WOUND CLOSURE SYSTEMS, DEVICES AND METHODS INCORPORATING THERAPEUTIC DEVICES

Abstract

A wound closure system includes a porous mesh, a first pressure sensitive adhesive (PSA) applied to a top surface of the porous mesh, a removable first liner covering the first PSA, a second PSA applied to a bottom surface of the porous mesh, and a removable second liner covering the second PSA. The second PSA is stronger or denser than the first PSA. A method of using the wound closure system includes removing the second liner to expose the second PSA, pressing the second PSA against skin to approximate wound edges, removing the first liner to expose the first PSA, and pressing a therapeutic device against the first PSA to secure the therapeutic device to the porous mesh. A liquid adhesive is applied over the porous mesh and the therapeutic device, and then cured for binding the porous mesh to skin and binding the therapeutic device to the porous mesh.

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 said porous mesh; a removable first liner covering said first pressure sensitive adhesive; a second pressure sensitive adhesive applied to the bottom surface of said porous mesh; a removable second liner covering said second pressure sensitive adhesive; said second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive.

2. The wound closure system as claimed in claim 1, further comprising a cross-linking or polymerization accelerator or catalyst disposed in or on said porous mesh.

3. The wound closure system as claimed in claim 1, wherein said porous mesh is flat, elongated along a longitudinal axis, and has a plurality of openings extending between the top and bottom surfaces thereof.

4. The wound closure system as claimed in claim 1, wherein said removable first liner is configured to be peeled away from the top surface of said porous mesh for exposing said first pressure sensitive adhesive, and wherein said removable second liner is configured to be peeled away from the bottom surface of said porous mesh for exposing said second pressure sensitive adhesive.

5. A method of using said wound closure system as claimed in claim 1, comprising: peeling said removable second liner away from the bottom surface of said porous mesh to expose said second pressure sensitive adhesive applied to the bottom surface of said porous mesh; pressing said second pressure sensitive adhesive applied to the bottom surface of said porous mesh against skin of a patient to approximate opposing edges of a wound; peeling said removable first liner away from the top surface of said porous mesh to expose said first pressure sensitive adhesive applied to the top surface of said porous mesh; pressing a therapeutic device against said first pressure sensitive adhesive to secure said therapeutic device over the top surface of said porous mesh; applying a liquid adhesive over the top surface of said porous mesh and at least a portion of said therapeutic device; allowing said liquid adhesive to cure for binding said porous mesh to the skin and binding said therapeutic device to said porous mesh.

6. The method as claimed in claim 5, wherein the pressing step comprises aligning said therapeutic device with the wound.

7. The method as claimed in claim 6, further comprising using said therapeutic device for draining exudate from the wound or infusing saline or medication into the wound.

8. The method as claimed in claim 5, wherein said liquid adhesive comprises a rapidly polymerizable or cross-linkable liquid adhesive.

9. The method as claimed in claim 5, wherein said therapeutic device is selected from the group of devices consisting of negative pressure wound therapy devices, negative pressure pumps, fluid suction devices, elongated tubes including drainage tubes and infusion tubes, elongated tubes having first and second mesh wings extending along lateral sides thereof, cannulas, and wound monitoring sensors.

10. A kit comprising: a wound closure system including a porous mesh having a top surface and a bottom surface, a first pressure sensitive adhesive applied to the top surface of said porous mesh, a removable first liner covering said first pressure sensitive adhesive, a second pressure sensitive adhesive applied to the bottom surface of said porous mesh, and a removable second liner covering said second pressure sensitive adhesive, said second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive; and a rapidly polymerizable liquid adhesive disposed within a dispenser container.

11. The kit as claimed in claim 10, further comprising one or more therapeutic devices configured to be secured over the top surface of said porous mesh.

12. The kit as claimed in claim 11, wherein said one or more therapeutic devices are selected from the group of devices consisting of negative pressure wound therapy devices, negative pressure pumps, fluid suction devices, elongated tubes including drainage tubes and infusion tubes, elongated tubes having first and second mesh wings extending along lateral sides thereof, cannulas, and wound monitoring sensors.

13. The kit as claimed in claim 10, further comprising a cross-linking or polymerization accelerator or catalyst disposed in or on said porous mesh.

14. A wound closure system comprising: a porous mesh having a top surface and a bottom surface; the bottom surface of said porous mesh being adhered to skin for approximating opposing edges of a wound; a therapeutic device including an elongated tube secured to the top surface of said porous mesh and overlying the wound, said elongated tube being configured for draining exudate from the wound; a liquid adhesive covering the top surface of said porous mesh and at least a portion of said elongated tube.

15. The wound closure system as claimed in claim 14, said therapeutic device further comprising first and second mesh wings secured to said elongated tube and extending along respective lateral sides of said elongated tube, wherein said liquid adhesive covers said first and second mesh wings for securing said therapeutic device to the top surface of said porous mesh.

16. The wound closure system as claimed in claim 14, wherein said elongated tube comprises a first elongated conduit that is coupled with a vacuum or negative pressure pump for draining the exudate from the wound.

17. The wound closure system as claimed in claim 16, wherein said elongated tube comprises a second elongated conduit that is coupled with a positive pressure pump configured to force saline or medication into said elongated tube for infusing the wound with the saline or the medication.

18. The wound closure system as claimed in claim 14, wherein said liquid adhesive is a topical skin adhesive or a rapidly polymerizable adhesive that forms an air-tight seal around the wound.

19. The wound closure system as claimed in claim 18, wherein the air-tight seal formed by said liquid adhesive is waterproof or comprises an antimicrobial barrier.

20. The wound closure system as claimed in claim 14, further comprising a cross-linking or polymerization accelerator or catalyst disposed in or on said porous mesh.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0098] FIG. 1 is a schematic view of a wound closure system including a porous mesh having a top surface and a bottom surface, first pressure sensitive adhesive overlying the top surface of the porous mesh, second pressure sensitive adhesive overlying 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, in accordance with one embodiment of the present patent application.

[0099] FIG. 2 is a top view of the removable top liner shown in FIG. 1, the removable top liner including a center section and first and second peripheral sections that bound the center section, in accordance with one embodiment of the present patent application.

[0100] FIG. 3 is a bottom view of the removable bottom liner shown in FIG. 1, the removable bottom liner including a center section and first and second peripheral sections that bound the center section, in accordance with one embodiment of the present patent application.

[0101] FIG. 4 is a top view of the porous mesh shown in FIG. 1, the top surface of the porous mesh being covered by the first pressure sensitive adhesive, in accordance with one embodiment of the present patent application.

[0102] FIG. 5 is a bottom view of the porous mesh shown in FIG. 1, the bottom surface of the porous mesh being covered by the second pressure sensitive adhesive, in accordance with one embodiment of the present patent application.

[0103] FIG. 6 shows the bottom surface of the porous mesh of FIG. 1 secured to skin by the second pressure sensitive adhesive, and a therapeutic device secured over the top surface of the porous mesh by the first pressure sensitive adhesive, in accordance with one embodiment of the present patent application.

[0104] FIG. 7 is a top view of the porous mesh and the therapeutic device shown in FIG. 6.

[0105] FIG. 8 shows a method of applying a liquid adhesive over the porous mesh and the therapeutic device shown in FIGS. 6 and 7, in accordance with one embodiment of the present patent application.

[0106] FIG. 9A shows a first stage of a method of securing a wound closure system over an incision formed in skin of a patient, in accordance with one embodiment of the present patent application.

[0107] FIG. 9B shows a second stage of a method of securing a wound closure system over the incision formed in skin of the patient, in accordance with one embodiment of the present patent application.

[0108] FIG. 9C shows a third stage of a method of securing a wound closure system over the incision formed in skin of the patient, in accordance with one embodiment of the present patent application.

[0109] FIG. 9D shows a fourth stage of a method of securing a wound closure system over the incision formed in skin of the patient, in accordance with one embodiment of the present patent application.

[0110] FIG. 9E shows a fifth stage a method of securing a wound closure system over the incision formed in skin of the patient, in accordance with one embodiment of the present patent application.

[0111] FIG. 10A shows a porous mesh being secured over an incision formed in a patient, in accordance with one embodiment of the present patent application.

[0112] FIG. 10B shows a releasable liner being peeled away from a top surface of the porous mesh shown in FIGS. 10A, in accordance with one embodiment of the present patent application.

[0113] FIG. 100 shows an elongated tube having mesh wings being secured over the top surface of the porous mesh shown in FIG. 10B, in accordance with one embodiment of the present patent application.

[0114] FIG. 10D shows a liquid adhesive being applied over both the elongated tube having mesh wings and the porous mesh shown in FIGS. 10B and 100, in accordance with one embodiment of the present patent application.

[0115] FIG. 11A shows a porous mesh being secured over an incision formed in a patient, the porous mesh having first and second peripheral sections of a releasable top liner overlying a top surface of the porous mesh, in accordance with one embodiment of the present patent application.

[0116] FIG. 11B shows the porous mesh of FIG. 11A after the first and second peripheral sections of the releasable top liner have been peeled away to fully expose the top surface of the porous mesh, in accordance with one embodiment of the present patent application.

[0117] FIG. 11C shows an elongated tube positioned over the top surface of the porous mesh shown in FIG. 11B, the elongated tube being in general alignment with the incision formed in the patient, in accordance with one embodiment of the present patent application.

[0118] FIG. 11D shows a curable adhesive being applied over both the elongated tube and the top surface of the porous mesh shown in FIG. 11C, in accordance with one embodiment of the present patent application.

[0119] FIG. 12 shows a perspective view of a wound closure system including a porous mesh approximating skin edges of the incision shown in FIG. 11B, the elongated tube of FIG. 11D secured over the incision, a drain tube in fluid communication with the elongated tube for draining bodily fluids from the incision, and an injection tube in fluid communication with the elongated tube for infusing saline or medication over the incision shown, in accordance with one embodiment of the present patent application.

[0120] FIG. 13 is a top plan view of a porous mesh having a releasable liner that covers a central region of a top surface of the porous mesh, in accordance with one embodiment of the present patent application.

[0121] FIG. 14A shows the porous mesh with the releasable liner of FIG. 13 positioned over a wound of a patient, in accordance with one embodiment of the present patent application.

[0122] FIG. 14B shows a liquid adhesive applied over the porous mesh and the releasable liner shown in FIG. 14A.

[0123] FIG. 14C shows the porous mesh and the liquid adhesive of FIG. 14B after the releasable liner of FIG. 14B has been peeled away from the top surface of the porous mesh to expose the central region of the top surface of the porous mesh.

[0124] FIG. 14D shows a therapeutic device positioned over the central region of the top surface of the porous mesh shown in FIG. 14C.

[0125] FIG. 15 shows a cross-sectional view of a therapeutic device including elongated channels that extend along a length of the therapeutic device and fenestrations that are in communication with the elongated channels, in accordance with one embodiment of the present patent application.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0126] Referring to FIG. 1, in one embodiment, a 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., pores) that extend between the top and bottom surfaces of the porous mesh. In one embodiment, the porous mesh may be used for approximating the opposing skin edges of a wound or incision. As used herein, the terms wound, and incision may be used interchangeably. As used herein, the terms wound approximation, incision approximation, and skin approximation may be used interchangeably.

[0127] The porous mesh 102 may be woven, non-woven, extruded, punched, perforated, molded, etc. In one embodiment, the porous mesh may be similar to a mesh patch sold under the federally registered trademark PRINEO by Ethicon, Inc. of Somerville, New Jersey. In one embodiment, the porous mesh 102 may be coated and/or impregnated with an initiator or accelerator of polymerization.

[0128] The porous mesh 102 may be of any shape that is necessary to cover a wound or incision, such as elliptical, circular, rectangular, square, etc. The porous mesh may have a length to width ratio of about 2:1 to 20:1. In one embodiment, the length of the porous mesh 102 may be about 10-50 cm. In one embodiment, the width of the porous mesh 102 may be about 2-10 cm.

[0129] In one embodiment, the openings 108 of the porous mesh 102 may be of any shape, including round, rectangular, triangular, elliptical, etc. The openings 108 may have diameters of about 0.2-2 mm. In one embodiment, the areas of the individual openings 108 may be from about 0.04 mm.sup.2 to about 4 mm.sup.2.

[0130] In one embodiment, the wound closure system 100 preferably includes a first pressure sensitive adhesive 110 that overlies the top surface 104 of the porous mesh 102. In one embodiment, a removable top liner 112 desirably covers the first pressure sensitive adhesive 110 and the top surface 104 of the porous mesh 102. In one embodiment, the removable top liner may be peeled away from the top surface 104 of the porous mesh 102 for exposing the first pressure sensitive adhesive 110 that overlies the top surface of the porous mesh. The first pressure sensitive adhesive 110 that overlies the top surface 104 of the porous mesh 102 may be utilized for securing a therapeutic device, such as a negative pressure wound therapy (NPWT) device, over the top surface of the porous mesh.

[0131] In one embodiment, the wound closure system 100 preferably includes second pressure sensitive adhesive 114 that overlies the bottom surface 106 of the porous mesh 102. In one embodiment, a removable bottom liner 116 desirably covers the second pressure sensitive adhesive 114 and the bottom surface 106 of the porous mesh 102. The removable bottom liner may be peeled away from the bottom surface 106 of the porous mesh 102 for exposing the second pressure sensitive adhesive 114 that overlies the bottom surface of the porous mesh. The second pressure sensitive adhesive 114 that overlies the bottom surface 106 of the porous mesh 102 may be utilized for securing the porous mesh to skin of a patient for approximating the opposing edges of a wound or incision.

[0132] In one embodiment, the releasable top and bottom liners 112, 116 may be made of synthetic or natural polymers that are easily peelable from the respective first and second pressure sensitive adhesives 110, 114.

[0133] Referring to FIG. 2, in one embodiment, the removable top liner 112 that covers the top surface 104 of the porous mesh 102 (FIG. 1) preferably includes a center segment 118 that extends over a center of the porous mesh and first and second peripheral segments 120A, 1208 that bound opposite lateral sides of the center segment 118. In one embodiment, the center segment 118 and the first and second peripheral segments 120A, 1208 of the removable top liner 112 may be peeled away from the top surface 104 of the porous mesh 102 (FIG. 1) for exposing the first pressure sensitive adhesive and the top surface of the porous mesh. The center segment 118 and the first and second peripheral segments may be removed independently of one another from the top surface of the porous mesh. For example, the center segment 118 of the removable top liner 112 may be peeled away from the porous mesh so that a surgeon can view a wound or an incision through the porous mesh for aligning the porous mesh with the incision. When aligning the porous mesh with the wound or incision, the first and second peripheral segments may be grasped by a surgeon for controlling and manipulating the porous mesh. In one embodiment, after the porous mesh has been secured to skin, the first and second peripheral segments 120A, 1208 of the removable top liner 112 may be peeled away from the top surface of the porous mesh.

[0134] Referring to FIG. 3, in one embodiment, the removal bottom liner 116 desirably covers the bottom surface 106 of the porous mesh 102 (FIG. 1). In one embodiment, the removable bottom liner 116 preferably includes a center segment 122 and first and second peripheral segments 124A, 124B that bound opposite lateral sides of the center segment 122. In one embodiment, the center segment 122 and the first and second peripheral segments 124A, 1248 of the removable bottom liner 116 may be peeled away from the bottom surface 106 of the porous mesh 102 (FIG. 1) independently of one another. For example, the center segment 122 of the removable bottom liner 116 may be peeled away from the bottom surface of the porous mesh so that a surgeon can view an incision through the porous mesh for aligning the porous mesh with the incision, whereupon the surgeon may approximate the opposing edges of the incision. The first and second peripheral segments 120A, 120B may initially remain in place as the bottom surface of the porous mesh is used for approximating skin edges. In one embodiment, after the porous mesh has been properly aligned with the incision, and after the opposing edges of the incision have been approximated, the first and second peripheral segments 120A, 120B of the removable bottom liner 116 may be peeled away from the bottom surface of the porous mesh for further securing the bottom surface of the porous mesh to skin that surrounds the incision.

[0135] Referring to FIG. 4, in one embodiment, the wound closure system 100 desirably includes the first pressure sensitive adhesive 110 (FIG. 1) that overlies the top surface 104 of the porous mesh 102. In one embodiment, the first pressure sensitive adhesive 110 may include a plurality of first pressure sensitive adhesive traces 110A-110M that extend over the top surface 104 of the porous mesh 102. The first pressure sensitive adhesive traces 110A-110M may be spaced from one another over the top surface of the porous mesh.

[0136] The first pressure sensitive adhesive traces 110A-110M may be in a form of linear segments of pressure sensitive adhesive (as shown in FIG. 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 overlying the top surface 104 of the porous mesh 102 may have a non-linear shape such as round, square, elliptical, dots, etc.

[0137] Referring to FIG. 5, in one embodiment, the wound closure system 100 preferably includes the second pressure sensitive adhesive 114 (FIG. 1) that overlies the bottom surface 106 of the porous mesh 102. In one embodiment, the second pressure sensitive adhesive 114 may include a plurality of second pressure sensitive adhesive traces 114A-114Y that extend over the bottom surface 106 of the porous mesh 102. The second pressure sensitive adhesive traces 114A-110Y may be spaced from one another over the bottom surface of the porous mesh.

[0138] The second pressure sensitive adhesive traces 114A-114Y may be in a form of linear segments of pressure sensitive adhesive (as shown in FIG. 5) and may extend at any angle relative to the length of the porous mesh 102. In one embodiment, the second pressure sensitive adhesive 114 over the bottom surface 106 of the porous mesh 102 may have a non-linear shape such as round, square, elliptical, dots, etc.

[0139] Referring to FIGS. 4 and 5, in one embodiment, the number of the second pressure sensitive adhesive traces 114A-114Y that cover the bottom surface 106 of the porous mesh 102 is greater than the number of the first pressure sensitive adhesive traces 110A-110M that cover the top surface 104 of the porous mesh. In one embodiment, the first pressure sensitive adhesive traces 110A-110M that cover the top surface of the porous mesh 102 may comprise an adhesive that is weaker than the adhesive used for forming the second pressure sensitive adhesive traces 114A-114Y that cover the bottom surface of the porous mesh. In one embodiment, the density of the first pressure sensitive adhesive traces 110A-110M that cover the top surface of the porous mesh 102 may be less than the density of the second pressure sensitive adhesive traces 114A-114Y that cover the bottom surface of the porous mesh. Utilizing pressure sensitive adhesive traces that are weaker and/or less dense over the top surface of the porous mesh will ensure that removal of the top liner 112 will not pull the porous mesh 102 off of the skin, that the removal of the top liner will not change skin edge approximation, and that a therapeutic device may be lifted away from and repositioned over the top surface of the porous mesh without pulling the porous mesh away from the patient's skin.

[0140] In one embodiment, the first and second pressure sensitive adhesives may comprise water soluble pressure sensitive adhesives including hydrocolloids; homo-polymer emulsion (PVA); water-based acrylic adhesives; polyurethane dispersions (PUDs); polyethylene glycol; dextrin/starch-based adhesives; N-vinyl pyrrolidone copolymers; polyvinyl alcohol; cellulose ethers; methylcellulose; carboxymethylcellulose; polyvinylpyrrolidone; polyvinyl acetates, or water insoluble pressure sensitive adhesives including acrylic adhesives; cyanoacrylate adhesives; epoxy; silicone based adhesives; and urethane.

[0141] Referring to FIG. 6, in one embodiment, the porous mesh 102 is positioned over a wound formed in tissue. The porous mesh is preferably utilized for approximating the opposing skin edges of the wound. The removable bottom liner 116 (FIG. 1) is peeled away from the bottom surface 106 of the porous mesh 102 to expose the second pressure sensitive adhesive 114 (e.g., traces 114A-114Y shown in FIG. 5) that overlies the bottom surface of the porous mesh. The second pressure sensitive adhesive 114 overlying the bottom surface of the porous mesh 102 may be pressed against the skin of a patient for securing the bottom surface 106 of the porous mesh 102 to the skin and/or for approximating the opposing skin edges of the wound.

[0142] The porous mesh 102 is used to approximate and hold in apposition or close approximation the edges of the wound, using the second pressure sensitive adhesive traces 114A-114Y (FIG. 5) for securing the porous mesh and for securing in close approximation or apposition the opposing edges of the wound.

[0143] In one embodiment, after the porous mesh 102 has been secured to the skin for approximating the skin edges of the wound, the removable top liner 112 (FIG. 1) may be peeled away from the top surface 104 of the porous mesh 102 to expose the first pressure sensitive adhesive 110 that overlies the top surface 104 of the porous mesh 102.

[0144] In one embodiment, a therapeutic device 126, such as a negative pressure wound therapy (NPWT) device, may be pressed onto the first pressure sensitive adhesive 110 that overlies the top surface 104 of the porous mesh 102 for securing the therapeutic device 126 over the top surface 104 of the porous mesh 102. The therapeutic device may be activated for generating negative pressure and/or a vacuum for draining bodily fluids from the wound. In one embodiment, the wound closure system 100 preferably includes a cannula 128 that may be coupled with the therapeutic device 126 for draining fluids (e.g., wound exudate) that are suctioned by the therapeutic device 126.

[0145] Referring to FIG. 7, in one embodiment, the porous mesh 102 is secured over the wound. The second pressure sensitive adhesive 114 (FIG. 6) overlying the bottom surface of the porous mesh is utilized for securing 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. A surgeon may manipulate the porous mesh 102 (e.g., repeatedly lifting, repositioning and/or smoothing the porous mesh) for approximating the opposing skin edges of the wound. In one embodiment, the therapeutic device 126 may be pressed against the first pressure sensitive adhesive 110 (FIG. 6) that overlies the top surface 104 of the porous mesh 102 for adhering the therapeutic device 126 to the top surface of the porous mesh. The cannula 128 may be connected with the therapeutic device 126 for draining fluid away from the wound.

[0146] In one embodiment, the longitudinal axis of the porous mesh 102 is aligned with and superimposed over the wound. The positioning of porous mesh over the wound is performed so that the longitudinal axis is aligned with the wound and overlaps the ends of the wound (i.e., the longitudinal axis of the porous mesh is in registration the wound or surgical incision).

[0147] Referring to FIG. 8, in one embodiment, a liquid adhesive 130 (e.g., a rapidly polymerizable or cross-linkable liquid adhesive) is preferably applied over the therapeutic device 126 and the porous mesh 102 that is secured to skin for approximating skin edges of the wound. In one embodiment, before curing, the liquid adhesive 130 may penetrate through the openings 108 of the porous mesh 102 for establishing contact with skin 100 in all areas not covered by the therapeutic device 126. In one embodiment, after curing, the liquid adhesive 130 preferably forms an air-tight seal around the therapeutic device 126 and the periphery of the porous mesh 102.

[0148] The liquid adhesive 130 may be a polymerizable or cross-linkable adhesive that is applied over the porous mesh 102 and the therapeutic device 126. The liquid adhesive 130 may be expressed from a container having a porous tip impregnated with a polymerization or cross-linking accelerator or initiator.

[0149] In one embodiment, the liquid adhesive does not contain a polymerization or cross-linking accelerator or initiator, rather the polymerization or cross-linking accelerator or activator/initiator may be present on or in the porous mesh 102 in a releasable or reactive form (i.e., available for rapid reaction when contacted by the liquid adhesive 130).

[0150] In one embodiment, after being applied over the porous mesh 102 and the therapeutic device 126, the liquid adhesive 130 preferably polymerizes and/or cross-links and solidifies, establishing a secure bond with the skin, the porous mesh 102, and the therapeutic device 126.

[0151] In one embodiment, the liquid adhesive 130 is polymerized or is crosslinked polymerized or is cross-linked after coming in contact with initiators and/or accelerators of adhesive polymerization and/or cross-linking, including naturally found initiators on the tissue, such as moisture, traces of proteins, etc. Such initiators and/or accelerators may be coated or disposed non-releasably, i.e., immobilized in or on the porous mesh 102 while retaining activity to initiate or accelerate polymerization and/or cross-linking. In one embodiment, initiators and/or accelerators are disposed releasably, i.e., they can be at least partially released into and mix with the liquid adhesive 130.

[0152] In one embodiment, the liquid adhesive 130 is polymerized or is cross-linked after coming in contact with initiators and/or accelerators releasably disposed in or on the porous mesh 102. Rapid polymerization and/or crosslinking of the liquid adhesive 130 results in bonding the porous mesh 102 to tissue (e.g., skin).

[0153] The liquid adhesive 130 may be any type of biocompatible and rapidly cross-linkable and/or polymerizable compound or mixture of compounds. As used herein, the terms rapidly cross-linkable and/or polymerizable mean that after initiators or accelerators are added, or after the adhesive is formed from two or more components, it is capable of curing, i.e., cross-linking and/or polymerizing within 0.2 minutes to about 20 minutes, and more preferably within 0.5-10 minutes. In one embodiment, the liquid adhesive may cure in about one minute.

[0154] In one embodiment, the liquid adhesive 130 may be formed prior to application onto the porous mesh 102, for instance by mixing two components contained in separate barrels or a two-barrel syringe, and passing the two components through a mixing tip. In this embodiment, there may be no crosslinking initiator or accelerator disposed inside of porous mesh 20. In one embodiment, the liquid adhesive 130 may be formed by mixing fibrinogen and thrombin together.

[0155] In one embodiment, the liquid adhesive 130 may comprise fibrinogen, and a crosslinking initiator or accelerator that is disposed inside the porous mesh 102 comprises thrombin.

[0156] Many other adhesive formulations may be used and are known to a skilled artisan. For example, mixtures containing PEG succinimidyl glutarate may be used as a liquid adhesive.

[0157] In certain embodiments, initiators and/or accelerators or rate modifiers of adhesive polymerization or cross-linking may be releasably disposed on the porous mesh 102 or releasably incorporated into the porous mesh. For example, one or more chemical substances may be dispersed in or on the porous mesh such as being chemically bound, physically bound, coated, absorbed, or adsorbed to the porous mesh.

[0158] For example, a polymerization initiator or accelerator or rate modifier may be loaded in or on the porous mesh so that the initiator or rate modifier provides the desired initiation or rate modification effect to a subsequently applied polymerizable adhesive composition. The polymerization initiator or rate modifier may be immobilized in or on porous mesh so that the initiator or rate modifier does not become detached from the porous mesh and its residues are dispersed in the resultant polymeric material. Alternatively, for example, the polymerization initiator or rate modifier may be initially attached to the porous mesh, but only in such a manner that it becomes mobilized or solubilized by a subsequently applied polymerizable adhesive composition and dispersed in the resultant polymeric material.

[0159] If desired, a combination of chemical substances may also be provided in or on porous mesh, to provide multiple effects. For example, a first chemical species (such as a polymerization initiator or rate modifier) may be immobilized in or on the mesh, while a second, different chemical species (such as a bioactive material) may be detachably attached to the mesh.

[0160] When present in or on the porous mesh, the chemical substances (i.e., polymerization initiator, rate modifier, and/or bioactive materials, or other additives), may be incorporated in or on the porous mesh in any suitable manner. For example, the chemical substance may be added to the porous mesh by contacting the mesh with a solution, mixture, or the like including the chemical substances. The chemical substance may be added to the mesh, for example, by dipping, spraying, roll coating, gravure coating, brushing, vapor deposition, or the like. Alternatively, the chemical substance may be incorporated into or onto the porous mesh during manufacture of the mesh, such as during molding.

[0161] The polymerization initiator or rate modifier loaded in or on the porous mesh may provide a number of advantages (e.g., to provide shorter polymerization time). The concentration of the polymerization initiator or rate modifier may be increased to provide even shorter (i.e., faster) polymerization time. Because the polymerization initiator or rate modifier is loaded directly in or on the porous mesh, it is not necessary to mix the polymerizable adhesive composition with a polymerization initiator or rate modifier prior to application. This may allow a longer working time, where the polymerizable monomer composition may be more precisely and carefully applied over a longer period of time. Such suitable initiators are known in the art and are described, for example, in U.S. Pat. Nos. 5,928,611 and 6,620,846 and U.S. Patent Application Publication No. 2002/0037310, the disclosures of which are hereby incorporated by reference herein.

[0162] In one embodiment, the therapeutic device 126 is a negative pressure wound therapy (NPWT) device that is configured for generating negative pressure for draining exudate from the wound. The wound exudate drawn into the negative pressure wound therapy device 126 may be directed into the cannula 128 for draining the wound exudate away from the patient.

[0163] Use of Wound Closure Systems. In one embodiment, application of a wound closure system may be performed in one or more of the steps disclosed below.

[0164] In one embodiment, standard surgical practices are utilized for preparing the wound including thorough wound cleansing before application of the porous mesh 102 (FIG. 8). The standard surgical practices may include cleansing, irrigating, debriding, obtaining hemostasis, and closing deep tissue layers so that there is no tension on the wound edges. The wound edges are preferably closely approximated prior to application of the porous mesh so that significant manual approximation is not required during application of the porous mesh.

[0165] In one embodiment, a sterile gauze may be used to dry the wound, such as patting the wound with the sterile gauze. Drying the wound will ensure direct tissue contact for adherence of the second pressure sensitive adhesive 114 and the porous mesh 102 (FIG. 8) around the wound.

[0166] In one embodiment, the wound closure system including the porous mesh, the therapeutic device, and the liquid adhesive are preferably aseptically transferred into a sterile field.

[0167] Referring to FIGS. 1 and 3, in one embodiment, the center section 122 of the bottom liner 116 may be peeled away from the bottom surface 106 of the porous mesh 102.

[0168] In one embodiment, a surgeon will hold the mesh 102 by the corners of the peripheral sections 124A, 1248 of the bottom liner 116 (FIG. 3) for ensuring the second pressure sensitive adhesive 114 (FIG. 8) applied to the bottom surface 106 of the porous mesh 102 may be adhered to the patient's skin.

[0169] In one embodiment, the porous mesh is positioned so that of the mesh is on either side of the wound or incision, ensuring approximately 1 cm of the mesh extends beyond the ends of the wound or incision. In one embodiment, a surgeon gently presses on the porous mesh to ensure intimate contact of the bottom surface of the porous mesh to a selected side of the wound. In one embodiment, the porous mesh may be gently pulled perpendicularly over the wound while adjusting the porous mesh with fingers or forceps to achieve skin edge approximation and affix the remainder of the porous mesh to the other side of the wound. If there are areas where the porous mesh is loose, a surgeon may gently pass a gloved finger or instrument over the affected area of the porous mesh to ensure complete adherence of the mesh to the skin.

[0170] In one embodiment, after the skin edges have been approximated and the porous mesh is deemed to be properly affixed to the skin, the first and second peripheral sections 124A, 1248 of the removable bottom liner 116 may be peeled away from the bottom surface of the porous mesh for adhering peripheral sections of the porous mesh to the skin.

[0171] In one embodiment, a sterile cutting tool may be utilized to trim the ends of the porous mesh, if necessary, to ensure that about one (1) cm of porous mesh material extends beyond the ends of the wound or incision.

[0172] In one embodiment, the first and second peripheral sections of the removable top liner 112 (FIG. 2) may be peeled away from the top surface of the porous mesh.

[0173] In one embodiment, the therapeutic device 126 may 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 place atop the porous mesh.

[0174] In one embodiment, after medical personnel ensure that the porous mesh is in intimate contact with the skin and after the therapeutic device is secured atop the porous mesh, the liquid adhesive may be applied.

[0175] In one embodiment, immediately after the therapeutic device has been placed atop the porous mesh, the liquid adhesive 130 is preferably applied over the porous mesh and at least a portion of the therapeutic device 126. In one embodiment, immediately prior to applying and spreading the liquid adhesive, in the event of bodily fluid seepage, medical personnel may use a sterile gauze to dry the deployed porous mesh.

[0176] Referring to FIG. 8, in one embodiment, the liquid adhesive 130 is spread smoothly and evenly over the therapeutic device 125, at least a portion of the cannula 128, and the entire length of the porous mesh 102 and the surrounding skin area using a tool such as a spreader or a flexible applicator tip. The liquid adhesive is preferably spread using short strokes and moving from one end of the mesh to the other end, making sure that the therapeutic 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 may also be applied over the edges or outer periphery of the porous mesh, covering a small margin of surrounding skin.

[0177] Once the liquid adhesive is applied to over the porous mesh and the therapeutic device, after about 1 minute, medical personnel may check that polymerization is complete by gently dabbing along the length of the porous mesh with a gloved finger, checking for tackiness. When no liquid or tackiness is apparent, the polymerization process is complete. Once the liquid adhesive is polymerized, the therapeutic device may be operated for performing various therapeutic activities including but not limited to draining bodily fluids from the wound, infusing the wound with saline or medications, and/or monitoring the wound using a sensor.

[0178] Referring to FIG. 9A, in one embodiment, after an incision (e.g., a wound) is formed in skin of a patient, a wound closure system 200 may be applied over the incision for approximating skin edges and promoting healing of the wound. In one embodiment, the wound closure system 200 preferably includes a porous mesh 202 that is adhered to skin that surrounds the incision. The porous mesh 202 may be at least partially transparent so that a surgeon may view the incision through the porous mesh for effectively aligning the porous mesh with the incision and for enabling the physician to approximate the opposing skin edges of the incision. The porous mesh preferably has a length that is greater than the length of the incision. In one embodiment, the porous mesh may be repeatedly lifted away from the skin for repositioning the porous mesh to ensure that the porous mesh is properly aligned with the incision and/or that the opposing skin edges of the incision are approximated.

[0179] Referring to FIG. 9B, in one embodiment, the wound closure system 200 preferably includes a therapeutic device 226 that may be positioned over a top surface of the porous mesh 202. In one embodiment, the therapeutic device 226 preferably includes an elongated tube 232 having a proximal end 234 and a distal end 236. The elongated tube 232 desirably has a length that extends from the proximal end 234 to the distal end 236 thereof. In one embodiment, the therapeutic device 226 preferably includes first and second mesh wings 238A, 238B that extend along opposite lateral sides of the elongated tube 232. In one embodiment, the first and second mesh wings 238A, 238B completely surround the sides of the elongated tube 232 and extend beyond the respective proximal and distal ends 234, 236 of the elongated tube 232. The outer perimeter of the first and second mesh wings 238A, 238B may be smaller than the outer perimeter of the porous mesh 202 so that when the therapeutic device 226 is secured atop the porous mesh 202 (FIG. 9A), the elongated tube 232 and the first and second mesh wings 238A, 238B are located entirely within the outer perimeter of the porous mesh.

[0180] Referring to FIG. 9C, in one embodiment, after the elongated tube 232 and the first and second mesh wings 238A, 238B of the therapeutic device 226 have been secured over a top surface of the porous mesh 202, a liquid adhesive 240 may be spread over the top of the elongated tube 232, the first and second mesh wings 238A, 238B and the porous mesh 202. The liquid adhesive 240 may be spread using a topical adhesive spreader 242 (e.g., a tool having a flexible blade; a brush). The liquid adhesive 240 preferably completely surrounds the outer perimeter of the porous mesh 202 and completely encapsulates the therapeutic device 226 and the porous mesh 202.

[0181] In one embodiment, the first and second mesh wings 238A, 238B are preferably utilized for positioning the elongated tube 232 over the incision. In one embodiment, the elongated tube 232 and the first and second mesh wings 238A, 238B may be cut to the length of the incision.

[0182] Referring to FIG. 9D, after the liquid adhesive 240 has been spread over the elongated tube 232, the first and second mesh wings 238A, 238B and the porous mesh 202, a wound treatment controller 244 may be coupled with the proximal end 234 of the elongated tube 232 of the therapeutic device 226. In one embodiment, the wound treatment controller 244 is configured for draining fluid from the incision/wound and/or infusing saline and/or medication over the incision/wound for promoting healing.

[0183] Referring to FIG. 9E, in one embodiment, the wound treatment controller 244 is preferably coupled with the proximal end 234 of the elongated tube 232 of the therapeutic device 226. In one embodiment, the elongated tube 232 has a first inlet 246 that is preferably configured for draining fluids (e.g., wound exudate) from the incision (FIG. 9A) and a second inlet 248 that is preferably configured for delivering saline or medication to the incision (FIG. 9A).

[0184] In one embodiment, the elongated tube 232 may have holes and/or slits that are used for draining fluid from a wound/incision or infusing saline or a medication onto 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 by using a pressure sensitive adhesive.

[0185] In one embodiment, the elongated tube 232 may have two ends, with one end of the elongated tube being attached to a vacuum for draining fluids (e.g., wound exudate) from the wound/incision and one end of tubing being attached to an inlet port for infusing/injecting fluids, saline irrigation, or medication over the wound/incision. The elongated tube is customizable. The length of the elongated tube may be adjusted, and different therapeutic devices may be used with the elongated tube to monitor the incision, etc. The elongated tube may also be flexed (e.g., bent into a curved configuration) for conforming to the shape of the wound/incision.

[0186] Referring to FIG. 10A, in one embodiment, a porous mesh 302 is preferably positioned over an incision formed in skin of a patient. A bottom surface of the porous mesh 302 may have a pressure sensitive adhesive for adhering the bottom surface of the porous mesh to the skin of the patient. When the porous mesh 302 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.

[0187] In one embodiment, the top surface of the porous mesh 302 is covered by one or more removable top liners. In FIG. 10A, a center segment of a removable top liner has been removed (e.g., peeled away) so that the incision is visible thought the porous mesh. In FIG. 10A, first and second peripheral segments 320A, 320B of the removable top liner remain covering the top surface of the porous mesh 302. The first and second peripheral segments 320A, 320B may be engaged by a surgeon's fingers for manipulating 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.

[0188] Referring to FIG. 10B, in one embodiment, after the porous mesh 302 has been aligned over the incision and has been configured for approximating the opposing skin edges of the incision, the peripheral segments of the removable top liner including the second peripheral segment 320B of the removable top liner may be peeled away from the top surface of the porous mesh 302.

[0189] Referring to FIG. 100, in one embodiment, when the center and first and second peripheral segments of the releasable top liner have been removed from covering the top surface of the porous mesh 302, the bottom surface of the porous mesh remains secured to the skin of the patient for approximating 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 traces of the pressure sensitive adhesive). In one embodiment, a therapeutic device 326 including an elongated tube 332 and first and second mesh wings 338A, 338B that extend along opposite lateral sides of the elongated tube is preferably positioned over the top surface of the porous mesh 302. The therapeutic device 326 may be similar to the therapeutic device 326 shown and describe above in FIGS. 9B-9E. In one embodiment, the elongated tube 332 is desirably aligned with the incision (FIG. 10B) so that the elongated tube 332 extends along the length of the incision.

[0190] Referring to FIG. 10D, in one embodiment, a liquid adhesive 340 is preferably applied over the therapeutic device 326, which includes the elongated tube 332 and the first and second mesh wings 338A, 338B. In addition, the liquid adhesive 340 is applied over the top surface of the porous mesh 302. In one embodiment, the liquid adhesive 340 preferably completely surrounds the outer periphery of the porous mesh 302 and encapsulates the therapeutic device 326 and the porous mesh 302. In one embodiment, an adhesive spreader 342 may be utilized for applying and/or spreading the liquid adhesive 340 over the therapeutic device 326 and the porous mesh 302.

[0191] In one embodiment, the liquid adhesive is configured to secure the therapeutic device 326 and the porous mesh over the incision and form a strong seal around the incision. The liquid adhesive may also form a microbial barrier, be waterproof, and/or allow medical personnel to monitor the wound healing process. The liquid adhesive may be any biocompatible adhesive known in the art, for example, a cyanoacrylate-based adhesive, a silicone-based adhesive, etc. as described above.

[0192] Referring to FIG. 11A, in one embodiment, a porous mesh 402 is preferably positioned over an incision formed in skin of a patient. A 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 skin of the patient. 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.

[0193] In one embodiment, the top surface of the porous mesh 402 is preferably covered by one or more removable top liners. In FIG. 11A, a center segment of the removable top liner has been removed so that the incision is visible through the porous mesh. In FIG. 11A, first and second peripheral segments 420A, 420B of the removable top liner remain in place over the top surface of the porous mesh 402. The first and second peripheral segments 420A, 420B may be gripped by a surgeon for controlling and/or manipulating the porous mesh 402 so that it may be properly aligned over the incision and/or for approximating the opposing skin edges of the incision.

[0194] Referring to FIG. 11B, in one embodiment, after the porous mesh 402 has been aligned over the incision, the peripheral segments 420A, 420B (FIG. 11A) of the removable top liner may be peeled away from the top surface of the porous mesh 402.

[0195] Referring to FIG. 11C, in one embodiment, when the center segment and the first and second peripheral segments of the releasable top liner have been removed from covering the top surface of the porous mesh 402, the bottom surface of the porous mesh remains secured to the skin of the patient for approximating the opposing skin edges of the incision. In one embodiment, a therapeutic device 426 including an elongated tube 432 is preferably positioned over the top surface 404 of the porous mesh 402. In one embodiment, the elongated tube 432 is desirably aligned with the incision (FIG. 11B) so that the elongated tube 432 extends along the length of the incision. The elongated tube 432 may be flexed into a shape (e.g., a curve) that mirrors and/or conforms to the shape of the underlying incision.

[0196] Referring to FIG. 11D, in one embodiment, a liquid adhesive 440 is preferably applied over the therapeutic device 426 including the elongated tube 432 and the top surface of the porous mesh 402. In one embodiment, an adhesive spreader 442 may be utilized for applying and/or spreading the liquid adhesive 440 over the therapeutic device 426 and the porous mesh 402. In one embodiment, the liquid adhesive 440 preferably completely surrounds the outer periphery of the porous mesh 402 and encapsulates the therapeutic device 426 and the porous mesh 402

[0197] Referring to FIG. 12, in one embodiment, a wound closure system 400 preferably includes a therapeutic device including the elongated tube 432 secured atop a porous mesh 402 (FIG. 11B), which, in turn, is adhered to skin for approximating skin edges of the incision shown in FIGS. 11A-11D. The elongated tube 432 is preferably bifurcated into a first part that is coupled with a drainage tube 450 utilized for draining fluids from the incision. The drainage tube 450 may have a proximal end coupled with a fluid container 452 that collects the fluid (e.g., wound exudate) that passes through the drainage tube 450. In one embodiment, the wound closure system 400 preferably includes an infusion tube 454 coupled with a syringe 456 that may be utilized for infusing saline and/or a medication into the wound. After the saline or medication is infused into the wound, the fluid may be drawn from the wound via the drainage tube 450 for being collected within the collection container 452. The wound may be continuously flushed with fluids (e.g., saline; medication) for enhancing healing of the wound, which may include a combination of infusing the wound with saline and/or medication and draining wound exudate from the wound.

[0198] Referring to FIGS. 13 and 14A, in one embodiment, a 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., pores; holes) that extend between the top and bottom surfaces 504, 506. In one embodiment, the porous mesh 502 desirably includes a center section 570 that extends along a central axis A.sub.1 and first and second peripheral sections 572A, 572B that extend along respective lateral sides of the center section 570. In one embodiment, the openings 508 located within the center section 570 of the porous mesh 502 have the same size as the openings 508 located within the first and second peripheral sections 572A, 572B of the porous mesh. In one embodiment, the openings 508 located within the center section 570 of the porous mesh 502 are smaller in size than the openings 508 located within the first and second peripheral sections 572A, 572B of the porous mesh.

[0199] Referring to FIG. 14A, in one embodiment, the bottom surface 506 of the porous mesh 502 is abutted against skin of a patient for approximating skin edges of a wound. The center section 570 of the porous mesh 502 that is covered by the releasable liner 512 is preferably aligned with the wound. The releasable liner 512 overlies the top surface 504 of the porous mesh 502 and covers the openings 508 located within the center section 570 of the porous mesh.

[0200] Referring to FIG. 14B, in one embodiment, a liquid adhesive 530 may be applied over the top surface 504 of the porous mesh 502 including the releasable liner 512 that covers the center section 570 of the porous mesh. The releasable liner 512 preferably prevents the liquid adhesive from closing of the openings 508A that are located within the center section 570 of the porous mesh 502. In one embodiment, in the stage shown in FIG. 14B, the liquid adhesive 530 preferably surrounds the outer perimeter of the porous mesh 502 and fully encapsulates the porous mesh and the releasable liner 512 that covers the center section 570 of the porous mesh. The releasable liner 512 preferably masks the openings 508A located within the center region 570 of the porous mesh.

[0201] Referring to FIGS. 14B and 14C, in one embodiment, the liquid adhesive 130 is preferably not fully cured or only partially cured so that the releasable liner 512 (FIG. 14B) may be peeled away from the top surface 504 of the porous mesh 502 removing uncured or partially cured adhesive on the releasable liner 512 to expose the openings 508A that are located within the center section 570 of the porous mesh 502. The openings 508A within the center section 570 are located within a gap of the partially or fully cured adhesive 530. The gap in the adhesive desirably extends along the length of the center region of the porous mesh.

[0202] Referring to FIG. 14D, in one embodiment, after the releasable liner 512 (FIG. 14B) is peeled away from the top surface 504 of the porous mesh 502, a therapeutic device 526 (e.g., a negative pressure wound therapy device) may be positioned and/or secured over the center section 570 of the porous mesh for being aligned with the wound. In one embodiment, the therapeutic device 526 is preferably configured for removing and/or draining bodily fluids (e.g., exudate) from the wound. The therapeutic device 526 may also be configured for delivering saline and/or medication to the wound or for monitoring the wound (e.g., a sensor).

[0203] Referring to FIG. 15, in one embodiment, a therapeutic device 626 may be incorporated into one or more of the wound closure systems disclosed herein. In one embodiment, the therapeutic device 626 may be used for draining a wound during negative pressure wound therapy and/or for infusing a therapeutic solution into a wound. In one embodiment, the therapeutic device 626 may be used for both draining a wound and infusing the wound with a therapeutic solution.

[0204] In one embodiment, the therapeutic device 626 may be made of a biocompatible material such as a polymer, silicone, or stainless steel. In one embodiment, the therapeutic device may be transparent.

[0205] In one embodiment, the therapeutic device 626 preferably has a top surface 650, a bottom surface 652, and side walls 654A, 654B that slope outwardly between the top and bottom surfaces 652, 654. In one embodiment, the top and bottom surfaces 650, 652 of the therapeutic device may be parallel to one another. In one embodiment, the therapeutic device 626 may have a low profile and may resemble the shape of a speed bump.

[0206] In one embodiment, the therapeutic device 626 may have a first elongated channel 656A that extends along the length of the therapeutic device. In one embodiment, the therapeutic device 626 preferably includes a first fenestration 658A (e.g., an opening) that is formed in the bottom surface 652 of the therapeutic device, which is in fluid communication with the first elongated channel 656A. In one embodiment, the first fenestration 658A may be positioned over a wound for placing the first elongated channel 656A in fluid communication with the wound. In one embodiment, a vacuum may be coupled with the first elongated channel 656A for draining fluid (e.g., exudate) from the wound. The fluid that is drained from the wound preferably passes through the first fenestration 658A and into the first elongated channel 656A for being removed from the wound. In one embodiment, the therapeutic device may include a first port that is in fluid communication with the first elongated channel 656A for coupling a drain tube with the first elongated channel 656A.

[0207] In one embodiment, the first elongated channel 656A and the first fenestration 658A may be used for infusing a therapeutic solution into the wound.

[0208] In one embodiment, the therapeutic device 626 may have a second elongated channel 656B that extends along the length of the therapeutic device and a second fenestration 658B formed in the bottom surface 652 of the therapeutic device that is in fluid communication with the second elongated channel 656B.

[0209] In one embodiment, the second elongated channel 656B and the second fenestration 658B may be used for draining fluid from a wound and/or for infusing the wound with a therapeutic solution. In one embodiment, the therapeutic device may include a second port that is in fluid communication with the second elongated channel 656B for coupling the second elongated channel with a drainage tube or an infusion tube.

[0210] In one embodiment, the therapeutic device 626 may have a third elongated channel 656C that extends along the length of the therapeutic device and a third fenestration 658C formed in the bottom surface 652 of the therapeutic device that is in fluid communication with the third elongated channel 656C.

[0211] In one embodiment, the third elongated channel 656C and the third fenestration 658C may be used for draining fluid from a wound and/or for infusing a therapeutic solution into the wound. In one embodiment, the therapeutic device may include a third port that is in fluid communication with the third elongated channel 656C for coupling the third elongated channel with a drainage tube or an infusion tube.

[0212] In one embodiment, the therapeutic device 626 may be secured over a top surface of a first layer of a porous dressing so that the first elongated channel 656A of the therapeutic device is positioned over the top surface of the first layer of the porous dressing with the first elongated channel positioned adjacent the wound.

[0213] In one embodiment, a second layer of a porous dressing may be applied over both the first layer of the porous dressing and over the top of the therapeutic device 626 to secure the therapeutic device to the top surface of the first layer of the porous dressing. The second layer of the porous dressing may contact the top surface 650 and the side surfaces 654A, 654B of the therapeutic device 626.

[0214] In one embodiment, a flowable adhesive may be applied over the first layer of the porous dressing, the second layer of the porous dressing and the therapeutic device 626. The flowable adhesive may be cured for forming an air-tight seal around the wound.

[0215] In one embodiment, a tube may be attached to the therapeutic device 626 for draining fluid (e.g., exudate) from the first elongated channel 656A of the therapeutic device. In one embodiment, the tube may be attached to a vacuum for applying negative pressure to the wound for draining fluid from the wound. In one embodiment, the tube may be attached to a therapeutic solution (e.g., saline; medication; an antibiotic solution) for infusing the therapeutic solution into the first elongated channel 656A. The therapeutic solution preferably passes through the first fenestration 658A for infusing the wound with the therapeutic solution.

[0216] In one embodiment, the elongated channel of the therapeutic device 656 desirably has two or more connection ports where fluid may be infused into and/or withdrawn from the wound.

[0217] In one embodiment, the connection ports may be located on the top surface 650 or on one or more of the side surfaces 654A, 654B of the therapeutic device 626. In one embodiment, a connection port may be attached to a vacuum via tubing, which is configured to apply negative pressure to a wound or incision. In one embodiment, a connection port may be attached to an infusing tube for infusing a therapeutic solution (e.g., saline; medication; antibiotic) into a wound or incision.

[0218] In one embodiment, the therapeutic device 626 may be transparent for enabling medical personnel to view the wound or incision during healing. In one embodiment, the flowable adhesive cures to a transparent covering for enabling medical personnel to view the wound or incision during healing. In one embodiment, the flowable adhesive is a silicone material.

[0219] While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.