Tissue ingrowth anchoring systems and methods and related products

• US 9,358,098 B2
• Filed: 02/16/2010
• Issued: 06/07/2016
• Est. Priority Date: 02/16/2010
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Feng, Brian Pak-Yun
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US12/706,213
• Publication Number:
  US 20110202075A1
• Time in Patent Office: 2,303 Days
• Field of Search: 623/1.47, 623/1.24, 623/1.26, 623 212- 219, 623/1.44
• US Class Current: 1/1
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Described, in certain aspects, are medical devices that can be used to anchor graft materials to bodily structures. These devices comprise an implantable graft structure and tissue ingrowth material. This implantable graft structure is comprised of a body of persistent material having a first face and one or more openings defined therein, wherein the persistent material body first face is configured for opposing a bodily structure wall upon implantation. This tissue ingrowth material is positioned at the one or more persistent material body openings, and is configured for receiving tissue ingrowth from the bodily structure wall effective to anchor the graft structure to the bodily structure wall. The invention also provides methods utilizing these and other inventive medical devices, for example, to anchor graft materials to vascular vessel walls and/or other bodily structures.

Claims

1. A medical device for implantation in a bodily vessel of a patient to form a tubular graft anchored and supported in position by tissue of the patient, comprising:

a) an implantable graft structure, the implantable graft structure comprised of a tubular body of persistent material having a first face on an exterior of the tubular body and configured for opposing a bodily vessel wall upon implantation, and a second face on an interior of the tubular body, wherein said persistent material comprises a first longitudinal region containing one or more openings extending from the first face to the second face, a second longitudinal region that does not contain openings extending from the first face to the second face, and a third longitudinal region containing one or more openings extending from the first face to the second face, wherein the second longitudinal region is positioned longitudinally between the first longitudinal region and the third longitudinal region;

b) a tissue ingrowth material positioned against the second face on the interior of the tubular body and extending over the one or more openings in the first longitudinal region and the third longitudinal region and beyond edges of the one or more openings in the first longitudinal region and the third longitudinal region to cover regions of the second face around the one or more openings in the first longitudinal region and third longitudinal region, the tissue ingrowth material configured for receiving tissue ingrowth from the bodily vessel wall effective to anchor the graft structure to the bodily vessel wall with ingrown tissue of the patient; and

c) a first bioabsorbable expandable frame element positioned within the first longitudinal region of the tubular body and a second bioabsorbable expandable frame element discrete from the first bioabsorbable expandable frame element and positioned within the third longitudinal region of the tubular body, the first bioabsorbable stent expandable frame element and the second expandable bioabsorbable frame element effective when expanded to hold the tubular body of persistent material in place in the bodily vessel for a duration sufficient for tissue ingrowth from the bodily vessel wall into the tissue ingrowth material so as to anchor the graft structure to the bodily vessel wall with ingrown tissue of the patient, the at least one first and second bioabsorbable frame elements thereafter being bioabsorbed to leave the tubular body of persistent material supported by the ingrown tissue of the patient.

2. The medical device of claim 1, wherein the tubular body of persistent material comprises a persistent synthetic polymeric material.

3. The medical device of claim 1, wherein the tissue ingrowth material comprises collagen.

4. The medical device of claim 3, wherein the tissue ingrowth material comprises an extracellular matrix material.

5. The medical device of claim 4, wherein the extracellular matrix material retains at least one growth factor native to a tissue source for the extracellular matrix material.

6. A method for treating a patient to form a tubular graft anchored and supported in position by tissue of the patient, the method comprising implanting in a bodily passage of the patient a medical device according to claim 1.

7. The medical device of claim 1 wherein said openings comprise slits or rectilinear or curvilinear voids.

8. A medical device for implantation in a bodily vessel of a patient to form a valved tubular graft anchored and supported in position by tissue of the patient, comprising:

a) an implantable graft structure comprising a tubular body of persistent material having a first face on an exterior of the tubular body and configured for opposing a bodily vessel wall upon implantation, and a second face on an interior of the tubular body, wherein said persistent material comprises a first longitudinal region containing one or more openings extending from the first face to the second face, a second longitudinal region that does not contain openings extending from the first face to the second face, and a third longitudinal region containing one or more openings extending from the first face to the second face, wherein the second longitudinal region is positioned longitudinally between the first longitudinal region and the third longitudinal region;

b) a tissue ingrowth material positioned against the second face on the interior of the tubular body and extending over the one or more openings contained in the first longitudinal region and the third longitudinal region and beyond edges of the one or more openings contained in the first longitudinal region and the third longitudinal region to cover regions of the second face around the one or more openings contained in the first longitudinal region and the third longitudinal region, the tissue ingrowth material configured for receiving tissue ingrowth from the vascular vessel wall effective to anchor the graft structure to the bodily vessel wall with ingrown tissue of the patient;

c) a first bioabsorbable expandable frame element positioned within the first longitudinal region of the tubular body and a second bioabsorbable expandable frame element discrete from the first bioabsorbable expandable frame element and positioned within the third longitudinal region of the tubular body, the first bioabsorbable expandable frame element and the second expandable bioabsorbable expandable frame element effective when expanded to hold the tubular body of persistent material in place in the bodily vessel for a duration sufficient for tissue ingrowth from the bodily vessel wall into the tissue ingrowth material so as to anchor the graft structure to the bodily vessel wall with ingrown tissue of the patient, the first bioabsorbable expandable frame element and the second bioabsorbable expandable frame element thereafter being bioabsorbed to leave the tubular body of persistent material supported by the ingrown tissue of the patient; and

d) a valve having one or more valve leaflets supported by the tubular body of persistent material and located within the tubular body longitudinally between the first bioabsorbable expandable frame element and the second bioabsorbable expandable frame element, the valve responsive to fluid flow within the bodily vessel.

9. The medical device of claim 8, wherein the first and second bioabsorbable expandable frame elements comprise a bioabsorbable polymer.

10. The medical device of claim 8, wherein the first bioabsorbable expandable frame element and the second bio absorbable expandable frame element are self-expanding frame elements.

11. The medical device of claim 9, wherein the bioabsorbable polymer is poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyhydroxyalkanaates, polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-ester), polyalkylene oxalate, or polyphosphazene.

12. The medical device of claim 8, wherein the one or more openings defined in the tubular body of persistent material include at least one slit.

13. The medical device of claim 8, wherein the tubular body of persistent material is comprised of a naturally-derived biocompatible material.

14. The medical device of claim 8, wherein the tubular body of persistent material is comprised of a collagen-containing material.

15. The medical device of claim 8, wherein the tubular body of persistent material is comprised of a non-naturally derived biocompatible material.

16. The medical device of claim 8, wherein the tubular body of persistent material is comprised of a synthetic polymeric material.

17. The medical device of claim 16, wherein the tubular body of persistent material is comprised of polytetrafluroethylene.

18. The medical device of claim 16, wherein the synthetic polymeric material is comprised of polyurethane.

19. The medical device of claim 8, wherein the tubular body of persistent material comprises a sheet-form material.

20. The medical device of claim 8, wherein the tubular body of persistent material comprises a non-sheet-form material.

21. The medical device of claim 8, wherein the tubular body of persistent material comprises a hollow and generally cylindrical tube of material.

22. The medical device of claim 8, wherein the tissue ingrowth material is comprised of a naturally-derived biocompatible material.

23. The medical device of claim 8, wherein the tissue ingrowth material is comprised of a remodelable material.

24. The medical device of claim 8, wherein the tissue ingrowth material is comprised of a collagen-containing material.

25. The medical device of claim 8, wherein the tissue ingrowth material is comprised of an extracellular matrix material.

26. The medical device of claim 25, wherein the extracellular matrix material comprises serosa, pericardium, dura mater, peritoneum, or dermal collagen.

27. The medical device of claim 25, wherein the extracellular matrix material comprises submucosa.

28. The medical device of claim 27, wherein the submucosa comprises porcine submucosa.

29. The medical device of claim 27, wherein the submucosa comprises small intestine submucosa, urinary bladder submucosa, or stomach submucosa.

30. The medical device of claim 8, wherein the tissue ingrowth material is comprised of a first tubular piece of tissue ingrowth material covering the one or more openings contained in the first longitudinal region and a second tubular piece of tissue ingrowth material discrete from the first tubular piece of tissue ingrowth material and covering the one or more openings contained in the third longitudinal region.

31. The medical device of claim 8, wherein the tissue ingrowth material is comprised of a synthetic polymeric material.

32. A method for treating a patient to form a valved tubular graft anchored and supported in position by tissue of the patient, the method comprising implanting in a bodily vessel of the patient a medical device according to claim 8.

33. The medical device of claim 8 wherein said openings comprise slits or rectilinear or curvilinear voids.