, or may be curved along the entire load curve. In the case where the load curve is nonlinear, the load curve may be convex, concave, or both. In addition, in some examples, the tangents to the load curve (i.e., the line between the two triangles) may also be substantially collinear.

[0122] In some variations, the elastic material may include a material having an elastic modulus E of at least about 1 MPa, about 1.5 MPa, about 2 MPa, about 2.5 MPa, about 3 MPa, about 3.5 MPa, about 4 MPa, about 5 MPa, about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa, about 10 MPa, about 11 MPa, about 12 MPa, about 13 MPa, about 14 MPa, or at least about 15 MPa or more. The material elastic modulus E may be no greater than about 20 MPa, about 15 MPa, about 10 MPa, about 9 MPa, about 8 MPa, about 7 MPa, about 6 MPa, or about 5 MPa, or about 4 MPa.

[0123] In addition to the absolute stress levels at specific strain levels described above, materials can also be characterized based on the ratio between a) the stress at a specific strain during loading and b) the stress at the same strain during unloading. For example, at each of the strain levels of 20%, 30%, and 40%, the material can have a ratio of at least 4:1 to about 3:2, but in other examples, the material can exhibit these ratios only at strain levels of 20%, 30%, or 40%, or at both 20% and 30% but not 40%, or at both 30% and 40% but not 20%. In other examples, the ratio at one, some, or all strain levels can be in the range of about 3:1 to about 2:1, or about 5:2 to about 2:1.

[0124] In some examples, the elastic material of the dressing can be configured under test conditions to achieve a stable stress level at a constant strain, for example, the material exhibits a limited amount of stress relaxation at a specific time period and a specific strain level. The time period can be at least about 8 hours, about 12 hours, about 18 hours, about 24 hours, about 36 hours, about 48 hours, about 72 hours, about 4 days, about 5 days, about 6 days, or about a week or longer. The strain level can be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, or about 80% or more. The stress of the exemplary dressing on various time curves can be configured to maintain an engineering stress of about 300KPa at an engineering strain of about 30% for about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, or about 8 hours or more, without significant deviation. The stress at 10% strain, 20% strain, and 40% strain may be lower or higher.

[0125] In some variations, the elastic material or dressing can be configured under test conditions to maintain a specific minimum stress level while being held at a constant strain for a specific period of time. In an example of evaluating the ability of a backing material to maintain stress and strain on the skin over time, the engineering strain was measured while each backing material was stretched to 60% strain at a rate of 100 microns per second for 10 minutes and then reduced to 30% strain at a rate of 100 microns per second for 9 hours. For example, the exemplary dressing was able to maintain an engineering stress level of approximately 350 KPa at an engineering strain of 30%. In some other examples, the minimum stress level can be about 100 KPa, about 120 KPa, about 140 KPa, about 160 KPa, about 180 KPa, about 200 KPa, about 220 KPa, about 240 KPa, about 260 KPa, about 280 KPa, about 300 KPa, about 320 KPa, about 340 KPa, about 360 KPa, about 380 KPa, about 400 KPa, about 420 KPa, about 440 KPa, about 460 KPa, about 480 KPa, about 500 KPa, about 600 KPa, about 700 KPa, about 800 KPa, about 900 KPa, or about 1000 KPa or more. In other configurations, the constant strain level can be different, having a level of about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75% or about 80%. The time period that the dressing can maintain the stress level can be at least about 2000 seconds, about 3000 seconds, about 4000 seconds, about 5000 seconds, about 6000 seconds, about 7000 seconds, about 8000 seconds, about 9000 seconds, about 10000 seconds, about 20000 seconds, about 30000 seconds, about 40000 seconds, about 50000 seconds, about 60000 seconds, about 7000 seconds, about 24 hours, about 36 hours, about 48 hours, about 72 hours, about 4 days, about 5 days, about 6 days, about 7 days, about 10 days, about two weeks, about one month or more. In some variations, the dressing, elastic material and / or adhesive material is configured to present a stress or strain level change of less than about 15% over a specific period of time when applied to a skin surface or a test surface. In other examples, the degree of variation can be about 12%, about 10%, about 8%, about 6%, about 5%, about 4%, about 3% or about 2% or less. Stress or strain can be engineering stress or strain, and / or true stress or strain. In some variations, the dressing includes an elastic sheet structure (e.g., a polysiloxane sheet) having an upper surface, a lower surface, a first edge and a second edge relative to the first edge, and one or more bonding areas. The dressing may also include a first release liner releasably attached to one or more bonding areas. The bonding area may include a pressure-sensitive adhesive. The dressing may be tapered or otherwise shaped to reduce skin tension at the edge.The dressing may have improved, reduced or no adhesive near its edges to reduce skin tension at the edges. Portions of the dressing may be untensioned and thereby reduce skin strain in certain areas where the dressing is applied. In some specific examples, one or more untensioned areas are located between an edge of the dressing and a tensioned area. In some further examples, the untensioned area is limited to this area and is not located between tensioned areas of a single dressing in use during application or use. In still further examples, the untensioned area is limited to areas along the edge of the dressing that intersect the strain axis of the tensioned area, but does not include areas along the edge of the dressing that are generally parallel to the strain axis.

[0126] The adhesive for attaching the dressing to the skin can be, for example, a pressure activated adhesive (PSA), such as polysiloxane, acrylic acid, styrene block copolymers, vinyl ether, nitrile or other PSA. In other variations, non-pressure sensitive adhesives can be used, including but not limited to heat-cured or light-cured adhesives. Pressure sensitive adhesives can be made of, for example, polyacrylate-based, polyisobutylene-based, polysiloxane-based pressure sensitive adhesives, etc. The T-peeling peel force and blunt probe adhesion of adhesive can be measured by standard test methods such as ASTM D1876 and ASTMD2979 or other suitable methods. In some variations, the T-peeling peel force or blunt probe viscosity test value of adhesive is configured to maintain a load of at least about 50MPa / mm in at least about 24 hours, about 48 hours, about 72 hours, about 1 week, about 2 weeks, about 3 weeks, about 4 weeks or longer. In other variations, in a specific time period, the load can be at least about 75MPa / mm, about 100MPa / mm, about 125MPa / mm or at least about 150MPa / mm. The degree of adhesion (e.g., as measured by T-peel peel force or blunt probe tack test values) can vary depending on the degree of strain applied to the skin or incision site, and in some variations, these time periods can be based on an average skin strain of about 10%, about 20%, about 30%, about 40%, or about 50% or more. In some variations, the adhesive may have a T-peel release force of at least about 150 kg / m, about 160 kg / m, about 170 kg / m, about 180 kg / m, about 190 kg / m, about 200 kg / m, about 210 kg / m, about 220 kg / m, about 230 kg / m, about 240 kg / m, about 250 kg / m, about 260 kg / m, about 270 kg / m, about 280 kg / m, about 290 kg / m, about 300 kg / m, about 310 kg / m, about 320 kg / m, about 330 kg / m, about 340 kg / m, about 350 kg / m, about 400 kg / m, about 450 kg / m, or at least about 500 kg / m or more. In some further modifications, the T-peeling peeling force can be no more than about 1000 kg / m, about 900 kg / m, about 800 kg / m, about 700 kg / m, about 600 kg / m, about 500 kg / m, about 400 kg / m or about 300 kg / m. The blunt probe tack test value of adhesive can be at least about 0.50 kg, about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg or about 0.75 kg or higher, and can be no more than about 1 kg, about 0.9 kg, about 0.8 kg, about 0.7 kg or about 0.6 kg. T-peeling peeling force and blunt probe adhesion can be measured by standardized test methods such as ASTM D1876 and ASTMD2979 or other suitable methods.Other features or variations of the device are described in US Application No. 11 / 888,978, filed August 3, 2007, the entire contents of which are incorporated herein by reference.

[0127] The release liner that protects the skin adhesive prior to application may comprise any of a variety of materials, including opaque and transparent materials. The release liner may comprise Mylar or paper, or any other material that has reduced adhesion to the adhesive material of the device. In variations where the device has multiple separate adhesive areas, a separate release liner may be provided for each area, or some areas may be covered by the same release liner.

[0128] The dressing packaging device, dressing support and / or dressing applicator may also include a tensioning device configured to stress and / or tighten the dressing before applying the dressing to a subject. The device may be used to tighten the dressing and / or maintain strain on the dressing.

[0129] Reference Figure 1A , shows a dressing 110 in a first configuration, wherein the dressing 110 is relatively strain-free / untensioned. The dressing 110 may include an elastic sheet 160, such as a silicone sheet or other elastic material, such as described herein, wherein one or more adhesive regions include a skin adhesive layer 140. The adhesive 140 may be provided in a manner such as Figure 1A The adhesive may be applied before or after the dressing 110 is stretched as shown. The adhesive used may be, for example, a suitable pressure sensitive adhesive (PSA) or a non-pressure sensitive adhesive.

[0130] The dressing 110 may be in an untensioned configuration ( Figure 1A ) is coupled to the outer surface 132 of the support structure 130 at the sides 135, 136 of the support structure 130 by a high tack adhesive at its edges or sides 105, 106. Adhesive 125 may be applied to the inner surface 131 of the support structure 130 between the sides 135, 136 of the support structure 130 to which the dressing 110 will be attached. Adhesive 125 may be continuous or discontinuous. Other attachment structures as described herein may additionally or alternatively be used to attach the dressing 110 to the support structure 130 in a tensioned configuration. The dressing 110 may be tensioned by pulling apart the edges or sides 135, 136, pushing the peak or central region 170 of the support structure 130 toward the dressing 110 or not, straightening the support structure 130, and applying pressure to the dressing 110 against the adhesive 125 to secure the dressing in a stressed configuration. For example, the clamps may be attached to the support structure 130 at the opposing sides 135 , 136 and then the two clamps may be pulled apart to tighten the dressing and straighten the support structure 130 .

[0131] The support structure 130 and adhesive 125 (or other attachment structure) enable the dressing 110 to maintain its taut configuration, such as Figure 1B and 1C As shown. A skin adhesive layer 140 may be applied to the top surface 111 of the dressing 110, and a removable liner 150 is placed on the adhesive layer 140. Thus, this process forms a pre-tensioned dressing 110 having a pre-attached, untensioned adhesive layer 140, but in other variations, the adhesive layer 140 may be applied prior to the pre-tensioning process, thereby forming a pre-tensioned dressing 110 having a pre-tensioned adhesive layer 140. In some variations, unlike conventional release liners for adhesive dressings that include paper or polymer films, the removable liner 150 includes an elastic material that may be attached to the adhesive layer 140 and the dressing 110 prior to tensioning, and then pre-tensioned together with the adhesive layer 140 and the dressing 110. In other variations, an adhesive may be pre-applied to the release liner, and then the combined release liner and adhesive layer are attached to the dressing.

[0132] In use, the adhesive liner 150 is removed and the dressing 110 is applied to the skin surface of the subject. The support structure 130 can then be removed from the dressing 110, at which point the stress or strain of the dressing causes the skin to stretch and / or apply a compressive force to the skin and / or compressively stretch the skin, thereby treating the skin. The liner 150 can also provide support, at least in part, to maintain the strain in the dressing 110.

[0133] The support structure 130 may be removed from the dressing 110 by peeling the support structure 130 from the dressing 110, wherein the adhesion between the dressing 110 and the support structure 130 is less than the adhesion between the dressing 110 and the skin to which it is applied. Alternatively, the dressing 110 may include a support structure 130 as further described herein (e.g., as described in reference to Figures 3A to 3I The release mechanism of the present invention is as follows.

[0134] Reference Figure 2A, a dressing 210 is shown in a first configuration, wherein the dressing 210 is relatively untensioned. The dressing 210 may include an elastic sheet, such as a silicone sheet or other elastic material, such as described herein, wherein one or more adhesive regions include a skin adhesive layer 240. The adhesive used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive. The dressing 210 may be coupled to the inner surface 231 of the support structure 230 at its edges or sides 205, 206 by a high tack adhesive 220 at the sides 235, 236 of the support structure 230. A relatively continuous layer of the high tack adhesive 220 may be applied to the inner surface 231 of the support structure 230 between the sides 235, 236 of the dressing 210 at which the dressing 210 will be attached to the inner surface 231 of the support structure 230. For example, as described herein, other attachment structures may be used additionally or alternatively to attach the dressing 210 to the support structure 230 in a tensioned configuration. The dressing 210 may be tightened by pulling the two edges or sides 235, 236 of the support structure 230 apart, straightening the support structure 230, and applying pressure to the dressing 210 against the adhesive 220. For example, a clamp may be attached to the support structure 230 at the two opposing edges 235, 236, and then the clamp may be pulled apart to tighten the dressing 210 and straighten the support structure 230. The support structure 230 and the adhesive 220 (or other attachment structure) may hold the dressing 210 in its tightened configuration, such as Figure 2B A skin adhesive layer 240 can be applied to the top surface 211 of the dressing 210, and a removable liner 250 is placed on the adhesive layer 240. The adhesive liner 250 can also at least partially provide support to maintain strain in the dressing 210.

[0135] In use, the liner 250 is removed and the dressing 210 can be applied to the skin surface of a subject. The support structure 230 can then be removed from the dressing 210, at which point the stress or strain of the dressing applies a (tangential) compressive force to the skin, thereby treating the skin.

[0136] The dressing 210 may include as further described herein (e.g., as described in reference Figures 3A to 3I Description) of the release mechanism.

[0137] Reference Figures 3A to 3I , showing the manufacture of a pre-tensioned assembly 351 including a pre-tensioned dressing. Figures 3A to 3D A tensioning device 341 for pre-tensioning a dressing is shown in use. Figures 3E to 3I Various features and stages of making the pre-tensioning assembly 351 are further illustrated.

[0138] The pre-tensioning assembly 351 may include a dressing assembly 308 and a strain retention structure or support structure 330 (see Fig. 3I). The pre-tensioning assembly 351 may be stored for a period of time before use.

[0139] The dressing assembly 308 may include a dressing 310 including a relatively flat elastic sheet 360 defining a plane. For example, the elastic sheet 360 may include a silicone sheet or other elastic material as described herein. The dressing assembly 308 may also include an attachment sheet 304, a tensioning sheet 307, a pretensioning assembly release 352, and a dressing release 319.

[0140] The attachment sheet 304 may be configured to attach the dressing 310 to the support structure 330 via the engagement element 322. The attachment sheet 304 of the dressing assembly 308 may include a first engagement wall or element 322 extending downwardly relative to the plane of the dressing 310 and including an inwardly extending hook 323. The engagement element 322 may be attached to the attachment sheet 304, for example, with an adhesive. The tensioning sheet 307 of the dressing assembly 308 may include a second engagement element 324 extending downwardly relative to the plane of the dressing 310 and including an inwardly extending hook 325. The tensioning sheet 307 may be configured to attach the dressing 310 to the support structure 330 via the engagement element 324. The engagement element 324 may be attached to the tensioning sheet 307, for example, with an adhesive. The tensioning sheet 307 may also be configured to transfer tension from the tensioning device 341 to the dressing 310 to tighten the dressing 310.

[0141] The pretensioning assembly release 352 can be configured to release the pretensioning assembly 351 (dressing 310 and support structure 330) from the tensioning device 341 (see, e.g., Figure 3E and 3I ). The dressing release mechanism 319 may be configured to release the dressing 310 from the engagement elements 322, 324 (including the hooks 323, 325), and thus release the dressing 310 from the support structure 330. The dressing release mechanism 319 may be configured to release the dressing 310 after the dressing 310 is applied to a subject.

[0142] The dressing 310 of the dressing assembly 308 may include a first edge or side 305 having a length, and a second edge or side 306 of a specific length. The dressing 310 may be coupled to an attachment sheet 304 at the first edge or side 305, which may be flexible but less elastic or inelastic relative to the dressing 310. The attachment sheet 304 may have a first side 382 and a second side 384. When assembled, the attachment sheet 304 may be bonded to the elastic sheet 360 of the dressing 310 at a section 375 of the attachment sheet 304 located at or near the side 382 of the attachment sheet 304, for example, using a combination of a silicone PSA / acrylic PSA to achieve the bonding. The attachment sheet 304 may be coupled to the engagement element 322 and the hook 323 at its side 384, for example, by bonding with an adhesive material, for example, using a combination of a silicone PSA / acrylic PSA. The attachment sheet 304 may couple the dressing 310 to a support 330 near a first side 305 of the dressing 310 via an engagement element 322 and a hook 323. The dressing 310 may be coupled at its second edge or side 306 to a tension sheet 307, which may be flexible but not elastic or less elastic than the dressing 310. The tension sheet 307 may have a first side 372, a middle location 373, and a second side 374. When assembled, the tension sheet 307 may be bonded to the elastic sheet 360 of the dressing 310 at a section 365 of the tension sheet 307 located at or near the side 372 of the tension sheet 307, for example, using a combination of a silicone PSA / acrylic PSA. The tension sheet 307 may be coupled to the sidewall 324 and hook 325 at the middle location 373, for example, by bonding with an adhesive material, for example, using a combination of a silicone PSA / acrylic PSA. When assembled into the pretensioning assembly 351, the tensioning sheet 307 can couple the dressing 310 to the support structure 330 near the second side 306 of the dressing 310 through the sidewall 324 and the hook 325. The tensioning sheet 307 can be loaded onto the tensioning device 341 at the second side 374, as described in more detail herein. According to some variations, the attachment sheet 304 or the tensioning sheet 307 can be made of, for example, low-density polyethylene.

[0143] Dressing assembly 308 Figure 3A 308 to the dressing assembly 308 can be removably attached to the support structure 330 when or after the dressing 310 is pre-tensioned to form the pre-tensioned assembly 351. The support 330 can be generally planar and include sides 335, 336 having respective edges 335a and 336a defining their lengths. Other support elements, support structures, and / or strain retention elements can be used, for example, the sides of the dressing 310 or the dressing assembly 308 can be clamped and the desired distance between the clamps can be maintained, for example, using separation elements.

[0144] The dressing 310 of the dressing assembly 308 may be applied by, for example, Figures 3A to 3D The pre-tensioned dressing 310 may then be stored in the pre-tensioned configuration for a period of time prior to use. The tensioning device 341 may be used at a point of manufacture, by an intermediary, or by an end user. The tensioning device 341 may include a planar portion 343 and a circular portion 344 configured to contain a rotating element 345. The rotating element 345 may have a middle portion 346 with a groove 347 to receive and engage the tensioning sheet 307 of the dressing assembly 308.

[0145] exist Figure 3A , the dressing assembly 308 can be shown in a first configuration on the tensioning device 341 in which the dressing assembly is relatively untensioned. The dressing assembly 308 can be positioned above the support structure 330. The support structure 330 can be positioned above the tensioning device 341 with the upper surface 333 of the support structure 330 facing / engaging with the back surface 311 of the dressing 310. The first edge 335a of the support structure 330 and the first side or edge 349 of the planar portion 343 of the tensioning device 341 can be engaged and retained by the engagement wall 322 and the hook 323. The second end 336 and edge 336a of the support 330 can be initially not engaged with the dressing 310, but in a mutually facing position with the dressing 310. This can allow the dressing 308 to be strained / tensioned to a desired degree without interference from the support structure 330.

[0146] In use, the end 374 of the tensioning sheet 307 may be inserted into the slot 347 of the middle portion 346 of the rotating element 345 of the tensioning device 341. The rotating element 345 may then be rotated until the tensioning sheet 307 is engaged. Initially, when attached to the tensioning device 341, the tensioning sheet 307 and the dressing 310 may be in an untensioned configuration, but with minimal slack. As the rotating element 345 is rotated, the dressing 310 may be tensioned / strained as the tensioning sheet 307 is pulled by the rotating element 345 relative to the dressing 310 in the direction of the tensile strain.

[0147] The dressing 310 may be tightened by rotating the rotating element 345, such as Figures 3A-3D After the tensioning sheet is loaded due to the rotation of the rotating element 345, the tensioning sheet 307 can bend around the rotating element 345, thereby shortening the distance between the rotating element 345 and the dressing 310 to stretch or tighten the dressing 310. The locking mechanism including the ratchet 337 on the rotating element 345 and the pawl 338 on the circular portion 344 can be used to lock the dressing 310 in a position such as Figures 3B to 3DWhen the tensioning sheet 307 is pulled toward the circular portion 344 of the tensioning device 341 in the tensile strain direction, the engaging element 324 and the hook 325 may also move in the tensile strain direction. The edge 336a of the support member includes a slope 336b, which can engage with the slope 326 on the hook 325 to guide the edge 336a of the support member 330 to engage with the hook 325 when the hook 325 moves toward the circular portion 344 of the tensioning device. (See Figures 3C to 3H ). The strain of the pre-tensioned dressing 310 can be controlled or determined using measuring elements or markings 342 on the rotating element 345, and the distance between each measuring element or marking can correspond to an increment of increased strain or distance. After the dressing assembly 308 is loaded onto the tensioning device 341, the strain can be determined by the amount that the rotating element 345 is rotated. Each marking 342 can correspond to a percentage strain or distance. 0% strain can be identified as the position when the dressing assembly 308 is loaded onto the tensioning device 341 with no slack and with minimal strain or tension. Figure 3A As shown, the 0% position can be displayed, where the mark 342a is aligned with the detent 338. As the rotating element 345 rotates, the identified 0% mark 342a can rotate a certain angle corresponding to the strain percentage. When the dressing is tightened to the desired amount x represented by the mark 342b, as shown in FIG. Figure 3B As shown, the mark 342b is aligned with the detent 338.

[0148] The support structure 330 can maintain the dressing 310 in its Figures 3B to 3IIn the tensioned configuration shown, wherein the engagement elements 322, 324 and hooks 323, 325 engage the support structure 330, movement or strain loss of the dressing 310 is prevented. One or more adhesive regions including a skin adhesive layer 340 may be applied to the top surface 312 of the dressing 310. The adhesive 340 used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive. The adhesive 340 is shown to be located on the dressing 310 in an untensioned configuration. However, the adhesive may be applied to the dressing 310 after the dressing 310 has been tensioned. A removable liner 350 may be placed on the adhesive layer 340. The liner 350 may further be selected to maintain strain in the dressing 310. Such a liner may include a rigid or semi-rigid material, such as an ultra-high molecular weight polyethylene (UHMWPE) with a release coating or layer, such as a fluoropolymer such as perfluoroalkoxy resin (PFA), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), or expanded polytetrafluoroethylene (ePTFE). Other hard plastics or resins that may be used include melamine, fiberglass, acrylonitrile butadiene styrene (ABS), or polyvinyl chloride (PVC). In other variations, the rigid liner may be a composite structure including a flexible liner with a rigid frame or rigid struts, which may include, for example, metal (e.g., stainless steel) or a hard plastic / resin.

[0149] After the dressing 310 is tensioned and the dressing assembly 308 may be engaged and secured with the support structure 330, the dressing assembly 308 and the support structure 330 may be separated from the tensioning device 341 to form a pre-tensioned assembly 351, which may be used immediately or stored for a period of time.

[0150] The pretensioning assembly release 352 may include a tear strip 353 that is attached to the tensioning sheet 307 between the middle position 373 and the second side portion 374 using an upper portion 354 and a lower portion 355, respectively (see FIG. Figure 3E ). The tear strip 353 can separate the pre-tensioning component 351 from the tensioning device 341 by tearing across the tensioning sheet 307 between the pre-tensioning component 351 and the tensioning device 341.

[0151] In use, after releasing the liner 350, the dressing 310 can be applied to a desired location on the subject's skin. The user can apply pressure to the back surface 333 of the support 330 to activate the adhesive on the dressing 310 and / or apply a compressive force to the wound. After being applied to the subject, the dressing 310 can be released from the support 330 using the release mechanism 319.

[0152] The release mechanism 319 may include a tear strip 309. The tear strips 309 of the release mechanism 319 may each extend beyond an end 366 of the elastic sheet 360. The tear strips 309 may each be coupled to the dressing assembly 308. The tear strips 309 may be coupled to the attachment sheet 304 of the dressing assembly 308 in a manner that defines a tear path 362, along which the tear strips 309 are pulled to separate the dressing 310 from the support 330. The tear strips 309 may be coupled to the tensioning sheet 307 of the dressing assembly 308 in a manner that defines a tear path 362, along which the tear strips 309 are pulled to separate the dressing 310 from the support 330. Each tear strip 309 may include a top section 347 and a bottom section 348. As shown, the bottom section 348 may not be attached to the support 330 or may be free relative to the support 330. The top section 347 of each tear strip 309 may be adjacent to but not attached to the dressing 310. The tensioning sheet 307 and the attachment sheet 304 may be manufactured to tear along the length of the material while providing tensile strength in other directions, particularly in the tensile direction of the material of the tensioning sheet 307 (the direction in which the dressing is stretched, compressed or strained). An example of such a material is an LDPE polymer, which is produced by an extrusion process that produces a directionally inclined / biased grain, whereby the material can be torn in the direction of the grain but is relatively tear-resistant in a direction transverse to the grain. Notches may be made in the tensioning sheet 307 and the attachment sheet 304 to facilitate tearing along the path 362. The tensioning sheet 307 and the attachment sheet 304 may additionally or alternatively include a material such as a low density polyethylene (LDPE) having perforations formed along the tear line 362.

[0153] The dressing 310 may be released from the support 330 by pulling the tear strip 309 to draw the tear strip across the path 362 of the tensioning sheet 307 and the attachment sheet 304. The respective sections 365 and 375 of the tensioning sheet 307 and the attachment sheet 304 may remain on the back surface 311 of the elastic sheet 360. The sections 385, 395 of the attachment sheet 304 and the tensioning sheet 307 that are bonded to the tear strip 309 may thereby be separated from the tensioning sheet 307 and the attachment sheet 304. The respective sections 365 and 375 of the tensioning sheet 307 and the attachment sheet 304 that are attached to the dressing 310 may thereby be separated from the remaining portions of the tensioning sheet 307 and the attachment sheet 304 that are attached to the support structure 330 at the ends 305 and 306. Thus, the dressing 310 may be released from the remaining portions of the support structure 330.

[0154] The dressing 310 may have unattached portions or edges 315 at its sides 305, 306 where the elastic sheet 360 is free relative to the tensioning sheet 307 and the attachment sheet 304, respectively. Thus, the dressing 310 may be strain-free at the unattached portions 315. The unattached portions 315 of the elastic dressing 310 may be strain-free and may be free of the adhesive of the adhesive layer 340 (or may have a reduced amount of adhesive thereon). Thus, less stress may occur at the unattached sides or edges defined by the sections 315.

[0155] In use, the adhesive liner 350 can be removed and the dressing 310 can be applied to the skin surface of the subject. After the dressing is applied to the skin surface of the subject, the tear strips 309 on each side of the dressing at the tear line can be pulled to separate the dressing 310 from the support structure 330, the attachment sheet 304 and the tension sheet 307. When the support structure 330, the attachment sheet 304 and the tension sheet 307 are removed from the dressing 310, the stress or strain of the dressing 310 can apply a (tangential) compressive force to the skin, thereby treating / treating the skin.

[0156] refer to Figure 4 , a plurality of tensioned dressings 410 may be tensioned in a manner similar to dressing 310, and each dressing may then be coupled to a first surface 460 of a single support 430 that is rolled up and stored in a rolled configuration for distribution, such as Figure 4 As shown. The stretched dressing 410 can be coupled to the first surface 460 of the single support 430 by an adhesive, such as a high tack / low peel PSA, which holds the dressing 410 in the stretched configuration. The pads 450 can be placed on the opposite second side 470 of the support 430 and positioned so that when the support 430 is rolled up, they are on the skin adhesive on top of the dressing 410. The adhesive pads 450 can also help minimize the creep characteristics of the stretched dressing 410. The support 430 can be rolled up to store the dressing 410. When the support 430 is unfolded, the adhesive pads 450 located on the second side 470 and opposite the dressing 410 can be released from the dressing 410. The dressings 410 can be separated by the perforations 480 so that they can be used separately.

[0157] Reference Figure 5, showing a dressing 510 in a tensioned configuration on a support structure 530. The support structure 530 may be composed of a relatively flexible material 533 and a relatively less flexible or relatively more rigid member 532 or segment flexibly coupled thereto. The support structure 530 may be configured to at least partially bend, flex, or conform to the contours of the body to which the dressing 510 is to be attached. The dressing 510 may be manufactured or used in a manner similar to the dressings 110, 210, 310, and 410 herein. Although the present invention has been specifically shown and described with reference to embodiments thereof, it will be appreciated by those skilled in the art that various changes in form and detail may be made thereto without departing from the scope of the invention. For all of the above embodiments, the steps of the method are not necessarily performed sequentially.

[0158] Reference Figures 10A to 10B , a pre-tensioned dressing assembly 1000 is shown, which includes a pre-tensioned dressing 1010, a support structure 1030, an attachment structure 1020, a release structure 1025 and a removable adhesive liner 1050.

[0159] Dressing assembly 1000 is configured to deliver or apply dressing 1010 to skin in a tightened configuration, wherein the dressing is retained on the skin during treatment. Dressing 1010 has a skin adhesive layer 1015 on its top surface. Before use, a removable adhesive liner 1050 is positioned on the top of the skin adhesive layer 1015 to protect the adhesive layer 1015. According to some examples of embodiments, dressing 1010 can be composed of an elastomer (e.g., polysiloxane, polyurethane, TPU, TPE or similar materials) and an elastic nonwoven fabric. According to some embodiments, the hardness of dressing 1010 can be in the range of about 40 to 80. According to some examples of embodiments, the thickness of dressing is in the range of 0.1mm to 7mm. According to some examples of embodiments, skin adhesive may include medical grade skin adhesive, such as polysiloxane, PSA, acrylic acid or other adhesives. The removable adhesive liner 1050 protects the skin adhesive 1015 and is removable from the skin adhesive 1015 and the dressing 1010 prior to application of the dressing.

[0160] The support structure 1030 can be used as an applicator to apply the dressing 1010 to the skin of a subject. The support structure 1030 is configured to maintain the strain in the pre-tensioned dressing for a minimum period of time before use. The period of time can be, for example, 2 months, 3 months, 4 months, 6 months, 8 months, less than 1 year, or up to 1 year, 2 years, 3 years, 4 years, 5 years or more. The strain can be the lowest specified strain level for a period of time or a minimum period of time. In some further variations, the material and / or configuration is selected to achieve a force drop of less than 20%, 25%, 30%, 40%, 50% within, for example, 3 months, 4 months, 6 months, 8 months or 12 months. The force drop within this time frame can be, for example, in the range of 15-20%, 15-25%, 15-30%, 20-30%. According to some embodiments, the support structure is relatively more flexible and compliant in one direction to allow conformation to the contours of the body area, while conversely, the support structure is rigid in the opposite direction to help maintain the dressing in a pre-tensioned state. According to some examples of embodiments, the support structure is composed of paperboard having a Taber stiffness in the transverse direction (i.e., parallel to the strain direction of the dressing) of 160 to 290 or 160 to 350, such as paperboard having a thickness in the range of 0.020" to 0.030". According to some examples of embodiments, the support structure is composed of paperboard, such as WESTROCK 22pt RESIST or ULTRASEAL (West Rock; Atlanta, GA) paperboard, or paperboard with a 0.022–0.028 caliper range.

[0161] The attachment structure 1020 is configured to releasably couple the support structure 1030 to the dressing 1010. The attachment structure 1020 includes a relatively flexible non-elastic layer 1021, such as an LDPE film, a metallocene LDPE, or other materials that do not have a proportional load relationship. The attachment structure 1020 may include, for example, an LDPE film having a thickness ranging from 0.002 inches to 0.004 inches, 0.0025 inches to 0.0035 inches, or 0.0028 inches to 0.0032 inches, or 0.06 mm to 0.10 mm, or 0.06 mm to 0.09 mm, or 0.07 mm to 0.08 mm. The flexible non-elastic material may be composed of a thermoplastic material (e.g., LDPE) that allows the layer to be bonded to the support structure by heat treatment. The attachment structure 1020 is configured to maintain the dressing strain over a desired period of time under different temperature, transportation, and storage conditions. After the dressing is pre-tensioned, the strain is maintained when the attachment structure 1020 is attached to the opposite sides 1013, 1014 of the dressing 1010 at the opposite sides 1033, 1034 of the support structure 1030, respectively. Fig. 10BAs shown, the attachment structure 1020 is connected to the dressing 1010 at the interface 1041. According to some examples of embodiments, the LDPE film strip of the non-elastic layer of the attachment structure 1020 is bonded to a side or edge area of ​​the elastic dressing 1010 with a differential double coating adhesive of polysiloxane and acrylic. For example, the material specification of the polysiloxane part can be SA1020 manufactured by Adhesive Applications, and the material specification of the acrylic part can be SA1911 manufactured by Adhesive Applications. The elastic dressing can be surface treated, for example, with corona, flame, reactive gas or plasma to provide a material with higher surface energy (approximately 50-60 dyne / cm) so as to be bonded to the traditional differential double coating adhesive. The attachment structure 1020 can have a single-layer or multi-layer structure.

[0162] like Fig. 10B As shown, the attachment structure 1020 is coupled to the support structure 1030 at an interface 1042. According to some examples of embodiments, the interface can be formed by thermal bonding. According to some examples, the interface 1042 is formed by heat sealing one or more film strips or material strips of the attachment structure 1020, such as the LDPE layer of the attachment structure 1020, to a paperboard film (e.g., WESTROCK RESIST or ULTRA SEAL or UltraSeal) is created by a support structure 1030. According to one example, a sealing temperature of 150 degrees Celsius is applied at a sealing pressure of 25-28 PSI for a sealing time of 1.5 seconds. In a number of other variations, the heat sealing temperature may be in the range of 140 degrees Celsius to 160 degrees Celsius, and / or the heat sealing time may be in the range of 1.0 seconds to 2.0 seconds.

[0163] The release structure 1025 is configured to release the dressing 1010 from the support structure 1030. According to some examples of embodiments, the release structure 1025 may include a portion and / or extension of the non-elastic layer 1021 of the attachment structure 1020. Preferably, the portion of the non-elastic layer 1021 is not directly bonded to the support structure 1030, or is not otherwise bonded at the bonding interface 1042 between the attachment structure 1020 and the support structure 1030. The non-elastic layer 1021 may have a texture direction that allows it to be separated along a linear direction. This may be further facilitated or enhanced by providing or forming a stress propagation feature structure 1026 (e.g., one or more perforations, notches, or cracks in the non-elastic layer 1021). The linear direction may be a machine direction that is substantially orthogonal to the transverse direction or the direction of strain of the dressing. The texture allows for a difference in tear resistance (Elmsdorf Tear ASTM D1922) between the machine direction and the transverse direction of the material. As shown, the release structure 1025 includes a stress propagation feature 1026, such as a perforation, notch, crack, or other stress propagation feature. In some examples, an air gap 1043 may be provided near the perforation 1026 to further facilitate separation. The release structure 1025 also includes a release tab 1027 that extends from the dressing 1010, the removable adhesive liner 1050, and / or the support structure 1030 to facilitate gripping and is used to cut the non-elastic layer 1021 along the texture, that is, along the adjacent dressing side 1013 and the support structure side 1033, and along the adjacent dressing side 1014 and the support structure side 1034 of the support structure, to separate the support structure 1030 from the dressing 1010. According to examples of some embodiments, a fabric reinforcement 1028 may be positioned between the dressing 1010 and the attachment structure 1020 adjacent the interface 1041 to assist in severing the attachment structure 1020 .

[0164] In use, the removable adhesive liner 1050 is removed from the skin adhesive layer 1015 and the pre-tensioned dressing 1010 is attached to the skin surface via the now exposed skin adhesive 1015. The release tab 1027 is actuated to sever the attachment structure 1020 along the grain, thereby separating the dressing 1010 from the support structure 1030.

[0165] Reference Figures 11A-11F , showing a process / method and sub-processes for manufacturing or assembling a pre-tensioned dressing.

[0166] like Fig.11A As shown, a device carrier with a precursor dressing assembly is attached to a manufacturing unit and the carrier is fed through the manufacturing unit 1100. As described herein, Figures 12A to 12BAn example of some embodiments of a device carrier with a precursor dressing assembly is shown in FIG. As described herein, Figures 13 to 15H Examples of some embodiments of manufacturing units and subunits are shown. At the first level 1101, a manufacturing liner is removed from a precursor dressing assembly. At the second level 1102, one side of the dressing is fixed or anchored to the corresponding side of the supporting structure. At the third level 1103, the dressing is tightened using a tensioning element attached to the dressing and the dressing is fixed to the supporting structure in a tightened configuration. At the fourth level 1104, any remaining unsealed portions of the tensioning element can be removed from the precursor dressing assembly. At the fifth level 1105, a removable adhesive liner is applied to the skin adhesive on the dressing assembly to form a finished dressing assembly. These levels can be performed at different locations along the manufacturing unit 1100, or one or more levels can be performed sequentially at the same location along the manufacturing unit 1100.

[0167] Reference Fig. 11B , showing a process or sub-process of removing a manufacturing liner. The two sides of the precursor dressing assembly are secured, 1110. For example, the sides may be clamped. The manufacturing protective liner may then be removed manually or otherwise, 1111. The precursor assembly may then proceed to the second stage.

[0168] Reference Fig. 11C , showing a process or sub-process of fixing or anchoring a side portion of a support element to a corresponding side portion of a support structure, 1102. Including as to Figures 10A to 10B The precursor dressing component of the attachment structure (e.g., Figures 12A-12B The precursor dressing assembly is then indexed and / or advanced to the second stage of the manufacturing process, 1121. The attachment structure has been disposed on the precursor assembly, attached to the dressing. The sides of the precursor assembly are secured, such as by being clamped or otherwise secured, 1122. A heat sealing element applies heat to the attachment structure and the adjacent support structure to form a heat-sealed thermal bond at the interface, thereby coupling the dressing to the support structure via the attachment structure, 1123. The precursor dressing assembly may then be moved to the third stage.

[0169] Reference Fig.11D, a process or sub-process for tensioning a dressing and securing the dressing in a tensioned configuration to a support structure is shown. A precursor dressing assembly is provided in which a first side of a support structure is coupled to a first side of a dressing by an attachment structure, and an opposite side of the dressing is attached to an attachment element that is not attached to a base plate, 1131. The first side of the support structure is secured, such as clamped or otherwise secured, 1132. The attachment structure on the opposite side is a free wing or unsecured side that forms a pull tab that can extend beyond the side of the support structure when the dressing is tensioned. The unsecured side pull tab or attachment structure is attached or clamped to a tensioning unit, 1133. The tensioning unit then lifts the dressing from the support structure by the attachment structure, 1134. The tensioning unit then tensions the dressing by the attachment structure, 1135. The dressing and attachment structure are then lowered onto the support structure, 1136. Clamp the dressing in place with the heat seal in place (see Fig. 16C , and second heat seal 1263), 1137. The heat sealing element applies heat to the attachment structure and the adjacent support structure to form a heat-sealed thermal bond at the interface between the support structure and the attachment structure, thereby coupling the dressing to the support structure in a taut configuration, 1138. The precursor dressing assembly can then be loosened and moved to the fourth stage.

[0170] Reference Fig.11E , showing a process or sub-process of removing the tensioning element. The precursor dressing assembly is provided with a tensioned dressing attached to the support structure but with strain gauges / pull tabs for applying strain to the dressing or wings or remaining width of the attachment structure, 1141. The attachment structure is heated or melted using a heating element, 1142. A knife or other cutting element strikes and cuts the attachment structure wings, 1143. An air jet may be used to remove debris or waste, 1144. The precursor dressing assembly may then be moved to a fifth stage.

[0171] Reference Fig.11F , a process or sub-process of applying a pad to a dressing is shown. A dressing assembly with a pre-tensioned dressing is provided (1151). The pad is indexed to a position above the skin adhesive layer of the dressing (1152). The pad is placed on the dressing over the adhesive layer (1153) and the pad is pressed onto the dressing using an actuator having a compliant surface (e.g., foam, rubber, etc.), 1154.

[0172] Although the processes and sub-processes described herein involve a variety of different manufacturing stages, the precursor assembly can be physically moved to a different stage or manufacturing unit, or can otherwise remain in place while steps in subsequent stages are performed. Any sub-process or combination of sub-processes described herein can be used in a method or pre-tensioned dressing manufacturing process.

[0173] Fig. 12A and12B A device carrier 1205 is shown, wherein the precursor dressing assembly 1200 is removably positioned on the carrier. The carrier 1205 can be a thin substrate, such as a POLYMASK SURFACE Low-adhesion film (Tekra; New Berlin, WI). The carrier 1205 and precursor dressing assembly 1200 can be formed into a roll to facilitate distribution and installation, for example, as described herein. Fig.13 The precursor dressing assembly 1200 is attached to a carrier 1205 with a low tack adhesive. The carrier 1205 can pass through one or more stages of the manufacturing unit and can be attached at the end of the one or more stages of the manufacturing unit. The carrier 1205 moves the precursor dressing assembly 1200 through one or more stages of the manufacturing unit.

[0174] The precursor dressing assembly 1200 shown may have some parts of the final dressing assembly preassembled and then coupled to the carrier 1205. The precursor dressing assembly 1200 shown as an example of some embodiments includes Figures 10A to 10B Attachment structures 1220a and 1220b are attached to dressing 1210 at an interface (not shown), such as interface 1041, which includes an adhesive, as described herein with reference to Figures 10A to 10B The attachment structures 1220a and 1220b are located on the support structure 1230, wherein the attachment structure 1220a is temporarily attached to the support structure 1230, and the attachment structure 1220b is not initially attached to the support structure 1230. The attachment structures 1220a and 1220b are formed of a non-elastic flexible material having heat bonding capability and a texture for achieving preferential release in a selected direction. Figures 10A to 10B Examples of such materials are described. The attachment structure has wings 1229 or pull tabs that extend beyond the width of the support structure 1230 on the side 1231 side. The release structure 1225 includes a pull tab 1227, and the stress spreading feature 1026 can be formed from the same sheet of material as the attachment structure 1220a or 1220b. A temporary manufacturing liner 1260 can be placed on the dressing 1210 above the skin adhesive layer.

[0175] Reference Fig.13 , showing that the manufacturing unit 1300 has a first subunit or station 1301, a second subunit or station 1302, a third subunit or station 1303, a fourth subunit or station 1304 and a fifth subunit or station 1305. The roller 1310 is configured to be mounted on the device carrier 1205 ( Figures 12A to 12B). Roller 1310 is also configured to feed device carrier 1205 and precursor dressing assembly 1210 through one or more subunits or stages of manufacturing unit 1300. Spacers 1306 are located between subunits or stations to control the position of dressing assembly 1210 in subunits 1301-1305.

[0176] The first subunit 1301 may be a liner stripping module comprising two opposing clamps 1311 that clamp two sides of the precursor dressing assembly to enable removal of the manufacturing liner placed over the skin adhesive of the dressing. Fig.16A As shown, the precursor dressing assembly 1200 has a manufacturing liner 1260 above the dressing 1230 when entering the first sub-unit. The manufacturing liner 1260 has been removed from the precursor dressing assembly 1200 when the precursor dressing assembly leaves the first sub-unit.

[0177] Refer to Fig.13 , the second subunit 1302 can be a first sealing module that is configured to fix or anchor one side of the support element 1230 to a corresponding side of the attachment structure 1220a. The subunit 1302 includes a heat sealing element 1322 that is arranged to apply heat to the attachment structure and the adjacent support structure to form a heat-sealed thermal bond at the interface between the support structure 1230 and the attachment structure 1220a. The indexing element 1306 positions the precursor dressing assembly 1200 in the machine direction and the cross-machine direction so that the heat seal portion 1262 is precisely located, for example, at the interface 1042 (between the support element 1230 and the attachment structure 1220a), such as Fig. 10B As shown. Fig. 16B As shown, the precursor dressing assembly 1200 does not have a heat seal when entering the second subunit 1302. When the precursor dressing assembly 1200 leaves the second subunit 1302, a heat seal 1262 has been formed on the precursor dressing assembly 1200.

[0178] The third subunit 1303, which may be a tensioning and sealing module, includes a first clamp 1331 actuated by an actuator 1331a. The first clamp is arranged to clamp and hold a first side portion of the support element 1230 while tensioning the dressing and heat sealing the opposite side portions of the dressing assembly. When the front dressing assembly is moved into the third subunit 1303, the first clamp 1331 is actuated by its actuator 1331a. The third subunit 1303 also includes a tensioning unit 1332, which includes a second clamp 1333 and a third clamp 1334 and their corresponding actuators 1333a, 1334a, the second and third clamps being configured to hold the unsecured wing 1229 during the tensioning and heat sealing process, as described with reference to FIG. Fig.11DThe tensioning unit 1332 is described in more detail. Fig.14 and 15A 15H. The third subunit 1303 also includes a heat sealing element 1338 arranged to apply heat to the attachment structure and the adjacent support structure to form a heat-sealed thermal bond at the interface between the support structure and the attachment structure, thereby coupling the dressing to the support structure in a taut configuration.

[0179] Reference Fig. 16C , the precursor dressing assembly 1200 is not tensioned when entering the third subunit 1303, and is clamped only on one side. Once entering the subunit 1303, the attachment structure 1220b is clamped along the inner length region 1265a and the outer length region 1265b, and the heating element is applied between the inner length region 1265a and the outer length region 1265b to form a second heat seal 1263. The second heat seal 1263 is formed on the precursor dressing assembly 1200 to attach the tensioned dressing 1210s to the support element 1230. The width of the outer length region 1265b is generally greater than the width of the inner length region 1265a, and the second heat seal 1263 can be relatively closer to (or otherwise adjacent to) the inner length region 1265a and relatively farther away from the outer length region 1265b. The clamps are then removed from regions 1265a and 1265b after the second heat seal 1263 is formed, and the dressing assembly 1200 can then exit the third subunit 1303.

[0180] Figures 15A to 15H Describes the execution Fig. 16C The function of the third subunit 1303 is depicted in the tensioning and sealing mechanism. Fig.15A In the embodiment, the precursor dressing assembly 1200 with the untensioned dressing 1210 enters the subunit 1303. The tensioning unit 1332 with the clamp 1331 is actuated by the actuator 1331a against the edge of the attachment structure 1220a and the support structure 1230 that were previously heat-sealed in the second subunit. Fig. 15B In the embodiment, the free wing 1229 of the opposing attachment structure 1220b is engaged with the upper / second and lower / third clamps 1333, 1334 by actuating the actuator 1333a of the upper clamp 1333 against the lower clamp 1334. Fig. 15C In the embodiment of the present invention, the actuator 1334a of the lower clamp 1334 is actuated to lift the dressing 1210 upwardly off its supporting structure 1230 via the clamped attachment structure 1220b. Fig.15D , the entire tensioning unit 1332 is then displaced laterally using the actuator 1336a of the lateral displacement assembly 1336, thereby tensioning the dressing 1210s through its attachment structure 1220b, as the opposing attachment structure 1220a remains clamped. Fig.15E In the embodiment of the present invention, the actuator 1334a of the lower clamp 1334 is actuated to lower the tensioned dressing 1210s back onto the support structure 1220. Fig.15F In the embodiment of the present invention, the fourth clamp 1337 is lowered by its actuator 1337a to further facilitate the clamping of the attachment structure 1220b, so that the stretched dressing 1210s is maintained on the support structure 1230 in a stretched configuration. Figure 15G In the embodiment, the actuator 1338a of the heat sealing element 1338 falls by its actuator 1338a, thereby heat-sealing the attachment structure 1220b to the support structure 1230 to form the second heat-sealed portion 1263. Then, in Fig.15H , the actuator 1338a of the heat sealing element 1338 is retracted along with the actuator 1337a of the fourth clamp 1337. The actuators 1331a, 1333a of the first and upper / second clamps 1331, 1333 are also retracted to loosen the attachment structures 1220a, 1220b and the support structure 1230, and the actuator 1336a of the lateral displacement assembly 1336 is restored to an untensioned position or configuration. The dressing assembly 1200 is then ready for the fourth subunit.

[0181] The fourth subunit 1304 can be configured as a removal or cutting module, which includes a clamp 1341 arranged to clamp the previously formed heat seal 1262. The fourth subunit 1304 also includes a heating element 1342, which is arranged to heat or melt the wing 1229 to facilitate cutting or severing. The fourth subunit 1304 also includes a knife or other cutting element 1443 (e.g., a PEEK blade) arranged to hit and / or cut the wing 1229. The fourth subunit 1304 also includes an air nozzle 1344, which is arranged to remove debris or waste.

[0182] like Fig.16D As shown, the precursor dressing assembly 1200 retains the wing 1229 when entering the fourth subunit 1304. When the precursor dressing assembly 1200 leaves the fourth subunit 1304, the wing 1229 has been removed from the precursor dressing assembly 1200.

[0183] Refer again Fig.13 , the fifth subunit 1305 may be a liner applicator module including an indexer 1351 configured to index a liner 1050 on a carrier web or carrier strip to a position above the skin adhesive layer of the dressing 1210. A laminator 1352 laminates or otherwise applies the liner 1050 to the adhesive side of the stretched dressing 1210s via a liner carrier (not shown).

[0184] like Fig.16EAs shown, the precursor dressing assembly 1200 does not have the liner 1050 when entering the fifth subunit 1305. When the precursor dressing assembly 1200 leaves the fifth subunit 1305, it is a finished dressing assembly with the liner 1050. The application can be performed by a roller, a clamp or a press. After applying the liner 1050, the roller, clamp or pressing mechanism is lifted, pulled away or separated from the stretched dressing 1210s or the liner 1050. The liner carrier can be separated from the liner 1050 or pulled away from the liner 1050 at this time or at a later stage of the manufacturing process. Similarly, the device carrier 1205 can be separated from the support structure 1030 or pulled away from the support structure 1030 while, before or after removing the liner carrier.

[0185] Although the present invention has been specifically shown and described with reference to the embodiments of the present invention, it should be understood by those skilled in the art that various changes in form and detail may be made thereto without departing from the scope of the present invention. For all the above embodiments, the steps of the method are not necessarily performed in sequence.

Claims

1. A tensioning processing device, comprising: a taut elastic dressing; an adhesive layer located on the surface of the elastic dressing; a support structure comprising a polymer coated paperboard having a Taber stiffness of at least 160; and two or more attachment structures between the tensioned elastic dressing and the support structure, the attachment structures comprising flexible inelastic strips, wherein the attachment structure is adhered to the dressing by a high shear adhesive and is heat bonded to the polymer coating of the paperboard, wherein the width of the heat bond area is in the range of 0.10 inches to 0.25 inches.

2. The tensioning treatment device according to claim 1, wherein: The length of the thermal bond area is greater than or equal to the length of the adhesive bond between the attachment structure and the dressing.

3. A method for manufacturing a tensioning treatment device, comprising: attaching a device carrier to a precursor dressing assembly; removing a manufacturing liner from the precursor dressing assembly; heat-fusing a first region of the dressing to a first region of the support structure; tensioning the dressing and heat-fusing a second region of the dressing in the tensioned configuration to a second region of the support structure; as well as Apply adhesive with liner.

4. The method according to claim 3, wherein: The dressing also includes a first attachment structure and a second attachment structure.

5. The method according to claim 3, further comprising: attaching a tensioning element to the dressing; as well as The tensioning element is pulled in a direction away from the first region of the dressing to tension the dressing.

6. The method according to claim 5, further comprising: lifting the tensioning element before pulling the tensioning element; as well as After pulling the tensioning element, the tensioning element is lowered.

7. The method according to claim 5, wherein: Attaching the tensioning element to the dressing occurs after heat-staking of the first region.

8. The method according to claim 4, wherein: Heat staking of the first and second regions of the dressing is performed on the first and second attachment structures.

9. The method according to claim 8, wherein: The first and second attachment structures each include two rows of perforations that are spaced apart from each other.

10. The method according to claim 9, wherein: The heat staking of the first and second areas is performed on each of the attachment structures outside the two rows of perforations.

11. A manufacturing assembly comprising: a conveyor assembly for moving a plurality of components along a travel path; a first clamping assembly configured to reversibly clamp together a first side portion of a subset of the plurality of components; a first heat staking assembly configured to heat staking a subset of the plurality of components together near a first side of the subset of the plurality of components; A tensioning assembly comprising: a second clamping assembly configured to reversibly clamp together a second side portion of a subset of the plurality of components; a first separation assembly configured to reversibly displace the second clamping assembly; and a second assembly configured to reversibly displace the tensioning assembly in a direction away from the first clamping assembly; and A second heat staking assembly is configured to heat staking the subset of the plurality of components together near a second side of the subset of the plurality of components.

12. The assembly according to claim 11, wherein The first clamping assembly and the second clamping assembly are configured to clamp in a first direction.

13. The assembly of claim 12, wherein: The first separation assembly is configured to lift the second clamping assembly in a second direction opposite to the first direction.

14. The assembly of claim 12, wherein: The second separation assembly is configured to displace the tensioning assembly in a third direction orthogonal to the first direction.

15. The assembly of claim 11, further comprising a third clamping assembly configured to reversibly clamp together a subset of the plurality of components, wherein the third clamping assembly is located between the first clamping assembly and the second clamping assembly.

16. The assembly of claim 15, wherein: The third clamping assembly is located between the first clamping assembly and the second hot melt assembly.

17. The assembly of claim 11, further comprising a cutting assembly configured to cut a subset of the plurality of components.

18. The assembly of claim 17, wherein: The cutting assembly is configured to cut the subset of the plurality of components proximate a second side of the subset of the plurality of components.

19. A tensioning assembly comprising: a first clamping assembly configured to reversibly clamp together a second side portion of the subset of the plurality of components; a first separation assembly configured to reversibly displace the second clamping assembly; a second assembly configured to reversibly displace the tensioning assembly in a direction away from the first clamping assembly; and A first heat staking assembly is configured to heat staking the subset of the plurality of components together near a second side of the subset of the plurality of components.

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