Surgical incision and closure apparatus

• US 9,642,621 B2
• Filed: 02/18/2015
• Issued: 05/09/2017
• 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:
  US14/625,366
• Publication Number:
  US 20150216527A1
• Time in Patent Office: 811 Days
• Field of Search: 606213, 606215-218
• 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. 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 longitudinally 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 longitudinally spaced-apart supports coupled to an upper surface thereof; and

coupling the first and second base panels together with a plurality of lateral ties, wherein the lateral ties each have a first end permanently fixed relative to respective a support of the first base panel, wherein coupling the first and second base panels together comprises reversibly and adjustably attaching a second end of each lateral tie opposite the first end to the second base panel, and wherein the first ends of the lateral ties are integrally formed with their respective supports on the first base panel.

2. The method of claim 1, further comprising disengaging and re-engaging the second end of a lateral tie from a support on the second base panel.

3. The method of claim 1, wherein the second base panel comprises one or more locks, and wherein the second ends of the lateral ties and the one or more locks together form a ratchet tightening mechanism.

4. The method of claim 1, further comprising independently adjusting the attachment of each lateral tie to the second base panel to vary the spacing between the first and second panels along their lengths.

5. The method of claim 1, further comprising placing a securing layer over the first and second base panels after the first and second base panels have been coupled to one another.

6. The method of claim 5, wherein the securing layer is configured to laterally extend beyond an outer lateral edge of the first or second base panel.

7. The method of claim 1, further comprising longitudinally separating one or more of the first or second base panels into a plurality of discrete and separate base panel segments.

8. The method of claim 7, wherein the one or more of the first or second base panels are longitudinally separated into the plurality of discrete and separate base panel segments along a plurality of preferentially separating regions distributed along a length of said one or more of the first or second base panels.

9. The method of claim 8, wherein the plurality of preferentially separating regions comprises one or more perforations through said one or more of the first or second base panels.

10. The method of claim 9, wherein the one or more perforations are disposed along a lateral line across said one or more of the first or second base panels.

11. The method of claim 8, wherein the plurality of preferentially separating regions allow said one or more of the first or second base panels to tear or separate into the plurality of discrete and separate base panel segments.

12. The method of claim 1, further comprising:

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 medical film over the first and second sacrificial covers, the medical film adhering to the upper surfaces of the first and second sacrificial covers,

wherein a first separation force necessary to separate the first and second sacrificial covers from the first and second base panels, respectively, is configured to be less than a second separation force necessary to separate the first and second sacrificial covers from the medical film.

13. The method of claim 12, wherein the medical film comprises a surgical drape, a barrier film, or a wound dressing.

14. The method of claim 12, further comprising removing the medical film and the sacrificial cover from the assembly while leaving the assembly adhered to skin.

15. The method of claim 12, further comprising placing a securing layer over the first and second base panels after the first and second base 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 first and second sacrificial covers over the securing layer.

16. The method of claim 12, wherein the securing layer is configured to laterally extend beyond an outer lateral edge of one or more of the first or second base panel when adhered thereto.

17. 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 comprising a longitudinal axis;

adhering a second base panel to a second side of the incision or wound opposite the first side, the second base panel comprising a longitudinal axis;

coupling the first and second base panels together with a plurality of lateral ties, wherein the first and second base panels are each unitary,

longitudinally stretching one or more of the first or second base panels with the first and second base panels adhered to the first and second sides of the incision or wound, respectively, and coupled together with the plurality of lateral ties, such that said one or more of the first or second base panels are separated into a plurality of discrete and separate base panel segments along the longitudinal axis thereof.

18. The method of claim 17, wherein said one or more of the first or second base panels are longitudinally separated into the plurality of discrete and separate base panel segments along a plurality of preferentially separating regions distributed along a length of said one or more of the first or second base panels.

19. The method of claim 18, wherein the plurality of preferentially separating regions comprises one or more perforations through said one or more of the first or second base panels.

20. The method of claim 19, wherein the one or more perforations are disposed along a lateral line across said one or more of the first or second base panels.

21. The method of claim 18, wherein the plurality of preferentially separating regions allow said one or more of the first or second base panels to tear or separate into the plurality of discrete and separate base panel segments beyond a threshold of longitudinal stretching.

22. The method of claim 17, wherein the first base panel has a first plurality of longitudinally spaced-apart supports coupled to an upper surface thereof, wherein the second base panel has a second plurality of longitudinally spaced-apart supports coupled to an upper surface thereof, wherein the lateral ties each have a first end permanently fixed to a support of the first base panel, and wherein coupling the first and second base panels together comprises reversibly and adjustably attaching a second end of each of the lateral ties to the second base panel.

23. The method of claim 22, further comprising disengaging and re-engaging the second ends of an individual lateral tie from a support on the second base panel.

24. The method of claim 22, wherein the second base panel comprises one or more locks, and wherein the second ends of the lateral ties and the one or more locks together form a ratchet tightening mechanism.

25. The method of claim 22, further comprising independently adjusting the attachment of each lateral tie to the second base panel to vary the spacing between the first and second base panels along their lengths.

26. The method of claim 17, further comprising placing a securing layer over the first and second base panels after the first and second base panels have been coupled to one another.

27. 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.

28. The method of claim 17, further comprising:

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 medical film over the first and second sacrificial covers, the medical film adhering to the upper surfaces of the first and second sacrificial covers,

wherein a first separation force necessary to separate the first and second sacrificial covers from the first and second base panels, respectively, is configured to be less than a second separation force to necessary separate the first and second sacrificial covers from the medical film.

29. The method of claim 28, wherein the medical film comprises a surgical drape, a barrier film, or a wound dressing.

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

31. The method of claim 28, further comprising placing a securing layer over the first and second base panels after the first and second base 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.

32. The method of claim 31, wherein the securing layer is configured to laterally extend beyond an outer lateral edge of one or more of the first or second base panel when adhered thereto.

33. 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 longitudinally 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 longitudinally 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 first and second sacrificial covers each having an adherent lower surface and an upper surface and each laterally extending from an inner lateral edge to beyond an outer lateral edge of the first and second base panels, respectively, when adhered thereto, the inner lateral edge of each of the first and second base panels being adjacent the wound or incision and the outer lateral edge of each of the first and second base panels being spaced apart from the wound or incision; and

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

34. The method of claim 33, wherein the medical film comprises a surgical drape, a barrier film, or a wound dressing.

35. The method of claim 33, further comprising removing the medical film and the first and second sacrificial covers from the assembly while leaving the assembly adhered to skin.

36. The method of claim 33, further comprising placing a securing layer over the first and second base panels after the first and second base 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 first and second sacrificial covers over the securing layer.

37. The method of claim 33, wherein the lateral ties each have a first end permanently fixed to a support of the first base panel, wherein coupling the first and second base panels together comprises reversibly and adjustably attaching the second end opposite the first end to the second base panel, and wherein the first ends of the lateral ties are integrally formed with their respective supports on the first base panel.

38. The method of claim 37, further comprising disengaging and re-engaging the second end of the lateral tie from a support on the second base panel.

39. The method of claim 37, wherein the second base panel comprises one or more locks, and wherein the second ends of the lateral ties and the one or more locks together form a ratchet tightening mechanism.

40. The method of claim 37, further comprising independently adjusting the attachment of each lateral tie to the second base panel to vary the spacing between the first and second base panels along their lengths.

41. The method of claim 37, further comprising placing a securing layer over the first and second base panels after the first and second base panels have been coupled to one another.

42. The method of claim 41, wherein the securing layer is configured to laterally extend beyond the outer lateral edge of one or more of the first or second base panel.

43. The method of claim 37, further comprising longitudinally separating one or more of the first or second base panels into a plurality of discrete and separate base panel segments.

44. The method of claim 43, wherein the one or more of the first or second base panels are longitudinally separated into the plurality of discrete and separate base panel segments along a plurality of preferentially separating regions distributed along a length of said one or more of the first or second base panels.

45. The method of claim 44, wherein the plurality of preferentially separating regions comprises one or more perforations through said one or more of the first or second base panels.

46. The method of claim 45, wherein the one or more perforations are disposed along a lateral line across said one or more of the first or second base panels.

47. The method of claim 44, wherein the plurality of preferentially separating regions allow said one or more of the first or second base panels to tear or separate into the plurality of discrete and separate base panel segments.