Medical valve leaflet structures with peripheral region receptive to tissue ingrowth

• US 8,303,647 B2
• Filed: 03/03/2006
• Issued: 11/06/2012
• Est. Priority Date: 03/03/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US11/367,979
• Publication Number:
  US 20060253188A1
• Time in Patent Office: 2,440 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.12, 623/2.13, 623/2.14
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

Composite leaflets and prosthetic valves incorporating the same are disclosed. An illustrative composite leaflet includes a flexible inner region, which is formed with a synthetic polymeric material, and a flexible peripheral region, which is formed with a remodelable material effective to promote tissue ingrowth. The peripheral region extends from at least a portion of the flexible inner region and is configured to contact a wall of a tubular body passage and thereby promote tissue ingrowth into the peripheral region from the wall of the tubular body passage.

Claims

1. A medical valve prosthesis for implantation within a bodily passage, the valve prosthesis comprising at least a first valve leaflet, the first valve leaflet including an outer portion configured to reside adjacent a wall of the bodily passage upon implantation, the first valve leaflet further including a composite leaflet body extending from said outer portion so as to reside away from said wall in a lumen of the bodily passage upon implantation, the composite leaflet body including a flexible inner region formed entirely with a synthetic polymeric sheet material, and further including a flexible peripheral region attached to said flexible inner region and formed with a remodelable sheet material, said flexible inner region abutting or partially overlapping said flexible peripheral region with said synthetic polymeric sheet material providing a free upper edge of the composite leaflet body, said free upper edge having a single layer thickness provided by said synthetic polymeric sheet material, with said single layer thickness extending between an exposed top face and an exposed bottom face of the synthetic polymeric sheet material which are both exposed in the composite leaflet body as a whole, wherein said flexible peripheral region is configured to contact a wall of the bodily passage upon implantation so as to promote cellular invasion and ingrowth into the remodelable sheet material from the wall of the bodily passage, and wherein said flexible inner region is configured to reside in the bodily passage upon implantation so that fluid flowing through the bodily passage can contact said exposed top face and said exposed bottom face of said synthetic polymeric sheet material.

2. The medical valve prosthesis of claim 1 wherein said flexible inner region includes material that does not overlap said flexible peripheral region.

3. The medical valve prosthesis of claim 2, wherein said remodelable sheet material comprises a remodelable extracellular matrix material.

4. The medical valve prosthesis of claim 3 wherein said remodelable extracellular matrix material comprises submucosa.

5. The medical valve prosthesis of claim 4, wherein said remodelable extracellular matrix material comprises porcine submucosa.

6. The valve prosthesis of claim 5, wherein said porcine submucosa comprises small intestine submucosa, urinary bladder submucosa, or stomach submucosa.

7. The medical valve prosthesis of claim 1, also including a frame attached to said first valve leaflet.

8. The medical valve prosthesis of claim 1 having at least two valve leaflets.

9. A composite medical valve leaflet for implantation within a tubular body passage, the composite medical valve leaflet comprising:

a flexible inner region; and

a flexible outer region attached to said flexible inner region,

said flexible inner region providing a free upper edge in the composite medical valve leaflet, said free upper edge having a single layer thickness that is provided by a single layer of a synthetic polymeric sheet material, said single layer thickness extending between an exposed top face and an exposed bottom face of said synthetic polymeric sheet material which are both exposed in the composite medical valve leaflet as a whole,

said flexible peripheral region comprising a remodelable sheet material having an edge that abuts or partially overlaps said synthetic polymeric sheet material;

said peripheral region configured to contact a wall of the tubular body passage upon implantation so as to promote tissue ingrowth into the remodelable material from the wall of the tubular body passage while allowing said synthetic polymeric sheet material to extend out into the lumen of the tubular body passage for contacting and modifying fluid flow through the body passage, wherein said synthetic polymeric sheet material extends beyond said edge of said remodelable sheet material such that fluid flowing through the body passage can contact said exposed top face and said exposed bottom face of said synthetic polymeric sheet material.

10. The medical valve leaflet of claim 9, wherein said remodelable sheet material comprises a remodelable extracellular matrix material.

11. The medical valve leaflet of claim 10, wherein said remodelable extracellular matrix material comprises submucosa.

12. The medical valve leaflet of claim 11, wherein said remodelable extracellular matrix material comprises porcine submucosa.

13. The medical valve leaflet of claim 9, wherein said inner region is attached to said peripheral region with an adhesive.

14. The medical valve leaflet of claim 9, which is configured for implantation in a vascular vessel.

15. The medical valve leaflet of claim 14, which is configured for implantation in a venous vessel.

16. The medical valve leaflet of claim 9, wherein said inner region is attached to said peripheral region with sutures.

17. A medical valve leaflet, comprising:

a first flexible sheet segment formed with a non-remodelable sheet material and including a first segment boundary portion, said non-remodelable sheet material having a thickness that extends between an exposed top face and an exposed bottom face of the non-remodelable sheet material; and

a second flexible sheet segment formed with a remodelable material and including a second segment boundary portion,

wherein the first segment boundary portion is attached to the second segment boundary portion to form a composite leaflet structure for implantation in a tubular body passage, with the first segment boundary portion abutting or partially overlapping the second segment boundary portion, the composite leaflet structure configured such that the first segment boundary portion is attached to the second segment boundary portion in one or more attachment locations to occur out away from a wall of the tubular body passage when the composite leaflet structure is implanted in the tubular body passage, wherein said non-remodelable sheet material provides a free upper edge in the composite leaflet structure with the exposed top face and the exposed bottom face of the non-remodelable sheet material both being exposed in the composite leaflet structure as a whole, and wherein said first flexible sheet segment is configured to extend out into the tubular body passage beyond said second flexible sheet segment when the medical valve leaflet is implanted in the tubular body passage such that fluid flowing through the tubular body passage can contact said exposed top face and said exposed bottom face of said non-remodelable sheet material.

18. The medical valve leaflet of claim 17, wherein said first flexible sheet segment overlaps said second flexible sheet segment.

19. The medical valve leaflet of claim 17, wherein said first flexible sheet segment is formed with a synthetic polymeric material.

20. The medical valve leaflet of claim 17, wherein said second flexible sheet segment includes two layers of material.

21. The medical valve leaflet of claim 17, wherein said second flexible sheet segment is configured to contact a wall of a tubular body passage and is receptive to tissue ingrowth into said second flexible sheet segment from the wall of the tubular body passage.

22. The medical valve leaflet of claim 17, wherein said first flexible sheet segment does not overlap said second flexible sheet segment.

23. The medical valve leaflet of claim 17, wherein said second flexible sheet segment is collagenous.

24. The medical valve leaflet of claim 17, wherein said second flexible sheet segment comprises an extracellular matrix material.

25. The medical valve leaflet of claim 24, wherein said extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

26. A medical valve prosthesis implantable within a tubular body passage for modifying fluid flow through the tubular body passage, the medical valve prosthesis comprising:

a composite valve leaflet, comprising;

a flexible inner region formed entirely with a non-remodelable sheet material, wherein the non-remodelable sheet material provides a free upper edge of the composite valve leaflet, said free upper edge having a thickness that extends between an exposed top face and an exposed bottom face of the non-remodelable sheet material which are both exposed in said composite valve leaflet as a whole; and

a flexible peripheral region extending from at least a portion of said flexible inner region, said flexible peripheral region comprising a remodelable sheet material having an edge that abuts or partially overlaps said non-remodelable sheet material;

said remodelable sheet material configured to extend outwardly into the tubular body passage lumen for attachment to the flexible inner region while maintaining contact with a wall of the tubular body passage when the valve prosthesis is implanted in the tubular body passage, wherein said flexible peripheral region is configured to promote tissue ingrowth into said remodelable sheet material from the tubular body passage while allowing said non-remodelable sheet material to extend out into the tubular body passage beyond said edge of the remodelable sheet material so that fluid flowing through the tubular body passage can contact said exposed top face and said exposed bottom face of said non-remodelable sheet material.

27. The medical valve prosthesis of claim 26 configured for implantation within a tubular body passage in the absence of a frame.

28. A prosthetic medical valve device configured for implantation within a bodily passage, the medical valve device comprising:

a plurality of valve leaflets that together provide a composite valve structure that is configured to reside in a lumen of the bodily passage for modifying flow through the passage, the composite valve structure comprising;

an inner valve region formed entirely with a synthetic polymeric sheet material, said synthetic polymeric sheet material providing a free upper edge of each of said plurality of valve leaflets, said free upper edge having a thickness that extends between an exposed top face and an exposed bottom face of the synthetic polymeric sheet material which are both exposed in the composite valve structure as a whole; and

a peripheral valve region comprising a remodelable material, the peripheral valve region including at least one flexible sheet segment that is configured to extend outwardly into the bodily passage lumen for attachment to the inner valve region while maintaining contact with a wall of the bodily passage when the valve device is implanted in the bodily passage,

wherein said peripheral valve region is configured to promote tissue ingrowth into said remodelable material from a wall of the bodily passage while allowing said synthetic polymeric sheet material to extend out into the bodily passage for contacting and modifying fluid flow through the bodily passage, wherein said synthetic polymeric sheet material extends beyond an edge of the remodelable material so that fluid flowing through the bodily passage can contact said exposed top face and said exposed bottom face of said synthetic polymeric sheet material.