Device for reduction of pressure effects of cardiac tricuspid valve regurgitation

• US 20040210306A1
• Filed: 04/17/2003
• Published: 10/21/2004
• Est. Priority Date: 04/17/2003
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: VenPro Corporation (Medtronic Plc)
• Inventors: McCarthy, Patrick M., Quijano, Rodolfo C.
• Granted Patent: US 7,530,995 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes

Abstract

A method of protecting an upper and a lower body of a patient from high venous pressures comprising: providing an elongate valve stent, wherein the stent comprises a first stent member with a first tissue valve secured to a first support structure being disposed at a first end of the stent and a second stent member with a second tissue valve secured to a second support structure being disposed at an opposite second end of the stent, wherein both support structures are collapsibly expandable, the second end being connected to the first end with at least one elongate connecting member; passing the elongate valve stent through a blood vessel with the first and second support structures in a collapsed position; and securing the first support structure to an inferior vena cava and the second support structure to a superior vena cava with both support structures in an expanded shape.

Claims

1. An elongate valve stent comprising:

a first end, a middle section, and an opposite second end that is connected to said first end with at least one elongate connecting member;

a first stent member disposed at and secured to the first end, said first stent member comprising a first support structure and a first tissue valve; and

a second stent member disposed at and secured to the second end, said second stent member comprising a second support structure and a second tissue valve.

2. The elongate valve stent of claim 1, wherein said first tissue valve is configured to permit fluid flow towards the middle section and prevent fluid flow in an opposite direction.

3. The elongate valve stent of claim 1, wherein said second tissue valve is configured to permit fluid flow towards the middle section and prevent fluid flow in an opposite direction.

4. The elongate valve stent of claim 1, wherein said first tissue valve is configured to permit fluid flow towards the middle section and the second tissue valve is configured to permit fluid flow from the middle section towards the second end.

5. The elongate valve stent of claim 1, wherein the first and second support structures are collapsibly expandable from a first collapsed position to a second expanded position.

6. The elongate valve stent of claim 5, wherein a circumference of the first support structure at the expanded position is equal to a circumference of the second support structure at the expanded position.

7. The elongate valve stent of claim 5, wherein a circumference of the first support structure at the expanded position is larger than a circumference of the second support structure at the expanded position.

8. The elongate valve stent of claim 1, wherein both support structures of said stent are self-expandable.

9. The elongate valve stent of claim 1, wherein the first or second support structure of said stent is expandable by an inflatable balloon.

10. The elongate valve stent of claim 1, wherein the first or second support structure of said stent is made of a shape-memory material having a first shape transition temperature of between about 30°

C. and 45°

C. and a second shape transition temperature of about 5°

C. and −

10°

C., said support structure being collapsibly deformed to below the second shape transition temperature during delivery and expanded after delivery in place upon reaching the first shape transition temperature.

11. The elongate valve stent of claim 1, wherein said tissue valve has at least one valve leaflet.

12. The elongate valve stent of claim 11, wherein said leaflet is made from a pericardium.

13. The elongate valve stent of claim 12, wherein the pericardium is selected from a group consisting of a bovine pericardium, an equine pericardium, a porcine pericardium, and an ovine pericardium.

14. The elongate valve stent of claim 11, wherein said leaflet is chemically treated by a chemical treating agent selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, epoxy compounds, genipin, and mixture thereof.

15. The elongate valve stent of claim 1, wherein said first or second tissue valve is a venous valve procured from a group consisting of a bovine jugular vein, an equine jugular vein, a porcine jugular vein, and an ovine jugular vein.

16. The elongate valve stent of claim 1, wherein said first or second tissue valve is a porcine valve.

17. The elongate valve stent of claim 1, wherein the elongate connecting members are essentially parallel to each other or in a spiral shape.

18. The elongate valve stent of claim 1, wherein said first or second support structure is made of a material selected from a group consisting of stainless steel, Nitinol, and plastics.

19. The elongate valve stent of claim 1, wherein said first or second support structure is coated with a therapeutic agent.

20. The elongate valve stent of claim 19, wherein said therapeutic agent is selected from a group consisting of anticoagulants, antithrombogenic agents, anti-proliferative agents, anti-inflammatory agents, antibiotics, stem cells, growth factors, angiogenesis agents, anti-angiogenesis agents, and statins.

21. The elongate valve stent of claim 1, wherein said first or second support structure further comprises means for anchoring said first or second support structure onto surrounding tissue of either the superior vena cava or the inferior vena cava.

22. The elongate valve stent of claim 1, wherein the at least one elongate connecting member comprises a length that is adjustable.

23. A method of protecting an upper and a lower body of a patient from high venous pressures comprising:

providing an elongate valve stent, wherein said stent comprises a first stent member with a first tissue valve secured to a first support structure being disposed at a first end of said stent and a second stent member with a second tissue valve secured to a second support structure being disposed at an opposite second end of said stent, wherein both support structures are collapsibly expandable, the second end being connected to said first end with at least one elongate connecting member;

passing the elongate valve stent through a blood vessel with the first and second support structures in a collapsed position; and

securing the first support structure to an inferior vena cava and the second support structure to a superior vena cava with both support structures in an expanded shape.

24. The method of claim 23, wherein said first and second tissue valves are configured to permit blood flow towards a right atrium of the patient and prevent blood flow in an opposite direction.

25. The method of claim 23, wherein the step of delivering the elongate valve stent endoluminally is through an incision at a blood vessel selected from a group consisting of a jugular vein, a femoral vein, and a subclavian vein.

26. The method of claim 23, wherein either the first or the second support structure is self-expandable.

27. The method of claim 23, wherein either the first or the second support structure is expandable by an inflatable balloon.

28. The method of claim 23, wherein either the first or the second support structure is made of a shape-memory material having a first shape transition temperature of between about 30°

C. and 45°

C. and a second shape transition temperature of about 5°

C. and −

10°

C., said support structure being collapsibly deformed to below the second shape transition temperature during delivery and expanded after delivery in place upon reaching the first shape transition temperature.

29. The method of claim 23, wherein either the first or the second support structure is made of a material selected from a group consisting of stainless steel, Nitinol, and plastics.

30. The method of claim 23, wherein either the first or the second support structure is coated with a therapeutic agent.

31. The method of claim 30, wherein said therapeutic agent is selected from a group consisting of anticoagulants, antithrombogenic agents, anti-proliferative agents, anti-inflammatory agents, antibiotics, stem cells, growth factors, angiogenesis agents, anti-angiogenesis agents, and statins.

32. The method of claim 23, wherein either the first or the second tissue valve has at least one valve leaflet.

33. The method of claim 32, wherein said leaflet is made from a pericardium.

34. The method of claim 33, wherein the pericardium is selected from a group consisting of a bovine pericardium, an equine pericardium, a porcine pericardium, and an ovine pericardium.

35. The method of claim 23, wherein either the first or the second tissue valve is chemically treated with a chemical selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, epoxy compounds, genipin, and mixture thereof.

36. The method of claim 23, wherein either the first or the second tissue valve is a venous valve procured from a group consisting of a bovine jugular vein, an equine jugular vein, a porcine jugular vein, and an ovine jugular vein.

37. The method of claim 23, wherein either the first or the second tissue valve is a porcine valve.

38. The method of claim 23, wherein said first or second support structure further comprises means for anchoring the stent onto surrounding tissue of the superior vena cava and the inferior vena cava.

39. The method of claim 23, wherein the at least one elongate connecting member has adjustable length, the method further comprising, after securing the first support structure to the inferior vena cava in the expanded shape, a length adjusting step for adjusting the length of said connecting member.

40. The method of claim 39, wherein the length adjusting step is carried out by positioning the second support structure at the superior vena cava before securing the second support structure in the expanded shape.