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EP-4586979-B1 - WOUND CLOSURE SYSTEM HAVING MEDICANT

EP4586979B1EP 4586979 B1EP4586979 B1EP 4586979B1EP-4586979-B1

Inventors

  • OU, DUAN LI
  • TANNHAUSER, ROBERT J.
  • KRIKSUNOV, LEO

Dates

Publication Date
20260513
Application Date
20240823

Claims (15)

  1. A skin closure system, comprising: (a) a surgical mesh including a first upper side and a first lower side, wherein the first lower side is configured to adhere to a section of skin of a patient that surrounds a wound such that the surgical mesh surrounds the wound, wherein the first lower side of the surgical mesh comprises a first area; (b) a topical skin adhesive configured to be applied to the first upper side of the surgical mesh, wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound; and (c) a strip configured to be secured relative to the surgical mesh, the strip comprising: (i) an elongated body comprising a second upper side and a second lower side, wherein the second lower side comprises a second area, wherein the second area of the second lower side of the elongated body is smaller than the first area of the first lower side of the surgical mesh, wherein the elongated body is configured to extend longitudinally along a central portion of the lower side of the elongated mesh while the surgical mesh surrounds the wound such that the elongated body is adjacent to the wound, and (ii) an active pharmaceutical ingredient integrated into the elongated body, wherein the active pharmaceutical ingredient is configured to diffuse from the elongated body toward the wound after the protective layer over the wound is formed.
  2. The skin closure system of claim 1, wherein the second area of the second lower side of the elongated body is between 5 percent and 30 percent of the first area of the first lower side of the surgical mesh.
  3. The skin closure system of any one of claims 1-2, wherein the elongated body is configured to inhibit penetration of the topical skin adhesive through the elongated body to the second lower side of the elongated body.
  4. The skin closure system of any one of claims 1-3, wherein the surgical mesh comprises a first porosity, wherein the elongated body comprises a second porosity, wherein the second porosity is lower than the first porosity.
  5. The skin closure system of any one of claims 1-3, wherein the elongated body comprises a material that is impervious to penetration of the topical skin adhesive.
  6. The skin closure system of any one of claims 1-5, wherein the surgical mesh comprises a first width, wherein the elongated body comprises a second width, wherein the second width is smaller than the first width.
  7. The skin closure system of any one of claims 1-6, further comprising a mask interposed between the second upper surface of the elongated body and the first upper surface of the surgical mesh.
  8. The skin closure system of claim 7, wherein the mask is directly on top of the second upper surface of the elongated body, wherein the mask extends longitudinally along the entire length of the elongated body.
  9. The skin closure system of claim 7, wherein the mask comprises a material that is impervious to penetration of the topical adhesive.
  10. The skin closure system of any one of claims 1-9, wherein the strip further comprises a pressure sensitive adhesive associated with the second lower side of the elongated body.
  11. The skin closure system of claim 10, wherein the pressure sensitive adhesive is disposed on the second lower side of the elongated body in a stripe pattern.
  12. The skin closure system of any one of claims 1-11, wherein the surgical mesh comprises polyethylene.
  13. The skin closure system of any one of claims 1-12, wherein the active pharmaceutical ingredient comprises triclosan.
  14. The skin closure system of any one of claims 1-13, wherein the elongated body comprises polyethylene terephthalate.
  15. A method of making the skin closure system of claim 1, wherein the active pharmaceutical ingredient comprises triclosan, the method comprising: (a) positioning the elongated body and a source reservoir within a sealed pouch, wherein the source reservoir comprises triclosan; (b) positioning the sealed pouch within a chamber; and (c) subjecting the chamber to an ethylene oxide sterilization process and thereby urging the triclosan to migrate from the source reservoir to the elongated body.

Description

BACKGROUND A wound closure system (also referred to as a skin closure system) may be used at the conclusion of a surgical procedure on a patient to close a wound (e.g., a surgical incision) that was formed in the patient's skin for accessing a target anatomical structure. By way of example, wound closure systems may include components such as sutures, substrates, and/or liquid topical skin adhesives that are applied by a surgeon to approximate the edges of the wound and, in some cases, form a stable and protective layer over the wound that promotes efficient healing. In some instances, one or more components of the applied wound closure system may be absorbed by the patient during the healing process. Following healing of the wound, remaining components of the wound closure system may be removed from the skin by a surgeon, and/or they may automatically separate from the skin such that they may be discarded by the patient. WO2021/080867A1 describes elastic therapeutic tapes which are adapted for adhesive application to the external skin of a mammal. US2023/158284A1 describes wound dressings which can generate nitric oxide. While various wound closure systems and associated components and methods have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the description given below, serve to explain the principles of the present invention. FIG. 1 depicts a perspective view of an example of a wound closure system that includes a wound closure device, an adhesive applicator, and an adhesive spreader;FIG. 2 depicts a disassembled perspective view of the wound closure device of FIG. 1, showing a mesh layer, a pressure sensitive adhesive layer, and a removable backing layer;FIG. 3A depicts a perspective view of the wound closure device of FIG. 1 aligned longitudinally with a wound in the skin of a patient, showing a central section of the backing layer having been removed;FIG. 3B depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound to approximate the edges of the wound;FIG. 3C depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound, showing remaining sections of the backing layer having been removed so the wound closure device is fully adhered to the skin;FIG. 3D depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound, showing application of a liquid topical skin adhesive onto the mesh layer with the adhesive applicator;FIG. 3E depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound, showing the adhesive spreader positioned against the patient at the start of an adhesive spreading stroke for spreading the applied topical skin adhesive over and through the wound closure device;FIG. 3F depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound, showing the adhesive spreader during a subsequent portion of the adhesive spreading stroke;FIG. 4 depicts a perspective view of an example of a wound closure system that includes the wound closure device of FIG. 1, the adhesive applicator of FIG. 1, the adhesive spreader of FIG. 1, and a localized active strip having an active therapeutic agent incorporated therein, the localized active strip being housed within a storage container;FIG. 5 depicts a perspective view of the localized active strip and storage container of FIG. 4, with the localized active strip being removed from the storage container;FIG. 6A depicts a perspective view of the localized active strip of FIG. 4 aligned longitudinally with a wound in the skin of a patient;FIG. 6B depicts a perspective view of the localized active strip of FIG. 4 applied to the patient's skin over the wound;FIG. 6C depicts a perspective view of the wound closure device of FIG. 1 aligned longitudinally with both the localized active strip of FIG. 4 and the wound in the skin of a patient, showing a central section of the backing layer having been removed;FIG. 6D depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound and the localized active strip of FIG. 4, showing remaining sections of the backing layer having been removed so the wound closure device is fully adhered to the skin;FIG. 6E depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the wound and the localized active strip of FIG. 4, showing application of a liquid topical skin adhesive onto the mesh layer with the adhesive applicator;FIG. 6F depicts a perspective view of the wound closure device of FIG. 1 applied to the patient's skin over the w