Injection and infusion site treatment devices and methods

Abstract

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

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 62 / 946,345, filed 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. Application No. 15 / 842,794, which are incorporated by reference herein in their entireties. [Background technology]

[0002] Scar formation in response to skin injury is part of the natural wound healing process. Wound healing is a continuous process over a period of time, but it is typically recognized as occurring in stages. The process begins with an inflammatory phase immediately after injury. During this phase, which typically lasts from 2 days to 1 week (depending on the wound), damaged tissue and foreign material are removed from the wound. The proliferative phase occurs some time after the inflammatory phase and is characterized by fibroblast proliferation and the production of collagen and proteoglycans. It is during the proliferative phase that extracellular matrix is ​​synthesized to provide structural integrity to the wound. The proliferative phase usually lasts for about 4 days to several weeks, depending on the nature of the wound, and it is during this phase that hypertrophic scars usually form. The final phase is called the remodeling phase. During the remodeling phase, the previously organized and randomly organized matrix is ​​remodeled into a tissue structure that is highly cross-linked and aligned to increase mechanical strength.

[0003] Although the histological features that characterize hypertrophic scars have been well documented, the basic pathophysiology is not well known. Hypertrophic scars are a secondary effect of excessive wound healing, generally resulting in overproduction of cells, collagen, and proteoglycans. Typically, these scars are elevated and characterized by a random distribution of tissue bundles. The appearance (i.e., size, shape, and color) of these scars varies depending on the part of the body where they form and the underlying ethnicity of the patient. Hypertrophic scars are very common and can occur after any full-thickness injury to the skin. Recently, this has been shown in U.S. Patent Application Publication No. 2006 / 0037091 (U.S. Patent Application No. 11 / 135,992, filed May 24, 2005, entitled "Method for Producing Hypertrophic Scarring Animal Model for Identification of Agents for Prevention and Treatment of Human Hypertrophic Scarring"), which is incorporated herein by reference in its entirety, showing that mechanical stress can increase hypertrophic scarring in a mouse model.

[0004] Keloids are typically characterized as tumors consisting of highly proliferative masses that arise within the dermis and adjacent subcutaneous tissues of susceptible individuals, most commonly following trauma. Keloids are often more severe than hypertrophic scars because they tend to spread into normal adjacent tissues, whereas hypertrophic scars tend to remain confined within the original scar borders.

[0005] Scar tissue can also form from repeated tissue injury, such as in patients who require repeated needle insertions for blood draws or injections or infusions of therapeutic agents for the treatment of chronic health problems, including, but not limited to, growth hormone injections, autoimmune diseases such as rheumatoid arthritis, and diabetes, and from other therapeutic or diagnostic procedures or devices that may utilize indwelling catheters or needles. Summary of the Invention [Means for solving the problem]

[0006] The devices, kits, and methods described herein may be for the treatment of a subject at a skin site, 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 controllably applying stress or strain to the epidermis and layers of skin tissue at or near the skin site, i.e., at or adjacent to a wound or treatment site on the subject's skin.

[0007] Also, the effects of scar tissue formation are not limited to cosmetic effects. For example, diabetic patients may develop scar tissue and / or lipohypertrophy at chronic injection sites. Lipohypertrophy is the increased formation of adipose tissue that is believed to be a hypertrophic effect from chronic localized insulin injections on adipocytes. Lipohypertrophy may adversely affect insulin injection or infusion rates due to structural changes in tissue, which may reduce insulin diffusion. A typical infusion using an insulin pump involves the placement of a cannula or needle into the delivery site (e.g., abdomen, arm, buttocks, thigh) every few days. Over time, this may induce lipoatrophic changes in the skin and subcutaneous structures, which may result in unpredictable or erratic insulin absorption. Finally, patients may be limited in available infusion sites on their body due to lipohypertrophy. While the lipohypertrophy and lipoatrophy effects are believed to be induced by insulin itself, it is hypothesized that tension unloading of the insulin site may also reduce this insulin effect and improve variability and / or overall absorption rate at the injection site. This may occur by reducing the formation of fibrosis, improving angiogenesis, and / or reducing vascular resistance to perfusion of tissues below or centered around the insertion site. In some variations, it is hypothesized that changes in skin tension and / or increased adhesive properties of the tensioned dressing or dressing components may extend the usable duration of the 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.

[0008] It is also believed that treatment of injection and / or infusion sites of diabetes therapy may also have other effects separate from affecting the development of scar tissue or lipohypertrophy. For example, treatment of injection sites and / or infusions at sites already treated with a skin tensioning device may improve the dispersion of insulin at the injection site by modifying the mechanical environment. For example, insulin leakage at the injection or infusion site may be reduced due to increased mechanical pressure at the skin surface, which may drive the injected therapy deeper into the tissue due to the pressure gradient generated within the tissue by the tensioning device. This and other mechanical effects of skin tensioning treatment may result in increased insulin bolus volume and / or surface area per unit injection. Mechanomodulation effects may result in improved insulin absorption with reduced average total insulin doses on a daily, weekly, and / or monthly basis, and / or improved daily, weekly, and / or monthly glycemic time in range, with reduced frequency or severity of hyperglycemia. The tensioning device may also reduce pain at the injection site as a result of mechanomodulation of nociceptors and / or reduce the risk of infection from occlusion and / or pump alarms as a result of mechanical stabilization of the tissue.

[0009] According to a variation, manipulating the mechanical or physical properties may thereby modulate the tensile or compressive stress at the skin site. The stress at the skin site may be reduced to a level below that experienced by normal skin and tissue. The stress at the skin site may be increased to a level above that experienced by normal skin and tissue. Stress or strain may be applied to the surrounding tissue in one, two, or more directions to manipulate the intrinsic or extrinsic stress at the skin site in one, two, or more directions. According to a variation, the devices and methods described herein may reduce or otherwise manipulate the stress experienced by the skin and / or wound and surrounding tissue to treat a subject. The device may also assist in preventing or reducing the occurrence of wound dehiscence.

[0010] In accordance with the devices, kits, and methods described herein, a skin treatment device, dermal device, wound treatment device, scar or keloid treatment device, scar or keloid amelioration or prevention device, bandage, or dressing may be provided (hereinafter referred to as a "dressing," "skin device," or "skin treatment device") that may be applied to, attached to, or bonded to one or more layers of a subject's skin or tissue.

[0011] In addition to ameliorating scar formation, other uses for such skin treatment devices include, but are not limited to, treating skin-related conditions such as acne, age spots, rosacea, warts, rashes (including but not limited to erythematous, macular, papular, and / or bullous conditions), psoriasis, skin irritation / hypersensitivity, allodynia, telangiectasias, port wine stains and other arteriovenous malformations, and ectopic dermatitis; treating or improving existing scars, wrinkles, stretch marks, loose or sagging skin, or other skin irregularities; during pre-operative preparation, e.g., as a thin tissue retractor to stabilize blood vessels during needle or catheter insertion, during a surgical procedure; post-operatively, e.g., prior to scar correction, wound incision, body contouring, pre- or post-operatively to pre-treat or pre-condition the skin, in mastectomy skin expansion, topically or subcutaneously. Whether or not the use of energy modalities, such as microwave, radiofrequency ablation, high intensity focused ultrasound, laser, infrared, incoherent light, etc., may or may not include lifting, fixing, holding, and moving skin in aesthetic skin treatment or resurfacing, during weight loss, or for various purposes, such as aesthetic purposes, hair removal or depilation, treating and / or closing skin injuries, such as incisions, wounds, chronic wounds, pressure sores, ulcers (including venous stasis ulcers), preventing or reducing the occurrence of wound dehiscence, diabetic skin or wound conditions, burn healing and / or relief, acting as an occlusive or negative pressure wound dressing, protecting an incision or wound, such as preventing splitting or opening, protecting the umbilicus of a newborn after cutting the umbilical cord. Such treatments may include the use of drugs or other therapeutic agents that may be applied to the skin using such devices. Drugs may include, but are not limited to, antibiotics, antifungals, immunomodulatory components, including corticosteroids and nonsteroidal immunomodulatory components. The agent may be provided in any of a variety of formulations, including, but not limited to, powders, gels, lotions, creams, pastes, suspensions, etc. The device may also be used for the purpose of delivering drugs to or through the skin, for example, by stretching the skin and applying the drug thereto.Different configurations of the device may be suitable for different body area sizes or geometries. Treatment may be applied to areas of any shape (e.g., linear, curved, star-shaped), size, or depth, and to 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, forearms, palms, dorsum of hands, fingers, nail beds, armpits, breasts, nipples, areolae, back, abdomen, groin, buttocks, perineum, labia, penis, scrotum, thighs, lower legs, plantar surface of feet, dorsum of feet, and / or toes. Such devices may also be referred to herein as "dressings," "skin devices," or "skin treatment devices."

[0012] In some situations, immediate, rapid, or easy application of a dressing may be desirable. The devices, kits, and methods described herein may be for preparation and / or application of the dressing to the skin, and separation of the applicator, tensioning device, or carrier, support, or base of the dressing from the skin device.

[0013] The devices, kits, or methods described herein may include a packaging, carrier, support, base, applicator, or tensioning device, each of which may at least temporarily contain, hold, carry, or support the dressing, may be used to prepare the dressing for application, may be used to deliver, orient, or apply the dressing, may be used to maintain the dressing in a stressed or strained configuration, may be used to apply stress or strain to the dressing, may be used to separate the dressing from the packaging, carrier, support, base, applicator, or tensioning device, and / or may be used to provide additional treatment to the wound, incision, or other treatment site during or after application of the dressing, and / or may be used to apply pressure to the wound, incision, or other treatment site. According to some variations, the packaging and / or applicator may provide structural support for the dressing while or after the adhesive liner is released. According to some variations, the assembly may be constructed to avoid folding or bending the dressing to such an extent that the adhesive on the dressing would stick to itself. For example, when several variations of bandage material are held or supported in a cantilever configuration at one point or along one edge of the bandage material, the bandage material will not buckle out of plane, deform laterally, or otherwise deform under their own mass or configuration.

[0014] In some other variations of the devices and methods herein, the device is with a substantially rigid support structure or provides structural support to the dressing and provides a certain resistance to bending or column strength when two opposite edges of the device and support structure are placed under a compressive load that causes axial compression or lateral deformation, for example, a force similar to the grip of a hand is applied to the edge of the device before the device buckles or folds.For example, the resistance to bending may be characterized as the peak force achieved when the device and support structure are compressed without being compressed by 25% of their original dimensions.This column strength or stiffness may vary depending on the direction along the device and support structure being measured.In some further variations, the peak force may 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 devices that include a generally flat or planar device and support structure having a thickness, the peak force may be measured by applying a compressive force along the shortest dimension of the device / support structure that is transverse to the thickness of the device / support structure. According to such variations, the device may have a length to width aspect ratio of, for example, greater than 1:1, 2:1, or 3:1.

[0015] The resistance to bending in the direction of strain of the dressing may also be measured by three-point bending, applying a lateral force to the midpoint of an applicator that is simply supported on two outer points at a given separation distance or support range. For example, the distance between the two points on the sample may be about 0.75 inches, and a force ranging from about 1 to 1.25 pounds may be applied to a sample about 0.35 inches wide, resulting in a deflection of about 0.05 inches. Resistance to bending may also be measured by characterizing the force at which buckling occurs on a simply supported beam. For example, a force of about 0.45 pounds may be applied to a simply supported sample about 0.35 inches wide, resulting in a deflection of about 0.004 inches. Resistance to bending may also be characterized by the deflection of the outer surface before failure or permanent deformation. By performing measurements of the support structure and deflection during the test procedure, a load-deflection curve may be generated, and the flexural modulus of the support structure may also be calculated. In some variations, the support structure may have 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.

[0016] In another example, a 7 cm wide by 19 cm long device may be configured with a support structure comprising a paperboard support sheet or structure. The support structure may have an average thickness within a range of about 0.008 inches to about 0.028 inches, or greater. In some specific variations, the support structure may have a thickness of about 0.012 inches, about 0.016 inches, about 0.018 inches, about 0.024 inches, about 0.28 inches, or about 0.032 inches, about 0.036 inches, about 0.04 inches, about 0.05 inches, or greater. In response to application of a force along a 19 centimeter long longitudinal edge, i.e., across the 7 cm width of the device, the support structure may provide sufficient stiffness or column strength to achieve a peak force of about 3 pounds or more, 4 pounds or more, or about 10 pounds or more while being compressed, crushed, deflected, buckled, or otherwise deformed by 25% (i.e., about 1.75 cm) along its 7 cm width. In some variations, the support structure may include folds or regions of reduced thickness to allow it to flex to some degree in at least one direction, or in both directions.

[0017] According to some variations, the device providing structural support may have multiple supporting cross elements or sections extending from one edge of the length to the opposite edge of the 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, e.g., cross elements extending laterally along two opposite edges and across the width (or length), and one or more cross elements extending across the width (or length) and between the cross elements along two opposite edges. Such cross elements may or may not be bonded or connected to each other, e.g., using a relatively flexible material. Such cross elements may have a total width relative to the length of the opposing edges of 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 having a total width relative to the length of the opposing sides of about 20% to 100%. Such cross elements may be compartmentalized and may provide flexibility when bending in one direction and stiffness versus flexibility in another direction.

[0018] The packaging and / or applicator may also provide structural support or stability for the dressing as it is oriented and / or applied to the skin of a subject. According to some variations, the dressing and packaging are configured to be reoriented in a wound-facing position before or after the wound device is prepared for application, e.g., the adhesive liner is removed. According to some variations, the packaging or applicator is configured to be used with one hand to orient and / or apply the device to the skin of a subject. For example, in some situations, especially when longer or larger dressings are used, the packaging or applicator provides structural support for the dressing so that a user may effectively hold, manipulate, and / or apply the prepared dressing with one hand. According to some variations, the assembly comprises a support structure. A dressing support structure is defined herein to mean a structure that is coupled, whether directly or indirectly, to the backside of a dressing to be applied to a subject. The support structure may further comprise a material or structure that is, at least in part, more rigid than the dressing to be applied to a subject. The support structure may comprise one or more elements or sections. This may be constructed from a single substrate, a laminate, or multiple elements bonded together and / or 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 opposing side to the 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 structures is a minimum average of support across the entire length or width of the device, e.g., an average of at least 20%, 25%, 30%, 35%, or 40% support across the entire dimension, e.g., length or width, of the device. According to some variations, the entire area of ​​the dressing is supported by the support structures. According to some variations, the base, carrier, or support of the dressing may comprise at least three support structures extending laterally between opposing sides of the dressing. According to some variations, the support structures comprise interconnected members or elements.According to some variations, the base, carrier, or support remains attached to the dressing as it is applied. According to some variations, greater structural support is provided to the dressing carrier, support, or base in a first direction, while greater flexibility is provided in a second direction, but less flexibility is in the first direction and less structural support is provided in the second direction. According to some variations, the one or more support structures may extend beyond the edge of the first opposing side. According to some variations, the one or more support structures may extend at least partially beyond at least a portion of the edge of the first opposing side and at least partially beyond at least a portion of the edge of the opposite side. According to some variations, the support structures may extend at least 3 mm from at least a portion of the edge of the dressing. According to some variations, the packaging or applicator is configured to improve sterile transfer of the dressing to the wound of the subject. According to variations, the packaging or applicator may be sufficiently wider or longer or have a sufficiently large area than the dressing to provide the ability to steer or manipulate the support or applicator so as to provide for sterile application and / or one-handed application without the need to touch the dressing. According to some variations, a distance limit is provided from the outer edge of the dressing carrier, support, or base to the base on the dressing or the dressing supported on the adhesive. Such limit may be selected to prevent or resist the user from touching the dressing or the adhesive of the dressing when gripping the edge to manipulate the dressing carrier, support, applicator, or base.

[0019] The devices, kits, and methods described herein may be for the treatment, amelioration, or prevention of scars and / or keloids by creating and / or maintaining a predetermined strain in an elastic skin treatment device that is then affixed to a skin surface using a skin adhesive to transmit a generally planar (e.g., compressive) force from the bandage to the skin surface.

[0020] In some variations, a dressing is provided that comprises an elastic sheet structure (e.g., comprising a silicone polyurethane, a TPE (thermoplastic elastomer), a synthetic rubber, or a copolyester material) that comprises 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 further comprise a first release liner that is releasably attached to the adhesive region or regions. The adhesive region may comprise a pressure sensitive adhesive. The dressing may be tapered or otherwise shaped to reduce skin tension at the edges. The dressing may have modified, reduced adhesive, or no adhesive near its edges to reduce skin tension at the edges. A portion of the dressing may be unstrained, thereby reducing strain in an area of ​​the skin to which the dressing is applied. In some specific examples, the undistorted area or areas are found between the edge of the dressing and the distorted area. In some further embodiments, the unstrained area is limited to this area and is not found among the unstrained areas of a single dressing in use during application or use, hi still further embodiments, the unstrained area is limited to the area along the edge of the dressing that intersects the strain axis of the strained area, rather than the area along the edge of the dressing that is generally parallel to the strain axis.

[0021] A packaging device, a dressing carrier, a dressing support, a dressing base, an applicator, and / or a tensioning device may be provided. The packaging device, the dressing carrier, the dressing support, the dressing base, the applicator, and / or the tensioning device may be configured to apply stress and / or strain to the dressing prior to application to a subject. The device may be used to apply and / or maintain strain 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 further include a releasable locking mechanism, attachment mechanism, or adhesive configured to maintain the member or mechanism in the strained configuration.

[0022] In some circumstances, application of a compressive force to a wound is desirable to reduce bleeding. According to some variations, the packaging, carrier, support, base, applicator, or tensioning device described herein may further be used to help reduce bleeding, for example, by allowing the application of a compressive force using the device while or after the dressing is being applied. A clotting additive may also be provided on the dressing.

[0023] According to one aspect, the packaging, carrier, support, base, applicator, and / or tensioning device may be sufficiently rigid or supportive in at least one direction to retain the shape of the dressing so that it is easy to manipulate.

[0024] According to some variations, the packaging is also sufficiently flexible in at least one direction to allow the dressing to bend or mold so that it conforms to the curvature or shape of the body or location on the skin where it is applied. In general, the flexibility of the packaging used to allow the dressing to conform to the treatment site may be configured so that the application of the dressing is relatively smooth or uniform on the skin and / or to provide a uniform, predetermined, or relatively predictable strain or force to an area of ​​the skin such that the treatment site is not substantially deformed during application of the dressing. The packaging or applicator may have flexibility in a first direction and greater stiffness in another direction. The packaging or applicator may include elements or sections that allow flexibility relative to adjacent elements or sections.

[0025] According to some variations, the packaging is also sufficiently flexible in at least one direction to allow the dressing to bend or mold so as to conform to the curvature or shape of the location on the body or skin where the dressing is applied. In general, the flexibility of the packaging used to allow the dressing to conform to the treatment site may be configured so that the treatment site is not substantially deformed during application of the dressing and / or so that application of the dressing is relatively smooth or uniform on the skin and / or to provide a uniform, predetermined, or relatively predictable strain and / or force to an area of ​​the skin. The packaging or applicator may be flexible in a first direction and more rigid in a second direction. The first direction may be transverse to the direction of strain application or have a component that is transverse to the direction of strain application. The second direction may be in the direction of strain application or have a component that is in the direction of strain application. The first direction may or may not be transverse to the second direction. The wrapper or applicator may include elements or compartments that allow flexibility relative to adjacent elements or compartments.

[0026] According to some variations, the desired flexibility, for example having at least one component that is transverse to the direction of strain application, may be characterized by a modified cantilever bending model, i.e., by simply applying a force to the free end of a beam supported from the other end while wrapping it around a cylindrical object with a known radius or curvature, defined as the inverse of the radius of curvature. According to one variation, the force to bend the packaging or applicator around an object with a given curvature may be about 3 pounds or less. According to one variation, the force may be about 0.3 pounds or less. According to one variation, the force to bend around a given curvature of about 2.5 inches radius may be about 3 pounds or less. In another variation, the force to bend around a given curvature of about 2.5 inches radius may be about 0.3 pounds or less.

[0027] According to some variations, a packaging, applicator, or tensioning device is provided that includes a base having an inner surface to which the dressing is removably attached, and a cover or lid having an inner surface that interfaces with the inner surface of the base when in an initial closed configuration. According to some variations, the base and cover are joined at corresponding edges along their corresponding lengths to form a book-like structure, whereby the cover may be rotated relative to the base to open the device. Alternatively, the cover may be lifted away from the base. According to some variations, a liner is attached to the cover that will expose the adhesive side of the dressing when the cover is lifted or opened.

[0028] In some variations, the book-like structure comprises a layered structure that in the closed configuration comprises a cover / lid, a treatment device, and a base in that relative order, while in the open configuration the relative order of the layered structure changes to cover / lid, base, and treatment device. The treatment device may also comprise one or more release layers. In one variation, in the closed configuration, a first side of the cover / lid contacts a first side of the treatment device and a first side of the base contacts a second side of the treatment device opposite the first side, while in the open configuration, a second side of the cover / lid (opposite the first side of the cover / lid) contacts a second side of the base (opposite the first side of the base) but does not contact the first side of the treatment device. In some variations, the cover / lid may be separated from the base during or after tensioning of the treatment device. In some variations, the treatment device may be asymmetrically attached to the book-like structure relative to a bending region of the book-like structure. In some cases, asymmetric attachment may provide the user with a mechanical advantage when tensioning the dressing and / or may reduce manufacturing costs by optimizing the amount of elastic material used in the dressing. In other variations, the dressing or skin treatment device may be symmetrically attached to the book-like structure relative to the bending region of the book-like structure.

[0029] 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 comprising an applicator comprising a base structure having an inner surface and a manipulation portion, a dressing comprising a first surface configured to be applied to the skin or wound of a subject, a back surface, the back surface of the dressing being removably coupled or anchored to the inner surface of the base structure, the first surface facing outwardly of the inner surface of the base structure, and a cover configured to removably cover the first surface of the dressing. The method may further include removing the cover to expose the first surface of the dressing, and using the manipulation portion of the base structure to apply the first surface of the dressing to the wound or skin of the subject. In another variation, a method for treating a wound is provided, comprising: applying a strain to an inner region of an elastic bandage between a first unstrained region and a second unstrained region, and attaching at least the strained inner region of the dressing to a skin site or to both the strained and unstrained regions.

[0030] According to some variations, the dressing packaging assembly comprises a base structure having an inner surface, a cover structure having an opposing surface, the base structure being movably coupled to the cover structure, a dressing comprising a first surface configured to be applied to a wound or skin of a subject, and a back surface, at least a portion of which is removably coupled to the inner surface of the base structure, the cover structure being configured to move from a first position, in which the opposing surface interfaces with and is substantially parallel to the first surface of the dressing, to a second position, 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 a variation, the dressing comprises a first attachment region coupled to an inner surface of the base structure and a second attachment region coupled to an opposing surface of the cover structure, the cover and the base being configured to apply a straining force to the dressing when the cover is moved from a first position to a second position. According to a variation, the tensioning structure is configured to apply a straining force to the dressing. According to a variation, the tensioning structure comprises a first structure configured to couple the dressing at the first attachment region to an inner surface of the base structure and a second structure configured to couple the dressing at the second attachment region to an opposing surface of the cover, the tensioning structure being configured to apply a straining force to the dressing between the first attachment region and the second attachment region when the cover structure is moved from a first position to a second position relative to the base structure. According to some variations, the dressing has a first width when the cover is in the first position and a second width when the cover is in the second position, the second width being 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.According to a variation, the base structure comprises at least one relatively rigid element and at least one relatively flexible element, the relatively rigid element being sufficiently rigid to support the dressing when a straining force is applied in a first direction, and the relatively flexible element allowing the base structure to flex in a second direction. According to a variation, the at least one relatively rigid element comprises a plurality of flexible coupled relatively rigid elements. According to a variation, the cover structure comprises at least one relatively rigid element and at least one relatively flexible element. According to a variation, the release device is configured to release the dressing from the base structure after the dressing has been applied to a wound or skin of the subject. According to some variations, the base structure is pivotally coupled to the cover structure.

[0031] According to a variation, the dressing packaging assembly comprises a base structure having an inner surface and comprising at least one support element and at least one flexible element, a first surface configured to be applied to a wound or skin of a subject, and a back surface, at least a portion of which is removably coupled to the inner surface of the base structure. According to a variation, the at least one rigid element comprises a plurality of rigid elements coupled to each other with at least one flexible element. According to a variation, the cover structure comprises an opposing surface configured to interface with the first surface of the dressing, and the cover structure is movably coupled to the base structure such that the cover moves from a first position where the opposing surface interfaces with the first surface of the dressing to a second position where the cover is separated from the first surface of the dressing. According to a variation, the cover structure is pivotally coupled to the base structure. According to a variation, the cover structure comprises at least one support element and at least one flexible element that is sufficiently flexible to allow shaping of the cover structure. According to a variation, the first surface of the bandage comprises an adhesive region. According to a variation, the first surface of the bandage comprises an adhesive backing that interfaces with the adhesive region on the bandage. According to a variation, the opposing surface of the cover structure comprises an adhesive backing that covers the adhesive region at a first location and is separated from the adhesive region at a second location. According to a variation, the bandage comprises an elastic material. According to a variation, the bandage comprises a first attachment region coupled to an inner surface of the base structure and a second attachment region coupled to an opposing surface of the cover structure, the cover and base being configured to apply a straining force when the cover is moved from the first location to the second location to strain the bandage. According to a variation, the assembly further comprises a tensioning structure configured to apply a straining force to the bandage.According to a variant, the tensioning structure comprises a first structure configured to couple the dressing in the first attachment region to an inner surface of the base structure and a second structure configured to couple the dressing in the second attachment region to an opposing surface of the cover, the tensioning structure being configured to apply a straining force to the dressing between the first and second attachment regions when the cover structure is moved from a first position to a second position relative to the base structure. According to a variant, the dressing between the first and second attachment regions has a first width when the cover is in the first position and a second width when the cover is in the second position, the second width being greater than the first width. According to a variant, 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.

[0032] According to a variant, a method for applying a dressing to a wound or skin of a subject includes providing a dressing packaging assembly comprising a base structure having an inner surface, a cover structure having an opposing surface, the base structure being movably coupled to the cover structure, a dressing comprising a first surface including an adhesive region, and a back surface, at least a portion of the back surface being removably coupled to the inner surface of the base structure, the opposing surface of the cover structure comprising an adhesive backing that covers the adhesive region when the cover structure is in a first position, pivoting the cover structure relative to the base 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 region, applying the first surface of the dressing to the wound or skin of the subject, and then subsequently releasing the dressing from the base structure. According to a variant of the method, at least a portion of the back surface of the dressing is coupled to the cover structure, further comprising pivoting the cover structure relative to the base structure to impart a strain to the dressing.

[0033] According to a variant, the bandage applicator comprises a first bandage attachment area and a second bandage attachment area with a variable separation distance between the first bandage attachment area and the second bandage attachment area, and a bend area between the first bandage attachment area and the second bandage attachment area that modifies the variable separation distance, wherein a first distance from a center of the bend area to the first bandage attachment area is different from a second distance from a center of the bend area to the second bandage attachment area.

[0034] According to a variant, the dressing tensioning device comprises a dressing carrier with a first carrier edge and a second opposing carrier edge defining a carrier width therebetween, a tensioning element configured to move from a first position to a second dressing tensioning position relative to the dressing carrier, a dressing assembly comprising a dressing including a first dressing edge coupled to the carrier adjacent the first carrier edge and a second dressing edge coupled to the attachment element, the attachment element being coupled to the tensioning element, wherein in the first position of the tensioning element the second dressing edge is at 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 at a second distance from the second carrier edge within the width of the carrier, the first distance being greater than the second distance. According to a variant, the first dressing edge is relatively fixed relative to the second dressing edge when the tensioning element is moved between the first and second positions.

[0035] According to a variation, the dressing packaging assembly comprises a base structure having an inner surface, a cover structure having an opposing surface, the base structure being movably coupled to the cover structure, and a dressing comprising a first surface configured to be applied to a wound or skin of a subject, and a back surface, at least a portion of the back surface being removably coupled to the inner surface of the base structure, the cover structure being configured to move from a first position in which the opposing surface interfaces with the first surface of the dressing to a second position in which the opposing surface is separated from the first surface of the dressing, the second position being 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 variant, the dressing comprises an elastic material. According to a variant, the dressing comprises a first attachment region coupled to an inner surface of the base structure and a second attachment region coupled to an opposing surface of the cover structure, the cover and the base being configured to apply a straining force and strain the dressing when the cover is moved from a first position to a second position. According to a variant, the assembly further comprises a tensioning structure configured to apply a straining force to the dressing. According to a variant, the tensioning structure comprises a first structure configured to couple the dressing at the first attachment region to an inner surface of the base structure and a second structure configured to couple the dressing at the second attachment region to an opposing surface of the cover, the tensioning structure being configured to apply a straining force to the dressing between the first attachment region and the second attachment region when the cover structure is moved from a first position to a second position relative to the base structure. According to a variant, the dressing has a first width when the cover is in the first position and a second width when the cover is in the second position, the second width being 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.According to a variant, the base structure comprises at least one relatively rigid element and at least one relatively flexible element, the relatively rigid element being sufficiently rigid to support the dressing material when a straining force is applied in a first direction, and the relatively flexible element allowing the base structure to flex in a second direction.

[0036] According to a variant, the dressing package comprises a dressing carrier having a first carrier edge, a second carrier edge opposite the first carrier edge, and a support structure extending between the first and second edges configured to support the dressing during application of the dressing to a subject; a dressing having a first dressing edge, a second dressing edge opposite the first dressing edge, a back surface, and an opposing skin interfacing surface; At least a portion is removably coupled to the dressing carrier, the first dressing edge and the second dressing edge are positioned between the first carrier edge and the second carrier edge, 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, the first and second margins each having a width of at least 3 millimeters.

[0037] In one variation, a bandage system is provided that includes a first support, a second support, a primary bending region therebetween, the primary bending region comprising a primary bending axis, a first attachment region attached to the first support, a second attachment region attached to the second support, a first separation region configured to separate from the first attachment region, and a second separation region configured to separate from the second attachment region. The first and second separation regions may include perforations. The bandage system may further include a retraction element located along the perforations. The treatment device may be asymmetrically attached to the first and second supports with respect to the primary bending region. A first distance between the first support and the primary bending axis may be different from a second distance between the second support and the primary bending axis. The bandage system may further 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 with 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 support may include at least one secondary bending region with a secondary bending axis that is not parallel to the primary bending axis. The at least one secondary bending region of the first support may be aligned with the at least one secondary bending region of the second support. The treatment device may further include a release liner that is bonded to the adhesive surface of the treatment device. The treatment device may include a perforated region. The dressing system may further include an elongated element attached adjacent to the perforated region. The elongated element may protrude beyond the perforated region of the treatment device. In some variations, at least a portion of the elongated element may be folded, and the folding may be along a substantial length of the treatment device. At least one of the first and second supports may include indicia that identifies a central region of the treatment device. The indicia may include a recessed edge, an ink mark, an embossing, or a window. The primary bending region may also be perforated. The first support may be configured to be detached from the second support and the treatment device, with or without maintaining the treatment device in the distorted 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. The release liner may be attached to the first support between an outer edge of the first support and the attached treatment device. The 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, configured either to maintain the treatment device in tension when it stretches and contacts the adhesive, and / or to maintain the treatment device against the first and / or second support.

[0038] In another variation, a bandage system is provided that includes a first tension member, a second tension member, a primary bending region therebetween, the primary bending region having a primary bending axis, and a treatment device attached asymmetrically to the first and second tension members with respect to the primary bending region. The treatment device may have a first end attached to the first tension member and a second end attached to the second tension member, and a first distance between the first tension member and the primary bending axis is different from a second distance between the second tension member and the primary bending axis. The bandage system may further include a closed configuration in which the treatment device is located between the first tension member and the second tension member, and an open configuration in which the second tension member is located between the first tension member and the treatment device. The second tension member may include at least one secondary bending region with 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 tension member may include at least one secondary bending region with a secondary bending axis that is not parallel to the primary bending axis. The at least one secondary bending region of the first tension member may be aligned with the at least one secondary bending region of the second tension 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 region. The dressing system may further include an elongated element attached adjacent to the perforated region. The elongated element may protrude beyond the perforated region of the treatment device. In some variations, at least a portion of the elongated element may be folded, and the folding may be along a substantial length of the treatment device. At least one of the first and second tension members may include indicia identifying a central region of the treatment device. The indicia may include a recessed edge, an ink mark, an embossing, or a window. The primary bending region may be perforated. The first tension member may be configured to be detached from the second tension member and the treatment device. The first tensioning member may be configured to be detached from the second tensioning member and the treatment device while maintaining the treatment device in the strained 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 tension member may include an attached release liner. The release liner may be attached to the first tension member between an outer edge of the first tension member and the attached treatment device.

[0039] In another variation, a bandage system is provided comprising a first applicator member, a second applicator member, a primary bending region therebetween, the primary bending region comprising a primary bending axis, and a treatment device attached to the first and second applicator members, the bandage system comprising 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 comprise at least one 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 comprise at least one secondary bending region comprising a secondary bending axis that is not parallel to the primary bending axis. The at least one secondary bending region of the first applicator member may be aligned with the at least one secondary bending region of the second applicator member. The treatment device may further comprise a release liner coupled to the adhesive surface of the treatment device. The treatment device may comprise a perforated region. The dressing system may further comprise an elongated element attached adjacent to 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 substantial length of the treatment device. At least one of the first and second applicator members may comprise indicia identifying a central region of the treatment device. The indicia may comprise a recessed edge, an ink mark, an embossing, or a window. The primary bending region may be perforated. The first applicator member is configured to be removed from the second applicator member and the treatment device. The first applicator member may be configured to be removed from the second applicator member and the treatment device while maintaining the treatment device in a distorted configuration. The second applicator member may comprise 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 a release liner attached thereto. The release liner may be attached to the first applicator member between an outer edge of the first applicator member and the attached treatment device.

[0040] The devices, kits, and methods herein may include a support, packaging, and / or applicator configured to maintain the pre-strained dressing in a strained configuration for a period of time after straining and prior to application to the skin of a subject. The devices and methods herein may include methods of manufacturing such pre-strained dressings.

[0041] According to one variation, the pre-strained, strain-shielded bandage assembly may be stored for a period of time after straining and prior to use. In some variations, the bandage may be configured to maintain a predictable and / or desired amount of tensile force for a predetermined period of time after initial straining. In some variations, the bandage may be configured to lose a predetermined maximum and / or minimum amount of tensile force (measured in the direction of tensile straining of the bandage) for one or more periods of time.

[0042] The desired time for application of the dressing to a subject may be when the dressing has a desired tensile force characteristic or range in its pre-strained, strain-shielded configuration. Such desired range may be selected to provide sufficient modulation of force on the skin to treat the skin while avoiding or minimizing disruptive irritation to the skin. As described herein, for a given dressing, different levels of stress or strain may be applied to skin at different locations and / or on different subjects. Also, different levels of force unloading may be desired for different locations on the skin of different individuals or subjects. Thus, different ranges of dressing force properties may be appropriate for different skin treatment applications.

[0043] Such desired force ranges may be selected based on a determination of the desired force characteristics to be applied to a particular subject, portion of skin, and / or for a particular skin treatment purpose. Such desired forces may be high enough to provide therapeutic mechanomodulation of the skin, yet low enough to prevent significant skin irritation.

[0044] The force properties of a pre-strained bandage may vary over time. An initial strain may be applied to the bandage, and the elastic material or other structure of the bandage has an initial tensile force property. The bandage may be maintained in a strained configuration at a particular strain level after it has been pre-strained for an initial period of time. During the initial period of time, the force properties of the elastic material may decrease, decay, or exhibit loss of force. After an initial predetermined period of time, the force properties of the elastic material may reach, decrease, or decay to a desired force level and / or range of force levels. The bandage elastic material force properties may remain within a desired range for at least a subsequent period of time. In some variations, the dressing material may have a modulus of elasticity in the range of about 1 MPa to about 15 MPa, sometimes about 1.5 MPa to about 6 MPa, and other times about 2 MPa to about 5 MPa, about 3 MPa to about 4 MPa, or about 3.5 MPa to 5 MPa, while having a peak load per width of maximum 0.6 strain 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, and other times less than about 0.6 N / mm, or less than about 0.5 N / mm. The peak load per width of maximum 0.6 strain may be 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 may be selected such that the material at a constant engineering strain of 20% is capable of maintaining an engineering stress of at least about 200 kPa, 250 kPa, 300 kPa, 400 kPa, or 500 kPa, 1,000 kPa, 1,500 kPa, 2,000 kPa, 2,500 kPa, 3,000 kPa, or more, for at least 8 hours with less than a 10% or 5% fluctuation or decrease in engineering stress.

[0045] According to an alternative embodiment, for example, the initial force or strain properties of the dressing may be selected so that a desired range of force values ​​occurs during which the rate of force loss is reduced and occurs over a longer period of time.

[0046] The initial strain and / or force level of the dressing may be selected so that the time of use falls within a desired time frame or period, based on the rate at which the dressing loses force over time.

[0047] According to a variant, the dressing may be initially strained or overstressed to provide an initial force per unit width above that of the desired range upon application to the skin. According to a variant, the initial strain and resulting initial force per width of the dressing may be selected based on the desired final resulting force properties and / or the desired time frame for use of the dressing. Such initial strain levels 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 a variant, the initial force is above the desired force range. Such initial force levels may be, for example, about 25% or up to 25%, about 35% or up to 35%, about 50% or up to 50%, about 75% or up to 75% or more than the desired force upon application of the dressing. Such initial force levels may be, for example, but not limited to, 2-5 Lbf / inch, 1.54-3.85 Lbf / inch, 1.33-3.33 Lbf / inch, or 0.85-2.20 Lbf / inch.

[0048] According to a variant, the dressing may be initially strained or tensile stressed to a desired strain or force level and configured to be maintained in the strained configuration for an initial time frame. According to a variant, the initial time frame may be, for example, one hour or more, one day or more, one week or more, or up to one month or more prior to application. According to a variant, the initial time frame may be one hour or more, one day or more, one week or more, or up to one month or more prior to final assembly or manufacturing in a preconditioning state of the material. Such a preconditioning state may strain the material at a constant strain or strain the material at various levels of strain.

[0049] According to some variations, the dressing may then be configured to maintain a desired minimum final force or force range for the duration of a subsequent predetermined time frame after the initial time frame. During the subsequent time frames, the device may be applied to the subject's skin for treatment. Such a desired force range may be about 0.5-1.0 Lbf / inch, 1.0-2.5 Lbf / inch, or about 1.6-2.1 Lbf / inch. The force loss during the subsequent time period may 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 may be, for example, 2 months or more, 3 months or more, 6 months or more, 12 months or more, 36 months or more, or 48 months or more.

[0050] The pre-strained dressing may then be coupled to a strain-maintaining element for an initial period of time, and the strain-maintaining element may remain on the dressing for a portion of a subsequent period of time until it is used.

[0051] According to variations, for example, the average initial force or strain properties of a dressing that has been prestrained at the time of manufacture (average may or may include, for example, an average per manufacturing lot, or a defined average within a given tolerance level) may be provided such that a desired range of average force values ​​occurs during which the average rate of loss of force is reduced and occurs over a longer period of time. In other variations, prestraining begins at the point of use. In yet other variations, part of the prestraining is performed at the point of manufacture, with additional straining or strain relaxation performed at the point of use. After prestraining, the dressing may then be packaged, sealed, and sterilized for future use.

[0052] The initial average strain and / or force level of the dressing may be selected based on the average rate of loss of force of the dressing over time, so that the time of use falls within a desired time frame or period.

[0053] According to a variant, the dressing may be initially strained or overstressed to provide an average initial force per unit width above that of the desired range upon application to the skin. According to a variant, the average initial strain and resulting initial force per width of the dressing may be selected based on the desired final resulting force properties and / or the desired time frame for use of the dressing. Such average initial strain levels 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 a variant, the average initial force is above the desired force range. Such average initial force levels may be, for example, about 25% or up to 25%, about 35% or up to 35%, about 50% or up to 50%, about 75% or up to 75% or more than the desired force upon application of the dressing. Such average initial force levels may be, for example, but not limited to, 2-5 Lbf / inch, 1.54-3.85 Lbf / inch, 1.33-3.33 Lbf / inch, or 0.85-2.20 Lbf / inch.

[0054] According to a variation, the dressing may be initially strained or stressed to a desired average strain or force level and configured to be maintained in the strained configuration for an initial time frame. According to a variation, the initial time frame may be one hour or more, one day or more, one week or more, or up to one month or more prior to application. According to a variation, the initial time frame may be one hour or more, one day or more, one week or more, or up to one month or more in a preconditioning state of the material prior to final assembly or manufacturing. Such a preconditioning state may strain the material at an average constant strain or strain the material at various levels of average strain.

[0055] According to some variations, the dressing may then be configured to maintain a desired minimum average final force or average force range for the duration of a subsequent predetermined time frame after the initial time frame. During the subsequent time frames, the device may be applied to the subject's skin for treatment. Such a desired average force range may be about 0.5-1.0 Lbf / inch, 1.31 Lbf / inch-1.41 Lbf / inch. The average force loss during the subsequent time period may 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 may be, for example, 2 months or more, 3 months or more, 6 months or more, 12 months or more, 36 months or more, or 48 months or more.

[0056] The pre-strained dressing may be bonded to a strain-maintaining element for an initial period during one or more manufacturing steps, and the strain-maintaining element may remain on the dressing until it is used, for a portion of a subsequent period during manufacturing, or during transportation or storage.

[0057] Example I below illustrates the percent change in force per unit width of selected pre-strained dressings maintained at constant strain over a period of time under test conditions. Example I

[0058] In this example, five (5) dressings were strained at 40% and five (5) dressings were strained at 60%. The dressings were constructed from MED 82-5010-10 by NUSIL TECHNOLOGY LLC (Carpenteria, CA). A maximum of 5 particulates per sheet less than or equal to 0.020 inches and a maximum of 5 surface gels and / or bubbles per sheet of 0.020 inches or less in size were present in the samples. The samples were initially 8 inches (+- about 0.02 inches) by 1 inch (+- about 1 inch) with a thickness of 0.010 inches. The samples had a durometer hardness value (Shore A scale) of about 50, a tensile strength of about 1,450 psi, an elongation of about 1,000, and a specific gravity of about 1.16. Gauge marks located at six inch (6 inch) centers were added. The gage length of the 40% strain sample increases to 8.4 inches when strained. The gage length of the 60% strain sample increases to 9.6 inches when strained. The samples were mounted in a strained configuration in a sample fixture or clamp with a locking bar between the sample fixture. The sample fixture was constructed from acrylic (PMMA) and coated with non-slip tape. When tested, the ends of the sample fixture were attached to the grips of a tensile tester Chatillon Model TCD225, 50 LBF load cell. Measurements were then taken after releasing the locking bar. The samples were stored in the test laboratory at ambient laboratory temperature for the duration of the test. The tensile force of the dressings was measured at various time intervals. Figure 6 illustrates the percent loss of force over time for each dressing. The initial average post-strain loss after 1 hour at 60% strain was about 30% and after 1 hour at 40% strain was about 25%. It was surprising to see that following the initial post-strain loss, the additional losses after the initial loss decreased at a slower rate, averaging about 15% over the two-year period (a total average loss of 45%).

[0059] In other examples, the maximum number of particulates per sheet may be 1, 5, 10, 20, or 25 or more, with a maximum size of 0.01 inch, 0.02 inch, 0.040 inch, 0.050 inch, or 0.07 inch, or 0.1 inch, 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 inch, 0.02 inch, 0.040 inch, 0.050 inch, or 0.07 inch, or 0.1 inch. In other variations, the dressing material may have a durometer hardness value of about Shore A 15 to about 90, sometimes about Shore A 35 to 75, and other times about Shore A 50 to 60, or Shore A 50 to 75.

[0060] Example II below illustrates the percent change in force per unit width of selected pre-strained dressings maintained at constant strain over a period of time under test conditions. Example II

[0061] In this example, ten dressing membranes were strained at 44%. The dressing membranes were constructed from polyurethane by 3M (St. Paul, MN). The samples were initially 8 inches (+- about 0.02 inches) by 1 inch (+- about 1 inch) with a thickness of 0.002 inches. The samples had a tensile strength of about 2.2 lbs / in and an elongation of about 300%. Gauge marks located at 6 inch centers were added. The gauge length of the 45% strain sample increases to 8.7 inches when strained. The samples were mounted in a strained configuration in a sample fixture or clamp with a locking bar between the sample fixtures. The sample fixture was constructed from acrylic (PMMA) and coated with non-slip tape. When tested, the ends of the sample fixture were attached to the grips of a Chatillon Model TCD225 tensile tester, 50 LBF load cell. Measurements were then taken after releasing the locking bar. The samples were stored in the test laboratory at ambient laboratory temperature for the duration of the test. The tensile strength of the dressing was measured at various time intervals.

[0062] Figure 9 illustrates the percent loss of force over time for each dressing. The initial average post-strain loss after 1 day at 45% strain was about 33%. Following the initial post-strain loss, it was surprising to see that the additional losses after the initial loss decreased at a slower rate, averaging about 12% over the 13-day period (a total average loss of 45%).

[0063] FIG. 7 is a schematic diagram of the percent force loss over time of the variation of an elastic material of a dressing strained by a predetermined amount and held in a strained configuration over time. According to FIG. 7, the dressing and / or dressing material is held at a constant strain for a period of time. The initial strain may be selected to provide different percent force loss values ​​at a particular time. The percent force loss values ​​and force values ​​may vary for different initial strain levels and different materials. A curve plot for a particular dressing material may be determined, for example, as described with respect to Example I. As the force loss percentage increases, the force value decreases for a particular material or dressing, and / or the average force loss value decreases for many manufactured materials or dressings pre-strained by substantially the same amount. At time T0, the material is strained. During the initial time frame of T0-T1, the percent force loss of the material occurs at a more rapid rate than that occurring in subsequent periods or time frames, e.g., T1-T3, T1-T2, and / or T2-T3. Time frames T1-T3, T1-T2, and / or T2-T3 represent example time frames that may or may not be selected based on desired force properties for the dressing, desired time for use of the properties, and / or desired rate of force loss. For example, a dressing may be pre-strained during manufacture and then stored or transported for later use during defined time frames, e.g., T1-T2, T2-T3, and / or T1-T3.

[0064] FIG. 8 is a schematic diagram of the force over time variation of an elastic material of a dressing that is strained by a predetermined amount and held in a strained configuration over time. According to FIG. 8, the dressing and / or dressing material is held at a constant strain for a period of time. The initial strain may be selected to provide different force values ​​at a particular time. The force values ​​and percent force value loss may vary for different initial strain levels and different materials. A curve plot for a particular dressing material may be determined, for example, as described with respect to Example I. As the force loss percentage increases, the force value decreases for a particular material or dressing, and / or the average force loss value decreases for many manufactured materials or dressings that have been pre-strained by substantially the same amount. At time T0, the material is strained. During the initial time frame T0-TA, the material loses force at a more rapid rate than occurs in subsequent periods or time frames, e.g., TA-TC, TA-TB, and / or TB-TC. Time frames T0-TA, TA-TB, and / or TB-TC represent example time frames that may or may not be selected based on desired force properties for the dressing, desired time for use of the properties, and / or desired rate of force loss. For example, a dressing may be pre-strained during manufacture and then stored or transported for later use during a defined time frame, e.g., TA-TB, TB-TC, and / or TB-TC.

[0065] In another example, a method is provided for modulating a tissue response at a target site, the method including providing a strained elastic structure with an access opening and a support structure, placing the strained elastic structure against the target site, releasing the strained elastic structure from the support structure, and inserting an access structure into the target site, the access structure being located within the access opening. The strained elastic structure may be an elastic sheet with an adhesive layer. Attaching the strained elastic structure to the target site may include adhering the strained elastic structure to a skin location. The support structure may include at least one pull tab, and releasing the strained elastic structure from the support structure may include actuating the pull tab to release the strained elastic structure from the support structure. The method may further include inserting the access structure through the access opening. The access structure may be a delivery tube, and the method may further include passing a sensor or an infusion cannula using the delivery tube. The access structure may be attached to a housing. The housing may include an outer skin configured to attach the housing to a skin surface. The housing may further include a support layer, and the adhesive may be located on a lower surface of the support layer. The method may further include adhering the housing to the resilient 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 indicia or alignment structure located on the distorted resilient structure.

[0066] In another embodiment, a tissue treatment device is provided that includes a strained elastic layer having a top surface, a bottom surface, and a treatment opening, a skin adhesive layer adhered to the bottom surface of the strained 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 layer structure with a central opening surrounding the treatment opening of the strained elastic layer, the strain support having sufficient rigidity to maintain the strained elastic layer in the strained 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 further include a perforated region from the central opening to an edge of the strain support. The alignment structure may include a separation region aligned with the perforated region of the strain support. The strain support may include a first end, a second end, and an arcuate body therebetween that defines the central opening of the strain support. The device may further comprise a strain support adhesive layer between the strained elastic layer and the strain support, the strain support adhesive layer having a lower T-peel force than the skin adhesive layer. The strained elastic layer may be heat crimped to the strain support. The strain support may further comprise perforations to facilitate separation of the strain support from the strained elastic layer.

[0067] In another embodiment, a device includes a deflected elastic base layer having a top surface, a bottom surface, a peripheral edge, and a treatment opening; a skin adhesive layer adhered to the bottom surface of the deflected elastic layer; a protective layer in releasable contact with the skin adhesive layer; and at least one deflected elastic intermediate layer, each elastic intermediate layer having a top surface, a bottom surface, a peripheral edge, and a treatment opening aligned with the treatment opening of the deflected elastic base layer, the bottom layer of one of the at least one intermediate elastic layer being attached to the top surface of the deflected elastic base layer, the at least one deflected elastic intermediate layer having a top surface, a bottom surface, a peripheral edge, and a treatment opening. A multi-layer tissue treatment device is provided, comprising: a strained elastic top layer, where the treatment openings of the strained elastic top layer are aligned with the treatment openings of the strained elastic base layer and where a bottom surface of the strained elastic top layer is attached to a top surface of one of the at least one intermediate elastic layer; and a strain support releasably attached to at least one of the strained elastic top layer, the strained elastic bottom layer, and the at least one elastic middle layer, where the strain support is configured to maintain strain in the elastic base layer, the at least one middle layer, and the elastic top layer. The outer periphery of the elastic top layer may be offset from the outer periphery of the intermediate elastic layer attached to the elastic base layer, and the outer periphery of the elastic middle layer attached to the elastic base layer may be offset from the outer periphery of the elastic base layer. The outer periphery of the elastic top layer may be offset inwardly from the outer periphery of the intermediate elastic layer attached to the elastic top layer, and the outer periphery of the elastic middle layer attached to the elastic base layer may be offset inwardly from the outer periphery of the elastic base layer. The device of claim 8, wherein the bottom surface of the elastic top layer is smaller than the top surface of the intermediate elastic layer attached to the elastic top layer, and the bottom surface of the elastic middle layer attached to the elastic base layer is smaller than the top surface of the elastic base layer. The bottom surface of the elastic top layer may be larger than the top surface of the intermediate elastic layer attached to the elastic top layer, and the bottom surface of the elastic middle layer that may be attached to the elastic base layer is larger than the top surface of the elastic base layer. The device of claim 8, wherein each of the strained elastic top layer, the strained elastic base layer, and the at least one elastic middle layer each have a different size.The elastic top layer may be smaller than all of the at least one elastic intermediate layer, and all of the at least one elastic intermediate layer may be smaller than the elastic base layer. The elastic top layer may be larger than all of the at least one elastic intermediate layer, and all of the at least one elastic intermediate layer may be larger than the elastic base layer. The at least one elastic intermediate layer may comprise two elastic intermediate layers. The at least one elastic intermediate layer may comprise two elastic intermediate layers. The strained elastic top layer and the at least one elastic intermediate layer may each comprise a pull tab. The pull tabs of the strained elastic top layer and the pull tabs of the at least one elastic intermediate layer may each be different sizes. The pull tabs of the elastic top layer may be smaller than all of the pull tabs of the at least one elastic intermediate layer. The pull tabs of the elastic top layer may be larger than all of the pull tabs of the at least one elastic intermediate layer. The strain support may be releasably attached to an upper surface of the strained elastic top layer. The attachment of the top layer and the at least one intermediate layer may utilize an anisotropic adhesive pattern. The anisotropic adhesive pattern may have a reduced amount of adhesive along the peel direction compared to the strain direction of the strained layer.

[0068] A multi-layer tissue treatment device is provided, comprising at least two strained elastic layers, comprising at least a top elastic layer and at least a base elastic layer, each of the at least two strained elastic layers having a top surface, a bottom surface, a size, a perimeter edge, and a treatment opening, the at least two strained elastic layers being releasably attached together in a stacked configuration, a skin adhesive layer adhered to the bottom surface of the base elastic layer, and a strain support releasably attached to the base elastic layer, the strain support being configured to maintain strain in the at least two strained elastic layers. The force per width level in the base elastic layer may be higher than the force per width level of any other of the at least two strained elastic layers. The base elastic layer may comprise at least 70% of the total force per width in the at least two strained elastic layers. The base elastic layer may comprise at least 90% of the total force per width in the at least two strained elastic layers. The base elastic layer may comprise a material of higher durometer hardness or have a greater thickness than the others in the at least two strained elastic layers. The at least two strained elastic layers may further comprise at least one intermediate elastic layer located in a stacked configuration between the top elastic layer and the base elastic layer. The outer peripheral edge of each of the at least two strained elastic layers may be offset from the outer peripheral edge of an adjacent strained elastic layer in the stacked configuration. The outer peripheral edge of each of the at least two strained elastic layers may be offset inwardly from the outer peripheral edge of an adjacent higher strained elastic layer in the stacked configuration. The outer peripheral edge of each of the at least two strained elastic layers may be offset outwardly from the outer peripheral edge of an adjacent higher strained elastic layer in the stacked configuration. The outer peripheral edge of each of the at least two strained elastic layers may be offset inwardly from the outer peripheral edge of an adjacent lower strained elastic layer in the stacked configuration. The size of each of the at least two strained elastic layers may be different. The size of each of the at least two strained elastic layers may be smaller than any adjacent lower strained elastic layer in the stacked configuration.The size of each of the at least two strained elastic layers may be greater than an adjacent higher strained elastic layer in the stacked configuration. The size of each of the at least two strained elastic layers may be less than any adjacent higher strained elastic layer in the stacked configuration. The size of each of the at least two strained elastic layers may be greater than an adjacent lower strained elastic layer in the stacked configuration. The device of claim 35, wherein at least one of the at least two strained elastic layers comprises a pull tab. Each pull tab of the at least one of the at least two strained elastic layers may comprise a different pull tab size. The attachment of the at least two strained elastic layers may utilize an anisotropic adhesive pattern. The attachment of the at least two strained elastic layers may comprise an adhesive layer therebetween with a reduced amount of adhesive along a direction orthogonal to the strain direction of the strained layers. The orthogonal direction is a peel direction of the at least two strained elastic layers. The attachment of the at least two strained elastic layers may comprise an adhesive layer that is thinner than the skin adhesive layer of the strained base layer.

[0069] In yet another embodiment, a treatment device is provided that includes a strained elastic layer with an upper surface, a lower surface, and an opening therebetween, a skin adhesive on the lower surface of the strained elastic layer, an infusion hub located on the upper surface of the strained elastic layer, with a catheter or needle extending through the opening in the strained elastic layer, fluid tubing attached to the infusion hub and in fluid communication with the catheter or needle, a strain support configured to maintain strain in the strained elastic layer, and at least one pull tab configured to releasably attach the strained elastic layer and the strain support together. The treatment device may further include an infusion set applicator releasably attached to the infusion hub. The device may further include two pull tabs located on opposite sides of the strained elastic layer. Each of the two pull tabs may include a perforation configured to be torn to allow the strained elastic layer and the infusion hub to separate from the strain support.

[0070] In another embodiment, a treatment device is provided that includes a strained elastic layer having an upper surface, a lower surface, and an opening therebetween, a skin adhesive on the lower surface of the strained elastic layer, an infusion hub located on the upper surface of the strained elastic layer, with a catheter or needle extending through the opening in the strained elastic layer, fluid tubing attached to the infusion hub and in fluid communication with the catheter or needle, a strain support configured to maintain strain in the strained elastic layer, and at least one pull tab configured to releasably attach the strained elastic layer and the strain support together. The treatment device may further include an infusion set applicator releasably attached to the infusion hub. The device may include two pull tabs located on opposite sides of the strained elastic layer. Each of the two pull tabs may include a perforation configured to be torn to allow the strained elastic layer and the infusion hub to separate from the strain support.

[0071] In another example, a method is provided for modulating a tissue response at a target site, the method comprising providing a strained elastic structure with an access opening and a support structure, placing the strained elastic structure against the target site, releasing the strained elastic structure from the support structure, and inserting an access structure into the target site, the access structure being located within the access opening. The strained elastic structure may be an elastic sheet with an adhesive layer. Attaching the strained elastic structure to the target site may include adhering the strained elastic structure to a skin location. The support structure may comprise at least one pull tab, and releasing the strained elastic structure from the support structure may include actuating the pull tab to release the strained elastic structure from the support structure. The method may further comprise inserting the access structure through the access opening. The access structure may be a delivery tube, and the method further comprises passing a sensor or an infusion cannula using the delivery tube. The access structure is attached to a housing. The housing may comprise an adhesive. The housing may further comprise a support layer, and the adhesive is located on a lower surface of the support layer. The method may further comprise 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 indicia or alignment structure located on the strained resilient structure.

[0072] In another embodiment, a method of treating a therapy site is provided, comprising: placing a first tension member at a first location adjacent to a target site, the first tension member being pre-tensioned along a first tension axis; placing a second tension member at a second location adjacent to the target site, the second tension member being pre-tensioned along a second tension axis, the second location being separated from the first location by a gap of 20 mm or less, the target site being located within the gap; and injecting or infusing a therapeutic agent at the target site. The first tension axis and the second tension axis may be parallel. The first tension member and the second tension member may be completely separate. The first and second tension members are integrally formed with a predetermined longitudinal gap therebetween, and the longitudinal gap may comprise a longitudinal gap axis. The longitudinal gap axis may be located between the first and second tension axes. The longitudinal gap, the first tension axis, and the second tension axis may each be parallel to one another. The predetermined longitudinal gap has an average width of less than 20 mm, less than 10 mm, or less than 5 mm. The method may further include adhering the infusion set to the first and second tension members prior to using the infusion set to inject the therapeutic agent.

[0073] In another embodiment, a method of treating lipoatrophy is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of a patient, and reducing the risk of lipoatrophy. The injection or infusion site may be an insulin or insulin analog injection or infusion site. The patient may be diabetic, and the lipoatrophy may be lipohypertrophy. The patient may not have any history of lipohypertrophy, or may have a history of lipohypertrophy. The method may further comprise reducing the risk of insulin resistance and / or reducing the rate of insulin or insulin analog dosage increase over a period of time. The period of time may be one year.

[0074] 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 of insulin or insulin analog dosage escalation over time.

[0075] In yet another embodiment, a method of treating diabetes may be provided that includes applying an adhesive skin tensioning device to an injection or infusion site of a diabetic patient to improve glucose time in range, which may be daily, weekly, or monthly glucose time in range.

[0076] In another example, a method may be provided for reducing the cost of diabetes treatment in a diabetic population, comprising applying an adhesive skin tensioning device to a diabetic patient's insulin or insulin analog injection or infusion site to reduce glycemic variability or the cost of severe adverse events.

[0077] In yet another embodiment, a method of treating a therapy site is provided that includes adhering a multi-layer strained bandage to a treatment site, releasing strain in the multi-layer strained bandage to transfer strain from the bandage to the treatment site and reducing tissue tension at the treatment site, attaching a first hub and a first catheter to the multi-layer bandage, delivering a therapeutic agent to the treatment site through the first hub and the first catheter, removing the first hub and first catheter from the multi-layer bandage by removing the first layer from the multi-layer bandage, attaching a second hub and a second catheter to the multi-layer bandage, delivering a therapeutic agent to the treatment site through the second hub and the second catheter, and removing the second hub and second catheter from the multi-layer bandage by removing the second layer from the multi-layer bandage.

[0078] In another embodiment, a method of positioning an infusion set is provided, comprising: adhering a strained skin tension relief device to a treatment location, the skin tension relief device comprising a strained 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 using the alignment structure; decoupling an infusion set hub from the infusion set applicator and actuating the infusion set applicator 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 strained skin tension relief device to release strain in the strained elastic layer. The method may further 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.

[0079] According to some variations, the elastic device may be strained at different strain values ​​during preconditioning. The present invention provides, for example, the following: (Item 1) 1. A tissue treatment device comprising: a strained elastic layer having a top surface, a bottom surface and a treatment opening; a skin adhesive layer adhered to a bottom surface of the strained elastic layer; a protective layer in releasable contact with the adhesive layer; a strain support removably attached to an upper surface of the elastic layer, the strain support comprising a layered structure with a central opening surrounding a treatment opening of the strained elastic layer, the strain support having sufficient rigidity to maintain the strained elastic layer in a strained configuration; at least one alignment structure located on the strain support and surrounding a central opening of the strain support; A device comprising: (Item 2) Item 14. The device of item 1, wherein the strain support further comprises a perforated region from the central opening to an edge of the strain support. (Item 3) Item 3. The device of item 2, wherein the alignment structure comprises a separation region aligned with a perforated region of the strain support. (Item 4) Item 4. The device of item 3, wherein the strain support comprises a first end, a second end and an arcuate body therebetween that defines a central opening of the strain support. (Item 5) Item 14. The device of item 1, further comprising a strained support adhesive layer between the strained elastic layer and the strained support, the strained support adhesive layer having a lower T-peel force than the skin adhesive layer. (Item 6) Item 14. The device of item 1, wherein the strained elastic layer is heat swaged to the strain support. (Item 7) Item 14. The device of item 1, wherein the strain support further comprises perforations to facilitate separation of the strain support from the strained elastic layer. (Item 8) 1. A multi-layer tissue treatment device comprising: a deflected elastic base layer having a top surface, a bottom surface, a perimeter edge, and a treatment opening; a skin adhesive layer adhered to a bottom surface of the strained elastic layer; a protective layer in releasable contact with the skin adhesive layer; at least one strained elastic intermediate layer, each elastic intermediate layer having a top surface, a bottom surface, a perimeter edge, and a treatment opening aligned with a treatment opening of the strained elastic base layer, the bottom layer of one of the at least one intermediate elastic layer being attached to a top surface of the strained elastic base layer; a strained elastic top layer having a top surface, a bottom surface, a perimeter edge, and a treatment opening, the treatment opening of the strained elastic top layer being aligned with the treatment opening of the strained elastic base layer, and the bottom surface of the strained elastic top layer being attached to a top surface of one of the at least one intermediate elastic layer; a strain support releasably attached to at least one of the strained elastic top layer, the strained elastic bottom layer, and the at least one elastic middle layer, the strain support configured to maintain strain in the elastic base layer, the at least one middle layer, and the elastic top layer; A device comprising: (Item 9) a peripheral edge of the elastic top layer is offset from a peripheral edge of the intermediate elastic layer attached to the elastic top layer; a peripheral edge of the elastic intermediate layer attached to the elastic base layer is offset from a peripheral edge of the elastic base layer; Item 8. The device according to item 8. (Item 10) an outer periphery of the elastic top layer is offset inwardly from an outer periphery of the intermediate elastic layer attached to the elastic top layer; the outer periphery of the elastic intermediate layer attached to the elastic base layer is offset inwardly from the outer periphery of the elastic base layer; Item 9. The device according to item 9. (Item 11) a bottom surface of the elastic top layer is smaller than a top surface of the intermediate elastic layer attached to the elastic top layer; a bottom surface of the elastic intermediate layer attached to the elastic base layer is smaller than a top surface of the elastic base layer; Item 8. The device according to item 8. (Item 12) a bottom surface of the elastic top layer is larger than a top surface of the intermediate elastic layer attached to the elastic top layer; a bottom surface of the elastic intermediate layer attached to the elastic base layer is larger than a top surface of the elastic base layer; Item 8. The device according to item 8. (Item 13) 9. The device of claim 8, wherein each of the strained elastic top layer, the strained elastic base layer, and the at least one elastic middle layer each have a different size. (Item 14) Item 14. The device of item 13, wherein the elastic top layer is smaller than all of the at least one elastic middle layer, and all of the at least one elastic middle layer are smaller than the elastic base layer. (Item 15) Item 14. The device of item 13, wherein the elastic top layer is larger than all of the at least one elastic middle layer, and all of the at least one elastic middle layer are larger than the elastic base layer. (Item 16) Item 15. The device of item 14, wherein the at least one elastic intermediate layer comprises two elastic intermediate layers. (Item 17) Item 16. The device of item 15, wherein the at least one elastic intermediate layer comprises two elastic intermediate layers. (Item 18) Item 14. The device of item 13, wherein the strained elastic top layer and the at least one elastic middle layer each include a pull tab. (Item 19) 20. The device of claim 18, wherein the pull tab of the strained elastic top layer and the pull tab of the at least one elastic middle layer are each different sizes. (Item 20) Item 19. The device of item 18, wherein the pull tabs of the elastic top layer are smaller than all of the pull tabs of the at least one elastic middle layer. (Item 21) Item 19. The device of item 18, wherein the pull tab of the elastic top layer is larger than all of the pull tabs of the at least one elastic middle layer. (Item 22) Item 9. The device of item 8, wherein the strain support is releasably attached to an upper surface of the strained elastic top layer. (Item 23) 9. The device of claim 8, wherein the attachment of the top layer and the at least one intermediate layer utilizes an anisotropic adhesive pattern. (Item 24) Item 24. The device of item 23, wherein the anisotropic adhesive pattern has a reduced amount of adhesive along a peel direction compared to a strain direction of the strained layer. (Item 25) 1. A multi-layer tissue treatment device comprising: at least two strained elastic layers, the at least two strained elastic layers comprising at least a top elastic layer and at least a base elastic layer, each of the at least two strained elastic layers comprising a top surface, a bottom surface, a size, a perimeter edge, and a treatment opening, the at least two strained elastic layers being releasably attached together in a stacked configuration; a skin adhesive layer adhered to a bottom surface of the base elastic layer; a strain support releasably attached to the base elastic layer, the strain support configured to maintain strain on the at least two strained elastic layers; A device comprising: (Item 26) Item 26. The device of item 25, wherein the force per unit width in the base elastic layer is higher than the force per unit width of any other of the at least two strained elastic layers. (Item 27) Item 26. The device of item 25, wherein the base elastic layer comprises at least 70% of the total force per unit width of the at least two strained elastic layers. (Item 28) Item 28. The device of item 27, wherein the base elastic layer provides at least 90% of the total force per unit width of the at least two strained elastic layers. (Item 29) Item 26. The device of item 25, wherein the base elastic layer comprises or has a thickness greater than that of a material of a higher durometer than others of the at least two strained elastic layers. (Item 30) Item 26. The device of item 25, wherein the at least two strained elastic layers further comprise at least one intermediate elastic layer positioned in the stacked configuration between the top elastic layer and the base elastic layer. (Item 31) Item 26. The device of item 25, wherein a peripheral edge of each of the at least two strained elastic layers is offset from the peripheral edge of an adjacent strained elastic layer in the stacked configuration. (Item 32) Item 32. The device of item 31, wherein an outer periphery of each of the at least two strained elastic layers is offset inwardly from the outer periphery of an adjacent, more highly strained elastic layer in the stacked configuration. (Item 33) Item 32. The device of item 31, wherein a peripheral edge of each of the at least two strained elastic layers is offset outwardly from the peripheral edge of an adjacent, higher strained elastic layer in the stacked configuration. (Item 34) Item 32. The device of item 31, wherein an outer periphery of each of the at least two strained elastic layers is offset inwardly from the outer periphery of an adjacent, lower strained elastic layer in the stacked configuration. (Item 35) Item 32. The device of item 31, wherein the sizes of each of the at least two strained elastic layers are different. (Item 36) Item 36. The device of item 35, wherein the size of each of the at least two strained elastic layers is smaller than any adjacent lower strained elastic layer in the stacked configuration. (Item 37) Item 36. The device of item 35, wherein a size of each of the at least two strained elastic layers is greater than an adjacent higher strained elastic layer in the stacked configuration. (Item 38) Item 36. The device of item 35, wherein the size of each of the at least two strained elastic layers is smaller than any adjacent higher strained elastic layer in the stacked configuration. (Item 39) Item 36. The device of item 35, wherein the size of each of the at least two strained elastic layers is greater than an adjacent lower strained elastic layer in the stacked configuration. (Item 40) Item 36. The device of item 35, wherein at least one of the at least two strained elastic layers comprises a pull tab. (Item 41) Item 41. The device of item 40, wherein each pull tab of at least one of the at least two strained elastic layers comprises a different pull tab size. (Item 42) 26. The device of claim 25, wherein the attachment of the at least two strained elastic layers utilizes an anisotropic adhesive pattern. (Item 43) Item 26. The device of item 25, wherein the attachment of the at least two strained elastic layers comprises an adhesive layer therebetween with a reduced amount of adhesive along a direction perpendicular to the strain direction of the strained layers. (Item 44) Item 44. The device of item 43, wherein the orthogonal direction is a peel direction of the at least two strained elastic layers. (Item 45) Item 29. The device of item 28, wherein the attachment of the at least two strained elastic layers comprises an adhesive layer that is thinner than the skin adhesive layer of the strained base layer. (Item 46) 1. A therapeutic device comprising: a strained elastic layer having an upper surface, a lower surface and an opening therebetween; a skin adhesive on a lower surface of the strained elastic layer; an injection hub positioned on an upper surface of the strained elastic layer, with a catheter or needle extending through an opening in the strained elastic layer; fluid tubing attached to the injection hub and in fluid communication with the catheter or needle; a strain support configured to maintain the strain in the strained elastic layer; at least one pull tab configured to releasably attach the strained elastic layer and the strain support together; A device comprising: (Item 47) Item 47. The therapeutic device of item 46, further comprising an infusion set applicator releasably attached to the infusion hub. (Item 48) Item 47. The therapeutic device of item 46, wherein the device comprises two pull tabs located on opposite sides of the strained elastic layer. (Item 49) Item 49. The treatment device of item 48, wherein the two pull tabs each include a perforation configured to be torn such that the strained elastic layer and infusion hub can be separated from the strain support. (Item 50) 1. A method for modulating a tissue response at a target site, comprising: providing a deflected resilient structure with an access opening and a support structure; placing the deflected elastic structure against a target site; Releasing the strained resilient structure from the support structure; and inserting an access structure into the target site, the access structure being positioned within the access opening; A method comprising: (Item 51) 51. The method of claim 50, wherein the strained elastic structure is an elastic sheet with an adhesive layer. (Item 52) 51. The method of claim 50, wherein attaching the strained elastic structure to the target site comprises adhering the strained elastic structure to a skin location. (Item 53) 51. The method of claim 50, wherein the support structure includes at least one pull tab, and releasing the strained resilient structure from the support structure includes actuating the pull tab to release the strained resilient structure from the support structure. (Item 54) Item 51. The method of item 50, further comprising inserting the access structure through the access opening. (Item 55) 51. The method of claim 50, wherein the access structure is a delivery tube, the method further comprising passing a sensor or an infusion cannula through the delivery tube. (Item 56) Item 51. The method of item 50, wherein the access structure is attached to the housing. (Item 57) Item 51. The method of item 50, wherein the housing comprises an adhesive. (Item 58) Item 58. The method of item 57, wherein the housing further comprises a support layer, and the adhesive is located on a lower surface of the support layer. (Item 59) Item 51. The method of item 50, further comprising adhering the housing to the resilient structure. (Item 60) 51. The method of claim 50, further comprising releasing the access structure from a delivery device after inserting the access structure into the target site. (Item 61) Item 61. The method of item 60, further comprising aligning the delivery device with indicia or alignment structure located on the distorted resilient structure. (Item 62) 1. A method of treating a therapy site, comprising: placing a first tension member at a first location adjacent to the target site, the first tension member being pre-tensioned along a first tension axis; placing a second tension member at a second location adjacent to the target site, the second tension member being pre-tensioned along a second tension axis, the second location being spaced from the first location by a gap of 20 mm or less, the target site being located within the gap; injecting or infusing a therapeutic agent at said target site; A method comprising: (Item 63) Item 63. The method of item 62, wherein the first tension axis and the second tension axis are parallel. (Item 64) Item 63. The method of item 62, wherein the first tension member and the second tension member are completely separate. (Item 65) Item 63. The method of item 62, wherein the first and second tension members are integrally formed with a predetermined longitudinal gap therebetween, the longitudinal gap comprising a longitudinal gap axis. (Item 66) Item 66. The method of item 65, wherein the longitudinal gap axis is located between the first and second tension axes. (Item 67) Item 67. The method of item 66, wherein the longitudinal gap, the first tension axis, and the second tension axis are each parallel to one another. (Item 68) Item 66. The method of item 65, wherein the predetermined longitudinal gap has an average width of less than 20 mm. (Item 69) 70. The method of claim 68, wherein the predetermined longitudinal gap has an average width of less than 10 mm. (Item 70) 70. The method of claim 69, wherein the predetermined longitudinal gap has an average width of less than 5 mm. (Item 71) Item 64. The method of item 63, further comprising adhering the infusion set to the first and second tension members prior to using the infusion set to inject the therapeutic agent. (Item 72) 1. A method of treating lipoatrophy, comprising: Applying an adhesive skin tensioning device to a patient's injection or infusion site to reduce the risk of lipoatrophy A method comprising: (Item 73) 73. The method of claim 72, wherein the injection or infusion site is an insulin or insulin analog injection or infusion site. (Item 74) 73. The method of claim 72, wherein the patient is diabetic and the lipoatrophy is lipohypertrophy. (Item 75) 75. The method according to item 74, wherein the patient does not have any history of lipohypertrophy. (Item 76) 75. The method of claim 74, wherein the patient has a history of lipohypertrophy. (Item 77) 73. The method of claim 72, further comprising reducing the risk of insulin resistance. (Item 78) 73. The method of claim 72, further comprising reducing the rate of insulin or insulin analog dosage increase over a period of time. (Item 79) Item 79. The method according to item 78, wherein the period is one year. (Item 80) 1. A method of treating diabetes, comprising: Applying an adhesive skin tensioning device to an injection or infusion site in a diabetic patient reduces the rate of insulin or insulin analogue dosage escalation over time. A method comprising: (Item 81) 1. A method of treating diabetes, comprising: Applying an adhesive skin tensioning device to an injection or infusion site in diabetic patients to improve glucose time in range A method comprising: (Item 82) 81. The method of claim 80, wherein the glucose time in range is the glucose time in range in days. (Item 83) 81. The method of claim 80, wherein the glucose time in range is glucose time in range in weeks. (Item 84) 81. The method of claim 80, wherein the time in glucose range is time in glucose range in months. (Item 85) 1. A method of reducing diabetes treatment costs in a diabetic population, comprising: The adhesive skin tensioning device is applied to the site of insulin or insulin analog injection or infusion in diabetic patients to reduce glycemic variability or the cost of severe adverse events. A method comprising: 1. A method of treating a therapy site, comprising: adhering a multi-layer strained dressing to the treatment site; releasing strain in the multi-layer strained dressing to transfer strain from the dressing to the treatment site and reduce tissue tension at the treatment site; attaching a first hub and a first catheter to the multi-layer dressing; delivering a therapeutic agent through the first hub and first catheter to the treatment site; removing the first hub and first catheter from the multi-layer dressing by removing a first layer from the multi-layer dressing; attaching a second hub and a second catheter to the multi-layer dressing; delivering the therapeutic agent through the second hub and second catheter to the treatment site; removing the second hub and second catheter from the multi-layer dressing by removing a second layer from the multi-layer dressing; A method comprising: (Item 86) 1. A method of positioning an infusion set, comprising: adhering a strained skin tension relief device to a treatment location, the skin tension relief device comprising a strained 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 using the alignment structure; actuating the infusion set applicator to decouple an infusion set hub from the infusion set applicator and insert a catheter of the infusion set hub through the treatment opening; removing the infusion set applicator; removing the strain support and protruding alignment structures from the strained skin tension relief device to release the strain in the strained elastic layer; A method comprising: (Item 87) Item 87. The method of item 86, further comprising selecting the protruding alignment structure from a plurality of different protruding alignment structures and attaching the selected protruding alignment structure to the strain support. (Item 88) Item 87. The method of item 86, wherein the protruding alignment structures are integrally formed with the strain support. [Brief description of the drawings]

[0080] [Figure 1] FIG. 1 is a perspective view of a variation of the dressing and packaging assembly in a closed configuration.

[0081] [Diagram 2]FIG. 2 is a perspective view of the dressing and packaging assembly of FIG. 1 with the cover open and in a position approximately 90 degrees from the closed position.

[0082] [Diagram 3] 3 is a bottom perspective view of the dressing and packaging assembly of FIG. 1 with the cover open in approximately a 360 degree configuration from the closed position.

[0083] [Figure 4] 4 is a top perspective view of the dressing and packaging assembly of FIG. 1 with the cover open in approximately a 360 degree configuration from the closed position.

[0084] [Figure 5A] FIG. 5A is a schematic bottom view of the dressing and packaging assembly in the position illustrated in FIG.

[0085] [Figure 5B] FIG. 5B is a cross-sectional view of FIG. 5A taken along line CC.

[0086] [Figure 5C] FIG. 5C is a cross-sectional view of FIG. 5A taken along line DD.

[0087] [Figure 6] FIG. 6 illustrates a variation of the dressing and packaging assembly.

[0088] [Figure 7] FIG. 7 is a perspective view of the dressing and packaging assembly with the cover in an open position 90 degrees from the closed position.

[0089] [Figure 8] FIG. 8 is a schematic end view of the dressing and packaging assembly of FIG. 7 in a distorted configuration with the cover open at approximately 360 degrees from the closed configuration.

[0090] [Figure 8A]FIG. 8A is an enlarged view of section A of FIG.

[0091] [Figure 8B] FIG. 8B is an enlarged view of section B of FIG. 8A.

[0092] [Figure 9] FIG. 9 is a top perspective view of the dressing and packaging assembly of FIG. 7 after release.

[0093] [Figure 10] FIG. 10 is a perspective view of another embodiment of a dressing and packaging assembly in a closed configuration.

[0094] [Figure 11] FIG. 11 is a perspective view of the dressing and packaging assembly of FIG. 10 with the cover in an approximately 90 degree configuration from the closed configuration.

[0095] [Figure 12A] FIG. 12A is a top perspective view of the dressing and packaging assembly of FIG. 10 with the cover in approximately a 360 degree configuration from a closed configuration.

[0096] [Figure 12B] FIG. 12B is a bottom perspective view of the dressing and packaging assembly of FIG. 10 with the cover in approximately a 360 degree configuration from the closed configuration.

[0097] [Figure 13] FIG. 13 is a top view of the packaging device in an open configuration.

[0098] [Figure 14] FIG. 14 is an exploded perspective view of the packaging device in an open configuration.

[0099] [Figure 15A] FIG. 15A is a perspective view of a variation of the dressing and packaging assembly in an unstrained configuration.

[0100] [Figure 15B] FIG. 15B is a bottom perspective view of the dressing and packaging assembly of FIG. 15A in a distorted configuration.

[0101] [Figure 15C] FIG. 15C is a bottom perspective view of the dressing and packaging assembly of FIG. 15A after removal of the carrier, support, or base cover.

[0102] [Figure 15D] FIG. 15D is a top perspective view of the device of FIG. 15A after removal of the carrier, support, or base cover.

[0103] [Figure 15E] FIG. 15E is a top perspective view of the device of FIG. 15A after removal of the carrier, support, or base.

[0104] [Figure 15F] FIG. 15F is a perspective view of the warped dressing after it has been separated from the mounting sheet.

[0105] [Figure 15G] FIG. 15G is a perspective view of the dressing assembly with the attachment sheet.

[0106] [Figure 15H] FIG. 15H is a perspective view of the dressing assembly of FIG. 15G with the mounting sheet peeled away.

[0107] [Figure 15I] FIG. 15I is a perspective view of the dressing assembly of FIG. 15G with the mounting sheet removed.

[0108] [Figure 15J] FIG. 15J is a cross-sectional view of the dressing assembly with the mounting sheet of FIG. 15G.

[0109] [Figure 16A]FIG. 16A is a perspective view of a variation of a dressing assembly with a removable mounting sheet.

[0110] [Figure 16B] FIG. 16B is a perspective view of the dressing assembly of FIG. 16A with the removable mounting sheet peeled away.

[0111] [Figure 16C] FIG. 16C is a perspective view of the dressing assembly of FIG. 16A with the mounting sheet removed.

[0112] [Figure 16D] FIG. 16D is a cross-sectional view of the dressing assembly with the mounting sheet of FIG. 16A.

[0113] [Figure 17A] FIG. 17A is a perspective view of a variation of a dressing assembly with a removable mounting sheet.

[0114] [Figure 17B] FIG. 17B is a perspective view of the dressing assembly of FIG. 17A with the removable mounting sheet peeled away.

[0115] [Figure 17C] FIG. 17C is a perspective view of the dressing assembly of FIG. 17A with the mounting sheet removed.

[0116] [Figure 17D] FIG. 17D is a cross-sectional view of the dressing assembly with the mounting sheet of FIG. 17A.

[0117] [Figure 18A] FIG. 18A is a perspective view of a variation of the dressing and packaging assembly in an unstrained configuration.

[0118] [Figure 18B] FIG. 18B is a top perspective view of the device of FIG. 18A in a warped and folded configuration.

[0119] [Figure 18C] FIG. 18C is a perspective view of the bottom side of the device in the warped and folded configuration of FIG. 18B.

[0120] [Figure 18D] FIG. 18D is a top perspective view of the device of FIG. 18A in a warped and folded configuration during removal of the mounting sheet.

[0121] [Figure 18E] FIG. 18E is a top perspective view of the device of FIG. 18A with the first side of the dressing assembly detached from the carrier and the cover removed.

[0122] [Figure 18F] FIG. 18F is a top perspective view of the device of FIG. 18A with the dressing assembly removed from the carrier.

[0123] [Figure 18G] FIG. 18G is a top perspective view of the device of FIG. 18A with the carrier detached and removed.

[0124] [Figure 18H] FIG. 18H is a perspective view of the device of FIG. 18A with the dressing separated from the mounting sheet.

[0125] [Figure 18I] FIG. 18I is a perspective view of the device of FIG. 18A with the dressing separated from the mounting sheet.

[0126] [Figure 18J] FIG. 18J is a side view of the device of FIG. 18A.

[0127] [Figure 19A] FIG. 19A is a perspective view of a variation of a dressing and packaging assembly device.

[0128] [Figure 19B] FIG. 19B is a top view of the dressing assembly of FIG. 19A in its undistorted configuration.

[0129] [Figure 19C] FIG. 19C is a top view of the dressing assembly of FIG. 19B in a distorted and attached configuration.

[0130] [Figure 19D] FIG. 19D is a top view of the dressing assembly of FIG. 19B in a distorted and removed configuration.

[0131] [Figure 19E] FIG. 19E is a top view of the dressing of FIG. 19B.

[0132] [Figure 20A] FIG. 20A is a top view of a variation of a dressing carrier, support, base tensioning device, or applicator.

[0133] [Figure 20B] FIG. 20B is a side view of the dressing carrier, support, base tensioning device, or applicator of FIG. 20A in a first configuration.

[0134] [Figure 20C] FIG. 20C is a side view of the dressing carrier, support, base tensioning device, or applicator of FIG. 20A in a second configuration.

[0135] [Figure 21A] FIG. 21A is a perspective view of a variation of a dressing carrier, support, base tensioning device, or applicator.

[0136] [Figure 21B] FIG. 21B is a top view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A.

[0137] [Figure 21C]FIG. 21C is a side view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A.

[0138] [Figure 21D] FIG. 21D is a top view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A in a bent configuration.

[0139] [Figure 21E] FIG. 21E is a cross-sectional view of FIG. 21D taken along line AA.

[0140] [Figure 22A] FIG. 22A is a perspective view of a variation of the dressing and packaging assembly in an unstrained configuration.

[0141] [Figure 22B] FIG. 22B is a perspective view of a variation of the dressing and packaging device in a distorted configuration.

[0142] [Figure 23A] FIG. 23A is a top perspective view of the dressing assembly, support structure and tensioning device in a relatively unstrained configuration.

[0143] [Figure 23B] FIG. 23B is a top perspective view of the dressing assembly, support structure, and tensioning device in a prestrained configuration.

[0144] [Figure 23C] FIG. 23C is a schematic side view of the dressing assembly, support structure, and tensioning device of FIG. 23B.

[0145] [Figure 23D] 23D is an enlarged schematic cross-sectional side view of the dressing assembly, support structure and tensioning device of FIG. 23.

[0146] [Figure 23E]FIG. 23E is an enlarged schematic detailed side view of a portion of the dressing and support structure of FIG. 23D.

[0147] [Figure 23F] FIG. 23F is a schematic side view of the dressing assembly and support structure in a prestrained configuration.

[0148] [Figure 23G] FIG. 23G is an enlarged side view of the dressing assembly and support structure of section A of FIG. 23F.

[0149] [Figure 23H] FIG. 23H is an enlarged side view of the dressing assembly and support structure of section B of FIG. 23F.

[0150] [Figure 23I] FIG. 23I is a top perspective view of the pre-strained assembly, including the dressing assembly and the remaining elements of the support structure.

[0151] [Figure 24] FIG. 24 is a perspective view of multiple prestrained dressings on a support element.

[0152] [Diagram 25] FIG. 25 illustrates a pre-strained dressing and support structure.

[0153] [Figure 26] FIG. 26 illustrates the percent loss of force over time for an elastic bandage material as described in Example I.

[0154] [Figure 27] FIG. 27 is a schematic diagram of percent force loss over time for a prestrained elastic material component of a dressing.

[0155] [Figure 28] FIG. 28 is a schematic diagram of tensile force over time for a pre-strained elastic material component of a dressing.

[0156] [Figure 29] FIG. 29 illustrates the percent loss of force over time for an elastic bandage material as described in Example II.

[0157] [Figure 30-1] Figures 30A-30C depict the use of a distorted dressing with an exemplary infusion set, and Figure 30D is a cross-sectional view of the distorted dressing and infusion set of Figure 30C. [Figure 30-2] Figures 30A-30C depict the use of a distorted dressing with an exemplary infusion set, and Figure 30D is a cross-sectional view of the distorted dressing and infusion set of Figure 30C.

[0158] [Figure 31-1] Figures 31A-31C depict a method of use of the distorted dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use. [Figure 31-2] Figures 31A-31C depict a method of use of the distorted dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use.

[0159] [Figure 32-1] 32A-32E depict various exemplary aperture configurations for the dressing. [Figure 32-2] 32A-32E depict various exemplary aperture configurations for the dressing.

[0160] [Diagram 33] FIG. 33 depicts the placement of a three-aperture dressing over the injection site.

[0161] [Diagram 34] FIG. 34 depicts an exemplary dressing with openings and various registration markings.

[0162] [Diagram 35]FIG. 35 depicts the use of the exemplary dressing of FIG. 34 with a delivery syringe.

[0163] [Diagram 36] FIG. 36 depicts the use of a dressing and visual guide tool with a delivery syringe.

[0164] [Figure 37] Figure 37A depicts another exemplary embodiment of a visual guide tool with a distal opening and one or more inward projections, and Figure 37B depicts the visual guide tool of Figure 37A overlaid on a dressing.

[0165] [Figure 38] 38A and 38B depict the use of the visual guide tool of FIGS. 37A and 37B with an infusion set delivery tool.

[0166] [Figure 39-1] Figure 39A is a perspective view of an exemplary infusion set delivery system including a pre-attached pre-strained dressing. Figures 39B-39D are top, side, and bottom views of the system of Figure 39A. Figure 39E is a bottom view of the system with its adhesive protective liner removed. [Figure 39-2] Figure 39A is a perspective view of an exemplary infusion set delivery system including a pre-attached pre-strained dressing. Figures 39B-39D are top, side, and bottom views of the system of Figure 39A. Figure 39E is a bottom view of the system with its adhesive protective liner removed.

[0167] [Figure 40-1]Figure 40A depicts placement of the delivery system of Figure 39E onto a treatment site. Figure 40B depicts the infusion set and pre-attached dressing of Figure 40A with the pull tab removed. Figure 40C depicts the infusion set of Figure 40B with the dressing support separated from the dressing and removal over the infusion set tubing. Figure 40D depicts the infusion set and pre-attached dressing. Figure 40E depicts an infusion set where the dressing support includes tearable perforations. [Figure 40-2] Figure 40A depicts placement of the delivery system of Figure 39E onto a treatment site. Figure 40B depicts the infusion set and pre-attached dressing of Figure 40A with the pull tab removed. Figure 40C depicts the infusion set of Figure 40B with the dressing support separated from the dressing and removal over the infusion set tubing. Figure 40D depicts the infusion set and pre-attached dressing. Figure 40E depicts an infusion set where the dressing support includes tearable perforations. [Figure 40-3] Figure 40A depicts placement of the delivery system of Figure 39E onto a treatment site. Figure 40B depicts the infusion set and pre-attached dressing of Figure 40A with the pull tab removed. Figure 40C depicts the infusion set of Figure 40B with the dressing support separated from the dressing and removal over the infusion set tubing. Figure 40D depicts the infusion set and pre-attached dressing. Figure 40E depicts an infusion set where the dressing support includes tearable perforations.

[0168] [Figure 41A] Figures 41A and 41B are top plan and top perspective views of another embodiment of a combined infusion set with multiple separable tension layers, respectively. [Figure 41B] Figures 41A and 41B are top plan and top perspective views of another embodiment of a combined infusion set with multiple separable tension layers, respectively.

[0169] [Diagram 42]42A-42C are top perspective views of the combined infusion set and method of using multiple tension layers depicted in FIGS. 41A and 41B.

[0170] [Diagram 43] 43A-43C are side elevational views of the method depicted in FIGS. 42A-43C.

[0171] [Diagram 44] FIG. 44A is a detailed side elevational view of the method of FIG. 42A, and FIG. 44B is a detailed view of the edges of multiple tension layers of FIG. 44A.

[0172] [Figure 45A] Figure 45A is a top plan view of another embodiment of a combined infusion set with multiple separable tension layers, and Figure 45B is a top perspective schematic view of the embodiment of Figure 45A. [Figure 45B] Figure 45A is a top plan view of another embodiment of a combined infusion set with multiple separable tension layers, and Figure 45B is a top perspective schematic view of the embodiment of Figure 45A.

[0173] [Diagram 46] 46A-46C are top perspective views of the combined infusion set and method of using multiple tension layers depicted in FIGS. 41A and 41B.

[0174] [Figure 47] Figures 47A and 47B are top and side elevation views of the method depicted in Figures 46A-46C, and Figure 47C is a detailed view of the edges of multiple tension layers of Figure 47B.

[0175] [Figure 48-1] Figures 48A and 48B are top plan and bottom perspective views of another exemplary infusion set delivery system with a pre-attached radially pre-strained skin tensioning device, and Figures 48C-48E depict installation and release of the pre-strained skin tensioning device. [Figure 48-2]Figures 48A and 48B are top plan and bottom perspective views of another exemplary infusion set delivery system with a pre-attached radially pre-strained skin tensioning device, and Figures 48C-48E depict installation and release of the pre-strained skin tensioning device.

[0176] [Figure 49] 49A-49E are front perspective, top plan, rear perspective, side elevation, and bottom plan views, respectively, of a skin tensioning device with pre-attached alignment structures to facilitate placement of an infusion set delivery system.

[0177] [Figure 50-1] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. [Figure 50-2] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. [Figure 50-3] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system.

[0178] [Figure 51] FIG. 51 is a front perspective view of an alternative support structure for the skin tensioning device depicted in FIGS. 49A-49E.

[0179] [Figure 52] FIG. 52 is a schematic diagram of another exemplary embodiment of a skin tensioning system comprising two separate skin distortion devices placed on opposite sides of an injection or infusion site.

[0180] [Diagram 53] FIG. 53 is a schematic diagram of another exemplary embodiment of a skin tensioning system comprising interconnected ledges separated by longitudinal gaps or slots.

[0181] [Figure 54]54A and 54B are top plan and side elevational views of an exemplary infusion hub and catheter with a pre-attached skin tensioning device.

[0182] [Figure 55] 55A and 55B are schematic perspective views of a radially tensioned skin treatment device used for manual injection.

[0183] [Figure 56] Figure 56A is a top perspective view of a skin tensioning device in which a woven needle injection port is used in conjunction with a syringe. Figure 56B is a bottom perspective view of the skin tensioning device of Figure 56A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0184] Detailed Description Previous attempts to treat scars and keloids have included surgery, silicone dressings, steroids, x-ray radiation, and cryotherapy. Each of these techniques has disadvantages. Perhaps the greatest disadvantage is that in the first instance, none of them effectively prevent or ameliorate the formation of scars or keloids. That is, these techniques have been used primarily to treat scars after they are already well established.

[0185] Unloading of extrinsic and / or intrinsic stress in the vicinity of a wound may ameliorate scar, hypertrophic scar, or keloid formation. The mechanical environment of an injury may be an important factor in tissue response to that injury. The mechanical environment includes extrinsic stress (i.e., physiological stress, including stress transmitted to the wound via muscle activity or physical movement) and intrinsic stress (i.e., skin stress resulting from the physical properties of the skin itself, including stress induced at the wound site due to swelling or contraction of the skin). The devices, dressings, kits, and methods described herein may control or regulate 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 may also control or regulate the mechanical environment to ameliorate scar and / or keloid formation. The mechanical environment of the skin may include stress, strain, or any combination of stress and strain. Control of the wound's mechanical environment can be active or passive, dynamic (e.g., by applying oscillatory stress), or static. The stresses and strains acting on the wound may involve layers of the skin, such as the outer stratum corneum, epidermis, and dermis, and underlying connective tissue layers, such as subcutaneous fat. The devices and methods described herein may protect the wound from its mechanical environment. The term "protect" is meant to encompass unloading the stresses experienced by the wound, and providing a physical barrier against contact, contaminants, and the like. The devices and methods described herein may protect the wound by unloading the wound and surrounding tissue from intrinsic and / or exogenous stresses. Thus, the devices and methods described herein may reduce the stresses experienced by the wound and surrounding tissue to levels lower than those experienced by normal skin and tissue. Unloading exogenous and / or intrinsic stresses in the vicinity of the wound may ameliorate the formation of scars, hypertrophic scars, or keloids.

[0186] The external mechanical environment of a cell can induce biological responses inside the cell and change cell behavior. Cells can sense and respond to changes in their mechanical environment using integrins, which are integral membrane proteins in the plasma membrane of the cell, and intracellular pathways. 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 trigger the secretion of cytokines, chemokines, growth factors, and other bioactive compounds that can increase or induce an inflammatory response. Such secretion can act within the cell that secretes them (intracrine), on the cell that secretes them (autocrine), on cells surrounding the cell that secretes them (paracrine), or at a distance from the point of secretion (endocrine). Intracrine interference can modify cell signaling, which in turn can modify cell behavior and biology, including recruitment of cells to the wound, proliferation of cells in the wound, and cell death in the wound. In addition, the extracellular matrix can be affected.

[0187] As mentioned above, the wound healing process can be characterized in three phases: the early inflammatory phase, the proliferation phase, and remodeling. The inflammatory phase occurs immediately after injury and typically lasts from about 2 days to a week. Blood clotting occurs to stop blood loss, and factors are released that attract cells that can clear debris, bacteria, and damaged tissue from the wound. In addition, factors are released to initiate the proliferation phase of wound healing. In the proliferation phase, which lasts from about 4 days to several weeks, fibroblasts grow and build new extracellular matrix by secreting collagen and proteoglycans. At the end of the proliferation phase, fibroblasts may act to further contact the wound. In the remodeling phase, randomly oriented collagen is organized and crosslinked along skin tension lines. Cells that are no longer needed may undergo apoptosis. The remodeling phase may continue for weeks or months or indefinitely after injury. Scars typically reach about 75-80% of the breaking strength of normal skin about 6-8 weeks after injury. In general, scars typically have a triangular cross-section, i.e., they are usually smallest in volume near the skin surface (i.e., the stratum corneum and epidermis) and increase in volume as they progress into the deeper layers of the dermis.

[0188] There are three general possible outcomes for the wound healing process. First, normal scarring may result. Second, pathological increase in scar formation, such as formation of hypertrophic scar or keloid, may result. Third, the wound may not heal completely and become a chronic wound or ulcer. The devices, kits, and methods described herein can ameliorate the formation of any type of scar. In addition, the devices, kits, and methods described herein can be adapted for various wound sizes and different thicknesses of skin, for example, the devices may be configured for use in different areas of the body. In addition, the devices, kits, and methods described herein can be adapted to ameliorate scar formation in skin of any type, for example, body location, age, race, or condition.

[0189] Without wishing to be bound by any particular theory, the inventors believe that mechanical strain acting on a wound or incision early in the proliferative phase of the wound healing process may inhibit cell apoptosis, leading to significant cell and matrix accumulation, and thus increased scarring or the production of hypertrophic scars. Given the fundamental similarity between hypertrophic scars and keloids in terms of excessive matrix formation, the inventors believe that the devices and methods described herein may also be useful in preventing and treating keloids by unloading or neutralizing at least some of the strain that may act on a wound or incision. This tensile strain may be exogenous and / or intrinsic strain, and may include, but is not limited to, strain from the inherent tensile forces found in normal, unwounded skin tissue.

[0190] Some 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 orient and apply and can have a tendency to fold and adhere to themselves.

[0191] The devices, kits, and methods described herein may treat skin at a skin site, including but not limited to, by controllably applying stress or strain to the epidermis and deeper layers of skin tissue at or near a skin site, i.e., at or adjacent to a wound or treatment site on the subject's skin, thereby ameliorating scar formation at the wound site ("skin treatment device"). The stress at the skin site may be reduced to a level below that experienced by normal skin and tissue. The stress or strain may be applied to the surrounding tissue in one, two, or more directions to reduce the intrinsic or extrinsic stress at the skin site in one, two, or more directions. Thus, the devices and methods described herein may reduce the stress experienced by the skin and / or wound and surrounding tissue to treat a subject. The device may also assist in preventing or reducing the occurrence of wound dehiscence.

[0192] The devices, kits, and methods described herein may provide a package and / or applicator for the dressing. According to one variation, the package and / or applicator is configured to provide for quick or easy preparation and / or application of the dressing. Some examples herein specifically refer to a package that also acts as a tensioning device to pre-strain the dressing, although other dressings may be provided that are not pre-strained and / or are not strained prior to application according to one or more variations or embodiments. The package may also operate as an applicator, where one or more elements of the package may be used to position and / or apply the dressing to the skin of a subject.

[0193] The devices, kits, and methods described herein may be for preparing and / or applying a dressing. Such preparation may include, for example, but is not limited to, removing an adhesive liner, straining or tensioning the dressing, orienting the dressing for application, and / or applying a medicinal or other material to a portion of the dressing prior to application.

[0194] The backing, adhesive liner, or release layer, and / or other packaging may provide a degree of structural stability to the flexible wound dressing. However, when removed, the flexible wound dressing may be somewhat difficult to use because it may fold and adhere to itself or the user, or otherwise provide difficult positioning across the wound. Also, the act of retracting or removing the liner and reorienting the dressing to the patient may increase the tendency to fold or collapse. Furthermore, because of the folding or collapsing nature of the dressing, during adhesive removal and subsequent reorientation, the user has a significant chance of compromising the sterility of the portion of the device to be applied to the wound site.

[0195] According to another variation, the packaging or applicator is configured to provide support for the dressing after it has been prepared and while it is being applied to a subject. According to some variations, the backing provides structural support or stability for the dressing as and / or after the adhesive liner is released. According to some variations, the dressing and packaging are configured to be pre-oriented in a wound-facing position, i.e., when the wound device is prepared for application and for immediate application thereafter. According to some variations, the packaging applicator is configured to be used with one hand to orient and / or apply the device to the skin of a subject.

[0196] According to some variations, the packaged dressing carrier, support, base tensioning device or applicator tensioning device, 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 variations, the dressing may be prestrained and coupled to the dressing carrier, support, base tensioning device, or applicator, as described, for example, in U.S. Provisional Application No. 61 / 512,340, filed July 17, 2011, which is incorporated herein by reference in its entirety. One or more dressing releases described herein may be used in conjunction with the dressing carrier, support, base tensioning device, or applicator.

[0197] In some further variations, the dressing, or one or more adhesive regions of the dressing, may be released, i.e., separated, from the liner by opening the package or applicator. According to some variations, the book-like package includes a cover and a base to which the dressing is removably attached. When or as the cover is opened, the liner may be manually or automatically released from the adhesive of the dressing. According to variations, the liner is attached to the cover and will expose the adhesive side of the dressing when the cover is lifted or opened. The base may be configured to provide structural support to the dressing while the liner is being removed and / or while the dressing is being applied to the subject's skin.

[0198] According to some variations, the packaging, tensioning device, dressing carrier, support, base, or applicator may further comprise an opening, window, or transparent or translucent portion through which the wound, incision, or other location may be visualized as the dressing is applied to the skin. According to some variations, the window guides the application of the dressing so that there is an optimal or desired distance between the wound and the edges of the dressing and / or so that the dressing is in an optimal location for unloading skin stresses.

[0199] According to some variations, the applicator, tensioning device, packaging or carrier, support, or base may provide varied or variable flexibility to allow the dressing to be shaped when applied to various body locations or contours.

[0200] According to some variations, the packaging or applicator is more rigid or provides sufficient column 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 provide a more conforming application to the curved or shaped skin surface of the subject or to allow the dressing to be curved or shaped. The first and second directions may or may not be mutually orthogonal. According to some variations, the packaging applicator, tensioning device, or dressing carrier, support, or base is sufficiently rigid or supports the dressing while allowing shaping of the dressing. According to some variations, the carrier or support, which may include a base and / or a cover, may comprise a section of relatively more rigid material flexibly coupled to an adjacent section to provide flexibility to allow shaping of the packaging / applicator and / or dressing while providing sufficient support of the dressing during application. According to some variations, the compartments are bonded to adjacent compartments using a flexible material such as a low density polyethylene (LDPE) material, or a composite of an adhesive and a thinner, more flexible material. Alternatively, the compartments may be formed as structures by manufacturing a substrate with cutouts, slots, grooves, creases, or other openings, or variations in the thickness of the substrate at different locations.

[0201] The packaging, applicator, tensioning device, or dressing carrier may have elements or features that provide flexibility in one direction perpendicular to the plane of the support, while limiting flexibility in another direction perpendicular to the plane of the support. According to some variations, the flexible elements may limit flexibility when the device is strained and allow flexibility when the device is applied to the skin. Each element may allow bending in a different direction than one or more of the other elements. The flexible elements may be straight or shaped according to the desired location of application or placement.

[0202] According to a variant, the flexible element is provided in combination with a support element that provides sufficient support to allow the user to maintain the dressing in the distorted configuration. According to a variant, one or more elements may be provided to maintain the distorted dressing in the distorted configuration, for example, a fastening element that secures the dressing in the distorted configuration until it is applied to the subject and released from the carrier, support, base tensioning device, or applicator. For example, after distorting the dressing, the dressing may be adhered or attached to one or more elements of the dressing, support, base tensioning device, or applicator, or dressing assembly, until it is released from the carrier, support, base tensioning device, or applicator, or assembly.

[0203] According to some variations, the applicator may further be used to help reduce bleeding, for example, by allowing the application of a compressive force using a support structure during or after the device is applied. One or more hemostatic or coagulant agents may be applied to or otherwise integrated with the dressing to help reduce bleeding. Potential agents include chitosan, calcium-loaded zeolite, microfibrillar collagen, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium dioxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, clotting factors (e.g., II, VII, VII, X, XIII, von Willebrand factor), coagulant promoters (e.g., propyl gallate), antifibrinolytic agents (e.g., epsilon aminocaproic acid), and the like. In some variations, the agents may be lyophilized and integrated into the dressing and activated upon contact with blood or other fluids. In some further variations, an activating agent may be applied to the dressing or treatment site before the dressing is used on the subject. In still other examples, a hemostatic agent may be applied separately or directly to the wound before application of the dressing or after application to the dressing via a catheter or tube. The device may also comprise one or more other active agents that may be useful in assisting some aspect of the wound healing process. For example, the active agent may be a pharmaceutical compound, a protein (e.g., a growth factor), a vitamin (e.g., vitamin E), or a combination thereof. Further examples of such agents may include, but are not limited to, various antibiotics (including, but not limited to, cephalosporins, bacitracin, polymyxin B sulfate, neomycin, polysporin), antiseptics (iodine solution, silver sulfadiazine, chlorhexidine, etc.), antifungals (nystatin, etc.), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (VEGF, etc.), and other therapies (e.g., botulinum toxin). Of course, the device may comprise more than one agent or agent, and the device may deliver one or more agents or agents.

[0204] According to a variation, the applicator and / or packaging may be sufficiently supportive or rigid to retain the shape of the dressing so that it is easy to manipulate. According to a variation, the applicator may be sufficiently wider and / or longer than the dressing or have a sufficiently large area so that it may provide for sterile application and / or one-handed application. According to a variation, a support structure is provided for the dressing. According to a 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 margin provides a supported edge or area to grip or manipulate the dressing or its carrier, base, or support without forcing or creating a higher probability of inadvertent user contact with the adhesive.

[0205] According to some variations, the package or applicator may also be used to provide a dressing configured to distort the dressing prior to application and ameliorate scar or keloid formation.

[0206] Described herein are devices that may be used to ameliorate scar and / or keloid formation at the skin or wound site. The scar may be any type of scar, e.g., normal scar, hypertrophic scar, etc. In general, the device may be configured to be removably secured to the skin surface near the wound. The device may protect the skin or wound from endogenous and / or exogenous stresses. In some variations, the device, e.g., a device that modifies the elastic properties of the skin, etc., may protect the skin or wound from endogenous stresses without affecting the exogenous stresses on the skin or wound. In other variations, the device may protect the skin or wound from exogenous stresses without affecting the endogenous stresses on the wound. Such variations may include situations in which muscle tissue and surrounding skin or wound tissue are paralyzed, e.g., through the use of botulinum toxin or the like. In still other variations, the device protects the skin or wound from both endogenous and exogenous stresses.

[0207] The devices or dressings described herein may treat skin at a skin site, including, but not limited to, by controllably applying stress or strain to the epidermis and deeper layers of skin tissue at or near the skin site, thereby reducing tensile or compressive stresses at the skin site itself, thereby ameliorating scar formation at the wound site. Stress at the skin site may be reduced to a level below that experienced by normal skin and tissue. Stress or strain may be applied to the surrounding tissue in one, two, or three more directions to reduce intrinsic or extrinsic stresses at the skin site in one, two, or three directions. The physical properties of the dressing and / or the method of applying the dressing may also be further configured to withstand or reduce the rate of skin peeling or tension blister formation from the application of strain to the incision site. For example, stretching of the adhesive region when applied to the skin surface may result in increased tissue density beneath the adhesive region. This may be the result of generally planar, tangential, or parallel compression of the skin tissue directly attached to the adhesive region resulting from relaxation of the adhesive region. In some examples, this tissue compression may reduce the risk of tissue stripping and / or blistering of the skin in direct contact with the adhesive, as opposed to a bandage "wrap" in which one end of the bandage is adhered to the skin and then stretched or pulled across the wound before the other end is attached to the skin on the other side of the wound. A bandage "wrap" may generate relatively high tissue strains at the first adhesive site while simultaneously generating tension in the bandage during application. This high tissue strain is then reduced when the bandage is attached to the skin at the second adhesive site, as the high peak stresses are then redistributed along the skin beneath the bandage. In contrast, when a pre-strained bandage is applied to the skin, little, if any, strains may be transferred to or generated by the skin as the adhesive region is applied to the desired location. However, when a prestrained bandage is allowed to relax, the skin strain (or peak strain) may be increased. Thus, with a prestrained bandage, temporary high tissue strains may be avoided or otherwise reduced during the application procedure.However, in other variations, the dressing may also be applied to the skin by wrapping, or by a combination of prestraining and wrapping.

[0208] The dressing may comprise an elastic member, such as a sheet of elastic material. The elastic material of the dressing may comprise 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, lattice, or woven configurations. The elastic material may be a biocompatible polymer, such as silicone, polyurethane, TPE (thermoplastic elastomer), synthetic rubber, or copolyester material. The thickness of the polymer sheet may be selected to provide a dressing with sufficient load capacity to achieve a desired recoverable strain and to prevent an undesirable amount of incremental deformation of the dressing over time. In some variations, the thickness across the dressing is not uniform, for example, the thickness across the dressing may be varied to change the stiffness, load capacity, or recovery strain in selected orientations and / or locations. The elastic material of the exemplary bandage may have a thickness within the range of about 50 microns to 1 mm or more, about 100 microns to about 500 microns, about 120 microns to about 300 microns, or in some variations, about 200 microns to about 260 microns. Exemplary bandages have edge thicknesses of about 500 microns or less, 400 microns or less, or about 300 microns or less, which are less likely to present a risk of skin separation from inadvertent lifting when inadvertently touched by clothing or objects. In some variations, the bandage is tapered near the edge to reduce thickness. The tapered edge may also mitigate peak tensile forces acting on skin tissue adjacent the adhesive edge of the bandage. This may or may not reduce the risk of skin blistering or other tension-related skin trauma. In other variations, the edges of the bandage may be thicker than the center of the bandage. It is hypothesized that in some configurations, a thicker dressing edge may provide a relative inward shift in the location of peak tensile forces acting near the dressing edge compared to a dressing of uniform thickness. The elastic material may have a load per width of at least 0.35 Newtons / mm at 60% engineering strain, or a load per width of at least 0.25 Newtons / mm at 45% engineering strain.The elastic material may have a load per width of about 2 Newtons / mm or less at about 45%-60% engineering strain, about 1 Newton / mm at about 45%-60% engineering strain, about 0.7 Newtons / mm at about 45%-60% engineering strain, or about 0.5 Newtons / mm or less at about 45%-60% engineering strain. The system elastic material may have a load per width that does not decrease from 0%-60% engineering strain, a load per width plot that increases linearly from 0%-60% engineering strain, or a load per width plot that is not convex from 0%-60% engineering strain. The elastic material may comprise an adhesive configured to maintain a substantially constant stress within a range of 200 kPa to about 500 kPa for at least 8 hours when strained to about 20%-30% engineering strain and attached to a surface. The elastic material may comprise an adhesive configured to maintain a substantially constant stress within a range of 200 kPa to about 400 kPa for at least 8 hours when strained to about 20% to 30% engineering strain 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.

[0209] The depicted dressings may have a generally rectangular configuration with a length and / or width of about 160 mm to about 60 mm, although in other variations the dressings may have any of a variety of lengths and widths and may comprise any of a variety of other shapes. Also, the corners of the dressings may be square or rounded, for example. Exemplary dressing lengths and / or widths may range from about 5 mm to about 1 meter or more, in some variations from about 20 mm to about 500 mm, in other variations from about 30 mm to about 50 mm, and in still other variations from 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 to the maximum dimension (e.g., width), excluding the minimum dimension (e.g., thickness) of the dressing, 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 may be oriented relative to the maximum dimension or relative to the orthogonal dimension to the maximum dimension. In some variations, the final compressive stress and strain imparted to the skin by the elastic material may be the result of a dynamic equilibrium between the tensile stress in the skin and the elastic material of the dressing. The skin at the skin site typically provides an inherent tension that stretches the incision site, regardless of whether any tissue has been excised from the skin site. The elastic material and adhesive regions may be configured to be applied to the skin location such that when the dressing is stretched to a particular tension and then adhered to the incision site, the tensile stress in the dressing is transferred to the incision site to compress the tissue directly beneath the dressing along an axis tangential to the skin surface, and the stress and strain imparted to the skin location has a net or resultant orientation, or with a similar axis to the orientation, or axis of the tensile stress in the dressing, which axis is also approximately tangential or planar to the outer surface of the elastic material and / or the skin location. The tension in the dressing will relax to a tension level that maintains equilibrium with the increased tension in the skin adjacent to the dressing.Application of the dressing to a skin location may involve placement of the dressing without overlapping or wrapping over itself, e.g., only adjacent areas of the dressing are interconnected, and non-adjacent areas of the dressing are not interconnected. The actual amount of stress and strain imparted to the skin may vary, e.g., depending on the particular individual, skin location, thickness or various mechanical properties of the skin layers (e.g., epidermis, dermis, or underlying connective tissue), and / or the degree of existing scarring. In some further variations, the wound treatment dressing may be selected or configured for use at specific body locations, such as the scalp, forehead, cheeks, neck, upper back, lower back, abdomen, upper torso (including, but not limited to, breasts), shoulders, upper arms, forearms, palms, dorsa of hands, fingers, thighs, lower legs, top or bottom of feet, and / or toes. Where applicable, some body regions may be further delineated into anterior, posterior, medial, lateral, proximal, and / or distal regions, e.g., arms and legs.

[0210] The dressing may be configured to impart a skin strain within the range of about 10% to about 60% or more, in other configurations about 15% to about 50%, and in still other configurations about 20% to about 30% or about 40%. To achieve the desired degree of skin strain, the dressing may be configured to undergo an elastic tensile strain within the range of about 20% to about 80% or more, sometimes about 30% to about 60%, and other times about 40% to about 50% or about 60%. The dressing may comprise any of a variety of elastic materials, including, but not limited to, silicone, styrene block copolymers, natural rubber, fluoroelastomers, perfluoroelastomers, polyether block amides, thermoplastic elastomers, thermoplastic polyurethanes, polyisoprene, polybutadiene, and the like. Exemplary dressing materials may have a Shore A durometer hardness within the range of about 20 to about 90, about 30 to about 80, about 50 to about 80. An exemplary dressing was constructed from MED82-5010-05 by NUSIL TECHNOLOGY LLC, Carpinteria, Calif. Other examples of suitable materials are described in U.S. Application Serial No. 11 / 888,978, previously incorporated by reference in its entirety.

[0211] When the dressing is applied to a skin location and allowed to at least partially recover to its base configuration, the recovery or equilibrium level of strain in the dressing may be within the range of about 4% to about 60% or more, in other configurations about 15% to about 50%, and in still other configurations about 20% to about 30% or about 40%. The ratio between the initial engineering tensile strain applied to the dressing prior to recovery and the resulting engineering compressive strain in the skin may vary depending on the type and location of the skin, but in some examples may be about 2:1. In other examples, the ratio may be within 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 may be determined relative to a reference location, e.g., an anatomical location, on the body or body part to facilitate reproducible measurements. A particular degree of strain may be characterized as either engineering strain or true strain, but may or may not be calculated based on other types of strain, or may be converted from other types of strain (e.g., the strain may be based on 45% engineering strain that is converted to true strain).

[0212] In some further variations, one or more properties of the elastic material may correspond to different features on the stress / strain curve of the material. For example, the engineering and true stress / strain curves for one specific embodiment of the dressing comprise a material that exhibits an engineering stress of about 1.2 MPa at about 60% engineering strain, while in other embodiments 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, or about 1.2 MPa to about 1.4 MPa. When unloading or relieving stress from the dressing, the material may be configured with an engineering stress of about 380 KPa at about 40% engineering strain, although in other embodiments the engineering stress during unloading of the material 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 unloading the material to about 30% engineering strain, the material exhibits an engineering stress of about 300 KPa, although in other embodiments the engineering stress during unloading of the material to about 30% strain may 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 about 20% engineering strain, the material may have an engineering stress of about 100 KPa, although in other examples, the unloading engineering stress at about 20% may be in the range of about 50 KPa to about 200 KPa, about 75 KPa to about 150 KPa, or about 100 KPa to about 125 KPa. In some examples, the material may be configured to achieve a specific range or level of engineering stress at at least each of the defined engineering strain levels described above, although in other examples, the material may be configured for lower levels of maximum engineering strain, for example, up to about 30% or about 40%.

[0213] In some embodiments, a portion of the stress / strain curve may have a particular geometric shape. For example, for a particular level of maximum strain, the load curve may be approximately linear on the corresponding true stress / strain curve. In embodiments using the dressings described herein, up to about 45% true strain, the load curve had an approximately linear configuration. In other embodiments, the configuration may be linear only along a portion of the load curve, or may be curved along the entire load curve. If the load curve is nonlinear, the load curve may be convex, concave, or both. Also, in some embodiments, the tangent to the load curve (i.e., the line between the two triangles) may also be approximately colinear.

[0214] 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 about 10 MPa, about 9 MPa, about 8 MPa, about 7 MPa, about 6 MPa, or about 5 MPa, or about 4 MPa or less.

[0215] In addition to the absolute stress levels at a certain strain level, as described above, materials may also be characterized in terms of the ratio between a) the stress to achieve a particular strain during loading and b) the stress at the same strain during unloading. For example, a material may have a ratio of at least 4:1 to about 3:2 at each of the 20%, 30%, and 40% strain levels, although in other examples, a material may exhibit these ratios only at the 20%, 30%, or 40% strain levels, 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 of the strain levels may be within the range of about 3:1 to about 2:1, or about 5:2 to about 2:1.

[0216] In some examples, the elastic material of the dressing may be configured under test conditions to achieve a stable level of stress at a constant strain, e.g., the material exhibits a limited amount of stress relaxation at a particular level of strain over a particular period of time. The period may 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 1 week or more. The level of strain may be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, or about 80% or more. Exemplary dressing stress over various time curves may be configured to maintain an engineering stress of about 300 KPa at about 30% engineering strain without significant deviation over a period of 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. The stresses at 10% strain, 20% strain, and 40% can be lower or higher.

[0217] In some variations, the elastic material or dressing may be configured under test conditions to maintain a certain minimum level of stress when held at a certain strain for a certain period of time. In an example to assess the ability of the backing material to maintain stress and strain on the skin over time, the engineering strain was measured while each backing material was subjected to a tensile strain of 60% at a rate of 100 microns per second, held for 10 minutes, then reduced to a strain of 30% at a rate of 100 microns per second and held for 9 hours. For example, an exemplary dressing is capable of maintaining an engineering stress level of about 350 KPa at an engineering strain of 30%. In some other embodiments, the minimum level of stress may 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 1,000 KPa or more. The level of constant strain may vary in other configurations, with levels 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 period of time during which the dressing is able to maintain the stress level may be at least about 2,000 seconds, about 3,000 seconds, about 4,000 seconds, about 5,000 seconds, about 6,000 seconds, about 7,000 seconds, about 8,000 seconds, about 9,000 seconds, about 10,000 seconds, about 20,000 seconds, about 30,000 seconds, about 40,000 seconds, about 50,000 seconds, about 60,000 seconds, about 70,000 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 2 weeks, about 1 month, or more. In some variations, the dressing, elastic material, and / or adhesive material is configured to exhibit less than about a 15% change in stress or strain level over a particular period when applied to a skin surface or 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.

[0218] The adhesive used may be a pressure activated adhesive (PSA), such as silicone, acrylic, styrene block copolymer, vinyl ester, nitrile, or other PSA. In other variations, non-pressure sensitive adhesives may be used, including but not limited to heat or light cured adhesives. Pressure sensitive adhesives may be made from, for example, polyacrylate-based, polyisobutylene-based, silicone-based pressure sensitive adhesives, synthetic rubber, acrylic, and polyisobutylene (PIB), hydrocolloids, and the like. The T-peel release force and blunt probe tack force of the adhesive may be measured by standardized test methods such as ASTM D1876 and ASTM D2979 or other suitable methods. In some variations, the T-peel release force or blunt probe tack test value of the adhesive is configured to maintain a load of at least about 50 mPa / mm for at least about 24 hours, about 48 hours, about 72 hours, about 1 week, about 2 weeks, about 3 weeks, about 4 weeks, or more. 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 over a particular period of time. The degree of adhesion (e.g., as measured by T-peel release 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 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 variations, the T-peel release force may be about 1,000 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 or less. The adhesive may have a blunt probe tack test value of 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 may be about 1 kg, about 0.9 kg, about 0.8 kg, about 0.7 kg, or about 0.6 kg or less. The T-peel release force and blunt probe tack force may be measured by standardized test methods such as ASTM D1876 and ASTM D2979, or other suitable methods. Other features or variations of this device are described in U.S. Application No. 11 / 888,978, filed Aug. 3, 2007, which is incorporated herein by reference in its entirety.

[0219] The release liner may comprise any of a variety of materials, including both 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, fluoropolymer-treated polyester film may be used, and for acrylic pressure-sensitive adhesives, silicone-treated polyester or Mylar film or silicone-treated kraft paper may be used. In variations in which the device has multiple separate adhesive regions, a separate release liner may be provided for each region, or several regions may be covered by the same release liner.

[0220] Examples of dressings, applicators, or tensioning devices that may be used in the devices, kits, or methods herein may include, but are not limited to, those provided in U.S. Application No. 12 / 854,859, filed August 11, 2010, the disclosure of which has been previously incorporated by reference in its entirety into this specification.

[0221] The packaging assembly, applicator, and / or tensioning device may include a tensioning structure, a first attachment portion configured to be releasably attached to the bandage, and a second attachment portion configured to be releasably attached to the bandage, and the tensioning structure may be configured to apply a separation force between the first attachment portion and the second attachment portion to induce strain in the bandage attached to the first and second attachment portions. The elastic bandage may be configured to be releasably attached to the bandage and the first and second attachment portions of the packaging assembly, and may include the attachment structure or may be integral with the attachment structure of the packaging device, applicator, or tensioning member. The tensioning structure may also act as an applicator device or be configured to allow a user to apply the bandage to the skin of a subject.

[0222] The attachment structure of the packaging device, bandage assembly, bandage carrier, support, base, applicator, tensioning or straining device may include any structure used to attach or couple the applicator, tensioning or straining device to the bandage. The bandage may or may not have attachment features or structures. Any such attachment features may be integral with or include any of the attachment structures or structures corresponding to the attachment structures of the packaging, applicator bandage, and / or tensioning device.

[0223] In some variations, the assembly may include one or more mechanisms or elements configured to facilitate separation, release, removal, or detachment of the dressing from a packaging, an applicator or tensioning device, other attachment elements, or other portions of the dressing assembly, including, but not limited to, the separation devices and methods described herein. The release elements or releasable attachment structures may include, for example, but are not limited to, pockets and tabs, hook-and-loop mechanisms, hooks, angled bars, pivoting, rotating, swinging, or sliding features associated with or coupled to the attachment structures, adhesives, removable adhesives, adhesive tapes or other adhesive devices, pegs, ripcords, towel rail configurations, sliding pins, friction locks, cam locks, vacuum or suction devices, snap connectors, carpet tacks, press-fit or other connections, levers, latches, locking members, spring members, or other mechanisms such as cutters or ripcords, or other structures or features that facilitate tearing, cutting, or separation of the pierced attachment structures or elements or otherwise severable structures to allow removal of the dressing from the applicator, packaging, other parts of the dressing assembly, and / or the attachment structures, features, elements, or parts. They may be self-releasing latches or spring members. They may be activated when a pressure member is applied to the skin treatment device prior to removing the applicator. They may be manually activated.

[0224] As described, a packaging or applicator, tensioning device and / or straining device may be provided in some embodiments to apply strain to the skin treatment device using an external force and / or to maintain the applied strain on the skin treatment device. The packaging, applicator, or tensioning device may be configured to pivot or rotate to tension the dressing. In some examples, the straining 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 amount of strain. Features described herein with respect to the packaging assembly, applicator, or tensioning device may also be used in any device used to strain the dressing. A packaging, applicator, tensioning or straining device described as being in an unstrained configuration is one in which no strain or relatively little strain may be applied when the dressing is attached to the packaging, applicator, tensioning or straining device. A packaging, applicator, tensioning or distortion device described in this specification as being in a distorted configuration is a configuration in which a strain is imparted, or in which a relatively greater strain can be imparted, relative to the undistorted configuration when the dressing is attached to the packaging, applicator, tensioning or distortion device or applied to the skin of a subject.

[0225] The packaging device, applicator, tensioning device, and corresponding attachment features may be configured to provide multi-directional strain or additional strain in orthogonal directions to the dressing.

[0226] The packaging device, applicator, tensioning device, and / or attachment structure contours may be linear, curved, or otherwise diverse. For example, the shape of the elements of the device may be configured to follow the shape of the area of ​​the subject's body to which the skin treatment device is to be attached. The packaging device, tensioning device, applicator, or elements thereof may be selected or configured to have a contour that has a desired contour for the particular body location or contour where the skin treatment device is to be placed on the skin of the subject. The packaging device, applicator, tensioning device, or elements thereof may be selected or configured to closely match a portion of the subject's body contour. The packaging device, applicator, or tensioning device, and / or elements or sections thereof may be curved, bendable, flexible, bendable, malleable, deformable, moldable, or moveable to provide alternative shapes or contours of the attached dressing. They may be relatively curved, bendable, flexible, malleable, bendable, deformable, moldable, or moveable in at least one direction while being more rigid in another direction.

[0227] A variety of locking, latching, fastening, attachment, or detent mechanisms may be used to maintain the packaging, applicator, or tensioning device in various configurations, including, but not limited to, unstrained, partially strained, and strained configurations. A variety of locking, latching, or detent mechanisms may be used to maintain the dressing in various configurations, including, but not limited to, unstrained, partially strained, and strained configurations. A predetermined strain of a given dressing may be achieved by locking the packaging, applicator, tensioning device, or dressing in a strained position. The predetermined amount of strain may be a predetermined absolute percentage of strain or force level that is independent of the shape and / or size of the treatment site. As a further example, this absolute percentage of strain or force level may be independent of the minimum strain or force to achieve sutureless wound closure (e.g., the relative strain or force to achieve opposing alignment of incision edges at the treatment site). Furthermore, the force required to achieve wound closure is not a predetermined strain or force as the final level of strain or force is not known until opposed alignment of the incision edges is achieved.

[0228] 1-5C, a variation of a dressing and packaging assembly 100 is illustrated. The packaging assembly 100 includes a book-like applicator and / or tensioning device 120, a dressing assembly 110 including a dressing 130, and a release portion 150 configured to release the dressing 130 from the applicator and / or tensioning device 120.

[0229] The dressing 130 comprises an elastic sheet 131 with one or more adhesive regions comprising a layer of skin adhesive 135 on a first surface 135a. The adhesive used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive.

[0230] Packaging assembly 100, applicator or tensioning device 120, and / or dressing assembly 110 may be configured to pre-strain dressing 130 and / or enable transfer of pre-strained dressing 130 to the skin of a subject. The applicator and / or tensioning device 120 may also provide for convenient, rapid, or sterile transfer of the adhesive portion of dressing 130 to the skin and / or wound site of a subject.

[0231] Device 120 includes a cover 121 and a base 122. Dressing assembly 110 is removably coupled or tethered to device 120, which may act as a dressing carrier or support. Cover 121 may be generally planar and include sides 123, 124 with corresponding edges 123a, 124a along its length and an edge 121a at an opposing end. Dressing carrier or base 122 may be generally planar and include sides 125, 126 with corresponding edges 125a, 126a along its length and an edge 122a at an opposing end.

[0232] According to some variations, the cover and / or base 121, 122, or elements or sections thereof, may be constructed to be sufficiently strong or rigid or not very flexible with respect to the attached dressing, to support the attached dressing until it is applied to the subject, as described with respect to the variations herein. Such materials may include, for example, plastics, such as polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or TEFLON®), 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 layers of flexible material between layers of paperboard, such as silicone, polyurethane, LDPE, or rubber materials. The material may also be a metal, such as ductile aluminum or stainless steel, for example. The metal may comprise a foil, ribbon, wire, or other form.

[0233] The cover 121 and base 122 are movably, hingedly, or pivotally coupled at the sides 123, 125. For example, a layer of material such as silicone, polyurethane, low density polyethylene, or rubber material may be glued to each of the cover and base, flexibly attaching them together at the sides 123, 125. Alternative devices and methods may be used to couple the cover 121 and base 122. For example, various composite structures or laminates may be used. The device may also be constructed from 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 with relative or absolute rigidity in a second direction, which may be transverse to the first direction. Although the cover 121 and base 122 depicted in Figures 1-5C generally have the same size and shape, in other examples, the cover 121 and base 122 may be different sizes and / or shapes. The cover 121 and / or base 122 may be bendable, foldable, curveable, flexible, malleable, or moldable, allowing for relatively more uniform placement at locations with various shapes or curvatures. For example, the cover and base 121, 122 as shown are each divided into sections 127 along their length that are bendable or movable relative to adjacent sections, allowing for flexibility of the device 120 along their length. The sections 127 may be constructed from a stiffer material that reduces flexing laterally or in other directions. Other configurations that vary the direction of stiffness and / or flexibility may be used. Configurations may include providing stiffness in the direction in which the dressing is strained that is sufficient to create and / or maintain the desired level of strain. The sections 127 may be joined by a material such as an elastomer, e.g., silicone, that flexibly holds the sections together in relation to each other. Other structures may also be used to flexibly join the sections or other elements. The material joining or connecting the cover and base 121, 122 may or may not be continuous with the material joining the section 127 to an adjacent section 127, and may or may not be attached to all or a portion of the sides of the cover and base 121, 122.Various attached structures, such as compartments, and / or cover and base and coupling elements, may provide structural support for the dressing carrier to be manipulated by the user. A margin between at least a portion of the structural support element, dressing carrier, or backing and the dressing may be provided, for example, at or near edges 121a, 123a, 124a, 122a, 125a, and / or 126a, as further described herein. In some further embodiments, the material attaching the cover 121 and base 122 may comprise a semi-rigid structure that may be biased into an open or closed configuration, or a configuration therebetween. In still other variations, the cover 121 and base 122 may be attached by any of a variety of articulating members, including, but not limited to, one or more pin-based hinge joints, rings attached to holes in the cover 121 and base 122, or ball and socket joints.

[0234] As illustrated in Figures 5A-5C, variations in the structure of the packaging are shown. The cover 121 and base 122 comprise relatively strong or rigid elements, e.g., battens 121a, 121b and battens 122a, 122b, respectively, attached with a sheet 128 of material, e.g., silicone, polyurethane, low density polyethylene, or rubber material, that also flexibly bonds to the cover and base 121, 122 at sides 123, 125. The compartment 127 may have alternative shapes and structures that bond the compartments 127 together. Thus, the device 120 may be constructed to bend or curve in a variety of ranges or in multiple directions. Thus, the device may be constructed to be used on a specific anatomical location or with various sizes, or to have a shape for a particular situation or individual.

[0235] According to some variations, the cover 121 and base 122 are each constructed at least in part from a clear plastic, semi-opaque, or other material that provides a window portion 159 through which a wound, incision, or other location may be visualized for correct placement of the dressing 130. The cover 121 and base 122 may or may not comprise the same material. The elastic sheet 131 and adhesive layer 135 may also be sufficiently transparent to allow visualization therethrough. A more opaque material may be provided on portions of the material to create a border for the window 159. The section 127 may be clear or semi-opaque to provide a window for viewing, locating, and / or centering the location of the wound or location on the skin relative to the dressing 130, or for locating the wound within the optimal or most effective strain zone of the dressing. Borders or other markings may assist the user in placing the dressing 130 in the proper position across the wound or incision.

[0236] The dressing 130 of the dressing assembly 110 has a first side or edge 133 having a length and a second side or edge 134 having a length. The dressing 130 is bonded to the packaging assembly 100 along the length of the dressing sides 133, 134. When the device 120 is closed, the adhesive layer 135 is covered by a release liner 149 that faces outwardly from the base 122 and is attached to the inner surface 177 of the cover 121. The dressing assembly 110 also includes an attachment sheet 141 having a first side 143 and a second side 144. When the dressing assembly 110 is opened, the attachment sheet 141 bonds the dressing 130 to the cover of the device 120, which applies a straining force to the dressing 130 through the attachment sheet 141. According to some variations, the attachment sheet 141 is flexible but relatively inelastic with respect to the dressing 130 and may be constructed from, for example, low density polyethylene. When assembled, the mounting sheet 141 is bonded (e.g., using a silicone PSA / acrylic PSA combination) to the elastic sheet 131 of the dressing at or near sides 134 and 143 of the dressing 130 and the mounting sheet 141, respectively. The mounting sheet 141 is bonded to the cover 121 at its sides 144 at attachment points 137 that define a line or area of ​​attachment 137a along the length of the cover 121. The dressing 130 is bonded to the second side 124 of the base 122 at a location near the first side 133 of the dressing 130. The elastic sheet 131 is thus attached at attachment points 138 that define a line or area of ​​attachment 138a along the length of the base 122. Several bonding methods or adhesives may be used to attach the mounting sheet 141 to the cover 121, for example, a low surface energy PSA such as an acrylic adhesive.

[0237] When the assembly 100 is in a closed configuration as illustrated in FIG. 1 and a 90 degree open configuration as illustrated in FIG. 2, the elastic sheet 131 is relaxed or unstrained, and the elastic sheet 131 has an unstrained width w1. When the assembly 100 is opened (e.g., by rotating or pivoting the cover 121 relative to the base 122) to 180 degrees or up to about 360 degrees, the orthogonal distance increases between the lines or areas of attachment 137a, 138a. According to some variations, the assembly is opened to about 180 degrees (minimum angular change) or more to provide for 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 defined by the lines or areas 137a, 138a, or corresponding attachment areas. The force stretches the elastic sheet and creates a strain. Tensioning and straining the dressing 130 increases the width between the attachment lines or regions 137a, 138a to w2. The width increase, i.e., w2-w1, may be a fraction of w1 or a percent strain as described herein. Although straining is illustrated as beginning when the cover 121 is opened approximately 90 degrees from the base 122, the dressing 130 may be attached to the cover 121 in several locations or configurations, which may vary the cover position or configuration at which straining begins. The edge 124a or side 124 of the cover 121 may act as a lever arm to provide a mechanical advantage, which may depend, among other things, on the distance of the point of attachment 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 base 122 at which tensioning of the dressing occurs. In addition, the point of attachment 138 of the inelastic mounting sheet 141 to the cover 121 may determine the amount of strain applied to the bandage, assuming, inter alia, that the length of the mounting sheet 141 remains the same and that the point of attachment 137 of the bandage assembly 110 to the base 122 remains the same.

[0238] According to one variation, the dressing 130 may be substantially fixed at one edge (e.g., at edge 134 at side 126 of base 122) while being unfixed at the opposite edge (e.g., edge 133 moves when strained relative to edge 125a of base 122). When cover 121 is opened and dressing 130 is strained, the width of the strained dressing may be smaller than the width of base 122 and / or cover 121 such that the area of ​​the dressing lies across the area of ​​base 122 and / or cover 121, i.e., base 122 and / or cover 121 border the outside of the area of ​​the dressing. According to another variation, the dressing may be fixed at both edges.

[0239] According to some variations, the dressing is sufficiently large relative to the device 120 so that there is relatively little interference by the device 120 when applied to the skin. According to one embodiment, the width of the distorted portion of the dressing may be about 10 mm, about 20 mm, about 30 mm, about 40 mm, or about 50 mm. Other distorted dimensions may be used. According to other variations, the distance between each of the edges 133, 134 of the dressing 130 and the edges 125a, 126a of the base 122 (and / or the edges 123a, 124a of the cover 121), respectively, is about 10 mm, 15 mm, or 20 mm or less. According to some variations, the distance between the edges 136a, 136b of the dressing and the edge 122a of the base is about 10 mm, about 15 mm, or about 20 mm or less.

[0240] According to some variations, the edges 133, 134, 136a, 136b of the dressing 130 are at least about 1.0 mm inward of at least a portion of the edges 125a, 126a, and / or 122a of the base 122 such that the edges 125a, 126a, and / or 122a of the base 122 may be grasped by a user with reduced likelihood of touching the dressing 130 or the adhesive layer 135. According to some variations, the ends 136a, 136b of the dressing 130 have a margin at least about 1.0 mm inward of the ends 122a of the base 122. According to some variations, the sides 133, 134 and ends 136a, 136b of the dressing 130 have a margin of about 10 mm from the sides 125, 126 and ends 122a of the base, respectively. According to some variations, the sides 133, 134 and ends 136a, 136b of the dressing 130 have margins of about 15 mm from the sides 125, 126 and ends 122a of the base, respectively. The margins between the sides 133, 134 or ends 136a, 136b of the dressing 130 and the sides 125, 126 and ends 122a of the base 122, respectively, may be different. As illustrated in FIG. 3, for example, margins m1 and m2 are about 3 mm or more, and margin m3 is about 15 mm. For example, if the edges of the cover 121 are used alternatively or in addition to grip the device 120 or to manipulate the dressing 130, similar margins may be provided between the dressing 130 and the edges 121a, 123a, and / or 124a of the cover 121. The adhesive side of the dressing 130 may then be placed onto the skin or wound site using the device 120 once the cover 121 is opened and the adhesive layer 135 is exposed. As shown in Figures 3 and 4, the cover 121 and base 122 may be rotated an additional amount relative to one another, for example up to about 360 degrees from the closed configuration, prior to applying the dressing 130. A locking mechanism may optionally be provided to lock or secure the device in the open, partially open, or closed position. In some embodiments, the locking mechanism may comprise a magnet, a hook and loop attachment structure, a snap, a latch, a clip, and the like.

[0241] The adhesive layer 135 of the elastic sheet 131 is protected by a release liner 149 before the applicator or tensioning device 120 is opened. The release liner 149 is attached or glued to the inner surface 177 of the cover 121 such that when the cover 121 is opened as shown in FIG. 2 and separated from the base 122 (prior to straining the elastic sheet 131), the release liner 149 is pulled away from the elastic sheet 131, exposing the adhesive layer 135. Alternatively, as shown in FIG. 6, a release liner 149a may be provided on the adhesive layer 135 that is not attached to the cover 121. When the device 120 is opened, prior to straining the dressing 130, the release liner 149a may be manually removed from the elastic sheet 131 to expose the adhesive layer 135.

[0242] After the dressing 130 is strained and the liner 149 or 149a is released, the dressing 130 may be applied to the desired location on the subject's skin. The window 159 may be used to visualize proper placement. The user may apply pressure to the backside 129 of the device 120 to activate the adhesive on the elastic sheet 131 and / or to apply compression to the wound. Alternatively, pressure may be applied to the inside 177 of the cover 121 if the cover 121 is rotated up to 360 degrees. Once applied to the subject, the elastic sheet 131 may be released from the packaging, applicator, or tensioning device 120 using a release structure or mechanism 150.

[0243] The release mechanism 150 may include cutters 151 positioned on opposite sides 133, 134, respectively, of the elastic sheet 131. Each cutter 151 includes a blade 152 on one end 153 with legs 154, 155 that extend to one or more opposing pull tabs 156 on an opposite end 157. The blades 152 include a sharp surface that may be generally V-shaped or otherwise shaped. The blades may be constructed, for example, from stainless steel, ceramic, or hard plastic. The blades 152 and pull tabs 156 each extend to ends 136a, 136b of the elastic sheet 131 and end 122a of the base 122, respectively. Cutter 151 is attached to the dressing assembly 110 in a manner that defines a general cutting path 162, 163 (depicted in best detail in FIG. 5A ) along which blade 152 is pulled by tab 156 to cut through the dressing assembly 110 and release the dressing 130. In some variations, the dressing may be scored, perforated, or otherwise configured to facilitate separation by the release mechanism.

[0244] As best seen in Figures 5B and 5C, tubes 164, 165 for receiving and guiding legs 154, 155, respectively, of cutter 151 are positioned along side 133 of elastic sheet 131. Tubes 164, 165 may be positioned such that cutting path 162 is between tubes 164 and 165. Tube 165 is coupled, e.g., glued, to adhesive surface 135 of elastic sheet 131 at a location closer to side 133 than cutting path 162. Tube 164 is coupled to back surface 139 of elastic sheet 131 by means of attachment sheet 141, which is also coupled to elastic sheet 131, at a location closer to side 133 than cutting path 162. Tube 164 is coupled to free end 145 of attachment sheet 141, which extends inwardly of cutting path 162 relative to side 133. Thus, the tube 164 may be positioned inside the cutting path 162 without being attached to the elastic sheet 131 inside the cutting path 162. This allows the dressing 130 to be released from the remainder of the packaging assembly 100, including the cutter 151 along with the tube 164 and attachment sheet 141. A protective member 170 is attached, e.g., glued, to the top of the tube 165. The protective member 170 includes a ledge 171 that extends across the cutting path 162 such that when the adhesive layer 135 is positioned on the subject's skin and the cutter 151 is actuated, the skin is protected from the blade 152.

[0245] Tubes 174, 175 for receiving and guiding legs 154, 155, respectively, are positioned along side 134 of elastic sheet 131. Tubes 174, 175 are positioned such that cutting path 163 is between tube 174 and tube 175. Tube 175 is bonded, e.g., glued, to adhesive surface 135 of elastic sheet 131 at a location closer to side 134 of elastic sheet 131 than cutting path 163. Tube 174 is bonded to back surface 139 of elastic sheet 131 by means of extension sheet 146. Tube 174 is bonded to free end 147 of extension sheet 146, which extends inward of cutting path 163 relative to the side. Tube 174 is also bonded to elastic sheet 131 at a location closer to side 134 than cutting path 163. Thus, the tube 174 may be positioned 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 along with the tube 175 and the expanding sheet 146. A protective member 170 is attached, e.g., glued, to the top of the tube 175. The protective member 170 includes a ledge 171 that extends across the cutting path 163 such that when the adhesive layer 135 is positioned on the subject's skin and the cutter 151 is actuated, the skin is protected from the blade 152.

[0246] The inside of the tubes 164, 165, 174, 175 may be coated with a lubricating material, for example, Kapton tape. The guide legs 154, 155 may be constructed from a low friction material, such as, for example, HDPE or UHMWPE, so that the legs 154, 155 may slide easily within the tubes 164, 165, 174, 175 to allow for smooth severing of the dressing 130 from the remainder of the packaging assembly 100.

[0247] When bandage 130 is strained and adhesive 135 is exposed, bandage 130 may be applied with adhesive side 135 facing the subject's skin. Side 133 of the elastic sheet may then be released from the applicator by pulling tab 146 to draw blade 152 across cutting path 162. Side 134 of the elastic sheet may then be released from the applicator by pulling tab 146 to draw blade 152 across cutting path 163. Elastic sheet 131 is thus released from package 100 (including release portion 150).

[0248] 7-9, another variation of a dressing and packaging assembly 200 is illustrated. The packaging assembly 200 comprises an applicator and / or tensioning device 220 and a dressing assembly 210 including a dressing 230. The dressing 230 comprises an elastic sheet 231 with one or more adhesive regions comprising 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.

[0249] Packaging assembly 200, applicator or tensioning device 220, and / or dressing assembly 210 may be configured to pre-strain dressing 230 and / or to enable transfer of pre-strained dressing 230 to the skin of a subject. Applicator or tensioning device 220 may also provide for convenient, sterile transfer of the adhesive portion of the dressing to the skin and / or wound site of a subject.

[0250] Device 220 may include a cover 221 and a base 222. Dressing assembly 210 may be removably coupled or tethered to device 220 and serve as a dressing carrier. Cover 221 may be generally planar and include sides 223, 224 with corresponding edges 223a, 224a defining its length, and an edge 221a at an opposing end. Base 222 may be generally planar and include sides 225, 226 with corresponding edges 225a and 226a defining its length, and an edge 222a at an opposing end.

[0251] According to some variations, the cover and / or base 221, 222, or elements or sections thereof, may be constructed to be sufficiently strong or rigid or not very flexible with respect to the attached dressing, to support the attached dressing until it is applied to the subject, as described with respect to the variations herein. Such materials may include, for example, plastics, such as polypropylene, polycarbonate, PTFE, LDPE, HDPE, UHMWPE, PVC, or acrylic, nylon, or paperboard. The elements or sections may be laminates of materials such as solid bleached sulfate paperboard, with layers of flexible material, such as silicone, polyurethane, low density polyethylene, or rubber materials, between layers of paperboard. The material may also be a metal, such as ductile aluminum or stainless steel, for example. The metal may comprise a foil, ribbon, wire, or other form. Other variations, such as those described with respect to the application or tensioning device 100, may also be applied to the device 200 as well.

[0252] Covers and bases 221 and 222 may be movably, pivotably, bendably or hingedly connected at sides 223, 225 in a manner similar to that described with respect to covers and bases 121, 122 herein, and may be constructed in a manner similar to covers and bases 121, 122 herein, in particular with section 227 being similar to section 127, and with bandage 230 being attached to device 220 and distorted by the device in a manner similar to that in which bandage 130 is attached to device 120.

[0253] Various attached structures, e.g., compartments and / or covers and bases and coupling elements, may provide structural support for the dressing carrier to be manipulated by a user. Edges between at least a portion of the structural support element, dressing carrier, or backing and the warped or unwarped dressing may be provided at or near edges 221a, 223a, 224a, 222a, 225a, and / or 226a, such as edges m1, m2, m3 shown in FIG. 3 herein.

[0254] According to some variations, the cover 221 and base 222 are each constructed at least in part from a clear plastic, semi-opaque, or other material that provides a window portion 259 through which the wound, incision, or other location may be visualized for correct placement of the dressing 230. The cover 221 and base 222 may or may not comprise the same material. The elastic sheet 231 and adhesive layer 235 may also be sufficiently transparent to allow visualization therethrough. A more opaque material may be provided on portions of the material to create a window border. The section 227 may be clear or semi-opaque to provide a window for viewing, locating, and / or centering the location of the wound or location on the skin relative to the dressing 230, or for locating the wound within the optimal or most effective strain zone of the dressing. Borders or other markings may assist the user in placing the dressing in the proper position across the wound or incision.

[0255] The dressing assembly 210 also includes an attachment sheet 241, an attachment sheet 251, and a dressing release structure or mechanism 250 that includes a pull tab 246, as described in more detail herein. The dressing 230 of the dressing assembly 210 has a first side 233 having a length and a second side 234 having a length. When the device 220 is closed, the adhesive layer 235 faces outwardly from the base 222 and is covered by a release liner 249 that is attached to the inner surface 277 of the cover 221.

[0256] The mounting sheet 241 has a first side 243 and a second side 244. The mounting sheet 241 bonds the dressing 230 to the cover 221 of the device 220 near the second side 234 of the dressing 230. The cover 221, when released, applies a straining force to the dressing 230 through the mounting sheet 241. The mounting sheet 241 is bonded to the cover 221 at its side 244 at attachment points 237, which may be provided as attachment lines or areas 237a, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. When assembled, the mounting sheet 241 is bonded to the elastic sheet 231 of the dressing 230 at a section 265 of the mounting sheet 241 at or near the side 234 of the mounting sheet 241, for example, using a silicone PSA / acrylic PSA combination. The mounting sheet 251 has a first side 253 and a second side 254. The mounting sheet 251 is bonded to the base 222 of the device 220 near the first side 233 of the dressing 230. The mounting sheet 251 is bonded to the base 222 at its side 254 at attachment points 238 that define attachment lines or areas 238a, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. When assembled, the mounting sheet 251 is bonded to the elastic sheet 231 of the dressing at a section 265 of the mounting sheet 251 at or near the side 253 of the mounting sheet 251, for example, using a silicone PSA / acrylic PSA combination.

[0257] The dressing 230 has unattached portions or edges 255 at its sides 233, 234 where the elastic sheet 231 is free from the attachment sheets 241, 251, respectively. Thus, the dressing 230 is not strained at the unattached portions 255. The pull tabs 246 are coupled to ends 281, 282, respectively, of the device 220. Each pull tab 246 comprises a top section 247 and a bottom section 248. The bottom section 248 is attached to the base 222 or cover 221 as shown, while the top section 247 is adjacent to the dressing 230 but is not attached thereto.

[0258] According to some variations, the attachment sheets 241, 245, while flexible, are relatively inelastic with respect to the dressing 230 and may be constructed, for example, from 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 tension direction of the material of the attachment sheet 241 (the direction in which the dressing is tensioned, stressed, or strained). An example of such a material is an LDPE polymer produced by an extrusion process that creates directionally biased grains, whereby the material is tearable in the direction of the grain but has relative resistance to tearing in a direction transverse to the grain. The pull tab 246 may initiate a tear at a cut in the attachment sheet 241 or 251, which should be completed along the line 262. The attachment sheets 241, 251 may additionally or alternatively comprise a material such as LDPE with perforations formed along the tear line 262.

[0259] Similar to assembly 100 herein, when assembly 200 is in a closed configuration and in a 90 degree open configuration as shown in FIG. 7, elastic sheet 231 is relaxed or unstrained, and elastic sheet 231 has an unstrained width w3. When assembly 200 is opened (e.g., by rotating or pivoting cover 221 relative to base 222) 180 degrees or up to about 360 degrees, the orthogonal distance increases between attachment lines or areas 237a, 238a. When device 220 is opened, it applies a separation force between attachment regions defined by attachment lines or areas 237a, 238a or corresponding attachment areas. The force stretches elastic sheet 231, creating a strain. The stretching and straining of dressing 230 increases the width between attachment lines or areas 237a, 238a to a width w4. The increase in width (i.e., width w4-width w3) may be a percentage of w3 or percent strain as described herein. Although straining is illustrated as beginning when cover 221 is opened approximately 90 degrees from base 222, dressing 230 may be attached to cover 221 in several locations or in several configurations, which may vary the position or configuration of cover 222 at which straining begins.

[0260] 8-8B, the cover 221 and base 222 may be rotated an additional amount relative to one another, 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 up to about 180 degrees (minimum angular change) or more to accommodate application of the dressing without interfering with the assembly.

[0261] The adhesive side of the dressing 230 may then be placed onto the skin or wound site using the device 220 once the cover 221 is opened and the adhesive layer 235 is exposed. The cover 221 and base 222 may be rotated an additional amount relative to one another, for example up to about 360 degrees from the closed configuration, prior to applying the dressing 230. The orientation of the cover 221 at which the dressing 230 begins to distort may be varied, for example, by varying the attachment location of the dressing assembly 210 to the cover 221. A locking mechanism may optionally be provided to lock or secure the device in an open, partially open, or closed position. In some embodiments, the locking mechanism may comprise a magnet, a hook and loop attachment structure, a snap, a latch, a clip, and the like.

[0262] The adhesive layer 235 of the elastic sheet 231 is protected by a release liner 249 before the applicator or tensioning device 220 is opened. The release liner 249 is attached to the inner surface 277 of the cover 221 such that when the cover 221 is opened and separated from the base 222 (prior to straining the elastic sheet 231), the release liner 249 is pulled away from the elastic sheet 231, pre-exposing the adhesive layer 235. Alternatively, as shown in FIG. 6, a release liner 149a may be provided on the adhesive layer 235 that is not attached to the cover 221. When the device 220 is opened, prior to straining, the release liner 149a may be manually removed from the elastic sheet 231 to expose the adhesive layer 235.

[0263] After the liner 249 or 149a is released and the dressing 231 is strained, the dressing 230 may be applied to the desired location on the subject's skin. The window may be used to visualize proper placement. The user may apply pressure to the backside 229 of the device 220 to activate the adhesive on the dressing 231 and / or to apply compression to the wound. If the cover 221 is rotated through 360 degrees, pressure may be applied to the inside 277 of the cover 221. Once applied to the subject, the dressing 230 may be released from the applicator or tensioning device 220 using a release mechanism 250.

[0264] Each of the pull tabs 246 of the release mechanism 250 extends to an end 236a of the elastic sheet 231. Each release pull tab 246 is attached to the dressing assembly 110 in a manner that defines a tear path 262 along which the tab 246 is pulled to separate the dressing 230 from the device. Cuts or perforations may be made in the attachment sheets 241, 251 to facilitate tearing along path 262.

[0265] The dressing 230 is applied to the subject. The dressing 230 may then be released from the device 220 by pulling the tab 246 to draw it across the path 262 of the mounting sheets 241, 251. The section 245 of the mounting sheets 241, 251 that is joined to the pull tab 246 is thereby separated from the mounting sheets, thereby separating the section 265 of the mounting sheets that is attached to the dressing 230 from the remaining portions of the mounting sheets 241 and 251 that are attached to the cover 221 and base 222, respectively. The dressing 230 is thus released from the remainder of the package 100, as shown in FIG. 9. The section 265 of the mounting sheets 241, 251 may remain on the back surface 239 of the silicone sheet 231, as shown in FIG. 9. The unattached section 245 of the elastic bandage 230 is not distorted and may be free of (or have a reduced amount of) adhesive from the adhesive layer 235. Thus, less stress is generated at the unattached side or edge defined by section 245.

[0266] 10-12B, a dressing and packaging assembly 300 is illustrated. The packaging assembly 300 includes a packaging device applicator 320 and a dressing assembly 310 that includes a dressing 330.

[0267] The packaging device or applicator 320 is configured to enable transfer of the dressing 330 to the subject's skin and may also provide for convenient, rapid, or sterile transfer of the adhesive portion of the skin treatment device to the subject's skin and / or wound site.

[0268] Packaging device or applicator 320 comprises a cover 321 and a bottom element, dressing carrier, or base 322 to which dressing assembly 310 is removably coupled or anchored. Cover 321 may be generally planar and include sides 323, 324 with corresponding edges 323a, 324a defining its length, and an edge 321a at an opposing end. Base 322 may be generally planar and include sides 325, 326 with corresponding edges 325a, 326a defining its length, and an edge 322a at an opposing end.

[0269] According to some variations, the cover 321 and base 322 are constructed in part from a material that is relatively inflexible, for example relative to the attached dressing 330. Such materials may include, for example, plastic, paperboard or laminates of materials, or metal, as described herein with reference to the cover 121 and base 122. The cover or base may be constructed in a manner, for example, as described with respect to the various applicators, tensioning devices, or dressing carriers shown in Figures 1-22B herein. The cover 321 and base 322 may or may not comprise the same material.

[0270] The cover 321 and base 322 are movably, pivotably, bendably, or hingedly joined at sides 323, 325 and may be otherwise constructed in a manner similar to that described herein with respect to the cover 121 and base 122. The packaging device or applicator 320 may include a window portion 359 through which a wound, incision, or other location may be visualized for precise placement of the dressing 330 in a manner similar to that described herein with respect to the use of windows 159, 259.

[0271] The assembly 300 is constructed to include a dressing assembly 310 with a skin dressing device 330. The dressing assembly 310 also includes a dressing release structure or mechanism 350, which may be a release device such as the various release and removal structures described herein with reference to FIGS. 1-22B. The dressing 330 may include various dressing materials, including, but not limited to, elastic bandages, gauze-type bandages, hydrocolloids. Various structures, such as compartments and / or covers and bases and coupling elements, may provide structural support for the dressing carrier to be manipulated by a user. A margin between at least a portion of the structural support element, dressing carrier, or backing and the dressing may be provided at or near edges 321a, 323a, 324a, 322a, 325a, and / or 326a, for example, as described herein.

[0272] When assembled with the packaging device or applicator 320, the dressing 330 is bonded to the base. The length of the dressing 330 adjacent its first side 333 is joined to the length of the base 322 adjacent its side 324 and the outside of the open portion 350. And the length of the dressing 330 adjacent its second side 334 is bonded to the length of the base 322 adjacent its side 325 and the outside of the open portion 350. Attachment sheets similar to sheets 141, 146 or 241, 251 may be used to attach the sides 333, 334 of the dressing 330 to the base 322. The adhesive layer 335 faces away from the cover 321 and base 322 when the applicator 320 is open.

[0273] According to a variant, the dressing 330 is sufficiently large relative to the device 320 so that there is relatively little interference by the device 320 when applied to the skin. According to an embodiment, the width of the distorted portion of the dressing may be about 20 mm, about 30 mm, about 40 mm, or about 50 mm. According to another variant, the distance between each of the edges 333a, 334a of the dressing 330 and the edges 325a, 326a of the base 322 (and / or the edges 323a, 324a of the cover 321), respectively, is about 10 mm, 15 mm, or 20 mm or less. According to a variant, the distance between the edges 336a, 336b of the dressing and the edge 322a of the base is about 10 mm, about 15 mm, or about 20 mm or less.

[0274] According to some variations, the edges 333, 334, 336a, 336b of the dressing 330 are at least about 3 mm inward of at least a portion of the edges 325a, 326a, and / or 322a of the base 322 such that the edges 325a, 326a, and / or 322a of the base 322 may be grasped by a user with reduced likelihood of touching the dressing 330 or the adhesive layer 335. According to some variations, the ends 336a, 336b of the dressing 130 have a margin at least about 3 mm inward of the end 322a of the base 322. According to some variations, the sides 333, 334 and ends 336a, 336b of the dressing 330 have a margin of about 10 mm from the sides 325, 326 and ends 322a of the base, respectively. According to some variations, the sides 333, 334 and ends 336a, 336b of the dressing 330 have margins of about 15 mm from the sides 325, 326 and ends 322a of the base, respectively. The margins between the edges 333, 334 or ends 336a, 336b of the dressing 330 and the sides 325, 326 and ends 322a of the base 322, respectively, may be different. For example, margins m1 and m2 are about 3 mm or more and margin m3 is about 15 mm, as illustrated in FIG. 3. Similar margins may be provided between the dressing 330 and the edges 322a, 325a, and / or 326a of the base 322. For example, if the edges of cover 321 are alternatively or additionally used to grip device 320 or manipulate dressing 330, similar edges may be provided between dressing 330 and edges 321a, 323a, and / or 324a of cover 321.

[0275] The adhesive layer 335 on the dressing 330 may be protected by a release liner 349 before the packaging device or applicator 320 is opened. The release liner 349 may be attached to the inner surface 377 of the cover 321 such that when the cover 321 is opened or separated from the base 322, the release liner 349 is pulled away from the dressing 330, exposing the adhesive layer 335. The release liner 349 may also be a protective liner that protects or covers the dressing prior to application. For example, the liner may cover the dressing to which a substance or drug or other agent is applied. One or more hemostatic or coagulant agents may be applied to or otherwise integrated with the dressing to help reduce bleeding. Potential agents include chitosan, calcium-loaded zeolite, microfibrillar collagen, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, clotting factors (e.g., II, VII, VII, X, XIII, von Willebrand factor), coagulant promoters (e.g., propyl gallate), antifibrinolytic agents (e.g., epsilon aminocaproic acid), and the like. In some variations, the agents may be lyophilized and integrated into the dressing and activated upon contact with blood or other fluids. In some further variations, an activating agent may be applied to the dressing or treatment site before the dressing is used on a subject. In still other examples, a hemostatic agent may be applied separately or directly to the wound prior to application of the dressing or after application to the dressing via a catheter or tube. The device may also comprise one or more other agents, which may be any suitable agent that may be useful in supporting some aspect of the wound healing process. For example, the active agent may be a pharmaceutical compound, a protein (e.g., a growth factor), a vitamin (e.g., vitamin E), or a combination thereof. Of course, the device may comprise more than one drug or agent, and the device may deliver one or more drugs or agents.Examples of such agents include, but are not limited to, various antibiotics (including, but not limited to, cephalosporins, bacitracin, polymyxin B sulfate, neomycin, polysporin), antiseptics (iodine solution, silver sulfadiazine, chlorhexidine, etc.), antifungals (nystatin, etc.), antiproliferatives (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (VEGF, etc.), and other treatments (e.g., botulinum toxin). The cover 321 may be torn or separated in several ways. The cover 321 may be opened like the cover of a book. Similar to devices 120 and 220, 420, 520, 620, 720, 820, 920, 1020 herein, elements 321, 322 may be rotated sufficiently and up to about 360 degrees to separate release liner 349, allowing the exposed adhesive side 335 of dressing 330 to be placed on the skin or wound site using packaging device or applicator 320. According to some variations, assembly 300 is opened up to about 180 degrees (minimum angular change) or more to provide for application of the dressing without interfering with assembly 300. Alternatively, for example, cover 321 may be attached to base 322 by adhesive and peeled away from dressing 330 or base 322 to which dressing 330 is coupled. Cover 321 itself may be a removable or separable release liner that can be peeled away from base 322. Alternatively, as shown in FIG. 6, a release liner 149a may be provided on the adhesive layer 335 that is not attached to the cover 321. When the device is opened, the release liner 149a may be manually removed from the dressing 330 to expose the adhesive layer 335. In such a case, the cover 321 may be omitted. After the device 300 is opened to the position shown in FIG. 11 or 12A and 12B, the dressing 330 may be applied to the desired location on the subject's skin. The window 359 may be used to visualize proper placement. A locking mechanism may optionally be provided to lock or secure the device in an open, partially open, or closed position.In some embodiments, the locking mechanism may comprise magnets, hook and loop attachment structures, snaps, latches, clips, and the like, and adhesives or glue structures. A compressive force may be applied to the backside 378 of the base 322 or the inside 377 of the cover when rotated approximately 360 degrees. Once applied to the subject, the dressing 330 may be released from the packaging device or applicator 320 using a release mechanism 350. The release mechanism 350 may include, for example, a cutting or piercing element, as described with respect to devices 150 and 250 herein. The release mechanism may further include one or more release elements as described herein and shown in FIGS. 1-22B.

[0276] FIG. 13 illustrates an alternative packaging or applicator 420 that may be used in any of the embodiments herein, including device elements or features that may be substituted for device elements or features of devices 120, 220, or 320, 520, 620, 720, 820, 920, 1020, 1120, 1220. FIG. 13 illustrates a cover 421 and a dressing carrier or base 422 that are constructed of a single substrate from a material such as nylon and / or polyethylene or metal. The device 420 may be manufactured from a single mold and / or may have portions cut out of the substrate, slots, grooves, creases, or other openings, or variations in substrate thickness at different locations. The cover 421 and base 422 each include a slot 428 that forms an element such as a section 427. The slot 428 allows for flexing of the device 420, allowing the attached dressing to conform to the contours of the subject's body to which it is to be applied. The cover 421 and the base 422 are coupled to each other using a connector feature 429 formed in the substrate. The cover 421 and the base 422 are hingedly or pivotally movable relative to each other by a slot 430 formed adjacent the connector feature 429 to allow flexing or movement of the connector feature 429 and thus the cover 421 and the base 422 relative to each other. As mentioned with respect to the device 100, in other variations, the slot 430 may comprise a groove or other structure that provides a reduced thickness to the cover 421 and the base 422. The device 420 may include a release mechanism as described with respect to Figures 1A-22B herein. The device 420 may be used in the same manner as the device described with reference to Figures 1A-22B herein, and may attach a dressing in the same manner as described with respect to the device described with reference to Figures 1A-22B herein.

[0277] Various structures, such as compartments, and / or cover and base, and coupling elements, slots, and grooves, may provide structural support and flexibility for the dressing carrier to be manipulated by a user. A margin between at least a portion of the structural support element, dressing carrier, or backing and an attached dressing may be provided, for example, at or near edges 421a, 423a, 424a, 422a, 425a, and / or 426a, as further described herein.

[0278] 14 illustrates an alternative packaging or applicator device 520 that may be used in any of the devices described herein with reference to FIGS. 1A-22B. The cover portion 521 and the dressing carrier or base portion 522 may be constructed from a laminated structure 530. A first layer 531 of the laminated structure 530 includes paperboard or a plastic material or other supporting material such as metal, having a slot 528 formed transversely across each of the cover 521 and base 522. The slot 528 forms a section 527 of the device 520 that allows for flexing of the section 527, allowing the attached dressing to conform to the contours of the body of the subject to which it is to be applied. The first layer 531 further includes a longitudinal slot 529 formed in the first layer 531 between the cover 521 and base 522. The first layer 531 further comprises a tab 540 with an opening that is used in the assembly of the device 520 and removed after assembly such that the cover 521 and base 522 are separated by the slot 529 and are no longer connected by the first layer 531. The second layer 532 of the laminate comprises an adhesive material such as a PSA acrylic, rubber, or silicone adhesive. The second layer 532 may or may not be about 0.001-0.006 thick. A flexible strip of material 534 is positioned along the length of the device 520, spanning the slot 529 and connecting the cover 521 and base 522. The cover 521 and base 522 are flexibly and hingedly or pivotally coupled with the strip of material 534 spanning the slot 529 to allow flexing or movement of the cover 521 and base 522 relative to one another and are movable relative to one another. The flexible strip 534 may have a generally similar contour as the first layer 531 and is attached using adhesive 535 to a third layer 533 which may comprise a thin material such as paper or plastic that holds together the structure of the device 520 including the compartments 527.

[0279] Device 520 may include release mechanisms, dressing attachment, and may be used in the same devices and assemblies as described with respect to Figures 1A-22B herein.

[0280] Various structures, such as compartments, adhesive structures, laminate layers, and / or covers and bases, and joining elements, slots, and grooves, may provide structural support and flexibility for the dressing carrier to facilitate manipulation by a user. A margin between at least a portion of the structural support element, dressing carrier, or backing and an attached dressing may be provided, for example, at or near edges 521a, 523a, 524a, 522a, 525a, and / or 526a, as further described herein.

[0281] 15A-15J, a variation of a dressing and packaging assembly 600 is illustrated. The packaging assembly 600 comprises an applicator and / or tensioning device 620 and a dressing assembly 610 including a dressing 630. The dressing 630 comprises an elastic sheet 631 with one or more adhesive regions comprising a layer of skin adhesive as described herein.

[0282] The features of Figures 15A-15J may be used in any of the variations herein that include device elements or features that may be substituted for the device elements or features of the devices and assemblies shown in Figures 1A-22B.

[0283] The packaging assembly 600, applicator, tensioning device 620, and / or dressing assembly 610 may be configured to pre-strain the dressing 630 and / or to enable transfer of the pre-strained dressing 630 to the skin of a subject. The applicator or tensioning device 620 may also provide for convenient, sterile transfer of the adhesive portion of the dressing to the skin and / or wound site of a subject.

[0284] Device 620 includes a cover 621 and a base 622. Dressing assembly 610 is removably coupled or tethered to device 620, which may act as a dressing carrier. Cover 621 may be generally planar and include sides 623, 624 with corresponding edges 623a and 624a defining its length, and an edge 621a at an opposing end. Base 622 may be generally planar and include sides 625, 626 with corresponding edges 625a, 626a defining its length, and an edge 622a at an opposing end.

[0285] According to some variations, the cover 621 and / or base 622, 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 it is applied to a subject, as described with respect to the variations herein. The materials and construction of the applicator or tensioning device 620, dressing 630, and packaging 600 may be similar to the packaging assemblies and / or dressings described with respect to the variations herein and shown in Figures 1A-22B.

[0286] The cover 621 and base 622 may be movably, pivotably, bendably, or hingedly coupled at sides 623, 624. For example, a layer of material 627, such as silicone, polyurethane, low density polyethylene, or a rubber material, may be glued to each of the cover and base and flexibly attach them together at sides 623, 625. The device 620 may be constructed in a manner similar to that described with respect to other devices herein and shown in Figures 1A-22B, including, but not limited to, materials, compartmentalization, strength and flexibility, visualization, straining features, and release liners.

[0287] Dressing assembly 610 also includes mounting sheet 641 and mounting sheet 651. Mounting sheet 641 may be a polyimide film or tape (e.g., DuPont TMThe dressing has a first side 643 that is attached to a second side 634 of the dressing using an adhesive structure 670, such as KAPTON® tape or a releasable adhesive by Eppendorf, Inc. The adhesive structure herein may include, but is not limited to, KAPTON® tape or a releasable adhesive, or a soft skin adhesive made from a material such as a silicone adhesive, silicone gel, or acrylic adhesive, configured to provide low skin trauma after repeated skin contact. The adhesive structure or KAPTON® tape also includes a material that is capable of adhering to the attachment sheet, yet is releasable from the selected dressing material, such that the attachment sheets impart a strain to the dressing when they are separated from one another.

[0288] As shown in FIG. 15J, the mounting sheet 641 and side 634 of the dressing may be attached on the same side 671 of the adhesive structure 670, with the mounting sheet 641 overlapping but not attached to the dressing 631.

[0289] The mounting sheet 641 has a second side 644 that is bonded to the cover 621 of the device 620, for example by bonding with a low surface energy PSA such as an acrylic adhesive. The mounting sheet 641 may also have folds or perforations 681 between its attachment to the adhesive structure 670 and its attachment to the cover 621. After the dressing is strained, the perforations 681 are located at the seam between the cover 621 and the base 622 or across the interior surface of the cover 621.

[0290] The mounting sheet 651 may be joined at its side 654 to the backside 698 of the base 622, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. Side 653 of the mounting sheet 651 may be attached to side 633 of the dressing with an adhesive structure 680, such as KAPTON® tape or a releasable adhesive, in a manner similar to adhesive structure 670 that attaches side 654 of dressing 630 to mounting sheet 641. The mounting sheet 651 may include a pull tab 688 located on the backside 698 of the base adjacent and inboard of an attachment zone 655 of the mounting sheet 651 to the back of the base 652.

[0291] When the cover 621 is opened, it exerts a distorting force on the dressing 630 through the attachment sheet 641 .

[0292] According to some variations, the mounting sheets 641, 651, while flexible, are relatively inelastic relative to the dressing 630 and may be constructed, for example, from low density polyethylene. The mounting sheets 641, 651 may be manufactured to be tearable along the length of the material while providing tensile strength in other directions, particularly in the tension direction of the material of the mounting sheet 641 (the direction in which the dressing is tensioned, stressed or strained). An example of such a material is an LDPE polymer produced by an extrusion process that creates anisotropic or directionally biased grains, whereby the material is tearable in the direction of the grain but has relative resistance to tearing in the direction transverse to the grain.

[0293] 15A shows the assembly 600 in an unstrained configuration. The adhesive tape 683 is exposed on the inner surface 694 of the base 622. The skin adhesive layer on the elastic sheet 631 of the dressing 630 may be protected by a release liner, similar to release liner 149a herein, before the applicator or tensioning device 620 is released.

[0294] Figure 15B shows the assembly 600 in a released, strained configuration. As shown in Figure 15B, when strained, the perforations 681 on the mounting sheet are aligned with the edges 623a and 625a of the cover 621 and base 622, respectively. A portion 641a of the mounting sheet 641 interfaces with an adhesive tape 683, which attaches the portion 641a to the base 622 and holds the dressing 630 in the strained configuration. A release liner 645 is attached to the underside of the mounting sheet 641 between the attachment to the cover 621 and the perforations 681. The liner 645 prevents the portion of the mounting sheet 641 that interfaces with the cover 621 from adhering to the adhesive tape 683.

[0295] Cover 621 and base 622 may be separable from one another, for example, by means of perforations 682 in layer 627 bonding cover 621 to base 622 and by separation of sheet 641 along perforations 681. Figure 15C shows assembly 600 with cover 621 separated from base 622. Strained dressing 630 may be applied to the skin of a subject using base 622 as an applicator.

[0296] FIG. 15D illustrates the backside 698 of the base 622 in position to apply the dressing 630 towards the skin of a subject. As shown, the edge 654 of the attachment sheet 651 may be wrapped around from the inside 694 of the base 622 to the backside 698 to which it is attached. A tear strip may be attached to the attachment sheet 651 between the attached edge and the unattached middle section. The pull tab 688 or tear strip may be pulled to remove the base 622 from the remainder of the bandage assembly, as shown in FIG. 15E. After the tab 688 is pulled, the unattached portion 651a of the attachment sheet 651 is peeled away from the base 622. After the base is removed, the remainder of the attachment sheets 641, 651 may be removed by peeling the KAPTON® tape from the bandage 630. FIG. 15F shows the bandage 630 after removal of the remainder of the bandage assembly.

[0297] Figures 15G-15J illustrate the configuration of the dressing assembly 610 as the KAPTON® tape or adhesive structures 670, 680 and mounting sheets 641, 651 are removed from the dressing 630. Figures 15G and 15J show the orientation of the KAPTON® tape or adhesive structures 670, 680 as they are peeled from the inside of the dressing 630 in a direction toward the sides 633, 634 of the dressing 630, or in the direction of strain of the dressing. Figure 15H shows the first structure 670 peeled across the side 633 of the dressing and away from the inside of the dressing. Figure 15I shows the first adhesive structure 670 removed from the dressing 630. The second adhesive structure 680 may be removed in a similar manner.

[0298] 16A-16D illustrate an alternative dressing assembly 710 in a configuration in which the dressing assembly 710 is separated from an applicator or tensioning device in a manner similar to that described with respect to FIGs. 15A-15J. FIG. 16A illustrates a first adhesive structure 770 and a second adhesive structure 780, each comprising KAPTON® tape or a releasable adhesive structure, used to attach mounting sheets 741, 751 to the dressing 730. As shown in FIG. 16A, the unattached ends of the adhesive structures 770, 780 are oriented away from the dressing 730. As shown in FIG. 16B, the second adhesive structure 780 has been peeled inward and removed in FIG. 16C.

[0299] 17A-17D illustrate an alternative dressing assembly configuration in which the dressing assembly 810 is separated from the applicator or tensioning device in a manner similar to that described with respect to FIGS. 15A-15J. FIG. 17D illustrates a first adhesive structure 870 and a second adhesive structure 880, each comprising KAPTON® tape or a releasable adhesive structure, used to attach mounting sheets 841, 851, respectively, to the dressing 830. As shown in FIGS. 17A and 17D, the adhesive structures 870, 880 are attached to the dressing 830 with an adhesive length 891. An additional length 892 is wrapped 180 degrees around the adhesive length 891. The additional length 892 has an end 893 that extends to the dressing 830 for easy access and removal. As shown in FIG. 17B, the first adhesive structure 870 may be pulled using end 893 in a direction partially perpendicular to the direction of strain to remove the attachment structures 841, 851 and adhesive structure 870 from the dressing 830, as further shown in FIG. 17C.

[0300] 18A-18I illustrate a variation of a dressing and packaging assembly 900. The packaging assembly 900 includes an applicator and / or tensioning device 920 and a dressing assembly 910 including a dressing 930. The device 220 may include a cover 921 and a base 922. The dressing assembly 910 is removably coupled or tethered to the device 920, which may act as a dressing carrier. The cover 921 may be generally planar and include sides 923, 924 with corresponding edges 923a and 924a defining its length, and edges 921a at opposing ends. The base 922 may be generally planar and include sides 925, 926 with corresponding edges 925a and 926a defining its length, and edges 922a at opposing ends.

[0301] The dressing assembly 910 also includes an attachment sheet 941 and an attachment sheet 951. The attachment sheet 941 has a first side 943 that is attached to the second side 934 of the dressing with an adhesive structure 970, such as KAPTON® tape or a releasable adhesive. The adhesive structure herein may include, but is not limited to, KAPTON® tape or a releasable adhesive, or a soft skin adhesive made from a material such as a silicone adhesive, silicone gel, or an acrylic adhesive, configured to provide low skin trauma after repeated skin contact. The adhesive structure or KAPTON® tape also includes a material that is capable of adhering to the attachment sheet, yet is releasable from the selected dressing material, such that the attachment sheets impart a strain to the dressing when they are separated from one another.

[0302] 18J, the mounting sheet 941 and side 934 of the dressing are attached on the same side 971 of the adhesive structure 970, with the mounting sheet 941 overlapping but not attached to the dressing 931. The mounting sheet 941 has a second side 944 that is bonded to the cover 921 of the device 920, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. The mounting sheet 941 may also have a pull tab 981 in the unattached area between the attachment to the adhesive structure 970 and the attachment to the cover 921. After the dressing is strained, the perforated pull tab 981 is located on the inner surface 960 of the cover 921, or alternatively, at the seam between the cover 921 and the base 922.

[0303] The mounting sheet 951 is joined at its side 954 to the backside 998 of the base 922, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. Side 953 of the mounting sheet 951 is attached to side 933 of the dressing 930 with an adhesive structure 980, such as KAPTON® tape or a releasable adhesive, and in a manner similar to adhesive structure 970 that attaches side 944 of the dressing 930 to the mounting sheet 941. The mounting sheet 951 may include a pull tab 988 located on the backside 998 of the base adjacent and inboard of an attachment zone 955 of the mounting sheet 951 to the back of the base 952.

[0304] According to some variations, the mounting sheets 941, 951, while flexible, are relatively inelastic relative to the dressing 930 and may be constructed, for example, from LDPE. The mounting sheets 941, 951 may be manufactured to be tearable along the length of the material while providing tensile strength in other directions, particularly in the tension direction of the material of the mounting sheet 941 (the direction in which the dressing is tensioned, stressed or strained). An example of such a material is an LDPE polymer produced by an extrusion process that creates anisotropic or directionally biased grains, whereby the material is tearable in the direction of the grain but has relative resistance to tearing in the direction transverse to the grain.

[0305] When the cover 921 is released, it applies a straining force to the dressing 930 through the mounting sheet 941. Figure 18A shows the assembly 900 in an unstrained configuration, while Figure 18B shows the assembly 900 in an released, strained configuration that may be applied to the skin. As shown in Figure 18C, tabs 981 on the mounting sheet 941 are located across the inner surface of the cover 921 when strained (folded back and exposed) and are accessible to the user. After applying the dressing 930, the cover 921 and base 922 may be removed.

[0306] The cover 921 and base 922 are separable from each other when the tab 988 is pulled. FIG. 18C shows the assembly with the cover positioned with the dressing facing down, for example, as it would be when applied to a subject's skin. As shown in FIG. 18D, the tab 988 is pulled to release the cover 921 from the remainder of the dressing assembly 910. As shown in FIG. 18E, the cover 921 is removed from the remainder of the device 920 to expose the second pull tab 998. As shown in FIG. 18F, the second pulled tab 998 releases the base 922 from the dressing assembly 910 with the mounting sheets 941, 951 unattached to the base 922. As shown in FIG. 18G, the base 922 may be removed along with the remaining mounting sheets 941, 951, and the adhesive structures 970, 980 may be peeled away from the dressing 930 as shown in FIG. 18H, with the dressing remaining on the skin in the configuration as shown in FIG. 18I.

[0307] 19A-19D, a variation of a dressing and packaging assembly 1000 is illustrated. The packaging assembly 1000 comprises an applicator and / or tensioning device 1020 and a dressing assembly 1010 including a dressing 1030. Figure 19A shows the dressing assembly 1010 coupled to the applicator or tensioning device 1020. The tensioning member or applicator 1020 may be constructed in a manner similar to the tensioning and applicators described herein and shown in Figures 1A-22B.

[0308] The device 1020 comprises a cover 1021 and a base 1022. A dressing assembly 1010 is removably coupled or tethered to the device 1020, which may act as a dressing carrier. The dressing assembly may be attached to a tension 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 using an adhesive structure 1070 as described with reference to adhesive structures 970, 980. The attachment sheet 1041 has a second side 1044 that is coupled to the cover 1021 of the device 1020, for example, by bonding using a low surface energy PSA such as an acrylic adhesive. The attachment sheet 1041 also has a ripcord 1088 sewn along its length in the unattached portion of the attachment sheet 1041 between its attachment to the adhesive structure 1070 and its attachment to the cover 1021. Various types of stitches may be used, including but not limited to a chain stitch or a lock stitch. After the dressing is strained, the ripcord 1088 is located on the exposed inner surface 1090 of the cover 1021, or alternatively, at the seam between the cover 1021 and the base 1022.

[0309] The mounting sheet 1051 is joined at its side 1054 to the backside of the base 1022, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. Side 1053 of the mounting sheet 1051 is attached to side 1033 of the dressing with an adhesive structure 1080, such as KAPTON® tape or a releasable adhesive, and in a manner similar to adhesive structure 1070 that attaches side 1034 of the dressing 1030 to the mounting sheet 1041. The mounting sheet 1051 includes a ripcord 1098 located between its attachment to the adhesive structure 1090 and its attachment to the back of the base. The ends of the ripcords 1088, 1098 extend out from the tension member 1020 for easy accessibility.

[0310] Figures 19A and 19B illustrate the dressing assembly 1010 in an unstrained configuration. The cover 1021, when opened, applies a straining force to the dressing 1030 through the attachment sheet 1041. Figure 19C illustrates the dressing assembly 1010 in a strained configuration.

[0311] After the dressing has been strained and applied, the ripcords 1088, 1098 are retracted to separate the portions of the attachment sheets 1041, 1051 attached to the tensioning device 1020 from the portions of the attachment sheets 1041, 1051 attached to the dressing 1030. The applicator or tensioning device 1020 may then be removed as shown in Figure 19D. The adhesive structures 1080, 1090 may then be peeled away to remove the remaining portions of the dressing assembly 1010 and the attachment sheets 1041, 1051 from the dressing as shown in Figure 19E.

[0312] 20A-20C, a variation of a dressing carrier, tensioning device, or applicator 1120 is shown. The device 1120 comprises a plurality of sections 1130 formed by folding a substrate 1150 on one side 1155 of a plane. The folds 1170 may be formed in one or more directions or with one or more shapes that are curved or linear. In addition, the folds may be formed on both sides, allowing both convex and concave shaping of the device. As shown, the folds 1170 allow for shaping of the device or the attached dressing. The folds 1170 as shown are formed on a first side 1155 of the plane of the device, while the second side 1165 is not folded. 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 flex at the fold 1170. The fold 1170 acts as a flexure element, while the remaining substrate at the fold 1170 may act as a flexure limiter.

[0313] When a convex bandage shape is desired for a concave surface, the bandage may be attached on the first side 1155 such that when the substrate is bent, the bandage forms a convex shape to match the concave contour to which the device is to be applied. When a concave bandage is desired for a convex body contour, the bandage may be positioned on the second side 1165 of the substrate 1150. Thus, when the substrate is bent, the bandage forms a concave shape to match the convex body contour to which the device is to be applied. Various bandage backings may be provided for different body locations or contours.

[0314] According to a variant, the fold may be orthogonal or have an orthogonal component relative to the section 1127 of the carrier, applicator or tensioning device. The section 1127 may be similar to the section shown in Figures 1A-22B.

[0315] 21A-21D, a variation of a bandage carrier, tensioning device, or applicator 1220 is shown. The device 1220 comprises a plurality of foam cells 1240 joined by an adhesive backing 1260. The foam cells 1240 form a plurality of sections 1227 that allow the device to flex in multiple directions to conform to the curvature, contour, or shape of the object to which the bandage is to be applied. The foam can generally be thick enough to provide additional column strength, i.e., resistance to bending, for straining the bandage. A backing or support may be provided for straining the bandage, for example, constructed from a material with a modulus of elasticity and an appropriate thickness that will at least counter the forces created by straining the bandage. The bandage strain may be secured, for example, using an adhesive on the back of a portion of the bandage assembly or mounting sheet. After the dressing is secured in place, the backing or support may be removed to allow for increased manipulation of the shape of the distorted dressing to further conform to the shape of the patient's body contours to which the dressing is to be applied.

[0316] As shown, separations 1270 between the foam sections allow for shaping of the device. Separations 1270 as shown are formed on a planar first side 1255 of the device, while the second side 1265 is not creased. When force is applied to the first side 1255, the substrate bends. When force is applied to the second side 1265, the substrate 1250 of the device does not flex at the separation. The crease acts as a flexure element, while the remaining substrate at the separation may act as a flexure limiter.

[0317] When a convex bandage shape is desired for a concave surface, the bandage may be attached on the first side 1255 such that when the substrate is bent, the bandage forms a convex shape to match the concave contour to which the device is to be applied. When a concave bandage shape is desired for a convex body contour, the bandage may be positioned on the second side 1265 of the substrate 1250. Thus, when the substrate is bent, the bandage forms a concave shape to match the convex body contour to which the device is to be applied. Various bandage backings may be provided for different body locations or contours.

[0318] 22A and 22B, a variation of a bandage and packaging assembly 1500 is illustrated. The packaging assembly 1500 comprises an applicator and / or tensioning device 1520 and a bandage assembly 1510 including a bandage 1530. The packaging assembly 1500, the applicator or tensioning device 1520, and / or the bandage assembly 1510 may be configured to pre-strain the bandage 1530 and / or to enable delivery of the pre-strained bandage 1530 to the skin of a subject.

[0319] The device 1520 may include a cover 1521 and a base 1522. The dressing assembly 1510 may be removably coupled or tethered to the device 1520 and serve as a dressing carrier. The cover 1521 and base 1522 may be movably, pivotably, bendably, or hingedly coupled at sides 1523, 1524 and constructed in a manner similar to that described with respect to the cover and base described in Figures 1A-22B. The attachment regions 1541, 1551 of the dressing assembly 1510 are attached near the free sides 1525, 1526 of the covers 1521, 1522, respectively, using, for example, a releasable adhesive or a removable adhesive structure. However, the attachment sheets or structures described with respect to Figures 1A-22B herein may be used. The attachment regions 1541, 1551 and / or the positioning of the dressing 1530 on the device 1520 may be symmetrical about a line defined by the attachment of the sides 1523, 1524 of the cover 1521 and base 1522, respectively. As shown in FIG. 22B, the dressing 1530 is strained with the cover 1521 and base 1522 open. The dressing 1530 may then be applied to the skin of a subject and the device 1520 may be peeled away from the dressing 1530. Additionally or alternatively, the cover 1521 and base 1522 may be separated using perforations 1551 formed in a substrate of the device 1520 or in an attachment structure 1550, such as a tape or layer of material that attaches the sides 1523 and 1524 of the cover 1521 and base 1522, respectively.

[0320] In some variations, the device 1520 may optionally include an adhesive coating or tape on the cover 1521 and / or base 1522 that may adhere to the dressing 1530 when the dressing 1530 is tensioned and the dressing further contacts the cover 1521 and base 1522. In some variations, the adhesive is configured to maintain the dressing 1530 in a tensioned state and / or against the cover 1521 and / or base 1522. The adhesive coating or tape may be located along the side regions 1523, 1524 of the cover 1521 and / or base 1522, but may also be provided adjacent the attachment regions 1541, 1551. Release liners may also be provided to reduce inadvertent adhesion of dressings or other structures to the adhesive until activation of the device 1520 is desired.

[0321] According to a variant, the various assemblies or devices described herein may provide a temporary wound dressing that may be applied before the wound is closed. The assembly may be configured to use a packaging or applicator to apply the dressing to the wound and to apply pressure to the wound before removing or separating the applicator, tensioning device or dressing carrier, base or support from the dressing. According to this variant, which may be provided in any of the embodiments described below, the packaging or applicator has sufficient rigidity to distribute a relatively even or steady force to the wound by applying pressure to the packaging or applicator when and / or after the dressing is applied to the wound. According to a variant, such a dressing may include, for example, a clotting agent or other agent or drug as described herein. According to another variant, a margin as described herein is provided on such a device between the dressing and the edge used to manipulate the device.

[0322] The assemblies or devices described herein may also form a dressing support structure. For example, the dressing support structure may include multiple sections of a 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 those described in Figures 1A-22B, that are joined or formed together. The multiple sections of the cover described herein may also provide support to the dressing when the cover is folded 360 degrees against a corresponding base structure.

[0323] In other embodiments, the strained bandage may be provided to the user as a prestrained bandage that is strained at the time of manufacture rather than at the time of use. Referring to Figures 23A-23I, the preparation of a prestrained assembly 2351 including a prestrained bandage is illustrated. A tensioning device 2341 used to prestrain the bandage is shown in use in Figures 23A-23D. Various features and steps of preparing the prestrained assembly 2351 are further illustrated in Figures 23E-23I.

[0324] The pre-strained assembly 2351 may comprise a dressing assembly 2308 and a strain-maintaining or support structure 2330 (see FIG. 23I). The pre-strained assembly 2351 may be stored for a period of time prior to use.

[0325] The dressing assembly 2308 may include a dressing 2310 comprising a relatively planar elastic sheet 2360 that defines a plane. The elastic sheet 2360 may comprise, for example, a silicone sheet or other elastic material as described herein. The dressing assembly 2308 may further comprise a mounting sheet 2304, a tensioning sheet 2307, a pre-strained assembly release portion 2352, and a dressing release portion 2319.

[0326] The mounting sheet 2304 may be configured to attach the dressing 2310 to the support structure 2330 using the engagement element 2322. The mounting sheet 2304 of the dressing assembly 2308 may include a first engagement wall or element 2322 that extends downwardly relative to the plane of the dressing 2310 and includes an inwardly extending hook 2323. The engagement element 2322 may be attached to the mounting sheet 2304 using, for example, an adhesive. The tension sheet 2307 of the dressing assembly 2308 may include a second engagement element 2324 that extends downwardly relative to the plane of the dressing 2310 and includes an inwardly extending hook 2325. The tension sheet 2307 may be configured to attach the dressing 2310 to the support structure 2330 using the engagement element 2324. The engagement element 2324 may be attached to the tension sheet 2307 using, for example, an adhesive. The tensioning sheet 2307 may also be configured to translate tension from the tensioning device 2341 to the bandage 2310 and impart strain to the bandage 2310 .

[0327] The pre-strained assembly release 2352 may be configured to release the pre-strained assembly 2351 (bandage 2310 and support structure 2330) from the tensioning device 2341 (see, for example, FIGS. 23E and 231). The dressing release mechanism 2319 may be configured to release the dressing 2310 from the engagement elements 2322, 2324 (including hooks 2323, 2325) and thus from the support structure 2330. The dressing release mechanism 2319 may be configured to release the dressing 2310 after it has been applied to a subject.

[0328] The dressing 2310 of the dressing assembly 2308 may have a first edge or side 2305 having a length and a second edge or side 2306 having a length. The dressing 2310 may be joined at the first edge or side 2305 to a mounting sheet 2304, which may be flexible but relatively less elastic or inelastic than the dressing 2310. The mounting sheet 2304 may have a first side 2382 and a second side 2384. When assembled, the mounting sheet 2304 may be joined to the elastic sheet 2360 of the dressing 2310 at a section 2375 of the mounting sheet 2304 at or near the side 2382 of the mounting sheet 2304 using, for example, a silicone PSA / acrylic PSA combination. The mounting sheet 2304 may be joined at its side 2384 to the engaging elements 2322 and hooks 2323, for example, by bonding with an adhesive material, for example, using a silicone PSA / acrylic PSA combination. The mounting sheet 2304 may join the dressing 2310 to the support 2330 near the first side 2305 of the dressing 2310 with the engaging elements 2322 and hooks 2323. The dressing 2310 may be joined at its second edge or side 2306 to a tensioning sheet 2307, which is flexible but may be inelastic or less elastic than the dressing 2310. The tensioning sheet 2307 may have a first side 2372, an intermediate location 2373, and a second side 2374. When assembled, the tension sheet 2307 may be bonded to the elastic sheet 2360 of the dressing 2310 at a section 365 of the tension sheet 2307 at or near the side 2372 of the tension sheet 2307, for example, using a silicone PSA / acrylic PSA combination. The tension sheet 2307 may be bonded to the side wall 2324 and hooks 2325 at an intermediate location 2373, for example, by bonding with an adhesive material, for example, using a silicone PSA / acrylic PSA combination. When assembled into the pre-strained assembly 2351, the tension sheet 2307 may bond the dressing 2310 to the support structure 2330 near the second side 2306 of the dressing 2310, using the side wall 2324 and hooks 2325.The tensioning sheet 2307 may be loaded onto the tensioning device 2341 on the second side 2374, as described in more detail herein. According to some variations, the mounting sheet 2304 or tensioning sheet 2307 may be constructed from, for example, low density polyethylene.

[0329] 23A positioned over a support structure 2330 to which it can be removably attached as or after the dressing 2310 is prestrained to form a prestrained assembly 2351. The support 2330 may be generally planar and include sides 2335, 2336 with corresponding edges 2335a and 2336a that define its length. Other support elements, support structures, and / or strain-maintaining elements may be used, for example, the sides of the bandage 2310 or dressing assembly 2308 may be clamped and a desired distance maintained between the clamps, for example, using a separation element.

[0330] The dressing 2310 of the dressing assembly 2308 may be prestrained using, for example, a tensioning device 2341 as shown in FIGS. 23A-23D. The prestrained dressing 2310 may then be stored in the prestrained configuration for a period of time prior to use. The tensioning device 2341 may be used at the point of manufacture, by an intermediary, or by an end user. The tensioning device 2341 may comprise a planar portion 2343 and a circular portion 2344 configured to contain a rotating element 2345. The rotating element 2345 may have a middle section 2346 with a slot 2347 for receiving and engaging the tensioning sheet 2307 of the dressing assembly 2308.

[0331] In FIG. 23A, the dressing assembly 2308 may be shown on the tensioning device 2341 in a first configuration in which it is relatively undistorted. The dressing assembly 2308 may be positioned over a support structure 2330. This support structure 2330 may be positioned over the tensioning device 2341 with an upper surface 2333 of the support structure 2330 interfacing with the underside 2311 of the dressing 2310. A first edge 2335a of the support structure 2330 and a first side or edge 2349 of the planar portion 2343 of the tensioning device 2341 may be engaged and held by the engagement wall 2322 and hook 2323. A second end 2336 and edge 2336a of the support 2330 may initially be released from engagement with the dressing 2310 but in a position to interface therewith. This may allow the dressing 2308 to be strained to a desired degree without interference from the support structure 2330 .

[0332] In use, the end 2374 of the tensioning sheet 2307 may be inserted into a slot 2347 in an intermediate section 2346 of a rotating element 2345 of the tensioning device 2341. The rotating element 2345 may then be rotated until the tensioning sheet 2307 is engaged. Initially, the tensioning sheet 2307 and dressing 2310 may be in an undistorted configuration with minimal deflection when attached to the tensioning device 2341. As the rotating element 2345 is rotated, the dressing 2310 may be strained as the tensioning sheet 2307 is pulled by the rotating element 2345 relative to the dressing 2310 in a tensile strain direction.

[0333] The dressing 2310 may be strained by pivoting the rotating element 2345 as shown in Figures 23A-23D. Once the tension sheet is loaded as the rotating element 2345 is pivoted, the tension sheet 2307 may wrap around the rotating element 2345, thereby shortening the distance between the rotating element 2345 and the dressing 2310 and stretching or straining the dressing 2310. A locking mechanism comprising a ratchet 2337 on the rotating element 2345 and a pawl 2338 on the circular portion 2344 may be used to lock the dressing 2310 in a strained configuration as shown in Figures 23B-23D. When the tension sheet 2307 is pulled in a tensile strain direction towards the circular portion 2344 of the tensioning device 2341, the engagement element 2324 and the hook 2325 may also move in the tensile strain direction. The edge 2336a of the support includes a ramp 2336b that can engage with a ramp 2326 on the hook 2325 to guide the edge 2336a of the support 2330 into engagement with the hook 2325 as the hook 2325 moves toward the circular portion 2344 of the tensioning device (see FIGS. 23C-23H). The strain of the pre-strained bandage 2310 may be controlled or determined using measuring elements or marks 2342 on the rotating element 2345, the distance between each of which may correspond to an increment of increased strain or distance. Once the bandage assembly 2308 is loaded onto the tensioning device 2341, the strain may be determined by the amount the rotating element 2345 is rotated. Each mark 2342 may correspond to a strain percentage or distance. 0% strain may be identified as the position where the bandage assembly 2308 is loaded onto the tensioning device 2341 without any deflection and with little to no strain or tension. As shown in Fig. 23A, the 0% position may be indicated where mark 2342a is aligned with prong 2338. As rotational element 2345 is rotated, the identified 0% mark 2342a may rotate by an amount corresponding to the percent strain. Mark 2342b as shown in Fig. 23B is aligned with prong 2338 when the dressing is strained to a desired amount x as indicated by mark 2342b.

[0334] The support structure 2330 may maintain the dressing 2310 in its strained configuration as shown in FIGS. 23B-23I during storage, and the engagement elements 2322, 2324 and hooks 2323, 2325 that engage the support structure 2330 prevent the dressing 2310 from moving or losing strain. One or more adhesive regions comprising a layer of skin adhesive 2340 may be applied to the upper surface 2312 of the dressing 2310. The adhesive 2340 used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive. The adhesive 2340 is shown on the dressing 2310 in an unstrained configuration. However, the adhesive may be applied to the dressing 2310 after the dressing 2310 has been strained. A removable liner 2350 may be placed over the adhesive layer 2340. The liner 2350 may further be selected to maintain the strain in the dressing 2310. Such liners may comprise rigid or semi-rigid materials, for example, ultra-high molecular weight polyethylene (UHMWPE) with a release coating or layer, a fluoropolymer such as perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), or expanded PTFE (ePTFE). Other rigid 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 rigid plastic / resin.

[0335] Once the bandage 2310 has been strained and the bandage assembly 2308 may be engaged and secured to the support structure 2330, the bandage assembly 2308 and support structure 2330 may be separated from the tensioning device 2341 to form a pre-strained assembly 2351 which may be used immediately or stored for a period of time.

[0336] The pre-strained assembly release portion 2352 may comprise a tear strip 2353 attached to the tensioning sheet 2307 between the intermediate location 2373 and the second side 2374 with upper and lower portions 2354, 2355, respectively (see FIG. 23E). The tear strip 2353 may act to separate the pre-strained assembly 2351 from the tensioning device 2341 by tearing across the tensioning sheet 2307 between the pre-strained assembly 2351 and the tensioning device 2341.

[0337] In use, after the liner 2350 is released, the dressing 2310 may be applied to a desired location on the skin of a subject. A user may apply pressure to the backside 2333 of the support 2330 to activate the adhesive on the dressing 2310 and / or apply compression to the wound. Once applied to the subject, the dressing 2310 may be released from the support 2330 using the release mechanism 2319.

[0338] The release mechanism 2319 may include a tear strip 2309. The tear strips 2309 of the release mechanism 2319 may each extend to an end 2366 of the elastic sheet 2360. The tear strips 2309 may each be coupled to the bandage assembly 2308. The tear strips 2309 may be coupled to the mounting sheet 2304 of the bandage assembly 2308 in a manner that defines a tear path 2362 along which the tear strips 2309 are drawn to separate the bandage 2310 from the support 2330. The tear strips 2309 may be coupled to the tension sheet 2307 of the bandage assembly 2308 in a manner that defines a tear path 2362 along which the tear strips 2309 are drawn to separate the bandage 2310 from the support 2330. Each tear strip 2309 may include a top section 2347 and a bottom section 2348. The bottom section 2348 may be unattached or free from the support 2330 as shown. The top section 2347 of each tear strip 2309 may be adjacent to the dressing 2310 but unattached thereto. The tensioning sheet 2307 and the attachment sheet 2304 may be manufactured to be tearable along the length of the material while providing tensile strength in other directions, particularly in the tensioning direction of the material of the tensioning sheet 2307 (the direction in which the dressing is tensioned, stressed, or strained). An example of such a material is an LDPE polymer produced by an extrusion process that creates directionally biased grains, whereby the material is tearable in the direction of the grain but has a relative resistance to tearing in a direction transverse to the grain. Incisions may be made in the tensioning sheet 2307 and the attachment sheet 2304 that facilitate tearing along the path 2362. The tension sheet 2307 and the attachment sheet 2304 may additionally or alternatively comprise a material such as low density polyethylene (LDPE) with perforations formed along the tear lines 2362 .

[0339] 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 tension sheet 2307 and the attachment sheet 2304. Sections 2365 and 2375 of the tension sheet 2307 and the attachment sheet 2304, respectively, may remain on the back side 2311 of the elastic sheet 2360. Sections 2385, 2395 of the attachment sheet 2304 and the tear sheet 2307, respectively, that are joined to the tear strip 2309 may thereby be separated from the tension sheet 2307 and the attachment sheet 2304. Sections 2365 and 2375 of tension sheet 2307 and attachment sheet 2304, respectively, that are attached to dressing 2310 may thereby be separated from the remainder of tension sheet 2307 and attachment sheet 2304 that are attached to support structure 2330 at their ends 2305 and 2306. Thus, dressing 2310 may be released from the remainder of support structure 2330.

[0340] The dressing 2310 may have an unattached portion or edge 2315 on its sides 2305, 2306, respectively, where the elastic sheet 2360 is released from the tension sheet 2307 and the attachment sheet 2304. Thus, the dressing 2310 may not be distorted at the unattached portion 2315. The unattached section 2315 of the elastic bandage 2310 may not be distorted and may be free of adhesive of the adhesive layer 340 (or may have a reduced amount of adhesive thereon). Thus, lower stresses may be generated at the unattached side or edge defined by the section 2315.

[0341] In use, the adhesive liner 2350 may be removed and the dressing 2310 may be applied to the surface of a subject's skin. Tear strips 2309 on each side of the dressing at the tear line may be retracted to separate the dressing 2310 from the support structure 2330, mounting sheet 2304, and tension sheet 2307 after the dressing has been applied to the surface of the subject's skin. When the support structure 2330, mounting sheet 2304, and tension sheet 2307 are removed from the dressing 2310, the stress or strain in the dressing 2310 may apply a (tangential) compressive force to the skin, thereby treating the skin.

[0342] 24, multiple warped dressings 2410 may be warped in a manner similar to dressing 2310, and then each may be rolled up as shown in FIG. 24 and attached to a first surface 2460 of a single support 2430 that is stored in the rolled configuration for dispensing. The warped dressings 2410 may be bonded to the first surface 2460 of the single support 2430 by an adhesive, such as, for example, a high tack / low peel PSA, that maintains the dressing 2410 in the warped configuration. Liners 2450 may be placed on a second, opposing side 2470 of the support 2430, positioned such that they are over the skin adhesive on the dressing 2410 when the support 2430 is rolled. The adhesive liner 2450 may also help minimize creep properties of the warped dressing 2410. The support 2430 may be rolled up for storing the dressing 2410. When the support 2430 is unrolled, the adhesive liner 2450 located on the second side 2470 and facing the dressing 2410 may be released from the dressing 2410. The dressings 2410 may be separated by perforations 2480 so that they may be used individually.

[0343] In some variations, the dressing may be used for the treatment of chronic injection sites or catheter sites required for various conditions, including, but not limited to, diabetes, cancer, immune deficiencies such as severe combined immunodeficiency, and the like. It is hypothesized that treatment of skin injection / infusion sites may not only reduce the occurrence of scar tissue or other hyperproliferative disorders associated with frequent injections or chronic infusions, but may also have other mechanical effects on pharmacokinetics, which may improve drug distribution in tissue, reduce drug leakage, increase depth of effect, reduce pain at the injection / infusion site, reduce risk of site infection, reduce risk of line / pump blockage at the infusion site, improve analyte or drug level variability, reduce inflammation layer thickness or depth, and reduce dosage levels. For diabetic patients, skin treatment may result in less glycemic fluctuation, improved time in range as measured by multiple daily fingersticks or continuous glucose monitoring (CGM), and increased insulin bolus volume and / or area in the subcutaneous tissue.

[0344] In some examples, the dressing, and optionally one or more of the dressing support structures, may include one or more openings that may facilitate use of the warped dressing with an indwelling catheter, cannula, or sensor inserted into tissue. In other examples, a device used with the dressing, such as a needle or needle biopsy tool for blood sampling, may be transiently inserted through the dressing. FIG. 30A depicts one embodiment of a warped dressing 3000 with an opening 3002 applied to a target site 3004 and released from its applicator (not shown) to transfer stress from the dressing 3000 and relieve tension on 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 opening 3002 into the skin or subcutaneous tissue at the treatment site. In this particular example depicted in Figures 30B-30D, an infusion set 3006 for use with a medication pump includes a housing 3008, connector tubing 3010, a support layer 3012 for an adhesive layer, and a needle 3014. In this particular embodiment, the needle has an acute orientation relative to the plane of the support layer 3012, but in other examples, the needle may have an orthogonal orientation, or may be coplanar or otherwise parallel to the plane of the housing or support layer. The needle length may or may not extend beyond the peripheral boundary of the housing or support layer. The needle sheath (not shown) and / or 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 Figure 30B, until the needle 3014 is fully inserted into the target site 3004 and the adhesive of the support layer 3012 is adhered to the dressing 3000 and / or the target site 3004. In some further variations, a protective dressing may be applied partially or completely over the strained dressing and infusion set, hi some variations, the direction of strain in the dressing may 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.

[0345] In addition to manual insertion of the needle of the infusion set or indwelling device through an opening in the dressing, 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 otherwise require less dexterity than a smaller infusion set, or may conceal the delivery needle from the user and / or may automatically insert and / or remove the delivery needle during the insertion procedure, which may improve compliance or other aspects of the user experience. In Figures 31A-31C, for example, a dressing 3000 with an opening 3002 may be placed at a target site 3004 where an infusion set 3020 includes an exposed orthogonal needle 3022 that is releasably coupled to a larger delivery device or device 3024. The delivery device 3024 and / or needle 3022 are aligned with the dressing 3000 and / or opening 3002 as shown in FIG. 31A and then placed against the dressing 3000 as shown in FIG. 31B. The actuator 3026 on the device 3024 is then activated to separate the pod 3024 from the infusion set 3020. In this particular embodiment, the infusion set 3020 does not have an adhesive backing layer that extends beyond the peripheral boundary of the infusion set housing 3021. Instead, the adhesive may be provided directly on the underside of the housing 3021 with or without any backing layer therebetween. FIGS. 31D and 31E are cross-sectional views depicting the actuation mechanism of the delivery device 3024 and the removal of the delivery device 3024 from the infusion housing 3021. The infusion housing 3021 may be mechanically attached to the delivery device 3024 by friction and / or by one or more mechanical interlocks 3030. To release the injection device 3020, the actuator 3026 is depressed and the plunger tip 3032 engages the catch lever 3034, releasing the injection housing 3021. The actuator 3026 and plunger tip 3032 are maintained in a disengaged position by a spring 3036.In another variation, the injection housing may be releasably attached using an adhesive, such as a gel, that temporarily adheres the plunger tip to the top surface of the injection housing.

[0346] While the exemplary dressings described above include a single centrally located circular opening, in other examples the opening 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 different openings and / or to facilitate alignment of the dressing with the target location and / or inserted device. Some variations may also include more than one opening, for example, two, three, four, five, or more openings. In still other examples, the dressing may be provided without an opening, and an infusion set, syringe, or needle of an insertion device is used to puncture the dressing and then inserted through the skin or tissue.

[0347] FIG. 32A depicts an exemplary embodiment of the dressing 3000 of FIGS. 30A-31C. The dressing 3000 comprises an oval shape with rounded corners and a centrally located circular opening 3002. The opening 3002 may have a diameter of approximately 0.10 inches to 0.30 inches or 0.05 inches to 0.20 inches. The dressing 3000 has a longitudinal length that exceeds its lateral width, although in other examples the dressing may be radially symmetric. The length and / or width of the dressing may be within the range of 4 cm to 16 cm, or 2.5 cm to 5 cm, or 9 cm. 2 ~19cm 2 or 46cm 2 ~70cm 2 may have a surface area of

[0348] FIG 32B depicts another exemplary embodiment of a dressing 3200 comprising multiple openings 3202, 3204, 3206. In this particular embodiment, the openings 3202, 3204, 3206 are linearly aligned with one another and, optionally, along a central longitudinal axis of the dressing 3200, as shown in FIG 32B. Optional indicia 3208, 3210, 3212 may be provided to facilitate changing the insertion location during a single use of the dressing 3200. FIG 33 depicts the dressing 3200 placed against a skin location.

[0349] 32C depicts another exemplary embodiment of a dressing 3220 comprising multiple openings 3222, 3224, 3226, 3228. In this example, one opening 3222 is centrally located while the other three openings 3224, 3226, 3228 are eccentrically located and none of the three openings are linearly arranged. In other examples, the openings may all be eccentrically located. Indicia 3230, 3232, 3234, and 3236 may be provided for each opening 3222, 3224, 3226, 3228, along with other optional indicia such as a spiral line 3238 that may be used to indicate relative location.

[0350] Other exemplary dressings may include dressings with one or more opening shapes that are non-circular. Figure 32D, for example, depicts a dressing 3240 with an oval opening 3242, and Figure 32E depicts a dressing 3250 with a diamond or parallelogram opening 3252.

[0351] FIG. 34 depicts another variation of a dressing 3400 that includes indicia 3404 to facilitate identification and / or alignment with the dressing opening 3402. In this particular embodiment, the indicia 3404 are provided in four orthogonal directions from the opening 3402. These indicia may be useful for identifying the location of the opening 3402, particularly in situations where the dressing 3400 comprises a transparent material and the underlying skin may be patchy or have extensive markings from scarring or skin damage, making identification of the opening 3402 more difficult. The indicia may be laser etched or printed onto the dressing surface. FIG. 35 depicts placement of a warped dressing 3400 onto a skin location and then its release from an applicator (not shown). Once adhered to the skin location, the markings 3404 may be used to facilitate insertion of a syringe needle 3406 or other access device, while strain transferred from the dressing 3400 may reduce tissue responses from needle insertion that form scar tissue or induce lipohypertrophy. While the markings 3404 in FIGS. 34 and 35 contact or are otherwise in close proximity to the opening 3402, in other examples the markings may be provided along the periphery of the dressing or span the dressing area between the opening and the edge of the dressing. This may be useful for aligning a laser device, which once positioned across the dressing may obscure the opening in 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, the dressing may be provided without an opening, and a needle from an infusion set, syringe, or insertion device is used to puncture the dressing and then inserted through the skin or tissue.

[0352] In other embodiments, such as depicted in FIG. 36, 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 indentation 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 include optional indicia or markings to facilitate alignment with the guide tool indentation 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 secondarily be 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 or the same size in other embodiments. The visual guide tool 3600 may also include indicia 3606 around its opening 3604, which may or may not include an opaque material that may make it easier to visualize the opening 3604. The underside of the visual guide tool may include an adhesive to help maintain the position of the tool 3600 during use. The tool 3600 includes an elongated body with an opening 3604 at a distal end, and a proximal end may be used to grasp and manipulate the tool 3600 during the procedure.

[0353] In one exemplary procedure, the user would clean and prepare the skin site with an isopropyl alcohol wipe or other sterile preparation. The dressing is then strained using an applicator if the dressing is not a pre-strained dressing and then placed on the desired site. The applicator is then removed to transfer the strain to the skin. If a visual guide is not required, the patient can insert a needle into an orifice in the dressing and administer the injection. If a visual guide is required, place a guide on the dressing, insert the needle through the visual target, and administer the injection. For cases where there is an existing dressing with multiple openings, subsequent injections may follow a rotational sequence, injecting at site number 1, followed by number 2, followed by number 3, and so on. In some variations, depending on the skin condition, the dressing may last up to 10 days, and injections using the dressing may be performed as frequently as three times per day. At the end of the wearing cycle (average 7-10 days), the dressing is removed and replaced with a new dressing.

[0354] 37A and 38B depict another embodiment of a visual guide tool 3700. In this embodiment, the tool 3700 comprises an elongated body 3702 with an enlarged distal end 3704 and a large distal opening 3706. The distal opening 3706 may be configured with a border edge 3708 that allows visualization of the outer edge of the dressing 3000, excluding radially inward ridges 3710, 3712, 3714, and 3716. These radially inward ridges 3710, 3712, 3714, and 3716 can help indicate the location of the dressing opening 3002 when the tool opening 3706 is positioned to surround the dressing 3000. Although four protrusions 3710, 3712, 3714, and 3716 are depicted in Figures 37A and 37B, in other embodiments a different number of protrusions may be provided at other locations along the boundary edge 3708 of the opening 3706 and may be of different shapes, sizes, and lengths than the four orthogonal protrusions 3710, 3712, 3714, and 3716 of Figures 37A and 37B, for example, the protrusions may have an arrowhead shape.

[0355] 38A and 38B, in some variations, the overhangs 3710, 3712, 3714, and 3716 may be configured to facilitate positioning of a delivery device or pod, such as the delivery device 3024 of FIGS. 31A-31B. In this example, the lengths of the overhangs 3710, 3712, 3714, and 3716 are configured such that when the pod 3024 is properly aligned with the overhangs 3710, 3712, 3714, and 3716 of the tool 3700, the ends 3718, 3720, 3722, 3724 of the overhangs 3710, 3712, 3714, and 3716, respectively, contact or are equally spaced apart from the outer periphery 3028 of the delivery device 3024. Thus, the configuration of radially inward ridges 3710, 3712, 3714, and 3716 may facilitate alignment and positioning of the pod 3024 during use.

[0356] 39A-39E, the strainable or strained dressing 3926 may be pre-strained at the time of manufacture into an infusion set 3921 or assembly as depicted in FIG. 39A-39E. The system may optionally include a delivery device 3900 with a body 3904, a lower edge 3906, and an actuator 3908. Releasably attached to the bottom of the body 3904 is an infusion housing 3921 of an infusion set 3920, including a needle 3922, connector tubing 3924, and a tension dressing layer 3926 that extends beyond the lower edge 3906 of the delivery device 3900 and the housing 3921. The tension dressing layer 3926 further comprises a skin adhesive on its lower surface that is removably covered by one or more adhesive protective liners 3928. The liner 3928 may include a liner tab 3930 extending further from the liner 3928 to facilitate removal of the liner 3928 from the adhesive on the tensile bandage layer 3926. The tensile bandage layer 3926 is maintained in a stressed configuration by a rigid applicator or tensile support structure 3932 that includes one or more pull tabs 3934 to facilitate separation of the tensile bandage layer 3926 from the tensile support structure 3932 during use. The pull tab 3934 attaches the dressing layer 3926 and the support structure 3932 together but includes perforations or adhesive that facilitate separation of the dressing layer 3926 and the support structure 3932 when the pull tab 3934 is pulled away from the device. The tension support structure 3932 or applicator may be removed from around the infusion housing 3921 by passing the structure 3932 over the connector tubing 3924 or by tearing the structure 3932 away from the housing 3921.

[0357] In one exemplary implantation procedure for the integrated infusion set 3920, a skin insertion site is selected and prepared with an isopropyl alcohol wipe or other sterile preparation. A protective needle sheath (not shown) is first removed from the needle 3922 of the integrated infusion set 3920 as it is engaged to the delivery system 3900. Next, the adhesive protective liner 3928 is removed to expose the adhesive on the underside of the pre-strained tension dressing layer 3926. However, in other embodiments, the needle cover may be integrated with the liner such that removal of the needle sheath removes the protective liner in parallel, or vice versa. The delivery system 3900 and infusion set 3920 are then positioned at the desired insertion site and the needle is advanced into the skin, either manually or via a needle advancement mechanism. Once inserted, the system 3900 may be used to push the infusion set 3920 against the skin or otherwise held in place to promote bonding between the adhesive and the skin tissue surrounding the needle 3922. An actuator 3908 on the system 3900 is then actuated to release the infusion set housing 3920 so that the delivery system 3900 may be removed, as depicted in FIG. 40A. In other examples, the infusion set 3920 with an integrated dressing may be inserted without the use of a delivery system 3900.

[0358] 40B, the pull tab 3934 is removed from the infusion set 3920, which allows the strained dressing layer 3926 to decouple from the tensile support structure 3932, thereby allowing the strained dressing layer 3926 to transfer its tensile stress to a compressive force acting on the tissue surrounding the needle 3922. In some variations, the tensile support structure 3932 may be left in place after the pull tab is removed, while in other examples, the tensile support structure 3932 may be removed to reduce the bulk and / or stiffness of the indwelling infusion set 3920. In some variations, the tension support structure 3932 may be removed by passing it over the connector tubing 3924 when the connector tubing 3924 is not yet coupled to the infusion pump, as depicted in FIG. 40C, leaving the infusion set 3920 with the dressing layer 3926 transmitting compression to the underlying skin tissue, as depicted in FIG. 40D. In other variations, as depicted in FIG. 40E, the tension support structure 3932 may include slits or perforations 3940, which may allow the tension support stru...

Claims

1. 1. An integrated infusion set comprising: an infusion set comprising an infusion housing, a needle, and connector tubing; a prestrained dressing attached to a bottom of the injection housing, the prestrained dressing comprising: a 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 tension support structure configured to maintain the tension bandaging layer in a stressed configuration, the tension support structure comprising one or more pull tabs; A pre-strained dressing comprising:

1. An integrated infusion set comprising:

2. 10. The infusion set of claim 1, wherein each of the one or more adhesive protective liners further comprises a liner tab extending from the adhesive protective liner and configured to facilitate removal of the adhesive protective liner from the skin adhesive.

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

4. The infusion set of claim 3 , wherein the delivery device comprises a body, a lower edge, and an actuator.

5. The infusion set of claim 4 , wherein the tensile dressing layer extends beyond the lower edge of the delivery device.

6. The infusion set of claim 4 , wherein the actuator is configured to separate the delivery device from the infusion housing.

7. 10. The infusion set of claim 1, wherein the tensile support structure comprises slits or perforations that allow the tensile support structure to be pulled or torn away from the infusion housing or connector tubing.

8. 10. The infusion set of claim 1, wherein the tensile support structure is a semi-rigid or rigid cardboard or polymer layer adhered to an upper surface of the tensile dressing layer.

9. The infusion set of claim 1 , wherein the prestrained dressing is a multi-layer dressing.

10. 10. The infusion set of claim 9, wherein the multi-layer dressing comprises a base layer and a peel-off top layer configured to remove the infusion set from the base layer.

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