Catheter for the transvascular implantation of prosthetic heart valves

• US 8,679,174 B2
• Filed: 01/12/2006
• Issued: 03/25/2014
• Est. Priority Date: 01/20/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Moszner, Robert, Figulla, Hans-Reiner, Ferrari, Markus, Damm, Christoph, Ottma, Rdiger
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US11/795,590
• Publication Number:
  US 20090234443A1
• Time in Patent Office: 2,994 Days
• Field of Search: 606/108, 606140-143, 606/153, 606/200, 623/1.11, 623/1.23, 623/2.11, 623/23.72
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses

Abstract

A catheter for the transvascular implantation of prosthetic heart valves, including self-expanding anchorage supports, which allow a minimally invasive implantation of prosthetic heart valves to reduce the risk to the patient during the implantation. A prosthetic heart valve including anchorage supports is temporarily housed in a folded form in a cartridge-type unit during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system, which includes a flexible region that can be guided through the aorta. Actuating elements run through the interior of the hollow guide system, permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

Claims

1. Catheter for the transvascular implantation of a valve prosthesis having a prosthetic valve attached to a support element, comprising:

a cartridge unit holding the valve prosthesis in a collapsed state, the valve prosthesis comprising a first plurality of support hoops with attachment elements on end regions of the support hoops, the cartridge unit comprising a first sleeve-shaped element including anchoring elements on a distal region, wherein the attachment elements engage the anchoring elements, a second sleeve-shaped element, and a third sleeve-shaped element configured to at least partially surround the valve prosthesis such that the support hoops are radially inward of the third sleeve-shaped element; and

operating elements disposed within a hollow guide system and extending to the cartridge unit, wherein the operating elements are configured to affect movement of the cartridge unit rotatably about its longitudinal axis to affect movement of the valve prosthesis rotatably and axially along its longitudinal axis;

wherein axial movement between the second and third sleeve-shaped elements in substantially opposite directions is configured to affect a sequential release of the valve prosthesis from a collapsed state to an expanded state.

2. Catheter as claimed in claim 1, further including a bendable region.

3. Catheter as claimed in claim 2, wherein the bendable region includes a plurality of joints and is configured to affect a bend in the catheter of 180 degrees.

4. Catheter as claimed in claim 1, wherein the catheter is configured such that a liquid coolant is circulated through an interior of the hollow guide system as far as the cartridge unit.

5. Catheter as claimed in claim 4, wherein the hollow guide system is configured to be liquid-proof.

6. Catheter as claimed in claim 1, wherein the second and third sleeve-shaped elements are telescopically disposed with respect to one another, and wherein the valve prosthesis is held in the collapsed state by the first and second sleeve-shaped elements.

7. Catheter as claimed in claim 6, wherein the third sleeve-shaped element is movable in a distal direction to permit the first plurality of support hoops to self-expand while the second sleeve-shaped element maintains the remainder of the valve prosthesis in the collapsed state.

8. Catheter as claimed in claim 7, wherein the second sleeve-shaped element is movable in a proximal direction to permit the remainder of the valve prosthesis to self-expand.

9. Catheter as claimed in claim 1, wherein the plurality of anchoring elements are configured to permit rotation of the support element about a longitudinal axis of the catheter.

10. Catheter as claimed in claim 1, wherein the first plurality of support hoops are configured to be positioned within a plurality of pockets of a native valve.

11. Catheter as claimed in claim 1, wherein the valve prosthesis further includes a body portion, and the first plurality of support hoops and the body portion are configured to clamp at least a portion of native valve leaflets when the valve prosthesis is implanted.

12. A catheter for implanting a valve prosthesis, comprising:

a cartridge unit configured to hold the valve prosthesis in a collapsed state, the valve prosthesis comprising a plurality of support hoops with attachment elements on end regions of the support hoops, the cartridge unit comprising;

a first sleeved-shaped element comprising anchoring elements on a distal region, wherein the attachment elements engage the anchoring elements;

a second sleeve-shaped element; and

a third sleeve-shaped element configured to at least partially surround the valve prosthesis such that the plurality of support hoops are radially inward of the third sleeve-shaped element;

wherein relative axial movement between the second and third sleeve-shaped elements in substantially opposite directions is configured to permit sequential expansion of the valve prosthesis from a collapsed form to an expanded form.

13. The catheter of claim 12, wherein axial movement of the third sleeve-shaped element in a distal direction relative to the first sleeve-shaped element permits the plurality of support hoops to radially expand from the collapsed form to the expanded form.

14. The catheter of claim 13, wherein axial movement of the second sleeve-shaped element in a proximal direction relative to the first sleeve-shaped element permits a body portion of the valve prosthesis to radially expand from the collapsed form to a partially expanded form.

15. The catheter of claim 14, wherein axial movement of the third sleeve-shaped element in the proximal direction relative to the first sleeve-shaped element collapses the plurality of support hoops.

16. The catheter of claim 14, wherein further axial movement of the third sleeve-shaped element in the distal direction relative to the first sleeve-shaped element permits the plurality of attachment elements to expand.

17. The catheter of claim 14, wherein relative axial movement of the first sleeve-shaped element in the proximal direction relative to the third sleeve-shaped element permits the plurality of attachment elements to expand.

18. The catheter of claim 12, wherein the first sleeve-shaped element and the valve prosthesis are configured to rotate about a longitudinal axis.

19. Catheter as claimed in claim 12, wherein the plurality of support hoops are configured to be positioned within a plurality of pockets of a native valve.

20. The catheter of claim 12, wherein the valve prosthesis further includes a body portion, and the plurality of support hoops and the body portion are configured to clamp at least a portion of native valve leaflets when the valve prosthesis is implanted.

21. A catheter for implanting a valve prosthesis including a support element and a prosthetic valve attached to the support element, comprising:

a cartridge unit disposed between proximal and distal ends of the catheter configured to selectively retain the valve prosthesis in a collapsed form, the valve prosthesis comprising;

a distal end, a proximal end, and a plurality of support hoops extending from the distal end of the support element toward the proximal end of the support element, the support hoops having attachment elements on end regions of the support hoops;

the cartridge unit comprising;

a first sleeve-shaped element comprising anchoring elements on a distal region, wherein the attachment elements engage the anchoring elements, a second sleeve-shaped element, and a third sleeve-shaped element configured to at least partially surround the valve prosthesis such that the plurality of support hoops are radially inward of the third sleeve-shaped element, wherein axial movement of the second and third sleeve-shaped elements in substantially opposite directions is configured to permit sequential expansion of the valve prosthesis from a collapsed state to an expanded state such that the plurality of support hoops are biased radially outward and configured to be positioned on a first side of a leaflet of a native valve and a remainder of the valve prosthesis is biased radially outward and configured to be positioned on a second side of the leaflet of the native valve, opposite the first side.

22. The catheter of claim 21, wherein the first sleeve-shaped element is configured to affect rotation of the valve prosthesis about a longitudinal axis of the cartridge unit.

23. The catheter of claim 21, wherein the cartridge unit is further configured to affect expansion of the remainder of the valve prosthesis after expansion of the plurality of support hoops.

24. The catheter of claim 21, wherein the expanded plurality of support hoops and the fully expanded remainder of the valve prosthesis are configured to clamp at least a portion of the native heart valve.

25. A catheter for implanting a valve prosthesis including a prosthetic valve attached to a support structure having a body portion and a plurality of support hoops with attachment elements on end regions of the support hoops, the catheter comprising:

a first sleeve-shaped element comprising anchoring elements on a distal region, wherein the attachment elements engage the anchoring elements;

a second sleeve-shaped element; and

a third sleeve-shaped element configured to at least partially surround the valve prosthesis such that the support hoops are radially inward of the third sleeve-shaped element;

wherein the is plurality of support hoops are connected to the body portion at a distal end of the body portion and extend toward a proximal end of the body portion; and

wherein axial movement of the second and third sleeve-shaped elements in substantially opposite directions is configured to permit sequential expansion of the valve prosthesis from a collapsed state to an expanded state.

26. The catheter of claim 25, wherein the expanded support hoops are configured to be positioned in pockets of a native heart valve.

27. The catheter of claim 25, wherein the expanded plurality of support hoops and the expanded body portion are configured to clamp a native valve.

28. A catheter for transvascular implantation of a valve prosthesis including a self-expanding anchoring support having a body portion and a plurality of support hoops and a prosthetic valve attached to the anchoring support with attachment elements on end regions of the support hoops, the catheter comprising:

(a) a cartridge unit for carrying the anchoring support and prosthesis and having a flexible tip at its proximal end, the cartridge unit comprising a first sleeve-shaped element including anchoring elements on a distal region, wherein the attachment elements engage the anchoring elements, a second sleeve-shaped element, and a third sleeve-shaped element configured to at least partially surround the valve prosthesis such that the support hoops are radially inward of the third sleeve-shaped element, wherein axial movement of the second and third sleeve-shaped elements in substantially opposite directions is configured to permit sequential expansion of the valve prosthesis from a collapsed state to an expanded state;

(b) a hollow guide system releasably connected to the cartridge unit at a proximal end of the hollow guide system; and

(c) a manipulating part attached to a distal end of the hollow guide system wherein operating elements are attached at one end to the manipulating part and at the other end to the cartridge unit, the hollow guide system has a bendable region at its proximal end adjacent to the cartridge unit, the hollow guide system is configured to contain a circulating coolant or pharmaceutical preparation; and

the guide system is substantially liquid proof.

29. Catheter as claimed in claim 28, wherein the bendable region includes a link chain with individual joints.

30. Catheter as claimed in claim 29, wherein the individual joints positively engage respectively in adjacent links.

31. Catheter as claimed in claim 28, wherein the operating elements include tension wires.

32. Catheter as claimed in claim 28, wherein the guide system is configured to circulate the liquid coolant through an interior of the guide system to the cartridge unit.

33. Catheter as claimed in claim 28, wherein the second and third sleeve-shaped elements are telescopically engaging in one another, between which the valve prosthesis is enclosed and clamped in the collapsed state until implantation.

34. Catheter as claimed in claim 28, wherein the catheter is configured for guiding a guide wire through an interior of the catheter.