SURGICAL INCISION AND CLOSURE APPARATUS

• US 20160220252A1
• Filed: 04/11/2016
• Published: 08/04/2016
• Est. Priority Date: 11/01/2011
• Status: Active Grant

• Current Assignee: Zipline Medical, Inc. (Stryker Corporation)
• Original Assignee: Zipline Medical, Inc. (Stryker Corporation)
• Inventors: BELSON, Amir, STORNE, Eric, SCHAER, Alan, RATHI, Pankaj, ICHIRYU, Keiichiro, D'AQUANNI, Peter, CLAUSON, Luke
• Granted Patent: US 9,554,800 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0466 Suture bridges
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/086 having flexible threads, filaments, laces or wires, e.g. parallel threads, extending laterally from a strip, e.g. for tying to opposing threads extending from a similar strip
• CPC Class Codes: A61B 2017/088 Sliding fasteners

Abstract

An apparatus for closing a surgical incision comprises left and right base panels, a plurality of closure components, and a plurality of left and right axial supports coupled to the respective base panels. The closure components couple the left and right base panels to each other laterally and have left and right ends coupled to the respective base panels. The closure components are positioned laterally across the left and right panels, the left axial supports are disposed between pairs of left closure component ends, the right axial supports are disposed between pairs of right closure component ends, and the left and right axial supports are offset from one another such that a serpentine arrangement of consecutive closure components and axial supports is formed. The apparatus can be made of antimicrobial materials or materials impregnated with antimicrobial agents. A flexible adhesive cover can be provided over the apparatus when in use.

Claims

1. An incision closure apparatus comprising:

a first base panel for being adhered to a first side of an incision or wound, the first base panel comprising an upper surface and a tissue adherent lower surface;

a second base panel for being adhered to a second side of the incision or wound opposite the first side, the second base panel comprising an upper surface and a tissue adherent lower surface;

a plurality of lateral ties coupling the first and second base panels to one another;

a first sacrificial cover configured to be adhered over the first base panel; and

a second sacrificial cover configured to be adhered over the second base panel,

wherein the first and second sacrificial covers each have an adherent lower surface for adhering to the assembly and an upper surface for adhering to a film placed thereover,

wherein a first separation force to separate the first and second sacrificial covers from the first and second base panels is less than a second separation force to separate the first and second sacrificial covers from the film.

2. The incision closure apparatus of claim 1, wherein the film comprises a surgical drape, a barrier film, or a wound dressing.

3. The incision closure apparatus of claim 1, wherein the film comprises a thin urethane sheet.

4. The incision closure apparatus of claim 1, wherein one or more of the first or second sacrificial covers comprises a plurality of perforations to facilitate tearing away of a region of the one or more first or second sacrificial cover.

5. The incision closure apparatus of claim 1, wherein one or more of the first or second sacrificial covers comprises one or more tabs to prevent adherence of the one or more of the first or second sacrificial covers to the adherent lower surface of one or more of the first or second base panels.

6. The incision closure apparatus of claim 1, wherein one or more of the first or second sacrificial covers is sized to extend laterally over one or more of the outer lateral edges of the first or second base panels.

7. The incision closure apparatus of claim 1, further comprising a first plurality of axially spaced-apart supports coupled to the upper surface of the first base panel and a second plurality of axially spaced-apart supports coupled to the upper surface of the second base panel.

8. The incision closure apparatus of claim 7, wherein one or more of the first or second plurality of axially spaced-apart supports comprise force distribution structures.

9. The incision closure apparatus of claim 7, wherein the supports comprise flexible, non-distensible materials.

10. The incision closure apparatus of claim 7, wherein the supports are embedded in or laminated to the upper surface of each panel.

11. The incision closure apparatus of claim 1, wherein the lateral ties each have one end fixed to the first or second base panel and a opposite end adjustably attached to the opposite base panel, thereby allowing the lateral ties to draw the first and second base panels together to compress a wound or incision covered by the incision closure apparatus.

12. The incision closure apparatus of claim 1, wherein one or more of the first or second base panels comprise an elastic matrix.

13. The incision closure apparatus of claim 12, wherein the elastic matrix comprises an elastomeric membrane, a woven fabric, a spun fabric, rubber, latex, urethane, polyurethane, silicone, or a thermo plastic elastomer (TPE).

14. The incision closure apparatus of claim 13, wherein the elastic matrix comprises a fabric woven from elastic elements and having inelastic elements along lateral edges of the one or more of the first or second base panels and extending laterally thereacross.

15. The incision closure apparatus of claim 1, wherein one or more of the first or second base panels have one or more preferentially separating regions, and wherein the one or more preferentially separating regions facilitate one or more of axial separation or lateral stretching of the one or more of the first or second base panels.

16. The incision closure apparatus of claim 15, wherein the one or more preferentially separating regions are disposed axially between axially adjacent supports on one or more of the first or second base panels.

17. The incision closure apparatus of claim 15, wherein the one or more preferentially separating regions comprise a plurality of perforations disposed along a lateral line of the one or more of the first or second base panels.

18. The incision closure apparatus of claim 15, wherein the one or more preferentially separating regions are disposed along a lateral edge of the one or more of the first or second base panels.

19. The incision closure apparatus of claim 1, wherein the tissue adherent lower surface of one or more of the first or second base panels comprises a hydrophilic adhesive material.

20. The incision closure apparatus of claim 19, wherein the hydrophilic adhesive material comprises one or more of a hydrocolloid, a hydrogel, an acrylic polymer, or poly(ethylene glycol).

21. The incision closure apparatus of claim 1, further comprising a securing layer adapted to be placed over an assembly of the first and second base panels and the lateral ties after the assembly has been secured over the incision or wound.

22. The incision closure apparatus of claim 21, wherein the securing layer is placed between the assembly of the first and second base panels and plurality of lateral ties and the sacrificial cover.

23. The incision closure apparatus of claim 21, wherein the securing layer has an inner self-adhesive surface.

24. The incision closure apparatus of claim 21, wherein the securing layer is configured to laterally extend beyond an outer lateral edge of the first or second base panel.

25. The incision closure apparatus of claim 21, wherein the securing layer has one or more preferentially separating regions to allow the securing layer to at least partially stretch axially in response to axial stretching of the incision or wound and surrounding tissue the incision closure appliance is placed over.

26. A method of closing a wound or incision, the method comprising:

adhering a first base panel to a first side of an incision or wound, the first base panel having a first plurality of axially spaced-apart supports coupled to an upper surface thereof;

adhering a second base panel to a second side of the incision or wound, the second base panel having a second plurality of axially spaced-apart supports coupled to an upper surface thereof;

coupling the first and second base panels together with a plurality of lateral ties;

placing a first sacrificial cover over the first base panel and a second sacrificial cover over the second base panel, the sacrificial covers each having an adherent lower surface and an upper surface; and

placing a film over the first and second sacrificial covers, the surgical drape adhering to the upper surfaces of the first and second sacrificial covers, wherein a first separation force to separate the first and second sacrificial covers from the first and second base panels, respectively, is less than a second separation force to separate the first and second sacrificial covers from the film.

27. The method of claim 26, wherein the film comprises a surgical drape, a barrier film, or a wound dressing.

28. The method of claim 26, further comprising removing the film and the sacrificial cover from the assembly while leaving the assembly adhered to skin.

29. The method of claim 26, further comprising placing a securing layer over the first and second panels after the first and second panels have been coupled to one another, and wherein placing the first and second sacrificial covers over the first and second base panels, respectively, comprises placing the sacrificial cover over the securing layer.

30. The method of claim 26, wherein the securing layer is configured to laterally extend beyond an outer lateral edge of the first or second base panel.