JP2024523360A - Tensioned Injection System with Removable Hub - Google Patents

Abstract

The devices, kits, and methods described herein are used at chronic injection sites or in conjunction with indwelling catheters or cannulas. A book-like packaging, applicator, and/or tensioning device with an opening and optional markings for aligning the catheter or cannula with the opening 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

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 in the U.S. on 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.

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

Although the histological features that characterize hypertrophic scars have been well documented, the basic pathophysiology is not well known. Hypertrophic scars are a secondary effect of excessive wound healing, generally resulting in overproduction of cells, collagen, and proteoglycans. Typically, these scars are elevated and characterized by a random distribution of tissue bundles. The appearance (i.e., size, shape, and color) of these scars varies depending on the part of the body where they form and the underlying ethnicity of the affected person. 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 (filed May 24, 2005, U.S. Patent Application No. 11/135,992, 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.

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

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

US Patent Application Publication No. 2006/0037091

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 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 epidermal tissue at or near the skin site, i.e., at or adjacent to a wound or treatment site on the subject's skin.

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 mm to 2.7 mm in various body sites and has a different density and elasticity compared to the subcutaneous tissue below. The epidermal tissue is developmentally derived from the endoderm and contains collagen and other connective tissues with higher tensile strength, while 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 the subcutaneous tissue may have some mechanobiological effects on the subcutaneous tissues and structures.

The effects of scar tissue formation are also not limited to cosmetic effects. For example, diabetic patients may develop scar tissue and/or lipohypertrophy at chronic injection sites. Lipohypertrophy is the increased formation of adipose tissue that is believed to be a hypertrophic effect from chronic localized insulin injections on adipocytes. Lipohypertrophy can adversely affect insulin injection or infusion rates due to structural changes in the tissue, which can reduce insulin diffusion. A typical infusion using an insulin pump involves placement of a cannula or needle into the delivery site (e.g., abdomen, arm, buttocks, thigh) every few days. Over time, this can 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 infusion 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 rate at the injection site. This may occur by reducing the formation of fibrosis, improving angiogenesis, and/or reducing vascular resistance to perfusion of tissues below or centered around the insertion site. In some variations, it is hypothesized that changes in skin tension and/or increased adhesive properties of 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.

It is also believed that treatment of injection and/or infusion sites of diabetes therapy may also have other effects separate from affecting scar tissue or lipohypertrophy development. 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 pressure gradients generated within the tissue by the tensioning device. This and other mechanical effects of skin tensioning treatment may result in increased insulin bolus volume and/or surface area per unit injection. Mechanomodulation effects may result in improved insulin absorption with reduced daily, weekly, and/or monthly average total insulin doses and/or improved daily, weekly, and/or monthly glycemic time in range, with reduced frequency or severity of hyperglycemia. The tensioning device may also reduce pain at the injection site as a result of mechanomodulation of nociceptors, and/or reduce the risk of infection from occlusion and/or pump alarms as a result of mechanically stabilizing the tissue.

The therapies described herein are not limited to the treatment of the sequelae of diabetes or diabetes treatment, and may also be applied to injectable therapies or other disease states involving subcutaneous lesions or disease states, or even intramuscular injections. It is hypothesized that a general change in drug absorption or diffusion in the subcutaneous layer, or a relative change 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 tumor therapies, hemodialysis, joints or sleep apnea implants, neurostimulator electrodes, contraceptive implants, and the like.

In one embodiment, an integrated infusion set is provided that includes an infusion assembly that includes an infusion conduit attached to an upper surface of a tensioned dressing layer, the infusion conduit configured for insertion into a treatment site, a releasable attachment structure that attaches an infusion hub to the upper surface of the tensioned dressing layer, a prestrained dressing comprising the tensioned dressing layer, a skin adhesive on a lower surface of the tensioned dressing layer, one or more adhesive protective liners that removably cover the skin adhesive, and a tension support structure configured to maintain the tensioned dressing layer in a stressed configuration, the tension support structure comprising one or more pull tabs. The infusion assembly further includes an infusion housing attachable to the infusion hub, the infusion housing may include tubing in fluid communication with a cavity of 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 comprise an infusion set applicator releasably attachable to the infusion hub and further comprise a needle configured to removably extend through the infusion hub and out of the distal end of the infusion conduit. The releasable attachment structure may comprise a removable section to which the infusion hub is attached. The releasable attachment structure may comprise two or more non-removable sections coupled to the removable section. The two or more non-removable sections coupled to the removable section may be coupled via a tear or frangible structure. The tear structure may comprise a plurality of perforations. The frangible structure may comprise frangible posts. The removable section may comprise a pull tab or handle. The non-removable section may comprise a split ring or a plurality of arcuate bodies attached to the tensioning dressing layer. The non-removable section may comprise a slot configured to movably receive a tab located on the removable section. The removable section 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, the hub base attached to the tensioning dressing layer. The hub body may comprise a releasable latch. The infusion set may further comprise a removal tool, the removal tool configured to actuate the releasable latch of the hub body and 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 comprise a protrusion with a tab, the protrusion configured to actuate the releasable latch of the hub body, the tab of the protrusion configured to lock to the hub body. The hub body may comprise an access channel to the release latch configured to receive the protrusion with the tab. The infusion housing may comprise a release latch configured to unlock the infusion housing from the infusion hub.

In another embodiment, a method of treating a treatment site is provided that includes removing a first infusion housing from an infusion hub that is attached to the treatment site via a tensioned dressing, and separating at least a portion of the infusion hub from the tensioned dressing while leaving the tensioned dressing attached to the treatment site. The method may further include inserting a cannula of the infusion hub into the treatment site and adhering the tensioned dressing around the treatment site. The step of inserting the cannula may be performed with 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 in parallel with a needle of the applicator. The method may further include 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 removal of the needle from the cannula of the infusion hub. The method may further include attaching the infusion housing to the infusion hub and injecting a therapy through the tubing of the infusion housing and through the cannula of the infusion hub. The method may further include leaving the tensioned 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 tensioned dressing. Separating the infusion hub from the tensioned dressing 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 tensioned dressing may include separating all of the infusion hub from the tensioned dressing. Separating at least a portion of the infusion hub from the tensioned bandage may include pulling a tab of the attachment structure that attaches the infusion hub to the tensioned bandage and tearing the attachment structure along the perforation to separate the infusion hub from the tensioned bandage and the non-removable portion of the attachment structure. Separating at least a portion of the infusion hub from the tensioned bandage may include breaking the infusion hub from the tensioned bandage. Breaking the infusion hub from the tensioned bandage may include breaking a frangible post of the attachment structure that is attached to the tensioned bandage and to the infusion hub. Separating at least a portion of the infusion hub from the tensioned 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 tensioned bandage may include rotating the infusion hub from a spiral interface of the attachment structure.

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

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.

In addition to ameliorating scar formation, other uses for such skin treatment devices include, but are not limited to, treating skin-related conditions such as acne, age spots, rosacea, warts, rashes (including but not limited to erythematous, macular, papular, and/or bullous conditions), psoriasis, skin irritation/hypersensitivity, allodynia, telangiectasias, port wine stains and other arteriovenous malformations, and ectopic dermatitis; treating or improving existing scars, wrinkles, stretch marks, loose or sagging skin, or other skin irregularities; during pre-operative preparation, e.g., as a thin tissue retractor to stabilize blood vessels during needle or catheter insertion during a surgical procedure; post-operatively, e.g., prior to scar correction, wound incision, body contouring, pre- or post-operatively to pre-treat or pre-condition the skin, topically or subcutaneously in mastectomy skin expansions. With or without the use of energy modalities such as, for example, microwave, radio frequency ablation, high intensity focused ultrasound, laser, infrared, incoherent light, etc., in aesthetic skin treatment or resurfacing, during weight loss, or for various purposes such as aesthetic purposes, lifting, fixing, holding, moving the skin, hair removal or depilation, treating and/or closing skin injuries such as incisions, wounds, chronic wounds, pressure sores, ulcers (including venous stasis ulcers), preventing or reducing the occurrence of wound dehiscence, diabetic skin or wound conditions, burn healing and/or relief, acting as an occlusive or negative pressure wound dressing, protecting an incision or wound, for example, preventing splitting or opening, protecting the umbilicus of a newborn after cutting the umbilical cord, etc. Such treatments may include the use of drugs or other therapeutic agents that may be applied to the skin using such devices. Agents may include, but are not limited to, antibiotics, antifungals, immunomodulatory components including corticosteroids and nonsteroidal immunomodulatory components. The agent may be provided in any of a variety of formulations, including, but not limited to, powders, gels, lotions, creams, pastes, suspensions, and the like. The device may also be used for the purpose of delivering drugs to or through the skin, for example, by stretching the skin and applying the drug thereto. Different configurations of the device may be suitable for different body area sizes or geometries. Treatment may be applied to areas of any shape (e.g., linear, curved, star-shaped), size, or depth, and to one or more areas of the body, including, but not limited to, the scalp, forehead, face (e.g., nose, eyelids, cheeks, lips, chin), ears, neck, shoulders, upper arms, forearms, palms, dorsa of the hands, fingers, nail beds, armpits, breasts, nipples, areolae, back, abdomen, groin, buttocks, perineum, labia, penis, scrotum, thighs, lower legs, plantar surfaces of the feet, dorsa of the feet, and/or toes. Such devices may also be referred to herein as "dressings," "skin devices," or "skin treatment devices."

In some situations, immediate, rapid, or simple application of a dressing may be desired. The devices, kits, and methods described herein may be for preparation and/or application of the dressing to the skin, as well as separation of the applicator, tensioning device, or carrier, support, or base of the dressing from the skin device.

The devices, kits, or methods described herein may include a packaging, carrier, support, base, applicator, or tensioning device, each of which may at least temporarily contain, hold, carry, or support the dressing, may be used to prepare the dressing for application, may be used to deliver, orient, or apply the dressing, may be used to maintain the dressing in a stressed or strained configuration, may be used to 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 during or after the adhesive liner is released. According to some variations, the assembly may be constructed to avoid folding or bending the dressing so much that the adhesive on the dressing sticks to itself. For example, when some variations of the dressing are held or supported in a cantilever configuration at one point or along one edge of the dressing, the dressings will not flex, deform laterally, or otherwise deform out of plane under their own mass or configuration.

In some other variations of the devices and methods herein, the device is a device with a substantially rigid support structure or that provides structural support to the dressing and a certain resistance to bending or column strength when two opposing edges of the device and support structure are placed under a compressive load that causes axial compression or lateral deformation, e.g., a force similar to the grip of a hand, is applied to the edges of the device before the device buckles or folds. For example, the resistance to bending may be characterized as the peak force achieved when the device and support structure are compressed by 25% of their original dimensions without being compressed. This column strength or stiffness may vary depending on the direction along the device and support structure being measured. In some further variations, the peak force may be at least about 0.02 Newtons per millimeter (N/mm), about 0.03 N/mm, about 0.05 N/mm, about 0.1 N/mm, about 0.15 N/mm, about 0.2 N/mm, about 0.3 N/mm, about 0.4 N/mm, or about 0.5 N/mm. In some variations of devices that include a generally flat or planar device and support structure having a thickness, the peak force may be measured by applying a compressive force along the shortest dimension of the device/support structure that is transverse to the thickness of the device/support structure. According to such variations, the device may have, for example, a length to width aspect ratio of greater than 1:1, 2:1, or 3:1.

The resistance to bending in the direction of strain of the dressing may also be measured by three-point bending, applying a lateral force to the midpoint of an applicator that is simply supported on two outer points at a given separation distance or support range. For example, the distance between the two points on the sample may be about 0.75 inches, and a force ranging from about 1 to 1.25 pounds may be applied to a sample about 0.35 inches wide, resulting in a deflection of about 0.05 inches. Resistance to bending may also be measured by characterizing the force at which buckling occurs on a simply supported beam. For example, a force of about 0.45 pounds may be applied to a simply supported sample about 0.35 inches wide, resulting in a deflection of about 0.004 inches. Resistance to bending may also be characterized by the deflection of the outer surface before failure or permanent deformation. By making 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.

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

According to some variations, the device providing structural support may have multiple supporting cross elements or sections extending from one edge of the length to the opposing edge of the length (or from one edge of the width to the opposing edge of the 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 the cross elements along two opposing edges. Such cross elements may or may not be bonded or connected to each other, e.g., with 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.

The packaging and/or applicator may also provide structural support or stability for the dressing as it is oriented and/or applied to the skin of a subject. According to some variations, the dressing and packaging are configured to be reoriented in a wound-facing position before or after the wound device is prepared for application, e.g., the adhesive liner is removed. According to some variations, the packaging or applicator is configured to be used with one hand to orient and/or apply the device to the skin of a subject. For example, in some situations, especially when longer or larger dressings are used, the packaging or applicator provides structural support for the dressing so that a user may effectively hold, manipulate, and/or apply the prepared dressing with one hand. According to some variations, the assembly comprises a support structure. A dressing support structure is defined herein to mean a structure that is coupled, whether directly or indirectly, to the backside of the dressing to be applied to the subject. The support structure may further comprise a material or structure that is, at least in part, more rigid than the dressing to be applied to the subject. The support structure may comprise 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 structure comprises interconnected members or elements. According to some variations, the base, carrier, or support remains coupled to the dressing as it is applied. According to some variations, greater structural support is provided to the dressing carrier, support, or base in a first direction, while greater flexibility is provided in a second direction, but less flexibility is in the first direction and less structural support is provided in the second direction. According to some variations, the one or more support structures may extend beyond an edge of the first opposing side. According to some variations, the one or more support structures may extend at least partially beyond at least a portion of the edge of the first opposing side and at least partially beyond at least a portion of the edge of the opposite side. According to some variations, the support 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 the wound of the subject. According to variations, the packaging or applicator may be sufficiently wider or longer than the dressing, or have a sufficiently large area, to provide the ability to steer or manipulate the support or applicator, such that it provides for sterile application and/or one-handed application without the need to touch the dressing. According to some variations, a distance limit is provided from the outer edge of the dressing carrier, support, or base to the dressing supported on the base or adhesive on the dressing. Such a limit may be selected to prevent or resist the user from touching the dressing or the adhesive of the dressing when gripping the edge to manipulate the dressing carrier, support, applicator, or base.

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 dressing to the skin surface.

In some variations, a bandage is provided that comprises an elastic sheet structure (e.g., including a silicone polyurethane, a TPE (thermoplastic elastomer), a synthetic rubber, or a copolyester material) that comprises an upper surface, a lower surface, a first edge and a second edge opposite the first edge, and one or more adhesive regions. The bandage may further comprise a first release liner that is releasably attached to the adhesive region or regions. The adhesive region may comprise a pressure sensitive adhesive. The bandage may be tapered or otherwise shaped to reduce skin tension at the edges. The bandage may have modified, reduced adhesive, 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 the single dressing 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.

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 stress and/or strain the bandage prior to application to a subject. The device may be used to strain and/or maintain strain on the bandage. In one variation, a bandage is provided that includes a first device attachment structure, zone, or region, a second device attachment structure, zone, or region, and a structure or mechanism configured to apply a separation force between the first and second device attachment structures, zones, or regions. The device may further include a releasable locking mechanism, attachment mechanism, or adhesive configured to maintain the member or mechanism in the strained configuration.

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

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.

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 location on the body or skin where the bandage is applied. In general, the flexibility of the packaging used to allow the bandage to conform to the treatment site may be configured to provide a uniform, predetermined, or relatively predictable strain or force to an area of skin such that the treatment site is not substantially deformed during application of the bandage, such that application of the bandage is relatively smooth or uniform on the skin. The packaging or applicator may have flexibility in a first direction and greater stiffness in another direction. The packaging or applicator may include elements or sections that allow flexibility relative to adjacent elements or sections.

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 location on the body or skin to which the bandage is applied. In general, the flexibility of the packaging used to cause 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 to provide a uniform, predetermined, or relatively predictable strain and/or force to an area of the skin. The packaging or applicator may be flexible in a first direction and more rigid in a second direction. The first direction may be transverse to the straining direction or have a component that is transverse to the straining direction. The second direction may be the straining direction or have a component that is in the straining direction. The first direction may or may not be transverse to the second direction. The packaging or applicator may include elements or compartments that allow flexibility relative to adjacent elements or compartments.

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

According to some variations, a packaging, applicator, or tensioning device is provided that includes a base having an inner surface to which the dressing is removably attached, and a cover or lid having an inner surface that interfacially contacts 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.

In some variations, the book-like structure comprises a layered structure that in the closed configuration comprises a cover/lid, a treatment device, and a base in that relative order, while in the open configuration the relative order of the layered structure changes to cover/lid, base, and treatment device. The treatment device may also comprise one or more release layers. In one variation, in the closed configuration a first side of the cover/lid contacts a first side of the treatment device and a first side of the base contacts a second side of the treatment device opposite the first side, while in the open configuration 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 reduce manufacturing costs by optimizing the amount of elastic material used in the dressing. In other variations, the dressing or skin treatment device may be symmetrically attached to the book-like structure relative to the bending region of the book-like structure.

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

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

According to a variation, the dressing packaging assembly comprises a base structure having an inner surface and comprising at least one support element and at least one flexible element, a 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. According to a variation, the at least one rigid element comprises a plurality of rigid elements coupled to each other with at least one flexible element. According to a variation, the cover structure comprises opposing surfaces configured to interface with the first surface of the dressing, and the cover structure is movably coupled to the base structure to move from a first position in which the opposing surfaces interface with the first surface of the dressing to a second position in which the cover is separated from the first surface of the dressing. According to a variation, the cover structure is pivotally coupled to the base structure. According to a variation, the cover structure comprises at least one support element and at least one flexible element that is sufficiently flexible to allow shaping of the cover structure. According to a variation, the first surface of the bandage comprises an adhesive region. According to a variation, the first surface of the bandage comprises an adhesive backing 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 location and separated from the adhesive region at a second location. According to a variation, the bandage comprises an elastic material. According to a variation, the bandage comprises a first attachment region coupled to an inner surface of the base structure and a second attachment region coupled to an opposing surface of the cover structure, the cover and base being configured to apply a straining force when the cover is moved from the first position to the second position to strain the bandage. According to a variation, the assembly further comprises a tensioning structure configured to apply a straining force to the bandage. According to a variant, the tensioning structure comprises a first structure configured to couple the dressing in the first attachment region to an inner surface of the base structure and a second structure configured to couple the dressing in the second attachment region to an opposing surface of the cover, the tensioning structure being configured to apply a straining force to the dressing between the first and second attachment regions when the cover structure is moved from a first position to a second position relative to the base structure. According to a variant, the dressing between the first and second attachment regions has a first width when the cover is in the first position and a second width when the cover is in the second position, the second width being greater than the first width. According to a variant, the second width is at least 4% greater than the first width. According to a variant, the second width is at least 20% greater than the first width. According to a variant, the second width is at least 40% greater than the first width.

According to a variant, a method of applying a dressing to a wound or skin of a subject includes the steps of providing a dressing package assembly comprising a base structure having an inner surface, a cover structure having an opposing surface, the base structure being movably coupled to the cover structure, a dressing comprising a first surface including an adhesive region, and a back surface, at least a portion of which is 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 to a second position relative to the base structure to separate the opposing surface from the first surface of the dressing and to separate the adhesive backing from the adhesive region, applying the first surface of the dressing to the wound or skin of the subject, and then subsequently releasing the dressing from the base structure. According to a variation of the method, at least a portion of the underside of the bandage is coupled to the cover structure, and further includes pivoting the cover structure relative to the base structure to apply strain to the bandage.

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

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 from a first position to a second bandage tensioning position relative to the bandage carrier; and a bandage assembly comprising a bandage including a first bandage edge coupled to the carrier adjacent 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 at a first distance from the second carrier edge within the width of the carrier and in the second position of the tensioning element the second bandage edge is at a second distance from the second carrier edge within the width of the carrier, the first distance being greater than the second distance. According to a variant, the first dressing edge is relatively fixed with respect to the second dressing edge when the tensioning element is moved between the first and second positions.

According to a variation, the dressing 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 dressing comprising a first surface configured to be applied to a wound or skin of a subject, and a back surface, at least a portion of the back surface being removably coupled to the inner surface of the base structure, the cover structure being configured to move from a first position in which the opposing surface is in interfacial contact with the first surface of the dressing to a second position in which the opposing surface is separated from the first surface of the dressing, the second position being rotated at least about 180 degrees relative to the first position. According to a variation, the first surface of the dressing comprises an adhesive region. According to a variation, the first surface of the dressing comprises an adhesive backing in interfacial contact with the adhesive region on the dressing. According to a variation, the opposing surface of the cover structure comprises an adhesive backing that covers the adhesive region when the cover structure is in the first position and is separated from the adhesive region when the cover structure is in the second position. According to a variation, the 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 the base being configured to apply a straining force and 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 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 variation, the base structure comprises at least one relatively rigid element and at least one relatively flexible element, the relatively rigid element being sufficiently rigid to support the dressing when a straining force is applied in a first direction, and the relatively flexible element allowing the base structure to flex in a second direction.

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

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

In another variation, a bandage 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 with respect 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 bandage 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 with a secondary bending axis that is not parallel to the primary bending axis. The secondary bending axis may be orthogonal to the primary bending axis. The first tensioning member may comprise at least one secondary bending region with a secondary bending axis that is not parallel to the primary bending axis. The at least one secondary bending region of the first tensioning member may be aligned with the at least one secondary bending region of the second tensioning member. The treatment device may further comprise a release liner coupled to the adhesive surface of the treatment device. The treatment device may comprise a perforated region. The dressing system may further comprise an elongated element attached adjacent to the perforated region. The elongated element may protrude beyond the perforated region of the treatment device. 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 tensioning members may comprise indicia identifying a central region of the treatment device. The indicia may comprise a recessed edge, an ink mark, an embossing, or a window. The primary bending region may be perforated. The first tensioning member may be configured to be removed from the second tensioning member and the treatment device. The first tensioning member may be configured to be removed 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.

In another variation, a bandage system is provided that includes a first applicator member, a second applicator member, a primary bending region therebetween, the primary bending region having a primary bending axis, and a treatment device attached to the first and second applicator members, the bandage system including a closed configuration in which the treatment device is located between the first applicator member and the second applicator member, and a closed configuration in which the second applicator member is located between the first applicator member and the treatment device. The second applicator member may include at least one secondary bending region 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 applicator 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 applicator member may be aligned with the at least one secondary bending region of the second applicator member. The treatment device may further include a release liner that is bonded to the adhesive surface of the treatment device. The treatment device may include a perforated region. The dressing system may further include an elongated element attached adjacent to the perforated region. The elongated element may protrude beyond the perforated region of the treatment device. 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 dressing system is in an open configuration rather than a closed configuration. The first applicator member may include an attached release liner. The release liner may be attached to the first applicator member between an outer edge of the first applicator member and the attached treatment device.

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

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.

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

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 objective. Such desired forces may be high enough to provide therapeutic mechanomodulation of the skin, yet low enough to prevent significant skin irritation.

The force properties of a pre-strained bandage may vary over time. An initial strain may be applied to the bandage, and the elastic material or other structure of the bandage has an initial tensile force property. The bandage may be maintained in a strained configuration at a particular strain level after it has been pre-strained for an initial period of time. During the initial period, the force properties of the elastic material may decrease, decay, or exhibit loss of force. After an initial predetermined period of time, the force properties of the elastic material may reach, decrease, or decay to a desired force level and/or range of force levels. The bandage elastic material force properties may be within a desired range for at least a subsequent period of time. In some variations, the dressing material may have a modulus in the range of about 1 MPa to about 15 MPa, sometimes about 1.5 MPa to about 6 MPa, and other times about 2 MPa to about 5 MPa, about 3 MPa to about 4 MPa, or about 3.5 MPa to 5 MPa, while having a peak load per width of maximum 0.6 strain of less than 3 N/mm, sometimes less than about 2.5 N/mm, sometimes less than 2 N/mm, sometimes less than 1 N/mm, sometimes less than about 0.75 N/mm, and other times less than about 0.6 N/mm, or less than about 0.5 N/mm. The peak load per width of maximum 0.6 strain may be at least about 0.35 N/mm, sometimes at least about 0.5 N/mm, and other times at least about 0.6 N/mm, 0.7 N/mm, 0.8 N/mm, 0.9 N/mm, or 1 N/mm. The material may be selected such that the material at a constant engineering strain of 20% is capable of maintaining an engineering stress of at least about 200 kPa, 250 kPa, 300 kPa, 400 kPa, or 500 kPa, 1,000 kPa, 1,500 kPa, 2,000 kPa, 2,500 kPa, 3,000 kPa, or more for at least 8 hours with less than a 10% or 5% fluctuation or decrease in engineering stress.

In accordance with an alternative embodiment, 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.

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.

According to a variant, the dressing may be initially strained or overstressed to provide an initial force per unit width above that of the desired range upon application to the skin. According to a variant, the initial strain of the dressing and the resulting initial force per width may be selected based on the desired final resulting force properties and/or the desired time frame for use of the dressing. Such initial strain levels may be, for example, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 70% or more, 80% or more, 90% or more, 100% or more. According to a variant, the initial force is above the desired force range. Such initial force levels may be, for example, about 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 dressing. Such initial force levels may be, for example, but not limited to, 2-5 Lbf/inch, 1.54-3.85 Lbf/inch, 1.33-3.33 Lbf/inch, or 0.85-2.20 Lbf/inch.

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

According to some variations, the dressing may then be configured to maintain a desired minimum final force or force range for the duration of a subsequent predetermined time frame after the initial time frame. During the subsequent time 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 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.

The pre-strained bandage may then be bonded to a strain-retaining element for an initial period of time. The strain-retaining element may remain on the bandage for a portion of a subsequent period of time until it is used.

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

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

According to a variant, the dressing may be initially strained or overstressed to provide an average initial force per unit width above that of the desired range upon application to the skin. According to a variant, the average initial strain of the dressing and the resulting initial force per width may be selected based on the desired final resulting force properties and/or the desired time frame for use of the dressing. Such average initial strain levels may be, for example, less than 20%, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 100% or more. According to a variant, the average initial force is above the desired force range. Such average initial force levels may be, for example, about 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 dressing. Such average initial force levels may be, for example, but not limited to, 2-5 Lbf/inch, 1.54-3.85 Lbf/inch, 1.33-3.33 Lbf/inch, or 0.85-2.20 Lbf/inch.

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 pre-conditioning state of the material prior to final assembly or manufacture. Such a pre-conditioning state may strain the material at an average constant strain or strain the material at various levels of average strain.

According to some variations, the dressing may then be configured to maintain a desired minimum average final force or average force range for the duration of subsequent predetermined time frames after the initial time frame. During the subsequent time frames, the device may be applied to the subject's skin for treatment. Such a desired average force range may be about 0.5-1.0 Lbf/inch, 1.31 Lbf/inch-1.41 Lbf/inch. The average force loss during the subsequent time period may be up to 3%, up to 5%, up to 8%, up to 10%, up to 15%, up to 20%, up to 25%, or more. The duration of the subsequent time period may be, for example, 2 months or more, 3 months or more, 6 months or more, 12 months or more, 36 months or more, or 48 months or more.

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

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

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

In another embodiment, a device includes a strained elastic base layer having a top surface, a bottom surface, a peripheral edge, and a treatment opening; a skin adhesive layer adhered to the bottom surface of the 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 peripheral edge, and a treatment opening aligned with the treatment opening of the strained elastic base layer, and a bottom layer of one of the at least one intermediate elastic layer attached to the top surface of the strained elastic base layer, the bottom layer having a top surface, a bottom surface, a peripheral edge, and a treatment opening. A multi-layer tissue treatment device is provided comprising a strained elastic top layer, the treatment openings of the strained elastic top layer being aligned with the treatment openings of the strained elastic base layer and the bottom surface of the strained elastic top layer being attached to the 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, the strain support being configured to maintain strain in the elastic base layer, the at least one middle layer, and the elastic top layer. The outer periphery of the elastic top layer may be offset from the outer periphery of the intermediate elastic layer attached to the elastic top layer, and the outer periphery of the elastic middle layer attached to the elastic base layer may be offset from the outer periphery of the elastic base layer. The outer periphery of the elastic top layer may be offset inwardly from the outer periphery of the intermediate elastic layer attached to the elastic top layer, and the outer periphery of the elastic middle layer attached to the elastic base layer may be offset inwardly from the outer periphery of the elastic base layer. 10. The device of claim 8, wherein the bottom surface of the elastic top layer is smaller than the top surface of the intermediate elastic layer attached to the elastic top layer, and the bottom surface of the elastic middle layer attached to the elastic base layer is smaller than the top surface of the elastic base layer. The bottom surface of the elastic top layer may be larger than the top surface of the intermediate elastic layer attached to the elastic top layer, and the bottom surface of the elastic middle layer that may be attached to the elastic base layer is larger than the top surface of the elastic base layer. 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 middle layer, and all of the at least one elastic middle layer may be smaller than the elastic base layer. The elastic top layer may be larger than all of the at least one elastic middle layer, and all of the at least one elastic middle layer may be larger than the elastic base layer. The at least one elastic middle layer may comprise two elastic middle layers. The at least one elastic middle layer may comprise two elastic middle layers. The strained elastic top layer and the at least one elastic intermediate layer may each include a pull tab. The pull tab of the strained elastic top layer and the pull tab of the at least one elastic intermediate layer may each be different sizes. The pull tab of the elastic top layer may be smaller than all of the pull tabs of the at least one elastic intermediate layer. The pull tab 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 the top surface of the strained elastic top layer. The attachment of the top layer and the at least one intermediate layer may utilize an anisotropic adhesive pattern. The anisotropic adhesive pattern may have a reduced amount of adhesive along a peel direction compared to a strain direction of the strained layer.

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

In yet 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 further include two pull tabs located on opposite sides of the strained elastic layer. Each of the two pull tabs may include a perforation configured to be torn to allow the strained elastic layer and the infusion hub to separate from the strain support.

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

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

In another embodiment, a method of treating a therapy site is provided that includes the steps of: 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 prior to using the infusion set to inject the therapeutic agent.

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

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 dose escalation over time.

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. The glucose time in range may be daily, weekly, or monthly glucose time in range.

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

In yet another embodiment, a method of treating a treatment site is provided that includes the steps of adhering a multi-layer strained bandage to a treatment site, releasing the strain of 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.

In another embodiment, a method of positioning an infusion set is provided, comprising the steps of adhering a strained skin tension unloading device to a treatment location, the skin tension unloading 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; uncoupling an infusion set hub from the infusion set applicator and actuating the infusion set applicator to insert a catheter of the infusion set hub through the treatment opening; removing the infusion set applicator; and removing the strain support and the protruding alignment structure from the strained skin tension unloading device to release strain in the strained elastic layer. The method may further include selecting a protruding alignment structure from a plurality of different protruding alignment structures and attaching the selected protruding alignment structure to the strain support. The protruding alignment structure may be integrally formed with the strain support.

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

In one embodiment, a method of treating subcutaneous tissue may be provided that includes 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 not have any 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 increase over a period of time. The period of time 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 implant site for an implantable pulse generator, an implantable pacemaker, or a defibrillator. The treatment site may be an implant site for a subcutaneous injection port.

In another embodiment, a method of modifying the pharmacokinetics of a drug is provided that includes 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.

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.

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. The time in range may be the percentage of time with a blood glucose level between 70 mg/dl and 180 mg/dl.

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. Hypoglycemia may be a blood glucose level below 70 mg/dl.

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. Hyperglycemia may be a blood glucose level above 180 mg/dl.

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 of a diabetic patient to reduce variability in insulin absorption compared to an untreated control group. The reduced variability in insulin absorption may be a reduced coefficient of variation of insulin C _max or AUC _INS as measured by a hyperinsulinemic euglycemic clamp test or a mixed meal tolerance test.

In another variation, a method of treating diabetes is provided that includes applying a tissue tensioning device to an injection or infusion site of a diabetic patient to increase insulin absorption compared to an untreated control group. Increased insulin absorption may be increased insulin _Cmax or AUC _INS as measured by a hyperinsulinemic euglycemic clamp test or a mixed meal tolerance test.

In another embodiment, a system for treating a chronic injection site is provided comprising an adhesive tensionable elastic bandage, the bandage comprising a first attachment structure and a second attachment structure, a plurality of injection openings, a first attachment opening and a second attachment opening, and at least one injection template comprising a first attachment structure and a second attachment opening, 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 bandage openings, and the at least one bandage 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 an injection template, and each of the bandage openings of the plurality of bandage openings may be aligned with an injection opening of the plurality of openings of the at least 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 injection openings of each injection template of the plurality of injection templates may comprise different locations than the other injection templates of the plurality of injection templates. The at least one injection template may comprise an injection template. The injection openings of the injection template may be arranged in a rectangular grid pattern. The injection openings of the injection template may be arranged in a staggered grid pattern. The adhesive strips may be removably coupled to the injection openings. The number of the adhesive strips may be less than the number of the injection openings. The number of the injection openings may be three or four times the number of the adhesive strips. The adhesive strips may be aligned longitudinally to a longitudinal axis of the injection template or transversely to a transverse axis perpendicular to the longitudinal axis of the injection template. The adhesive strips may be parallel to each other and not parallel to the longitudinal or transverse axes of the injection template. Each of the adhesive strips may extend beyond an edge of the injection template. The first and second mounting structures may have different shapes. The first and second mounting openings 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.

In another embodiment, a system for treating a chronic injection site is provided that includes an adhesive tensionable tissue treatment device having a plurality of injection openings 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 openings are arranged in a rectangular grid pattern. The system may further include an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device.

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 tension in the tensioned tissue treatment device and transferring the tension to the adhered skin surface, attaching a first injection template to the tensioned tissue treatment device, the first injection template including a plurality of needle insertion openings, inserting a first needle through a first needle insertion opening of the plurality of 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 of 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 needle insertion opening of the plurality of 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.

In another embodiment, an injection guide system is provided that includes a plurality of injection guides, each injection guide having at least one opening and an adhesive undersurface, the plurality of injection guides being in a separated configuration, each injection guide being 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 adhesive undersurfaces of the plurality of injection guides. The system may further include 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 include a dressing that includes a plurality of dressing openings, the plurality of dressing openings configured to align with at least the openings of each injection guide of the plurality of injection guides. The plurality of injection guides may include an adhesive foam strip. The adhesive undersurface 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.

In another embodiment, a method of preparing a bandage may be provided that includes 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 adhering of 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 include removing the release liner from the plurality of separate injection guides. The method may further include removing the carrier sheet from the plurality of separate injection guides after adhering the plurality of separate injection guides to the bandage. The adhering of 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.

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

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

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

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

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

FIG. 5B is a cross-section of FIG. 5A taken along line CC.

FIG. 5C is a cross section of FIG. 5A taken along line DD.

FIG. 6 illustrates a variation of the dressing and packaging assembly.

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.

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, and Figure 8B is an enlarged view of section B of 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, and Figure 8B is an enlarged view of section B of 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, and Figure 8B is an enlarged view of section B of Figure 8A.

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

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

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.

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.

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

FIG. 13 is a top view of the packaging device in an open configuration.

FIG. 14 is an exploded perspective view of the packaging device in an open configuration.

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

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

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.

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

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

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

FIG. 15G is a perspective view of the dressing assembly with the attachment sheet.

FIG. 15H is a perspective view of the dressing assembly of FIG. 15G with the attachment sheet peeled away.

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

FIG. 15J is a cross-section of the dressing assembly with the mounting sheet of FIG. 15G.

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

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

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

FIG. 16D is a cross-section of the dressing assembly with the mounting sheet of FIG. 16A.

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

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

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

FIG. 17D is a cross-section of the dressing assembly with the mounting sheet of FIG. 17A.

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

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

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

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.

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.

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

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

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

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

FIG. 18J is a side view of the device of FIG. 18A.

FIG. 19A is a perspective view of a variation of a dressing and packaging assembly device.

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

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

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

FIG. 19E is a top view of the dressing of FIG. 19B.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FIG. 24 is a perspective view of multiple prestrained dressings on a support element.

FIG. 25 illustrates a pre-strained dressing and support structure.

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

FIG. 27 is a schematic illustration of the percent force loss over time for a prestrained elastic material component of a dressing.

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

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

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. 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. 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. 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.

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

32A-32E depict various exemplary aperture configurations for the dressing. 32A-32E depict various exemplary aperture configurations for the dressing. 32A-32E depict various exemplary aperture configurations for the dressing. 32A-32E depict various exemplary aperture configurations for the dressing. 32A-32E depict various exemplary aperture configurations for the dressing.

FIG. 33 depicts the placement of a three-aperture dressing over the injection site.

FIG. 34 depicts an exemplary dressing with an opening and various alignment markings.

FIG. 35 depicts the use of the exemplary dressing of FIG. 34 with a delivery syringe.

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

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

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

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

41A and 41B are top plan and top perspective views of another embodiment of a combined infusion set with multiple separable tensioning layers, respectively. 41A and 41B are top plan and top perspective views of another embodiment of a combined infusion set with multiple separable tensioning layers, respectively.

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

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

44A is a detailed side elevational 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.

Figures 45A and 45B are top plan and top perspective schematic views of another embodiment of a combined infusion set with multiple separable tensioning layers. Figures 45A and 45B are top plan and top perspective schematic views of another embodiment of a combined infusion set with multiple separable tensioning layers.

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

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 multiple tensioning layers of Figure 47B.

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

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 features to facilitate placement of an infusion set delivery system.

50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system. 50A-50D depict the use of the skin tensioning device of FIGS. 49A-49E with an infusion set delivery system.

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

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.

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

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

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

56A and 56B are top and bottom perspective views of a skin tensioning device in which a woven needle injection aperture is used in conjunction with a syringe.

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 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 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 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.

FIG. 58 is a perspective view of another exemplary tensioning skin treatment system comprising a multi-day removable injection template.

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

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

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

FIG. 63 is a perspective view of another tensioning skin treatment system.

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

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 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 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 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 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 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 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.

FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively. FIG. 66A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set. FIG. 66B is a top perspective view of the system of FIG. 66A with the infusion set connector and tubing removed. FIG. 66C is a top perspective view of the system of FIG. 66A and 66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed. FIG. 66D is a top perspective view of the system of FIG. 66A-66C with the infusion hub and infusion catheter removed from the dressing. FIG. 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. FIG. 66E-66H correspond to FIG. 66A-66D, respectively.

FIG 67A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, FIG 67B is a top perspective view of the system of FIG 67A showing the infusion set connector and tubing as it is removed, and FIG 67C is a top perspective view of the system of FIGs 67A and 67B showing the infusion set hub and catheter as it is removed. FIG 67A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, FIG 67B is a top perspective view of the system of FIG 67A showing the infusion set connector and tubing as it is removed, and FIG 67C is a top perspective view of the system of FIGs 67A and 67B showing the infusion set hub and catheter as it is removed. FIG 67A is a top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, FIG 67B is a top perspective view of the system of FIG 67A showing the infusion set connector and tubing as it is removed, and FIG 67C is a top perspective view of the system of FIGs 67A and 67B showing the infusion set hub and catheter as it is removed.

Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, and Figures 68B-68F are top perspective views illustrating the step of removing the infusion set of Figure 68A from the dressing. Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, and Figures 68B-68F are top perspective views illustrating the step of removing the infusion set of Figure 68A from the dressing. Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, and Figures 68B-68F are top perspective views illustrating the step of removing the infusion set of Figure 68A from the dressing. Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, and Figures 68B-68F are top perspective views illustrating the step of removing the infusion set of Figure 68A from the dressing. Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, and Figures 68B-68F are top perspective views illustrating the step of removing the infusion set of Figure 68A from the dressing. Figure 68A is an exploded top perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removable infusion set, and Figures 68B-68F are top perspective views illustrating the step of removing the infusion set of Figure 68A from the dressing.

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

FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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. FIG. 70A is a side view of an embodiment of a treatment system including a dressing with an integrated separable 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 FIG. 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 Previous attempts to treat scars and keloids have included surgery, silicone dressings, steroids, x-ray radiation, and cryotherapy. Each of these techniques has disadvantages. Perhaps the greatest disadvantage is that in the first instance, none of them effectively prevent or ameliorate the formation of scars or keloids. That is, these techniques have been used primarily to treat scars after they are already well established.

Unloading of extrinsic and/or intrinsic stresses in the vicinity of a wound may ameliorate scar, hypertrophic scar, or keloid formation. The mechanical environment of an injury may be an important factor in tissue response to that injury. The mechanical environment includes extrinsic stresses (i.e., physiological stresses, including stresses transmitted to the wound via muscle activity or physical movement) and intrinsic stresses (i.e., epidermal stresses resulting from the physical properties of the skin itself, including stresses induced at the wound site due to swelling or contraction of the skin). The devices, dressings, kits, and methods described herein may control or regulate the mechanical environment of the skin, including, but not limited to, the mechanical environment of the wound. The devices, dressings, kits, and methods described herein may also control or regulate the mechanical environment to ameliorate scar and/or keloid formation. The mechanical environment of the skin may include stress, strain, or any combination of stress and strain. Control of the wound's mechanical environment can be active or passive, dynamic (e.g., by applying oscillatory stress), or static. The stresses and strains acting on the wound may involve layers of the skin, such as the outer stratum corneum, epidermis, and dermis, 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 the 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 intrinsic and/or exogenous stresses. Thus, the devices and methods described herein may reduce the stresses experienced by the wound and surrounding tissue to levels lower than those experienced by normal skin and tissue. Unloading exogenous and/or intrinsic stresses in the vicinity of the wound may ameliorate the formation of scars, hypertrophic scars, or keloids.

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

As described above, the wound healing process can be characterized in three phases: the early inflammatory phase, the proliferation phase, and remodeling. The inflammatory phase occurs immediately after injury and typically lasts from about two days to one week. Blood clotting occurs to stop blood loss, and factors are released to attract cells that can clear debris, bacteria, and damaged tissue from the wound. In addition, factors are released to initiate the proliferation phase of wound healing. In the proliferation phase, which lasts from about four days to several weeks, fibroblasts grow and build new extracellular matrix by secreting collagen and proteoglycans. At the end of the proliferation phase, fibroblasts can act to further contact the wound. In the remodeling phase, randomly oriented collagen is organized and crosslinked along skin tension lines. Cells that are no longer needed can undergo apoptosis. The remodeling phase can continue for weeks or months or indefinitely after injury. Scars typically reach about 75-80% of normal skin's breaking strength 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 layers of the dermis.

There are three general possible outcomes to 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 the formation of any type of scar. In addition, the devices, kits, and methods described herein can be adapted for various wound sizes and different thicknesses of skin, for example, the devices may be configured for use on different areas of the body. In addition, the devices, kits, and methods described herein can be adapted to ameliorate scar formation in skin of any type, for example, body location, age, race, or condition.

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 may inhibit cell apoptosis, leading to significant accumulation of cells and matrix, and thus increased scarring or production of hypertrophic scars. Given the underlying 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 extrinsic and/or intrinsic strain, including, but not limited to, strain from the inherent tensile forces found in normal, unwounded skin tissue.

Some wound dressings have a backing, adhesive liner, and/or packaging that is removed prior to application of the wound dressing. Many existing dressings can be difficult to orient and apply and can have a tendency to fold and adhere to themselves.

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 the subject's skin, thereby ameliorating scar formation at the wound site ("skin treatment device"). 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 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 stress experienced by the skin and/or wound and surrounding tissue to treat a subject. The device may also assist in preventing or reducing the occurrence of wound dehiscence.

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

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

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 as it may fold and adhere to itself or the user, or otherwise provide difficult positioning across the wound. Also, the act of retracting or removing the liner and reorienting the dressing to the patient may increase the tendency to fold or collapse. Furthermore, because of the folding or collapsing nature of the dressing, during adhesive removal and subsequent reorientation, the user has a significant chance of compromising the sterility of the portion of the device to be applied to the wound site.

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

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

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.

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 stresses.

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.

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

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

According to a variant, the flexible element is provided in combination with a support element that provides sufficient support to allow the user to maintain the bandage in the strained configuration. According to a variant, one or more elements, for example, a fastening element that fastens the bandage in the strained configuration until it is applied to the 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.

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

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

According to some variations, the packaging or applicator may also be used to provide a dressing that is configured to distort the dressing prior to application and ameliorate scar or keloid formation.

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

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

The dressing may comprise an elastic member, such as a sheet of elastic material. The elastic material of the dressing may comprise a single layer of material, or multiple layers of the same or different materials. The material may have any of a variety of configurations, including solid, foam, lattice, or woven configurations. The elastic material may be a biocompatible polymer, such as silicone, polyurethane, TPE (thermoplastic elastomer), synthetic rubber, or copolyester material. The thickness of the polymer sheet may be selected to provide a dressing with sufficient load capacity to achieve a desired recoverable strain and to prevent undesirable amounts of incremental deformation of the dressing over time. In some variations, the thickness across the dressing is not uniform, e.g., the thickness across the dressing may be varied to change the stiffness, load capacity, or recovery strain at selected orientations and/or locations. The elastic material of the exemplary bandage may have a thickness within the range of about 50 microns to 1 mm or more, about 100 microns to about 500 microns, about 120 microns to about 300 microns, or in some variations, about 200 microns to about 260 microns. Exemplary bandages have an edge thickness of about 500 microns or less, 400 microns or less, or about 300 microns or less, and are less likely to present a risk of skin separation from inadvertent lifting when inadvertently touched by clothing or objects. In some variations, the bandage is tapered near the edges to reduce the thickness. The tapered edges may also mitigate peak tensile forces acting on skin tissue adjacent the adhesive edges 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 at least 0.25 Newtons/mm at 45% engineering strain. The elastic material may have a load per width of about 2 Newtons/mm or less at about 45%-60% engineering strain, about 1 Newton/mm at about 45%-60% engineering strain, about 0.7 Newtons/mm at about 45%-60% engineering strain, or about 0.5 Newtons/mm or less at about 45%-60% engineering strain. The system elastic material may have a load per width that does not decrease from 0% to 60% engineering strain, a load per width plot that increases linearly from 0% to 60% engineering strain, or a load per width plot that is not convex from 0% to 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% to 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 less than 5% over at least 8 hours.

The depicted dressings may have a generally rectangular configuration with a length and/or width of about 160 mm to about 60 mm, although in other variations the dressings may have any of a variety of lengths and widths and may comprise any of a variety of other shapes. Also, the corners of the dressings may be square or rounded, for example. The length and/or width of exemplary dressings may be within the range of about 5 mm to about 1 meter or more, in some variations about 20 mm to about 500 mm, in other variations about 30 mm to about 50 mm, and in still other variations about 50 mm to about 100 mm. In some variations, the ratio of the maximum dimension of the dressing (e.g., its length) to the orthogonal dimension to the maximum dimension (e.g., width), excluding the minimum dimension (e.g., thickness) of the dressing, may be in the range of about 1:3, about 1:2, about 1:1, about 2:1, about 3:1, about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, or about 10:1, or more. In some variations, the strain axis of the dressing in use may be oriented relative to the maximum dimension or relative to the orthogonal dimension to the maximum dimension. In some variations, the final compressive stress and strain imposed by the elastic material on the skin may be the result of a dynamic equilibrium between the tensile stress in the skin and the elastic material of the dressing. The skin at the skin site typically comprises an inherent tension that stretches the incision site, regardless of whether any tissue has been excised from the skin site. The elastic material and adhesive regions may be configured to be applied to the skin location such that when the bandage is stretched to a particular tension and then adhered to the incision site, the tensile stress in the bandage is transferred to the incision site to compress the tissue directly beneath the bandage along an axis tangential to the skin surface, and the stress and strain imposed on the skin location has a net or resulting orientation, or with a similar axis to the orientation, or axis of the 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 the bandage. Application of the bandage to the skin location may involve placement of the bandage without overlapping or wrapping over itself, for example, only adjacent regions of the bandage are interconnected and non-adjacent regions of the bandage are not interconnected. The actual amount of stress and strain imposed on the skin may vary, for example, depending on the particular person, skin location, thickness or various mechanical properties of the skin layers (e.g., epidermis, dermis, or underlying connective tissue), and/or the degree of existing scarring. In some further variations, the wound treatment dressing may be selected or configured for use at specific body locations, such as the scalp, forehead, cheeks, neck, upper back, lower back, 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.

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

When the dressing is applied to a skin location and allowed to at least partially recover to its base configuration, the recovery or equilibrium level of strain in the dressing may be within the range of about 4% to about 60% or more, in other configurations about 15% to about 50%, and in still other configurations about 20% to about 30% or about 40%. The ratio between the initial engineering tensile strain applied on the dressing prior to recovery and the resulting engineering compressive strain in the skin may vary depending on the type and location of the skin, but in some examples may be about 2:1. In other examples, the ratio may be within the range of about 4:1 to about 5:4, about 3:1 to about 5:3, or about 5:2 to about 2:1. These skin strain characteristics may be determined relative to a reference location, e.g., an anatomical location, on the body or body part to facilitate reproducible measurements. A particular degree of strain may be characterized as either engineering strain or true strain, but may or may not be calculated based on other types of strain, or may be converted from other types of strain (e.g., the strain may be based on 45% engineering strain that is converted to true strain).

In some further variations, one or more properties of the elastic material may correspond to different features on the stress/strain curve of the material. For example, the engineering and true stress/strain curves for one specific embodiment of the dressing comprise a material that exhibits an engineering stress of about 1.2 MPa at about 60% engineering strain, while in other embodiments the engineering stress may be in the range of about 900 KPa to about 3.5 MPa, about 1 MPa to about 2.2 MPa, about 1 MPa to about 2 MPa, about 1.1 MPa to about 1.8 MPa, about 1.1 MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When unloading or relieving the 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 examples 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 examples the engineering stress during unloading of the material to about 30% strain may be in the range of about 250 KPa to about 500 KPa, about 275 KPa to about 450 KPa, about 300 KPa to about 400 KPa, or about 325 KPA to about 375 KPa. When unloaded to about 20% engineering strain, the material may have an engineering stress of about 100 KPa, although in other examples, the unloading engineering stress at about 20% may be in the range of about 50 KPa to about 200 KPa, about 75 KPa to about 150 KPa, or about 100 KPa to about 125 KPa. In some examples, the material may be configured to achieve a specific range or level of engineering stress at at least each of the defined engineering strain levels described above, although in other examples, the material may be configured for a lower level of maximum engineering strain, for example, up to about 30% or about 40%.

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 dressing material described herein, up to about 45% true strain, the load curve had an approximately linear configuration. In other embodiments, the configuration may be linear only along a portion of the load curve, or may be curved along the entire load curve. If the load curve is nonlinear, the load curve may be convex, concave, or both. Also, in some embodiments, the tangent to the load curve (i.e., the line between the two triangles) may also be approximately colinear.

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.

In addition to the absolute stress levels at a certain strain level, as described above, materials may also be characterized in terms of the ratio between a) the stress to achieve a particular strain during loading and b) the stress at the same strain during unloading. For example, a material may have a ratio of at least 4:1 to about 3:2 at each of the 20%, 30%, and 40% strain levels, although in other examples, a material may exhibit these ratios only at the 20%, 30%, or 40% strain levels, or at both 20% and 30% but not 40%, or at both 30% and 40% but not 20%. In other examples, the ratio at one, some, or all of the strain levels may be within the range of about 3:1 to about 2:1, or about 5:2 to about 2:1.

In some examples, the elastic material of the dressing may be configured under test conditions to achieve a stable level of stress at a constant strain, e.g., the material exhibits a limited amount of stress relaxation at a particular level of strain over a particular period of time. The period may be at least about 8 hours, about 12 hours, about 18 hours, about 24 hours, about 36 hours, about 48 hours, about 72 hours, about 4 days, about 5 days, about 6 days, or about 1 week, or more. The level of strain may be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, or about 80%, or more. The stress of the exemplary dressing over various time curves may be configured to maintain an engineering stress of about 300 KPa at about 30% engineering strain without significant deviations 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.

In some variations, the elastic material or dressing may be configured under test conditions to maintain a certain minimum level of stress when held at a certain strain for a certain period of time. In an example to assess the ability of the backing material to maintain stress and strain on the skin over time, the engineering strain was measured while each backing material was tensile strained to 60% at a rate of 100 microns per second, held for 10 minutes, then reduced to 30% strain at a rate of 100 microns per second and held for 9 hours. For example, an exemplary dressing is capable of maintaining an engineering stress level of about 350 KPa at an engineering strain of 30%. In some other examples, 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 an engineering stress or strain and/or a true stress or strain.

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, for example, from polyacrylate-, polyisobutylene-, silicone-based pressure-sensitive adhesives, synthetic rubber, acrylic, and polyisobutylene (PIB), hydrocolloids, and the like. The T-peel release force and blunt probe tack force of the adhesive may be measured by standardized test methods such as ASTM D1876 and ASTM D2979 or other suitable methods. In some variations, the T-peel release force or blunt probe tack test value of the adhesive is configured to maintain a load of at least about 50 mPa/mm for at least about 24 hours, about 48 hours, about 72 hours, about 1 week, about 2 weeks, about 3 weeks, about 4 weeks, or more. In other variations, the load may be at least about 75 mPa/mm, about 100 mPa/mm, about 125 mPa/mm, or at least about 150 mPa/mm over a particular period of time. The degree of adhesion (e.g., as measured by T-peel release force or blunt probe tack test values) may vary depending on the degree of strain applied to the skin or incision site, and in some variations, these periods may be based on average skin strains 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. The T-peel release force and blunt probe tack force may be measured by standardized test methods such as ASTM D1876 and ASTM D2979, or other suitable methods. Other features or variations of the device are described in U.S. Application No. 11/888,978, filed Aug. 3, 2007, which is incorporated herein by reference in its entirety.

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.

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 Aug. 11, 2010, the disclosure of which is previously incorporated herein by reference in its entirety.

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

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

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

As described, a packaging or applicator, tensioning device, and/or straining device may be provided in some embodiments to apply strain to the skin treatment device using an external force and/or to maintain the strain applied to the skin treatment device. The packaging, applicator, or tensioning device may be configured to pivot or rotate to tension the dressing. In some examples, the straining device may be configured to apply and/or maintain a single predetermined or preset strain, or multiple predetermined or preset strains, or a predetermined maximum or minimum amount of strain. Features described herein with respect to the packaging assembly, applicator, or tensioning device may also be used in any device used to strain the dressing. A packaging or applicator, tensioning or straining device described as being in an unstrained configuration is in a configuration in which the dressing may not be strained or may be relatively less 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 in a configuration in which the dressing is strained, or can be strained relatively more, relative to the unstrained configuration when the dressing is attached to the packaging, applicator, tensioning or straining device, or applied to the skin of a subject.

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

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

Various locking, latching, fastening, attachment, or detent mechanisms may be used to maintain the packaging, applicator, or tensioning device in various configurations, including, but not limited to, unstrained, partially strained, and strained configurations. 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 of a given dressing may be achieved. The predetermined amount of strain may be a predetermined absolute percentage of a 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 a strain or force level may be independent of a minimum strain or force to achieve sutureless wound closure (e.g., a relative strain or force to achieve opposing placement 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 opposing alignment of the incision edges is achieved.

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

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

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

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

According to some variations, the cover and/or base 121, 122, or elements or sections thereof, may be constructed to be sufficiently strong or rigid or not very flexible with respect to the attached dressing, to support the attached dressing until it is applied to the subject, as described with respect to the variations herein. Such materials may include, for example, plastics, such as polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or TEFLON®), LDPE, high density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE), polyvinyl chloride (PVC), or acrylic, nylon, or paperboard. The elements or sections may be laminates of materials such as solid bleached sulfate paperboard, with layers of flexible material between layers of paperboard, such as silicone, polyurethane, LDPE, or rubber materials. The material may also be a metal, such as ductile aluminum or stainless steel. The metal may comprise a foil, ribbon, wire, or other form.

The cover 121 and base 122 are movably, hingedly, or pivotally coupled at the sides 123, 125. For example, a layer of material such as silicone, polyurethane, low density polyethylene, or rubber material may be glued to each of the cover and base, flexibly attaching them together at the sides 123, 125. Alternative devices and methods may be used to couple the cover 121 and base 122. For example, various composite structures or laminates may be used. The device may also be constructed from a single substrate that provides flexibility in some selected areas and rigidity in other areas, or provides relative or absolute flexibility in a first direction with relative or absolute rigidity in a second direction, which may be transverse to the first direction. Although the cover 121 and base 122 depicted in FIG. 1-5C generally have the same size and shape, in other examples the cover 121 and base 122 may be of 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 are each divided into sections 127 along their length that are bendable or movable relative to adjacent sections, allowing for flexibility of the device 120 along their length. The sections 127 may be constructed from a stiffer material that reduces flexing laterally or in other directions. Other configurations that vary the direction of stiffness and/or flexibility may be used. The configurations may include providing stiffness in the direction in which the dressing is strained that is sufficient to create and/or maintain the desired level of strain. The sections 127 may be bonded by a material such as an elastomer, e.g., silicone, that flexibly holds the sections together in relation to each other. Other structures may also be used to flexibly bond the sections or other elements. The material joining or connecting the cover and base 121, 122 may or may not be continuous with the material joining the section 127 to an adjacent section 127, and may or may not be attached to all or a portion of the sides of the cover and base 121, 122. Various attached structures, e.g., sections and/or the 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, e.g., at or near edges 121a, 123a, 124a, 122a, 125a, and/or 126a, as further described herein. In some further embodiments, the material joining 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 articulations, including, but not limited to, one or more pin-based hinge joints, rings attached to holes in the cover 121 and base 122, or ball and socket joints.

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

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 may be visualized for correct placement of the dressing 130. The cover 121 and base 122 may or may not comprise the same material. The elastic sheet 131 and adhesive layer 135 may also be sufficiently transparent to allow visualization therethrough. A more opaque material may be provided on portions of the material to create a border for the window 159. The section 127 may be clear or semi-opaque to provide a window for viewing, 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 location across the wound or incision.

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

When the assembly 100 is in a closed configuration as illustrated in FIG. 1 and in a 90 degree open configuration as illustrated in FIG. 2, the elastic sheet 131 is relaxed or unstrained, and the elastic sheet 131 has an unstrained width w1. When the assembly 100 is opened (e.g., by rotating or pivoting the cover 121 relative to the base 122) to 180 degrees or up to about 360 degrees, the orthogonal distance increases between the lines or areas of attachment 137a, 138a. According to some variations, the assembly is opened to about 180 degrees (minimum angular change) or more to provide for application of the dressing without interference of the assembly 100. When the device 120 is opened, it applies a separation force between the attachment areas defined by the lines or areas 137a, 138a, or the corresponding attachment areas. The force tensions the elastic sheet and creates a strain. Tensioning and straining the dressing 130 increases the width between the lines or areas of attachment 137a, 138a to w2. The increase in width, i.e., w2-w1, may be a fraction of w1 or a percent strain as described herein. Although straining is illustrated as beginning when the cover 121 is opened approximately 90 degrees from the base 122, the dressing 130 may be attached to the cover 121 in several locations or several configurations, which may vary the cover position or configuration at which straining begins. The edge 124a or side 124 of the cover 121 may act as a lever arm to provide a mechanical advantage, which may depend, among other things, on the distance of the point of attachment 138 of the dressing assembly 110 on the cover to the edge 124a of the cover 121, as well as the angle of the cover 121 relative to the base 122 at which tensioning of the dressing occurs. In addition, the point of attachment 138 of the inelastic attachment sheet 141 to the cover 121 may determine the amount of strain applied to the dressing, assuming, among other things, that the length of the attachment sheet 141 remains the same and that the point of attachment 137 of the dressing assembly 110 to the base 122 remains the same.

According to one variant, 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 as it is 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 lies across the area of base 122 and/or cover 121, i.e., base 122 and/or cover 121 border the outside of the area of the dressing. According to another variant, the dressing may be fixed at both edges.

According to some variations, the dressing is sufficiently large relative to the device 120 such 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 dressing may be about 10 mm, about 20 mm, about 30 mm, about 40 mm, or about 50 mm. Other strained dimensions may be used. According to other variations, the distance between each of the edges 133, 134 of the dressing 130 and the edges 125a, 126a of the base 122 (and/or the edges 123a, 124a of the cover 121), respectively, is about 10 mm, 15 mm, or 20 mm or less. According to some variations, the distance between the edges 136a, 136b of the dressing and the edge 122a of the base is about 10 mm, about 15 mm, or about 20 mm or less.

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

The adhesive layer 135 of the elastic sheet 131 is protected by a release liner 149 before the applicator or tensioning device 120 is opened. The release liner 149 is attached or glued to the inner surface 177 of the cover 121 such that when the cover 121 is opened as shown in FIG. 2 and separated from the base 122 (prior to straining the elastic sheet 131), the release liner 149 is pulled away from the elastic sheet 131 and exposes 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.

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

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

As best seen in FIGS. 5B and 5C, tubes 164, 165 for receiving and guiding legs 154, 155 of cutter 151, respectively, are positioned along side 133 of elastic sheet 131. Tubes 164, 165 may be positioned such that cutting path 162 is between tubes 164 and 165. Tube 165 is bonded, e.g., glued, to adhesive surface 135 of elastic sheet 131 at a location closer to side 133 than cutting path 162. Tube 164 is bonded to back surface 139 of elastic sheet 131 with attachment sheet 141 also bonded to elastic sheet 131 at a location closer to side 133 than cutting path 162. Tube 164 is bonded to free end 145 of attachment sheet 141, which extends inwardly of cutting path 162 relative to side 133. Thus, the tube 164 may be positioned inside the cutting path 162 without being attached to the elastic sheet 131 inside the cutting path 162. This allows the dressing 130 to be released from the remainder of the packaging assembly 100, including the cutter 151 along with the tube 164 and the 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.

Tubes 174, 175 for receiving and guiding legs 154, 155, respectively, are positioned along the side 134 of the elastic sheet 131. Tubes 174, 175 are positioned such that the cutting path 163 is between tubes 174 and 175. Tube 175 is bonded, e.g., glued, to adhesive surface 135 of elastic sheet 131 at a location closer to side 134 of elastic sheet 131 than cutting path 163. Tube 174 is bonded to back surface 139 of elastic sheet 131 with extension sheet 146. Tube 174 is bonded to free end 147 of extension sheet 146, which extends inward of cutting path 163 relative to the side. Tube 174 is also bonded to elastic sheet 131 at a location closer to side 134 than cutting path 163. Thus, the tube 174 may be positioned inside the cutting path 163 without being attached to the elastic sheet 131 inside the cutting path 163. This allows the dressing 130 to be released from the remainder of the packaging assembly 100, including the cutter 151 along with the tube 175 and the expanding sheet 146. A protective member 170 is attached, e.g., glued, to the top of the tube 175. The protective member 170 includes a ledge 171 that extends across the cutting path 163 such that 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.

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

When the dressing 130 is strained and the adhesive 135 is exposed, the dressing 130 may be applied with the adhesive side 135 facing the skin of the subject. The side 133 of the elastic sheet may then be released from the applicator by pulling the tab 146 to draw the blade 152 across the cutting path 162. And the side 134 of the elastic sheet may then be released from the applicator by pulling the tab 146 to draw the blade 152 across the cutting path 163. Thus, the elastic sheet 131 is released from the package 100 (including the release portion 150).

With reference to Figures 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.

The packaging assembly 200, the applicator or tensioning device 220, and/or the dressing assembly 210 may be configured to pre-strain the dressing 230 and/or to enable transfer of the pre-strained dressing 230 to the skin of a subject. The 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.

The device 220 may include a cover 221 and a base 222. The dressing assembly 110 may be removably coupled or tethered to the device 220 and serve as a dressing carrier. The cover 221 may be generally planar and include sides 223, 224 with corresponding edges 223a, 224a defining its length, and an edge 221a at an opposing end. The base 222 may be generally planar and include sides 225, 226 with corresponding edges 225a and 226a defining its length, and an edge 222a at an opposing end.

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

The cover and base 221 and 222 may be movably, pivotably, flexibly, or hingedly coupled 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 being similar to section 127, and with dressing 230 being attached to and strained by device 220 in a manner similar to that in which dressing 130 is attached to device 120.

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

According to some variations, the cover 221 and base 222 are each constructed at least in part from a clear plastic, semi-opaque, or other material that provides a window portion 259 through which the wound, incision, or other location may be visualized for correct placement of the dressing 230. The cover 221 and base 222 may or may not comprise the same material. The elastic sheet 231 and adhesive layer 235 may also be sufficiently transparent to allow visualization therethrough. A more opaque material may be provided on portions of the material to create a window border. The section 227 may be clear or semi-opaque to provide a window for viewing, 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 location across the wound or incision.

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

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

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

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

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 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 minus 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.

As shown in FIG. 8-8B, the cover 221 and base 222 may be rotated an additional amount relative to one another, for example, up to about 360 degrees from the closed configuration, prior to applying the dressing 230. According to some variations, the assembly is opened up to about 180 degrees (minimum angular change) or more to provide for application of the dressing without interference from the assembly.

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

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 is pulled away from the elastic sheet 231, pre-exposing the adhesive layer 235. Alternatively, as shown in FIG. 6, a release liner 149a may be provided on the adhesive layer 235 that is not attached to the cover 221. When the device 220 is opened, prior to straining, the release liner 149a may be manually removed from the elastic sheet 231 to expose the adhesive layer 235.

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 the release mechanism 250.

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. Cuts or perforations may be made in the attachment sheets 241, 251 to facilitate tearing along the path 262.

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

With reference to Figures 10-12B, a dressing and packaging assembly 300 is illustrated. The packaging assembly 300 includes a packaging device applicator 320 and a dressing assembly 310 that includes a dressing 330.

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.

The packaging device or applicator 320 comprises a cover 321 and a bottom element, dressing carrier, or base 322 to which the dressing assembly 310 is removably coupled or anchored. The cover 321 may be generally planar and include sides 323, 324 with corresponding edges 323a, 324a defining its length, and edges 321a at opposing ends. The base 322 may be generally planar and include sides 325, 326 with corresponding edges 325a, 326a defining its length, and edges 322a at opposing ends.

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

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

Assembly 300 is constructed to include a dressing assembly 310 with a skin dressing device 330. 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. Dressing 330 may include a variety of dressing materials, including, but not limited to, elastic bandages, gauze-type bandages, hydrocolloids. Various structures, such as compartments and/or covers and bases, and coupling elements, may provide structural support for the dressing carrier to be manipulated by a user. A margin between at least a portion of the structural support element, dressing carrier, or backing and the dressing may be provided at or near edges 321a, 323a, 324a, 322a, 325a, and/or 326a, for example, as described herein.

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 release 350. Also, the length of the dressing 330 adjacent its second side 334 is bonded to the length of the base 322 adjacent its side 325 and the outside of the release 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 the base 322 when the applicator 320 is opened.

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

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

The adhesive layer 335 on the dressing 330 may be protected by a release liner 349 before the packaging device or applicator 320 is opened. The release liner 349 may be attached to the inner surface 377 of the cover 321 such that when the cover 321 is opened or separated from the base 322, the release liner 349 is pulled away from the dressing 330, exposing the adhesive layer 335. The release liner 349 may also be a protective liner that protects or covers the dressing prior to application. For example, the liner may cover 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), coagulant promoters (e.g., propyl gallate), antifibrinolytic agents (e.g., epsilon aminocaproic acid), and the like. In some variations, the agents may be lyophilized and integrated into the dressing and activated upon contact with blood or other fluids. In some further variations, an activating agent may be applied to the dressing or treatment site before the dressing is used on a subject. In still other examples, a hemostatic agent may be applied separately or directly to the wound prior to application of the dressing or after application to the dressing via a catheter or tube. The device may also comprise one or more other agents, which may be any suitable agent that may be useful in assisting some aspect of the wound healing process. For example, the active agent may be a pharmaceutical compound, a protein (e.g., 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), antiseptics (iodine solution, silver sulfadiazine, chlorhexidine, etc.), antifungals (nystatin, etc.), antiproliferatives (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (VEGF, etc.), and other treatments (e.g., botulinum toxin). The cover 321 may be pulled apart or separated in several ways. The cover 321 may be opened like a book cover. Similar to devices 120 and 220, 420, 520, 620, 720, 820, 920, 1020 herein, the elements 321, 322 may be rotated sufficiently and up to about 360 degrees to separate the release liner 349, allowing the exposed adhesive side 335 of the dressing 330 to be placed on the skin or wound site using a packaging device or applicator 320. According to some variations, the assembly 300 is opened up to about 180 degrees (minimum angular change) or more to provide for application of the dressing without interference of the assembly 300. Alternatively, for example, the cover 321 may be attached to the base 322 by an adhesive and peeled away from the dressing 330 or the base 322 to which the dressing 330 is coupled. The cover 321 itself may be a removable or separable release liner that may be peeled away from the base 322. Alternatively, as shown in FIG. 6, a release liner 149a may be provided on the adhesive layer 335 that is not attached to the cover 321. When the device is opened, the release liner 149a may be manually removed from the dressing 330 to expose the adhesive layer 335. In such a case, the cover 321 may be omitted. After the device 300 is opened to the position shown in FIG. 11 or 12A and 12B, the dressing 330 may be applied to a desired location on the subject's skin. The window 359 may be used to visualize proper placement. A locking mechanism may optionally be provided to lock or secure the device in an open, partially open, or closed position. In some embodiments, the locking mechanism may comprise magnets, hook-and-loop attachment structures, snaps, latches, clips, and the like, as well as adhesives, or other adhesive structures. A compressive force may be applied to the backside 378 of the base 322 or the inside 377 of the cover when rotated approximately 360 degrees. Once applied to the subject, the dressing 330 may be released from the packaging device or applicator 320 using a release mechanism 350. The release mechanism 350 may include, for example, a cutting 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 as described herein and shown in FIGS. 1-22B.

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

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

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

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

Various structures, such as compartments, adhesive structures, layers of lamination, and/or covers and bases as well as bonding 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 521a, 523a, 524a, 522a, 525a, and/or 526a, as further described herein.

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

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.

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

The device 620 includes a cover 621 and a base 622. The dressing assembly 610 is removably coupled or tethered to the device 620, which may act as a dressing carrier. The 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 opposing end. The 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 opposing end.

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 dressing to support the attached dressing until it is applied to a subject, as described with respect to the variations herein. The materials and construction of the applicator or tensioning device 620, dressing 630, and packaging 600 may be similar to the packaging assemblies and/or dressings described with respect to the variations herein and shown in Figures 1A-22B.

The cover 621 and base 622 may be movably, pivotably, flexibly, or hingedly coupled at sides 623, 624. For example, a layer of material 627, such as silicone, polyurethane, low density polyethylene, or rubber material, may be glued to each of the cover and base and flexibly attach them together at sides 623, 625. The device 620 may be constructed in a manner similar to that described with respect to other devices herein and shown in 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 mechanisms, and release liners.

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

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 but not attached to the dressing 631.

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

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 with 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 and inboard of the attachment zone 655 of the mounting sheet 651 to the backside of the base 652.

When the cover 621 is opened, it applies a straining force to the dressing material 630 through the mounting sheet 641.

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

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

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

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

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

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

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

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 the 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 the adhesive structure 870 from the dressing 830, as further shown in FIG. 17C.

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

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

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

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 and inboard of the attachment zone 955 of the mounting sheet 951 to the backside of the base 952.

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

When the cover 921 is released, it applies a straining force through the mounting sheet 941 to the dressing 930. FIG. 18A shows the assembly 900 in an unstrained configuration, while FIG. 18B shows the assembly 900 in an released, strained configuration that may be applied to the skin. When strained, as shown in FIG. 18C, tabs 981 on the mounting sheet 941 are located across 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.

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

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

The device 1020 includes a cover 1021 and a base 1022. A dressing assembly 1010 is removably coupled or tethered to the device 1020, which may act as a dressing carrier. The dressing assembly may be attached to a tensioning member or applicator in a manner similar to the assemblies described herein. The dressing assembly 1010 includes an attachment sheet 1041 and an attachment sheet 1051. The attachment sheet 1041 has a first side 1043 that is attached to the second side 1034 of the dressing 1030 using an adhesive structure 1070 as described with reference to adhesive structures 970, 980. The attachment sheet 1041 has a second side 1044 that is coupled to the cover 1021 of the device 1020, for example, by bonding using a low surface energy PSA such as an acrylic adhesive. The attachment sheet 1041 also has a ripcord 1088 sewn along its length at 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.

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

19A and 19B illustrate the bandage assembly 1010 in an unstrained configuration. When the cover 1021 is opened, it applies a straining force to the bandage 1030 through the attachment sheet 1041. FIG. 19C illustrates the bandage assembly 1010 in a strained configuration.

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

20A-20C, a variation of a dressing carrier, tensioning device, or applicator 1120 is shown. The device 1120 comprises a plurality of sections 1130 formed by folding a substrate 1150 on one side 1155 of a planar surface. The folds 1170 may be formed in one or more directions or with one or more shapes that are 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 dressing. 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 bend at the fold 1170. The fold 1170 acts as a bending element, while the remaining substrate at the fold 1170 may act as a bending limiter.

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.

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

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 can generally be thick enough 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 a modulus of elasticity and an appropriate thickness that will at least resist the forces created by straining the bandage, may be provided for straining the bandage. The strain of the bandage 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 to allow 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.

As shown, the separation 1270 between the foam sections allows for molding of the device. The separation 1270 as shown is 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 crease acts as a flex element, while the remaining substrate at the separation may act as a flex limiter.

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

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

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

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

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

The assemblies or devices described herein may also form a dressing support structure. For example, the dressing support structure may include multiple sections of a base structure. The dressing support structure may include at least three sections extending from at least a first side of the dressing to a second side of the dressing. The dressing support structure may include multiple sections, such as those described in Figures 1A-22B, that are joined or formed together. The multiple sections of the cover described herein may also provide support to the dressing when the cover is folded 360 degrees against a corresponding base structure.

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

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

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

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

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

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

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

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

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

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

The bandage 2310 may be strained by pivoting the rotating element 2345, as shown in FIGS. 23A-23D. Once the tensioning sheet is loaded as the rotating element 2345 is pivoted, the tensioning sheet 2307 may wrap around the rotating element 2345, thereby shortening the distance between the rotating element 2345 and the bandage 2310, stretching or straining the bandage 2310. A locking mechanism, comprising a ratchet 2337 on the rotating element 2345 and a pawl 2338 on the circular portion 2344, may be used to lock the bandage 2310 in the strained configuration, as shown in FIGS. 23B-23D. When the tensioning sheet 2307 is pulled in a tensile strain direction towards the circular portion 2344 of the tensioning device 2341, the engagement elements 2324 and hooks 2325 may also move in the tensile strain direction. The edge 2336a of the support includes a ramp 2336b that may engage with a ramp 2326 on the hook 2325 to guide the edge 2336a of the support 2330 into engagement with the hook 2325 as the hook 2325 moves towards the circular portion 2344 of the tensioning device (see FIGS. 23C-23H). The strain of the pre-strained dressing 2310 may be controlled or determined using measurement elements or marks 2342 on the rotating element 2345, the distance between each of which may correspond to an increment of increased strain or distance. Once the dressing assembly 2308 is loaded onto the tensioning device 2341, the strain may be determined by the amount the rotating element 2345 rotates. Each mark 2342 may correspond to a strain percentage or distance. 0% strain may be identified as the position where the dressing assembly 2308 is loaded onto the tensioning device 2341 without any deflection and with little strain or tension. As shown in FIG. 23A, the 0% position may be indicated where the mark 2342a is aligned with the pawl 2338. As the rotating element 2345 is rotated, the identified 0% mark 2342a may rotate by an amount corresponding to the percent strain. As shown in FIG. 23B, the mark 2342b is aligned with the pawl 2338 when the dressing is strained to the desired amount x indicated by the mark 2342b.

The support structure 2330 may maintain the dressing 2310 in its strained configuration as shown in FIGS. 23B-23I during storage, and the engagement elements 2322, 2324 and hooks 2323, 2325 engaging the support structure 2330 prevent the dressing 2310 from moving or losing strain. One or more adhesive regions comprising a layer of skin adhesive 2340 may be applied to the upper surface 2312 of the dressing 2310. The adhesive 2340 used may be, for example, a suitable pressure activated adhesive (PSA) or a non-pressure sensitive adhesive. The adhesive 2340 is shown on the dressing 2310 in an unstrained configuration. However, the adhesive may be applied to the dressing 2310 after the dressing 2310 has been strained. A removable liner 2350 may be placed over the adhesive layer 2340. The liner 2350 may also be selected to maintain strain in the dressing 2310. Such liners may include rigid or semi-rigid materials, such as ultra-high molecular weight polyethylene (UHMWPE) with a release coating or layer, fluoropolymers such as perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), or expanded PTFE (ePTFE). Other rigid plastics or resins that may be used include melamine, fiberglass, acrylonitrile butadiene styrene (ABS), or polyvinyl chloride (PVC). In other variations, the rigid liner may be a composite structure, including a flexible liner with a rigid frame or rigid struts, which may include, for example, metal (e.g., stainless steel) or rigid plastic/resin.

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

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

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

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

The dressing 2310 may be released from the support 2330 by pulling the tear strip 2309 to draw the tear strip across the path 2362 of the tensioning sheet 2307 and the mounting sheet 2304. Sections 2365 and 2375 of the tensioning sheet 2307 and the mounting sheet 2304, respectively, may remain on the backside 2311 of the elastic sheet 2360. Sections 2385, 2395 of the mounting sheet 2304 and the tear sheet 2307, respectively, that are joined to the tear strip 2309 may thereby be separated from the tensioning sheet 2307 and the mounting sheet 2304. Sections 2365 and 2375 of tensioning sheet 2307 and attachment sheet 2304, respectively, that are attached to bandage 2310 may thereby be separated from the remaining portions of tensioning sheet 2307 and attachment sheet 2304 that are attached to support structure 2330 at their ends 2305 and 2306. Thus, bandage 2310 may be released from the remaining portions of support structure 2330.

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

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

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

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

In other variations, the tensioned tissue treatments described herein may also be used to treat epidermal or subcutaneous tissue conditions that may result from injections, infusions, or implants. In one example, the tensioned tissue treatment system may be applied to the insertion site of a drug-eluting oral contraceptive implant, such as the NEXPLANON® etonogestrel implant (Merck, Whitehouse Station, NJ). The implant is a radiopaque, soft, flexible progestin-eluting implant consisting of an ethylene vinyl acetate (EVA) copolymer core doped with barium sulfate to provide radiopacity with 68 mg of the progestin etonogestrel released over a period of up to three years. Difficulties or complications with implant removal have been reported in 1.5% of cases, with inclusion of the implant in fibrotic tissue being the most common cause. It is believed that treatment of the insertion site and final implant location with a tensioned tissue treatment system may reduce the development of fibrotic tissue surrounding the implant, which may reduce complication rates during the extraction procedure. It has been found that lipoatrophy at the subdermal contraceptive implant site leads to loss of contour with significant aesthetic impact. Localized lipoatrophy of the subdermal contraceptive may be due to either of the components within the implant acting directly on the surrounding fat cells or due to a foreign body type reaction. Injection site nodularity in the subdermal layer is another common reaction to diabetes medication injections such as GLP-1 (i.e., exenatide) agonist therapy used by T2D patients. Paresthesia, pain, and blood clotting risk at the implantation site may also be reduced during the three-year treatment cycle with the implant, regardless of whether fibrotic tissue development is reduced. In some variations, the tensioned tissue treatment device may be applied to the implantation site for the entire duration of implantation, while in other variations, the tensioned tissue treatment may be applied for a period within the range of 4-6 weeks, 4-8 weeks, 6-8 weeks, 6-12 weeks after implantation or following extraction. In some further variations, the treatment may be applied to the proposed implantation site for 4-6 weeks, 4-8 weeks, 6-8 weeks, 6-12 weeks prior to implantation. This may reduce or break down existing fibrosis or otherwise allow tissue to remodel prior to implantation, facilitate the implantation procedure, and aid in the promotion of healing and other tissue responses after implantation. An initial limited cycle of treatment may be sufficient to modify or slow the initial tissue remodeling process or inflammation and reduce adverse reactions associated with implantation. The user may be instructed to place the tensioned dressing to cover at least 1 cm, 2 cm, or 3 cm or more of skin area surrounding the implant. The direction of tension in the dressing may be oriented along or transverse to the longitudinal axis of the implant.

The implant may also be an injectable material such as a depot of injectable contraceptive like DEPO-PROVERA® (Pfizer, New York, NY), a medroxyprogesterone acetate formulation with polyethylene glycol and polysorbate carriers that is injected every three months. Drug levels peak three weeks after injection and are undetectable 120-200 days after injection.

Another depot injection is SUBLOCADE® (INDIVIOR, North Chesterfield, VA), a monthly depot formulation of buprenorphine for the treatment of opioid use disorder for patients undergoing treatment with another buprenorphine product. SUBLOCADE® is intended to be injected subcutaneously into the rotational abdominal site free of skin conditions between the pyloric and intertubercular planes of the abdomen. A Phase 3 trial of SUBLOCADE® found a 16.5% rate of injection site reactions, including pain, itching, redness, bruising, swelling, induration, cellulitis, and other discomfort.

In another embodiment, injectable tumor therapeutics may also be used. For example, PHESGO® (Genentech, South San Francisco, Calif.), a combination therapy of pertuzumab and trastuzumab monoclonal antibodies and recombinant human hyaluronidase for the treatment of HER2+ breast cancer. PHESGO® may be used in conjunction with a tensioning skin dressing to modulate drug levels and/or reduce injection site reactions such as pain, itching, etc.

In yet other variations, the tensioned tissue treatment system may be used in conjunction with injectable therapies for autoimmune or inflammatory diseases, including, but not limited to, rheumatoid arthritis, psoriasis, lupus, and the like. Subcutaneous injections include disease-modifying antirheumatic drugs (DMARDs) such as methotrexate, ACTEMRA® (tocilizumab) (Genentech, South San Francisco, Calif.), which can be injected subcutaneously on a weekly basis for the treatment of rheumatoid arthritis, giant cell arteritis, cytokine release syndrome, juvenile rheumatoid arthritis, and systemic sclerosis-associated interstitial lung disease, and ILARIS® (canakinumab) (Novartis, East Hanover, Massachusetts), which can be injected subcutaneously every 4 weeks for the treatment of periodic fever syndrome, TNF receptor-associated periodic fever, hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency, Still's disease, and juvenile rheumatoid arthritis. and KEVZARA® (IL-6 receptor agonist) (Sanofi, Bridgewater, NJ), which can be injected subcutaneously every two weeks in combination with methotrexate or other conventional disease-modifying antirheumatic drugs for the treatment of severe rheumatoid arthritis.

Treatment with tensioned skin dressings may be provided continuously during use of the depot injections described above, or for a limited period following each injection, e.g., 3-5 days, 3-7 days, 5-10 days, or 7-14 days after injection. The dressings may contain apertures to facilitate a cyclic injection pattern with therapeutic agents requiring multiple successive injections.

While the particular examples above involve drug eluting devices, in other variations, the implant may be a non-drug eluting implant, for example, but not limited to, cosmetic body modification, including epidermal or subdermal beads, rods, or horns, or therapeutic implants such as hyoid bone implants for the treatment of obstructive sleep apnea. For implants intended for long or undefined treatment durations, tensioned tissue treatment may be applied for periods ranging from 4-6 weeks, 4-8 weeks, 6-8 weeks, 6-12 weeks after implantation. Fibrous capsule formation may occur around the implant during the end-stage healing response. Eventually, atrophy may occur due to reduced blood supply. It is hypothesized that tensioned dressings may have an effect on fibrous encapsulation. This may include a reduction in final size and/or flexibility compared to untreated controls.

Injectable materials may also include autologous fat or other materials available from manufacturers such as JUVEDERM® (Allergan Aesthetics, Madison, NJ), RADIESSE® (Merz, Franksville, WI), RESTYLANE® (Galderma, Fort Worth, MA), whether the injection is performed using a needle or a flexible blunt tip microcannula such as the DERMASCULPT MICROCANNULA® by CosmoFrance (Miami, FL), the PIX'L cannula by Thiebaud (Paris, France), and the Merz cannula by TSK Labs (Tochigi, Japan). TX). The use of a tensioned skin dressing over the injection site may reduce swelling and/or bruising that may occur. The tensioned skin dressing is applied for 3-5 days, 5-7 days, 7-10 days, 3-7 days, or 7-14 days after injection, and the tensioned skin dressing may be reapplied after each injection of the treatment regimen. In some variations, the tensioned dressing may be indicated only upon onset of a localized adverse reaction, or may be applied prophylactically to reduce the risk or rate of onset of such an adverse reaction. Treatment of dermal filler injections at the subcutaneous junction via threading or drilling techniques may reduce the visibility of the injected area by reducing scar formation and/or migration of the filler site along the area. Treatment with a cosmetic filler in conjunction with a tensioned skin dressing may be provided for a limited period of time following each injection, for example, 3-5 days, 3-7 days, 5-10 days, or 7-14 days after injection. The tensioned skin dressing may be sized to ensure coverage of the injection area with a margin of at least 1 cm, 2 cm, or 3 cm. In some variations, the direction of tension in the skin dressing may be selected to be generally transverse to the direction or average direction of the threaded or drilled injection path. It is hypothesized that tensioned tissue therapy may reduce the likelihood of bleeding ecchymosis that may result from increased tissue resistance during insertion of the microcannula when tension-relieving dressing therapy is used prior to injection and pre-existing fibrosis has been pre-treated and/or reduced. In addition, tolerability of the procedure and treatment compliance may be increased if patient discomfort levels are reduced due to reduced scar tissue accumulation. Patients have reported discomfort from insertion in scar tissue causing pain and the noise of the blunt cannula passing through hard dense scar tissue.

In other variations, the tensioned tissue treatment described herein may be provided for or used in conjunction with various infusion devices that may be used for various therapeutic and/or diagnostic procedures. These include intradermal infusion devices, subcutaneous infusion devices, and intravascularly implantable infusion ports. These infusion devices may be used, for example, to provide insulin infusions for the treatment of diabetes, intravenous or subcutaneous immunoglobulin infusions for the treatment of immune deficiency syndromes, chemotherapy infusions for the treatment of various cancers, and the like. In some of the embodiments described below, the tensioned tissue treatment system may be integrated with or specifically tailored to the infusion device, while in other variations, the tensioned tissue treatment device may be applied between infusions or injections or for a specific period of time after each infusion or injection. As described in more detail below, the use of tensioning tissue therapy may reduce, slow or prevent the development of intradermal scar tissue, which may improve or slow the rate of change in absorption or diffusion kinetics of any intradermal or subcutaneous injection or infusion, and/or reduce the development of chronic pain or paresthesia resulting from repeated tissue trauma from injections or infusions. Examples of such devices include the SAF-Q and OPTIFLOW infusion sets and SCIG60 infusion pump by EMED Technologies (El Dorado Hills, Calif.), the PORT-A-CATH® implantable venous access system by Smiths Medical (Dublin, Ohio), the INSUFLON multi-injection subcutaneous catheter by Unomedical (Roskilde, Denmark), and the I-PORT ADVANCE injection port by Medtronic MiniMed (Northridge, Calif.). Tensioned tissue treatment may be applied for periods ranging from 4-6 weeks, 4-8 weeks, 6-8 weeks, 6-12 weeks after implantation of such devices, and/or for 3-5 days, 5-7 days, 7-10 days, 3-7 days, or 7-14 days after each injection. For injection systems that are adhered to the skin, the tensioned tissue treatment system described herein may be applied first, and then the injection system is inserted through an opening in the tensioned tissue treatment device. Use of the tensioned tissue treatment system may improve, reduce, and/or prevent catheter or port erosion through the skin, catheter blockage, device migration or rotation, device extravasation, fibrin sheath formation, injection, inflammation, necrosis or pigmentation over the implant area, pain at the port pocket site, catheter tip malposition or retraction, erosion of the inserted vessel, and/or the risk of vascular thrombosis.

In another embodiment, the tensioned tissue treatment system is used in conjunction with a hemodialysis procedure and applied to the needle insertion site of a dialysis graft or fistula. In some variations, a single tensioned tissue treatment device may be applied and cover both needle insertion sites, while in other variations, two tensioned tissue treatment devices are used, one for each needle insertion site. In these embodiments, the direction of tension applied to the hemodialysis patient's arm may be along the longitudinal or transverse direction of the arm. It is hypothesized that the use of tensioned tissue treatment at the hemodialysis needle insertion site may reduce the risk of pain, ulceration, and/or tissue calcification development in the integumentary and/or subcutaneous tissue overlying the graft or fistula. In another example, the use of tensioned tissue treatment for patients who are not eligible for an AV fistula due to excess scar tissue accumulation from previous IVs, blood tests, or medications may reshape the tissue sufficiently to allow for a fistula formation procedure. In some further variations, tensioned tissue therapy may further reduce the rate of fistula thrombosis by reducing mechanical stress on the graft that may activate short-term inflammation or local clotting pathways at the insertion site. Therapy would typically be applied between hemodialysis visits, for example, 48-72 hours per application following hemodialysis. Tensioned tissue therapy may also be provided along the implantation site of a new hemodialysis graft or AV fistula plastic surgery or AV fistula revision procedure. For AV fistulas, treatment with the tensioned tissue device may be 1-2 weeks, 2-4 weeks, 4-8 weeks, 8-12 weeks, or the entire maturation time from surgery to first use of the fistula. For AV grafts, treatment with the tensioned tissue device may be within the range of, for example, 1-2 weeks, 2-3 weeks, or 2-4 weeks.

In still other embodiments, the tensioning tissue treatment device may be used to treat the post-implantation site of a pacemaker housing, an implantable cardioverter defibrillator (ICD), or an implantable pulse generator of a neuromodulation system, and the subcutaneous implantation site of a neuromodulation electrode. Neuromodulation systems such as the SPECTRA WAVEWRITER and PRECISION SCS systems by Boston Scientific (Marlborough, MA), the INTELLIS and RESTORE neurostimulator systems by Medtronic (Minneapolis, MN), the SENZA OMNIA system by Nevro (Redwood City, CA), and the PROCLAIM and PRODIGY SCS systems by Abbott (Austin, TX) may be used to perform spinal cord stimulation (SCS) to treat low back pain. Treatment may reduce or prevent implantation site pain, paresthesia, numbness, spinal cord compression, swelling, inflammation, ulceration or erosion, capsular fibrosis, tissue ingrowth, and/or implant migration. In some cases, a tough fibrous capsule forms around the implant and begins to compress the implant or the capsule contracts, causing tenderness and pain. This effect can be reduced by treatment with a tensioning tissue treatment device.

In other examples, the tensioned tissue treatment device may be used to directly treat diseases involving subcutaneous tissues or structures. These may include autoimmune diseases, metabolic diseases, endocrine diseases, genetic diseases, inflammatory diseases, neoplastic diseases, infectious diseases, and the like. For example, certain diseases may result in the development of subcutaneous calcifications in the dermis or subcutaneous tissue, often as a result of inflammation from a variety of etiologies. It is believed that symptomatic treatment of calcifications visible on medical imaging may reduce pain or progression of calcifications by application of a tensioned tissue treatment device as described herein. Such diseases may include autoimmune diseases such as dermatomyositis and scleroderma, metabolic diseases such as hyperparathyroidism, and inflammatory conditions such as sarcoidosis, as well as calciphylaxis of the subcutaneous vasculature associated with end-stage renal disease, multiple myeloma, rheumatoid arthritis, and liver cirrhosis. Calcifications with associated tissue erosion may also be treated. Symptomatic treatment with a tensioned tissue treatment device may be applied, for example, to integumentary or subcutaneous calcifications for 1-2 weeks, 2-4 weeks, 4-8 weeks, or 8-12 weeks.

In other examples, the tensioned tissue treatment device may be used to treat reticular or branched livedo, or other vascular diseases of medium-sized vessels found in subcutaneous tissue. These disease phenomena are characterized by a patchy, reticular pattern of skin coloration believed to result from altered blood flow, vasospasm, venous dilation, thrombosis, or increased blood viscosity. The tensioned tissue treatment device may be used alone or in conjunction with systemic therapy to target the underlying cause of the skin condition. Causes may include, for example, vasculitis, polyarteritis nodosa, temporal arteritis, Takayasu's arteritis, lupus erythematosus, Still's disease, rheumatic fever, endocarditis, hepatitis, antiphospholipid syndrome, cryoglobulinemia, deep vein thrombosis, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, and the like. Drug-induced vascular changes may also be treated. Treatment cycles using tensioned tissue treatment devices may range from 1-2 weeks, 2-4 weeks, 4-8 weeks, 8-12 weeks, as appropriate. Treatment may also temporarily improve the cosmetic appearance of congenital vascular malformations, which may last for hours, days, or weeks following the temporary treatment.

In some other embodiments, the tensioned tissue treatment device may be used in conjunction with a body sculpting or contouring procedure. Treatments combined with these procedures may expedite healing or improve the contouring effect after the procedure by reducing subcutaneous tissue inflammation during the healing process. Such procedures may include invasive energy-based, cold-based, or mechanical-based lipolysis or septum destruction, as well as non-invasive vacuum and massage therapy, which may be combined with an invasive body sculpting procedure or used alone. The use of invasive lipolysis procedures has been associated with the development of subcutaneous fibrosis, which may be the result of improper removal of destroyed subcutaneous cells or connective tissue. In some examples, the tensioned tissue treatment system may be applied after an invasive body sculpting procedure, or between an invasive and a non-invasive body sculpting procedure, or between treatments of a multiple treatment regimen. Treatment following an invasive body sculpting procedure may be performed for, for example, 1 week to 3 months, or 2 weeks to 6 weeks, or 4 weeks to 12 weeks, while treatment during a multiple treatment regimen will vary depending on the treatment schedule, which may be as described above, or within 3-5 days, 5-7 days, 7-10 days, 3-7 days, or 7-14 days after each procedure of the regimen or treatment schedule.

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

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

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

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

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

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

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

57A-57D depict another embodiment of a tensioned tissue treatment system 5700 comprising a dressing 5702 and one or more removably attachable injection templates 5704a-c. The templates 5704a-c (a subset of three of five exemplary templates are depicted) are temporarily applied to the dressing to indicate to the user where to inject, while being removable so that bulk or discomfort of the tensioned tissue treatment system is reduced during injection. As with many of the exemplary embodiments depicted herein, the dressing 5702 is depicted diagrammatically without the applicator or tension applicator described elsewhere herein for simplicity. Each of the templates 5704a-c has the same size and shape, but each includes multiple injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c at different locations on the template 5704a-c relative to the other templates 5704a-c. Thus, each template 5704 is used on a different day, assisting the user in cycling through injection sites for each day's injections. Indicia 5714a-c may also be provided on the templates 5704a-c to help a user or caregiver identify which template 5704a-c to use for each period of time. The indicia 5714a-c preferably comprise a set of sequential indicia or words indicating a numeric or alphabetic sequence, although in other variations, other sets of indicia may comprise other sets of indicia that may be non-sequential. The injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c of each template 5704a-c are grouped or clustered together in different areas of each template 5704a-c, although in other variations the injection openings on each template may be located in different locations relative to the other templates but not clustered such that the perimeter of the shape defined by the openings on each template may overlap or intersect with the perimeter of the shape provided on the other templates of the same set. This exemplary template also includes four injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c, although in other variations two, three, five or six openings may be provided per set or group of injection openings per template. In another embodiment, the injection template is a clear thin film polymer (e.g., polyethylene terephthalate, polycarbonate, or the like) over which the outline of the dressing shape may be printed for visual matching. Because of the material, the thin polymer film can adhere and temporarily bond to the silicone dressing without the need for adhesives or other attachment mechanisms. Once the template 5704a-c is aligned and attached to the dressing 5702, the template openings 5714a-c, 5706a-c, 5708a-c, 5710a-c will generally be coaxially aligned with one of the corresponding groups of dressing openings 5724a-e of the dressing 5702, facilitating or enabling injection through the template openings 5714a-c, 5706a-c, 5708a-c, 5710a-c and the groups of dressing openings 5724a-e. Some variation in the alignment of the template openings 5714a-c, 5706a-c, 5708a-c, 5710a-c and the dressing openings 5724a-e may occur due to variations in the tensioned size of the dressing 5702. However, in other variations, the dressing openings of the embodiments herein are not provided and a needle may be passed through the template opening and then punctured through the dressing for injection.

To facilitate reproducible alignment of the injection template 5704a-c to the dressing 5702, one or more complementary alignment structures 5720, 5722, 5716a-c, 5718a-c may be provided on the dressing 5702 and the template 5704a-c. In this particular example, flat but raised alignment structures 5720, 5722 are bonded, heat fused, or welded to the top surface of each end of the dressing 5702. In other examples, the alignment structures may be openings in the dressing that can be aligned with raised alignment structures on the bottom surface of the template. The complementary alignment structures or openings 5716a-c and 5718a-c are arranged on the template 5704a, which can form an interdigitation or interlock with the alignment structures 5720, 5722. In some variations, the geometric shapes of the alignment structures 5720, 5722 are different, e.g., squares and triangles, to limit the orientation of the injection template 5704a-c when attached to the bandage 5702. Other shapes that may be used include rectangles, slots, circles, ovals, or other polygonal shapes. The shapes may be configured with tolerances that allow for alignment when the bandage is stretched or contracted along the orientation direction between the alignment structures. For example, the raised alignment structures 5720, 5722 may be slightly undersized when compared to the complementary alignment structures or openings 5716a-c and 5718a-c on the templates 5704a-c to accommodate variations in the length of the bandage as it is adhered to the skin from movement and/or positioning. In some further embodiments, the complementary alignment structures may be further configured to provide a removable snap fit between the bandage and the template to resist inadvertent misalignment or unintentional separation. The template may be manufactured as a single layer or multi-layer structure with a woven or non-woven structure and may include materials such as polyamide, polyester, polyethylene, paperboard, and the like. Any indicia on the template may be ink printed, silk screen printed, embossed, die cut, stamped, or laser etched onto the surface of the template. In yet another variation, the template may include an elastic material that accommodates variations in stretch length and/or width of the dressing as it is adhered to the skin. With an elastic template, the elastic material may have a force per millimeter width lower than that of the dressing itself, e.g., 50% or less, 40% or less, 30% or less, 20% or less, or 10% or less, such that tension in the underlying tissue and dressing is not substantially altered by the temporary attachment of the template.

The size of the injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c may vary, with diameters or maximum lateral dimensions within the range of about 3 mm to 20 mm, 5 mm to 15 mm, or 8 mm to 12 mm. The size of the injection openings may be large enough so that a user may properly cleanse the injection site with an alcohol swab prior to injection and/or for proper visibility by patients with poor vision, e.g., diabetic retinopathy. The outer periphery of the injection opening may optionally be raised to provide tactile feedback to facilitate needle positioning, which may assist users with poor vision or color blindness.

While the tensioned tissue treatment system 5700 of FIGS. 57A-57D includes multiple different templates 5704a-c, each for use over a different period of time, e.g., one day, in other embodiments, the treatment system may include templates configured with injection openings for multiple periods of time. In FIG. 58, for example, tensioned tissue treatment system 5800 includes dressing 5802 similar to dressing 5702 from FIG. 57A, but template 5804 is configured with multiple groups of injection openings 5808a-g, each group optionally labeled by its unique indicia 5806a-g and/or separated by separation indicia 5818. During use, template 5804 is attached to dressing 5802 via alignment structures 5810, 5812, 5816, 5818. Once attached, the groups of injection openings 5808a-g of the template 5804 will be generally or coaxially aligned with the corresponding groups of injection openings 5820a-g of the dressing 5802. This facilitates or enables injection through the injection openings 5820a-g of the template 5804 and through the groups of injection openings 5820a-g of the dressing 5802. As described elsewhere, some variation in the alignment of the groups of injection openings 5820a-g and the groups of injection openings 5820a-g of the dressing 5802 may occur due to variations in the tensioned size of the dressing 5802. The user then identifies the set of openings 5808a-g to be used and then identifies that set of openings 5808a-g to be used for the injection of the injection openings to be used based on the time of day or meal. The exemplary system 5800 illustrated in FIG. 58 includes three injection openings per group 5808a-g, although in other variations, two, four, five, or six openings may be provided per group, as described elsewhere herein. Each group 5808a-g has a linear array of openings that are transverse to the long axis of the template 5804, although in other variations, each group 5808a-g may have a cluster array that is equally spaced around a central point to ensure proper injection circulation, with no overlap between groups 5080a-g. Other features of system 5800 may otherwise be similar to the range of features as described with respect to system 5700.

59A-59E depict another variation of a tensioned tissue treatment system 5900. The system 5900 includes a dressing 5902 with a multi-period template 5904 similar to the system 5800 of FIG. 58, except that each subgroup of template openings 5908a-g is covered by a single removable adhesive cover 5920a-g. The first opening of each group 5908a-g is aligned with the first opening of the other groups relative to the longitudinal axis of the template 5904, and similarly, each subsequent opening of each subgroup is aligned with the corresponding opening of the other subgroup. This results in the subgroups of openings 5908a-g forming a rectangular grid of openings. However, in other variations, the arrangement and alignment of the subgroups may be different, as will be described with respect to other exemplary embodiments below. Each cover 5920a-g has a shape and size sufficient to cover all corresponding openings in the group of openings 5908a-g and further configured to extend beyond the outer edge 5926 of the template 5904 to facilitate grasping and removal of each cover 5920a-g by a user. Each cover 5908a-g optionally further comprises different indicia 5924a-g to assist a user in identifying the group of openings 5908a-g to be used each day. The indicia 5924a-g may comprise sequential numbers, letters, or words, or may comprise symbols. While the covers 5924a-g depicted in FIGS. 59A-59E are configured to extend beyond the same side of the dressing edge 5926 and are arranged continuously from one end of the template 5904 to the other, in other variations the covers may be arranged to extend from either of the two sides of the template, e.g., in an alternating manner and/or in a non-continuous arrangement. The latter may be beneficial to provide greater spacing between groups of openings based on the order in which the covers and groups of openings are removed according to the indicia on the covers. With indicia 5924a-g located on the covers 5920a-g, other indicia such as sequential indicia 5806a-g or separation indicia 5814 found in the system 5800 of FIG. 58 may or may not be provided. The covers may comprise a flexible polymer or paper material, and the adhesive that adheres the covers 5920a-g to the template 5904 may be a pressure sensitive adhesive, such as polyacrylate-based, polyisobutylene-based, silicone-based pressure sensitive adhesives, synthetic rubber, acrylic, and polyisobutylene (PIB), hydrocolloids, and the like. Preferably, the T-peel force of the cover adhesive is significantly lower than the T-peel force provided to the dressing 5902 when the template 5904 is attached to the dressing 5902 before the covers 5920a-g are removed, so that the dressing 5902 or template 5904 do not pull apart during use. The alignment structures 5910, 5912, 5914, 5916 of the dressing 5902 and template 5904 may otherwise be similar to the systems 5700, 5800 described above or other variations described elsewhere herein. Once aligned, the portions of the template openings 5908a-g are aligned with the corresponding portions of the dressing openings 5928a-g of the dressing 5902.

In use, the system 5900 involves the removal of any previously applied dressing 5902. Depending on the type of adhesive provided on the dressing, water or alcohol or a softening adhesive remover may be used to avoid or reduce the risk of medical adhesive-related skin damage. A new injection area is identified and cleaned, and then a new dressing 5902 of the system 5900 is applied to the new injection area. The template 5904 is then grasped and the first or next successive cover 5908a-g is grasped and peeled away from the template 5904 and removably attached to the dressing via the matching structures 5910, 5912, 5914, 5916. If the group of openings 5908a-g to be used has already been removed earlier in the day or period, the user may use an alcohol swab to wipe the exposed group of openings 5908a-g prior to attachment to the dressing 5902. The user then prepares the injection, selects an opening in the group of openings 5908a-g based on the time of day or mealtime, and injects the therapeutic agent through the selected opening. After the injection is completed, the template 5904. This procedure is repeated several times per day until the dressing is changed, as shown in FIGS. 59B-59E, which illustrate days 1-3 of a newly applied system 5900.

60A-60D depict another variation of tensioned tissue treatment system 6000 similar to system 5700 and variations thereof, except that instead of one attachment feature located at each end of the dressing and template, which are different in shape, the attachment features each have the same size and shape, but there are different numbers of them at each end. In the example of FIGS. 60A-60D, one end of dressing 6002 includes a single circular shape 6012a while the other end includes two circular shapes 6014a, 6016a. Similarly, the complementary attachment structures on templates 6004a-c include a single complementary circular opening 6012a-c at one end of templates 6004a-c and two complementary circular openings 6014a-c, 6016a-c at the other end. The difference in the number of features at each end defines the relative orientation of dressing 6002 and templates 6004a-c. Once the template 6004a-c is aligned and attached to the dressing 6002, the groups of template openings 6020a-c will generally be coaxially aligned with one of the corresponding groups of dressing openings 6024a-e of the dressing 6002. This facilitates or allows injection through the groups of template openings 6020a-c and the groups of dressing openings 6024a-e. In still further variations, other shapes other than circular may also be provided, and even in embodiments where different shapes are provided, the number of shapes may still vary and/or different sizes of the same shapes may be included. The number of shapes on each end may be in the range of 1-5, 1-4, 1-3, or 1-2. The shapes may be linearly arranged or clustered around a common center point. In yet other variations, instead of different sized openings on the template that form complementary interfits with protruding features on the dressing, hook-and-loop applicators, adhesives, and/or magnetic attachment structures may be used to removably join the dressing and template.

Due to variations in equilibrium between the tensioned tissue treatment device and the underlying tissue, the resting size, and therefore the distance between the attachment structures on the dressing components of the system, may vary. To accommodate these variations during template attachment and injection of therapeutic agent, a linear set of attachment structures may be provided, or modified openings may be provided, configured to form an interdigitation with the attachment structures of the dressing transverse to the template's transverse axis, but allowing for longitudinally variable positioning along the longitudinal axis. FIG. 61A depicts an example of an alternative template 6104 that may be used with the system 5700 of FIGS. 57A-57D. The present template 6100 includes a single attachment opening 6102 at one end and multiple openings 6104a-c at the other end. During use, one single attachment opening 6102 is first attached to the dressing and then the opening 6104a-c that best fits for attachment to the corresponding attachment structure on the dressing is selected, minimizing any folding or rippling or overstretching in the template 6104 or dressing. Figure 61B depicts an embodiment of an alternative template 6120 that may be used with system 5700 in which, instead of triangular attachment openings, trapezoidal attachment openings 6122 are configured to form an interlock with the triangular attachment structure of the dressing anywhere along the length of the trapezoidal opening 6122. The trapezoidal openings 6122 are oriented along the longitudinal length of the template to accommodate variable dressing lengths and thus variable dressing attachment structure positions. Figure 61C depicts an exemplary alternative template 6140 that may be used with system 6000 of Figures 60A-60D that includes two oval openings 6142a, 6142b oriented along the longitudinal length of the template to accommodate variable positions of the two circular openings of dressing 6002 of system 6000. Figure 61D depicts an exemplary alternative template 6160 that may be used with systems 5800 or 5900 that also includes a trapezoidal opening 6162 to accommodate variable positions of the triangular attachment structures of the corresponding dressing. In each of templates 6100, 6120, 6140, 6160, the attachment openings may be larger than the corresponding attachment structures 6104a-c, 6122, 6142a-b, 6162 to accommodate variable dressing lengths and thus variable dressing attachment structure positions. In each of templates 6100, 6120, 6140, and 6160, the attachment opening on the right side of the template is configured to accommodate variable attachment positions, but in other variations, the attachment opening on the left side of the template may also be so configured.

62A depicts another embodiment of a tensioned tissue treatment system 6200 comprising a dressing 6202 without any template. Instead, a plurality of openings 6204 are surrounded by a plurality of adhesive removable rings 6206. The rings 6206 are preferably made of soft foam. As each opening 6204 is used, the foam rings 6206 may be removed or peeled away from the dressing 6202 to indicate its use. In this particular embodiment, no indicia or groupings are necessarily provided, and the user may be instructed to use any previously unused openings 6202 indicated by the remaining or existing foam rings 6204, and may or may not be instructed to use openings 6202 in any particular order or manner, for example, across each row or column of the grid of openings 6202, to another row or column, whether adjacent or not.

62B and 62C depict other exemplary embodiments of tensioned tissue treatment dressings 6220, 6240 that are not used with a template. In these particular embodiments, each dressing 6220, 6240 includes an individual adhesive cover 6222 for each dressing opening (not shown). Each cover includes a main body 6222a that surrounds each dressing opening and is adhered to the dressing. A smaller flap 6222b is also included. The flap 6222b may be non-adhesive to the dressing surface to facilitate gripping of the cover 6222 to peel off the main body 6222a. The dressing 6240 of FIG. 62C is similar to the dressing 6220 of FIG. 62B, except that each of the covers 6242 also includes indicia 6242c in addition to the adhesive main body 6242a and non-adhesive flap 6242b. The indicia 6242c on each cover 6242 may be arranged in groups 6244a-g to facilitate sequence of use by day or other time period. In this particular example, the indicia 6242c in each group 6244a-g may be the same, but in other variations, each indicia 6242c may be different. As described with respect to other embodiments, the indicia 6242c may be sequential numbers or letters, or may comprise other symbols indicating times or meals, e.g., sunrise, months, food symbols. With reference to FIGS. 62D-62G, use of the dressing 6220 depicts its initial use with removal of the first cover 6222 via the flap 6222b to peel away the adhesive body 6222a and expose the underlying dressing opening 6224a. The covers 6222 may be removed in order to use the next closest adjacent cover 6222, as depicted in FIG. 62G, although in other variations, any unused cover 6222 on the dressing 6220 may be selected for use.

63 depicts another embodiment of a tensioned tissue treatment system 6300 comprising a dressing 6302 with multiple removable tabs or covers 6304a-g. In this particular embodiment, the covers 6304a-g are removable from the dressing 6302 to expose an injection opening (not shown). However, each cover 6304a-g has one or more raised protrusions or projections so that a user with limited vision, for example a user suffering from diabetic retinopathy or other visual impairment, may identify an unused opening in the dressing 6302, remove the cover 6304a-g, and perform an injection. The protrusions on each cover 6304a-g may comprise sequentially incremented numbers of protrusions to indicate a period of use, as shown in FIG. 63, although in other variations the protrusions may be braille letters or numbers to indicate or track the sequence of use.

64A and 64B depict another variation of a tensioned tissue treatment system 6400 comprising a dressing 6402 with a longitudinal axis 6404 and a transverse axis 6406 and a plurality of openings 6408, which in turn comprise subgroups of openings 6408a-g, each subgroup of openings covered by an adhesive removable cover strip 6410a-g. However, in system 6400, the plurality of openings 6408 optionally have a transverse staggered arrangement, with the first opening of each subgroup 6208a-g being longitudinally aligned with the first opening of the other subgroups 6408a-g, but each successive opening of subgroups 6408b-g being transversely offset from the earlier opening within each subgroup, and optionally aligned with the earlier opening of the next adjacent subgroup 6408b-g. This results in the sections 6408a-g being linearly arranged, as are the adhesive cover strips 6410a-g, but oriented at an angle to both the longitudinal and lateral axes of the dressing 6400, as depicted in FIG. 64A. In the particular example of FIG. 64A, the plurality of openings 6408 comprises seven sections 6408a-g, each with four openings, and a cover strip 6410a-g per section. Each adhesive cover strip further comprises an optional removable foam ring 6412 around each of the openings. As each injection hole is used, the foam ring 6412 associated with the injection opening is removed. This indicates to the user that the opening has already been used and should not be used again for the duration of the dressing application. In other variations, the foam ring around each dressing is not removable from its strip 6410a-g, but the strips 6410a-g are removed, as illustrated in FIG. 64B for strip 6410a, to indicate use by day or period.

It is hypothesized that the staggered arrangement of openings and subgroups of openings in system 6200 may provide a greater separation distance between injections performed each day while still grouping the openings in a manner to provide for multi-day or weekly use per dressing or system. In the particular example of Figs. 64A and 64B, the vertical spacing between adjacent openings of adjacent subgroups may be within the range of about 0.49 inches, or 0.4 inches to 0.6 inches, or 0.3 inches to 0.5 inches, and the horizontal spacing between adjacent openings of adjacent subgroups may be within the range of about 0.21 inches, or 0.15 inches to 0.3 inches, or 0.12 inches to 0.35 inches. The resulting distance between adjacent openings of the same subgroup would be about 0.533 inches, or within the range of 0.5 inches to 0.6 inches, or 0.45 inches to 0.7 inches.

In other embodiments, instead of temporarily attaching and then removing an injection template, a set of injection guides may be permanently provided on the dressing. The injection guides may be pre-attached to the dressing during the manufacturing process, but in other variations, the injection guides may be adhered to the dressing after the dressing is attached and after the dressing tension is released to unload tension in the tissue. FIGS. 65A-65G depict an injection guide system 6500 comprising a plurality of separate adhesive injection guides 6504a-g removably covered by a plurality of guide covers 6506a-g. The plurality of adhesive injection guides 6504a-g are arranged or configured to align with a plurality of pre-formed dressing openings in the dressing, with a subgroup of the dressing openings 6512a-g aligning with the openings 6510a-g of the injection guides 6504a-g. By providing multiple separate injection guides 6504a-g, the dressing 6502 is allowed to stretch and flex between the guides 6504a-g compared to a single unitary template. Being less stiff, this allows the guides 6504a-g to remain on the dressing 6502 during the entire use of the dressing 6502, rather than being a temporary attachment used during injections. Once attached to the dressing 6502, the openings 6510a-g of the injection guide 6504 are aligned with the groups 6512a-g of dressing openings 6512 of the dressing 6502, allowing injection through the guide openings 6510a-g and the corresponding groups of dressing openings 6512a-g. To protect the unused groups 6512a-g of dressing openings, the unused injection guides 6504a-g are covered by removable guide covers 6506a-g. Each guide cover 6506a-g comprises a flexible strip of material that covers and is removably adhered to the injection guide 6504a-g, with a portion of the strip material being devoid of adhesive and extending beyond the perimeter or edge of the injection guide 6504a-g to facilitate grasping and removal thereof. Optional cover indicia 6508a-g may be provided to indicate the order of use. The surfaces of the injection guides 6504a-g may be coated to facilitate removal of the guide covers 6506a-g.

As described above, the injection guides and guide covers may be pre-attached to the dressing during the manufacturing process, but in the embodiment depicted in FIGS. 65A-65G, the guides 6504a-g and guide covers 6512a-g may be provided separately from the dressing 6502 and are adhered or attached to the dressing 6502 at the time of use or after manufacture. To facilitate their attachment to the dressing, the guides 6504a-g and covers 6506a-g may be pre-arranged on the carrier sheet 6520 with a low tack adhesive, and the guides 6504a-g may be spaced, oriented, and aligned in a manner to match corresponding portions of the dressing openings 6512a-g with the plurality of guides 6504a-g. The carrier sheet 6520 may include a flexible or semi-rigid, but inelastic, polymer sheet that may be transparent to facilitate visual alignment of the carrier sheet 6520 and the dressing 6502. To further facilitate alignment, graphic indicia 6522 may be provided on the carrier sheet that corresponds to the edges of the dressing and/or opening locations on the dressing, or other indicia on the dressing that are specifically complementary to the carrier sheet or the plurality of guides 6504a-g. For more precise alignment, the graphic indicia 6522 may include a complementary checkerboard pattern or other optical interference pattern that corresponds to the complementary graphic indicia on the dressing. In an alternative embodiment, the carrier sheet may include a transparent window and an opaque outer frame, with the boundaries of the window and frame forming a shape that corresponds to the dressing. In addition to the carrier structure or sheet 6520, a release liner 6524 may be provided to releasably protect the adhesive on the underside of the plurality of injection guides 6504a-g until the user is ready to attach the guides 6504a-g to the dressing 6502. Together, these structures may comprise a guide applicator 6530.

In use, the selected tissue site for injection is cleaned in preparation for application of the tensioning dressing 6502. The dressing 6502 is applied as described elsewhere herein. The guide applicator 6530 is then prepared by removal of the release liner 6524 to expose a plurality of adhesive injection guides 6504a-g that are adhered in a predetermined arrangement or configuration onto the adhesive on the underside of the carrier sheet 6520 via corresponding guide covers 6506a-g. The user then uses the indicia 6522 on the carrier sheet 6520 to view the dressing 6502 through the carrier sheet 6520 and align the guides 6504a-g with the openings on the dressing 6502. Once the desired visual alignment is achieved, the user applies pressure to the guides 6504a-g through the carrier sheet 6520 to maximize adhesion of the guides 6504a-g to the dressing 6502. The carrier sheet 6520 is then peeled away from the guide covers 6506a-g, exposing the guides 6504a-g and covers 6506a-g, leaving them on the dressing 6502. The first cover 6506a is grasped and pulled away, exposing the opening of the first injection guide 6504a. The opening and the exposed skin/tissue surface at the opening are then sterilized using an alcohol pad or other sterilization technique, and then the injectable therapeutic is prepared and injected through the sterilized opening of the guide. The same sterilization of the remaining openings of the injection guide 6504a is performed for subsequent injections, and when access to the next injection guide 6504b-g is required, the next cover 6506b-g is removed.

As can be noted from the above procedure, application of the injection guide 6504a-g and cover 6506a-g to the dressing 6502 involves a multi-layer adhesive combination of structures where the adhered layers are preferentially separated at different stages of the procedure. To facilitate this, different adhesives with different peel force removal values are used. The strongest or highest peel force adhesive is provided on the adhesive layer of the dressing for adhesion to the skin and the injection guide to the dressing. This reduces the risk of inadvertent peeling or removal of the dressing from the skin or the injection guide from the dressing when the guide cover is being peeled off. The next relatively highest adhesive is the adhesive used to adhere the guide cover to the injection guide. This reduces the risk that the cover may be inadvertently removed or peeled away when the carrier sheet is removed during the application procedure. The next highest adhesive is on the underside of the carrier sheet or applicator template, which is pulled apart after the injection guide is adhered to the dressing. The lowest peel force is between the release liner and the injection guide. As described above, since the adhesive on the injection guide needs to have the highest relative strength to avoid inadvertent removal when the guide cover is removed, to achieve a lower peel force of the release liner from the injection guide, the release liner may include a fluorosilicone or silicone liner, such as FRA-310 (Fox River Associates; Geneva, Illinois), 3M 9744 or 3M 5051 (3M; St. Paul, Minn.), and equivalents, to allow easy separation of the liner from the strong adhesive provided on the injection guide.

The injection guide may comprise an adhesive foam tape or strip material such as Adhesive Applications BW1125-1 or 1008-1 (Adhesive Applications; Easthampton, MA). The carrier sheet may comprise a transparent polymeric rigid or semi-rigid sheet material that may be covered by a low tack adhesive carrier or protective film known in the art such as Pregis 1614C (Pregis; Deerfield, IL). The guide cover may comprise a flexible polymeric material coated with a removable acrylic adhesive such as A5000 by Adhesive Applications.

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

In other embodiments, such as depicted in FIG. 36, a visual guide tool 3600 may be optionally provided or used to facilitate alignment of the syringe needle 3406 with the dressing opening 3402. The visual guide tool 3600 includes a peripheral indentation 3602 or opening that may facilitate alignment of the visual guide tool 3600 with the peripheral edge of the dressing 3400. The dressing 3400 may also include optional indicia or markings to facilitate alignment with the guide tool indentation 3602. By aligning the peripheral edge of the guide tool 3600 with the peripheral edge of the dressing 3400, the opening 3402 of the dressing 3400 may then be secondarily aligned with the opening 3604 of the guide tool 3600. The opening 3604 of the guide tool 3600 may preferably be smaller than the opening 3402 of the dressing 3400, but in other embodiments may be larger or the same size. The visual guide tool 3600 may also include markings 3606 around its opening 3604, which may or may not include an opaque material that may make it easier to visualize the opening 3604. The underside of the visual guide tool may include an adhesive to help maintain the position of the tool 3600 during use. The tool 3600 includes an elongated body with an opening 3604 at a distal end, and a proximal end may be used to grasp and manipulate the tool 3600 during the procedure.

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

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

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

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

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

40B, the pull tab 3934 is then removed from the infusion set 3920, which allows the strained dressing layer 3926 to decouple from the tension support structure 3932, thereby allowing the strained dressing layer 3926 to transfer its tensile stress to a compressive force acting on the tissue surrounding the needle 3922. In some variations, the tension support structure 3932 may be left in place after the pull tab is removed, while in other examples, the tension support structure 3932 may be removed to reduce the bulk and/or stiffness of the indwelling infusion set 3920. In some variations, the tension support structure 3932 may be removed by passing it over the connector tubing 3924 when the connector tubing 3924 is not yet coupled to the infusion pump, as depicted in FIG. 40C, leaving the infusion set 3920 with the dressing layer 3926 transmitting compression to the underlying skin tissue, as depicted in FIG. 40D. In other variations, as depicted in FIG. 40E, the tension support structure 3932 may include slits or perforations 3940, which may allow the tension support structure 3932 to be pulled away or torn away from the infusion set housing 3921 or the connector tubing 3924, whether or not the connector tubing 3924 is attached. The infusion set 3920 is ready for use and may be removed and a new infusion set may be installed at the end of the usage cycle, which may be in the range of 7-10 days, but may be replaced sooner if it is blocked or damaged.

In some other examples, rather than visual indicia or markings, one or more physical alignment features may be provided on the dressing to facilitate alignment. In Figures 49A-49E, a pre-strained elastic member or dressing 4900 is provided with a pre-attached removable alignment feature 4902 configured to align an infusion set with an access opening 4926 of the dressing 4900. This alignment feature 4902 is configured for use with a MINIMED ^™ QUICK-SERTER ^™ (Medtronic, Fridley, MN) infusion set applicator 4904, although one skilled in the art will understand that the alignment feature may be tailored to the shape and function of any other infusion set applicator or delivery device. The pre-strained dressing 4900 is maintained in the pre-strained configuration by a semi-rigid or rigid strain support 4906 attached or adhered to the top surface of the dressing 4900 and surrounding the alignment structure 4902. The strain support may be configured to have some flexibility in at least one direction to allow the dressing to contour to the tissue surface. In some variations, the direction of flexibility may be orthogonal to the direction of strain of the dressing. The shear bond strength between the strain support and the strained elastic member exceeds the force produced by the strain of the elastic member. Attachment of the support 4906 to the dressing 4900 may be accomplished with an adhesive or may be heat swaged to the dressing 4900, depending on the material selected for the dressing 4900. For example, if polyurethane is used for the dressing 4900, the support 4906 may comprise PETG and can be heat swaged to the dressing 4900. For example, heat crimps may be used to bond the strained elastic member to the strain support. The heat crimps may have a width of, for example, about 1 mm, 2 mm, or 5 mm. The bond provides the proper shear force without creep in the direction of strain while also allowing the support structure to be peeled away from the elastic member. The strain support may also include perforations to facilitate splitting of the strain support and its separation and removal from the elastic member, and optionally tabs to facilitate gripping and tearing of the perforations. Alternative embodiments of the device may also include perforations, and a pull tab separation mechanism as described with respect to the dressing 3926 of Figures 39A-39E may also be adapted to this embodiment.

This particular alignment structure 4902 comprises a unibody structure with three interconnected alignment flanges 4908, 4910, 4912 along a base 4914 and a base opening 4916. The opening 4916 is sized and shaped to form a mechanical interfit with the applicator 4904 and may be oval, circular, polygonal, or other custom shape complementary to the periphery of the applicator 4904. The base 4914 may also comprise a perimeter to increase the surface area of attachment to the dressing 4900. Although interconnected along the base 4914, in other embodiments the flanges may be separate from one another. In some further embodiments, the flanges 4908, 4910, 4912 and/or the base 4914 may be integrally formed with the strain support 4906. In still other embodiments, the alignment structure 4902 may be provided separately and attached to the strain support 4906 at the point of use. The alignment structure 4902 may also be selected from a number of different alignment structures, each configured for use with a different available infusion set applicator. The selected alignment structure is then attached to the strain support prior to use.

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

The shape of the dressing 4900 may be any of a variety of shapes, including, but not limited to, an oval, circular, or polygonal shape. Similarly, the access opening 4926 may also comprise an oval, circular, or polygonal shape and be sized to accommodate the catheter of an infusion set. The access opening 4926 may comprise a diameter or lateral dimension within a range of, for example, 1-20 mm, 2-10 mm, or 3-5 mm. The alignment structure 4902 may comprise a polymeric material that may be thermoformed or injection molded, 3D printed, or CNC machined.

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

50A, the dressing 4900 and alignment structure 4902 are applied and adhered to the selected target site. The adhesive liner of the infusion set held by the applicator 4904 is removed and the applicator 4904 is aligned with the alignment structure 4902 with the infusion tubing 4920 and finger grip 4922 correctly oriented in the recess. The applicator 4904 is then inserted into the opening of the alignment structure 4902 until it is fully seated, as illustrated in FIG. 50B. In some variations, visual indicia on the alignment structure 4902, tactile feedback may be provided to confirm to the user that the applicator 4904 is fully seated. In FIG. 50C, the actuator 4924 of the applicator 4904 is depressed to insert the needle/cannula of the infusion set through the opening in the dressing 4900 and into the skin. The actuator 4924 is then activated again to decouple the applicator from the infusion set hub 4938. In this particular example, the actuator 4924 includes an outer annular button 4930 and an inner button 4932 to separately deploy the needle/cannula and decouple, but not yet separate, the applicator 4904.

The alignment structure 4902 and the dressing support 4906 are then removed from the dressing 4900 by applying downward pressure to the released applicator 4904 as the alignment structure 4902 and the support 4906 are pulled apart. To facilitate their removal, the support 4906 may include perforations 4934 that may be peeled or pulled apart so that the alignment structure 4902 and the support 4906 may thus be torn so that the dressing 4900 may contract from its strained configuration. In other variations, as shown in FIG. 51, the support 5100 of the alignment structure 5102 may include an arcuate configuration with tabbed ends 5104 that may be grasped and used to pull the support 5100 and alignment structure 5102 from around the applicator 5106 and tubing 5108. This then separates the infusion hub 4938 from the applicator 4904 and the rigid support 4906 from the dressing 4902, which allows the dressing 4902 to contract from its prestrained configuration.

48A-48E depict an example of an infusion system 4800 with a delivery device 4802 releasably holding an infusion hub 4804 with a pre-attached radially pre-strained skin tensioning device 4806. The delivery device 4802 comprises a body 4808 and an actuator 4810, similar to the delivery device 3900 of FIG. 39A. The pre-attached radially pre-strained skin tensioning device 4806 comprises a radially outwardly strained adhesive elastic layer 4812 that is maintained in a pre-strained state by semi-rigid strain supports 4814a, 4814b, which may comprise semi-rigid or rigid cardboard or polymer layers adhered to the top surface of the elastic layer. This particular embodiment comprises a strain support with two sections 4814a and 4814b, but in other examples a single support may be provided, or a three, four, or five section support may be provided.

After the injection system 4800 has been applied to the desired anatomical location and the actuator 4810 has been activated, the injection hub 4804 may be released and separated from the delivery body 4808, leaving the injection hub 4804 and skin tensioning device 4806 attached to the anatomical location, as illustrated in FIG. 48E. The function and patency of the injection tubing 4816, hub 4804, and catheter 4818 may be checked. If functioning properly, the strain supports 4814a and 4814b may be removed or separated from the elastic layer 4812, which will then radially compress the adhered skin or tissue toward the center of the elastic layer 4812 around the hub 4804 and catheter 4818. The function and patency of the injection tubing 4816, hub 4804, and catheter 4818 are then rechecked before initiating therapy. In some variations, a radially strained skin tensioning device may reduce the risk or rate of kinking or occlusion of the catheter 4818 compared to a skin tensioning device that strains along a single axis of strain. The shape of the elastic layer 4812 may be circular, as depicted in FIGS. 48A-48E, although in other examples, the elastic layer may be oval, elliptical, square, rectangular, star, or other shapes. An oval or elliptical shape may be used when the catheter is not inserted orthogonally into tissue, but rather along an acute angle to the treatment site, and the forces acting on the catheter or infusion hub may not be radially symmetric.

In some embodiments, a dressing with an integrated infusion set is provided. The device may be used, for example, to treat, minimize, or slow the progression of subcutaneous growths or lipohypertrophy in a subject provided with infusion therapy as described in more detail herein. The infusion set is removable from the dressing. After a period of time, for example after the life cycle of the infusion set has ended, the infusion set may be removed from the dressing. The tensioned dressing substrate may then remain attached to the subject for an additional period of time without a catheter placed within the skin.

In some embodiments, the integrated infusion pump and dressing may include a bandage substrate with a bandage attachment structure with attachment features that allow an infusion set to be attached, for example, during manufacturing or assembly, and may provide for user separation of the infusion hub, or a portion thereof, of the infusion set from the bandage with a release structure. The device may provide for permanent removal of the infusion hub to prevent reuse of the infusion set or infusion hub with the bandage. All or a portion of the attachment structure or structures may remain on the bandage when the infusion hub is separated.

The attachment structure may include, for example, a dressing attachment structure that is attached to a dressing substrate. The dressing attachment structure may be a physical structure that may or may not be removed in whole or in part from the dressing, for example, when the release structure is used to release the infusion hub. The attachment sheet or structure and its associated features may be the same as or similar to those described with respect to Figures 1A-22B, including, but not limited to, the attachment sheets used for dressing assemblies 100, 210, 320, 610, 810, 910, and 1000.

The release structure or releasable attachment structure may include, for example, but not limited to, pockets and tabs, hook-and-loop mechanisms, hooks, angled bars, pivoting, rolling, rocking, or sliding features associated with or coupled to the attachment structure, adhesives, removable adhesives, adhesive tapes or other adhesive devices, pegs, rip strings, 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 rip strings, or other structures or features to facilitate tearing, cutting, or separation of the attachment structure or element or otherwise cuttable structure that permits removal of the bandage from the applicator, packaging, other portions of the dressing assembly, and/or the attachment structure, feature, element, or portion. They may be self-releasing latches or spring members. The release assemblies may be integrated within the dressing assembly and/or applicator, or may be provided separately for use with the dressing assembly. They may be activated when a pressure member is applied to the skin treatment device prior to removing the applicator. They may also be activated manually.

The dressing and infusion set may include an infusion hub configured to receive an infusion housing or connector. The infusion set may additionally include an infusion housing or connector. These treatment systems may be all-in-one infusion sets integrated into the dressing. They may be manufactured together, rather than assembled by a clinician at the point of use, as described with respect to other embodiments herein.

66A-66H, a system 6600 is illustrated that includes a dressing 6610 and an infusion set 6650. The infusion set 6650 includes an infusion set housing or connector 6660 with infusion tubing 6661 and a release element 6662 for releasing the housing 6660 from an infusion hub 6670 and an attached catheter 6680. By actuating or squeezing the release element 6662, the housing 6660 may be unlatched from the hub 6670 or friction between the housing 6660 and the hub 6670 may be reduced to facilitate removal and separation. Fluid communication between the lumens of the tubing 6661 may be provided through an opening or channel in the hub 6670, which may include a seal therebetween.

The dressing 6610 includes a substrate 6620, an attachment element 6630, and an opening 6640 in the dressing 6610 for receiving a catheter 6680. The attachment element 6630 is attached to the substrate 6620 on opposing sides 6632a, 6632b, for example, with an adhesive, bonding, or other attachment mechanism. The attachment sheet, structure, or element 6630 further includes a removable portion or element 6633 having a release or decoupling element, for example, a pull tab 6634, and a tear structure or element 6635 (e.g., a tear line, weakened section, perforation, or other tear element) extending through the attachment element 6630 adjacent the side 6632. In some variations, the removable portion or element 6633 may lack any attachment to the underlying dressing substrate 6620. In other variations, the removable portion or element 6633 may be attached to the surface of the dressing substrate via non-adhesive static or van der Waals forces, or using a differential adhesive, such as a hybrid or composite silicone/acrylic adhesive. The infusion set hub 6670 is attached to the removable element 6633, for example, using an adhesive, bond, mount, or attachment element.

66C-66H illustrate the use of the system 6600. As shown in FIG. 66E, the dressing 6610 is placed on, attached to, or adhered to the subject, the infusion set 6650 is attached to the dressing 6610, and the catheter 6680 extends into position within the subject through the opening 6640. The dressing substrate 6620 may be attached to the subject's skin, for example, using a skin adhesive, and may be removed by peeling it off from the skin when desired. When desired to do so, the infusion set housing 6660 may be removed by actuating the release element 6662. The infusion hub 6670 and catheter 6680 may remain attached to the subject along with the dressing 6610. If additional infusion therapy is desired, the same or a different infusion set housing 6660 may be reattached to the hub 6670. As shown in FIGS. 66C and 66G, when the infusion set is to be permanently removed, the hub 6670 is removed by grasping and pulling the pull tab 6634 to tear the removable element 6633 along the tear element or line 6635. As shown in FIGS. 66D and 66H, the pull tab 6634 is pulled or actuated until the removable element 6633 is separated from the dressing substrate 6620 using the tear structure 6635, e.g., perforation or tear line 6635. The dressing substrate 6620 may then remain attached to the subject for an additional period of time without the infusion set remaining within the skin.

67A-67C, a system 6700 is illustrated that includes a dressing 6710 and an infusion set 6750. The infusion set 6750 includes an infusion set housing or connector 6760 with infusion tubing 6761 and an infusion hub 6770 and a release element 6762 for releasing the housing 6760 from an attached infusion conduit, e.g., a needle or catheter 6780. The dressing 6710 includes a substrate 6720 and an opening 6740 in the dressing 6710 for receiving the catheter 6780.

The infusion hub 6770 of the infusion set 6750 is configured to receive the infusion set housing 6760 and provide fluid communication between the tubing 6761 of the infusion housing 6760 and the infusion conduit 6780. The device 6700 further includes a mounting structure 6772 for mounting the infusion hub 6770 to the dressing substrate 6720.

The mounting structure 6772 may include one or more substrate attachment sections 6773 that are attached to the substrate 6720 using, for example, adhesives, chemical bonding, heat welding, or other attachment mechanisms. The mounting structure may further include a release element or structure. For example, the mounting structure 6772 may further include a removable section 6774 that is coupled to or integral with the infusion hub 6770. The mounting structure 6772 may further include a tear element 6775 (e.g., a tear line, a frangible element, a weakened section, a perforation, or other removal element) that couples the removable section 6774 to the one or more substrate attachment sections 6773. The substrate attachment sections 6773, the removable sections 6773, and the tear element 6775 of the mounting structure may be constructed from a single unibody material.

The attachment structure 6772 may comprise a split ring attachment structure that allows the dressing to apply compression to the insertion area. The split ring attachment structure may be made from a soft plastic to reduce the stiffness of the dressing, reduce interference with the subject's clothing, and minimize discomfort when wearing a large rigid element on the skin. The removable section 6774 may be a circular flange formed with or attached to the infusion hub 6770. The substrate attachment element 6773 may be an arc-shaped element that is attached to the circular flange with a frangible, breakable, or tear element 6775.

As depicted in FIG. 67A, in use, the dressing 6710 is placed on, attached to, or adhered to the subject, the infusion set 6750 is attached to the dressing 6710, and the catheter 6780 extends into position within the subject through the opening 6740. The dressing substrate 6720 may be attached to the subject's skin using, for example, a skin adhesive as described elsewhere herein, and may be removed by peeling it off from the skin when desired.

As shown in FIG. 67B, during use of the infusion set 6750, the infusion set housing 6760 may be placed on or removed from the infusion hub 6770, for example, by actuating the release element 6762. As shown in FIG. 67C, when the infusion set 6750 is to be permanently or completely removed, the hub 6770 is removed by twisting the hub 6770 and breaking the tear element 6775. The removable section 6774 including the catheter 6778 may then be separated from the attachment section 6773. The dressing substrate 6720 may then remain attached to the subject for an additional period of time without the catheter remaining indwelling within the skin.

68A-68F, a system 6800 is illustrated that includes a dressing 6810 and an infusion set 6850. The infusion set 6850 includes an infusion set housing or connector 6860 with infusion tubing 6861 and a release element 6862 for releasing the housing 6860 from an infusion hub 6870 and an attached catheter 6880.

The dressing 6810 includes a substrate 6820, an attachment element 6830, and an opening 6840 in the dressing 6810 and a aligned opening 6837 in the attachment structure 6830 for receiving a catheter 6880. The attachment element 6830 is attached to the substrate 6820 on opposing sides 6832, for example, with an adhesive, bond, or other attachment mechanism. The attachment element 6830 further includes a release element, for example, a circular perforation or tear section 6835 (e.g., having a tear line, weakened section, perforation, or other tear element) around the opening 6837. The circular tear section 6835 generally aligns with the circumference 6877 of the infusion hub 6870, where the infusion hub is attached to the attachment element 6830, for example, with an adhesive, glue, bond, or other fastening structure 6834.

68A, in use, the dressing 6810 is placed on, attached to, or adhered to the subject, the infusion set 6850 is attached to the dressing 6810, and the catheter 6880 extends into position within the subject through the opening 6840. The dressing substrate 6820 may be attached to the subject's skin, for example, with a skin adhesive, and may be removed by peeling it off from the skin when desired.

During use of the infusion set 6850, the infusion set housing 6860 may be placed on or removed from the infusion hub 6870, for example, by actuating the release element 6862. As shown in FIGS. 68C and 68D, the infusion set housing 6860 is removed. In FIG. 68E, when the infusion set 6850 is to be permanently or completely removed, the hub 6870 is removed by twisting the hub 6870 and separating the hub 6870 at the perforation 6875. The hub 6870 including the catheter 6880 may then be separated from the remainder of the dressing substrate 6820 and the attachment element 6830, as depicted in FIG. 68F. The dressing substrate 6820 may then remain attached to the subject for an additional period of time without the catheter placed within the skin.

69A-69K, a system 6900 is illustrated that includes a dressing 6910 and an infusion set 6950. The infusion set 6950 includes an infusion set housing 6960 with infusion tubing 6961 and a release element 6962 for releasing the housing 6960 from an infusion hub 6970 with an attached catheter 6980. The dressing 6910 includes a substrate 6920 and an opening 6940 in the dressing 6910 for receiving the catheter 6980. A dressing connector 6925 is attached to the dressing 6910 and configured to releasably couple the infusion hub 6970 to the dressing 6910.

The infusion hub 6970 of the infusion set 6950 is configured to reversibly receive the infusion set housing 6960 and provide fluid communication between the tubing 6961 of the infusion housing 6960 and the infusion conduit 6980. The tubing 6961 is fluidly coupled to a lumen 6963 of the housing 6960, which terminates inwardly in a fluid seal 6963, e.g., a silicone seal or grommet. When the infusion housing 6960 is coupled to the infusion hub 6970, the fluid seal 6963 is configured to align with and seal with the fluid seal 6963 of the lumen 6982 of the hub 6970. This lumen 6982 is in communication with the infusion conduit 6980. In embodiments in which the infusion conduit 6980 comprises a soft cannula or catheter, an additional needle lumen 6982 and self-sealing needle seal 6983 may be provided to allow a solid needle or trocar (not shown) of the applicator to provide mechanical support and the ability to pierce tissue to facilitate insertion of the infusion conduit. The needle lumen 6982 may be oriented to provide a linear insertion and removal path of the solid needle or trocar through the infusion conduit 6980. The solid needle or trocar is then removed from the infusion conduit 6980 along with the applicator once insertion of the conduit 6980 is completed. A complementary mechanical interfit between the internal cavity shape of the infusion housing 6960 and the external shape of the hub 6970 may be provided to facilitate fluid seal and luminal alignment. In some other variations, a sealed circumferential recess or channel may be provided on the inner surface of the housing and/or the outer surface of the hub with a seal to allow fluid communication between the housing and the hub that is independent of the angular orientation of the housing and therefore does not require angular alignment. These various fluid channel configurations may be adapted to provide fluid communication with other infusion sets described herein that have separable infusion housings and hubs, including systems 6600, 6700, 6800, and 7000.

The infusion hub 6970 includes an attachment structure 6972 for attaching the infusion hub 6970 to the dressing connector 6925. The infusion hub 6970 further includes a release element, e.g., a removable attachment section 6974 coupled to or integral with the engagement element 6971. The attachment structure 6972 may include a flange 6975 having a bendable arm 6973 with an extending tab 6976 configured to engage the dressing connector 6925. The dressing connector 6925 may include one or more connector sections 6926 that are attached to the substrate 6920, e.g., with an adhesive, bond, or other attachment mechanism 6927. The dressing connector 6925 may include a split ring attachment structure that allows the dressing 6910 to apply compression to the insertion area. The split ring attachment structure may be made of a soft plastic to reduce the stiffness of the dressing and reduce interference with the subject's clothing.

The connector section 6926 includes a recess or cutout 6929 configured to receive the extending tab 6976 of the infusion hub 6970 along a direction perpendicular to the treatment surface. The cutout 6929 communicates with a lateral slot 6928 for rotatably receiving the extending tab 6976. The cutout 6929 at the end of the slot 6928 is configured to lock the extending tab 6976 in place.

As shown in FIGS. 69A and 69B, in use, the dressing 6910 is placed on, attached to, or adhered to the subject, the infusion set 6950 is attached to the dressing 6910, and the catheter 6980 extends into position within the subject through the opening 6940. The dressing substrate 6920 may be attached to the subject's skin, for example, with a skin adhesive, and may be removed by peeling it off from the skin when desired.

In FIG. 69C, during use of the infusion set 6950, the infusion set housing 6960 may be placed on or removed from the infusion hub 6970, for example, by actuating the release element 6962. When the infusion set 6950 is to be permanently or completely removed, the hub 6970 is removed by a) depressing the bendable arm 6973 to release the extending tab 6976 from the cutout 6929, b) twisting or pivoting the hub 6970 to move the extending tab 6976 through the slot 6928 into the opening 6927, and c) lifting the hub 6970 and detaching it from the dressing connector 6925 and the dressing 6910, in accordance with FIG. 69E. The dressing substrate 6920 may then remain attached to the subject for an additional period of time without a catheter placed within the skin, as in FIG.

FIG. 69K depicts an example configuration of a fluid channel that provides fluid communication between catheter tubing 6961 and a fluid conduit 6980 to provide insulin or other infusion therapy. A seal such as a silicone ring 6963.

70A-70K, a system 7000 is illustrated that includes a dressing 7010 and an infusion set 7050. The infusion set 7050 includes an infusion set housing 7060 with infusion tubing 7061 and a release element 7062 for releasing the housing 7060 from an infusion hub 7070 with an attached catheter 7080. The dressing 7010 includes a substrate 7020 and an opening 7040 in the dressing 7010 for receiving the catheter 7080. A dressing connector 7025 is attached to the dressing 7010 and configured to releasably couple the infusion hub 7070 to the dressing 7010.

The injection hub 7070 further includes an outer engagement hub 7071, a tool receptacle 7072 that runs from the top to the bottom of the injection hub 7070, and a center section 7073. The center section 7073 includes an opening 7074 through which injection fluid is delivered from the injection tubing 7061 to the catheter 7080. The center section 7073 also includes a spring arm 7076 with a connector tab 7077 that extends through it into the tool receptacle 7072. The inner wall of the outer engagement hub 7071 includes a hub cutout edge section 7079 for attaching a removal tool 7090 to the injection hub 7070.

The dressing connector 7025 includes a hub receptacle opening 7026 for receiving the central section 7073 (including the connector tab 7077) of the infusion hub 7070. The hub receptacle opening 7026 communicates with a catheter opening 7027 for receiving the catheter 7080. The openings 7026, 7027, and 7074 are further aligned with the openings 7040 in the dressing substrate 7020 such that the catheter 7080 extends through the openings 7040 in the dressing 7010 when the system is assembled. The attachment structure may include a dressing connector 7025 that further includes an engagement tab 7028 that receives the connector tab 7077 at the end of the spring-biased arm 7076 when the infusion hub 7070 is attached to the dressing 7010 using the dressing connector 7025.

The dressing 7010 with integrated infusion set 7050 is shown assembled in FIG. 70A. The infusion set housing 7060 is coupled to the infusion hub 7070 using an engagement hub 7071 and released using a release element 7062. The infusion hub 7070 is attached to the dressing 7010 using the dressing connector 7025. The catheter 7080 is placed through openings 7027 and 7040 in the hub 7070 and dressing 7010, respectively. The center portion 7073, spring arm 7076 with tabs, and connector tab 7077 are positioned through the opening 7026. The spring arm 7076 is biased outward such that the connector tab 7077 engages the engagement tab 7028 when the arm 7076 is pushed into the opening 7026.

As shown in FIG. 70A, in use, the dressing 7010 is placed on, attached to, or adhered to the subject, the infusion set 7050 is attached to the dressing 7010, and the catheter 7080 extends into position within the subject through the opening 7080. The dressing substrate 7020 may be attached to the subject's skin, for example, with a skin adhesive, and may be removed by peeling it off from the skin when desired.

In FIG. 70B, during use of the infusion set 7050, the infusion set housing 7060 may be placed on or removed from the infusion hub 7070, for example, by actuating the release element 7062.

When the infusion set 7050 is to be permanently or completely removed, the hub 7070 is removed by using the release structure or removal tool shown in FIG. 70J. The removal tool 7090 includes a handle portion 7091 with a distal spring-loaded projection 7092 having an attachment tab 7093.

The projections 7092 and mounting tabs 7093 are inserted into the receptacles 7072 in the hub 7070, biasing the spring arms 7076 inwardly and disengaging the connector tabs 7077 from the engagement tabs 7028. The mounting tabs 7093 of the removal tool 7090 engage the cutout edge sections 7079 of the infusion hub 7070, attaching the tool 7090 to the infusion hub 7070. The infusion hub 7070 may then be removed from the dressing 7010 using the tool.

The dressing substrate 7020 may then remain attached to the subject for an additional period of time without the catheter being placed within the skin.

The substrate of the dressings 6610, 6710, 6810, 6910, and 7010 may be flexible and elastic, or may be relatively inflexible. According to one variation, the dressing may be strained prior to application. The dressing may be provided in a pre-strained configuration as described in detail herein. The dressings 6610, 6710, 6810, 6910, and 7010 may include a removable applicator and strain support configured to maintain strain in the strained elastic layer of the dressing substrate, as depicted in the exemplary embodiment of FIG. 39B. Other applicators and systems 6600, 6700, 6800, 6900, and 7000 may also include a removable applicator as described herein. The strain support may be used as an applicator. Exemplary embodiments of applicators, strain supports, tension supports, and dressing supports that may be used with or incorporated with these dressings include those described with respect to the dressings or infusion systems 3006, 3921, 4500, 4800, 4900, and 5200 described elsewhere herein.

In addition to the radially strained injection system 4800, a radially pre-strained skin tensioning device 5500 may be provided for use with manual injection using a syringe 5502, as shown in FIGS. 55A and 55B. The skin tensioning device 5500 comprises an elastic layer 5504 with an access opening 5506. The skin tensioning device 5500 may be adhered to a target location and then the radial strain supports 5508a, 5508b may be removed to allow the elastic layer 5504 to radially compress the underlying skin towards the access opening 5506. The access opening may comprise a shape with a diameter or lateral dimension within a range of, for example, 1-20 mm, 2-10 mm, or 3-5 mm.

56A and 56B, in some other variations of the skin tensioning device 5600, whether radially or uniaxially strained, the access opening 5602 of the device may include a fabric patch 5604. The patch 5604 may be configured with a woven fabric that allows the needle 5606 of the syringe 5608 to still pass through the access opening 5602 while providing some physical coverage of the injection site. The increased breathability may extend the use time of the device 5600. The fabric patch 5604 may provide increased water vapor transport across the skin tensioning device 5600 and may also be used to absorb excess insulin that may leak from the injection site. The fabric patch 5604 may be coated, infused, or woven with an anti-infective agent such as an antibiotic or silver strands. The fabric 5608 may include, for example, nylon, non-woven cotton, polyester or polypropylene, an elastomeric polymer compound, or silver alginate.

In yet another alternative embodiment, as shown in FIGS. 54A and 54B, a skin treatment system 5400 includes a tension relief dressing 5402, but instead of an access opening or cloth patch, an injection port 5404 is provided on the dressing 5402. The dressing 5402 and port 5404 may include any of the applicators as described herein, noting that the area of the dressing 5402 attached to the port 5404 will not be under the same strain as the portion of the dressing 5402 surrounding the port 5404. The injection port 5404 includes a catheter 5406 such that a syringe attached to the port 5402 or a syringe needle inserted into the port can deliver a therapeutic agent through the catheter 5406 and into the skin or tissue. The use of a port may reduce pain or discomfort associated with the therapy as compared to direct needle injection.

41A-43C, in another embodiment, the infusion set 4100 and multi-layer tensioned bandage 4102 may be used for subcutaneous or intravascular infusion. The infusion set 4100 is connectable to an infusion source or pump, such as an insulin pump or other therapeutic pump, and includes infusion tubing 4104 in fluid communication with an interior cavity of the infusion housing 4104, which in turn is in fluid communication with a hypodermic needle or catheter 4106 that is inserted into tissue or a vessel. The bottom surface of the infusion housing 4104 is adhered or attached to the top layer 4108a of the multi-layer tensioned bandage 4102. Each layer 4108a-4108c is sized smaller in size and includes a perimeter 4110a-4110c that is positioned within and offset from the perimeter 4110b-4110d of the layer 4108b-4108d immediately below it, except for optional flaps 4112a-4112c. The elasticity of the top and middle layers 4108a, 4108b, 4108c may be configured to be lower than the elastic modulus of the base elastic layer 4108d. The base layer 4108d may also have a higher durometer (e.g., 60 Shore A vs. 50 Shore A vs. 30 Shore A) or include a thicker material (e.g., 10 mils vs. 7 mils vs. 5 mils vs. 0.5 mils) compared to the other layers 4108a-c. In other variations, the non-base layers may be provided with holes or perforations to reduce the total cross-sectional area of the non-base layers, which may reduce the amount of strain contributed from the non-base layers. In this configuration, the compression force per unit width comes primarily from about 50%, 60%, 75%, 90% of the contribution of the base elastic layer 4108d, or any range between any two of these contribution percentages. Based on this, the amount of adhesive strength between the layers may be relatively lower than the bond strength between the skin and the base layer 4108d. The adhesive of the layers 4108a-4108c may also be pattern coated on the layers 4108a-4108c to promote peeling in a direction perpendicular to the strain. For example, multiple narrow strips of adhesive may be provided in the direction of peeling. The width of the adhesive perpendicular to the direction of strain in the elastic member may be 0.1 inches, 0.165 inches, 0.2 inches, 0.3 inches, or 0.5 inches, or any range between any two of such widths. In another example, an adhesive pattern may be provided that has less adhesive in the peel direction compared to the strain direction, for example, 20% less, 40% less, 60% less, 80% less, or a range between any two of these percentages, or other types of anisotropic adhesive patterns. The interlayer adhesive used to join all of the layers 4108a-d together may have a lower thickness compared to the skin adhesive (e.g., 0.5 mils vs. 0.25 mils vs. 0.1 mils). In another variation, an adhesive with high tensile strength but low shear strength may be used to facilitate removal of the upper layer of the multi-layer tensioning dressing by pulling the layer or adhesive layer sideways rather than upwards. This nesting configuration results in a stepped dressing profile, as depicted in Figures 44A and 44B, which may redistribute the edge stresses of the skin tensioning device across a larger surface area, rather than concentrating them at the edges of a single layer skin tensioning device. In some variations, the separation between the perimeters 4110a-4110d of adjacent layers 4108a-4108d is uniform along the entire perimeter, for example, a uniform perimeter difference within a range of 1-5 mm, 2-5 mm, or 2-4 mm, or 2-3 mm. In some further examples, the uniform perimeter difference between two adjacent layers 4108a-4108d is the same for every two adjacent layers 4108a-4108d. In other examples, the uniform perimeter difference may be different between at least one pair of two adjacent layers. For example, the perimeters 4110a and 4110b may be the same as 4110b and 4110c, but the uniform perimeter difference between layers 4110c and 4110d may be smaller or larger than the uniform perimeter difference of other pairs of layers 4108a-4108c. While layer 4108d in FIG. 41A does not have a flap, other embodiments may also include a flap. The flaps 4112a-4112c may or may not include an adhesive on their underside, which may facilitate separation and gripping of the flaps 4112a-4112c from the other layers for removal. The layers 4108a-4108d also each include a central opening (not shown) through which the needle or catheter 4106 of the infusion set 4100 may be inserted. This nested layer configuration of the multi-layer dressing 4102 may not have flaps. The flexible mounting sheet 4108 is sized and configured with a perimeter 4112 that is smaller than the perimeter 4114 of the multi-layer tensioned dressing 4102.

41A and 41B includes a four-layer skin tensioning device 4102, but in other examples, the skin tensioning device may include two, three, five, or more layers. The infusion set 4100 and skin tensioning device 4102 may be preassembled at the point of manufacture, assembled at the point of use, or assembled consecutively at the treatment site, with the skin tensioning device 4102 installed first, followed by the infusion set 4100 through and over the skin tensioning device 4102. The applicator for the skin tensioning device 4102 may be a book-type applicator as described herein. In another variation, the infusion device 4100 may be pre-attached to one flexible layer of adhesive material that is larger than the infusion set housing 4104 and includes similar materials and adhesives as the layers of the multi-layer skin tensioning device. During use, the skin tensioning device is strained and applied to the skin, but the injection device 4100 and its pre-attached flexible layer material are not strained when applied to the multi-layer skin tensioning device.

42A-43C, when the infusion set 4100 needs to be replaced, for example, due to an obstruction or to reduce the risk of infection, the flap 4112a of the top layer 4108a may be grasped and then lifted to separate the adhesive of the top layer 4108a from the middle layer 4108b or otherwise peel the top layer 4108a away from the middle layer 4108b, thereby also lifting the infusion 4100 along with the top layer 4108a and withdrawing the catheter 4106 from the skin while leaving the other layers 4108b-d of the multi-layered skin tensioning device on the skin, thereby minimizing the frequency with which the adhered skin tensioning device becomes detached from the skin. This may reduce irritation of the underlying skin from repeated removal of the adhered device. Once the infusion set 4100 has been removed along with the top layer 4108a, a new infusion set 4100 may be applied directly to the middle layer 4108b by aligning the delivery location of the catheter 4106 of the new infusion set 4100 with the opening 4114b of the middle layer 4108b. This cycle of removal and reapplication may be performed multiple times equal to the number of layers in the skin tensioning device, with subsequent cycles of a new infusion set being removed and applied to the next layer, and the base layer 4108d may also be used and later removed along with the final infusion set 4100.

As in other embodiments described herein, the skin adhesive on the bottom layer of the skin tensioning device may be the same as or different from the adhesive used to attach the strain support to the dressing and/or the adhesive used to attach the layers of the skin tensioning device together. In some examples, the skin adhesive may be selected with a T-peel force greater than the adhesive used to attach the support. In other examples, the adhesive used to attach the support may have a higher T-peel force. A higher T-peel force may be selected when a given strain in the dressing is required to resist strain loss during storage of the pre-strained device. A protective or adhesive release sheet may be applied to the skin adhesive to protect it against unintentional adhesion during storage or application. Coatings on the release sheet and layers of the dressing may also be provided to facilitate peeling or removal of the release sheet, layers, and strain support during use. The strain support for this embodiment may include a perforation and pull-tab separation mechanism (not shown) as described with respect to dressing 3926 in FIG. 39A to releasably maintain strain associated with at least layer 4108d, but may also be configured to directly releasably maintain strain in the other layers 4108a-c as well.

45A and 45B depict another embodiment of an infusion set 4500 with a multi-layered dressing 4502 pre-attached to an infusion hub 4504, tubing 4506, and catheter 4508, but in this variation, the lower layers 4510b-d are smaller than the adjacent upper layers 4510a-c. This configuration is also a stepped dressing profile, which may redistribute the edge stresses of the skin tensioning device across a larger surface area, rather than concentrating them at the edges of a single layer of the skin tensioning device. However, the base layer 4510d has a smaller adhered surface area, and the upper layers 4510a-c are adhered to the skin only around their periphery. As in the embodiment depicted in FIGS. 41A-44B, the separation between the perimeters 4512a-4512d of adjacent layers 4512a-4512d may be uniform along the entire perimeter, e.g., a uniform perimeter difference within the range of 1-5 mm, 2-5 mm, or 2-4 mm, or 2-3 mm. The uniform perimeter difference between two adjacent layers 4510a-4510b may be the same for every two adjacent layers 4510a-4510d, or may be different. In other examples, the uniform perimeter difference may be different between at least one pair of two adjacent layers. Layers 4510a-d may also include optional flaps 4514a-c to facilitate grasping and removal of layers 4510a-c. Other features of the device are otherwise similar to the four-layer skin tensioning device 4102 of FIGS. 41A-41B, e.g., heat crimping and adhesive construction.

46A-47C, when the infusion set 4500 needs to be replaced, for example, due to blockage or to reduce the risk of infection, the flap 4514a of the top layer 4510a may be grasped and then lifted to separate the adhesive of the top layer 4510a from the middle layer 4510b or otherwise peel the top layer 4510a away from the middle layer 4510b, thereby also lifting the infusion hub 4504 along with the top layer 4108a and withdrawing the catheter 4108 out from the skin while leaving the other layers 4510b-d of the multi-layered skin tensioning device 4502 on the skin. This minimizes the frequency with which the adhered skin tensioning device 4502 is pulled away from the skin. This may reduce irritation of the underlying skin from repeated removal of the adhered device 4502. Once the infusion hub 4504 has been removed along with the top layer 4510a, a new infusion set 4500 may be applied directly to the middle layer 4510b by aligning the delivery location of the catheter 4508 of the new infusion set 4500 with the opening 4516 of the middle layer 4510b. This cycle of removal and reapplication may be performed multiple times equal to the number of layers in the skin tensioning device, with subsequent cycles of the new infusion set being removed and applied to the next layer, and the base layer 4510d may also be used and later removed along with the final infusion set 4100. The strain support for this embodiment may include a perforation and pull tab separation mechanism (not shown) as described with respect to the dressing 3926 of FIG. 39A to releasably maintain strain associated with at least layer 4510d, but may also be configured to directly releasably maintain strain in the other layers 4510a-c as well.

In another embodiment, a skin tensioning system for treating a therapeutic injection or infusion site may comprise a pair of tension bandages 5200 and 5202, as depicted in FIG. 52. Each of the bandages 5200 and 502 may be provided with a bandage tension applicator (not shown) as described herein, e.g., a book-like applicator. The bandages 5200, 5202 may have separate applicators, but in some embodiments may be provided on the same applicator with a predetermined spacing or gap 5204 between the bandages 5200, 5202 as configured in the applicator. During use, or as provided in the applicator, the gap 5204 may be within a range of, for example, about 1-20 mm, 2-10 mm, 3-8 mm, 4-6 mm. The bandages 5200, 5202 are tensioned along tensioning axes 5206, 5208, respectively, if the bandages are not pre-tensioned at the time of manufacture. The applicator may also include visual alignment markings so that any predefined spacing or gap 5204 between the dressings 5200, 5202 may be aligned or oriented as needed to a particular injection or infusion site. The dressings 5200, 5202 are each placed adjacent a desired injection or infusion site 5210 on opposite sides of the target site 5210. Each dressing 5200, 5202 may include treatment edges 5212, 5214 that are aligned in a parallel manner to define a gap 5204 between the dressings 5200, 5202. The gap 5204 on the skin or on the applicator may be characterized by a longitudinal gap axis 5216, which may also be parallel to the tension axes 5206, 5208 of the corresponding dressings 5200, 5202. After each dressing 5200, 5202 is centered about the target site 5210, the respective applicator or strain support is released, allowing the dressings 5200, 5202 to at least partially relax and compress the skin surrounding the target site 5210. This resulting skin compression is generated at the target site 5210 without any dressing completely surrounding or covering the target site 5210, but support of skin tension perpendicular to the tensioning axis 5206, 5208 and gap axis 5216 is reduced because the two dressings 5206, 5208 are completely separated along that direction.

In yet another embodiment, a skin tensioning bandage 5300 for treating a therapeutic injection or infusion site may comprise a pair of tensioning lugs or sections 5302 and 5304, as depicted in FIG. 53. Sections 5302 and 5304 are each integrally formed with an interconnect or bridge 5306 and separated by a gap 5308 between the sections. The gap 5308 may be within a range of about 1-20 mm, 2-10 mm, 3-8 mm, 4-6 mm, for example. The bandage 5300 may comprise an applicator as described elsewhere herein. The bandage sections 5302, 5304 are tensioned along tensioning axes 5310, 5312, respectively. The applicator may also comprise visual alignment markings such that the gap 5308 may be aligned or oriented to a particular injection or infusion site as needed. Each of the dressing sections 5302, 5304 is positioned with the target site within the gap 5308. After the dressing 5300 is positioned and adhered to the desired target site, the applicator or strain support is released, allowing the dressing sections 5302, 5304 to at least partially relax and compress the skin surrounding the target site.

Any of the skin tension unloading devices corresponding to Figures 30A-56B may be evaluated using the proposed study design to evaluate the effect of skin tension unloading on insulin pharmacokinetics, dosage, therapeutic efficacy, and/or lipohypertrophy development described below, including potential health economic benefits. Diabetic patients currently treated with insulin may be randomized into a treatment or control group, and treatment comprising the use of a skin tension unloading device selected from those corresponding to Figures 30A-56B may be used for 4 weeks to 2 years, 8 weeks to 1 year, 4 weeks to 5 years or more, as described herein. The dressing or skin tension unloading device, or layers, and/or infusion set may be changed every 3 days, or every 2-14 days, 3-10 days, 10-14 days, 5-7 days, 3-5 days, 2-3 days over the selected study period.

It is hypothesized that applying a skin tension unloading device in a substantially sustained manner may reduce the risk, progression, or severity of lipoatrophy, including lipohypertrophy, in insulin-dependent patients. By reducing or limiting the development of lipohypertrophy, dose progression or therapy effect variability associated with lipohypertrophy may be inhibited or reduced. It is also hypothesized that some of the effects on dose progression and therapy effect variability may be independent of the development or progression of lipohypertrophy and may be a direct result of the skin tension unloading device on tissue mechanics and pharmacokinetics. The use of a skin tension unloading device configured with a predetermined level of strain would allow for the delivery of a controlled, consistent level of strain and allow the effects of different consistent levels of strain to be measured, compared to other skin tensioning devices that are manually adjusted in an ad hoc manner, such as many sutureless wound closure devices. Initial studies may include patients with existing lipohypertrophy and/or high daily insulin dosage requirements to more easily identify clinical effects. Using longitudinal data from the study, outcome flow charts will be developed and costs per event will be estimated so that cost-effectiveness and/or health economics analyses can be performed. Quality-adjusted life-year costs may also be calculated, along with measures of patient quality of life.

One proposed study evaluating the effect of one or more of the tension unloading devices will be evaluated in insulin-dependent patients with existing lipohypertrophic masses to assess whether the tension unloading device can modify the pharmacokinetics or delivery kinetics of insulin for patients who inject or infuse insulin or insulin analogs at sites with existing lipohypertrophy. Diabetic patients will be screened for lipohypertrophic masses within 6-10 cm and then randomized to receive the tension unloading device during the study. Each patient will be randomized on a study date and patients will each undergo two glucose absorption tests after an overnight fast, with the tests separated by a minimum of 7 days and an overnight fast prior to the test. Indwelling catheters will be placed for each patient to provide blood samples for blood glucose and insulin levels during the study cycle. Baseline levels will be measured and then each patient will receive a subcutaneous injection of 10 units of insulin through the access opening of the skin tension unloading device in the treatment group or directly into the skin location in the control group. Blood samples will be taken every 5 minutes for the first 30 minutes, then every 10 minutes for the next 60 minutes, then every 30 minutes for the next 2.5 hours. The maximum plasma insulin concentration as well as the time to maximum insulin concentration in each period will be determined and the area under the insulin concentration curve will be analyzed to assess any direct effect of the skin unloading device on insulin absorption.

In another proposed study, patients would be randomized to receive a skin unloading treatment kit in conjunction with insulin or insulin analog injections or infusions for use over a treatment cycle of, for example, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 6 months, 9 months, 18 months, or 24 months. Tension unloading treatment would be used as indicated, with replacement of the device or changing layers of a multi-layer device every 2, 3, 4, or 5 days, or as needed. Blood glucose would be measured at least 4 times per day, and compliance with blood glucose measurements and use of the tension unloading device would be assessed. The analysis would be an intention-to-treat analysis, with the mean amplitude of glucose excursion calculated over the treatment cycle, and postprandial area under the curve calculated for each mealtime over the treatment cycle. Alternatively or in addition, hemoglobin A1C would be measured at baseline and at each follow-up to assess the effect of the skin tension unloading device. Health economics studies and/or patient quality of life studies may also be included in the analysis.

Patient inclusion criteria may include one or more of the following:
- Patients with or without a history of lipohypertrophy - Patients with lipohypertrophy masses in the range of 5-10 cm - Patients with high daily insulin dose requirements of at least 0.9 UI per Kg - Patients with a minimum insulin use of 50 IU/day - Treatment with insulin or insulin analogues for at least 1 year prior to enrollment - Prior experience with fast acting insulin analogues for at least 6 months - Patients with type I or type II diabetes - Treatment self-administered or given by caregiver - Current treatment includes at least 2-4 injections per day or insulin pump use - Body mass index in the range of 20-35 kg/ ^m2 - Stable weight (≦5% weight change) for 3 months prior to enrollment
Hemoglobin A1C ≦8.5%
- C-peptide <0.6 nmol/L at screening

Patient exclusion criteria may include one or more of the following:
- Pre-existing lipoatrophy or lipohypertrophy - Children aged 5 years or younger - Patients not currently being treated with insulin or analogues - Women with gestational diabetes - History of hypoglycemia unawareness - History of diabetic ketoacidosis within 6 months of screening - History of cardiovascular disease - History of arrhythmias

The primary and secondary endpoints will assess the development or presence of lipohypertrophy and/or changes in blood glucose or glycemic variables at each visit. The initial assessment and each follow-up visit will include the following assessments:
- Continuous ultrasound scanning using a linear 20 MHz probe with B-mode imaging ○ Classification:
Simple subcutaneous hypertrophy Diffuse hyperechoic subcutaneous dystrophy Nodular hyperechoic dystrophy Focal and diffuse hyperechoic subcutaneous dystrophy Nodular hypoechoic subcutaneous dystrophy Subcutaneous atrophy Combined multilamellar dystrophy ○ Level of fibrosis Isohyperechogenic Isoechogenic Isohypoechogenic - Direct and tangential light examination and color photography of the treatment area against a dark background - Classification of the treatment area regarding shape and size using palpation and skin calipers:
o Small nodules - visible on examination, easy to palpate, with an elastic consistency o Larger nodules - clearly visible on examination, easy to palpate, with a firm to elastic consistency o Flat plates - slightly elevated, somewhat visible, difficult to palpate except by pinching the skin, with an elastic consistency o Flat nodules - not visible but palpable by deep palpation or by pinching the skin, with an elastic consistency o Includes sizes < 4 cm and > 4 cm - clinical grades 0 to 3:
0 - no change 1 - visible hypertrophy but normal consistency on palpation 2 - substantial thickening and denser consistency 3 - evidence of lipohypertrophy - Diabetes Questionnaire validated (only at start and end of study)
Questionnaire on problems with diabetes Questionnaire on satisfaction with diabetes treatment

At the end of the study, percentage changes in prandial and total daily insulin doses, time in range (70-140 mg/dl) and out of range (<70 mg/dl and >180 mg/dl) for studies with patients using continuous glucose monitoring devices, hemoglobin A1C, number of hypoglycemic events, number of diabetic ketoacidosis events will be calculated and compared between treatment and control groups. For studies with patients with CGM or insulin pumps, assessment of pain during cannula/infusion set insertion and removal, cannula/infusion set malfunctions (occlusion, needle deformation) will be assessed and compared.

In some further variations, the various tissue tension unloading devices and systems described herein may be used for both the sensors of the Continuous Subcutaneous Insulin Infusion Set (SCII) and the CGM system, i.e., the closed loop therapy/sensing system, also known as the "artificial pancreas" or dual subcutaneous approach. It is hypothesized that the tension unloading device may facilitate longer wear times, reduce physiological or sensor-based latency, sensor drift for the infusion set and/or CGM sensor system, resulting in improved glucose control. This may be a result of reducing mechanical irritation or inflammation at the infusion and/or sensor site that may lead to fibrosis. The CGM device measures glucose concentration in the interstitium. Increases and decreases in interstitial glucose are related to blood glucose, likely via diffusion. Inaccuracies from CGM calibration quality and loss of sensitivity and random noise are all affected by the time delay due to transport from blood glucose to interstitial glucose.

In another proposed study, the effect of applying a tensioning tissue treatment device to insulin injection or infusion sites with lipohypertrophy will be analyzed. Eligible participants will include adults aged 18-70 years with type 1 diabetes who have been taking insulin by multiple injections per day (at least 3 injections per day) for at least 2 years and have at least two distinct palpable lipohypertrophy lesions on the abdomen for use for injections. Each LH lesion must be a minimum of 3 cm in one dimension. LH lesions less than 2 years old will be selected. Subjects may or may not use a continuous glucose monitor but will be asked to wear a CGM as part of the study protocol. HbA1c must be within the range of 7.5%-10.5% at the screening visit. Punch biopsies of LH lesions may be obtained at the start and final study visits.

Initial testing and patient screening procedures may include a physical exam for LH pathology with registration of LH measurements. A CBC/chemistry blood panel, urinalysis, HbA1c will be obtained. CGM will be administered over 10-14 days to monitor the patient.

Patients who meet the eligibility criteria will return for a next visit where CGM data will be downloaded to capture glycemic profiles and establish baseline glycemia and insulin usage. A punch or needle biopsy of one of the lipohypertrophic areas will be performed and closure will be performed with sutures if required. For patients with three or more LH lesions who meet the eligibility criteria, two LH lesions will be selected based on randomized selection and the LH lesion to be biopsied will be randomly selected from the two selected LH lesions. For punch biopsies, the biopsy size will be within the range of 1 mm to 10 mm, 1 mm to 8 mm, or 5 mm to 8 mm in diameter and will be verified during the biopsy procedure to include at least some subcutaneous tissue. For needle biopsies, the needle size may be an 18-gauge to 25-gauge needle. A tensioning tissue treatment device will then be applied to the biopsied LH lesion. Each patient will be informed of the two locations of the LH lesions and will be instructed not to perform any injections into either of the LH lesions for the duration of the study. Patients are also instructed on how to switch their insulin regimen to a fast-acting insulin analog. Due to limited availability of drug assays such as those available for insulin lispro, e.g., HUMALOG (Lilly; Indianapolis, Ind.) and fast-acting insulin lispro, e.g., LYUMJEV (Lilly; Indianapolis, Ind.), the fast-acting insulin selected for the regimen may be selected to be different from that used during insulin PK-PD studies, e.g., insulin aspart, e.g., NOVOLOG® (Novo Nordisk; Plainsboro, NJ).

The tensioned tissue treatment device will be applied to selected LH lesions for a period ranging from 4-12 weeks, or 6-8 weeks, or 4-6 weeks before returning for study follow-up. At the next follow-up visit, insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp (HEC) test. Each subject's blood glucose will be adjusted to 100 mg/dL (± 5 mg/dL) prior to the start of the study procedure using either glucose or insulin without subcutaneous injection. Any insulin infusion will be tapered and stopped over at least 10 minutes prior to the clamp test. Each subject will undergo six 6-hour HEC tests, two per injection site, and the sequence will be individually randomized. At the start of each study, 0.15 units/kg of insulin will be injected first into normal adipose tissue, untreated LH lesions, and LH lesions treated with the tensioned tissue treatment device, as defined by the randomized sequence. A euglycemic clamp device is then used to record blood glucose levels every minute during the clamp procedure and automatically adjust the glucose infusion rate to maintain blood glucose within the target range. Insulin levels are measured during the test, for example, at 15, 30, 45, 60, 80, 100, 120, 150, 180, 210, 240, and 300 minutes after insulin injection into the test site. From the HEC test, the area under the insulin concentration curve, _Cmax insulin level, and area under the blood glucose infusion rate curve, and the intrapatient coefficient of variation for each of these measurements can be calculated for each test injection into normal adipose tissue, untreated LH lesion, and treated LH lesion. It is hypothesized that the untreated LH lesion will have the lowest AUC _INS , _Cmax , and AUC _GIR for each test, and the highest corresponding coefficient of variation, compared to the normal adipose tissue and treated LH lesion sites, and that the treated LH lesion sites will show improvement over the untreated LH lesion sites. The effect size of change or progression of tissue firmness as measured by CUTOMETER® (Courage + Khazaka electronic GmbH; Kohn, DE) and/or pharmacokinetic/pharmacodynamic improvement is assumed to be at least 10%, 15%, 20%, or 25% for treated LH lesions compared to untreated LH lesions. Following completion of the HEC study, each subject will resume their usual diabetes therapy for two weeks while continuing to use the CGM and apply the tensioning tissue treatment device to the same LH lesion selected for treatment.

At the next 2-week return visit, LH lesions will be remeasured, the CGM data from the last cycle will be downloaded, and pre-study laboratory data will be obtained. Each subject will also resume use of short-acting insulin as before in the HEC study to wash out any long-acting insulin used by the subject in their usual diabetes therapy. The washout period will be at least 12 hours to 3 days prior to the mixed meal tolerance test (MMTT), depending on the type of insulin used in their usual diabetes regimen. During the MMTT, 75 g of rapidly absorbed carbohydrate (56% of the dietary caloric content), 20 g of fat (33%), and 15.2 g of protein (11%) will be consumed. Data acquisition for the MMTT will otherwise be identical to that for the HEC study. It is hypothesized that the untreated LH lesions will again have the lowest AUC _INS , C _max , and AUC _GIR and the highest corresponding coefficients of variation per test compared to normal adipose tissue and treated LH lesion sites, with the treated LH lesion sites showing improvement over the untreated LH lesion sites. Following completion of the MMTT, each subject will resume their usual diabetes therapy and discontinue use of tensioning tissue therapy. End-of-study laboratory and physical examinations will be performed. In some variations of the study, the MMTT is performed once per test site, while in other variations of the study it is performed twice per site and the results may be averaged.

Another study will assess the effect of applying tensioning tissue therapy to normal adipose tissue. Eligible participants will include adults aged 18-70 years with type 1 diabetes who take insulin by multiple injections per day (at least 3 injections per day) for at least 2 years. Subjects may or may not use a continuous glucose monitor but will be asked to wear a CGM as part of the study protocol. HbA1c must be within the range of 7.5%-10.5% at the screening visit. Initial testing will include a physical exam, CBC/chemistry blood panel, urinalysis, and laboratory tests for HbA1c. The CGM will be applied for 10-14 days to monitor the patient.

At the next visit, CGM data is downloaded to establish baseline glycemia and insulin usage. A tensioning tissue treatment device is then applied to one of two selected injection sites that are free of lipohypertrophy. The patient is also instructed on how to switch their insulin regimen to a fast-acting insulin analog. Due to limited availability of drug assays such as those available for insulin lispro, e.g., HUMALOG (Lilly; Indianapolis, IN), and fast-acting insulin lispro, e.g., LYUMJEV (Lilly; Indianapolis, IN), the fast-acting insulin selected for the regimen may be selected to be different from that used during insulin PK-PD testing, e.g., insulin aspart, e.g., NOVOLOG® (Novo Nordisk; Plainsboro, NJ).

The tensioning tissue treatment device will be applied to the selected injection sites for a period ranging from 4-12 weeks, or 6-8 weeks, or 4-6 weeks before returning for study follow-up. At the next follow-up visit, insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp (HEC) test. Each subject's blood glucose will be adjusted to 100 mg/dL (± 5 mg/dL) prior to the start of the study procedure using either glucose or insulin without subcutaneous injection. Any insulin infusion will be tapered and stopped for at least 10 minutes prior to the clamp test. Each subject will undergo four 6-hour HEC tests, two per injection site, and the sequence will be individually randomized. At the start of each test, 0.15 units/kg of insulin will be initially injected twice into untreated normal adipose tissue and twice into the treated injection site for a total of four tests. A euglycemic clamp instrument will then be used to record blood glucose levels every minute during the clamp procedure and automatically adjust glucose infusion rates to maintain blood glucose within the target range. Insulin levels are measured during the test, for example, at 15, 30, 45, 60, 80, 100, 120, 150, 180, 210, 240, and 300 minutes after insulin injection into the test site. From the HEC test, the area under the insulin concentration curve, _Cmax insulin level, and blood glucose infusion rate area under the curve, and the intra-patient coefficient of variation for each of these measurements can be calculated for each test injection into the untreated normal adipose tissue and the treated injection site. It is assumed that the untreated injection site will have the lowest AUC _INS , _Cmax , and AUC _GIR per test, and the highest corresponding coefficient of variation, compared to the treated injection site. Following the completion of the HEC test, each subject will resume their usual diabetes therapy for two weeks while continuing to use the CGM and continue to apply the tensioned tissue treatment device to the same injection site selected for treatment with the tensioned tissue treatment system.

At the next 2-week return visit, injection sites will be reevaluated, the CGM data from the last cycle will be downloaded, and pre-study laboratory data will be obtained. Each subject will also resume use of short-acting insulin as before in the HEC study to wash out any long-acting insulin used by the subject in their usual diabetes therapy. The washout period will be at least 12 hours to 3 days prior to the mixed meal tolerance test (MMTT), depending on the type of insulin used in their usual diabetes regimen. During the MMTT, 75 g of rapidly absorbed carbohydrate (56% of the meal caloric content), 20 g of fat (33%), and 15.2 g of protein (11%) will be consumed. Data acquisition for the MMTT will otherwise be identical to that for the HEC study. It is again assumed that the untreated injection sites will have the lowest AUC _INS , C _max , and AUC _GIR per study, and the highest corresponding coefficients of variation, compared to the treated LH lesion sites. Following completion of the MMTT, each subject will resume their usual diabetes therapy and discontinue use of the tensioning tissue treatment. End-of-study laboratory and physical examinations will be performed. In some variations of the study, the MMTT is performed once per test site, while in other variations of the study, it is performed twice per site and the results may be averaged.

In a variation of the proposed study above, patients would wear and collect 14 days of continuous glucose monitoring data over multiple cycles. Using the data, time in range (TIR), glucose control index (GMI), and various hyperglycemic measures would be assessed using three different injection sites: normal adipose tissue, a lipohypertrophic site treated with the tensioned tissue treatment device, and a lipohypertrophic site control group not treated with the tensioned tissue treatment device. Insulin usage during the study cycle would also be tracked. The three sites would be measured using blinded CGM at the following time points: 0-2 weeks for baseline, 6-8 weeks for the first comparison point, and 10-12 weeks for the second comparison point. The order of data collection would be randomized between the analysis of treated and untreated LH lesions and the analysis between treated LH lesions and normal adipose tissue. The glucose control index for the measurement cycle would be calculated by:
GMI(%)=3.31+0.02392×mean glucose in mg/dl

TIR will be calculated as the percentage of CGM data spent in very low and low hypoglycemic states of <54 mg/dl and <70 mg/dl, in the range of 70-80 mg/dl, and in high and very high hyperglycemic states of >180 mg/dl and >250 mg/dl. Glycemic variability will be calculated using the coefficient of variation (CV) and standard deviation over the measurement period. Daily glucose file graphs with median glucose values, middle 50% values, and 10th and 90th% distribution lines will be generated. LH lesions will be measured at baseline and tracked during the study period for size, density, and firmness as measured by various firmness metrics generated by CUTOMETER®. It is hypothesized that treatment of LH lesions with a tensioned tissue treatment device may increase TIR, reduce GV measurements, and reduce the percentage time spent in hypoglycemic states (alone or in combination), hyperglycemic states (alone or in combination), or total hypoglycemia/hyperglycemia (combined).

Although the present invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention. With respect to all of the above described embodiments, the steps of the method need not be performed sequentially.

Claims (111)

1. An integrated infusion set, comprising:
an injection assembly attached to an upper surface of the tensile dressing layer, said injection assembly comprising:
an infusion conduit configured for insertion into the treatment site;
a releasable attachment structure for attaching the infusion hub to the upper surface of the tensioned dressing layer;
1. A prestrained bandage, comprising:
a tensioning dressing layer;
a skin adhesive on a lower surface of the tension dressing layer;
one or more adhesive protective liners removably covering the skin adhesive;
An integrated infusion set comprising: a tension support structure configured to maintain the tension bandage layer in a stressed configuration, the tensile support structure comprising one or more pull tabs; and an infusion assembly comprising a pre-strained bandage. The infusion set of claim 1, wherein 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 configured to receive the injection hub and provide fluid communication between the tubing and the injection conduit. The infusion set of claim 2, wherein the infusion conduit is an infusion needle or an infusion catheter. The infusion set of claim 2, further comprising an infusion set applicator releasably attachable to the infusion hub and further comprising a needle configured to removably extend through the infusion hub and out of the distal end of the infusion conduit. The infusion set of claim 1, wherein the releasable attachment structure comprises a removable section to which the infusion hub is attached. The infusion set of claim 5, wherein the releasable attachment structure comprises two or more non-removable segments coupled to the removable segment. The infusion set of claim 6, wherein the two or more non-removable segments that are coupled to the removable segment are coupled via a tearable or frangible structure. The infusion set of claim 7, wherein the tear structure comprises a plurality of perforations. The infusion set of claim 7, wherein the frangible structure comprises a frangible support. The infusion set of any one of claims 5-9, wherein the removable section comprises a pull tab or handle. 8. The infusion set of claim 7, wherein the non-removable section comprises a split ring or multiple arcuate bodies attached to the tensioning dressing layer. The infusion set of claim 5, wherein the non-removable section includes a slot configured to movably receive a tab located on the removable section. The infusion set of claim 12, wherein the removable section is integrally formed with the infusion hub. The infusion set of claim 12, wherein the slot is an arcuate slot. The infusion set of claim 2, wherein the infusion hub further comprises a hub body and a hub base, the hub body being releasably attachable to the hub base, and the hub base being attached to the tensioning dressing layer. The infusion set of claim 15, wherein the hub body includes a releasable latch. The infusion set of claim 15, further comprising a removal tool, the removal tool configured to actuate a releasable latch on the hub body to facilitate separation of the hub body from the hub base. The infusion set of claim 15, wherein the hub base comprises a material that is softer than the hub body. The infusion set of claim 17, wherein the removal tool comprises a protrusion with a tab, the protrusion configured to actuate a releasable latch of the hub body, and the tab of the protrusion configured to engage the hub body. 20. The infusion set of claim 19, wherein the hub body includes an access channel to the release latch configured to receive a protrusion with the tab. The infusion set of claim 2, wherein the injection housing includes a release latch configured to unlock the injection housing from the injection hub. 1. A method of treating a treatment area, comprising:
Removing a first infusion housing from an infusion hub that is attached to the treatment site via a tensioning dressing;
and separating at least a portion of the infusion hub from the tensioning bandage while leaving the tensioning bandage attached to the treatment site. inserting a cannula of the injection hub into the treatment site;
23. The method of claim 22, further comprising: adhering the tensioning dressing around the treatment area. 24. The method of claim 23, wherein inserting the cannula is performed using an applicator coupled to the injection hub. 25. The method of claim 24, wherein inserting the cannula of the injection hub includes inserting the cannula of the injection hub into the treatment site parallel to a needle of the applicator. 26. The method of claim 25, further comprising decoupling the applicator from the injection hub after inserting the cannula of the injection hub. 27. The method of claim 26, wherein decoupling the applicator from the injection hub also causes removal of the needle from the cannula of the injection hub. Attaching an injection housing to the injection hub;
24. The method of claim 23, further comprising injecting a therapy through tubing of the infusion housing and through a cannula of the infusion hub. 23. The method of claim 22, further comprising leaving the tensioned dressing on the treatment area for at least 12 hours after separating the infusion hub. The method of claim 29, wherein the tensioning dressing is left on the treatment area for at least 24 hours. 31. The method of claim 30, wherein the tensioning dressing is left on the treatment area for at least 48 hours. 23. The method of claim 22, further comprising separating an infusion housing from the infusion hub prior to separating the infusion hub from the tensioned dressing. Separating the infusion hub from the tensioning dressing comprises:
Inserting a removal tool into the injection body of the injection hub;
and pulling the injection body away from the injection base of the injection hub. 23. The method of claim 22, wherein separating at least a portion of the infusion hub from the tensioned bandage comprises separating all of the infusion hub from the tensioned bandage. Separating at least a portion of the infusion hub from the tensioning dressing comprises:
pulling a tab of an attachment structure that attaches the infusion hub to the tensioning dressing;
and tearing the attachment structure along perforations to separate the infusion hub from the tensioning dressing and non-removable portions of the attachment structure. 23. The method of claim 22, wherein separating at least a portion of the infusion hub from the tensioned bandage comprises breaking the infusion hub from the tensioned bandage. 27. The method of claim 26, wherein breaking the infusion hub from the tensioned dressing comprises breaking a frangible post of an attachment structure attached to the tensioned dressing and to the infusion hub. 23. The method of claim 22, wherein separating at least a portion of the infusion hub from the tensioned dressing comprises rotating the infusion hub from a mounting slot of a mounting structure. 23. The method of claim 22, wherein separating at least a portion of the infusion hub from the tensioned dressing comprises rotating the infusion hub from a helical interface of an attachment structure. 1. A system for treating a chronic injection site, comprising:
an adhesive tensionable elastic bandage, the bandage comprising a first attachment structure and a second attachment structure;
at least one injection template comprising a plurality of injection openings, a first attachment opening, and a second attachment opening;
the first mounting structure is configured to form a releasable interlock with the first mounting opening and the second mounting structure is configured to form a releasable interlock with the second mounting opening. 12. The system of claim 11, wherein the adhesive tensionable bandage comprises a plurality of bandage openings, at least one bandage opening being aligned with each of the injection openings of the plurality of openings of the at least one injection template. 42. The system of claim 41, wherein the at least one injection template comprises an injection template, and each of the dressing openings of the plurality of dressing openings is aligned with an injection opening of the plurality of openings of the one injection template. The system of claim 40, wherein the at least one injection template comprises a plurality of injection templates. The system of claim 43, wherein the plurality of injection templates consists of seven injection templates. 44. The system of claim 43, wherein the injection openings of each injection template of the plurality of injection templates have different locations than other injection templates of the plurality of injection templates. The system of claim 40, wherein the at least one injection template comprises one injection template. The system of claim 46, wherein the injection openings of the one injection template are arranged in a rectangular grid pattern. The system of claim 46, wherein the injection openings of the one injection template are arranged in a staggered grid pattern. The system of claim 47, wherein a plurality of adhesive strips are removably coupled to the plurality of injection openings. The system of claim 49, wherein the number of the plurality of adhesive strips is less than the number of the plurality of injection openings. The system of claim 50, wherein the number of the plurality of injection openings is three or four times the number of the plurality of adhesive strips. 51. The system of claim 50, wherein the adhesive strips are aligned longitudinally to a longitudinal axis of the injection template or aligned transversely to a transverse axis perpendicular to the longitudinal axis of the injection template. The system of claim 49, wherein the adhesive strips are parallel to one another and not parallel to a longitudinal or lateral axis of the injection template. The system of claim 49, wherein each of the plurality of adhesive strips extends beyond an edge of the injection template. The system of claim 40, wherein the first mounting structure and the second mounting structure have different shapes. The system of claim 55, wherein the first mounting opening and the second mounting opening have different shapes. The system of claim 40, further comprising an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device. A system for treating chronic injection sites, 1. A system comprising: an adhesive tensionable tissue treatment device comprising a plurality of injection openings 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 system of claim 58, wherein the plurality of injection openings are arranged in a rectangular grid pattern. 59. The system of claim 58, further comprising an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device. A system for treating chronic injection sites, 1. A system comprising: an adhesive tensionable tissue treatment device comprising a plurality of injection openings 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 system of claim 61, wherein the plurality of injection openings are arranged in a rectangular grid pattern. 62. The system of claim 61, further comprising an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device. 1. An injection guide system 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 such that each injection guide is spaced apart from the other injection guides;
an adhesive carrier sheet, the adhesive carrier sheet maintaining the plurality of injection guides in a separated configuration;
a release liner, the release liner removably adhered to an adhesive undersurface of the plurality of injection guides. 67. The system of claim 66, further comprising a plurality of adhesive injection guide covers, said plurality of adhesive injection guide covers releasably adhered to said plurality of injection guides and positioned between said plurality of injection guides and said adhesive carrier sheet. 67. The system of claim 66, further comprising: a dressing comprising a plurality of dressing openings configured to align with at least an opening of each injection guide of the plurality of injection guides. The system of claim 66, wherein the plurality of injection guides comprises adhesive foam strips. The system of claim 66, wherein the adhesive undersurface of each injection guide has stronger adhesive properties than the adhesive carrier sheet. The system of claim 70, wherein the adhesive injection guide cover has stronger adhesive properties than the adhesive carrier sheet. The system of claim 71, wherein the adhesive properties of the adhesive undersurface of each injection guide are stronger than the adhesive injection guide cover. 1. A method of preparing a dressing comprising the steps of:
aligning a plurality of separate injection guides with a plurality of dressing openings on the dressing, each injection guide comprising a plurality of openings;
and adhering the plurality of separate injection guides to the dressing. 74. The method of claim 73, wherein adhering the plurality of separate injection guides to the plurality of dressing openings is performed such that the plurality of openings of each injection guide are aligned with the dressing opening. 74. The method of claim 73, further comprising removing release liners from the plurality of separate injection guides. 76. The method of claim 75, further comprising removing the carrier sheet from the plurality of separate injection guides after adhering the plurality of separate injection guides to the dressing. 74. The method of claim 73, wherein the adhering of the plurality of separate injection guides to the dressing is performed simultaneously. 74. The method of claim 73, wherein each of the plurality of separate injection guides further comprises a removable guide cover. 1. A method of treating an injection site, comprising:
adhering a tensioned tissue treatment device to a skin surface;
Releasing a portion of the tension in the tensioning tissue treatment device and transmitting tension to the adhered skin surface;
Attaching a first injection template to the tensioned tissue treatment device, the first injection template comprising a plurality of needle insertion openings;
inserting a first needle through a first needle insertion opening of the plurality of needle insertion openings;
and removing the first injection template from the tensioning tissue treatment device. 80. The method of claim 79, further comprising removing a first cover strip of the first injection template, the first cover strip surrounding or covering the first needle opening. reattaching the first injection template to the tensioning tissue device;
inserting a second needle through a second needle insertion opening of the plurality of needle insertion openings;
removing the first injection template;
80. The method of claim 79, wherein the first cover strip also surrounds or covers the second needle insertion opening. 82. The method of claim 81, wherein removing the first cover strip is performed prior to inserting the first needle through the first needle insertion opening. 1. A method of treating an injection site, comprising:
adhering a tensioned tissue treatment device to a skin surface;
Releasing a portion of the tension in the tensioning tissue treatment device and transmitting tension to the adhered skin surface;
Attaching a first injection template to the tensioned tissue treatment device, the first injection template comprising a plurality of needle insertion openings;
inserting a first needle through a first needle insertion opening of the plurality of needle insertion openings;
and removing the first injection template from the tensioning tissue treatment device. 84. The method of claim 83, further comprising removing a first cover strip of the first injection template, the first cover strip surrounding or covering the first needle opening. reattaching the first injection template to the tensioning tissue device;
inserting a second needle through a second needle insertion opening of the plurality of needle insertion openings;
removing the first injection template;
84. The method of claim 83, wherein the first cover strip also surrounds or covers the second needle insertion opening. 86. The method of claim 85, wherein removing the first cover strip is performed prior to inserting the first needle through the first needle insertion opening. A method of treating diabetes comprising applying an adhesive skin tensioning device to an injection or infusion site to increase the percentage of time within glycemic control. The method of claim 87, wherein the time in range is the percentage of time with a blood glucose level between 70 mg/dl and 180 mg/dl. A method of treating diabetes comprising applying an adhesive skin tensioning device to an injection or infusion site to reduce the percentage of time in hypoglycemia. The method of claim 89, wherein hypoglycemia is a blood glucose level below 70 mg/dl. A method of treating diabetes, comprising applying an adhesive skin tensioning device to an injection or infusion site to reduce the percentage of time in hyperglycemia. The method of claim 91, wherein hyperglycemia is a blood glucose level above 180 mg/dl. 1. A method of treating diabetes, comprising:
A method comprising applying an adhesive skin tensioning device to an injection or infusion site of a diabetic patient to reduce variability in insulin absorption compared to an untreated control group. 94. The method of claim 93, wherein the reduced variability of insulin absorption is a reduced coefficient of variation of insulin Cmax or AUCINS as measured by a hyperinsulinemic euglycemic clamp test or a mixed meal tolerance test. 1. A method of treating subcutaneous tissue, comprising:
applying an adhesive skin tensioning device to a treatment site on a patient to reduce the development or progression of subcutaneous lesions comprising calcification, cellular proliferation, or hypertrophy. The method of claim 94, wherein the treatment site is a device implantation, injection, or infusion site. The method of claim 94, wherein the subcutaneous lesion is a lipoatrophic lesion. The method of claim 97, wherein the lipoatrophic lesion is a lipohypertrophic lesion. 97. The method of claim 96, wherein the injection or infusion site is an insulin or insulin analog injection or infusion site. The method of claim 95, wherein the patient is diabetic and the subcutaneous lesion is lipohypertrophy. The method of claim 100, wherein the patient does not have any history of lipohypertrophy. The method of claim 100, wherein the patient has a history of lipohypertrophy. The method of claim 100, further comprising reducing the risk of insulin resistance. 101. The method of claim 100, further comprising reducing the rate of insulin or insulin analog dosage increase over a period of time. The method of claim 104, wherein the period is one year. 97. The method of claim 96, wherein the injection site is a hemodialysis fistula or graft site. 97. The method of claim 96, wherein the injection site is a tumor therapy injection site. The method of claim 107, wherein the tumor therapy injection site is a pertuzumab and/or trastuzumab injection site. The method of claim 96, wherein the treatment site is an implant site for an implantable pulse generator, an implantable pacemaker, or a defibrillator. The method of claim 96, wherein the treatment site is the implantation site of a subcutaneous injection port. A method for modifying the pharmacokinetics of a drug, comprising applying an adhesive skin tensioning device with a predetermined tension to a site of injection or infusion of a therapeutic agent.

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