Device for reduction of pressure effects of cardiac tricuspid valve regurgitation

• US 7,530,995 B2
• Filed: 04/17/2003
• Issued: 05/12/2009
• Est. Priority Date: 04/17/2003
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: McCarthy, Patrick M., Quijano, Rodolfo C.
• Primary Examiner(s): Bui; Vy Q.
• Application Number:
  US10/418,677
• Publication Number:
  US 20040210306A1
• Time in Patent Office: 2,217 Days
• Field of Search: 623/1.24, 623/1.26, 623/900, 623/904
• US Class Current: 623/1.24
• 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 stent member comprising a first support structure including a plurality of serpentine bands, wherein adjacent serpentine bands are connected by at least one connector strut and a first tissue valve disposed thereon, said first tissue valve including at least two leaflets structured to open and close permitting the flow of blood therethrough in the open position;

a second stent member distinct and separated from said first stent member by a predetermined distance, said second stent member comprising a second support structure including a plurality of serpentine bands, wherein adjacent serpentine bands are connected by at least one connector strut and a second tissue valve disposed thereon, said second tissue valve including at least two leaflets structured to open and close permitting the flow of blood therethrough in the open position; and

at least two elongate connecting members extending between and connecting at least one serpentine band of the first stent member to at least one serpentine band of the second stent member.

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.degree. C. and 45.degree. C. and a second shape transition temperature of about 5.degree. C. and −

10.degree. 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 at least two leaflets are made from a pericardium.

12. The elongate valve stent of claim 11, wherein the pericardium is selected from a group consisting of a bovine pericardium, an equine pericardium, a porcine pericardium, and an ovine pericardium.

13. The elongate valve stent of claim 1, wherein said at least two leaflets are chemically treated by a chemical treating agent selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, epoxy compounds, genipin, and mixture thereof.

14. 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.

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

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

17. 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.

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

19. The elongate valve stent of claim 18, 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.

20. 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.

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

22. The elongate valve stent of claim 1 wherein said first stent member is configured to be implanted in a superior vena cava.

23. The elongate valve stent of claim 1 wherein said second stent member is configured to be implanted in an inferior vena cava.

24. The elongate valve stent of claim 1 wherein said first stent member is configured to be implanted in a superior vena cava and said second stent member is configured to be implanted in an inferior vena cava.

25. A elongate valve stent for protecting an upper body and a lower body of a patient from high venous pressures comprising:

a first stent member comprising a first support structure including a plurality of serpentine bands, wherein adjacent serpentine bands are connected by at least one connector strut and a first tissue valve disposed thereon, said first tissue valve structured to be implanted in a superior vena cava and including at least two leaflets structured to open and close permitting the flow of blood therethrough in the open position;

a second stent member distinct and separate from said first stent member, said second stent member comprising a second support structure including a plurality of serpentine bands, wherein adjacent serpentine bands are connected by at least one connector strut and a second tissue valve disposed thereon, said second tissue valve structured to be implanted in an inferior vena cava and including at least two leaflets structured to open and close permitting the flow of blood therethrough in the open position; and

at least one elongate connecting member extending between and connecting at least one serpentine band of the first stent member to at least one serpentine band of the second stent member

wherein said first and second valves are configured to permit blood flow towards a right atrium and prevent blood flow in an opposite direction.

26. An elongate valve stent comprising:

a first stent member comprising a first support structure including a plurality of serpentine bands, wherein adjacent serpentine bands are connected by at least one connector strut and a first tissue valve disposed thereon;

a second stent member separate and distinct from said first stent member, said second stent member comprising a second support structure including a plurality of serpentine bands, wherein adjacent serpentine bands are connected by at least one connector strut and a second tissue valve disposed thereon; and

at least one elongate connecting member sized and configured to provide radial flexibility and longitudinal stiffness, said elongate connecting member extending between and connecting at least one serpentine band of the first stent member to at least one serpentine band of the second stent member.