Closure device and method for ulcerative and irregular skin defects

Abstract

Devices, methods, and systems for treating ulcers or skin defects are disclosed. The first and second base panels of the closure device are respectively adhered to the first and second sides of an ulcer or skin defect. A lateral tether couples the first and second base panels together and provides a predetermined separation distance or lateral spacing between the inner edges of the panels. The predetermined separation distance or lateral spacing is sufficient to treat ulcers or skin defects of the most common size, for example to accommodate ulcers or skin defects having a short axis of at most 50 mm. The ends of the lateral tethers are fixed to one panel and their opposite ends are adjustably and reversibly attached to the other panel such that the separation distance can be reduced or adjusted to provide a lateral compressive force to an ulcer or skin defect, thereby promoting healing.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 201980056564.8, whose application date is August 27, 2019 and whose invention name is “Closing device and method for ulcers and irregular skin defects”.

[0002] Cross-references

[0003] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 725,705, the entire contents of which are incorporated herein by reference. The subject matter of this application is related to subject matter in the following U.S. patent applications: U.S. Patent Application Nos. 13 / 286,757 (now USPN 8,323,313), 13 / 665,160, 14 / 180,524 (USPN 9,050,086), 14 / 180,564, 14 / 625,366 (USPN 9,642,621), 15 / 081,526 (USPN 9,474,529), 15 / 081,550 (USPN 9,554,799), 15 / 081,595 (USPN 9,642,622), 15 / 096,083 (USPN 9,554,800), 15 / 130,149 (USPN 9,561,034) and 15 / 369,293 and U.S. Provisional Patent Application Serial No. 62 / 725,705 and PCT Application Nos. PCT / US2015 / 028066, PCT / US2016 / 028297 and PCT / US2017 / 028537, the entire contents of which are incorporated herein by reference. background

[0004] The present disclosure relates to medical devices, methods and systems, and in particular to medical devices, methods and systems for assisting in the closure and healing of wounds and incisions, especially ulcers and irregular skin defects.

[0005] Staples and sutures have been used for many years to close wounds and incisions. However, for use with certain wounds and incisions, staples and sutures may be far from ideal, such as because of the irregular shape of the wound and incision or the closure force caused by the staples or sutures is concentrated on certain tissue areas, which may result in leaving additional scars or causing healing that is far from optimal. Moreover, after being in place, staples and sutures can be difficult to adjust and reverse, such as when it is necessary to adjust the re-approach to the wound edge or incision edge (that is, to bring together in a good alignment). In many such cases, liquid glue, which is often cyanoacrylate, can be used alone or in combination with staples, sutures, simple tape strips, or meshes attached to the wound or incision. The liquid glue can be attached to the wound or incision to cure or harden so that the wound or incision remains in place and at least partially protects the wound or incision from the external environment. But after curing, the liquid glue will be very hard. When exposed to lateral forces, this can result in blistering and loss of adhesion at the interface of the cured glue with the uncovered skin. The cured glue may also break apart, exposing the underlying wound or incision. Therefore, improved devices, methods, and systems for assisting in the closure and healing of wounds and incisions would be desirable. Summary of the invention

[0006] The present disclosure provides improved medical devices, methods and systems for assisting in the closure and healing of wounds and incisions, particularly ulcers and irregular skin defects.

[0007] Disclosed herein are methods for treating an ulcer or skin defect. An exemplary method includes the steps of adhering a first panel of a closure device to skin on a first side of the ulcer or skin defect; adhering a second panel of the closure device to skin on a second side of the ulcer or skin defect, wherein there is a separation distance between the inner lateral edges of the first and second panels, the separation distance being at least 10 mm; and compressing the ulcer or skin defect laterally between the first and second panels, thereby reducing the separation distance between the inner lateral edges of the first and second panels.

[0008] The methods disclosed herein may be suitable for treating ulcers and skin defects of various shapes and sizes. The ulcer or skin defect may have a short axis of at most 50 mm. The ulcer or skin defect may have a short axis of at most 40 mm. The ulcer or skin defect may have a short axis of at most 30 mm. The ulcer or skin defect may have a short axis of at most 20 mm. The ulcer or skin defect may have a short axis of at most 10 mm. The separation distance between the inner lateral edges of the first and second panels before laterally compressing the ulcer or skin defect may be at least 20 mm. The separation distance between the inner lateral edges of the first and second panels before laterally compressing the ulcer or skin defect may be at least 30 mm.

[0009] The method may further include removing one or more liners from the closure device prior to adhering the first and second panels to the skin. The one or more liners may be aligned in an orientation transverse to the longitudinal axis of the first and second panels. The method may further include removing the intermediate liner and removing one or more additional liners adjacent to the intermediate liner prior to adhering the closure device to the skin. The method may further include removing one or more liners adjacent to the intermediate liner and removing the intermediate liner prior to adhering the closure device to the skin. The method may further include removing the first liner from the first base panel and removing the second liner from the second base panel prior to adhering the closure device to the skin.

[0010] The method may further include adhering the first and second panels to the skin including pressing the adhesive substrate of the first and second panels against the skin. The adhesive substrate of the first and second panels may include a hydrocolloid adhesive. The first and second panels may include a base layer positioned on the hydrocolloid adhesive, the base layer being harder than the hydrocolloid adhesive. The first and second panels may each also include one or more force distribution structures coupled to the base layer, the force distribution structures being harder than the base layer.

[0011] The method may also include: one or more lateral ties connecting the first and second base panels to each other. The one or more lateral ties may be at least partially elastic. The one or more lateral ties may include an elastic component or a spring component. The method may also include: disengaging the one or more lateral ties from one or more of the first or second base panels to provide access to the ulcer or skin defect for care. The method may also include: after care, reengaging the one or more lateral ties to one or more of the first or second base panels. Care may include cleaning, debridement, application of medication, application of skin substitutes, application of negative pressure, or application of one or more oxygen introduction devices to the ulcer or skin defect. Lateral compression of the ulcer or skin defect may include adjusting one or more attachment points of the one or more lateral ties to the first or second panel. The ulcer or skin defect may be a diabetic foot ulcer, a venous leg ulcer, an arterial ulcer, a cracked wound, a cracked infection, a fasciotomy, a pressure or decubitus ulcer, or a biopsy incision.

[0012] The method may further include adhering the first and second panels of the closure device to position the closure device on the ulcer or skin defect in a first orientation, and wherein the method further includes: positioning the second closure device on the ulcer or skin defect in a second orientation different from the first orientation, and adhering the base panel of the second closure device to the skin on third and fourth sides of the ulcer or skin defect.

[0013] The method may further include further reducing the separation distance between the inner lateral edges of the first and second panels after the ulcer or skin defect has at least partially healed. The method may include: further reducing the separation distance between the inner lateral edges of the first and second panels after the ulcer or skin defect has at least partially healed includes progressively tightening one or more lateral ties coupling the first and second base panels to each other over a period of time to restore or increase the compressive force to promote healing of the ulcer or skin defect.

[0014] One or more of the first or second base panels may have a lateral elastic gradient that elasticity increases from its inner edge to its outer edge. This lateral elastic gradient may be provided by one or more of the following modes: by overlapping one or more of the material with different elasticities, the material step layer with the same elasticity and the first or second base panels, embossing, perforation or styling in the mode without material area to one or more of the first or second base panels. One or more of the first or second base panels may have a vertical elastic gradient that elasticity increases from its upper surface to its bottom surface. The vertical elastic gradient may be provided by vertically overlapping layers with different elasticities or thickness. One or more of the inner edge or outer edge of the first or second base panels may be sinusoidal or scalloped, to minimize or distribute shearing forces or minimize the formation of skin blisters.

[0015] A closure device for treating an ulcer or skin defect is disclosed herein. An exemplary closure device includes: a first panel having a first adhesive bottom surface for adhering to skin on a first side of the ulcer or skin defect; a second panel having a second adhesive bottom surface for adhering to skin on a second side of the ulcer or skin defect; a plurality of lateral ties coupling the first and second panels to each other, the plurality of lateral ties maintaining a separation distance of at least 10 mm between the inner lateral edges of the first and second panels; and one or more liners coupled to the first and second adhesive bottom surfaces.

[0016] The separation distance may be at least 20 mm. The separation distance may be at least 30 mm. The separation distance may be at least 40 mm. The separation distance may be at least 50 mm.

[0017] The one or more liners may be aligned in an orientation transverse to the longitudinal axis of the first and second panels. The one or more liners may include an intermediate liner precursor and one or more additional liners adjacent to the intermediate liner. The one or more liners may include a first liner removably coupled to a first adhesive primer layer of the first base panel precursor, and a second liner removably coupled to a second adhesive primer layer of the second base panel.

[0018] The first and second adhesive substrates of the first and second panels may include a hydrocolloid adhesive. The first and second panels may include a substrate positioned on the hydrocolloid adhesive, the substrate being harder than the hydrocolloid adhesive.

[0019] The first and second panels may each further comprise one or more force distribution structures coupled to the base layer, the force distribution structures being stiffer than the base layer. The one or more lateral ties may be at least partially elastic. The one or more lateral ties may comprise an elastic member or a spring member. The one or more lateral ties may at least partially disengage and reengage to provide access to an ulcer or skin defect for care. The one or more lateral ties may be at least partially adjustable to reduce the separation distance between the inner lateral edges of the first and second panels and apply a compressive force to the tissue therebetween when the device is adhered to the skin.

[0020] One or more of the first or second base panels can have the lateral elastic gradient that elasticity increases from its inner edge to its outer edge.This lateral elastic gradient can be provided by one or more modes in the following: will have the material of different elasticity, have the material step layer of same elasticity and one or more overlap in the first or second base panel, one or more in the first or second base panel are embossed, perforated or shaped in the mode without material area.One or more of the first or second base panel can have the vertical elastic gradient that elasticity increases from its upper surface to its bottom surface.This vertical elastic gradient can be provided by the vertical overlap layer with different elasticity or thickness.One or more of the inner edge or the outer edge in the first or second base panel can be sinusoidal or scalloped, to minimize or distribute shear force or minimize the formation of skin blisters.

[0021] Disclosed herein is a closure device for treating an ulcer or skin defect. An exemplary closure device includes an adhesive substrate, a base layer, a plurality of support portions coupled to the base layer, and a plurality of adjustable ties coupled to the plurality of support portions, wherein the adhesive substrate and the base layer define a central treatment hole for accommodating the ulcer or skin defect, and wherein the plurality of adjustable ties are adjustable to reduce the area of ​​the central treatment hole and apply a compressive force to tissue thereby surrounded by the central treatment hole.

[0022] Each lateral tie may include a fixed end and an adjustable end. The lateral ties may be arranged end-to-end along the periphery of the closure device. The fixed end of the lateral ties may be adjacent to the adjustable end of the lateral ties. The device may also include a central hub structure. The fixed end of the lateral ties may be coupled to the central hub structure, and the adjustable end of the lateral ties is coupled to a support portion associated with the base layer.

[0023] The bottom layer may include a hydrocolloid adhesive. The main layer may be attached to the hydrocolloid adhesive and positioned more rigid than the hydrocolloid adhesive. The plurality of support portions may be more rigid than the base layer. One or more lateral ties may be at least partially disengaged and reengaged.

[0024] Device can have the lateral elastic gradient that elasticity increases from its inner edge to its outer edge.This lateral elastic gradient can be provided by one or more modes in the following: will have the material with different elasticity, have the material step layer of same elasticity and one or more overlap in the first or second base panel, one or more in the first or second base panel are embossed, perforated or shaped in the mode without material area.Device can have the vertical elastic gradient that elasticity increases from its upper surface to its bottom surface.This vertical elastic gradient can be provided by vertical overlap layer with different elasticity or thickness.One or more in the inner edge or outer edge of one or more in the first or second base panel can be sinusoidal or scalloped, to minimize or distribute shear force or minimize the formation of skin blisters.Device can have the outer shape of triangle, rectangle, square, pentagon, hexagon or other polygon.

[0025] Disclosed herein are methods for treating an ulcer or skin defect. Exemplary methods may include the steps of: attaching a closure device to an ulcer or skin defect and positioning the closure device so that the ulcer or skin defect is surrounded by a central treatment hole of the closure device; adhering the closure device to the skin surrounding the ulcer or skin defect; and tightening one or more adjustable linkages of the closure device to apply a compressive force to tissue surrounding the ulcer or skin defect surrounded by the central treatment hole.

[0026] Each lateral linkage may include a fixed end and an adjustable end. The lateral linkages may be arranged end to end along the periphery of the closure device. The fixed end of the lateral linkage may be adjacent to the adjustable end of the lateral linkage. The closure device may also include a central hub structure. The fixed end of the lateral linkage may be connected to the central hub structure, and the adjustable end of the lateral linkage is connected to a support portion associated with the base layer. The ulcer or skin defect may be a diabetic foot ulcer, a venous leg ulcer, an arterial ulcer, a cracked wound, a cracked infection, a fasciotomy, a pressure or bedsore ulcer, or a biopsy incision. The ulcer or skin defect may have a short axis of at most 30 mm. The ulcer or skin defect may have a short axis of at most 20 mm. The ulcer or skin defect may have a short axis of at most 10 mm.

[0027] The wound closure device described herein may include a pair of flexible adhesive panels disposed on opposite sides of a wound or incision. Lateral ties couple the panels together and separate the panels, thereby providing sufficient space for the panels to surround an ulcer or irregular skin defect. After the closure device is adhered to the skin near the ulcer or irregular skin defect, the lateral ties may then be tightened to close the separation distance between the panels and apply an inward compressive force, thereby promoting healing.

[0028] Incorporated by Reference

[0029] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The novel features of the present disclosure are particularly set forth in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by referring to the following detailed description and the accompanying drawings, which set forth illustrative embodiments in which the principles of the present disclosure are employed, and the accompanying drawings:

[0031]

[0032]

[0033] Figure 1A A top view of a closure device according to an embodiment of the present disclosure is shown.

[0034] Figure 1B Show Figure 1A Another top view of the closing device.

[0035] Figure 1C Show Figure 1A Side view of a closed device.

[0036] Figure 1D Show Figure 1A Another top view of the closing device.

[0037] Figure 1E Show Figure 1A Another top view of a closure device of the present invention, the closure device comprising a wound or incision covering area.

[0038] Figure 1F Show Figure 1A A top view of the lining of a closure device.

[0039] Figure 2A A top view of a wide closure device according to an embodiment of the present disclosure is shown.

[0040] Figure 2B Showing the device lining removed, Figure 2A A top view of a wide closure device.

[0041] Figures 3A-3F A method of applying a closure device to a wound or skin defect according to an embodiment of the present disclosure is shown.

[0042] Figure 3A Shows a top view of a wound or skin defect.

[0043] Figure 3B The closure device is shown with a liner removed.

[0044] Figure 3C The closure device with a liner removed is shown deployed over a wound or skin defect.

[0045] Figure 3D The closure device is shown with the remaining liner removed; the closure device is pressed and adhered to the skin surrounding the wound or skin defect.

[0046] Figure 3E A closure device is shown adhered to the skin with lateral tethers of the closure device tensioned to apply lateral compressive forces to a wound or skin defect.

[0047] Figure 3F An additional closure device is shown adhered to the skin around a wound or skin defect and oriented transversely relative to the first closure device.

[0048] Figure 4A and Figure 4B A top view and a perspective view, respectively, are shown of a closure device with straight lateral edges according to an embodiment of the present disclosure.

[0049] Figure 5A and Figure 5B A top view and a perspective view, respectively, are shown of a closure device having straight lateral edges and a multi-layered main panel according to an embodiment of the present disclosure.

[0050] Fig. 6A and Figure 6B A top view and a perspective view, respectively, are shown of a closure device with rounded lateral edges according to an embodiment of the present disclosure.

[0051] Fig. 7A and Figure 7B A top view and a perspective view, respectively, are shown of a closure device having rounded lateral edges and a multi-layered main panel according to an embodiment of the present disclosure.

[0052] Fig. 8A and Figure 8BA top view and a perspective view are respectively shown of a closure device according to an embodiment of the present disclosure, the closure device having a lateral linkage with an elastic or spring member.

[0053] Fig. 9A , Fig. 9B and Fig. 9C A stereoscopic view, a top view and a schematic diagram are respectively shown of a closure device according to an embodiment of the present disclosure, wherein the closure device has a central open wound or incision area and connecting elements, wherein the connecting elements are circumferentially arranged in a ring connected end to end around the central open wound or incision area.

[0054] Fig. 10A and Fig. 10B A perspective view and a top view, respectively, are shown of a closure device having a central open wound or incision area and tethering elements arranged radially around the central open wound or incision area according to an embodiment of the present disclosure.

[0055] Fig.11A and Fig. 11B Top views of a closure device with and without a cast sheet according to an embodiment of the present disclosure are shown, respectively, the closure device having a central open wound or incision area of ​​5 cm or less and tie elements arranged to flank the open wound or incision area.

[0056] Fig. 12A and Fig. 12B Top views of a closure device with and without a cast sheet according to an embodiment of the present disclosure are shown, respectively, the closure device having a central open wound or incision area of ​​2 cm or less and tie elements arranged to flank the open wound or incision area.

[0057] Fig.13A and Fig. 13B Top views of a closure device with and without a casting sheet according to an embodiment of the present disclosure are shown, respectively, wherein the closure device has a central open wound or incision area of ​​5 cm or less, an elastic element, and connecting elements arranged to be located on both sides of the open wound or incision area.

[0058] Fig.14A and Fig. 14B A top view and a side view, respectively, of a closure device having a central open wound or incision area, a single closure element, and opposing curved bases arranged to flank the open wound or incision area, according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0059] The following description may refer to the following terms, which are further described below.

[0060] Arterial skin ulcers: Arterial skin ulcers account for up to 20% of all leg ulcers and develop when arterial disease is present (sometimes in combination with venous disease). These ulcers tend to be extremely painful and are usually located on the toes and feet where poorly functioning arteries are less likely to circulate blood. These types of ulcers are typically caused by hardening of the arteries, which can lead to insufficient oxygenation of the skin and underlying tissues. This kills the affected tissue and causes wounds.

[0061] Clean wounds (Class I). Class I clean wounds are wounds resulting from surgical procedures, such as in the case of an elective operating room (OR). Another condition for a clean wound is that the wound does not involve the respiratory tract, gastrointestinal tract (GI), or GU (genitourinary tract). Laparoscopic surgery, skin biopsy, and vascular surgery are some examples.

[0062] Clean contaminated wounds (Class II). Class II contaminated wounds involve normal tissue colonized by bacteria. Wounds involving the respiratory tract, GI / GU (gastrointestinal / genitourinary tract) fall into this category, as do wounds that have been opened to remove staples or sutures.

[0063] Closure by primary intention. Primary closure is immediate wound closure using sutures, staples, surgical tape, or tissue adhesive. Typically, this closure is used for clean or contaminated wounds after thorough cleaning and debridement.

[0064] Closure by secondary intention. Secondary closure allows the wound to heal naturally without any closure methods as above. This is a common strategy for severely contaminated wounds (such as animal bites) and infected wounds.

[0065] Tertiary closure: See delayed primary closure.

[0066] Contaminated wounds (category III). Category III contaminated wounds contain foreign or infected material - the most common presentation in the ED. Severe contamination is not necessary to meet this classification, any contact with a foreign body such as a bullet, razor blade or other sharp material would suffice.

[0067] Debridement. Debridement is the removal of all hyperkeratotic (thickened skin), infected and nonviable including necrotic (dead) tissue, slough, foreign debris, and residual material from dressings from the tissue.

[0068] Delayed primary closure. Delayed primary closure is a strategy that waits about 48 hours to close the wound after it has been proven to be free of any signs of infection. It is sometimes referred to as tertiary closure. This is a strategy commonly used for clean contaminated wounds and clean wounds that are older than 6 hours.

[0069] Diabetic foot ulcers. Diabetic foot ulcers, also called neuropathic skin ulcers, occur in people who have little or no feeling in their feet due to diabetic nerve damage. These skin ulcers occur at pressure points on the foot, such as on the heel, big toe, or other points where footwear rubs against the footwear. The cost of treating each ulcer episode varies widely depending on the depth of the ulcer, with an average estimated cost of $13,179. (Stockl K, Vanderplas A, Tafesse E, Chang E. Costs of lower-extremity ulcers among patients with diabetes. Diabetes Care 2004; 27: 2129-2134.)

[0070] Fasciotomy. Fasciotomy is the standard of care for acute compartment syndrome (ACS). Historically, fasciotomy incisions were either left open or immediately closed; however, infection rates and recurrent compartment syndrome were unacceptably high. In an attempt to improve outcomes, a number of different wound closure techniques have been published, including immediate closure, delayed primary closure, and most importantly, filling the void with a skin graft. Immediate or delayed primary wound closure, when compared to secondary closure and skin grafts, can help reduce infection rates and improve cosmetic outcomes. However, primary closure is not always possible due to tissue edema. (Jauregui J et.al.Fasciotomy closure techniques:A meta-analysis.2017Journal of Orthopedic Surgery,25(1)1-8.)

[0071] Infected (Class IV) Wounds. Infected (Class IV) wounds are wounds with purulent drainage. This category includes wounds with foreign matter such as pieces of metal or other debris lodge in the wound. This category may also include traumatic wounds where treatment is delayed due to a foul source, infected surgical wounds, or any wound exposed to pus or fecal matter.

[0072] Negative Pressure Wound Therapy (NPWT). NPWT generally involves the application of a therapeutic dressing, which typically includes a wound pad or sponge, an adhesive-backed occlusive sheet with a vacuum port, and a vacuum (ie, negative pressure) generating device.

[0073] Off-load. Off-loading means taking pressure off the ulcer area by having the person wear special footwear, braces, special casts, or by using a wheelchair or crutches.

[0074] Pressure or decubitus ulcers: Pressure or decubitus ulcers or sores are localized areas of cell death caused by prolonged pressure (action) between any bony prominence and an external object, such as a bed or wheelchair. The tissues are deprived of their blood supply and eventually die. Commonly affected areas in the elderly include the heel (8%), greater trochanter (15%), sacrum (23%), and ischial joints (sitz bones) (24%). They are common in people who are bedridden, especially the elderly. People with dementia are particularly susceptible.

[0075] Venous skin ulcers. Venous ulcer formation is usually caused by an increase in dynamic venous pressure (venous hypertension). This often causes limb oedema. External compression has been the mainstay of combating these problems. It is the most common ulcer, accounting for up to 80% of all leg ulcers. Chronic venous insufficiency can lead to venous congestion ulcer formation, which can occur as a result of previous deep vein thrombosis. The basic dysfunction is deep vein valvular insufficiency. Ulcers usually occur around the ankle, especially in the medial malleolus area. There is a loss of epidermis and, depending on the degree of venous congestion, parts of the dermis may also be involved. The skin develops a characteristic brown colouration due to the deposition of melanin and hemosiderin. When capillaries rupture, red blood cells are released and break down, subsequently releasing hemosiderin.

[0076] The wound closure device and method of use thereof may be applicable to ulcers and irregularly shaped wounds, examples of which are described in Table 1 below.

[0077]

[0078]

[0079] Table 1

[0080] The need to reduce tension during wound closure is currently addressed by tension sutures or stretching devices designed to exploit the viscoelastic properties of the skin to apply controlled and evenly distributed tension along the wound edges using incremental traction. The principle of using tension sutures or commercially available devices to stretch the wound edges can be problematic because if excessive tension is applied, the technique can result in incidental skin damage, necrosis, and tearing of the skin margins during approximation of the opposing wound edges. In addition, commercial devices can be invasive, cumbersome, and can damage the wound edges.

[0081] Delayed primary closure of surgical wounds or injuries can be used to address: wound dehiscence, delayed closure of contaminated wounds (e.g., gunshot and knife wounds) after treatment, and incremental closure of fasciotomies. Currently, the inventors are aware of no products specifically for this purpose, which leaves the treatment to incremental adjustable tension sutures or secondary healing.

[0082] Diabetic foot ulcers (DFUs) occur in at least 15 percent of all diabetic people and are responsible for approximately 20% of all hospitalization costs for patients with diabetes. The most common causes of DFUs are diabetic peripheral neuropathy, pre-existing foot deformities (e.g., Charcot neuropathic arthropathy or partial foot amputation), biomechanical deformities, and / or peripheral vascular disease (PVD). Management focuses on secondary healing and typically includes debridement, systemic antibiotics, unloading pressure from the area, creating and maintaining a clean, moist wound environment with specialized dressings and topically-applied medications. Newer approaches include negative pressure wound therapy (NPWT), which involves frequent changes of specialized dressings and a vacuum generator device tethered to the dressing.

[0083] Surgical wound closures that are at particularly high risk for dehiscence may benefit from an adjunct that recruits healthy tissue beyond the immediate incision site to help unload forces and cushion the incision from any potential distraction. Sternotomy is an example of such an adjunct, where the outcome of wound dehiscence is often fatal.

[0084] The present disclosure includes improved wound closure devices, systems, and methods of use thereof.

[0085] Figures 1A-1EA closure device 1 according to an embodiment of the present disclosure is shown. The closure device 1 may include two base panels 2a, 2b coupled to each other by a plurality of reversibly adjustable lateral ties 4. Each base panel may include a bottom adhesive layer 13, an intermediate layer or body 11, and a plurality of force distribution structures 10 coupled to the top of the intermediate layer 11. The layers may be successively stiffer or less elastic from bottom to top, providing a vertical elastic gradient, reducing loss of adhesion and skin blistering when the skin to which the closure device is attached moves.

[0086] The bottom adhesive layer 13 may be covered by one or more removable liners. For example, a center liner removable from the tab may be on one side of the closure device 1, and a pair of side liners 12 removable from the tab may be on the opposite side of the closure device, such as on Figures 1A-1E , Figure 3B and Figure 3C Alternative liner configurations are also contemplated, such as a liner covering the entire bottom of each base panel, as in Figure 2A-2B , Figures 4A-4B , Figure 5A-5B , Figure 6A-6B and Figure 7A-7B or a cast sheet covering the entire top of each base panel and a liner covering the entire bottom of each base panel, as in Figures 11A-11B , Figures 12A-12B and Figures 13A-13B These liners 12 can be peeled off from the tabs at their longitudinal ends and / or lateral ends. Fig.11A , Fig. 12A , Fig.13A and Fig.14A As can be seen in the figure, each base panel may include a liner covering an adhesive layer and a cast sheet 16 that can be removed from the top of each base panel. The cast sheet can assist in the deployment of each base panel. For example, the cast sheet adhered to each base panel can provide rigidity and stability to the base panel, making the base panel easier to handle and deploy. After deployment, the cast sheet can be removed. The bottom adhesive layer 13 may include a hydrocolloid adhesive. The lateral edges of the liner and / or liner tabs may be as shown. Figures 4A-4B and Figure 5A-5B As shown in the figure, it is straight, or it can be Figure 6A-6B , Figure 7A-7B , Fig.11A , Fig. 12A and Fig.13A The rounded corners are shown in .

[0087] The middle layer or body 11 of the base panel may lie on the bottom adhesive layer 13. The middle layer or body 11 of the base panel may include a material such as a polymer material (e.g., polyurethane). In some embodiments, the body of the base panel may include multiple, stepped layers, such as Figure 5A-5B , Figure 7A-7B and Figures 11A-11B In some embodiments, the body of the base panel 2a, 2b may include a plurality of perforations 7, such as Figures 11A-11B , Figures 12A-12B , Figures 13A-13B and Fig.14A . In some embodiments, the plurality of perforations 7 are reflected by perforations in the adhesive layer. The perforations 7 can provide lateral stress relief for severe strains on the device. The perforations 7 can help protect the skin to which the adhesive is applied from severe lateral strains. For example, the perforations 7 can accommodate the stretching and contraction of the underlying skin in all directions by facilitating the base panel to stretch and contract with the skin, thereby reducing the risk of loss of adhesion and / or reducing the risk of blistering due to otherwise too strong skin adhesion.

[0088] A force distribution structure may be coupled to the top surface of the base panel, and the ends of the lateral ties 4 may be coupled to the force distribution structure to distribute the forces resulting from the attachment of the wound closure device to the skin gathered through the attachment points of the lateral ties. For example, the lateral ties may have a fixed end 5a at one base panel 2a and an adjustable coupling end 5b at another base panel 2b with a lock 6, as in Figures 1A-1E The lateral ties may be coupled to the base panels 2a, 2b at a predetermined adjustable distance to provide a predetermined lateral gap 8 between the inner lateral edges of the base panels, as shown in Figure 1A-1B The spacing between the base panels can be large enough to surround the most common ulcers. A set of such closure devices can be provided, each closure device in the set having a lateral gap 8 and a spacing of different sizes. Figure 2A , Fig.11A , Fig. 12A and Fig.13A shows a top view of a wide closure device, and Figure 2B , Fig. 11B , Fig. 12B and Fig. 13B The wide closure device is shown with the release liner removed.

[0089] Alternatively or in combination, a set of closure devices 1 with different base panel lengths can be provided. The separation distance can be increased or reduced by adjusting the adjustable end of the lateral ties 5b, and the separation distance can be adjusted to be larger or smaller at different lateral ties. The separation distance can start from, for example, 10mm or more, 20mm or more, 30mm or more, 40mm or more, or 50mm or more. The closure device can be configured to surround and process an ulcer or skin defect portion with, for example, a short axis of at most 50mm, 40mm, 30mm, at most 20mm or at most 10mm. The lateral ties 4 will usually be harder than the middle layer or body of the base panel, and may include materials such as nylon.

[0090] In some embodiments, particularly as shown in Fig. 8A , Figure 8B , Fig.13A and Fig. 13B In those embodiments with a larger separation distance, the lateral linkages may be provided with one or more springs or resilient members along the length of the lateral linkages, and / or the lateral linkages may be adjustable from either corresponding base. The springs or resilient members 14 may provide dimensional stability to the lateral linkages 4, allowing some movement of the lateral linkages 4 relative to each other in a direction transverse to the length of the lateral linkages 4 and in a direction along the length of the lateral linkages 4, while limiting excessive movement. Figures 8A-8B and Figures 13A-13B As shown in FIG, the tying elements can have their fixed ends connected to the elastic member 14 located above the open wound or incision 15, while the adjustable ends 5b are connected to the force distribution structure 3 associated with the upper surface of the intermediate main layer 11 on the base structures 2a, 2b of the two wings. Fig. 8A and Figure 8B As shown in , the spring or resilient member 14 may be in the form of a length of hard material having a serpentine configuration. Fig.13A and Fig. 13B As shown in , the spring or elastic member 14 may be in the form of a separate hard material unit between the groups of two lateral linkages. The material may be similar or identical to the material of the force distribution structural element 3 and / or the lateral linkage 4, such as nylon.

[0091] The closure device may share many features in common with the closure devices described in the following U.S. patent applications: U.S. Patent Application Nos. 13 / 286,757 (now USPN 8,323,313), 13 / 665,160, 14 / 180,524 (USPN 9,050,086), 14 / 180,564, 14 / 625,366 (USPN 9,642,621), 15 / 081,526 (USPN 9,474,529), 15 / 081,550 (USPN 9,554,799), 15 / 081,595 (USPN 9,642,622), 15 / 096,083 (USPN 9,554,800), 15 / 130,149 (USPN 9,561,034) and 15 / 369,293, and PCT application numbers PCT / US2015 / 028066, PCT / US2016 / 028297 and PCT / US2017 / 028537, the entire contents of the above patent applications are incorporated herein by reference.

[0092] Figures 3A-3F A method of applying a closure device to a wound 15 or skin defect SD is shown. The ulcer or skin defect may be a diabetic foot ulcer, a venous leg ulcer, an arterial ulcer, a dehiscent wound, a dehiscent infected area, a fasciotomy area, a pressure or decubitus ulcer, or a biopsy incision. Figure 3B As shown in the figure, the center liner 12 can be peeled off from the rest of the closure device by using the tab 19 of the center substrate. With the adhesive layer of the closure device exposed, the closure device can be attached to the wound or skin defect SD and positioned to surround the wound 15 or skin defect between the inner lateral edges of the base panels 2a, 2b, and the closure device can be pressed against the skin near the wound or skin defect SD to adhere the closure device 1 to the skin, as shown in the figure. Figure 3C Subsequently, the two liners laterally adjacent to the central liners can be peeled off to expose the remainder of the adhesive layer 13, and the closure device 1 can be pressed against the skin to fully adhere the closure device to the skin, as shown in FIG. Figure 3D After adhesion, the lateral ties 4 can be adjusted and tightened to apply lateral compression force to the wound or skin defect, such as Figure 3E In some cases, additional wound closure devices may also be applied similarly to the wound or skin closure SD, such as Figure 3F The additional wound closure device may be arranged in a transverse orientation to the first wound closure device, such as Figure 3F Also, in some cases, liquid glue, antimicrobial agents, antibacterial agents, and / or other therapeutic agents may be applied to the wound or skin defect SD before, after, or during application of one or more closure devices.

[0093] Form factors for closure devices other than two parallel base panels are also disclosed. A closure device according to an embodiment of the present disclosure may be in the form of a patch having an open central wound or incision treatment hole 20, such as, for example, Figures 9A-9C , Figures 10A-10B and Fig.14A As shown. Figures 9A-9C , Figures 10A-10B and Fig.14A As shown in , the closed-shaped closure device can be generally circular, oval, elliptical or hexagonal, but can also be configured in other geometric shapes, such as triangular, rectangular, square, pentagonal or in another polygonal shape. The shape of the peripheral edge of the closed-shaped closure device can be scalloped or sinusoidal to provide flexibility to the closure device in response to lateral forces near the closure device after adhesion, thereby reducing the possibility of skin blistering and loss of adhesion.

[0094] like Figures 9A-9C As shown in , the closed shape closure device may include a single base 9 having an adhesive bottom layer 13 and an intermediate main layer 11, similar to the adhesive bottom layer 13 and the base panel main layer 11 described above. A plurality of tie elements similar to the above-described lateral tie elements 4 may be attached to a force distribution element 10 fixedly connected to the upper surface of the intermediate main layer 11. The tie elements may be arranged circumferentially in an end-to-end ring surrounding a central open wound or incision area 22. Each tie element may include a fixed end 5a fixedly attached to its corresponding force distribution element and an adjustable end 5b adjustably attached to its corresponding force distribution element. The fixed end of each tie element may be adjacent to the adjustable end of the next tie element that is inverted (over). As shown Fig. 9B and Fig. 9C As shown in , the tethering elements can be reversibly tightened to shrink the central open wound or incision area and provide a compressive force to the area.

[0095] like Figures 10A-10B and Fig.14A As shown in , other arrangements of closure devices for closed shapes are also provided for linking elements. Figures 10A-10BAs shown in , the linkage elements can have their fixed ends connected to a central hub structure 21 located within a central open wound or incision treatment hole 20, while the adjustable ends 5b are connected to a force distribution structure 3 that is connected to the upper surface of the intermediate main layer 11 and is closer to the periphery of the closure device. This arrangement structure allows the center of the hub structure 21 to be open and free of any interfering structures (such as the free ends of the linkage elements). In other embodiments, the adjustable ends 5b are connected to the central hub structure 21, and the excess material can be easily cut or sheared off after adjustment as needed. The central hub structure 21 can be made of the same material as the linkage elements 4 and the force distribution structure 10, such as nylon. As shown in FIG. Fig.14A As shown in FIG, the tying element may be a single closure element 17 having a fixed end 18a coupled to a force distribution structure 10 associated with an upper surface of a first base structure 2a opposite to a second base structure 2b to which an adjustable end 18b of the closure element is coupled. The base structure may be curved to form an ellipse, circle, hexagon, square, etc.

[0096] One or more components of the incision closure appliance or incision closure appliance assembly disclosed herein include various base components, base panels, force distribution structures, axial supports, lateral supports, closure components, tethered components, tethered elements, belts, locks, adhesive layers, and one or more of the adhesive layers may include, be coated with, or otherwise contain one or more of antifungal materials, antibacterial materials, antimicrobial materials, antiseptic materials, or medicated materials. For example, such materials may be included in the hydrocolloid adhesive layer as another layer or coating (covering at least a portion of the adhesive layer) between the skin and the adhesive layer, included in the base component cover or at least in the adhesive layer of the base component cover, and the like. One or more wells, grooves, openings, pores, or similar structures may be provided on the device or equipment to facilitate such inclusion. In many embodiments, such materials may include one or more of silver, iodide, zinc, chlorine, copper, or natural materials such as tea tree oil as active agents. Examples of such antifungal materials, antibacterial materials, antimicrobial materials, antiseptic materials or medicated materials include, but are not limited to, Acticoat available from Smith & Nephew plc in the United Kingdom. TM . Series materials, Acticoat available from Smith & Nephew plc, UK TM Moisture Control series materials, available from Coloplast A / S in Denmark, are available in Contree TM Foam series materials, UrgoCell available from Urgo Limited in the UK (a subsidiary of Laboratoires URGO in France) TMSilver series materials, available from Smith & Nephew plc, UK TM Hydrocolloid series materials, Aquacel available from ConvaTec Inc., Skillman, NJ TM Ag series materials, Silvered available from Kinetic Concepts, Inc. of San Antonio, Texas TM Actisorb is a family of materials available from Kinetic Concepts, Inc. of San Antonio, Texas. TM Silver 220, available from Urgo Limited, UK (a subsidiary of Laboratoires URGO, France) as Urgotul TM SSD series materials, Inadine available from Kinetic Concepts, Inc., San Antonio, Texas TM Series of materials, Iodoflex available from Smith & Nephew plc, UK TM Series materials, Sorbsan Silver available from Aspen Medical Europe Ltd., UK TM series materials, Polymem Silver available from Ferris Mfg. Corp., Burr Ridge, Illinois TM Series materials, available from Kinetic Concepts, Inc. of San Antonio, Texas, as Promogram TM Series materials, available from Kinetic Concepts, Inc. of San Antonio, Texas, as Promogram Prisma TM series materials, and Arglaes available from Medline Industries, Inc. of Mundelein, Illinois TM Series of Materials. Components of the closure devices described herein may include, be coated with, or otherwise contain one or more of an antifungal material, an antibacterial material, an antimicrobial material, an antiseptic material, or a medicated material, including, but not limited to, one or more of the materials listed above.

[0097] In many embodiments, topical medicaments are directly included in the wound closure appliance described herein. Since wound closure devices are usually applied in the immediate vicinity of wounds or incisions that require medicinal protection, it would be beneficial to include such medicaments directly in the closure device. For example, in wounds with a risk of infection, it would be beneficial to include antimicrobial agents. Antimicrobial agents may include antibiotic drugs and antiseptic metal ions and related compounds, which may include silver, iodine, copper and chlorine or natural materials such as tea tree oil. For example, in wounds that are prone to fungus, a medicament such as zinc may be necessary. Any combination of these agents may also be beneficial and may therefore be included in the wound closure appliance.

[0098] Topical agents may be incorporated into the closure device to impart to the closure device the ability to wick exudate away from the wound (eg, to direct unwanted organisms away from the wound and / or to prevent skin maceration) while maintaining adequate hydration of the wound to improve healing.

[0099] According to another aspect of the present disclosure, after assembly of a closure device (e.g., closure apparatus 1), a coating may be applied to the outer surface to prevent adhesion to a wound dressing. An exemplary coating may be a non-sticky fluoropolymer coating applied and cured to the device 1, typically in a process that does not require a temperature exceeding 60°C for 5 minutes and more preferably at 45°C for any length of time. Although protection of all external surfaces may also be desirable, adhesion of the coating to the polyurethane film of the wound closure device is most desirable. The thickness of the fluoropolymer film may range from 0.25 microns to 5.0 microns, preferably about 1-3 microns. Coating is typically performed with a release liner or other suitable material in contact with the skin adhesive surface to prevent the coating from contaminating the skin adhesive. Such a coating will typically be applied as part of the manufacturing process so that no additional coating needs to be applied by the user. However, in other embodiments, just before the dressing is applied, the user may instead apply a preferably sterile oil-based liquid or gel to the outside of the closure device 1 to prevent adhesion. Examples include petrolatum and silicone oil.

[0100] Other coatings may be applied that have a desired curing temperature that does not damage the device adhesive (typically above 60°C). These coatings may include silicone compounds or oils (cured to a solid substance or uncured), parylene, and other coatings known in the art. The coating may preferably remain bonded to the closure device after the dressing is removed, however it may also function by hardening the applied adhesive and / or acting as a sacrificial layer that is pulled up with the dressing rather than the underlying device. Sacrificial coatings will be thicker, typically in the range of 0.0005"-0.010".

[0101] Although application to the entire completed device is preferred, the coating may be applied to selective areas of the device by masking the areas not to be coated. This may be useful if the coating is incorporated into an intermediate process that must subsequently apply component bonding to the uncoated areas of the device, or if coating of other components (e.g., locks and straps) results in undesirably low friction (e.g., the strap fails to remain engaged in the lock or the strap slips out of the user's hand). In other cases, the coating may be on a material that is applied separately to the device (e.g., a polyurethane film strip). This may be useful if the coating process requires elevated temperatures or uses solvents that are incompatible with the rest of the device.

[0102] In other embodiments, the coating material may have an antimicrobial compound incorporated into the coating. The coatings described above preferably conform to the device surface and remain adhered to the closure device at least until the wound dressing is applied. The coatings described also provide minimal resistance to stretching of the closure device (up to 50%), and the coatings themselves do not loose their protective effect when the dressing is worn against the closure device.

[0103] In other embodiments, an antimicrobial and / or topical medicinal agent may be applied to the wound or defect before, during, or after the device is applied to the skin. The antimicrobial and / or topical medicinal agent may be any of those agents mentioned herein.

[0104] Although preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Without departing from the present disclosure, those skilled in the art will now appreciate many variations, changes and substitutions. It should be understood that in practicing the invention of the present disclosure, various alternatives to the embodiments of the present disclosure described herein may be adopted. It is intended that the appended claims define the scope of the present invention, and that methods and structures within the scope of these claims and their equivalents are thereby encompassed.

Claims

1. A device for treating ulcers or skin defects, comprising: a first panel having a first adhesive base layer for adhering to the skin on a first side of the ulcer or skin defect; a second panel having a second adhesive base layer for adhering to the skin on a second side of the ulcer or skin defect; a plurality of lateral ties coupling the first panel and the second panel to each other; one or more liners coupled to the first adhesive primer layer and the second adhesive primer layer; a first casting sheet covering a top surface of the first panel, wherein the first casting sheet extends outwardly from lateral ends of the first panel; and a second casting sheet covering a top surface of the second panel, wherein the second casting sheet extends outwardly from a lateral end of the second panel, wherein the one or more liners include tabs extending outwardly from ends of the first and second cast sheets to assist in peeling the one or more liners from the first and second panels prior to adhering the first adhesive primer layer to the first side of the ulcer or skin defect and adhering the second adhesive primer layer to the second side of the ulcer or skin defect, wherein the first casting sheet can be removed from the top surface of the first panel after adhering the first adhesive base layer to the first side of the ulcer or skin defect, and Wherein, after adhering the second adhesive base layer to the second side of the ulcer or skin defect, the second casting sheet can be removed from the top surface of the second panel.

2. The device according to claim 1, wherein: The plurality of lateral ties are configured to maintain a separation distance of at least 10 mm between the inner lateral edges of the first panel and the second panel.

3. The device according to claim 1, wherein: The one or more liners include a first liner removably coupled to a first adhesive primer layer on the first panel and a second liner removably coupled to a second adhesive primer layer on the second panel.

4. The device according to claim 1, wherein: The first and second adhesive substrates of the first and second panels include a hydrocolloid adhesive.

5. The device according to claim 4, wherein: The first and second panels include a base layer positioned affixed to the hydrocolloid adhesive, the base layer being stiffer than the hydrocolloid adhesive, wherein the first and second panels each further include one or more force distribution structures coupled to the base layer, the force distribution structures being stiffer than the base layer.

6. The device according to claim 5, wherein: The first casting sheet and the second casting sheet do not cover the one or more force distribution structures.

7. The device according to claim 5, wherein: the plurality of lateral ties each having a fixed end coupled to the one or more force distribution structures of a first panel and an adjustable end coupled to the one or more force distribution structures of a second panel, wherein the plurality of lateral ties include one or more elastic members along the length of the plurality of lateral ties between the fixed end and the adjustable end, and Wherein, each of the one or more elastic members couples two of the plurality of lateral ties to each other.

8. The device of claim 1, wherein: The plurality of lateral ties are at least partially elastic.

9. The device of claim 8, wherein: The plurality of lateral ties are capable of at least partially disengaging and reengaging to provide access to the ulcer or skin defect for care.

10. The device of claim 1, wherein: The plurality of lateral ties are at least partially adjustable to reduce a separation distance between respective inner lateral edges of the first and second panels and apply a compressive force to tissue therebetween when the device is adhered to the skin.

11. The device of claim 1, wherein: One or more of the inner or outer edges of one or more of the first and second panels are sinusoidal or scalloped to minimize or distribute shear forces or minimize the formation of skin blisters.

12. The device of claim 1, wherein: The first panel includes a plurality of perforations extending in a direction generally parallel to an inner edge of the first panel, and Wherein, the second panel includes a plurality of perforations extending in a direction substantially parallel to an inner edge of the second panel.

13. A closure device for treating an ulcer or a skin defect, the closure device comprising: a first panel having a first adhesive bottom surface for adhering to the skin on a first side of the ulcer or skin defect; a second panel having a second adhesive bottom surface for adhering to the skin on a second side of the ulcer or skin defect, a plurality of lateral ties coupling the first and second panels to each other, wherein the first and second panels have respective longitudinal axes; and a plurality of liners coupled to the first and second adhesive bottom surfaces, wherein the plurality of liners are aligned in an orientation transverse to respective longitudinal axes of the first panel and the second panel, wherein the plurality of liners includes an intermediate liner positioned between a first adjacent liner and a second adjacent liner, and Wherein, the intermediate liner is configured to be removed from the first panel and the second panel before the first adjacent liner and the second adjacent liner are removed.

14. The closure device of claim 13, wherein: The first panel includes a first base layer, Wherein, the second panel includes a second base layer, wherein the first panel and the second panel each further include one or more force distribution structures coupled to the first base layer and the second base layer, respectively, and Wherein the one or more force distribution structures are stiffer than the first substrate and the second substrate.

15. The closure device of claim 13, wherein: The plurality of lateral ties are at least partially elastic.

16. The closure device of claim 15, wherein: The plurality of lateral linkages include elastic or spring members.

17. The closure device of claim 16, wherein: The resilient or spring member has a meandering configuration that couples the plurality of lateral ties to each other at locations between the first and second panels.

18. The closure device of claim 16, wherein: The plurality of lateral ties are capable of at least partially disengaging and reengaging to provide access to an ulcer or skin defect for care.

19. The closure device of claim 13, wherein: The plurality of lateral ties are at least partially adjustable to reduce a separation distance between respective inner lateral edges of the first and second panels and apply a compressive force to tissue therebetween when the closure device is adhered to the skin.

20. The closure device of claim 13, wherein: One or more of the inner or outer edges of one or more of the first and second panels are sinusoidal or scalloped to minimize or distribute shear forces or minimize the formation of skin blisters.

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