Device for laceration or incision closure

• US 7,838,718 B2
• Filed: 07/24/2003
• Issued: 11/23/2010
• Est. Priority Date: 07/24/2003
• Status: Expired due to Fees

• Current Assignee: Clozex Medical LLC (3M Company)
• Original Assignee: Clozex Medical LLC (3M Company)
• Inventors: Lebner, Michael
• Primary Examiner(s): Lewis; Kim M
• Application Number:
  US10/626,040
• Publication Number:
  US 20050020957A1
• Time in Patent Office: 2,679 Days
• Field of Search: 602 41- 59, 606213-516, 128/888, 128/889
• US Class Current: 602/54
• CPC Class Codes: A61B 17/0466 Suture bridges
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• 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: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• CPC Class Codes: A61F 13/0259 characterised by the release liner covering the skin adhering layer
• CPC Class Codes: A61F 2013/00451 for surgical sutures, e.g. butterfly type

Abstract

The disclosed two-component device includes a first component comprising a first adhesive-backed anchoring member and one or more first connecting members, produced separately from the first adhesive-backed anchoring member. The first connecting member is attached to the first adhesive-backed anchoring member, extending from One edge thereof in a first direction. Also disclosed is a second component comprising a second adhesive-backed anchoring member and one or more second connecting members, produced separately from the second adhesive-backed anchoring member. The second component is attached to the second adhesive-backed anchoring member, extending from one edge thereof in a second direction generally opposite to the first direction. Adhesive for attaching the one or more first connecting members to the second anchoring member and adhesive for attaching the one or more second connecting members to the first anchoring member is provided. Methods of use are also disclosed.

Claims

1. An interlaced two-component device for closing a laceration or incision, comprising:

a) a first component comprising a first adhesive-backed anchoring member produced from an elastic polymeric material not reinforced with an inelastic structural component thereby providing improved adhesion relative to an otherwise identical first component produced from an inelastic material while maintaining the physical relationship between wound edges in an applied device for a period of time sufficient for the laceration or incision to heal naturally;

b) one or more first connecting members, produced from a substantially inelastic material, adhesively attached to the first adhesive-backed anchoring member and extending from one edge thereof in a first direction;

c) a second component comprising a second adhesive-backed anchoring member produced from an elastic polymeric material not reinforced with an inelastic structural component thereby providing improved adhesion relative to an otherwise identical second component produced from an inelastic material while maintaining the physical relationship between wound edges in an applied device for the period of time sufficient for the laceration or incision to heal;

d) one or more second connecting members, produced from a substantially inelastic material, adhesively attached to the second adhesive-backed anchoring member and extending from one edge thereof in a second direction generally opposite to the first direction wherein the one or more first connecting members and one or more second connecting members are sufficiently spaced apart to facilitate fine adjustment of the first component relative to the second component for substantially parallel alignment of the edge of the first component with the edge of the second component during closure of the wound or incision;

e) means for attaching the one or more first connecting members directly to the second anchoring member and means for attaching the one or more second connecting members directly to the first anchoring member, the attachment of the connecting members to the anchoring members forming attached and bridging portions of the one or more connecting members, the attached portions being attached to an anchoring member, and the bridging portions spanning the over-laceration area between the first and second anchoring members.

2. The two-component device of claim 1 further comprising a pulling element attached to the one or more first connecting members, or extensions thereof, and a pulling element attached to the one or more second connecting members, or extensions thereof.

3. The two-component device of claim 2 wherein the pulling elements and anchoring members are coded to enable user distinction.

4. The two-component device of claim 3 wherein the coding comprises an observable geometric distinction between the shape of the pulling elements and the shape of the anchoring members.

5. The two-component device of claim 3 wherein the coding comprises printed indicia enabling user distinction between pulling elements and anchoring members.

6. The two-component device of claim 3 wherein the coding comprises distinguishing colors.

7. The two-component device of claim 2 wherein the pulling elements and extensions of connecting members are removable following application of the device.

8. The two-component device of claim 2 wherein the pulling element is reinforced with a pull bar.

9. The two-component device of claim 1 which is produced from a vapor-permeable material.

10. The two-component device of claim 1 wherein the means for attaching connecting members to anchoring members is adhesive, adhesive being applied to at least a portion of the lower surface of the connecting members.

11. The two-component device of claim 10 wherein the adhesive-backed surface of each anchoring member is protected by one or more release liners, and the adhesive-backed surface of each connecting member is protected by one or more release liners.

12. The two-component device of claim 11 wherein the release liners are optionally coded to indicate sequence of removal.

13. The two-component device of claim 12 wherein the adhesive-backed surfaces of the first and second anchoring members each are protected by a first and a second release liner, the first release liner protecting adhesive-backed surfaces along the edge from which the one or more connecting members extend, and the second release liner protecting the adhesive-backed surfaces along the length of the edge of the anchoring member which is generally opposite the edge from which the one or more connecting members extend.

14. The two-component device of claim 13 wherein the coding comprises printed indicia enabling user distinction between the first release liner and the second release liner.

15. The two-component device of claim 13 wherein the coding comprises distinguishing colors between the first release liner and the second release liner.

16. The two-component device of claim 1 wherein the anchoring members are provided with one or more alignment indicators.

17. The two-component device of claim 1 wherein the anchoring members are reinforced with a wound edge bar.

18. A method for closing a laceration or incision, the method comprising:

a) Providing an interlaced two-component device for closing a laceration or incision, comprising;

i) a first component comprising a first adhesive-backed anchoring member produced from an elastic polymeric material not reinforced with an inelastic structural component thereby providing improved adhesion relative to an otherwise identical first component produced from an inelastic material while maintaining the physical relationship between wound edges in an applied device for a period of time sufficient for the laceration or incision to heal naturally;

ii) one or more first connecting members, produced from a substantially inelastic material, adhesively attached to the first adhesive-backed anchoring member and extending from one edge thereof in a first direction;

iii) a second component comprising a second adhesive-backed anchoring member produced from an elastic polymeric material not reinforced with an inelastic structural component thereby providing improved adhesion relative to an otherwise identical second component produced from an inelastic material while maintaining the physical relationship between wound edges in an applied device for the period of time sufficient for the laceration or incision to heal naturally;

iv) one or more second connecting members, produced from a substantially inelastic material, adhesively attached to the second adhesive-backed anchoring member and extending from one edge thereof in a second direction generally opposite to the first direction wherein the one or more first connecting members and one or more second connecting members are sufficiently spaced apart to facilitate fine adjustment of the first component relative to the second component for substantially parallel alignment of the edge of the first component with the edge of the second component during closure of the wound or incision;

v) means for attaching the one or more first connecting members directly to the second anchoring member and means for attaching the one or more second connecting members directly to the first anchoring member, the attachment of the connecting members to the anchoring members forming attached and bridging portions of the one or more connecting members, the attached portions being attached to an anchoring member, and the bridging portions spanning the over-laceration area between the first and second anchoring members;

b) attaching the first and second components to the skin on opposite sides of the laceration or incision, the edge of the first and second components from which the one or more connecting members extend being the edge closest to the laceration or incision;

c) closing the laceration or incision by adjusting the position of the first and second anchoring members relative to each other in both an X and a Y dimension; and

d) fixing the relationship between the first and second anchoring members established in step c) by attaching the one or more first connecting members to the second anchoring member, and the one or more second connecting members to the second anchoring member.

19. The method of claim 18 wherein the device further comprises a pulling element attached to the one or more first connecting members, or extensions thereof, and a pulling element attached to the one or more second connecting members, or extensions thereof.

20. The method of claim 19 wherein the pulling elements and anchoring members are coded to enable user distinction.

21. The two-component device of claim 20 wherein the coding comprises an observable geometric distinction between the shape of the pulling elements and the shape of the anchoring members.

22. The method of claim 20 wherein the coding comprises printed indicia enabling user distinction between pulling elements and anchoring members.

23. The method of claim 20 wherein the coding comprises distinguishing colors.

24. The method of claim 19 wherein the pulling elements and extensions of connecting members are removable following application of the device.

25. The method of claim 19 wherein the pulling element is reinforced with a pull bar.

26. The method of claim 18 wherein the device is produced from a vapor-permeable material.

27. The method of claim 18 wherein the means for attaching connecting members to anchoring members is adhesive, adhesive being applied to at least a portion of the lower surface of the connecting members.

28. The method of claim 27 wherein the adhesive-backed surface of each anchoring member is protected by one or more release liners, and the adhesive-backed surface of each connecting member is protected by one or more release liners.

29. The method of claim 28 wherein the release liners are optionally coded to indicate sequence of removal.

30. The method of claim 29 wherein the adhesive-backed surfaces of the first and second anchoring members each are protected by a first and a second release liner, the first release liner protecting adhesive-backed surfaces along the edge from which the one or more connecting members extend, and the second release liner protecting the adhesive-backed surfaces along the length of the edge of the anchoring member which is generally opposite the edge from which the one or more connecting members extend.

31. The method of claim 30 wherein the coding comprises printed indicia enabling user distinction between the first release liner and the second release liner.

32. The method of claim 30 wherein the coding comprises distinguishing colors between the first release liner and the second release liner.

33. The method of claim 18 wherein the anchoring members are provided with one or more alignment indicators.

34. The method of claim 18 wherein the anchoring members are reinforced with a wound edge bar.