Wound closure systems, devices and methods incorporating therapeutic devices
By using a wound closure system with porous mesh and pressure-sensitive adhesive, the problem of difficulty in maintaining closed and controlled negative pressure during the healing process of surgical wounds is solved, and the proximity, closure and negative pressure treatment of wounds is achieved, reducing concurrency and dressing replacement needs.
Patent Information
- Application Number
- CN202380050767.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-06-30
- Filing Date
- 2023-06-29
- Publication Date
- 2025-02-18
AI Technical Summary
The prior art is difficult to achieve proximity, closure, controlled removal of effluents, maintain closure during healing, no need for dressing to be replaced, and allows controlled application of negative pressure.
Using a wound closure system including a porous mesh and a pressure-sensitive adhesive, the wound edge is brought close by the application of a pressure-sensitive adhesive and the treatment device is fixed with a fast polymerizable liquid adhesive to form an airtight seal to maintain closure and Apply negative pressure.
The proximity and closure of surgical wounds is achieved, the controlled removal of effluent is facilitated, complications during healing are reduced, the steps of dressing replacement are avoided, and the controllable application of negative pressure is allowed to promote healing.
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Figure CN119486691A_ABST
Abstract
Description
Background Art Technical Field
[0001] The present patent application relates generally to surgical procedures, and more particularly to systems, devices, and methods for closing wounds and promoting effective wound healing.
[0002] Description of Related Technology
[0003] During surgery, a surgical incision is an incision made through the skin and / or soft tissue to facilitate an operation or procedure. In many cases, multiple incisions may be required. Generally speaking, surgical incisions are made as small and unobtrusive as possible to facilitate safe and timely surgical conditions.
[0004] At the end of a surgical procedure, the surgical incision must be closed. Over the years, many different techniques have been developed to close surgical incisions. One widely used technique involves the use of sutures with a single knot or a series of knots. In recent years, absorbable sutures and barbed sutures have been used to close surgical incisions. In addition, surgical staples have been used to close surgical incisions, thereby reducing the amount of time required to close a surgical incision.
[0005] Other systems for closing wounds and incisions involve the use of mesh tapes that adhere to the skin. With these systems, the skin or tissue portions separated by the incision are approximated or brought close together by forming as narrow a gap as possible in the area of the surgical incision. The approximated incision is then covered with an adhesive mesh tape to keep the skin or tissue closed and juxtaposed until the wound heals, and the tape is then removed.
[0006] For example, Ethicon, Inc. of Somerville, New Jersey, The skin closure system sold under the trademark of TRANSACTION® comprises a mesh having a pressure sensitive adhesive and a polymerization initiator disposed on the mesh. The mesh is applied to a wound on the skin, and then a polymerizable cyanoacrylate-based adhesive is applied to the mesh and the mesh is bonded to the skin.
[0007] Another technical advancement is disclosed in the commonly assigned U.S. Patent No. 8,777,986 to Straehnz et al., which is hereby incorporated by reference herein for closing a surgical incision without using sutures or surgical staples. The 8,777,986 patent discloses an incision guide and a wound closure device, the wound closure device comprising a surgical mesh having a top surface and a bottom surface and a first incision guide and a second incision guide attached to the top surface of the surgical mesh. The bottom surface of the mesh is adhered to the tissue using a transparent or translucent adhesive. The first incision guide and the second incision guide have opposing alignment surfaces that are suitable for guiding a cutting instrument through the mesh and into the tissue for incision. The device has a closing element that is movable along the length of the respective first incision guide and the second incision guide to pull the first alignment surface and the second alignment surface toward each other, thereby closing the incision opening of the tissue.
[0008] US Patent Application Publication No. 2015 / 0314114 discloses a device for bandaging and treating wounds, skin lesions / ulcers, sores and burns, comprising at least one biocompatible membrane and at least one conduit coupled to the membrane.
[0009] U.S. Patent Application Publication No. 2014 / 0121649 discloses a surgical wound dressing assembly for surgical tube wounds or other devices entering the human body, including a covering layer having an adhesive on the outer periphery of the underside of the covering layer, an absorbent ring fixed to the underside of the covering layer, an internal transparent window allowing a nurse or other medical staff to view the wound site through the window to check for infection or bleeding, and a port formed in the window area to allow a tube or other device to pass through the wound dressing.
[0010] U.S. Patent No. 10,993,708 to Quintero et al., assigned to Ethicon, Inc. of Somerville, New Jersey, the disclosure of which is hereby incorporated by reference herein, teaches a skin closure device with an intermittent closure. The skin closure device includes a flat porous mesh that is elongated along a longitudinal axis and has an upper side, a lower side facing the wound, and a central portion immediately adjacent to the longitudinal axis. The flat porous mesh has a plurality of holes and windows formed in the flat porous mesh. The windows are significantly larger than the holes and are arranged along the longitudinal axis in the central portion. A crosslinking promoter or initiator or a polymerization promoter or initiator is disposed in or on the mesh, and a pressure-sensitive adhesive is disposed on at least a portion of the lower surface of the mesh.
[0011] Due to various comorbidities, some patients may require a wound closure system, some may require negative pressure wound therapy, some may require close monitoring using sensors, others may require wound drainage, and so on.
[0012] However, there is currently no single solution that can achieve access to a surgical wound, closure, controlled removal of exudate, maintain closure during healing, eliminate the need for dressing changes, and allow for controlled application of negative pressure.
[0013] Therefore, there remains a need for improved wound closure systems for patients with a variety of conditions. There is also a need for a universal, customizable, and / or highly versatile wound closure system that can be applied to a wound and accommodate additional modalities (e.g., negative pressure wound therapy devices; sensors), or that does not require accommodating additional modalities if not required. Summary of the invention
[0014] Patients with significant comorbidities often require advanced wound closure methods, including appropriate skin tissue approximation / closure and negative pressure, to minimize postoperative complications and delayed recovery time.
[0015] In one embodiment, the wound closure system preferably allows for surgical wound approximation, skin closure, exudate removal, maintains closure during healing, eliminates the need for dressing changes, and / or allows for controllable application of negative pressure.
[0016] In one embodiment, the wound closure system preferably provides controlled wound drainage, wound irrigation, wound cleansing, antimicrobial irrigation, administration of analgesic medications, and the like.
[0017] In one embodiment, the wound closure system preferably includes a mesh (e.g., a porous mesh) having a pressure sensitive adhesive (PSA) applied to both the bottom skin-facing surface for wound access and the top surface configured to secure one or more therapeutic devices, if desired.
[0018] In one embodiment, a pressure sensitive adhesive may be applied to both the top and bottom surfaces of the porous mesh.
[0019] In one embodiment, the pressure sensitive adhesive is covered by a liner (eg, a backing paper) that can be removed and / or peeled away to expose the pressure sensitive adhesive.
[0020] In one embodiment, the pressure sensitive adhesive applied to the bottom, skin-facing surface of the porous mesh is applied more firmly or more densely than the pressure sensitive adhesive applied to the top surface of the porous mesh.
[0021] In one embodiment, a polymerization catalyst or accelerator may be disposed in or on the porous mesh to promote or enhance the curing of the liquid adhesive.
[0022] In one embodiment, the wound closure system (also referred to herein as the skin closure system) preferably includes a porous mesh coated with a pressure-sensitive adhesive on both sides. The pressure-sensitive adhesive applied to the skin-facing surface of the bottom is used to make the wound edge (also referred to herein as the skin edge) close or close, and the pressure-sensitive adhesive applied to the top surface of the porous mesh provides a sticky surface (due to PSA) that allows one or more treatment devices (such as a drainage tube that can be connected to a negative pressure pump for draining wound exudate) to be placed (possibly repositioned) on the top of the porous mesh. The treatment device can also allow the introduction of drugs after surgery, or allow sensors to be placed on the porous mesh to monitor the wound. Once one or more treatment devices are in place and the wound is close, a liquid adhesive that can be rapidly polymerized or a liquid adhesive that can be rapidly cross-linked can be applied to the unfolded porous mesh, and one or more treatment devices are fixed on the top of the porous mesh.
[0023] When cured, the liquid adhesive preferably forms an air-tight or waterproof seal around the approximated wound or incision.
[0024] In one embodiment, a method of using a wound closure system may include removing a first liner from a skin-facing side of a mesh and positioning the mesh with the skin-facing side over a wound to approximate the wound.
[0025] In one embodiment, a method may include removing a second liner from an opposing top surface of a mesh and positioning a therapeutic device (eg, a negative pressure wound therapy device; a sensor; a medical device; an accessory, etc.) on the top surface of the mesh.
[0026] In one embodiment, after initial placement on top of the mesh, the therapeutic device can be pulled off the mesh and repositioned one or more times on the top surface of the mesh. It may be necessary to reposition the therapeutic device to obtain optimal or better therapeutic effect.
[0027] In one embodiment, a rapidly polymerizable adhesive may be applied to the top of the mesh and to at least a portion of the top of the therapeutic device.
[0028] In one embodiment, the adhesive is polymerized for use in bonding the porous mesh to the skin and / or wound and further bonding the therapeutic device to the porous mesh.
[0029] In one embodiment, the wound closure system preferably includes an adhesive mesh placed over the incision to close the incision. In one embodiment, both sides of the adhesive mesh have a pressure sensitive adhesive applied thereto. One side of the adhesive mesh is in close contact with the skin and is used to approximate the wound edges, and the other side of the adhesive mesh has a pressure sensitive adhesive for precisely placing tubing and other accessories (e.g., sensors; negative pressure wound therapy devices) over the incision line.
[0030] In one embodiment, a drain tube having holes and / or slits may be placed in contact with the top surface of the mesh to adhere to a pressure sensitive adhesive applied to the top surface of the mesh. In one embodiment, the drain tube may have two ends, a first end coupled to a vacuum device to drain exudate, and a second end comprising an inlet for injecting fluids, saline, or medications that may be infused into the wound or incision that has been approached. The primary function of the drain tube is to drain exudate from the incision.
[0031] The above-described wound closure system is highly customizable, whereby a healthcare provider can adjust the length of the drain tube as needed and can select which types of therapeutic devices should be secured to the top surface of the mesh (e.g., selecting which types of sensors are needed to monitor an approaching incision).
[0032] In one embodiment, a topical skin adhesive can be applied to the top of a treatment device (e.g., an elongated tube) fixed to the top surface of the mesh. The tubing and treatment device (e.g., a sensor) can be aligned with the incision line. Once cured, the adhesive preferably forms a firm airtight seal around the incision. The adhesive can also form a waterproof and / or antimicrobial barrier and can further enable medical personnel to monitor the wound healing process. The topical skin adhesive can be any rapidly polymerizable biocompatible adhesive known to those skilled in the art or a rapidly cross-linkable biocompatible adhesive. In one embodiment, the topical skin adhesive can be a cyanoacrylate-based adhesive, such as those manufactured by Ethicon, Inc. of Somerville, New Jersey, with the Skin Adhesive - A 2-octyl cyanoacrylate based adhesive sold under the trademark SKIN ADHESIVE® Topical Skin Glue. Alternatively, the adhesive system may be manufactured by Ethicon, Inc. of Somerville, New Jersey, under the trademark SKIN ADHESIVE®. -Sold under the trademark of the skin closure system. In certain embodiments, some cyanoacrylate-based adhesives may act in synergy with a promoter or polymerization catalyst disposed on the mesh. Alternatively, the topical skin adhesive may be, for example, a two-component silicone skin or tissue adhesive, such as the adhesive disclosed in US 2021 / 0371658 and US2021 / 0369639, which have been assigned to Ethicon, Inc. of Somerville, New Jersey, and the disclosures of these patent applications are hereby incorporated herein by reference. Other silicone-based adhesive systems have been disclosed in, for example, U.S. Patent Nos. 10,533,074 and 11,161,937, both of which have been assigned to Ethicon, Inc. of Somerville, New Jersey, and the disclosures of these patents are hereby incorporated herein by reference. In one embodiment, the silicone adhesive may include a composition comprising a cross-linkable silicone polymer having a reactive functional group; a composition containing silica; a silicone cross-linking agent; and a catalyst. In one embodiment, the catalyst comprises a platinum tetramethyl divinyl disiloxane diethyl maleate complex. The crosslinkable silicone polymer may be selected from the group consisting of vinyl terminated polydialkylsiloxanes, vinyl terminated polydimethylsiloxanes, vinyl terminated polydiphenylsilane-dimethylsiloxane copolymers, vinyl terminated polyphenylmethylsiloxanes, vinyl terminated polyfluoropropylmethyl-dimethylsiloxane copolymers, vinyl terminated polydiethylsiloxanes, and SiH terminated polydimethyldisiloxanes. In one embodiment, the silica-containing composition may include a trimethylsilyl surface treated silica filler. The silicone crosslinker may be selected from the group consisting of polymethylhydrogensiloxanes, polymethylhydrogen-co-polydimethylsiloxanes, polyethylhydrogensiloxanes, polymethylhydrogensiloxane-co-octylmethylsiloxanes, and polymethylhydrogensiloxane-co-methylphenylsiloxanes.
[0033] In one embodiment, the wound closure system preferably includes a porous mesh having a top surface and a bottom surface, a first pressure-sensitive adhesive applied to the top surface of the porous mesh, a removable first liner covering the first pressure-sensitive adhesive, a second pressure-sensitive adhesive applied to the bottom surface of the porous mesh, and a removable second liner covering the second pressure-sensitive adhesive.
[0034] In one embodiment, the second pressure-sensitive adhesive is stronger or denser than the first pressure-sensitive adhesive. In one embodiment, the second pressure-sensitive adhesive has a greater bond strength than the first pressure-sensitive adhesive. In one embodiment, the first pressure-sensitive adhesive and the second pressure-sensitive adhesive may have the same bond strength, however, the mass or volume of the second pressure-sensitive adhesive applied to the bottom surface of the porous mesh is greater relative to the mass / volume of the first pressure-sensitive adhesive applied to the top surface of the porous mesh.
[0035] In one embodiment, the cross-linking promoter or catalyst or the polymerization promoter or catalyst is preferably disposed in or on the porous mesh.
[0036] In one embodiment, the porous mesh is flat, elongated along a longitudinal axis, and has a plurality of openings (eg, pores) extending between its top and bottom surfaces.
[0037] In one embodiment, the removable first liner is configured to be peelable from the top surface of the porous mesh for exposing the first pressure sensitive adhesive.
[0038] In one embodiment, the removable second liner is configured to be peeled away from the bottom surface of the porous mesh for exposing the second pressure sensitive adhesive.
[0039] In one embodiment, a method of using the wound closure system disclosed herein may include peeling a removable second liner from the bottom surface of the porous mesh to expose a second pressure-sensitive adhesive applied to the bottom surface of the porous mesh, and pressing the second pressure-sensitive adhesive applied to the bottom surface of the porous mesh against the patient's skin to approximate the opposing edges of the wound.
[0040] In one embodiment, the method may include peeling a removable first liner from the top surface of the porous mesh to expose a first pressure-sensitive adhesive applied to the top surface of the porous mesh, and pressing a therapeutic device against the first pressure-sensitive adhesive to secure the therapeutic device to the top surface of the porous mesh.
[0041] In one embodiment, the method may include applying a liquid adhesive to the top surface of the porous mesh and to at least a portion of the therapeutic device, and curing the liquid adhesive to bond the porous mesh to the skin and the therapeutic device to the porous mesh.
[0042] In one embodiment, the liquid adhesive preferably includes a rapidly polymerizable liquid adhesive or a rapidly cross-linkable liquid adhesive.
[0043] In one embodiment, the treatment device is aligned with the wound before being pressed against the top surface of the porous mesh. In one embodiment, if the treatment device is not properly aligned with the wound, it can be lifted off the top surface of the porous mesh and repositioned one or more times until the treatment device is aligned with the wound.
[0044] In one embodiment, the therapeutic device may be used to drain exudate from a wound or to infuse saline or medication into a wound.
[0045] The treatment device can be a medical device, including but not limited to a negative pressure wound treatment device, a negative pressure pump, a fluid suction device, a slender tube (including a drainage tube and an infusion tube), a slender tube having a first mesh wing and a second mesh wing extending along the side of the slender tube, a cannula, a wound monitoring sensor, a camera, and combinations thereof.
[0046] In one embodiment, a kit for treating a wound may include a wound closure system having a porous mesh with a top surface and a bottom surface, a first pressure-sensitive adhesive applied to the top surface of the porous mesh, a removable first liner covering the first pressure-sensitive adhesive, a second pressure-sensitive adhesive applied to the bottom surface of the porous mesh, and a removable second liner covering the second pressure-sensitive adhesive, the second pressure-sensitive adhesive being stronger or denser than the first pressure-sensitive adhesive.
[0047] In one embodiment, the kit preferably includes a rapidly polymerizable liquid adhesive disposed within a dispenser container.
[0048] In one embodiment, the kit may include one or more treatment devices configured to be fixed on the top surface of the porous mesh. The one or more treatment devices may include a negative pressure wound treatment device, a negative pressure pump, a fluid suction device, an elongated tube including a drainage tube and an infusion tube, an elongated tube having a first mesh wing and a second mesh wing extending along the side of the elongated tube, a cannula, and a wound monitoring sensor.
[0049] In one embodiment, a cross-linking accelerator or catalyst or a polymerization accelerator or catalyst may be disposed in or on the porous web for interaction with the rapidly polymerizable liquid adhesive disposed within the dispenser container.
[0050] In one embodiment, the wound closure system advantageously comprises a porous mesh having a top surface and a bottom surface, the bottom surface of the porous mesh being adhered to the skin to approximate the opposing edges of the wound, and a treatment device comprising an elongated tube secured to the top surface of the porous mesh and covering the wound, the elongated tube being configured to drain exudate from the wound.
[0051] In one embodiment, the wound closure system preferably includes a liquid adhesive covering the top surface of the porous mesh and at least a portion of the elongated tubes.
[0052] In one embodiment, the treatment device may include first and second mesh wings secured to the elongated tube and extending along respective sides of the elongated tube.
[0053] In one embodiment, a liquid adhesive preferably covers the first mesh wing and the second mesh wing for securing the therapeutic device to the top surface of the porous mesh.
[0054] In one embodiment, the elongated tube may include a first elongated conduit coupled to a vacuum pump or negative pressure pump for draining exudate from the wound.
[0055] In one embodiment, the elongated tube may include a second elongated conduit coupled to a positive pressure pump configured to press saline or medication into the elongated tube to infuse the wound with saline or medication.
[0056] In one embodiment, the liquid adhesive may be a topical skin adhesive or a rapidly polymerizable adhesive that forms an airtight seal around a wound.
[0057] In one embodiment, the hermetic seal formed by the liquid adhesive may be waterproof or may include an antimicrobial barrier.
[0058] In one embodiment, a crosslinking accelerator or catalyst or a polymerization accelerator or catalyst may be disposed in or on the porous mesh. The crosslinking accelerator or catalyst or the polymerization accelerator or catalyst preferably interacts with the liquid adhesive applied to the mesh to rapidly cure the adhesive.
[0059] In one embodiment, the wound closure system may be secured to the wound and remain in place for about 7 to 14 days.
[0060] In one embodiment, during treatment of a wound, the therapeutic device can be removed from the mesh after being adhered to the top of the mesh.
[0061] In one embodiment, during treatment of a wound, a first treatment device may be removed from being secured on top of the mesh and replaced with a second treatment device secured on top of the mesh. The first treatment device and the second treatment device may have different functions and / or capabilities.
[0062] In one embodiment, a wound closure system may include one or more drain tubes having different lengths, whereby the one or more drain tubes may be customized to fit the length of the drain tube to the length of the wound or incision.
[0063] In one embodiment, the drain tube may be transparent or partially transparent to allow a medical professional to view the wound or incision beneath the drain tube, which may help the medical professional align the drain tube with the wound or incision.
[0064] In one embodiment, the drain tube may be made of silicone.
[0065] In one embodiment, a pressure sensitive adhesive can be applied directly to a therapeutic device (e.g., an elongated tube, a drainage tube, a negative pressure wound therapy device, a sensor, etc.) such that the therapeutic device can be adhered to the mesh or skin adjacent to an approximate wound edge or an approximate skin edge.
[0066] In one embodiment, the liquid adhesive or topical skin adhesive applied to the therapeutic device may have antimicrobial properties, anticoagulant properties, antifouling properties, and / or anti-occlusion properties.
[0067] In one embodiment, the wound closure system may include a first layer (e.g., a first mesh; a bottom mesh) of a porous dressing having a top surface and a bottom surface. In one embodiment, the top surface and / or the bottom surface of the first layer of the porous dressing may be adhesive and / or have an adhesive (e.g., a pressure sensitive adhesive) disposed thereon.
[0068] In one embodiment, the first layer of the porous dressing may include a bottom surface that is sticky or has an adhesive (e.g., a pressure sensitive adhesive) applied thereto for securing (e.g., adhering) the first layer of the porous dressing to tissue (e.g., skin).
[0069] In one embodiment, a therapeutic device (e.g., a drainage tube; a suction device; a sensor) can be positioned on the top surface of the first layer of the porous dressing. In one embodiment, the therapeutic device can have an adhesive surface or have an adhesive applied thereto to attach the therapeutic device to the top surface of the first layer of the porous dressing.
[0070] In one embodiment, the therapeutic device may have an elongated channel configured for draining a wound or incision. In one embodiment, the bottom surface of the therapeutic device may have one or more fenestrations formed therein that communicate with the elongated channel and are positioned against the top surface of the first layer of the porous dressing. In one embodiment, the therapeutic device has a sticky bottom surface and / or has an adhesive provided thereon for securing the bottom surface of the therapeutic device to the top surface of the first layer of the porous dressing.
[0071] In one embodiment, the wound closure system may include a second layer (e.g., a second mesh; a top mesh) of a porous dressing having a top surface and a bottom surface. In one embodiment, the bottom surface of the second layer of the porous dressing is positioned over a therapeutic device (e.g., a drainage tube; a suction device; a sensor) and the top surface of the first layer of the porous dressing. The second layer of the porous dressing may be flexible to conform to the shape of the therapeutic device. In one embodiment, the bottom surface of the second layer of the porous dressing may be adhesive and / or include an adhesive for securing the second layer of the porous mesh to one or more surfaces of the therapeutic device and / or the first layer of the porous dressing.
[0072] In one embodiment, one or more surfaces of the therapeutic device may be sticky and / or have an adhesive applied thereto for attaching the second layer of the porous dressing to the therapeutic device.
[0073] In one embodiment, where the second layer of the porous dressing is positioned on the first layer of the porous dressing and the therapeutic device is disposed therebetween, the flowable adhesive can be applied to the second layer of the porous dressing, the first layer of the porous dressing, and the therapeutic device disposed between the second layer of the porous dressing and the first layer of the porous dressing.
[0074] In one embodiment, the therapeutic device can be a suction device placed on top of a wound or incision and held in place by one or more layers of porous dressings and a local skin adhesive. In one embodiment, the therapeutic device has one or more connection ports at which fluid can be infused into and / or discharged from a wound or incision. One or more connection ports can be located on the top or side of the therapeutic device. In one embodiment, a first connection port can be attached to a vacuum device via a pipeline to apply negative pressure to a wound or incision. In one embodiment, a second connection port can be attached to a pipeline configured to be able to infuse a therapeutic solution (e.g., saline; medicine) into a wound or incision.
[0075] In one embodiment, the therapeutic device may be transparent to enable medical personnel to monitor the wound or incision during healing.
[0076] In one embodiment, the treatment device can be cut to a length that matches the length of the wound or incision.
[0077] In one embodiment, the therapeutic device may be attached to a pump or drain.
[0078] In one embodiment, the therapeutic device may have a low profile to minimize the distance the therapeutic device protrudes above the skin surface.
[0079] In one embodiment, the therapeutic device may be made of silicone.
[0080] The wound closure system disclosed herein may be used in patients with severe comorbidities who require advanced wound closure methods, including providing adequate skin tissue approximation / closure and negative pressure wound therapy, to minimize post-operative complications and delayed recovery time.
[0081] The wound closure systems disclosed herein preferably enable healthcare professionals to achieve access to surgical wounds, wound closure, controlled removal of exudate, maintain closure during healing, eliminate the need for dressing changes, and apply negative pressure wound therapy in a controlled manner.
[0082] The disclosed wound closure systems can be used for wound drainage, wound irrigation, wound cleansing, antimicrobial irrigation, analgesic medication administration, and the like.
[0083] In one embodiment, the wound closure system can be placed on the top of the wound or incision and held in place by a local skin adhesive. In one embodiment, the therapeutic device has one or more connection ports, at which fluid can be infused into the wound or incision and / or extracted from the wound or incision. The connection port can be located on the top or side of the therapeutic device. A connection port can be attached to a vacuum device via a pipeline to apply negative pressure to the wound or incision. A connection port can be attached to a pipeline to infuse saline or a drug into the wound or incision.
[0084] In one embodiment, a method of closing a wound may include approximating the edges of a wound or incision using a first layer of a porous dressing and positioning a therapeutic device (e.g., a drain; a suction device; a sensor) on a top surface of the first layer of the porous dressing.
[0085] In one embodiment, the method preferably includes securing the therapeutic device to the top surface of the first layer of the porous dressing such that the elongated channel of the therapeutic device is positioned on the top surface of the first layer of the porous dressing, wherein the elongated channel is positioned adjacent to the wound or incision.
[0086] In one embodiment, the method preferably includes applying a second layer of the porous dressing over the first layer of the porous dressing and the therapeutic device to secure the elongated channels of the therapeutic device to the top surface of the first porous dressing.
[0087] In one embodiment, the method includes applying a flowable adhesive to a first layer of a porous dressing, a second layer of a porous dressing, and a therapeutic device. The flowable adhesive can cure to form an airtight seal around a wound or incision.
[0088] In one embodiment, the method preferably includes attaching a tube to the treatment device for draining fluid (e.g., exudate) from or for infusing fluid into the elongated channel of the treatment device. In one embodiment, the tube can be attached to a vacuum device for applying negative pressure to the wound to drain the wound. In one embodiment, the tube can be attached to a source of a treatment solution (e.g., saline; medication; antibiotic solution) to infuse the treatment solution into the wound or incision.
[0089] In one embodiment, the elongated channel of the treatment device (e.g., a drainage tube; a suction device) advantageously has two connection ports at which fluids can be infused into the wound or incision and / or withdrawn from the wound or incision.
[0090] In one embodiment, the connection port may be located on the top or on one or more sides of the treatment device.
[0091] In one embodiment, the connection port may be attached via tubing to a vacuum device configured to apply negative pressure to the wound or incision.
[0092] In one embodiment, the connection port can be attached to an infusion tube to infuse a therapeutic solution (eg, saline; medication; antibiotics) into the wound or incision.
[0093] In one embodiment, the elongated channel of the treatment device may have a T-shaped cross-sectional shape.
[0094] In one embodiment, the flowable adhesive cures into a transparent covering to enable medical personnel to view the wound or incision during healing.
[0095] In one embodiment, the flowable adhesive is a silicone material.
[0096] In one embodiment, the treatment device preferably has a low profile (eg, a speed bump shape) with tapered edges.
[0097] In one embodiment, the treatment device has an elongated channel that opens at the bottom surface of the treatment device for providing suction in direct contact with the wound or incision.
[0098] These and other preferred embodiments of the present patent application are described in more detail herein. BRIEF DESCRIPTION OF THE DRAWINGS
[0099] Figure 1 is a schematic diagram of a wound closure system according to an embodiment of the present patent application, the wound closure system comprising a porous mesh having a top surface and a bottom surface, a first pressure-sensitive adhesive covering the top surface of the porous mesh, a second pressure-sensitive adhesive covering the bottom surface of the porous mesh, a removable top liner covering the top surface of the porous mesh, and a removable bottom liner covering the bottom surface of the porous mesh.
[0100] Figure 2 According to one embodiment of the present patent application Figure 1 A top view of a removable top liner shown in , the removable top liner comprising a central portion and a first peripheral portion and a second peripheral portion defining the central portion.
[0101] Figure 3 According to one embodiment of the present patent application Figure 1 A bottom view of a removable bottom liner shown in , the removable bottom liner comprising a central portion and a first peripheral portion and a second peripheral portion defining the central portion.
[0102] Figure 4 According to one embodiment of the present patent application Figure 1A top view of a porous mesh shown in FIG. 1 , the top surface of the porous mesh being covered by a first pressure-sensitive adhesive.
[0103] Figure 5 According to one embodiment of the present patent application Figure 1 A bottom view of the porous mesh shown in FIG. 1 , the bottom surface of the porous mesh being covered by a second pressure-sensitive adhesive.
[0104] Figure 6 An embodiment of the present patent application is shown. Figure 1 The bottom surface of the porous mesh is secured to the skin by a second pressure-sensitive adhesive, and the treatment device is secured to the top surface of the porous mesh by a first pressure-sensitive adhesive.
[0105] Figure 7 yes Figure 6 Top view of the porous mesh and therapeutic device shown in .
[0106] Figure 8 According to one embodiment of the present patent application, a liquid adhesive is applied to Figure 6 and Figure 7 The porous mesh and treatment device shown in the method.
[0107] Fig. 9A A first stage of a method of securing a wound closure system to an incision formed in the skin of a patient according to one embodiment of the present patent application is shown.
[0108] Fig. 9B A second stage of a method of securing a wound closure system to an incision formed in the skin of a patient according to one embodiment of the present patent application is shown.
[0109] Fig. 9C A third stage of a method of securing a wound closure system to an incision formed in the skin of a patient according to one embodiment of the present patent application is shown.
[0110] Fig.9D A fourth stage of a method of securing a wound closure system to an incision formed in the skin of a patient according to one embodiment of the present patent application is shown.
[0111] Fig.9E A fifth stage of a method of securing a wound closure system to an incision formed in the skin of a patient according to one embodiment of the present patent application is shown.
[0112] Fig. 10A A porous mesh is shown secured to an incision formed on a patient according to one embodiment of the present patent application.
[0113] Fig. 10BA peelable liner according to one embodiment of the present patent application is shown. Fig. 10A The top surface of the porous mesh shown in FIG. 1 is peeled off.
[0114] Fig. 10C The elongated tube with mesh wings according to one embodiment of the present patent application is shown to be fixed in Fig. 10B On the top surface of the porous mesh shown in .
[0115] Fig. 10D An embodiment of the present patent application is shown. Fig. 10B and Fig. 10C An elongated tube with mesh wings and a liquid adhesive on a porous mesh is shown in FIG.
[0116] Fig.11A A porous mesh secured to an incision formed in a patient's body according to one embodiment of the present patent application is shown, the porous mesh having first and second peripheral portions of a releasable top liner covering a top surface of the porous mesh.
[0117] Fig. 11B FIG. 1 shows a top liner after the first peripheral portion and the second peripheral portion of the peelable top liner have been peeled off to fully expose the top surface of the porous mesh according to one embodiment of the present patent application. Fig.11A porous mesh.
[0118] Fig. 11C The positioning according to one embodiment of the present patent application is shown in Fig. 11B The elongated tube on the top surface of the porous mesh shown in FIG. 1 is roughly aligned with the incision formed in the patient's body.
[0119] Fig.11D An embodiment of the present patent application is shown in FIG. Fig. 11C The curable adhesive on the top surface of the elongated tube and the porous mesh is shown in FIG.
[0120] Fig.12 A perspective view of a wound closure system according to an embodiment of the present patent application is shown. The wound closure system includes Fig. 11B The porous mesh close to the skin edge of the incision shown in FIG. Fig.11D A slender tube in the incision, a drainage tube connected to the slender tube fluid for draining body fluids from the incision, and an injection tube connected to the slender tube fluid for infusing saline or drugs into the incision shown.
[0121] Fig.13 is a top plan view of a porous web having a releasable liner covering a central region of a top surface of the porous web according to one embodiment of the present patent application.
[0122] Fig.14A A device having a plurality of electrodes positioned on a patient's wound according to an embodiment of the present patent application is shown. Fig.13 A porous mesh with a peelable liner.
[0123] Fig. 14B Shows the application of Fig.14A The porous web and liquid adhesive on the release liner shown in .
[0124] Fig. 14C Shows Fig. 14B The porous mesh and liquid adhesive, at this time Fig. 14B The peelable liner in has been peeled off from the top surface of the porous mesh to expose the central area of the top surface of the porous mesh.
[0125] Fig.14D Shows the positioning Fig. 14C The therapeutic device is shown on the central area of the top surface of the porous mesh.
[0126] Fig.15 A cross-sectional view of a treatment device according to one embodiment of the present patent application is shown, the treatment device comprising an elongated channel extending along the length of the treatment device and a fenestration communicating with the elongated channel. DETAILED DESCRIPTION
[0127] Reference Figure 1 In one embodiment, the wound closure system 100 preferably includes a porous mesh 102 having a top surface 104, a bottom surface 106, and a plurality of openings 108 (e.g., holes) extending between the top and bottom surfaces of the porous mesh. In one embodiment, the porous mesh can be used to approximate opposing skin edges of a wound or incision. As used herein, the terms wound and incision can be used interchangeably. As used herein, the terms wound approximation, incision approximation, and skin approximation can be used interchangeably.
[0128] The porous mesh 102 may be woven, nonwoven, extruded, stamped, perforated, molded, etc. In one embodiment, the porous mesh may be similar to the porous mesh manufactured by Ethicon, Inc. of Somerville, New Jersey under the federally registered trademark In one embodiment, the porous mesh 102 may be coated and / or impregnated with an initiator or promoter of polymerization.
[0129] The porous mesh 102 may have any shape necessary to cover a wound or incision, such as an oval, a circle, a rectangle, a square, etc. The aspect ratio of the porous mesh may be about 2:1 to 20:1. In one embodiment, the length of the porous mesh 102 may be about 10 cm to 50 cm. In one embodiment, the width of the porous mesh 102 may be about 2 cm to 10 cm.
[0130] In one embodiment, the openings 108 of the porous mesh 102 can be any shape, including circular, rectangular, triangular, oval, etc. The diameter of the openings 108 can be about 0.2 mm to 2 mm. In one embodiment, the area of a single opening 108 can be about 0.04 mm. 2 To about 4mm 2 .
[0131] In one embodiment, the wound closure system 100 preferably includes a first pressure-sensitive adhesive 110 covering the top surface 104 of the porous mesh 102. In one embodiment, a removable top liner 112 advantageously covers the first pressure-sensitive adhesive 110 and the top surface 104 of the porous mesh 102. In one embodiment, the removable top liner can be peeled off from the top surface 104 of the porous mesh 102 to expose the first pressure-sensitive adhesive 110 covering the top surface of the porous mesh. The first pressure-sensitive adhesive 110 covering the top surface 104 of the porous mesh 102 can be used to secure a therapeutic device, such as a negative pressure wound therapy (NPWT) device, to the top surface of the porous mesh.
[0132] In one embodiment, the wound closure system 100 preferably includes a second pressure-sensitive adhesive 114 covering the bottom surface 106 of the porous mesh 102. In one embodiment, a removable bottom liner 116 advantageously covers the second pressure-sensitive adhesive 114 and the bottom surface 106 of the porous mesh 102. The removable bottom liner can be peeled off from the bottom surface 106 of the porous mesh 102 to expose the second pressure-sensitive adhesive 114 covering the bottom surface of the porous mesh. The second pressure-sensitive adhesive 114 covering the bottom surface 106 of the porous mesh 102 can be used to secure the porous mesh to the patient's skin to approximate the opposing edges of a wound or incision.
[0133] In one embodiment, the releasable top liner 112 and bottom liner 116 may be made of synthetic or natural polymers that may be easily peeled from the respective first pressure sensitive adhesive 110 and second pressure sensitive adhesive 114 .
[0134] Reference Figure 2 In one embodiment, the porous mesh 102 ( Figure 1) of the top surface 104 of the removable top liner 112 preferably includes a central section 118 extending on the center of the porous mesh and a first peripheral section 120A and a second peripheral section 120B defining opposite sides of the central section 118. In one embodiment, the central section 118 and the first peripheral section 120A and the second peripheral section 120B of the removable top liner 112 can be removed from the porous mesh 102 ( Figure 1 ) is peeled off from the top surface 104 of the removable top liner 112 to expose the top surface of the first pressure-sensitive adhesive and the porous mesh. The central section 118 and the first and second peripheral sections can be removed from the top surface of the porous mesh independently of each other. For example, the central section 118 of the removable top liner 112 can be peeled off from the porous mesh so that the surgeon can view the wound or incision through the porous mesh to align the porous mesh with the incision. When the porous mesh is aligned with the wound or incision, the first and second peripheral sections can be grasped by the surgeon to control and manipulate the porous mesh. In one embodiment, after the porous mesh has been fixed to the skin, the first and second peripheral sections 120A, 120B of the removable top liner 112 can be peeled off from the top surface of the porous mesh.
[0135] refer to Figure 3 In one embodiment, removing the bottom liner 116 advantageously covers the porous mesh 102 ( Figure 1 ) bottom surface 106. In one embodiment, the removable bottom liner 116 preferably includes a central section 122 and a first peripheral section 124A and a second peripheral section 124B defining opposite sides of the central section 122. In one embodiment, the central section 122 and the first peripheral section 124A and the second peripheral section 124B of the removable bottom liner 116 can be independently removed from the porous mesh 102 ( Figure 1 ) from the bottom surface 106 of the porous mesh. For example, the central section 122 of the removable bottom liner 116 can be peeled off from the bottom surface of the porous mesh so that the surgeon can view the incision through the porous mesh to align the porous mesh with the incision, and then the surgeon can approximate the opposite edges of the incision. When the bottom surface of the porous mesh is used to approximate the skin edges, the first peripheral section 120A and the second peripheral section 120B can initially remain in place. In one embodiment, after the porous mesh has been properly aligned with the incision, and after the opposite edges of the incision have been approximated, the first peripheral section 120A and the second peripheral section 120B of the removable bottom liner 116 can be peeled off from the bottom surface of the porous mesh to further be used to fix the bottom surface of the porous mesh to the skin around the incision.
[0136] Reference Figure 4In one embodiment, the wound closure system 100 advantageously includes a first pressure-sensitive adhesive 110 ( Figure 1 In one embodiment, the first pressure sensitive adhesive 110 may include a plurality of first pressure sensitive adhesive traces 110A to 110M extending on the top surface 104 of the porous mesh 102. The first pressure sensitive adhesive traces 110A to 110M may be spaced apart from each other on the top surface of the porous mesh.
[0137] The first pressure-sensitive adhesive traces 110A to 110M may be in the form of linear segments of pressure-sensitive adhesive (eg, Figure 4 ), and may extend at any angle relative to the length of the porous mesh 102. In one embodiment, the first pressure-sensitive adhesive 110 covering the top surface 104 of the porous mesh 102 may have a non-linear shape, such as a circle, square, oval, dot, and the like.
[0138] Reference Figure 5 In one embodiment, the wound closure system 100 preferably includes a second pressure-sensitive adhesive 114 ( Figure 1 In one embodiment, the second pressure sensitive adhesive 114 may include a plurality of second pressure sensitive adhesive traces 114A to 114Y extending on the bottom surface 106 of the porous mesh 102. The second pressure sensitive adhesive traces 114A to 110Y may be spaced apart from each other on the bottom surface of the porous mesh.
[0139] The second pressure-sensitive adhesive traces 114A to 114Y may be in the form of linear segments of pressure-sensitive adhesive (eg, Figure 5 ), and can extend at any angle relative to the length of the porous mesh 102. In one embodiment, the second pressure-sensitive adhesive 114 on the bottom surface 106 of the porous mesh 102 can have a non-linear shape, such as a circle, square, oval, dot, etc.
[0140] Reference Figure 4 and Figure 5In one embodiment, the number of second pressure-sensitive adhesive traces 114A to 114Y covering the bottom surface 106 of the porous mesh 102 is greater than the number of first pressure-sensitive adhesive traces 110A to 110M covering the top surface 104 of the porous mesh. In one embodiment, the first pressure-sensitive adhesive traces 110A to 110M covering the top surface of the porous mesh 102 may include an adhesive with a lower viscosity than the adhesive used to form the second pressure-sensitive adhesive traces 114A to 114Y covering the bottom surface of the porous mesh. In one embodiment, the consistency of the first pressure-sensitive adhesive traces 110A to 110M covering the top surface of the porous mesh 102 may be less than the consistency of the second pressure-sensitive adhesive traces 114A to 114Y covering the bottom surface of the porous mesh. Utilizing a trace of low viscosity and / or consistency pressure sensitive adhesive on the top surface of the porous mesh will ensure that removal of the top liner 112 will not pull the porous mesh 102 away from the skin, removal of the top liner will not change the proximity of the skin edges, and the therapeutic device can be lifted off the top surface of the porous mesh and repositioned on the top surface of the porous mesh without pulling the porous mesh away from the patient's skin.
[0141] In one embodiment, the first pressure-sensitive adhesive and the second pressure-sensitive adhesive may include water-soluble pressure-sensitive adhesives, including hydrocolloids; homopolymer emulsions (PVA); water-based acrylic adhesives; polyurethane dispersions (PUD); polyethylene glycol; dextrin / starch-based adhesives; N-vinyl pyrrolidone copolymers; polyvinyl alcohol; cellulose ethers; methyl cellulose; carboxymethyl cellulose; polyvinyl pyrrolidone; polyvinyl acetate, or water-insoluble pressure-sensitive adhesives, including acrylic adhesives; cyanoacrylate adhesives; epoxy resins; silicone-based adhesives; and urethanes.
[0142] Reference Figure 6 In one embodiment, the porous mesh 102 is positioned over a wound formed in tissue. The porous mesh is preferably used to approximate the opposing skin edges of the wound. The removable bottom liner 116 ( Figure 1 ) is peeled off from the bottom surface 106 of the porous mesh 102 to expose the second pressure-sensitive adhesive 114 (e.g., Figure 5 A second pressure sensitive adhesive 114 covering the bottom surface of the porous mesh 102 can be pressed against the patient's skin for securing the bottom surface 106 of the porous mesh 102 to the skin and / or for approximating opposing skin edges of a wound.
[0143] The porous mesh 102 is used to approximate and maintain the wound edges in juxtaposition or very close proximity, using second pressure sensitive adhesive traces 114A to 114Y ( Figure 5 ) to secure the porous mesh and to ensure that the opposing edges of the wound are juxtaposed or very close.
[0144] In one embodiment, after the porous mesh 102 has been secured to the skin to approximate the skin edges of the wound, the removable top liner 112 ( Figure 1 ) can be peeled off from the top surface 104 of the porous mesh 102 to expose the first pressure sensitive adhesive 110 covering the top surface 104 of the porous mesh 102.
[0145] In one embodiment, a therapeutic device 126, such as a negative pressure wound therapy (NPWT) device, can be pressed onto the first pressure-sensitive adhesive 110 covering the top surface 104 of the porous mesh 102 for securing the therapeutic device 126 to the top surface 104 of the porous mesh 102. The therapeutic device can be activated to generate negative pressure and / or vacuum to drain body fluids from the wound. In one embodiment, the wound closure system 100 preferably includes a cannula 128 that can be coupled to the therapeutic device 126 for draining fluids (e.g., wound exudate) aspirated by the therapeutic device 126.
[0146] Reference Figure 7 In one embodiment, the porous mesh 102 is fixed to the wound. A second pressure-sensitive adhesive 114 ( Figure 6 ) is used to secure the bottom surface of the porous mesh 102 to the skin. In one embodiment, the wound is visible through the porous mesh 102, which facilitates alignment of the porous mesh with the wound. The surgeon can manipulate the porous mesh 102 (e.g., repeatedly lift, reposition, and / or smooth the porous mesh) to approximate the opposing skin edges of the wound. In one embodiment, the treatment device 126 can be pressed against the first pressure-sensitive adhesive 110 ( Figure 6 ) to adhere the treatment device 126 to the top surface of the porous mesh. A cannula 128 can be connected to the treatment device 126 to drain fluid from the wound.
[0147] In one embodiment, the longitudinal axis of the porous mesh 102 is aligned with and superimposed on the wound. The porous mesh is positioned on the wound so that the longitudinal axis is aligned with the wound and overlaps the ends of the wound (ie, the longitudinal axis of the porous mesh is aligned with the wound or surgical incision).
[0148] Reference Figure 8In one embodiment, a liquid adhesive 130 (e.g., a rapidly polymerizable liquid adhesive or a rapidly cross-linkable liquid adhesive) is preferably applied to the treatment device 126 and the porous mesh 102, which is fixed to the skin to approximate the skin edges of the wound. In one embodiment, before curing, the liquid adhesive 130 can penetrate through the openings 108 of the porous mesh 102 to make contact with the skin 100 in all areas not covered by the treatment device 126. In one embodiment, after curing, the liquid adhesive 130 preferably forms an airtight seal around the perimeter of the treatment device 126 and the porous mesh 102.
[0149] The liquid adhesive 130 may be a polymerizable adhesive or a cross-linkable adhesive applied to the porous mesh 102 and the therapeutic device 126. The liquid adhesive 130 may be extruded from a container having a porous tip impregnated with a polymerization accelerator or initiator or a cross-linking accelerator or initiator.
[0150] In one embodiment, the liquid adhesive does not include a polymerization promoter or initiator or a cross-linking promoter or initiator, but rather the polymerization promoter or activator / initiator or the cross-linking promoter or activator / initiator may be present on or in the porous mesh 102 in a strippable or reactive form (i.e., capable of reacting rapidly when in contact with the liquid adhesive 130).
[0151] In one embodiment, after being applied to the porous mesh 102 and the therapeutic device 126 , the liquid adhesive 130 preferably polymerizes and / or cross-links and cures, thereby creating a secure bond with the skin, the porous mesh 102 , and the therapeutic device 126 .
[0152] In one embodiment, the liquid adhesive 130 is polymerized or cross-linked after contact with an initiator and / or promoter for the polymerization of the adhesive and / or an initiator and / or promoter for the cross-linking of the adhesive (including initiators naturally present on the tissue, such as moisture, trace proteins, etc.). Such initiators and / or promoters can be coated or arranged to be non-peelable, that is, fixed in the mesh 102 or on the porous mesh, while maintaining activity to initiate or promote polymerization and / or cross-linking. In one embodiment, the initiator and / or promoter are arranged to be peelable, that is, they can be at least partially peeled into the liquid adhesive 130 and mixed with the liquid adhesive.
[0153] In one embodiment, the liquid adhesive 130 polymerizes or crosslinks after contacting an initiator and / or promoter that is releasably disposed in or on the mesh 102. Rapid polymerization and / or crosslinking of the liquid adhesive 130 causes the porous mesh 102 to bond to tissue (e.g., skin).
[0154] Liquid adhesive 130 can be any type of biocompatible and rapidly cross-linkable and / or rapidly polymerizable compound or mixture of compounds. As used herein, "rapidly cross-linkable and / or rapidly polymerizable" means that after adding an initiator or promoter, or after forming an adhesive from two or more components, it can be cured, i.e., cross-linked and / or polymerized, within 0.2 minutes to about 20 minutes, more preferably within 0.5 minutes to 10 minutes. In one embodiment, the liquid adhesive can be cured in about one minute.
[0155] In one embodiment, liquid adhesive 130 can be formed before being applied to porous mesh 102, for example, by mixing two components contained in a separate barrel or double barrel syringe, and passing the two components through a mixing head. In this embodiment, a cross-linking initiator or accelerator may not be provided inside porous mesh 20. In one embodiment, liquid adhesive 130 can be formed by mixing fibrinogen and thrombin together.
[0156] In one embodiment, the liquid adhesive 130 may include fibrinogen, and the cross-linking initiator or accelerator disposed within the porous mesh 102 may include thrombin.
[0157] Many other adhesive formulations can be used and are known to the skilled person. For example, a mixture containing PEG succinimidyl glutarate can be used as a liquid adhesive.
[0158] In certain embodiments, an initiator and / or accelerator for the polymerization of the binder or an initiator and / or accelerator or rate modifier for the cross-linking of the binder may be releasably disposed on or releasably incorporated into the porous mesh 102. For example, one or more chemical substances may be dispersed in or on the porous mesh, such as by chemical bonding, physical bonding, coating, absorption or adsorption to the porous mesh.
[0159] For example, polymerization initiator or accelerator or speed regulator can be loaded in or on the porous mesh, so that initiator or speed regulator provide the initiation or speed regulating effect of expectation for the subsequent polymerizable adhesive composition applied.Polymerization initiator or speed regulator can be fixed in or on the porous mesh, so that this initiator or speed regulator does not break away from the porous mesh, and its residue is dispersed in the resulting polymeric material.Alternatively, for example, polymerization initiator or speed regulator can be initially attached to the porous mesh, but just attach in a particular way, so that it is driven or dissolved by the subsequent polymerizable adhesive composition applied and is dispersed in the resulting polymeric material.
[0160] If desired, combinations of chemical substances may also be disposed in or on the porous mesh to provide a variety of effects. For example, a first chemical substance (such as a polymerization initiator or a rate regulator) may be fixed in or on the mesh, while a different second chemical substance (such as a bioactive material) may be detachably attached to the mesh.
[0161] When present in or on the mesh, the chemical substance (i.e., polymerization initiator, speed regulator and / or bioactive material or other additive) can be incorporated into or on the porous mesh in any suitable manner. For example, the chemical substance can be added to the porous mesh by contacting the mesh with a solution, mixture, etc. comprising the chemical substance. The chemical substance can be added to the mesh by, for example, dipping, spraying, roller coating, gravure coating, brushing, vapor deposition, etc. Alternatively, the chemical substance can be incorporated into or on the porous mesh during the manufacture of the porous mesh, such as during molding.
[0162] The polymerization initiator or the speed regulator loaded in or on the porous mesh can provide many advantages (for example, to provide shorter polymerization time). The concentration of the polymerization initiator or the speed regulator can be increased to provide a shorter (that is, faster) polymerization time. Because the polymerization initiator or the speed regulator are directly loaded in or on the porous mesh, it is not necessary to mix the polymerizable adhesive composition and the polymerization initiator or the speed regulator before applying. The action time can be extended like this, thereby the polymerizable monomer composition can be applied more accurately and carefully in a longer time period. Such suitable initiator is known in the art, and is described in, for example, U.S. Patent No. 5,928,611 and 6,620,846 and U.S. Patent Application Publication No. 2002 / 0037310, and the disclosures of these patent applications are hereby incorporated herein by reference.
[0163] In one embodiment, the treatment device 126 is a negative pressure wound therapy (NPWT) device configured to generate negative pressure to drain exudate from a wound. Wound exudate drawn into the negative pressure wound treatment device 126 can be directed into the cannula 128 to drain the wound exudate from the patient.
[0164] Use of wound closure systems In one embodiment, application of the wound closure system may be performed according to one or more of the following steps.
[0165] In one embodiment, the wound is prepared using standard surgical practices, including applying a porous mesh 102 ( Figure 8). Standard surgical practice may include cleaning, rinsing, debridement, hemostasis and closure of deep tissue layers so that there is no tension on the wound edges. Preferably, the wound edges are brought very close before applying the porous mesh so that a large amount of manual access is not required during the application of the porous mesh.
[0166] In one embodiment, sterile gauze may be used to dry the wound, such as by patting the wound with sterile gauze. Drying the wound will ensure direct tissue contact so that the second pressure-sensitive adhesive 114 and the porous mesh 102 ( Figure 8 ) adheres around the wound.
[0167] In one embodiment, the wound closure system including the porous mesh, the therapeutic device, and the liquid adhesive is preferably aseptically transferred into a sterile field.
[0168] Reference Figure 1 and Figure 3 In one embodiment, the central portion 122 of the bottom liner 116 can be peeled away from the bottom surface 106 of the porous mesh 102.
[0169] In one embodiment, the surgeon will place the Figure 3 ) holds the mesh 102 at the corners of the peripheral sections 124A, 124B to ensure that the second pressure-sensitive adhesive 114 ( Figure 8 ) can be adhered to the patient's skin.
[0170] In one embodiment, the porous mesh is positioned so that 1 / 2 of the mesh is located on either side of the wound or incision, thereby ensuring that approximately 1 cm of the mesh extends beyond the end of the wound or incision. In one embodiment, the surgeon gently presses the porous mesh to ensure that the bottom surface of the porous mesh is in close contact with the selected side of the wound. In one embodiment, the porous mesh can be gently pulled vertically over the wound while adjusting the porous mesh with fingers or tweezers to achieve close proximity of the skin edge and attaching the remainder of the porous mesh to the other side of the wound. If there is an area where the porous mesh is loose, the surgeon gently moves a gloved finger or instrument over the affected area of the porous mesh to ensure complete adhesion of the mesh to the skin.
[0171] In one embodiment, after the skin edges have been approximated and the porous mesh is deemed properly attached to the skin, the first and second peripheral segments 124A, 124B of the removable bottom liner 116 can be peeled off from the bottom surface of the porous mesh to adhere the peripheral segments of the porous mesh to the skin.
[0172] In one embodiment, a sterile cutting tool may be used to trim the ends of the porous mesh, if necessary, to ensure that approximately one (1) centimeter of porous mesh material extends beyond the ends of the wound or incision.
[0173] In one embodiment, the removable top liner 112 ( Figure 2 ) can be peeled off from the top surface of the porous mesh.
[0174] In one embodiment, the therapeutic device 126 can be pressed against the first pressure sensitive adhesive 110 applied to the top surface 104 of the porous mesh 102 to secure the therapeutic device in the correct position on top of the porous mesh.
[0175] In one embodiment, the liquid adhesive may be applied after the healthcare provider ensures that the porous mesh is in close contact with the skin and after the therapeutic device is secured on top of the porous mesh.
[0176] In one embodiment, immediately after the therapeutic device has been placed on top of the porous mesh, liquid adhesive 130 is preferably applied to the porous mesh and at least a portion of the therapeutic device 126. In one embodiment, if a body fluid leak occurs just before the liquid adhesive is applied and spread, the healthcare provider can use sterile gauze to dry the unfolded porous mesh.
[0177] Reference Figure 8 In one embodiment, a tool such as an applicator or a flexible applicator tip is used to smoothly and evenly apply liquid adhesive 130 to the treatment device 125, at least a portion of the cannula 128, the entire length of the porous mesh 102, and the surrounding skin area. The liquid adhesive is preferably applied using short strokes and moving from one end of the mesh to the other, thereby ensuring that the treatment device is covered and the porous mesh is saturated as the liquid adhesive is applied along the entire length of the porous mesh. The liquid adhesive 130 can also be applied to the edges or periphery of the porous mesh, thereby covering a small portion of the surrounding skin.
[0178] Once the liquid adhesive is applied to the porous mesh and the treatment device, after about 1 minute, the medical staff can check for adhesion by tapping along the length of the porous mesh with a gloved finger to check whether polymerization is complete. When there is no obvious liquid or adhesion, the polymerization process is complete. Once the liquid adhesive is polymerized, the treatment device can be operated to perform various treatment activities, including but not limited to draining body fluids from the wound, infusing saline or drugs into the wound, and / or using sensors to monitor the wound.
[0179] Reference Fig. 9AIn one embodiment, after an incision (e.g., a wound) is formed in the patient's skin, a wound closure system 200 can be applied to the incision to approximate the skin edges and promote healing of the wound. In one embodiment, the wound closure system 200 preferably includes a porous mesh 202 adhered to the skin around the incision. The porous mesh 202 can be at least partially transparent so that the surgeon can view the incision through the porous mesh to effectively align the porous mesh with the incision and enable the doctor to approximate the opposite skin edges of the incision. The length of the porous mesh is preferably greater than the length of the incision. In one embodiment, the porous mesh can be repeatedly lifted off the skin to reposition the porous mesh to ensure that the porous mesh is properly aligned with the incision and / or the opposite skin edges of the incision are approximated.
[0180] Reference Fig. 9B In one embodiment, the wound closure system 200 preferably includes a treatment device 226 that can be positioned on the top surface of the porous mesh 202. In one embodiment, the treatment device 226 preferably includes an elongated tube 232 having a proximal end 234 and a distal end 236. The elongated tube 232 advantageously has a length extending from its proximal end 234 to its distal end 236. In one embodiment, the treatment device 226 preferably includes a first mesh wing 238A and a second mesh wing 238B extending along opposite sides of the elongated tube 232. In one embodiment, the first mesh wing 238A and the second mesh wing 238B completely surround the sides of the elongated tube 232 and extend beyond the respective proximal end 234 and distal end 236 of the elongated tube 232. The outer circumference of the first mesh wing 238A and the second mesh wing 238B can be smaller than the outer circumference of the porous mesh 202 so that when the treatment device 226 is fixed on the top of the porous mesh 202 ( Fig. 9A ), the elongated tube 232 and the first mesh wing 238A and the second mesh wing 238B are completely located within the periphery of the porous mesh.
[0181] Reference Fig. 9C In one embodiment, after the elongated tube 232 and the first mesh wing 238A and the second mesh wing 238B of the treatment device 226 have been secured to the top surface of the porous mesh 202, the liquid adhesive 240 can be applied to the elongated tube 232, the first mesh wing 238A and the second mesh wing 238B, and the top of the porous mesh 202. A topical adhesive applicator 242 (e.g., a tool with a flexible blade; a brush) can be used to apply the liquid adhesive 240. The liquid adhesive 240 preferably completely surrounds the periphery of the porous mesh 202 and completely encapsulates the treatment device 226 and the porous mesh 202.
[0182] In one embodiment, the first mesh wing 238A and the second mesh wing 238B are preferably used to position the elongated tube 232 over the incision. In one embodiment, the elongated tube 232 and the first mesh wing 238A and the second mesh wing 238B can be cut to the length of the incision.
[0183] Reference Fig.9D After the liquid adhesive 240 is spread throughout the elongated tube 232, the first mesh wing 238A and the second mesh wing 238B, and the porous mesh 202, a wound treatment controller 244 can be coupled to the proximal end 234 of the elongated tube 232 of the treatment device 226. In one embodiment, the wound treatment controller 244 is configured to drain fluid from the incision / wound and / or infuse saline and / or medication on the incision / wound to promote healing.
[0184] Reference Fig.9E In one embodiment, the wound treatment controller 244 is preferably coupled to the proximal end 234 of the elongated tube 232 of the treatment device 226. In one embodiment, the elongated tube 232 has a first inlet 246 and a second inlet 248, the first inlet preferably being configured to drain fluid (e.g., wound exudate) from the incision ( Fig. 9A ), and the second inlet is preferably configured for delivering saline or medication to the incision ( Fig. 9A ).
[0185] In one embodiment, the elongated tube 232 may have holes and / or slits for draining fluid from a wound / incision or infusing saline or medication into the wound / incision. In one embodiment, the elongated tube 232 may be placed on top of a porous mesh and may be adhered to the porous mesh using a pressure sensitive adhesive.
[0186] In one embodiment, the elongated tube 232 may have two ends, one end of which is attached to a vacuum device for draining fluid (e.g., wound exudate) from the wound / incision, and one end of the conduit is attached to an inlet port for infusing / injecting fluid, saline irrigation, or medication on the wound / incision. The elongated tube is customizable. The length of the elongated tube can be adjusted, and different treatment devices can be used with the elongated tube to monitor incisions, etc. The elongated tube can also be bent (e.g., bent into a curved configuration) to conform to the shape of the wound / incision.
[0187] Reference Fig. 10AIn one embodiment, the porous mesh 302 is preferably positioned over an incision formed in the patient's skin. The bottom surface of the porous mesh 302 may have a pressure-sensitive adhesive for adhering the bottom surface of the porous mesh to the patient's skin. When the porous mesh 302 has been positioned over the incision, the porous mesh is preferably aligned with the incision and preferably approximates the opposite skin edges of the incision.
[0188] In one embodiment, the top surface of the porous mesh 302 is covered by one or more removable top liners. Fig. 10A In , a central section of the removable top liner has been removed (e.g., peeled off) so that the cutout can be seen through the porous mesh. Fig. 10A , the first peripheral section 320A and the second peripheral section 320B of the removable top liner remain covering the top surface of the porous mesh 302. The first peripheral section 320A and the second peripheral section 320B can be engaged by the surgeon's fingers to manipulate the porous mesh 302 so that the porous mesh is properly aligned over the incision and / or for effectively approximating the opposing skin edges of the incision.
[0189] Reference Fig. 10B In one embodiment, after the porous mesh 302 has been aligned over the incision and has been configured to approximate the opposing skin edges of the incision, a peripheral segment of the removable top liner including a second peripheral segment 320B of the removable top liner can be peeled off from the top surface of the porous mesh 302.
[0190] Reference Fig. 10C In one embodiment, when the center of the removable top liner and the first and second peripheral segments have been removed from the top surface of the covering porous mesh 302, the bottom surface of the porous mesh remains secured to the patient's skin to approximate the opposing skin edges of the incision ( Fig. 10B ). The top surface of the porous mesh may be covered with a pressure sensitive adhesive (e.g., spaced-apart traces of pressure sensitive adhesive). In one embodiment, a treatment device 326 including an elongated tube 332 and first and second mesh wings 338A, 338B extending along opposite sides of the elongated tube is preferably positioned on the top surface of the porous mesh 302. The treatment device 326 may be similar to that described above in FIG. 9B to FIG. 9E In one embodiment, the elongated tube 332 is advantageously aligned with the incision ( Fig. 10B ) so that the elongated tube 332 extends along the length of the incision.
[0191] Reference Fig. 10DIn one embodiment, liquid adhesive 340 is preferably applied to treatment device 326, which includes elongated tube 332 and first mesh wing 338A and second mesh wing 338B. In addition, liquid adhesive 340 is applied to the top surface of porous mesh 302. In one embodiment, liquid adhesive 340 preferably completely surrounds the periphery of porous mesh 302 and encapsulates treatment device 326 and porous mesh 302. In one embodiment, adhesive applicator 342 can be used to apply and / or spread liquid adhesive 340 on treatment device 326 and porous mesh 302.
[0192] In one embodiment, the liquid adhesive is configured to secure the treatment device 326 and the porous mesh to the incision and form a secure seal around the incision. The liquid adhesive can also form a microbial barrier, waterproof and / or allow medical personnel to monitor the wound healing process. The liquid adhesive can be any biocompatible adhesive known in the art, such as cyanoacrylate-based adhesives, silicone-based adhesives, etc. as described above.
[0193] Reference Fig.11A In one embodiment, the porous mesh 402 is preferably positioned over an incision formed in the patient's skin. The bottom surface of the porous mesh 402 may have an adhesive (e.g., a pressure sensitive adhesive) for adhering the bottom surface of the porous mesh to the patient's skin. When the porous mesh 402 has been positioned over the incision, the porous mesh is preferably aligned with the incision and preferably approximates the opposing skin edges of the incision.
[0194] In one embodiment, the top surface of the porous mesh 402 is preferably covered by one or more removable top liners. Fig.11A In the , the center section of the removable top liner has been removed so that the cutout can be seen through the porous mesh. Fig.11A , the first peripheral section 420A and the second peripheral section 420B of the removable top liner are held in place on the top surface of the porous mesh 402. The first peripheral section 420A and the second peripheral section 420B can be grasped by the surgeon to control and / or manipulate the porous mesh 402 so that the porous mesh can be properly aligned over the incision and / or used to approximate the opposing skin edges of the incision.
[0195] Reference Fig. 11B In one embodiment, after the porous mesh 402 has been aligned over the cutout, the peripheral sections 420A, 420B ( Fig.11A ) can be peeled off from the top surface of the porous mesh 402.
[0196] Reference Fig. 11CIn one embodiment, when the central section of the removable top liner and the first and second peripheral sections have been removed from the top surface covering the porous mesh 402, the bottom surface of the porous mesh remains secured to the patient's skin to approximate the opposing skin edges of the incision. In one embodiment, the treatment device 426 including the elongated tube 432 is preferably positioned on the top surface 404 of the porous mesh 402. In one embodiment, the elongated tube 432 is advantageously aligned with the incision ( Fig. 11B ), so that the elongated tube 432 extends along the length of the incision. The elongated tube 432 can be bent into a shape (e.g., a curve) that is a mirror image and / or consistent with the shape of the underlying incision.
[0197] Reference Fig.11D In one embodiment, liquid adhesive 440 is preferably applied to treatment device 426 including elongated tube 432 and the top surface of porous mesh 402. In one embodiment, adhesive applicator 442 can be used to apply and / or spread liquid adhesive 440 on treatment device 426 and porous mesh 402. In one embodiment, liquid adhesive 440 preferably completely surrounds the periphery of porous mesh 402 and encapsulates treatment device 426 and porous mesh 402.
[0198] Reference Fig.12 In one embodiment, the wound closure system 400 preferably includes a treatment device, which includes a porous mesh 402 ( Fig. 11B ) The elongated tube 432 at the top of the porous mesh is then adhered to the skin so that FIG. 11A to FIG. 11D 450 is close to the skin edge of the incision shown in . The elongated tube 432 is preferably bifurcated into a first portion, which is connected to a drainage tube 450 for draining fluid from the incision. The drainage tube 450 may have a proximal end connected to a fluid container 452, which collects fluid (e.g., wound exudate) passing through the drainage tube 450. In one embodiment, the wound closure system 400 preferably includes an infusion tube 454 connected to a syringe 456, which can be used to infuse saline and / or medication into the wound. After the saline or medication is infused into the wound, the fluid can be drained from the wound via the drainage tube 450 and collected in the collection container 452. The wound can be continuously irrigated with a liquid (e.g., saline; medication) to enhance wound healing, which may include infusing saline and / or medication into the wound and combining it with draining wound exudate from the wound.
[0199] Reference Fig.13 and Fig.14AIn one embodiment, the wound closure system 500 preferably includes a porous mesh 502 having a top surface 504, a bottom surface 506, and a plurality of openings 508 (e.g., holes) extending between the top surface 504 and the bottom surface 506. In one embodiment, the porous mesh 502 advantageously includes a central portion 570 extending along a central axis A1 and a first peripheral portion 572A and a second peripheral portion 572B extending along respective sides of the central portion 570. In one embodiment, the openings 508 located in the central portion 570 of the porous mesh 502 have the same size as the openings 508 located in the first peripheral portion 572A and the second peripheral portion 572B of the porous mesh. In one embodiment, the size of the openings 508 located in the central portion 570 of the porous mesh 502 is smaller than the size of the openings 508 located in the first peripheral portion 572A and the second peripheral portion 572B of the porous mesh.
[0200] Reference Fig.14A In one embodiment, the bottom surface 506 of the porous mesh 502 is placed against the patient's skin to approximate the skin edges of the wound. The central portion 570 of the porous mesh 502 covered by the peelable liner 512 is preferably aligned with the wound. The peelable liner 512 covers the top surface 504 of the porous mesh 502 and covers the opening 508 located in the central portion 570 of the porous mesh.
[0201] Reference Fig. 14B In one embodiment, liquid adhesive 530 may be applied to the top surface 504 of a porous mesh 502 including a peelable liner 512 covering a central portion 570 of the porous mesh. The peelable liner 512 preferably prevents the liquid adhesive from closing the opening 570A located in the central portion 508 of the porous mesh 502. In one embodiment, in Fig. 14B In the stage shown in , the liquid adhesive 530 preferably surrounds the periphery of the porous mesh 502 and completely encapsulates the porous mesh and the releasable liner 512 covering the central portion 570 of the porous mesh. The releasable liner 512 preferably masks the openings 508A located within the central region 570 of the porous mesh.
[0202] Reference Fig. 14B and Fig. 14C In one embodiment, the liquid adhesive 130 is preferably not completely cured or only partially cured so that the peelable liner 512 ( Fig. 14B) can be peeled from the top surface 504 of the porous mesh 502, thereby removing the uncured or partially cured adhesive on the releasable liner 512 to expose the openings 508A located in the central portion 570 of the porous mesh 502. The openings 508A in the central portion 570 are located within the gaps in the partially or fully cured adhesive 530. The gaps in the adhesive advantageously extend along the length of the central region of the porous mesh.
[0203] Reference Fig.14D In one embodiment, the peelable liner 512 ( Fig. 14B ) After being peeled off from the top surface 504 of the porous mesh 502, the treatment device 526 (e.g., a negative pressure wound treatment device) can be positioned and / or secured on the central portion 570 of the porous mesh to align with the wound. In one embodiment, the treatment device 526 is preferably configured to remove and / or drain body fluids (e.g., exudate) from the wound. The treatment device 526 can also be configured to deliver saline and / or drugs to the wound or to monitor the wound (e.g., a sensor).
[0204] Reference Fig.15 In one embodiment, the therapeutic device 626 can be incorporated into one or more of the wound closure systems disclosed herein. In one embodiment, the therapeutic device 626 can be used to drain the wound and / or to infuse a therapeutic solution into the wound during negative pressure wound therapy. In one embodiment, the therapeutic device 626 can be used to both drain the wound and infuse a therapeutic solution into the wound.
[0205] In one embodiment, the therapeutic device 626 can be made of a biocompatible material such as a polymer, silicone, or stainless steel. In one embodiment, the therapeutic device can be transparent.
[0206] In one embodiment, the treatment device 626 preferably has a top surface 650, a bottom surface 652, and sidewalls 654A, 654B that slope outwardly between the top surface 652 and the bottom surface 654. In one embodiment, the top surface 650 and the bottom surface 652 of the treatment device can be parallel to each other. In one embodiment, the treatment device 626 can have a low profile and can be shaped like a speed bump.
[0207] In one embodiment, the treatment device 626 may have a first elongated channel 656A extending along the length of the treatment device. In one embodiment, the treatment device 626 preferably includes a first fenestration 658A (e.g., an opening) formed in the bottom surface 652 of the treatment device, the first fenestration being in fluid communication with the first elongated channel 656A. In one embodiment, the first fenestration 658A may be positioned over the wound to place the first elongated channel 656A in fluid communication with the wound. In one embodiment, a vacuum device may be coupled to the first elongated channel 656A to drain fluid (e.g., exudate) from the wound. The fluid drained from the wound preferably passes through the first fenestration 658A and enters the first elongated channel 656A to be removed from the wound. In one embodiment, the treatment device may include a first port in fluid communication with the first elongated channel 656A to couple a drainage tube to the first elongated channel 656A.
[0208] In one embodiment, the first elongated channel 656A and the first fenestration 658A may be used to infuse a therapeutic solution into the wound.
[0209] In one embodiment, the therapeutic device 626 may have a second elongated channel 656B extending along the length of the therapeutic device and a second fenestration 658B formed in the bottom surface 652 of the therapeutic device in fluid communication with the second elongated channel 656B.
[0210] In one embodiment, the second elongated channel 656B and the second fenestration 658B can be used to drain fluid from the wound and / or to infuse a therapeutic solution into the wound. In one embodiment, the therapeutic device can include a second port in fluid communication with the second elongated channel 656B to connect the second elongated channel to a drainage tube or an infusion tube.
[0211] In one embodiment, the therapeutic device 626 may have a third elongated channel 656C extending along the length of the therapeutic device and a third fenestration 658C formed in the bottom surface 652 of the therapeutic device in fluid communication with the third elongated channel 656C.
[0212] In one embodiment, the third elongated channel 656C and the third fenestration 658C can be used to drain fluid from the wound and / or to infuse a therapeutic solution into the wound. In one embodiment, the therapeutic device can include a third port in fluid communication with the third elongated channel 656C to connect the third elongated channel to a drainage tube or an infusion tube.
[0213] In one embodiment, the therapeutic device 626 can be secured to the top surface of the first layer of the porous dressing such that the first elongated channel 656A of the therapeutic device is positioned on the top surface of the first layer of the porous dressing, wherein the first elongated channel is positioned adjacent to the wound.
[0214] In one embodiment, a second layer of porous dressing can be applied over the first layer of porous dressing and on top of the therapeutic device 626 to secure the therapeutic device to the top surface of the first layer of porous dressing. The second layer of porous dressing can contact the top surface 650 and side surfaces 654A, 654B of the therapeutic device 626.
[0215] In one embodiment, a flowable adhesive may be applied to the first layer of the porous dressing, the second layer of the porous dressing, and the treatment device 626. The flowable adhesive may cure to form an airtight seal around the wound.
[0216] In one embodiment, a tube may be attached to the treatment device 626 for draining fluid (e.g., exudate) from the first elongated channel 656A of the treatment device. In one embodiment, the tube may be attached to a vacuum device for applying negative pressure to the wound to drain fluid from the wound. In one embodiment, a tube may be attached to a treatment solution (e.g., saline; medication; antibiotic solution) for infusing the treatment solution into the first elongated channel 656A. The treatment solution preferably passes through the first fenestration 658A to infuse the treatment solution into the wound.
[0217] In one embodiment, the elongated channel of the treatment device 656 advantageously has two or more connection ports at which fluids can be infused into the wound and / or withdrawn from the wound.
[0218] In one embodiment, the connection port can be located on the top surface 650 or on one or more of the side surfaces 654A, 654B of the treatment device 626. In one embodiment, the connection port can be attached to a vacuum device via a tube that is configured to apply negative pressure to the wound or incision. In one embodiment, the connection port can be attached to an infusion tube to infuse a treatment solution (e.g., saline; medication; antibiotics) into the wound or incision.
[0219] In one embodiment, the treatment device 626 can be transparent to enable medical personnel to view the wound or incision during healing. In one embodiment, the flowable adhesive cures into a transparent covering to enable medical personnel to view the wound or incision during healing. In one embodiment, the flowable adhesive is a silicone material.
[0220] Although the foregoing is directed to embodiments of the present invention, other and further embodiments of the present invention may be devised without departing from the basic scope of the present invention, which is limited only by the scope of the following claims. For example, the present invention contemplates that any feature shown in any embodiment described herein or incorporated by reference may be combined with any feature shown in any other embodiment described herein or incorporated by reference and still fall within the scope of the present invention.
Claims
1. A wound closure system comprising: A porous mesh having a top surface and a bottom surface; a first pressure sensitive adhesive applied to the top surface of the porous mesh; a removable first liner covering the first pressure sensitive adhesive; a second pressure sensitive adhesive applied to the bottom surface of the porous mesh; a removable second liner covering the second pressure sensitive adhesive; The second pressure sensitive adhesive is stronger or denser than the first pressure sensitive adhesive.
2. The wound closure system according to claim 1, further comprising a cross-linking accelerator or catalyst or a polymerization accelerator or catalyst disposed in or on the porous mesh.
3. The wound closure system according to claim 1 or claim 2, wherein: The porous mesh is flat, elongated along a longitudinal axis, and has a plurality of openings extending between a top surface and a bottom surface thereof.
4. A wound closure system according to any preceding claim, wherein: The removable first liner is configured to be peelable from the top surface of the porous mesh for exposing the first pressure sensitive adhesive, and wherein the removable second liner is configured to be peelable from the bottom surface of the porous mesh for exposing the second pressure sensitive adhesive.
5. The wound closure system according to any preceding claim, further comprising: a treatment device comprising an elongated tube secured to the top surface of the porous mesh, the elongated tube being configured to drain exudate from a wound; as well as A liquid adhesive covers the top surface of the porous mesh and at least a portion of the elongated tubes.
6. The wound closure system of claim 5, the treatment device further comprising a first mesh wing and a second mesh wing secured to the elongated tube and extending along respective sides of the elongated tube, wherein The liquid adhesive covers the first mesh wing and the second mesh wing for securing the therapeutic device to the top surface of the porous mesh.
7. A wound closure system according to claim 5 or claim 6, wherein: The elongated tube includes a first elongated conduit coupled to a vacuum pump or a negative pressure pump for draining exudate from a wound.
8. The wound closure system according to any one of claims 5 to 7, wherein: The elongated tube includes a second elongated conduit coupled to a positive pressure pump configured to force saline or medication into the elongated tube.
9. The wound closure system according to claim 5 or claim 6, wherein: The liquid adhesive is a topical skin adhesive or a rapidly polymerizable adhesive suitable for forming an airtight seal around a wound.
10. The wound closure system of claim 9, wherein: The hermetic seal formed by the liquid adhesive is waterproof or includes an antimicrobial barrier.
11. A kit comprising: The wound closure system according to any one of claims 1 to 4; as well as A rapidly polymerizable liquid adhesive is disposed within a dispenser container.
12. The kit of claim 11, further comprising one or more treatment devices configured to be secured to the top surface of the porous mesh.
13. The kit of claim 12, wherein: The one or more therapeutic devices are selected from the group consisting of: a negative pressure wound therapy device, a negative pressure pump, a fluid suction device, a slender tube including a drainage tube and an infusion tube, a slender tube having a first mesh wing and a second mesh wing extending along the side of the slender tube, a cannula and a wound monitoring sensor.
14. The kit of claim 12, wherein: The treatment device comprises an elongated tube adapted to drain exudate from a wound.
15. The kit of claim 14, the treatment device further comprising first and second mesh wings secured to the elongated tube and extending along respective sides of the elongated tube.
16. A kit according to claim 14 or claim 15, wherein: The elongated tube comprises a first elongated conduit coupled to a vacuum pump or a negative pressure pump adapted to drain exudate from a wound.
17. A kit according to any one of claims 14 to 16, wherein: The elongated tube includes a second elongated conduit coupled to a positive pressure pump configured to force saline or medication into the elongated tube.
18. A method of using the wound closure system according to any one of claims 1 to 4, comprising: peeling the removable second liner from the bottom surface of the porous mesh to expose the second pressure-sensitive adhesive applied to the bottom surface of the porous mesh; pressing the second pressure-sensitive adhesive applied to the bottom surface of the porous mesh against the patient's skin to approximate opposing edges of the wound; peeling the removable first liner from the top surface of the porous mesh to expose the first pressure sensitive adhesive applied to the top surface of the porous mesh; pressing a therapeutic device against the first pressure-sensitive adhesive to secure the therapeutic device to the top surface of the porous mesh; applying a liquid adhesive to the top surface of the porous mesh and to at least a portion of the therapeutic device; The liquid adhesive is cured to bond the porous mesh to the skin and the therapeutic device to the porous mesh.
19. The method according to claim 18, wherein: The compressing step includes aligning the treatment device with the wound.
20. The method of claim 18 or claim 19, further comprising using the treatment device to drain exudate from the wound or to infuse saline or medication into the wound.
21. The method according to any one of claims 18 to 20, wherein: The liquid adhesive includes a rapidly polymerizable liquid adhesive or a rapidly cross-linkable liquid adhesive.
22. The method according to any one of claims 18 to 22, wherein: The treatment device is selected from the group of devices consisting of: a negative pressure wound treatment device, a negative pressure pump, a fluid suction device, a slender tube including a drainage tube and an infusion tube, a slender tube having a first mesh wing and a second mesh wing extending along the side of the slender tube, a cannula and a wound monitoring sensor.
Citation Information
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