Surgical incision and closure apparatus

• US 9,089,328 B2
• Filed: 02/14/2014
• Issued: 07/28/2015
• 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
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US14/180,564
• Publication Number:
  US 20140222070A1
• Time in Patent Office: 529 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 appliance comprising:

a base including a left panel and a right panel, each panel having a tissue adherent lower surface, an upper surface, a first lateral edge, and a second lateral edge;

left and right force distribution structures coupled to the left and right panels, respectively, wherein each force distribution structure is adapted to allow axial expansion of the panel along one of the first or second lateral edges and to limit one or more of lateral expansion across the panel or axial expansion along the opposite lateral edge; and

a plurality of closure components which may be secured to the left and right panels to draw the panels together after the panels are adhered to tissue and an incision made therebetween;

wherein the plurality of closure components comprise left closure component ends secured to the left panel and right closure component ends secured to the right panel, and

wherein the plurality of closure components are positioned laterally across the left and right panels with one or more of the left force distribution structures disposed between at least some axially adjacent left closure component ends and one or more of the right force distribution structures disposed between at least some axially adjacent right closure component ends to form a serpentine arrangement of force distribution structures and closure components.

2. The incision closure appliance of claim 1, wherein the first lateral edges of each panel comprise inner edges of each panel, wherein the inner edges of each panel face toward one another.

3. The incision closure appliance of claim 2, wherein the plurality of closure components are configured to draw the inner edges of the left and right base panels together to compress an incision covered by the incision closure apparatus.

4. The incision closure appliance of claim 1, wherein the second lateral edges of each panel comprise outer edges of each panel, wherein the outer edges of each panel face away from one another.

5. The incision closure appliance of claim 1, wherein one or more of the left and right panels of the base comprises an elastic matrix.

6. The incision closure appliance of claim 5, 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).

7. The incision closure appliance of claim 5, wherein the elastic matrix comprises a fabric woven from elastic elements and having inelastic elements along the first or second lateral edge and extending laterally thereacross.

8. The incision closure appliance of claim 5, wherein each force distribution structure comprises a spine disposed axially adjacent to the first lateral edge of the panel and a plurality of axially spaced-apart lateral supports disposed laterally and extending from the spine toward the first lateral edge of the panel.

9. The incision closure appliance of claim 8, wherein the spine and lateral supports are formed from flexible, non-distensible materials.

10. The incision closure appliance of claim 8, wherein the force distribution structures are embedded in or laminated to the upper surface of each panel.

11. The incision closure appliance of claim 8, wherein the plurality of closure components comprises a plurality of right engagement members, a plurality of left engagement members, and a plurality of lateral struts holding the right and left engagement members laterally spaced apart by a predefined distance, wherein the right engagement members are adapted to releaseably engage the supports of the right panel and the left engagement members are adapted to releasably engage the supports of the left panel.

12. The incision closure appliance of claim 11, wherein at least some of the supports have cleats near the one or more of the first and second lateral edges and the engagement members have slots which receive the cleats.

13. The incision closure appliance of claim 11, wherein the lateral struts are adjustably connected to at least one of the engagement members to permit adjustment of the predefined distance.

14. The incision closure appliance of claim 8, wherein the plurality of closure components comprises a plurality of independent lateral ties attached to at least some of the lateral supports, wherein the lateral ties are configured to be secured between lateral supports.

15. The incision closure appliance of claim 14, wherein the independent lateral ties each have one end fixed to a panel and a second end adjustably attached to the other panel.

16. The incision closure appliance of claim 15, wherein the second end comprises a ratchet tightening mechanism.

17. The incision closure appliance of claim 1, further comprising a securing layer adapted to be placed over an assembly of the base and the closure components after the assembly has been secured over an incision in a patient'"'"'s skin.

18. The incision closure appliance of claim 17, wherein the securing layer has an inner self-adhesive surface.

19. The incision closure appliance of claim 17, wherein the securing layer is configured to extend over one or more of the first or second lateral edges of the left and right base panels.

20. The incision closure appliance of claim 17, wherein the securing layer has one or more perforations to allow the securing layer to at least partially stretch axially in response to axial stretching of an incision and surrounding tissue the incision closure appliance is placed over.

21. The incision closure appliance of claim 1, wherein a left force distribution structure couples every other axially adjacent pair of left closure component ends together on the left panel.

22. The incision closure appliance of claim 1, wherein a right force distribution structure couples every other axially adjacent pair of right closure component ends together on the right panel.

23. The incision closure appliance of claim 1, wherein the tissue adherent lower surface comprises a hydrophilic adhesive material.

24. The incision closure appliance of claim 23, wherein the hydrophilic adhesive material comprises one or more of a hydrocolloid, a hydrogel, an acrylic polymer, or poly(ethylene glycol).

25. The incision closure appliance of claim 1, wherein at least one force distribution structure the plurality of left and right force distribution structures is C-shaped.

26. The incision closure appliance of claim 25, wherein the C-shaped force distribution structure comprises an axial portion for limiting axial expansion of the left or right base panel and a lateral portion for limiting lateral expansion of the left or right base panel.

27. An incision closure appliance comprising:

a base including a left panel and a right panel, each panel having a tissue adherent lower surface, an upper surface, an inner lateral edge, and an outer lateral edge;

left and right force distribution structures coupled to the left and right panels, respectively, wherein each force distribution structure includes a plurality of axially spaced-apart axial supports, each support having a distal attachment point and a proximal attachment point, wherein each force distribution structure is adapted to allow axial expansion of the panel along the inner lateral edge and to limit one or more lateral expansion across the panel or axial expansion along the outer lateral edge; and

a plurality of lateral ties, wherein each lateral tie extends between a distal attachment point on an axial support on the left panel and an axially aligned proximal attachment point on the right panel to form a serpentine arrangement of axial supports and lateral ties, wherein the lateral ties each have one end fixed to one of the attachment points and a second end adjustably attached to the other of the attachment points allowing the lateral ties to draw the left and right panels together after the panels are adhered to tissue.

28. The incision closure appliance of claim 27, wherein the plurality of lateral ties are configured to draw the inner edges of the left and right base panels together to compress an incision covered by the incision closure apparatus.

29. The incision closure appliance of claim 27, wherein each of the left and right panels of the base comprises an elastic matrix.

30. The incision closure appliance of claim 29, 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).

31. The incision closure appliance of claim 30, wherein the elastic matrix comprises a fabric woven from elastic elements and having inelastic elements along the first or second lateral edge and extending laterally thereacross.

32. The incision closure appliance of claim 27, wherein each force distribution structure is disposed axially adjacent the inner edge of the panel.

33. The incision closure appliance of claim 27, wherein each force distribution structure is disposed axially adjacent the outer edge of the panel.

34. The incision closure appliance of claim 27, wherein each force distribution structure is disposed axially between the inner edge and the outer edge of the panel.

35. The incision closure appliance of claim 27, wherein the force distribution structures and lateral ties comprise flexible, non-distensible materials.

36. The incision closure appliance of claim 35, wherein the force distribution structures are embedded in or laminated to the upper surface of each panel.

37. The incision closure appliance of claim 27, wherein each lateral ties is fixedly attached at one end to one of the attachment points and releaseably attached to a lock at the other attachment point, wherein the lateral tie and lock together form a ratchet tightening mechanism.

38. The incision closure appliance of claim 27, further comprising a securing layer adapted to be placed over an assembly of the base and the closure components after the assembly has been secured over an incision in a patient'"'"'s skin.

39. The incision closure appliance of claim 38, wherein the securing layer has an inner self-adhesive surface.

40. The incision closure appliance of claim 38, wherein the securing layer is configured to extend over one or more of the first or second lateral edges of the left and right base panels.

41. The incision closure appliance of claim 38, wherein the securing layer has one or more perforations to allow the securing layer to at least partially stretch axially in response to axial stretching of an incision and surrounding tissue the incision closure appliance is placed over.

42. The incision closure appliance of claim 27, wherein the tissue adherent lower surface comprises a hydrophilic adhesive material.

43. The incision closure appliance of claim 42, wherein the hydrophilic adhesive material comprises one or more of a hydrocolloid, a hydrogel, an acrylic polymer, or poly(ethylene glycol).

44. The incision closure appliance of claim 27, wherein the axial supports are C-shaped.

45. The incision closure appliance of claim 44, wherein the C-shaped axial supports comprises an axial portion for limiting axial expansion of the left or right base panel and a lateral portion for limiting lateral expansion of the left or right base panel.