Surgical Incision and Closure Apparatus

• US 20140222070A1
• Filed: 02/14/2014
• Published: 08/07/2014
• 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, SCHAER, Alan, ICHIRYU, Keiichiro, STORNE, Eric, RATHI, Pankaj, D'AQUANNI, Peter
• Granted Patent: US 9,089,328 B2
• Time in Patent Office: Days
• US Class Current: 606/216
• 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.

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 component 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 closure component 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 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.

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

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

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

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

26. 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.

27. The incision closure appliance of claim 26, 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.

28. A method for closing an incision in a patient'"'"'s skin, the method comprising:

adhering right and left base panels to the right and left, respectively, of the incision;

drawing inner edges of the right and left base panels together to compress the incision therebetween; and

allowing axial expansion of the right and left base panels along first lateral edges of the right and left base panels while limiting one or more of lateral expansion across the right and left base panels or axial expansion along second lateral edges of the left and right base panels opposite the first lateral edges.

29. The method of claim 28, wherein drawing the inner edges together comprises tightening a plurality of closure components coupled to the right and left base panels,

wherein allowing axial expansion of the right and left base panels comprises providing a plurality of left and right force distribution structures coupled to the left and right panels, respectively, and

wherein the plurality of closure components and the plurality of left and right base panels are coupled together to form a serpentine arrangement.

30. The method of claim 28, further comprising placing a securing layer over the right and left base panels such that the securing layer extends over the first and second lateral edges of the right and left base panels.