Surgical incision and closure apparatus

• US 9,554,800 B2
• Filed: 04/11/2016
• Issued: 01/31/2017
• 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
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US15/096,083
• Publication Number:
  US 20160220252A1
• Time in Patent Office: 295 Days
• Field of Search: 606/213, 606215-218
• 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 for use with a common medical film, the apparatus comprising:

a first base panel for being adhered to a first side of an incision or wound, the first base panel comprising an outer lateral edge, 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 outer lateral edge, 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 adhered over the first base panel and laterally extending beyond the outer lateral edge of the first base panel when adhered thereto; and

a second sacrificial cover adhered over the second base panel and laterally extending beyond the outer lateral edge of the first base panel when adhered thereto,

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

wherein a first separation force necessary to separate the first and second sacrificial covers from the first and second base panels is configured to be less than a second separation force necessary to separate the first and second sacrificial covers from the medical 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 the first and second base panels each comprise inner lateral edges, and wherein the first or second sacrificial covers are configured to extend to the inner lateral edges of the first or second base panels, respectively, when adhered thereto, thereby leaving a gap between the inner lateral edges of the first and second base panels uncovered by the first and second sacrificial covers.

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

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 longitudinal 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 longitudinally between longitudinally 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 first and second sacrificial covers.

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 the lateral edges of one or more of the first or second base panels.

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 longitudinally in response to longitudinal stretching of the incision or wound and surrounding tissue the incision closure appliance is placed over.