Methods and systems for modifying vascular valves

• US 7,442,206 B2
• Filed: 10/27/2005
• Issued: 10/28/2008
• Est. Priority Date: 10/28/2004
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/260,360
• Publication Number:
  US 20060136045A1
• Time in Patent Office: 1,097 Days
• Field of Search: 623/1.24, 623/2.1, 623/904, 606/142
• 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:

connecting at least two valve leaflets in a vascular valve in at least one location with an extracellular matrix material, so as to promote tissue of the patient to remodel and connect said leaflets, wherein said extracellular matrix material is in the form of a suture.

2. The method of claim 1, wherein said extracellular matrix material comprises, submucosa, dura mater, pericardium, renal capsule membrane, or basement membrane.

3. The method of claim 2, wherein said submucosa comprises mammalian submucosa.

4. The method of claim 3, wherein said mammalian submucosa comprises porcine, bovine, or ovine submucosa.

5. The method of claim 4, wherein said porcine submucosa comprises adult porcine submucosa.

6. The method of claim 3, wherein said mammalian submucosa comprises intestinal submucosa, stomach submucosa, urinary bladder submucosa, or uterine submucosa.

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

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

connecting at least two valve leaflets in a vascular valve in at least one location with a remodelable material, so as to promote tissue of the patient to remodel and connect said leaflets, wherein said remodelable material is a hybrid of extracellular matrix material and bioabsorbable synthetic polymer.

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

connecting together at least two valve leaflets in a vascular valve with an extracellular matrix material, wherein said extracellular matrix material is connected to the center of each valve leaflet at least in part by a suture.

10. The method of claim 9, wherein said vascular valve is a venous valve.

11. The method of claim 10, wherein said vascular valve has two valve leaflets.

12. The method of claim 11, wherein said valve leaflets are connected in at least one location proximate the junction of each valve leaflet to the common wall of said vessel.

13. A method for modulating the flow of blood in a vascular vessel, comprising:

connecting together at least two valve leaflets in a vascular valve at the center of each leaflet with an extracellular matrix material, wherein said extracellular matrix is a multilaminate sheet of extracellular matrix material.

14. A method for modulating the flow of blood in a vascular vessel, comprising:

connecting together at least two valve leaflets in a vascular valve at the center of each leaflet with an extracellular matrix material, wherein said extracellular matrix material comprises a twisted band of mammalian submucosa.

15. A method for modulating the flow of blood in a vascular vessel, comprising:

connecting together at least two valve leaflets in a vascular valve at the center of each leaflet with an extracellular matrix material, wherein said extracellular matrix material comprises a gel.

16. A method for treating a venous insufficiency in a leg of a patient, comprising:

connecting a first valve leaflet in a venous valve to a second valve leaflet in the venous valve with at least one bioremodelable material comprising a gel form extracellular matrix material, wherein said bioremodelable 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, so as to promote tissue of the patient to remodel said bioremodelable material to connect said first valve leaflet to said second valve leaflet.

17. The method of claim 16, wherein said bioremodelable material is delivered to said venous valve with a delivery device.

18. The method of claim 17, wherein said delivery device comprises a catheter.

19. The method of claim 16, wherein said securing comprises stapling.

20. The method of claim 16, wherein said bioremodelable material is small intestine submucosa and said clip comprises an ECM material.

21. The method of claim 16, wherein:

said bioremodelable material is delivered to said venous valve with a delivery device,

said bioremodelable material is positioned with a positioning device at a first location on said first valve leaflet and at a second location on said second valve leaflet; and

said bioremodelable material is secured to said first valve leaflet at said first location and to said second valve leaflet at said second location.

22. The method of claim 21, wherein said positioning device is a catheter.

23. The method of claim 21, wherein said bioremodelable material is secured at least in part with staples.

24. A method for modulating the flow of blood in a vascular vessel, comprising:

connecting together a region of at least two valve leaflets in a vascular valve with an extracellular matrix material, wherein said valve leaflets are connected in at least one location proximate the junction of each valve leaflet to the common wall of said vessel and wherein said extracellular matrix is a multilaminate sheet of extracellular matrix material.

25. A method for modulating the flow of blood in a vascular vessel, comprising:

connecting together a region of at least two valve leaflets in a vascular valve with an extracellular matrix material, wherein said valve leaflets are connected in at least one location proximate the junction of each valve leaflet to the common wall of said vessel and wherein said extracellular matrix material comprises a twisted band of mammalian submucosa.

26. A method for modulating the flow of blood in a vascular vessel, comprising:

connecting together a region of at least two valve leaflets in a vascular valve with an extracellular matrix material, wherein said valve leaflets are connected in at least one location proximate the junction of each valve leaflet to the common wall of said vessel and wherein said extracellular matrix material comprises a gel.