Tensioned Injection System with Removable Hub

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 to align the catheter or cannula with the opening may be used to apply the dressing to a subject. The packaging, applicator, and / or tensioning device may apply and / or maintain a strain in the elastic dressing.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a) a continuation of U.S. Application No. 17 / 838,027, filed June 10, 2022, and b) claims priority to U.S. Provisional Application No. 63 / 211,359, filed June 16, 2021, which are incorporated herein by reference in their entireties. This application is also related to U.S. National Stage Application No. 17 / 784,328, filed December 10, 2020, U.S. Provisional Application No. 62 / / 946,345, filed December 10, 2019, U.S. Patent No. 8,592,640, U.S. Patent No. 9,248,048, U.S. Patent No. 9,844,470, and U.S. Patent No. 11,013,638, which are incorporated herein by reference 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 two days to one 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 from about four days to several weeks, depending on the nature of the wound, and it is during this phase that a hypertrophic scar usually forms. The final phase is called the remodeling phase. During the remodeling phase, the previously organized, randomly organized matrix is ​​remodeled into a highly cross-linked and aligned tissue structure that increases mechanical strength.

[0003] Although the histological features characteristic of hypertrophic scars have been well documented, the underlying pathophysiology is not well known. Hypertrophic scars are a secondary effect of excessive wound healing, generally resulting in the 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 on which they form and the underlying ethnicity of the affected individual. 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 tissue of susceptible individuals, most commonly following trauma. Keloids are often more severe than hypertrophic scars because they tend to spread into normal adjacent tissue, whereas hypertrophic scars tend to remain confined within the original scar boundaries.

[0005] Scar tissue can also form from repeated tissue injury, such as in patients requiring 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. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2006 / 0037091 Summary of the Invention [Means for solving the problem]

[0007] 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 outer skin tissue at or near the skin site, i.e., at or adjacent to the wound or treatment site on the subject's skin.

[0008] However, some tissue responses and diseases are associated with tissues below the epidermal layer of the skin. The subcutaneous region, or hypodermis, is the deepest layer within the skin and varies in depth from the epidermis. Skin thickness averages 1.5 to 2.7 mm across various body regions and has a different density and elasticity compared to the underlying subcutaneous tissue. While the epidermal tissue is developmentally derived from the endoderm and contains collagen and other connective tissues with higher tensile strength, the hypodermis is developmentally derived from the mesoderm and contains loose, loose connective tissue. For these reasons, it is uncertain whether planar load forces acting on the epidermis will be conducted through the dermis to the hypodermis or other anatomical structures below the epidermis. Nevertheless, it is hypothesized herein that mechanical interactions between the epidermis / dermis and subcutaneous tissue may have some mechanobiological effects on subcutaneous tissues and structures.

[0009] 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, which is believed to be a hypertrophic effect of chronic, localized insulin injections on adipocytes. Lipohypertrophy can adversely affect insulin injection or infusion rates due to structural changes in the tissue, which can reduce insulin diffusion. A typical injection using an insulin pump involves placing a cannula or needle into a delivery site (e.g., abdomen, arm, buttocks, thigh) every few days. Over time, this can induce lipoatrophic changes in the skin and subcutaneous structures, which can lead to unpredictable or erratic insulin absorption. Ultimately, patients may be limited in available injection sites on their body due to lipohypertrophy. While lipohypertrophy and lipoatrophy effects are believed to be induced by insulin itself, it is hypothesized that tension unloading of the injection site may also reduce this insulin effect and improve variability and / or overall absorption at the injection site. This may occur by reducing fibrosis formation, 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 tensioning dressings or dressing components may extend the usable duration of an infusion set or sensor, for example, from 2-3 days to 4-7 days. This may also result in a reduction in the size, surface area, depth, and / or severity of inflammation at the injection / infusion site.

[0010] It is also believed that treatment of injection and / or infusion sites of diabetes therapies may have other effects separate from affecting the development of scar tissue or lipohypertrophy. For example, treatment of injection sites and / or injections at sites already treated with a skin tensioning device may improve insulin dispersion 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 an increase in insulin bolus volume and / or surface area per unit injection. Mechanomodulation effects may result in improved insulin absorption, accompanied by a reduction in the average total insulin dose daily, weekly, and / or monthly, and / or improved glycemic time in range daily, weekly, and / or monthly, and a reduction in the 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 and / or pump alarms from occlusion as a result of mechanically stabilizing the tissue.

[0011] The therapies described herein are not limited to the treatment of diabetic sequelae or diabetes treatment, but may also be applied to injectable therapies or subcutaneous lesions or disease states, or even other disease states involving intramuscular injections. It is hypothesized that general changes in drug absorption or diffusion in the subcutaneous layer, or relative changes in vascular flow between the dermis and subcutaneous tissue, reduced tissue inflammation in the dermis and / or hypodermis, and / or prevention or reduction of the development of subcutaneous tissue lesions may be achieved. This may include the treatment or prevention of other lipodystrophy conditions, both acquired and inherited. The therapies described herein may be used for continuous, one-time, or intermittent treatment, or temporary or intermittent treatment of chronic injection, infusion, or implantation sites. This may include, for example, treatment of sites for indwelling insulin pumps, indwelling or implanted continuous glucose monitoring sensors, chronic injections of autoimmune or oncology therapies, hemodialysis, joint or sleep apnea implants, neurostimulator electrodes, contraceptive implants, and the like.

[0012] In one embodiment, an integrated infusion set is provided, comprising: an infusion assembly attached to an upper surface of a tension bandage layer, the infusion assembly configured for insertion into a treatment site; an infusion conduit; a releasable attachment structure attaching an infusion hub to the upper surface of the tension bandage layer; a pre-strained dressing comprising the tension bandage layer, a skin adhesive on a lower surface of the tension bandage layer, one or more adhesive protective liners removably covering the skin adhesive; and a tension support structure configured to maintain the tension bandage layer in a stressed configuration, the tension support structure comprising one or more pull tabs. The infusion assembly further comprises an infusion housing attachable to the infusion hub, the infusion housing may include tubing in fluid communication with a cavity in the infusion housing, the cavity configured to receive the infusion hub and provide fluid communication between the tubing and the infusion conduit. The infusion conduit may be an infusion needle or an infusion catheter. The infusion set may further include an infusion set applicator releasably attachable to the infusion hub and further include a needle configured to removably extend through the infusion hub and out the distal end of the infusion conduit. The releasable attachment structure may include a removable segment to which the infusion hub is attached. The releasable attachment structure may include two or more non-removable segments coupled to the removable segment. The two or more non-removable segments coupled to the removable segment may be coupled via a tear or frangible structure. The tear structure may include multiple perforations. The frangible structure may include frangible struts. The removable segment may include a pull tab or handle. The non-removable segment may include a split ring or multiple arcuate bodies attached to the tensioning dressing layer. The non-removable segment may include a slot configured to movably receive a tab located on the removable segment. The removable segment may be integrally formed with the infusion hub. The slot may be an arcuate slot. The infusion hub may further comprise a hub body and a hub base, the hub body releasably attachable to the hub base, and the hub base attached to the tensioning dressing layer. The hub body may comprise a releasable latch.The infusion set may further include a removal tool configured to actuate a releasable latch on the hub body to facilitate separation of the hub body from the hub base. The hub base may comprise a softer material than the hub body. The removal tool may include a protrusion with a tab configured to actuate the releasable latch on the hub body, the tab of the protrusion configured to lock onto the hub body. The hub body may include an access channel to the release latch configured to receive the protrusion with the tab. The injection housing may include a release latch configured to unlock the injection housing from the injection hub.

[0013] In another embodiment, a method of treating a treatment site is provided, comprising removing a first infusion housing from an infusion hub attached to the treatment site via a tensioning bandage, and separating at least a portion of the infusion hub from the tensioning bandage while leaving the tensioning bandage attached to the treatment site. The method may further comprise inserting a cannula of the infusion hub into the treatment site and adhering the tensioning bandage around the treatment site. The cannula inserting step may be performed using an applicator coupled to the infusion hub. The cannula of the infusion hub may include inserting the cannula of the infusion hub into the treatment site alongside a needle of the applicator. The method may further comprise decoupling the applicator from the infusion hub after inserting the cannula of the infusion hub. Decoupling the applicator from the infusion hub may also cause the needle to be removed from the cannula of the infusion hub. The method may further include attaching the infusion housing to the infusion hub and infusing therapy through the tubing of the infusion housing and through the cannula of the infusion hub. The method may further include leaving the tensioning dressing on the treatment site for at least 12, 24, or 48 hours after separating the infusion hub. The method may further include separating the infusion housing from the infusion hub prior to separating the infusion hub from the tensioning bandage. Separating the infusion hub from the tensioning bandage may include inserting a removal tool into the infusion body of the infusion hub and pulling the infusion body away from the infusion base of the infusion hub. Separating at least a portion of the infusion hub from the tensioning bandage may include separating all of the infusion hub from the tensioning bandage. Separating at least a portion of the infusion hub from the tensioning bandage may include pulling a tab on an attachment structure that attaches the infusion hub to the tensioning bandage and tearing the attachment structure along the perforations to separate the infusion hub from the tensioning bandage and the non-removable portion of the attachment structure. Separating at least a portion of the infusion hub from the tensioning bandage may include breaking the infusion hub from the tensioning bandage.Breaking the infusion hub from the tensioning bandage may include breaking a frangible post of an attachment structure attached to the tensioning bandage and to the infusion hub. Separating at least a portion of the infusion hub from the tensioning bandage may include rotating the infusion hub from an attachment slot of the attachment structure. Separating at least a portion of the infusion hub from the tensioning bandage may include rotating the infusion hub from a spiral interface of the attachment structure.

[0014] According to variations, manipulating mechanical or physical properties may thereby modulate 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 surrounding tissue in one, two, or more directions to manipulate endogenous or exogenous stress at the skin site in one, two, or more directions. According to variations, the devices and methods described herein may reduce or otherwise manipulate stress experienced by the skin and / or wound and surrounding tissue to treat a subject. The device may also help prevent or reduce the occurrence of wound dehiscence.

[0015] 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.

[0016] 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 resection, body contouring, pre- or post-operatively to pre-treat or pre-condition the skin; in mastectomy skin expansion, topically or subcutaneously. These devices may or may not include, for example, the use of energy modalities such as microwaves, radiofrequency ablation, high-intensity focused ultrasound, lasers, infrared light, incoherent light, etc., to lift, fixate, hold, or move skin for various purposes, such as in aesthetic skin treatment or resurfacing, during weight loss, or for aesthetic purposes; hair removal or epilation; treating and / or closing skin injuries, such as incisions, wounds, chronic wounds, pressure sores, and ulcers (including venous stasis ulcers); preventing or reducing the occurrence of wound dehiscence and diabetic skin or wound conditions; burn healing and / or relief; acting as an occlusive or negative pressure wound dressing; protecting an incision or wound, e.g., preventing splitting or opening, and protecting the umbilicus of a newborn after cutting the umbilical cord. Such treatments may include the use of drugs or other therapeutic agents that can be applied to the skin using such devices. Agents may include, but are not limited to, antibiotics, antifungals, corticosteroids, and immunomodulatory components, including 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 sizes or geometries of body regions. 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 the hands, fingers, nail beds, axillae, breasts, nipples, areolae, back, abdomen, groin, buttocks, perineum, labia, penis, scrotum, thighs, lower legs, plantar surfaces of the feet, dorsum of the feet, and / or toes. Such devices may also be referred to herein as "dressings," "skin devices," or "skin treatment devices."

[0017] In some situations, immediate, fast, or simple application of a dressing may be desirable. The devices, kits, and methods described herein may be for preparing and / or applying a dressing to the skin, and separating an applicator, tensioning device, or dressing carrier, support, or base from the skin device.

[0018] The devices, kits, or methods described herein may include packaging, carriers, supports, bases, applicators, or tensioning devices, each of which may at least temporarily contain, hold, carry, or support a 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 stress or strain 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 bandage material so much that the adhesive on the bandage material would stick to itself. For example, when some variations of the bandage material are held or supported in a cantilever configuration at one point or along one edge of the bandage, the bandage material will not sag, deform laterally, or otherwise deform out of plane under its own mass or configuration.

[0019] In some other variations of the devices and methods herein, the two opposing edges of the device and support structure are placed under a compressive load that causes axial compression or lateral deformation before the device buckles or folds, for example, when a force similar to the grip of a hand is applied to the edge of the device, the device has a substantially rigid support structure, or provides structural support to the dressing and a certain resistance to bending or column strength.For example, the resistance to bending can be characterized as the peak force achieved when the device and support structure are compressed by 25% of their original dimensions without being compressed.This column strength or rigidity can 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 comprising 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, which is transverse to the thickness of the device / support structure. According to such variations, the device may have, for example, a length-to-width aspect ratio of greater than 1:1, 2:1, or 3:1.

[0020] The resistance of a dressing to bending in the direction of strain may also be measured by three-point bending, in which a lateral force is applied 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 approximately 0.75 inches, and a force ranging from approximately 1 to 1.25 pounds may be applied to a sample approximately 0.35 inches wide, resulting in a deflection of approximately 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 approximately 0.45 pounds may be applied to a simply supported sample approximately 0.35 inches wide, resulting in a deflection of approximately 0.004 inches. Resistance to bending may also be characterized by the strain on 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.

[0021] 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 ranging from 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 a 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 that 7 cm width. In some variations, the support structure may include folds or regions of reduced thickness to allow it to flex to some extent in at least one direction, or both directions.

[0022] According to some variations, a device providing structural support may have multiple supporting cross elements or segments extending from one edge of its length to an opposing edge of its length (or from one edge of its width to an opposing edge of its width). According to some variations, there may be three or more cross elements, e.g., cross elements extending laterally along two opposing edges and across the width (or length), and one or more cross elements extending across the width (or length) and between cross elements along two opposing edges. Such cross elements may or may not be bonded or connected to each other, for example, 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.

[0023] The packaging and / or applicator may also provide structural support or stability for the dressing as it is oriented and / or applied to the subject's skin. 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., before or after 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 subject's skin. For example, in some situations, particularly when longer or larger dressings are used, the packaging or applicator provides structural support for the dressing so that a user can effectively grasp, manipulate, and / or apply the prepared dressing with one hand. According to some variations, the assembly includes 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 include a material or structure that is, at least in part, more rigid than the dressing to be applied to the subject. The support structure may include one or more elements or sections. It 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 when 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 present in the first direction and less structural support is provided in the second direction. According to some variations, one or more support structures may extend beyond the edge of a first opposing side. According to some variations, one or more support structures may extend at least partially beyond at least a portion of the edge of a 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 structure 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 a wound of a 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 manipulate or manipulate the support or applicator so as to provide 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 a limit may be selected to prevent or resist the user from touching the dressing or the adhesive on the dressing when grasping the edge to manipulate the dressing carrier, support, applicator, or base.

[0024] 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 the skin surface using a skin adhesive to transmit a generally planar (e.g., compressive) force from the bandage to the skin surface.

[0025] In some variations, a bandage is provided comprising an elastic sheet structure (e.g., comprising a silicone polyurethane, TPE (thermoplastic elastomer), synthetic rubber, or copolyester material) having an upper surface, a lower surface, a first edge, a second edge opposite the first edge, and one or more adhesive regions. The bandage may further comprise a first release liner releasably attached to the adhesive region or regions. The adhesive regions may comprise a pressure-sensitive adhesive. The bandage may be tapered or otherwise shaped to reduce skin tension at the edges. The bandage may have modified, reduced, or no adhesive near its edges to reduce skin tension at the edges. A portion of the bandage may be unstrained, thereby reducing strain in an area of ​​skin to which the bandage is applied. In some specific examples, the unstrained area or areas are found between the edge of the bandage and the strained area. In some further embodiments, the unstrained area is limited to this area and is not found among the strained areas of a single dressing in use during application or use. In 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.

[0026] A packaging device, a bandage carrier, a bandage support, a bandage base, an applicator, and / or a tensioning device may be provided. The packaging device, the bandage carrier, the bandage support, the bandage base, the applicator, and / or the tensioning device may be configured to impart stress and / or strain to the bandage prior to application to a subject. The device may be used to impart and / or maintain strain to the bandage. In one variation, a bandage is provided comprising a first device attachment structure, zone, or region, a second device attachment structure, zone, or region, and a structure or mechanism configured to impart a separation force between the first and second device attachment structures, zones, or regions. The device may further comprise a releasable locking mechanism, attachment mechanism, or adhesive configured to maintain the member or mechanism in the strained configuration.

[0027] In some situations, 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 enabling the application of a compressive force using the device during or after the dressing is applied. A clotting additive may also be provided on the dressing.

[0028] 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.

[0029] According to some variations, the packaging is also sufficiently flexible in at least one direction to allow the bandage to bend or mold to conform to the curvature or shape of the body or skin location where the bandage is applied. Generally, the flexibility of the packaging used to allow the bandage to conform to the treatment site may be configured so that the treatment site is not substantially deformed during application of the bandage, so that application of the bandage is relatively smooth or uniform on the skin, and / or so that a uniform, predetermined, or relatively predictable strain or force is applied to an area of ​​skin. The packaging or applicator may be flexible in one direction and more rigid in another direction. The packaging or applicator may include elements or sections that allow flexibility relative to adjacent elements or sections.

[0030] According to some variations, the packaging is also sufficiently flexible in at least one direction to allow the bandage to bend or mold to conform to the curvature or shape of the body or skin location to which the bandage is applied. Generally, the flexibility of packaging used to allow the bandage to conform to the treatment site may be configured so that the treatment site is not substantially deformed during application of the bandage, and / or so that application of the bandage is relatively smooth or uniform on the skin, and / or so that a uniform, predetermined, or relatively predictable strain and / or force is applied to an area of ​​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 strain-imparting direction or have a component transverse to the strain-imparting direction. The second direction may be the strain-imparting direction or have a component in the strain-imparting direction. The first direction may or may not be transverse to the second direction. The package or applicator may include elements or compartments that allow flexibility relative to adjacent elements or compartments.

[0031] According to some variations, the desired flexibility, for example, having at least one component transverse to the direction of strain application, may be characterized using a modified cantilever beam 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 package or applicator around an object with a predetermined 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 predetermined curvature with a radius of about 2.5 inches may be about 3 pounds or less. In another variation, the force to bend around a predetermined curvature with a radius of about 2.5 inches may be about 0.3 pounds or less.

[0032] According to some variations, a packaging, applicator, or tensioning device is provided that includes a base having an inner surface to which a 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 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.

[0033] In some variations, the book-like structure comprises a layered structure comprising, in the closed configuration, 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, the 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 attached symmetrically to the book-like structure relative to the bending region of the book-like structure.

[0034] In another embodiment, a method for applying a bandage to a surface is provided. According to some variations, the method may include providing a bandage package comprising: an applicator including a base structure having an inner surface and a manipulation portion; a bandage having a first surface configured to be applied to the skin or wound of a subject; a back surface, the back surface of the bandage being removably coupled or anchored to the inner surface of the base structure and the first surface facing away from the inner surface of the base structure; and a cover configured to removably cover the first surface of the bandage. The method may further include removing the cover to expose the first surface of the bandage; and using the manipulation portion of the base structure to apply the first surface of the bandage to the wound or skin of the subject. In another variation, a method for treating a wound is provided, comprising straining 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 bandage to a skin site or to both the strained and unstrained regions.

[0035] 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, 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 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 is in interfacial contact with and 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 is in interfacial contact 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 base being configured to apply a straining force to strain the dressing when the cover is moved from the first position to the 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 the inner surface of the base structure and a second structure configured to couple the dressing at the second attachment region to the 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 the first position to the 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 some variations, the second width is at least 20% greater than the first width. According to some variations, the second width is at least 40% greater than the first width.According to variations, 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 variations, the at least one relatively rigid element comprises a plurality of flexible coupled relatively rigid elements. According to variations, the cover structure comprises at least one relatively rigid element and at least one relatively flexible element. According to variations, the release device is configured to release the dressing from the base structure after the dressing has been applied to the wound or skin of the subject. According to some variations, the base structure is pivotally coupled to the cover structure.

[0036] According to a variation, the dressing packaging assembly includes a base structure having an inner surface and including at least one support element and at least one flexible element; a dressing including 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 includes multiple rigid elements coupled to each other using at least one flexible element. According to a variation, the cover structure includes an opposing surface configured to interface with the first surface of the dressing, and the cover structure is movably coupled to the base structure so as to move 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 includes at least one support element and at least one flexible element that is sufficiently flexible to allow the cover structure to be shaped. 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 in interfacial contact with the adhesive region on the bandage. According to a variation, the opposing surface of the cover structure comprises an adhesive backing covering the adhesive region at a first position and separated from the adhesive region at a second position. 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 the opposing surface of the cover structure, the cover and base being configured to apply a straining force to strain the bandage when the cover is moved from the first position to the second position. 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 material in the first attachment region to an inner surface of the base structure and a second structure configured to couple the dressing material in the second attachment region to an opposing surface of the cover, and the tensioning structure is configured to apply a straining force to the dressing material 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 variation, 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 variation, the second width is at least 4% greater than the first width. According to a variation, the second width is at least 20% greater than the first width. According to a variation, the second width is at least 40% greater than the first width.

[0037] According to a variant, a method for applying a bandage to a wound or skin of a subject includes the steps of providing a bandage 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 bandage 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 bandage and to separate the adhesive backing from the adhesive region; applying the first surface of the bandage to the wound or skin of the subject, and then subsequently releasing the bandage from the base structure. According to a variant of the method, at least a portion of the back surface of the bandage is coupled to the cover structure, and the method further includes the step of pivoting the cover structure relative to the base structure to impart strain to the bandage.

[0038] 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 bending area between the first bandage attachment area and the second bandage attachment area that modifies the variable separation distance, wherein a first distance from the center of the bending area to the first bandage attachment area is different from a second distance from the center of the bending area to the second bandage attachment area.

[0039] According to a variant, the bandage tensioning device comprises a bandage carrier having a first carrier edge and a second opposing carrier edge defining a carrier width therebetween; a tensioning element configured to move relative to the bandage carrier from a first position to a second bandage tensioning position; and a bandage assembly comprising a bandage including a first bandage edge coupled to the carrier adjacent to the first carrier edge; and a second bandage 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 bandage edge is a first distance from the second carrier edge within the width of the carrier, and in the second position of the tensioning element, the second bandage edge is 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 with respect to the second dressing edge when the tensioning element is moved between the first and second positions.

[0040] According to a variation, the bandage packaging assembly includes 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 bandage including 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 is configured to move from a first position in which the opposing surface is in interface contact with the first surface of the bandage to a second position in which the opposing surface is separated from the first surface of the bandage, the second position being rotated at least approximately 180 degrees relative to the first position. According to a variation, the first surface of the bandage includes an adhesive region. According to a variation, the first surface of the bandage includes an adhesive backing that is in interface contact with the adhesive region on the bandage. According to a variation, the opposing surface of the cover structure includes an adhesive backing that covers the adhesive region when the cover structure is in the first position and is separated from the adhesive region when the cover structure is in the second position. According to a variation, the 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 to strain the bandage when the cover is moved from the first position to the second position. According to a variation, the assembly further comprises a tensioning structure configured to apply a straining force to the bandage. According to a variation, the tensioning structure comprises a first structure configured to couple the bandage at the first attachment region to the inner surface of the base structure and a second structure configured to couple the bandage at the second attachment region to the opposing surface of the cover, the tensioning structure being configured to apply a straining force to the bandage between the first attachment region and the second attachment region when the cover structure is moved from the first position to the second position relative to the base structure. According to a variation, 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 variation, the second width is at least 20% greater than the first width. According to a variation, the second width is at least 40% greater than the first width.According to a 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 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.

[0041] According to a variant, the dressing package comprises a dressing carrier comprising a first carrier edge, a second carrier edge opposite the first carrier edge, and a support structure extending between the first and second edges configured to support the dressing during application of the dressing to a subject; a dressing comprising the first dressing edge, the second dressing edge opposite the first dressing edge, a back surface, and an opposing skin-interface contact surface, wherein at least one of the back surfaces Both portions are removably coupled to the dressing carrier, and 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 defining a first margin between the first dressing edge and the first carrier edge, and the second dressing edge defining a second margin between the second dressing edge and the second carrier edge, and the first and second margins each having a width of at least 3 millimeters.

[0042] In one variation, a bandaging system is provided comprising 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 comprise perforations. The bandaging system may further comprise a retraction element located along the perforations. The treatment device may be asymmetrically attached to the first and second supports relative 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 bandaging system may further comprise 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 having 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 having 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 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 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 also be perforated. The first support may be configured to be detached from the second support and the treatment device, and may or may not do so while maintaining the treatment device in the strained 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 to either maintain the treatment device in a tensioned state when it stretches and contacts the adhesive and / or to maintain the treatment device against the first and / or second support.

[0043] In another variation, a bandaging system is provided that includes a first tensioning member, a second tensioning member, a primary bending region therebetween, the primary bending region having a primary bending axis, and a treatment device asymmetrically attached to the first and second tensioning members relative to the primary bending region. The treatment device may have a first end attached to the first tensioning member and a second end attached to the second tensioning member, and a first distance between the first tensioning member and the primary bending axis is different from a second distance between the second tensioning member and the primary bending axis. The bandaging system may further include a closed configuration in which the treatment device is located between the first tensioning member and the second tensioning member, and an open configuration in which the second tensioning member is located between the first tensioning member and the treatment device. The second tensioning member may include at least one secondary bending region having a secondary bending axis that is not parallel to the primary bending axis. The secondary bending axis may be orthogonal to the primary bending axis. The first tensioning member may include at least one secondary bending region having a secondary bending axis that is not parallel to the primary bending axis. The at least one secondary bending region of the first tensioning member may be aligned with the at least one secondary bending region of the second tensioning member. The treatment device may further include a release liner coupled to the adhesive surface of the treatment device. The treatment device may include a perforated 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 fold may be along a substantial length of the treatment device. At least one of the first and second tensioning 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 tensioning member may be configured to be detached from the second tensioning 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 tensioning member may include an attached release liner. The release liner may be attached to the first tensioning member between an outer edge of the first tensioning member and the attached treatment device.

[0044] 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 positioned between the first applicator member and the second applicator member, and a closed configuration in which the second applicator member is positioned 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 an adhesive surface of the treatment device. The treatment device may include a perforated region. The bandaging 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. 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 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 applicator member is configured to be detached from the second applicator member and the treatment device. The first applicator member may be configured to be detached from the second applicator member and the treatment device while maintaining the treatment device in a strained configuration. The second applicator member may include an adhesive element configured to adhere to the treatment device when the bandaging system is in an open configuration rather than a closed configuration. The first applicator member may include an attached release liner. A release liner may be attached to the first applicator member between the outer edge of the first applicator member and the attached treatment device.

[0045] The devices, kits, and methods herein may include a support, packaging, and / or applicator configured to maintain the pre-strained dressing in the 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 making such pre-strained dressings.

[0046] 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.

[0047] The desired time for application of a bandage to a subject may be when the bandage, in its pre-strained, strain-shielded configuration, has a desired tensile force characteristic or range. Such a 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 bandage, 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 desirable 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.

[0048] 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.

[0049] The force properties of a pre-strained bandage can vary over time. An initial strain may be applied to the bandage, and the elastic material or other structure of the bandage will have initial tensile force properties. The bandage may be pre-strained for an initial period of time, after which it may be maintained in a strained configuration at a particular strain level. During the initial period, the force properties of the elastic material may decrease, decay, or exhibit a 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 at 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 at 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 a fluctuation or decrease in engineering stress of less than 10% or 5%.

[0050] According to a variant, for example, the initial force or strain properties of the dressing material may be selected so that a desired range of force values ​​occurs over a period during which the rate of force loss is reduced and occurs over a longer period of time.

[0051] 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.

[0052] In a variation, the bandage may be initially strained or overstressed to provide an initial force per unit width above the desired range upon application to the skin. In a variation, the initial strain and resulting initial force per unit width of the bandage may be selected based on the desired final resulting force profile and / or the desired time frame for use of the bandage. 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, 70% or more, 80% or more, 90% or more, or 100% or more. In a variation, the initial force exceeds the desired force range. Such initial force levels may be, for example, about or up to 25%, about or up to 35%, about or up to 50%, about or up to 75%, or more than the desired force upon application of the bandage. 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.

[0053] In some variations, the dressing may be initially strained or stressed to a desired strain or force level and configured to be maintained in the strained configuration for an initial time frame. In some variations, 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. In some variations, 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 a constant strain or at various levels of strain.

[0054] Then, according to some variations, the dressing may 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 frame, 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 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 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.

[0055] The pre-strained dressing may then be bonded 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.

[0056] According to variations, for example, the average initial force or strain properties of a dressing pre-strained at the time of manufacture (average may include, for example, an average per manufacturing lot, or a defined average within a given tolerance level) may be provided so that a desired range of average force values ​​occurs during which the average rate of force loss is reduced and occurs over a longer period of time. In other variations, pre-straining begins at the point of use. In yet other variations, some of the pre-straining is performed at the time of manufacture, with additional straining or strain relaxation performed at the time of use. After pre-straining, the dressing may then be packaged, sealed, and sterilized for future use.

[0057] The initial average 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 average rate of force loss of the dressing over time.

[0058] According to a variation, the bandage may be initially strained or overstressed to provide an average initial force per unit width above the desired range upon application to the skin. According to a variation, the average initial strain and resulting initial force per unit width of the bandage may be selected based on the desired final resulting force properties and / or the desired time frame for use of the bandage. 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, or 100% or more. According to a variation, the average initial force exceeds the desired force range. Such average initial force levels may be, for example, about or up to 25%, about or up to 35%, about or up to 50%, about or up to 75%, or more than the desired force upon application of the bandage. Such average initial force levels may be, for example, but not limited to, 2 to 5 lbf / inch, 1.54 to 3.85 lbf / inch, 1.33 to 3.33 lbf / inch, or 0.85 to 2.20 lbf / inch.

[0059] 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 may strain the material at various levels of average strain.

[0060] Then, according to some variations, the dressing may 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 frame, the device may be applied to the subject's skin for treatment. Such a desired average force range may be approximately 0.5 to 1.0 lbf / inch, 1.31 to 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.

[0061] 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 subsequent portion of the period during manufacturing, or during transportation or storage.

[0062] In another example, a method for modulating a tissue response at a target site is provided, the method including providing a strained elastic structure with an access opening and a support structure, positioning the strained elastic structure relative to the target site, releasing the strained elastic structure from the support structure, and inserting the access structure into the target site, the access structure being positioned 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 through 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 features located on the strained resilient structure.

[0063] In another embodiment, a tissue treatment device is provided comprising: 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 in releasable contact with the adhesive layer; a strain support removably attached to the top surface of the elastic layer, the strain support comprising a layered structure with a central opening surrounding the treatment opening in 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 comprise a perforated region from the central opening to an edge of the strain support. The alignment structure may comprise a separation region aligned with the perforated region of the strain support. The strain support may comprise 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.

[0064] In another embodiment, a device includes a strained elastic base layer having a top surface, a bottom surface, a periphery, and a treatment opening; a skin adhesive layer adhered to the bottom surface of the strained elastic layer; a protective layer in releasable contact with the skin adhesive layer; and at least one strained elastic intermediate layer, each elastic intermediate layer having a top surface, a bottom surface, a periphery, and a treatment opening aligned with the treatment opening of the strained elastic base layer, wherein the bottom layer of one of the at least one intermediate elastic layer is attached to the top surface of the strained elastic base layer; and at least one strained elastic intermediate layer having a top surface, a bottom surface, a periphery, and a treatment opening. A multi-layer tissue treatment device is provided, comprising: a strained elastic top layer, wherein treatment openings in the strained elastic top layer are aligned with treatment openings in the strained elastic base layer and wherein 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, wherein 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 peripheral edge of the elastic top layer may be offset from the outer peripheral edge of the intermediate elastic layer attached to the elastic top layer, and the outer peripheral edge of the elastic middle layer attached to the elastic base layer may be offset from the outer peripheral edge of the elastic base layer. The outer peripheral edge of the elastic top layer may be offset inward from the outer peripheral edge of the intermediate elastic layer attached to the elastic top layer, and the outer peripheral edge of the elastic middle layer attached to the elastic base layer may be offset inward from the outer peripheral edge of the elastic base layer. 10. The device of claim 8, wherein 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, and a bottom surface of the elastic middle layer attached to the elastic base layer is smaller than a top surface of the elastic base layer. The bottom surface of the elastic top layer may be larger than a top surface of the intermediate elastic layer attached to the elastic top layer, and a bottom surface of the elastic middle layer attached to the elastic base layer may be larger than a top surface of the elastic base layer. Each of the strained elastic top layer, the strained elastic base layer, and the at least one elastic middle layer may 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 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. 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.

[0065] In another embodiment, a multi-layer tissue treatment device is provided, comprising at least two strained elastic layers, including 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, 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 configured to maintain strain in the at least two strained elastic layers. The force per width level of 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 of the at least two strained elastic layers. The base elastic layer may comprise at least 90% of the total force per width of the at least two strained elastic layers. The base elastic layer may include a material with a higher durometer than 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 include at least one intermediate elastic layer positioned 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 inward 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 outward 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 inward from the outer peripheral edge of an adjacent, lower-strained elastic layer in the stacked configuration. The sizes 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 larger 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 smaller 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 larger than any 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 at least one of the at least two strained elastic layers may comprise a different pull tab size. Attachment of the at least two strained elastic layers may utilize an anisotropic adhesive pattern. 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.

[0066] In yet another embodiment, a treatment device is provided comprising: 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 comprise an infusion set applicator releasably attached to the infusion hub. The device may further comprise two pull tabs located on opposite sides of the strained elastic layer. Each of the two pull tabs may comprise a perforation configured to tear to separate the strained elastic layer and the infusion hub from the strain support.

[0067] 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 tear to separate the strained elastic layer and the infusion hub from the strain support.

[0068] In another example, a method for modulating a tissue response at a target site is provided, the method including providing a strained elastic structure with an access opening and a support structure, positioning the strained elastic structure relative to the target site, releasing the strained elastic structure from the support structure, and inserting the access structure into the target site, the access structure being positioned 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 further includes passing a sensor or an infusion cannula through the delivery tube. The access structure is attached to a housing. The housing may include an adhesive. The housing may further include a support layer, with the adhesive 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 features located on the strained resilient structure.

[0069] In another embodiment, a method for treating a therapy site is provided, comprising: placing a first tensioning member at a first location adjacent to a target site, the first tensioning member being pre-tensioned along a first tensioning axis; placing a second tensioning member at a second location adjacent to the target site, the second tensioning member being pre-tensioned along a second tensioning 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 tensioning axis and the second tensioning axis may be parallel. The first tensioning member and the second tensioning member may be completely separate. The first and second tensioning members may be integrally formed with a predetermined longitudinal gap therebetween, the longitudinal gap comprising a longitudinal gap axis. The longitudinal gap axis may be located between the first and second tensioning axes. The longitudinal gap, the first tensioning axis, and the second tensioning axis may each be parallel to one another. The 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 tensioning members before using the infusion set to infuse the therapeutic agent.

[0070] In another embodiment, a method for treating lipoatrophy is provided, comprising applying an adhesive skin tensioning device to a patient's injection or infusion site to reduce the risk of lipoatrophy. The injection or infusion site may be an insulin or insulin analog injection or infusion site. The patient may have diabetes, 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 may be one year.

[0071] In another embodiment, a method of treating diabetes is provided that includes 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 increases over time.

[0072] 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 glucose time in range in days, weeks, or months.

[0073] 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.

[0074] In yet another embodiment, a method of treating a treatment site is provided, comprising the steps of adhering a multi-layer strained bandage to a treatment site; releasing strain in the multi-layer strained bandage to transfer the 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 the 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 the second catheter from the multi-layer bandage by removing the second layer from the multi-layer bandage.

[0075] In another embodiment, a method of positioning an infusion set is provided, comprising: adhering a strained skin tension relieving device to a treatment location, the skin tension relieving 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 protruding alignment structure from the strained skin tension relieving device to release strain in the strained elastic layer. The method may further comprise 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.

[0076] According to some variations, the elastic device may be strained at different strain values ​​during preconditioning.

[0077] In one embodiment, a method for treating subcutaneous tissue may be provided, comprising applying an adhesive skin tensioning device to a treatment site on a patient to reduce the development or progression of a subcutaneous lesion comprising calcification, cellular proliferation, or hypertrophy. The treatment site may be a device implantation, injection, or infusion site. The subcutaneous lesion may be a lipoatrophic lesion. The lipoatrophic lesion may be a lipohypertrophic lesion. The injection or infusion site may be an insulin or insulin analog injection or infusion site. The patient may be diabetic, and the subcutaneous lesion may be lipohypertrophic. The patient may have no history of lipohypertrophy or may have a history of lipohypertrophy. The method may further include reducing the risk of insulin resistance and / or reducing the rate of insulin or insulin analog dosage increases over a period of time. The period may be one year. The infusion site may be a hemodialysis fistula or graft site. The injection site may be a tumor therapy injection site. The tumor therapy injection site may be a pertuzumab and / or trastuzumab injection site. The treatment site may be an implantation site for an implantable pulse generator, an implantable pacemaker, or a defibrillator. The treatment site may be an implantation site for a subcutaneous injection port.

[0078] In another embodiment, a method of modifying the pharmacokinetics of a drug is provided, comprising applying an adhesive skin tensioning device with a predetermined tension to a site of injection or infusion of a therapeutic agent, the injection or infusion may be performed while the skin tensioning device is activated at the injection or infusion site.

[0079] In yet another embodiment, a method of treating diabetes is provided that includes applying an adhesive skin tensioning device to an injection or infusion site of a diabetic patient to improve or slow the progression of tissue stiffness at the injection or infusion site.

[0080] In another embodiment, a method of treating diabetes is provided that includes applying an adhesive skin tensioning device to an injection or infusion site to increase the percentage of time in range of glycemic control, where time in range can be the percentage of time with a blood glucose level between 70 mg / dL and 180 mg / dL.

[0081] In another variation, a method of treating diabetes is provided that includes applying an adhesive skin tensioning device to an injection or infusion site to reduce the percentage of time in hypoglycemia, which can be a blood glucose level below 70 mg / dl.

[0082] In another variation, a method of treating diabetes is provided that includes applying an adhesive skin tensioning device to an injection or infusion site to reduce the percentage of time in hyperglycemia, which may be a blood glucose level above 180 mg / dl.

[0083] In yet another variation, a method of treating diabetes is provided that includes applying an adhesive skin tensioning device to an injection or infusion site in a diabetic patient to reduce variability in insulin absorption compared to an untreated control group. The reduced variability in insulin absorption is associated with a reduction in insulin C as measured by a hyperinsulinemic-euglycemic clamp test or a mixed meal tolerance test. max or AUC INS The coefficient of variation may be reduced.

[0084] In another variation, a method of treating diabetes is provided that includes applying a tissue tensioning device to an injection or infusion site in a diabetic patient to increase insulin absorption compared to an untreated control group, where increased insulin absorption is measured by increased insulin secretion as measured by a hyperinsulinemic-euglycemic clamp test or a mixed meal tolerance test. Cmax or AUC INS may be.

[0085] In another embodiment, a system for treating chronic injection sites is provided, comprising: an adhesive tensionable elastic bandage, the bandage comprising a first attachment structure and a second attachment structure; and at least one injection template comprising a plurality of injection openings, a first attachment opening, and a second attachment opening, wherein the first attachment structure may be configured to form a releasable interlock with the first attachment opening and the second attachment structure may be configured to form a releasable interlock with the second attachment opening. The adhesive tensionable bandage may comprise a plurality of dressing openings, and at least one dressing opening may be aligned with each of the injection openings of the plurality of openings of the at least one injection template. The at least one injection template may comprise one injection template, and each of the dressing openings of the plurality of dressing openings may be aligned with an injection opening of the plurality of openings of the one injection template. The at least one injection template comprises a plurality of injection templates. The plurality of injection templates consists of seven injection templates. The multiple injection openings of each injection template of the multiple injection templates may have different locations than the other injection templates of the multiple injection templates. The at least one injection template may comprise one injection template. The multiple injection openings of one injection template may be arranged in a rectangular grid pattern. The multiple injection openings of one injection template may be arranged in a staggered grid pattern. A plurality of adhesive strips may be removably coupled to the multiple injection openings. The number of the multiple adhesive strips may be less than the number of the multiple injection openings. The number of the multiple injection openings may be three or four times the number of the multiple adhesive strips. The multiple adhesive strips may be aligned longitudinally with a longitudinal axis of the injection template or aligned transversely with a transverse axis perpendicular to the longitudinal axis of the injection template. The multiple adhesive strips may be parallel to each other and not parallel to the longitudinal or transverse axis of the injection template. Each of the multiple adhesive strips may extend beyond the edge of the injection template. The first and second mounting structures may have different shapes.The first attachment opening and the second attachment opening may have different shapes. The system may further include an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device. The applicator may include a carrier sheet and, optionally, a release liner.

[0086] In another embodiment, a system for treating a chronic injection site is provided, comprising an adhesive tensionable tissue treatment device comprising a plurality of injection orifices surrounded by a plurality of removable adhesive rings, the adhesive rings having a lower T-peel force than the adhesive tensionable tissue treatment device. The plurality of injection orifices are arranged in a rectangular grid pattern. The system may further comprise an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device.

[0087] In another variation, a method of treating an injection site is provided that includes adhering a tensioned tissue treatment device to a skin surface, releasing a portion of the tension in the tensioned tissue treatment device to transfer the tension to the adhered skin surface, attaching a first injection template to the tensioned tissue treatment device, the first injection template including multiple needle insertion openings, inserting a first needle through a first of the multiple needle insertion openings, and removing the first injection template from the tensioned tissue treatment device. The method may further include removing a first cover strip from the first injection template, the first cover strip surrounding or covering the first needle opening. The method may also include reattaching the first injection template to the tensioned tissue device, inserting a second needle through a second of the multiple needle insertion openings, and removing the first injection template, the first cover strip also surrounding or covering the second needle insertion opening. The step of removing the first cover strip may be performed prior to inserting the first needle through the first needle insertion opening.

[0088] In another embodiment, an injection guide system is provided, comprising: a plurality of injection guides, each injection guide comprising at least one opening and an under-adhesive surface, the plurality of injection guides being in a separated configuration in which each injection guide is spaced apart from the other injection guides; an adhesive carrier sheet that maintains the plurality of injection guides in the separated configuration; and a release liner that is removably adhered to the under-adhesive surfaces of the plurality of injection guides. The system may further comprise a plurality of adhesive injection guide covers that are releasably adhered to the plurality of injection guides and positioned between the plurality of injection guides and the adhesive carrier sheet. The system may further comprise a dressing comprising a plurality of dressing openings configured to align with at least the opening of each injection guide of the plurality of injection guides. The plurality of injection guides may comprise an adhesive foam strip. The under-adhesive surface of each injection guide may have stronger adhesive properties than the adhesive carrier sheet. The adhesive injection guide cover may have stronger adhesive properties than the adhesive carrier sheet. The adhesive properties of the adhesive undersurface of each injection guide may be stronger than the adhesive injection guide cover.

[0089] In another embodiment, a method of preparing a bandage may be provided, comprising aligning a plurality of separate injection guides with a plurality of bandage openings on the bandage, each injection guide comprising a plurality of openings, and adhering the plurality of separate injection guides to the bandage. The step of adhering the plurality of separate injection guides to the plurality of bandage openings may be performed such that the plurality of openings of each injection guide are aligned with the bandage openings. The method may further comprise removing release liners from the plurality of separate injection guides. The method may further comprise removing the carrier sheet from the plurality of separate injection guides after adhering the plurality of separate injection guides to the bandage. The step of adhering the plurality of separate injection guides to the bandage may be performed such that the adhering of the plurality of separate injection guides is performed simultaneously. Each injection guide of the plurality of separate injection guides further comprises a removable guide cover. [Brief explanation of the drawings]

[0090] [Figure 1] FIG. 1 is a perspective view of a variation of the dressing and packaging assembly in a closed configuration.

[0091] [Figure 2] 2 is a perspective view of the dressing and packaging assembly of FIG. 1 with the cover open at a position approximately 90 degrees from the closed position.

[0092] [Figure 3] 3 is a bottom perspective view of the dressing and packaging assembly of FIG. 1 with the cover open in an approximately 360 degree configuration from the closed position.

[0093] [Figure 4] 4 is a top perspective view of the dressing and packaging assembly of FIG. 1 with the cover open in an approximately 360 degree configuration from the closed position.

[0094] [Figure 5A]FIG. 5A is a schematic bottom view of the dressing and packaging assembly in the position illustrated in FIG.

[0095] [Figure 5B] FIG. 5B is a cross section of FIG. 5A taken along line CC.

[0096] [Figure 5C] FIG. 5C is a cross section of FIG. 5A taken along line DD.

[0097] [Figure 6] FIG. 6 illustrates a variation of the dressing and packaging assembly.

[0098] [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.

[0099] [Figure 8A] Figure 8 is a schematic end view of the dressing and packaging assembly of Figure 7 in a strained configuration with the cover open at approximately 360 degrees from the closed configuration. Figure 8A is an enlarged view of section A of Figure 8. Figure 8B is an enlarged view of section B of Figure 8A.

[0100] [Figure 8B] Figure 8 is a schematic end view of the dressing and packaging assembly of Figure 7 in a strained configuration with the cover open at approximately 360 degrees from the closed configuration. Figure 8A is an enlarged view of section A of Figure 8. Figure 8B is an enlarged view of section B of Figure 8A. [Figure 8C] Figure 8 is a schematic end view of the dressing and packaging assembly of Figure 7 in a strained configuration with the cover open at approximately 360 degrees from the closed configuration. Figure 8A is an enlarged view of section A of Figure 8. Figure 8B is an enlarged view of section B of Figure 8A.

[0101] [Figure 9] FIG. 9 is a top perspective view of the dressing and packaging assembly of FIG. 7 after release.

[0102] [Figure 10] FIG. 10 is a perspective view of another embodiment of a dressing and packaging assembly in a closed configuration.

[0103] [Figure 11] 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.

[0104] [Figure 12A] 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.

[0105] [Figure 12B] FIG. 12B is a bottom perspective view of the dressing and packaging assembly of FIG. 10 with the cover in an approximately 360 degree configuration from the closed configuration.

[0106] [Figure 13] FIG. 13 is a top view of the packaging device in an open configuration.

[0107] [Figure 14] FIG. 14 is an exploded perspective view of the packaging device in an open configuration.

[0108] [Figure 15A] FIG. 15A is a perspective view of a variation of the dressing and packaging assembly in an unstrained configuration.

[0109] [Figure 15B] FIG. 15B is a bottom perspective view of the dressing and packaging assembly of FIG. 15A in a strained configuration.

[0110] [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.

[0111] [Figure 15D] FIG. 15D is a top perspective view of the device of FIG. 15A after removal of the carrier, support, or base cover.

[0112] [Figure 15E] FIG. 15E is a top perspective view of the device of FIG. 15A after removal of the carrier, support, or base.

[0113] [Figure 15F] FIG. 15F is a perspective view of the strained dressing after it has been separated from the mounting sheet.

[0114] [Figure 15G] FIG. 15G is a perspective view of the dressing assembly with the mounting sheet.

[0115] [Figure 15H] FIG. 15H is a perspective view of the dressing assembly of FIG. 15G with the mounting sheet peeled away.

[0116] [Figure 15I] FIG. 15I is a perspective view of the dressing assembly of FIG. 15G with the mounting sheet removed.

[0117] [Figure 15J] FIG. 15J is a cross section of the dressing assembly with the mounting sheet of FIG. 15G.

[0118] [Figure 16A] FIG. 16A is a perspective view of a variation of a dressing assembly with a removable mounting sheet.

[0119] [Figure 16B] FIG. 16B is a perspective view of the dressing assembly of FIG. 16A with the removable mounting sheet peeled away.

[0120] [Figure 16C]FIG. 16C is a perspective view of the dressing assembly of FIG. 16A with the mounting sheet removed.

[0121] [Figure 16D] FIG. 16D is a cross section of the dressing assembly with the mounting sheet of FIG. 16A.

[0122] [Figure 17A] FIG. 17A is a perspective view of a variation of a dressing assembly with a removable mounting sheet.

[0123] [Figure 17B] FIG. 17B is a perspective view of the dressing assembly of FIG. 17A with the removable mounting sheet peeled away.

[0124] [Figure 17C] FIG. 17C is a perspective view of the dressing assembly of FIG. 17A with the mounting sheet removed.

[0125] [Figure 17D] FIG. 17D is a cross section of the dressing assembly with the mounting sheet of FIG. 17A.

[0126] [Figure 18A] FIG. 18A is a perspective view of a variation of the dressing and packaging assembly in an unstrained configuration.

[0127] [Figure 18B] FIG. 18B is a top perspective view of the device of FIG. 18A in a strained and folded configuration.

[0128] [Figure 18C] FIG. 18C is a perspective view of the bottom side of the device in the strained and folded configuration of FIG. 18B.

[0129] [Figure 18D] FIG. 18D is a top perspective view of the device of FIG. 18A in a strained and folded configuration during removal of the mounting sheet.

[0130] [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.

[0131] [Figure 18F] FIG. 18F is a top perspective view of the device of FIG. 18A with the dressing assembly removed from the carrier.

[0132] [Figure 18G] FIG. 18G is a top perspective view of the device of FIG. 18A with the carrier detached and removed.

[0133] [Figure 18H] FIG. 18H is a perspective view of the device of FIG. 18A with the dressing separated from the mounting sheet.

[0134] [Figure 18I] FIG. 18I is a perspective view of the device of FIG. 18A with the dressing separated from the mounting sheet.

[0135] [Figure 18J] FIG. 18J is a side view of the device of FIG. 18A.

[0136] [Figure 19A] FIG. 19A is a perspective view of a variation of a dressing and packaging assembly device.

[0137] [Figure 19B] FIG. 19B is a top view of the dressing assembly of FIG. 19A in an unstrained configuration.

[0138] [Figure 19C] FIG. 19C is a top view of the dressing assembly of FIG. 19B in a strained and attached configuration.

[0139] [Figure 19D] FIG. 19D is a top view of the dressing assembly of FIG. 19B in a strained and removed configuration.

[0140] [Figure 19E] FIG. 19E is a top view of the dressing of FIG. 19B.

[0141] [Figure 20A] FIG. 20A is a top view of a variation of a dressing carrier, support, base tensioning device, or applicator.

[0142] [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.

[0143] [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.

[0144] [Figure 21A] FIG. 21A is a perspective view of a variation of a dressing carrier, support, base tensioning device, or applicator.

[0145] [Figure 21B] FIG. 21B is a top view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A.

[0146] [Figure 21C] FIG. 21C is a side view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A.

[0147] [Figure 21D] FIG. 21D is a top view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A in a flexed configuration, and FIG. 21E is a cross-section of FIG. 21D along line AA. [Figure 21E] FIG. 21D is a top view of the dressing carrier, support, base tensioning device, or applicator of FIG. 21A in a flexed configuration, and FIG. 21E is a cross-section of FIG. 21D along line AA.

[0148] [Figure 22A] FIG. 22A is a perspective view of a variation of the dressing and packaging assembly in an unstrained configuration.

[0149] [Figure 22B] FIG. 22B is a perspective view of a variation of the dressing and packaging device in a strained configuration.

[0150] [Figure 23A] FIG. 23A is a top perspective view of the dressing assembly, support structure, and tensioning device in a relatively unstrained configuration.

[0151] [Figure 23B] FIG. 23B is a top perspective view of the dressing assembly, support structure, and tensioning device in the pre-strained configuration.

[0152] [Figure 23C] FIG. 23C is a schematic side view of the dressing assembly, support structure, and tensioning device of FIG. 23B.

[0153] [Figure 23D] FIG. 23D is an enlarged schematic side cross-sectional view of the dressing assembly, support structure, and tensioning device of FIG. 23C.

[0154] [Figure 23E] FIG. 23E is an enlarged, schematic, detailed side view of a portion of the dressing and support structure of FIG. 23D.

[0155] [Figure 23F] FIG. 23F is a schematic side view of the dressing assembly and support structure in a pre-strained configuration.

[0156] [Figure 23G] FIG. 23G is an enlarged side view of the dressing assembly and support structure of section A of FIG. 23F.

[0157] [Figure 23H] FIG. 23H is an enlarged side view of the dressing assembly and support structure of section B of FIG. 23F.

[0158] [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.

[0159] [Figure 24] FIG. 24 is a perspective view of multiple pre-strained dressings on a support element.

[0160] [Figure 25] FIG. 25 illustrates a pre-strained dressing and support structure.

[0161] [Figure 26] FIG. 26 illustrates the percent loss of force over time for an elastic bandage material as described in Example I.

[0162] [Figure 27] FIG. 27 is a schematic illustration of percent force loss over time for a pre-strained elastic material component of a dressing.

[0163] [Figure 28] FIG. 28 is a schematic illustration of tensile force over time for a pre-strained elastic material component of a dressing.

[0164] [Figure 29] FIG. 29 illustrates the percent loss of force over time for an elastic bandage material as described in Example II.

[0165] [Figure 30A] Figures 30A-30C depict the use of a strained dressing with an exemplary infusion set, and Figure 30D is a cross-sectional view of the strained dressing and infusion set of Figure 30C. [Figure 30B] Figures 30A-30C depict the use of a strained dressing with an exemplary infusion set, and Figure 30D is a cross-sectional view of the strained dressing and infusion set of Figure 30C. [Figure 30C] Figures 30A-30C depict the use of a strained dressing with an exemplary infusion set, and Figure 30D is a cross-sectional view of the strained dressing and infusion set of Figure 30C. [Figure 30D] Figures 30A-30C depict the use of a strained dressing with an exemplary infusion set, and Figure 30D is a cross-sectional view of the strained dressing and infusion set of Figure 30C.

[0166] [Figure 31A] Figures 31A-31C depict a method of use of the strained dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use. [Figure 31B] Figures 31A-31C depict a method of use of the strained dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use. [Figure 31C] Figures 31A-31C depict a method of use of the strained dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use. [Figure 31D] Figures 31A-31C depict a method of use of the strained dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use. [Figure 31E] Figures 31A-31C depict a method of use of the strained dressing with an infusion set delivery device, and Figures 31D and 31E are cross-sectional views of the method of use.

[0167] [Figure 32A]32A-32E depict various exemplary aperture configurations for the dressing. [Figure 32B] 32A-32E depict various exemplary aperture configurations for the dressing. [Figure 32C] 32A-32E depict various exemplary aperture configurations for the dressing. [Figure 32D] 32A-32E depict various exemplary aperture configurations for the dressing. [Figure 32E] 32A-32E depict various exemplary aperture configurations for the dressing.

[0168] [Figure 33] FIG. 33 depicts the placement of a three-aperture dressing over the injection site.

[0169] [Figure 34] FIG. 34 depicts an exemplary dressing with openings and various alignment markings.

[0170] [Figure 35] FIG. 35 depicts the use of the exemplary dressing of FIG. 34 with a delivery syringe.

[0171] [Figure 36] FIG. 36 depicts the use of a dressing and visual guide tool with a delivery syringe.

[0172] [Figure 37] Figure 37A depicts another exemplary embodiment of a visual guide tool comprising a distal opening and one or more inward flaring portions, and Figure 37B depicts the visual guide tool of Figure 37A overlaid on a dressing.

[0173] [Figure 38] 38A and 38B depict the use of the visual guide tool of FIGS. 37A and 37B with an infusion set delivery tool.

[0174] [Figure 39A] 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 39B] 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 39C] 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 39D] 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 39E] 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.

[0175] [Figure 40A]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 comprises tearable perforations. [Figure 40B] 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 comprises tearable perforations. [Figure 40C] 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 comprises tearable perforations. [Figure 40D] 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 comprises tearable perforations. [Figure 40E]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 comprises tearable perforations.

[0176] [Figure 41A] Figures 41A and 41B are top plan and top perspective views of another embodiment of a combined infusion set with multiple separable tensioning layers. [Figure 41B] Figures 41A and 41B are top plan and top perspective views of another embodiment of a combined infusion set with multiple separable tensioning layers.

[0177] [Figure 42] 42A-42C are top perspective views of the combined infusion set and method of using multiple tensioning layers depicted in FIGS. 41A and 41B.

[0178] [Figure 43] 43A-43C are side elevational views of the method depicted in FIGS. 42A-43C.

[0179] [Figure 44] FIG. 44A is a detailed side elevation view of the method of FIG. 42A, and FIG. 44B is a detailed view of the edges of the multiple tensioning layers of FIG. 44A.

[0180] [Figure 45A] Figure 45A is a top plan view of another embodiment of a combined infusion set with multiple separable tensioning 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 tensioning layers, and Figure 45B is a top perspective schematic view of the embodiment of Figure 45A.

[0181] [Figure 46] 46A-46C are top perspective views of the combined infusion set and method of using multiple tensioning layers depicted in FIGS. 41A and 41B.

[0182] [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 the tensioning layers of Figure 47B.

[0183] [Figure 48A] 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 the installation and release of the pre-strained skin tensioning device. [Figure 48B] 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 the installation and release of the pre-strained skin tensioning device. [Figure 48C] 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 the installation and release of the pre-strained skin tensioning device. [Figure 48D] 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 the installation and release of the pre-strained skin tensioning device. [Figure 48E] 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 the installation and release of the pre-strained skin tensioning device.

[0184] [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.

[0185] [Figure 50A] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. [Figure 50B] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. [Figure 50C] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. [Figure 50D] 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system.

[0186] [Figure 51] FIG. 51 is a front perspective view of an alternative support structure for the skin tensioning device depicted in FIGS. 49A-49E.

[0187] [Figure 52] FIG. 52 is a schematic illustration of another exemplary embodiment of a skin tensioning system comprising two separate skin tensioning devices placed on opposite sides of an injection or infusion site.

[0188] [Figure 53]FIG. 53 is a schematic illustration of another exemplary embodiment of a skin tensioning system comprising interconnected lobes separated by longitudinal gaps or slots.

[0189] [Figure 54] 54A and 54B are top plan and side elevation views of an exemplary infusion hub and catheter with a pre-attached skin tensioning device.

[0190] [Figure 55] 55A and 55B are schematic perspective views of a radially tensioned skin treatment device used for manual injection.

[0191] [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.

[0192] [Figure 57A] Figure 57A is a perspective view of an exemplary tensioning skin treatment system including a removable injection template, and Figures 57B-57D depict different injection templates that can be used with the system of Figure 57A. [Figure 57B] Figure 57A is a perspective view of an exemplary tensioning skin treatment system including a removable injection template, and Figures 57B-57D depict different injection templates that can be used with the system of Figure 57A. [Figure 57C] Figure 57A is a perspective view of an exemplary tensioning skin treatment system including a removable injection template, and Figures 57B-57D depict different injection templates that can be used with the system of Figure 57A. [Figure 57D] Figure 57A is a perspective view of an exemplary tensioning skin treatment system including a removable injection template, and Figures 57B-57D depict different injection templates that can be used with the system of Figure 57A.

[0193] [Figure 58] FIG. 58 is a perspective view of another exemplary tensioning skin treatment system including a multi-day removable injection template.

[0194] [Figure 59A] FIG. 59A is a perspective view of another exemplary tensioning skin treatment system comprising a weekly removable injection template with a removable indicator strip, and FIGS. 59B-59E depict the sequential removal of the indicator strip. [Figure 59B] FIG. 59A is a perspective view of another exemplary tensioning skin treatment system comprising a weekly removable injection template with a removable indicator strip, and FIGS. 59B-59E depict the sequential removal of the indicator strip. [Figure 59C] FIG. 59A is a perspective view of another exemplary tensioning skin treatment system comprising a weekly removable injection template with a removable indicator strip, and FIGS. 59B-59E depict the sequential removal of the indicator strip. [Figure 59D] FIG. 59A is a perspective view of another exemplary tensioning skin treatment system comprising a weekly removable injection template with a removable indicator strip, and FIGS. 59B-59E depict the sequential removal of the indicator strip. [Figure 59E] FIG. 59A is a perspective view of another exemplary tensioning skin treatment system comprising a weekly removable injection template with a removable indicator strip, and FIGS. 59B-59E depict the sequential removal of the indicator strip.

[0195] [Figure 60] Figure 60A is a perspective view of another exemplary tensioning skin treatment system including a removable injection template, and Figures 60B-60D depict different injection templates that can be used with the system of Figure 60A.

[0196] [Figure 61]61A-61D are top views of an injection template with variable alignment features.

[0197] [Figure 62A] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62B] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62C] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62C] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62D] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62E] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62F]Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B. [Figure 62G] Figure 62A is a perspective view of another tensioning skin treatment system comprising a removable ring. Figures 62B and 62C are perspective views of additional skin treatment systems comprising individual removable covers for each dressing opening. Figures 62D-62G depict use of the exemplary system of Figure 62B.

[0198] [Figure 63] FIG. 63 is a perspective view of another tensioning skin treatment system.

[0199] [Figure 64] Figure 64A is a top view of another embodiment of a tensioning skin treatment system with removable strip ring markers, and Figure 64B is the top of the system of Figure 64A with one strip ring marker removed.

[0200] [Figure 65A] Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing. [Figure 65B] Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing. [Figure 65C] Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing. [Figure 65D] Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing. [Figure 65E] Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing. [Figure 65F] Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing. [Figure 65G]Figure 65A is a top plan view of another embodiment of a tensioning skin treatment system including an injection guide and cover adhesive set and with an applicator. Figure 65B is a bottom plan view of the system of Figure 65A with the release liner removed. Figure 65C is an exploded view of the system of Figure 65A. Figure 65D is an exploded view of the system of Figure 65B with a dressing. Figures 65E-65G depict initial use of the system adhered to a dressing.

[0201] [Figure 66A] Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66B] Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66C]Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66D] Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66E]Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66F] Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66G]Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively. [Figure 66H] Figure 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 66B is a top perspective view of the system of Figure 66A with the infusion set connector and tubing removed. Figure 66C is a top perspective view of the system of Figures 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. Figure 66D is a top perspective view of the system of Figures 66A-66C with the infusion hub and infusion catheter removed from the dressing. Figures 66E-66H are side views depicting use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject. Figures 66E-66H correspond to Figures 66A-66D, respectively.

[0202] [Figure 67A] Figure 67A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 67B is a top perspective view of the system of Figure 67A showing the infusion set connector and tubing as it is removed. Figure 67C is a top perspective view of the system of Figures 67A and 67B showing the infusion set hub and catheter as it is removed. [Figure 67B]Figure 67A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 67B is a top perspective view of the system of Figure 67A showing the infusion set connector and tubing as it is removed. Figure 67C is a top perspective view of the system of Figures 67A and 67B showing the infusion set hub and catheter as it is removed. [Figure 67C] Figure 67A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 67B is a top perspective view of the system of Figure 67A showing the infusion set connector and tubing as it is removed. Figure 67C is a top perspective view of the system of Figures 67A and 67B showing the infusion set hub and catheter as it is removed.

[0203] [Figure 68A] Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figures 68B-68F are top perspective views illustrating steps of removing the infusion set of Figure 68A from the dressing. [Figure 68B] Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figures 68B-68F are top perspective views illustrating steps of removing the infusion set of Figure 68A from the dressing. [Figure 68C] Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figures 68B-68F are top perspective views illustrating steps of removing the infusion set of Figure 68A from the dressing. [Figure 68D] Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figures 68B-68F are top perspective views illustrating steps of removing the infusion set of Figure 68A from the dressing. [Figure 68E]Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figures 68B-68F are top perspective views illustrating steps of removing the infusion set of Figure 68A from the dressing. [Figure 68F] Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figures 68B-68F are top perspective views illustrating steps of removing the infusion set of Figure 68A from the dressing.

[0204] [Figure 69A] Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69B]Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69C] Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69D]Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69E] Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69F]Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69G] Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69H]Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69I] Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69J]Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub. [Figure 69K] Figure 69A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. Figure 69B is a top perspective view of the treatment system of Figure 69A. Figure 69C is a top perspective view of the system of Figures 69A and 69B with the infusion set connector and tubing removed. Figure 69D is a top perspective view of the system of Figures 69A-69C with the infusion set connector and tubing removed and the infusion hub in a secured position on the dressing connector. Figure 69E is a top perspective view of the system of Figures 69A-69D with the infusion hub rotated to an unlocked position and removed from the dressing connector. Figure 69F is a top perspective view of the dressing and dressing connector with the infusion hub removed. Figure 69G is a top view of the infusion hub engaged with the dressing connector. Figure 69H is a cross-section of Figure 69G along line AA. Figure 69I is a side view of the infusion hub engaged with the dressing connector. Figure 69J is a partial cross-sectional underside view of the infusion hub and dressing connector of Figure 691. Figure 69K is a side cross-sectional view of the infusion housing and hub.

[0205] [Figure 70A] FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70B] FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70C]FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70D] FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70E]FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70F] FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70G]FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70H] FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70I]FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70J] FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. [Figure 70K]FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated detachable or removable infusion set. FIG. 70B is a side view of the treatment system of FIG. 70A with the infusion set connector and tubing removed. FIG. 70C is a top perspective view of the system of FIGS. 70A and 70B with the infusion set connector and tubing removed. FIG. 70D is a top perspective view of the system of FIG. 70C with a removal tool. FIG. 70E is a top perspective view of the system of FIG. 70D with the removal tool fully docked into the infusion hub. FIG. 70G is a top perspective view of the dressing and dressing connector with the infusion hub removed. FIG. 70F is a top perspective cross-section of the system of FIG. 70G. FIG. 70H is a side cross-section of the system as shown in FIG. 70D. FIG. 70I is a side cross-section of the system as shown in FIG. 70E. FIG. 70J is a side cross-section of the system as shown in FIG. 70F. FIG. 70K is a top perspective view of a tool for removing a portion of the infusion set. DETAILED DESCRIPTION OF THE INVENTION

[0206] Detailed Description Previous attempts to treat scars and keloids have included surgery, silicone dressings, steroids, x-ray irradiation, and cryotherapy. Each of these techniques has disadvantages. Perhaps the greatest disadvantage is that none of them effectively prevent or ameliorate scar or keloid formation in the first instance. That is, these techniques are primarily used to treat scars after they are already well established.

[0207] Unloading extrinsic and / or intrinsic stress near a wound can ameliorate scar, hypertrophic scar, or keloid formation. The mechanical environment of an injury can be an important factor in the 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., outer skin stress resulting from the physical properties of the skin itself, including stress induced at the wound site due to skin swelling or contraction). 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 a 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 skin layers such as the outer stratum corneum, epidermis, and dermis, as well as 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 stresses experienced by the wound as well as 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 endogenous 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 endogenous stresses near the wound may ameliorate the formation of scars, hypertrophic scars, or keloids.

[0208] The external mechanical environment of a cell can induce biological responses within the cell, altering cell behavior. Cells can sense and respond to changes in their mechanical environment using integrins, integral membrane proteins in the cell's plasma membrane, and intracellular pathways. Intracellular pathways are initiated by receptors attached to the cell membrane and the cell membrane, which 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 secreting cell (intracrine), on the secreting cell (autocrine), on cells surrounding the secreting cell (paracrine), or at a distance from the point of secretion (endocrine). Intracrine interference can alter cell signaling, which in turn can alter cell behavior and biology, including cell recruitment to, proliferation in, and death in wounds. In addition, the extracellular matrix can be affected.

[0209] As described above, the wound healing process can be characterized by three phases: the early inflammatory phase, the proliferative phase, and remodeling. The inflammatory phase occurs immediately after injury and typically lasts from about two days to one week. Blood clotting occurs, stopping blood loss, and factors are released to attract cells that can remove debris, bacteria, and damaged tissue from the wound. In addition, factors are released to initiate the proliferative phase of wound healing. During the proliferative phase, which lasts from about four days to several weeks, fibroblasts grow and build new extracellular matrix by secreting collagen and proteoglycans. At the end of the proliferative phase, fibroblasts can act to further contact the wound. During the remodeling phase, randomly oriented collagen is organized and crosslinked along skin tension lines. Cells no longer needed may undergo apoptosis. The remodeling phase can continue for weeks, 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. That is, scars 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 dermal layers.

[0210] There are three general possible outcomes for the wound healing process. First, a normal scar may result. Second, a pathological increase in scar formation, such as the formation of a 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 any type of scar formation. In addition, the devices, kits, and methods described herein can be adapted for various wound sizes and different skin thicknesses; for example, the devices may be configured for use on different areas of the body. In addition, the devices, kits, and methods described herein can be adapted to ameliorate scar formation in any type of skin, for example, body location, age, race, or condition.

[0211] While not 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 can inhibit cell apoptosis, leading to significant cell and matrix accumulation and therefore 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 a portion of the strain that may act on a wound or incision. This tensile strain may be exogenous and / or endogenous, including, but not limited to, strain from the inherent tensile forces found in normal, unwounded skin tissue.

[0212] Some wound dressings have backings, adhesive liners, and / or packaging that are 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.

[0213] 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 epidermal tissue at or near a skin site, i.e., at or adjacent to a wound or treatment site on a subject's skin, thereby reducing tensile or compressive stress at the skin site, 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 surrounding tissue in one, two, or more directions to reduce 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 help prevent or reduce the occurrence of wound dehiscence.

[0214] The devices, kits, and methods described herein may provide packaging and / or an applicator for the bandage material. According to one variation, the packaging and / or applicator is configured to provide for quick or easy preparation and / or application of the bandage material. While some examples herein specifically refer to packaging that also acts as a tensioning device to pre-strain the bandage material, other bandages may be provided that are not pre-strained and / or not strained prior to application according to one or more variations or embodiments. The packaging may also operate as an applicator, where one or more elements of the packaging may be used to position and / or apply the bandage to the subject's skin.

[0215] 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 drug or other material to a portion of the dressing prior to application.

[0216] 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 dressing's tendency to fold or collapse, 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.

[0217] 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 subject's skin.

[0218] 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 has been applied to the skin. According to variations, the dressing may be pre-strained and coupled to the dressing carrier, support, base tensioning device, or applicator, for example, as described 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.

[0219] 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 packaging or applicator. According to some variations, the book-like packaging 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.

[0220] 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 edge of the dressing and / or so that the dressing is in an optimal location for unloading skin stress.

[0221] 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.

[0222] 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 bandage, while being relatively more flexible and less rigid in at least a second direction to provide a more conformal application to the curved or shaped skin surface of the subject or to allow the bandage 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 bandage carrier, support, or base is sufficiently rigid or supports the bandage while allowing the bandage to be shaped. According to some variations, the carrier or support, which may include a base and / or cover, may comprise a section of relatively more rigid material flexibly coupled to an adjacent section to provide flexibility to allow the packaging / applicator and / or bandage to be shaped while providing sufficient support for the bandage 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 substrate. Alternatively, the compartments may be formed as structures by manufacturing the substrate with cutouts, slots, grooves, creases, or other openings, or variations in the thickness of the substrate at different locations.

[0223] 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 application or placement location.

[0224] According to a variation, the flexible element is provided in combination with a support element that provides sufficient support to allow a user to maintain the bandage in the strained configuration. According to a variation, one or more elements, such as fastening elements that secure the bandage in the strained configuration until it is applied to a subject and released from the carrier, support, base tensioning device, or applicator, may be provided to maintain the strained bandage in the strained configuration. For example, after straining the bandage, the bandage may be adhered or attached to one or more elements of the bandage, support, base tensioning device, or applicator, or bandage assembly, until it is released from the carrier, support, base tensioning device, or applicator, or assembly.

[0225] According to some variations, the applicator may further be used to help reduce bleeding, for example, by allowing the application of compressive force using a support structure during or after application of the device. 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), procoagulants (e.g., propyl gallate), antifibrinolytic agents (e.g., epsilon aminocaproic acid), and the like. In some variations, the agents may be lyophilized, 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 include one or more other active agents 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. 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 drug or agent, and the device may deliver one or more drugs or agents.

[0226] According to one 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 bandage, or have a sufficiently large area, so that it can provide for sterile application and / or one-handed application. According to a variation, a support structure is provided for the bandage. According to a variation, a margin is provided as a support structure between the bandage or bandage adhesive and one or more edge portions of the support structure. Such a margin provides a supported edge or area for grasping or manipulating the bandage or its carrier, base, or support without forcing or creating a higher likelihood of inadvertent user contact with the adhesive.

[0227] According to some variations, the packaging or applicator may also be used to provide a dressing configured to strain the dressing prior to application and to ameliorate scar or keloid formation.

[0228] Described herein are devices that can be used to ameliorate scar and / or keloid formation at the skin or wound site. The scar can be any type of scar, e.g., a normal scar, a hypertrophic scar, etc. Generally, the device can be configured to be removably secured to the skin surface near the wound. The device can 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, can protect the skin or wound from endogenous stresses without affecting the exogenous stresses on the skin or wound. In other variations, the device can protect the skin or wound from exogenous stresses without affecting the endogenous stresses on the wound. Such variations can 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.

[0229] The devices or dressings described herein may treat skin at a skin site, including, but not limited to, ameliorating scar formation at a wound site by controllably applying stress or strain to the epidermis and deeper layers of outer skin tissue at or near the skin site, thereby reducing tensile or compressive stresses at the skin site itself. Stress at the skin site may be reduced to levels below those experienced by normal skin and tissue. Stress or strain may be applied to surrounding tissue in one, two, or three 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 resist 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 approximately 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 peeling and / or blistering of skin in direct contact with the adhesive, as opposed to bandage "wrap," in which one end of a bandage is adhered to the skin and then tensioned or pulled across the wound before the other end is attached to the skin on the opposite side of the wound. Bandage "wrap" may generate tension in the bandage during application while simultaneously generating relatively high tissue strain at the first adhesive site. This high tissue strain then decreases when the bandage is attached to the skin at the second adhesive site because the high peak stress is redistributed along the skin beneath the bandage. In contrast, when a prestrained bandage is applied to skin, little, if any, strain may be transmitted or generated in the skin because the adhesive region is applied in the desired location. However, when a prestrained bandage is allowed to relax, the strain (or peak strain) in the skin may increase. 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 pre-straining and wrapping.

[0230] The bandage may comprise an elastic member, such as a sheet of elastic material. The elastic material of the bandage 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 bandage with sufficient load capacity to achieve a desired recoverable strain and to prevent undesirable amounts of incremental deformation of the bandage over time. In some variations, the thickness across the bandage is not uniform; for example, the thickness across the bandage may be varied to change the stiffness, load capacity, or recovery strain in selected orientations and / or locations. The elastic material of exemplary bandages may have a thickness ranging from about 50 microns to 1 mm or more, from about 100 microns to about 500 microns, from about 120 microns to about 300 microns, or in some variations, from 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 an object. In some variations, the bandage is tapered near the edges to reduce thickness. Tapered edges may also mitigate peak tensile forces acting on skin tissue adjacent to 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 plot 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.

[0231] The depicted dressings may have a generally rectangular configuration with a length and / or width of about 160 mm to about 60 mm, but 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. The corners of the dressings may also be square or rounded, for example. The length and / or width of exemplary dressings 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 dressing's maximum dimension (e.g., its length) to the orthogonal dimension to its maximum dimension (e.g., width), excluding the dressing's minimum dimension (e.g., thickness), may be within a 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 greater. 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 imposed on 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. Skin at a skin site typically provides inherent tension that stretches the incision site, regardless of whether any tissue has been excised from the skin site. The elastic material and adhesive region may be configured to be applied to the skin location such that when the bandage is stretched to a particular tension and then adhered to the incision site, tensile stress in the bandage is transferred to the incision site to compress the tissue directly beneath the bandage along an axis tangent to the skin surface, with the stress and strain imposed on the skin location having a net or resulting orientation, or a similar axis to the orientation, or axis of tensile stress in the bandage, 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 bandage will relax to a tension level that maintains equilibrium with the increased tension in the skin adjacent to the bandage.Application of a bandage to a skin location may involve placement of the bandage without overlapping or wrapping over itself; for example, only adjacent areas of the bandage are interconnected, and non-adjacent areas of the bandage are not. The actual amount of stress and strain imposed on the skin may vary, depending, for example, on the particular person, skin location, thickness or various mechanical properties of skin layers (e.g., epidermis, dermis, or underlying connective tissue), and / or the extent of existing scarring. In some further variations, wound treatment dressings may be selected or configured for use at specific body locations, such as the scalp, forehead, cheek, neck, upper back, lower back, abdominal region, upper torso (including, but not limited to, breasts), shoulders, upper arms, forearms, palmar regions, dorsum of hands, fingers, thighs, lower legs, dorsal or plantar surfaces 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.

[0232] The dressing may be configured to impose a skin strain within a 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 a 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 copolymer, natural rubber, fluoroelastomer, perfluoroelastomer, polyether block amide, thermoplastic elastomer, thermoplastic polyurethane, polyisoprene, polybutadiene, and the like. Exemplary dressing materials may have a Shore A durometer hardness within a range of about 20 to about 90, about 30 to about 80, or 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 No. 11 / 888,978 (previously incorporated by reference in its entirety).

[0233] When a 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 in 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 on the dressing before recovery and the resulting engineering compressive strain in the skin may vary depending on the skin type and location, but in some embodiments may be about 2:1. In other embodiments, the ratio may be in the range of about 4:1 to about 5:4, about 3:1 to about 5:3, or about 5:2 to about 2:1. These skin strain characteristics may be determined relative to a reference location on the body or body part, e.g., an anatomical location, 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).

[0234] 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 a dressing comprise a material exhibiting 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 specified 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%.

[0235] In some embodiments, a portion of the stress / strain curve may have a particular 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, the load curve had an approximately linear configuration up to about 45% true strain. 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.

[0236] In some variations, the elastic material comprises a material having a modulus of elasticity 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 modulus of elasticity 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.

[0237] In addition to the absolute stress levels at a given 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.

[0238] In some embodiments, the elastic material of the dressing may be configured under test conditions to achieve a stable level of stress at a constant strain; for example, the material exhibits a limited amount of stress relaxation at a particular level of strain over a specific 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.

[0239] In some variations, the elastic material or dressing may be configured under test conditions to maintain a specific minimum level of stress when held at a constant strain for a specific period of time. In an example to assess the ability of a backing material to maintain stress and strain on the skin over time, the engineering strain was measured while each backing material was subjected to a tensile strain of 60% at a rate of 100 microns per second, held for 10 minutes, and 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 approximately 350 KPa at a 30% engineering strain. 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 over 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 engineering stress or strain and / or true stress or strain.

[0240] The adhesive used may be a pressure-activated adhesive (PSA), such as, for example, silicone, acrylic, styrene block copolymer, vinyl ether, 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-, polyisobutylene-, and 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 for a particular period of time. The degree of adhesion (e.g., as measured by T-peel release force or blunt probe tack test value) may vary depending on the degree of strain applied on 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 blunt probe tack test value of the adhesive may be at least about 0.50 kg, about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg, or about 0.75 kg, or more, 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. 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 US Application No. 11 / 888,978, filed August 3, 2007, which is incorporated herein by reference in its entirety.

[0241] 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, a fluoropolymer-treated polyester film may be used, and for acrylic pressure-sensitive adhesives, a 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.

[0242] 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.

[0243] 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 and second attachment portions, causing 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 subject's skin.

[0244] The attachment structure of the packaging device, bandage assembly, dressing 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 structure. Any such attachment feature may be integral with or include any of the attachment structure or structure corresponding to the attachment structure of the packaging, applicator dressing, and / or tensioning device.

[0245] 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 element, or other portion 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, but are not limited to, pockets and tabs, hook-and-loop mechanisms, hooks, angled bars, pivoting, rolling, swinging, or sliding features associated with or coupled to the attachment structure, adhesives, removable adhesives, adhesive tape 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 for facilitating tearing, cutting, or separation of a perforated attachment structure or element or otherwise severable structure to enable removal of the dressing from the applicator, packaging, other portions of the dressing assembly, and / or attachment structure, feature, element, or portion. 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 also be manually activated.

[0246] 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 maintain an applied strain on the skin treatment device. The packaging, applicator, or tensioning device may be configured to pivot or rotate to tension the bandage. 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 a packaging assembly, applicator, or tensioning device may also be used in any device used to strain a bandage. A packaging or applicator, tensioning or straining device described as being in an unstrained configuration is in a configuration in which the bandage may be unstrained or relatively little strained when attached to the packaging, applicator, tensioning or straining device. A packaging, applicator, tensioning or straining device described herein as being in a strained configuration is one in which the dressing is strained, or can be strained relatively more, relative to the unstrained configuration when attached to the packaging, applicator, tensioning or straining device or when applied to the skin of a subject.

[0247] 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.

[0248] The contours of the packaging device, applicator, tensioning device, and / or attachment structure may be linear, curved, or otherwise varied. 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 with a desired contour for the particular body location or contour where the skin treatment device is to be placed on the subject's skin. The packaging device, applicator, tensioning device, or elements thereof may be selected or configured to closely conform to 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 movable to provide alternative shapes or contours for the attached dressing. They may be relatively curved, bendable, flexible, malleable, bendable, deformable, moldable, or movable in at least one direction, while being more rigid in another direction.

[0249] Various locking, latching, securing, attaching, 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. Various 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. By locking the packaging, applicator, tensioning device, or dressing in a strained position, a predetermined strain for a given dressing may be achieved. 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 required to achieve sutureless wound closure (e.g., the relative strain or force required 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.

[0250] 1-5C, a variation of a bandage and packaging assembly 100 is illustrated. Packaging assembly 100 includes a book-like applicator and / or tensioning device 120, a bandage assembly 110 including a bandage 130, and a release portion 150 configured to release bandage 130 from applicator and / or tensioning device 120.

[0251] The dressing 130 comprises an elastic sheet 131 with one or more adhesive regions comprising on a first surface 135a a layer of skin adhesive 135. The adhesive used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive.

[0252] 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. 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.

[0253] 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 edges 121a at opposite ends. Dressing carrier or base 122 may be generally planar and include sides 125, 126 with corresponding edges 125a, 126a along its length and edges 122a at opposite ends.

[0254] 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 relative to the attached dressing to support the attached dressing until it is applied to a subject, as described with respect to variations herein. Such materials may include, for example, plastics such as polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or 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 sulfuric acid paperboard with layers of flexible material, such as silicone, polyurethane, LDPE, or rubber material, between layers of paperboard. The material may also be a metal, such as ductile aluminum or stainless steel. The metal may comprise a foil, ribbon, wire, or other form.

[0255] The cover 121 and base 122 are movably, hingedly, or pivotally coupled at sides 123, 125. For example, layers 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 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 regions and rigidity in other regions, or that 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. While the cover 121 and base 122 depicted in FIGS. 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 on locations with various shapes or curvatures. For example, the cover and base 121, 122 as shown may each be 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 lateral or other flexing. Other configurations that vary the stiffness and / or direction of flexibility may be used. The configuration 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 relative to one another. 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 compartments 127 to adjacent compartments 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, e.g., compartments and / or cover and base and joining 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, 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 can be biased into an open or closed configuration, or a configuration in between. 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 joints.

[0256] As illustrated in Figures 5A-5C, variations in the structure of the packaging are shown. Cover 121 and base 122 include relatively strong or rigid elements, such as battens 121a, 121b and 122a, 122b, respectively, attached using a sheet 128 of material, such as silicone, polyurethane, low-density polyethylene, or a rubber material, that also flexibly couples to cover and base 121, 122 at sides 123, 125. Compartments 127 may have alternative shapes and structures that couple compartments 127 together. Thus, device 120 may be constructed to flex or curve over a variety of ranges or in multiple directions. Thus, the device may be constructed for use on specific anatomical locations or with various sizes, or may be constructed with a shape for a particular situation or individual.

[0257] 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 the wound, incision, or other location can be visualized for accurate 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, positioning, and / or centering the location of the wound or location on the skin relative to the dressing 130, or for positioning 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 over the wound or incision.

[0258] 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's sides 133, 134. When the device 120 is closed, the adhesive layer 135 is covered by a release liner 149 that faces away from the base 122 and is attached to the inner surface 177 of the cover 121. The dressing assembly 110 also includes a mounting sheet 141 having a first side 143 and a second side 144. When the device is opened, the mounting sheet 141 bonds the dressing 130 to the cover of the device 120, applying a straining force to the dressing 130 through the mounting sheet 141. According to some variations, the mounting sheet 141 is flexible while being relatively inelastic with respect to the dressing 130 and may be constructed from, for example, low-density polyethylene. Once assembled, the mounting sheet 141 is bonded to the elastic sheet 131 of the dressing (e.g., using a silicone PSA / acrylic PSA combination) at or near sides 134 and 143 of the dressing 130 and mounting sheet 141, respectively. The mounting sheet 141 is bonded to the cover 121 at its sides 144 at attachment points 137 that define lines or areas 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. Thus, the elastic sheet 131 is attached at attachment points 138 that define lines or areas 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.

[0259] When assembly 100 is in the closed configuration as shown in FIG. 1 and the 90-degree open configuration as shown in FIG. 2, elastic sheet 131 is relaxed or unstrained, and elastic sheet 131 has an unstrained width w1. As assembly 100 is opened (e.g., by rotating or pivoting cover 121 relative to base 122) to 180 degrees or up to about 360 degrees, the orthogonal distance increases between attachment lines or areas 137a, 138a. According to some variations, the assembly is opened to more than about 180 degrees (minimum angular change) to provide for application of the dressing without interference of assembly 100. When device 120 is opened, it applies a separation force between the attachment regions defined by attachment lines or areas 137a, 138a, or corresponding attachment areas. The force tensions the elastic sheet and creates strain. Tensioning and straining the bandage 130 increases the width between the lines or areas of attachment 137a, 138a to w2. The width increase, i.e., w2-w1, may be a fraction of w1 or percent strain as described herein. While straining is illustrated as beginning when the cover 121 is opened approximately 90 degrees from the base 122, the bandage 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 bandage assembly 110 on the cover to the edge 124a of the cover 121, as well as the angle of the cover 121 relative to the base 122 at which tensioning of the bandage occurs. Additionally, 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.

[0260] 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 less than the width of base 122 and / or cover 121, such that the area of ​​the dressing spans 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.

[0261] According to some variations, the bandage 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 strained portion of the bandage may be about 10 mm, about 20 mm, about 30 mm, about 40 mm, or about 50 mm. Other strain dimensions may be used. According to other variations, the distance between each of the edges 133, 134 of the bandage 130 and the edges 125 a, 126 a of the base 122 (and / or the edges 123 a, 124 a 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 136 a, 136 b of the bandage and the edge 122 a of the base is about 10 mm, about 15 mm, or about 20 mm or less.

[0262] According to some variations, edges 133, 134, 136a, 136b of bandage 130 are at least about 1.0 mm inward of at least a portion of edges 125a, 126a, and / or 122a of base 122 so that edges 125a, 126a, and / or 122a of base 122 can be grasped by a user with reduced likelihood of touching bandage 130 or adhesive layer 135. According to some variations, ends 136a, 136b of bandage 130 have a margin at least about 1.0 mm inward of end 122a of base 122. According to some variations, sides 133, 134 and ends 136a, 136b of bandage 130 have a margin of about 10 mm from sides 125, 126 and end 122a of the base, respectively. According to some variations, sides 133, 134 and ends 136a, 136b of bandage 130 have margins of approximately 15 mm from sides 125, 126 and end 122a of the base, respectively. The margins between sides 133, 134 or ends 136a, 136b of bandage 130 and sides 125, 125 and end 122a of base 122, respectively, may vary. As illustrated in FIG. 3, for example, margins m1 and m2 are approximately 3 mm or greater, and margin m3 is approximately 15 mm. For example, if the edges of cover 121 are used alternatively or in addition to gripping device 120 or manipulating bandage 130, similar margins may be provided between bandage 130 and edges 121a, 123a, and / or 124a of 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.

[0263] 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 pulls 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.

[0264] 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 apply compression to the wound. Alternatively, if the cover 121 is rotated through 360 degrees, pressure may be applied to the inside 177 of the cover 121. 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.

[0265] Release mechanism 150 may include cutters 151 positioned on opposite sides 133, 134 of elastic sheet 131, respectively. 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. Blade 152 includes a sharp surface that may be generally V-shaped or otherwise shaped. Blade may be constructed from, for example, stainless steel, ceramic, or hard plastic. Blade 152 and pull tab 156 each extend to ends 136a, 136b of elastic sheet 131 and end 122a of base 122, respectively. Cutter 151 is attached to bandage 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 bandage assembly 110 and release bandage 130. In some variations, the bandage may be scored, perforated, or otherwise configured to facilitate separation by the release mechanism.

[0266] As shown in most detail in Figures 5B and 5C, tubes 164, 165 for receiving and guiding legs 154, 155 of cutter 151, respectively, are positioned along side surface 133 of elastic sheet 131. Tubes 164, 165 may be positioned such that cutting path 162 is between tubes 164, 165. Tube 165 is coupled, e.g., glued, to adhesive surface 135 of elastic sheet 131 at a location closer to side surface 133 than cutting path 162. Tube 164 is coupled to back surface 139 of elastic sheet 131 at a location closer to side surface 133 than cutting path 162, using attachment sheet 141 that is also coupled to elastic sheet 131. Tube 164 is coupled to free end 145 of attachment sheet 141, which extends inward of cutting path 162 relative to side surface 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 the skin is protected from the blade 152 when the adhesive layer 135 is positioned on the subject's skin and the cutter 151 is actuated.

[0267] Tubes 174, 175 for receiving and guiding legs 154, 155, respectively, are positioned along side surface 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 surface 134 of elastic sheet 131 than cutting path 163. Tube 174 is bonded to back surface 139 of elastic sheet 131 using 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 surface. Tube 174 is also bonded to elastic sheet 131 at a location closer to side surface 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 the skin is protected from the blade 152 when the adhesive layer 135 is positioned on the subject's skin and the cutter 151 is actuated.

[0268] 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 rest of the packaging assembly 100.

[0269] 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. Thus, elastic sheet 131 is released from package 100 (including release portion 150).

[0270] 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.

[0271] Packaging assembly 200, applicator or tensioning device 220, and / or dressing assembly 210 may be configured to pre-strain dressing 230 and / or 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.

[0272] Device 220 may include a cover 221 and a base 222. Dressing assembly 110 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 opposite end. Base 222 may be generally planar and include sides 225, 226 with corresponding edges 225a, 226a defining its length, and an edge 222a at an opposite end.

[0273] 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 relative to the attached bandage material to support the attached bandage material until it is applied to a subject, as described with respect to 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 material, between layers of paperboard. The material may also be a metal, such as ductile aluminum or stainless steel. 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.

[0274] The cover and base 221 and 222 may be movably, pivotably, flexibly or hingedly connected at sides 223, 225 in a manner similar to that described for cover and base 121, 122 herein, and may be constructed in a manner similar to cover and base 121, 122 herein, in particular, with section 227 similar to section 127 and with bandage 230 attached to and strained by device 220 in a manner similar to that in which bandage 130 is attached to device 120.

[0275] Various attached structures, e.g., compartments and / or covers and bases and connecting elements, may provide structural support for the dressing carrier to be manipulated by a user. For example, margins between at least a portion of the structural support element, dressing carrier, or backing and the strained or unstrained dressing, such as margins m1, m2, m3 shown in Figure 3 herein, may be provided at or near edges 221a, 223a, 224a, 222a, 225a, and / or 226a.

[0276] 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 can be visualized for accurate 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 over portions of the material to create a window border. The section 227 may be clear or semi-opaque to provide a window for viewing, positioning, and / or centering the location of the wound or location on the skin relative to the dressing 230, or for positioning 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 over the wound or incision.

[0277] Dressing assembly 210 also includes a mounting sheet 241, a mounting sheet 251, and a dressing release structure or mechanism 250 comprising a pull tab 246, as described in more detail herein. Dressing 230 of dressing assembly 210 has a first side 233 having a length and a second side 234 having a length. When device 220 is closed, adhesive layer 235 faces away from base 222 and is covered by release liner 249 that is attached to inner surface 277 of cover 221.

[0278] Mounting sheet 241 has a first side 243 and a second side 244. Mounting sheet 241 bonds bandage 230 to cover 221 of device 220 near second side 234 of bandage 230. Cover 221, when released, applies a straining force to bandage 230 through mounting sheet 241. Mounting sheet 241 is bonded to cover 221 on 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, mounting sheet 241 is bonded to elastic sheet 231 of dressing 230 at section 265 of mounting sheet 241 at or near side 243 of mounting sheet 241, for example, using a silicone PSA / acrylic PSA combination. Mounting sheet 251 has a first side 253 and a second side 254. Mounting sheet 251 bonds bandage 230 to base 222 of device 220 near first side 233 of bandage 230. Mounting sheet 251 is bonded to base 222 on its side 254 at attachment points 238 defining attachment lines or areas 238a, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. When assembled, mounting sheet 251 is bonded to elastic sheet 231 of the bandage at section 265 of mounting sheet 251 at or near side 253 of mounting sheet 251, for example, using a silicone PSA / acrylic PSA combination.

[0279] Dressing 230 has unattached portions or edges 255 at its sides 233, 234 where elastic sheet 231 is free from mounting sheets 241, 251, respectively. Thus, dressing 230 is not strained at unattached portions 255. Pull tabs 246 are coupled to ends 281, 282, respectively, of device 220. Each pull tab 246 comprises a top section 247 and a bottom section 248. Bottom section 248 is attached to base 222 or cover 221 as shown, while top section 247 is adjacent to, but not attached to, dressing 230.

[0280] According to some variations, the mounting sheets 241, 245 are flexible yet relatively inelastic relative to the dressing 230 and may be constructed, for example, from low-density polyethylene. The mounting 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 tensioning direction of the material of the mounting sheet 241 (the direction in which the dressing is tensioned, stressed, or strained). An example of such a material is LDPE polymer produced by an extrusion process that creates directionally biased grain, thereby making the material tearable in the direction of the grain but relatively resistant to tearing in directions transverse to the grain. The pull tab 246 may initiate a tear at a notch in the mounting sheet 241 or 251, which should be completed along the line 262. The mounting sheets 241, 251 may additionally or alternatively comprise a material such as LDPE with perforations formed along the tear line 262.

[0281] 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) to 180 degrees or up to about 360 degrees, the orthogonal distance increases between attachment lines or areas 237a, 238a. When device 220 is opened, this applies a separation force between the attachment regions defined by attachment lines or areas 237a, 238b or corresponding attachment areas. The force tensions elastic sheet 231, creating a strain. Tensioning and straining 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 a 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 cover 222 may be in when straining begins.

[0282] 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 to about 180 degrees (minimum angular change) or more to accommodate application of the dressing without interference from the assembly.

[0283] 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 bandage 230. The orientation of the cover 221 at which the dressing 230 begins to strain 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.

[0284] The adhesive layer 235 of the elastic sheet 231 is protected by a release liner 249 before the applicator and 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 pulls away from the elastic sheet 231, pre-exposing the adhesive layer 235. Alternatively, as shown in FIG. 6 , a release liner 149 a 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 149 a may be manually removed from the elastic sheet 231 to expose the adhesive layer 235.

[0285] 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 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.

[0286] The pull tabs 246 of the release mechanism 250 each extend 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. Score or perforations may be made in the attachment sheets 241, 251 to facilitate tearing along path 262.

[0287] Dressing 230 is applied to the subject. Dressing 230 may then be released from device 220 by pulling tab 246 to draw tab 246 across path 262 of mounting sheets 241, 251. Section 245 of mounting sheets 241, 251 that is joined to pull tab 246 is thereby separated from the mounting sheet, thereby separating section 265 of the mounting sheet attached to dressing 230 from the remainder of mounting sheets 241 and 251 that are attached to cover 221 and base 222, respectively. Thus, dressing 230 is released from the remainder of package 100, as shown in FIG. 9. Section 265 of mounting sheets 241, 251 may remain on back surface 239 of silicone sheet 231, as shown in FIG. 9. The unattached section 245 of the elastic bandage 230 is not strained and may be free of (or have a reduced amount of) adhesive from the adhesive layer 235. Thus, lower stresses occur at the unattached side or edge defined by section 245.

[0288] 10-12B, there is illustrated a dressing and packaging assembly 300. The packaging assembly 300 comprises a packaging device applicator 320 and a dressing assembly 310 that includes a dressing 330.

[0289] 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.

[0290] Packaging device or applicator 320 includes 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 edges 321a at opposite ends. Base 322 may be generally planar and include sides 325, 326 with corresponding edges 325a, 326a defining its length, and edges 322a at opposite ends.

[0291] 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, for example, in a manner 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.

[0292] 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 the wound, incision, or other location may be visualized for accurate placement of the dressing 330 in a manner similar to that described herein with respect to the use of windows 159, 259.

[0293] 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 a variety of dressing materials, including, but not limited to, elastic bandages, gauze-type bandages, and hydrocolloids. Various structures, such as compartments and / or covers and bases and connecting 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, for example, at or near edges 321a, 323a, 324a, 322a, 325a, and / or 326a, as described herein.

[0294] 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. The length of the dressing 330 adjacent its second side 334 is also 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 opened.

[0295] According to a variation, the bandage 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 one embodiment, the width of the strained portion of the bandage may be about 20 mm, about 30 mm, about 40 mm, or about 50 mm. According to other variations, the distance between each of the edges 333 a, 334 a of the bandage 330 and the edges 325 a, 326 a of the base 322 (and / or the edges 323 a, 324 a of the cover 321), respectively, is about 10 mm, 15 mm, or 20 mm or less. According to a variation, the distance between the edges 336 a, 336 b of the bandage and the edge 322 a of the base is about 10 mm, about 15 mm, or about 20 mm or less.

[0296] According to some variations, edges 333, 334, 336a, 336b of bandage 330 are at least about 3 mm inward of at least a portion of edges 325a, 326a, and / or 322a of base 322 so that edges 325a, 326a, and / or 322a of base 322 can be grasped by a user with reduced likelihood of touching bandage 330 or adhesive layer 335. According to some variations, ends 336a, 336b of bandage 330 have a margin at least about 3 mm inward of end 322a of base 322. According to some variations, sides 333, 334 and ends 336a, 336b of bandage 330 have a margin of about 10 mm from sides 325, 326 and end 322a of the base, respectively. According to some variations, sides 333, 334 and ends 336a, 336b of dressing 330 have margins of about 15 mm from sides 325, 326 and end 322a of the base, respectively. The margins between edges 333, 334 or ends 336a, 336b of dressing 330 and sides 325, 325 and end 322a of base 322, respectively, may vary. As illustrated in FIG. 3, for example, margins m1 and m2 are about 3 mm or greater, and margin m3 is about 15 mm. Similar margins may be provided between dressing 330 and edges 322a, 325a, and / or 326a of base 321. Also, for example, if the edges of cover 321 are used alternatively or in addition to gripping device 320 or manipulating bandage 330, similar edges may be provided between bandage 330 and edges 321a, 323a, and / or 324a of cover 321.

[0297] 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 pulls 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 a 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), procoagulants (e.g., propyl gallate), antifibrinolytic agents (e.g., epsilon aminocaproic acid), and the like. In some variations, the agents may be lyophilized, 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 before application of the dressing or after application of 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 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. 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 may include, but are not limited to, various antibiotics (including, but not limited to, cephalosporins, bacitracin, polymyxin B sulfate, neomycin, polysporin), disinfectants (iodine solution, silver sulfadiazine, chlorhexidine, etc.), antifungals (nystatin, etc.), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (VEGF, etc.), and other treatments (e.g., botulinum toxin). Cover 321 may be torn or separated in several ways. Cover 321 may be opened like the cover of a book. Similar to devices 120 and 220, 420, 520, 620, 720, 820, 920, and 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 interference of assembly 300. Alternatively, for example, cover 321 may be attached to base 322 by adhesive and may be peeled 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 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 FIGS. 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 a magnet, a hook-and-loop attachment structure, a snap, a latch, a clip, and the like, as well as an adhesive or other adhesive structure. 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 element or a piercing element, as described with respect to devices 150 and 250 herein. The release mechanism may further include one or more release elements described herein and shown in FIGS. 1-22B.

[0298] FIG. 13 illustrates an alternative packaging or applicator 420 that may be used with 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, and 1220. FIG. 13 illustrates a cover 421 and a dressing carrier or base 422 constructed of a single substrate from a material such as nylon and / or polyethylene or metal. Device 420 may be manufactured from a single mold and / or may have portions, slots, grooves, creases, or other openings cut out of the substrate, or variations in substrate thickness at different locations. Cover 421 and base 422 each include slots 428 that form elements such as compartments 427. Slots 428 allow device 420 to flex and conform to the contours of the subject's body to which the attached dressing is to be applied. The cover 421 and base 422 are coupled to one another using connector features 429 formed in the substrate. The cover 421 and base 422 are hingedly or pivotally movable relative to one another by slots 430 formed adjacent the connector features 429 to allow flexion or movement of the connector features 429 and, therefore, the cover 421 and base 422 relative to one another. As noted with respect to device 100, in other variations, the slots 430 may comprise grooves or other structures that provide a reduced thickness for the cover 421 and 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.

[0299] Various structures, such as compartments and / or covers and bases, as well as connecting 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 the attached dressing may be provided, for example, at or near edges 421 a, 423 a, 424 a, 422 a, 425 a, and / or 426 a, as further described herein.

[0300] FIG. 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 laminate structure 530. A first layer 531 of the laminate structure 530 comprises paperboard or other support material, such as a plastic material or metal, with a slot 528 formed laterally across each of the cover 521 and base 522. The slot 528 forms a section 527 of the device 520 that allows it to flex and conform to the contours of the body of a subject to which the attached dressing is to be applied. The first layer 531 further includes a longitudinal slot 529 formed therein between the cover 521 and base 522. First layer 531 further includes tab 540 with an opening that is used in assembly of device 520 and removed after assembly so that cover 521 and base 522 are separated by slot 529 and are no longer connected by first layer 531. Second layer 532 of the laminate includes an adhesive material, such as a PSA acrylic, rubber, or silicone adhesive. Second layer 532 may or may not be approximately 0.001-0.006 mm thick. A flexible strip of material 534 spans slot 529 and connects cover 521 and base 522 and is positioned along the length of device 520. Cover 521 and base 522 are flexibly and hingedly or pivotally coupled with strip of material 534 spanning slot 529 to allow flexure or movement of 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 to the first layer 531 and is attached using adhesive 535 to a third layer 533 comprising a thin material such as paper or plastic that holds the structure of the device 520 together, including the compartment 527.

[0301] Device 520 may include a release mechanism, dressing attachment, and may be used in devices and assemblies in the same manner as those described with respect to Figures 1A-22B herein.

[0302] Various structures, such as compartments, adhesive structures, laminate layers, and / or cover and base as well as connecting 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 the attached dressing may be provided, for example, at or near edges 521 a, 523 a, 524 a, 522 a, 525 a, and / or 526 a, as further described herein.

[0303] 15A-15J, a variation of a bandage and packaging assembly 600 is illustrated. Packaging assembly 600 comprises an applicator and / or tensioning device 620 and a bandage assembly 610 including a bandage 630. Dressing 630 comprises an elastic sheet 631 with one or more adhesive regions comprising a layer of skin adhesive as described herein.

[0304] 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.

[0305] Packaging assembly 600, applicator, tensioning device 620, and / or dressing assembly 610 may be configured to pre-strain dressing 630 and / or enable transfer of pre-strained dressing 630 to the skin of a subject. 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.

[0306] 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 624b defining its length, and an edge 621a at an opposite end. Base 622 may be generally planar and include sides 625, 626 with corresponding edges 625a and 626a defining its length, and an edge 622a at an opposite end.

[0307] 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 not very flexible relative to the attached bandage to support the attached bandage until it is applied to a subject, as described with respect to variations herein. The materials and construction of the applicator or tensioning device 620, the bandage 630, and the packaging 600 may be similar to the packaging assemblies and / or dressings described with respect to variations herein and shown in FIGS. 1A-22B.

[0308] The cover 621 and base 622 may be movably, pivotably, flexibly, or hingedly connected 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, flexibly attaching 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 FIGS. 1A-22B, and may be constructed in a manner similar to that described herein, including, but not limited to, with respect to materials, compartmentalization, strength and flexibility, visualization, straining mechanism, and release liner.

[0309] 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 adhesive structure 670 has a first side 643 that is attached to the second side 634 of the dressing using an adhesive structure 670, such as KAPTON® tape or a releasable adhesive by KAPTON® or a soft skin adhesive made from materials such as 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 mounting sheet, yet is releasable from the selected bandage material, so as to impart strain to the dressing when the mounting sheets are separated from one another.

[0310] As shown in FIG. 15J, the mounting sheet 641 and the side 634 of the dressing may be attached on the same side 671 of the adhesive structure 670, with the mounting sheet 641 overlapping the dressing 631 but not attached to it.

[0311] Mounting sheet 641 has a second side 644 that is bonded to cover 621 of device 620, for example, by bonding with a low surface energy PSA such as an acrylic adhesive. Mounting sheet 641 may also have folds or perforations 681 between its attachment to adhesive structure 670 and its attachment to cover 621. After the dressing is strained, perforations 681 are located at the seam between cover 621 and base 622 or across the interior surface of cover 621.

[0312] 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. The side 653 of the mounting sheet 651 may be attached to the side 633 of the dressing using an adhesive structure 680, such as KAPTON® tape or a releasable adhesive, in a manner similar to the adhesive structure 670 that attaches the side 654 of the dressing 630 to the mounting sheet 641. The mounting sheet 651 may include a pull tab 688 located on the backside 698 of the base adjacent to and inboard of an attachment zone 655 of the mounting sheet 651 to the back of the base 652.

[0313] When the cover 621 is opened, it applies a straining force to the dressing 630 through the attachment sheet 641 .

[0314] According to some variations, the mounting sheets 641, 651 are flexible yet relatively inelastic with respect 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 tensioning 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 LDPE polymer produced by an extrusion process that creates anisotropic or directionally biased grain, whereby the material is tearable in the direction of the grain but has relative resistance to tearing in the direction transverse to the grain.

[0315] 15A shows assembly 600 in an unstrained configuration. Adhesive tape 683 is exposed on the inner surface 694 of base 622. The skin adhesive layer on elastic sheet 631 of dressing 630 may be protected by a release liner similar to release liner 149a herein before applicator or tensioning device 620 is released.

[0316] Figure 15B shows assembly 600 in a released, strained configuration. As shown in Figure 15B, when strained, perforations 681 on the mounting sheet are aligned with edges 623a and 625a of cover 621 and base 622, respectively. Portion 641a of mounting sheet 641 interfaces with adhesive tape 683, which attaches portion 641a to base 622 and holds dressing 630 in the strained configuration. A release liner 645 is attached to the underside of mounting sheet 641 between its attachment to cover 621 and perforations 681. Liner 645 prevents the portion of mounting sheet 641 interfacing with cover 621 from adhering to adhesive tape 683.

[0317] The cover 621 and base 622 may be separable from one another, for example, using perforations 682 in layer 627 that bonds 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. The strained dressing 630 may be applied to the subject's skin using base 622 as an applicator.

[0318] FIG. 15D illustrates the backside 698 of the base 622 in a position to apply the bandage 630 toward the skin of a subject. As shown, the edge 654 of the mounting sheet 651 may wrap 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 mounting sheet 651 between the attached edge and the unattached middle section. The pull tab 688 or tear strip may be pulled to detach the base 622 from the remainder of the bandage assembly, as shown in FIG. 15E. After the tab 688 is pulled, the unattached portion 651 a of the mounting sheet 651 is released from the base 622. After the base is removed, the remainder of the mounting 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.

[0319] 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 151 shows the first adhesive structure 670 removed from the dressing 630. The second adhesive structure 680 may be removed in a similar manner.

[0320] 16A-16D illustrate an alternative bandage assembly 710 in a configuration in which the bandage 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 bandage 730. As shown in FIG. 16A, the unattached ends of the adhesive structures 770, 780 are oriented away from the bandage 730. As shown in FIG. 16B, the second adhesive structure 780 has been peeled inward and, in FIG. 16C, has been removed.

[0321] 17A-17D illustrate an alternative bandage assembly configuration in which the bandage 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 bandage 830. As shown in FIGS. 17A and 17D, the adhesive structures 870, 880 are attached to the bandage 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 bandage 830 for easy access and removal. As shown in FIG. 17B, the first adhesive structure 870 may be pulled using the 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 material 830, as further shown in FIG. 17C.

[0322] 18A-18I illustrate a variation of a dressing and packaging assembly 900. Packaging assembly 900 includes an applicator and / or tensioning device 920 and a bandage assembly 910 including a bandage 930. Device 920 includes a cover 921 and a base 922. Dressing assembly 910 is removably coupled or tethered to device 920, which may act as a dressing carrier. Cover 921 may be generally planar and include sides 923, 924 with corresponding edges 923a and 924a defining its length, and an edge 921a at an opposing end. Base 922 may be generally planar and include sides 925, 926 with corresponding edges 925a and 926a defining its length, and an edge 922a at an opposing end.

[0323] The dressing assembly 910 also includes a mounting sheet 941 and a mounting sheet 951. The mounting sheet 941 has a first side 943 that is attached to the second side 934 of the dressing using 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, a 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 mounting sheet but is releasable from the selected dressing material so as to impart strain to the dressing when the mounting sheets are separated from one another.

[0324] 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 its attachment to the adhesive structure 970 and its 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.

[0325] 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. The side 953 of the mounting sheet 951 is attached to the side 933 of the dressing 930 with an adhesive structure 980, such as KAPTON® tape or a releasable adhesive, in a manner similar to the adhesive structure 970 that attaches the 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 to and inboard of an attachment zone 955 of the mounting sheet 951 to the back of the base 952.

[0326] According to some variations, the mounting sheets 941, 951 are flexible yet relatively inelastic with respect 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 tensioning 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 LDPE polymer produced by an extrusion process that creates anisotropic or directionally biased grain, whereby the material is tearable in the direction of the grain but has relative resistance to tearing in the direction transverse to the grain.

[0327] When the cover 921 is opened, 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 opened, strained configuration that may be applied to the skin. As shown in Figure 18C, when strained, tabs 981 on the mounting sheet 941 are located over the inner surface of the cover 921 (folded back and exposed) and are accessible to the user. After applying the dressing 930, the cover 921 and base 922 may be removed.

[0328] 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, 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 rest of the dressing assembly 910. As shown in FIG. 18E, the cover 921 is removed from the remainder of the device 920, exposing the second pull tab 998. As shown in FIG. 18F, the second pulled tab 998 releases the base 922 from the bandage assembly 910, leaving the mounting sheets 941, 951 unattached to the base 922. As shown in Figure 18G, the base 922 may be removed with the remaining mounting sheets 941, 951, and the adhesive structures 970, 980 may be peeled away from the dressing 930 as shown in Figure 18H, leaving the dressing on the skin in the configuration as shown in Figure 18I.

[0329] 19A-19D, a variation of a bandage and packaging assembly 1000 is illustrated. The packaging assembly 1000 comprises an applicator and / or tensioning device 1020 and a bandage assembly 1010 including a bandage 1030. Figure 19A shows the bandage 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.

[0330] 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 can act as a dressing carrier. The dressing assembly may be attached to a tensioning member or applicator in a manner similar to the assemblies described herein. The dressing assembly 1010 includes a mounting sheet 1041 and a mounting sheet 1051. The mounting sheet 1041 has a first side 1043 that is attached to the second side 1034 of the dressing 1030 using an adhesive structure 1070 as described with reference to adhesive structures 970, 980. The mounting sheet 1041 has a second side 1044 that is bonded 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 side 1090 of the cover 1021, or alternatively, at the seam between the cover 1021 and the base 1022.

[0331] 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 using an adhesive structure 1080, such as KAPTON® tape or a releasable adhesive, in a manner similar to adhesive structure 1070 attaching side 1034 of the dressing 1030 to the mounting sheet 1041. The mounting sheet 1051 includes a ripcord 1098 located between its attachment to adhesive structure 1090 and its attachment to the back of the base. The ends of the ripcords 1088, 1098 extend outward from the tensioning member 1020 for easy accessibility.

[0332] Figures 19A and 19B illustrate the dressing assembly 1010 in an unstrained configuration. When the cover 1021 is opened, it applies a straining force to the dressing 1030 through the mounting sheet 1041. Figure 19C illustrates the dressing assembly 1010 in a strained configuration.

[0333] After the dressing has been strained and applied, the ripcords 1088, 1098 are retracted to separate the portions of the mounting sheets 1041, 1051 attached to the tensioning device 1020 from the portions of the mounting sheets 1041, 1051 attached to the bandage 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 bandage assembly 1010 and the mounting sheets 1041, 1051 from the bandage as shown in Figure 19E.

[0334] 20A-20C, a variation of a bandage carrier, tensioning device, or applicator 1120 is shown. The device 1120 includes multiple sections 1130 formed by folding a substrate 1150 on one side 1155 of a planar surface. The folds 1170 may be formed in one or more directions or with one or more shapes, curved or linear. Additionally, the folds may be formed on both sides, allowing for both convex and concave shaping of the device. As shown, the folds 1170 allow for shaping of the device or attached bandage. The folds 1170 as shown are formed on a first side 1155 of the planar surface of the device, while a second side 1165 is not folded. When 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.

[0335] 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 shape 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.

[0336] According to a variant, the fold may be orthogonal or have an orthogonal component relative to the carrier, applicator or tensioning device section 1127. The section 1127 may be similar to the section shown in Figures 1A-22B.

[0337] 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 compartments 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 generally can be sufficiently thick to provide additional column strength, i.e., resistance to bending, for straining the bandage. For example, a backing or support constructed from a material with an elastic modulus and appropriate thickness that will at least resist the forces created by straining the bandage may be provided for 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, the backing or support may be removed, allowing 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.

[0338] As shown, separations 1270 between the foam sections allow for shaping of the device. The separations 1270 as shown are formed on a first side 1255 of the planar surface 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 fold acts as a flex element, while the remaining substrate at the separation can act as a flex limiter.

[0339] When a convex bandage shape is desired for a concave surface, the bandage may be attached on 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 second side 1265 of 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.

[0340] 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 containing 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.

[0341] 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, pivotally, bendably, or hingedly coupled at sides 1523, 1524 and constructed in a manner similar to that described with respect to the cover and base illustrated in Figures 1A-22B. 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 removable adhesive structure. However, the attachment sheets or attachment structures described with respect to Figures 1A-22B herein may also be used. 22B , the bandage 1530 is strained with the cover 1521 and base 1522 open. The bandage 1530 may then be applied to the subject's skin, and the device 1520 may be peeled away from the bandage 1530. Additionally or alternatively, the cover 1521 and base 1522 may be separated using perforations 1551 formed in the substrate of the device 1520 or in an attachment structure 1550, such as a tape or la...

Claims

1. An integrated injection set, comprising: A prestretched dressing material, wherein the prestretched dressing material comprises: A tension dressing material layer; A skin adhesive on the lower surface of the tension dressing material layer; One or more adhesive protection liners removably covering the skin adhesive; A tension support structure configured to maintain the tension dressing material layer in a stressed configuration, the tension support structure comprising one or more pull tabs; A prestretched dressing material comprising the above; An injection assembly attached to the upper surface of the tension dressing material layer, the injection assembly comprising: An injection conduit configured for insertion into a treatment site; A releasable attachment structure for attaching an injection hub to the upper surface of the tension dressing material layer; An injection assembly comprising the above; An integrated injection set comprising the above.

2. The injection assembly further comprises an injection hub and an injection housing attachable to the injection hub, the injection housing comprising tubing in fluid communication with a cavity of the injection housing, the cavity being configured to receive the injection hub and provide fluid communication between the tubing and the injection conduit. The injection set according to claim 1.

3. The injection conduit is an injection needle or an injection catheter. The injection set according to claim 2.

4. The injection set according to claim 2, further comprising an injection set applicator removably attachable to the injection hub, and further comprising a needle configured to extend removably out from the distal end of the injection conduit through the injection hub.

5. The releasable attachment structure comprises a detachable section, and the injection hub is attached to the detachable section. The injection set according to claim 1.

6. The injection set according to claim 5, wherein the releasable attachment structure comprises two or more non-releasable sections coupled to the releasable section. **Claim 7** The injection set according to claim 6, wherein the two or more non-releasable sections coupled to the releasable section are joined by a frangible or easily breakable structure, frangible struts, or perforations. **Claim 8** The injection set according to claim 5, wherein the releasable section comprises a pull tab or handle. **Claim 9** The injection set according to claim 7, wherein the non-releasable section comprises a split ring or a plurality of arcuate bodies attached to the tension bandage layer. **Claim 10** The injection set according to claim 7, wherein the non-releasable section comprises a slot configured to movably receive a tab located on the releasable section, and the slot is optionally an arcuate slot. **Claim 11** The injection set according to claim 10, wherein the releasable section is integrally formed with the injection hub. **Claim 12** The injection set according to claim 2, wherein the injection hub further comprises a hub body and a hub base, the hub body is releasably attachable to the hub base, the hub base is attached to the tension bandage layer, and the hub base optionally comprises a material softer than the hub body. **Claim 13** The injection set according to claim 12, wherein the hub body comprises a releasable latch. **Claim 14** Further comprising a removal tool, the removal tool is configured to actuate the releasable latch of the hub body and facilitate separation of the hub body from the hub base, the removal tool optionally comprises a protrusion with a tab, the protrusion is configured to actuate the releasable latch of the hub body, the tab of the protrusion is configured to latch to the hub body, and the hub body comprises an access channel to the releasable latch configured to receive the protrusion with the tab. The injection set according to claim 13.

15. The injection set according to claim 2, wherein the injection housing comprises a release latch configured to unlock the injection housing from the injection hub.

Images