SURGICAL INCISION AND CLOSURE APPARATUS WITH INTEGRATED FORCE DISTRIBUTION

• US 20130296930A1
• Filed: 10/31/2012
• Published: 11/07/2013
• 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, Johnson, Eric T., Ragland, Robert R., Burke, Phillip C., Clauson, Luke
• Granted Patent: US 10,123,800 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

Apparatus for closing a surgical incision comprise a base having left and right panels, a force distribution structure coupled to each panel, and a closure component which releasably attaches to the force distribution structure to draw the inner edges of the panels together in order to close adhered tissue edges. The force distribution structures allow the inner edges of the panels to expand while restraining expansion of the outer edges of the panels and limiting elongation of the lateral dimension of the panels. The incision closure appliance may be placed on skin or other tissue prior to forming the incision to be available to close said incision at the end of the surgical procedure.

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, an inner edge, and an outer 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 the inner edge and to limit lateral expansion across the panel and axial expansion along the outer edge; and

a closure assembly which may be secured to the left and right panels to draw the inner edges of the panels together after the panels are adhered to tissue and an incision made therebetween.

2. An incision closure appliance as in claim 1, wherein each panel of the base comprises an elastic matrix.

3. An incision closure appliance as in claim 2, wherein the elastic matrix comprises an elastomeric membrane, a woven fabric, or a spun fabric.

4. An incision closure appliance as in claim 2, wherein the elastic matrix comprises a fabric woven from elastic elements and having inelastic elements along the outer edge and extending laterally thereacross.

5. An incision closure appliance as in claim 2, wherein each force distribution structure comprises a spine disposed axially adjacent to the outer edge of the panel and a plurality of axially spaced-apart lateral supports disposed laterally and extending from the spine toward the inner edge of the panel.

6. An incision closure appliance as in claim 5, wherein the spine and lateral supports are formed from flexible, non-distensible materials.

7. An incision closure appliance as in claim 5, wherein the spine and supports are formed integrally as a comb-like structure.

8. An incision closure appliance as in claim 5, wherein the force distribution structure are embedded in or laminated to the upper surface of each panel.

9. An incision closure appliance as in claim 1, further comprising removable space maintainer which holds the right and left panels at a fixed distance while they are being adhered to tissue.

10. An incision closure appliance as in claim 9, wherein the removable space maintainer comprises a pair of tabs which are removably placed at each axial end of the base.

11. An incision closure appliance as in claim 9, wherein the removable space maintainer comprises a strip which is removably placed over an axial gap between the right and left panels.

12. An incision closure appliance as in claim 5, wherein the closure component comprises a right engagement member, a left engagement member and a plurality of lateral struts holding the engagement members laterally apart by a predefined distance, wherein the right engagement member is adapted to releasably engage the supports of the right panel along the inner edge and the left engagement member is adapted to releasably engage the supports of the left panel along the inner edge.

13. An incision closure appliance as in claim 12, wherein at least some of their supports have cleats near the inner edge and the engagement members have slots which receive the cleats.

14. An incision closure appliance as in claim 12, wherein the lateral struts are adjustably connected to at least one of the engagement members to permit adjustment of the predefined distance.

15. An incision closure appliance as in claim 5, 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 support.

16. An incision closure appliance as in claim 15, wherein the independent lateral ties each have one end fixed to a panel and a second end adjustable attached to the other panel.

17. An incision closure appliance as in claim 16, wherein the second end comprises a ratchet tightening mechanism.

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

19. An incision closure appliance as in claim 18, wherein the securing layer has an inner self-adhesive surface.

20. An incision closure appliance comprising:

a base having an upper surface and a tissue adherent lower surface, said base being configured to be placed on a tissue surface to allow an incision in the tissue to be made through the base;

a closure component configured to draw together sides of the panel to close the incision; and

a sacrificial cover over at least a portion of the upper surface of the base, said sacrificial cover configured to lie between the upper surface of the base and a lower surface of an overlying adherent surgical incision drape and to separate from the base when the drape is pulled from over the base wherein the base can remain adhered to the tissue as the drape is removed.

21. An incision closure appliance as in claim 20, wherein the sacrificial cover comprises a thin film or sheet which is frangibly attached to the base.

22. An incision closure appliance as in claim 21, wherein the base has spaced-apart edges and the thin film or sheet is frangibly attached along the edges.

23. An incision closure appliance as in claim 20, the base comprises left and right panels, wherein the sacrificial cover comprises left and right portions which cover each panel, respectively, but do not cover a gap between said panels, wherein said gap is available to make the incision in tissue.