Methods and systems for modifying vascular valves

• US 7,833,267 B2
• Filed: 10/24/2008
• Issued: 11/16/2010
• Est. Priority Date: 10/28/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A.
• Primary Examiner(s): Gherbi; Suzette J
• Application Number:
  US12/257,720
• Publication Number:
  US 20090048669A1
• Time in Patent Office: 753 Days
• Field of Search: 623/1.24, 623/2.1, 623/16.11, 623/904, 600/37
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Described are methods and systems for modifying vascular valves in order to reduce retrograde blood flow through the valves. Preferred methods include connecting vascular valve leaflets with at least one remodelable material, such that the valve leaflets become fused by the ingrowth of the patient'"'"'s native tissue. Preferred remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.

Claims

1. A method for modifying a vascular valve in a patient, comprising:

accessing a vascular valve in the body of a patient; and

attaching a remodelable material to at least a first valve leaflet and a second valve leaflet in the vascular valve, the remodelable material effective upon implantation to become replaced by native patient tissue so as to provide a remodeled tissue spanning between the first valve leaflet and the second valve leaflet to fuse the first valve leaflet to the second valve leaflet.

2. The method of claim 1, wherein said remodelable material comprises an extracellular matrix material.

3. The method of claim 2, wherein said extracellular matrix material comprises submucosa, dura mater, pericardium, renal capsule membrane, or basement membrane.

4. The method of claim 1, wherein said remodelable material comprises a bioabsorbable synthetic polymer.

5. The method of claim 1, wherein said remodelable material is a hybrid of extracellular matrix material and bioabsorbable synthetic polymer.

6. The method of claim 2, wherein said extracellular matrix material is in the form of a suture.

7. The method of claim 1, wherein said remodelable material includes a portion positioned over a lip of the first valve leaflet and a lip of the second valve leaflet.

8. The method of claim 1, wherein the remodeled tissue spanning between the first valve leaflet and the second valve leaflet is free from any foreign body component.

9. A method for modifying the flow of blood in a vascular vessel, comprising:

accessing a vascular valve in the body of a patient; and

connecting a first valve leaflet in the vascular valve to a second valve leaflet in the vascular valve with a material that is receptive to tissue ingrowth so as to promote native patient tissue to grow into the material to fuse the first valve leaflet to the second valve leaflet.

10. The method of claim 9, wherein said first valve leaflet and said second valve leaflet are connected in a central region of each said leaflet.

11. The method of claim 9, wherein said first valve leaflet and said second valve leaflet are connected in at least one location proximate a junction of each of said leaflets to a common wall of said vessel.

12. The method of either claim 9, wherein said tissue ingrowth receptive material is connected to each valve leaflet at least in part by suture.

13. The method of either claim 9, wherein said tissue ingrowth receptive material comprises a sheet of extracellular matrix material.

14. The method of either claim 9, wherein said tissue ingrowth receptive material comprises a twisted band of mammalian submucosa.

15. The method of claim 9, wherein said tissue ingrowth receptive material comprises a bioabsorbable synthetic polymer.

16. The method of claim 9, wherein said tissue ingrowth receptive material includes a portion extending through at least one of said first valve leaflet and said second valve leaflet.

17. The method of claim 9, wherein said tissue ingrowth receptive material includes a portion positioned on an exterior surface of said first valve leaflet between said first valve leaflet and the wall of said vessel.

18. A method for modifying a vascular valve in a patient, comprising:

accessing a vascular valve in the body of a patient; and

locating an extracellular matrix material in the vascular valve such that the extracellular matrix material contacts a first valve leaflet and extends therefrom to contact a second valve leaflet so as to promote native patient tissue to grow into the extracellular matrix material to fuse the first valve leaflet to the second valve leaflet.

19. The method of claim 18, wherein said extracellular matrix material comprises an extracellular matrix sheet material harvested from a collagenous tissue source.

23. The method of claim 18, wherein said extracellular matrix material is placed between said first valve leaflet and said second valve leaflet and is secured with one or more staple, suture, and/or clip.

24. The method of claim 23, wherein said extracellular matrix material comprises a gel.

25. The method of claim 23, wherein said extracellular matrix material is small intestine submucosa and said clip comprises an extracellular matrix material.

20. A method for modifying a vascular valve in a patient, comprising:

locating an extracellular matrix material in a vascular valve such that the extracellular matrix material contacts a first valve leaflet and extends therefrom to contact a second valve leaflet so as to promote native patient tissue to grow into the extracellular matrix material to fuse the first valve leaflet to the second valve leaflet, wherein said extracellular matrix material is delivered to said vascular valve with a delivery catheter.

21. The method of claim 20, wherein said extracellular matrix material is secured to said first valve leaflet and said second valve leaflet.

22. The method of claim 21, wherein securement of said extracellular matrix material to said first valve leaflet and said second valve leaflet comprises stapling.