US20220379018A1

Movatterモバイル変換

Info

Publication number: US20220379018A1
Application number: US17/838,027
Authority: US
Inventors: Kelley J. Lipman; Jasper Jackson; John A. Zepeda; Philip J. Wadlow; Reuben E. Lasrado
Original assignee: Neodyne Biosciences Inc
Current assignee: Neodyne Biosciences Inc
Priority date: 2019-12-10
Filing date: 2022-06-10
Publication date: 2022-12-01
Also published as: US20240131255A1; US11980738B1; US20240299646A1

Abstract

Devices, kits and methods described herein are be used at chronic injection site or in conjunction with an indwelling catheter or cannula. A book-like packaging, applicator and/or tensioning device with an opening and optional indicia to align the catheter or cannula to the opening may be used to apply a dressing to a subject. The packaging, applicator and/or tensioning device may apply and/or maintain a strain in an elastic dressing.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a) a continuation-in-part of PCT Application No. PCT/US2020/064378, filed Dec. 10, 2020, which claims priority to U.S. Provisional Application No. 62/946,345, filed on Dec. 10, 2019, and b) claims priority to U.S. Provisional Application No. 63/211,359, filed Jun. 16, 2021, which are hereby incorporated by reference in their entirety. This application is also related to U.S. Pat. Nos. 8,592,640, 9,248,048, 9,844,470, and 11,013,638, which are hereby incorporated by reference in their entirety.

BACKGROUND

Scar formation in response to cutaneous injury is part of the natural wound healing process. Wound healing is a lengthy and continuous process, although it is typically recognized as occurring in stages. The process begins immediately after injury, with an inflammatory stage. During this stage, which typically lasts from two days to one week (depending on the wound), damaged tissues and foreign matter are removed from the wound. The proliferative stage occurs at a time after the inflammatory stage and is characterized by fibroblast proliferation and collagen and proteoglycan production. It is during the proliferative stage that the extracellular matrix is synthesized in order to provide structural integrity to the wound. The proliferative stage usually lasts about four days to several weeks, depending on the nature of the wound, and it is during this stage when hypertrophic scars usually form. The last stage is called the remodeling stage. During the remodeling stage, the previously constructed and randomly organized matrix is remodeled into an organized structure that is highly cross-linked and aligned to increase mechanical strength.

While the histological features characterizing hypertrophic scars have been well documented, the underlying pathophysiology is not well known. Hypertrophic scars are a side effect of excessive wound healing, and generally result in the overproduction of cells, collagen, and proteoglycans. Typically, these scars are raised and are characterized by the random distribution of tissue bundles. The appearance (i.e., size, shape, and color) of these scars varies depending on the part of the body in which they form, and the underlying ethnicity of the person affected. Hypertrophic scars are very common, and may occur following any full thickness injury to the skin. Recently, it has been shown in U.S. Patent Application Publication 2006/0037091 (U.S. patent application Ser. No. 11/135,992 entitled “Method for Producing Hypertrophic Scarring Animal Model for Identification of Agents for Prevention and Treatment of Human Hypertrophic Scarring,” filed May 24, 2005) which is hereby incorporated by reference in its entirety, that mechanical stress may increase hypertrophic scarring in a murine model.

Keloids are typically characterized as tumors consisting of highly hyperplastic masses that occur in the dermis and adjacent subcutaneous tissue in susceptible individuals, most commonly following trauma. Keloids are often more severe than hypertrophic scars, since they tend to invade normal adjacent tissue, while hypertrophic scars tend to remain confined within the original scar border.

Scar tissue may also be formed from repetitive tissue injuries, such as patients who require repeated needle insertions for blood draws or injections or infusions of therapeutic agents for treatment of chronic health issues, including but not limited growth hormone injection, autoimmune diseases such rheumatoid arthritis, and diabetes, and also from other therapeutic or diagnostic procedures or devices that may utilize an indwelling catheter or needle.

BRIEF SUMMARY

Devices, kits and methods described herein may be for treatment of a subject at a skin site including without limitation for wound treatment or the treatment, amelioration, or prevention of scars and/or keloids, by manipulating mechanical or physical properties of skin or by shielding skin from stresses, and/or by controllably stressing or straining the epidermis and layers of dermal tissue at or near a skin site, i.e., at or adjacent a wound or a treatment site of a subject's skin.

Some tissue responses and diseases, however, are associated with tissues below the dermal layer of the skin. The subcutaneous region, or hypodermis, is the deepest layer in the skin and varies in depth from the epidermis. Skin thickness averages between 1.5 mm and 2.7 mm at various body sites, and has a different density and elasticity compared to the subcutaneous tissue below it. While dermal tissues are developmentally derived from endoderm and comprises collagen and other connective tissue having higher tensile strength, the hypodermis is developmentally derived from mesoderm and comprises loose areolar connective tissue. For these reasons, it is unclear whether planar load forces acting on the epidermis will transmit through the dermis and to the hypodermis or other anatomical structures below the epidermis. Nevertheless, it is hypothesized herein that the mechanical interplay between the epidermis/dermis and the subcutaneous tissue may have some mechanobiologic effect on subcutaneous tissues and structures.

Also, the impact of scar tissue formation are not limited to cosmetic effects. For example, diabetes patients may develop scar tissue and/or lipohypertrophy at chronic injections sites. Lipohypertrophy is an increased formation of fat tissue that is thought to be a hypertrophic effect from chronic localized insulin injections on adipose cells. The lipohypertrophy can adversely affect insulin injection or infusion rates due to structural changes in the tissue that can decrease the diffusion of insulin. Typical infusion using insulin pumps involves the placement of a cannula or needle into the delivery site (e.g., abdomen, arms, buttocks, thighs) every few days. Over time, this can induce lipodystrophic changes in the skin and subcutaneous structure, which can result in unpredictable or erratic insulin absorption. Eventually the patient may be limited in the available infusion sites on their body due to lipohypertrophy. Although, the effects of lipohypertrophy and lipodystrophy are thought to be induced by the insulin itself, it is hypothesized that tension offloading of the infusion location may also reduce this insulin effect, and may improve the variability and/or overall absorption rates at the infusion site. This may occur by reducing the formation of fibrosis, improving the vascularization, and/or reducing vascular resistance to perfusing the tissue under or about the insertion site. In some variations, it is hypothesized that the change in skin tension and/or the increased adhesive properties of the tensioned dressing or dressing component may extend the usable duration of the infusion set or sensor, e.g. from 2-3 days to 4 to 7 days. This may also result in a reduction of the size, surface area, depth and/or severity of inflammation at the injection/infusion site(s).

It is also believed that treatment of the injection and/or infusion sites of diabetes therapy may also have other effects separate from affecting the development of scar tissue or lipohypertrophy. For example, treatment of an injection site and/or injection at a site that has already been treated with a skin tensioning device may improve the dispersion of insulin at the injection site by altering the mechanical environment. For example, insulin leakage at the injection or infusion site may be reduced because of increased mechanical pressure at the skin surface, which may drive injected therapy deeper into the tissue because of the pressure gradient generated in the tissue by the tensioning device. This and other mechanical effects of skin tension treatment may result in an increased insulin bolus volume and/or surface area per unit injection. The mechanomodulation effects may results in improved insulin absorption, with a reduced average total daily, weekly and/or monthly insulin dosage, and/or improved daily, weekly and/or monthly time-in-range of blood glucose, with a reduced frequency or degree of hyperglycemia. The tensioning device may also reduce pain at the injection site, as a result of mechanomodulation of the nociceptors, and/or may reduce the risk of infection and/or pump alarms from occlusion, as a result of mechanically stabilizing the tissue.

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

In one embodiment, an integrated infusion set is provided, comprising an infusion assembly attached to an upper surface of the tension dressing layer, wherein the infusion assembly comprises an infusion conduit configured for insertion into a treatment location, and a releasable attachment structure attaching the infusion hub to an upper surface of the tensioned dressing layer; a pre-strained dressing, the pre-strained dressing comprising a tensioned 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, and a tension support structure configured to maintain the tension dressing layer in a stressed configuration, the tension support structure comprising one or more pull tabs. The infusion assembly may further comprise an infusion housing attachable to the infusion hub, the infusion housing comprising tubing in fluid communication with a cavity of the infusion housing, wherein the cavity is configured to receive the infusion hub and to provide fluid communication between the tubing and the infusion conduit. The infusion conduit may be an infusion needle or infusion catheter. The infusion set may further comprise 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 a 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 a frangible strut. The removable section may comprise a pull tab or handle. The non-removable section may comprise a split ring or plurality of arcuate bodies attached to the tensioned dressing layer. The non-removable sections may comprise slots configured to movably receive tabs located on the removable section. The removable section may be integrally formed with the infusion hub. The slots may be arcuate slots. The infusion hub may further comprise a hub body and a hub base, and wherein the hub body is releasably attachable to the hub base, and the hub base is attached to the tensioned 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 to facilitate separation of the hub body from the hub base. The hub base may comprise a softer material than the hub body. The removal tool may comprise prongs with tabs, wherein the prongs are configured to actuate the releasable latch of the hub body, and the tabs of the prongs are configured to lock to the hub body. The hub body may comprise access channels to the release latch which configured to receive the prongs with tabs. The infusion housing may comprise a release latch configured to unlock the infusion housing from the infusion hub.

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

According to the devices, kits and methods described herein, a skin treatment device, skin device, wound treatment device, scar or keloid treatment device, scar or keloid amelioration or prevention device, bandage, or dressing may be provided that may be applied, attached to or coupled to one or more layers of the skin or tissue of a subject (hereinafter referred to as “dressing”, “skin device” or “skin treatment device”).

In addition to amelioration of scar formation, other uses for such skin treatment device may or may not include without limitation, for example, treating skin related conditions such as acne, blemishes, rosacea, warts, rashes (including but not limited to erythematous, macular, papular and/or bullous conditions), psoriasis, skin irritation/sensitivity, allodynia, telangiectasia, port wine stains and other arterio-venous malformations, and ectopic dermatitis; treating or improving existing scars, wrinkles, stretch marks, loose or sagging skin or other skin irregularities; lifting, pinning, holding, moving skin for various purposes such as during pre-operative preparation, during surgical procedures for example as a low-profile tissue retractor, to stabilize blood vessels during needle or catheter insertion, postoperatively, pre or post operatively for pre-treating or preconditioning skin for example, prior to scar revision, wound incision, body contouring, in mastectomy skin expansion, aesthetic skin treatment or resurfacing whether topical or subdermal, whether or not using an energy modality such as, for example, microwave, radio-frequency ablation, high-intensity focused ultrasound, laser, Infrared, incoherent light, during weight loss, or for aesthetic purposes; hair removal or hair loss; treating and/or closing skin injuries for example, incisions, wounds, chronic wounds, bed sores, ulcers (including venous stasis ulcers), preventing or reducing the incidence of wound dehiscence, diabetic skin or wound conditions, burn healing and/or relief; acting as an occlusive or negative-pressure wound dressing; protecting incisions or wounds, e.g. prevention of splitting or opening, protecting newborn belly buttons after cutting umbilical cord. Such treatments may include use of a drug or other therapeutic agent that may be applied to the skin with such device. The agents may include but are not limited to antibiotics, anti-fungals, immune modulators including corticosteroids and non-steroidal immune modulators. The agents may be provided in any of a variety of formulations, including but not limited powders, gels, lotions, creams, pastes, suspensions, etc. The devices may also be used for purposes of delivering a drug to the skin or through the skin, for example by stretching the skin and applying a drug thereto. Different configurations of the device may be amenable to the size or geometry of different body regions. The treatments may be applied to regions of any shape (e.g. linear, curved, stellate), size or depth, and to one or more regions of the body, including but not limited to the scalp, forehead, face (e.g. nose, eyelid, cheeks, lips, chin), ears, neck, shoulder, upper arm, lower arm, palm, dorsum of the hand, fingers, nailbed, axilla, chest, nipple, areola, back, abdomen, inguinal region, buttocks, perineal region, labia, penis, scrotum, thigh, lower leg, plantar surface of the foot, dorsal surface of the foot, and/or toes. Such devices may also be referred to herein as a “dressing”, “skin device” or “skin treatment device”.

In some situations, an immediate, quick or simple application of a dressing may be desired. Devices, kits and methods described herein may be for the preparation and/or application of a dressing to the skin and the separation of the applicator, tensioning device or dressing carrier, support or base 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: contain, hold, carry or support a dressing at least temporarily; may be used to prepare a dressing for application; may be used to deliver, orient or apply a dressing; may be used to maintain a dressing in a stressed or strained configuration; may be used to stress or strain a dressing; may be used to separate the dressing from the packaging, carrier, support, base, applicator or tensioning device and/or may be used during or after application of a dressing to provide additional treatment to a wound, incision or other treatment location; and/or may be used to apply pressure to a wound, incision or other treatment location. According to some variations, a packaging and/or applicator may provide structural support for a dressing while or after an adhesive liner is released. According to some variations, the assembly may be constructed to avoid folding or bending of the dressing to the extent that the adhesive on the dressing sticks to itself. For example, when some variations of the dressing are held or supported at one point or along one edge of the dressing in a cantilever configuration, the dressings will not bow, laterally deform, or otherwise deform out of plane, under their own mass or configuration.

In some other variations of the devices and methods herein, a device with a substantially rigid support structure or that provides structural support to a dressing and that provides a particular 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 a hand grasping force is applied to an edge of the device, before the device buckles or folds. For example, a resistance to bending may be characterized as the peak force that is achieve as the device and support structure are compressed without compressed by 25% of its original dimension. This column strength or rigidity may vary, depending upon the direction along the device and support structure being measured. In some further variations, the peak force may be at least about 0.02 Newtons per millimeter (N/mm), about 0.03 N/mm, about 0.05 N/mm, about 0.1 N/mm, about 0.15 N/mm, about 0.2 N/mm, about 0.3 N/mm, about 0.4 N/mm or about 0.5 N/mm. In some variations of devices comprising generally flat or planar devices and support structures 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 an aspect ratio of length to width that is greater than 1:1, 2:1 or 3:1, for example.

A resistance to bending in the direction of dressing strain may also be measured by three-point bending, applying a transverse force to the midpoint of the applicator simply supported on two outer points at a given distance apart or support span. For example, the distance between the two points of a sample may be approximately 0.75 inches and a force that ranges from about 1 to 1.25 pounds may be applied to a sample approximately 0.35 inches in width resulting in a deflection of approximately 0.05 inches. A resistance to bending may also be measured by characterizing the force at which buckling occurs on a simply supported beam. For example, a force of approximately 0.45 pounds may be applied to a simply supported sample approximately 0.35 inches in width and may result in a deflection of approximately 0.004 inches. The resistance to bending may also be characterized by the strain of the outer surface before fracture or permanent deformation. By taking measurements of the support structure and the deflections 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 comprise a flexural modulus of at least about 0.9 GPa, while in other embodiments, the flexural modulus is at least about 1 GPa, at least about 1.1 GPa, at least about 1.2 GPa, at least about 1.3 GPa, or at least about 1.4 GPa.

In another example, a device of 7 cm wide by 19 cm long may be configured with a support structure comprising a paperboard, support sheet or support structure. The support structure may have an average thickness in the range of about 0.008″ to about 0.028″ or greater. In some specific variations, the support structure may have a thickness of about 0.012″, about 0.016″, about 0.018″, about 0.024″, about 0.28″ or about 0.032″, about 0.036″, about 0.04″, about 0.05″ or greater. Upon the application of force along the lengthwise edge of the 19 centimeter length, i.e. across the 7 cm width of the device, the support structure may provide sufficient rigidity or column strength to achieve peak forces of about 3 pound or more, 4 pounds or more, or of about 10 pounds or more, while being compressed, collapsed, bowed, buckled or otherwise deformed by 25% along its 7 cm width (i.e. about 1.75 cm). In some variations, the support structure may comprise scoring or regions of reduced thickness to permit some bending it at least one direction or in both directions.

According to some variations, a device that provides structural support may have a plurality or supporting cross elements or segments extending from one edge of the length to an opposing edge or the length (or from one edge of a width to an opposing edge of a width); According to some variations there may be three or more cross elements, e.g., a cross element extending along two opposing edges and transversely across a width (or a length) and one or more cross elements extending across the width (or length) and between the cross elements along the two opposing edges. Such cross elements may or may not be coupled or connected to each other, for example, with a relatively flexible material. Such cross elements may have a total aggregate width with respect to the length of an opposing edge 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 that have a total aggregate width, relative to the length of the opposing side, between about 20% to 100%. Such cross elements may be segmented and may provide flexibility when bending in a direction and rigidity relative to the flexibility, in another direction.

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 pre-determined strain in an elastic skin treatment device that is then affixed to the skin surface using skin adhesives to transfer a generally planar(e.g. compressive) force from the bandage to the skin surface.

In some variations, a dressing is provided, comprising an elastic sheet structure (e.g., a comprising a silicone polyurethane, TPE (thermoplastic elastomers), synthetic rubber or co-polyester material) comprising an upper surface, a lower surface, a first edge and a second edge opposite the first edge, and one or more adhesive regions. The dressing may further comprise a first release liner releasably attached to the adhesive region or regions. The adhesive region(s) may comprise a pressure sensitive adhesive. The dressing may be tapered or otherwise shaped to reduce skin tension at the edges. The dressing may have modified, reduced or no adhesive near its edges to reduce skin tension at the edges. Portions of the dressing may be unstrained and may thereby reduce strain in certain areas of the skin where the dressing is applied. In some specific examples, the unstrained area or areas are found between the edges of the dressing and the strained area(s). In some further examples, the unstrained areas are limited to this area and are not found, during application or use, between the strained areas of a single dressing, in use. In still further examples, the unstrained areas are limited to areas along the edges of a dressing that intersect the strain axis of the strained area(s), but not to areas along the edges of the dressing that are generally parallel to the strain axis.

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

In some situations, application of a compressive force to a wound is desirable to reduce bleeding. According to some variations, the packaging, carrier, support, base, applicator or tensioning device described herein may be further used to help reduce bleeding, e.g., by allowing application of a compressive force using the device while or after the dressing is applied. A coagulative additive may also be provided on a 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 hold a dressing's form so that it is easy to manipulate.

According to some variations, the packaging is also sufficiently flexible in at least one direction to permit curving or shaping of the dressing to conform to the curvature or shape of the location on the body or skin where the dressing is applied. Generally, the flexibility of the packaging used to conform the dressing to the treatment site may be configured so that the treatment site is not substantially deformed during the application of the dressing; so that the application of the dressing is relatively smooth or uniform on the skin; and/or provides a uniform, predetermined, or relatively predictable strain or force to an area of skin The packaging or applicator may have flexibility in a first direction and greater rigidity in another direction. The packaging or applicator may include elements or segments that permit flexibility with respect to adjacent elements or segments.

According to some variations, the packaging is also sufficiently flexible in at least one direction to permit curving or shaping of the dressing to conform to the curvature or shape of the location on the body or skin where the dressing is applied. Generally, the flexibility of the packaging used to conform the dressing to the treatment site may be configured so that the treatment site is not substantially deformed during the application of the dressing; and/or so that the application of the dressing is relatively smooth or uniform on the skin; and/or provides a uniform, predetermined, or relatively predictable strain and/or force to an area of skin. The packaging or applicator may have flexibility in a first direction and greater rigidity in a second direction. The first direction may be transverse to the direction of straining or have a component that is transverse to the direction of straining. The second direction may by the direction of straining or have a component that is in the direction of straining. The first direction may or may not be transverse with respect to the second direction. The packaging or applicator may include elements or segments that permit flexibility with respect to adjacent elements or segments.

According to some variations a desired flexibility, for example having at least one component transverse to the direction of straining, may be characterized by a modified cantilevered beam bending model, i.e. applying a force to the free end of a beam, simply supported from the other end, while wrapping it around a cylindrical object with a known radius of curvature or curvature, defined as the reciprocal of the radius of the curvature. According to one variation, the force to bend the packaging or applicator around an object with a predetermined curvature may be no greater than about 3 pounds. According to one variation, the force may be no greater than about 0.3 pounds. According to one variation, the force to bend around a predetermined curvature of about a 2.5 inch radius may be no greater than about 3 pounds. In another variation, the force to bend around a predetermined curvature of about a 2.5 inch radius may be no greater than about 0.3 pounds.

According to some variations, a packaging, applicator or tensioning device is provided comprising a base having an inner surface to which a dressing is removably attached, and a cover or lid having an inner surface interfacing the inner surface of the base when in an initial closed configuration. According to some variations, the base and cover are coupled at corresponding edges along their corresponding lengths to form a book-like structure whereby the cover may be rotated with respect to the base to open the device. Alternatively the cover may be lifted off of the base. According to variations, a liner is attached to the cover and will expose an adhesive side of a dressing when the cover is lifted or opened.

In some variations, the book-like structure, in the closed configuration, comprises a layered structure comprising 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 a cover/lid, a base, and a treatment device. The treatment device may also comprise one or more release layers. In one variation, in the closed configuration, a first face of the cover/lid is in contact with a first face of the treatment device, and a first face of the base is in contact with the second surface of the treatment device opposite the first surface, while in the open configuration, a second face of the cover/lid (opposite the first face of the cover/lid) is in contact with a second face of the base (opposite the first face of the base) but not with the first face 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 attached asymmetrically to the book-like structure, relative to the bending region of the book-like structure. In some instances, the asymmetric attachment may provide the user with a mechanical advantage when tensioning the dressing, and/or may reduce manufacturing costs by optimizing the amount of elastic material used in the dressing. In other variations, the dressing or skin treatment device may be attached symmetrically to the book-like structure, relative to the bending region of the book-like structure.

In another embodiment, a method of applying a dressing to a surface is provided. According to some variations the method may comprise providing a dressing packaging 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 a skin or wound of a subject; and a back surface, wherein the back surface of the dressing is removably coupled or anchored to the inner surface of the base structure, and wherein the first surface faces away from the inner surface of the base structure; and a cover configured to removably cover the first surface of the dressing. A method may further comprise removing the cover to expose a first surface of a dressing; and using the manipulation portion of the base structure to apply the first surface of the dressing to a wound or skin of a 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 both strained and unstrained regions.

According to variation, a method of applying a dressing to a wound or skin of a subject comprises: providing a dressing packaging assembly comprising: a base structure having an inner surface; a cover structure having an opposing surface, wherein the base structure is movably coupled to the cover structure; and a dressing comprising a first surface including an adhesive region, and a back surface, wherein at least a portion of the back surface is removably coupled to the inner surface of the base structure, and wherein the opposing surface of the cover structure comprises an adhesive backing covering the adhesive region when the cover structure is in the first position; pivoting the cover structure with respect to the base structure to a second position to separate the opposing surface from the first surface of the dressing and to separate the adhesive backing from the adhesive region; applying the first surface of the dressing to a wound or skin of a subject, then subsequently releasing the dressing from the base structure. According to variations of the method, at least a portion of the back surface of the dressing is coupled to the cover structure and further comprising pivoting the cover structure with respect to the base structure to strain the dressing.

According to variations, a dressing tensioning device comprises: a dressing carrier comprising a first carrier edge and a second opposing carrier edge defining a carrier width therebetween; a tensioning element configured to move with respect to the dressing carrier from a first position to a second dressing tensioning position; and a dressing assembly comprising a dressing including a first dressing edge coupled to the carrier adjacent the first carrier edge; a second dressing edge coupled to an attachment element wherein the attachment element coupled to the tensioning element; wherein in the first position of the tensioning element, the second dressing edge is a first distance from the second carrier edge within the width of the carrier, and in the second position of the tensioning element, the second dressing edge is a second distance from the second carrier edge within the width of the carrier, wherein the first distance is greater than the second distance. According to variations, 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 variations, a dressing packaging comprises: a dressing carrier comprising a first carrier edge, a second carrier edge opposing the first carrier edge, and a support structure extending between the first edge and the second edge, configured to support a dressing during application of the dressing to a subject; and a dressing comprising a first dressing edge, a second dressing edge opposing the first dressing edge, a back surface and an opposing skin interfacing surface, wherein at least a portion of the back surface is removably coupled to the dressing carrier wherein the first dressing edge and the second dressing edge are positioned between the first carrier edge and the second carrier edge, and wherein the first dressing edge defines a first margin between the first dressing edge and the first carrier edge and the second dressing edge defines a second margin between the second dressing edge and the second carrier edge, wherein each of the first and second margins have a width of at least three millimeters.

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

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

A desired time for application of the dressing to a subject may be when the dressing, in its pre-strained and strain shielded configuration, has a tensile force characteristic or range thereof that is desired. Such desired range may be selected to provide sufficient modulation of the forces on the skin to treat the skin while avoiding or minimizing disruption irritation to the skin. As noted herein, for a given dressing, different levels of stress or strain may be imparted to the skin at different locations and/or on different subjects. Also different levels of force offloading may be desirable for different individuals or different locations on a subject's skin. Thus different ranges of dressing force properties may be appropriate for different skin treatment applications.

Such desired force range may be selected based on a determination desired force properties to be applied to a particular subject, portion of skin and/or for a particular skin treatment purpose. Such desired force may be high enough to provide a therapeutic mechanomodulation of the skin while be low enough to prevent significant skin irritation.

Force properties of a pre-strained dressings may vary over time. An initial strain may be applied to the dressing where the elastic material or other structure, of the dressing has an initial tensile force characteristic. The dressing may be maintained in a strained configuration at a particular strain level after it is pre-strained for an initial period of time. During the initial period of time, the force properties of the elastic material may diminish, decay or exhibit a loss of force. After an initial predetermined period of time, the force properties of the elastic material may reach, diminish to or decay to a desired force level and/or range of force levels. The dressing elastic material force characteristics may be within the desired range for at least a subsequent period of time. In some variations, the dressing material may have an elastic 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 up to a 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 up to a 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 able to maintain an engineering stress of at least about 200 kPa, 250 kPa, 300 kPa, 400 kPa, or 500 kPa, 1000 kPa, 1500 kPa, 2000 kPa, 2500 kPa, 3000 kPa or more for at least 8 hours with less than a 10% or 5% variation or decrease in engineering stress.

According to a variation, for example, the initial force or strain properties of a dressing may be selected so that the desired range of force values occur during a period of time where the percentage loss of force 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 percentage loss of force of the dressing over time.

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

According to variations, a dressing may be configured to be initially strained or tensile stressed to a desired strain or force level and maintained in the strained configuration for an initial time frame. According to variations, the initial time frame may be, for example, 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more prior to application. According to variations, the initial time frame may be 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more in a material pre-conditioning state prior to final assembly or manufacture. Such preconditioning state may be straining the material at a constant strain or straining the material at varied levels of strain.

Then according to some variations, for the duration of a subsequent pre-determined time frame after the initial time frame, the dressing may be configured to maintain a desired minimum final force or force range. During the subsequent time frame, the device may be applied to a subject's skin for treatment. Such desired force range may be from about 0.5 to 1.0 Lbf/inch, 1.0 to 2.5 Lbf/inch or from about 1.6 to 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 dressing may then be coupled to a strain maintaining element during an initial period of time. The strain maintaining element may remain on the dressing during a portion of the subsequent period of time until it is used.

According to a variation for example, the average initial force or strain properties (average may include or may comprise an average, for example, per manufacturing lot, or a specified average within a given tolerance level) of a dressings pre-strained at manufacturing may be provided so that the desired range of average force values occur during a period of time where the average percentage loss of force is reduced and occurs over a longer period of time. In other variations, the pre-straining is initiated at the point-of-use. In still other variations, a portion of the pre-straining is performed at the point-of-manufacture, and additional straining or strain relief is performed at the point-of-use. After pre-straining, the dressing may then be packaged, sealed and sterilized for future use.

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

According to variations, the dressings may be initially strained or over-stressed to provide a greater average initial force per unit width than that of a desired range at the time of application to skin. According to variations, the average initial strain and resulting initial force per width of a dressing may be selected based on desired final and resulting force properties and/or a desired time frame for use of the dressing. Such average initial strain level may be, for example, less than 20%, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 100% or more. According to variations, the average initial force is greater than a desired force range. Such average initial force level may be for example about or up to 25%, about or up 35%, about or up to 50%, about or up to 75%, or more than the desired force at the time of application of the dressing. Such average initial force level may be but is not limited to, for example, between 2 and 5 Lbf/inch, 1.54 and 3.85 Lbf/inch, 1.33 and 3.33 Lbf/inch. or 0.85 to 2.20 Lbf/inch

According to variations, a dressing may be configured to be initially strained or tensile stressed to a desired average strain or force level and maintained in the strained configuration for an initial time frame. According to variations, the initial time frame may be 1 hour or more, 1 day or more, 1 week or more, or up to 1 month or more prior to application. According to variations, the initial time frame may be 1 hour or more, 1 day or more, 1 week or more or up to 1 month or more in a material pre-conditioning state prior to final assembly or manufacture. Such preconditioning state may be straining the material at an average constant strain or straining the material at varied levels of average strain.

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

A pre-strained dressing may be coupled to a strain maintaining element during an initial period of time during one or more manufacturing steps. The strain maintaining element may remain on the dressing during a portion of the subsequent period of time during manufacturing or in transport or storage until it is used.

In another example, a method for modulating tissue response at a target site is provided, comprising providing a strained elastic structure with an access opening and a support structure, placing the strained elastic structure against a target site, releasing the strained elastic structure from the support structure, and inserting an access structure into the target site, wherein the access structure is located in the access opening. The strained elastic structure may be an elastic sheet with an adhesive layer. Attaching the strained elastic structure to the target site may comprise 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 comprise 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 wherein the method may further comprise passing a sensor or infusion cannula using the delivery tube. The access structure may be attached to a housing. The housing may comprises a skin configured to attach the housing to a skin surface. The housing may further comprise a support layer, and the adhesive may be located on the inferior surface of the support layer. The method may further comprise adhering the housing to the elastic structure. The method may further comprise releasing the access structure from a delivery device after inserting the access structure into the target site. The method may further comprise aligning the delivery device with indicia or alignment structures located on the strained elastic structure.

In another embodiment, a tissue treatment device is provided, comprising a strained elastic layer comprising a top surface, a bottom surface and a treatment opening, a skin adhesive layer adhered to the bottom surface of the strained elastic layer, a protective layer releasably contacting the adhesive layer, a strain support removably attached to the top surface of the elastic layer, the strain support comprising a layer structure with a center opening surrounding the treatment opening of the strained elastic layer, the strain support having sufficient rigidity to maintain the strained elastic layer in a strained configuration, and at least one alignment structure located on the strain support and surrounding the center opening of the strain support. The strain support may further comprise a perforation region from the center opening to an edge of the strain support. The alignment structure may comprise a separation region aligned with the perforation region of the strain support. The strain support may comprise a first end, a second end, and an arcuate body therebetween defining the center opening of the strain support. The device may further comprise a strain support adhesive layer between the strained elastic layer and the strain support, wherein the strain support adhesive layer has a lower T-peel force than the skin adhesive layer. The strained elastic layer may be heat staked to the strain support. The strain support may further comprise perforations to facilitate separation of the strain support from the strained elastic layer.

In still another embodiment, a treatment device is provided, comprising a strained elastic layer comprising 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 of 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 the strain in the strained elastic layer, and at least one pull tab configured to releasably attach the strained elastic layer and strain support together. The treatment device may further comprise an infusion set applicator that is releasably attached to the infusion hub. The device may further comprise two pull tabs located on opposite sides of the strained elastic layer. Each of the two pull tabs may comprise perforations configured to tear and so that the strained elastic layer and infusion hub can separate from the strain support.

In another example, a treatment device is provided, comprising a strained elastic layer comprising 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 of 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 the strain in the strained elastic layer, and at least one pull tab configured to releasably attach the strained elastic layer and strain support together. The treatment device may further comprise an infusion set applicator that is releasably attached to the infusion hub. The device may comprises two pull tabs located on opposite sides of the strained elastic layer. Each of the two pull tabs may comprise perforations configured to tear and so that the strained elastic layer and infusion hub can separate from the strain support.

In another embodiment, a method of treating a therapeutic site is provided, comprising placing a first tensioning member at a first location next to a target site, wherein the first tensioning member is pre-tensioned along a first tensioning axis, placing a second tensioning member at a second location next to the target site, wherein the second tensioning member is pre-tensioned along a second tensioning axis and wherein the second location is spaced apart from the first location by a gap no greater than 20 mm and wherein the target site is located in the gap, and injecting or infusing a therapeutic agent at the target site. The first tensioning axis and the second tensioning axis may be parallel. The first tensioning member and the second tensioning member may be completely separate. The first and second tensioning members may be integrally formed with a predetermined longitudinal gap therebetween, the longitudinal gap 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 each other. The predetermined longitudinal gap has an average of width of less than 20 mm, less than 10 mm, or less than 5 mm. The method may further comprise adhering an infusion set to the first and second tensioning members before using the infusion set to infuse the therapeutic agent.

In another embodiment, a method of treating lipodystrophy is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of a patient to reduce the risk of lipodystrophy. The injection or infusion site may be an insulin or insulin analogue injection or infusion site. The patient may be diabetic and the lipodystrophy may be lipohypertrophy. The patient may have no prior history of lipohypertrophy, or may have a prior history of lipohypertrophy. The method may further comprise reducing the risk of insulin resistance, and/or reducing the rate of insulin or insulin analogue dosage increase over a time period. The time period may be one year.

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

In still another embodiment, a method of treating diabetes may be provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of diabetes patient to improve glucose time-in-range. The glucose time-in-range may be a daily, weekly, or monthly glucose time-in-range.

In another example, a method of reducing diabetes treatment costs in a diabetic population may be provided, comprising applying an adhesive skin tensioning device to an insulin or insulin analogue injection or infusion site of diabetes patient to reduce the costs of blood glucose variability or serious adverse events.

In still another example, a method of treating a therapy site is provided, comprising adhering a multi-layer strained dressing to a treatment site, releasing the strain of the multi-layer strained dressing to transfer strain from the dressing to the treatment site to reduce tissue tension at the treatment site, attaching a first hub and a first catheter to the multi-layer dressing, delivering a therapeutic agent through the first hub and first catheter to the treatment site, removing the first hub and first catheter from the multi-layer dressing by removing a first layer from the multi-layer dressing, attaching a second hub and a second catheter to the multi-layer dressing, delivering the therapeutic agent through the second hub and second catheter to the treatment site, removing the second hub and second catheter from the multi-layer dressing by removing a second layer from the multi-layer dressing.

In another embodiment, a method of positioning an infusion set is provided, comprising adhering a strained skin tension off-loading device to a treatment location, wherein the skin tension off-loading device comprises a strained elastic layer with a treatment opening, a strain support and a protruding alignment structure surrounding the treatment opening, positioning an infusion set applicator over the treatment opening by using the alignment structure, actuating the infusion set applicator to decouple an infusion set hub from the infusion set applicator and to insert a catheter of the infusion set hub through the treatment opening, removing the infusion set applicator, and removing the strain support and protruding alignment structure from the strained skin tension off-loading device to release the strain in the strained elastic layer. The method may further comprise selecting the 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 pre-conditioning.

In one embodiment, a method of treating subcutaneous tissue may be provided, comprising applying an adhesive skin tensioning device to a treatment site of a patient to reduce the development or progression of a subcutaneous lesion comprising calcifications, cellular proliferation or hypertrophy. The treatment site may be a device implantation, injection or infusion site. The subcutaneous lesion may be a lipodystrophy lesion. The lipodystrophy lesion may be a lipohypertrophy lesion. The injection or infusion site may be an insulin or insulin analogue injection or infusion site. The patient may be diabetic and the subcutaneous lesion may be lipohypertrophy. The patient may have no prior history of lipohypertrophy or a prior history of lipohypertrophy. The method may further comprise reducing the risk of insulin resistance, and/or reducing the rate of insulin or insulin analogue dosage increase over a time period. The time period may be one year. The infusion site may be a hemodialysis fistula or graft site. The injection site may be an oncologic therapy injection site. The oncology therapy injection site may be a pertuzumab and/or trastuzumab injection site. The treatment site may be an implantation site of an implantable pulse generator, implantable pacemaker or defibrillator. The treatment site may be an implantation site of a subcutaneous infusion port.

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

In still another embodiment, a method of treating diabetes is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of diabetes patient to improve or slow the progression of tissue stiffness in an injection or infusion site.

In another embodiment, a method of treating diabetes is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site to increase the percentage of time-in-range of glycemic control. Time-in-range may be the percentage of time with blood glucose levels between 70 mg/dl and 180 mg/dl.

In another variation, a method of treating diabetes is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site to decrease the percentage of time in hypoglycemia. Hypoglycemia may be a blood glucose levels less than 70 mg/dl.

In another variations, a method of treating diabetes is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site to decrease the percentage of time in hyperglycemia. Hyperglycemia may be a blood glucose levels greater than 180 mg/dl.

In still another variation, a method of treating diabetes is provided, comprising applying an adhesive skin tensioning device to an injection or infusion site of diabetes patient to decrease variability in insulin absorption compared to untreated controls. The decrease in variability of insulin absorption may be a decreased coefficient of variation of insulin C_maxor AUC_INSas measured by a hyperinsulinemic euglycemic clamp testing or mixed-meal tolerance testing.

In another variation, a method of treating diabetes is provided, comprising applying a tissue tensioning device to an injection or infusion site of diabetes patient to increase insulin absorption compared to untreated controls. The increased insulin absorption may be an increased insulin c_maxor AUC_INSas measured by a hyperinsulinemic euglycemic clamp testing or mixed-meal tolerance testing.

In another example, a system for treating chronic injection sites is provided, comprising an adhesive tensionable tissue treatment device comprising a plurality of injection openings surrounded by a plurality of removable adhesive rings, wherein the adhesive rings have 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 comprise an applicator configured to maintain a predetermined tension in the tensionable tissue treatment device.

In another variation, a method of treating injection sites is provided, comprising adhering a tensioned tissue treatment device to a skin surface, releasing some tension in the tensioned tissue treatment device to transfer tension force 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 detaching the first injection template from the tensioned tissue treatment device. The method may further comprise removing a first cover strip of the first injection template, wherein the first cover strip surrounds or covers the first needle opening. The method may also comprise 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 detaching the first injection template, wherein the first cover strip also surrounds or covers the second needle insertion opening. Removing the first cover strip may be performed before inserting the first needle through the first needle insertion opening.

BRIEF DESCRIPTION OF THE DRAWINGS

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

FIG.2 is a perspective view of the dressing and packaging assembly ofFIG.1 with a cover open at about a ninety degree position from the closed position.

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

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

FIG.5A is a schematic bottom view of the dressing and packaging assembly in the position illustrated inFIG.3.

FIG.5B is a cross section ofFIG.5A along the lines C-C.

FIG.5C is a cross section ofFIG.5A along the lines D-D.

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

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

FIG.8A is a schematic end view of the dressing and packaging assembly ofFIG.7 in a strained configuration with the cover open at about 360 degrees from a closed configuration.

FIG.8B is an expanded view of section B ofFIG.8A.

FIG.8C is an expanded view of section C ofFIG.8A.

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

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

FIG.11 is a perspective view of the dressing and packaging assembly ofFIG.10 with a cover in approximately 90 degree configuration from the closed configuration.

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

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

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

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

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

FIG.15B is a bottom15F perspective view of the dressing and packaging assembly ofFIG.15A in a strained configuration.

FIG.15C is a bottom perspective view of the dressing and packaging assembly ofFIG.15A after removing the cover of the carrier, support or base.

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

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

FIG.15F is a perspective view of a strained dressing after it is separated from the attachment sheets.

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

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

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

FIG.15J is a cross section of the dressing assembly with attachment sheets ofFIG.15G.

FIG.16A is a perspective view of a variation of a dressing assembly with removable attachment sheets.

FIG.16B is a perspective view of the dressing assembly of FIG.16Awith a peeled removable attachment sheet.

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

FIG.16D is a cross section of the dressing assembly with attachment sheets ofFIG.16A

FIG.17A is a perspective view of a variation of a dressing assembly with removable attachment sheets.

FIG.17B is a perspective view of the dressing assembly of FIG.17Awith a peeled removable attachment sheet.

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

FIG.17D is a cross section of the dressing assembly with attachment sheets ofFIG.17A.

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

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

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

FIG.18D is a top perspective view of the device ofFIG.18A in a strained and folded configuration while detaching an attachment sheet.

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

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

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

FIG.18H is a perspective view of the device ofFIG.18A with the dressing being separated from the attachment sheets.

FIG.18I is a perspective view of the device ofFIG.18A with the dressing separated from the attachment sheets.

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

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

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

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

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

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

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

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

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

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

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

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

FIG.21D is a top view of the dressing carrier, support, base tensioning device or applicator ofFIG.21A in a flexed configuration.

FIG.21E is a cross-section ofFIG.21D along the lines A-A

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

FIG.22B is a perspective view of a variation of a 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 ofFIG.23B.

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

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

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

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

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

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

FIG.24 is a perspective view of a plurality of pre-strained 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 elastic dressing material as describe in Example I.

FIG.27 is a schematic illustration of percent force loss over time for a pre-strained 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 elastic dressing material as describe in Example II.

FIGS.30A to30C depict the use of a strained dressing with an exemplary infusion set.FIG.30D is a cross sectional view of the strained dressing and infusion set inFIG.30C.

FIGS.31A to31C depict the method of use of a strained dressing with an infusion set delivery device.FIGS.31D and31E are cross sectional views of the method of use.

FIGS.32A to32E depict various exemplary aperture configurations for the dressing.

FIG.33 depicts the placement of a three-aperture dressing onto an injection location.

FIG.34 depicts an exemplary dressing comprising an aperture and various alignment indicia.

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

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

FIG.37A depicts another exemplary embodiment of a visual guide tool comprising distal opening and one or more inward projections.FIG.37B depicts the visual guide tool ofFIG.37A overlaid on a dressing.

FIGS.38A and38B depict the use of the visual guide tool inFIGS.37A and37B with an infusion set delivery tool.

FIG.39A is a perspective view of an exemplary infusion set delivery system that includes a pre-attached pre-strained dressing.FIG.39B to39D are top, side and bottom views of the system inFIG.39A.FIG.39E is a bottom view of the system with its adhesive protective liners removed.

FIG.40A depicts the placement of the delivery system inFIG.39E onto a treatment site.FIG.40B depicts the infusion set and pre-attached dressing inFIG.40A with the pull tabs removed.FIG.40C depicts the infusion set inFIG.40B with the dressing support separated from the dressing and withdrawal over the infusion set tubing.FIG.40D depicts the infusion set and pre-attached dressing.FIG.40E depicts the infusion set with the dressing support comprising tearable perforations.

FIG.41A is a superior plan view of another embodiment of a combined infusion set with a multiple separable tensioning layers.FIG.41B is a superior perspective view of the embodiment inFIG.41A.

FIGS.42A to42C are superior perspective view of a method of using the combined infusion set and multiple tensioning layers depicted inFIGS.41A and41B.

FIGS.43A to43C are side elevational views of the method depicted inFIGS.42A to42C.

FIG.44A is a detailed side elevational view of the method inFIG.42A;FIG.44B is a detailed view of the edges of the multiple tensioning layers inFIG.44A.

FIG.45A is a superior plan view of another embodiment of a combined infusion set with a multiple separable tensioning layers.FIG.45B is a superior perspective schematic view of the embodiment inFIG.45A.

FIGS.46A to46C are superior perspective view of a method of using the combined infusion set and multiple tensioning layers depicted inFIGS.41A and41B.

FIGS.47A and47B are top and side elevational views of the method depicted inFIGS.46A to46C.FIG.47cis a detailed view of the edges of the multiple tensioning layers inFIG.47B.

FIGS.48A and48B are superior plan and inferior perspective views of another exemplary infusion set delivery system with a pre-attached radially pre-strained skin tensioning device;FIGS.48C to48E depicts the placement and release of the pre-strained skin tensioning device.

FIGS.49A to49E are front perspective, superior plan, rear perspective, side elevational and inferior plan views, respectively, of a skin tensioning device with pre-attached alignment structure to facilitate placement of an infusion set delivery system.

FIGS.50A to50E depicts the use of the skin tensioning device inFIGS.49A to49E with an infusion set delivery system.

FIG.51 is a front perspective view of an alternate support structure for the skin tensioning device depicted inFIGS.49A to49E.

FIG.52 is a schematic illustration of another exemplary embodiment of a skin tensioning system comprising two separate skin straining device placed on opposing 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 a longitudinal gap or slot.

FIGS.54A and54B are superior plan and side elevational views of an exemplary infusion hub and catheter with a pre-attached skin tensioning device.

FIGS.55A and55B are schematic perspective views of a radially tensioned skin treatment device used for manual injection.

FIG.56A is a superior perspective of a skin tensioning device with a woven needle injection aperture being used with a syringe.FIG.56B is an inferior perspective view of the skin tensioning device inFIG.56A.

FIG.57A is a perspective view of an exemplary tensioned skin treatment system comprising removable injection templates.FIGS.57B to57D depict different injection templates that are usable with the system inFIG.57A.

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

FIG.59A is a perspective view of another exemplary tensioned skin treatment system comprising a weekly removable injection template with removable indicator strips;FIGS.59B to59E depicts the serial removal of the indicator strips.

FIG.60A is a perspective view of another exemplary tensioned skin treatment system comprising removable injection templates.FIGS.60B to60D depict different injection templates that are usable with the system inFIG.60A.

FIGS.61A to61D are top views of injection templates comprising a variable alignment structure.

FIG.62A is a perspective view of another tensioned skin treatment system comprising removable rings.FIGS.62B and62C are perspective views of an additional skin treatment system comprising individual removable covers for each dressing opening.FIGS.62D to62G depicts the use of the exemplary system inFIG.62B.

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

FIG.64A is a top view of another embodiment of a tensioned skin treatment system comprising removable strip ring markers.FIG.64B is a top of the system inFIG.64A with one strip ring marker removed.

FIG.65A is a top plan view of another embodiment of a tensioned skin treatment system, comprising an adhesive set of injection guides and covers, with an applicator.FIG.65B is a bottom plan view of the system inFIG.65A, with the release liner removed.FIG.65C is an exploded view of the system inFIG.65A.FIG.65D is an exploded view of the system inFIG.65B, with a dressing.FIG.65E to65G depicts the initial use of the system adhered to a dressing.

FIG.66A is a superior perspective view of an embodiment of a treatment system, including a dressing with an integrated, separable or removable infusion set.FIG.66B is a superior perspective view of the system inFIG.66A, with the infusion set connector and tubing removed.FIG.66C is a superior perspective view of the system inFIGS.66A and66B with the infusion set connector and tubing removed and the infusion hub and infusion catheter in the process of being removed.FIG.66D is superior perspective view of the system inFIG.66A to66C, with the infusion hub and infusion catheter removed from the dressing.FIG.66E to66H are side views depicting the use of the system to remove an infusion set from a dressing while leaving the dressing adhered to a subject.FIG.66E toFIG.66H correspond respectively toFIG.66A toFIG.66D.

FIG.67A is a superior perspective view of an embodiment of a treatment system, including a dressing with an integrated, separable or removeable infusion set.FIG.67B is a superior perspective view of the system inFIG.67A, showing the infusion set connector and tubing as it is removed.FIG.67C is a superior perspective view of the system inFIGS.67A and67B showing the infusion set hub and catheter as they are removed.

FIG.68A is an exploded superior perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removeable infusion set.FIGS.68B to68F are superior perspective views illustrating steps of removing the infusion set ofFIG.68A from the dressing.

FIG.69A is an exploded superior perspective view of an embodiment of a treatment system including a dressing with an integrated separable or removeable infusion set.FIG.69B is a superior perspective view of the treatment system, ofFIG.69A.FIG.69C is a superior perspective view of the system inFIGS.69A and69B, with the infusion set connector and tubing being removed.FIG.69D is a superior perspective view of the system inFIGS.69A-69C, with the infusion set connector and tubing removed and the infusion hub in a secured position on dressing connectors.FIG.69E is a superior perspective view of the system inFIGS.69A-69D, with the infusion hub rotated to an unsecured position and being removed from dressing connectorsFIG.69F is a superior perspective view of the dressing and dressing connector with the infusion hub removed.FIG.69G is a superior view of an infusion hub engaged with a dressing connector.FIG.69H is a cross section ofFIG.69G along the lines A-A.FIG.69I is a side view of an infusion hub engaged with a dressing connector.FIG.69J is a partial cross section inferior view of the infusion hub and dressing connector ofFIG.69I.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, ofFIG.70A with the infusion set connector and tubing being removed.FIG.70C is a superior perspective view of the system inFIGS.70A and70B with the infusion set connector and tubing removed.FIG.70D is a superior perspective view of the system inFIG.70C with a removal tool.FIG.70E is a superior perspective view of the system ofFIG.70D with the removal tool fully docked into the infusion hub.FIG.70G is a superior perspective view of the dressing and dressing connector with the infusion hub removed.FIG.70F is a superior perspective cross section of the system ofFIG.70G.FIG.70H is a side cross section of the system as shown inFIG.70D.FIG.70I is a side cross section of the system as shown inFIG.70E.FIG.70J is a side cross section of the system as shown inFIG.70F.FIG.70K is a superior perspective view of a tool for removing a portion of an infusion set.

DETAILED DESCRIPTION

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

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

As noted above, the wound healing process may be characterized in three stages: early inflammatory phase, the proliferative phase, and remodeling. The inflammatory phase occurs immediately after injury and typically lasts about two days to one week. Blood dotting takes place to halt blood loss and factors are released to attract cells that can remove debris, bacteria and damaged tissue from the wound. In addition, factors are released to initiate the proliferative phase of wound healing. In the proliferative phase, which lasts about four days to several weeks, fibroblasts grow and build a new extracellular matrix by secreting collagen and proteoglycans. At the end of the proliferative phase, fibroblasts can act to contract the wound further. 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 may continue for many weeks or months, or indefinitely after injury. Scars typically reach about 75-80% of normal skin breaking strength about 6-8 weeks after injury. In general, scars typically have a triangular cross-section. That is, a scar is usually smallest in volume near the skin surface (i.e., stratum corneum and epidermis) and increases in volume as it progresses into the deeper layers of the dermis.

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

Without wishing to be bound by any particular theory, we believe that mechanical strain acting on a wound or incision early in the proliferative phase of the wound healing process may inhibit cellular apoptosis, leading to a significant accumulation of cells and matrix, and hence increased scarring or the production of hypertrophic scars. Given the underlying similarities between hypertrophic scars and keloids with respect to excessive matrix formation, we believe that the devices and methods described herein may also be useful in preventing and treating keloids by offloading or neutralizing at least some of the strain that may be acting on the wound or incision. This tensile strain may be exogenous and/or endogenous strain, and may include but is not limited to the strain from the intrinsic tensile forces found in normal intact skin tissue.

A number of wound dressings have backings, adhesive liners and/or packaging that are removed prior to application of a wound dressing. Many existing dressings can be clumsy to orient and apply and can have a tendency to fold and adhere to themselves.

Devices, kits and methods described herein may treat skin at a skin site (“skin treatment device”), including without limitation, to ameliorate the formation of scars at wound sites by controllably stressing or straining the epidermis and deeper layers of dermal tissue at or near a skin site, i.e., at or adjacent a wound or treatment site of a subject's skin, thereby reducing tensile or compressive stress at the skin site. The stress at the skin site may be reduced to levels below that experienced by normal skin and tissue. The stress or strain may be applied to surrounding tissue in one, two, or more directions to reduce endogenous or exogenous stress at the skin site in one, two or more directions. Thus, devices and methods described herein may reduce the stress experienced by skin and/or a wound and surrounding tissues in order to treat a subject. The device may also assist in preventing or reducing the incidence of wound dehiscence.

Devices, kits and methods described herein may provide a packaging and/or applicator for a dressing. According to one variation, the packaging and/or applicator is configured to provide quick or easy preparation and/or application of a dressing. While some examples herein specifically refer to a packaging that also acts as a tensioning device to pre-strain a dressing, other dressings that are not pre-strained and/or strained prior to application may be provided in accordance with 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.

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

Backings, adhesive liners or release layers, and/or other packaging may provide some structural stability to a flexible wound dressing. However, when removed, the flexible wound dressing can be somewhat clumsy to use because it may fold and adhere to itself or the user, or otherwise provide for difficult positioning over the wound. Also the act of pulling or removing the liner and reorienting the dressing to the patient may increase the tendency to fold or flop. Furthermore, because of the folding or floppiness of the dressing, during adhesive removal and subsequent reorientation, the user has a significant possibility of compromising the sterility of a portion of the device to be applied to a wound site.

According to another variation, a packaging or applicator is configured to provide support for the dressing after the dressing is prepared and while the dressing is applied to a subject. According to some variations, a backing provides structural support or stability of the dressing as and/or after an adhesive liner is released. According to some variations, a dressing and packaging is configured to be pre-oriented in a position facing a wound i.e., for immediate application when and after the wound device is prepared for application. 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 packaging dressing carrier, support, base tensioning device or applicator tensioning device and/or applicator provide a release mechanism to separate the applied dressing from the packaging and/or applicator after the dressing is applied to the skin. According to a variation, a dressing may be prestrained and coupled to a dressing carrier, support, base tensioning device or applicator, for example as set forth in U.S. Provisional Application Ser. No. 61/512,340 filed on Jul. 17, 2011 and incorporated in its entirety herein by reference. One or more dressing releases described herein may be used with a 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 a packaging or applicator. According to some variations, a book-like packaging is provided with a cover, and a base to which a 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, a liner is attached to the cover and will expose an adhesive side of a dressing when the cover is lifted or opened. The base may be configured to provide structural support to the dressing while the liner is removed and/or while the dressing is applied to the skin of a subject.

According to some variations, the packaging, tensioning device, dressing carrier, support, base or applicator may further comprise an opening, a window, or a clear or semi-opaque portion through which a 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 a dressing so that there is an optimal or desired distance between the wound and the edges of the dressing and/or so that the dressing is in an optimal location for unloading skin stresses.

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, a packaging or applicator is more rigid or provides sufficient column strength in at least a first direction to be supportive of a dressing, while being relatively more flexible and less rigid in at least second direction to provide for a more conforming application to a curved or shaped skin surface of a subject or to permit curvature or shaping of the dressing where it is applied. The first and second directions may or may not be orthogonal to each other. According to some variations, a packaging applicator, tensioning device or dressing carrier, support or base is sufficiently rigid or supportive of a dressing while permitting shaping of the dressing, According to some variations, the carrier or support which may include a base and/or a cover may comprise segments of relatively more rigid material flexibly coupled to adjacent segments to provide flexibility to permit shaping of packaging/applicator and/or dressing while providing sufficient support of the dressing during application. According to some variations, segments are coupled to adjacent segments by way of a flexible material, such as a low-density polyethylene (LDPE) material, or a composite of adhesive and a thinner more flexible substrate. Alternatively, segments may be formed as a structure by manufacturing a substrate with cut-outs, slots, grooves, scoring or other openings or variations in thickness of the substrate at different locations.

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

According to variations, flexible elements are provided in combination with support elements that provide sufficient support to allow a user to maintain the dressing in a strained configuration. According to variations, one or more elements may be provided to maintain a strained dressing in a strained configuration, for example a securing element that secures the dressing in a strained configuration until it is applied to a subject and is released from the carrier, support, base tensioning device or applicator. For example, after straining the dressing, the dressing may be adhered or attached to one or more elements of a dressing, support, base tensioning device or applicator or dressing assembly until it is released from the carrier, support, base tensioning device or applicator or assembly.

According to some variations, the applicator may be further used to help reduce bleeding, e.g., by allowing application of a compressive force using a support structure while or after the device is applied. One or more hemostatic or coagulative agents may be applied to, or otherwise integrated with 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-acetyl glucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X, XIII, Von Willebrand factor), procoagulants (e.g. propyl gallate), antifibrinolytics (e.g. epsilon aminocaproic acid), and the like. In some variations, the agents may be freeze-dried and integrated into the dressing and activated upon contact with blood or other fluid. In some further variations, an activating agent may be applied to the dressing or the treatment site before the dressing is used on the subject. In still other examples, the hemostatic agent may be applied separately and directly to the wound before application of the dressing, or after application to the dressing via a catheter or tube. The devices may also comprise one or more other active agents that may be useful in aiding in 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 combinations thereof. A further example of such medicament may include, but is not limited to various antibiotics (including but not limited to cephalosporins, bacitracin, polyxyxin B sulfate, neomycin, polysporin), antiseptics (such as iodine solutions, silver sulfadiazine, chlorhexidine), antifungals (such as nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), grow factors (such as VEGF) and other treatments (e.g. botulism toxin. Of course, the devices may comprise more than one medicament or agent, and the devices may deliver one or more medicaments or agents.

According to one variation, the applicator and or packaging may be sufficiently supportive or rigid to hold a dressing's form so that it is easy to manipulate. According to a variation, the applicator may be sufficiently wider and/or longer or have a sufficiently larger area than a dressing so that it may provide sterile application and/or one-handed application. According to variations, a support structure is provided for a 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 margins provide a supported edge or area to grasp or manipulate the dressing or its carrier, base or support, without necessitating or creating a greater likelihood of inadvertent user contact with the adhesive.

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

Devices are described here that may be used for ameliorating the formation of scars and/or keloids at a skin or wound site. The scars may be any type of scar, e.g., a normal scar, a hypertrophic scar, etc. In general, the devices may be configured to be removably secured to a skin surface near a wound. The devices may shield the skin or wound from endogenous stress and/or exogenous stress. In some variations, the devices may shield the skin or wound from endogenous stress without affecting exogenous stress on the skin or wound, e.g., devices that modify the elastic properties of the skin, etc. In other variations, the devices may shield the skin or wound from exogenous stress without affecting endogenous stress on the wound. Such variations may include situations where the musculature and surrounding skin or wound tissue has been paralyzed, e.g., through the use of botulinum toxin or the like. In still other variations, the devices shield the skin or wound from both endogenous and exogenous stress.

The devices or dressings described herein may treat skin at a skin site including without limitation to ameliorate the formation of scars at wound sites by controllably stressing or straining the epidermis and deeper layers of dermal tissue at or near a skin site, thereby reducing tensile or compressive stress at the skin site itself. The stress at the skin site may be reduced to levels below that experienced by normal skin and tissue. The stress or strain may be applied to surrounding tissue in one, two, or three directions to reduce endogenous or exogenous stress at the skin site in one, two or three directions. The physical characteristics of the dressing and/or the method of applying the dressing may also be further configured to resist or reduce the rate of skin stripping or tension blistering from the application of strain to the incision site. For example, the stretching of the adhesive regions when applied to the skin surface may result in an increased tissue density under the adhesive region. This may be the result of generally planar, tangential or parallel compression of skin tissue that is directly attached to that adhesive region, resulting from the relaxation of the adhesive region. In some examples, this tissue compression may reduce the risk of tissue stripping and/or blistering of skin in direct contact with the adhesive, in contrast to bandage “strapping” where one end of a bandage is adhered to the skin and then tensioned or pulled across a wound before the other end is attached to the skin on the opposite side of the wound. Bandage “strapping”, while generating tension in the bandage during the application, may simultaneously generate a relatively high tissue strain at the first adhesion site. This high tissue strain then decreases when the bandage is attached to the skin at a second adhesion site as the high peak stresses are 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 transferred or generated in the skin as the adhesive regions are applied to the desired locations. When the pre-strained bandage is permitted to relax, however, the strain (or peak strain) in the skin may be increased. Thus, with a pre-strained bandage, temporary high tissue strain may be avoided or otherwise reduced during the application procedure. In other variations, however, the dressing may also be applied to the skin by strapping, or by a combination of pre-straining and strapping.

Although the depicted dressings may have a generally rectangular configuration with a length and/or width of about 160 mm to about 60 mm, in other variations the dressing may have any of a variety of lengths and widths, and may comprise any of a variety of other shapes. Also, the corners of the dressing may be squared or rounded, for example. The lengths and/or widths of an exemplary dressing may be in the range of about 5 mm to about 1 meter or more, in some variations about 20 mm to about 500 mm, and 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 an orthogonal dimension to the maximum dimension (e.g. width), excluding the minimum dimension of the dressing (e.g. the thickness), may be in the range of about 1:3, about 1:2, about 1:1, about 2:1, about 3:1, about 4:1 about 5:1, about 6:1, about 7:1, about 8:1, about 9:1 or about 10:1 or greater. In some variations, the strain axis of the dressing in use may be oriented with respect to the maximum dimension or to the orthogonal dimension to the maximum dimension. In some variations, the final compressive stress and strain imposed onto the skin by the elastic material may be the result of the 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 incision site, whether or not any tissue was excised from the skin site. The elastic material and the adhesive region may be configured to be applied to a skin location so that when the dressing is stretched to a particular tension and then adhered to the incision site, tensile stress in the dressing is transferred to the incision site to compress the tissue directly under the dressing along a tangential axis to the skin surface, the stress and strain imposed onto the skin location has a net or resultant orientation or axis is also generally tangential or planar to the elastic material and/or the outer surface of the skin location, with a similar axis to the orientation or axis of the tensile stress in the dressing. The tension in the dressing will relax to a tension level that maintains equilibrium with increased tension in the skin adjacent to the dressing. The application of the dressing to the skin location may involve the placement of the dressing without overlapping or being wrapped onto itself, e.g. wherein only adjacent regions of the dressing are interconnected and wherein non-adjacent regions of the dressing are not interconnected. The actual amount of stress and strain imposed on the skin may vary, depending upon the particular person, skin location, the thickness or various mechanical characteristics of the skin layers (e.g. epidermis, dermis, or underlying connective tissues), and/or the degree of pre-existing scarring, for example. In some further variations, the wound treatment dressing may be selected or configured for use at a specific body location, such as the scalp, forehead, cheek, neck, upper back, lower back, abdominal region, upper torso (including but not limited to the breast folds), shoulder, upper arm, lower arm, palm regions, the dorsum of the hand, finger, thigh, lower leg, the dorsum or plantar surface of the foot, and/or toe. Where applicable, some body regions may be further delineated into anterior, posterior, medial, lateral, proximal and/or distal regions, e.g. the arms and legs.

The dressing may be configured to impose a skin strain in 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 elastic tensile strain in 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 silicones, styrenic block copolymers, natural rubbers, fluoroelastomers, perfluoroelastomers, polyether block amides, thermoplastic elastomers, thermoplastic polyurethane, polyisoprene, polybutadiene, and the like. The material of the exemplary dressing may have a Shore A durometer in the range of about 20 to about 90, about 30 to about 80, about 50 to about 80. The exemplary dressing was constructed of MED 82-5010-05 by NUSIL TECHNOLOGY LLC (Carpinteria, Calif.). Other examples of suitable materials are described in U.S. application Ser. No. 11/888,978, which was 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 level or equilibrium level of strain in the dressing may be in the range of about 4% to about 60% or more, in other configurations about 15% to about 50%, and in still other configurations, about 20% to about 30% or about 40%. The ratio between the initial engineering tensile strain placed onto the dressing before recovery and the resulting engineering compressive strain in the skin may vary depending upon the skin type and location, but in some examples, may be about 2:1. In other examples, the ratio may be in the range of about 4:1 to about 5:4, about 3:1 to about 5:3, or about 5:2 to about 2:1. These skin strain characteristics may be determined with respect to a reference position of the body or body part, e.g. anatomical position, to facilitate reproducible measurements. The particular degree of strain may be characterized as either an engineering strain or a true strain, but may or may not be calculated based upon or converted from the other type of strain (e.g. the strain may be based upon a 45% engineering strain that is converted to a true strain).

In some further variations, one or more characteristics of the elastic material may correspond to various features on the stress/strain curve of the material. For example, the engineering and true stress/strain curves for one specific example of the dressing comprises a material that exhibits an engineering stress of about 1.2 MPa at about 60% engineering strain, but in other examples, the engineering stress may be in the range of about 900 KPa to about 3.5 MPa, about 1 MPa to about 2.2 MPa, about 1 MPa to about 2 MPa, about 1.1 MPa to about 1.8 MPa, about 1.1 MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When unloading or relieving stress from the dressing, the material may be configured with an engineering stress of about 380 KPa at about 40% engineering strain, but in other examples, the engineering stress during unloading of the material to about a 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 an engineering strain of about 30%, the material exhibits an engineering stress of about 300 KPa, but in other examples, the engineering stress when unloading 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 unloading to an engineering strain of about 20%, the material may have an engineering stress of about 100 KPa, but 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 at least achieve a specific range or level of engineering stress at each of the specified engineering strain levels described above, but in other examples, the material may be configured for lower levels of maximum engineering strain, e.g. up to about 30% or about 40%.

In some examples, certain portions of the stress/strain curve may have a particular morphology. For example, for a particular level of maximum strain the loading curve may be generally linear on the corresponding true stress/strain curve. In an example using a dressing described herein, up to a true strain of about 45%, the loading curve had a generally linear configuration. In other examples, the configuration may only be linear along a portion of the loading curve or may be curved along the entire loading curve. Where the loading curve is non-linear, the loading curve may be convex, concave or both. Also, in some examples, the tangent line of the loading curve (i.e. the line between the two triangles) may also be generally co-linear.

In some variations, the elastic material comprises a material having an elastic modulus E of at least about 1 MPa, about 1.5 MPa, about 2 MPa, about 2.5 MPa, about 3 MPa, about 3.5 MPa, about 4 MPa, about 5 MPa, about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa or at least about 10 MPa or greater. The material elastic modulus E may be no greater than about 10 MPa, about 9 MPa, about 8 MPA, about 7 MPa, about 6 MPa, or about 5 MPa, or about 4 MPa.

In addition to the absolute stress levels at certain strain levels described above, the material may also be characterized with respect to 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, the material may have a ratio of at least 4:1 to about 3:2 at each of the 20%, 30% and 40% strain levels, but in other examples, the material may exhibit these ratios only at 20%, at 30%, or at 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 in 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 testing conditions to achieve a stable level of stress at a constant strain, e.g. the material exhibits a limited amount of stress relaxation over a particular period of time and at a particular level of strain. The period of time 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 a 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 an engineering strain of about 30% without noticeable deviation over a period of about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, or about 8 hours or more. The stresses at 10% strain, 20% strain, and at 40% may be lower or higher.

In some variations, the elastic material or the dressing may be configured under testing conditions to maintain a particular minimum level of stress when held at a constant strain over a particular time period. In an example to assess the ability of a backing material to maintain a stress and strain on skin over time, engineering strains were measured while each backing material was tensile strained to 60% at a rate of 100 microns per second and held for 10 minutes, and then dropped to a strain of 30% at a rate of 100 microns per second and held for 9 hours. For example, the exemplary dressing is able to maintain 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 1000 KPa or greater. The level of constant strain may be different in other configuration, with a level of about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%. The time period over which the dressing is able to maintain a stress level may be at least about 2000 seconds, about 3000 seconds, about 4000 seconds, about 5000 seconds, about 6000 seconds, about 7000 seconds, about 8000 seconds, about 9000 seconds, about 10000 seconds, about 20000 seconds, about 30000 seconds, about 40000 seconds, about 50000 seconds, about 60000 seconds, about 70000 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, the elastic material and/or the adhesive material is configured to exhibit less than about a 15% change in stress or strain level over the 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, for example, a pressure activated adhesive (PSA), as a silicone, acrylic, styrene block copolymer, vinyl ether, nitrile or other PSA. In other variations, a non-pressure sensitive adhesive may be used, including but not limited a heat or light-cured adhesive. The pressure sensitive adhesive may be made from, e.g., polyacrylate-based, polyisobutylene-based, silicone-based pressure sensitive adhesives, synthetic rubber, acrylic, and polyisobutylene (PIB), hydrocolloid, and the like. The T-peel release force and blunt probe tack force of the adhesive may be measured by a standardized test method, such as ASTM D1876 and ASTMD2979 or other appropriate method. In some variations, the T-peel release force or blunt probe tack test value of the adhesive is configured to maintain loads 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 loads may be at least about 75 mPa/mm, about 100 mPa/mm, about 125 mPa/mm, or at least about 150 mPa/mm over the particular time period. The degree of adhesion (e.g. as measured by the T-peel release force or blunt probe tack test value) may vary depending upon the degree of strain placed onto the skin or incision site, and in some variations, these time periods may be based upon an average skin strain of about 10%, about 20%, about 30%, about 40%, or about 50% or more. In some variations, the adhesive may have a T-peel release force of at least about 150 kg/m, about 160 kg/m, about 170 kg/m, about 180 kg/m, about 190 kg/m, about 200 kg/m, about 210 kg/m, about 220 kg/m, about 230 kg/m, about 240 kg/m, about 250 kg/m, about 260 kg/m, about 270 kg/m, about 280 kg/m, about 290 kg/m, about 300 kg/m, about 310 kg/m, about 320 kg/m, about 330 kg/m, about 340 kg/m, about 350 kg/m, about 400 kg/m, about 450 kg/m, or at least about 500 kg/m or higher. In some further variations, the T-peel release force may be no greater than about 1000 kg/m, about 900 kg/m, about 800 kg/m, about 700 kg/m, about 600 kg/m, about 500 kg/m, about 400 kg/m or about 300 kg/m. The blunt probe tack test value of 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 higher, and may be no greater than about 1 kg, about 0.9 kg, about 0.8 kg, about 0.7 kg, or about 0.6 kg. The T-peel release force and blunt probe tack force may be measured by a standardized test method, such as ASTM D1876 and ASTMD2979 or other appropriate method. Other features or variations of the device are described in U.S. application Ser. No. 11/888,978, filed on Aug. 3, 2007, incorporated in its entirety herein by reference.

The release liners may comprise any of a variety of materials, including both opaque and transparent materials. The release liners may comprise Mylar or paper, or any other material with reduced adhesion to the adhesive material(s) of the device. For example, for a silicone adhesive, a fluoropolymer-treated polyester film may be used, and for an acrylic pressure sensitive adhesive, a silicone treated polyester or Mylar film or silicone treated craft paper may be used. In variations where the device has multiple separate adhesive regions, separate release liners may be provided for each region, or some 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 those provided in U.S. application Ser. No. 12/854,859 filed Aug. 11, 2010, the disclosure of which is already incorporated in its entirety herein by reference without limitation.

The packaging assembly, applicator and/or tensioning device may comprise a tensioning structure, and a first attachment portion configured to releasably attach to a dressing and a second attachment portion configured to releasably attach to the dressing, wherein the tensioning structure may be configured to exert a separation force between the first attachment portion and the second attachment portion to cause a strain in a dressing attached to the first and second attachment portions. An elastic dressing may be configured to releasably attach to the first and second attachment portions of a dressing and packaging assembly and may include an attachment structure or may be integral with attachment structures of a packaging device, applicator or tensioning member. The tensioning structure may also act as an applicator device or may be configured to permit a user to apply a dressing to skin of a subject.

Attachment structures of a packaging device, dressing assembly, dressing carrier, support, base, applicator, tensioning or straining device may include any structures that are used to attach or couple an applicator, tension or straining device to a dressing. A dressing may or may not have attachment features or structures. Any such attachment features may be integral with or include any of the attachment structures or corresponding structures to the attachment structures of the packaging, applicator dressing and/or tensioning device.

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

As noted, a packaging or applicator, tensioning device and/or straining device may be provided in some embodiments to impart a strain to a skin treatment device with an external force and/or to maintain a strain imparted 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 impart and/or maintain a single predetermined or pre-set strain or a plurality of predetermined or pre-set strains, or predetermined maximum or minimum amounts of strain. Features described herein with respect to a packaging assembly, applicator or tensioning device may also be used in any device that is used to strain a dressing. A packaging or applicator, tensioning or straining device that is described as being in an unstrained configuration is in a configuration in which a dressing may be unstrained or relatively less strained when attached to the packaging, applicator, tensioning or straining device. A packaging, applicator, tensioning, or straining device that is described herein as being in a strained configuration, is in a configuration in which a dressing may be strained or relatively more strained when attached to the packaging, applicator, tensioning or straining device, or with respect to an unstrained configuration, when applied to a subject's skin.

Packaging devices, applicators, tensioning devices, and corresponding attachment features may be configured to provide multi-direction strain or additional strain in an orthogonal direction to a dressing.

The packaging device, applicator, tensioning device and/or attachment structure profile may be straight, curved or otherwise varied. For example, the shape of the elements of a 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. A packaging device, tensioning device, applicator or elements thereof may be selected or configured to have a profile that has a desirable profile for a particular body location or profile where the skin treatment device is to be placed on a subject's skin. A packaging device, applicator, tensioning device or elements thereof may be selected or configured to closely match a portion of a subject's body profile. The packaging device, applicator or tensioning device and/or an element or segment thereof, may be curved, curvable, flexible, bendable, malleable, deformable, shapeable or movable to provide alternative shapes or profiles of an attached dressing. They may be relatively curved, curvable, flexible, malleable, bendable, deformable, shapeable or movable in at least one direction while being more rigid in another direction.

A variety of locking, latching, securing, attaching or detent mechanisms may be used to maintain the packaging, applicator or tensioning device in a various configurations including but not limited to unstrained, partially strained, strained configurations. A variety of locking, latching or detent mechanisms may be used to maintain a dressing in a variety of configurations including unstrained, partially strained, strained. 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 strain or level of force that is independent of the shape and/or size of the treatment site. As a further example, this absolute percentage of strain or level of force may be independent of the minimum strain or force to achieve sutureless wound closure (e.g. a relative strain or force to achieve opposition of the incision edges of a treatment site). Furthermore, the force needed to achieve wound closure is not a predetermined strain or force, since the final level of strain or force is not known until opposition of the incision edges is achieved.

Referring toFIGS.1 to5C, a variation of a dressing andpackaging assembly100 is illustrated. Thepackaging assembly100 comprises a book-like applicator and/ortensioning device120, a dressingassembly110 including a dressing130, and arelease150 configured to release the dressing130 from the applicator and/ortensioning device120.

The dressing130 comprises an elastic sheet131with one or more adhesive regions comprising a layer ofskin adhesive135 on afirst surface135a.The adhesive used may be, for example, a suitable pressure activated adhesive (PSA), or a non-pressure sensitive adhesive.

Thepackaging assembly100, applicator ortensioning device120 and/or dressingassembly110 may be configured to pre-strain the dressing130 and/or permit transfer of thepre-strained dressing130 to the skin of a subject. The applicator and/ortensioning device120 may also provide for a convenient, expeditious or sterile transfer of an adhesive portion of the dressing130 to a skin and/or wound site of a subject.

Thedevice120 comprises acover121 and abase122. The dressingassembly110 is removably coupled or anchored to thedevice120 which may act as a dressing carrier or a support. Thecover121 may be generally planar and include

sides

123,124 with

corresponding edges

123a,124aalong its length, and edges121aat opposing ends. The dressing carrier orbase122 may be generally planar and include

sides

125,126 with

corresponding edges

125a,126aalong its length and edges122aat opposing ends.

According to some variations, the cover and/or

base

121,122 or elements or segments thereof may be constructed to be sufficiently firm or rigid or less flexible relative to an attached dressing to support an attached dressing until it is applied to a subject as described with respect to the variations herein. Such material may comprise, for example, a plastic, e.g., polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or TEFLON®), LDPE, high-density polyethylene (HDPE), ultra high-molecular weight polyethylene (UHMWPE), polyvinyl chloride (PVC) or acrylic, nylon or a paperboard. The elements or segments may be a laminate of a material, such as a solid bleach sulfate paperboard with a layer of flexible material between layers of paperboard, for example, silicone, polyurethane, LDPE or a rubber material. The material may also be a metal as for example, ductile aluminum or stainless steel. The metal may comprise a foil, ribbon, wire or other form.

Cover121 andbase122 are movably, hingedly or pivotably coupled at

sides

123,125. For example, a layer of material such as silicone, polyurethane, low-density polyethylene or a rubber material may be glued to each of the cover and base, flexibly attaching them together at

sides

123,125. Alternative devices and methods may be used to couple thecover121 andbase122. For example, various composite structures or laminates may be used. Also devices may be constructed out of a single substrate that provides flexibility in some selected regions and rigidity in others, or a relative or absolute flexibility in a first direction with a relative or absolute rigidity in a second direction that may be transverse to the first direction. Although thecover121 andbase122 depicted inFIGS.1 to5C have generally the same size and shape, in other examples, thecover121 andbase122 may be different sizes and/or shapes. Cover121 and/orbase122 may be bendable, foldable, curvable, flexible, malleable or shapeable permitting relatively more even placement on a location with a varying shape or curvature. For example, cover and

base

121,122 as illustrated are each divided intosegments127 along lengths that are bendable or movable with respect to adjacent segments, permitting flexibility of thedevice120 along its length. Thesegments127 may be constructed of a more rigid material that reduces flexion in a widthwise or other direction. Other configurations that vary the directions of rigidity and/or flexibility may be use. Configurations may include providing rigidity in a direction in which a dressing is strained that is sufficient to create and/or maintain a desired level of strain. Thesegments127 may be coupled by a material, such as an elastomer, e.g., silicone that flexibly holds the segments together in relationship to each other. Other construction may also be used to flexibly couple segments or other elements. The material coupling or binding the cover and

base

121,122, may or may not be continuous with the material that couples thesegments127 toadjacent segments127, and may or may not be attached to all or a portion of a side of cover and

base

121,122. The various attached structures, e.g. the segments and/or the cover and base and coupling elements may provide a structural support for the dressing carrier to be manipulated by a user. Margins between at least a portion of the structural support elements, dressing carrier or backing, and the dressing may be provided at or

near edges

121a,123a,124a,122a,125a,and/or126a,for example as described further herein. In some further embodiments, the material attaching thecover121 andbase122 may comprise a semi-rigid structure that may be biased to an open or a closed configuration, or a configuration therebetween. In still other variations, thecover121 andbase122 may be attached by any of a variety of articulations, including but not limited to one or more a pin-based hinge joints, rings attached to holes in thecover121 andbase122, or ball-and-socket joints.

As exemplified inFIGS.5A-5C, a variation of construction of a package is shown. Cover121 andbase122 comprise relatively firm or rigid elements, for example battens121a,121band battens122a,122brespectively that are attached by way of asheet128 of material, such as, e.g., silicone, polyurethane, low-density polyethylene or a rubber material that also flexibly couples cover and

base

121,122 at

sides

123,125.Segments127 may have alternative shapes and construction coupling thesegments127 together. Thus, thedevice120 may be constructed to bend or curve to varied extents or in multiple directions. Accordingly, a device may be constructed to be used on a specific anatomical location or with varying sizes, or may be constructed to have a shape for a particular situation or individual.

According to some variations each of thecover121 andbase122 is constructed at least in part of a clear plastic, semi-opaque or other material that provides awindow portion159 through which a wound, incision, or other location may be visualized for accurate placement of thedressing130. Thecover121 andbase122 may or may not comprise the same material. Theelastic sheet131 andadhesive layer135 may also be sufficiently clear to permit visualization through them. A more opaque material may be provided on portions of the material to create boundaries of awindow159. Thesegments127 may be clear or semi-opaque to provide the window for viewing, positioning, and/or centering the location of a wound or position on skin with respect to the dressing130 or for positioning the wound within an optimal or most effective strain zone of the dressing. The boundaries or other markings may assist a user in placing the dressing130 in an appropriate position over the wound or incision.

The dressing130 of the dressingassembly110 has a first side or edge133 having a length, and a second side or edge134 having a length. The dressing130 is coupled to thepackaging assembly100 along the lengths of the dressing's

sides

133,134. When thedevice120 is closed, theadhesive layer135 faces away from thebase122 and is covered by arelease liner149 that is attached to theinside surface177 of thecover121. The dressingassembly110 also includes anattachment sheet141 having afirst side143 and asecond side144. Theattachment sheet141 couples the dressing130 to the cover of thedevice120 which when opened, exerts a straining force on the dressing130 through theattachment sheet141. According to some variations, theattachment sheet141 is flexible while being relatively inelastic with respect to the dressing130 and may be constructed, e.g., out of a low density polyethylene. When assembled, theattachment sheet141 is bonded to theelastic sheet131 of the dressing at (for example, using a combination of a silicone PSA/acrylic PSA) or near the

sides

134 and143 of the dressing130 andattachment sheet141 respectively. Theattachment sheet141 is coupled at itsside144 to thecover121 at attachment points137 defining a line or area ofattachment137aalong the length of thecover121. The dressing130 is coupled to thesecond side124 of the base122 at a location near thefirst side133 of thedressing130. As such, theelastic sheet131 is attached at attachment points138 defining a line or area ofattachment138aalong a length of thebase122. A number of bonding methods or adhesives may be used to attach theattachment sheet141 to thecover121, for example, a low surface energy PSA such as an acrylic adhesive.

When theassembly100 is in a closed configuration as illustrated inFIG.1 and at an open 90 degree configuration as shown inFIG.2, theelastic sheet131 is relaxed or unstrained, with theelastic sheet131 having an unstrained width w1. As theassembly100 is opened to 180 degrees or up to about 360 degrees (e.g. by rotating or pivoting thecover121 with respect to the base122), the orthogonal distance increases between lines or areas of

attachment

137a,138a.According to some variations the assembly is opened to no less than about 180 degrees (minimum angular change) to provide for application of a dressing without interference of theassembly100. When thedevice120 is opened, it exerts a separation force between attachment regions defined by attachment lines or

areas

137a,138aor corresponding attachment areas. The force tensions the elastic sheet, creating a strain. Tensioning and imparting a strain on the dressing130 increases the width between attachment lines or

areas

137a,138ato w2. The increase in the width, i.e., w2 minus w1, may be a percentage of w1 or a percent strain as described herein. While straining is illustrated as starting when thecover121 is opened about 90 degrees from thebase122, the dressing130 may be attached to thecover121 at a number of locations or in a number of configurations that may vary the cover position or configuration at which straining begins. Theedge124aorside124 of thecover121 may act as a lever arm to provide a mechanical advantage, which may depend, among other things, on the distance of the point ofattachment138 of the dressingassembly110 on the cover to theedge124aof thecover121 as well as the angle of thecover121 with respect to the base122 at which the tensioning of the dressing occurs. Additionally, the point ofattachment138 of theinelastic attachment sheet141 to thecover121 may determine amount of strain applied to the dressing, assuming among other things, the length of theattachment sheet141 remains the same and the point ofattachment137 of the dressingassembly110 to the base122 remains the same

According to one variation, the dressing130 may be substantially fixed at one edge, (e.g. atedge134 at the side126 of the base122) while not being fixed at an opposite edge (e.g.,edge133 moves when strained with respect to edge125aof base122). When thecover121 is opened and the dressing130 is strained, the width of the strained dressing may be less than the width of thebase122 and/or thecover121 so that the area of the dressing is located over the area of thebase122 and or thecover121, i.e. thebase122 and/or cover121 margins outside of the area of the dressing. According to other variations the dressing may be fixed at both edges.

According to some variations, the dressing is sufficiently large with respect to thedevice120 so that when applied to the skin, there is relatively less interference by thedevice120. According to one example, 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 other variations, the distance between each of

edges

133,134 of the dressing130 and the

edges

125a,126aof the base122 respectively (and/or the

edges

123a,124aof the cover121) is no greater than about 10 mm, 15 mm or 20 mm. According to some variations, the distance between theedges136a,136bof the dressing and theedges122aof the base is no greater than about 10 mm, about 15 mm or about 20 mm.

According to some variations, edges133,134,136a,136bof the dressing130 are at least about 1.0 mm inward of at least a portion of the

edges

125a,126a,and/or122aof the base122 so that the

edges

125a,126a,and/or122aof the base122 may be gripped by a user with a reduced likelihood of touching the dressing130 or theadhesive layer135. According to some variations, theends136a,136bof the dressing130 have a margin of at least about 1.0 mm inward of theends122aof thebase122. According to some variations the

sides

133,134 and ends136a,136bof the dressing130 have a margin of about 10 mm from the

sides

125,126 and ends122aof the base respectively. According to some variations the

sides

133,134 and ends136a,136bof the dressing130 have a margin of about 15 mm from the

sides

125,126 and ends122aof the base respectively. Each of the margins between

sides

133,134 or ends136a,136bof the dressing130 and

sides

125,125, and ends122aof the base122 may be different. As illustrated inFIG.3, for example, margins m1 and m2 are about no less than 3 mm and margin m3 is about 15 mm. Similar margins may be provided between the dressing130 and the

edges

121a,123a,and/or124aof thecover121, for example if the edges of thecover121 are used alternatively or additionally to grasp thedevice120 or manipulate thedressing130. Then, once thecover121 is opened and theadhesive layer135 is exposed, the adhesive side of the dressing130 may be placed on a skin or wound site using thedevice120. As shown inFIGS.3 and4 thecover121 andbase122 may be rotated an additional amount, with respect to each other, e.g., up to approximately 360 degrees from the closed configuration prior to applying thedressing130. A locking mechanism may optionally be provided to lock or secure the device in an open, partially opened or closed position. In some examples, the locking mechanism may comprise magnets, hook-and-look attachment structures, snaps, latches, clips and the like.

Theadhesive layer135 of theelastic sheet131 is protected by arelease liner149 before the applicator ortensioning device120 is opened. Therelease liner149 is attached or glued to theinside surface177 of thecover121 so that when thecover121 is opened as shown inFIG.2, and is separated from the base122 (prior to straining the elastic sheet131), therelease liner149 is pulled away from theelastic sheet131 exposing theadhesive layer135. Alternatively, as shown inFIG.6, arelease liner149amay be provided on theadhesive layer135 that is not attached to thecover121. When thedevice120 is opened, and prior to straining the dressing130, therelease liner149amay be manually removed from theelastic sheet131 to expose theadhesive layer135.

After the dressing130 is strained, and the

liner

149 or149ais released, the dressing130 may be applied to a desired location on a subject's skin. Thewindow159 may be used to visualize proper placement. The user may apply pressure to theback side129 of thedevice120 to activate the adhesive on theelastic sheet131 and/or to apply compression to a wound. Alternatively, if thecover121 is rotated to 360 degrees, pressure may be applied to the inside177 of thecover121. Once applied to a subject, theelastic sheet131 may be released from the packaging, applicator ortensioning device120 using a release structure ormechanism150.

Therelease mechanism150 may comprisecutters151 each positioned on

opposite sides

133,134 of theelastic sheet131. Eachcutter151 comprises ablade152 on oneend153 with

legs

154,155 extending to opposing pull tab ortabs156 on anopposite end157. Theblade152 comprises a sharp surface that may be generally v-shaped or otherwise shaped. The blade may be constructed, e.g., of stainless steel, ceramic or hard plastic. Theblade152 and thepull tabs156 each extend proud of theends136a,136bofelastic sheet131, respectively and ends122aof thebase122.Cutters151 are attached to thedressing assembly110 in a manner that definesgeneral cutting paths162,163 (depicted best inFIG.5A) along which theblades152 are pulled bytabs156 to cut the dressingassembly110 to release thedressing130. In some variations, the dressing may be scored, perforated or otherwise configured to facilitate separation by the release mechanism.

As best shown inFIGS.5B and5C,

tubes

164,165 for receiving and guiding

legs

154,155 respectively of acutter151, are positioned along theside133 of theelastic sheet131. The

tubes

164,165 may be positioned so that the cuttingpath162 is between thetube164 and thetube165. Thetube165 is coupled, e.g., glued to theadhesive surface135 of theelastic sheet131 at a location closer to theside133 than the cuttingpath162. Thetube164 is coupled to theback surface139 of theelastic sheet131 by way of theattachment sheet141, which is also coupled to theelastic sheet131 at a location closer to theside133 than the cuttingpath162. Thetube164 is coupled to afree end145 of theattachment sheet141 that extends inward of the cuttingpath162 with respect to theside133. Thus, thetube164 may be positioned inside of the cuttingpath162 without being attached to theelastic sheet131 inside of the cuttingpath162. This allows the dressing130 to be released from the remainder of thepackaging assembly100 including thecutter151 withtube164 andattachment sheet141. Aprotective member170 is attached, e.g. glued to the top oftube165. Theprotective member170 includes aledge171 that extends over the cuttingpath162 so that when theadhesive layer135 is positioned on the skin of a subject and thecutter151 is actuated, the skin is protected from theblade152.

Tubes

174,175 for receiving and guiding

legs

154,155 respectively are positioned along theside134 of theelastic sheet131. The

tubes

174,175 are positioned so that the cuttingpath163 is between thetube174 and thetube175. Thetube175 is coupled, e.g., glued to theadhesive surface135 of theelastic sheet131 at a location closer to theside134 ofelastic sheet131 than the cuttingpath163. Thetube174 is coupled to theback surface139 of theelastic sheet131 by way of theextender sheet146. Thetube174 is coupled to afree end147 of theextender sheet146 that extends inward of the cuttingpath163 with respect to the side.Tube174 is also coupled to theelastic sheet131 at a location closer to theside134 than the cuttingpath163. Thus thetube174 may be positioned inside of the cuttingpath163 without being attached to theelastic sheet131 inside of the cuttingpath163. This allows the dressing130 to be released from the remainder of thepackaging assembly100 including thecutter151 withtube175 andextender sheet146. Aprotective member170 is attached, e.g., glued to the top oftube175. Theprotective member170 includes aledge171 that extends over the cuttingpath163 so that when theadhesive layer135 is positioned on the skin of a subject and thecutter151 is actuated, the skin is protected from theblade152.

The inside of the

tubes

164,165,174,175 may be coated with a lubricious material, e.g. with Kapton tape. The guiding

legs

154,155 may be constructed of a low friction material such as, e.g., HDPE or UHMWPE, so the

legs

154,155 may readily slide in the

tubes

164,165,174,175 to permit smooth cutting of the dressing130 from the remainder of thepackaging assembly100.

When the dressing130 is strained and the adhesive135 is exposed, the dressing130 may be applied with theadhesive side135 towards the skin of a subject. Theside133 of the elastic sheet may then be released from the applicator by pulling thetabs146 to draw theblade152 across cuttingpath162. Also, theside134 of the elastic sheet may then be released from the applicator by pulling thetabs146 to draw theblade152 across cuttingpath163. Thus theelastic sheet131 is released from the packaging100 (including the release150).

Referring toFIGS.7 to9, another variation of a dressing andpackaging assembly200 is illustrated. Thepackaging assembly200 comprises an applicator and/ortensioning device220 and adressing assembly210 including adressing230. The dressing230 comprises anelastic sheet231 with one or more adhesive regions comprising a layer ofskin adhesive235. The adhesive used may be, for example, a suitable pressure activated adhesive (PSA), or a non-pressure sensitive adhesive.

Thepackaging assembly200, applicator ortensioning device220, and/or dressingassembly210 may be configured to pre-strain the dressing230 and/or permit transfer of thepre-strained dressing230 to the skin of a subject. The applicator ortensioning device220 may also provide for a convenient sterile transfer of an adhesive portion of the dressing to a skin and/or wound site of a subject.

Thedevice220 may comprise acover221 and abase222. The dressingassembly210 is removably coupled or anchored to thedevice220, and may serve as a dressing carrier. Thecover221 may be generally planar and include

sides

223,224 with

corresponding edges

223aand224adefining its length and edges221aat opposing ends. The base222 may be generally planar and include

sides

225,226 with

corresponding edges

225aand226adefining its length and edges222aat opposing ends.

According to some variations, the cover and/or

base

221,222 or elements or segments thereof may be constructed to be sufficiently firm or rigid or less flexible relative to an attached dressing to support an attached dressing until it is applied to a subject as described with respect to the variations herein. Such material may comprise, for example, a plastic, e.g., polypropylene, polycarbonate, PTFE, LDPE, HDPE, UHMWPE, PVC or acrylic, nylon or a paperboard. The elements or segments may be a laminate of a material, such as a solid bleach sulfate paperboard with a layer of flexible material between layers of paperboard, for example, silicone, polyurethane, low-density polyethylene or a rubber material, The material may also be a metal as for example, ductile aluminum or stainless steel. The metal may comprise a foil, ribbon, wire or other form. The other variations as described for application ortensioning device100 may be applied todevice200 also.

The cover and

base

221 and222 may be movably, pivotably, bendably or hingedly coupled at

sides

223,225 in a manner similar to that described with respect to cover and

base

121,122 herein and may be constructed in a manner similar to cover and

base

121,122 herein, among other things, withsegments227 similar tosegments127 and dressing230 attached todevice220 and strained by device in a similar manner as dressing130 is attached todevice120.

The various attached structures, e.g. the segments and/or the cover and base and coupling elements may provide a structural support for the dressing carrier to be manipulated by a user. Margins between at least a portion of the structural support elements, dressing carrier or backing and the strained or unstrained dressing may be provided at or

near edges

221a,223a,224a,222a,225a,and/or226a,such as, for example, margins m1, m2, m3 shown inFIG.3 herein.

According to some variations, each of thecover221 andbase222 is constructed at least in part of a clear plastic, semi-opaque or other material that provides awindow portion259 through which a wound, incision or other location may be visualized for accurate placement of thedressing230. Thecover221 andbase222 may or may not comprise the same material. Theelastic sheet231 andadhesive layer235 may also be sufficiently clear to permit visualization through them. A more opaque material may be provided on portions of the material to create boundaries of a window.Segments227 may be clear or semi-opaque to provide a window for viewing, positioning, and/or centering the location of a wound or position on skin with respect to the dressing230 or for positioning the wound within an optimal or most effective strain zone of the dressing. The boundaries or other markings may assist a user in placing the dressing in an appropriate position over the wound or incision.

The dressingassembly210 also includes anattachment sheet241,attachment sheet251, and a dressing release structure or mechanism250 comprisingpull tabs246 as described in more detail herein. The dressing230 of the dressingassembly210 has afirst side233 having a length, and asecond side234 having a length. When thedevice220 is closed, theadhesive layer235 faces away from thebase222 and is covered by arelease liner249 that is attached to theinside surface277 of thecover221.

Theattachment sheet241 has afirst side243 and asecond side244. Theattachment sheet241 couples the dressing230 to thecover221 of thedevice220 near thesecond side234 of thedressing230. Thecover221, when opened, exerts a straining force on the dressing230 through theattachment sheet241. Theattachment sheet241 is coupled at itsside244 to thecover221 at attachment points237, which may be provided as an attachment line orarea237a,for example, by bonding with a low surface energy PSA such as an acrylic adhesive. When assembled, theattachment sheet241 is bonded to theelastic sheet231 of the dressing230 atsection265 ofattachment sheet241 at or near theside243 of theattachment sheet241, for example, using a combination of a silicone PSA/acrylic PSA. Theattachment sheet251 has afirst side253 and asecond side254. Theattachment sheet251 couples the dressing230 to thebase222 of thedevice220 near thefirst side233 of thedressing230. Theattachment sheet251 is coupled at itsside254 to the base222 at attachment points238 defining the attachment line orarea238a,for example, by bonding with a low surface energy PSA, such as an acrylic adhesive. When assembled, theattachment sheet251 is bonded to theelastic sheet231 of the dressing atsection265 ofattachment sheet251 at or near theside253 of theattachment sheet251, for example, using a combination of a silicone PSA/acrylic PSA.

Dressing230 has unattached portions oredges255 at its

sides

233,234 where theelastic sheet231 is free from the

attachment sheets

241,251 respectively. Accordingly, the dressing230 is not strained atunattached portions255. Thepull tabs246 are each coupled to ends281,282 of thedevice220. Eachpull tab246 comprises atop section247 andbottom section248. Thebottom sections248 are attached to the base222 or cover221 as illustrated whiletop sections247 are adjacent but unattached to thedressing230.

According to some variations, the

attachment sheets

241,245 are flexible while being relatively inelastic with respect to the dressing230 and may be constructed, e.g., out of a low density polyethylene. The

attachment sheets

241,245 may be manufactured to be tearable along the material length while providing tensile strength in other directions, in particular in the tensioning direction of the material of the attachment sheet241 (direction in which dressing is tensioned, stressed or strained). An example of such material is an LDPE polymer which is produced by an extrusion process that creates a directionally biased grain whereby the material is tearable with the direction of the grain, but has a relative resistance to tearing in the direction transverse to the grain. Thepull tab246 may start a tear at a notch in the

attachment sheet

241 or251 that is to be completed alonglines262. The

attachment sheets

241,251 may additionally or alternatively comprise a material such as an LDPE with perforations formed along tear lines262.

attachment

237a,238a.When thedevice220 is opened, it exerts a separation force between attachment regions defined by attachment lines orareas237a,238bor corresponding attachment areas. The force tensions theelastic sheet231 creating a strain. Tensioning and imparting a strain on the dressing230 increases the width between attachment lines or

areas

237a,238ato width w4. The increase in the width (i.e. width w4 minus width w3) may be a percentage of w3 or a percent strain as described herein. While straining is illustrated as starting when thecover221 is opened about 90 degrees from thebase222. The dressing230 may be attached to thecover221 at a number of locations or in a number of configurations that may vary at which position or configuration thecover222 may be when the straining begins.

As shown inFIGS.8 to8B, thecover221 andbase222 may be rotated an additional amount, with respect to each other, e.g., up to approximately 360 degrees from the closed configuration prior to applying thedressing230. According to some variations the assembly is opened to no less than about 180 degrees (minimum angular change) to provide for application of the dressing without interference from the assembly.

Then, once thecover221 is opened and theadhesive layer235 is exposed, the adhesive side of the dressing230 may be place on a skin or wound site using thedevice220. Thecover221 andbase222 may be rotated an additional amount, with respect to each other, e.g., up to approximately 360 degrees from the closed configuration prior to applying thedressing230. The orientation of thecover221 at which the dressing230 begins to strain may be varied, e.g. by varying the attachment location of the dressingassembly210 to thecover221. A locking mechanism may optionally be provided to lock or secure the device in an open, partially opened or closed position. In some examples, the locking mechanism may comprise magnets, hook-and-loop attachment structures, snaps, latches, clips and the like.

Theadhesive layer235 of theelastic sheet231 is protected by arelease liner249 before the applicator andtensioning device220 is opened. Therelease liner249 is attached to theinside surface277 of thecover221 so that when thecover221 is opened and is separated from thebase222, (prior to straining the elastic sheet231) therelease liner249 is pulled away from theelastic sheet231 exposing theadhesive layer235 prior. Alternatively, as shown inFIG.6, arelease liner149amay be provided on theadhesive layer235 that is not attached to thecover221. When thedevice220 is opened, but prior to straining, therelease liner149amay be manually removed from theelastic sheet231 to expose theadhesive layer235.

After the

liner

249 or149ais released and the dressing231 is strained, the dressing230 may be applied to a desired location on a subject's skin. The window may be used to visualize proper placement. The user may apply pressure to theback side229 of thedevice220 to activate the adhesive on the dressing231 and/or to apply compression to a wound. If thecover221 is rotated to 360 degrees, pressure may be applied to the inside277 of thecover221. Once applied to a subject, the dressing230 may be released from applicator ortensioning device220 using the release mechanism250.

Thepull tabs246 of the release mechanism250 each extend proud of theend236aofelastic sheet231. Eachrelease pull tab246 is attached to thedressing assembly110 in a manner that definestear paths262 along which thetabs246 are pulled to separate the dressing230 from the device. Notches or perforations may be made in the

attachment sheets

241,251 that facilitate tearing alongpaths262.

The dressing230 is applied to a subject. The dressing230 may then be released from thedevice220 by pulling thetabs246 to draw thetabs246 acrosspaths262 of the

attachment sheets

241,251. Thesections245 of the

attachment sheets

241,251 that bonded to thepull tabs246 are thereby separated from the attachment sheets thereby separating thesections265 of the attachment sheets that are attached to the dressing230 are from the remainder of the

attachment sheets

241 and251 that are attached to thecover221 andbase222 respectively. Thus, the dressing230 is released from the remainder of thepackaging100 as shown inFIG.9.Sections265 of the

attachment sheets

241,251 may remain on theback surface239 of thesilicone sheet231 as shown inFIG.9.Unattached sections245 of theelastic dressing230 are unstrained and may be free from the adhesive of the adhesive layer235 (or may have a reduced amount of adhesive thereon). Thus less stress occurs at the unattached sides or edges defined bysections245.

Referring toFIGS.10 to12B, a dressing andpackaging assembly300 is illustrated. Thepackaging assembly300 comprises apackaging device applicator320 and adressing assembly310 including adressing330.

The packaging device orapplicator320 is configured to permit transfer of the dressing330 to the skin of a subject and may also provide for a convenient, expeditious or sterile transfer of an adhesive portion of the skin treatment device to a skin and/or wound site of a subject.

The packaging device orapplicator320 comprises acover321 and a bottom element, dressing carrier orbase322, to whichdressing assembly310 is removably coupled or anchored. Thecover321 may be generally planar and include

sides

323,324 with

corresponding edges

323a,324adefining its length and edges321aat opposing ends. The base322 may be generally planar and include

side

325,326 with

corresponding edges

325a,326adefining its length and edges322aat opposing ends.

According to some variations, thecover321 andbase322 are constructed in part of a relatively inflexible material, e.g., with respect to an attacheddressing330. Such material may comprise, for example, a plastic, paperboard or a laminate of a material, or metal as described herein with reference to cover121 andbase122. The cover or base may be constructed in a manner as described, for example, with respect to the various applicator, tensioning devices or dressing carriers shown inFIGS.1 to22B herein. Thecover321 andbase322 may or may not comprise the same material.

Cover321 andbase322 may be movably, pivotably, bendably or hingedly coupled at

sides

323,325 and otherwise constructed in a manner similar to that described herein with respect to cover121 andbase122. The packaging device orapplicator320 may include awindow portion359 through which a wound, incision, or other location may be visualized for accurate placement of the dressing330 in a manner similar to that described herein with respect to the use of

windows

159,259.

Theassembly300 is constructed including adressing assembly310 with askin dressing device330. The dressingassembly310 also includes a dressing release structure ormechanism350 which may be a release device such as various release and removal structures described herein with reference toFIGS.1 to22B. The dressing330 may comprise a variety of dressing materials, including but not limited to elastic bandages, gauze type bandages, hydrocolloids. The various structures, e.g. the segments and/or the cover and base and coupling elements may provide a structural support for the dressing carrier to be manipulated by a user. Margins between at least a portion of the structural support elements, dressing carrier or backing and the dressing may be provided at or

near edges

321a,323a,324a,322a,325a,and/or326a,for example as described herein.

When assembled with the packaging device orapplicator320, the dressing330 is coupled to the base. A length of the dressing330 adjacent itsfirst side333 is bonded to a length of the base322 adjacent itsside324 and outside ofrelease350. Also a length of the dressing330 adjacent itssecond side334 is coupled to a length of the base322 adjacent itsside325 and outside ofrelease350. An attachment sheet similar to

sheets

141,146 or241,251 may be used to attach

sides

333,334 of dressing330 to thebase322. Theadhesive layer335 faces away from thecover321 andbase322 when theapplicator320 is opened.

According to variation, the dressing330 is sufficient large with respect to thedevice320 so that when applied to the skin, there is relatively less interference by thedevice320. According to one example, 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 other variations, the distance between each of edges333a,334aof the dressing330 and the

edges

325a,326aof the base322 respectively (and/or the

edges

323a,324aof the cover321) is no greater than about 10 mm, 15 mm or 20 mm. According to variations the distance between the edges336a,336bof the dressing and theedges322aof the base is no greater than about 10 mm, about 15 mm or about 20 mm.

According to some variations, edges333,334,336a,336bof the dressing330 are at least about 3 mm inward of at least a portion of the

edges

325a,326a,and/or322aof the base322 so that the

edges

325a,326a,and/or322aof the base322 may be gripped by a user with a reduced likelihood of touching the dressing330 or theadhesive layer335. According to some variations, the ends336a,336bof the dressing130 have a margin of at least about 3 mm inward of theends322aof thebase322. According to some variations the

sides

333,334 and ends336a,336bof the dressing330 have a margin of about 10 mm from the

sides

325,326 and ends322aof the base respectively. According to some variations the

sides

333,334 and ends336a,336bof the dressing330 have a margin of about 15 mm from the

sides

325,326 and ends322aof the base respectively. Each of the margins between

edges

333,334 or ends336a,336bof the dressing330 and

sides

325,325, and ends322aof the base322 may be different. As illustrated inFIG.3, for example, margins m1 and m2 are about no less than 3 mm and margin m3 is about 15 mm. Similar margins may be provided between the dressing330 and the

edges

322a,325a,and/or326aof thebase322, Also similar margins may be provided between the dressing330 and the

edges

321a,323a,and/or324aof thecover321, for example if the edges of thecover321 are used alternatively or additionally to grasp thedevice320 or manipulate thedressing330.

Theadhesive layer335 on the dressing330 may be protected by arelease liner349 before the packaging device orapplicator320 is opened. Therelease liner349 may be attached to theinside surface377 ofcover321 so that when thecover321 is opened or is separated from thebase322, therelease liner349 is pulled away from the dressing330 exposing theadhesive layer335. Therelease liner349 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 medicament or other agent is applied. One or more hemostatic or coagulative agents may be applied to, or otherwise integrated with 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-acetyl glucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X, XIII, Von Willebrand factor), procoagulants (e.g. propyl gallate), antifibrinolytics (e.g. epsilon aminocaproic acid), and the like. In some variations, the agents may be freeze-dried and integrated into the dressing and activated upon contact with blood or other fluid. In some further variations, an activating agent may be applied to the dressing or the treatment site before the dressing is used on the subject. In still other examples, the hemostatic agent may be applied separately and directly to the wound before application of the dressing, or after application to the dressing via a catheter or tube. The devices may also comprise one or more other agents that may be any suitable agent that may be useful in aiding in 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 combinations thereof. Of course, the devices may comprise more than one medicament or agents, and the devices may deliver one or more medicaments or agents. An example of such medicament may include, but is not limited to various antibiotics (including but not limited to cephalosporins, bactitracin, polyxyxin B sulfate, neomycin, polysporin), antiseptics (such as iodine solutions, silver sulfadiazine, chlorhexidine), antifungals (such as nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), grow factors (such as VEGF) and other treatments (e.g. botulism toxin). Thecover321 may be pulled away or separated in a number of manners. Thecover321 may be opened like a cover of a book. Similar to

devices

120 and220,420,520,620,720,820,920,1020 herein, the

elements

321,322 may be rotated sufficiently to separate therelease liner349 and up to approximately 360 degrees allowing the exposedadhesive side335 of the dressing330 to be place on a skin or wound site using the packaging device orapplicator320. According to some variations theassembly300 is opened to no less than about 180 degrees (minimum angular change) to provide for application of the dressing without interference of theassembly300. Alternatively, for example, thecover321 may be attached to thebase322 by an adhesive and may be peeled off of the dressing330 or the base322 to which the dressing330 is coupled. Thecover321 itself may be a removable, or separable release liner that may be peeled from thebase322. Alternatively, as shown inFIG.6, arelease liner149amay be provided on theadhesive layer335 that is not attached to thecover321. When the device is opened, therelease liner149amay be manually removed from the dressing330 to expose theadhesive layer335. In such case, thecover321 may be omitted. After thedevice300 is opened to position shown inFIG.11 or12A and12B, the dressing330 may be applied to a desired location on a subject's skin. Thewindow359 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 examples, the locking mechanism may comprise magnets, hook-and-look attachment structures, snaps, latches, clips and the like as well as adhesives, or other adhesive structures. A compressive force may be applied to theback side378 ofbase322 or inside377 of cover if rotated approximately 360 degrees. Once applied to a subject, the dressing330 may be released from packaging device orapplicator320 using arelease mechanism350. Therelease mechanism350 may include a cutting element or a perforated element as described for example with respect todevices150 and250 herein. The release mechanism may further include one more release elements described herein and show inFIGS.1 to22B.

FIG.13 illustrates an alternative packaging orapplicator420 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 or320,520,620,720,820,920,1020,1120,1220.FIG.13 illustrates acover421 and a dressing carrier orbase422 that are constructed of a single substrate out of a material such as nylon and/or polyethylene or a metal. Thedevice420 may be manufactured from a single mold and/or may have portions cut out of the substrate, slots, grooves, scoring or other openings or variations in thickness of the substrate at different locations. Thecover421 andbase422 each compriseslots428 that form elements such assegments427. Theslots428 permit flexion of thedevice420 allowing it to conform to a subject's body contours where an attached dressing is to be applied. Cover421 andbase422 are coupled to each other by way of connection features429 that are formed in the substrate. Thecover421 andbase422 are hingedly or pivotably moveable with respect to each other by virtue ofslots430 that are formed adjacent connection features429, to permit flexion or movement of the connector features429 and thus thecover421 andbase422 with respect to each other. As mentioned with respect todevice100, in other variations,slots430 may comprise grooves or other structures providing a reduced thickness relative to thecover421 andbase422. Thedevice420 may include a release mechanism as described with respect toFIGS.1A-22B herein. Thedevice420 may be used in the same manner as the devices described with reference toFIGS.1A to22B herein and may attach a dressing in the same manner as described with respect to devices described with reference toFIGS.1A to22B herein.

The various structures, e.g. the segments and/or the cover and base and coupling elements, slots and grooves may provide a structural support as well as flexibility for the dressing carrier to be manipulated by a user. Margins between at least a portion of the structural support elements, dressing carrier or backing and an attached dressing may be provided at or

near edges

421a,423a,424a,422a,425a,and/or426a,for example as described further herein.

FIG.14 illustrates an alternative packaging orapplicator device520 that may be used in any of the devices described herein with reference toFIGS.1A to22B. Acover portion521 and a dressing carrier orbase portion522 may be constructed of alaminate structure530. Afirst layer531 of thelaminate structure530 comprises a paperboard or other support material such as a plastic material ormetal having slots528 formed widthwise across each of thecover521 andbase522. Theslots528

form segments

527 that permit flexion ofsegments527 of thedevice520 allowing it to conform to a subject's body contours where an attached dressing is to be applied. Thefirst layer531 further comprises lengthwiseslot529 between thecover521 andbase522 formed in thefirst layer531. Thefirst layer531 further comprisestabs540 with openings that are used in assembly of thedevice520 and are removed after assembly so that thecover521 andbase522 are separated byslot529 and are no longer connected by thefirst layer531. Thesecond layer532 of the laminate comprises an adhesive material such as a PSA acrylic, rubber or silicone adhesive. Thesecond layer532 may or may not be about 0.001 to 0.006 thick. Aflexible strip534 of material is positioned along the length of thedevice520 over theslot529 and connecting thecover521 andbase522. Thecover521 andbase522 are flexibly and hingedly or pivotably coupled and moveable with respect to each other by way of thestrip534 of material over theslot529 to permit flexion or movement of thecover521 andbase522 with respect to each other. Theflexible strip534 is attached with an adhesive535 to athird layer533 that comprises a thin material such as paper or plastic that may have generally a similar outline as thefirst layer531 and that holds the structure of thedevice520, includingsegments527, together.

Thedevice520 may include a release mechanism, dressing attachment and may be used in the same manner devices and assemblies as described with respect toFIGS.1A-22B herein.

The various structures, e.g. the segments, adhesive structures, laminate layers and/or the cover and base and coupling elements, slots and grooves may provide structural support as well as flexibility for the dressing carrier, to facilitate manipulation by a user. Margins between at least a portion of the structural support elements, dressing carrier or backing and an attached dressing may be provided at or

near edges

521a,523a,524a,522a,525a,and/or526a,for example as described further herein.

Referring toFIGS.15A to15J, a variation of a dressing andpackaging assembly600 is illustrated. Thepackaging assembly600 comprises an applicator and/ortensioning device620 and adressing assembly610 including adressing630. The dressing630 comprises anelastic sheet631, with one or more adhesive regions comprising a layer of skin adhesive such as described herein.

The features inFIGS.15A to15J may be used in any of the variations herein including device elements or features that may being substituted for device elements or features of devices and assemblies shown inFIGS.1A to22B.

Thepackaging assembly600 applicator,tensioning device620 and/or dressingassembly610 may be configured to pre-strain the dressing630 and/or permit transfer of thepre-strained dressing630 to the skin of a subject. The applicator ortensioning device620 may also provide for a convenient sterile transfer of an adhesive portion of the dressing to a skin and/or wound site of a subject.

Thedevice620 comprises a cover621 and abase622. The dressingassembly610 is removably coupled or anchored to thedevice620 which may act as a dressing carrier. The cover621 may be generally planar and include

sides

623,624 withcorresponding edges623aand624bdefining its length and edges621aat opposing ends. The base622 may be generally planar and include

sides

625,626 with

corresponding edges

625aand626adefining its length and edges622aat opposing ends.

According to some variations, the cover621 and/orbase622 or elements or segments thereof may be constructed to be sufficiently firm or rigid or less flexible relative to an attached dressing to support an attached dressing until it is applied to a subject as described with respect to the variations herein. The materials and construction of the applicator ortensioning device620, dressing630 andpackaging600 may be of similar to the packaging assemblies and/or dressings described in variations herein and shown inFIGS.1A to22B.

The cover621 and base and622 may be movably, pivotably, bendably or hingedly coupled at

sides

623,624. For example, a layer ofmaterial627 such as silicone, polyurethane, low-density polyethylene or a rubber material may be glued to each of the cover and base, flexibly attaching them together at

sides

623,625. Thedevice620 may be constructed in a manner similar to that described with respect to other devices herein and shown inFIGS.1A to22B and may be constructed in a similar manner as described herein including but not limited to with respect to materials, segmentation, strength and flexibility, visualization, straining mechanisms, and release liners.

The dressingassembly610 also includes anattachment sheet641,attachment sheet651. Theattachment sheet641 has afirst side643 that is attached to thesecond side634 of the dressing by way of anadhesive structure670 such as polyimide film or tape (e.g. KAPTON® by DuPont™) or a peelable adhesive. Adhesive structures herein may include but are not limited to KAPTON® tape or peelable adhesive configured to provide low skin trauma after repeated skin contact or a soft skin adhesive, made of material such as silicone adhesive, silicone gel, or acrylic adhesive. The adhesive structure or KAPTON® tape also comprises a material that is able to adhere to the attachment sheets to impart strain to the dressing when the attachment sheets are separated from each other, while being peelable from a selected dressing material.

As shown inFIG.15J, theattachment sheet641 andside634 of the dressing may be attached on same side671 of theadhesive structure670 with theattachment sheet641 overlapping but unattached to thedressing631.

Theattachment sheet641 has asecond side644 that is coupled to the cover621 of thedevice620 for example, by bonding with a low surface energy PSA, such as an acrylic adhesive.Attachment sheet641 may also have a score orperforation681 between its attachment to theadhesive structure670 and its attachment to the cover621. After the dressing has been strained, theperforation681 is located at the seam between the cover621 and thebase622, or over the inside surface of the cover621.

Theattachment sheet651 may be coupled at itsside654 to theback side698 of thebase622 for example, by bonding with a low surface energy PSA, such as an acrylic adhesive. Theside653 ofattachment sheet651 may be attached to theside633 of the dressing by way of anadhesive structure680 such as KAPTON® tape or a peelable adhesive, and in a manner similar to theadhesive structure670 that attaches theside654 of the dressing630 to theattachment sheet641. Theattachment sheet651 may include apull tab688 that is located on theback side698 of the base adjacent and inside of theattachment zone655 of theattachment sheet651 to the back of the base652.

The cover621, when opened, exerts a straining force on the dressing630 through theattachment sheet641.

According to some variations, the

attachment sheets

641,651 are flexible while being relatively inelastic with respect to the dressing630 and may be constructed, e.g., out of a low density polyethylene. The

attachment sheets

641,651 may be manufactured to be tearable along the material length while providing tensile strength in other directions, in particular in the tensioning direction of the material of the attachment sheet641 (direction in which dressing is tensioned, stressed or strained). An example of such material is an LDPE polymer which is produced by an extrusion process that creates an anisotropic or directionally biased grain whereby the material is tearable with the direction of the grain, but has a relative resistance to tearing in the direction transverse to the grain.

FIG.15A shows theassembly600 in an unstrained configuration. Anadhesive tape683 is exposed on theinside surface694 of thebase622. A skin adhesive layer on theelastic sheet631 of the dressing630 may be protected by a release liner similar to releaseliner149aherein before the applicator ortensioning device620 is opened

FIG.15B shows theassembly600 in an opened and strained configuration. As shown inFIG.15B, when strained, theperforation681 on the attachment sheet is aligned with the

edges

623aand625aof the cover621 andbase622, respectively. Aportion641aof theattachment sheet641 interfaces with theadhesive tape683 attachingportion641ato thebase622 and holding the dressing630 in the strained configuration. A release liner645 is attached to the underside of theattachment sheet641 between the attachment to the cover621 and theperforation681. The liner645 prevents the portion of theattachment sheet641 that interfaces the cover621 from adhering to theadhesive tape683.

The cover621 andbase622 may be separable from each other by way of, for example, aperforation682 in thelayer627 that couples the cover621 to thebase622 and by separation of thesheet641 alongperforation681.FIG.15C shows theassembly600 with the cover621 separated from thebase622. Thestrained dressing630 may be applied to a subject's skin using thebase622 as an applicator.

FIG.15D illustrates theback side698 of the base622 in a position of applying the dressing630 toward the skin of a subject. As shown, theedge654 ofattachment sheet651 may be wrapped around from the inside694 of the base622 to theback side698 where it is attached. A tear strip may be attached to theattachment sheet651 between the attached edge and an unattached middle section. Thepull tab688 or tear strip may be pulled to detach the base622 from the remainder of the dressing assembly as shown inFIG.15E. After thetab688 is pulled, an unattached portion651aof theattachment sheet651 is freed from thebase622. After the base is removed, the remaining portions of the

attachment sheets

641,651 may be removed by peeling the KAPTON® tape off of thedressing630.FIG.15F shows the dressing630 after removal of the remainder of the dressing assembly.

FIGS.15G to15J illustrate a configuration of the dressingassembly610 as the KAPTON® tape or

adhesive structures

670,680 and

attachment sheets

641,651 are removed from the dressing630.FIGS.15G and15J show the orientation of the KAPTON® tape or

adhesive structures

670,680 as they are peeled in a direction from inside the dressing630 towards the

sides

633,634 of the dressing630, or in a direction of dressing strain.FIG.15H shows thefirst structure670 peeled away from the inside of the dressing across theside633 of the dressing.FIG.15I shows the firstadhesive structure670 removed from the dressing630. The secondadhesive structure680 may be removed in a similar manner.

FIGS.16A to16D illustrate analternative dressing assembly710 in a configuration in which adressing assembly710 is separated from the applicator or tensioning device in a manner similar to that described with respect toFIGS.15A to15J.FIG.16A illustrates a firstadhesive structure770 and a secondadhesive structure780, each comprising KAPTON® tape or a peelable adhesive structure used to attach

attachment sheets

741,751 to the dressing730, As shown inFIG.16A the unattached ends of the

adhesive structures

770,780 are oriented away from the dressing730. As shown inFIG.16B, the secondadhesive structure780 is peeled inwardly and inFIG.16C, is removed.

FIGS.17A to17D illustrate an alternative dressing assembly configuration in which adressing assembly810 is separated from the applicator or tensioning device in a manner similar to that described with respect toFIGS.15A to15J.FIG.17D illustrates a firstadhesive structure870 and a secondadhesive structure880, each comprising KAPTON® tape or a peelable adhesive structure used to attach

attachment sheets

841,851 respectively to thedressing830. As shown inFIGS.17A and17D, the

adhesive structures

870,880 are attached to the dressing830 with adheredlength891. Anadditional length892 is wrapped 180 degrees about the adheredlength891. Theadditional length892 has anend893 that extends proud of the dressing830 for easy access and removal. As shown inFIG.17B, the firstadhesive structure870 may be pulled using theend893, in a direction that is in part perpendicular to the direction of strain, to remove the

attachment structures

841,851 andadhesive structure870 from the dressing830 as further shown inFIG.17C.

FIGS.18A to18I illustrate a variation of a dressing andpackaging assembly900. Thepackaging assembly900 comprises an applicator and/ortensioning device920 and adressing assembly910 including adressing930. Thedevice920 comprises acover921 and abase922. The dressingassembly910 is removably coupled or anchored to thedevice920 which may act as a dressing carrier. Thecover921 may be generally planar and include

sides

923,924 with corresponding edges923aand924adefining its length and edges921aat opposing ends. The base922 may be generally planar and include

sides

925,926 with

corresponding edges

925aand926adefining its length and edges922aat opposing ends.

The dressingassembly910 also includes anattachment sheet941 andattachment sheet951. Theattachment sheet941 has afirst side943 that is attached to thesecond side934 of the dressing by way of anadhesive structure970 such as KAPTON® tape or a peelable adhesive. Adhesive structures herein may include but are not limited to KAPTON® tape or peelable adhesive configured to provide low skin trauma after repeated skin contact or a soft skin adhesive, made of material such as silicone adhesive, silicone gel, or acrylic adhesive. The adhesive structure or KAPTON® tape also comprises a material that is able to adhere to the attachment sheets to impart strain to the dressing when the attachment sheets are separated from each other, while being peelable from a selected dressing material.

As shown inFIG.18J, theattachment sheet941 andside934 of the dressing are attached onsame side971 of theadhesive structure970 with theattachment sheet941 overlapping but unattached to the dressing931. Theattachment sheet941 has a second side944 that is coupled to thecover921 of thedevice920 for example, by bonding with a low surface energy PSA such as an acrylic adhesive.Attachment sheet941 may also have apull tab981 in an unattached region between the attachment to theadhesive structure970 and attachment to thecover921. After the dressing has been strained, theperforation pull tab981 is located at theinside surface960 of thecover921 or alternatively at the seam between thecover921 and thebase922.

Theattachment sheet951 is coupled at its side954 to theback side998 of thebase922 for example, by bonding with a low surface energy PSA such as an acrylic adhesive. The side953 ofattachment sheet951 is attached to the side933 of the dressing930 by way of anadhesive structure980 such as KAPTON® tape or a peelable adhesive, and in a manner similar to theadhesive structure970 that attaches the side944 of the dressing930 to theattachment sheet941. Theattachment sheet951 may include apull tab988 that is located on theback side998 of the base adjacent and inside of the attachment zone955 of theattachment sheet951 to the back of the base952.

According to some variations, the

attachment sheets

941,951 are flexible while being relatively inelastic with respect to the dressing930 and may be constructed, e.g., out of a LDPE. The

attachment sheets

941,951 may be manufactured to be tearable along the material length while providing tensile strength in other directions, in particular in the tensioning direction of the material of the attachment sheet941 (direction in which dressing is tensioned, stressed or strained). An example of such material is an LDPE polymer which is produced by an extrusion process that creates an anisotropic or directionally biased grain whereby the material is tearable with the direction of the grain, but has a relative resistance to tearing in the direction transverse to the grain.

Thecover921, when opened, exerts a straining force on the dressing930 through theattachment sheet941.FIG.18A shows theassembly900 in an unstrained configuration, whileFIG.18B shows theassembly900 in an opened and strained configuration which may be applied to the skin. As shown inFIG.18C, when strained, thetab981 on theattachment sheet941 is located over the inner surface of the cover921 (folded back and exposed) and is accessible to a user. After applying the dressing930, thecover921 andbase922 may be removed.

Thecover921 andbase922 are separable from each when thetab988 is pulled.FIG.18C shows the assembly with the cover positioned with the dressing face down for example as it would be when applied to the skin of a subject. As shown inFIG.18D thetab988 is pulled to release thecover921 from the remainingdressing assembly910. As shown inFIG.18E thecover921 is removed from the remainder of thedevice920, exposing thesecond pull tab998. As shown inFIG.18F, the second pulledtab998 has released the base922 from the dressingassembly910 with

attachment sheets

941,951 unattached to thebase922. As shown inFIG.18G, thebase922 is removed and the remainder of the

attachment sheets

941,951 and the

adhesive structures

970,980 may be peeled away from the dressing930 as shown ifFIG.18H with the dressing remaining on the skin in a configuration as shown inFIG.18I.

Referring toFIGS.19A through19D, a variation of a dressing andpackaging assembly1000 is illustrated. Thepackaging assembly1000 comprises an applicator and/ortensioning device1020 and adressing assembly1010 including adressing1030.FIG.19A shows thedressing assembly1010 coupled to the applicator ortensioning device1020. The tensioning member orapplicator1020 may be constructed in a similar manner as the tensioning and applicators described herein and shown inFIGS.1A to22B.

Thedevice1020 comprises acover1021 and abase1022. Thedressing assembly1010 is removably coupled or anchored to thedevice1020 which may act as a dressing carrier. The dressing assembly may be attached to the tensioning member or applicator in a manner similar to the assemblies described herein. Thedressing assembly1010 includes anattachment sheet1041 andattachment sheet1051. Theattachment sheet1041 has afirst side1043 that is attached to thesecond side1034 of the dressing1030 by way of an adhesive structure1070 such described with reference to

adhesive structures

970,980. Theattachment sheet1041 has asecond side1044 that is coupled to thecover1021 of thedevice1020 for example, by bonding with a low surface energy PSA such as an acrylic adhesive.Attachment sheet1041 also has aripcord1088 stitched along its length at an unattached portion of theattachment sheet1041, between its attachment to the adhesive structure1070 and attachment to thecover1021. Various types of stitches may be used including but not limited to a chainstitch or a lockstitch. After the dressing has been strained, theripcord1088 is located at the exposedinner side1090 of thecover1021 or alternatively at the seam between thecover1021 and thebase1022.

Theattachment sheet1051 is coupled at itsside1054 to the back side of thebase1022 for example, by bonding with a low surface energy PSA such as an acrylic adhesive. The side1053 ofattachment sheet1051 is attached to the side1033 of the dressing by way of anadhesive structure1080 such as KAPTON® tape or a peelable adhesive, and in a manner similar to the adhesive structure1070 that attaches theside1034 of the dressing1030 to theattachment sheet1041. Theattachment sheet1051 includes aripcord1098 that is located between attachment to theadhesive structure1090 and attachment to the back of the base. The ends of the

ripcords

1088,1098 extend out of thetensioning member1020 for easy accessibility.

FIGS.19A and19B illustrate thedressing assembly1010 in an unstrained configuration. Thecover1021, when opened, exerts a straining force on the dressing1030 through theattachment sheet1041.FIG.19C illustrates thedressing assembly1010 in a strained configuration.

After the dressing is strained and applied, the

ripcords

1088,1098 are pulled to separate the portion of the

attachment sheets

1041,1051 attached to thetensioning device1020 from the portions of the

attachment sheets

1041,1051 attached to thedressing1030. The applicator ortensioning device1020 may then be removed as shown inFIG.19D. The

adhesive structures

1080,1090 may then be peeled away to remove the remaining portion of thedressing assembly1010 and

attachment sheets

1041,1051, from the dressing as shown inFIG.19E.

Referring toFIGS.20A to20C, a variation is shown of a dressing carrier, tensioning device orapplicator1120. Thedevice1120 comprises a plurality ofsegments1130 formed by scoring asubstrate1150 on oneside1155 of a planar surface. Thescores1170 may be formed in one or more directions or having one or more shapes, curved or straight. Additionally the scores may be formed on both sides permitting both convex and concave shaping of a device. As illustrated, thescores1170 permit shaping of the device or an attached dressing. Thescores1170 as illustrated are formed on afirst side1155 of a planar surface of the device while thesecond side1165 is not scored. When a force is applied to thesecond side1165, the substrate bends. When a force is applied to thefirst side1155, thesubstrate1150 the device does not flex at thescores1170. The remaining substrate at thescores1170 may act as flexion limiter while thescores1170 act as a flex element.

When a convex dressing shape is desired for a concave surface, the dressing may be attached on thefirst side1155 so that when the substrate is bent, the dressing forms a convex shape to match a concave contour where the device is to be applied. When a concave dressing shape is desired for a convex body contour, the dressing may be positioned on thesecond side1165 of thesubstrate1150. So that when the substrate is bent, the dressing forms a concave shape to match a convex body contour where the device is to be applied. Various dressing backings may be provided for different body locations or contours.

According to variations, the score may be orthogonal or have orthogonal components with respect to thesegments1127 of the carrier, applicator or tensioning device. Thesegments1127 may be similar to segments shown inFIGS.1A to22B.

Referring toFIGS.21A to21D, a variation is shown of a dressing carrier, tensioning device orapplicator1220. Thedevice1220 comprises a plurality offoam cells1240 coupled by andadhesive backing1260. Thefoam cells1240 form a plurality ofsegments1227 that permit flexing in multiple directions so that the device conforms to a curvature, profile or shape of a subject where the dressing is to be applied. The foam may be sufficiently thick to generally provide added column strength for straining a dressing, i.e. a resistance to bending. A backing or support may be provided for straining a dressing, for example constructed of a material with an elastic modulus and appropriate thickness that will, at minimum, counteract the force created by straining the dressing. The dressing strain may be fixed, for example, using an adhesive on the back of a portion of the dressing assembly or attachment sheet. After the dressing is fixed, the backing or support may be removed permitting increased manipulation of the shape of the strained dressing to conform to a greater degree to the shape of the patient's body contours where the dressing is to be applied.

As illustrated, theseparations1270 between the foam sections permit shaping of the device. Theseparations1270 as illustrated are formed on a first side1255 of a planar surface of the device while the second side1265 is not scored. When a force is applied to the first side1255, the substrate bends. When a force is applied to the second side1265, the substrate1250 the device does not flex at the separations. The remaining substrate at the separations may act as flexion limiter while the scores act as a flex element.

When a convex dressing shape is desired for a concave surface, the dressing may be attached on the first side1255 so that when the substrate is bent, the dressing forms a convex shape to match a concave contour where the device is to be applied. When a concave dressing shape is desired for a convex body contour, the dressing may be positioned on the second side1265 of the substrate1250. So that when the substrate is bent, the dressing forms a concave shape to match a convex body contour where the device is to be applied. Various dressing backings may be provided for different body locations or contours.

Referring toFIGS.22A and22B, a variation of a dressing and packaging assembly1500 is illustrated. The packaging assembly1500 comprises an applicator and/or tensioning device1520 and a dressing assembly1510 including adressing1530. The packaging assembly1500, applicator or tensioning device1520, and/or dressing assembly1510 may be configured to pre-strain the dressing1530 and/or permit transfer of thepre-strained dressing1530 to the skin of a subject.

The device1520 may comprise a cover1521 and a base1522. The dressing assembly1510 is removably coupled or anchored to the device1520, and may serve as a dressing carrier. The cover1521 and base1522 are movably, pivotably, bendably or hingedly coupled at sides1523,1524 and may be constructed in a manner similar to that described with respect to covers and bases described inFIGS.1A to22B.Attachment regions1541,1551 of the dressing assembly1510 are attached near free sides1525,1526 of cover1521,1522 respectively, for example by way of a peelable adhesive or removable adhesive structures. However an attachment sheet or attachment structure described with respectFIGS.1A to22B herein may be used. Theattachment regions1541,1551 and or positioning of the dressing1530 on the device1520, may be symmetric with respect to a line defined by attachment of sides1523,1524 of the cover1521 and base1522 respectively. As shown inFIG.22B, the dressing1530 is strained with the cover1521 and base1522 are opened. The dressing1530 may then be applied to the skin of a subject and the device1520 may be peeled away from thedressing1530. In addition or alternatively, the cover1521 and base1522 may be separated by way of a perforation formed in the substrate of the device1520 or a perforation1551 formed in an attachment structure1550 such as a tape or layer of material that attaches sides1523 and1524 of the cover1521 and base1522 respectively.

In some variations, the device1520 may optionally comprise an adhesive coating or adhesive tape on the cover1521 and/or base1522 which may adhere to thedressing1530 when the dressing1530 is tensioned and the dressing comes in further contact with the cover1521 and base1522. In some variations, the adhesive is configured to maintain the dressing1530 in a tensioned state and/or against the cover1521 and/or base1522. The adhesive coating or adhesive tape may be located along the side regions1523,1524 of the cover1521 and/or base1522, but many also be provided adjacent to theattachment regions1541,1551. Release liners may also be provided to reduce inadvertent adhesion of the dressing or other structures to the adhesive until activation of the device1520 is desired.

According to variations the various assemblies or devices described herein may provide a temporary wound dressing that may be applied before a wound is closed. The assembly may be configured to apply a dressing to a wound and to use the packaging or applicator 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 variation which may be provided with any of the embodiments described below, the packaging or applicator has sufficient rigidity to distribute a relatively even or firm force to a wound by applying pressure to the packaging or applicator when and/or after the dressing is applied to a wound. According to a variation, such dressing may include a coagulation agent or other agent or medicament, for example as described herein. According to another variation, margins as described herein, are provided on such a device between a dressing and edges 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 comprise of a plurality of segments of the base structures. The dressing support structure may comprise at least 3 segments that extend at least from a first side of the dressing to a second side of the dressing. The dressing support structure may comprise a plurality of segments such as segments described inFIGS.1A to22B that are coupled or formed together. The plurality of segments of a cover described herein may also provide support to a dressing when the cover is folded over 360 degrees with respect to the corresponding base structure.

In other examples, the strained dressing may be provided to the user as pre-strained dressing that is strained at the point-of-manufacture, rather than at the point-of-use. Referring toFIGS.23A to23I, preparation of apre-strained assembly2351 that includes a pre-strained dressing is illustrated. Atensioning device2341 used to prestrain the dressing is shown in use inFIGS.23A to23D. Various features and stages of preparingprestrained assembly2351 are further shown inFIGS.23E to23I.

Thepre-strained assembly2351 may comprise adressing assembly2308 and strain maintaining structure orsupport structure2330. (SeeFIG.23I) Thepre-strained assembly2351 may be stored for a period of time prior to use.

Thedressing assembly2308 may include a dressing2310 comprising a relatively planarelastic sheet2360 defining a plane. Theelastic sheet2360 may comprise a silicone sheet or other elastic material, for example, as described herein. Thedressing assembly2308 may further comprise anattachment sheet2304,tensioning sheet2307, apre-strained assembly release2352 and adressing release2319.

Theattachment sheet2304 may be configured to attach the dressing2310 to asupport structure2330 by way of engagingelement2322. Theattachment sheet2304 of thedressing assembly2308 may include a first engaging wall orelement2322 extending downward with respect to the plane of thedressing2310 and including an inwardly extending hook2323.Engaging element2322 may be attached to theattachment sheet2304, for example, with an adhesive. Thetensioning sheet2307 of thedressing assembly2308 may include a secondengaging element2324 extending downward with respect to the plane of thedressing2310 and including an inwardly extendinghook2325. Thetensioning sheet2307 may be configured to attach the dressing2310 to thesupport structure2330 by way of engagingelement2324.Engaging element2324 may be attached totensioning sheet2307, for example, with an adhesive. Thetensioning sheet2307 may also be configured to translate tension from thetensioning device2341 to the dressing2310 to strain thedressing2310.

Thepre-strained assembly release2352 may be configured to release the pre-strained assembly2351 (the dressing2310 and support structure2330) from the tensioning device2341 (see, e.g.,FIGS.23E and23I). The dressingrelease mechanism2319 may be configured to release the dressing2310 from theengaging elements2322,2324 (including hooks2323,2325) and thus from thesupport structure2330. The dressingrelease mechanism2319 may be configured to release thedressing2310 after thedressing2310 is applied to a subject.

The dressing2310 of thedressing assembly2308 may have a first edge orside2305 having a length, and a second edge orside2306 having a length. The dressing2310 may be coupled at a first edge orside2305 to theattachment sheet2304 which may be flexible yet relatively less elastic or in-elastic than thedressing2310. Theattachment sheet2304 may have afirst side2382 and asecond side2384. When assembled, theattachment sheet2304 may be bonded to theelastic sheet2360 of the dressing2310 atsection2375 ofattachment sheet2304 at or near theside2382 of theattachment sheet2304, for example, using a combination of a silicone PSA/acrylic PSA. Theattachment sheet2304 may be coupled at itsside2384 to engagingelement2322 and hook2323, for example, by bonding with an adhesive material, e.g., using a combination of a silicone PSA/acrylic PSA. Theattachment sheet2304 may couple the dressing2310 by way of engagingelement2322 and hook2323, to thesupport2330 near thefirst side2305 of thedressing2310. The dressing2310 may be coupled at its second edge orside2306 to thetensioning sheet2307 which may be flexible yet non-elastic or less elastic than thedressing2310. Thetensioning sheet2307 may have a first side2372 a middle location2373 and a second side2374. When assembled, thetensioning sheet2307 may be bonded to theelastic sheet2360 of the dressing2310 atsection365 oftensioning sheet2307 at or near theside2372 of thetensioning sheet2307, for example, using a combination of a silicone PSA/acrylic PSA. Thetensioning sheet2307 may be coupled at a middle location2373 toside wall2324 andhook2325, for example, by bonding with an adhesive material, for example, using a combination of a silicone PSA/acrylic PSA. When assembled into thepre-strained assembly2351, thetensioning sheet2307 may couple the dressing2310 by way ofside wall2324 andhook2325 to thesupport structure2330 near thesecond side2306 of thedressing2310. Thetensioning sheet2307 may be loaded onto thetensioning device2341 at the second side2374 as described in more detail herein. According to some variations, theattachment sheet2304 ortensioning sheet2307 may be constructed, e.g., out of a low density polyethylene.

Thedressing assembly2308 is shown inFIG.23A, positioned over asupport structure2330 to which it may be removably attached when or after thedressing2310 is pre-strained to form thepre-strained assembly2351. Thesupport2330 may be generally planar and include

sides

2335,2336 with corresponding

edges

2335aand2336adefining its length. Other support elements, support structures and/or strain maintaining elements may be used, for example, the sides of the dressing2310 or dressingassembly2308 may be clamped and a desired distance maintained between the clamps, e.g., using a separating element.

The dressing2310 of thedressing assembly2308 may be strained, for example, with atensioning device2341 as shown inFIGS.23A to23D. Thepre-strained dressing2310 may then be stored in a pre-strained configuration for a period of time prior to use. Thetensioning device2341 may be used at a point of manufacture, by an intermediary, or by an end user. Thetensioning device2341 may comprise aplanar portion2343 and acircular portion2344 configured to contain arotating element2345. Therotating element2345 may have amiddle section2346 with aslot2347 to receive and engage thetensioning sheet2307 of thedressing assembly2308.

InFIG.23A thedressing assembly2308 may be shown in a first configuration on thetensioning device2341 where it is relatively unstrained. Thedressing assembly2308 may be positioned oversupport structure2330. Thissupport structure2330 may be positioned over thetensioning device2341 with theupper surface2333 of thesupport structure2330 interfacing theback side2311 of thedressing2310. Afirst edge2335aof thesupport structure2330 and a first side oredge2349 of theplanar portion2343 of thetensioning device2341 may be engaged and held by engagingwall2322 and hook2323. Thesecond end2336 andedge2336aof thesupport2330 may initially be free from engagement with but is in a position interfacing thedressing2310. This may permit the dressing2308 to be strained to a desired degree without interference of thesupport structure2330.

In use, the end2374 of thetensioning sheet2307 may be inserted into theslot2347 in themiddle section2346 of therotating element2345 of thetensioning device2341. Then therotating element2345 may be rotated until thetensioning sheet2307 is engaged. Initially thetensioning sheet2307 and dressing2310 may be in an unstrained configuration but with minimal slack, when attached to thetensioning device2341. As therotating element2345 is rotated, the dressing2310 may be strained as thetensioning sheet2307 is pulled in a tensile straining direction with respect to the dressing2310 by therotating element2345.

The dressing2310 may be strained by turning therotating element2345 as shown inFIGS.23A-23D. Once the tensioning sheet is loaded as therotating element2345 is turned, thetensioning sheet2307 may wrap around therotating element2345 thereby shortening the distance between therotating element2345 and thedressing2310, to stretch or strain thedressing2310. A lockingmechanism comprising ratchets2337 on therotating element2345 and apawl2338 on thecircular portion2344 may be used to lock thedressing2310 in a strained configuration as shown inFIGS.23B to23D. When thetensioning sheet2307 is pulled in a tensile straining direction towards thecircular portion2344 of thetensioning device2341, the engagingelement2324 andhook2325 may also move in the tensile straining direction. Theedges2336aof the support comprises aramp2336bthat may engage with aramp2326 on thehook2325 to guide theedge2336aof thesupport2330 into engagement with thehook2325 as thehook2325 moves towards thecircular portion2344 of the tensioning device. (SeeFIGS.23C to23H). The strain of thepre-strained dressing2310 may be controlled or determined using measurement elements ormarks2342 on therotating element2345 the distance between each of which may correspond to an increment of increased strain or distance. Once adressing assembly2308 is loaded on thetensioning device2341, the strain may be determined by the amount therotating element2345 rotates. Eachmark2342 may correspond to a percentage strain or a distance. A 0% strain may be identified as the position in which thedressing assembly2308 is loaded onto thetensioning device2341 with no slack and minimal strain or tension. As shown inFIG.23A the 0% position may be shown wheremark2342ais aligned with thepawl2338. As therotary element2345 is rotated, the identified 0% mark2342amay rotate a certain degree which corresponds to a percent strain.Mark2342bas shown inFIG.23B is aligned with thepawl2338 when the dressing is strained to a desired amount x indicated bymark2342b.

Thesupport structure2330 may maintain the dressing2310 in its strained configuration as shown inFIGS.23B to23I during storage where the

engaging elements

2322,2324 and hooks2323,2325 engaging thesupport structure2330, prevent movement of the dressing2310 or loss of strain. One or more adhesive regions comprising a layer of skin adhesive2340 may be applied to thetop surface2312 of thedressing2310. The adhesive2340 used may be, for example, a suitable pressure activated adhesive (PSA), or a non-pressure sensitive adhesive. The adhesive2340 is shown on a dressing2310 in an unstrained configuration. However, the adhesive may be applied to thedressing2310 after thedressing2310 has been strained. Aremovable liner2350 may be placed over theadhesive layer2340. Theliner2350 may further be selected to maintain the strain in thedressing2310. Such liner may comprise rigid or semi-rigid material, for example, ultra-high molecular weight polyethylene (UHMWPE) with a release coating or layer, e.g., a fluoropolymer such as perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE) or expanded PTFE (ePTFE). Other hard plastics or resins that may be used include melamine, fiberglass, acrylonitrile butadiene styrene (ABS) or polyvinyl chloride (PVC). In other variations, the rigid liner may be a composite structure comprising a flexible liner with a rigid frame or rigid struts, which may comprise, for example, a metal (e.g. stainless steel), or a hard plastic/resin.

Once the dressing2310 is strained and thedressing assembly2308 may be secured in engagement with thesupport structure2330, thedressing assembly2308 andsupport structure2330 may be separated from thetensioning device2341 to form thepre-strained assembly2351 that may be used immediately or stored for a period of time.

Thepre-strained assembly release2352 may comprise atear strip2353 that is attached to thetensioning sheet2307 between the middle location2373 and the second side2374 with upper and lower portions2354,2355 respectively (SeeFIG.23E). Thetear strip2353 may act to separate thepre-strained assembly2351 from thetensioning device2341 by tearing across thetensioning sheet2307 between thepre-strained assembly2351 and thetensioning device2341.

In use, after theliner2350 is released, the dressing2310 may be applied to a desired location on a subject's skin. The user may apply pressure to theback side2333 of thesupport2330 to activate the adhesive on thedressing2310 and/or to apply compression to a wound. Once applied to a subject, the dressing2310 may be released from thesupport2330 using therelease mechanism2319.

Therelease mechanism2319 may comprise tear strips2309. The tear strips2309 of therelease mechanism2319 may each extend proud of theend2366 ofelastic sheet2360. The tear strips2309 may each be coupled to thedressing assembly2308. Atear strip2309 may be coupled to theattachment sheet2304 of the dressing assembly308 in a manner that definestear path2362 along which thetear strip2309 is pulled to separate the dressing2310 from thesupport2330. Atear strip2309 may be coupled to thetensioning sheet2307 of thedressing assembly2308 in a manner that definestear path2362 along which thetear strip2309 is pulled to separate the dressing2310 from thesupport2330. Eachtear strip2309 may comprise atop section2347 andbottom section2348. Thebottom sections2348 may be unattached or free from thesupport2330 as illustrated. Thetop sections2347 of eachtear strip2309 may be adjacent but unattached to thedressing2310. Thetensioning sheet2307 andattachment sheet2304 may be manufactured to be tearable along the material length while providing tensile strength in other directions, in particular in the tensioning direction of the material of the tensioning sheet2307 (direction in which dressing is tensioned, stressed or strained) An example of such material is an LDPE polymer which is produced by an extrusion process that creates a directionally biased grain whereby the material is tearable with the direction of the grain, but has a relative resistance to tearing in the direction transverse to the grain. Notches may be made in thetensioning sheet2307 andattachment sheet2304 that facilitate tearing alongpaths2362. Thetensioning sheet2307 andattachment sheet2304 may additionally or alternatively comprise a material such as a low-density polyethylene (LDPE) with perforations formed alongtear lines2362.

The dressing2310 may be released from thesupport2330 by pulling the tear strips2309 to draw the tear strips acrosspaths2362 of thetensioning sheet2307 andattachment sheet2304.

Sections

2365 and2375 respectively of thetensioning sheet2307 andattachment sheet2304 may remain on theback side2311 of theelastic sheet2360. The

sections

2385,2395 respectively, of theattachment sheet2304 andtear sheet2307 bonded to the tear strips2309 may thereby be separated from thetensioning sheet2307 andattachment sheet2304. The

sections

2365 and2375 respectively of thetensioning sheet2307 andattachment sheet2304 that are attached to the dressing2310 may thereby be separated from the remainder of thetensioning sheet2307 andattachment sheet2304 that are attached to thesupport structure2330 at its

ends

2305 and2306. Thus, the dressing2310 may be released from the remainder of thesupport structure2330.

The dressing2310 may have unattached portions oredges2315 at its

sides

2305,2306 where theelastic sheet2360 is free from thetensioning sheet2307 andattachment sheets2304 respectively. Accordingly, the dressing2310 may be unstrained atunattached portions2315.Unattached sections2315 of theelastic dressing2310 may be unstrained and may be free from the adhesive of the adhesive layer340 (or may have a reduced amount of adhesive thereon). Thus less stress may occur at the unattached sides or edges defined bysections2315.

In use, theadhesive liner2350 may be removed and the dressing2310 applied to the surface of a subject's skin. Tear strips2309 on each side of the dressing at tear lines may be pulled to separate the dressing2310 from thesupport structure2330,attachment sheet2304 andtensioning sheet2307, after the dressing is applied to the surface of skin of a subject. When thesupport structure2330,attachment sheet2304 andtensioning sheet2307 are removed from the dressing2310, the stress or strain of the dressing2310 may apply a (tangential) compressive force to the skin to thereby treat the skin.

Referring toFIG.24, a plurality ofstrained dressings2410 may be strained in a manner similar to dressing2310 and then may each be attached to afirst surface2460 ofsingle support2430 which is rolled and stored in a rolled configuration for dispensing as shown inFIG.24. Thestrained dressings2410 may be coupled to thefirst surface2460 of thesingle support2430 by an adhesive, such as, e.g., a high tack/low peel PSA, which maintains thedressings2410 in a strained configuration.Liners2450 may be placed on a second andopposite side2470 of thesupport2430 and are positioned so that when thesupport2430 is rolled, they are over a skin adhesive on the top of thedressings2410. Theadhesive liner2450 may also help minimize creep properties of thestrained dressings2410. Thesupport2430 may be rolled to store thedressings2410. When thesupport2430 is unrolled, theadhesive liner2450 positioned on thesecond side2470 and opposing adressing2410 may release from thedressing2410.Dressings2410 may be separated by aperforation2480 so that they may be individually used.

In some variations, the dressing may be used for the treatment of chronic injection sites or catheter sites that are required for a variety of conditions, including but not limited diabetes, cancer, immune disorders such as severe combined immunodeficiency disease, 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 have other mechanical effects on pharmacokinetics, that may improve drug dispersion in the tissue, reduce drug leakage, increase the depth of effect, reduce pain at the injection/infusion site, reduce site infection risk, reduce risk of line/pump occlusion at an infusion site, improve analyte or drug level variability, reduce inflammatory layer thickness or depth, reduce dosing level. For diabetes patients, the skin treatment may result in fewer glycemic excursions, improved time-in-range as measured by multiple daily fingerstick or continuous glucose monitoring (CGM), increased insulin bolus volume and/or area in the subcutaneous tissue.

In other variations, the tensioned tissue treatments described herein may be also be used to treat subdermal or subcutaneous tissue conditions, which may result from injection, 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, N.J.). This implant is a radiopaque, soft, flexible progestin eluting implant that consists of ethylene vinyl acetate (EVA) copolymer core that has been doped with barium sulfate to provide radio-opacity, with 68 mg of progestin etonogestrel that is released for up to three years. Difficulties or complications with the removal of the implant have been reported in 1.5% of cases, with encasement of the implant in fibrotic tissue being the most common cause. It is believed that treatment of 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 the complication rate during the explantation procedure. Fat atrophy at the subdermal contraceptive implant site has been known to lead to loss of contour, with a significant aesthetic impact. Fat atrophy local to subdermal contraceptive may be due to any of the components in the implant acting directly on surrounding fat cells or by means of foreign body type reaction. Injection site nodule formation in the subcutaneous layer is another common reaction to diabetes drug treatment injections such as GLP-1 (i.e. exenatide) agonist therapy used by T2D patients. Paresthesias, pain, and blot clot risk at the implantation site may also be reduced during the three-year treatment period with the implant whether or not 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 the implantation, but in other variations, tensioned tissue treatment may be applied for a period of time in the range of 4 to 6 weeks, 4 to 8 weeks, 6 to 8 weeks, 6 to 12 weeks after implantation, or following explantation. In some further variations, treatment may be applied to the proposedimplantation site 4 to 6 weeks, 4 to 8 weeks, 6 to 8 weeks, 6 to 12 weeks prior to implantation. This may reduce or break up existing fibrosis or otherwise cause the tissue to remodel pre-implantation, and facilitate the implantation procedure and facilitate promote post-implantation healing and other tissue responses. An initial limited period of treatment may be sufficient to alter or slow the initial tissue remodeling process or inflammation to reduce the adverse reactions associated with the implantation. The user may be instructed to place the tensioned dressing to cover the skin area that is at least 1 cm, 2 cm, or 3 cm or more surrounding the implant. The direction of tension of 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 depo formulation of an injectable contraceptive like DEPO-PROVERA® (Pfizer, New York, N.Y.), a medroxyprogesterone acetate formulation with a polyethylene glycol and polysorbate carrier that is injected every three months. Drug levels peak 3 weeks after injection and become undetectable between 120 to 200 days post-injection.

Another depo injection is SUBLOCADE® (INDIVIOR, North Chesterfield, Va.), a monthly depo formulation of buprenorphine for the treatment of opioid use disorder for patients who are undergoing treatment with another buprenorphine product. SUBLOCADE® is intended to be injected subcutaneously at a rotating abdominal site, free of skin conditions, between the transpyloric and transtubercular plane of the abdomen.Phase 3 studies of SUBLOCADE® found a 16.5% rate of injection site reactions, which included, pain, itching, redness, bruising, swelling, induration, cellulitis and other discomfort.

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

In still other variations, the tensioned tissue treatment system may be used in conjunction with injectable therapies for autoimmune or inflammatory disorders, including but not limited rheumatoid arthritis, psoriasis, lupus, and the like. Subcutaneous injections may include disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, weekly subcutaneous injectable ACTEMRA® (tocilizumab) (Genentech, South San Francisco, Calif.) for treatment of rheumatoid arthritis, giant cell arteritis, cytokine release syndrome, juvenile idiopathic arthritis and systemic sclerosis-associated interstitial lung disease, ever four week subcutaneously injectable ILARIS® (Canakinumab) (Novartis, East Hanover, N.J.) for treatment of periodic fever syndrome, TNF receptor associated periodic fever, hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency, Still's disease, and juvenile idiopathic arthritis, every two weeks subcutaneous injectable KEVZARA®(IL-6 receptor agonist) (Sanofi, Bridgewater, N.J.) in combination with methotrexate or other convention disease-modifying anti-rheumatic drug for the treatment of severe rheumatoid arthritis,

Treatment with a tensioned skin dressing may be provided continuously during use of the depo injections above, or for a limited period of time following each injection, e.g. 3 to 5 days, 3 to 7 days, 5 to 10 days, or 7 to 14 days post-injection. The dressing may contain apertures to facilitate a rotational injection patterns with therapeutic agents require multiple serial injections.

Although the particular example above involves a drug eluting device, in other variations, the implant may be a non-drug eluting implant, e.g. cosmetic body modifications including but not limited to dermal or subdermal beads, rods or horns, or therapeutic implants such as a hyoid bone implant for treatment of obstructive sleep apnea. For implants intended for extended or undefined treatment durations, tensioned tissue treatment may be applied for a period of time in the range of 4 to 6 weeks, 4 to 8 weeks, 6 to 8 weeks, 6 to 12 weeks after implantation. Fibrous capsule formation may occur around implants during the end-stage healing response. Eventually, atrophy may occur due to diminished blood supply. It is hypothesized that the tensioned dressing may have an effect on the fibrous capsulation. This may include a reduction in the final size and/or the pliability, compared to untreated controls.

The injectable material may also be an autologous fat, or a cosmetic fillers such as JUVEDERM® (Allergan Aesthetics, Madison, N.J.), RADIESSE® (Merz, Franksville, Wis.), RESTYLANE® (Galderma, Fort Worth, Tex.), whether injections are performed using a needle or a flexible blunt-tipped microcannula, such as the DERMASCULPT MICROCANNULA® by CosmoFrance (Miami, Fla.), PIX'L cannula by Thiebaud (Paris, France) and Merz cannulas by TSK Labs (Tochigi, Japan). Use of a tensioned skin dressing over the injection site(s) may reduce the swelling and/or bruising that may occur. Tensioned skin dressing may be applied for 3 to 5 days, 5 to 7 days, 7 to 10 days, 3 to 7 days, or 7 to 14 days post injection, with the tensioned skin dressing reapplied with each injection of the treatment regimen. In some variations, the tensioned dressing may be indicated only with the onset of the local size adverse reactions, or may be applied preventatively, to reduce the risk or rate of onset of such adverse reactions. Treatment of dermal filler injection at the subcutaneous junction via threading or tunneling techniques may reduce visibility of the injection tract by reducing scar formation along the tract and/or migration of the filler location. Treatment with cosmetic fillers with a tensioned skin dressing may be provided for a limited period of time following each injection, e.g. 3 to 5 days, 3 to 7 days, 5 to 10 days, or 7 to 14 days post-injection. The tensioned skin dressing may be sized to ensure coverage of the injection area(s) by at least a 1 cm, 2 cm or 3 cm margin. In some variations, the direction of tension in the skin dressing may be selected to be generally transverse to the direction or average directions of the threading or tunneling injection paths. It is hypothesized that the tensioned tissue treatment may reduce the chance of ecchymosis that may result from increased tissue resistance during insertion of microcannulas, when the tension off-loading dressing therapy is used prior to injections and existing fibrosis has been pre-treated and/or reduced. Additionally, tolerability of the procedure and treatment compliance may increase if the patient's discomfort level has decreased due to reduced scar tissue build-up. Patients have reported discomfort from insertions in scar tissue causing pain and noise of a blunt cannula passing through hard dense scar tissue.

In another embodiment, the tensioned tissue treatment system is used in conjunction with hemodialysis procedures and applied to the needle insertion sites of the dialysis graft or fistula. In some variations, a single tensioned tissue treatment device may be applied, covering 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 the tension applied to the arm of the hemodialysis patient may be along the longitudinal or the transverse direction of the arm. It is hypothesized that the use of tensioned tissue treatment at the hemodialysis needle insertion sites may reduce the risk of developing pain, ulceration and/or tissue calcification in the dermal and/or subcutaneous tissue overlying the graft or fistula. In another example, use of tensioned tissue treatment on patients that are not eligible for an AV fistula due to excessive scar tissue build up from previous IV, blood work, or medication, may remodel tissue sufficiently to allow for the fistulization procedure. In some further variations, the tensioned tissue treatment may even reduce the rate of thrombosis of a fistula by reducing short-term inflammation at the insertion site, or mechanical stresses in the graft that may activate local clotting pathways. Therapy will be typically applied between hemodialysis visits, e.g. 48 to 72 hours each application following hemodialysis. The tensioned tissue therapy may also be provided along the implantation site of a new hemodialysis graft or AV fistula formation surgery or AV fistula revision procedure. For AV fistulas, treatment with tensioned tissue devices may be 1 to 2 weeks, 2 to 4 week, 4 to 8 weeks, 8 to 12 weeks, or the entire maturation time from the surgery to the first use of the fistula. For AV grafts, treatment with tensioned tissue devices may be in the range of 1 to 2 weeks, 2 to 3 weeks, or 2 to 4 weeks, for example.

In still other embodiments, the tensioned tissue treatment devices may be used to treat the post-implantation site of a pacemaker housing, implantable cardioverter defibrillator (ICD), or implantable pulse generator of a neuromodulation system, and the subcutaneous implantation site of a neuromodulation electrode. The neuromodulation systems may be used to perform spinal cord stimulation (SCS) to treat low back pain, such as the SPECTRA WAVEWRITER and PRECISION SCS systems by Boston Scientific (Marlborough, Mass.), the INTELLIS and RESTORE neurostimulator system by Medtronic (Minneapolis, Minn.), the SENZA OMNIA system by Nevro (Redwood City, Calif.) and the PROCLAIM and PRODIGY SCS systems by Abbott (Austin, Tex.). Treatment may reduce or prevent implantation site pain, paresthesia, paralysis, spinal cord compression, swelling, inflammation, ulceration or erosion, capsular fibrosis, tissue ingrowth and/or implant migration. In some instances, firm fibrotic capsules form around the implant and begin to squeeze the implant or capsular contracture, causing tenderness and pain. This effect may be reduced with treating using a tensioned tissue treatment device.

In other examples, the tensioned tissue treatment devices may be used to directly treat diseases that involve subcutaneous tissue or structures. These may include autoimmune diseases, metabolic diseases, endocrine diseases, genetic diseases, inflammatory diseases, oncologic diseases, infectious diseases, and the like. For example, certain disease may result in the development of subcutaneous calcifications in the dermis or subcutaneous tissues, often as a result of inflammation from a variety of etiologies. It is believed that symptomatic treatment of calcifications visualized on medical imaging may reduce pain or progression of calcifications with the application of tensioned tissue treatment devices as described herein. Such diseases may include autoimmune diseases such as dermatomyositis and scleroderma, metabolic disease 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 tensioned tissue treatment devices may be applied for 1 to 2 weeks, 2 to 4 week, 4 to 8 weeks, 8 to 12 weeks, for example, to dermal or subcutaneous calcifications.

In other examples, the tensioned tissue treatment devices may be used to treat livedo reticularis or livedo racemosa, or other vascular diseases of the medium size blood vessels found in the subcutaneous tissue. These disease phenomena are characterized by blotchy, net-like colored patterns of the skin, which are thought to originate from alterations in blood flow, vasospasm, venodilation, thrombosis or increased blood viscosity. The tensioned tissue treatment devices may be used alone or in conjunction with systemic therapy directed to the underlying cause of the skin condition. Causes may include, for example, vasculitis, polyarteritis nodosa, temporal arteritis, Takayasu arteritis, lupus erythematosus, Still's disease, rheumatic fever, endocarditis, hepatitis, anti-phospholipid syndrome, cryoglobulinemia, deep vein thrombosis, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, and the like. Medication-induced vascular changes may also be treated. Treatment periods with the tensioned tissue treatment devices may be in the range of 1 to 2 weeks, 2 to 4 week, 4 to 8 weeks, 8 to 12 weeks, as needed. Treatment may also temporarily improve the cosmesis of congenital vascular malformations, which may persist for hours, days or weeks following temporary treatment.

In some other embodiments, tensioned tissue treatment devices may be used in conjunction with body sculpting or contouring procedures. Treatment combined with these procedures may accelerate healing post-procedure or improve the contouring effect by reducing subcutaneous tissue inflammation during the healing process. Such procedures may include invasive energy-based, cooling-based or mechanical-based lipolysis or septae disruption, as well as non-invasive vacuum and massage therapies that may be combined with invasive body sculpting procedures or used alone. Use of invasive lipolysis procedures has been associated with development of subcutaneous fibrosis, which may be the result of inadequate removal of disrupted subcutaneous cells or connective tissues. In some examples, tensioned tissue treatment systems 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 after an invasive body sculpting procedure may be performed for 1 week to 3 months, or 2 weeks to 6 weeks, or 4 weeks to 12 weeks, for example, while treatments between multi-treatment regimens will vary depending on the treatment schedule, which could be as above, or in the range of 3 to 5 days, 5 to 7 days, 7 to 10 days, 3 to 7 days, or 7 to 14 days after each procedure of the regimen or treatment schedule.

In some examples, the dressing, and optionally one or more structures of the dressing support structure, may comprise one or more openings that may facilitate the use of the strained dressing with an indwelling catheter, cannula or sensor that is inserted into the tissue. In other examples, the device used with the dressing may be transiently inserted through the dressing, e.g. a needle for a blood draw, or needle biopsy tool.FIG.30A depict one embodiment of thestrained dressing3000 with anopening3002 that has been applied to atarget site3004 and released from its applicator (not shown) to transfer stress from the dressing3000 to de-tension thetreatment site3004. An indwelling device, such as an infusion set for an insulin pump system or an indwelling sensor system, may then be placed through theaccess aperture3002 and into the skin or subcutaneous tissue at the treatment site. In this particular example depicted inFIGS.30B to30D, aninfusion set3006 for use with a medication pump comprises ahousing3008,connector tubing3010, asupport layer3012 for an adhesive layer, and aneedle3014. In this particular embodiment, the needle has an acute angle orientation relative to the plane of thesupport layer3012, but in other examples, the needle may have an orthogonal orientation, or may be in the same plane or otherwise parallel to the plane of the housing or support layer. The needle length may or may not extend beyond the peripheral boundaries of the housing or support layer. The needle sheath (not shown) and/or adhesive protection layer (not shown) of the infusion set3006 is removed. Theneedle3014 is then aligned with theopening3002, as shown inFIG.30B, until theneedle3014 is fully inserted into thetarget site3004 and the adhesive of thesupport layer3012 is adhered to thedressing3000 and/ortarget site3004. In some further variations, a protective dressing may be partially or completed applied over the strained dressing and infusion set. In some variations, the direction of strain in the dressing may be parallel or preferably transverse to the direction of the needle insertion into the target site, or parallel or preferably transverse to the length of the dressing.

In addition to the manual insertion of the needle of an infusion set or indwelling device through an aperture of the dressing, in some variations, the infusion set or indwelling device may comprise a delivery tool or system to facilitate the insertion or placement of the infusion set or indwelling device. The delivery tool may be easier or otherwise require less dexterity to grip than the smaller infusion set, or may hide the delivery needle from the user and/or may automatically insert and/or withdraw the delivery needle during the insertion procedure, which may improve compliance or other aspects of the user experience. InFIGS.31A to31C, for example, the dressing3000 withaperture3002 may be placed at thetarget site3004, but where the infusion set3020 comprises an exposedorthogonal needle3022 is releasably coupled to a larger delivery device ordevice3024. Thedelivery device3024 and/orneedle3022 is aligned with the dressing3000 and/oraperture3002, as shown inFIG.31A, and then place against the dressing3000, as shown inFIG.31B. Theactuator3026 on thedevice3024 is then activated to separate thepod3024 from theinfusion set3020. In this particular embodiment, the infusion set3020 does not have an adhesive support layer that extends beyond the peripheral boundary of the infusion set housing3021. Instead, the adhesive may be provided directly on the inferior surface of the housing3021, with or without any support layer therebetween.FIGS.31D and31E are cross-sectional views depicting the actuation mechanism of thedelivery device3024 and the detachment of thedelivery device3024 from the infusion housing3021. The infusion housing3021 may be mechanically attached to thedelivery device3024 by friction and/or by one or moremechanical interlocks3030. To release theinfusion device3020, theactuator3026 is depressed andplunger tip3032 engagescatch lever3034 to release infusion housing3021. Theactuator3026 and theplunger tip3032 are maintained in the non-engaged position by aspring3036. In another variation, the infusion housing may be releasably attached using an adhesive such as a gel that temporarily adheres the plunger tip to the superior surface of the infusion housing.

Although the exemplary dressings above comprise a single circular aperture that is centrally located, in other examples, the apertures may have other shapes, sizes and/or eccentric locations, and may comprise other markings or indicia. The markings or indicia may be used to differentiate between 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 aperture, e.g. two, three, four, five or more apertures. In still other examples, a dressing may be provided without an aperture, and the needle of the infusion set, syringe or insertion device is used to pierce the dressing and then inserted through the skin or tissue.

FIG.32A depicts the exemplary embodiment of the dressing3000 inFIGS.30A to31C. The dressing3000 comprises an oblong shape with rounded corners and a centrally locatedcircular opening3002. Theopening3002 may have a diameter of about 0.10″ to 0.30″, or 0.05″ to 0.20″. The dressing3000 has a longitudinal length that is greater than its transverse width, but in other examples, the dressing may be radially symmetrical. The length and/or width of the dressing may be in the range of 4 cm to 16 cm, or 2.5 cm to 5 cm, or have a surface area of 9 cm²to 19 cm², or 46 cm²to 70 cm².

FIG.32B depicts another exemplary embodiment of adressing3200, comprising

multiple openings

3202,3204,3206. In this particular embodiment, the

openings

3202,3204,3206 are linearly aligned with each other, and optionally linearly aligned along the central longitudinal axis of the dressing3200, as shown inFIG.32B.

Optional indicia

3208,3210,3212 may be provided to facilitate changing of the insertion location during a single use of thedressing3200.FIG.33 depicts dressing3200 placed against a skin location.

FIG.32C depicts another exemplary embodiment of adressing3220, comprising

multiple openings

3222,3224,3226,3228. In this example, oneopening3222 is centrally located, but the other three

openings

3224,3226,3228 are eccentrically located and no three openings are linearly arranged. In other examples, all of the openings may be eccentrically located.

Indicia

3230,3232,3234 and3236 may optionally be provided for each

opening

3222,3224,3226,3228, along with other optional indicia such as thespiral lines3238, which may be used to indicate relative locations.

Other exemplary dressings may include dressings with one or more opening shapes that are non-circular.FIG.32D, for example, depicts a dressing3240 with an oval opening3242, andFIG.32E depicts a dressing3250 with a diamond shaped or parallelogram shapedopening3252.

FIG.57A to57D depicts another embodiment of a tensionedtissue treatment system5700, comprising adressing5702 and one or more removably attachable injection templates5704a-c.The templates5704a-c(a subset of three of five exemplary templates are depicted) are temporarily applied to the dressing in order to indicate to the user where to inject, while being removable so that bulkiness or discomfort of the tensioned tissue treatment system is reduced between injections. As with many of the exemplary embodiments depicted herein, the dressing5702 is depicted schematically without an applicator or tension applicator that are described elsewhere herein for simplicity. Each of the templates5704a-chave the same size and shape but includes a plurality of injection openings5706a-c,5708a-c,5710a-c,5712a-c,each at a different location on the template5704a-crelative to the other templates5704a-c.Thus, each template5704 is used on a different day to assist the user to rotate injection sites with each injection every day. Indicia5714a-cmay also be provided on the template5704a-cto help the user or caretaker with identifying which template5704a-cto use for each time period. The indicia5714a-cpreferably comprises a set of ordinal indicia or words indicating a numerical or alphabetic series, but in other variations may comprise other sets of indicia that may be non-ordinal. Although the injection openings5706a-c,5708a-c,5710a-c,5712a-cof each template5704a-care grouped or clustered together in different areas of each template5704a-c,in other variations, the injection openings on each template may be located at 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 the perimeter of the shape provided on other templates of the same set. This exemplary template also comprises four injection openings5706a-c,5708a-c,5710a-c,5712a-c,but in other variations, two, three, five or six openings may be provided for each set or group of injection openings for each template. In another embodiment, the injection template is a transparent thin film polymer (e.g. polyethylene terephthalate, polycarbonate, or similar) and may be printed with an outline of the dressing shape to visually align over. Because of the materials, the thin polymer film may cling and temporarily adhere to the silicone dressing without the need for an adhesive or other attachment mechanism. Once the template5704a-cis aligned and attached to thedressing5702. The template openings5714a-c,5706a-c,5708a-c,5710a-cwill be generally coaxially aligned with one of the corresponding groups of dressing openings5724a-eof the dressing5702, to facilitate or permit injections through the template openings5714a-c,5706a-c,5708a-c,5710a-cand the groups of dressing openings5724a-e.Some variations in alignment of the template openings5714a-c,5706a-c,5708a-c,5710a-cand the dressing openings5724a-emay occur due to variations in the tensioned size of thedressing5702. In other variations, however, dressing openings of the embodiments herein are not provided and a needle may be passed through the template opening and then pierces through the dressing for the injection.

To facilitate the reproducible alignment of the injection templates5704a-cto thedressing5702, one or more

complementary alignment structures

5720,5722,5716a-c,5718a-cmay be provided on thedressing5702 and templates5704a-c.In this particular example, flat but raised

alignment structures

5720,5722 are bonded, heat melded or welded to the upper surface of each end of thedressing5702. In other examples, the alignment structures may be apertures in the dressing which may be aligned with raised alignment structures on lower surface of the templates. Complementary alignment structures or openings5716a-cand5718a-care arranged on thetemplate5704a,which can form interfit or interlock with the

alignment structures

5720,5722. In some variations the geometric shapes of the

alignment structure

5720,5722 are different, e.g. square and triangle, so as to limit the orientations of the injection template5704a-cwhen attached to thedressing5702. Other shapes that may be used include rectangles, slots, circles, ovals or other polygonal shapes. The shapes may be configured with a tolerance that allows alignment when the dressing is stretched or contracted in along the orientation direction between the alignment structures. For example, the raised

alignment structures

5720,5722 may be slightly undersized when compared to the complimentary alignment structures or openings5716a-cand5718a-con the template(s)5704a-c,to accommodate variations in the length of the dressing when 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 snapfit between the dressing and template, to resist inadvertent misalignment or unintended separation. The template may be manufactured a single layer or multi-layer structure, comprising woven or a non-woven structure, and include materials such as polyamide, polyester, polyethylene, paperboard, and the like. Any indicia on the template may be ink printed, silk-screened, embossed, die-cut, stamped or laser etched on the surface of the template. In still other variations, the template(s) may comprise an elastic material that accommodate variations in the stretched length and/or width of the dressing when it is adhered to the skin. With an elastic template, the elastic material may comprise a force per millimeter width that is lower than the force per millimeter width of the dressing itself, e.g. 50% or less, 40% or less, 30% or less 20% or less, or 10% or less, so that the tension in underlying tissue and the dressing is no substantially altered by the temporary attachment of the template.

The size of the injection openings5706a-c,5708a-c,5710a-c,5712a-cmay vary, with a diameter or maximum transverse dimension in 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 sufficiently large so that the user can adequate clean the injection site with an alcohol swab prior to injection, and/or for adequate visibility by patients with poor vision, e.g. diabetic retinopathy. The perimeter of the injection openings may be optionally raised to provide tactile feedback to facilitate positioning of a needle, which may assist users with poor vision or color blindness.

While the tensionedtissue treatment system5700 inFIGS.57A to57D comprises a plurality of different templates5704a-c,each for use with a different time period, e.g. one day, in other examples, a treatment system may include a template configured with injection openings for multiple time periods. InFIG.58, for example, the tensionedtissue treatment system5800 comprises a dressing5802 that is similar to dressing5702 fromFIG.57A, but wherein thetemplate5804 is configured with multiple groups of injection openings5808a-g,each group optionally labeled by its own indicia5806a-gand/or separated byseparation indicia5818. During use, thetemplate5804 is attached to the dressing5802 via the

alignment structures

5810,5812,5816,5818. Once attached, the groups of injection openings5808a-gof thetemplate5804 will be generally or coaxially aligned with the corresponding groups of injection openings5820a-gof thedressing5802. This facilitates or permits injections through the injection openings5820a-gof thetemplate5804 and through the groups of injection openings5820a-gof thedressing5802. As noted elsewhere, some variations in alignment of groups of injection openings5820a-gand the groups of injection openings5820a-gof the dressing5802 may occur due to variations in the tensioned size of the dressing5802.The user then identifies which set of openings5808a-gto be used, and then, based on the time of day or meal, identifies which of the injection openings for that set of openings5808a-gto be used for the injection used. Theexample system5800, illustrated inFIG.58, includes three injection openings per group5808a-g,but noted elsewhere herein, while in other variations, two, four, five or six openings may be provided per group. Each group5808a-ghas a linear arrangement of openings that is transverse to the long axis of thetemplate5804, but in other variations may have a cluster arrangement equally spaced around a central point to ensure proper injection rotation, without overlap between groups5080a-g. The other features of thesystem5800 may otherwise be similar to the range of features as described forsystem5700.

FIGS.59A to59E depict another variation of a tensionedtissue treatment system5900. Thesystem5900 comprises a dressing5902 with amulti-time period template5904 similar to thesystem5800 inFIG.58, but wherein each subgroup of template openings5908a-gis covered by a single removable adhesive cover5920a-g.The first openings of each group5908a-gis aligned with first openings of the other groups with respect to the longitudinal axis of thetemplate5904, as is each of the subsequent openings of each subgroup with the corresponding openings of the other subgroups. This results in the subgroup of openings5908a-gforming a rectangular grid of openings. In other variations, however, the arrangement and alignments of the subgroups may be different, as will be described for other exemplary embodiments below. Each cover5920a-ghas a shape and size sufficient to cover all the corresponding openings in a group of openings5908a-g,and further configured to extend beyond theouter edge5926 of thetemplate5904, to facilitate grasping and removal of each cover5920a-gby a user. Each cover5908a-goptionally further comprises different indicia5924a-gto assist the user to identify which group of openings5908a-gto use each day. The indicia5924a-gmay comprise ordinal numbers, letters or words, or may comprise symbols. Although the covers5924a-gdepicted inFIGS.59A-59E are configured to extend beyond the same side of theedge5926 of the dressing and are arranged consecutively from one end of thetemplate5904 to the other end, in other variations, the covers may be arranged to extend from either of the two sides of the template, e.g. in an alternating fashion, and/or in a non-consecutive arrangement. The latter may be beneficial to provide greater spacing between the groups of openings based on the order in which the covers and groups of openings are removed per the indicia on the covers. With the indicia5924a-glocated on the covers5920a-g,other indicia, like the ordinal indicia5806a-gor theseparation indicia5814 found in thesystem5800 inFIG.58, may or may not be provided. The covers may comprise a flexible polymeric or paper material, and the adhesive adhering the cover5920a-gto thetemplate5904 may be a pressure sensitive adhesive, e.g., polyacrylate-based, polyisobutylene-based, silicone-based pressure sensitive adhesives, synthetic rubber, acrylic, and polyisobutylene (PIB), hydrocolloid, and the like. Preferably, the t-peel force of the cover adhesive is significantly lower than the t-peel force provided on thedressing5902, so that the dressing5902 or thetemplate5904 is not pulled off during use if thetemplate5904 is attached to thedressing5902 before the cover5920a-gis removed. The

alignment structures

5910,5912,5914,5916 of thedressing5902 andtemplate5904 may otherwise be similar to

systems

5700,5800 described previously, or the other variants described elsewhere herein. Once aligned, the subgroups of template openings5908a-gare aligned with corresponding subgroups of dressing openings5928a-gof thedressing5902.

In use, thesystem5900 involves the removal of any dressing5902 that was previously applied. Depending on the type of adhesive provided on the dressing, water or an alcohol or emollient adhesive remover may be used to avoid or reduce the risk of medical adhesive related skin injury. The new injection area is identified and cleaned, and then thenew dressing5902 of thesystem5900 is applied to the new injection area. Thetemplate5904 is then grasped, and the first or the next consecutive cover5908a-gis grasped and peeled away from thetemplate5904 and removably attached to the dressing via the

alignment structures

5910,5912,5914,5916. If the group of openings5908a-gto be used already been removed earlier in the day or time period, the user may use an alcohol swab to wipe the exposed group of openings5908a-gprior to attachment to thedressing5902. The user then prepares the injection and selects the opening in the group of openings5908a-gbased on the time of day or meal time, and injects the therapeutic agents through the selected opening. After the injection is completed, thetemplate5904. This procedure is repeated several times per day until the dressing is replaced, as shown inFIGS.59B to59E, illustrating Days 1-3 of a newly appliedsystem5900.

FIGS.60A to60D depicts another variation of a tensionedtissue treatment system6000, which is similar tosystem5700 and its variants, except that instead of one attachment shape located at each end of the dressing and template(s), with the shapes being different, the attachment shapes are each the same size and shape, but there are different numbers of them at each end. In the example inFIGS.60A to60D, one end of the dressing6002 comprises a singlecircular shape6012a,while the other end comprises two

circular shapes

6014a,6016a.Likewise the complementary attachment structures on the templates6004a-ccomprise a single complementary circular opening6012a-cat one end of the templates6004a-cand two complementary circular openings6014a-c,6016a-cat the other end. The difference in the number of shapes at each end specifies the relative orientation of dressing6002 and template6004a-c.Once the template6004a-cis aligned and attached to thedressing6002. The groups of template openings6020a-cwill be generally coaxially aligned with one of the corresponding groups of dressing openings6024a-eof thedressing6002. This facilitates or permits injections through the groups of template openings6020a-cand the groups of dressing openings6024a-e. In still further variations, other shapes besides circles may be provided, and even in embodiments where different shapes are provided, the number of shapes may still be different and/or different sizes of the same shape may be included. The number of shapes on each end may be in the range of one to five, one to four, one to three or one to two. The shapes may be arranged linearly or may be clustered around a common center point. In still other variations, instead of a different size openings on the templates that form a complementary interfit with protruding shapes on the dressing, hook-and-loop applicators, adhesives, and/or magnetic attachment structures may be used to removably couple the dressing and templates.

Due to variations in the equilibrium state between a tensioned tissue treatment device and the underlying tissue, the resting size, and therefore the distance between the attachment structures on the dressing component of the system may vary. To accommodate these variations during template attachment and the injection of the therapeutic agent, a linear set of attachment structures may be provided, or a modified opening may be provided wherein the opening is configured to form an interfit with the attachment structure of the dressing across a transverse axis of the template, but permits longitudinally variable positions along the longitudinal axis.FIG.61A depicts an example of an alternate template6104 that may be used with thesystem5700 inFIGS.57A to57D. Thistemplate6100 comprising asingle attachment opening6102 at one end, and a plurality of openings6104a-cat the other end. During use onesingle attachment opening6102 is first attached to the dressing, then the opening6104a-cof best fit to attach to the corresponding attachment structure on the dressing is selected to minimize any fold or ruffles, or excessive stretching in the template6104 or dressing.FIG.61B depicts an embodiment of analternate template6120 that may be used withsystem5700 in wherein instead of triangular attachment opening, atrapezoidal attachment opening6122 which is configured to form an interlock with a triangular attachment structure of a dressing anywhere along the length of thetrapezoidal opening6122. Thetrapezoidal opening6122 is oriented along the longitudinal length of the template, so as accommodate variable dressing lengths and therefore variable dressing attachment structure positions.FIG.61C depicts an exemplaryalternate template6140 that may be used with thesystem6000 inFIGS.60A to60D, comprising two

oval openings

6142a,6142bthat are oriented along the longitudinal length of the template, to accommodate variable positions of the two circular openings of the dressing6002 ofsystem6000.FIG.61D depicts an exemplaryalternate template6160 that may be used with

systems

5800 or5900, also with atrapezoidal opening6162 to accommodate the variable position of a triangular attachment structure of a corresponding dressing. In each of the

templates

6100,6120,6140,6160, the attachment opening may be larger than the corresponding attachment structure(s)6104a-c,6122,6142a-b,6162, to accommodate variable dressing lengths and therefore variable dressing attachment structure positions. In each of the

templates

6100,6120,6140,6160, the attachment opening on the right of the template was configured to accommodate the variable attachment position, but in other variations, the attachment opening on the left side of the template may be configured as such.

FIG.62A depicts another embodiment of a tensionedtissue treatment system6200, comprising a dressing6202 without any template. Instead, the plurality ofopenings6204 are surrounded by a plurality of adhesiveremovable rings6206. Therings6206 are preferably made of a soft foam. As eachopening6204 is used, thefoam ring6206 may be removed or peeled off from the dressing6202 to indicate its usage. In this particular embodiment, no indicia or groups are necessarily provided, and the user may be instructed to use any previously unused opening6202 s indicated by the remaining or existing foam rings6204, and may or may not be instructed to use theopenings6202 in any particular order or manner, e.g. across the each row or column of the grid ofopenings6202, and to the another row or column, whether adjacent or not

FIGS.62B and62C depict other exemplary embodiments of tensioned

tissue treatment dressings

6220,6240 which are not used with templates. In these particular embodiments, each dressing6220,6240 comprises individual adhesive covers6222 for each dressing opening (not shown). Each cover includes amain body6222athat is adhered to the dressing surrounding each dressing opening. Asmaller flap6222bis also included. Theflap6222bmay be non-adhesive to the dressing surface, to facilitate grasping of thecover6222 for peeling off themain body6222a.

Dressing

6240 inFIG.62C is similar to dressing6220 inFIG.62B, except that each of thecovers6242 also includes anindicia6242c,in addition to the adhesivemain body6242aandnon-adhesive flap6242b.Theindicia6242con eachcover6242 may be arranged in groups6244a-gto facilitate the order of use by day or other time period. In this particular example, theindicia6242cof each group6244a-gmay be identical, but in other variations, eachindicia6242cmay be different. As noted for other embodiments, theindicia6242cmay be ordinal numbers or letters, or may comprise other symbols indicating a time of day or meal, e.g. sunrise, moon, food symbols. Referring toFIGS.62D to62G, the use of dressing6220 depicts its initial use with the removal of afirst cover6222 via theflap6222b,to peel away theadhesive body6222a,to expose the underlying dressing opening6224a.Thecovers6222 may be removed in order using the next closestadjacent cover6222, as depicted inFIG.62G, but in other variations, anyunused cover6222 on the dressing6220 may be selected for use.

FIG.63 depicts another embodiment of a tensionedtissue treatment system6300 comprising a dressing6302 with a plurality of removable tabs or covers6304a-g.In this particular embodiment, the covers6304a-gare detachable from the dressing6302 to expose the injection opening (not shown). Each cover6304a-g,however, has one or more raised bumps or protrusions, so that limited sight users, e.g. those with diabetic retinopathy or other visual impairment, can identify unused openings of the dressing6302, remove the cover6304a-gand perform the injection. The bumps on each cover6304a-gmay comprise a sequentially incremented number of bumps to indicate the time period of use, as shown inFIG.63, but in other variations, the bumps may be braille alphabet or numbers to indicated sequential letters or numbers to indicate or to track the order of use.

FIGS.64A and64B depict another variation of a tensionedtissue treatment system6400, comprising a dressing6402 with alongitudinal axis6404 and atransverse axis6406, and a plurality ofopenings6408, which in turn comprise subgroups ofopenings6408a-g,where each subgroup of opening are covered an adhesive removable cover strip6410a-g. Insystem6400, however, the plurality ofopenings6408 have an optionally transversely staggered arrangement, wherein the first openings of each subgroup6208a-gis aligned longitudinally with first openings of theother subgroups6408a-g,but each sequential opening of asubgroup6408b-gis transversely offset from the earlier opening within each subgroup and optionally aligned with the earlier opening of the nextadjacent subgroup6408b-g.This results insubgroups6408a-gthat are linearly arranged but oriented at an angle to both the longitudinal and transverse axes of the dressing6400, as depicted inFIG.64A, as are the adhesive cover strips6410a-g.In the particular example inFIG.64A, the plurality ofopenings6408 comprise sevensubgroups6408a-g,each with four openings, and a cover strip6410a-gfor each of the subgroups. Each of the adhesive cover strips further comprise optional removable foam rings6412 around each of the openings. As each injection hole is used, thefoam ring6412 associated with the injection opening is removed. This indicates to the user that the opening has already been used and not to use it again for the duration of the dressing application. In other variations, the foam rings around each dressing are not removable from its strip6410a-g,but the strip6410a-gis removed, as illustrated inFIG.64B forstrip6410a,to indicate usage for each day or time period.

It is hypothesized that the staggered arrangement of openings and subgroups of openings insystem6200 may provide a greater separation distance between the injections performed each day while still grouping the openings in a manner to provide for multi-day or weekly use for each dressing or system. In the particular example inFIGS.64A and64B, the longitudinal spacing between adjacent openings of adjacent subgroups may be about 0.49″, or in the range of 0.4″ to 0.6″, 0.3″ to 0.5″, and the transverse spacing between adjacent openings of adjacent subgroups may be about 0.21″, or in the range of 0.15″ to 0.3″, or 0.12″ to 0.35″. The resulting distance between adjacent openings of the same subgroup would be about 0.533″, or in the range of 0.5″ to 0.6″, 0.45″ to 0.7″.

In other embodiments, instead of temporarily attaching and then removing an injection template, a set of injection guides may be provided permanently on the dressing. While the injection guides may be pre-attached to the dressing during the manufacturing processes, in other variations, the injection guides may be adhered to the dressing after the dressing has been attached and after the dressing tension has been released to offload the tension in the tissue.FIGS.65A to65G, depicts aninjection guide system6500 comprising a plurality of separate adhesive injection guides6504a-g,which are removably covered by a plurality of guide covers6506a-g.The plurality of adhesive injection guides6504a-gare arranged or configured to align with a plurality of pre-formed dressing openings of a dressing, with subgroups6512a-gof the dressing openings in alignment with the openings6510a-gof the injection guides6504a-g.By providing a plurality of separate injection guides6504a-g,the dressing6502 is able to stretch and bend between the guides6504a-gin comparison a single unibody template. Being less rigid, this allows the guides6504a-gto remain on the dressing6502 during the entire use of the dressing6502, rather than temporary attachment used during injections. Once attached to thedressing6502, the openings6510a-gof the injection guides6504 are aligned with the subgroups6512a-gof dressing openings6512 of the dressing6502 to permit injections through guide openings6510a-gand the corresponding groups of dressing openings6512a-g.To protect unused subgroups6512a-gof dressing openings the unused injection guides6504a-gare covered by removable guide covers6506a-g.Each guide cover6506a-gcomprises a flexible strip of material that covers and is removably adhered to the injection guide6504a-g,with a portion of the strip material lacking adhesive and extending beyond the perimeter or edge of the injection guide6504a-gto facilitate its grasping and removal. Optional cover indicia6508a-gmay be provided, to indicate the order of use. The surface of the injection guide6504a-gmay be coated to facilitate removal of the guide covers6506a-g.

As noted previously, the injection guides and guide covers may be pre-attached to the dressing during the manufacturing process, but in the embodiment depicted inFIGS.65A to65G, the guides6504a-gand guide covers6512a-gmay be provided separately from the dressing6502 and are adhered or attached to the dressing6502 at the point-of-use or post-manufacturing. To facilitate their attachment to the dressing, the guides6504a-gand covers6506a-gmay be pre-arranged on acarrier sheet6520 with a low-tack adhesive, with the guides6504a-gspaced apart, oriented and aligned in a manner to match the corresponding subgroups of dressing openings6512a-gwith the plurality of guides6504a-g.Thecarrier sheet6520 may comprise a flexible or semi-rigid, but non-elastic polymeric sheet which may be transparent to facilitate visual alignment of thecarrier sheet6520 and thedressing6502. To further facilitate alignment,graphical indicia6522 may be provided on the carrier sheet which corresponds to the edges of the dressing and/or aperture locations on the dressings, or other indicia on the dressing that are specifically complementary to the carrier sheet or the plurality of guides6504a-g.For more precise alignment, thegraphical indicia6522 may include complementary checkerboard patterns or other optical interference patterns corresponding to complementary graphical indicia on the dressing. In alternate embodiments, the carrier sheet may comprise a transparent window and an opaque outer frame, wherein the boundary of the window and frame forms a shape corresponding to the dressing. In addition to the carrier structure orsheet6520, arelease liner6524 may be provided to releasably protect the adhesive on the underside of the plurality of injection guides6504a-guntil the user is ready to attach the guides6504a-gto dressing6502. Together, these structures may comprise aguide applicator6530.

In use, the selected tissue site for injections is cleaned in preparation for the application of the tensioneddressing6502. The dressing6502 is applied as described elsewhere herein. Next, theguide applicator6530 is prepared by the removal of therelease liner6524, to expose the plurality of adhesive injection guides6504a-gthat are adhered in a predetermined arrangement or configuration on the adhesive underside of thecarrier sheet6520, via the corresponding guide covers6506a-g.The user then views the dressing6502 through thecarrier sheet6520, using theindicia6522 on thecarrier sheet6520 to align the guides6504a-gto the openings on thedressing6502. Once the desired visual alignment is achieved, the user applies pressure to guides6504a-gthrough thecarrier sheet6520 to maximize adhesion of the guides6504a-gto thedressing6502. Thecarrier sheet6520 is then peeled away from the guide covers6506a-gto expose and leave the guides6504a-gand covers6506a-gon thedressing6502. Thefirst cover6506ais grasped and pulled away, to expose the openings of thefirst injection guide6504a.The opening and skin/tissue surface exposed in the opening are then sterilized with an alcohol pad or other sterilization procedure, and then the injectable therapeutic agent is prepared and injected through the sterilized opening of the guide. The same sterilization of remaining openings of theinjection guide6504ais performed for subsequent injections, and thenext cover6506b-gis removed when access to thenext injection guide6504b-gis needed.

The injection guides may comprise an adhesive foam tape or strip material, such as Adhesive Applications BW1125-1 or 1008-1 (Adhesive Applications; Easthampton, Mass.). The carrier sheet may comprise a transparent polymeric rigid or semi-rigid sheet material, which may be covered by a low-tack adhesive carrier or protective film known in the art, such as Pregis 1614C (Pregis; Deerfield, Ill.). The guide covers 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 dressing3400 comprising indicia3404 to facilitate identification and/or alignment with thedressing opening3402. In this particular embodiment, theindicia3404 are provided in four orthogonal directions from theopening3402. These indicia may be helpful for identifying the location of theopening3402, especially in circumstances where the dressing3400 comprises a clear material and wherein the underlying skin may be mottled or has extensive markings from scarring or skin damage, which may make identification of theopening3402 more difficult. The indicia may be laser etched or printed onto the dressing surface.FIG.35 depicts the placement of astrained dressing3400 onto a skin location and then released from its applicator (not shown). Once adhered to the skin location, theindicia3404 may be used to facilitate the insertion of asyringe needle3406 or other access device, while the strain transferred from the dressing3400 may reduce the tissue response from the needle insertion to form scar tissue or to induce lipohypertrophy. Although theindicia3404 inFIGS.34 and35 are in contact or otherwise close proximity to theopening3402, in other examples, the indicia may be providing along the periphery of the dressing, or span the dressing area between the opening and edges of the dressing. This may be useful for aligning larger devices that may obscure the opening of the dressing once positioned over the dressing. Alternatively, the material of dressing3400 may be opaque and/or colored to provide contrast with the dressing and thedressing opening3402. In still other examples, a dressing may be provided without an aperture, and the needle of the infusion set, syringe or insertion device is used to pierce the dressing and then inserted through the skin or tissue.

In other examples as depicted inFIG.36, avisual guide tool3600 may be optionally provided or used to facilitate alignment of thesyringe needle3406 with thedressing opening3402. Thevisual guide tool3600 includesperipheral indentations3602 or openings that may facilitate alignment of thevisual guide tool3600 with the peripheral edges of thedressing3400. The dressing3400 may also be provided with optional indicia or markings to facilitate alignment with theguide tool indentations3602. By aligning the peripheral edge of theguide tool3600 with the peripheral edge of the dressing3400, theopening3402 of the dressing3400 may then be secondarily aligned with theopening3604 of theguide tool3600. Theopening3604 of theguide tool3600 preferably may be smaller than theopening3402 of the dressing3400, but in other examples may be larger or the same size. Thevisual guide tool3600 may also includeindicia3606 around itsopening3604, and may or may not comprise an opaque material, which may make it easier to visualize theopening3604. The undersurface of the visual guide tool may comprise an adhesive to facilitate maintaining the position of thetool3600 during use. Thetool3600 may comprise an elongate body with theopening3604 at the distal end, with the proximal end used to grasp and manipulate thetool3600 during the procedure.

In one exemplary procedure, the user will clean and prepare skin site with isopropyl alcohol wipes or other sterile preparations. The dressing is then strained using an applicator, if the dressing is not a pre-strained dressing, and then placed onto the desired site. The applicator is then removed to transfer the strain to the skin. If a visual guide is not needed, the patient can insert the needle into the orifice in the dressing and administer the infusion. If a visual guide is required, place guide on top of dressing and insert the needle through the visual target and administer the infusion. For where there is a preexisting dressing with multiple openings, subsequent injection can follow a rotational sequence and inject insite #1, followed by #2, followed by #3, etc. In some variations, depending on skin conditions, a dressing may last up to 10 days and injections using the dressing may take place at frequencies of 3 per day. The dressing is removed and replaced with a new dressing at the end of the wear period (average 7-10 days).

FIGS.37A and38B depict another example of avisual guide tool3700. In this example, thetool3700 comprises anelongate body3702 with an enlargeddistal end3704 and a largedistal opening3706. Thedistal opening3706 may be configured withboundary edge3708 that permits visualization of the outer edge of the dressing3000, excluding the radially

inward projections

3710,3712,3714, and3716. These radially

inward projections

3710,3712,3714, and3716 may help to point to the location of thedressing opening3002 when thetool opening3706 is positioned to surround thedressing3000. Although four

projections

3710,3712,3714, and3716 are depicted inFIGS.37A and37B, in other examples, a different number of projections may be provided and at other locations along theboundary edge3708 of theopening3706, and may be different shapes, sizes, and lengths than the four

orthogonal projections

3710,3712,3714, and3716 inFIGS.37A and37B, e.g. the projections may comprise arrowhead shapes.

As depicted inFIGS.38A and38B, in some variations, the

projections

3710,3712,3714, and3716 may be configured to facilitate positioning of a delivery device or pod, such as thedelivery device3024 fromFIGS.31A to31B. In this example, the lengths of the

projections

3710,3712,3714, and3716 are configured so that the

ends

3718,3720,3722,3724 of the

projections

3710,3712,3714, and3716 are each on contact with or equally spaced from theperimeter edge3028 of thedelivery device3024 when thepod3024 is properly aligned with the

projections

3710,3712,3714, and3716 of thetool3700. Thus, the configuration of the radially

inward projections

3710,3712,3714, and3716 may facilitate alignment and positioning of thepod3024 during use.

In another variation, depicted inFIGS.39A to39E, the strainable orstrained dressing3926 may be a pre-strained at the point of manufacture to aninfusion set3921 or assembly, as depicted inFIGS.39A to39E. The system may optionally include adelivery device3900 with abody3904, alower edge3906 and anactuator3908. Releasably attached to the bottom of thebody3904 is aninfusion housing3921 of the infusion set3920, and includes aneedle3922,connector tubing3924 and atension dressing layer3926 that extends beyond thelower edge3906 of thedelivery device3900 andhousing3921. Thetension dressing layer3926 further comprises a skin adhesive on its lower surface, which is removably covered by one or more adhesiveprotective liners3928. Theliners3928 may comprise aliner tab3930 that extends further from theliner3928 to facilitate removal of theliner3928 from the adhesive on thetension dressing layer3926. Thetension dressing layer3926 is maintained in a stressed configuration by a rigid applicator ortension support structure3932 that includes one ormore pull tabs3934 to facilitate the separation of thetension dressing layer3926 from thetension support structure3932 during use. Thepull tabs3934 attach thedressing layer3926 andsupport structure3932 together, but comprises perforations or adhesives that facilitate separation of thedressing layer3926 andsupport structure3932 when thepull tabs3934 are pulled away from the device. Thetension support structure3932 or applicator may be removed from around theinfusion housing3921 by passing thestructure3932 over theconnector tubing3924, or by tearing thestructure3932 away from thehousing3921.

In one exemplary implantation procedure for theintegrated infusion set3920, a skin insertion site is selected and prepared with isopropyl alcohol wipes or other sterile preparation. The protective needle sheath (not shown) is first removed from theneedle3922 of the integrated infusion set3920 as it is engaged to thedelivery system3900. Next, the adhesiveprotective liners3928 are removed to expose the adhesive on the inferior surface of the prestrainedtension dressing layer3926. In other examples, however, the needle cover may be integrated with a liner, such that removal of the needle sheath concurrently removes the protective liners or vice versa. Thedelivery system3900 and infusion set3920 is 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, thesystem3900 may be used to push the infusion set3920 against the skin or otherwise held in place to facilitate bonding between the adhesive and the skin tissue surrounding theneedle3922. Theactuator3908 on thesystem3900 is then actuated to release the infusion sethousing3920 so that thedelivery system3900 may be removed, as depicted inFIG.40A. In other examples, the infusion set3920 with integrated dressing may be inserted without the use of thedelivery system3900.

Next, thepull tabs3934 are removed from the infusion set3920, which allows thestrained dressing layer3926 to decouple from thetension support structure3932, thereby allowingstrained dressing layer3926 to transfer its tensile stress to a compressive force acting on the tissue surrounding theneedle3922, as shown inFIG.40B. In some variations, thetension support structure3932 may be left in place after the pull tabs are removed, but in other examples, thetension support structure3932 may be removed, to decrease the bulk and/or rigidity of theindwelling infusion set3920. In some variations, thetension support structure3932 may be removed by passing thetension support structure3932 over theconnector tubing3924, as depicted inFIG.40C, if theconnector tubing3924 is not yet coupled to the infusion pump, leaving the infusion set3920 with thedressing layer3926 transferring compression to the underlying skin tissue, as shown inFIG.40D. In other variations, as depicted inFIG.40E, thetension support structure3932 may comprise a slit orperforations3940, which may allow thetension support structure3932 to be pulled away or torn away, from the infusion sethousing3921 or theconnector tubing3924, whether theconnector tubing3924 has been attached or not. The infusion set3920 is ready for use, and may be removed and a new infusion set may be placed at the end of the use period, which may be in the range of 7 to 10 days, but may be replaced earlier if occluded or damaged.

In some other examples, rather than visual indicia or markings, one or more physical alignment structures may be provided on the dressing to facilitate alignment. InFIGS.49A to49E, a pre-strained elastic member or dressing4900 with a pre-attachedremovable alignment structure4902 is provided that is configured to align an infusion set with access opening4926 of thedressing4900. Thisalignment structure4902 is configured for use with the MINIMED™ QUICK-SERTER™ (Medtronic, Fridley, Minn.) infusion setapplicator4904, but one of skill in the art understands that the alignment structure may be tailored to the shape and function of any other infusion set applicator or delivery device. Thepre-strained dressing4900 is maintained in a pre-strained configuration by semi-rigid orrigid strain support4906 attached or adhered to the top surface of the dressing4900, and surrounding thealignment structure4902. The strain support may be configured to have some flexibility in at least one direction in order to contour the dressing 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 is greater than the force produced by the straining of the elastic member. The attachment of thesupport4906 to the dressing4900 may be achieved with an adhesive, or may be heat staked to thedressing4900, depending on the materials selected for thedressing4900. For example, if a polyurethane is used for thedressing4900, thesupport4906 may comprise PETG and can be heat staked to thedressing4900. For example, a heat stake may be used to bond the strained elastic member to the strain support. The heat stake may have a width of about 1 mm, 2 mm or 5 mm, for example. The bond provides adequate 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 comprise perforations to facilitate the splitting of the strain support and its separation and removal from the elastic member, and optionally tabs to facilitate grasping and tearing of the perforations. Alternate embodiments of the device may also include the perforations and pull tabs separation mechanism as described for dressing3926 inFIGS.39A to39E may also be adapted to this embodiment.

Thisparticular alignment structure4902 comprises a unibody structure with three

interconnected alignment flanges

4908,4910,4912 along abase4914 andbase opening4916. Theopening4916 is sized and shaped to form a mechanical interfit with theapplicator4904, and may be oval, circular, polygonal or other custom shape complementary to the perimeter of theapplicator4904. Thebase4914 may also comprise a lip to increase the surface of area of attachment to thedressing4900. Although interconnected along thebase4914, in other examples, the flanges may be separate from each other. In some further examples, the

flanges

4908,4910,4912 and/orbase4914 may be integrally formed witheat strain support4906. In still other examples, thealignment structure4902 may be provided separately and is attached to thestrain support4906 at the point-of-use. Thealignment structure4902 may also be selected from a plurality 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 thealignment structure4902 may vary depending on the material used for thestructure4902 and therigid support4906. The

alignment flanges

4910 and4912 are configured to provide arecess4918 accommodate the infusion settubing4920, and one or more of thealignment flanges4908 may comprise a gripping structures to facilitate handling of the dressing4900, such as finger grips, recesses orridges4922. The

alignment flanges

4910 and4912 may be further configured to be pulled apart to facilitate removal of thealignment structure4902 from thetubing4920. After or concomitantly with the removal of thealignment structure4902, thestrain support4906 is removed to permit the dressing4900 to contract from the strained configuration to its less strained configuration. In this particular configuration of thealignment structure4902, the height of the

flanges

4908,4910,4912 may be in the range of about 1-10 mm, 2-8 mm, or 3-6 mm, for example. The inner surfaces of the

flanges

4908,4910,4912 may be comprise an orthogonal orientation or may comprise a slight obtuse angle, e.g. 91-95 degrees, 91-100 degrees or 91-105 degrees, so that the initial placement of theapplicator4904 itself does not require precise alignment but guides theapplicator4904 to a more precise location with further insertion. The spacing of the

flanges

4908,4910 and4912, in addition to accommodating thetubing4920, may also be configured to provide access to the sides of theapplicator4904, which may also havefinger grips4936, so that theactuator4924 of theapplicator4904 is not used to position theapplicator4904.

The shape of the dressing4900 may be any of a variety of shapes, including but not limited to an oval, circular or polygonal shape. Likewise, theaccess opening4926 may also comprise an oval, circular or polygonal shape, and sized to accommodate the catheter of the infusion set. Theaccess opening4926 may comprise a diameter or transverse dimension in the range of 1-20 mm, 2-10 mm, or 3-5 mm, for example. Thealignment structure4902 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 the skin or tissue may be the same or different adhesive used to attach the strain support to the dressing. In some examples, the skin adhesive may be selected with a greater T-peel force 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 where the predetermined strain in the dressing is needed to resist strain loss during storage of a 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. Coatings on the release sheet and the dressing may also be provided to facilitate peeling or removal of the release sheet and the strain support during use.

Referring toFIG.50A, the dressing4900 andalignment structure4902 is applied and adhered to the selected target site. The adhesive liner of the infusion set held by theapplicator4904 is removed and theapplicator4904 is aligned withalignment structure4902, with thetubing4920 and the finger grips4922 of the infusion correctly oriented to the recesses. Theapplicator4904 is then inserted into the opening of thealignment structure4902 until it is fully seated, as illustrated inFIG.50B. In some variations, visual indicia on thealignment structure4902, tactile feedback may be provided to confirm to the user that theapplicator4904 is fully seated. InFIG.50C, theactuator4924 of theapplicator4904 is depressed to insert the needle/cannula of the infusion set through the opening of thedressing4900 and into the skin. InFIG.50D, theactuator4924 is then activated a second time to decouple the applicator from theinfusion set hub4938, as shown inFIG.50E. In this particular example, theactuator4924 comprises an outerannular button4930 and aninner button4932 to separately deploy the needle/cannula and to decouple but not yet separate theapplicator4904.

Next, thealignment structure4902 and thedressing support4906 are removed from the dressing4900 by applying downward pressure on the releasedapplicator4904 as thealignment structure4902 andsupport4906 are pulled away. To facilitate their removal, thesupport4906 may comprise aperforation4934 that can be torn so that thealignment structure4902 andsupport4906 may be peeled or pulled off, so that the dressing4900 can contract from its strained configuration, In other variations, as shown inFIG.51, thesupport5100 of thealignment structure5102 may comprise an arcuate configuration with atabbed end5104 that may be grasped and used to pull out thesupport5100 andalignment structure5102 from the periphery of theapplicator5106 and thetubing5108. This then separates theinfusion hub4938 from theapplicator4904, and therigid support4906 from the dressing4902, which allows the dressing4902 to contract from its pre-strained configuration.

FIGS.48A to48E depict example of aninfusion system4800 with adelivery device4802 that releasably holds aninfusion hub4804 with a pre-attached radially pre-strainedskin tensioning device4806. Thedelivery device4802 comprises abody4808 andactuator4810, similar to thedelivery system3900 inFIG.39A. The pre-attached radially pre-strainedskin tensioning device4806 comprise a radially outward strained adhesiveelastic layer4812 that is maintained in the pre-strained state by a

semi-rigid strain support

4814a,4814bthat may comprise a semi-rigid or rigid card stock or polymer layer that is adhered to the top surface of the elastic layer. Although this particular embodiment comprises a strain support with two

sections

4814aand4814b,in other examples, a single support may be provided, or a 3, 4 or 5 part support may be provided.

After theinfusion system4800 is applied to the desired anatomical location, and theactuator4810 is activated, theinfusion hub4804 is released and can be separated from thedelivery body4808, leaving theinfusion hub4804 andskin tensioning device4806 attached to the anatomical location, as illustrated inFIG.48E. The function and patency of theinfusion tubing4816,hub4804 andcatheter4818 may be checked. If functioning correctly, the

strain support

4814aand4814bmay be removed or separated from theelastic layer4812, which will then radially compress the adhered skin or tissue toward the center of theelastic layer4812 around thehub4804 andcatheter4818. The function and patency of theinfusion tubing4816,hub4804 andcatheter4818 is 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 thecatheter4818 in comparison to skin tensioning devices strain along a single strain axis. The shape of theelastic layer4812 may be circular as depicted inFIGS.48A to48E, but in other examples, the elastic layer may be oval, oblong, square, rectangular, star or other shape. An oval or oblong shape may be used when the catheter is not orthogonally inserted into the tissue, but rather inserted along an acute angle to the treatment site, where the forces acting on the catheter or infusion hub may not be radially symmetrical.

In an embodiment, 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 growth or lipohypertrophy in subjects 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 infusion set life cycle has finished, the infusion set may be detached from the dressing. The tensioned dressing substrate may then remain attached to the subject for an additional period of time without the catheter indwelling in skin.

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

Attachment structures may include for example a dressing attachment structure attached to a dressing substrate. A dressing attachment structure may be, for example, a physical structure that may or may not, in whole or in part be removed from a dressing when release structures are used to release the infusion hub. The attachment sheets or structures, and related features thereof, may be the same or similar as those described forFIGS.1A to22B, including but not limited to the attachment sheets used for dressing

assemblies

100,210,320,610,810,910 and1000.

Release structures or releasable attachment structures may include but are not limited to pockets and tabs, hook and loop mechanism, hooks, angled bars, pivoting, rolling, rocking or sliding features associated with or coupled to attachment structures, adhesives, removable adhesives, adhesive tapes or other adhesive devices, pegs, rip string, towel bar configurations, sliding pins, friction locks, cam locks, vacuum or suction devices, snap connectors, carpet tack, press fit connections or other connections, levers, latches, locking members, spring members, for example, or other mechanisms such as cutters or rip string or other structures or features to facilitate tearing, cutting or separation of attachment structures or elements perforated or otherwise severable structures, that permit removal of dressing from the applicator, packaging, other portions of the dressing assembly and/or attachment structures, features, elements or portions They may be self-releasing latches or spring members. The release assembly may be integrated in the dressing assembly and/or applicator, or may be provided separately to be used with the dressing assembly. They may be actuated when a pressure member is applied to a skin treatment device prior to removing the applicator. They may be manually actuated.

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

Referring toFIGS.66A to66H, asystem6600 is illustrated comprising adressing6610 and aninfusion set6650. The infusion set6650 includes an infusion set housing orconnector6660 withinfusion tubing6661 and releaseelements6662 for releasing thehousing6660 from aninfusion hub6670 and attachedcatheter6680. By actuating or squeezing therelease elements6662, thehousing6660 may be unlatched from thehub6670, or the friction between thehousing6660 andhub6670 may be reduced to facilitate removal and separation. Fluid communication between the lumen of thetubing6661 may be provided via an opening or channel in thehub6670, which may include a seal therebetween.

The dressing6610 includes asubstrate6620, anattachment element6630 and anopening6640 in the dressing6610 for receiving thecatheter6680. Theattachment element6630 is attached on opposing sides6632a,6632bto thesubstrate6620, for example with an adhesive, bond or other attachment mechanism. The attachment sheet, structure orelement6630 further includes a removable portion orelement6633 having a release or decoupling element, for example, apull tab6634 and tear structures or elements6635 (e.g., tear lines, weakened sections, perforations or other tear elements) extending through theattachment element6630

adjacent sides

6632. In some variations, the removable portion orelement6633 may lack any attachment to theunderlying dressing substrate6620. In other variations, the removable portion orelement6633 may be attached to the surface of the dressing substrate via non-adhesive static forces or Van der Waals forces, or with a differential adhesive, such as a hybrid or compound silicone/acrylic adhesive. Thehub6670 of the infusion set is attached to theremovable element6633 for example by way of an adhesive, bond, mount or attachment element.

FIGS.66C to66H illustrate the use of thesystem6600. As shown inFIG.66E, the dressing6610 is placed on and attached or adhered to a subject with the infusion set6650 attached to thedressing6610 and thecatheter6680 extending through theopening6640 in place in a subject. Thedressing substrate6620 may be attached, for example, by way of a skin adhesive, to the skin of a subject and may be removed by peeling from the skin when desired. When it is desirable to do so, the infusion sethousing6660 may be removed by actuating therelease elements6662. Theinfusion hub6670 andcatheter6680 may remain attached to the subject with thedressing6610. The same or a different infusion sethousing6660 may be reattached to thehub6670 if additional infusion treatment is desired. As shown inFIGS.66C and66G, when the infusion set is to be permanently removed, thehub6670 is removed by grasping and pulling thepull tab6634 and tearing theremovable element6633 along tear elements orlines6635. As shown inFIGS.66D and66H, thepull tab6634 is pulled or actuated until theremovable element6633 is separated by way oftear structures6635, e.g., the perforations ortear lines6635 from thedressing substrate6620. Thedressing substrate6620 may then remain attached to the subject for an additional period of time without the infusion set indwelling in skin.

Referring toFIGS.67A to67C, asystem6700 is illustrated comprising adressing6710 and aninfusion set6750. The infusion set6750 includes an infusion set housing orconnector6760 withinfusion tubing6761 and releaseelements6762 for releasing thehousing6760 from aninfusion hub6770 and attached infusion conduit, e.g. needle orcatheter6780. The dressing6710 includes asubstrate6720, and anopening6740 in the dressing6710 for receiving thecatheter6780.

Theinfusion hub6770 of the infusion set6750 is configured to receive the infusion sethousing6760 and to provide fluid communication between thetubing6761 of theinfusion housing6760 and theinfusion conduit6780. Thedevice6700 further includes anattachment structure6772 for attaching theinfusion hub6770 to thedressing substrate6720.

Theattachment structure6772 may include one or moresubstrate attachment sections6773 attached to thesubstrate6720, for example with an adhesive, chemically bonded, heat welded, or other attachment mechanism. The attachment structure may further include release elements or release structures. For example, theattachment structure6772 further includes aremovable section6774 coupled to or integral with theinfusion hub6770. Theattachment structure6772 further includes tear elements6775 (e.g., tear lines, breakable elements, weakened sections, perforations or other detachment elements) coupling theremovable section6774 to the one or more substrate attachment sections6773.The attachment structure'ssubstrate attachment sections6773,removable section6774, tearelements6775 may be constructed of a single unibody material.

Theattachment structure6772 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 of a soft plastic to reduce rigidity of the dressing and reduce interference with a subject's clothing and to minimize discomfort when wearing a large rigid element on skin. Theremovable section6774 may be a circular flange formed with or attached to theinfusion hub6770. Thesubstrate attachment elements6773 may be arced elements attached to the circular flange with frangible, breakable or tearelements6775.

In use, the dressing6710 is placed on and attached or adhered to a subject with the infusion set6750 attached to thedressing6710 and thecatheter6780 extending through theopening6740 in place in a subject, as depicted inFIG.67A. Thedressing substrate6720 may be attached, for example, by way of a skin adhesive as described elsewhere herein, to the skin of a subject and may be removed by peeling from the skin when desired.

As illustrated inFIG.67B, during use of the infusion set6750, the infusion sethousing6760 may be placed on or removed from theinfusion hub6770 for example actuating therelease elements6762 As shown inFIG.67C, when the infusion set6750 is to be permanently or entirely removed, thehub6770 is removed by twisting thehub6770 and breaking thetear elements6775. Theremovable section6774 including catheter6778 may then be separated from theattachment sections6773. Thedressing substrate6720 may then remain attached to the subject for an additional period of time without the catheter indwelling in skin.

Referring toFIGS.68A to68F, asystem6800 is illustrated comprising adressing6810 and aninfusion set6850. The infusion set6850 includes an infusion set housing orconnector6860 withinfusion tubing6861 and releaseelements6862 for releasing thehousing6860 from aninfusion hub6870 and attachedcatheter6880.

The dressing6810 includes asubstrate6820, anattachment element6830 and anopening6840 in thedressing6810 and aligned opening6837 in theattachment structure6830, for receiving thecatheter6880. Theattachment element6830 is attached on opposingsides6832 to thesubstrate6820, for example with an adhesive, bond or other attachment mechanism. Theattachment element6830 further includes a release element, for example, a circular perforation or tear section6835 (e.g., having tear lines, weakened sections, perforations or other tear elements) around theopening6837. Thecircular tear section6835 generally aligns with thecircumference6877 of theinfusion hub6870 where the infusion hub is attached to theattachment element6830, e.g., with an adhesive, glue, bond orother securing structure6834.

Referring toFIG.68A, in use, the dressing6810 is placed on and attached or adhered to a subject with the infusion set6850 attached to thedressing6810, and thecatheter6880 extending through theopening6840 and in place in a subject. Thedressing substrate6820 may be attached, for example, by way of a skin adhesive, to the skin of a subject and may be removed by peeling from the skin when desired.

During use of the infusion set6850, the infusion sethousing6860 may be placed on or removed from theinfusion hub6870, for example, by actuating therelease elements6862. As shown inFIGS.68C and68D, the infusion sethousing6860 is removed. InFIG.68E, when the infusion set6850 is to be permanently or entirely removed, thehub6870 is removed by twisting thehub6870 and separating thehub6870 at the perforations6875. Thehub6870 includingcatheter6880 may then be separated from thedressing substrate6820 and remaining portions of theattachment element6830, as depicted inFIG.68F. Thedressing substrate6820 may then remain attached to the subject for an additional period of time without the catheter indwelling in skin.

Referring toFIGS.69A to69K, asystem6900 is illustrated comprising adressing6910 and aninfusion set6950. The infusion set6950 includes an infusion sethousing6960 withinfusion tubing6961 and releaseelements6962 for releasing thehousing6960 from aninfusion hub6970 with attachedcatheter6980. The dressing6910 includes asubstrate6920, and anopening6940 in the dressing6910 for receiving thecatheter6980. Adressing connector6925 is attached to thedressing6910 and is configured to releasably couple theinfusion hub6970 to thedressing6910.

Theinfusion hub6970 of the infusion set6950 is configured to reversibly receive the infusion sethousing6960 and provide fluid communication between thetubing6961 of theinfusion housing6960 and theinfusion conduit6980.Tubing6961 is fluidically joined to alumen6963 of thehousing6960 which terminates inwardly at afluid seal6963, e.g. a silicone seal or grommet. When theinfusion housing6960 is coupled to theinfusion hub6970, thefluid seal6963 is configured to align and seal with thefluid seal6963 of thelumen6982 of thehub6970. Thislumen6982 communicates with theinfusion conduit6980. In embodiments wherein theinfusion conduit6980 comprises a soft cannula or catheter, anadditional needle lumen6982 and self-sealingneedle seal6983 may be provided to allow a solid needle or trocar (not shown) of an applicator to provide mechanical support and ability to pierce tissue, in order to facilitate insertion of the infusion conduit. Theneedle lumen6982 may be oriented to provide a linear insertion and withdrawal path of the solid needle or trocar through theinfusion conduit6980. The solid needle or trocar is then withdrawn from theinfusion conduit6980 with the applicator once insertion of theconduit6980 is completed. A complementary mechanical interfit between the interior cavity shape of theinfusion housing6960 and the outer shape of thehub6970 may be provided to facilitate alignment of the fluid seals and lumens. In some other variations, a sealed circumferential recess or channel may be provided on the interior surface of the housing and/or the outer surface of the hub with seals, to allow fluid communication between the housing and hub that is independent of the angular orientation of the housing, and therefore not require angular alignment. These various fluid channel configurations may be adapted to provide fluid communications with the other infusion sets described herein that have separable infusion housings and hubs, including

systems

6600,6700,6800 and7000.

Theinfusion hub6970 includes anattachment structure6972 for attaching theinfusion hub6970 to thedressing connector6925. Theinfusion hub6970 further includes a release element, for example, aremovable attachment section6974 coupled to or integral with the engagement element6971. Theattachment structure6972 may comprise aflange6975 havingbendable arms6973 withextension tabs6976 configured to engage the dressing connector6925.Thedressing connector6925 may include one ormore connector sections6926 attached to thesubstrate6920, for example with an adhesive, bond orother attachment mechanism6927. Thedressing connector6925 may comprise a split ring attachment structure that allows the dressing6910 to apply compression to the insertion area. The split ring attachment structure may be made of a soft plastic to reduce rigidity of the dressing and reduce interference with a subject's clothing.

Theconnector sections6926 comprise recesses orcutouts6929 configured to receiveextension tabs6976 of theinfusion hub6970 along an orthogonal direction to the treatment surface. Cutouts6929 are in communication withtransverse slots6928 for rotatably receivingextension tabs6976.Cutouts6929 at the end of theslots6928 are configured to lock theextension tabs6976 in place.

As shown inFIGS.69A and69B, in use, the dressing6910 is placed on and attached or adhered to a subject with the infusion set6950 attached to thedressing6910 and thecatheter6980 extending through theopening6940 in place in a subject. Thedressing substrate6920 may be attached, for example, by way of a skin adhesive, to the skin of a subject and may be removed by peeling from the skin when desired.

InFIG.69C, during use of the infusion set6950, the infusion sethousing6960 may be placed on or removed from theinfusion hub6970 for example actuating therelease elements6962. When the infusion set6950 is to be permanently or entirely removed, thehub6970 is removed by a) depressing thebendable arms6973 to release theextension tabs6976 from thecutouts6929, b) twisting or turning thehub6970 to move theextension tabs6976 through theslots6928 toopenings6927, and c) lifting thehub6970 to detach it from thedressing connector6925 and dressing6910, perFIG.69E. Thedressing substrate6920 may then remain attached to the subject for an additional period of time without the catheter indwelling in skin, as inFIG.69F.

FIG.69K depicts an exemplary configuration of fluid channels providing fluid communication between thecatheter tubing6961 and thefluid conduit6980, for providing insulin therapy or other infused therapy. Seals, such as silicone rings6963 and

Referring toFIGS.70A to70K, asystem7000 is illustrated comprising adressing7010 and aninfusion set7050. The infusion set7050 includes an infusion sethousing7060 withinfusion tubing7061 and releaseelements7062 for releasing thehousing7060 from aninfusion hub7070 with attachedcatheter7080. The dressing7010 includes asubstrate7020, and anopening7040 in the dressing7010 for receiving thecatheter7080. Adressing connector7025 is attached to thedressing7010 and is configured to releasably couple theinfusion hub7070 to thedressing7010.

Theinfusion hub7070 further includes: anouter engagement hub7071;tool receptacles7072 from the superior side through the inferior side of theinfusion hub7070; and acentral section7073. Thecentral section7073 includes anopening7074 through which infusion fluid is delivered frominfusion tubing7061 to thecatheter7080. Thecentral section7073 also includesspring arms7076 withconnector tabs7077 extending into and throughtool receptacles7072. An inner wall of theouter engagement hub7071 includes a cut outedge section7079 of the hub for attaching aremoval tool7090 tool to theinfusion hub7070.

Thedressing connector7025 includes ahub receptacle opening7026 for receiving the central section7073 (including connector tabs7077) of theinfusion hub7070. Thehub receptacle opening7026 is in communication with acatheter opening7027 for receiving thecatheter7080. The

openings

7026,7027, and7074 are further aligned with theopening7040 in thedressing substrate7020, so that when the system is assembled, thecatheter7080 extends throughopening7040 in dressing7010. The attachment structure may comprise adressing connector7025 further includesengagement tabs7028 that receiveconnector tabs7077 at the ends of the springbiased arms7076 when theinfusion hub7070 is attached with thedressing connector7025 to thedressing7010.

The dressing7010 with integrated infusion set7050 is shown assembled inFIG.70A. The infusion sethousing7060 is coupled by way ofengagement hub7071 to theinfusion hub7070 and is released usingrelease elements7062. Theinfusion hub7070 is attached to the dressing7010 by way of thedressing connector7025. Thecatheter7080 is placed through

openings

7027 and7040 respectively in thehub7070 and dressing7010. Thecentral portion7073,spring arms7076 withtabs connector tabs7077 are positioned through theopening7026. Thespring arms7076 are biased outward so that theconnector tabs7077 engage theengagement tabs7028 when thearms7076 are pushed into theopening7026.

In use, the dressing7010 is placed on and attached or adhered to a subject with the infusion set7050 attached to thedressing7010 and thecatheter7080 extending through theopening7080 in place in a subject, as shown inFIG.70A. Thedressing substrate7020 may be attached, for example, by way of a skin adhesive, to the skin of a subject and may be removed by peeling from the skin when desired.

InFIG.70B, during use of the infusion set7050, the infusion sethousing7060 may be placed on or removed from theinfusion hub7070 for example actuating therelease elements7062.

When the infusion set7050 is to be permanently or entirely removed, thehub7070 is removed by using the release structure or removal tool shown inFIG.70J. Theremoval tool7090 includes ahandle portion7091 with distal spring-loadedprongs7092 havingattachment tabs7093.

Theprongs7092 andattachment tabs7093 are inserted into thereceptacles7072 in thehub7070 deflecting thespring arms7076 inward, disengagingconnector tabs7077 fromengagement tabs7028. Theattachment tabs7093 of theremoval tool7090 engage the cut outedge section7079 of theinfusion hub7070 attaching thetool7090 to theinfusion hub7070. Theinfusion hub7070 may then be removed from the dressing7010 using the tool.

Thedressing substrate7020 may then remain attached to the subject for an additional period of time without the catheter indwelling in skin.

The substrates of the

dressings

6610,6710,6810,6910, and7010 may be flexible and resilient 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 detail herein. herein. The

dressings

6610,6710,6810,6910, and7010 may include a removable applicator and strain support configured to maintain the strain in the strained elastic layer of the dressing substrate, as depicted in the examplary embodiment inFIG.39B. Other applicator and the

systems

6600,6700,6800,6900, and7000 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 or incorporated with these dressings include those described for dressings or

infusion systems

3006,3921,4500,4800,4900 and5200 described elsewhere herein.

In addition to a radiallystrained infusion system4800, a radially pre-strainedskin tensioning device5500 may be provided for use with manual injection with asyringe5502, as shown inFIGS.55A and55B. Theskin tensioning device5500 comprises anelastic layer5504 with anaccess opening5506. Theskin tensioning device5500 may be adhered to the target location and then the radial strain supports5508a,5508bmay be removed to permit theelastic layer5504 to radially compress the underlying skin toward theaccess opening5506. The access opening may comprise a diameter or a shape with a transverse dimension in the range of 1-20 mm, 2-10 mm, or 3-5 mm, for example.

Referring toFIGS.56A and56B, in some other variations of askin tensioning device5600, whether radially strained or single-axis strained, the access opening5602 of the device may comprise afabric patch5604. Thepatch5604 may be configured with a woven fabric that permits theneedle5606 of thesyringe5608 to still pass through theaccess opening5602 while providing some physical coverage of the injection site. The increased breathability may extend to use time of thedevice5600. Thefabric patch5604 may provide increased water vapor transfer across theskin tensioning device5600 and may also be used to absorb an excess insulin that may leak from the injection site. Thefabric patch5604 may be coated, infused or woven with an anti-infective agent, such as an antibiotic or silver strands. Thefabric5608 may comprise a nylon, non-woven cotton, polyester or polypropylene, an elastic polymer blend, or silver alginate, for example.

In still another alternative embodiment, askin treatment system5400 comprising a tension off-loading dressing5402 but instead of an access opening or fabric patch, aninjection port5404 is provided on thedressing5402, as shown inFIGS.54A and54B. The dressing5402 andport5404 may be provided with any of the applicators as described herein, noting that the region of the dressing5402 attached to theport5404 will not under the same strain as the portion of the dressing5402 peripheral to theport5404. Theinjection port5404 includes acatheter5406 such that syringes attached to theport5402 or syringe needles inserted into the port are able to deliver therapeutic agents through thecatheter5406 and into the skin or tissue. Use of the port may reduce pain or discomfort associated with therapy, compared to direct needle injection.

Referring toFIGS.41A to43C, in another embodiment, aninfusion set4100 and a multi-layertensioned dressing4102 may be used for subcutaneous infusion or intravascular infusion. The infusion set4100 comprises aninfusion tubing4104 that is connectable to an infusion source or pump, such as an insulin pump or other therapy pump, and is in fluid communication with an internal cavity of aninfusion housing4104 which is in turn in fluid communication with a subcutaneous needle orcatheter4106 which is inserted into the tissue or vasculature. The bottom surface of theinfusion housing4104 is adhered or attached to thetop layer4108aof the multi-layertensioned dressing4102. Each oflayers4108ato4108ccomprises aperimeter4110ato4110cthat is sized to be smaller in size and is positioned within and offset from theperimeter4110bto4110dof thelayer4108bto4108dimmediately below it, except for anoptional flap4112ato4112c.The elasticity of the top and

intermediate layers

4108a,4108b,4108cmay be configured to be lower than the modulus of elasticity of the baseelastic layer4108d.Thebase layer4108dmay also have a higher durometer (e.g. 60 Shore A vs. 50 Shore A vs. 30 Shore A) or comprise a thicker material (e.g. 10 mil vs. 7 mil vs. 5 mill vs. 0.5 mil) compared to the other layers4108a-c.In other variations, the non-base layers may comprise holes or perforations to reduce the total cross-sectional area of the non-base layer, which can reduce the amount of strain contributed from the non-base layers. With this configuration, the compressive force per unit width results primarily from the contribution of the baseelastic layer4108d,about 50%, 60%, 75%, 90% or any range between any two of these contribution percentages. Based on this, the amount of adhesion strength between the layers may be relatively lower than the bond strength between the skin and thebase layer4108d.The adhesive oflayers4108ato4108c,may also be pattern coated onto thelayers4108ato4108cto facilitate peeling in a direction orthogonal to the strain. For example, multiple narrow strips of adhesive may be provided in the direction of the peel. The width of the adhesive orthogonal to the direction of the strain in the elastic member may be 0.1″, 0.165″, 0.2″, 0.3″ or 0.5″ or any range between any two of such widths. In another examples, an adhesive pattern may be provided where less adhesive is peel direction as compared to the strain direction, e.g. 20% less, 40% less, 60% less, 80% less, or a range between any two of these percentages, or other type of anisotropic adhesive pattern. The interlayer adhesives used to join all of the layers4108a-dtogether may comprise a lower thickness compared to the skin adhesive (e.g. 0.5 mil, vs. 0.25 mil, vs. 0.1 mil). In other variations, an adhesive with a high-tensile strength but low shear strength may be used, to facilitate removal of an upper layer of the multi-layer tensioned dressing by pulling the layer or adhesive layer laterally rather than upward. This nested configuration results in a stepped dressing profile, as depicted inFIGS.44A and44B, which may redistribute edge stresses of a skin tensioning device across a greater surface area, rather than concentrate them at the edge of a single layer skin tensioning device. In some variations, the separation between theperimeters4110ato4110dofadjacent layers4108ato4108dmay be uniform along the entire perimeter, e.g. a uniform perimeter difference in the range of 1 to 5 mm, 2 to 5 mm, or 2 to 4 mm, or 2 to 3 mm, for example. In some further examples, the uniform perimeter difference between twoadjacent layers4108ato4108dis the same for every twoadjacent layers4108ato4108d.In other examples, the uniform perimeter difference may be different between at least one pair of two adjacent layers. For example, the

perimeters

4110aand4110bmay be the same as4110band4110c,but the uniform perimeter difference between

layers

4110cand4110dmay be smaller or larger then uniform perimeter difference of the other pairs oflayers4108ato4108c.

Layer

4108dinFIG.41A does not have a flap, but in other embodiments may also be provided with a flap. Theflaps4112ato4112cmay or may not comprise adhesive on its inferior surface, which may facilitate separation and grasping of theflap4112ato4112cfrom the other layers for removal. Each of thelayers4108ato4108dalso comprises a center opening (not shown) through which the needle orcatheter4106 of the infusion set4100 may be inserted. This nested layer configuration of themulti-layer dressing4102 may not have a flap The flexible attachment sheet4108 is sized and configured with a perimeter4112 that is smaller than a perimeter4114 of the multi-layertensioned dressing4102.

As depicted inFIGS.42A to43C, when the infusion set4100 needs to be replaced, e.g. due to occlusion or to reduce the risk of infection, theflap4112aof thetop layer4108amay be grasped and then lifted up to separate the adhesive of thetop layer4108afrom theintermediate layer4108b,or to otherwise peel away thetop layer4108afrom theintermediate layer4108b,thereby also lifting up theinfusion4100 up with thetop layer4108a,and pulling out thecatheter4106 from the skin, while leaving theother layers4108b-dof the multi-layer skin tensioning device on the skin, thereby minimizing the frequency that the adhered skin tensioning device is separate from the skin. This may reduce irritation of the underlying skin from repeated removal of an adhered device. Once the infusion set4100 is removed along with thetop layer4108a,a new infusion set4100 may be applied to directly to theintermediate layer4108b,by aligning the delivery location of thecatheter4106 of the new infusion set4100 with the opening4114bof theintermediate layer4108b.This cycle of removal and reapplication may be performed several times equal to the number of layers in the skin tensioning device, with subsequent cycles of new infusion sets removed and applied to the next layer, with thebase layer4108dalso being used and later removed with thefinal infusion set4100.

Like other embodiments described herein, the skin adhesive on the bottom layer of the skin tensioning device may be the same or different adhesive used to attach the strain support to the dressing, and/or the adhesive used to attach the multiple layers of the skin tensioning device together. In some examples, the skin adhesive may be selected with a greater T-peel force 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 where the predetermined strain in the dressing is needed to resist strain loss during storage of a 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. Coatings on the release sheet, and layers of the dressing may also be provided to facilitate peeling or removal of the release sheet, the layers, and the strain support during use. The strain support for this embodiment may include the perforation and pull tab separation mechanism (not shown) as described for dressing3926 inFIG.39A, to releasably maintain the strain with at leastlayer4108d,but may also be configured to directly releasably maintain strain in the other layers4108a-cas well.

FIGS.45A and45B depict another example of aninfusion set4500 with amulti-layer dressing4502 pre-attached to aninfusion hub4504,tubing4506 andcatheter4508, but in this variation, thelower layers4510b-dare smaller than the adjacent upper layers4510a-c.This configuration is also a stepped dressing profile, which may redistribute edge stresses of a skin tensioning device across a greater surface area, rather than concentrate them at the edge of a single layer skin tensioning device. Thebase layer4510d,however, has a smaller adhered surface area, and the upper layers4510a-care only adhered to the skin about their periphery. Like the embodiment depicted inFIGS.41A to44B, the separation between theperimeters4512ato4512dofadjacent layers4512ato4512dmay be uniform along the entire perimeter, e.g. a uniform perimeter difference in the range of 1 to 5 mm, 2 to 5 mm, or 2 to 4 mm, or 2 to 3 mm, for example. The uniform perimeter difference between twoadjacent layers4510a4510bmay be the same for each twoadjacent layers4510ato4510d,or may be different. In other examples, the uniform perimeter difference may be different between at least one pair of two adjacent layers. The layers4510a-dmay also comprise optional flaps4514a-c,to facilitate grasping and removal of the layers4510a-c. The other features of the device may otherwise be similar to the four-layerskin tensioning device4102 inFIGS.41A and41B, e.g. the heat staking and adhesive configurations.

As depicted inFIGS.46A to47C, when the infusion set4500 needs to be replaced, e.g. due to occlusion or to reduce the risk of infection, theflap4514aof thetop layer4510amay be grasped and then lifted up to separate the adhesive of thetop layer4510afrom theintermediate layer4510b,or to otherwise peel away thetop layer4510afrom theintermediate layer4510b,thereby also lifting up theinfusion hub4504 up with thetop layer4108a,and pulling out the catheter4108 out of the skin, while leaving theother layers4510b-dof the multi-layerskin tensioning device4502 on the skin. This minimizes the frequency that the adheredskin tensioning device4502 is pulled off of the skin. This may reduce irritation of the underlying skin from repeated removal of an adhereddevice4502. Once theinfusion hub4504 is removed along with thetop layer4510a,a new infusion set4500 may be applied to directly to theintermediate layer4510b,by aligning the delivery location of thecatheter4508 of the new infusion set4500 with theopening4516 of theintermediate layer4510b.This cycle of removal and reapplication may be performed several times equal to the number of layers in the skin tensioning device, with subsequent cycles of new infusion sets removed and applied to the next layer, with thebase layer4510dalso being used and later removed with thefinal infusion set4100. The strain support for this embodiment may include the perforation and pull tab separation mechanism (not shown) as described for dressing3926 inFIG.39A, to releasably maintain the strain with at leastlayer4510d,but may also be configured to directly releasably maintain strain in the other layers4510a-cas well.

In another embodiment, a skin tensioning system for treating a therapy injection or infusion site may comprise a pair of

tension dressings

5200 and5202, as depicted inFIG.52. Each of thedressings5200 and502 may be provided a dressing tension applicator (not shown) as described herein, e.g. book applicator. The

dressings

5200,5202 may have separate applicators, but in some embodiments, may be provided on the same applicator with a predetermined spacing orgap5204 between the

dressings

5200,5202 as configured in the applicator. During use, or as supplied in the applicator, thegap5204 may be in the range of about 1-20 mm, 2-10 mm, 3-8 mm, 4-6 mm, for example. Each of the

dressings

5200,5202 are tensioned along a

tensioning axis

5206,5208, if the dressings were not pretensioned at the point-of-manufacture. The applicator may also comprise visual alignment indicia so that any prespecified spacing orgap5204 between the

dressings

5200,5202 may be aligned or oriented as needed to a particular injection or infusion site. Each of the

dressings

5200,5202 are placed adjacent to the desired injection orinfusion site5210, on opposite sides of thetarget site5210. Each dressing5200,5202 may comprise a

treatment edge

5212,5214 that are aligned in a parallel fashion to define thegap5204 between the

dressings

5200,5202. Thegap5204 on the skin or on the applicator may be characterized by alongitudinal gap axis5216, which may also be parallel to the tension axes5206,5208 of the corresponding

dressings

5200,5202. After each dressing5200,5202 is positioned about thetarget site5210, the applicator or strain support for each is released, allowing the

dressings

5200,5202 to at least partially relax and compress the skin surrounding thetarget site5210. This resulting skin compression is generated at thetarget site5210 without any dressing completely surrounding or covering thetarget site5210, although support of skin tension orthogonal to the

tensioning axes

5206,5208 andgap axis5216 is reduced because the two

dressings

5206,5208 are completely separate along that direction.

In still another embodiment, a skin tensioning dressing5300 for treating a therapy injection or infusion site may comprise a pair of tension lobes or

sections

5302 and5304, as depicted inFIG.53. Each of the

sections

5302 and5304 are integrally formed with an interconnect orbridge5306 and a separated by asection gap5308. Thegap5308 may be in the range of about 1-20 mm, 2-10 mm, 3-8 mm, 4-6 mm, for example. The dressing5300 may be provided with an applicator as described elsewhere herein. Each of the

dressing section

5302,5304 are tensioned along a tensioning axes5310,5312. The applicator may also comprise visual alignment indicia so that thegap5308 may be aligned or oriented as needed to a particular injection or infusion site. Each of the

dressing sections

5302,5304 are positioned with the target site is in thegap5308. After thedressing5300 is located 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 off-loading devices corresponding toFIGS.30A to56B may be evaluated with proposed study designs to evaluate the effects of skin tension offloading on insulin pharmacokinetics, dosing, therapeutic efficacy, and/or the development of lipohypertrophy are described below, including potential health economic benefits. Diabetes patients currently treated with insulin will be randomized to a treatment group or control group, with treatment comprising use of the skin tension offloading devices selected from those corresponding toFIGS.30A to56B may be used for 4 weeks to 5 years or more, 4 weeks to 2 years, 8 weeks to 1 year as described herein. The dressings or skin tension offloading devices, or a layer and/or infusion set may be changed every three days, or every 2 to 14 days, 3 to 10 days, 10 to 14 days, 5 to 7 days, 3 to 5 days, 2 to 3 days for the selected study period.

It is hypothesized that applying a skin tension offloading device in a substantially continuous fashion may reduce the risk, progression or severity of a lipodystrophy, including lipohypertrophy in insulin-dependent patients. By reducing or limited the development of lipohypertrophy, dose progression or therapeutic effect variability relating to lipohypertrophy may be slowed or reduce. It is also hypothesized that some of the effects on dose progression and therapeutic effect variability may be independent of the development or progression of lipohypertrophy, and may be a direct result of the skin tension off-loading device on tissue mechanics and pharmacokinetics. The use of a skin tension offloading device configured with predetermined levels of strain will permit controlled and consistent delivery of strain level and to measure effects of different consistent levels of strain, compared to other skin tensioning devices that are manually adjusted in an ad hoc fashion, as with many sutureless wound closure devices. Initial studies may include patients with preexisting lipohypertrophy and/or high daily insulin dosing requirements, to more easily identify clinical effects. Using the long-term data from the studies, an outcome flowchart will be developed and costs per event will be estimated so that a cost-effectiveness and/or health economic analysis may be performed. In conjunction with patient quality of life measures, a quality-adjusted life-year cost may also be calculated.

In one proposed study evaluating the effects of one or more of the tension offloading devices will be evaluated in insulin-dependent patients with preexisting lipohypertrophy mass, to assess whether the tension offloading devices can alter the pharmacokinetics or delivery kinetics of insulin to patients who inject or infusion insulin or an insulin analogue to a site with pre-existing lipohypertrophy. Diabetes patients will be screened for lipohypertrophy masses in the range of 6-10 cm and then randomized to have a tension offloading device applied during the study. Each patient will be randomized to a test day where they will each undergo two glucose absorption tests after an overnight fast, where the tests are separated by a minimum of 7 days and an overnight fast before the tests. An indwelling catheter will be placed for each patient to provide blood samples for blood glucose and insulin levels during the test period. Baseline levels are measured and then each patient will receive a subcutaneous injection of 10 units of insulin through the access opening of the skin tension offloading device in the treatment group, or directly to the skin location in the control group. Blood samples will be obtained every five minutes for the first thirty minutes, then every ten minutes for the next 60 minutes, then every 30 minutes for the next 2.5 hours. The maximum concentration of plasma insulin at each time period will be determined as well as the time to maximum insulin concentration, and the area under the insulin concentration curve will be analyzed to assess any direct effect of the skin offloading device on insulin absorption.

In another proposed study, patients will be randomized to receive skin offloading treatment kits in conjunction with insulin or insulin analogue injection or infusion, for use over a treatment period of 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 6months 9 months, 12 months, 18 months or 24 months, for example. The tension off-loading treatments will be used as directed with replacement of the device, or change in a layer of a multi-layer device, every 2 days, 3 days, 4 days or 5 days, or as needed. Blood glucose will be measured at least 4 times per day, and compliance with blood glucose measurements and use of tension offloading devices will be assessed. The analysis will be an intent-to treat analysis and the mean amplitude of glucose excursion will be calculated over the treatment period and the postprandial area under the curve will be calculated for each mealtime over the treatment period. Alternatively or in addition, hemoglobin A1C will be measured at baseline and at each follow-up to assess the effects of the skin tension offloading device. A health economic study and/or a patient quality-of-life study may also be included in the analysis.

Patient inclusion criteria may include one or more of the following:

- Patients with or without prior history of lipohyperdystrophy
- Patients with a lipohypertrophy mass in the range 5-10 cm
- Patients with high daily insulin dose requirements of a least 0.9 UI per Kg
- Patients with minimum insulin use of 50 IU/day
- Treatment with insulin or insulin analogue for at least one year prior to enrollment
- Prior experience with rapid-acting insulin analog for at least 6 months
- Type I or Type II diabetic patients
- Treatment is self-administered or given by a caregiver
- Current treatment includes at least two to four injections per day, or insulin pump use
- Body Mass Index in the range of 20 to 35 kg/m².
- Stable body weight for 3 months prior to enrollment (≤5% change in body weight)
- 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 lipodystrophy or lipohypertrophy
- Children under the age of 5 years
- Patient not currently treated with insulin or analogue
- Women with gestational diabetes
- History of hypoglycemic unawareness
- History of diabetic ketoacidosis within 6 months of screening
- History of cardiovascular disease
- History of arrhythmia

The primary and secondary endpoint(s) will assess the development or presence of lipohypertrophy and/or changes in blood glucose or blood glucose variability factors at each visit. The initial assessment and each follow-up visit will include evaluation of:

- Serial ultrasound scans using a linear 20 MHz probe using 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
    - Complex multilayer dystrophy
  - Fibrosis level
    - Iso-hyperechogenic
    - Isoechogenic
    - Iso-hypoechogenic
- Direct and tangential light inspection and color photography of the treatment site, against a dark background
- Classification of the treatment site as to shape and size using palpation and skin calipers:
  - Small nodule—visible on inspection, easy to palpate with an elastic consistency
  - Large nodule—clearly visible on inspection, easy to palpate, with a hard to elastic consistency
  - Flat plate—slightly raised and somewhat visible, difficult to palpate except with skin pinching, with an elastic consistency
  - Flat nodule—not visible but palpable on deep palpation or skin pinching, with an elastic consistency
  - Size, including <4 cm and >4 cm
- Clinical Grading, from zero to 3:
  - 0—no changes
  - 1—visible hypertrophy but normal consistency on palpation
  - 2—substantial thickening and denser consistency
  - 3—evidence of lipoatrophy
- Validated diabetes questionnaires (start and end of study only)
  - Problem Areas in Diabetes Questionnaire
  - Diabetes Treatment Satisfaction Questionnaire

At the end of the study, the percentage change in prandial insulin and total daily insulin dosing, 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, the number of hypoglycemic events, the number of diabetic ketoacidosis events will be calculated and compared between the treatment and control groups. For studies involving patients with CGM or insulin pumps, pain assessments during cannula/infusion set insertion removal, cannula/infusion set malfunction (occlusion, needle deformation), will be assessed and compared.

In some further variations, the various tissue tension off-loading devices and systems described herein may be used for both a continuous subcutaneous insulin infusion set (SCII) and for a sensor of a CGM system, i.e. a closed loop therapy/sensing system, also known as an “artificial pancreas” or a double subcutaneous approach. It is hypothesized that the tension off-loading devices may promote a longer wear time, reduce physiologic or sensor-based latency, sensor drift for the infusion set and/or CGM sensor system, which may result in improved glucose control. This may be the result of reducing mechanical irritation or inflammation at the infusion and/or sensor site, which may lead to fibrosis. CGM devices measure glucose concentrations in the interstitium. Interstitial glucose fluctuations relate to blood glucose presumably via diffusion. CGM calibration quality and inaccuracy from loss of sensitivity and random noise, are all affected by the time lag due to blood glucose to interstitial glucose transport.

In another proposed study, the effects of applying a tensioned tissue treatment device to an insulin injection or infusion site with lipohypertrophy will be analyzed. Eligible participants will include adults aged 18 to 70 years withtype 1 diabetes taking insulin by multiple daily injections (at least three injections daily) for at least two years and who have at least two distinct palpable lipohypertrophy lesions on the abdomen for use for the 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 be using a continuous glucose monitor but will be asked to wear a CGM as part of the study protocol. HbA1c must be in the range of 7.5% to 10.5% at the screening visit. A punch biopsy of an LH lesion may be obtained at the start and at the last study visit.

The initial examination and patient screening procedure may include a physical examination for the LH lesions, with recordation of the LH dimensions. CBC/chemistry blood panels, urinalysis, HbA1c will be obtained. A CGM will be applied for 10 to 14 days to monitor the patients.

Patients meeting eligibility criteria return for the next visit, where the CGM data is downloaded to capture glycemic profiles establish baseline blood glucose and insulin use. A punch or needle biopsy of one of the lipohypertrophy region is performed and closure is performed, if needed, with sutures. For patients with three or more LH lesions satisfying eligibility criteria, the two LH lesions will be selected based on randomized selection, and the biopsied LH lesion is randomly selected from the two selected LH lesions. For punch biopsies, the biopsy size may be in the range of 1 mm to 10 mm, 1 mm to 8 mm, or 5 mm to 8 mm in diameter, and verified during the biopsy procedure to include at least some subcutaneous tissue. For needle biopsies, the needle size may be 18 gauge to 25 gauge needle. A tensioned tissue treatment device is then applied to the LH lesion that was biopsied. Each patient is taught the two locations of the LH lesions and taught not to perform any injections into the either of the LH lesions for the duration of the study. The patient is also instructed on how to change over their insulin regimen to a rapid-acting insulin analogue. Because of the limited availability of drug assays, such as those available for insulin lispro, e.g. HUMALOG (Lilly; Indianapolis, Ind.), and rapid-acting insulin lispro, e.g. LYUMJEV (Lilly; Indianapolis, Ind.), the rapid-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, N.J.).

The tensioned tissue treatment devices are applied to selected LH lesion for a time period in the range of 4 to 12 weeks, or 6 to 8 weeks, or 4 to 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) testing. The blood glucose of each subject will be adjusted to 100 mg/dL (±5 mg/dL) prior to the start of the test procedure, using either glucose or insulin, without simultaneous infusion. Any insulin infusion is tapered off and stopped for at least 10 minutes prior to clamp testing. Each subject will undergo six 6-hour HEC tests, two for each of the injection sites, with the sequence individually randomized. At the start of each test, 0.15 units/kg of insulin will be initially injected, into normal adipose tissue, the untreated LH lesion, and the LH lesion that was treated with the tensioned tissue treatment device, as specified by the randomized sequence. The euglycemic clamp equipment is then used to record blood glucose levels every minute during the clamp procedure, and to automatically adjust a glucose infusion rate to maintain the blood glucose within the target range. Insulin levels are measured during the test, e.g. at 15, 30, 45 60, 80, 100, 120, 150, 180, 210, 240 and 300 minutes after the insulin injection into the test site. From the HEC testing, the area-under-the insulin concentration curve, the C_maxinsulin level and the area-under-the blood glucose infusion rate curve, and the intrasubject coefficient of variation for each of these measures may be calculated for each test injection into normal adipose tissue, the untreated LH lesion and the treated LH lesion. It is hypothesized that the untreated LH lesion will have the lowest AUC_INS, C_maxand AUC_GIR, and the highest corresponding coefficient of variation for each test compared to normal adipose tissue and the treated LH lesion site, with the treated LH lesion site showing an improvement over the untreated LH lesion site. The change or progression in tissue stiffness, as measured by a CUTOMETER® (Courage+Khazaka electronic GmbH; Kohn, DE) and/or the effect size of the pharmacokinetic/pharmacodynamics improvements is hypothesized to be at least 10%, 15%, 20% or 25% for the treated LH lesion compared to the untreated LH lesion. Following completion of the HEC testing, each subject will resume their usual diabetes therapy for two weeks, while continuing to use the CGM and to apply the tensioned tissue treatment device to the same LH lesion that was selected for treatment.

Upon the next two week return visit, the LH lesions are re-measured, and last period of CGM data will be downloaded and pre-testing labs are obtained. Each subject will also re-initiate the use of a shorter acting insulin as before with the HEC testing, in order to wash-out any longer-acting insulin used by the subject with their usual diabetes therapy. The a washout period will be at least 12 hours to three days prior to the mixed-meal tolerance testing (MMTT), depending on the type of insulin used in their usual diabetes regimen. During the MMTT, a rapidly absorbed of 75 g of carbohydrate (56% meal caloric content), 20 g of fat (33%) and 15.2 g protein (11%) is consumed. The data acquisition for the MMTTs would otherwise be the same as for the HEC testing. It is hypothesized that the untreated LH lesion will again have the lowest AUC_INS, C_maxand AUC_GIR, and the highest corresponding coefficient of variation for each test compared to normal adipose tissue and the treated LH lesion site, with the treated LH lesion site showing an improvement over the untreated LH lesion site. Following completion of the MMTTs, each subject will resume their usual diabetes therapy and cease the use of the tensioned tissue treatment. End-of-study labs and physical examination will be performed. In some variations of the study, the MMTT is performed once for each test site, but in other variations of the study, may be performed twice for each site and the results averaged.

In another study, the effects of applying tensioned tissue treatment on normal adipose tissue will be assessed. Eligible participants will include adults aged 18 to 70 years withtype 1 diabetes taking insulin by multiple daily injections (at least three injections daily) for at least two years. Subjects may or may not be using a continuous glucose monitor but will be asked to wear a CGM as part of the study protocol. HbA1c must be in the range of 7.5% to 10.5% at the screening visit. The initial examination includes a physical examination, lab tests for CBC/chemistry blood panels, urinalysis, and HbA1c. A CGM will be applied for 10 to 14 days to monitor the patients.

At the next visit, the CGM data is downloaded to establish baseline blood glucose and insulin use. A tensioned tissue treatment device is then applied to one of two selected injection sites that is free of lipohypertrophy. The patient is also instructed on how to change over their insulin regimen to a rapid-acting insulin analogue Because of the limited availability of drug assays, such as those available for insulin lispro, e.g. HUMALOG (Lilly; Indianapolis, Ind.), and rapid-acting insulin lispro, e.g. LYUMJEV (Lilly; Indianapolis, Ind.), the rapid-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, N.J.).

The tensioned tissue treatment devices are applied to selected injection sites for a time period in the range of 4 to 12 weeks, or 6 to 8 weeks, or 4 to 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) testing. The blood glucose of each subject will be adjusted to 100 mg/dL (±5 mg/dL) prior to the start of the test procedure, using either glucose or insulin, without simultaneous infusion. Any insulin infusion is tapered off and stopped for at least 10 minutes prior to clamp testing. Each subject will undergo four 6-hour HEC tests, two for each injection site, with the sequence individually randomized. At the start of each test, 0.15 units/kg of insulin will be initially injected, twice into untreated normal adipose tissue, twice into the treated injection site, for a total of four tests. The euglycemic clamp equipment is then used to record blood glucose levels every minute during the clamp procedure, and to automatically adjust a glucose infusion rate to maintain the blood glucose within the target range. Insulin levels are measured during the test, e.g. at 15, 30, 45 60, 80, 100, 120, 150, 180, 210, 240 and 300 minutes after the insulin injection into the test site. From the HEC testing, the area-under-the insulin concentration curve, the C_maxinsulin level and the area-under-the blood glucose infusion rate curve, and the intrasubject coefficient of variation for each of these measures may be calculated for each test injection into untreated normal adipose tissue, and the treated injection site. It is hypothesized that the untreated injection site will have the lowest AUC_INS, C_maxand AUC_GIR, and the highest corresponding coefficient of variation for each test compared to the treated injection site. Following completion of the HEC testing, each subject will resume their usual diabetes therapy for two weeks, while continuing to use the CGM and to apply the tensioned tissue treatment device to the same injection site that was selected for treatment with the tensioned tissue treatment system.

Upon the next two week return visit, injection sites will be re-evaluated, and last period of CGM data will be downloaded and pre-testing labs are obtained. Each subject will also reinitiate the use of a shorter acting insulin as before with the HEC testing, in order to wash-out any longer-acting insulin used by the subject with their usual diabetes therapy. The washout period will be at least 12 hours to three days prior to the mixed-meal tolerance testing (MMTT), depending on the type of insulin used in their usual diabetes regimen. During the MMTT, a rapidly absorbed of 75 g of carbohydrate (56% meal caloric content), 20 g of fat (33%) and 15.2 g protein (11%) is consumed. The data acquisition for the MMTTs would otherwise be the same as for the HEC testing. It is hypothesized that the untreated injection site will again have the lowest AUC_INS, C_maxand AUC_GIR, and the highest corresponding coefficient of variation for each test compared to the treated LH lesion site. Following completion of the MMTTs, each subject will resume their usual diabetes therapy and cease the use of the tensioned tissue treatment. End-of-study labs and physical examination will be performed. In some variations of the study, the MMTT is performed once for each test site, but in other variations of the study, may be performed twice for each site and the results averaged.

In variant of the proposed studies above, patients will wear and collecting 14 days of continuous glucose monitoring data for multiple periods. Using the data, time-in-range (TIR), the glucose management index (GMI) and various hyperglycemic measurements will be assessed using three different injection sites: normal adipose tissue, a lipohypertrophy site that is treated with a tensioned tissue treatment device, and a lipohypertrophy site control that is not treated with a tensioned tissue treatment device. Insulin usage during the study period will also be tracked. The three sites would be measured, using blinded CGM at the following time points: 0 to 2 weeks for a baseline, 6 to 8 weeks for the first comparison point and 10 to 12 weeks for the second comparison point. The order of data gathering is randomized, between an analysis of treated and untreated LH lesions, and an analysis between the treated LH lesion and normal adipose tissue. The glucose management index for the measurement period will be calculated by:

GMI(%)=3.31+0.02392×mean glucose in mg/dl

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

While this invention has been particularly shown and described with references 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. For all of the embodiments described above, the steps of the methods need not be performed sequentially.