dressing assembly

专利摘要:
ASSEMBLY OF DRESSING The devices, kits and methods described here can be for the treatment of the skin, including, without limitation, wound healing, for the treatment, improvement and / or prevention of scars or keloids. A book-type package, applicator and / or tensioning device can be used to apply a dressing to an individual. The packaging, applicator and / or tensioning device can apply and / or maintain a tension on an elastic bandage.
公开号:BR112013017506B1
申请号:R112013017506-0
申请日:2012-01-06
公开日:2021-01-26
发明作者:Jasper Jackson；John A. Zepeda；Adam C. French；Darren G. Doud；Geoffrey C. Gurtner；Brett A. Follmer；William R. Beasley；Paul Yock；Keiichiro Ichiryu；Manuel A. Cardona Pamplona；Tor C. Krog；Kemal Levi
申请人:Neodyne Biosciences, Inc.；
IPC主号:

专利说明:

[0001] [001] This claim claims benefit under 35 USC §119 (e) for US Provisional Order No. Serial 61 / 430,908, filed on January 7, 2011 and for US Provisional Order No. Serial 61 / 443,647, filed on February 16, 2011, and is part of a continuation of US Order No. Serial 12 / 854,859, filed on August 11, 2010, all of which are incorporated herein by reference in their entirety. This order is also related to U.S. Order No. 11 / 888,978, filed on August 3, 2007, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION
[0002] [002] Scar formation in response to skin damage is part of the natural wound healing process. Wound healing is a long and continuous process, although it is typically recognized as occurring in stages. The process begins immediately after the injury, with an inflammatory stage. During this stage, which typically lasts from two days to a week (depending on the wound), damaged tissue and foreign matter are removed from the wound. The proliferative stage occurs in a moment after the inflammatory stage and is characterized by proliferation of fibroblasts and production of collagen and proteoglycan. 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 matrix previously built and randomly organized is remodeled into an organized structure that is highly reticulated and aligned to increase mechanical strength.
[0003] [003] While the histological features that characterize hypertrophic scars have been well documented, the underlying pathophysiology is not well known. Hypertrophic scars are a side effect of excessive wound healing, and usually result in overproduction of cells, collagen and proteoglycans. Typically, these scars are high and are characterized by the random distribution of bundles of tissue. The appearance (ie, 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 affected person. Hypertrophic scars are very common, and can occur after any full-thickness skin lesion. It was recently demonstrated in US Patent Application Publication 2006/0037091 (US Patent Application Serial No. 11 / 135,992 entitled "Method for Producing Hypertrophic Scarring Animal Model for Identification of Agents for Prevention and Treatment of Human Hypertrophic Scarring", filed on May 24, 2005) which is incorporated by reference in its entirety, that mechanical stress can increase hypertrophic scarring in a murine model.
[0004] [004] Keloids are typically characterized as tumors that consist of highly hyperplastic masses that occur in the dermis and adjacent subcutaneous tissue in susceptible individuals, most commonly after trauma. Keloids are often more severe than hypertrophic scars, as they tend to invade normal adjacent tissue, while hypertrophic scars tend to remain confined within the edges of the original scar. BRIEF SUMMARY OF THE INVENTION
[0005] [005] The devices, kits and methods described herein can be for treating an individual in a skin location including, without limitation, for the treatment of wounds or for the treatment, improvement or prevention of scars and / or keloids, by manipulation mechanical or physical properties of the skin or by protecting the skin from stress, and / or by controllably pressing or tensioning the epidermis and layers of dermal tissue in or near a skin site, that is, in a wound or adjacent to her or to an individual's skin care facility. According to variations, the manipulation of mechanical or physical properties can, in this way, modulate the tensile or compressive stress at the skin site. Stress at the skin site can be reduced to levels below those experienced by normal skin and tissue. Stress at the skin site can be increased to levels above that of normal skin and tissue. Stress or tension can be applied to the surrounding tissue in one, two or more directions to handle endogenous or exogenous stress at the skin site in one, two or more directions. According to variations, the devices and methods described herein can reduce or otherwise manipulate the stress suffered by the skin and / or a wound and surrounding tissues in order to treat an individual. The devices can also help prevent or reduce the incidence of wound dehiscence.
[0006] [006] According to the devices, kits and methods described herein, a device for skin treatment, skin device, device for treating wounds, device for treating scars or keloids, device, bandage or dressing for improvement or prevention of scars or keloids that can be applied, attached or attached to one or more layers of an individual's skin or tissue (hereinafter referred to as "dressing", "skin device" or "skin treatment device").
[0007] [007] In addition to improving the formation of scars, other uses for this skin treatment device may or may not include, without limitation, for example, the treatment of skin-related conditions such as acne, blemishes, rosacea, warts , rashes (including, without limitation, erythematous, macular, papular and / or bullous conditions), psoriasis, skin irritation / sensitivity, allodynia, telangiectasis, port wine stains and other arteriovenous malformations and ectopic dermatitis; the treatment or improvement of existing scars, wrinkles, stretch marks, loose or flabby skin or other skin irregularities; lifting (lifting), fixation, containment, skin movement for various purposes, such as during preoperative preparation, during surgical procedures, for example, as a retractor of low profile tissue, to stabilize blood vessels during needle insertion or catheter, post-operatively, pre- or post-operatively for pre-treatment or preconditioning of the skin, for example, before revision of scars, wound incision, definition of body contour, in the cutaneous expansion of mastectomy , aesthetic treatment or remodeling of the skin, whether topical or subdermal, using or not using an energy modality such as microwave, radiofrequency ablation, high-intensity concentrated ultrasound, laser, infrared, incoherent light, during weight loss or for aesthetic purposes; hair removal or hair loss; treatment and / or closure of skin lesions, for example, incisions, wounds, chronic wounds, decubitus ulcers, ulcers (including venous stasis ulcers), preventing or reducing the incidence of wound dehiscence, skin conditions or diabetic wounds, scarring and / or burn relief; action as an occlusive dressing or negative pressure from wounds; protection from incisions or wounds, for example, prevention of separation or opening, protection of the newborn's umbilical buttons after cutting the umbilical cord. Such treatments may include the use of a drug or other therapeutic agent that can be applied to the skin with this device. The agents can include, without limitation, antibiotics, antifungals, immune modulators, including corticosteroids and non-steroidal immune modulators. The agents can be supplied in any of several formulations including, without limitation, powders, gels, lotions, creams, pastes, suspensions, etc. The devices can also be used for the purpose of delivering a drug to the skin or through the skin, for example, by stretching the skin and applying a drug to it. Different device configurations can be receptive to the size or geometry of different regions of the body. Treatments can be applied to regions of any shape (for example, linear, curved, starry), size or depth, and to one or more regions of the body, including, without limitation, the scalp, forehead, face (for example, nose) , eyelids, cheeks, lips, chin), ears, neck, shoulder, arm, forearm, palm, back of hands, fingers, nail bed, armpit, chest, nipple, areola, back, abdomen, inguinal region, buttocks, perineal region, vaginal lips, penis, scrotum, thigh, legs, 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".
[0008] [008] In some situations, an immediate, quick or simple application of a dressing may be desired. The devices, kits and methods described herein can be for the preparation and / or application of a dressing to the skin and for the separation of the applicator, tensioning device or loader, support or base of the dressing by the skin device.
[0009] [009] The devices, kits or methods described herein may include a packaging, charger, support, base, applicator or tensioning device, each of which may: contain, maintain, load or support a dressing at least temporarily; can be used to prepare a dressing for application; it can be used to release, guide or apply a dressing; can be used to maintain a dressing in a pressed or tensioned configuration; it can be used to press or tension a dressing; it can be used to separate the dressing from the package, carrier, support, base, applicator or tensioning device and / or it can be used during or after applying a dressing to provide additional treatment to a wound, incision or other treatment location; and / or can be used to apply pressure to a wound, incision or other treatment location. According to some variations, a package and / or applicator can provide structural support for a dressing during or after an adhesive liner is released. According to some variations, the assembly can be constructed to avoid folding or flexing the dressing to the point that the adhesive on the dressing sticks to itself. For example, when some variations of the dressing are maintained or supported at one point or along an edge of the dressing in a beam configuration, the dressings will not buckle, deform laterally or otherwise deform outside the plane, under your own mass or configuration.
[0010] [0010] In some other variations of the devices and methods presented here, a device with a substantially rigid support structure or that provides structural support to a dressing and that provides a particular resistance to flexion or column resistance when two opposite edges of the device and of the support structure are placed under a compressive load that causes axial compression or lateral deformation, for example, when a force similar to the grip force of a hand is applied to an edge of the device, before the device deforms or bends. For example, a flexural strength can be characterized as the peak force that is obtained as the device and the support structure are compressed by 25% of its original dimension. This column strength or stiffness can vary, depending on the direction along the device and the support structure being measured. In some additional variations, the peak force can be at least about 0.02 Newtons per millimeter (N / mm), about 0.03 N / mm, about 0.05 N / mm, about 0, 1 N / mm, about 0.15 N / mm, about 0.2 N / mm, about 0.3 N / mm, about 0.4 N / mm or about 0.5 N / mm. In some variations of devices comprising devices and support structures generally flat or flat having a thickness, the peak force can be measured by applying a compressive force along the shortest dimension of the device / support structure that is transverse to the device thickness / support structure. According to these 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.
[0011] [0011] A resistance to flexion in the direction of tension of the dressing can also be measured by flexing three points, applying a transverse force to the midpoint of the applicator simply supported on two external points apart by a certain distance or support interval. For example, the distance between the two points of a sample can be approximately 1.905 cm and a force ranging from about 0.454 to 0.567 kg can be applied to a sample approximately 8.89 mm wide, resulting in a deflection of approximately 1.27 mm. Flexural strength can also be measured by characterizing the force at which deformation occurs in a beam simply supported. For example, a force of approximately 0.204 kilograms can be applied to a supported sample of just approximately 8.89 millimeters wide and can result in a deflection of approximately 0.102 millimeters. Flexural strength can also be characterized by the external surface tension before fracture or permanent deformation. By measuring the support structures and deflections during the test procedure, a load deflection curve can be generated and the flexural modulus of the support structure can also be calculated. In some variations, the support structure may comprise a flexural modulus of at least about 0.9 GPa, while in other embodiments, the flexural modulus is at least about 1 GPa, at least about 1.1 GPa, at least at least about 1.2 GPa, at least about 1.3 GPa, or at least about 1.4 GPa.
[0012] [0012] In another example, a device 7 cm wide by 19 cm long can be configured with a support structure comprising cardboard, support sheet or support structure. The support structure can have an average thickness in the range of about 0.203 mm to about 0.711 mm or more. In some specific variations, the support structure may have a thickness of about 0.305 mm, about 0.406 mm, about 0.457 mm, about 0.61 mm, about 7.112 mm or about 0.813 mm, about 0.914 mm , about 1.016 mm, about 1.27 mm or more. By applying force along the length of the 19 cm long edge, that is, across the 7 cm width of the device, the support structure can provide sufficient column stiffness or strength to obtain peak forces of around 1.361 kilogram or more, 1,814 kilogram or more, or about 4,536 kilograms or more, while being compressed, collapsed, arched, warped or otherwise tensioned by 25% across its 7 cm width (ie, about 1.75 cm). In some variations, the support structure may comprise perforations or regions of reduced thickness to allow for some flexing in at least one direction or in both directions.
[0013] [0013] According to some variations, a device that provides structural support may have several supporting elements or cross segments that extend from one edge of length to an opposite edge or to length (or from an edge of a width to an edge opposite of a width); according to some variations there may be three or more cross elements, for example, a cross element that extends along two opposite edges and transversely crosses a width (or a length) and one or more cross elements that extend across the width (or length) and between the crossed elements along the two opposite edges. These cross elements may or may not be coupled or connected with each other, for example, with a relatively flexible material. These cross elements can have a total aggregate width with respect to the length of an opposite 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 can be provided which have a total aggregate width, in relation to the length of the opposite side, between about 20% to 100%. These cross elements can be segmented and can provide flexibility when flexing in one direction and stiffness in relation to flexibility in the other direction.
[0014] [0014] The package and / or applicator can also provide support or structural stability of the dressing as it is oriented and / or applied to an individual's skin. According to some variations, the dressing and packaging are configured to be pre-oriented in a position facing a wound before or after the wound device is prepared for application, for example, of the adhesive liner being removed. According to some variations, the packaging or applicator is configured to be used with one hand to guide and / or apply the device to an individual's skin. For example, in some situations, particularly when a longer or larger dressing is used, a package or applicator provides structural support for a dressing in such a way that a user can effectively maintain, manipulate and / or apply the pre-prepared dressing with a of the hands. According to some variations, the assembly comprises a support structure. A dressing support structure in this order means a structure that is attached, directly or indirectly, to a posterior surface of a dressing that must be applied to an individual. The support structure may further comprise, at least in part, a material or structure that is more rigid than the dressing to be applied to an individual. The support structure can comprise one or more elements or segments. It can be built by a single substrate, a laminate or several elements coupled together and / or to the dressing. According to some variations, at least 20%, 25%, 30%, 35% or 40% of a dressing length or width are supported by one or more support structures that extend from an opposite first side to an opposite side along a length or width of the dressing. In some additional variations, the percentage of a length or width that is supported by the support structure (s) is a minimum support average across the entire length or width of the device, for example, at least an average 20%, 25%, 30%, 35% or 40% support across a whole dimension of the device, for example, length or width. According to some variations, an entire area of a dressing is supported by a support structure. According to some variations, a base, carrier or support of a dressing can comprise at least three support structures that extend transversely between opposite sides of the dressing. According to some variations, a support structure comprises interconnected members or elements. According to some variations, a base, carrier or support remains attached to the dressing as it is applied. According to some variations, greater structural support is provided for a carrier, support or dressing base in a first direction, while greater flexibility is provided in a second direction, while lesser flexibility is provided in the first direction and lesser structural support is provided in the second direction. direction. According to some variations, one or more support structures may extend beyond an edge of the first opposite side. According to some variations, one or more support structures, at least in part, may extend beyond at least a portion of an edge of an opposite first side and at least in part beyond at least a portion of an edge of an opposite side. According to some variations, a support structure can extend at least 3 mm from at least a portion of an edge of the dressing. According to some variations, the package or applicator is configured to increase the sterile transfer of a dressing to an individual's wound. Depending on variations, the package or applicator may be sufficiently wider or longer, or may have an area sufficiently larger than a dressing, providing the ability to maneuver or manipulate the support or applicator so that it provides the application sterile and / or application with one hand without the need to touch the dressing. According to some variations, a margin of distance is provided by the outer edges of the carrier, support or base of the dressing to the dressing supported on the base or adhesive on the dressing. These margins can be selected to prevent or make it difficult for a user to touch the dressing or dressing adhesive when grasping the edges to manipulate the carrier, support, applicator or dressing base.
[0015] [0015] The devices, kits and methods described here can be for the treatment, improvement or prevention of scars and / or keloids by creating and / or maintaining a predetermined tension in an elastic device for skin treatment that is then affixed to the surface skin using skin patches to transfer a generally flat (for example, compressive) force from the bandage to the skin surface.
[0016] [0016] In some variations, a dressing is provided that comprises an elastic laminar structure (for example, one that comprises a polyurethane silicone material, TPE (thermoplastic elastomers), synthetic rubber or copolyester) that comprises an upper surface, a lower surface , a first edge and a second edge opposite the first edge, and one or more adhesive regions. The dressing can also comprise a first release liner attached in a way that can be released to the adhesive region or regions. The adhesive region (or regions) may comprise a pressure sensitive adhesive. The dressing can be tapered or otherwise shaped to reduce skin tension at the edges. The dressing may have modified, reduced, or no adhesive close to its edges to reduce skin tension at the edges. Portions of the dressing can be unstretched and can thus reduce tension in certain areas of the skin where the dressing is applied. In some specific examples, the non-tensioned area or areas are found between the edges of the dressing and the tensioned area (s). In some additional examples, the non-stressed areas are limited to that area and are not found, during application or use, between the stressed areas of a single dressing, in use. In yet other additional examples, the non-tensioned areas are limited to the areas along the edges of a dressing that cross the tension axis of the tensioned area (s), but not to the areas along the edges of the dressing. which are generally parallel to the tension axis.
[0017] [0017] A packaging device, dressing loader, dressing support, dressing base, applicator and / or tensioning device can be provided. The packaging device, dressing carrier, dressing support, dressing base, applicator and / or tensioning device can be configured to press and / or tension a dressing before application to an individual. A device can be used to tension and / or maintain tension in a dressing. In a variation, a dressing is provided which comprises a first structure, zone or region of adhesion of the device, a second structure, zone or region of adhesion of the device, and a structure or mechanism configured to exert a separating force between the first and the second structure, zone or region of adhesion of the device. The device may further comprise a release-capable locking mechanism, adhesion mechanism or adhesive, configured to maintain the member or mechanism in a tensioned configuration.
[0018] [0018] In some situations, applying 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 here can also be used to help reduce bleeding, for example, by applying a compressive force using the device during or after the dressing is applied. applied. A coagulation additive can also be provided in a dressing.
[0019] [0019] According to one aspect, the packaging, carrier, support, base, applicator and / or tensioning device can be sufficiently rigid or supportive in at least one direction, to maintain the shape of a dressing so that it is easy to manipulate.
[0020] [0020] According to some variations, the packaging is also flexible enough in at least one direction to allow curving or shaping the dressing to adapt to the curvature or shape of the location on the body or skin where the dressing is applied. Generally, the flexibility of the package used to adapt the dressing to the treatment site can be configured in such a way that the treatment site is not substantially deformed during the application of the dressing; thus, the application of the dressing is relatively smooth or uniform on the skin; and / or provides a uniform, predetermined or relatively predictable tension or force to an area of the skin. The package or applicator may have flexibility in the first direction and greater rigidity in the other direction. The package or applicator may include elements or segments that allow flexibility with respect to the adjacent elements or segments.
[0021] [0021] According to some variations, the packaging is also flexible enough in at least one direction to allow the curving or shaping of the dressing to adapt to the curvature or shape of the location on the body or skin where the dressing is applied. Generally, the flexibility of the package used to adapt the dressing to the treatment site can be configured in such a way that the treatment site is not substantially deformed during the application of the dressing; and / or in such a way that the application of the dressing is relatively smooth or uniform on the skin; and / or provides a uniform, predetermined or relatively predictable tension and / or force to an area of skin. The package or applicator may have flexibility in the first direction and greater rigidity in the second direction. The first direction can be transversal to the tensioning direction or have a component that is transversal to the tensioning direction. The second direction can be the tensioning direction or have a component that is in the tensioning direction. The first direction may or may not be transversal with respect to the second direction. The package or applicator may include elements or segments that allow flexibility with respect to adjacent elements or segments.
[0022] [0022] According to some variations, a desired flexibility, for example, which has at least one component transversal to the tensioning direction, can be characterized by a modified beam beam flexing model, that is, the application of a force to the beam. free end of a beam, supported simply by the other end, while it is wrapped around a cylindrical object with a known radius of curvature or curvature, defined as the reciprocal of the radius of curvature. According to a variation, the force to flex the package or applicator around an object with a predetermined curvature cannot be greater than about 1.361 kg. According to a variation, the force cannot be greater than about 0.136 kg. According to a variation, the force to flex around a predetermined curvature with a radius of about 6.35 centimeters cannot be greater than about 1.361 kg. In another variation, the force to flex around a predetermined curvature with a radius of about 6.35 centimeters cannot be greater than about 0.136 kilograms.
[0023] [0023] According to some variations, a packaging, applicator or tensioning device is provided that comprises a base that has an internal surface to which a dressing is removably attached, and a cover or flap that has an internal surface that makes interface with the internal 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 by which the cover can be rotated with respect to the base to open the device. Alternatively, the cover can be detached from 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.
[0024] [0024] In some variations, the book-type structure, in the closed configuration, comprises a stratified structure comprising a cover / flap, a treatment device and a base, in that relative order, while in the open configuration, the relative order of the structure layer changes to a cover / flap, a base and a treatment device. The treatment device may also comprise one or more release layers. In a variation, in the closed configuration, a first face of the cover / flap 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 / flap (opposite the first face of the cover / flap) 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 / flap can be detached from the base during or after tensioning the treatment device. In some variations, the treatment device can be attached asymmetrically to the book-type structure, in relation to the flexing region of the book-type structure. In some cases, asymmetric adhesion can provide the user with a mechanical advantage when tensioning the dressing, and / or can reduce manufacturing costs by optimizing the amount of elastic material used in the dressing. In other variations, the dressing or device for skin treatment can be symmetrically attached to the book-type structure, in relation to the flexing region of the book-type structure.
[0025] [0025] 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 package comprising: an applicator comprising a base structure having an internal surface and a handling portion; a dressing comprising a first surface configured to be applied to an individual's skin or wound; and a posterior surface, in which the posterior dressing surface is removably coupled or anchored to the internal surface of the base structure, and in which the first surface faces away from the internal surface of the base structure; and a cover configured to removably cover the first dressing surface. One method may further comprise removing the cover to expose a first dressing surface; and using the manipulation portion of the base structure to apply the first dressing surface to an individual's wound or skin. In another variation, a method is provided for the treatment of a wound, which comprises the tensioning of an internal region of an elastic bandage between a first non-tensioned region and a second non-tensioned region, and the adhesion of at least the tensioned internal region of the wound. dressing to a skin location or to both the tensioned and the non-tensioned regions.
[0026] [0026] According to some variations, a dressing package assembly comprises: a base structure that has an internal surface; a roof structure having an opposite surface, where the base structure is movably coupled to the roof structure; and a dressing comprising a first surface configured to be applied to a wound or the skin of an individual, and a posterior surface, wherein at least a portion of the posterior surface is removably coupled to the internal surface of the base structure; and wherein the cover structure is configured to move from a first position where the opposite surface interfaces and is substantially parallel to the first surface with the dressing to a second position where the opposite surface is separated from the first dressing surface. According to variations, the first dressing surface comprises an adhesive region. According to variations, the first dressing surface comprises an adhesive liner that interfaces with an adhesive region on the dressing. According to variations, the opposite surface of the covering structure comprises an adhesive liner that covers the adhesive region when the covering structure is in the first position and separated from the adhesive region when the covering structure is in the second position. According to variations, the dressing comprises an elastic material. According to variations, the dressing comprises a first adhesion region coupled to the internal surface of the base structure and a second adhesion region coupled to the opposite surface of the covering structure, where the cover and base are configured to exert a tensioning force. to tension the dressing when the cover is moved from the first position to the second position. According to variations, a tensioning structure is configured to exert tensioning force on the dressing. According to variations, the tensioning structure comprises: a first structure configured to couple the dressing in the first region of adhesion to the internal surface of the base structure; and a second structure configured to couple the dressing in the second region of adhesion to the opposite surface of the covering; wherein the tensioning structure is configured to exert the tensioning force on the dressing between the first adhesion region and the second adhesion region when the covering structure is moved with respect to the base structure from the first position to the second position. According to some variations, the dressing has a first width when the cover is in the first position and a second width when the cover is in the second position, where the second width is greater than the first width. According to variations, the second width is at least 20% larger than the first width. According to variations, the second width is at least 40% larger than the first width. According to variations, the base structure comprises at least one relatively rigid element and at least one relatively flexible element, wherein the relatively rigid element is sufficiently rigid to support the dressing when the tensioning force is applied in a first direction; and wherein the relatively flexible element allows the base structure to flex in a second direction. According to variations, the at least one relatively rigid element comprises several relatively rigid flexible elements coupled. According to variations, the cover structure comprises at least one relatively rigid element and at least one relatively flexible element. According to variations, a release device is configured to release the dressing from the base structure after the dressing is applied to a wound or an individual's skin. According to some variations, the base structure is pivotally coupled to the roof structure.
[0027] [0027] According to variations, a dressing package assembly comprises: a base structure that has an internal surface and that comprises at least one support element and at least one flexible element; and a dressing comprising a first surface configured to be applied to a wound or the skin of an individual, and a posterior surface, wherein at least a portion of the posterior surface is removably coupled to the internal surface of the base structure. According to variations, the at least one rigid element comprises several rigid elements coupled to each other with the at least one flexible element. According to variations, a covering structure comprises an opposite surface configured to interface with the first dressing surface, where the covering structure is movably coupled to the base structure to move from a first position where the opposite surface interfaces with the first dressing surface, up to a second position where the cover is separated from the first dressing surface. According to variations, the roof structure is pivotally coupled to the base structure. According to variations, the roof structure comprises at least one support element and at least one flexible element sufficiently flexible to allow modeling of the roof structure. According to variations, the first dressing surface comprises an adhesive region. According to variations, the first dressing surface comprises an adhesive liner that interfaces with an adhesive region on the dressing. According to variations, the opposite surface of the roof structure comprises an adhesive liner that covers the adhesive region in the first position and is separated from the adhesive region in the second position. According to variations, the dressing comprises an elastic material. According to variations, the dressing comprises a first adhesion region coupled to the internal surface of the base structure and a second adhesion region coupled to the opposite surface of the covering structure, where the cover and base are configured to exert a tensioning force. to tension the dressing when the cover is moved from the first position to the second position. According to variations, the assembly still comprises a tensioning structure configured to exert the tensioning force on the dressing. According to variations, the tensioning structure comprises: a first structure configured to couple the dressing in the first region of adhesion to the internal surface of the base structure; and a second structure configured to couple the dressing in the second region of adhesion to the opposite surface of the covering; wherein the tensioning structure is configured to exert the tensioning force on the dressing between the first adhesion region and the second adhesion region when the covering structure is moved with respect to the base structure from the first position to the second position. According to variations, the dressing between the first and second adhesion regions has a first width when the cover is in the first position and a second width when the cover is in the second position, where the second width is greater than the first width . According to variations, the second width is at least 4% larger than the first width. According to variations, the second width is at least 20% greater than the first width. According to variations, the second width is at least 40% larger than the first width.
[0028] [0028] According to variation, a method of applying a dressing to a wound or the skin of an individual comprises: providing a dressing packaging assembly comprising: a base structure having an internal surface; a roof structure having an opposite surface, where the base structure is movably coupled to the roof structure; and a dressing comprising a first surface that includes an adhesive region, and a rear surface, where at least a portion of the rear surface is removably coupled to the inner surface of the base structure, and where the opposite surface of the base structure cover comprises an adhesive liner that covers the adhesive region when the cover structure is in the first position; pivoting rotation of the covering structure with respect to the base structure to a second position to separate the opposite surface from the first dressing surface and to separate the adhesive liner from the adhesive region; applying the first surface of the dressing to a wound or to an individual's skin, subsequently releasing the dressing from the base structure. According to variations in the method, at least a portion of the posterior dressing surface is coupled to the covering structure and further comprising the pivoting rotation of the covering structure with respect to the base structure for tensioning the dressing.
[0029] [0029] According to variations, a dressing applicator comprises a first dressing adhesion region and a second dressing adhesion region which comprises a variable separation distance between the first dressing adhesion region and the second dressing adhesion region. dressing, and a flexion region between the first dressing adhesion region and the second dressing adhesion region that alters the variable separation distance, and where a first distance from a center of the flexing region to the first adhesion area of the dressing is different from a second distance from the center of the flexion region to the second area of adhesion of the dressing.
[0030] [0030] According to variations, a dressing tensioning device comprises: a dressing loader comprising a first edge of the loader and a second opposite edge of the loader that define a width of the loader between them; a tensioning element configured to move with respect to the dressing loader from a first position to a second dressing tensioning position; and a dressing assembly comprising a dressing that includes a first dressing edge coupled to the carrier adjacent to the first carrier edge; a second dressing edge coupled to an adhesion element, where the adhesion element is coupled to the tensioning element; wherein in the first position of the tensioning element, the second edge of the dressing is at a first distance from the second edge of the carrier within the width of the carrier, and in the second position of the tensioning element, the second edge of the dressing is at a second distance the second edge of the magazine within the width of the magazine, where the first distance is greater than the second distance. According to variations, the first edge of the dressing is relatively fixed with respect to the second edge of the dressing when the tensioning element is moved between the first and second positions.
[0031] [0031] According to variations, a dressing package assembly comprises: a base structure that has an internal surface; a roof structure having an opposite surface, where the base structure is movably coupled to the roof structure; and a dressing comprising a first surface configured to be applied to a wound or the skin of an individual, and a posterior surface, wherein at least a portion of the posterior surface is removably coupled to the internal surface of the base structure; wherein the covering structure is configured to move from a first position where the opposite surface interfaces with the first surface to the dressing to a second position where the opposite surface is separated from the first dressing surface, where the second position is at minus about 180 degrees rotated with respect to the first position. According to variations, the first dressing surface comprises an adhesive region. According to variations, the first dressing surface comprises an adhesive liner that interfaces with an adhesive region on the dressing. According to variations, the opposite surface of the covering structure comprises an adhesive liner that covers the adhesive region when the covering structure is in the first position and separated from the adhesive region when the covering structure is in the second position. According to variations, the dressing comprises an elastic material. According to variations, the dressing comprises a first adhesion region coupled to the internal surface of the base structure and a second adhesion region coupled to the opposite surface of the covering structure, where the cover and base are configured to exert a tensioning force. to tension the dressing when the cover is moved from the first position to the second position. According to variations, the assembly still comprises a tensioning structure configured to exert the tensioning force on the dressing. According to variations, the tensioning structure comprises: a first structure configured to couple the dressing in the first region of adhesion to the internal surface of the base structure; and a second structure configured to couple the dressing in the second region of adhesion to the opposite surface of the covering; wherein the tensioning structure is configured to exert the tensioning force on the dressing between the first adhesion region and the second adhesion region when the covering structure is moved with respect to the base structure from the first position to the second position. According to variations, the dressing has a first width when the cover is in the first position and a second width when the cover is in the second position, where the second width is greater than the first width. According to variations, the second width is at least 20% larger than the first width. According to variations, the second width is at least 40% larger than the first width. According to variations, the base structure comprises at least one relatively rigid element and at least one relatively flexible element, wherein the relatively rigid element is sufficiently rigid to support the dressing when the tensioning force is applied in a first direction; and wherein the relatively flexible element allows the base structure to flex in a second direction.
[0032] [0032] According to variations, a bandage pack comprises: a bandage carrier comprising a first edge of the carrier, a second edge of the carrier opposite the first edge of the carrier, and a support structure extending between the first edge and the second edge, configured to support a dressing while applying the dressing to an individual; and a dressing comprising a first edge of the dressing, a second edge of the dressing opposite the first edge of the dressing, a posterior surface and an opposite surface that interfaces with the skin, wherein at least a portion of the posterior surface is coupled in a manner removable to the dressing carrier, where the first edge of the dressing and the second edge of the dressing are positioned between the first edge of the dressing and the second edge of the dressing, and where the first edge of the dressing defines a first margin between the first edge of the dressing and the first edge of the loader and the second edge of the dressing defines a second margin between the second edge of the dressing and the second edge of the loader, where each of the first and second margins is at least three millimeters wide.
[0033] [0033] In a variation, a dressing system is provided, comprising a first support, a second support and a primary flexing region between them, the primary flexing region comprising a primary flexing axis, and a treatment device that it comprises a first adhesion region attached to the first support and a second adhesion region attached to the second support, a first separation region configured to separate from the first adhesion region and a second separation region configured to separate from the second adhesion region. The first and second separation regions can comprise perforations. The dressing system can also comprise a traction element located along the perforations. The treatment device can be attached asymmetrically to the first and second supports, in relation to the primary flexion region. A first distance between the first support and the primary flexing axis can be different from a second distance between the second support and the primary flexing axis. The dressing system may further comprise a closed configuration in which the treatment device is located between the first support and the second support, and a closed configuration in which the second support is located between the first support and the treatment device. The second support may comprise at least a secondary flexion region that comprises a secondary flexion axis that is not parallel to the primary flexion axis. The secondary flexing axis can be orthogonal to the primary flexing axis. The first support can comprise at least a secondary flexion region that comprises a secondary flexion axis that is not parallel to the primary flexion axis. The (at least one) secondary flexion region of the first support can be aligned with (at least one) secondary flexion region of the second support. The treatment device may further comprise a release liner coupled to an adhesive surface of the treatment device. The treatment device can comprise a perforation region. The dressing system may further comprise an elongated member attached adjacent the perforation region. The elongated member may protrude beyond the perforation region of the treatment device. In some variations, at least a portion of the elongated member may be folded, and the fold may be along a substantial length of the treatment device. At least one of the first and second supports may comprise indicia that identify a central region of the treatment device. The evidence may comprise a recessed edge, ink mark, protrusion or window. The primary flexion region can also be drilled. The first support can be configured to detach from the second support and the treatment device, and may or may not do so while maintaining the treatment device in a tensioned configuration. The second support may comprise an adhesive element configured to adhere to the treatment device when the dressing system is in the open configuration, but not in the closed configuration. The first support may comprise an attached release liner. The release liner can be attached to the first support between an outer edge of the first support and the attached treatment device. An internal surface of the first and / or second support facing the treatment device can include an adhesive, for example, an adhesive coating or adhesive tape, which is configured to keep the treatment device in a tensioned state as it is stretched and makes contact with the adhesive, and / or to hold the treatment device against the first and / or second supports.
[0034] [0034] In another variation, a dressing system is provided, comprising a first tensioning member, a second tensioning member, and a primary flexing region between them, the primary flexing region comprising a primary flexing axis, and a treatment device asymmetrically attached to the first and second tensioning members, in relation to the primary flexion region. The treatment device may comprise a first end attached to the first tensioning member and a second end attached to a second tensioning member, wherein a first distance between the first tensioning member and the primary flexing shaft is different from a second distance between the second tensioning member and the primary flexing axis. The dressing system may further comprise a closed configuration in which the treatment device is located between the first tensioning member and the second tensioning member, and an open configuration in which the second tensioning member is located between the first tensioning member and the treatment device. The second tensioning member can comprise at least one secondary flexing region comprising a secondary flexing axis that is not parallel to the primary flexing axis. The secondary flexing axis can be orthogonal to the primary flexing axis. The first tensioning member can comprise at least one secondary flexing region comprising a secondary flexing axis that is not parallel to the primary flexing axis. The at least one secondary flexing region of the first tensioning member can be aligned with at least one secondary flexing region of the second tensioning member. The treatment device may further comprise a release liner coupled to an adhesive surface of the treatment device. The treatment device can comprise a perforation region. The dressing system may further comprise an elongated member attached adjacent the perforation region. The elongated member may protrude beyond the perforation region of the treatment device. In some variations, at least a portion of the elongated member may be folded, and the fold may be along a substantial length of the treatment device. At least one of the first and second tensioning members may comprise indicia that identify a central region of the treatment device. The evidence may comprise a recessed edge, ink mark, protrusion or window. The primary flexion region can be drilled. The first tensioning member can be configured to detach from the second tensioning member and the treatment device. The first tensioning member can be configured to detach from the second tensioning member and the treatment device while maintaining the treatment device in a tensioned configuration. The second tensioning member may comprise an adhesive element configured to adhere to the treatment device when the dressing system is in the open configuration, but not in the closed configuration. The first tensioning member may comprise an attached release liner. The release liner can be attached to the first tensioning member between an outer edge of the first tensioning member and the attached treatment device.
[0035] [0035] In another variation, a dressing system is provided, comprising a first applicator member, a second applicator member, and a primary flexing region between them, the primary flexing region comprising a primary flexing axis, and a treatment device attached to the first and second members of the applicator, wherein the dressing system comprises a closed configuration in which the treatment device is located between the first member of the applicator and the second member of the applicator, and a closed configuration in which the second applicator member is located between the first applicator member and the treatment device. The second member of the applicator may comprise at least one secondary flexion region comprising a secondary flexion axis which is not parallel to the primary flexion axis. The secondary flexing axis can be orthogonal to the primary flexing axis. The first member of the applicator may comprise at least one secondary flexing region comprising a secondary flexing axis that is not parallel to the primary flexing axis. The (at least one) secondary flexion region of the first applicator member can be aligned with (at least one) secondary flexion region of the second applicator member. The treatment device may further comprise a release liner coupled to an adhesive surface of the treatment device. The treatment device can comprise a perforation region. The dressing system may further comprise an elongated member attached adjacent the perforation region. The elongated member may protrude beyond the perforation region of the treatment device. At least a portion of the elongate member may be folded, and the fold may be along a substantial length of the treatment device. At least one of the first and second members of the applicator may comprise indicia that identify a central region of the treatment device. The evidence may comprise a recessed edge, ink mark, protrusion or window. The primary flexion region can be drilled. The first member of the applicator is configured to stand out from the second member of the applicator and the treatment device. The first applicator member can be configured to detach from the second applicator member and the treatment device while maintaining the treatment device in a tensioned configuration. The second member of the applicator may comprise an adhesive element configured to adhere to the treatment device when the dressing system is in the open configuration, but not in the closed configuration. The first applicator member may comprise an attached release liner. The release liner can be attached to the first applicator member between an outer edge of the first applicator member and the attached treatment device. BRIEF DESCRIPTION OF THE DRAWINGS
[0036] [0036] Figure 1 is a perspective view of a variation of a dressing and packaging assembly in a closed configuration.
[0037] [0037] Figure 2 is a perspective view of the dressing and packaging assembly of Figure 1 with an open cover in a position about ninety degrees from the closed position.
[0038] [0038] Figure 3 is a bottom perspective view of the dressing and packaging assembly of Figure 1 with an open cover in a configuration of about 360 degrees from the closed position.
[0039] [0039] Figure 4 is a top perspective view of the dressing and packaging assembly of Figure 1 with an open cover in a configuration of about 360 degrees from the closed position.
[0040] [0040] Figure 5A is a schematic bottom view of the dressing and packaging assembly in the position illustrated in Figure 3.
[0041] [0041] Figure 5B is a cross section of Figure 5A along lines C-C.
[0042] [0042] Figure 5C is a cross section of Figure 5A along lines D-D.
[0043] [0043] Figure 6 illustrates a variation of a dressing and packaging assembly.
[0044] [0044] Figure 7 is a perspective view of a dressing and packaging assembly with a cover in an open position 90 degrees from a closed position.
[0045] [0045] Figure 8 is a final schematic view of the dressing and packaging assembly of Figure 7 in a tensioned configuration with the cover open at about 360 degrees from a closed configuration.
[0046] [0046] Figure 8A is an expanded view of section A of Figure 8.
[0047] [0047] Figure 8B is an expanded view of section B of Figure 8.
[0048] [0048] Figure 9 is a top perspective view of the dressing and packaging assembly of Figure 7 after release.
[0049] [0049] Figure 10 is a perspective view of another example of a dressing and packaging assembly in a closed configuration.
[0050] [0050] Figure 11 is a perspective view of the dressing and packaging assembly of Figure 10 with a cover in a configuration approximately 90 degrees from the closed configuration.
[0051] [0051] Figure 12A is a top perspective view of the dressing and packaging assembly of Figure 10 with a cover in a configuration approximately 360 degrees from the closed configuration.
[0052] [0052] Figure 12B is a bottom perspective view of the dressing and packaging assembly of Figure 10 with a cover in a configuration approximately 360 degrees from the closed configuration.
[0053] [0053] Figure 13 is a top view of a packaging device in an open configuration.
[0054] [0054] Figure 14 is an expanded perspective view of a packaging device in an open configuration.
[0055] [0055] Figure 15A is a perspective view of a variation of the dressing and packaging assembly in a non-tensioned configuration.
[0056] [0056] Figure 15B is a bottom perspective view of the dressing and packaging assembly of Figure 15A in a tensioned configuration.
[0057] [0057] Figure 15C is a bottom perspective view of the dressing and packaging assembly of Figure 15A after removing the cover from the carrier, support or base.
[0058] [0058] Figure 15D is a top perspective view of the device in Figure 15A after removing the cover from the charger, support or base.
[0059] [0059] Figure 15E is a top perspective view of the device in Figure 15A after removing the charger, bracket or base.
[0060] [0060] Figure 15F is a perspective view of a tensioned dressing after being separated from the adhesion sheets.
[0061] [0061] Figure 15G is a perspective view of a dressing assembly with adhesion sheets.
[0062] [0062] Figure 15H is a perspective view of the dressing assembly of Figure 15G with a detached adhesion blade.
[0063] [0063] Figure 15I is a perspective view of the dressing assembly of Figure 15G with an adhesion blade removed.
[0064] [0064] Figure 15J is a cross section of the dressing assembly with adhesion sheets from Figure 15G.
[0065] [0065] Figure 16A is a perspective view of a variation of a dressing assembly with removable adhesion blades.
[0066] [0066] Figure 16B is a perspective view of the dressing assembly of Figure 16A with a detachable removable adhesion blade.
[0067] [0067] Figure 16C is a perspective view of the dressing assembly of Figure 16A with an adhesion blade removed.
[0068] [0068] Figure 16D is a cross-section of the dressing assembly with adhesive sheets from Figure 16A.
[0069] [0069] Figure 17A is a perspective view of a variation of a dressing assembly with removable adhesion blades.
[0070] [0070] Figure 17B is a perspective view of the dressing assembly of Figure 17A with a detachable removable adhesion blade.
[0071] [0071] Figure 17C is a perspective view of the dressing assembly of Figure 17A with an adhesion blade removed.
[0072] [0072] Figure 17D is a cross-section of the dressing assembly with adhesive sheets from Figure 17A.
[0073] [0073] Figure 18A is a perspective view of a variation of the dressing and packaging assembly in a non-tensioned configuration.
[0074] [0074] Figure 18B is a top perspective view of the Figure 18A device in a tensioned and folded configuration.
[0075] [0075] Figure 18C is a perspective view of the underside of the device in the tensioned and folded configuration of Figure 18B.
[0076] [0076] Figure 18D is a top perspective view of the Figure 18A device in a tensioned and folded configuration while an adhesion blade is highlighted.
[0077] [0077] Figure 18E is a top perspective view of the device in Figure 18A with a first side of the dressing assembly detached from the magazine and the cover removed.
[0078] [0078] Figure 18F is a top view of the device in Figure 18A with the dressing assembly detached from the magazine.
[0079] [0079] Figure 18G is a top perspective view of the device in Figure 18A with the charger detached and removed.
[0080] [0080] Figure 18H is a perspective view of the device in Figure 18A with the dressing being separated from the adhesion sheets.
[0081] [0081] Figure 18I is a perspective view of the device in Figure 18A with the dressing separate from the adhesion sheets.
[0082] [0082] Figure 18J is a side view of the device in Figure 18A.
[0083] [0083] Figure 19A is a perspective view of a variation of a dressing and packaging assembly device.
[0084] [0084] Figure 19B is a top view of a non-tensioned configuration of a dressing assembly in Figure 19A.
[0085] [0085] Figure 19C is a top view of a tensioned and attached configuration of the dressing assembly in Figure 19B.
[0086] [0086] Figure 19D is a top view of a tensioned and detached configuration of the dressing assembly in Figure 19B.
[0087] [0087] Figure 19E is a top view of a dressing from Figure 19B.
[0088] [0088] Figure 20A is a top view of a variation of a dressing loader, support, base tensioning device or applicator.
[0089] [0089] Figure 20B is a side view of the dressing loader, support, base tensioning device or applicator of Figure 20A in a first configuration.
[0090] [0090] Figure 20C is a side view of the dressing loader, support, base tensioning device or applicator of Figure 20A in a second configuration.
[0091] [0091] Figure 21A is a perspective view of a variation of a dressing loader, support, base tensioning device or applicator.
[0092] [0092] Figure 21B is a top view of the dressing loader, support, base tensioning device or applicator of Figure 21A.
[0093] [0093] Figure 21C is a side view of the dressing loader, support, base tensioning device or applicator of Figure 21A.
[0094] [0094] Figure 21D is a top view of the dressing loader, support, base tensioning device or applicator of Figure 21A in a flexed configuration.
[0095] [0095] Figure 21E is a cross section of Figure 21D along lines A-A.
[0096] [0096] Figure 22A is a perspective view of a variation of a dressing and packaging assembly in a non-tensioned configuration.
[0097] [0097] Figure 22B is a perspective view of a variation of a dressing and packaging device in a tensioned configuration. DETAILED DESCRIPTION OF THE INVENTION
[0098] [0098] Previous attempts to treat scars and keloids included surgery, silicone dressings, steroids, X-ray irradiation and cryotherapy. Each of these techniques has disadvantages. Perhaps the biggest disadvantage is that to start with none of them effectively prevents or improves the formation of scars or keloids. That is, these techniques were primarily used to treat scars after they are well established.
[0099] [0099] The reduction of exogenous and / or endogenous stress in the vicinity of the wound can improve the formation of scars, hypertrophic scars or keloids. The mechanical environment of an injury can be an important factor in the tissue response to that injury. The mechanical environment includes exogenous stress (that is, physiological stress that includes stress transferred to the wound through muscle action or physical movement of the body) and endogenous stress (that is, dermal stress that originates from the physical properties of the skin itself, including stress induced at the wound site as a result of edema or skin contraction). The devices, dressings, kits and methods described herein can control or regulate the mechanical environment of a skin including, without limitation, the mechanical environment of a wound. The devices, dressings, kits and methods described here can also control or regulate the mechanical environment to improve the formation of scars and / or keloids. The mechanical environment of the skin can include stress, tension or any combination of stress and tension. The control of the mechanical environment of a wound can be active or passive, dynamic (for example, by applying oscillating stress) or static. The stresses and strains that act on the wound can involve the skin layers, for example, the external stratum corneum, the epidermis and dermis, as well as the underlying layers of connective tissue, for example, subcutaneous fat. The devices and methods described here can protect a wound from its mechanical environment. The term "protect" is intended to encompass the reduction of stress suffered by the wound, as well as the provision of a physical barrier against contact, contaminants, and the like. The devices and methods described herein can protect a wound by protecting the wound and surrounding tissues from endogenous stress and / or exogenous stress. In this way, the devices and methods described here can reduce the stress suffered by a wound and surrounding tissues to a lesser level than that suffered by normal skin and tissue. The reduction of exogenous and / or endogenous stress in the vicinity of the wound can improve the formation of scars, hypertrophic scars or keloids.
[0100] [00100] The external mechanical environment of a cell can trigger biological responses within the cells and change the cell's behavior. Cells can perceive and respond to changes in their mechanical environment using integrin, an integral membrane protein in the plasma membrane of cells, and intracellular pathways. Intracellular pathways are initiated by receptors attached to cell membranes and the cell membrane that can perceive 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. These secretions can act on the cells that secrete them (intracrine), on the cells that secrete them (autocrine), on the cells that surround the cells that secrete them (paracrine), or they can act at a distance from the secretion point (endocrine). Intracrine interference can alter cell signaling, which in turn alters the cell's behavior and biology, including recruitment of cells to the wound, proliferation of cells in the wound, and cell death in the wound. In addition, the extracellular matrix can be affected.
[0101] [00101] As noted above, the wound healing process can be characterized in three stages: the initial inflammatory phase, the proliferative phase and remodeling. The inflammatory phase occurs immediately after injury and typically lasts about two days to a week. Blood clotting occurs to stop 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 further contract the wound. In the remodeling phase, randomly oriented collagen is organized and cross-linked along the skin's tension lines. Cells that are no longer needed can undergo apoptosis. The remodeling phase can continue for many weeks or months, or indefinitely after the injury. The scars typically reach about 75-80% of the resistance to breakage of normal skin about 6-8 weeks after the injury. In general, scars typically have a triangular cross-section. That is, a scar is usually smaller in volume near the skin's surface (ie, stratum corneum and epidermis) and increases in volume as it progresses within deeper layers of the dermis.
[0102] [00102] There are three common end results for a wound healing process. First, a normal scar can result. Second, a pathological increase in the formation of scars can result, for example, the formation of a hypertrophic scar or a keloid. Third, the wound may not heal completely and become a chronic wound or ulcer. The devices, kits and methods described here can improve the formation of any type of scar. In addition, the devices, kits and methods described here can be adapted for different wound sizes and different skin thicknesses, for example, the devices can be configured for use in different areas of the body. In addition, the devices, kits and methods described herein can be adapted to improve the formation of scars on any type of skin, for example, body location, age, race or condition.
[0103] [00103] Without attaching to any particular theory, we believe that the mechanical tension that acts on a wound or incision early in the proliferative phase of the wound healing process can inhibit cellular apoptosis, leading to a significant accumulation of cells and matrix and , in this way, to increase the healing or the production of hypertrophic scars. Considering the underlying similarities between hypertrophic scars and keloids in relation to excessive matrix formation, we believe that the devices and methods described here can also be useful in preventing and treating keloids by reducing or neutralizing at least part of the tension that may be acting on the wound or incision. This tension may be exogenous and / or endogenous tension, and may include, without limitation, the tension of the intrinsic tension forces found in normal intact skin tissue.
[0104] [00104] Several wound dressings have linings, adhesive linings and / or packaging that are removed before applying a wound dressing. Many existing dressings can be difficult to orient and apply and may have a tendency to curl and adhere to themselves.
[0105] [00105] The devices, kits and methods described herein can treat the skin in one location of the skin ("device for skin treatment"), including without limitation, improving the formation of scars in wound sites by pressing or tensioning in a controllable manner of the epidermis and deeper layers of dermal tissue in or near a skin site, that is, in a wound or adjacent to it or an individual's skin treatment site, thereby reducing tensile or compressive stress on the skin. skin site. Stress at the skin site can be reduced to levels below those experienced by normal skin and tissue. Stress or tension can be applied to the surrounding tissue in one, two or more directions to reduce endogenous or exogenous stress at the skin site in one, two or more directions. In this way, the devices and methods described here can reduce the stress suffered by the skin and / or a wound and surrounding tissues in order to treat an individual. The device can also help prevent or reduce the incidence of wound dehiscence.
[0106] [00106] The devices, kits and methods described here can provide a package and / or applicator for a dressing. According to a variation, the package and / or applicator is configured to provide quick or easy preparation and / or application of a dressing. Although some examples specifically presented here refer to a package that also acts as a tensioning device to pre-tension a dressing, other dressings that are not pre-tensioned and / or tensioned before application can be supplied according to one or more variations or modalities. The package can also operate as an applicator in which one or more elements of the package can be used to position and / or apply the dressing to an individual's skin.
[0107] [00107] The devices, kits and methods described here can be for the preparation and / or application of a dressing. Such preparation may include, without limitation, for example, removing an adhesive liner, tensioning or stretching a dressing, orienting a dressing for application and / or applying a medication or other material to a portion of the dressing before application.
[0108] [00108] Coatings, adhesive linings or release layers, and / or other packaging, can provide some structural stability to a flexible wound dressing. However, when removed, the flexible wound dressing can be a little difficult to use, as it can bend and adhere to itself or the user, or otherwise be difficult to position on the wound. In addition, the act of pulling or removing the lining and reorienting the dressing to the patient can increase the tendency to bend or collapse. In addition, because of the folding or collapse of the dressing, during the removal of the adhesive 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.
[0109] [00109] According to another variation, a package or applicator is configured to provide support for the dressing after the dressing is prepared and while the dressing is applied to an individual. According to some variations, a coating provides support or structural stability of the dressing during and / or after an adhesive liner is released. According to some variations, a dressing and packaging are configured to be pre-oriented in a position facing a wound, that is, 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 guide and / or apply the device to an individual's skin.
[0110] [00110] According to some variations, the dressing pack 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 can be pre-tensioned and attached to a dressing carrier, support, base tensioning device or applicator, for example, as shown in US Provisional Order No. 61 / 512.340 deposited in 17 July 2011 and incorporated herein in full by reference. One or more dressing release mechanisms described herein can be used with a dressing loader, support, base tensioning device or applicator.
[0111] [00111] In some additional variations, the dressing or one or more adhesive regions of the dressing can be released, that is, separated, from the liner by opening a package or applicator. According to some variations, a book-type package is provided with a cover and a base to which a dressing is removably attached. When or as the cover is opened, the liner can be manually or automatically released from the dressing adhesive. 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 can be configured to provide structural support to the dressing while the liner is removed and / or while the dressing is applied to an individual's skin.
[0112] [00112] According to some variations, the packaging, tensioning device, dressing loader, support, base or applicator can also comprise an opening, a window or a transparent or semi-opaque portion through which a wound, incision or other location can be visualized as the dressing is applied to the skin. According to some variations, the window guides the application of a dressing in such a way that there is an optimal or desired distance between the wound and the edges of the dressing and / or in such a way that the dressing is in an optimal location for stress reduction of the skin.
[0113] [00113] According to some variations, the applicator, tensioning device, packaging or loader, support or base can provide varied or variable flexibility to allow the dressing to be modeled when applied to various locations or contours of the body.
[0114] [00114] According to some variations, a package or applicator is more rigid or provides sufficient column strength in at least one first direction to support a dressing, while being relatively more flexible and less rigid at least in a second direction to provide a more suitable application to a curved or shaped surface of an individual's skin or to allow 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 loader, bandage support or base is sufficiently rigid or supports a bandage while allowing the bandage to be modeled. 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 allow the packaging / applicator and / or the dressing while providing sufficient support of the dressing during application. According to some variations, the segments are coupled to the adjacent segments by means of a flexible material, for example, a low density polyethylene (LDPE) material, or an adhesive compound and a thinner and more flexible substrate. Alternatively, the segments can be formed as a structure by fabricating a substrate with cutouts, crevices, grooves, scratches or other openings or variations in the thickness of the substrate at different locations.
[0115] [00115] The package, applicator, tensioning device, or dressing loader may have elements or characteristics that 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, flexible elements can limit flexibility when the device is being tensioned and allow flexibility when the device is being applied to the skin. Each of the elements may allow more bending in a different direction than one or more of the other elements. Flexible elements can be straight or shaped according to a desired application or placement location.
[0116] [00116] According to variations, flexible elements are provided in combination with support elements that provide sufficient support to allow a user to keep the dressing in a tensioned configuration. According to variations, one or more elements can be provided to maintain a tensioned dressing in a tensioned configuration, for example, a fixing element that secures the dressing in a tensioned configuration until it is applied to an individual and is released from the carrier , support, base tensioning device or applicator. For example, after tensioning the dressing, the dressing can be adhered to 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, tensioning device base or applicator or assembly.
[0117] [00117] According to some variations, the applicator can also be used to help reduce bleeding, for example, by allowing the application of a compressive force using a support structure during or after the device is applied. One or more hemostatic or coagulant agents can be applied or otherwise integrated into the dressing to help reduce bleeding. Potential agents include chitosan, calcium-loaded zeolite, microfibrillar collagen, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetyl glucosamine, thrombin, factor coagulation (or factors) (eg, II, VII, VII, X, XIII, von Willebrand factor), procoagulants (eg, propyl gallate), antifibrinolytics (eg, epsilon aminocaproic acid), and the like. In some variations, the agents can be lyophilized and integrated into the dressing and activated after contact with blood or other fluid. In some additional variations, an activating agent can be applied to the dressing or the treatment site before the dressing is used on the individual. In still other examples, the hemostatic agent can be applied separately and directly to the wound before applying the dressing, or after application to the dressing by means of a catheter or tube. The devices may also comprise one or more other active agents that may be useful in assisting in some aspect of the wound healing process. For example, the active agent can be a pharmaceutical compound, a protein (for example, a growth factor), a vitamin (for example, vitamin E), or combinations of these. An additional example of such drugs may include, without limitation, various antibiotics (including, without limitation, cephalosporins, bacitracin, polymyxin B sulfate, neomycin, polysporin), antiseptics (eg, iodine solutions, silver sulfadiazine, chlorhexidine), antifungals ( eg nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (eg VEGF) and other treatments (eg botulinum toxin). Of course, devices can comprise more than one drug or agent, and devices can deliver one or more drugs or agents.
[0118] [00118] According to a variation, the applicator and / or packaging can support or be rigid enough to contain the form of a dressing so that it is easy to handle. According to a variation, the applicator may be sufficiently wider and / or longer or have an area sufficiently larger than a dressing so that it can provide sterile application and / or application with one hand. According to variations, a support structure for a dressing is provided. According to a variation, a margin is provided as a support structure between the dressing or adhesive of the dressing and one or more portions of the edge of the support structure. These margins provide a supported edge or area for grabbing or manipulating the dressing or its carrier, base or support, without requiring or creating a greater likelihood of the user's inadvertent contact with the adhesive.
[0119] [00119] According to some variations, the package or applicator can also be used to tension a dressing before application to provide a dressing configured to improve scar or keloid formation.
[0120] [00120] Here are described devices that can be used to improve the formation of scars and / or keloids on a skin or wound site. The scars can be any type of scar, for example, a normal scar, a hypertrophic scar, etc. In general, devices can be configured to be removably attached to a skin surface near a wound. The devices can protect the skin or wound from endogenous stress and / or exogenous stress. In some variations, devices can protect the skin or wound from endogenous stress without affecting exogenous stress on the skin or wound, for example, devices that modify the elastic properties of the skin, etc. In other variations, the devices can protect the skin or wound from exogenous stress without affecting endogenous stress in the wound. These variations may include situations in which the musculature and the skin or tissue of the surrounding wound have been paralyzed, for example, through the use of botulinum toxin or the like. In yet other variations, the devices protect the skin or wound from both endogenous and exogenous stress.
[0121] [00121] The devices or dressings described herein can treat the skin in one location of the skin including, without limitation, to improve the formation of scars in wound sites by controllably pressing or tensioning the epidermis and deeper layers of dermal tissue on or near a skin site, thereby reducing tensile or compressive stress on the site of the skin itself. Stress at the skin site can be reduced to levels below those experienced by normal skin and tissue. Stress or tension can be applied to the 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 can also be configured to resist or reduce the rate of skin stripping or blistering by applying tension to the incision site. For example, stretching of the adhesive regions, when applied to the skin surface, can result in increased tissue density under the adhesive region. This can be the result of generally flat, 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 instances, this tissue compression may reduce the risk of tissue stripping and / or blistering of the skin with direct contact with the adhesive, in contrast to the "strapping" of the bandage, where one end of a bandage is adhered to the skin and then tensioned or pulled through a wound before the other end is attached to the skin on the opposite side of the wound. The "lashing" of the bandage, while generating tension in the bandage during application, can simultaneously generate relatively high tissue tension at the first site of adhesion. This elevated tissue tension then decreases when the bandage is attached to the skin at a second site of adhesion, as the high peak stresses are redistributed across the skin under the bandage. In contrast, when a pre-tensioned bandage is applied to the skin, little or no tension can be transferred or generated on the skin, as the adhesive regions are applied at the desired locations. When the pre-tensioned bandage is allowed to relax, however, the tension (or peak tension) in the skin can be increased. In this way, with a pre-tensioned bandage, temporary high tissue tension can be avoided or otherwise reduced during the application procedure. In other variations, however, the dressing can also be applied to the skin by lashing, or by a combination of pre-tensioning and lashing.
[0122] [00122] The dressing may comprise an elastic member, for example, a sheet of elastic material. The elastic material of the dressing may comprise a single layer of material or multiple layers of the same or different materials. The material can have any of several configurations, including a solid, foam, lattice or braided configuration. The elastic material can be a biocompatible polymer, for example, silicone material, polyurethane, TPE (thermoplastic elastomers), synthetic rubber or copolyester. The material of the polymer sheets can be selected to give the dressings sufficient load-bearing capacity to achieve the desired recoverable stresses, and to avoid unwanted amounts of deformation of the dressings over time. In some variations, the thickness through the dressings is not uniform, for example, the thickness through the dressing can be varied to change the stiffness, load-carrying capacity or recovery stresses in selected orientations and / or locations. The elastic material of the exemplary dressing can have a thickness in the range of about 50 micrometers to 1 mm or more, about 100 micrometers to about 500 micrometers, about 120 micrometers to about 300 micrometers or, in some variations, about 200 micrometers to about 260 micrometers. Exemplary dressings have an edge thickness of about 500 micrometers or less, 400 micrometers or less, or about 300 micrometers or less may exhibit a lower risk of skin separation due to inadvertent elevation when inadvertently rubbed against clothing or objects. In some variations, dressings are tapered close to the edges to reduce thickness. A tapered edge can also improve peak tension forces acting on skin tissue adjacent to the adhesive edges of the dressing. This may or may not reduce the risk of skin blistering or other stress-related skin trauma. In other variations, the edges of the dressing may be thicker than the middle portion of the dressing. It is hypothesized that, in some configurations, a thicker bandage edge could provide a relative shift into the location of peak tension forces acting near the bandage edge, compared to uniformly thick bandages. The elastic material can have a load per width of at least 0.35 Newton per mm at a projected stress of 60% or a load per width of at least 0.25 Newton per mm at a projected stress of 45%. The elastic material can have a load per width of at most about 2 Newtons per mm at the projected stress of about 45% to 60%, about 1 Newton per mm at the projected stress of about 45% to 60%, about 0.7 Newtons per mm at the projected stress of about 45% to 60% or at most about 0.5 Newton per mm at the projected stress of about 45% to 60%. The elastic material of the system can have a load by width that does not decrease from a projected stress of 0% to 60%, a load graph by width that increases linearly from a projected stress of 0% to 60% or a load graph by width that is not convex from a projected tension of 0% to 60%. The elastic material may comprise an adhesive configured to maintain substantially constant stress in the range of 200 kPa to about 500 kPa for at least 8 hours when tensioned to a projected tension of about 20% to 30% and attached to a surface. The elastic material may comprise an adhesive configured to maintain a substantially constant stress in the range of 200 kPa to about 400 kPa for at least 8 hours when tensioned to a projected tension of about 20% to 30% and attached to a surface. Substantially constant stress can vary by less than 10% over at least 8 hours, or by less than 5% over at least 8 hours.
[0123] [00123] Although the disclosed 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 can be any of several lengths and widths, and can comprise any one of several other formats. In addition, the corners of the dressing can be square or rounded, for example. The lengths and / or widths of an exemplary dressing can 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 other variations, about 50 mm to about 100 mm. In some variations, the ratio of the maximum dressing dimension (for example, its length) to an orthogonal dimension to the maximum dimension (for example, width), excluding the minimum dressing dimension (for example, thickness), may be in the about 1: 3, about 1: 2, about 1: 1, about 2: 1, about 3: 1, about 4: 1, about 5: 1, about 6: 1, about 7: 1, about 8: 1, about 9: 1 or about 10: 1 or more. In some variations, the tension axis of the dressing in use may be oriented with respect to the maximum dimension or with the orthogonal dimension up to the maximum dimension. In some variations, the final compressive stress and tension imposed on the skin by the elastic material may be the result of the dynamic balance between the stress stress on the skin and the elastic material of the dressing. The skin at the skin site typically comprises an inherent tension that stretches the incision site, whether or not any tissue has been removed from the skin site. The elastic material and the adhesive region can be configured to be applied to a location of the skin in such a way that, when the dressing is stretched to a particular tension and then adhered to the incision site, the stress stress on the dressing is transferred to the location incision to compress the tissue directly under the dressing along a tangential axis to the surface of the skin, and the stress and tension imposed on the location of the skin have a liquid or resultant orientation or axis that are also generally tangential or flat with the material elastic and / or the external surface of the skin location, with an axis similar to the orientation or tension stress axis in the dressing. The tension in the dressing will relax to a level of tension that maintains balance with the increased tension in the skin adjacent to the dressing. The application of the dressing to the location of the skin may involve placing the dressing without overlapping or wrapping itself, for example, in which only adjacent regions of the dressing are interconnected and in which non-adjacent regions of the dressing are not interconnected. The actual amount of stress and tension imposed on the skin can vary, depending on the particular person, the location of the skin, the thickness or various mechanical characteristics of the skin layers (eg, epidermis, dermis or underlying connective tissues) and / or the degree of pre-existing healing, for example. In some additional variations, the wound treatment dressing can be selected or configured for use at a specific body location, for example, the scalp, forehead, cheek, neck, upper back, lower back, abdominal region, upper torso (including, without limitation, breast folds), shoulder, arm, forearm, palm regions, back of hands, fingers, thigh, legs, back or plantar surface of the feet and / or toes . When applicable, some regions of the body can also be delineated in anterior, posterior, medial, lateral, proximal and / or distal regions, for example, the arms and legs.
[0124] [00124] The dressing can be configured to impose a tension on the skin in the range of about 10% to about 60% or more, in other configurations about 15% to about 50% and, still in other configurations, about 20% to about 30% or about 40%. To obtain the desired degree of tension on the skin, the dressing can be configured to be subjected to an elastic tension 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 can comprise any of several elastic materials, including, without limitation, silicones, styrenic block copolymers, natural rubbers, fluorelastomers, perfluoroelastomers, polyether block amides, thermoplastic elastomers, thermoplastic polyurethane, polyisoprene, polybutadiene, and the like. The exemplary dressing material can 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 from MED 82-5010-05 by NUSIL TECHNOLOGY LLC (Carpinteria, CA). Other examples of suitable materials are described in U.S. Order No. 11 / 888,978, which was previously incorporated by reference in its entirety.
[0125] [00125] When the dressing is applied to a skin location and it is allowed to recover at least partially its base configuration, the level of recovery or tension balance level in the dressing can be in the range of about 4% to about 60% or more, in other configurations about 15% to about 50% and, still in other configurations, about 20% to about 30% or about 40%. The ratio between the initial projected stress placed on the dressing prior to recovery and the resulting planned compressive stress on the skin can vary, depending on the type and location of the skin, but in some instances it can be about 2: 1. In other examples, the ratio can be in the range of about 4: 1 to about 5: 4, about 3: 1 to about 5: 3, or about 5: 2 to about 2: 1. These characteristics of skin tension can be determined with respect to a position of the reference body or body part, for example, anatomical position, to facilitate reproducible measurements. The particular degree of stress can be characterized as a projected stress or a real stress, but it may or may not be calculated on the basis of or converted from the other stress type (for example, the stress can be based on a 45% projected stress) which is converted to a real voltage).
[0126] [00126] In some additional variations, one or more characteristics of the elastic material can correspond to several characteristics in the stress / tension curve of the material. For example, the projected and actual stress / tension curves for a specific example of the dressing comprise a material that exhibits a projected stress of about 1.2 MPa to about 60% of the projected stress, but in other examples, stress can 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 reducing or relieving the stress of the dressing, the material can be configured with a projected stress of about 380 KPa at about 40% of the projected tension, but in other examples, the projected stress when the material is discharged to a tension about 40% can be in the range of about 300 KPa to about 700 KPa, about 325 KPa to about 600 KPa, about 350 KPa to about 500 KPa or about 375 KPA to about 425 KPa. When the material is discharged to a projected stress of about 30%, the material exhibits a projected stress of about 300 KPa, but in other examples, the projected stress when discharging the material to a stress of about 30% can be in the range of about 250 KPa to about 500 KPa, about 275 KPa to about 450 KPa, about 300 KPa to about 400 KPa or about 325 KPA to about 375 KPa. When discharging to a projected stress of about 20%, the material may have a projected stress of about 100 KPa, but in other examples, the projected stress reduction of up to 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 can be configured to achieve at least a specific range or projected stress level at each of the specified projected stress levels described above, but in other examples, the material can be configured to reduce stress levels maximum projected, for example, up to about 30% or about 40%.
[0127] [00127] In some examples, certain portions of the stress / tension curve may have a particular morphology. For example, for a particular maximum stress level, the discharge curve can generally be linear over the corresponding actual stress / stress curve. In an example using a dressing described here, up to an actual tension of about 45%, the discharge curve had a generally linear configuration. In other examples, the configuration can be linear only along a portion of the discharge curve or it can be curved along the entire discharge curve. When the discharge curve is non-linear, the discharge curve can be convex, concave or both. In addition, in some instances, the tangent line of the discharge curve (that is, the line between the two triangles) can also generally be collinear.
[0128] [00128] In some variations, the elastic material comprises a material that has an elastic modulus E of at least about 1 MPa, about 1.5 MPa, about 2 MPa, about 2.5 MPa, about 3 MPa , about 3.5 MPa, about 4 MPa, about 5 MPa, about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa, or at least about 10 MPa or more. The elastic modulus E of the material cannot be 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.
[0129] [00129] In addition to the absolute stress levels at certain stress levels described above, the material can also be characterized with respect to the ratio between: a) the stress to obtain a particular stress during loading, and b) the stress at the same stress during unloading. For example, the material can have a ratio of at least 4: 1 to about 3: 2 at each of the stress levels of 20%, 30% and 40%, but in other examples, the material can exhibit these proportions only at voltage levels of 20%, 30% or 40% or as much as 20% as 30%, but not 40% or as much as 30% as 40%, but not 20%. In other examples, the ratio in one, some or all of the voltage levels can be in the range of about 3: 1 to about 2: 1, or about 5: 2 to about 2: 1.
[0130] [00130] In some examples, the elastic material of the dressing can be configured under test conditions to obtain a stable stress level at a constant tension, for example, the material exhibits a limited amount of stress relaxation over a period of time. particular time and at a particular tension level. The time period can be at least about 8 hours, about 12 hours, about 18 hours, about 24 hours, about 36 hours, about 48 hours, about 72 hours, about 4 days, about 4 days, about 5 days, about 6 days, or about the week or more. The tension level can be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70% or about 80% or more. The stress of the exemplary dressing over several time curves can be configured to maintain a projected stress of around 300 KPa at a projected stress of about 30% with no 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. Stresses at a 10% tension, a 20% tension and a 40% tension can be minor or major.
[0131] [00131] In some variations, the elastic material or dressing can be configured under test conditions to maintain a minimum level of particular stress when kept under constant tension over a particular period of time. In an example to assess a coating material's ability to maintain stress and tension on the skin over time, projected stresses were measured while each coating material was tensioned up to 60% at a rate of 100 micrometers per second and maintained for 10 minutes, and then reduced to a voltage of 30% at a rate of 100 micrometers per second and maintained for 9 hours. For example, the exemplary dressing is capable of maintaining a projected stress level of around 350 KPa at a projected tension of 30%. In some other examples, the minimum stress level can be about 100 KPa, about 120 KPa, about 140 KPa, about 160 KPa, about 180 KPa, about 200 KPa, about 220 KPa, about 240 KPa, about 260 KPa, about 280 KPa, about 300 KPa, about 320 KPa, about 340 KPa, about 360 KPa, about 360 KPa, about 380 KPa, about 400 KPa, about 420 KPa, about 440 KPa, about 460 KPa, about 480 KPa, about 500 KPa, about 600 KPa, about 700 KPa, about 800 KPa, about 900 KPa or about 1000 KPa or more. The constant voltage level may be different in another 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 length of time over which the dressing is able to maintain a stress level can be at least about 2,000 seconds, about 3,000 seconds, about 4,000 seconds, about 5,000 seconds, about 6,000 seconds, about 7,000 seconds, about 8,000 seconds, about 9,000 seconds, about 10,000 seconds, about 20,000 seconds, about 30,000 seconds, about 40,000 seconds, about 50,000 seconds, about 60,000 seconds, about 70,000 seconds, about 24 hours, about 36 hours, about 48 hours, about 72 hours, about 4 days, about 5 days, about 6 days, about 7 days, about 10 days, about 2 weeks, about 1 month or more. In some variations, the dressing, elastic material and / or adhesive material is configured to exhibit less than about a 15% change in the level of stress or tension over a particular period when applied to a skin surface or test surface. In other examples, the degree of change can be about 12%, about 10%, about 8%, about 6%, about 5%, about 4%, about 3% or about 2% or less. Stress or tension can be projected stress or tension, and / or real stress or tension.
[0132] [00132] The adhesive used can be, for example, a pressure activated adhesive (PSA), for example, a PSA made of silicone, acrylic, copolymer in styrene block, vinyl ether, nitrile or another PSA. In other variations, a non-pressure sensitive adhesive may be used including, without limitation, a heat-cured or light-cured adhesive. The pressure sensitive adhesive can be made, for example, from pressure sensitive adhesives based on polyacrylate, based on polyisobutylene, based on silicone, synthetic rubber, acrylic and polyisobutylene (PIB), hydrocolloid, and the like. The "T" peeling release force and the force to stick to the blunt probe of the adhesive can be measured by a standardized test method, for example, ASTM D1876 and ASTMD2979 or another appropriate method. In some variations, the "T" peeling release force or test value to stick to the blunt adhesive probe is set to hold 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 can 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 (for example, as measured by the "T" peeling release force or by the test value for sticking to a blunt probe) may vary, depending on the degree of tension placed on the skin or incision site, and in some variations, these time periods can be based on an average skin tension of about 10%, about 20%, about 30%, about 40% or about 50% or more. In some variations, the adhesive may have a "T" peeling 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 greater. In some additional variations, the "T" peeling release force cannot be greater than about 1,000 kg / m, about 900 kg / m, about 800 kg / m, about 700 kg / m, about 600 kg / m, about 500 kg / m, about 400 kg / m or about 300 kg / m. The test value for sticking to a blunt adhesive probe can be at least about 0.50 kg, about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg or about 0.75 kg or greater, and cannot be greater than about 1 kg, about 0.9 kg, about 0.8 kg, about 0.7 kg, or about 0.6 kg . The "T" peeling release force and the force to stick to a blunt probe can be measured by a standardized test method, for example, ASTM D1876 and ASTMD2979 or another appropriate method. Other features or variations of the device are described in U.S. Order No. 11 / 888,978, filed on August 3, 2007, hereby incorporated in its entirety by reference.
[0133] [00133] Release liners can comprise any of several 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 (or materials) of the device. For example, for a silicone adhesive, a fluoropolymer-treated polyester film can be used, and for a pressure sensitive acrylic adhesive, a silicone-treated polyester film or Mylar or silicone-treated craft paper can be used. In variations in which the device has multiple separate adhesive regions, separate release liners can be provided for each region, or some regions can be covered by the same release liner.
[0134] [00134] Examples of dressings, applicators or tensioning devices that may be used in the devices, kits or methods presented herein may include those provided in US Order No. 12 / 854,859 filed on August 11, 2010, the disclosure of which is here incorporated in its entirety by reference, without limitation.
[0135] [00135] The packaging assembly, applicator and / or tensioning device may comprise a tensioning structure, and a first adhesion portion configured to be releasably attached to a dressing and a second adhesion portion configured to attach in a manner releasable to the dressing, in which the tensioning structure can be configured to exert a separating force between the first adhesion portion and the second adhesion portion to cause tension in a dressing attached to the first and second adhesion portions. An elastic bandage can be configured to releasably attach to the first and second adhesion portions of a dressing and packaging assembly, and can include an adhesion structure or can be integral with adhesion structures of a packaging device, applicator or tensioning member. The tensioning structure can also act as an applicator device or can be configured to allow a user to apply a bandage to an individual's skin.
[0136] [00136] The adhesion structures of a packaging device, dressing assembly, dressing carrier, support, base, applicator, tensioning or stretching device can include any structures that are used to attach or attach an applicator, tensioning device or stretching to a dressing. A dressing may or may not have resources or adherence structures. Any of these adhesion features can be integral or include any of the adhesion structures or structures corresponding to the adhesion structures of the packaging, dressing and / or tensioning device.
[0137] [00137] In some variations, the assembly may comprise one or more mechanisms or elements configured to facilitate the separation, release, removal or detachment of the packaging dressing, applicator or tensioning device, other adhesion elements or other portions of the dressing assembly , including, without limitation, the separation devices and methods described herein. Release elements or release structures that can be released may include, without limitation, bags and flaps, hook and loop mechanism, hooks, angled bars, pivoting, scrolling, swinging or sliding features associated with or attached to the adhesion structures, adhesives, removable adhesives, adhesive tapes or other adhesive devices, tongue configurations, torn strings, towel bar, sliding pins, friction locks, cam locks, vacuum or suction devices, hitch connectors, carpet tacks, pressure connections or other connections, levers, latches, locking members, spring members, for example, or other mechanisms such as, for example, cutters or torn ropes or other structures or resources to facilitate the act of tearing, cutting or separating the adhesion structures or perforated elements or structures that can otherwise be separated, which allow the removal of the dressing from the applicator, packaging, other portions of the hand nage of dressing and / or adhesion structures, resources, elements or portions. They can be self-releasing latches or spring members. They can be triggered when a pressure member is applied to a skin treatment device before removing the applicator. They can be triggered manually.
[0138] [00138] As noted, a package or applicator, tensioning device and / or stretching device can be provided in the same manner to transmit a tension to a device for treating the skin with an external force and / or to maintain a tension transmitted to the skin. device for skin treatment. The packaging, applicator or tensioning device can be configured to pivot or rotate to tension the dressing. In some examples, the tensioning device can be configured to transmit and / or maintain a single predetermined or preset voltage or several predetermined or preset voltages, or predetermined maximum or minimum amounts of voltage. The features described here with respect to a packaging assembly, applicator or tensioning device can also be used on any device that is used to tension a dressing. A package or applicator, tensioning or stretching device that is described as being in a non-tensioned configuration is in a configuration in which a dressing can be un-tensioned or relatively less tensioned when attached to the packaging, applicator, tensioning or stretching device. A package, applicator, tensioning or stretching device that is described herein as being in a tensioned configuration, is in a configuration in which a dressing can be tensioned or relatively more tensioned when attached to the packaging, applicator, tensioning or stretching device, or with respect to a non-tensioned configuration, when applied to an individual's skin.
[0139] [00139] Packaging devices, applicators, tensioning devices and corresponding bonding features can be configured to provide tension in several directions or additional tension in a direction orthogonal to a dressing.
[0140] [00140] The profile of the packaging device, applicator, tensioning device and / or adhesion structure can be straight, curved or otherwise varied. For example, the shape of the elements of a device can be configured to match the shape of the individual's body area to which the skin treatment device is to be attached. A packaging device, tensioning device, applicator or elements thereof can be selected or configured to have a profile that has a desirable profile for a particular location or body profile where the skin treatment device is to be placed on an individual's skin. . A packaging device, applicator, tensioning device or elements thereof can be selected or configured to closely match a portion of an individual's body profile. The packaging device, applicator or tensioning device and / or an element or segment thereof can be curved, curved, flexible, foldable, malleable, deformable, modelable or movable to provide alternative shapes or profiles of an attached dressing. They can be relatively curved, curved, flexible, malleable, collapsible, deformable, modelable or mobile in at least one direction while being more rigid in the other direction.
[0141] [00141] Several locking, locking, fixing, attachment or detention mechanisms can be used to maintain the packaging, applicator or tensioning device in various configurations including, without limitation, untensioned, partially tensioned, tensioned configurations. Various locking, closing or detent mechanisms can be used to maintain a dressing in a variety of configurations, including non-tensioned, partially tensioned, tensioned configurations. By locking the package, applicator, tensioning device or dressing in a tensioned position, a predetermined tension of a certain dressing can be obtained. The predetermined amount of stress can be an absolute predetermined percentage of the stress or strength level that is independent of the shape and / or size of the treatment site. As an additional example, this absolute percentage of the tension or level of force may be independent of the minimum tension or force to achieve wound closure without suturing (for example, a relative tension or force to obtain opposition from the incision edges of a treatment site) ). In addition, the force required to achieve wound closure is not a predetermined tension or force, as the final tension or force level is not known until opposition to the edges of the incision is obtained.
[0142] [00142] With respect to Figures 1 to 5C, a variation of a dressing assembly and packaging 100 is illustrated. The package assembly 100 comprises an applicator and / or tensioning device of the book type 120, a dressing assembly 110 that includes a dressing 130 and a release 150 configured to release dressing 130 from the applicator and / or tensioning device 120.
[0143] [00143] The dressing 130 comprises an elastic sheet 131 with one or more adhesive regions comprising a layer of skin adhesive 135 on a first surface 135a. The adhesive used can be, for example, a suitable pressure-activated adhesive (PSA), or a non-pressure sensitive adhesive.
[0144] [00144] The packaging assembly 100, applicator or tensioning device 120 and / or dressing assembly 110 can be configured to pre-tension the dressing 130 and / or allow the transfer of the pre-tensioned dressing 130 to an individual's skin. The applicator and / or tensioning device 120 can also provide a convenient, rapid or sterile transfer of an adhesive portion of the dressing 130 to an individual's skin and / or wound site.
[0145] [00145] The device 120 comprises a cover 121 and a base 122. The dressing assembly 110 is removably attached or anchored to the device 120 which can act as a dressing carrier or a support. The cover 121 can be generally flat and includes sides 123, 124 with corresponding edges 123a, 124a along its length, and edges 121a at opposite ends. The carrier or dressing base 122 can be generally flat and includes sides 125, 126 with corresponding edges 125a, 126a along its length and edges 122a at opposite ends.
[0146] [00146] According to some variations, the cover and / or base 121, 122 or elements or segments thereof can be constructed to be sufficiently firm or rigid or less flexible in relation to an attached dressing to support an attached dressing until it is applied to an individual, as described with respect to the variations presented here. Such material may comprise, for example, a plastic, for example, polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or TEFLON®), LDPE, high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), polyvinyl chloride (PVC) or acrylic, nylon or cardboard. The elements or segments can be a laminate of a material, for example, a cardboard with solid bleach sulfate, with a layer of flexible material between the cardboard layers, for example, silicone, polyurethane, LDPE or a rubber material. The material can also be a metal, for example, malleable aluminum or stainless steel. The metal may comprise a sheet, ribbon, wire or other metallic form.
[0147] [00147] The cover 121 and base 122 are movably coupled, hinged or pivoting on the sides 123, 125. For example, a layer of material such as silicone, polyurethane, low density polyethylene or a material of rubber, can be glued to the cover and the base, flexibly attaching them together on the sides 123, 125. Alternative devices and methods can be used to couple the cover 121 and the base 122. For example, several structures or composite laminates can also be used. In addition, devices can also be constructed from a single substrate that provides flexibility in some selected regions and stiffness in others, or relative or absolute flexibility in a first direction with relative or absolute stiffness in a second direction that can be transverse to first direction. Although cover 121 and base 122 disclosed in Figures 1 to 5C generally have the same size and shape, in other examples, cover 121 and base 122 may be of different sizes and / or shapes. The cover 121 and / or base 122 can be warped, foldable, curved, flexible, malleable or modelable, allowing for a relatively more balanced placement in a location with a variable shape or curvature. For example, the cover and base 121, 122, as illustrated, are each divided into segments 127 along lengths that are flexible or movable with respect to adjacent segments, allowing flexibility of the device 120 along its length . The segments 127 can be constructed of a more rigid material that reduces flexion transversely or in another direction. Other configurations that vary the directions of stiffness and / or flexibility can be used. Configurations may include providing stiffness in a direction in which a dressing is tensioned that is sufficient to create and / or maintain a desired level of tension. The segments 127 can be coupled by a material, for example, an elastomer, for example, silicone, which flexibly retains the segments together in relationship to each other. Another construction can also be used to flexibly couple segments or other elements. The material that couples or joins the cover and base 121, 122 may or may not be continuous with the material that couples segments 127 to adjacent segments 127, and may or may not be attached to an entire side or to a portion of one side of the cover and base 121, 122. The various attached structures, for example, the segments and / or the cover and base and the coupling elements, can provide a structural support for the dressing loader to be manipulated by a user. Margins between at least a portion of the structural support elements, carrier or dressing of the dressing and the dressing can be provided at or near the edges 121a, 123a, 124a, 122a, 125a and / or 126a, for example, as further described herein . In some additional embodiments, the material that attaches the cover 121 and the base 122 can comprise a semi-rigid structure that can be tilted into an open or closed configuration, or a configuration between them. In yet other variations, cover 121 and base 122 can be attached by any of several joints, including, without limitation, one or more hinge joints with pins, rings attached to holes in cover 121 and base 122, or joints of the ball and socket type.
[0148] [00148] As exemplified in Figures 5A-5C, a variation of the construction of a package is shown. The cover 121 and base 122 comprise relatively firm or rigid elements, for example, beams 121a, 121b and beams 122a, 122b, respectively, which are attached in the form of a blade 128 in width, for example, silicone, polyurethane, polyethylene of low density or a rubber material that also flexibly couples the cover and base 121, 122 on the sides 123, 125. Segments 127 can have alternative shapes and constructions that couple segments 127 together. In this way, device 120 can be constructed to deform or curve to varying degrees or in multiple directions. Consequently, a device can be built to be used in a specific anatomical location or with varying sizes, or it can be built to be shaped for a particular situation or individual.
[0149] [00149] According to some variations, each of the cover 121 and the base 122 is constructed, at least in part, by a transparent, semi-opaque plastic material or another material that provides a fenestrated portion 159 through which a wound , incision or other location can be viewed for precise placement of dressing 130. Coverage 121 and base 122 may or may not comprise the same material. The elastic foil 131 and the adhesive layer 135 can also be sufficiently transparent to allow viewing through them. A more opaque material can be provided in portions of the material to create the contours of a window 159. Segments 127 can be transparent or semi-opaque to provide the window for viewing, positioning and / or centralizing the location of a wound or position in the skin with respect to dressing 130 or for positioning the wound within an optimal or more effective tension zone of the dressing. Contours or other markings can assist a user in placing dressing 130 in an appropriate position on the wound or incision.
[0150] [00150] The dressing 130 of the dressing assembly 110 has a first side or edge 133 that has a length, and a second side or edge 134 that has a length. The dressing 130 is attached to the packaging assembly 100 along the lengths of the sides of the dressing 133, 134. When the device 120 is closed, the adhesive layer 135 faces away from the base 122 and is covered by a release liner 149 that is attached to the inner surface 177 of the cover 121. The dressing assembly 110 also includes an adhesion blade 141 that has a first side 143 and a second side 144. The adhesion blade 141 couples the dressing 130 to the cover of the device 120 which, when open, it exerts a tensioning force on dressing 130 by means of adhesion blade 141. According to some variations, adhesion blade 141 is flexible and, at the same time, relatively inelastic with respect to dressing 130 and can be constructed, for example, by a low density polyethylene. When assembled, the adhesion blade 141 is joined to the elastic blade 131 of the dressing (for example, using a combination of a silicone PSA / acrylic PSA) on the sides 134 and 143 of the dressing 130, or close to them, and the membership 141 respectively. Adhesion blade 141 is attached on its side 144 to cover 121 at adhesion points 137 that define a line or area of adhesion 137a along the length of cover 121. Dressing 130 is attached to second side 124 of base 122 in a location near the first side 133 of dressing 130. In this way, the elastic blade 131 is attached to the adhesion points 138 that define a line or area of adhesion 138a along a length of the base 122. Various bonding methods or adhesives can be used used to attach adhesion sheet 141 to cover 121, for example, a PSA with low surface energy such as, for example, an acrylic adhesive.
[0151] [00151] When the assembly 100 is in a closed configuration, as shown in Figure 1, and in an open configuration 90 degrees, as shown, in Figure 2, the elastic blade 131 is relaxed or not tensioned, with the elastic blade 131 that has an unstressed width w1. As the assembly 100 is opened up to 180 degrees or up to about 360 degrees (for example, by rotating or pivoting about an axis of the cover 121 with respect to the base 122), the orthogonal distance increases between the lines or areas of accession 137a, 138a. According to some variations, the assembly is opened at least about 180 degrees (minimum angular change) to allow the application of a dressing without interference from the assembly 100. When the device 120 is open, it exerts a separating force between the regions adhesion lines defined by lines or adhesion areas 137a, 138a or corresponding adhesion areas. The force tensions the elastic blade, creating tension. Tensioning and transmitting a tension in dressing 130 increases the width between the lines or adhesion areas 137a, 138a through w2. The increase in width, that is, w2 minus w1, can be a percentage of w1 or a percentage stress, as illustrated here. Although tensioning is illustrated as starting when cover 121 is opened about 90 degrees from base 122, dressing 130 can be attached to cover 121 in various locations or in various configurations that can vary the position or configuration of the cover in which the tensioning begins. The edge 124a or side 124 of the cover 121 can act as a lever arm to provide a mechanical advantage, which may depend, among other things, on the distance from the adhesion point 138 of the dressing assembly 110 on the cover to the edge 124a of the cover 121, as well as the angle of the cover 121 with respect to the base 122 on which the dressing tensioning occurs. In addition, the adhesion point 138 of the inelastic adhesion blade 141 to the covering 121 can determine the amount of tension applied to the dressing, assuming, among other things, that the length of the adhesion blade 141 remains the same and that the adhesion 137 of dressing assembly 110 to base 122 remains the same.
[0152] [00152] According to a variation, dressing 130 can be substantially attached to one edge, (for example, on edge 134 on side 126 of base 122), while not being attached to an opposite edge (for example , the edge 133 moves when tensioned with respect to the edge 125a of the base 122). When the cover 121 is open and the dressing 130 is tensioned, the width of the tensioned dressing can be less than the width of the base 122 and / or the cover 121, so that the area of the dressing is located over the area of the base 122 and / or cover 121, that is, on the margins of base 122 and / or cover 121 outside the dressing area. According to other variations, the dressing can be fixed on both edges.
[0153] [00153] According to some variations, the dressing is sufficiently large with respect to device 120, such that, when applied to the skin, there is relatively less interference by device 120. According to an example, the width of the tensioned portion of the The dressing can be about 10 mm, about 20 mm, about 30 mm, about 40 mm or about 50 mm. Other tensioned dimensions can be used. According to other variations, the distance between each of the edges 133, 134 of the dressing 130 and the edges 125a, 126a of the base 122, respectively (and / or of the edges 123a, 124a of the cover 121), is at most about 10 mm, 15 mm or 20 mm. According to some variations, the distance between the edges 136a, 136b of the dressing and the edges 122a of the base is at most about 10 mm, about 15 mm or about 20 mm.
[0154] [00154] According to some variations, edges 133, 134, 136a, 136b of dressing 130 are at least about 1.0 mm into at least a portion of edges 125a, 126a, and / or 122a of base 122 , in such a way that the edges 125a, 126a and / or 122a of the base 122 can be gripped by a user with a reduced probability of touching the dressing 130 or the adhesive layer 135. According to some variations, the ends 136a, 136b of the dressing 130 has a margin of at least about 1.0 mm into the ends 122a of the base 122. According to some variations, the sides 133, 134 and the ends 136a, 136b of the dressing 130 have a margin of about 10 mm from the sides 125, 126 and the ends 122a of the base, respectively. According to some variations, the sides 133, 134 and the ends 136a, 136b of the dressing 130 have a margin of about 15 mm from the sides 125, 126 and the ends 122a of the base, respectively. Each of the margins between the sides 133, 134 or the ends 136a, 136b of the dressing 130 and side 125, 125 and the ends 122a of the base 122 may be different. As shown in Figure 3, for example, the m1 and m2 margins are at least about 3 mm and the m3 margin is about 15 mm. Similar margins can be provided between the dressing 130 and the edges 121a, 123a, and / or 124a of the cover 121, for example, if the edges of the cover 121 are used alternatively or additionally to grip the device 120 or manipulate the dressing 130. A Then, after the cover 121 is opened and the adhesive layer 135 is exposed, the adhesive side of the dressing 130 can be placed on a skin or wound site using the device 120. As shown in Figures 3 and 4, the cover 121 and the base 122 can be rotated by an additional amount, relative to each other, for example, up to approximately 360 degrees of the closed configuration prior to the application of dressing 130. A locking mechanism can optionally be provided to lock or secure the device in one position open, partially open or closed. In some instances, the locking mechanism may comprise magnets, hook and loop type adhesion structures, pressure fasteners, latches, clips and the like.
[0155] [00155] The adhesive layer 135 of the elastic blade 131 is protected by a release liner 149 before the applicator or tensioning device 120 is opened. The release liner 149 is attached or glued to the inner surface 177 of the cover 121 in such a way that, when the cover 121 is open, as shown in Figure 2, and is separated from the base 122 (before tensioning the elastic blade 131), the release liner 149 is moved away from the elastic blade 131 exposing the adhesive layer 135. Alternatively, as shown in Figure 6, a release liner 149a can be provided in the adhesive layer 135 that is not attached to the cover 121. When the device 120 is open, and before tensioning the dressing 130, the release liner 149a can be manually removed from the elastic blade 131 to expose the adhesive layer 135.
[0156] [00156] After dressing 130 is tensioned and liner 149 or 149a is released, dressing 130 can be applied to a desired location on an individual's skin. Window 159 can be used to view the proper placement. The user can apply pressure to the rear 129 of the device 120 to activate the adhesive on the elastic blade 131 and / or to apply compression to a wound. Alternatively, if the cover 121 is rotated up to 360 degrees, pressure may be applied to the inside 177 of the cover 121. After being applied to an individual, the elastic blade 131 can be released from the package, applicator or tensioning device 120 using a frame or release mechanism 150.
[0157] [00157] The release mechanism 150 may comprise cutters 151 each positioned on the opposite sides 133, 134 of the elastic blade 131. Each cutter 151 comprises a blade 152 at one end 153 with legs 154, 155 extending to the flap or flaps for pulling opposing 156 at an opposite end 157. the blade 152 comprises a sharp surface which can generally be in the form of a "V" or other shape. The blade can be constructed, for example, from stainless steel, ceramic or hard plastic. The blade 152 and the pull tabs 156 extend protruding at the ends 136a, 136b of the elastic blade 131, respectively, and at the ends 122a of the base 122. The cutters 151 are attached to the dressing assembly 110 in order to define cutting paths general 162, 163 (best shown in Figure 5A) along which blades 152 are pulled by tabs 156 to cut dressing assembly 110 to release dressing 130. In some variations, the dressing may be scratched, perforated or some other way configured to facilitate separation by the release mechanism.
[0158] [00158] As best shown in Figures 513 and 5C, tubes 164, 165 for receiving and guiding legs 154, 155, respectively, of a cutter 151, are positioned along the side 133 of the elastic blade 131. Tubes 164, 165 can be positioned in such a way that the cutting path 162 is between the tube 164 and the tube 165. The tube 165 is coupled, for example, glued, to the adhesive surface 135 of the elastic blade 131 at a location closer to the side 133 of the than the cutting path 162. The tube 164 is coupled to the rear surface 139 of the elastic blade 131 by means of the adhesion blade 141, which is also coupled to the elastic blade 131 in a location closer to the side 133 than to the cutting path 162. Tube 164 is coupled to a free end 145 of the adhesion blade 141 that extends into the cutting path 162 with respect to the side 133. In this way, the tube 164 can be positioned within the cutting path 162 without being attached to the elastic blade 131 inside the vi cutting 162. This allows dressing 130 to be released from the rest of the packaging assembly 100, including cutter 151 with tube 164 and adhesion blade 141. A protective member 170 is attached, for example, glued, to the top of the tube 165. The protective member 170 includes a protrusion 171 that extends over the cutting path 162 in such a way that, when the adhesive layer 135 is positioned on the skin of an individual and the cutter 151 is activated, the skin is protected from blade 152.
[0159] [00159] Tubes 174, 175 to receive and guide the legs 154, 155, respectively, are positioned along the side 134 of the elastic blade 131. The tubes 174, 175 are positioned in such a way that the cutting path 163 is between the tube 174 and tube 175. Tube 175 is coupled, for example, glued, to the adhesive surface 135 of elastic blade 131 at a location closer to the side 134 of elastic blade 131 than to cutting path 163. Tube 174 is coupled to the rear surface 139 of the elastic blade 131 by means of the extension blade 146. The tube 174 is coupled to a free end 147 of the extension blade 146 which extends into the cutting path 163 with respect to the side. Tube 174 is also attached to the elastic blade 131 at a location closer to the side 134 than to the cutting path 163. In this way, the tube 174 can be positioned within the cutting path 163 without being attached to the elastic blade 131 within the cutting path 163. This allows dressing 130 to be released from the rest of the packaging assembly 100, including cutter 151 with tube 175 and extending blade 146. A protective member 170 is attached, for example, glued, to the top of the tube 175. The protective member 170 includes a protrusion 171 that extends over the cutting path 163 in such a way that, when the adhesive layer 135 is positioned on the skin of an individual and the cutter 151 is activated, the skin is protected from the blade 152.
[0160] [00160] The interior of tubes 164, 165, 174, 175 can be coated with a lubricating material, for example, with Kapton tape. Guide legs 154, 155 can be constructed of a low-friction material, such as HDPE or UHMWPE, such that legs 154, 155 can easily slide through tubes 164, 165, 174, 175 to allow cutting dressing 130 of the rest of the packaging assembly 100.
[0161] [00161] When dressing 130 is tightened and adhesive 135 is exposed, dressing 130 can be applied with adhesive side 135 towards an individual's skin. The side 133 of the elastic blade can then be released from the applicator by pulling the tabs 146 to pull the blade 152 through the cutting path 162. In addition, the side 134 of the elastic blade can then be released from the applicator by pulling on the tabs 146 to pull the blade 152 through the cutting path 163. In this way, the elastic blade 131 is released from the package 100 (including the release mechanism 150).
[0162] [00162] In relation to Figures 7 to 9, another variation of a dressing assembly and packaging 200 is illustrated. The packaging assembly 200 comprises an applicator and / or tensioning device 220 and a dressing assembly 210, which includes a dressing 230. Dressing 230 comprises an elastic sheet 231 with one or more adhesive regions comprising a layer of skin adhesive 235. The adhesive used can be, for example, a suitable pressure-activated adhesive (PSA), or a non-sensitive adhesive. pressure.
[0163] [00163] The packaging assembly 200, applicator or tensioning device 220 and / or dressing dressing 210 can be configured to pre-tension the dressing 230 and / or allow the transfer of the pre-tensioned dressing 230 to the skin of an individual. The applicator or tensioning device 220 may also allow for a convenient sterile transfer of an adhesive portion of the dressing to an individual's skin and / or wound site.
[0164] [00164] The device 220 can comprise a cover 221 and a base 222. The dressing assembly 210 is removably attached or anchored to the device 220, and can serve as a dressing carrier. The cover 221 can be generally flat and includes sides 223, 224 with corresponding edges 223a and 224a that define its length and edges 221a at opposite ends. The base 222 can be generally flat and includes sides 225, 226 with corresponding edges 225a and 226a that define its length and edges 222a at opposite ends.
[0165] [00165] According to some variations, the cover and / or base 221,222 or elements or segments thereof can be constructed to be sufficiently firm or rigid or less flexible in relation to an attached dressing to support an attached dressing until it is applied to an individual, as described in relation to the variations presented here. Such material may comprise, for example, a plastic, for example, polypropylene, polycarbonate, PTFE, LDPE, HDPE, UHMWPE, PVC or acrylic, nylon or a cardboard. The elements or segments can be a laminate of a material, for example, a cardboard with a solid bleaching sulphate, with a layer of flexible material between the cardboard layers, for example, silicone, polyurethane, low density polyethylene or a rubber material , The material can also be a metal, such as malleable aluminum or stainless steel. The metal may comprise a sheet, ribbon, wire or other metallic form. The other variations described for applying the tensioning device 100 can also be applied to the device 200.
[0166] [00166] The cover and base 221 and 222 can be mobilely coupled, pivotally, foldable or hinged on the sides 223, 225 in a similar manner to that described in relation to the cover and base 121, 122 presented here, and can be constructed similarly to the cover and base 121, 122 presented here, among other things, with segments 227 similar to segments 127, and dressing 230 attached to device 220 and tensioned by the device in a similar manner to that by which dressing 130 is attached to device 120.
[0167] [00167] The various attached structures, for example, the segments and / or the cover and base and coupling elements, can provide a structural support for the dressing loader to be manipulated by a user. Margins between at least a portion of the structural support elements, carrier or dressing of the dressing and the tensioned or non-tensioned dressing can be provided at or near the edges 221a, 223a, 224a, 222a, 225a and / or 226a, for example example, margins m1, m2, m3 shown in Figure 3.
[0168] [00168] According to some variations, each of the cover 221 and base 222 is constructed, at least in part, by a transparent, semi-opaque plastic material or another material that provides a fenestrated portion 259 through which a wound, incision or other location can be viewed for precise placement of dressing 230. Cover 221 and base 222 may or may not comprise the same material. The elastic sheet 231 and the adhesive layer 235 can also be sufficiently transparent to allow viewing through them. A more opaque material can be provided in portions of the material to create the contours of a window. Segments 227 can be transparent or semi-opaque to provide a window for viewing, positioning and / or centralizing the location of a wound or position on the skin with respect to dressing 230 or for positioning the wound within an optimum tension zone or more effective dressing. Contours or other markings can assist a user in placing the dressing in an appropriate position on the wound or incision.
[0169] [00169] The dressing assembly 210 also includes an adhesion blade 241, adhesion blade 251 and a dressing release structure or mechanism 250 comprising pull tabs 246, as described in more detail herein. The dressing 230 of the dressing assembly 210 has a first side 233 that has a length, and a second side 234 that has a length. When the device 220 is closed, the adhesive layer 235 faces away from the base 222 and is covered by a release liner 249 which is attached to the inner surface 277 of the cover 221.
[0170] [00170] Adhesion blade 241 has a first side 243 and a second side 244. Adhesion blade 241 couples dressing 230 to cover 221 of device 220 near second side 234 of dressing 230. Cover 221, when open, exerts a tensioning force on dressing 230 by means of adhesion blade 241. Adhesion blade 241 is coupled on its side 244 to cover 221 at adhesion points 237, which can be supplied as a line or adhesion area 237a, for example. for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. When assembled, the adhesion blade 241 is attached to the elastic blade 231 of the dressing 230 in section 265 of the adhesion blade 241 on the side 243 of the adhesion blade 241, or close to it, for example, using a combination of a silicone PSA / Acrylic PSA. Adhesion blade 251 has a first side 253 and a second side 254. Adhesion blade 251 couples dressing 230 to base 222 of device 220 near first side 233 of dressing 230. Adhesion blade 251 is attached to its side 254 to the base 222 at the adhesion points 238 that define the adhesion line or area 238a, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. When assembled, adhesion sheet 251 is attached to elastic band 231 of the dressing in section 265 of adhesion sheet 251 on side 253 of adhesion sheet 251, or close to it, for example, using a combination of a silicone PSA / PSA acrylic.
[0171] [00171] Dressing 230 has unattached portions or edges 255 on its sides 233, 234 where elastic sheet 231 is free from adhesion sheets 241, 251, respectively. Consequently, dressing 230 is not tensioned on unattached portions 255. The pull tabs 246 are each coupled to the ends 281, 282 of the device 220. Each pull tab 246 comprises an upper section 247 and a lower section 248. The lower sections 248 are attached to the base 222 or cover 221, as illustrated, while the upper sections 247 are adjacent, but not attached, to the dressing 230.
[0172] [00172] According to some variations, the adhesion sheets 241, 245 are flexible and, at the same time, relatively inelastic with respect to dressing 230 and can be constructed, for example, by a low density polyethylene. Adhesive blades 241, 245 can be manufactured so that they can be torn along the length of the material, while at the same time providing tensile strength in other directions, in particular in the direction of tensioning the material of the adhesion blade 241 (direction in which the dressing is stretched, stressed or tensioned). An example of such a material is an LDPE polymer that is produced by an extrusion process that creates a grain with a directional tendency by which the material can be torn with the grain direction, but has a relative resistance to tearing in the direction transverse to the grain. grain. The pull tab 246 can begin to tear at a notch in the adhesion blade 241 or 251 which must be completed along lines 262. The adhesion blades 241, 251 can additionally or alternatively comprise a material such as, for example, an LDPE , with perforations formed along the lines to tear 262.
[0173] [00173] Similar to assembly 100 shown here, when assembly 200 is in a closed configuration and in an open configuration 90 degrees, as shown in Figure 7, elastic blade 231 is relaxed or un-tensioned, with elastic blade 231 having a unstressed width w3. As the assembly 200 is opened up to 180 degrees or up to 360 degrees (for example, by rotating or pivoting about an axis of the cover 221 with respect to the base 222), the orthogonal distance increases between the lines or areas of adhesion 237a , 238a. When the device 220 is open, it exerts a separating force between the adhesion regions defined by lines or adhesion areas 237a, 238b or corresponding adhesion areas. The force tensions the elastic blade 231 creating tension. The tensioning and transmission of a tension in the dressing 230 increases the width between the lines or areas of adhesion 237a, 238a up to the width w4. The increase in width (i.e. width w4 minus width w3) can be a percentage of w3 or a percentage stress, as shown here. Although tensioning is illustrated as starting when cover 221 is open about 90 degrees from base 222, dressing 230 can be attached to cover 221 in several locations or in different configurations that may vary in what position or configuration cover 222 may be. when tensioning begins.
[0174] [00174] As shown in Figures 8 to 8B, the cover 221 and base 222 can be rotated by an additional amount, with respect to each other, for example, up to approximately 360 degrees of the closed configuration, before applying the dressing 230. according to some variations, the assembly is opened at least about 180 degrees (minimum angular change) to allow the application of the dressing without interference from the assembly.
[0175] [00175] Next, after the cover 221 is opened and the adhesive layer 235 is exposed, the adhesive side of the dressing 230 can be placed on a skin or wound site using device 220. The cover 221 and base 222 can be rotated by an additional amount, in relation to each other, for example, up to approximately 360 degrees of the closed configuration, before applying dressing 230. The orientation of the cover 221 in which dressing 230 begins to tension can be varied, for example, by varying the location of the adhesion of the dressing assembly 210 to the cover 221. A locking mechanism can optionally be provided to lock or secure the device in an open, partially open or closed position. In some instances, the locking mechanism may comprise magnets, hook and loop type adhesion structures, pressure fasteners, latches, clips and the like.
[0176] [00176] The adhesive layer 235 of the elastic blade 231 is protected by a release liner 249 before the applicator and tensioning device 220 is opened. The release liner 249 is attached to the inner surface 277 of the cover 221 in such a way that, when the cover 221 is opened and is separated from the base 222 (before tensioning the elastic blade 231), the release liner 249 is moved away from the blade elastic 231 exposing the previous adhesive layer 235. Alternatively, as shown in Figure 6, a release liner 149a can be provided in adhesive layer 235 that is not attached to the cover 221. When the device 220 is opened, but before tensioning, the release liner 149a can be manually removed of the elastic sheet 231 to expose the adhesive layer 235.
[0177] [00177] After the lining 249 or 149a is released and the dressing 231 is tensioned, the dressing 230 can be applied to a desired location on an individual's skin. The window can be used to view the proper placement. The user can apply pressure to the back 229 of device 220 to activate the adhesive on dressing 231 and / or to apply compression to a wound. If the cover 221 is rotated up to 360 degrees, pressure may be applied to the interior 277 of the cover 221. Once applied to an individual, the dressing 230 can be released from the applicator or tensioning device 220 using the release mechanism 250.
[0178] [00178] Each of the pull tabs 24 6 of the release mechanism 250 extends protruding at the end 236a of the elastic blade 231. Each pull tab of release 246 is attached to the dressing assembly 110 in a way that defines ways to tear 262 along which the flaps 246 are pulled to separate the dressing 230 from the device. Notches or perforations can be made in the adhesion blades 241, 251, which facilitates the act of tearing along the 262 tracks.
[0179] [00179] The dressing 230 is applied to an individual. The dressing 230 can then be released from the device 220 by pulling the tabs 246 to pull the tabs 246 through the pathways 262 of the adhesion blades 241, 251. The sections 245 of the adhesion blades 241, 251 that have joined with the tabs for pulling 246 are thus separated from the adhesion sheets, thereby separating sections 265 from the adhesion sheets that are attached to dressing 230 from the rest of the adhesion sheets 241 and 251 which are attached to cover 221 and base 222, respectively. In this way, dressing 230 is released from the rest of package 100, as shown in Figure 9. Sections 265 of adhesion sheets 241, 251 can remain on the rear surface 239 of silicone sheet 231, as shown in Figure 9. Sections not attached 245 of elastic bandage 230 are unstressed and may be free of adhesive from adhesive layer 235 (or may have a reduced amount of adhesive on them). Thus, less stress occurs on the sides or unattached edges defined by sections 245.
[0180] [00180] In relation to Figures 10 to 12B, a dressing and packaging assembly 300 is illustrated. The packaging assembly 300 comprises a packaging device applicator 320 and a dressing assembly 310 that includes a dressing 330.
[0181] [00181] The packaging device or applicator 320 is configured to allow the transfer of dressing 330 to an individual's skin and can also provide a convenient, fast or sterile transfer of an adhesive portion of the device for treating the skin to a skin and / or an individual's wound site.
[0182] [00182] The packaging device or applicator 320 comprises a cover 321 and a lower element, carrier or base of the dressing 322, to which the dressing assembly 310 is removably attached or anchored. The cover 321 can be generally flat and includes sides 323, 324 with corresponding edges 323a, 324a that define its length and edges 321a at opposite ends. The base 322 can be generally flat and includes the sides 325, 326 with corresponding edges 325a, 326a that define its length and edges 322a at opposite ends.
[0183] [00183] According to some variations, the cover 321 and base 322 are constructed, in part, of a relatively non-flexible material, for example, with respect to an attached dressing 330. This material can comprise, for example, a plastic, cardboard or a laminate of a material, or metal, as illustrated here with reference to cover 121 and base 122. The cover or base can be constructed in a manner as described, for example, with respect to the various applicator or tensioning or loading devices of dressings shown in Figures 1 to 22B. The cover 321 and base 322 may or may not comprise the same material.
[0184] [00184] The cover 321 and base 322 can be mobilely coupled, pivotally, deformable or by hinges on the sides 323, 325 and, otherwise, built in a similar way to the one described here with respect to cover 121 and base 122. The packaging device or applicator 320 may include a fenestrated portion 359 through which a wound, incision or other location can be viewed for accurate placement of dressing 330 in a similar manner to that described here with respect to the use of windows 159, 259.
[0185] [00185] The assembly 300 is constructed including a dressing assembly 310 with a dressing device for the skin 330. The dressing assembly 310 also includes a structure or mechanism for releasing the dressing 350 that can be a release device such as example, various release and removal structures described herein with reference to Figures 1 to 22B. Dressing 330 may comprise a variety of dressing materials, including, without limitation, elastic bandages, gauze-type bandages, hydrocolloids. The various structures, for example, the segments and / or the cover and base and coupling elements, can provide a structural support for the dressing loader to be manipulated by a user. Margins between at least a portion of the structural support elements, carrier or dressing of the dressing and the dressing can be provided at the edges 321a, 323a, 324a, 322a, 325a and / or 326a, for example, as illustrated herein.
[0186] [00186] When assembled with the packing device or applicator 320, dressing 330 is attached to the base. A length of dressing 330 adjacent to its first side 333 is attached to a length of the base 322 adjacent to its side 324 and outside the release mechanism 350. In addition, a length of dressing 330 adjacent to its second side 334 is coupled to a length of the base 322 adjacent to its side 325 and outside the release mechanism 350. An adhesion blade similar to blades 141, 146 or 241, 251 can be used to attach the sides 333, 334 of dressing 330 to the base 322. The layer Adhesive 335 faces away from cover 321 and base 322 when applicator 320 is opened.
[0187] [00187] According to a variation, dressing 330 is sufficiently large with respect to device 320 such that, when applied to the skin, there is relatively less interference by device 320. According to an example, the width of the tensioned portion of the The dressing can be about 20 mm, about 30 mm, about 40 mm or about 50 mm. According to other variations, the distance between each of the edges 333a, 334a of the dressing 330 and the edges 325a, 326a of the base 322, respectively (and / or the edges 323a, 324a of the cover 321), is at most about 10 mm, 15 mm or 20 mm. According to variations, the distance between the edges 336a, 336b of the dressing and the edges 322a of the base is at most about 10 mm, about 15 mm or about 20 mm.
[0188] [00188] According to some variations, the edges 333, 334, 336a, 336b of dressing 330 are at least about 3 mm into at least a portion of the edges 325a, 326a and / or 322a of the base 322, in such a way so that the edges 325a, 326a and / or 322a of the base 322 can be gripped by a user with a reduced probability of touching the dressing 330 or the adhesive layer 335. According to some variations, the ends 336a, 336b of the dressing 130 have a margin of at least about 3 mm into the ends 322a of the base 322. According to some variations, the sides 333, 334 and the ends 336a, 336b of dressing 330 have a margin of about 10 mm from the sides 325, 326 and the ends 322a of the base, respectively. According to some variations, the sides 333, 334 and the ends 336a, 336b of dressing 330 have a margin of about 15 mm from the sides 325, 326 and the ends 322a of the base, respectively. Each of the margins between the edges 333,334 or the ends 336a, 336b of the dressing 330 and the sides 325, 325 and the ends 322a of the base 322 can be different. As shown in Figure 3, for example, the m1 and m2 margins are at least about 3 mm, and the m3 margin is about 15 mm. Similar margins can be provided between dressing 330 and edges 322a, 325a, and / or 326a of base 322. In addition, similar margins can be provided between dressing 330 and edges 321a, 323a and / or 324a of coverage 321, for example, if the edges of the cover 321 are used alternatively or additionally to grip the device 320 or manipulate the dressing 330.
[0189] [00189] Adhesive layer 335 in dressing 330 can be protected by a release liner 349 before the packaging device or applicator 320 is opened. The release liner 349 can be attached to the inner surface 3 77 of the cover 321 in such a way that, when the cover 321 is opened or is separated from the base 322, the release liner 349 is removed from the dressing 330, exposing the adhesive layer 335 The release liner 349 can also be a protective liner that protects or covers the dressing before application. For example, the liner may cover a dressing to which a substance or medication or other agent is applied. One or more hemostatic or coagulant agents can be applied or otherwise integrated into the dressing to help reduce bleeding. Potential agents include chitosan, calcium-loaded zeolite, microfibrillar collagen, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetyl glucosamine, thrombin, factor coagulation (or factors) (eg, II, VII, VII, X, XIII, von Willebrand factor), procoagulants (eg, propyl gallate), antifibrinolytics (eg, epsilon aminocaproic acid), and the like. In some variations, the agents can be lyophilized and integrated into the dressing and activated after contact with blood or other fluid. In some additional variations, an activating agent can be applied to the dressing or the treatment site before the dressing is used on the individual. In still other examples, the hemostatic agent can be applied separately and directly to the wound before applying the dressing, or after application to the dressing by means of a catheter or tube. The devices may also comprise one or more other agents, which may be any suitable agent that may be useful in assisting in some aspect of the wound healing process. For example, the active agent can be a pharmaceutical compound, a protein (for example, a growth factor), a vitamin (for example, vitamin E), or combinations of these. Of course, the devices can comprise more than one drug or agents, and the devices can deliver one or more drugs or agents. An example of these drugs may include, without limitation, various antibiotics (including, without limitation, cephalosporins, bacitracin, polymyxin B sulfate, neomycin, polysporin), antiseptics (eg, iodine solutions, silver sulfadiazine, chlorhexidine), antifungals ( for example, nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus, paclitaxel), growth factors (for example, VEGF) and other treatments (for example, botulinum toxin). The cover 321 can be removed or separated in several ways. Cover 321 can be opened like a book cover. Similar to devices 120 and 220, 420, 520, 620, 720, 820, 920, 1020 shown here, elements 321, 322 can be rotated sufficiently to separate the release liner 349 and up to approximately 360 degrees, allowing the adhesive side 335 exposed dressing 330 is placed on a skin or wound site using the packing device or applicator 320. According to some variations, assembly 300 is opened up to at least about 180 degrees (minimum angular change) to allow applying the dressing without interference from the assembly 300. Alternatively, for example, the cover 321 can be attached to the base 322 by an adhesive and can be removed from the dressing 330 or the base 322 to which the dressing 330 is attached. The cover 321 itself can be a removable or separable release liner that can be removed from the base 322. Alternatively, as shown in Figure 6, a release liner 149a can be provided in adhesive layer 335 that is not attached to the cover 321. When the device is opened, the release liner 149a can be manually removed from the dressing 330 to expose the adhesive layer 335. In that case, the cover 321 can be omitted. After the device 300 is opened to the position shown in Figures 11 or 12A and 12B, dressing 330 can be applied to a desired location on an individual's skin. Window 359 can be used to view the proper placement. A locking mechanism can optionally be provided to lock or secure the device in an open, partially open or closed position. In some instances, the locking mechanism may comprise magnets, hook and loop adhesion structures, pressure fasteners, latches, clips and the like, in addition to adhesives or other adhesive structures. A compressive force can be applied to the rear 378 of the base 322 or within 377 of the cover if rotated approximately 360 degrees. After being applied to an individual, the dressing 330 can be released from the packaging device or applicator 320 using a release mechanism 350. The release mechanism 350 can include a cutting element or a perforated element, as described, for example, with with respect to devices 150 and 250 shown here. The release mechanism may further include one or more release elements described herein and shown in Figures 1 to 22B.
[0190] [00190] Figure 13 illustrates an alternative packaging or applicator 420 that can be used in any of the modalities presented here, which includes elements or features of the device that can replace elements or features of the device of devices 120, 220 or 320, 520, 620, 720,820,920, 1020, 1120, 1220. Figure 13 illustrates a cover 421 and a carrier or dressing base 422 that are constructed from a single substrate of a material such as, for example, nylon and / or polyethylene or a metal. The device 420 may be manufactured by a single mold and / or may have cut portions of the substrate, cracks, grooves, scratches or other openings or variations in the thickness of the substrate at different locations. The cover 421 and the base 422 comprise slits 428 that form elements such as segments 427. Slits 428 allow the device 420 to flex, allowing them to adapt to the contours of an individual's body where an attached dressing is to be applied . The cover 421 and base 422 are coupled to each other by means of connection resources 429 which are formed on the substrate. The cover 421 and base 422 are movable by hinges or pivotally in relation to each other as a result of the cracks 430 that are formed adjacent to the connection resources 429, to allow flexing or movement of the connecting resources 429 and, thus, the covering 421 and base 422 in relation to each other. As mentioned with respect to device 100, in other variations, slots 430 may comprise grooves or other structures that provide reduced thickness in relation to cover 421 and base 422. Device 420 may include a release mechanism as described with respect to Figures 1A-22B shown here. The device 420 can be used in the same way as the devices described with reference to Figures 1A to 22B presented here, and can attach a dressing in the same way described with respect to the devices described with reference to Figures 1A to 22B presented here.
[0191] [00191] The various structures, for example, the segments and / or the cover and base and coupling elements, cracks and grooves can provide structural support, as well as flexibility, for the dressing loader to be manipulated by a user. Margins between at least a portion of the structural support elements, carrier or dressing of the dressing and an attached dressing can be provided at the edges 421a, 423a, 424a, 422a, 425a and / or 426a, for example, as additionally here described.
[0192] [00192] Figure 14 illustrates an alternative packaging or applicator device 520 that can be used in any of the devices described herein with reference to Figures 1A to 22B. A cover portion 521 and a carrier portion or dressing base 522 can be constructed with a laminated structure 530. A first layer 531 of the laminated structure 530 comprises a cardboard or other support material such as a plastic or metal material , which has slits 528 formed transversely through the cover 521 and the base 522. Slits 528 form segments 527 that allow flexion of the segments 527 of the device 520, which allows them to adapt to the contours of an individual's body where an attached dressing must be be applied. The first layer 531 still comprises a slit along the length 529 between the cover 521 and base 522 formed in the first layer 531. The first layer 531 still comprises flaps 540 with openings that are used in the assembly of the device 520 and are removed after assembly, such that the cover 521 and the base 522 are separated by the slot 529 and are no longer connected by the first layer 531. The second layer 532 of the laminate comprises an adhesive material such as an acrylic PSA, rubber or silicone adhesive . The second layer 532 may or may not have a thickness of about 0.001 to 0.006. A flexible strip 534 of material is positioned along the length of the device 520 over the slot 52 9 and that connects the cover 521 and the base 522. The cover 521 and the base 522 are flexibly coupled and movable and with hinges or hinges. pivoting shape in relation to each other by means of tape 534 of material over the slot 529 to allow flexion or movement of the cover 521 and the base 522 in relation to each other. The flexible tape 534 is attached with an adhesive 535 to a third layer 533 which comprises a thin material such as paper or plastic, which can generally have a contour similar to that of the first layer 531 and which holds the structure of the device 520 together , including segments 527.
[0193] [00193] Device 520 can include a dressing release mechanism, and can be used in the same way as devices and assemblies, as described with respect to Figures 1A-22B presented here.
[0194] [00194] The various structures, for example, the segments, adhesive structures, laminated layers and / or the cover and base and coupling elements, cracks and grooves can provide structural support, as well as flexibility for the dressing loader, to facilitate manipulation by a user. Margins between at least a portion of the structural support elements, carrier or dressing of the dressing and an attached dressing can be provided at the edges 521a, 523a, 524a, 522a, 525a and / or 526a, for example, as additionally here described.
[0195] [00195] With respect to Figures 15A to 15J, a variation of a dressing assembly and packaging 600 is illustrated. The packaging assembly 600 comprises an applicator and / or tensioning device 620 and a dressing assembly 610 that includes a dressing 630 The dressing 630 comprises an elastic sheet 631, with one or more adhesive regions comprising a layer of skin adhesive, as shown here.
[0196] [00196] The features in Figures 15A to 15J can be used in any of the variations presented here, including device elements or features that can replace device elements or features of devices and assemblies shown in Figures 1A to 22B.
[0197] [00197] The packaging assembly applicator 600, tensioning device 620 and / or dressing assembly 610 can be configured to pre-tension the dressing 630 and / or allow the transfer of the pre-tensioned dressing 630 to the skin of an individual. The applicator or tensioning device 620 may also allow for a convenient sterile transfer of an adhesive portion of the dressing to an individual's skin and / or wound site.
[0198] [00198] The device 620 comprises a cover 621 and a base 622. The dressing assembly 610 is removably attached or anchored to the device 620 which can act as a dressing carrier. The cover 621 can be generally flat and includes sides 623, 624 with corresponding edges 623a and 624b that define its length and edges 621a at opposite ends. The base 622 can be generally flat and includes sides 625, 626 with corresponding edges 625a and 626a that define its length and edges 622a at opposite ends.
[0199] [00199] According to some variations, cover 621 and / or base 622, or elements or segments thereof, can be constructed to be sufficiently firm or rigid or less flexible in relation to an attached dressing to support an attached dressing up to that it be applied to an individual, as described with respect to the variations presented here. The materials and construction of the applicator or tensioning device 620, dressing 630 and packaging 600 can be similar to the packaging assemblies and / or dressings described in the variations presented here and shown in Figures 1A to 22B.
[0200] [00200] The cover 621 and the base and 622 can be movably, pivotally, deformable or hinged on the sides 623, 624. For example, a layer of material 627 such as silicone, polyurethane , low density polyethylene or a rubber material, can be glued to the roof and the base, flexibly attaching them together on the sides 623, 625. The device 620 can be constructed in a similar way to that described with respect to the other devices presented here and shown in Figures 1A to 22B, and can be constructed in a similar manner, as illustrated here, including, without limitation, with respect to materials, segmentation, strength and flexibility, visualization, tensioning mechanisms and release linings.
[0201] [00201] The dressing assembly 610 also includes an adhesion blade 641, adhesion blade 651. The adhesion blade 641 has a first side 643 which is attached to the second side 634 of the dressing by means of an adhesive structure 670 such as for example, a polyimide film or tape (for example, KAPTON® by DuPontTM) or a removable adhesive. The adhesive structures mentioned may include, without limitation, KAPTON® tape or removable adhesive configured to generate minor skin trauma after repeated contact with the skin, or a soft skin adhesive made with material such as silicone adhesive, gel silicone or acrylic adhesive. The adhesive structure or KAPTON® tape also comprises a material that is able to adhere to the adhesion sheets to transmit tension to the dressing when the adhesion sheets are separated from one another and, at the same time, removable from a selected dressing material.
[0202] [00202] As shown in Figure 15J, the adhesion blade 641 and the side 634 of the dressing can be attached on the same side 671 of the adhesive structure 670 with overlapping of the adhesion blade 641, but not attached to the dressing 631.
[0203] [00203] Adhesion blade 641 has a second side 644 that is coupled to cover 621 of device 620, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. Adhesion blade 641 may also have a scratch or perforation 681 between its adhesion to adhesive structure 670 and its adhesion to cover 621. After the dressing has been tensioned, perforation 681 is located at the seam between cover 621 and base 622, or on the inner surface of the 621 cover.
[0204] [00204] The adhesion blade 651 can be attached on its side 654 to the rear part 698 of the base 622, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. The side 653 of the adhesion blade 651 can be attached to the side 633 of the dressing by means of an adhesive structure 680 such as, for example, a KAPTON® tape or a removable adhesive, and similarly to the adhesive structure 670 that attaches the side 654 from dressing 630 to the adhesion blade 641. The adhesion blade 651 can include a pull tab 688 which is located at the rear 698 of the adjacent base and within the adhesion zone 655 of the adhesion blade 651 to the rear of the base 652 .
[0205] [00205] The cover 621, when opened, exerts a tensioning force on the dressing 630 by means of the adhesion blade 641.
[0206] [00206] According to some variations, the adhesion sheets 641, 651 are flexible and, at the same time, relatively inelastic with respect to dressing 630 and can be constructed, for example, by a low density polyethylene. Adhesive blades 641, 651 can be manufactured so that they can be torn along the length of the material while providing tensile strength in other directions, in particular in the direction of tensioning the material of the adhesion blade 641 (direction in which the dressing is stretched, stressed or tensioned). An example of such a material is an LDPE polymer that is produced by an extrusion process that creates an anisotropic grain or with a directional tendency by which the material can be torn with the grain direction, but has a relative resistance to tearing in the direction transversal to the grain.
[0207] [00207] Figure 15A shows assembly 600 in a non-tensioned configuration. An adhesive tape 683 is exposed on the inner surface 694 of the base 622. A layer of skin adhesive on the elastic blade 631 of the dressing 630 can be protected by a release liner similar to the release liner 149a, before the applicator or tensioning device 620 is open.
[0208] [00208] Figure 15B shows assembly 600 in an open and tensioned configuration. As shown in Figure 15B, when tensioned, the perforation 681 in the adhesion blade is aligned with the edges 623a and 625a of the cover 621 and base 622, respectively. A portion 641a of adhesion blade 641 interfaces with adhesive tape 683 which attaches portion 641a to base 622 and which holds dressing 630 in the tensioned configuration. A release liner 645 is attached to the underside of adhesion blade 641 between adhesion to cover 621 and perforation 681. The liner 645 prevents the portion of adhesion blade 641 that interfaces with cover 621 from sticking to the adhesive tape 683.
[0209] [00209] The cover 621 and base 622 can be separable from each other by, for example, a perforation 682 in layer 627 that couples the cover 621 to the base 622 and by separating the blade 641 along the perforation 681. The Figure 15C shows assembly 600 with cover 621 separated from base 622. Tensile dressing 630 can be applied to an individual's skin using base 622 as an applicator.
[0210] [00210] Figure 15D illustrates the posterior part 698 of the base 622 in a position of applying the dressing 630 towards the skin of an individual. As shown, the edge 654 of the adhesion blade 651 can be wound from inside 694 of the base 622 to the rear part 698 to which it is attached. An opening tape can be attached to the 651 adhesion blade between the attached edge and an unattached middle section. The pull tab 688 or opening tape can be pulled to detach base 622 from the rest of the dressing assembly, as shown in Fig. 15E. After the flap 688 is pulled, an unattached portion 651a of the adhesion blade 651 is released from the base 622. After the base is removed, the remaining portions of the adhesion foils 641, 651 can be removed by pulling the KAPTON® tape from the dressing 630. Figure 15F shows dressing 630 after removing the rest of the dressing assembly.
[0211] [00211] Figures 15G to 15J illustrate a dressing assembly configuration 610 as KAPTON® tape or adhesive structures 670, 680 and adhesion sheets 641, 651 are removed from dressing 630. Figures 15G and 15J show the orientation of the KAPTON® tape or the adhesive structures 670, 680 as they are removed in a direction from within the dressing 630 towards the sides 633, 634 of the dressing 630, or in a direction of tension of the dressing. Figure 15H shows the first structure 670 removed from within the dressing through side 633 of the dressing. Fig. 15I shows the first adhesive structure 670 removed from dressing 630. The second adhesive structure 680 can be removed in a similar manner.
[0212] [00212] Figures 16A to 16D illustrate an alternative dressing assembly 710 in a configuration in which a dressing assembly 710 is separated from the applicator or tensioning device in a similar manner to that described with respect to Figures 15A to 15J. Figure 16A illustrates a first adhesive structure 770 and a second adhesive structure 780, each comprising a KAPTON® tape or a removable adhesive structure used to attach adhesion sheets 741, 751 to dressing 730. As shown in Figure 16a, the ends Unattached to adhesive structures 770, 780 are oriented away from dressing 730. As shown in Figure 16B, the second adhesive structure 780 is removed from the inside and, in Figure 16C, is removed.
[0213] [00213] Figures 17A to 17D illustrate an alternative dressing assembly configuration in which a dressing assembly 810 is separated from the applicator or tensioning device in a similar manner to that described with respect to Figures 15A to 15J. Figure 17D illustrates a first adhesive structure 870 and a second adhesive structure 880, each comprising a KAPTON® tape or a removable adhesive structure used to attach adhesion sheets 841, 851, respectively, to dressing 830. As shown in Figures 17A and 17D, the adhesive structures 870, 880 are attached to the dressing 830 with the adhered length 891. An additional length 892 is wrapped 180 degrees around the adhered length 891. The additional length 892 has an end 893 that extends protruding from the dressing 830 for easy access and removal. As shown in Figure 17B, the first adhesive structure 870 can be pulled using end 893 in a direction that is, in part, perpendicular to the direction of tension, to remove adhesion structures 841, 851 and adhesive structure 870 from dressing 830 , as shown in Figure 17C.
[0214] [00214] Figures 18A to 18I illustrate a variation of a dressing and packaging assembly 900. Packaging assembly 900 comprises an applicator and / or tensioning device 920 and a dressing assembly 910 that includes a dressing 930. Device 920 it comprises a cover 921 and a base 922. The dressing assembly 910 is removably attached or anchored to the device 920 which can act as a dressing carrier. The cover 921 can be generally flat and includes sides 923, 924 with corresponding edges 923a and 924a that define its length, and edges 921a at opposite ends. The base 922 can be generally flat and includes sides 925, 926 with corresponding edges 925a and 926a that define its length and edges 922a at opposite ends.
[0215] [00215] The dressing assembly 910 also includes an adhesion blade 941 and adhesion blade 951. The adhesion blade 941 has a first side 943 which is attached to the second side 934 of the dressing by means of an adhesive structure 970 such as example, a KAPTON® tape or a removable adhesive. The adhesive structures mentioned may include, without limitation, KAPTON® tape or removable adhesive configured to generate minor skin trauma after repeated contact with the skin, or a soft skin adhesive made with material such as silicone adhesive, gel silicone or acrylic adhesive. The adhesive structure or KAPTON® tape also comprises a material that is able to adhere to the adhesion sheets to transmit tension to the dressing when the adhesion sheets are separated from one another and, at the same time, removable from a selected dressing material.
[0216] [00216] As shown in Figure 18J, the adhesion blade 941 and the side 934 of the dressing are attached on the same side 971 of the adhesive structure 970 with the overlap of the adhesion blade 941, but not attached to the dressing 931. The adhesion blade 941 has a second side 944 which is coupled to the cover 921 of the device 920, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. Adhesion blade 941 may also have a tab for pulling 981 in an unattached region between adhesion to adhesive structure 970 and adhesion to cover 921. After the dressing has been tensioned, the pull tab for perforation 981 is located on the surface internal 960 of cover 921 or, alternatively, in the splice between cover 921 and base 922.
[0217] [00217] The adhesion blade 951 is attached on its side 954 to the rear part 998 of the base 922, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. The side 953 of the adhesion blade 951 is attached to the side 933 of the dressing 930 by means of an adhesive structure 980 such as, for example, a KAPTON® tape or a removable adhesive, and similarly to the adhesive structure 970 that attaches the side 944 from dressing 930 to the adhesion blade 941. The adhesion blade 951 may include a pull tab 988 which is located at the rear 998 of the adjacent base and within the adhesion zone 955 of the adhesion blade 951 to the rear of the base 952 .
[0218] [00218] According to some variations, the adhesion sheets 941, 951 are flexible and, at the same time, relatively inelastic with respect to dressing 930 and can be built, for example, with an LDPE. Adhesive blades 941, 951 can be manufactured so that they can be torn along the length of the material, while at the same time providing tensile strength in other directions, in particular in the direction of tensioning the material of the 941 adhesion blade (direction in which the dressing is stretched, stressed or tensioned). An example of such a material is an LDPE polymer that is produced by an extrusion process that creates an anisotropic grain or with a directional tendency by which the material can be torn with the grain direction, but has a relative resistance to tearing in the direction transversal to the grain.
[0219] [00219] The cover 921, when opened, exerts a tensioning force on the dressing 93 0 through the adhesion blade 941. Figure 18A shows the assembly 900 in a non-tensioned configuration, while Figure 18B shows the assembly 900 in a open and tensioned configuration that can be applied to the skin. As shown in Figure 18C, when tensioned, the tab 981 on the adhesion blade 941 is located on the inner surface of the cover 921 (folded back and exposed) and is accessible to a user. After dressing 930, cover 921 and base 922 can be removed.
[0220] [00220] The cover 921 and base 922 are separable from each other when the flap 988 is pulled. Figure 18C shows the assembly with the cover positioned with the dressing facing downwards, for example, as it would be when applied to an individual's skin. As shown in Figure 18D, tab 988 is pulled to release cover 921 from the remaining dressing assembly 910. As shown in Figure 18E, cover 921 is removed from the rest of device 920, exposing the second pull tab 998. As shown in Fig. 18F, the second pull tab 998 released base 922 from dressing assembly 910 with the adhesion blades 941, 951 not attached to base 922. As shown in Fig. 18G, base 922 is removed from the rest of the adhesion sheets 941, 951 and adhesive structures 970, 980 can be removed from dressing 930, as shown in Figure 18H, with the dressing remaining on the skin in a configuration, as shown in Figure 18I.
[0221] [00221] In relation to Figures 19A to 19D, a variation of a dressing assembly and packaging 1000 is illustrated. The packaging assembly 1000 comprises an applicator and / or tensioning device 1020 and a dressing assembly 1010 that includes a dressing 1030 Figure 19A shows the dressing assembly 1010 coupled to the applicator or tensioning device 1020. The tensioning member or applicator 1020 can be constructed similarly to the tensioning and applying devices described herein and shown in Figures 1A to 22B.
[0222] [00222] The device 1020 comprises a cover 1021 and a base 1022. The dressing assembly 1010 is removably attached or anchored to the device 1020 which can act as a dressing carrier. The dressing assembly can be attached to the tensioning member or applicator in a similar way to the assemblies described here. The dressing assembly 1010 includes the adhesion blade 1041 and the adhesion blade 1051. The adhesion blade 1041 has a first side 1043 which is attached to the second side 1034 of the dressing 1030 by means of an adhesive structure 1070, as described with reference to the adhesive structures 970, 980. The adhesion sheet 1041 has a second side 1044 that is coupled to the cover 1021 of the device 1020, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. The 1041 adhesion blade also has an opening rope 1088 sewn along its length on an unattached portion of the 1041 adhesion blade, between its adhesion to the adhesive structure 1070 and the adhesion to the cover 1021. Various types of seams can be used , including, without limitation, a chain stitch or fixed stitch sewing. After the dressing has been tensioned, the opening rope 1088 is located on the exposed inner side 1090 of the cover 1021 or, alternatively, on the seam between the cover 1021 and the base 1022.
[0223] [00223] The 1051 adhesion blade is attached on its side 1054 to the rear of the base 1022, for example, by joining with a PSA with low surface energy such as, for example, an acrylic adhesive. The side 1053 of the adhesion blade 1051 is attached to the side 1033 of the dressing by means of an adhesive structure 1080 such as, for example, a KAPTON® tape or a removable adhesive, and similarly to the adhesive structure 1070 that attaches the side 1034 of the dressing. dressing 1030 to the 1041 adhesion slide. The 1051 adhesion slide includes an opening rope 1098 that is located between the adhesion to the adhesive structure 1090 and the adhesion to the back of the base. The ends of the opening strings 1088, 1098 extend out of the tensioning member 1020 to facilitate accessibility.
[0224] [00224] Figures 19A and 19B illustrate the dressing assembly 1010 in a non-tensioned configuration. The cover 1021, when opened, exerts a tensioning force on the dressing 1030 by means of the adhesion blade 1041. Figure 19C illustrates the dressing assembly 1010 in a tensioned configuration.
[0225] [00225] After the dressing is tensioned and applied, the opening cords 1088, 1098 are pulled to separate the portion of the adhesion foils 1041, 1051 attached to the tensioning device 1020 from the portions of the adhesion foils 1041, 1051 attached to the dressing 1030 The applicator or tensioning device 1020 can then be removed, as shown in Figure 19D. The adhesive structures 1080, 1090 can then be removed to remove the remaining portion of the dressing assembly 1010 and the adhesive sheets 1041, 1051 from the dressing, as shown in Figure 19E.
[0226] [00226] In relation to Figures 20A to 20C, a variation of a dressing loader, tensioning device or applicator 1120 is shown. The device 1120 comprises several segments 1130 formed by scratching a substrate 1150 on a side 1155 of a flat surface . The 1170 streaks can be formed in one or more directions or have one or shapes, curved or straight. In addition, the scratches can be formed on both sides, which allows both convex and concave modeling of a device. As illustrated, the 1170 scratches allow modeling of the device or an attached dressing. The scratches 1170 as illustrated are formed on a first side 1155 of a flat surface of the device, while the second side 1165 is not scratched. When a force is applied to the second side 1165, the substrate curves. When a force is applied to the first side 1155 of the substrate 1150, the device does not flex at the 1170 lines. The remaining substrate at the 1170 lines can act as a bending limiter, while the 1170 lines act as a bending element.
[0227] [00227] When a convex dressing format is desired for a concave surface, the dressing can be attached on the first side 1155 so that when the substrate is folded, the dressing forms a convex shape to match a concave contour where the device must be applied. When a concave dressing is desired for a convex body contour, the dressing can be positioned on the second side 1165 of substrate 1150. In such a way that when the substrate is folded, the dressing creates a concave shape to match a convex contour of the body where the device is to be applied. Various dressing coatings can be provided for different locations or body contours.
[0228] [00228] According to variations, the risk may be orthogonal or may have components orthogonal with respect to the 1127 segments of the loader, applicator or tensioning device. The segments 1127 can be similar to the segments shown in Figures 1A to 22B.
[0229] [00229] In relation to Figures 21A to 21D, a variation of a dressing loader, tensioning device or applicator 1220 is shown. The device 1220 comprises several foam cells 1240 coupled by an adhesive liner 1260. The foam cells 1240 form several segments 1227 that allow flexing in multiple directions so that the device adapts to an individual's curvature, profile or shape where the dressing is to be applied. The foam may be thick enough to generally provide increased column strength for tensioning a dressing, i.e., flexural strength. A coating or support can be provided for tensioning a dressing, for example, constructed of a material with an elastic modulus and appropriate thickness that will, at least, counteract the force created by tensioning the dressing. The dressing tension can be fixed, for example, with the use of an adhesive on the back of a portion of the dressing assembly or the adhesion blade. After the dressing is fixed, the coating or support can be removed, which allows increased manipulation of the tensioned dressing format to adapt to a greater degree to the shape of the patient's body contours where the dressing is to be applied.
[0230] [00230] As illustrated, the 1270 separations between the foam sections allow the modeling of the device. The separations 1270, as illustrated, are formed on a first side 1255 of a flat surface of the device, while the second side 1265 is not scratched. When a force is applied to the first side 1255, the substrate folds. When a force is applied to the second side 1265 of the substrate 1250, the device does not flex at the separations. The remaining substrate in the separations can act as a bending limiter, while the scratches act as a bending element.
[0231] [00231] When a convex shape of the dressing is desired for a concave surface, the dressing can be attached on the first side 1255 so that when the substrate is folded, the dressing forms a convex shape to match a concave contour where the device must be applied. When a concave dressing is desired for a convex body contour, the dressing can be positioned on the second side 1265 of substrate 1250. In such a way that, when the substrate is folded, the dressing creates a concave shape to match a convex contour of the body where the device is to be applied. Various dressing coatings can be provided for different locations or body contours.
[0232] [00232] In relation to Figures 22A and 22B, a variation of a dressing assembly and packaging 1500 is illustrated. The packaging assembly 1500 comprises an applicator and / or tensioning device 1520 and a dressing assembly 1510 that includes a dressing 1530 The packaging assembly 1500, applicator or tensioning device 1520 and / or dressing assembly 1510 can be configured to pre-tension the dressing 1530 and / or allow the transfer of the pre-tensioned dressing 1530 to the skin of an individual.
[0233] [00233] The device 1520 can comprise a cover 1521 and a base 1522. The dressing assembly 1510 is removably attached or anchored to the device 152 0, and can serve as a dressing carrier. The cover 1521 and base 1522 are movably coupled, pivoting, foldable or hinged on the sides 1523, 1524, and can be constructed in a similar manner to that described with respect to the covers and bases described in Figures 1A to 22B . Adhesion regions 1541, 1551 of the dressing assembly 1510 are attached near the free sides 1525, 1526 of the cover 1521, 1522, respectively, for example, by means of a removable adhesive or removable adhesive structures. However, an adhesion slide or adhesion structure described with reference to Figures 1A to 22B presented here can be used. The adhesion regions 1541, 1551 and / or the positioning of the dressing 1530 on the device 1520 can be symmetrical with respect to a line defined by the adhesion of the sides 1523, 1524 of the cover 1521 and base 1522, respectively. As shown in Figure 22B, dressing 1530 is tensioned when cover 1521 and base 1522 are opened. The dressing 1530 can then be applied to the skin of an individual and the device 1520 can be removed from the dressing 1530. In addition, or alternatively, the cover 1521 and base 1522 can be separated through a perforation formed in the substrate of the device 1520, or a perforation 1551 formed in an adhesion structure 1550 such as, for example, a tape or layer of material that attaches the sides 1523 and 1524 of the cover 1521 and base 1522, respectively.
[0234] [00234] In some variations, device 1520 may optionally comprise an adhesive coating or adhesive tape on cover 1521 and / or base 1522, which can adhere to dressing 1530 when dressing 1530 is tensioned and the dressing comes in additional contact with cover 1521 and base 1522. In some variations, the adhesive is configured to keep dressing 1530 in a tensioned state and / or against cover 1521 and / or base 1522. The adhesive coating or tape may be located along the side regions 1523, 1524 of cover 1521 and / or base 1522, but can also be supplied adjacent to adhesion regions 1541, 1551. Release liners can also be provided to reduce inadvertent adhesion of the dressing or other structures to the adhesive until that the activation of the 1520 device is desired.
[0235] [00235] According to variations, the various assemblies or devices described here can provide a temporary wound dressing that can be applied before a wound is closed. The assembly can be configured to apply a dressing to a wound and to use the wrapper or applicator to apply pressure to the wound prior to removal or separation of the applicator, tensioning device or dressing carrier, dressing base or support. According to this variation, which can be provided with any of the modalities described below, the package or applicator has enough rigidity to distribute a relatively equal or firm force to a wound by applying pressure to the package or applicator when and / or after the dressing be applied to a wound. According to a variation, such a dressing can include a coagulation agent or other agent or medication, for example, as illustrated herein. According to another variation, margins, as illustrated here, are provided on that device between a dressing and the edges used to manipulate the device.
[0236] [00236] The assemblies or devices described here can also form a dressing support structure. For example, the support structure of the dressing can comprise several segments of base structures. The dressing support structure can comprise at least 3 segments that extend from at least one first side of the dressing to a second side of the dressing. The support structure of the dressing can comprise several segments such as, for example, the segments described in Figs. 1A to 22B, which are coupled or formed together. The various segments of a cover described here can also provide support for a dressing when the cover is folded more than 360 degrees with respect to the corresponding base structure.
[0237] [00237] Although this invention has been particularly shown and described with reference to its modalities, it must be understood by those skilled in the art that various changes can be made in terms of form and details, without departing from the scope of the invention. For all the modalities described above, the steps of the methods do not need to be performed sequentially.

权利要求:
Claims (19)
[0001]
Dressing assembly (100, 200) comprising: - a first support structure (122, 222) which has an internal surface (123, 223); - a second support structure (121, 221) having an opposite surface (125, 225), in which the first support structure (122, 222) is movably coupled to the second support structure (121, 222) in a primary flexion region comprising a primary flexion axis; and - an elastic bandage (130, 230) configured to be applied to a subject's skin or wound, comprising a first adhesion region (138a, 238a) coupled to the first support structure (122, 222), a second region of adhesion adhesion (137a, 237a) coupled to the second support structure (121, 221); characterized by the fact that a first separation region configured to separate from the first adhesion region (138a, 238a) and a second separation region configured to separate from the second adhesion region (137a, 237a); wherein the first support structure (122, 222) and the second support structure (121, 221) are configured to move relative to each other around the primary flexing axis of a first position, where the opposite surface (125, 225) interfaces and is substantially parallel to the first dressing surface (130, 230), and where the dressing (130, 230) is in a relaxed configuration, up to a second position where the first support structure ( 122, 222) and the second support structure (121, 221) exert a pre-determined tension on the dressing (130, 230) in a tensioned configuration.
[0002]
Assembly according to claim 1, characterized by the fact that the dressing (130, 230) comprises a first surface that has an adhesive region (135, 235).
[0003]
Assembly according to claim 2, characterized by the fact that the first dressing surface (130, 230) comprises an adhesive liner that interfaces with the adhesive region on the dressing (130, 230).
[0004]
Assembly according to claim 2, characterized in that the opposite surface (125, 225) of the second support structure (121, 221) comprises an adhesive liner (149, 249) that is covering the adhesive region (125, 225) of the dressing (130, 230) when the second support structure (121, 221) is in the first position and is separated from the adhesive region (125, 225) when the second support structure (121, 221) is in the second position .
[0005]
Assembly according to claim 2, further characterized by comprising a tensioning structure (141, 241) coupling the second adhesion region (137a, 237a) of the dressing (130, 230) with the second support structure (121, 221 ).
[0006]
Assembly according to claim 5, characterized by the fact that the tensioning structure (141, 241) comprises a sheet of a material less elastic than the dressing (130, 230) in a tensioning direction.
[0007]
Assembly according to claim 1, further characterized by comprising a tensioning structure (141, 241) coupling the first adhesion region (138a, 238a) of the dressing (130, 230) with the first support structure (122, 222 ).
[0008]
Assembly according to claim 7, characterized by the fact that the tensioning structure (141, 241) comprises a more rigid material than the dressing in a tensioning direction.
[0009]
Assembly according to claim 8, characterized in that the dressing (130, 230) has a first width when the second support structure (121, 122) is in the first position and a second width when the second support structure (121, 122) is in the second position, where the second width is greater than the first width, and where the dressing (130, 230) is tensioned in the second width.
[0010]
Assembly according to claim 9, characterized by the fact that the second width is at least 20% greater than the first width.
[0011]
Assembly according to claim 9, characterized by the fact that the second width is at least 40% greater than the first width.
[0012]
Assembly according to claim 1, characterized in that the first support structure (122, 222) comprises at least one relatively rigid structure (127, 227) and at least one relatively flexible structure, wherein the relatively rigid structure (127, 227) is sufficiently rigid to support the dressing when the tensioning force is applied in a first direction; and wherein the relatively flexible structure allows the first support structure (122, 222) to flex in a second direction.
[0013]
Assembly according to claim 12, characterized in that the at least one relatively rigid structure (127, 227) comprises a plurality of relatively rigid flexible coupled structures.
[0014]
Assembly according to claim 1, characterized in that the second support structure (121, 221) comprises at least one relatively rigid structure (127, 227) and at least one relatively flexible structure sufficiently flexible to allow the modeling of the second support structure (120).
[0015]
Assembly according to claim 1, further comprising a release device (150, 250) configured to release the dressing from the first support structure (122, 222) after the dressing (130, 230) is applied to a wound or to an individual's skin, while the dressing (130, 230) is in the second tensioned configuration.
[0016]
Assembly according to claim 1, characterized by the fact that the first adhesion region (138a, 238a) of the dressing and the second adhesion region (137a, 237a) of the dressing comprise a variable separation distance between the first dressing region adhesion (138a, 238a) of the dressing and the second adhesion region (137a, 237a) of the dressing, and in which a first distance from a center of the flexion region to the first dressing adhesion region (138a, 238a) is different from a second distance from the center of the flexion region to the second adhesion region (137a, 237a) of the dressing.
[0017]
Assembly according to claim 1, characterized by the fact that the primary flexion region is perforated.
[0018]
Assembly according to claim 17, characterized by the fact that the first support structure (122, 222) is configured to separate from the second support structure (121, 221) and the dressing (130, 250).
[0019]
Assembly according to claim 18, characterized by the fact that the first support structure (122, 222) is configured to separate from the second support structure (121, 221) and the dressing (130, 150) while maintaining the dressing in the tensioned configuration.

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同族专利:

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公开号 | 公开日

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CA2824045C|2019-04-09|

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JP5968909B2|2016-08-10|

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KR101944844B1|2019-02-01|

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US11013638B2|2021-05-25|

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JP2014506176A|2014-03-13|

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US20130281904A1|2013-10-24|

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US9844470B2|2017-12-19|

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WO2012094648A1|2012-07-12|

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MX2013007919A|2013-08-29|

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US9248048B2|2016-02-02|

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MX345460B|2017-02-01|

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KR20140036150A|2014-03-25|

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EP2661246A1|2013-11-13|

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AU2012204174B2|2016-07-21|

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CN103415272B|2015-04-29|

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CR20130356A|2015-10-07|

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CN103415272A|2013-11-27|

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US20130012858A1|2013-01-10|

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AU2012204174A1|2013-08-01|

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EP2661246A4|2015-07-29|

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IL227301A|2019-07-31|

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BR112013017506A2|2016-09-27|

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IL227301D0|2013-09-30|

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CA2824045A1|2012-07-12|

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US20180104107A1|2018-04-19|

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法律状态:
2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-04-07| B25G| Requested change of headquarter approved|Owner name: NEODYNE BIOSCIENCES, INC. (US) |

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2020-08-11| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-01-26| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161430908P| true| 2011-01-07|2011-01-07|

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US61/430,908|2011-01-07|

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US201161443647P| true| 2011-02-16|2011-02-16|

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US61/443,647|2011-02-16|

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PCT/US2012/020561|WO2012094648A1|2011-01-07|2012-01-06|Wound or skin treatment devices and methods|

---