Injection and infusion site treatment devices and methods

Abstract

The devices, kits, and methods described herein are used for chronic injection sites or in conjunction with an indwelling catheter or cannula. A book-like package, applicator, and / or tensioner with an opening and optional markings for aligning a catheter or cannula with the opening can be used to apply the dressing to a subject. The package, applicator, and / or tensioner can apply and / or maintain strain in an elastic dressing.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 946,345 filed on December 10, 2019. This application is also related to U.S. Patent No. 8,592,640, U.S. Patent No. 9,248,048, U.S. Patent No. 9,844,470, and U.S. Patent Application No. 15 / 842,794, the entire contents of which are incorporated herein by reference. Background Art

[0003] 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.

[0004] 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. 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.

[0005] 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.

[0006] Scar tissue may also form from repetitive tissue injury, such as in patients who require repeated needle insertion for blood draws or injections or infusions of therapeutic agents to treat chronic health problems, including, but not limited to, growth hormone injections, autoimmune diseases (e.g., rheumatoid arthritis), and diabetes, and from other therapeutic or diagnostic procedures or devices that utilize indwelling catheters or needles. Summary of the invention

[0007] The devices, kits and methods described herein can be used to treat a skin site of a subject, including but not limited to wound treatment or the treatment, amelioration or prevention of scars and / or keloids, by manipulating the mechanical or physical properties of the skin, or by protecting the skin from stress, and / or by controlling the stress or strain experienced by the epidermal and dermal tissue layers at or near the skin site (i.e., at or near a wound or treatment site on the subject's skin).

[0008] Furthermore, the effects of scar tissue formation are not limited to cosmetic effects. For example, patients with diabetes may develop scar tissue and / or develop lipohypertrophy at chronic injection sites. Lipohypertrophy is an increase in adipose tissue formation and is considered a hypertrophic effect of chronic local insulin injections on adipocytes. Lipohypertrophy can adversely affect insulin injection or infusion rates due to structural changes in the tissue that reduce the diffusion of insulin. A typical infusion using an insulin pump involves placement of a cannula or needle into the delivery site (e.g., abdomen, arm, buttocks, thigh) every few days. Over time, this can lead to lipodystrophy changes in the skin and subcutaneous structures, resulting in unpredictable or erratic insulin absorption. Ultimately, patients may be limited in the infusion sites available on their bodies due to lipohypertrophy. While the effects of lipohypertrophy and lipodystrophy are thought to be caused by the insulin itself, it is speculated that tension unloading of the infusion site can also reduce this insulin effect and can improve variability and / or overall absorption rate of the infusion site. This can be achieved by reducing the formation of fibrosis, improving vascularization, and / or reducing vascular resistance to the tissues beneath or around the perfusion insertion site. In some variations, it is speculated that changes in skin tension and / or increased attachment properties of a tensioned dressing or dressing component may extend the usable duration of an infusion set or sensor, for example from 2-3 days to 4-7 days. This may also result in a reduction in the size, surface area, depth, and / or severity of inflammation at the injection / infusion site.

[0009] It is also believed that treatment of injection and / or infusion sites for diabetes treatment may also have other effects besides affecting the development of scar tissue or fat hyperplasia. For example, treatment of injection sites and / or injections at sites that have been treated with a skin tensioning device may improve the dispersion of insulin at the injection site by changing the mechanical environment. For example, insulin leakage at the injection or infusion site may be reduced by increasing the mechanical pressure on the skin surface, which may drive the injected therapy deeper into the tissue due to the pressure gradient created in the tissue by the tensioning device. This and other mechanical effects of skin tensioning treatment may result in an increase in the volume and / or surface area of ​​the insulin dose per unit of injection. The mechanical modulation effect may result in: improved insulin absorption, a reduction in the average daily, weekly and / or monthly total insulin dose; and / or improved daily, weekly and / or monthly blood sugar / glucose range time, reducing the frequency or degree of hyperglycemia. The tensioning device may also reduce pain at the injection site by mechanical modulation of nociceptors, and / or may reduce the risk of infection and / or the risk of pump alarms due to blockage by mechanically stabilizing the tissue.

[0010] According to variations, manipulation of mechanical or physical properties can adjust tensile or compressive stress at a skin site. Stress at a skin site can be reduced to a level below that experienced by normal skin and tissue. Stress at a skin site can be increased to a level above that experienced by normal skin and tissue. Stress or strain can be applied to surrounding tissue in one, two, or more directions to control endogenous or exogenous stress at a skin site in one, two, or more directions. According to variations, the devices and methods described herein can reduce or otherwise control stress experienced by the skin and / or wound and surrounding tissue in order to treat a subject. The device can also help prevent or reduce the occurrence of wound dehiscence.

[0011] 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.

[0012] 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.

[0013] In some cases, it may be desirable to apply a dressing immediately, quickly, or simply. The devices, kits, and methods described herein can be used to make and / or apply a dressing to the skin, as well as to separate an applicator, tensioner, or dressing carrier, support, or backing from a skin device.

[0014] The devices, kits, or methods described herein may include a package, a carrier, a support, a backing, an applicator, or a tensioning device, each of which may: at least temporarily contain, hold, carry, or support a dressing; may be used to prepare a dressing for application; may be used to transport, orient, or apply a dressing; may be used to hold a dressing in a stressed or tensioned configuration; may be used to stress or tension a dressing; may be used to separate a dressing from the package, carrier, support, backing, applicator, or tensioning device, and / or may be used during or after application of a dressing to provide additional treatment to a wound, incision, or other treatment site; and / or may be used to apply pressure to a wound, incision, or other treatment site. According to some variations, the package and / or applicator may provide structural support for the dressing while or after the adhesive pad is released. According to some variations, the assembly may be configured to prevent the dressing from folding or bending to the extent that the adhesive on the dressing sticks to itself. For example, when some variations of dressings are held or supported in a cantilever configuration at a point or along one edge of the dressing, the dressing will not bend, deform laterally, or otherwise deform out of plane under its own mass or configuration.

[0015] In some other variations of the devices and methods described herein, the device has a substantially rigid support structure, or the device provides structural support for the dressing and can provide a specific bending resistance or breaking strength when two opposite edges of the device and the supporting structure are under a compressive load that causes axial compression or lateral deformation (e.g., applying a force similar to a hand grip to the edge of the device) before the device is bent or folded. For example, the bending resistance can be characterized as the peak force obtained when the device and the supporting structure are compressed without being compressed to 25% of their original size. The breaking strength or stiffness can vary, depending on the direction along the device and the supporting structure being measured. In some further variations, the peak force can be at least about 0.02 Newtons per millimeter (N / mm), about 0.03 N / mm, about 0.05 N / mm, about 0.1 N / mm, about 0.15 N / mm, about 0.2 N / mm, about 0.3 N / mm, about 0.4 N / mm, or about 0.5 N / mm. In some variations of a device comprising a generally flat or planar device and a support structure having a thickness, the peak force can be measured by applying a compressive force along the shortest dimension of the device / support structure transverse to the thickness of the device / support structure. According to such variations, the device can have an aspect ratio of, for example, greater than 1:1, 2:1, or 3:1.

[0016] Bending resistance in the direction of dressing strain can also be measured by three-point bending, i.e., a lateral force is applied at the midpoint of the applicator, which is simply supported at two external points at a given distance or support span. For example, the distance between the two points of the sample can be about 0.75 inches, and a force ranging from about 1 pound to 1.25 pounds can be applied to a sample with a width of about 0.35 inches, resulting in a deflection of about 0.05 inches. Bending resistance can also be measured by characterizing the force when buckling / bending occurs on a simply supported beam. For example, a force of about 0.45 pounds can be applied to a simply supported sample with a width of about 0.35 inches and can result in a deflection of about 0.004 inches. Bending resistance can also be characterized by the strain of the outer surface before fracture or permanent deformation. By measuring the support structure and deflection during the test, a load-deflection curve can be generated, and the flexural modulus of the support structure can also be calculated. In some variations, the support structure may comprise a flexural modulus of at least about 0.9 GPa, while in other embodiments the flexural modulus is at least about 1 GPa, at least about 1.1 GPa, at least about 1.2 GPa, at least about 1.3 GPa, or at least about 1.4 GPa.

[0017] In another example, a 7 cm wide 19 cm long device may be configured with a supporting structure comprising cardboard, a supporting sheet or a supporting structure. The average thickness of the supporting structure may be in the range of about 0.008 inch to about 0.028 inch or more. In some specific modifications, the supporting structure may have a thickness of about 0.012 inch, about 0.016 inch, about 0.018 inch, about 0.024 inch, about 0.28 inch, or about 0.032 inch, about 0.036 inch, about 0.04 inch, about 0.05 inch or more. When applying force along the longitudinal edge of 19 cm length, i.e., across the 7 cm width of the device, the supporting structure may provide enough rigidity or breaking strength to achieve about 3 pounds or more, 4 pounds or more, or about 10 pounds or more of peak force while being compressed, collapsed, bent, twisted or otherwise deformed by 25% (i.e., about 1.75 cm) along its 7 cm width. In some variations, the support structure may include scoring or areas of reduced thickness to allow for some flexure in at least one or both directions.

[0018] According to some variations, the device providing structural support may have a plurality of supporting cross elements or segments extending from one edge of the length to the opposite edge or length (or from one edge of the width to the opposite edge of the width); according to some variations, there may be three or more cross elements, for example, a cross element extending along two opposite edges and laterally across the width (or length), and one or more cross elements extending along two opposite edges across the width (or length) and between the cross elements. Such cross elements may or may not be coupled or connected to each other, for example, with a relatively flexible material. The total width of such cross elements relative to the length of the opposite edges may be about 20% or more, about 25% or more, about 30% or more, or about 35% or more. According to some variations, one or more cross elements may be provided, the total width of which is between about 20% and 100% relative to the length of the opposite side. Such cross elements may be segmented and may provide flexibility when bent in one direction and provide greater rigidity than the flexibility in another direction.

[0019] The packaging and / or applicator may 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 dressing and packaging are configured to be pre-oriented in a position facing the wound before or after the wound device is prepared for application, such as before or after the adhesive pad is removed. According to some variations, 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 some variations, the assembly includes a supporting structure. The dressing support structure defined herein refers to a structure that is directly or indirectly connected to the back of the dressing to be applied to the subject. The supporting structure may also include, at least in part, a material or structure that is more rigid than the dressing to be applied to the subject. The supporting structure may include one or more elements or sections. It may be composed of a single substrate, a laminate, or a plurality of elements that are connected together and / or connected to the dressing. According to some variations, at least 20%, 25%, 30%, 35% or 40% of the length or width of the dressing is supported by one or more support structures extending from a first opposite side to an opposite side along the length or width of the dressing. In some further variations, the percentage of the length or width supported by the support structure is a minimum average support across the entire length or width of the device, such as an average support of at least 20%, 25%, 30%, 35% or 40% of the entire size (e.g., length or width) of the device. According to some variations, the entire area of ​​the dressing is supported by the support structure. According to some variations, the back cover, carrier or support of the dressing may include at least three support structures extending laterally between opposite sides of the dressing. According to some variations, the support structure includes interconnected members or elements. According to some variations, when the dressing is applied, the back cover, carrier or support remains connected to the dressing. According to some variations, a dressing carrier, support, or back cover is provided with greater structural support in a first direction and greater flexibility in a second direction, while providing less flexibility in the first direction and less structural support in the second direction. According to some variations, one or more support structures may extend beyond the edge of the first opposing side. According to some variations, one or more support structures may at least partially extend beyond at least a portion of the edge of the first opposing side and at least partially extend beyond at least a portion of the edge of the opposing side. According to some variations, the support structure may extend at least 3 mm from at least a portion of the edge of the dressing. According to some variations, the package or applicator is configured to improve the aseptic transfer of the dressing to the wound of the subject. According to variations, the package or applicator may be sufficiently wider or longer than the dressing, or have a sufficiently larger area than the dressing, thereby providing the ability to manipulate or operate the support or applicator so that it provides aseptic application and / or single-handed application without contacting the dressing.According to some variations, a distance margin is provided from the outer edge of the dressing carrier, support or back cover to the dressing supported on the back cover or the adhesive on the dressing. Such a margin may be selected to prevent or discourage a user from contacting the dressing or the dressing adhesive when grasping the edge to manipulate the dressing carrier, support, applicator or back cover.

[0020] The devices, kits and methods described herein can be used to treat, ameliorate or prevent scars and / or keloids by creating and / or maintaining a predetermined strain in an elastic skin treatment device and then securing the elastic skin treatment device to the skin surface using a skin adhesive to transfer a generally planar (e.g., compressive) force from the bandage to the skin surface.

[0021] In some variations, a dressing is provided that includes 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 the first edge, and one or more adhesive regions. The dressing may also include a first release liner releasably attached to the one or more adhesive regions. The adhesive region 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 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 strain in 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 a region along an edge of the dressing that intersects the strain axis of the strained region, but is not limited to a region along an edge of the dressing that is generally parallel to the strain axis.

[0022] A packaging device, a dressing carrier, a dressing support, a dressing back cover, an applicator and / or a tensioning device may be provided. The packaging device, the dressing carrier, the dressing support, the dressing back cover, the applicator and / or the tensioning device may be configured to apply stress and / or strain to the dressing before being applied to a subject. A device may be used to tighten and / or maintain tension on the dressing. In one variation, a dressing is provided that includes a first device attachment structure, zone or region, a second device attachment structure, zone or region, and a structure or mechanism configured to apply a separation force between the first and second device attachment structures, zones or regions. The device may also include a releasable locking mechanism, attachment mechanism or adhesive that is configured to maintain the member or mechanism in a tightened configuration.

[0023] In some cases, it is desirable to apply compression to the wound to reduce bleeding. According to some variations, the packaging, carrier, support, back cover, applicator, or tensioning device described herein may further be used to help reduce bleeding, for example, by allowing compression to be applied using the device simultaneously with or after application of the dressing to help reduce bleeding. Coagulation additives may also be provided on the dressing.

[0024] According to one aspect, the packaging, carrier, support, back cover, applicator and / or tensioning device may be sufficiently rigid or supportive in at least one direction to maintain the shape of the dressing, thereby allowing it to be easily handled.

[0025] According to some variations, the package is also sufficiently flexible in at least one direction to allow the dressing to bend or shape to conform to the curvature or shape of the body or skin where the dressing is applied. In general, the flexibility of the package for conforming the dressing to the treatment site can be configured so that the treatment site does not deform significantly during application of the dressing; so that the application of the dressing to the skin is relatively smooth or uniform; and / or to provide a uniform, predetermined or relatively predictable strain or force to the skin area. The package or applicator may be flexible in a first direction and have greater rigidity in another direction. The package or applicator may include elements or sections that allow flexibility relative to adjacent elements or sections.

[0026] According to some variations, the package is also sufficiently flexible in at least one direction to allow the dressing to bend or shape to conform to the curvature or shape of the location on the body or skin where the dressing is applied. Typically, the flexibility of the package used to conform the dressing to the treatment site can be configured so that the treatment site does not deform significantly during the application of the dressing; and / or so that the application of the dressing on the skin is relatively smooth or uniform; and / or to provide a uniform, predetermined or relatively predictable strain and / or force to the skin area. The package or applicator can be flexible in a first direction and have greater rigidity in a second direction. The first direction can be transverse to the strain direction, or have a component transverse to the strain direction. The second direction can be the strain direction or have a component in the strain direction. The first direction can be transverse to the second direction, or it can be non-transverse. The package or applicator can include elements or sections that allow flexibility relative to adjacent elements or sections.

[0027] According to some variations, the desired flexibility (e.g., having at least one component transverse to the strain direction) can be characterized by a modified cantilever beam bending model, i.e., a force is applied to the free end of the beam (the beam is simply supported from the other end) while bending it around a cylindrical object with a known radius of curvature or curvature (defined as the inverse of the radius of curvature). According to one variation, the force to bend the package or applicator around the object at a predetermined curvature may be no greater than about 3 pounds. According to one variation, the force may be no greater than about 0.3 pounds. According to one variation, the force to bend around a predetermined curvature with a radius of about 2.5 inches may be no greater than about 3 pounds. In another variation, the force to bend around a predetermined curvature with a radius of about 2.5 inches may be no greater than about 0.3 pounds.

[0028] According to some variations, a package, applicator or tensioning device is provided, comprising: a back cover having an inner surface to which a dressing is removably attached; and a front cover or cover having an inner surface, the inner surface of the front cover facing / engaging with the inner surface of the back cover in an initial closed configuration. According to some variations, the back cover and the front cover are connected at respective edges along their respective lengths to form a book-like structure, whereby the front cover can be rotated relative to the back cover to open the device. Alternatively, the front cover can be lifted off the back cover. According to variations, a pad is attached to the front cover, and when the front cover is lifted or opened, the pad will expose the adhesive side of the dressing.

[0029] In some variations, the book-like structure in a closed configuration comprises a layered structure that includes, in order, a front cover / cover, a handling device, and a back cover, while in an open configuration, the relative order of the layered structure changes to front cover / cover, back cover, and handling device. The handling device may also include one or more release layers. In one variation, in the closed configuration, a first face of the front cover / cover contacts a first face of the handling device, and a first face of the back cover contacts a second face of the handling device opposite to the first face, while in the open configuration, a second face of the front cover / cover (opposite to the first face of the front cover / cover) contacts a second face of the back cover (opposite to the first face of the back cover), but not the first face of the handling device. In some variations, the front cover / cover may be separated from the back cover during or after tensioning the handling device. In some variations, the handling device may be asymmetrically attached to the book-like structure relative to a curved region of the book-like structure. In some cases, the asymmetrical attachment may provide a mechanical advantage to the user when tensioning the dressing, and / or may reduce manufacturing costs by optimizing the amount of elastic material used in the dressing. In other variations, a dressing or skin treatment device may be attached to the book-like structure symmetrically relative to the curved region of the book-like structure.

[0030] In another embodiment, a method of applying a dressing to a surface is provided. According to some variations, the method may include providing a dressing package, the dressing package including: an applicator including a backing structure having an inner surface and a manipulation portion; a dressing including a first surface and a rear surface configured to be applied to the skin or wound of a subject, wherein the rear surface of the dressing is removably coupled or anchored to the inner surface of the backing structure, wherein the first surface faces away from the inner surface of the backing structure; and a cover configured to removably cover the first surface of the dressing. A method may further include: removing the cover to expose the first surface of the dressing; and applying the first surface of the dressing to the wound or skin of the subject using the manipulation portion of the backing structure. In another variation, a method for treating a wound is provided, including: tensioning an inner region of an elastic bandage between a first untensioned region and a second untensioned region; and attaching at least the tensioned inner region of the dressing to a skin site or attaching both the tensioned and untensioned regions of the dressing to a skin site.

[0031] According to some variations, a dressing package assembly comprises: a back cover structure having an inner surface; a cover structure having an opposing surface, wherein the back cover structure is movably coupled to the cover structure; and a dressing, the dressing comprising a rear surface and a first surface configured to be applied to a wound or skin of a subject, wherein at least a portion of the rear surface is removably coupled to the inner surface of the back cover structure; and wherein the cover structure is configured to be movable from a first position to a second position, in which the opposing surface faces / engages with the first surface of the dressing and is substantially parallel to the first surface, and in which the opposing surface is separated from the first surface of the dressing. According to variations, the first surface of the dressing comprises an adhesive region. According to variations, the first surface of the dressing comprises an adhesive backing that interfaces with the adhesive region on the dressing. According to variations, the opposing surface of the cover structure comprises an adhesive backing that covers the adhesive region when the cover structure is in the first position and is separated from the adhesive region when the cover structure is in the second position. According to variations, the dressing comprises an elastic material. According to variations, the dressing includes a first attachment area coupled to an inner surface of a back cover structure and a second attachment area coupled to an opposite surface of a cover structure, wherein the cover and the back cover are configured to apply a strain force to tighten the dressing when the cover moves from a first position to a second position. According to variations, the tensioning structure is configured to apply a strain force on the dressing. According to variations, the tensioning structure includes: a first structure configured to couple the dressing to the inner surface of the back cover structure at the first attachment area; and a second structure configured to couple the dressing to the opposite surface of the cover at the second attachment area; wherein the tensioning structure is configured to apply a strain force to the dressing between the first attachment area and the second attachment area when the cover structure moves from the first position to the second position relative to the back cover structure. According to some variations, when the cover is in the first position, the dressing has a first width, and when the cover is in the second position, the dressing has a second width, wherein the second width is greater than the first width. According to variations, the second width is at least 20% greater than the first width. According to variations, the second width is at least 40% greater than the first width. According to variations, the back cover structure comprises at least one relatively rigid element and at least one relatively flexible element, wherein the relatively rigid element is sufficiently rigid to support the dressing when a strain force is applied in a first direction; and wherein the relatively flexible element allows the back cover structure to bend in a second direction. According to variations, the at least one relatively rigid element comprises a plurality of flexibly coupled relatively rigid elements. According to variations, the cover structure comprises at least one relatively rigid element and at least one relatively flexible element. According to variations, the release device is configured to release the dressing from the back cover structure after the dressing is applied to a wound or skin of a subject. According to some variations, the back cover structure is pivotally coupled to the cover structure.

[0032] According to a variation, the dressing packaging assembly comprises: a back cover structure having an inner surface and comprising at least one supporting element and at least one flexible element; and a dressing, the dressing comprising a rear surface and a first surface configured to be applied to a wound or skin of a subject, wherein at least a portion of the rear surface is removably coupled to the inner surface of the back cover structure. According to a variation, at least one rigid element comprises a plurality of rigid elements mutually coupled to at least one flexible element. According to a variation, a cover structure comprises an opposing surface configured to engage with a first surface of the dressing, wherein the cover structure is movably coupled to the back cover structure to move from a first position in which the opposing surface and the first surface of the dressing face each other / engage with each other to a second position in which the cover is separated from the first surface of the dressing. According to a variation, the cover structure is pivotally coupled to the back cover structure. According to a variation, the cover structure comprises at least one supporting element and at least one flexible element sufficiently flexible to allow the cover structure to be formed. According to a variation, the first surface of the dressing comprises an adhesive region. According to a variation, the first surface of the dressing comprises an adhesive backing that interfaces with the adhesive region on the dressing. According to a variation, the opposing surface of the cover structure comprises an adhesive backing that covers the adhesive region in a first position and is separated from the adhesive region in a second position. According to a variation, the dressing includes an elastic material. According to a variation, the dressing includes a first attachment area coupled to an inner surface of the back cover structure and a second attachment area coupled to an opposite surface of the cover structure, wherein the cover and the back cover are configured to apply a strain force to tighten the dressing when the cover moves from a first position to a second position. According to a variation, the assembly also includes a tensioning structure configured to apply a strain force on the dressing. According to a variation, the tensioning structure includes: a first structure configured to couple the dressing to the inner surface of the back cover structure at the first attachment area; and a second structure configured to couple the dressing to the opposite surface of the cover at the second attachment area, wherein the tensioning structure is configured to apply a strain force to the dressing between the first attachment area and the second attachment area when the cover structure moves from the first position to the second position relative to the back cover structure. According to a variation, when the cover is in the first position, the dressing between the first and second attachment areas has a first width, and when the cover is in the second position, the dressing between the first and second attachment areas has a second width, wherein the second width is greater than the first width. According to a variation, the second width is at least 4% greater than the first width. According to a variant, the second width is at least 20% greater than the first width. According to a variant, the second width is at least 40% greater than the first width.

[0033] According to a variation, a method of applying a dressing to a wound or skin of a subject includes: providing a dressing package assembly, the dressing package assembly including: a back cover structure having an inner surface; a cover structure having an opposing surface, wherein the back cover structure is movably coupled to the cover structure; and a dressing including a rear surface and a first surface including an adhesive area, wherein at least a portion of the rear surface is removably coupled to the inner surface of the back cover structure, and wherein the opposing surface of the cover structure includes an adhesive backing covering the adhesive area when the cover structure is in a first position; pivoting the cover structure relative to the back cover structure to a second position to separate the opposing surface from the first surface of the dressing and to separate the adhesive backing from the adhesive area; applying the first surface of the dressing to the wound or skin of the subject, and then subsequently releasing the dressing from the back cover structure. According to a variation of the method, at least a portion of the rear surface of the dressing is coupled to the cover structure, and also includes pivoting the cover structure relative to the back cover structure to tighten the dressing.

[0034] According to a variation, the dressing applicator includes: a first dressing attachment area and a second dressing attachment area, the first dressing attachment area and the second dressing attachment area including a variable spacing distance therebetween; and a bending area between the first dressing attachment area and the second dressing attachment area, the bending area changing the variable spacing distance, wherein a first distance from a center of the bending area to the first dressing attachment area is different from a second distance from a center of the bending area to the second dressing attachment area.

[0035] According to a variation, a dressing tensioning device comprises: a dressing carrier comprising a first carrier edge and an opposing second carrier edge, the first carrier edge and the opposing second carrier edge defining a carrier width therebetween; a tensioning element configured to move relative to the dressing carrier from a first position to a second dressing tensioning position; and a dressing assembly comprising a dressing comprising a first dressing edge coupled to the carrier proximate the first carrier edge; a second dressing edge coupled to an attachment element, wherein the attachment element is coupled to the tensioning element; wherein in the first position of the tensioning element, the second dressing edge is a first distance from the second carrier edge within the width of the carrier, and in the second position of the tensioning element, the second dressing edge is a second distance from the second carrier edge within the width of the carrier, wherein the first distance is greater than the second distance. According to a variation, the first dressing edge is relatively fixed relative to the second dressing edge when the tensioning element moves between the first and second positions.

[0036] According to a variation, a dressing packaging assembly comprises: a back cover structure having an inner surface; a cover structure having an opposing surface, wherein the back cover structure is movably coupled to the cover structure; and a dressing, the dressing comprising a rear surface and a first surface configured to be applied to a wound or skin of a subject, wherein at least a portion of the rear surface is removably coupled to the inner surface of the back cover structure; wherein the cover structure is configured to be movable from a first position to a second position, wherein the opposing surface faces / engages with the first surface of the dressing, and wherein the opposing surface is separated from the first surface of the dressing, wherein the second position is rotated at least about 180 degrees relative to the first position. According to a variation, the first surface of the dressing comprises an adhesive region. According to a variation, the first surface of the dressing comprises an adhesive backing that interfaces with the adhesive region on the dressing. According to a variation, the opposing surface of the cover structure comprises an adhesive backing that covers the adhesive region when the cover structure is in the first position and is separated from the adhesive region when the cover structure is in the second position. According to a variation, the dressing comprises an elastic material. According to a variation, the dressing comprises a first attachment area coupled to an inner surface of a back cover structure and a second attachment area coupled to an opposite surface of a cover structure, wherein the cover and the back cover are configured to apply a strain force to tighten the dressing when the cover moves from a first position to a second position. According to a variation, the assembly further comprises a tensioning structure configured to apply a strain force on the dressing. According to a variation, the tensioning structure comprises: a first structure configured to couple the dressing to the inner surface of the back cover structure at a first attachment area; and a second structure configured to couple the dressing to the opposite surface of the cover at a second attachment area; wherein the tensioning structure is configured to apply a strain force to the dressing between the first attachment area and the second attachment area when the cover structure moves from the first position to the second position relative to the back cover structure. According to a variation, when the cover is in the first position, the dressing has a first width, and when the cover is in the second position, the dressing has a second width, wherein the second width is greater than the first width. According to a variation, the second width is at least 20% greater than the first width. According to a variation, the second width is at least 40% greater than the first width. According to a variation, the backing structure comprises at least one relatively rigid element and at least one relatively flexible element, wherein the relatively rigid element is sufficiently rigid to support the dressing when a strain force is applied along a first direction; and wherein the relatively flexible element allows the backing structure to bend in a second direction.

[0037] According to a variation, a dressing package includes: a dressing carrier comprising a first carrier edge, a second carrier edge opposite the first carrier edge, and a support structure extending between the first edge and the second edge, the support structure being configured to support the dressing during application of the dressing to a subject; and a dressing comprising a first dressing edge, a second dressing edge opposite the first dressing edge, a rear surface, and an opposing skin engaging surface, wherein at least a portion of the rear surface is removably connected to the dressing carrier, wherein the first dressing edge and the second dressing edge are located between the first carrier edge and the second carrier edge, and wherein the first dressing edge defines a first margin between the first dressing edge and the first carrier edge, and the second dressing edge defines a second margin between the second dressing edge and the second carrier edge, wherein each of the first and second margins has a width of at least three millimeters.

[0038] In one variation, a dressing system is provided, comprising: a first support; a second support; and a main bending region between the first support and the second support, the main bending region comprising a main bending axis; and a treatment device, the treatment device comprising a first attachment region attached to the first support and a second attachment region attached to the second support, a first separation region configured to be separated from the first attachment region, and a second separation region configured to be separated from the second attachment region. The first and second separation regions may include perforations. The dressing system may also include a pulling element positioned along the perforations. The treatment device may be attached to the first and second supports asymmetrically relative to the main bending region. The first distance between the first support and the main bending axis may be different from the second distance between the second support and the main bending axis. The dressing system may also include a closed configuration in which the treatment device is located between the first support and the second support and a closed configuration in which the second support is located between the first support and the treatment device. The second support may include at least one secondary bending region, the secondary bending region including a secondary bending axis that is not parallel to the main bending axis. The secondary bending axis may be orthogonal to the main bending axis. The first support may include at least one secondary bending area, which includes a secondary bending axis that is not parallel to the main bending axis. The at least one secondary bending area of ​​the first support may be aligned with the at least one secondary bending area of ​​the second support. The treatment device may also include a release liner coupled to the adhesive surface of the treatment device. The treatment device may include a perforated area. The dressing system may also include an elongated element attached near the perforated area. The elongated element may protrude beyond the perforated area of ​​the treatment device. In some variations, at least a portion of the elongated element may be folded, and the fold may be along most of the length of the treatment device. At least one of the first and second supports may include a mark identifying the central area of ​​the treatment device. The mark may include a recessed edge, an ink mark, an embossing, or a window. The main bending area may also be perforated. The first support may be configured to be detachable from the second support and the treatment device, and may or may not be detachable from the second support and the treatment device while the treatment device is maintained in a tensioned configuration. The second support may include an adhesive element configured to adhere to the treatment device when the dressing system is in an open configuration rather than a closed configuration. The first support may include an attached release liner. A release liner may be attached to the first support between an outer edge of the first support and the attached treatment device. An inner surface of the first and / or second support facing the treatment device may include an adhesive, such as an adhesive coating or adhesive tape, which is configured to hold the treatment device in tension when the treatment device is stretched and contacts the adhesive, and / or is configured to hold the treatment device against the first and / or second support.

[0039] In another variation, a dressing system is provided, comprising: a first tensioning member; a second tensioning member; a primary bending region between the first tensioning member and the second tensioning member, the primary bending region comprising a primary bending axis; and a treatment device asymmetrically attached to the first and second tensioning members relative to the primary bending region. The treatment device may include a first end attached to the first tensioning member and a second end attached to the second tensioning member, wherein a first distance between the first tensioning member and the primary bending axis is different from a second distance between the second tensioning member and the primary bending axis. The dressing system may also include a closed configuration in which the treatment device is located between the first tensioning member and the second tensioning member and an open configuration in which the second tensioning member is located between the first tensioning member and the treatment device. The second tensioning member may include at least one secondary bending region including a secondary bending axis that is not parallel to the primary bending axis. The secondary bending axis may be orthogonal to the primary bending axis. The first tensioning member may include at least one secondary bending region including a secondary bending axis that is not parallel to the primary bending axis. At least one secondary bending region of the first tensioning member may be aligned with at least one secondary bending region of the second tensioning member. The treatment device may further include a release liner coupled to the adhesive surface of the treatment device. The treatment device may include a perforated area. The dressing system may further include an elongated element attached near the perforated area. The elongated element may protrude beyond the perforated area of ​​the treatment device. In some variations, at least a portion of the elongated element may be folded, and the fold may be along a majority of the length of the treatment device. At least one of the first and second tensioning members may include a marking identifying a central area of ​​the treatment device. The marking may include a recessed edge, an ink mark, an embossing, or a window. The main bending area may be perforated. The first tensioning member may be configured to be detachable from the second tensioning member and the treatment device. The first tensioning member may be configured to be detachable from the second tensioning member and the treatment device while maintaining the treatment device in a tensioned configuration. The second tensioning member may include an adhesive element configured to adhere to the treatment device when the dressing system is in an open configuration rather than a closed configuration. The first tensioning member may include an attached release liner. The release liner may be attached to the first tensioning member between an outer edge of the first tensioning member and the attached treatment device.

[0040] In another variation, a dressing system is provided, comprising: a first applicator member; a second applicator member; and a primary bending region between the first applicator member and the second applicator member, the primary bending region comprising a primary bending axis; and a treatment device attached to the first and second applicator members, wherein the dressing system comprises a closed configuration in which the treatment device is located between the first applicator member and the second applicator member and a closed configuration in which the second applicator member is located between the first applicator member and the treatment device. The second applicator member may include at least one secondary bending region, the secondary bending region comprising a secondary bending axis that is not parallel to the primary bending axis. The secondary bending axis may be orthogonal to the primary bending axis. The first applicator member may include at least one secondary bending region, the secondary bending region comprising a secondary bending axis that is not parallel to the primary bending axis. At least one secondary bending region of the first applicator member may be aligned with at least one secondary bending region of the second applicator member. The treatment device may also include a release liner coupled to an adhesive surface of the treatment device. The treatment device may include a perforated region. The dressing system may also include an elongated element attached near the perforated region. The elongated element may protrude beyond the perforated region of the treatment device. At least a portion of the elongated element may be folded, and the fold may be along a majority of the length of the treatment device. At least one of the first and second applicator members may include a marking identifying a central area of ​​the treatment device. The marking may include a recessed edge, an ink mark, an embossing, or a window. The main bending area may be perforated. The first applicator member is configured to be detachable from the second applicator member and the treatment device. The first applicator member may be configured to be detachable from the second applicator member and the treatment device while maintaining the treatment device in a tensioned configuration. The second applicator member may include an adhesive element configured to adhere to the treatment device when the dressing system is in an open configuration rather than a closed configuration. The first applicator member may include an attached release liner. The release liner may be attached to the first applicator member between the outer edge of the first applicator member and the attached treatment device.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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, and 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%.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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 straining the material at a constant strain, or straining the material at different strain levels.

[0050] 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 a 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] According to variations, the dressing can 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 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 average strain, or to strain the material at different average strain levels.

[0056] 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.

[0057] 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.

[0058] Example I below illustrates the percent change in force per unit width for selected pre-tensioned dressings maintained at a constant strain for a period of time under test conditions.

[0059] Embodiment 1:

[0060] In this example, five (5) dressings were at 40% strain and five dressings were at 60% strain. The dressings were made from MED 82-5010-10 from NUSIL TECHNOLOGY LLC (Carpenteria, CA). There were a maximum of 5 particles less than or equal to 0.020" per piece and a maximum of 5 surface gels and / or bubbles no larger than 0.020" per piece in the sample. The sample initially measured 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") centered gauge markings were added. The gauge length of the sample at 40% strain increased to 8.4 inches at strain. The gauge length of the sample at 60% strain increased to 9.6 inches at strain. The sample is attached to the sample fixture or clamp in a tensioned configuration with a locking bar between the sample fixtures. The sample fixtures are made of Acrylic (PMMA) and coated with a non-slip tape. When testing, the ends of the sample fixtures are attached to the grips of a Chatillon TCD225 model tensile tester, 50LBF load cell. The measurement is then performed after releasing the locking bar. During the test, the sample is stored in the laboratory at the laboratory ambient temperature. The tension of the dressing is measured at different time intervals. Fig.26 The percent force loss over time for each dressing is shown. The initial average post-strain loss after 1 hour at 60% strain was approximately 30%, and after 1 hour at 40% strain was approximately 25%. After the initial post-strain loss, surprisingly, the additional losses after the initial loss decreased at a slower rate and averaged approximately 15% over the 2-year period (total average loss of 45%).

[0061] In other examples, the maximum number of particles per sheet may be 1, 5, 10, 20 or 25 or more, with a maximum size of 0.01", 0.02", 0.040", 0.050" or 0.07", or 0.1", and the maximum number of surface gels and / or bubbles may be 1, 5, 10, 20 or 25 or more, with a maximum size of 0.01", 0.02", 0.040", 0.050" or 0". In other variations, the dressing material may have a hardness value of about 15 to about 90 Shore A, sometimes about 35 to 75 Shore A, other times about 50 to 60 Shore A, or 50 to 75 Shore A.

[0062] Example II below illustrates the percent change in force per unit width for selected pre-tensioned dressings maintained at a constant strain for a period of time under test conditions.

[0063] Embodiment II:

[0064] In this example, 10 dressing films were under 45% strain. The dressing films were made from polyurethane from 3M Company (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 pounds per inch and the elongation was approximately 300%. Six inch (6") centered gauge markings were added. The gauge length of the 45% strain sample increased to 8.7 inches at strain. The samples were attached to the sample fixtures or clamps in a tensioned configuration with locking bars between the sample fixtures. The sample fixtures were made from Acrylic (PMMA) and were coated with non-slip tape. When testing, the ends of the sample fixtures were attached to the clamps of a Chatillon TCD225 tensile tester, 50 LBF load cell. The measurements were then taken after the locking bars were released. During testing, the samples were stored in the laboratory at ambient laboratory temperature. The tension of the dressing was measured at various time intervals.

[0065] Fig.29 The percentage force loss over time for each dressing is shown. The initial average post-strain loss after one day at 45% strain was approximately 33%. After the initial post-strain loss, surprisingly, the additional losses after the initial loss decreased at a slower rate and averaged approximately 12% over a 13-day period (total average loss of 45%).

[0066] Fig. 27 Graph showing the percentage of force loss over time for a dressing elastic material that is strained to a predetermined amount and maintained in a taut configuration. Fig. 27 , the dressing and / or dressing material maintains a constant strain over a period of time. An initial strain may be selected to provide different force loss percentage values ​​at a specific time. For different initial strain levels and different materials, the force loss percentage value and force value may be different. The graph of a specific dressing material may be determined, for example, as described in Example 1. As the force loss percentage increases, the force value of a specific material or dressing decreases, and / or the average force loss value of many manufacturing materials or dressings of substantially the same amount of pre-tensioning decreases. At time T0, the material is tightened. Within the initial time range of T0 to T1, the force loss percentage of the material occurs / force loss faster than during a subsequent time period or time range (e.g., from T1 to T3, from T1 to T2, and / or from T2 to T3) at a faster rate. Time ranges T1 to T3, T1 to T2, and / or T2 to T3 represent exemplary time ranges, which may or may not be selected based on the desired force characteristics of the dressing, the desired time of characteristic use, and / or the desired rate of force loss. For example, the dressing may be pre-strained during manufacture and then stored or shipped during a specific time frame (eg, T1 to T2, T2 to T3, and / or T1 to T3) for later use.

[0067] Fig.28Schematic diagram of the force on a dressing elastic material that is strained to a predetermined amount and maintained in a taut configuration over time. Fig.28 , the dressing and / or dressing material maintains a constant strain over a period of time. Initial strain can be selected to provide different force values ​​at a specific time. For different initial strain levels and different materials, force values ​​and force value loss percentages may be different. The curve graph of a specific dressing material can be determined, for example, as described in Example 1. As the force loss percentage increases, the force value of a specific material or dressing decreases, and / or the average force loss value of many manufacturing materials or dressings of substantially the same amount of pre-tensioning is reduced. At time T0, the material is tightened. Within the initial time range of T0 to TA, the material loses force at a faster rate 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). Time ranges T0 to TA, TA to TB and / or TB to TC represent exemplary time ranges, which may or may not be selected based on the desired force characteristics of the dressing, the desired time of characteristic use and / or the desired rate of force loss. For example, a dressing may be pre-strained during manufacture and then stored or shipped for later use during a specific time frame (eg, TA to TB, TB to TC, and / or TB to TC).

[0068] In another example, a method for regulating a tissue response at a target site is provided, comprising providing a support structure and a taut elastic structure having an access opening; placing the taut elastic structure against the target site; releasing the taut elastic structure from the support structure; and inserting an access structure into the target site, wherein the access structure is located in the access opening. The taut elastic structure may be an elastic sheet having an adhesive layer. Attaching the taut elastic structure to the target site may include adhering the taut elastic structure to a skin location. The support structure may include at least one pull tab, and releasing the taut elastic structure from the support structure may include actuating the pull tab to release the taut elastic structure from the support structure. The method may also include inserting the access structure through the access opening. The access structure may be a delivery tube, and wherein the method may further include delivering a sensor or an infusion cannula using the delivery tube. The access structure may be attached to a housing. The housing may include a skin engaging portion configured to attach the housing to a skin surface. The housing may also include a support layer, and the adhesive may be located on a lower surface of the support layer. The method may also include adhering the housing to the elastic structure. The method may further include releasing the access structure from the delivery device after inserting the access structure into the target site.The method may further include aligning the delivery device with a marker or alignment structure located on the tensioned elastic structure.

[0069] In another embodiment, a tissue treatment device is provided, comprising: a stretched elastic layer having a top surface, a bottom surface, and a treatment opening; a skin adhesive layer adhered to the bottom surface of the stretched elastic layer; a protective layer releasably contacting the adhesive layer; a strain support removably attached to the top surface of the elastic layer, the strain support comprising a layered structure having a central opening surrounding the treatment opening of the stretched elastic layer, the strain support having sufficient rigidity to maintain the stretched elastic layer in a stretched configuration; and at least one alignment structure located on the strain support and surrounding the central opening of the strain support. The strain support may also include a perforated area from the central opening to an edge of the strain support. The alignment structure may include a separation area aligned with the perforated area of ​​the strain support. The strain support may include a first end, a second end, and an arcuate body located between the first end and the second end, the arcuate body defining a central opening of the strain support. The device may also include a strain support adhesive layer between the stretched elastic layer and the strain support, wherein the strain support adhesive layer has a lower T-peel force than the skin adhesive layer. The strain support may be heat fused to the strain support. The strain support may also include perforations to facilitate separation of the strain support from the strain support.

[0070] In another embodiment, a multi-layer tissue treatment device is provided, comprising: a stretched elastic bottom layer, the stretched elastic bottom layer comprising a top surface, a bottom surface, a peripheral edge, and a treatment opening; a skin adhesive layer adhered to the bottom surface of the stretched elastic layer; a protective layer releasably contacting the skin adhesive layer; at least one stretched elastic intermediate layer, wherein each elastic intermediate layer comprises a top surface, a bottom surface, a peripheral edge, and a treatment opening aligned with the treatment opening of the stretched elastic bottom layer, and wherein the bottom layer of one of the at least one intermediate elastic layers is attached to the top surface of the stretched elastic bottom layer; a stretched elastic top layer, the top surface, a peripheral edge, and a treatment opening, wherein the treatment opening of the stretched elastic top layer is aligned with the treatment opening of the stretched elastic bottom layer, and the bottom surface of the stretched elastic top layer is attached to the top surface of one of the at least one intermediate elastic layers; and a strain support member releasably attached to at least one of the at least one elastic intermediate layer, the stretched elastic top layer, and the stretched elastic bottom layer, wherein the strain support member is configured to maintain strain of the elastic bottom layer, the at least one intermediate layer, and the elastic top layer. The outer peripheral edge of the elastic top layer may deviate from the outer peripheral edge of the middle elastic layer attached to the elastic top layer, and wherein the outer peripheral edge of the elastic middle layer attached to the elastic bottom layer may deviate from the outer peripheral edge of the elastic bottom layer. The outer peripheral edge of the elastic top layer may be offset inwardly from the outer peripheral edge of the middle elastic layer attached to the elastic top layer, and wherein the outer peripheral edge of the elastic middle layer attached to the elastic bottom layer may be offset inwardly from the outer peripheral edge of the elastic bottom layer. The bottom surface of the elastic top layer is smaller than the top surface of the middle elastic layer attached to the elastic top layer, and wherein the bottom surface of the elastic middle layer attached to the elastic bottom layer is smaller than the top surface of the elastic bottom layer. The bottom surface of the elastic top layer may be larger than the top surface of the middle elastic layer attached to the elastic top layer, and wherein the bottom surface of the elastic middle layer that may be attached to the elastic bottom layer is larger than the top surface of the elastic bottom layer. Each of the elastic middle layers of the tensioned elastic top layer, the tensioned elastic bottom layer, and the at least one elastic middle layer each has a different size. The elastic top layer may be smaller than all of the at least one elastic middle layers, and wherein all of the at least one elastic middle layers may be smaller than the elastic bottom layer. The elastic top layer may be larger than all of the at least one elastic middle layers, and wherein all of the at least one elastic middle layers may be larger than the elastic bottom layer. The at least one elastic interlayer may include two elastic interlayers. The at least one elastic interlayer may include two elastic interlayers. The tensioned elastic top layer and the at least one elastic interlayer may each include a pull tab. The pull tab of the tensioned elastic top layer and the pull tab of the at least one elastic interlayer may each have different sizes. The pull tab of the elastic top layer may be smaller than all pull tabs of the at least one elastic interlayer. The pull tab of the elastic top layer may be larger than all pull tabs of the at least one elastic interlayer. The strain support may be releasably attached to the top surface of the tensioned elastic top layer.The attachment of the top layer and the at least one intermediate layer may be accomplished using an anisotropic adhesive pattern.The anisotropic adhesive pattern may have a reduced amount of adhesive in the peel direction compared to the strain direction of the strained layer.

[0071] In another embodiment, a multilayer tissue treatment device is provided, comprising: at least two tensioned elastic layers, the at least two tensioned elastic layers comprising at least one top elastic layer and at least one bottom elastic layer, wherein each of the at least two tensioned elastic layers comprises a top surface, a bottom surface, a size, a peripheral edge, and a treatment opening, and wherein the at least two tensioned elastic layers are releasably attached together in a laminated structure; a skin adhesive layer adhered to the bottom surface of the bottom elastic layer; a strain support releasably attached to the bottom elastic layer, wherein the strain support is configured to maintain the strain of the at least two tensioned elastic layers. The force per width in the bottom elastic layer can be higher than the force per width level of any other layer in the at least two tensioned elastic layers. The bottom elastic layer can include at least 70% of the combined force per width in the at least two tensioned elastic layers. The bottom elastic layer can include at least 90% of the combined force per width in the at least two tensioned elastic layers. The bottom elastic layer can include a harder material or a greater thickness than another tensioned elastic layer in the at least two tensioned elastic layers. The at least two stretched elastic layers may further include at least one intermediate elastic layer, the at least one intermediate elastic layer being located between the top elastic layer and the bottom elastic layer in a laminated structure. The peripheral edge of each of the at least two stretched elastic layers may deviate from the peripheral edge of the adjacent stretched elastic layer in the laminated structure. The peripheral edge of each of the at least two stretched elastic layers may be offset inwardly from the peripheral edge of the adjacent higher stretched elastic layer in the laminated structure. The peripheral edge of each of the at least two stretched elastic layers may be offset outwardly from the peripheral edge of the adjacent higher stretched elastic layer in the laminated structure. The peripheral edge of each of the at least two stretched elastic layers may be offset inwardly from the peripheral edge of the adjacent lower stretched elastic layer in the laminated structure. The size of each of the at least two stretched elastic layers may be different. The size of each of the at least two stretched elastic layers may be smaller than the size of any adjacent lower stretched elastic layer in the laminated structure. The size of each of the at least two stretched elastic layers may be larger than the size of the adjacent higher stretched elastic layer in the laminated structure. The dimensions of each of the at least two strained elastic layers may be smaller than the dimensions of any adjacent higher strained elastic layer in the laminated structure. The dimensions of each of the at least two strained elastic layers may be larger than the dimensions of an adjacent lower strained elastic layer in the laminated structure. At least one of the at least two strained elastic layers comprises a pull tab. The pull tabs of at least one of the at least two strained elastic layers may each have a different pull tab size. The attachment of the at least two strained elastic layers may be achieved using an anisotropic adhesive pattern. The attachment of the at least two strained elastic layers may include an adhesive layer therebetween, the adhesive layer having a reduced amount of adhesive along an orthogonal direction orthogonal to the strain direction of the strained layers.The orthogonal direction is the peeling direction of the at least two stretched elastic layers.The attachment of the at least two stretched elastic layers may comprise an adhesive layer that is thinner than the stretched bottom layer's skin adhesive layer.

[0072] In still another embodiment, a treatment device is provided, comprising: a stretched elastic layer comprising an upper surface, a lower surface, and an opening between the upper surface and the lower surface; a skin adhesive located on the lower surface of the stretched elastic layer; an infusion hub located on the upper surface of the stretched elastic layer, a catheter or needle extending through the opening of the stretched elastic layer; a fluid tube attached to the infusion hub and in fluid communication with the catheter or needle; a strain support configured to maintain strain in the stretched elastic layer; and at least one pull tab configured to releasably attach the stretched elastic layer and the strain support together. The treatment device may also include an infusion set applicator / infusion system applicator releasably attached to the infusion hub. The device may also include two pull tabs located on opposite sides of the stretched elastic layer. Each of the two pull tabs may include a perforation configured to be torn open so that the stretched elastic layer and the infusion hub can be separated from the strain support.

[0073] In another example, a treatment device is provided, comprising: a stretched elastic layer, the stretched elastic layer comprising an upper surface, a lower surface, and an opening between the upper surface and the lower surface; a skin adhesive located on the lower surface of the stretched elastic layer; an infusion hub located on the upper surface of the stretched elastic layer, a catheter or needle extending through the opening of the stretched elastic layer; a fluid tube attached to the infusion hub and in fluid communication with the catheter or needle; a strain support configured to maintain strain in the stretched elastic layer; and at least one pull tab configured to releasably attach the stretched elastic layer and the strain support together. The treatment device may also include an infusion applicator releasably attached to the infusion hub. The device may also include two pull tabs located on opposite sides of the stretched elastic layer. Each of the two pull tabs may include a perforation configured to be torn open so that the stretched elastic layer and the infusion hub can be separated from the strain support.

[0074] In another example, a method for regulating a tissue response at a target site is provided, comprising: providing a support structure and a taut elastic structure having an access opening; placing the taut elastic structure against the target site; releasing the taut elastic structure from the support structure; and inserting an access structure into the target site, wherein the access structure is located in the access opening. The taut elastic structure may be an elastic sheet having an adhesive layer. Attaching the taut elastic structure to the target site may include adhering the taut elastic structure to a skin location. The support structure may include at least one pull tab, and releasing the taut elastic structure from the support structure may include actuating the pull tab to release the taut elastic structure from the support structure. The method may also include inserting the access structure through the access opening. The access structure may be a delivery tube, and wherein the method may further include delivering a sensor or an infusion cannula using the delivery tube. The access structure may be attached to a housing. The housing may include an adhesive. The housing may also include a support layer, and the adhesive may be located on a lower surface of the support layer. The method may also include adhering the housing to the elastic structure. The method may also include releasing the access structure from a delivery device after inserting the access structure into the target site. The method may further include aligning the delivery device with a marking or alignment structure located on the tensioned elastic structure.

[0075] In another embodiment, a method of treating a treatment site is provided, comprising: placing a first tensioning member at a first position proximate to a target site, wherein the first tensioning member is pre-tensioned along a first tensioning axis; placing a second tensioning member at a second position proximate to the target site, wherein the second tensioning member is pre-tensioned along a second tensioning axis, and wherein the second position is separated from the first position by a gap of no more than 20 mm, and wherein the target site is located in the gap; and injecting or infusing a therapeutic agent at the target site. The first tensioning axis and the second tensioning axis may be parallel. The first tensioning member and the second tensioning member may be completely separate. The first and second tensioning members may be integrally formed with a predetermined longitudinal gap therebetween, the longitudinal gap including the longitudinal gap axis. The longitudinal gap axis may be located between the first and second tensioning axes. The longitudinal gap, the first tensioning axis, and the second tensioning axis may each be parallel to one another. The average width of the predetermined longitudinal gap is less than 20 mm, less than 10 mm, or less than 5 mm. The method may also include adhering an infusion set to the first and second tensioning members prior to infusing the therapeutic agent using the infusion set.

[0076] In another embodiment, a method of treating lipodystrophy is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of a patient to reduce the risk of lipodystrophy. The injection or infusion site may be an insulin or insulin analog injection or infusion site. The patient may be a diabetic patient, and the lipodystrophy may be lipohypertrophy. The patient may not have a past medical history of lipohypertrophy, or may have a past medical history of lipohypertrophy. The method may also include reducing the risk of insulin resistance, and / or reducing the rate at which the insulin or insulin analog dosage is increased over a period of time. The period of time may be one year.

[0077] In another embodiment, a method of treating diabetes is provided comprising applying an adhesive skin tensioning device to an injection or infusion site of a diabetic patient to reduce the rate at which the insulin or insulin analog dosage is increased over time.

[0078] In another embodiment, a method of treating diabetes can be provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of a diabetic patient to improve blood sugar / glucose time in range. The glucose time in range can be daily, weekly, or monthly glucose time in range.

[0079] In another example, a method of reducing the cost of diabetes treatment for a diabetic population may be provided, comprising applying an adhesive skin tensioning device to an insulin or insulin analog injection or infusion site of a diabetic patient to reduce the cost of blood sugar excursions or serious adverse events.

[0080] In still another example, a method of treating a treatment site is provided, comprising: adhering a multi-layer, taut dressing to the treatment site; releasing strain from the multi-layer, taut dressing to transfer strain from the dressing to the treatment site, thereby reducing tissue tension at the treatment site; attaching a first hub and a first conduit to the multi-layer dressing; delivering a therapeutic agent to the treatment site through the first hub and the first conduit; removing the first hub and the first conduit from the multi-layer dressing by removing the first layer from the multi-layer dressing; attaching a second hub and a second conduit to the multi-layer dressing; delivering a therapeutic agent to the treatment site through the second hub and the second conduit; and removing the second hub and the second conduit from the multi-layer dressing by removing the second layer from the multi-layer dressing.

[0081] In another embodiment, a method of positioning an infusion set is provided, comprising: adhering a skin tension relief device to a treatment site, wherein the skin tension relief device comprises a tensioned elastic layer with a treatment opening, a strain support, and a protruding alignment structure surrounding the treatment opening; positioning an infusion set applicator over the treatment opening by utilizing the alignment structure; actuating the infusion set applicator so as to separate an infusion set hub from the infusion set applicator and so as to insert a catheter of the infusion set hub through the treatment opening; removing the infusion set applicator; and removing the strain support and the protruding alignment structure from the tensioned skin tension relief device to release strain in the tensioned elastic layer. The method may also include selecting a protruding alignment structure from a plurality of different protruding alignment structures, and attaching the selected protruding alignment structure to the strain support. The protruding alignment structure may be integrally formed with the strain support.

[0082] According to some variants, during preconditioning, the elastic device may be strained / tensioned at different strain values. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] Figure 1 is a perspective view of a variation of a dressing and packaging assembly in a closed configuration.

[0084] Figure 2 for Figure 1 A perspective view of the dressing and packaging assembly is shown with the cover in an approximately 90 degree open position from a closed position.

[0085] Figure 3 for Figure 1 A bottom perspective view of the dressing and packaging assembly is shown with the cover in a configuration open approximately 360 degrees from a closed position.

[0086] Figure 4 for Figure 1 A top perspective view of the dressing and packaging assembly is shown with the cover in a configuration open approximately 360 degrees from a closed position.

[0087] Figure 5A For Figure 3 Schematic bottom view of the dressing and packaging assembly in the shown position.

[0088] Figure 5B for Figure 5A Sectional view along line CC.

[0089] Figure 5C for Figure 5A Sectional view along line DD.

[0090] Figure 6 Variations of dressing and packaging assemblies are shown.

[0091] Figure 7A perspective view of the dressing and packaging assembly with the cover in an open position 90 degrees from the closed position.

[0092] Fig. 8A for Figure 7 A schematic end view of the dressing and packaging assembly is shown in a stretched configuration with the cover opened approximately 360 degrees from the closed configuration.

[0093] Figure 8B for Fig. 8A Magnified view of section 8B.

[0094] Figure 8C for Fig. 8A Magnified view of section 8C.

[0095] Fig. 9 for Figure 7 A top perspective view of the dressing and packaging assembly shown after release.

[0096] Fig.10 is a perspective view of another example of a dressing and packaging assembly in a closed configuration.

[0097] Fig.11 for Fig.10 A perspective view of the dressing and packaging assembly is shown with the cover in an approximately 90 degree configuration to the closed configuration.

[0098] Fig. 12A for Fig.10 A top perspective view of the dressing and packaging assembly is shown with the cover in an approximately 360 degree configuration to the closed configuration.

[0099] Fig. 12B for Fig.10 A bottom perspective view of the dressing and packaging assembly is shown with the cover in an approximately 360 degree configuration to the closed configuration.

[0100] Fig.13 is a top view of the packaging device in an open configuration.

[0101] Fig.14 is an exploded perspective view of the packaging device in an open configuration.

[0102] Fig.15A is a perspective view of a variation of a dressing and packaging assembly in a non-tensioned configuration.

[0103] Fig. 15B for Fig.15A A bottom perspective view 15F of the dressing and packaging assembly is shown in a strained configuration.

[0104] Fig. 15C After removing the cover of the carrier, support or back cover, Fig.15ABottom perspective view of the dressing and packaging assembly.

[0105] Fig.15D After removing the cover of the carrier, support or back cover, Fig.15A Top perspective view of the device shown.

[0106] Fig.15E After removing the carrier, support or back cover, Fig.15A Top perspective view of the device shown.

[0107] Fig.15F A perspective view of the stretched dressing after being separated from the attachment panels.

[0108] Figure 15G A perspective view of a dressing assembly with an attachment panel.

[0109] Fig.15H for Figure 15G A perspective view of the dressing assembly is shown with the attachment sheet peeled back.

[0110] Fig.15I for Figure 15G A perspective view of the dressing assembly is shown with the attachment sheet removed.

[0111] Fig.15J for Figure 15G Cross-section of the dressing assembly with attachment panel shown.

[0112] Fig.16A A perspective view of a variation of a dressing assembly with a removable attachment panel.

[0113] Fig. 16B for Fig.16A A perspective view of the dressing assembly is shown with the removable attachment sheet being peeled away.

[0114] Fig. 16C for Fig.16A A perspective view of the dressing assembly is shown with the attachment sheet removed.

[0115] Fig.16D for Fig.16A Cross-section of the dressing assembly with attachment panel shown.

[0116] Fig.17A A perspective view of a variation of a dressing assembly having a removable attachment panel.

[0117] Fig. 17B for Fig.17A A perspective view of the dressing assembly is shown with the removable attachment sheet being peeled away.

[0118] Fig. 17C for Fig.17A A perspective view of the dressing assembly is shown with the attachment sheet removed.

[0119] Fig.17D for Fig.17A Cross-section of the dressing assembly with attachment panel shown.

[0120] Fig.18A is a perspective view of a variation of a dressing and packaging assembly in an untensioned configuration.

[0121] Fig.18B In the tensioned and folded configuration Fig.18A Top perspective view of the device shown.

[0122] Fig.18C For Fig.18B Bottom perspective view of the device in a stretched and folded configuration.

[0123] Fig.18D In the tensioned and folded configuration Fig.18A A top perspective view of the device is shown with the attachment tab detached.

[0124] Fig.18E for Fig.18A A top perspective view of the device is shown with the first side of the dressing assembly separated from the carrier and the cover removed.

[0125] Fig.18F for Fig.18A A top perspective view of the device is shown with the dressing assembly removed from the carrier.

[0126] Figure 18G for Fig.18A A top perspective view of the device is shown with the carrier separated and removed.

[0127] Fig.18H for Fig.18A A perspective view of the device is shown with the dressing being separated from the attachment panel.

[0128] Fig.18I for Fig.18A A perspective view of the device is shown with the dressing separated from the attachment panel.

[0129] Fig.18J for Fig.18A Side view of the device shown.

[0130] Fig.19A A perspective view of a variation of a dressing and packaging assembly apparatus.

[0131] Fig.19B for Fig.19A A top view of an untensioned configuration of a dressing assembly.

[0132] Fig.19C for Fig.19BTop view of the tensioning and attachment configuration of the dressing assembly shown.

[0133] Fig.19D for Fig.19B A top view of the dressing assembly shown in the tensioned and released configuration.

[0134] Fig.19E for Fig.19B Top view of the dressing shown.

[0135] Fig. 20A A top view of a variation of a dressing carrier, support, backing tensioner or applicator.

[0136] Fig. 20B In the first configuration Fig. 20A Side view of a dressing carrier, support, back tensioner or applicator.

[0137] Fig. 20C For the second configuration Fig. 20A Side view of a dressing carrier, support, back tensioner or applicator.

[0138] Fig.21A A perspective view of a variation of a dressing carrier, support, backing tensioner or applicator.

[0139] Fig. 21B for Fig.21A A top view of a dressing carrier, support, back tensioner or applicator.

[0140] Fig. 21C for Fig.21A Side view of a dressing carrier, support, back tensioner or applicator.

[0141] Fig.21D For the bent configuration Fig.21A A top view of the dressing carrier, support, backing tensioner or applicator shown.

[0142] Fig.21E for Fig.21D Section view along line AA.

[0143] Fig.22A is a perspective view of a variation of a dressing and packaging assembly in an untensioned configuration.

[0144] Fig. 22B is a perspective view of a variation of a dressing and packaging device in a tensioned configuration.

[0145] Fig.23A A top perspective view of the dressing assembly, support structure, and tensioning device in a relatively untensioned configuration.

[0146] Fig. 23B A top perspective view of the dressing assembly, support structure, and tensioning device in a pre-tensioned configuration.

[0147] Fig.23C for Fig. 23B Schematic side view of a dressing assembly, support structure, and tensioning device.

[0148] Fig.23D for Fig.23C Schematic enlarged side cross-sectional view of a dressing assembly, support structure, and tensioning device.

[0149] Fig.23E for Fig.23D An enlarged schematic detailed side view of a portion of the dressing and support structure is shown.

[0150] Fig.23F Schematic side view of a dressing assembly and support structure in a pre-tensioned configuration.

[0151] Figure 23G for Fig.23F Magnified side view of the dressing assembly and support structure in section A.

[0152] Fig.23H for Fig.23F Magnified side view of the dressing assembly and support structure in section B.

[0153] Fig.23I A top perspective view of the pre-tensioned assembly, including the remaining elements of the dressing assembly and support structure.

[0154] Fig.24 A perspective view of multiple pre-tensioned dressings on a support element.

[0155] Fig.25 A pre-tensioned dressing and support structure are shown.

[0156] Fig.26 The percent force loss over time of an elastic dressing material as described in Example 1 is shown.

[0157] Fig. 27 Graph showing the percentage of force loss over time for the pre-tensioned elastic component of the dressing.

[0158] Fig.28 Schematic diagram of the tension variation over time for the pre-tensioned elastic material component of the dressing.

[0159] Fig.29 The percent force loss over time of an elastic dressing material as described in Example II is shown.

[0160] Figures 30A to 30CThe use of a tensioned dressing in an exemplary infusion set is shown. Fig.30D yes Fig. 30C Cross-sectional view of the stretched dressing and infusion set.

[0161] Figures 31A to 31C Depicted is a method of using a taut dressing with an infusion set delivery device. Fig.31D and 31E It is a cross-sectional diagram of the method of use.

[0162] Figures 32A to 32E Various exemplary pore configurations of dressings are depicted.

[0163] Fig.33 Depicted is the placement of a three-port dressing over the injection site.

[0164] Fig.34 An exemplary dressing including holes and various alignment marks is depicted.

[0165] Fig.35 Depicted Fig.34 An exemplary dressing in use with a delivery syringe.

[0166] Fig.36 The use of the dressing and visual guidance tool with the delivery syringe is depicted.

[0167] Fig.37A Another exemplary embodiment of a vision guide tool is depicted that includes a distal opening and one or more inward protrusions. Fig.37B Depicts the layer of dressing Fig.37A Visual guidance tools.

[0168] Fig.38A and 38B Shows Fig.37A and 37B Use of visual guidance tools with infusion set delivery tools.

[0169] Fig.39A is a perspective view of an exemplary infusion set delivery system including a pre-attached, pre-tensioned dressing. Figures 39B to 39D yes Fig.39A Top, side and bottom views of the system. Fig.39E is a bottom view of the system with the adhesive protective liner removed.

[0170] Fig.40A Depicted Fig.39E Placement of the delivery system at the treatment / treatment site. Fig.40B Shows Fig.40A The infusion set and pre-attached dressing with the pull tab removed. Fig.40C Shows Fig.40BAn infusion set in which the dressing support is separated from the dressing and retracted from over the infusion set tube. Fig.40D An infusion set and pre-attached dressing are depicted. Fig.40E An infusion set with a dressing support comprising tearable perforations is depicted.

[0171] Fig.41A A top plan view of another embodiment of a combined infusion set and multiple separable tensioning layers. Fig.41B yes Fig.41A A top perspective view of an embodiment of the invention.

[0172] Figures 42A to 42C for Fig.41A and 41B A top perspective view of a method of use of a combined infusion set and multiple tensioning layers is shown.

[0173] Figures 43A to 43C for Figures 42A to 42C Side view of the method shown.

[0174] Fig.44A for Fig.42A Detailed side view of the middle approach; Fig.44B yes Fig.44A Detailed view of the edges of multiple tension layers in .

[0175] Fig.45A A top plan view of another embodiment of a combined infusion set and multiple separable tensioning layers. Fig.45B yes Fig.45A A schematic top perspective view of an embodiment of the invention is shown in FIG.

[0176] Figures 46A to 46C for Fig.41A and 41B A top perspective view of a method of use of a combined infusion set and multiple tensioning layers is shown.

[0177] Fig.47A and 47B for Figures 46A to 46C Top and side views of the method shown. Fig.47C yes Fig.47B Detailed view of the edges of multiple tension layers in .

[0178] Fig.48A and 48B are top plan and bottom perspective views of another exemplary infusion set delivery system with a pre-attached radially pre-tensioned skin tensioning device; Figures 48C to 48E The placement and release of a pre-tensioned skin tensioning device is depicted.

[0179] Figures 49A to 49EFront perspective, top plan, rear perspective, side, and bottom plan views, respectively, of a skin tensioning device with pre-attached alignment features to facilitate placement of an infusion set delivery system.

[0180] Figures 50A to 50E Describes Figures 49A to 49E Use of skin tensioning devices with infusion delivery systems.

[0181] Fig.51 for Figures 49A to 49E A front perspective view of an alternative support structure for a skin tensioning device is shown.

[0182] Fig.52 is a schematic diagram of another exemplary embodiment of a skin tensioning system comprising two separate skin tensioning devices placed on opposite sides of an injection or infusion site.

[0183] Fig.53 is a schematic diagram of another exemplary embodiment of a skin tensioning system comprising interconnected petals separated by longitudinal gaps or slits.

[0184] Fig.54A and 54B are top plan and side views of an exemplary infusion hub and catheter with a pre-attached skin tensioning device.

[0185] Fig.55A and 55B is a schematic perspective view of a radially tensioned skin treatment device for manual injection.

[0186] Fig.56A A top perspective view of a skin tensioning device with a braided needle injection port for use with a syringe. Fig.56B yes Fig.56A Bottom perspective view of the skin tensioning device in FIG. DETAILED DESCRIPTION

[0187] Previous attempts to treat scars and keloids have included surgery, silicone dressings, steroids, X-ray exposure, and cryotherapy. Each of these techniques has disadvantages. Perhaps the biggest disadvantage is that none of them are effective in preventing or ameliorating the formation of scars or keloids in the first place. That is, these techniques are primarily used to treat scars that are already established.

[0188] 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.

[0189] 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.

[0190] 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.

[0191] 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).

[0192] Without wishing to be bound by any particular theory, it is believed 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.

[0193] Many wound dressings have a backing, adhesive liner and / or packaging that is removed prior to application of the wound dressing. Many existing dressings can be difficult to handle when orienting and applying and have a tendency to fold and adhere to themselves.

[0194] The devices, kits, and methods described herein can treat skin at a skin site ("skin treatment device"), including, but not limited to, reducing tensile or compressive stress at a skin site by forming controllable stress or strain at or near a skin site (i.e., at or near a wound or treatment site on the subject's skin) in the deep layers of the epidermis and dermis, thereby improving scar formation at the wound site. The stress at the skin site can be reduced to a level lower 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 reduce endogenous or exogenous stress at the skin site in one, two, or more directions. Therefore, the devices and methods described herein can reduce 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.

[0195] The devices, kits, and methods described herein may provide packaging and / or applicators for dressings. According to one variation, the packaging and / or applicator is configured to provide quick or easy dressing preparation and / or application. Although some examples herein specifically relate to packaging that is also used as a tensioning device to pre-tension a dressing, according to one or more variations or embodiments, other dressings that are not pre-tensioned and / or tensioned before application may be provided. The packaging may also operate as an applicator, wherein one or more elements of the packaging may be used to position and / or apply a dressing to the skin of a subject.

[0196] The devices, kits and methods described herein can be used for making and / or applying a dressing. Such making can include, but is not limited to, for example, removing an adhesive liner prior to application, pulling or tensioning a dressing, orienting a dressing for application and / or applying a drug or other material to a portion of a dressing.

[0197] The backing, adhesive liner or release layer and / or other packaging may provide some structural stability to the flexible wound dressing. However, when removed, the flexible wound dressing may be somewhat difficult to handle because it may fold and adhere to itself or the user, or may be difficult to position on the wound. In addition, the action of pulling or removing the liner and reorienting the dressing to the patient may increase the tendency to fold or sag. In addition, due to the folding or sagging of the dressing, during the adhesive removal and subsequent reorientation process, the user may be likely to compromise the sterility of a portion of the device to be applied to the wound site.

[0198] According to another variation, the package or applicator is configured to provide support for the dressing after it is made and when it is applied to a subject. According to some variations, the backing provides structural support or stability for the dressing when and / or after the adhesive pad is released. According to some variations, the dressing and package are configured to be pre-oriented in a position facing the wound, i.e., so that the wound device can be applied immediately when and after it is ready for application. According to some variations, the package applicator is configured to orient and / or apply the device to the skin of the subject with one hand.

[0199] According to some variations, the package dressing carrier, support, back cover tensioner or applicator tensioner and / or applicator provide a release mechanism for separating the applied dressing from the package and / or applicator after the dressing is applied to the skin. According to one variation, the dressing can be pre-tensioned and coupled to the dressing carrier, support, back cover tensioner or applicator, such as described in U.S. Provisional Application Serial No. 61 / 512,340 filed on July 17, 2011, which is incorporated herein by reference in its entirety. One or more dressing releases described herein can be used in conjunction with a dressing carrier, support, back cover tensioner or applicator.

[0200] In some further variations, the dressing or one or more adhesive areas of the dressing can be released, i.e. separated, from the liner by opening the package or applicator. According to some variations, the book-like package is provided with a front cover and a back cover, to which the dressing is removably attached. When the front cover is opened or as the dressing is opened, the liner can be manually or automatically released from the adhesive of the dressing. According to variations, the liner is attached to the front cover, and when the front cover is lifted or opened, the liner will expose the sticky side of the dressing. The back cover can be configured to provide structural support for the dressing when the liner is removed and / or when the dressing is applied to the subject's skin.

[0201] According to some variations, the package, tensioner, dressing carrier, support, back cover or applicator may further include an opening, window or transparent or translucent portion through which a wound, incision or other location may be viewed when the dressing is applied to the skin. According to some variations, the window guides application of the dressing so that there is an optimal or desired distance between the wound and the edge of the dressing and / or so that the dressing is in an optimal position for relieving stress on the skin.

[0202] According to some variations, the applicator, tensioning device, packaging or carrier, support or backing may provide different or variable flexibility to allow the dressing to be shaped when applied to different body parts or contours.

[0203] According to some variations, the package or applicator is more rigid or provides sufficient breaking strength in at least a first direction to support the dressing, while being relatively more flexible and less rigid in at least a second direction to be more conformable to a curved or shaped skin surface of a subject, or to allow the dressing to bend or shape where it is applied. The first and second directions may be orthogonal or non-orthogonal to each other. According to some variations, the package applicator, tensioning device or dressing carrier, support or back cover is sufficiently rigid or sufficient to support the dressing while allowing the dressing to be shaped. According to some variations, the carrier or support, which may include the back cover and / or the front cover, may include sections of relatively more rigid material flexibly connected to adjacent sections to provide flexibility, thereby allowing the package / applicator and / or dressing to be shaped, while providing sufficient support for the dressing during application. According to some variations, the sections are connected to adjacent sections by a flexible material, such as a low density polyethylene (LDPE) material or a composite of an adhesive and a thinner, more flexible substrate. Alternatively, the segments may be formed into structures by manufacturing the substrate with cuts, slits, grooves, scores or other openings, or with varying substrate thicknesses at different locations.

[0204] The package, applicator, tensioning device or dressing carrier may have elements or features that provide flexibility in one direction orthogonal to the plane of the support and simultaneously limit flexibility in another direction orthogonal to the plane of the support. According to some variations, the flexible element may limit flexibility when the device is tensioned, while allowing flexibility when the device is applied to the skin. Each element may allow bending in a direction different from one or more other elements. The flexible element may be straight or shaped according to the desired application or placement location.

[0205] According to a variation, the flexible element is provided in combination with a support element that provides sufficient support to allow a user to maintain the dressing in a strained configuration. According to a variation, one or more elements may be provided to maintain the strained dressing in the strained configuration, such as a fixing element that fixes the dressing in the strained configuration until it is applied to a subject and released from a carrier, support, backing tensioner or applicator. For example, after the dressing is strained, the dressing may adhere or attach to one or more elements of a dressing, support, backing tensioner or applicator or dressing assembly until it is released from the carrier, support, backing tensioner or applicator or assembly.

[0206] According to some variations, an applicator can be further used to help reduce bleeding, for example, by allowing the use of a support 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, Von Willebrand 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 can 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 (such as a growth factor), a vitamin (such as vitamin E), or a combination thereof. Other examples of such drugs can include, but are not limited to, various antibiotics (including, but not limited to, cephalosporins, bacteriocins (bactitracin), polymyxin B sulfate (polyxyxin Bsulfate), neomycin, polysporin), antibacterial agents (such as iodine solution, silver sulfadiazine, chlorhexidine), antifungal agents (such as nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, beautiful limus (biolimus), paclitaxel), growth factors (such as vascular endothelial growth factor (VEGF)) and other therapeutic agents (such as 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.

[0207] According to one variation, the applicator and / or packaging may have sufficient support or rigidity to maintain the shape of the dressing so that it is easy to manipulate. According to one 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 one variation, a margin is provided as a support structure between the dressing or dressing adhesive and one or more edge portions of the support structure. Such a margin provides a supported edge or area to grasp or manipulate the dressing or its carrier, back cover or support without necessarily or resulting in a greater likelihood of the user inadvertently contacting the adhesive.

[0208] According to some variations, the package or applicator may also be used to tighten the dressing prior to application to provide a dressing for ameliorating scar or keloid formation.

[0209] This article 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. Typically, the device can be configured to be removably fixed to the skin surface near the wound. The device can protect the skin or wound from endogenous stress and / or exogenous stress. In some variations, the device can protect the skin or wound from endogenous stress without affecting the exogenous stress on the skin or wound, such as a device that changes skin elasticity, etc. In other variations, the device can protect the skin or wound from exogenous stress without affecting the endogenous stress on the wound. This variation may include situations where muscle tissue and surrounding skin or wound tissue have been paralyzed, such as paralysis caused by the use of botulinum toxin, etc. In other variations, the device protects the skin or wound from endogenous and exogenous stress.

[0210] Device as herein described or dressing can treat the skin of skin part, including but not limited to improving the scar formation of wound part by controlling stress or strain to the epidermis and dermis tissue deep layer near skin part or skin part so as to reduce the tensile or compressive stress of skin part itself.The stress of skin part can be reduced to the level lower than normal skin and tissue borne.Stress or strain can be applied to surrounding tissue in one, two or three directions, to reduce the endogenous or exogenous stress of skin part in one, two or three directions.The physical property of dressing and / or the method for applying dressing can also be further configured to resist or reduce skin peeling or tension blister rate due to applying strain to incision part.For example, when applied to skin surface, the stretching of bonding area can cause the tissue density under bonding area to increase.This may be the result of the roughly plane, tangential or parallel compression of the skin tissue directly attached to this bonding area, and this roughly plane, tangential or parallel compression is caused by the relaxation of bonding area. In some examples, such tissue compression can reduce the risk of tissue peeling and / or blistering of the skin in direct contact with the adhesive, in contrast to bandage "banding," in which one end of the bandage is adhered to the skin and then tensioned or pulled across the wound before the other end is attached to the skin on the opposite side of the wound. Bandage "banding," while creating tension in the bandage during application, can produce relatively high tissue strains at the first bonding site. Then, when the bandage is attached to the skin at the second attachment site, this high tissue strain will be reduced due to the redistribution of the high peak stress along the skin under the bandage. In contrast, when a pre-tensioned bandage is applied to the skin, little if any strain is transferred or generated in the skin when the adhesive area is applied to the desired location. However, when the pre-tensioned bandage is allowed to relax, the strain (or peak strain) in the skin may increase. Therefore, with a pre-tensioned bandage, temporary high tissue strains can be avoided or reduced during application. However, in other variations, the dressing may also be applied to the skin by strapping or by a combination of pre-tensioning and strapping.

[0211] The dressing may include an elastic member, such as an elastic material sheet. 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 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 may be selected so that the dressing has sufficient load-bearing capacity to obtain the desired recoverable strain and prevent the dressing from producing an undesirable amount of creep 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 the range of about 200 microns to about 260 microns in some variations. Exemplary dressings have an edge thickness of about 500 microns or less, 400 microns or less, or about 300 microns or less, with less risk of skin separation due to inadvertent lifting when accidentally rubbed against clothing or objects. In some variations, the dressing tapers near the edge to reduce thickness. The tapered edge can 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 can be thicker than the middle of the dressing. It is assumed that in some configurations, the thicker edge of the dressing can provide a relative inward movement of the peak tension position acting near the edge of the dressing compared to a dressing of uniform thickness. The elastic material can have a load per width of at least 0.35 Newtons per millimeter at an engineering strain of 60%, or a load per width of at least 0.25 Newtons per millimeter at an engineering strain of 45%. The elastic material may have a per width load of no more than about 2 Newtons per millimeter at an engineering strain of about 45% to 60%, about 1 Newton per millimeter at an engineering strain of about 45% to 60%, about 0.7 Newtons per millimeter at an engineering strain of about 45% to 60%, or no more than about 0.5 Newtons per millimeter at an engineering strain of about 45% to 60%. The system elastic material may have a per width load that does not decrease from 0% to 60% engineering strain, a per width load curve that increases linearly from 0% to 60% engineering strain, or a per width load curve that does not bulge from 0% to 60% engineering strain. The elastic material may include an adhesive that is 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 elastic material may include an adhesive 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.

[0212] Although the dressing may have a generally rectangular configuration with a length and / or width of about 160 mm to about 60 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 1:3, about 1:2, 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 skin at the skin site generally includes an inherent tension that stretches the incision site, regardless of whether any tissue is removed from the skin site. 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 incision site, the tensile stress in the dressing is transmitted to the incision site to compress the tissue directly below the dressing along a tangential axis of the skin surface, and the stress and strain applied to the skin site have a net or synthetic orientation or axis that 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 a dressing to a skin location can include placing a 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 according to the thickness of a specific person, skin location, skin layer (e.g., epidermis, dermis, or underlying connective tissue) or various mechanical properties and / or the extent of a pre-existing scar. In some further variations, a wound treatment dressing can be selected or configured for a specific body location, such as the scalp, forehead, cheek, neck, upper back, lower back, abdominal region, upper trunk (including but not limited to breast folds), shoulder, upper arm, lower arm, palm region, back of hand, finger, thigh, calf, instep or sole of foot and / or toe. Where applicable, some body regions can be further divided into anterior, posterior, middle, lateral, proximal region, and / or distal region, such as arms and legs.

[0213] The dressing may be configured to apply skin strains ranging from about 10% 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, from about 50 to about 80. An exemplary dressing is comprised of MED 82-5010-05 from NUSIL TECHNOLOGY LLC (Carpinteria, CA).Other examples of suitable materials are described in U.S. Patent Application No. 11 / 888,978, previously incorporated herein by reference in its entirety.

[0214] 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 4% 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).

[0215] 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, but in other examples, the engineering stress may be in the range of about 900 KPa to about 3.5 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 released from stress, the material may 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 material unloading to about 40% strain may 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 an engineering strain of about 30%, the material exhibits an engineering stress of about 300 KPa, but in other examples, when the material is unloaded to a strain of about 30%, 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 can have an engineering stress of about 100 KPa, but in other examples, the unloaded engineering stress at about 20% can 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. In some examples, the material can 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 can be configured for a lower level of maximum engineering strain, such as up to about 30% or about 40%.

[0216] In some examples, certain portions of the stress / strain curve may have a particular morphology. For example, for a particular level of maximum strain, the load curve is generally linear on the corresponding true stress / strain curve. In an example using the dressing described herein, the load curve has 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.

[0217] In some variations, the elastic material comprises 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, or at least about 10 MPa or more. The material elastic modulus E may be no greater than about 10 MPa, about 9 MPa, about 8 MPa, about 7 MPa, about 6 MPa, or about 5 MPa, or about 4 MPa.

[0218] 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.

[0219] 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.

[0220] In some variations, the elastic material or dressing may be configured under test conditions to maintain a specific minimum stress level while 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 change may be about 12%, about 10%, about 8%, about 6%, about 5%, about 4%, about 3%, or about 2% or less.The stress or strain may be an engineering stress or strain, and / or a true stress or strain.

[0221] Adhesive used can be, for example, pressure activated adhesive (PSA), such as polysiloxane, acrylic acid, styrene block copolymer, vinyl ether, nitrile or other PSA. In other variations, non-pressure sensitive adhesive can be used, including but not limited to heat curing or light curing adhesive. Pressure sensitive adhesive can be made of, for example, polyacrylate-based, polyisobutylene-based, polysiloxane-based pressure sensitive adhesive, synthetic rubber, acrylic acid and polyisobutylene (PIB), hydrocolloid, etc. The T-peeling peeling 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 peeling force or blunt probe viscosity test value of adhesive are configured to keep at least about 50MPa / mm load 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 time. In other variations, the load may be at least about 75 MPa / mm, about 100 MPa / mm, about 125 MPa / mm, or at least about 150 MPa / mm for a particular period of time. The degree of adhesion (e.g., as measured by T-peel peel force or blunt probe tack test values) may vary depending on the degree of strain applied to the skin or incision site, and in some variations, these time periods may 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.

[0222] The release liner 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. For example, for silicone adhesives, a polyester film treated with a fluoropolymer may be used, and for acrylic pressure sensitive adhesives, a polyester or Mylar film treated with silicone or kraft paper treated with silicone may be used. In variations where the device has a plurality of separated adhesive regions, a separate release liner may be provided for each region, or some regions may be covered with the same release liner.

[0223] Examples of dressings, applicators, or tensioning devices that may be used with the devices, kits, or methods herein may include those provided in U.S. Application Serial No. 12 / 854,859, filed August 11, 2010, the disclosure of which is incorporated herein by reference in its entirety, but is not limited thereto.

[0224] The packaging assembly, applicator and / or tensioning device may include a tensioning structure, a first attachment portion configured to be releasably attached to a dressing, and a second attachment portion configured to be releasably attached to the dressing, wherein the tensioning structure may be configured to apply a separation force between the first attachment portion and the second attachment portion to produce a 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 the packaging assembly, and may include an attachment structure or may be integral with the attachment structure of the packaging device, applicator or tensioning member. The tensioning structure may also be used as an applicator device, or may be configured to allow a user to apply the dressing to the skin of a subject.

[0225] The attachment structure of the packaging device, dressing assembly, dressing carrier, support, back cover, applicator, tensioning or tensioning device may include any structure for attaching or coupling the applicator, tensioning or tensioning device to the dressing. The dressing may or may not have an attachment feature or structure. Any such attachment feature may be integral with or include any attachment structure or corresponding structure of the attachment structure of the packaging, applicator dressing and / or tensioning device.

[0226] In some variations, the assembly may include one or more mechanisms or elements configured to facilitate separation, release, removal or disassembly of the dressing from the packaging, applicator or tensioning device, other attachment elements or other parts of the dressing assembly, including but not limited to the separation devices and methods described herein. The release element or releasable attachment structure may include but is not limited to, for example, a pocket and pull tab, a hook and loop mechanism, a hook, a corner bar, a pivoting, rolling, rocking or sliding feature structure associated with or connected to the attachment structure, an adhesive, a removable adhesive, an adhesive strip or other adhesive device, a latch / hook, a tear cord, a towel rack-like structure, a sliding pin, a friction lock, a cam lock, a vacuum or suction device, a snap connector, a carpet tack, a press-fit connection or other connection, a lever, a latch, a locking member, a spring member, or other mechanism such as a cutter or tear cord or other structure or feature to facilitate tearing, cutting or separation of a perforated attachment structure or element or other detachable structure, which allows the dressing to be removed from the applicator, packaging, other parts of the dressing assembly and / or the attachment structure, feature, element or portion. They may be self-releasing latches or spring members. They may be actuated when a pressure member is applied to the skin treatment device before removing the applicator. They may be manually actuated.

[0227] As described above, in some embodiments, a package or applicator, a tensioning device and / or a tensioning device may be provided to apply strain to the skin treatment device by an external force, and / or to maintain the strain applied to the skin treatment device. The package, applicator or tensioning device may be configured to pivot or rotate to tension the dressing. In some examples, the strain device may be configured to apply and / or maintain a single predetermined or preset strain or multiple predetermined or preset strains, or a predetermined maximum or minimum strain amount. The features described herein regarding the packaging assembly, applicator or tensioning device may also be used in any device for tensioning a dressing. The package or applicator, tensioning or tensioning device described as being in an untensioned configuration is in a configuration in which the dressing may be untensioned or relatively less tensioned when the dressing is attached to the package, applicator, tensioning or tensioning device. A package, applicator, tensioning or straining device described herein as being in a strained configuration is in a configuration in which the dressing can be strained or relatively more strained when the dressing is attached to the package, applicator, tensioning or straining device, or when the dressing is applied to the skin of a subject compared to an unstrained configuration.

[0228] The packaging device, applicator, tensioning device, and corresponding attachment features may be configured to provide multi-directional strain to the dressing, or additional strain in orthogonal directions.

[0229] The contour of the packaging device, applicator, tensioner and / or attachment structure can be straight, curved or otherwise varied. For example, the shape of the elements of the device can be configured to follow the shape of the area of ​​the subject's body to which the skin treatment device will be attached. The packaging device, tensioner, applicator or its elements can be selected or configured to have a contour with a desired contour for a specific body part or contour on which the skin treatment device will be placed on the subject's skin. The packaging device, applicator, tensioner or its elements can be selected or configured to closely match a portion of the subject's body contour. The packaging device, applicator or tensioner and / or its elements or sections can be curved, curvilinear, flexible, bendable, ductile, deformable, formable or removable to provide an alternative shape or contour of the attached dressing. They can be relatively curvilinear, curvilinear, pliable, ductile, bendable, deformable, formable or removable in at least one direction, and more rigid in another direction.

[0230] Various locking, latching, fixing, attaching or braking mechanisms can be used to keep the package, applicator or tensioner in various configurations, including but not limited to an untensioned configuration, a partially tensioned configuration, and a tensioned configuration. A variety of locking, latching or braking mechanisms can be used to keep the dressing in a variety of configurations, including an untensioned configuration, a partially tensioned configuration, and a tensioned configuration. By locking the package, applicator, tensioner or dressing in a tensioned position, a predetermined strain of a given dressing can be achieved. The predetermined strain amount can be a predetermined absolute strain percentage or force level that is independent of the shape and / or size of the treatment site. As another example, the absolute strain percentage or force level can be independent of the minimum strain or force to achieve seamless wound closure (e.g., the relative strain or force to achieve the incision edges of the treatment site). In addition, the force desired to achieve wound closure is not a predetermined strain or force, because the final level of the strain or force is not known until the incision edges are opposed.

[0231] refer to Figures 1 to 5C , shows a variation of a dressing and packaging assembly 100. The packaging assembly 100 includes a book-shaped applicator and / or tensioning device 120, a dressing assembly 110 including a dressing 130, and a release member 150 configured to release the dressing 130 from the applicator and / or tensioning device 120.

[0232] The dressing 130 comprises an elastic sheet 131 having on its first surface 135a one or more adhesive areas comprising a skin adhesive layer 135. The adhesive used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive.

[0233] The packaging assembly 100, the applicator or tensioning device 120, and / or the dressing assembly 110 can be configured to pre-tension the dressing 130 and / or allow the pre-tensioned dressing 130 to be transferred to the subject's skin. The applicator and / or tensioning device 120 can also provide for convenient, rapid, or aseptic transfer of the adhesive portion of the dressing 130 to the subject's skin and / or wound site.

[0234] The device 120 includes a cover 121 and a back cover 122. The dressing assembly 110 is removably coupled to or anchored to the device 120, which can serve as a dressing carrier or support. The cover 121 can be generally planar and include sides 123, 124 and edges 121a at opposite ends, the sides 123, 124 having respective edges 123a, 124a along their lengths. The dressing carrier or back cover 122 can be generally planar and include sides 125, 126 and edges 122a at opposite ends, the sides 125, 126 having respective edges 125a, 126a along their lengths.

[0235] According to some variations, the front and / or back covers 121, 122 or elements or sections thereof may be constructed to be sufficiently strong or rigid or less flexible relative to the attached dressing to support the attached dressing until the dressing is applied to a subject, as described with respect to variations herein. Such materials may include, for example, plastics such as polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or ), LDPE, high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), polyvinyl chloride (PVC) or acrylic, nylon or paperboard. The elements or segments can be laminates of materials, such as solid bleached sulfate paperboard, with a layer of flexible material, such as silicone, polyurethane, low density polyethylene (LDPE) or rubber material between the layers of paperboard. The material can also be a metal, such as ductile aluminum or stainless steel. The metal can include foil, tape, wire or other forms.

[0236] The front cover 121 and the back cover 122 are movably, hingedly or pivotally connected at the sides 123, 125. For example, a layer of material such as silicone, polyurethane, low-density polyethylene or a rubber material can be bonded to each of the front cover and the back cover to flexibly connect them together at the sides 123, 125. Optional devices and methods can be used to connect the front cover 121 and the back cover 122. For example, various composite structures or laminates can be used. In addition, the device can be composed of a single substrate that provides flexibility in some selected areas and rigidity in other areas, or provides relative or absolute flexibility in a first direction and relative or absolute rigidity in a second direction transverse to the first direction. Although Figures 1 to 5CThe cover 121 and back cover 122 depicted in the figure have approximately the same size and shape, but in other examples, the cover 121 and back cover 122 can be different sizes and / or shapes. The cover 121 and / or back cover 122 can be bendable, foldable, bendable, flexible, malleable or plastic, allowing relatively more uniform placement on positions with different shapes or curvatures. For example, each of the cover and back cover 121, 122 as shown in the figure is divided into a plurality of sections 127 along the length, which are bendable or movable relative to adjacent sections, thereby allowing the flexibility of the device 120 along its length. The section 127 can be made of a more rigid material that reduces bending in the lateral or other directions. Other configurations that change the rigidity and / or flexibility direction can be used. The configuration can include providing sufficient rigidity in the direction in which the dressing is tightened to produce and / or maintain a desired strain level. The sections 127 may be coupled by a material such as an elastomer, such as a polysiloxane, which flexibly holds the sections together. Other structures may also be used to flexibly couple sections or other elements. The material coupling or bonding the cover and back cover 121, 122 may be continuous or discontinuous with the material coupling the section 127 to the adjacent section 127, and may or may not be attached to all or part of the sides of the cover and back cover 121, 122. Various attachment structures (e.g., sections and / or cover and back cover and coupling elements) may provide structural support for the dressing carrier manipulated by the user. A margin between at least a portion of the structural support element, the dressing carrier or the backing and the dressing may be provided at or near the edges 121a, 123a, 124a, 122a, 125a, and / or 126a, for example as further described herein. In some further embodiments, the material to which the front cover 121 and the back cover 122 are attached may include a semi-rigid structure that may be biased to an open configuration or a closed configuration, or a configuration therebetween. In other variations, the front cover 121 and the back cover 122 may be attached by any of a variety of hinge structures, including but not limited to one or more pin-based hinge joints, rings attached to holes in the front cover 121 and the back cover 122, or a ball joint.

[0237] like Figures 5A-5CAs shown, a variation of the packaging structure is shown. The cover 121 and the back cover 122 include relatively strong or rigid elements, such as slats 121a, 121b and slats 122a, 122b attached by a sheet of material 128, respectively, and the material of the sheet of material 128 is, for example, polysiloxane, polyurethane, low-density polyethylene or a rubber material, which also flexibly connects the cover 121 and the back cover 122 at the side 123, 125. The section 127 can have an alternative shape and structure that connects the section 127 together. Therefore, the device 120 can be configured to bend or flex to varying degrees or in multiple directions. Therefore, the device can be configured for a specific anatomical position or configured to have different sizes, or can be configured to have a shape for a specific situation or individual.

[0238] According to some variations, both the cover 121 and the back cover 122 are at least partially made of transparent plastic, translucent material, or other material that can provide a window portion 159, through which the wound, incision, or other location can be observed to accurately place the dressing 130. The cover 121 and the back cover 122 may or may not include the same material. The elastic sheet 131 and the adhesive layer 135 may also be transparent enough to allow observation through them. A more opaque material may be provided on a portion of the material to create the border of the window 159. The section 127 may be transparent or translucent to provide a window for observing, locating, and / or centering the position of the wound or the position on the skin relative to the dressing 130, or for locating the wound within the best or most effective strain zone of the dressing. The border or other markings can help the user place the dressing 130 in the appropriate position on the wound or incision.

[0239] The dressing 130 of the dressing assembly 110 includes a first side or edge 133 having a length, and a second side or edge 134 having a length. The dressing 130 is coupled to the packaging assembly 100 along the length of the sides 133, 134 of the dressing. When the device 120 is closed, the adhesive layer 135 faces away from the back cover 122 and is covered by a release liner 149 attached to the inner surface 177 of the front cover 121. The dressing assembly 110 also includes an attachment sheet 141 having a first side 143 and a second side 144. The attachment sheet 141 couples the dressing 130 to the front cover of the device 120, and when the front cover is opened, a strain force is applied to the dressing 130 through the attachment sheet 141. According to some variations, the attachment sheet 141 is flexible while being relatively inelastic / less elastic relative to the dressing 130, and may be comprised of, for example, low-density polyethylene. When assembled, the attachment sheet 141 is bonded to the elastic sheet 131 of the dressing at or near the sides 134 and 143 of the dressing 130 and the attachment sheet 141, respectively (e.g., using a combination of a silicone PSA / acrylic PSA). The attachment sheet 141 is coupled to the cover 121 at its side 144 at an attachment point 137, which defines an attachment line or area 137a along the length of the cover 121. The dressing 130 is coupled to the second side 124 of the back cover 122 at a location near the first side 133 of the dressing 130. In this way, the elastic sheet 131 is attached at an attachment point 138, which defines an attachment line or attachment area 138a along the length of the back cover 122. Many bonding methods or adhesives can be used to attach the attachment sheet 141 to the cover 121, for example, a low surface energy PSA such as an acrylic adhesive.

[0240] When the component 100 is in Figure 1 The closed configuration shown and Figure 2In the 90 degree open configuration shown, the elastic sheet 131 is in a relaxed or untensioned state, wherein the elastic sheet 131 has an untensioned width w1. When the assembly 100 is opened to 180 degrees or up to about 360 degrees (e.g., by rotating or pivoting the front cover 121 relative to the back cover 122), the orthogonal distance between the attachment lines or attachment areas 137a, 138a increases. According to some variations, the assembly is opened to not less than about 180 degrees (minimum angle change) to provide for the application of the dressing without interfering with the assembly 100. When the device 120 is opened, it applies a separation force between the attachment areas or corresponding attachment areas defined by the attachment lines or areas 137a, 138a. The force tightens the elastic sheet, generating strain. Tightening and applying strain on the dressing 130 increases the width between the attachment lines or attachment areas 137a, 138a to w2. The increment in width, i.e., w2 minus w1, can be a percentage of w1 or a strain percentage as described herein. Although strain / tensioning is shown to begin when the cover 121 is opened approximately 90 degrees from the back cover 122, the dressing 130 can be attached to the cover 121 at a number of locations or in a number of configurations that can change the position or configuration of the cover at which tensioning begins. The edge 124a or side 124 of the cover 121 can act as a lever arm to provide a mechanical advantage, which can depend, among other things, on the distance from the attachment point 138 of the dressing assembly 110 on the cover to the edge 124a of the cover 121 and the angle of the cover 121 relative to the back cover 122 when tensioning of the dressing occurs. In addition, the attachment point 138 of the inelastic attachment tab 141 to the cover 121 can determine the amount of strain applied to the dressing, especially assuming that the length of the attachment tab 141 remains constant and the attachment point 137 of the dressing assembly 110 to the back cover 122 remains constant.

[0241] According to one variation, the dressing 130 may be fully secured at one edge (e.g., at edge 134 at side 126 of back cover 122) and unsecured at the opposite edge (e.g., edge 133 moves relative to edge 125a of back cover 122 when tightened). When cover 121 is opened and the dressing 130 is tightened, the width of the tightened dressing may be less than the width of back cover 122 and / or cover 121, so that the area of ​​the dressing is located above the area of ​​back cover 122 and / or cover 121, i.e., back cover 122 and / or cover 121 have a margin outside the dressing area. According to other variations, the dressing may be secured at both edges.

[0242] According to some variations, the dressing is sufficiently large relative to the device 120 so that when the dressing is applied to the skin, the interference caused by the device 120 is relatively small. According to one example, the width of the stretched portion of the dressing can be about 10 mm, about 20 mm, about 30 mm, about 40 mm, or about 50 mm. Other stretched dimensions can be used. According to other variations, the respective distances between each of the edges 133, 134 of the dressing 130 and the edges 125a, 126a of the back cover 122 (and / or the edges 123a, 124a of the cover 121) are no greater than about 10 mm, 15 mm, or 20 mm. According to some variations, the distances between the edges 136a, 136b of the dressing and the edge 122a of the back cover are no greater than about 10 mm, about 15 mm, or about 20 mm.

[0243] According to some variations, the edges 133, 134, 136a, 136b of the dressing 130 are located at least about 1.0 mm inward from at least a portion of the edges 125a, 126a, and / or 122a of the back cover 122, so that a user can hold the edges 125a, 126a, and / or 122a of the back cover 122, thereby reducing the possibility of contacting the dressing 130 or the adhesive layer 135. According to some variations, the ends 136a, 136b of the dressing 130 have a margin of at least about 1.0 mm inside the end 122a of the back cover 122. According to some variations, the sides 133, 134 and ends 136a, 136b of the dressing 130 have a margin of about 10 mm relative to the sides 125, 126 and end 122a of the back cover, respectively. According to some variations, the sides 133, 134 and ends 136a, 136b of the dressing 130 have a margin of about 15 mm relative to the sides 125, 126 and end 122a of the back cover, respectively. Each of the margins between the sides 133, 134 or ends 136a, 136b of the dressing 130 and the sides 125, 125 and end 122a of the back cover 122 may be different. Figure 3 As shown, for example, margins m1 and m2 are approximately not less than 3 mm, and margin m3 is approximately 15 mm. For example, if the edge of cover 121 can be used alternatively or additionally to grasp the device 120 or manipulate the dressing 130, similar margins can be provided between the dressing 130 and the edges 121a, 123a and / or 124a of cover 121. Then, once cover 121 is opened and adhesive layer 135 is exposed, the adhesive side of dressing 130 can be placed on the skin or wound site using device 120. Figure 3 and Figure 4As shown, the front cover 121 and the back cover 122 can be rotated an additional amount relative to each other, such as about 360 degrees from the closed configuration, before applying the dressing 130. A locking mechanism can optionally be provided to lock or secure the device in an open position, a partially open position, or a closed position. In some examples, the locking mechanism can include a magnet, a hook and loop attachment structure, a snap, a latch, a clip, etc.

[0244] Before the applicator or tensioner 120 is opened, the adhesive layer 135 of the elastic sheet 131 is protected by a release liner 149. The release liner 149 is attached or bonded to the inner surface 177 of the cover 121 so that when the cover 121 is opened, the elastic sheet 131 is protected by a release liner 149. Figure 2 When the cover 122 is opened and separated from the back cover 122 (before the elastic sheet 131 is tightened), the release liner 149 is pulled away from the elastic sheet 131, thereby exposing the adhesive layer 135. Alternatively, as shown in FIG. Figure 6 As shown, release liner 149a may be disposed on adhesive layer 135 that is not attached to cover 121. When device 120 is opened, and before dressing 130 is tightened, release liner 149a may be manually removed from elastic sheet 131 to expose adhesive layer 135.

[0245] After the dressing 130 is tightened and the liner 149 or 149a is released, the dressing 130 can be applied to the desired location on the subject's skin. The window 159 can be used to visualize the correct placement. The user can apply pressure to the back 129 of the device 120 to activate the adhesive on the elastic sheet 131 and / or apply pressure to the wound. Alternatively, if the cover 121 is rotated to 360 degrees, pressure can be applied to the inside 177 of the cover 121. Once applied to the subject, the elastic sheet 131 can be released from the packaging, applicator or tensioning device 120 using the release structure or mechanism 150.

[0246] The release mechanism 150 may include cutters 151, each located on opposite sides 133, 134 of the elastic sheet 131. Each cutter 151 includes a blade 152 on one end 153, the blade having legs 154, 155 extending to opposite pull tabs 156 on opposite ends 157. The blade 152 includes a sharp surface that is generally v-shaped or other shapes. The blade can be made of, for example, stainless steel, ceramic, or hard plastic. The blade 152 and the pull tab 156 extend from the ends 136a, 136b of the elastic sheet 131 and the end 122a of the bottom cover 122, respectively. The cutter 151 is arranged to define an overall cutting path 162, 163 (at Figure 5A 10, the blade 152 is pulled along the path by the pull tab 156 to cut the dressing assembly 110, thereby releasing the dressing 130. In some variations, the dressing may be scored, perforated, or otherwise configured to facilitate separation by a release mechanism.

[0247] like Figure 5B and 5C As best shown, tubes 164, 165 for receiving and guiding the legs 154, 155 of the cutter 151, respectively, are positioned along the side 133 of the elastic sheet 131. The tubes 164, 165 can be positioned so that the cutting path 162 is located between the tubes 164 and 165. The tube 165 is coupled (e.g., glued) to the adhesive surface 135 of the elastic sheet 131 at a location closer to the side 133 than the cutting path 162. The tube 164 is coupled to the rear surface 139 of the elastic sheet 131 by the attachment sheet 141, which is also coupled to the elastic sheet 131 at a location closer to the side 133 than the cutting path 162. The tube 164 is coupled to the free end 145 of the attachment sheet 141, which extends inboard of the cutting path 162 relative to the side 133. Thus, tube 164 can be positioned inside of cutting path 162 without being attached to elastic sheet 131 inside of cutting path 162. This allows dressing 130 to be released from the remainder of packaging assembly 100 including cutter 151 with tube 164 and attachment sheet 141. Protective member 170 is attached, e.g., glued, to the top of tube 165. Protective member 170 includes a boss portion 171 extending above cutting path 162 so that when adhesive layer 135 is located on the subject's skin and cutter 151 is actuated, the skin is protected from blade 152.

[0248] Tubes 174, 175 for receiving and guiding the legs 154, 155, respectively, are positioned along the side 134 of the elastic sheet 131. The tubes 174, 175 are positioned so that the cutting path 163 is located between the tubes 174 and 175. The tube 175 is coupled (e.g., glued) to the adhesive surface 135 of the elastic sheet 131 at a position closer to the side 134 of the elastic sheet 131 than the cutting path 163. The tube 174 is coupled to the rear surface 139 of the elastic sheet 131 through the extension sheet 146. The tube 174 is coupled to the free end 147 of the extension sheet 146, which extends inside the cutting path 163 relative to the side. The tube 174 is also coupled to the elastic sheet 131 at a position closer to the side 134 than the cutting path 163. Therefore, the tube 174 can be located inside the cutting path 163 without being attached to the elastic sheet 131 inside the cutting path 163. This allows the dressing 130 to be released from the remainder of the packaging assembly 100 including the cutter 151 with tube 175 and the extension piece 146. The protective member 170 is attached, for example glued, to the top of the tube 175. The protective member 170 includes a boss portion 171 extending above the cutting path 163 so that when the adhesive layer 135 is located on the subject's skin and the cutter 151 is actuated, the skin is protected from the blade 152.

[0249] The interior of the tubes 164, 165, 174, 175 may be coated with a lubricating material, such as Kapton tape. The guide legs 154, 155 may be constructed of a low friction material such as HDPE or UHMWPE so that the legs 154, 155 can slide easily in the tubes 164, 165, 174, 175 to allow for smooth cutting of the dressing 130 from the rest of the packaging assembly 100.

[0250] When the dressing 130 is tightened and the adhesive 135 is exposed, the dressing 130 can be applied with the adhesive side 135 facing the skin of the subject. The side 133 of the elastic sheet can then be released from the applicator by pulling the pull tab 146 to pull the blade 152 through the cutting path 162. In addition, the side 134 of the elastic sheet can then be released from the applicator by pulling the pull tab 146 to pull the blade 152 through the cutting path 163. Thus, the elastic sheet 131 is released from the package 100 (including the release member 150).

[0251] refer to Figures 7 to 9 , another variation of a dressing and packaging assembly 200 is shown. The packaging assembly 200 includes an applicator and / or tensioning device 220 and a dressing assembly 210 including a dressing 230. The dressing 230 includes an elastic sheet 231 having one or more adhesive regions including a layer of skin adhesive 235. The adhesive used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive.

[0252] The packaging assembly 200, the applicator or tensioning device 220, and / or the dressing assembly 210 can be configured to pre-tension the dressing 230 and / or allow the pre-tensioned dressing 230 to be transferred to the subject's skin. The applicator or tensioning device 220 can also provide for convenient aseptic transfer of the adhesive portion of the dressing to the subject's skin and / or wound site.

[0253] The device 220 may include a cover 221 and a back cover 222. The dressing assembly 210 is removably coupled to or anchored to the device 220 and may serve as a dressing carrier. The cover 221 may be generally planar and include sides 223, 224 and edges 221a at opposite ends, the sides 223, 224 having respective edges 223a, 224a defining their lengths. The back cover 222 may be generally planar and include sides 225, 226 and edges 222a at opposite ends, the sides 225, 226 having respective edges 225a, 226a defining their lengths.

[0254] According to some variations, the front and / or back cover 221, 222 or its elements or sections may be constructed to be sufficiently strong or rigid, or have less flexibility relative to the attached dressing to support the attached dressing until the dressing is applied to the subject, as described in the variations herein. Such materials may include, for example, plastics, such as polypropylene, polycarbonate, polytetrafluoroethylene (PTFE), LDPE, high-density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE), polyvinyl chloride (PVC) or acrylic, nylon or paperboard. The elements or sections may be laminates of materials, such as solid bleached sulfate paperboard, with a layer of flexible material, such as silicone / polysiloxane (silicone), polyurethane, low-density polyethylene or rubber material between the layers of paperboard. The material may also be a metal, such as ductile aluminum or stainless steel. The metal may include foil, tape, wire or other forms. Other variations described for applying or tensioning device 100 may also be used for device 200.

[0255] The cover 221 and the back cover 222 can be movably, pivotably, bendably or hingedly connected at the sides 223, 225 in a manner similar to the manner described herein with respect to the cover and back cover 121, 122, and can be constructed in a manner similar to the construction of the cover and back cover 121, 122 described herein, in particular, section 227 is similar to section 127, and the dressing 230 is attached to the device 220 and is tightened by the device in a manner similar to the way the dressing 130 is attached to the device 120.

[0256] Various attachment structures (e.g., segments and / or front and back covers and coupling elements) can provide structural support for the dressing carrier that is manipulated by the user. A margin between at least a portion of the structural support element, the dressing carrier or backing and a tensioned or untensioned dressing can be provided at or near edges 221a, 223a, 224a, 222a, 225a, and / or 226a, such as those described herein. Figure 3 The margins m1, m2, and m3 are shown in FIG.

[0257] According to some variations, each of the cover 221 and the back cover 222 is at least partially made of transparent plastic, translucent material, or other material that can provide a window portion 259, through which the wound, incision, or other location can be observed to accurately place the dressing 230. The cover 221 and the back cover 222 may or may not include the same material. The elastic sheet 231 and the adhesive layer 235 may also be transparent enough to allow observation through them. A more opaque material may be provided on a portion of the material to create a border of the window. The section 227 may be transparent or translucent to provide a window for observing, locating, and / or centering the position of the wound or the position on the skin relative to the dressing 230, or for locating the wound within the best or most effective strain zone of the dressing. Boundaries or other markings can help the user place the dressing in the appropriate position on the wound or incision.

[0258] The dressing assembly 210 also includes an attachment sheet 241, an attachment sheet 251, and a dressing release structure or mechanism 250, which includes a pull tab 246, as described in more detail herein. It includes a first side portion 233 having a length, and a second side portion 234 having a length. When the device 220 is closed, the adhesive layer 235 faces away from the back cover 222 and is covered by a release liner 249 attached to the inner surface 277 of the front cover 221.

[0259] The attachment sheet 241 has a first side 243 and a second side 244. The attachment sheet 241 couples the dressing 230 to the cover 221 of the device 220 near the second side 234 of the dressing 230, which applies a strain force on the dressing 230 through the attachment sheet 241 when the cover 221 is opened. The attachment sheet 241 is coupled to the cover 221 at its side 244 at an attachment point 237, which can be provided as an attachment line or attachment area 237a, for example by bonding with a low surface energy PSA such as an acrylic adhesive. When assembled, the attachment sheet 241 is bonded to the elastic sheet 231 of the dressing 230 at a section 265 of the attachment sheet 241 located at or near the side 243 of the attachment sheet 241 (for example, using a combination of a silicone PSA / acrylic PSA). The attachment sheet 251 has a first side 253 and a second side 254. The attachment sheet 251 couples the dressing 230 to the back cover 222 of the device 220 near a first side 233 of the dressing 230. The attachment sheet 251 is coupled to the back cover 222 at its side 254 at an attachment point 238 defining an attachment line or attachment area 238a, for example by bonding with a low surface energy PSA such as an acrylic adhesive. When assembled, the attachment sheet 251 is bonded to the elastic sheet 231 of the dressing at a section 265 of the attachment sheet 251 located at or near the side 253 of the attachment sheet 251 (e.g., using a combination of a silicone PSA / acrylic PSA).

[0260] The dressing 230 has an unattached portion or edge 255 at its side 233, 234, where the elastic sheet 231 is separated from / free relative to the attachment sheet 241, 251, respectively. Therefore, the dressing 230 will not be tightened at the unattached portion 255. The pull tabs 246 are each coupled to the ends 281, 282 of the device 220. Each pull tab 246 includes a top section 247 and a bottom section 248. As shown, the bottom section 248 is attached to the back cover 222 or the front cover 221, while the top section 247 is adjacent to but not attached to the dressing 230.

[0261] According to some variations, the attachment sheets 241, 245 are flexible, but relatively inelastic relative to the dressing 230, and may be constructed of, for example, low-density polyethylene. The attachment sheets 241, 245 may be manufactured to be tearable along the length of the material while providing tensile strength in other directions, particularly in the tensile direction of the material of the attachment sheet 241 (the direction in which the dressing is stretched, stressed, or tightened). An example of such a material is an LDPE polymer, which is produced by an extrusion process that produces a directional tilted / biased texture, whereby the material can be torn in the direction of the texture, but has relative tear resistance in a direction transverse to the texture. The pull tab 246 may begin tearing at a notch in the attachment sheet 241 or 251, which will be completed along line 262. The attachment sheets 241, 251 may additionally or alternatively include a material such as LDPE having perforations formed along the tear line 262.

[0262] Similar to assembly 100 herein, when assembly 200 is in a closed configuration and as Figure 7 In the configuration shown as being opened 90 degrees, the elastic sheet 231 is in a relaxed or untensioned state, and the elastic sheet 231 has an untensioned width w3. When the assembly 200 is opened to 180 degrees or up to 360 degrees (for example, by rotating or pivoting the cover 221 relative to the back cover 222), the orthogonal distance between the attachment lines or attachment areas 237a, 238a increases. When the device 220 is opened, it applies a separation force between the attachment areas or corresponding attachment areas defined by the attachment lines or attachment areas 237a, 238b. This force tightens the elastic sheet 231, generating strain. Tightening and applying strain on the dressing 230 increases the width between the attachment lines or attachment areas 237a, 238a to a width w4. The increment of the width (i.e., the width w4 minus the width w3) can be a percentage of w3 or a strain percentage as described herein. When the cover 221 is opened approximately 90 degrees from the back cover 222, it begins to tighten / generate strain. The dressing 230 may be attached to the cover 221 at a number of locations or in a number of configurations that can change the position or configuration of the cover 222 at which tensioning is initiated.

[0263] like Figures 8A to 8C As shown, the front cover 221 and the back cover 222 may be rotated an additional amount relative to each other, for example, up to about 360 degrees from the closed configuration, prior to applying the dressing 230. According to some variations, the assembly is opened to no less than about 180 degrees (minimum angular change) to provide for application of the dressing without interference from the assembly.

[0264] Then, after opening the cover 221 and exposing the adhesive layer 235, the device 220 can be used to place the adhesive side of the dressing 230 on the skin or wound site. Before applying the dressing 230, the cover 221 and the back cover 222 can be rotated an additional amount relative to each other, such as up to about 360 degrees from the closed configuration. For example, the orientation of the cover 221 when the dressing 230 begins to strain can be changed by changing the attachment position of the dressing assembly 210 to the cover 221. A locking mechanism can optionally be provided to lock or secure the device in an open position, a partially open position, or a closed position. In some examples, the locking mechanism can include a magnet, a hook and loop attachment structure, a snap, a latch, a clip, etc.

[0265] Before the applicator and tensioning device 220 is turned on, the adhesive layer 235 of the elastic sheet 231 is protected by a release liner 249. The release liner 249 is attached to the inner surface 277 of the front cover 221 so that when the front cover 221 is opened and separated from the back cover 222 (before the elastic sheet 231 is tensioned), the release liner 249 is pulled away from the elastic sheet 231, thereby pre-exposing the adhesive layer 235. Alternatively, as Figure 6 As shown, release liner 149a may be disposed on adhesive layer 235 that is not attached to cover 221. Release liner 149a may be manually removed from elastic sheet 231 to expose adhesive layer 235 when device 220 is opened, but before tensioning.

[0266] After releasing the liner 249 or 149a and pulling the dressing 231 taut, the dressing 230 can be applied to the desired location on the subject's skin. The window can be used to observe correct placement. The user can apply pressure to the back 229 of the device 220 to activate the adhesive on the dressing 231 and / or apply pressure / compression to the wound. If the cover 221 is rotated to 360 degrees, pressure can be applied to the inside 277 of the cover 221. After the dressing 230 is applied to the subject, the dressing 230 can be released from the applicator or tensioning device 220 using the release mechanism 250.

[0267] Each pull tab 246 of the release mechanism 250 extends from the end 236a of the elastic sheet 231. Each release pull tab 246 is attached to the dressing assembly 110 in a manner defining a tear path 262, along which the pull tab 246 is pulled to separate the dressing 230 from the device. Notches or perforations may be made in the attachment sheets 241, 251, which facilitate tearing along the path 262.

[0268] The dressing 230 is applied to the subject. The dressing 230 can then be released from the device 220 by pulling the pull tab 246 to draw the pull tab 246 through the path 262 of the attachment sheets 241, 251. The section 245 of the attachment sheets 241, 251 that is coupled to the pull tab 246 is thereby separated from the attachment sheet, thereby separating the section 265 of the attachment sheet that is attached to the dressing 230 from the remaining portions of the attachment sheets 241 and 251 that are connected to the front cover 221 and the back cover 222, respectively. Thus, the dressing 230 is released from the remainder of the package 100, as shown in FIG. Fig. 9 The sections 265 of the attachment sheets 241, 251 may remain on the rear surface 239 of the silicone sheet 231, as shown. Fig. 9 The unattached section 245 of the elastic dressing 230 is strain-free and may be free of the adhesive of the adhesive layer 235 (or may have a reduced amount of adhesive thereon). Therefore, less stress occurs at the unattached side or edge defined by the section 245.

[0269] refer to Figures 10 to 12B , a dressing and packaging assembly 300 is shown. The packaging assembly 300 includes a packaging device applicator 320 and a dressing assembly 310 including a dressing 330.

[0270] The packaging device or applicator 320 is configured to allow transfer of the dressing 330 to the skin of a subject and may also facilitate, quickly or aseptically transfer the adhesive portion of the skin treatment device to the skin and / or wound site of the subject.

[0271] The packaging device or applicator 320 includes a cover 321 to which the dressing assembly 310 is removably coupled or anchored and a bottom element, i.e., a dressing carrier or back cover 322. The cover 321 can be generally planar and include sides 323, 324 and edges 321a at opposite ends, the sides 323, 324 having respective edges 323a, 324a defining their lengths. The back cover 322 can be generally planar and include sides 325, 326 and edges 322a at opposite ends, the sides 325, 326 having respective edges 325a, 326a defining their lengths.

[0272] According to some variations, the front cover 321 and the back cover 322 are partially composed of a material that is relatively inflexible, for example relative to the attached dressing 330. Such a material may include, for example, plastic, cardboard, or a laminate of materials as described herein with reference to the front cover 121 and the back cover 122, or metal. The front cover or the back cover may be, for example, Figures 1 to 22B The various applicators, tensioners, or dressing carriers shown in FIG. 320 may be constructed in the manner described. The front cover 321 and the back cover 322 may or may not include the same material.

[0273] The cover 321 and the back cover 322 may be attached at the sides 323, 325 in a removable, pivotable, bendable or hinged manner, or may be constructed in a manner similar to the construction of the cover 121 and the back cover 122 described herein. The packaging device or applicator 320 may include a window portion 359 through which a wound, incision or other location may be viewed for accurate placement of the dressing 330 in a manner similar to that described herein with respect to the use of windows 159, 259.

[0274] Assembly 300 includes a dressing assembly 310 with a skin dressing device 330. Dressing assembly 310 also includes a dressing release structure or mechanism 350, which can be a release device, such as the one described herein. Figures 1 to 22B The dressing 330 may include a variety of dressing materials, including but not limited to elastic bandages, gauze-type bandages, hydrocolloids. Various structures such as sections and / or front and back covers and coupling elements may provide structural support for the dressing carrier that is manipulated by the user. A margin between at least a portion of the structural support element, the dressing carrier or the backing and the dressing may be provided at or near the edges 321a, 323a, 324a, 322a, 325a and / or 326a, for example as described herein.

[0275] When assembled with the packaging device or applicator 320, the dressing 330 is coupled to the back cover. A section of the dressing 330 adjacent to its first side 333 is bonded to a section of the back cover 322 adjacent to its side 324 and located outside the release mechanism 350. In addition, a section of the dressing 330 adjacent to its second side 334 is coupled to a section of the back cover 322 adjacent to its side 325 and located outside the release mechanism 350. An attachment sheet similar to sheets 141, 146 or 241, 251 can be used to attach the sides 333, 334 of the dressing 330 to the back cover 322. When the applicator 320 is opened, the adhesive layer 335 faces away from the front cover 321 and the back cover 322.

[0276] According to variations, the dressing 330 is sufficiently large relative to the device 320 so that when the dressing is applied to the skin, the interference caused by the device 320 is relatively small. According to one example, the width of the stretched portion of the dressing can be about 20 mm, about 30 mm, about 40 mm, or about 50 mm. According to other variations, the distance between each of the edges 333a, 334a of the dressing 330 and the corresponding edge 325a, 326a of the back cover 322 (and / or the corresponding edge 323a, 324a of the front cover 321) is no greater than about 10 mm, 15 mm, or 20 mm. According to variations, the distance between the edges 336a, 336b of the dressing and the edge 322a of the back cover is no greater than about 10 mm, about 15 mm, or about 20 mm.

[0277] According to some variations, the edges 333, 334, 336a, 336b of the dressing 330 are located at least about 3 mm inboard of at least a portion of the edges 325a, 326a, and / or 322a of the back cover 322, so that a user can grip the edges 325a, 326a, and / or 322a of the back cover 322 with a reduced likelihood of contacting the dressing 330 or the adhesive layer 335. According to some variations, the ends 336a, 336b of the dressing 330 have a margin of at least about 3 mm inboard of the end 322a of the back cover 322. According to some variations, the sides 333, 334 and ends 336a, 336b of the dressing 330 have a margin of about 10 mm relative to the sides 325, 326 and end 322a of the back cover, respectively. According to some variations, the sides 333, 334 and ends 336a, 336b of the dressing 330 have a margin of about 15 mm relative to the sides 325, 326 and end 322a of the back cover, respectively. Each of the margins between the sides 333, 334 or ends 336a, 336b of the dressing 330 and the sides 325, 325 and end 322a of the back cover 322 may be different. Figure 3 As shown, for example, margins m1 and m2 are approximately not less than 3 mm, and margin m3 is approximately 15 mm. Similar margins may be provided between the dressing 330 and the edges 322a, 325a, and / or 326a of the back cover 322. For example, if the edge of the front cover 321 is alternatively or additionally used to grasp the device 320 or manipulate the dressing 330, similar margins may be provided between the dressing 330 and the edges 321a, 323a, and / or 324a of the front cover 321.

[0278] Prior to opening the packaging device or applicator 320, the adhesive layer 335 on the dressing 330 may be protected by a release liner 349. The release liner 349 may be attached to the inner surface 377 of the cover 321 so that when the cover 321 is opened or separated from the back cover 322, the release liner 349 is pulled away from the dressing 330, thereby exposing the adhesive layer 335. The release liner 349 may also be a protective liner that protects or covers the dressing before it is applied. For example, the liner may cover a dressing coated with a substance or drug or other agent. One or more hemostats or coagulants may be applied to the dressing or otherwise combined with the dressing to help reduce bleeding. Potential agents 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, Von Willebrand factor), procoagulants (e.g., propyl gallate), antifibrinolytic agents (e.g., ε-aminocaproic acid), etc. In some variations, the agent can be freeze-dried and integrated into the dressing and activated / activated when in contact with blood or other fluids. In some further variations, an activator can be applied to the dressing or treatment site before the dressing is used for a subject. Still in other embodiments, a hemostatic agent can be applied to the wound separately and directly before applying the dressing, or a hemostatic agent can be applied to the wound separately and directly after applying the dressing through a catheter or tube. The device can also include one or more other agents, which can be any suitable agent that helps in some aspects of the wound healing process. For example, the activator / active agent can be a drug compound, a protein (e.g., a growth factor), a vitamin (e.g., vitamin E), or a combination thereof. Of course, the device can include more than one drug or agent, and the device can deliver one or more drugs or agents. Examples of such drugs can include, but are not limited to, various antibiotics (including, but not limited to, cephalosporins, bacteriocins, polymyxin 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). Cover 321 can be pulled open or separated in a variety of ways. Cover 321 can be opened like the cover of a book.Similar to the devices 120 and 220, 420, 520, 620, 720, 820, 920, 1020 herein, the elements 321, 322 can be rotated sufficiently to separate the release liner 349, and can be rotated up to about 360 degrees, thereby allowing the exposed adhesive side 335 of the dressing 330 to be placed on the skin or wound site using the packaging device or applicator 320. According to some variations, the assembly 300 is opened to no less than about 180 degrees (minimum angle change) to provide for application of the dressing without interference from the assembly 300. Alternatively, for example, the cover 321 can be attached to the back cover 322 by an adhesive and can be peeled off from the dressing 330 or the back cover 322 to which the dressing 330 is attached. The cover 321 itself can be a removable or detachable release liner that can be peeled off from the back cover 322. Alternatively, as. Figure 6 As shown, release liner 149a can be disposed on adhesive layer 335 that is not attached to cover 321. When the device is opened, release liner 149a can be manually removed from dressing 330 to expose adhesive layer 335. In this case, cover 321 can be removed. Fig.11 12A and 12B, the dressing 330 can be applied to the desired location on the subject's skin. Window 359 can be used to visualize correct placement. A locking mechanism can optionally be provided to lock or secure the device in an open position, a partially open position, or a closed position. In some examples, the locking mechanism can include magnets, hook and loop attachment structures, snaps, latches, clips, etc., as well as adhesives or other adhesive structures. If rotated approximately 360 degrees, a compressive force can be applied to the back side 378 of the back cover 322 or the inside 377 of the front cover. After application to the subject, the dressing 330 can be released from the packaging device or applicator 320 using a release mechanism 350. The release mechanism 350 may include a cutting element or a perforating element, such as described with respect to devices 150 and 250 herein. The release mechanism may also include one or more of the components described herein and described herein. Figures 1 to 22B The release element shown in FIG.

[0279] Fig.13 An alternative package or applicator 420 is shown that can be used with any of the embodiments herein and includes device elements or features that can replace those of devices 120 , 220 , or 320 , 520 , 620 , 720 , 820 , 920 , 1020 , 1120 , 1220 . Fig.13A cover 421 and a dressing carrier or back cover 422 are shown, which are composed of a single substrate made of a material such as nylon and / or polyethylene or metal. The device 420 can be made from a single mold, and / or can have portions cut from the substrate, slots / slits, grooves, notches or other openings, or variations in the thickness of the substrate at different locations. Each of the cover 421 and the back cover 422 includes a slot 428 forming an element such as a section 427. The slot 428 allows the device 420 to flex, thereby allowing it to conform to the contours of the subject's body to which the attached dressing is to be applied. The cover 421 and the back cover 422 are connected to each other by a connecting feature structure 429 formed in the substrate. The cover 421 and the back cover 422 can be hinged or pivotally moved relative to each other by a slot 430 formed adjacent to the connecting feature structure 429 to allow the connecting feature structure 429 to flex or move and thus allow the cover 421 and the back cover 422 to flex or move relative to each other. As described with respect to device 100, in other variations, slot 430 may include a groove or other structure that provides a reduced thickness relative to front cover 421 and back cover 422. Device 420 may include as described herein with respect to Figure 1-22B The release mechanism described herein. Figures 1 to 22B The device described herein can be used in the same manner and can be used in the same manner as the device described herein Figures 1 to 22B Attach the dressing in the same manner as described for the device.

[0280] Various structures (e.g., sections and / or front and back covers and coupling elements, slots, and grooves) can provide structural support and flexibility for the dressing carrier to be manipulated by the user. A margin between at least a portion of a structural support element, dressing carrier, or backing and an attached dressing can be provided at or near edges 421a, 423a, 424a, 422a, 425a, and / or 426a, e.g., as further described herein.

[0281] Fig.14 An alternative packaging or applicator device 520 is shown which may be used herein with reference to Figures 1 to 22BAny device described. The cover portion 521 and the dressing carrier or back cover portion 522 can be composed of a laminated structure 530. The first layer 531 of the laminated structure 530 includes cardboard or other supporting material, such as a plastic material or metal, which has a narrow groove 528 formed transversely across each of the cover 521 and the back cover 522. The narrow groove 528 forms sections 527 that allow the sections 527 of the device 520 to bend, thereby allowing it to fit / conform to the body contours of the subject to which the attached dressing is to be applied. The first layer 531 also includes a longitudinal narrow groove 529 formed in the first layer 531 between the cover 521 and the back cover 522. The first layer 531 also includes a pull tab 540 with an opening, which is used for assembly of the device 520 and is removed after assembly is completed, so that the cover 521 and the back cover 522 are separated by the narrow groove 529 and are no longer connected by the first layer 531. The second layer 532 of the laminate includes an adhesive material, such as a PSA acrylic, rubber, or silicone adhesive. The second layer 532 may or may not be approximately 0.001 to 0.006 thick. A flexible material strip 534 is positioned on the slot 529 along the length of the device 520 and connects the front cover 521 and the back cover 522. The front cover 521 and the back cover 522 are flexibly and hingedly or pivotally connected and movable relative to each other by the material strip 534 on the slot 529 to allow the front cover 521 and the back cover 522 to bend or move relative to each other. The flexible strip 534 is attached to the third layer 533 with an adhesive 535, and the third layer 533 includes a thin material such as paper or plastic, which may have a profile roughly similar to the first layer 531 and holds the structure of the device 520 including the section 527 together.

[0282] Device 520 may include a release mechanism, dressing accessories, and may be used in conjunction with any of the foregoing disclosures. Figure 1-22B The devices and components described are used in the same manner.

[0283] Various structures (e.g., segments, adhesive structures, laminate layers and / or front and back covers, and coupling elements, slots, and grooves) can provide structural support and flexibility to the dressing carrier to facilitate user handling. A margin between at least a portion of a structural support element, dressing carrier, or backing and an attached dressing can be provided at or near edges 521a, 523a, 524a, 522a, 525a, and / or 526a, e.g., as further described herein.

[0284] refer to Figures 15A to 15J , shows a variation of a dressing and packaging assembly 600. The packaging assembly 600 includes an applicator and / or tensioning device 620 and a dressing assembly 610 including a dressing 630. The dressing 630 includes an elastic sheet 631 having one or more adhesive regions including a skin adhesive layer, for example as described herein.

[0285] Figures 15A to 15J The features in the text may be used in any variation of the text, including alternative Figures 1 to 22B The device elements or features of the devices and components shown in .

[0286] The applicator, tensioner 620, and / or dressing assembly 610 of packaging assembly 600 can be configured to pre-tension dressing 630 and / or allow transfer of pre-tensioned dressing 630 to the subject's skin. Applicator or tensioner 620 can also provide for convenient aseptic transfer of the adhesive portion of the dressing to the subject's skin and / or wound site.

[0287] The device 620 includes a cover 621 and a back cover 622. The dressing assembly 610 is removably coupled or anchored to the device 620, which can act as a dressing carrier. The cover 621 can be generally planar and include sides 623, 624 and edges 621a at opposite ends, with the sides 623, 624 having respective edges 623a, 624b defining their lengths. The back cover 622 can be generally planar and include sides 625, 626 and edges 622a at opposite ends, with the sides 625, 626 having respective edges 625a, 626a defining their lengths.

[0288] According to some variations, the cover 621 and / or back cover 622 or elements or sections may be constructed to be sufficiently strong or rigid, or less flexible relative to the attached dressing, to support the attached dressing until the dressing is applied to a subject, as described with respect to the variations herein. The materials and construction of the applicator or tensioner 620, the dressing 630, and the package 600 may be similar to those described in the variations herein and Figures 1 to 22B The packaging components and / or dressings shown in .

[0289] The front cover 621 and the back cover 622 may be movably, pivotably, bendably, or hingedly coupled at the sides 623, 624. For example, a material layer 627 composed of a material such as polysiloxane, polyurethane, low-density polyethylene, or a rubber material may be bonded to each of the front and back covers, thereby flexibly attaching them together at the sides 623, 625. The device 620 may be similar to the devices described herein and described in detail in the accompanying drawings. Figures 1 to 22B is constructed in a manner similar to that shown in and may be constructed in a manner similar to that described herein, including but not limited to materials, segmentation, strength and flexibility, visualization, strain mechanisms / tensioning mechanisms, and release liners.

[0290] The dressing assembly 610 also includes an attachment sheet 641, an attachment sheet 651. The attachment sheet 641 has a first side portion 643, which is attached by an adhesive structure 670 (such as a polyimide film or tape (such as DuPont TM of ) or a peelable adhesive) is attached to the second side portion 634 of the dressing. The adhesive structure herein may include, but is not limited to, a peelable adhesive or a tape, or a soft skin adhesive made of a material such as a silicone adhesive, silicone gel, or acrylic adhesive. Adhesive structures or The strip also includes a material that can adhere to the attachment panels to impart tension to the dressing when the attachment panels are separated from one another, while also being releasable from the selected dressing material.

[0291] like Fig.15J As shown, the attachment tab 641 and the side 634 of the dressing can be attached to the same side 671 of the adhesive structure 670, wherein the attachment tab 641 overlaps the dressing 631 but is not attached to the dressing 631.

[0292] The attachment sheet 641 has a second side 644 that is coupled to the cover 621 of the device 620, for example by bonding using a low surface energy PSA such as an acrylic adhesive. The attachment sheet 641 may also have a score or perforation 681 between its attachment to the adhesive structure 670 and its attachment to the cover 621. The perforations 681 are located at the seam between the front cover 621 and the back cover 622, or on the inner surface of the cover 621 after the dressing is tightened.

[0293] The attachment sheet 651 can be coupled to the back side 698 of the back cover 622 at its side 654, for example, by bonding using a low surface energy PSA such as an acrylic adhesive. The side 653 of the attachment sheet 651 can be bonded to the back side 698 of the back cover 622 by, for example, bonding using a low surface energy PSA such as an acrylic adhesive. The adhesive structure 680 of the tape or peelable adhesive is attached to the side 633 of the dressing in a manner similar to the adhesive structure 670 that attaches the side 654 of the dressing 630 to the attachment sheet 641. The attachment sheet 651 may include a pull tab 688 located on the back surface 698 of the back cover and adjacent to and inward of the attachment area 655 of the attachment sheet 651 on the back surface of the back cover 652.

[0294] When the cover 621 is open, it applies tension to the dressing 630 via the attachment tabs 641 .

[0295] According to some variations, the attachment tabs 641, 651 are flexible, but relatively inelastic relative to the dressing 630, and may be constructed, for example, from low density polyethylene. The attachment tabs 641, 651 may be manufactured to be tearable along the length of the material while providing tensile strength in other directions, particularly in the tensile direction of the material of the attachment tab 641 (the direction in which the dressing is stretched, stressed, or tensioned). An example of such a material is an LDPE polymer, which is produced by an extrusion process that produces a directionally slanted / biased grain, whereby the material may tear in the direction of the grain, but is relatively tear resistant in a direction transverse to the grain.

[0296] Fig.15A The assembly 600 is shown in an untensioned configuration. The adhesive strip 683 is exposed on the inner surface 694 of the back cover 622. Before the applicator or tensioning device 620 is opened, the skin adhesive layer on the elastic sheet 631 of the dressing 630 can be protected by a release liner similar to the release liner 149a herein.

[0297] Fig. 15B The assembly 600 is shown in an open and tensioned configuration. Fig. 15B As shown, when tightened, the perforations 681 on the attachment sheet are aligned with the edges 623a and 625a of the front cover 621 and the back cover 622, respectively. A portion 641a of the attachment sheet 641 engages with the adhesive strip 683, thereby attaching the portion 641a to the back cover 622 and holding the dressing 630 in the strained / tensioned configuration. A release liner 645 is attached to the underside of the attachment sheet 641 between the attachment portion attached to the front cover 621 and the perforations 681. The liner 645 prevents the portion of the attachment sheet 641 that engages the front cover 621 from adhering to the adhesive strip 683.

[0298] The front cover 621 and the back cover 622 may be separated from each other by means of, for example, a perforation 682 in the layer 627 coupling the front cover 621 to the back cover 622 and by separating the sheet 641 along the perforation 681 . Fig. 15C Assembly 600 is shown with cover 621 separated from back cover 622. Back cover 622 may be used as an applicator to apply tensioned dressing 630 to the skin of a subject.

[0299] Fig.15D The back side 698 of the back cover 622 is shown in a position for applying the dressing 630 toward the skin of a subject. As shown, the edge 654 of the attachment sheet 651 can be bent from the inner side 694 of the back cover 622 to the back side 698 to which it is attached. The tear strip can be attached to the attachment sheet 651 between the attached edge and the unattached middle portion. Fig.15EAs shown, the pull tab 688 or tear strip can be pulled to separate the back cover 622 from the remainder of the dressing assembly. After pulling the pull tab 688, the unattached portion 651a of the attachment sheet 651 is released from the back cover 622. After removing the back cover, the back cover can be removed by peeling off the dressing 630. This removes the remaining portions of the attachment tabs 641 , 651 . Fig.15F Dressing 630 is shown after the remainder of the dressing assembly has been removed.

[0300] Figures 15G to 15J Shown is removal of dressing 630 The tape or adhesive structures 670 , 680 and attachment panels 641 , 651 are configured as the dressing assembly 610 . Figure 15G and 15J Shows when The orientation of the tape or adhesive structures 670, 680 when peeled away in a direction from the inside of the dressing 630 towards the sides 633, 634 of the dressing 630, or in the direction of strain of the dressing. Fig.15H The first structure 670 is shown peeled away from the inside of the dressing across the side 633 of the dressing. Fig.15I The first adhesive structure 670 is shown removed from the dressing 630. The second adhesive structure 680 can be removed in a similar manner.

[0301] FIG. 16A to FIG. 16D An alternative dressing assembly 710 configuration is shown, wherein the dressing assembly 710 is similar to the configuration for FIG. 15A to FIG. 15J The described approach is separate from the applicator or tensioning device. Fig.16A A first adhesive structure 770 and a second adhesive structure 780 are shown, each of which includes a first adhesive structure 770 and a second adhesive structure 780 for attaching the attachment sheet 741, 751 to the dressing 730. tape or peelable adhesive structure. Fig.16A As shown, the unattached ends of the adhesive structures 770, 780 are oriented away from the dressing 730. Fig. 16B As shown, the second adhesive structure 780 is peeled inwardly and Fig. 16C has been removed.

[0302] FIG. 17A to FIG. 17D Another dressing assembly configuration is shown in which the dressing assembly 810 is separated from the applicator or tensioner in a manner similar to that shown in FIG. FIG. 15A to FIG. 15J The method described is similar. Fig.17D A first adhesive structure 870 and a second adhesive structure 880 are shown, each of which includes a first adhesive structure 870 and a second adhesive structure 880 for attaching the attachment sheet 841, 851 to the dressing 830, respectively. tape or peelable adhesive structure. Fig.17A and17D As shown, the adhesive structures 870, 880 are attached to the dressing 830 with an adhesive length 891. The additional length 892 is bent 180 degrees around the adhesive length 891. The additional length 892 has an end 893 extending from the dressing 830 to facilitate access and removal. Fig. 17B As shown, the end 893 can be used to pull the first adhesive structure 870 in a direction that is partially perpendicular to the strain direction to remove the attachment structures 841, 851 and the adhesive structure 870 from the dressing 830, as shown. Fig. 17C As shown further.

[0303] Figures 18A to 18I A variation of a dressing and packaging assembly 900 is shown. The packaging assembly 900 includes an applicator and / or tensioning device 920 and a dressing assembly 910 including a dressing 930. The device 920 includes a cover 921 and a back cover 922. The dressing assembly 910 is removably coupled or anchored to the device 920, which can act as a dressing carrier. The cover 921 can be generally planar and include sides 923, 924 and edges 921a at opposite ends, the sides 923, 924 having respective edges 923a and 924a defining their lengths. The back cover 922 can be generally planar and include sides 925, 926 and edges 922a at opposite ends, the sides 925, 926 having respective edges 925a, 926a defining their lengths.

[0304] The dressing assembly 910 also includes an attachment sheet 941 and an attachment sheet 951. The attachment sheet 941 has a first side portion 943, which is attached to the first side portion 943 by an adhesive structure 970 (such as The adhesive structure herein may include, but is not limited to, a peelable adhesive or a removable adhesive configured to provide low skin damage after repeated skin contact. tape, or a soft skin adhesive made of a material such as a silicone adhesive, silicone gel, or acrylic adhesive. Adhesive structures or The strip also includes a material that can adhere to the attachment panels to impart tension to the dressing when the attachment panels are separated from one another, while also being releasable from the selected dressing material.

[0305] like Fig.18JAs shown, the attachment sheet 941 and the side 934 of the dressing can be attached to the same side 971 of the adhesive structure 970, wherein the attachment sheet 941 overlaps the dressing 931 but is not attached to the dressing 931. The attachment sheet 941 has a second side 944 that is coupled to the cover 921 of the device 920, for example, by bonding using a low surface energy PSA (such as an acrylic adhesive). The attachment sheet 941 can also have a pull tab 981 in an unattached area between its attachment to the adhesive structure 970 and its attachment to the cover 921. After the dressing is tightened, the perforated pull tab 981 is located at the inner surface 960 of the cover 921, or at the seam between the cover 921 and the back cover 922.

[0306] The attachment sheet 951 can be coupled to the back side 998 of the back cover 922 at its side 954, for example, by bonding using a low surface energy PSA such as an acrylic adhesive. The side 953 of the attachment sheet 951 can be bonded to the back side 998 of the back cover 922 by, for example, bonding using a low surface energy PSA such as an acrylic adhesive. The adhesive structure 980 of the tape or peelable adhesive is attached to the side 933 of the dressing in a manner similar to the adhesive structure 970 that attaches the side 944 of the dressing 930 to the attachment sheet 941. The attachment sheet 951 may include a pull tab 988 located on the back surface 998 of the back cover and adjacent to and inward of the attachment area 955 of the attachment sheet 951 on the back surface of the back cover 952.

[0307] According to some variations, the attachment tabs 941, 951 are flexible, but relatively inelastic relative to the dressing 930, and may be constructed, for example, from low density polyethylene. The attachment tabs 941, 951 may be manufactured to be tearable along the length of the material while providing tensile strength in other directions, particularly in the tensile direction of the material of the attachment tab 941 (the direction in which the dressing is stretched, stressed, or tensioned). An example of such a material is an LDPE polymer that is produced by an extrusion process that produces a directionally slanted / biased grain, whereby the material may tear in the direction of the grain, but is relatively tear resistant in a direction transverse to the grain.

[0308] When the cover 921 is open, it applies tension to the dressing 930 via the attachment tabs 941 . Fig.18A The assembly 900 is shown in an untensioned configuration, while Fig.18B The assembly 900 is shown in an open and tightened configuration that can be applied to the skin. Fig.18C As shown, when tightened, the pull tab 981 on the attachment sheet 941 is located above the inner surface of the cover 921 (folded back and exposed) and can be accessed by the user. After applying the dressing 930, the front cover 921 and the back cover 922 can be removed.

[0309] When the pull tab 988 is pulled, the front cover 921 and the back cover 922 can be separated from each other. Fig.18C The cover is shown positioned with the assembly of the dressing facing downward, such as when the dressing is applied to the skin of a subject. Fig.18D As shown, pull tab 988 is pulled to release cover 921 from the remaining dressing assembly 910. Fig.18E As shown, the cover 921 is removed from the remainder of the device 920, thereby exposing the second pull tab 998. Fig.18F As shown, the second pull tab 998 has released the back cover 922 from the dressing assembly 910, wherein the attachment panels 941, 951 are not attached to the back cover 922. Figure 18G As shown, the back cover 922 is removed and the remaining portions of the attachment panels 941, 951 and the adhesive structures 970, 980 can be peeled off from the dressing 930, as shown. Fig.18H As shown, the dressing is Fig.18I The configuration shown remains on the skin.

[0310] refer to FIG. 19A to FIG. 19D , shows a variation of a dressing and packaging assembly 1000. The packaging assembly 1000 includes an applicator and / or tensioning device 1020 and a dressing assembly 1010 including a dressing 1030. Fig.19A A dressing assembly 1010 is shown coupled to an applicator or tensioning device 1020. The tensioning member or applicator 1020 may be used in a manner similar to that described herein and Figures 1 to 22B The tensioner and applicator shown are constructed in a similar manner.

[0311] The device 1020 includes a cover 1021 and a back cover 1022. The dressing assembly 1010 is removably coupled or anchored to the device 1020, which can act as a dressing carrier. The dressing assembly can be coupled to a tensioning member or applicator in a manner similar to the assemblies described herein. The dressing assembly 1010 includes an attachment sheet 1041 and an attachment sheet 1051. The attachment sheet 1041 has a first side 1043 that is attached to a second side 1034 of the dressing 1030 by an adhesive structure 1070, such as described with reference to the adhesive structures 970, 980. The attachment sheet 1041 has a second side 1044 that is coupled to the cover 1021 of the device 1020, such as by bonding with a low surface energy PSA such as an acrylic adhesive. The attachment sheet 1041 also has a drawstring 1088 sewn along its length at an unattached portion of the attachment sheet 1041 between the attachment of the attachment sheet 1041 to the adhesive structure 1070 and the attachment of the attachment sheet 1041 to the cover 1021. Various types of stitches may be used, including but not limited to chain stitches or lock stitches. The drawstring 1088 is located on the exposed inner side 1090 of the cover 1021 after the dressing is tightened, or alternatively at the seam between the cover 1021 and the back cover 1022.

[0312] The attachment sheet 1051 can be coupled to the back side of the back cover 1022 at its side 1054, for example, by bonding using a low surface energy PSA such as an acrylic adhesive. The side 1053 of the attachment sheet 1051 can be bonded to the back side of the back cover 1022 by, for example, bonding using a low surface energy PSA such as an acrylic adhesive. The adhesive structure 1080 of the tape or peelable adhesive is attached to the side 1033 of the dressing in a similar manner to the adhesive structure 1070 that attaches the side 1034 of the dressing 1030 to the attachment sheet 1041. The attachment sheet 1051 includes a drawstring 1098 located between the attachment to the adhesive structure 1090 and the attachment to the back of the back cover. The ends of the drawstrings 1088, 1098 extend out of the tensioning member 1020 to facilitate access.

[0313] Fig.19A and 19B The dressing assembly 1010 is shown in an untensioned configuration. When the cover 1021 is open, the cover 1021 applies tension on the dressing 1030 via the attachment tabs 1041. Fig.19C The dressing assembly 1010 is shown in a tensioned state.

[0314] After the dressing is tightened and applied, the drawstrings 1088, 1098 are pulled to separate the portions of the attachment panels 1041, 1051 attached to the tensioning device 1020 from the portions of the attachment panels 1041, 1051 attached to the dressing 1030. Fig.19D As shown, the applicator or tensioning device 1020 can be removed. The adhesive structures 1080, 1090 can then be peeled off to remove the remaining portions of the dressing assembly 1010 and the attachment panels 1041, 1051 from the dressing, as shown. Fig.19E shown.

[0315] refer to Figures 20A to 20C , showing a variation of a dressing carrier, tensioning device or applicator 1120. The device 1120 includes a plurality of sections 1130 formed by scoring a substrate 1150 on one side 1155 of a planar surface. The scoring 1170 may be formed in one or more directions, or have one or more shapes, curved or straight. In addition, the scoring may be formed on both sides, thereby allowing for convex and concave shapes of the device. As shown, the scoring 1170 allows for shaping of the device or attached dressing. The scoring 1170 shown is formed on a first side 1155 of the planar surface of the device, while the second side 1165 is free of scoring. When a force is applied to the second side 1165, the substrate bends. When a force is applied to the first side 1155, the substrate 1150 of the device does not bend at the scoring 1170. The remaining substrate at the scoring 1170 may act as a bend limiter, while the scoring 1170 acts as a bending element.

[0316] When a concave surface requires a convex dressing shape, the dressing may be attached to the first side 1155 so that when the substrate is bent, the dressing forms a convex shape to match the concave contour where the device is to be applied. When a convex body contour requires a concave dressing shape, the dressing may be located on the second side 1165 of the substrate 1150. Thus, when the substrate is bent, the dressing forms a concave shape to match the convex body contour where the device is to be applied. Different dressing backings may be provided for different body parts or contours.

[0317] According to a variation, the notch may be orthogonal or have an orthogonal component to the segment 1127 of the carrier, applicator or tensioner. The segment 1127 may be similar to Figures 1 to 22B The sections shown.

[0318] refer to Figures 21A to 21D , showing a variation of a dressing carrier, tensioning device or applicator 1220. The device 1220 includes a plurality of foam units 1240 coupled by an adhesive backing 1260. The foam units 1240 form a plurality of sections 1227 that allow bending in a plurality of directions so that the device can conform to / fit the curvature, contour or shape of the subject where the dressing is to be applied. The foam may be thick enough to generally provide additional breaking strength, i.e., resistance to bending, for the tensioned dressing. A backing or support for tensioning the dressing may be provided, for example, made of a material having an elastic modulus and an appropriate thickness that will at least resist / offset the forces generated by tensioning the dressing. The dressing strain may be fixed, for example, using an adhesive on the back of a portion of the dressing assembly or of an attachment sheet. After the dressing is fixed, the backing or support may be removed, thereby allowing more manipulation of the shape of the tensioned dressing to conform to the shape of the contours of the patient's body to which the dressing will be applied to a greater extent.

[0319] As shown, the separations 1270 between the foam sections allow the device to be shaped. The separations 1270 shown are formed on the first side 1255 of the planar surface of the device, while the second side 1265 is not scored. When a force is applied to the first side 1255, the substrate bends. When a force is applied to the second side 1265, the substrate 1250 of the device does not bend at the separations. The remaining substrate at the separations can act as a bend limiter, while the score acts as a bending element.

[0320] When a concave surface requires a convex dressing shape, the dressing may be attached to the first side 1255 so that when the substrate is bent, the dressing forms a convex shape to match the concave contour where the device is to be applied. When a convex body contour requires a concave dressing shape, the dressing may be located on the second side 1265 of the substrate 1250. Thus, when the substrate is bent, the dressing forms a concave shape to match the convex body contour where the device is to be applied. Different dressing backings may be provided for different body parts or contours.

[0321] refer to Fig.22A and 22B , showing a variation of a dressing and packaging assembly 1500. Packaging assembly 1500 includes an applicator and / or tensioning device 1520 and a dressing assembly 1510 including a dressing 1530. Packaging assembly 1500, applicator or tensioning device 1520, and / or dressing assembly 1510 may be configured to pre-strain / pre-tension dressing 1530 and / or allow transfer of a pre-tensioned dressing 1530 to the skin of a subject.

[0322] The device 1520 may include a cover 1521 and a back cover 1522. The dressing assembly 1510 may be removably coupled or anchored to the device 1520 and may serve as a dressing carrier. The cover 1521 and the back cover 1522 may be movably, pivotally, bendably, or hingedly coupled at the sides 1523, 1524 and may be similar to the embodiment of the present invention. Figures 1 to 22B The attachment areas 1541, 1551 of the dressing assembly 1510 are attached to the free sides 1525, 1526 of the covers 1521, 1522, respectively, for example, by a peelable adhesive or a removable adhesive structure. However, the above-described adhesive structures may be used. Figures 1 to 22B The attachment regions 1541, 1551 and / or the dressing 1530 may be positioned symmetrically on the device 1520 relative to a line defined by the attachment locations of the sides 1523, 1524 of the front cover 1521 and the back cover 1522, respectively. Fig. 22B As shown, the dressing 1530 is tightened when the front cover 1521 and the back cover 1522 are opened. The dressing 1530 can then be applied to the subject's skin and the device 1520 can be peeled off the dressing 1530. Additionally or alternatively, the front cover 1521 and the back cover 1522 can be separated by perforations formed in the substrate of the device 1520 or perforations 1551 formed in the attachment structure 1550, such as a band or material layer that attaches the side portions 1523 and 1524 of the front cover 1521 and the back cover 1522, respectively.

[0323] In some variations, the device 1520 optionally includes an adhesive coating or adhesive strip on the front cover 1521 and / or the back cover 1522 that can adhere to the dressing 1530 when the dressing 1530 is tensioned and the dressing is further in contact with the front cover 1521 and the back cover 1522. In some variations, the adhesive is configured to hold the dressing 1530 in a tensioned state and / or against the front cover 1521 and / or the back cover 1522. The adhesive coating or adhesive strip can be located along the side regions 1523, 1524 of the front cover 1521 and / or the back cover 1522, but can also be located adjacent to the attachment regions 1541, 1551. A release liner can also be provided to reduce inadvertent adhesion of the dressing or other structure to the adhesive until the device 1520 is needed to be activated.

[0324] According to a variation, the various assemblies or devices described herein may provide a temporary wound dressing that can be used prior to wound closure. The assembly may be configured to apply a dressing to a wound and apply pressure to the wound using a package or applicator prior to removing or separating an applicator, tensioning device, or dressing carrier, back cover, or support from the dressing. According to this variation, the variation may be provided with any of the embodiments described below, wherein the package or applicator has sufficient rigidity to distribute a relatively uniform or firm force to the wound by applying pressure to the package or applicator during and / or after the dressing is applied to the wound. According to one variation, such a dressing may include a coagulant or other agent or drug, such as those described herein. According to another variation, on such a device, a margin as described herein is provided between the dressing and an edge for manipulating the device.

[0325] The assemblies or devices described herein may also form a dressing support structure. For example, the dressing support structure may include multiple sections of the back cover / base structure. The dressing support structure may include at least three sections extending from at least a first side of the dressing to a second side of the dressing. The dressing support structure may include multiple sections, such as Figures 1 to 22B The sections described in the above are connected or formed together. The sections of the cover described here can also provide support for the dressing when the cover is folded 360 degrees relative to the corresponding back cover structure.

[0326] In other examples, such a stretched dressing may be provided to the user as a pre-stretched dressing that is strained / stretched at the point of manufacture rather than at the point of use. Figures 23A to 23I , showing the manufacture of a pre-tensioned assembly 2351 including a pre-tensioned dressing. Figures 23A to 23D A tensioning device 2341 for pre-tensioning a dressing is shown in use. Figures 23E to 23I Various features and stages in making the pre-tensioning assembly 2351 are further shown.

[0327] The pre-tensioning assembly 2351 may include a dressing assembly 2308 and a strain retention structure or support structure 2330 (see Fig.23I ). The pre-tensioning assembly 2351 may be stored for a period of time before use.

[0328] The dressing assembly 2308 may include a dressing 2310 that includes a relatively flat elastic sheet 2360 that defines a plane. For example, the elastic sheet 2360 may include a silicone sheet or other elastic material as described herein. The dressing assembly 2308 may also include an attachment sheet 2304, a tensioning sheet 2307, a pre-tensioning assembly release 2352, and a dressing release 2319.

[0329] The attachment sheet 2304 can be configured to attach the dressing 2310 to the support structure 2330 via the engagement element 2322. The attachment sheet 2304 of the dressing assembly 2308 can include a first engagement wall or element 2322 extending downwardly relative to the plane of the dressing 2310 and including an inwardly extending hook 2323. The engagement element 2322 can be attached to the attachment sheet 2304, for example, with an adhesive. The tensioning sheet 2307 of the dressing assembly 2308 can include a second engagement element 2324 extending downwardly relative to the plane of the dressing 2310 and including an inwardly extending hook 2325. The tensioning sheet 2307 can be configured to attach the dressing 2310 to the support structure 2330 via the engagement element 2324. The engagement element 2324 can be attached to the tensioning sheet 2307, for example, with an adhesive. The tensioning sheet 2307 can also be configured to transfer tension from the tensioning device 2341 to the dressing 2310 to tighten the dressing 2310 .

[0330] The pretensioning assembly release 2352 can be configured to release the pretensioning assembly 2351 (dressing 2310 and support structure 2330) from the tensioning device 2341 (see, e.g., Fig.23E and 23I ). The dressing release mechanism 2319 can be configured to release the dressing 2310 from the engagement elements 2322, 2324 (including the hooks 2323, 2325), and thus release the dressing 2310 from the support structure 2330. The dressing release mechanism 2319 can be configured to release the dressing 2310 after the dressing 2310 is applied to the subject.

[0331] The dressing 2310 of the dressing assembly 2308 may include a first edge or side 2305 having a length, and a second edge or side 2306 of a specific length. The dressing 2310 may be coupled to an attachment sheet 2304 at the first edge or side 2305, and the attachment sheet 2304 may be flexible, but less elastic or inelastic relative to the dressing 2310. The attachment sheet 2304 may have a first side 2382 and a second side 2384. When assembled, the attachment sheet 2304 may be bonded to the elastic sheet 2360 of the dressing 2310 at a section 2375 of the attachment sheet 2304 located at or near the side 2382 of the attachment sheet 2304, for example, using a combination of a silicone PSA / acrylic PSA to achieve the bonding. The attachment sheet 2304 may be coupled to the engagement element 2322 and the hook 2323 at its side 2384, such as by bonding with an adhesive material, such as using a silicone PSA / acrylic PSA combination. The attachment sheet 2304 may couple the dressing 2310 to the support 2330 near the first side 2305 of the dressing 2310 via the engagement element 2322 and the hook 2323. The dressing 2310 may be coupled to a tensioning sheet 2307 at its second edge or side 2306, which may be flexible but not elastic or less elastic than the dressing 2310. The tensioning sheet 2307 may have a first side 2372, a middle position 2373, and a second side 2374. When assembled, the tensioning sheet 2307 can be bonded to the elastic sheet 2360 of the dressing 2310 at a section 365 of the tensioning sheet 2307 located at or near a side 2372 of the tensioning sheet 2307, for example, using a combination of a silicone PSA / acrylic PSA. The tensioning sheet 2307 can be coupled to the side wall 2324 and the hook 2325 at an intermediate location 2373, for example, by bonding with an adhesive material, for example, using a combination of a silicone PSA / acrylic PSA. When assembled into the pre-tensioning assembly 2351, the tensioning sheet 2307 can couple the dressing 2310 to the support structure 2330 near the second side 2306 of the dressing 2310 through the side wall 2324 and the hook 2325. The tensioning sheet 2307 can be loaded onto the tensioning device 2341 at the second side 2374, as described in more detail herein. According to some variations, attachment sheet 2304 or tension sheet 2307 may be made of, for example, low-density polyethylene.

[0332] Dressing assembly 2308 Fig.23A2308 to the dressing assembly 2308 can be removably attached to the support structure 2330 when or after the dressing 2310 is pre-tensioned to form the pre-tensioned assembly 2351. The support 2330 can be generally planar and include sides 2335, 2336 having respective edges 2335a and 2336a defining their lengths. Other support elements, support structures, and / or strain retention elements can be used, for example, the sides of the dressing 2310 or the dressing assembly 2308 can be clamped and the desired distance between the clamps maintained, for example, using separation elements.

[0333] The dressing 2310 of the dressing assembly 2308 may be applied by, for example, Figures 23A to 23D The pre-tensioned dressing 2310 may then be stored in a pre-tensioned configuration for a period of time prior to use. The tensioning device 2341 may be used at a point of manufacture, by an intermediary, or by an end user. The tensioning device 2341 may include a planar portion 2343 and a circular portion 2344 configured to contain a rotating element 2345. The rotating element 2345 may have a middle portion 2346 with a groove 2347 to receive and engage the tensioning sheet 2307 of the dressing assembly 2308.

[0334] exist Fig.23A , the dressing assembly 2308 can be shown in a first configuration on the tensioning device 2341 in which the dressing assembly is relatively untensioned. The dressing assembly 2308 can be positioned above the support structure 2330. The support structure 2330 can be positioned above the tensioning device 2341 with the upper surface 2333 of the support structure 2330 facing / engaging with the back surface 2311 of the dressing 2310. The first edge 2335a of the support structure 2330 and the first side or edge 2349 of the planar portion 2343 of the tensioning device 2341 can be engaged and retained by the engagement wall 2322 and the hook 2323. The second end 2336 and edge 2336a of the support 2330 can be initially not engaged with the dressing 2310, but in a mutually facing position with the dressing 2310. This can allow the dressing 2308 to be strained / tensioned to a desired degree without interference from the support structure 2330.

[0335] In use, the end 2374 of the tensioning sheet 2307 may be inserted into the slot 2347 of the middle portion 2346 of the rotating element 2345 of the tensioning device 2341. The rotating element 2345 may then be rotated until the tensioning sheet 2307 is engaged. Initially, when attached to the tensioning device 2341, the tensioning sheet 2307 and the dressing 2310 may be in an untensioned configuration, but with minimal slack. As the rotating element 2345 rotates, the dressing 2310 may be tensioned / strained as the tensioning sheet 2307 is pulled by the rotating element 2345 relative to the dressing 2310 in the direction of the tensile strain.

[0336] The dressing 2310 may be tightened by rotating the rotating element 2345, such as Figures 23A-23D After the tensioning sheet is loaded due to the rotation of the rotating element 2345, the tensioning sheet 2307 can bend around the rotating element 2345, thereby shortening the distance between the rotating element 2345 and the dressing 2310 to stretch or tighten the dressing 2310. A locking mechanism including ratchet teeth 2337 on the rotating element 2345 and pawls 2338 on the circular portion 2344 can be used to lock the dressing 2310 in a position such as Figures 23B to 23D When the tensioning sheet 2307 is pulled toward the circular portion 2344 of the tensioning device 2341 in the tensile strain direction, the engaging element 2324 and the hook 2325 may also move in the tensile strain direction. The edge 2336a of the support member includes a slope 2336b, which can engage with the slope 2326 on the hook 2325 to guide the edge 2336a of the support member 2330 to engage with the hook 2325 when the hook 2325 moves toward the circular portion 2344 of the tensioning device. (See Figures 23C to 23H ). The strain of the pre-tensioned dressing 2310 can be controlled or determined using measuring elements or markings 2342 on the rotating element 2345, and the distance between each measuring element or marking can correspond to an increment of increased strain or distance. After the dressing assembly 2308 is loaded onto the tensioning device 2341, the strain can be determined by the amount that the rotating element 2345 is rotated. Each marking 2342 can correspond to a percentage strain or distance. 0% strain can be identified as the position when the dressing assembly 2308 is loaded onto the tensioning device 2341 with no slack and with minimal strain or tension. Fig.23A As shown, the 0% position can be displayed, where the mark 2342a is aligned with the detent 2338. As the rotating element 2345 rotates, the identified 0% mark 2342a can rotate a certain angle corresponding to the strain percentage. When the dressing is tightened to the desired amount x represented by the mark 2342b, as shown in FIG. Fig. 23B As shown, mark 2342b is aligned with pawl 2338.

[0337] The support structure 2330 can maintain the dressing 2310 in its Figures 23B to 23I In the tensioned configuration shown, wherein the engagement elements 2322, 2324 and hooks 2323, 2325 engage the support structure 2330, movement or strain loss of the dressing 2310 is prevented. One or more adhesive regions including a skin adhesive layer 2340 can be applied to the top surface 2312 of the dressing 2310. The adhesive 2340 used can be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive. The adhesive 2340 is shown to be located on the dressing 2310 in an untensioned configuration. However, the adhesive can be applied to the dressing 2310 after the dressing 2310 has been tensioned. A removable liner 2350 can be placed on the adhesive layer 2340. The liner 2350 can be further selected to maintain the strain in the dressing 2310. 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.

[0338] After the dressing 2310 has been tensioned and the dressing assembly 2308 may be engaged and secured with the support structure 2330, the dressing assembly 2308 and the support structure 2330 may be separated from the tensioning device 2341 to form a pre-tensioned assembly 2351, which may be used immediately or stored for a period of time.

[0339] The pretensioning assembly release 2352 may include a tear strip 2353 that is attached to the tensioning sheet 2307 between the middle position 2373 and the second side portion 2374 using an upper portion 2354 and a lower portion 2355, respectively (see FIG. Fig.23E ). The tear strip 2353 can separate the pre-tensioning component 2351 from the tensioning device 2341 by tearing across the tensioning sheet 2307 between the pre-tensioning component 2351 and the tensioning device 2341.

[0340] In use, after releasing the liner 2350, the dressing 2310 can be applied to the desired location on the subject's skin. The user can apply pressure to the back 2333 of the support 2330 to activate the adhesive on the dressing 2310 and / or apply compression to the wound. After being applied to the subject, the dressing 2310 can be released from the support 2330 using the release mechanism 2319.

[0341] The release mechanism 2319 can include a tear strip 2309. The tear strips 2309 of the release mechanism 2319 can each extend beyond an end 2366 of the elastic sheet 2360. The tear strips 2309 can each be coupled to the dressing assembly 2308. The tear strips 2309 can be coupled to the attachment sheet 2304 of the dressing assembly 308 in a manner that defines a tear path 2362 along which the tear strips 2309 are pulled to separate the dressing 2310 from the support 2330. The tear strips 2309 can be coupled to the tensioning sheet 2307 of the dressing assembly 2308 in a manner that defines a tear path 2362 along which the tear strips 2309 are pulled to separate the dressing 2310 from the support 2330. Each tear strip 2309 can include a top section 2347 and a bottom section 2348. As shown, the bottom section 2348 may not be attached to the support 2330 or may be free relative to the support 2330. The top section 2347 of each tear strip 2309 may be adjacent to the dressing 2310 but not attached to the dressing 2310. The tensioning sheet 2307 and the attachment sheet 2304 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 2307 (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 2307 and the attachment sheet 2304 to facilitate tearing along the path 2362. The tensioning sheet 2307 and the attachment sheet 2304 may additionally or alternatively include a material such as low density polyethylene (LDPE) having perforations formed along the tear line 2362.

[0342] The dressing 2310 may be released from the support 2330 by pulling the tear strip 2309 to draw the tear strip across the path 2362 of the tensioning sheet 2307 and the attachment sheet 2304. The respective sections 2365 and 2375 of the tensioning sheet 2307 and the attachment sheet 2304 may remain on the back side 2311 of the elastic sheet 2360. The sections 2385, 2395 of the attachment sheet 2304 and the tensioning sheet 2307 that are bonded to the tear strip 2309 may thereby be separated from the tensioning sheet 2307 and the attachment sheet 2304. The respective sections 2365 and 2375 of the tensioning sheet 2307 and the attachment sheet 2304 that are attached to the dressing 2310 may thereby be separated from the remaining portions of the tensioning sheet 2307 and the attachment sheet 2304 that are attached to the support structure 2330 at the ends 2305 and 2306. Thus, the dressing 2310 can be released from the remainder of the support structure 2330.

[0343] The dressing 2310 may have unattached portions or edges 2315 at its sides 2305, 2306 where the elastic sheet 2360 is free relative to the tensioning sheet 2307 and the attachment sheet 2304, respectively. Thus, the dressing 2310 may be strain-free at the unattached portions 2315. The unattached portions 2315 of the elastic dressing 2310 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 2315.

[0344] In use, the adhesive liner 2350 can be removed and the dressing 2310 applied to the skin surface of the subject. After the dressing is applied to the skin surface of the subject, the tear strips 2309 on each side of the dressing at the tear line can be pulled to separate the dressing 2310 from the support structure 2330, the attachment sheet 2304, and the tensioning sheet 2307. When the support structure 2330, the attachment sheet 2304, and the tensioning sheet 2307 are removed from the dressing 2310, the stress or strain of the dressing 2310 can apply a (tangential) compressive force to the skin, thereby treating / treating the skin.

[0345] refer to Fig.24 , multiple tensioned dressings 2410 may be tensioned in a manner similar to dressing 2310, and each dressing may then be coupled to a first surface 2460 of a single support 2430 that is rolled up and stored in a rolled configuration for distribution, such as Fig.24 As shown. The stretched dressing 2410 can be coupled to the first surface 2460 of the single support 2430 by an adhesive, such as a high tack / low peel PSA, which holds the dressing 2410 in the stretched configuration. The pads 2450 can be placed on the opposite second side 2470 of the support 2430 and positioned so that when the support 2430 is rolled up, they are on the skin adhesive on top of the dressing 2410. The adhesive pads 2450 can also help minimize the creep characteristics of the stretched dressing 2410. The support 2430 can be rolled up to store the dressing 2410. When the support 2430 is unfolded, the adhesive pads 2450 located on the second side 2470 and opposite the dressing 2410 can be released from the dressing 2410. The dressings 2410 can be separated by the perforations 2480 so that they can be used separately.

[0346] In some variations, the dressing may be used to treat chronic injection sites or catheter sites as required for various conditions including, but not limited to, diabetes, cancer, immune disorders such as severe combined immunodeficiency, etc. It is speculated that treatment of skin injection / infusion sites may not only reduce the development of scar tissue or other hyperproliferative diseases associated with frequent injections or chronic infusions, but may also have other mechanical effects on drug dynamics, which may improve drug dispersion in tissue, reduce drug leakage, increase depth of action, reduce pain at the injection / infusion site, reduce risk of site infection, reduce risk of line / pump clogging at the infusion site, improve analyte or drug level variability, reduce inflammatory layer thickness or depth, and reduce dosage levels. For diabetic patients, skin treatment may result in fewer blood glucose excursions, improved time range (as measured by multi-day fingerstick or continuous glucose monitoring (CGM)), increased insulin dosage volume, and / or subcutaneous tissue area.

[0347] In some examples, the dressing, and optionally one or more structures comprising the dressing support structure, may include one or more openings that may facilitate the use of a tensioned dressing with a sensor, indwelling catheter, or cannula inserted into tissue. In other examples, a device for use with the dressing may be momentarily inserted through the dressing, such as a needle or needle biopsy tool for drawing blood. Fig. 30A One embodiment of a tensioned dressing 3000 having an opening 3002 is depicted which has been applied to a target site 3004 and released from its applicator (not shown) to transfer stress from the dressing 3000 to de-tension the treatment site 3004. An indwelling device such as an infusion set for an insulin pump system or an indwelling sensor system may then be placed through the access hole 3002 into the skin or subcutaneous tissue of the treatment site. Figures 30B to 30D In the particular example shown, an infusion set 3006 for use with a drug pump includes a housing 3008, a connecting tube 3010, a support layer 3012 for an adhesive layer, and a needle 3014. In this particular embodiment, the needle has an acute angle orientation relative to the plane of the support layer 3012, but in other examples, the needle can have an orthogonal orientation, or can be in the same plane as the plane of the housing or support layer or otherwise parallel to the plane of the housing or support layer. The length of the needle may or may not extend beyond the peripheral boundary of the housing or support layer. The needle sheath (not shown) and / or the adhesive protective layer (not shown) of the infusion set 3006 are removed. The needle 3014 is then aligned with the opening 3002, as shown in FIG. Fig. 30BAs shown, until the needle 3014 is fully inserted into the target site 3004 and the adhesive of the support layer 3012 adheres to the dressing 3000 and / or the target site 3004. In some further variations, the protective dressing can be partially or completely applied over the already tightened dressing and infusion set. In some variations, the direction of strain in the dressing can be parallel or preferably transverse to the direction of needle insertion into the target site, or parallel or preferably transverse to the length of the dressing.

[0348] In addition to manually inserting the infusion set needle or indwelling device through the dressing hole, in some variations, the infusion set or indwelling device may include a delivery tool or system to facilitate insertion or placement of the infusion set or indwelling device. The delivery tool may be easier to grasp or require less grasping dexterity than a smaller infusion set, or may hide the delivery needle from the user and / or may automatically insert and / or withdraw the delivery needle during the insertion process, which may improve compliance or improve other aspects of the user experience. For example, in FIG. 31A to FIG. 31C In the embodiment of the present invention, a dressing 3000 having holes 3002 can be placed at a target site 3004, but wherein an infusion set 3020 includes exposed orthogonal needles 3022 that are releasably coupled to a larger delivery device or devices 3024. The delivery devices 3024 and / or needles 3022 are aligned with the dressing 3000 and / or holes 3002, such as Fig.31A As shown, the dressing 3000 is then placed against the Fig.31B Then, the actuator 3026 on the device 3024 is activated to separate the container 3024 from the infusion set 3020. In this particular embodiment, the infusion set 3020 does not have an adhesive support layer extending beyond the peripheral boundary of the infusion set housing 3021. Instead, the adhesive can be directly disposed on the lower surface of the housing 3021, with or without any support layer in between. Fig.31D and 31E is a cross-sectional view depicting the actuation mechanism of the delivery device 3024 and the separation of the delivery device 3024 from the infusion set housing 3021. The infusion set housing 3021 can be mechanically attached to the delivery device 3024 by friction and / or by one or more mechanical interlocks 3030. To release the infusion set 3020, the actuator 3026 is depressed and the plunger tip 3032 engages the catch lever 3034 to release the infusion set housing 3021. The actuator 3026 and the plunger tip 3032 are held in a non-engaged position by a spring 3036. In another variation, the infusion set housing can be releasably attached using an adhesive such as a gel that temporarily adheres the plunger tip to the upper surface of the infusion set housing.

[0349] Although the exemplary dressing described above includes a centrally located single circular hole, in other examples, the hole may have other shapes, sizes, and / or eccentric locations, and may include other markings or indicia. The markings or indicia may be used to distinguish between different openings, and / or to facilitate alignment of the dressing with a target location and / or inserted device. Some variations may also include more than one hole, such as two, three, four, five or more holes. In still other examples, a dressing may be provided without a hole, and a needle of an infusion set, syringe, or insertion device may be used to pierce the dressing and then inserted through the skin or tissue.

[0350] Fig.32A Depicted Figures 30A to 31C 3000. The dressing 3000 comprises an oblong / round shape with rounded corners and a centrally located circular opening 3002. The opening 3002 may have a diameter of approximately 0.10" to 0.30", or 0.05" to 0.20". The dressing 3000 has a longitudinal length that is greater than its transverse width, but in other examples the dressing may be radially symmetrical. The length and / or width of the dressing may range from 4 cm to 16 cm, or from 2.5 cm to 5 cm, or the dressing may have a 9 cm 2 Up to 19cm 2 , or 46cm 2 Up to 70cm 2 surface area.

[0351] Fig.32B Another exemplary embodiment of a dressing 3200 is depicted that includes a plurality of openings 3202, 3204, 3206. In this particular embodiment, the openings 3202, 3204, 3206 are linearly aligned with each other and optionally along a central longitudinal axis of the dressing 3200, as shown in FIG. Fig.32B Optional markings 3208, 3210, 3212 may be provided to facilitate changing the insertion position during a single use of the dressing 3200. Fig.33 Dressing 3200 is depicted in position against the skin.

[0352] Fig.32CAnother exemplary embodiment of a dressing 3220 is depicted, which includes a plurality of openings 3222, 3224, 3226, 3228. In this example, one opening 3222 is centrally located, but the other three openings 3224, 3226, 3228 are eccentrically located, and no three openings are linearly arranged. In other examples, all openings may be eccentrically located. Markings 3230, 3232, 3234, and 3236 may optionally be provided for each opening 3222, 3224, 3226, 3228, which may be accompanied by other optional markings, such as a spiral line 3238 that may be used to indicate relative position.

[0353] Other exemplary dressings may include dressings having one or more non-circular opening shapes. For example, Fig.32D A dressing 3240 is depicted having an oval opening 3242, and Fig.32E A dressing 3250 is depicted having openings 3252 that are diamond or parallelogram shaped.

[0354] Fig.34 Another variation of a dressing 3400 is depicted that includes markings 3404 that facilitate identification and / or alignment with a dressing opening 3402. In this particular embodiment, the markings 3404 are disposed in four orthogonal directions from the opening 3402. These markings may help identify the location of the opening 3402, particularly where the dressing 3400 comprises a transparent material and where the underlying skin may be mottled or have numerous markings from scars or skin lesions (which may make identification of the opening 3402 more difficult). The markings may be laser etched or printed on the dressing surface. Fig.35 A tensioned dressing 3400 is depicted being placed on a skin site and then released from its applicator (not shown). Once adhered to the skin site, the marker 3404 can be used to facilitate insertion of a syringe needle 3406 or other access device, while the strain transferred from the dressing 3400 can reduce tissue reactions such as scar tissue formation or induction of fat hyperplasia due to needle insertion. Fig.34 and 35 In one embodiment, the marking 3404 of the dressing 3400 is in contact with or otherwise in close proximity to the opening 3402, but in other examples, the marking may be provided along the perimeter of the dressing, or across the area of ​​the dressing between the opening and the edge of the dressing. This may be useful for aligning larger devices that may obscure the opening of the dressing once positioned on the dressing. Alternatively, the material of the dressing 3400 may be opaque and / or colored to provide contrast with the dressing and the dressing opening 3402. In still other examples, a dressing may be provided without a hole, and a needle of an infusion set, syringe, or insertion device is used to pierce the dressing and then inserted through the skin or tissue.

[0355] exist Fig.36 In other examples shown, a visual guide tool 3600 may optionally be provided or used to facilitate alignment of the syringe needle 3406 with the dressing opening 3402. The visual guide tool 3600 includes a peripheral notch 3602 or opening that may facilitate alignment of the visual guide tool 3600 with the peripheral edge of the dressing 3400. The dressing 3400 may also be provided with optional markings or indicia to facilitate alignment with the guide tool notch 3602. By aligning the peripheral edge of the guide tool 3600 with the peripheral edge of the dressing 3400, the opening 3402 of the dressing 3400 may then be re-aligned with the opening 3604 of the guide tool 3600. The opening 3604 of the guide tool 3600 may preferably be smaller than the opening 3402 of the dressing 3400, but may be larger than or the same size as the opening 3402 in other examples. The visual guide tool 3600 may also include markings 3606 around its opening 3604, and may or may not include an opaque material, which may make it easier to see the opening 3604. The lower surface of the visual guide tool may include an adhesive to facilitate maintaining the position of the tool 3600 during use. The tool 3600 may include an elongated body with an opening 3604 at a distal end, wherein the proximal end is used to grasp and manipulate the tool 3600 during a procedure.

[0356] In an exemplary procedure, the user will clean and prepare the skin site using an isopropyl alcohol wipe or other sterile preparation. If the dressing is not a pre-tensioned dressing, the dressing is tightened using an applicator and then placed at the desired site. The applicator is then removed to transfer the strain to the skin. If visual guidance is not required, the patient can insert the needle into the hole of the dressing and perform the infusion. If visual guidance is required, the guide is placed on the dressing and the needle is inserted into the visual target and the infusion is performed. In the case where there is a pre-existing dressing with multiple openings, subsequent injections can follow a rotational order and inject at site #1, then site #2, then site #3, and so on. In some variations, depending on the skin condition, the dressing can last up to 10 days, and injections using the dressing can be performed as frequently as 3 times a day. At the end of the wearing period (7-10 days on average), the dressing is removed and replaced with a new dressing.

[0357] Fig.37A and 38BAnother example of a visual guide tool 3700 is depicted. In this example, the tool 3700 includes an elongated body 3702 having an enlarged distal end 3704 and a large distal opening 3706. The distal opening 3706 can be configured with a boundary edge 3708 that allows visualization of the outer edge of the dressing 3000, except at radially inward projections 3710, 3712, 3714, and 3716. When the tool opening 3706 is positioned around the dressing 3000, these radially inward projections 3710, 3712, 3714, and 3716 can help point to the location of the dressing opening 3002. Although in Fig.37A and 37B Four protrusions 3710, 3712, 3714, and 3716 are depicted in FIG. 3 , but in other examples, a different number of protrusions may be provided and located at other locations along the boundary edge 3708 of the opening 3706 and may have the same Fig.37A and 37B The four orthogonal protrusions 3710, 3712, 3714 and 3716 have different shapes, sizes and lengths. For example, the protrusion may include an arrow shape.

[0358] like Fig.38A and 38B As shown, in some variations, protrusions 3710, 3712, 3714, and 3716 may be configured to facilitate positioning of a delivery device or container, such as Figures 31A to 31B In this embodiment, the lengths of the protrusions 3710, 3712, 3714, and 3716 are configured such that when the container 3024 is properly aligned with the protrusions 3710, 3712, 3714, and 3716 of the tool 3700, the ends 3718, 3720, 3722, 3724 of the protrusions 3710, 3712, 3714, and 3716 are each in contact with or equidistant from the peripheral edge 3028 of the delivery device 3024. Thus, the configuration of the radially inward protrusions 3710, 3712, 3714, and 3716 can facilitate alignment and positioning of the container 3024 during use.

[0359] exist Figures 39A to 39E In another variation shown, the tensioned or tensionable dressing 3926 may be pre-tensioned during manufacture of the infusion set 3921 or assembly, such as Figures 39A to 39E3906 and the like. The system may optionally include a delivery device 3900 having a body 3904, a lower edge 3906, and an actuator 3908. An infusion housing 3921 of an infusion set 3920 is releasably attached to the bottom of the body 3904 and includes a needle 3922, a connector tube 3924, and a tension dressing layer 3926 extending beyond the housing 3921 and the lower edge 3906 of the delivery device 3900. The tension dressing layer 3926 also includes a skin adhesive on its lower surface, which is removably covered by one or more adhesive protective liners 3928. The liner 3928 may include a liner pull tab 3930 further extending from the liner 3928 to facilitate removal of the liner 3928 from the adhesive on the tension dressing layer 3926. The tensioned dressing layer 3926 is held in a stressed / stressed configuration by a rigid applicator or tensioned support structure 3932 that includes one or more pull tabs 3934 to facilitate separation of the tensioned dressing layer 3926 from the tensioned support structure 3932 during use. The pull tabs 3934 attach the dressing layer 3926 and the support structure 3932 together, but include perforations or adhesive that facilitate separation of the dressing layer 3926 and the support structure 3932 when the pull tabs 3934 are pulled away from the device. The tensioned support structure 3932 or applicator can be removed from around the infusion set housing 3921 by passing the structure 3932 over the connector tube 3924, or by tearing the structure 3932 off the housing 3921.

[0360] In an exemplary implantation procedure of the integrated infusion set 3920, a skin insertion site is selected and prepared using an isopropyl alcohol wipe or other sterile preparation. When the integrated infusion set 3920 is engaged with the delivery system 3900, the protective needle sheath (not shown) is first removed from the needle 3922 of the integrated infusion set 3920. Next, the adhesive protective liner 3928 is removed to expose the adhesive on the lower surface of the pre-tensioned tension dressing layer 3926. However, in other examples, the needle cover can be integrated with the liner so that the removal of the needle sheath also removes the protective liner, and vice versa. The delivery system 3900 and the infusion set 3920 are then positioned at the desired insertion position, and the needle is pushed into the skin manually or by a needle advancement mechanism. After insertion, the system 3900 can be used to push the infusion set 3920 against the skin, or otherwise remain in place to promote bonding between the adhesive and the skin tissue around the needle 3922. The actuator 3908 on the system 3900 is then actuated to release the infusion set housing 3920 so that the delivery system 3900 can be removed, as shown. Fig.40A In other examples, the infusion set 3920 with an integrated dressing can be inserted without the use of the delivery system 3900 .

[0361] Next, the pull tab 3934 is removed from the infusion set 3920, which decouples the tensioned dressing layer 3926 from the tension support structure 3932, thereby allowing the tensioned dressing layer 3926 to convert its tensile stress into a compressive force on the tissue surrounding the needle 3922, as shown in FIG. Fig.40B In some variations, the tensioning support structure 3932 may be left in place after the pull tab is removed, but in other examples, the tensioning support structure 3932 may be removed to reduce the bulk and / or stiffness of the indwelling infusion set 3920. In some variations, if the connector tube 3924 is not yet coupled to an infusion pump, the tensioning support structure 3932 may be removed by placing the tensioning support structure 3932 over the connector tube 3924, as shown. Fig.40C As shown, the infusion set 3920 is left behind along with a dressing layer 3926 that transmits the compressive force to the underlying skin tissue, as shown. Fig.40D In other variations, such as Fig.40E As shown, the tension support structure 3932 may include slits or perforations 3940 that allow the tension support structure 3932 to be pulled or torn away from the infusion set housing 3921 or connector tube 3924, whether or not the connector tube 3924 has been attached. The infusion set 3920 is ready for use and can be removed and a new one can be placed at the end of the use period, which can be in the range of 7 to 10 days, but can be replaced sooner if clogged or damaged.

[0362] In other examples, one or more physical alignment structures may be provided on the dressing rather than visual markings or indicia to aid in alignment. Figures 49A to 49E In the present invention, a pre-tensioned elastic member or dressing 4900 having a pre-attached removable alignment structure 4902 is provided, which is configured to align an infusion set with an access opening 4926 of the dressing 4900. The alignment structure 4902 is configured to align with the MINIMED TM QUICK-SERTER TM(Medtronic, Fridley, MN) infusion set applicator 4904, but those skilled in the art understand that the alignment structure can be customized to suit the shape and function of any other infusion set applicator or delivery device. The pre-tensioned dressing 4900 is maintained in a pre-tensioned configuration by a semi-rigid or rigid strain support 4906, which is attached or adhered to the top surface of the dressing 4900 and surrounds the alignment structure 4902. The strain support can be configured to have a certain flexibility in at least one direction so that the dressing conforms to the contour of the tissue surface. In some variations, the direction of flexibility can be orthogonal to the strain direction of the dressing. The shear bond strength between the strain support and the tensioned elastic member is greater than the force generated by the strain of the elastic member. Depending on the material selected for the dressing 4900, the attachment of the support 4906 to the dressing 4900 can be achieved by an adhesive, or can be hot-melted to the dressing 4900. For example, if polyurethane is used for the dressing 4900, the support 4906 may include PETG and may be hot melted to the dressing 4900. For example, a hot melt may be used to bond a tensioned elastic member to a strain support. The hot melt may have a width of, for example, approximately 1 mm, 2 mm, or 5 mm. The bond provides sufficient shear force without creeping in the direction of strain while also allowing the support structure to be peeled away from the elastic member. The strain support may also include perforations to facilitate the splitting of the strain support and its separation and removal from the elastic member, and the strain support may optionally include a pull tab to facilitate grasping and tearing the perforations. Alternative embodiments of the device may also include perforations and as Figures 39A to 39E The pull-tab separation mechanism described for dressing 3926 may also be applicable to this embodiment.

[0363] This special alignment structure 4902 comprises a one-piece structure having three interconnected alignment flanges 4908, 4910, 4912 and a base opening 4916 disposed along a base 4914. The size and shape of the opening 4916 are determined to form a mechanical fit with the applicator 4904 and may be oval, circular, polygonal, or other custom shapes complementary to the periphery of the applicator 4904. The base 4914 may also include a lip to increase the area attached to the dressing 4900. Although interconnected along the base 4914, in other examples, the flanges may be separated from each other. In some further examples, the flanges 4908, 4910, 4912 and / or the base 4914 may be integrally formed with the strain support 4906. Still in other examples, the alignment structure 4902 may be provided separately and attached to the strain support 4906 at the point of use. The alignment structure 4902 may also be selected from a plurality of different alignment structures, each alignment structure being configured to be used with a different available infusion set applicator. The selected alignment structure is then attached to the strain support prior to use.

[0364] The attachment of the alignment structure 4902 may vary depending on the materials used for the structure 4902 and the rigid support 4906. The alignment flanges 4910 and 4912 are configured to provide a recess 4918 that accommodates the infusion set tube 4920, and one or more of the alignment flanges 4908 may include a gripping structure to facilitate manipulation of the dressing 4900, such as a finger grip, recess, or ridge 4922. The alignment flanges 4910 and 4912 may be further configured to be pulled away to facilitate removal of the alignment structure 4902 from the tube 4920. After or in conjunction with removal of the alignment structure 4902, the strain support 4906 is removed to allow the dressing 4900 to contract from the strained configuration to its less strained configuration. In this particular configuration of alignment structure 4902, for example, the height of flanges 4908, 4910, 4912 can be in the range of about 1-10 mm, 2-8 mm, or 3-6 mm. The inner surfaces of flanges 4908, 4910, 4912 can include an orthogonal orientation, or can include a slight obtuse angle, such as 91-95 degrees, 91-100 degrees, or 91-105 degrees, so that the initial placement of applicator 4904 itself does not require precise alignment, but rather guides applicator 4904 to a more precise position as further insertion occurs. In addition to accommodating tube 4920, the gap between flanges 4908, 4910, and 4912 can also be configured to provide access to the side of applicator 4904, and applicator 4904 can also have a finger grip 4936 so that actuator 4924 of applicator 4904 is not used to position applicator 4904.

[0365] The shape of the dressing 4900 can be various shapes, including but not limited to oval, circular or polygonal. Similarly, the access opening 4926 can also include an oval, circular or polygonal shape and its size is suitable for accommodating the catheter of the infusion set. The access opening 4926 can include a diameter or lateral dimension in the range of 1-20 mm, 2-10 mm or 3-5 mm, for example. The alignment structure 4902 can include a polymer material, which can be thermoformed or injection molded, 3D printed or CNC machined.

[0366] The skin adhesive on the dressing used to attach to the skin or tissue may be the same or different from the adhesive used to attach the strain support to the dressing. In some embodiments, the skin adhesive can be selected to have a greater T-peel force than the adhesive used to attach the support. In other examples, the adhesive used to attach the support can have a higher T-peel force. A higher T-peel force can be selected when a predetermined strain in the dressing is required to resist strain loss during storage of the pre-tensioning device. A protective or sticky release sheet can be applied to the skin adhesive to protect the skin adhesive from inadvertent adhesion during storage or application. A coating can also be provided on the release sheet and the dressing to facilitate peeling or removal of the release sheet and strain support during use.

[0367] refer to Fig.50A , the dressing 4900 and alignment structure 4902 are applied and adhered to the selected target site. The adhesive pad of the infusion set held by the applicator 4904 is removed, and the applicator 4904 is aligned with the alignment structure 4902, with the tube 4920 and finger grip 4922 of the infusion set properly oriented toward the recess. The applicator 4904 is then inserted into the opening of the alignment structure 4902 until it is fully seated, as shown. Fig.50B In some variations, visual markings on the alignment structure 4902, tactile feedback may be provided to confirm to the user that the applicator 4904 is fully in place. Fig.50C 4900, the actuator 4924 of the applicator 4904 is depressed to insert the needle / cannula of the infusion set into the skin through the opening of the dressing 4900. The actuator 4924 is then activated a second time to separate the applicator from the infusion hub 4938. In this particular example, the actuator 4924 includes an outer ring button 4930 and an inner button 4932 to respectively deploy the needle / cannula and decouple the applicator 4904 but not yet separate the applicator 4904.

[0368] Next, the alignment structure 4902 and the dressing support 4906 are removed from the dressing 4900 by applying downward pressure on the released applicator 4904 as the alignment structure 4902 and the support 4906 are pulled apart. To facilitate their removal, the support 4906 may include perforations 4934 that can be torn open so that the alignment structure 4902 and the support 4906 can be peeled off or pulled away so that the dressing 4900 can be collapsed from its tightened configuration. In other variations, such as Fig.51As shown, the support 5100 of the alignment structure 5102 may include an arcuate configuration having an end 5104 with a pull tab that can be grasped and used to pull the support 5100 and alignment structure 5102 away from the periphery of the tube 5108 and applicator 5106. This then separates the infusion hub 4938 from the applicator 4904 and separates the rigid support 4906 from the dressing 4902, which allows the dressing 4902 to contract from its pre-tensioned configuration.

[0369] Figures 48A to 48E An example of an infusion system 4800 is depicted with a delivery device 4802 that releasably holds an infusion hub 4804 with a pre-attached radially pre-tensioned skin tensioning device 4806. The delivery device 4802 includes a body 4808 and an actuator 4810, similar to Fig.39A The delivery system 3900 in FIG. 4 is a schematic diagram of a delivery system 3900 of FIG. 4. The pre-attached radially pre-tensioned skin tensioning device 4806 includes a radially outwardly tensioned cohesive elastic layer 4812, which is maintained in a pre-tensioned state by semi-rigid strain supports 4814a, 4814b, which may include a semi-rigid or rigid card material or polymer layer adhered to the top surface of the elastic layer. Although this particular embodiment includes a strain support having two sections 4814a and 4814b, in other examples, a single support may be provided, or 3, 4, or 5 partial supports may be provided.

[0370] After the infusion system 4800 is applied to the desired anatomical location and the actuator 4810 is activated, the infusion hub 4804 is released and can be separated from the delivery body 4808, thereby attaching the infusion hub 4804 and the skin tensioning device 4806 to the anatomical location, such as Fig.48E As shown. The function and patency of the infusion tube 4816, hub 4804 and catheter 4818 can be checked. If the function is normal, the strain supports 4814a and 4814b can be removed or separated from the elastic layer 4812, which will then radially compress the adhered skin or tissue toward the center of the elastic layer 4812 around the hub 4804 and catheter 4818. Then, before starting treatment, the function and patency of the infusion tube 4816, hub 4804 and catheter 4818 are checked again. In some variations, a radially tightened skin tensioning device can reduce the risk or rate of kinking or occlusion of the catheter 4818 compared to a skin tensioning device strained along a single strain axis. The shape of the elastic layer 4812 can be as follows: Figures 48A to 48EThe circular shape shown, however, in other examples, the elastic layer can be oval, oblong, square, rectangular, star-shaped, or other shapes. An oval or oblong shape can be used when the catheter is not inserted perpendicularly into the tissue, but rather at an acute angle to the treatment site, where the forces acting on the catheter or infusion hub may not be radially symmetrical.

[0371] In addition to the radially tensioned infusion system 4800, a radially pre-tensioned skin tensioning device 5500 may be provided for manual injection using a syringe 5502, such as Fig.55A and 55B The skin tensioning device 5500 includes an elastic layer 5504 having an access opening 5506. The skin tensioning device 5500 can be adhered to a target location and then the radial strain supports 5508a, 5508b can be removed to allow the elastic layer 5504 to radially compress the underlying skin toward the access opening 5506. The access opening can include a diameter or transverse dimension in the range of 1-20 mm, 2-10 mm, or 3-5 mm, for example.

[0372] refer to Fig.56A and 56B In some other variations of the skin tensioning device 5600, the access opening 5602 of the device, whether radially tensioned or tensioned along a single axis, may include a fabric patch 5604. The patch 5604 may be constructed with a woven fabric that allows the needle 5606 of the syringe 5608 to still pass through the access opening 5602 while providing some physical coverage of the injection site. The increased breathability may extend the use time of the device 5600. The fabric patch 5604 may provide increased water vapor transfer through the skin tensioning device 5600 and may also be used to absorb excess insulin that may leak from the injection site. The fabric patch 5604 may be coated, impregnated, or woven with an anti-infective agent, such as an antibiotic or silver strands. For example, the fabric 5608 may include nylon, non-woven cotton, polyester or polypropylene, an elastic polymer blend, or silver alginate.

[0373] In another alternative embodiment, the skin treatment system 5400 includes a tension-relief dressing 5402, but an injection port 5404 is provided on the dressing 5402 rather than an access opening or fabric patch, such as Fig.54A and 54BAs shown. Dressing 5402 and port 5404 can be provided with any applicator as described herein, noting that the area of ​​dressing 5402 attached to port 5404 will not be under the same strain as the portion of dressing 5402 that is peripheral to port 5404. Injection port 5404 includes conduit 5406 so that a syringe attached to port 5402 or a syringe needle inserted into the port can deliver a therapeutic agent into the skin or tissue through conduit 5406. The use of a port can reduce pain or discomfort associated with treatment compared to direct needle injection.

[0374] refer to Figures 41A to 43CIn another embodiment, the infusion set 4100 and the multi-layer tension dressing 4102 can be used for subcutaneous or intravascular infusion. The infusion set 4100 includes an infusion tube 4104 that can be connected to an infusion source or pump, such as an insulin pump or other therapeutic pump, and is in fluid communication with the lumen of the infusion set housing 4104, which in turn is in fluid communication with a subcutaneous needle or catheter 4106 inserted into tissue or vascular system. The bottom surface of the infusion set housing 4104 is adhered or attached to the top layer 4108a of the multi-layer tension dressing 4102. Each of the layers 4108a-4108c includes a perimeter 4110a-4110c that is smaller in size than the perimeter 4110b-4110d of the layer 4108b-4108d immediately below and is located just within and offset from the perimeter 4110b-4110d of the layer 4108b-4108d immediately below except for optional flaps 4112a-4112c. The elasticity of the top and middle layers 4108a, 4108b, 4108c can be configured to have a lower elastic modulus than the bottom elastic layer 4108d. Compared with other layers 4108a-c, bottom layer 4108d can also have higher hardness (e.g., 60 Shore A to 50 Shore A to 30 Shore A) or include thicker material (e.g., 10 mils to 7 mils to 5 mils to 0.5 mils). In other variations, non-bottom layer can include holes or perforations to reduce the total cross-sectional area of ​​non-bottom layer, which can reduce the amount of strain caused by non-bottom layer. Utilizing this configuration, the compression force per unit width mainly comes from the contribution of bottom elastic layer 4108d, about 50%, 60%, 75%, 90% or any range between any two of these contribution percentages. Based on this, the amount of adhesion strength between layers can be relatively lower than the bonding strength between skin and bottom layer 4108d. The adhesive of layers 4108a to 4108c can also be patterned and applied to layers 4108a to 4108c, so as to peel off in a direction orthogonal to strain. For example, multiple narrow adhesive strips can be provided in the peeling direction. The width of the adhesive orthogonal to the direction of strain in the elastic member can be 0.1 inches, 0.165 inches, 0.2 inches, 0.3 inches, or 0.5 inches, or any range between any two such widths. In another example, an adhesive pattern can be provided in which there is less adhesive in the peel direction than in the strain direction, such as 20% less, 40% less, 60% less, 80% less, or a range between any two of these percentages, or other types of anisotropic adhesive patterns can be provided. The interlayer adhesive used to connect all layers 4108a-d together can include a smaller thickness (e.g., 0.5 mils, versus 0.25 mils, versus 0.1 mils) than the skin adhesive.In other variations, an adhesive having a high tensile strength but low shear strength may be used to facilitate removal of the upper layer of a multi-layer tensioned dressing by pulling the upper layer or adhesive layer laterally rather than upwardly. Fig.44A and 44B As shown, this nested configuration results in a stepped dressing profile that can redistribute edge stresses of the skin tensioning device over a larger surface area, rather than concentrating them at the edge of a single layer of the skin tensioning device. In some variations, the spacing between the perimeters 4110a to 4110d of adjacent layers 4108a to 4108d can be uniform along the entire perimeter, for example, a uniform perimeter difference in the range of 1 mm to 5 mm, 2 mm to 5 mm, or 2 mm to 4 mm, or 2 mm to 3 mm. In some further examples, the uniform perimeter difference between two adjacent layers 4108a to 4108d is the same for every two adjacent layers 4108a to 4108d. In other examples, the uniform perimeter difference can be different between at least one pair of two adjacent layers. For example, perimeters 4110a and 4110b may be the same as 4110b and 4110c, but the uniform perimeter difference between layers 4110c and 4110d may be less than or greater than the uniform perimeter difference of other layer pairs of layers 4108a-4108c. Fig.41A The layer 4108d in the multi-layer dressing 4102 does not have a wing, but may be provided with a wing in other embodiments. The wings 4112a to 4112c may or may not include an adhesive on their lower surface, which may help separate the wings 4112a to 4112c from the other layers and facilitate gripping for removal. Each of the layers 4108a to 4108d also includes a central opening (not shown) through which a needle or catheter 4106 of the infusion set 4100 can be inserted. This nested layer configuration of the multi-layer dressing 4102 may not have a wing. The flexible attachment sheet 4108 may be sized and configured to have a perimeter 4112 that is smaller than the perimeter 4114 of the multi-layer tensioned dressing 4102.

[0375] although Fig.41A and 41BThe exemplary embodiment shown includes four laye...

Claims

1. An integrated infusion system comprising: an infusion set comprising an infusion housing, a needle, and a connector tube; and a pre-tensioned dressing attached to the bottom of the infusion housing, the pre-tensioned dressing comprising: Tension dressing layer; a skin adhesive on a lower surface of the tension dressing layer; one or more adhesive protective liners removably covering the skin adhesive; A tensioning support structure is configured to maintain the tensioned dressing layer in a tensioned configuration, the tensioning support structure comprising one or more pull tabs.

2. The infusion system according to claim 1, wherein: The one or more adhesive protection liners each further include a liner pull tab extending from the adhesive protection liner, the liner pull tab being configured to facilitate removal of the adhesive protection liner from the skin adhesive.

3. The infusion system of claim 1, further comprising a delivery device.

4. The infusion system according to claim 3, wherein: The delivery device includes a body, a lower edge, and an actuator.

5. The infusion system according to claim 4, wherein: The tensioned dressing layer extends beyond a lower edge of the delivery device.

6. The infusion system according to claim 4, wherein: The actuator is configured to separate the delivery device from the infusion housing.

7. The infusion system according to claim 1, wherein: The tensioning support structure includes slits or perforations to allow the tensioning support structure to be pulled or torn off the infusion housing or connector tube.

8. The infusion system according to claim 1, wherein: The tensioned support structure is a semi-rigid or rigid cardstock or polymer layer adhered to the top surface of the tensioned dressing layer.

9. The infusion system according to claim 1, wherein: The pre-tensioned dressing is a multi-layer dressing.

10. The infusion system according to claim 8, wherein: The dressing includes a bottom layer and a peel-away top layer configured to enable the infusion set to be removed from the bottom layer.

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