Multi-barbed device for retaining tissue in apposition and methods of use

• US 6,991,643 B2
• Filed: 12/20/2000
• Issued: 01/31/2006
• Est. Priority Date: 12/20/2000
• Status: Expired due to Fees

• Current Assignee: Vahid Saadat
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid
• Primary Examiner(s): IZAGUIRRE, ISMAEL
• Application Number:
  US09/746,579
• Publication Number:
  US 20020077661A1
• Time in Patent Office: 1,868 Days
• Field of Search: 606/221, 606/213, 606/215, 606/151, 606/153, 602/41, 604/304, 2908-920, 24/725, 24442-447, 24D/IG.29
• US Class Current: 606/221
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4618 of cartilage
• CPC Class Codes: A61F 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30894 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/4628 with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/418 : Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A multi-barbed apparatus is provided, and methods of use, for penetrating two sides of a wound and holding the edges in apposition. The apparatus may be inserted within a wound or underneath the skin, and mechanically adheres the two sides of the wound together. The apparatus includes a biocompatible substrate carrying a multiplicity of tissue penetrating barbs on a least one side thereof, and may be formed as a rigid or flexible sheet, tube or other shape.

Claims

1. Apparatus for closing a wound comprising:

a first elongated substrate including first and second surfaces; and

a second elongated substrate including first and second surfaces,

wherein the second surfaces are configured to mate with each other,

wherein the first surfaces are covered by a multiplicity of barbs configured to adhere for adhering to the wound.

2. The apparatus of claim 1, wherein the multiplicity of barbs projects from the first surface.

3. The apparatus of claim 2, wherein each elongated substrate further comprises portions defining a plurality of perforations that extend from the first surface to the second surface.

4. The apparatus of claim 3, wherein the plurality of perforations define suture eyelets.

5. The apparatus of claim 1, wherein each elongated substrate further comprises a coating of a therapeutic agent.

6. The apparatus of claim 1, wherein each elongated substrate is impregnated with a therapeutic agent.

7. The apparatus of claim 1 further comprising a therapeutic agent selected from a family of angiogenic growth factors.

8. The apparatus of claim 1, wherein the first and second surfaces are tied together using a suture.

9. The apparatus of claim 1, wherein each elongated substrate comprises a series of units interconnected by joints.

10. A method for performing an anastomosis comprising:

providing a device comprising an elongated tubular substrate of a biocompatible material having a first surface coated or impregnated with a therapeutic agent, multiple rows of barbs projecting from the first surface;

positioning the elongated substrate within a wound so that the multiplicity of barbs is directed towards the tissue defining a perimeter of the wound; and

squeezing the perimeter of the wound against the multiplicity of barbs to adhere the perimeter of the wound to the elongated substrate.

11. The method of claim 10 further comprising, during wound healing, releasing a predetermined amount of the therapeutic agent into the vicinity of the wound.

12. A method for closing a tissue wound comprising:

providing a device comprising first and second elongated substrate halves, each of the first and second elongated substrate halves comprising a biocompatible material having a first surface and a multiplicity of barbs projecting from the first surface;

positioning the first elongated substrate half within a wound so that the multiplicity of barbs is directed towards the tissue defining a first portion of the perimeter of the wound;

squeezing the first portion of the perimeter of the wound against the multiplicity of barbs to adhere the first portion of the perimeter of the wound to the first elongated substrate half;

positioning the second elongated substrate half within the wound so that the multiplicity of barbs is directed towards the tissue defining a second portion of the perimeter of the wound; and

squeezing the second portion of the perimeter of the wound against the multiplicity of barbs to adhere the second portion of the perimeter of the wound to the second elongated substrate half; and

moving the first and second substrate halves into apposition.

13. The method of claim 12 wherein moving the first and second substrate halves into apposition comprises threading suture material through eyelets in the first and second elongated substrate halves and knotting the suture material.

14. Apparatus for closing a wound comprising:

an elongated substrate comprising a biocompatible material, the elongated substrate having a first and a second surface, a plurality of perforations extending from the first surface and adapted to define suture eyelets; and

multiple rows of barbs projecting from the first and second surfaces, wherein the multiple rows of barbs have having tissue-penetrating distal ends;

a plurality of perforations extending from the first surface and adapted to define suture eyelets; and

suture extending through at least one of the plurality of perforations.

15. The apparatus of claim 14, wherein the elongated substrate further comprises a coating of a therapeutic agent.

16. The apparatus of claim 14, wherein the elongated substrate is impregnated with a therapeutic agent.

17. The apparatus of claim 14, wherein each barb includes a shank coupling the tissue-penetrating distal end to the substrate, and one or more projections from the shank.

18. The apparatus of claim 17, wherein each barb is cut from the substrate.

19. The apparatus of claim 14, wherein the elongated substrate has the form of a tube.

20. The apparatus of claim 19, wherein the tube includes an interior lumen formed by the first surface.

21. The apparatus of claim 19, wherein the tube includes an exterior surface forming the first surface.

22. The apparatus of claim 14 further comprising a stent-like structure, wherein the elongated substrate forms a side anastomosis site of the apparatus.

23. The apparatus of claim 14, wherein the elongated substrate comprises a series of units interconnected by joints.

24. The apparatus of claim 14 further comprising a region of artificial cartilage coupled to the elongated substrate.

25. The apparatus of claim 14 further comprising a replacement intervertebral disc coupled to the elongated substrate.

26. Apparatus for closing a wound comprising:

an elongated substrate comprising a biocompatible material and impregnated with a therapeutic agent, the elongated substrate having a first surface; and

multiple rows of barbs projecting from the first surface, the multiple rows of barbs having tissue-penetrating distal ends,

wherein the elongated substrate has the form of a tube comprising an interior lumen formed by the first surface.

27. The apparatus of claim 26, wherein the elongated substrate further comprises a coating of the therapeutic agent.

28. The apparatus of claim 26, wherein each barb includes a shank coupling the tissue-penetrating distal end to the substrate, and one or more projections from the shank.

29. The apparatus of claim 28, wherein each barb is cut from the substrate.

30. The apparatus of claim 26 further comprising a stent-like structure, wherein the elongated substrate forms a side anastomosis site of the apparatus.

31. Apparatus for closing a wound comprising:

an elongated substrate comprising a biocompatible material and impregnated with a therapeutic agent, the elongated substrate having a first surface; and

multiple rows of barbs projecting from the first surface, the multiple rows of barbs having tissue-penetrating distal ends,

wherein the elongated substrate has the form of a tube comprising an exterior surface formed by the first surface.

32. The apparatus of claim 31, wherein the elongated substrate further comprises a coating of the therapeutic agent.

33. The apparatus of claim 31, wherein each barb includes a shank coupling the tissue-penetrating distal end to the substrate, and one or more projections from the shank.

34. The apparatus of claim 33, wherein each barb is cut from the substrate.

35. The apparatus of claim 31 further comprising a stent-like structure, wherein the elongated substrate forms a side anastomosis site of the apparatus.

36. Apparatus for repairing cartilage comprising:

an elongated substrate comprising a biocompatible material, the elongated substrate having a first surface,

a multiplicity of barbs projecting from the first surface, the multiplicity of barbs having tissue-penetrating distal ends; and

a region of artificial cartilage coupled to the elongated substrate.

37. The apparatus of claim 36, wherein the elongated substrate further comprises a coating of a therapeutic agent.

38. The apparatus of claim 36, wherein the elongated substrate is impregnated with a therapeutic agent.

39. The apparatus of claim 36, wherein each one of the multiplicity of barbs includes a shank coupling the tissue-penetrating distal end to the substrate, and one or more projections from the shank.

40. The apparatus of claim 39, wherein the multiplicity of barbs are cut from the substrate.

41. Apparatus for repairing an intervertebral disc comprising:

an elongated substrate comprising a biocompatible material, the elongated substrate having a first surface,

a multiplicity of barbs projecting from the first surface, the multiplicity of barbs having tissue-penetrating distal ends; and

a replacement intervertebral disc coupled to the elongated substrate.

42. The apparatus of claim 41, wherein the elongated substrate further comprises a coating of a therapeutic agent.

43. The apparatus of claim 41, wherein the elongated substrate is impregnated with a therapeutic agent.

44. The apparatus of claim 41, wherein each one of the multiplicity of barbs includes a shank coupling the tissue-penetrating distal end to the substrate, and one or more projections from the shank.

45. The apparatus of claim 44, wherein the multiplicity of barbs are cut from the substrate.

46. The apparatus of claim 41 further comprising a region of artificial cartilage coupled to the elongated substrate.