Surgical incision and closure apparatus with integrated force distribution

• US 10,123,800 B2
• Filed: 10/31/2012
• Issued: 11/13/2018
• 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
• Primary Examiner(s): Templeton, Christopher L
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US13/665,160
• Publication Number:
  US 20130296930A1
• Time in Patent Office: 2,204 Days
• Field of Search: 606213, 606215-219, 602 41, 602 42, 602 53, 602 54
• 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, a longitudinal axis, 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 comprises an axial spine disposed substantially parallel to the longitudinal axis of the left or right panel and a plurality of lateral supports extending laterally from the axial spine and disposed substantially perpendicularly to the longitudinal axis of the left or right panel, wherein the axial spine and the plurality of lateral supports are integral with one another, wherein the lateral supports are axially separate and spaced apart from one another, wherein the force distribution structures are configured to allow the inner edges of the panels to expand while restraining expansion of the outer edges of the panels, and wherein the axial spine and lateral supports are configured to preserve dimensional stability of the panels when the panels are deformed; and

a closure assembly securable to the left and right panels to draw the inner edges of the panels together, wherein the closure assembly comprises one or more lateral ties, each lateral tie having a fixed end fixedly coupled to one of the left or right force distribution structures and a free end opposite the fixed end, the free end being adjustably coupled to the opposing left or right force distribution structure.

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 the elastic matrix is isotropic.

6. An incision closure appliance as in claim 1, wherein the axial spine of each force distribution structure is disposed axially adjacent to the outer edge of the panel, and wherein the plurality of lateral supports are axially spaced-apart and extend laterally from the axial spine toward the inner edge of the panel.

7. An incision closure appliance as in claim 1, wherein the axial spine and lateral supports are formed from flexible, non-distensible materials.

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

9. An incision closure appliance as in claim 8, wherein the removable space maintainer comprises a strip which is removably placed over an axial gap between the right and left panels.

10. An incision closure appliance as in claim 1, wherein the fixed end of each lateral tie is fixedly coupled to the axial spine of the one of the left or right force distribution structures.

11. An incision closure appliance as in claim 1, wherein the free end of each lateral tie is adjustably coupled to the opposing left or right force distribution structure with an adjustable ratchet tightening mechanism.

12. 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 assembly after the assembly has been secured over an incision on a patient'"'"'s skin.

13. An incision closure appliance as in claim 12, wherein the securing layer has an inner self-adhesive surface.

14. An incision closure appliance as in claim 1, wherein the fixed end is integral with the one of the left or right force distribution structures.