Low Profile Heart Valve and Delivery System

• US 20080234814A1
• Filed: 06/03/2008
• Published: 09/25/2008
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Krolik, Jeff, Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Brandt, Brian D., Geshlider, Robert A., Salahieh, Amr, Dueri, Jean-Pierre
• Granted Patent: US 8,048,153 B2
• Time in Patent Office: Days
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

Apparatus for endovascularly replacing a patient'"'"'s heart valve, including: a delivery catheter having a diameter of 21 french or less; an expandable anchor disposed within the delivery catheter; and a replacement valve disposed within the delivery catheter. The invention also includes a method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: inserting a catheter having a diameter no more than 21 french into the patient; endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve through the catheter; and deploying the anchor and the replacement valve.

Claims

1. A method of endovascularly replacing a heart valve of a patient, comprising:

endovascularly delivering a replacement valve and an expandable anchor within a delivery catheter to a vicinity of the heart valve; and

expanding the anchor by applying an axially directed actuation force on the anchor with a delivery tool after the anchor is completely outside of the delivery catheter.

2. The method of claim 1 wherein expanding the anchor comprises radially expanding the anchor.

3. The method of claim 1 wherein applying an axially directed actuation force on the anchor with a delivery tool comprises applying a distally directed actuation force and a proximally directed actuation force on the anchor with a delivery tool.

4. The method of claim 3 wherein applying a distally directed actuation force on the anchor comprises applying a distally directed actuation force on the anchor with a first delivery tool component and wherein applying a proximally directed actuation force on the anchor comprises applying a proximally directed actuation force on the anchor with a second delivery tool component.

5. The method of claim 1 wherein applying an axially directed actuation force on the anchor with a delivery tool comprises applying a proximally directed actuation force on the anchor.

6. The method of claim 1 wherein applying an axially directed actuation force on the anchor with a delivery tool comprises applying a distally directed actuation force on the anchor.

7. The method of claim 1 further comprising allowing the anchor to self-expand to a partially expanded configuration outside of the delivery catheter before expanding the anchor by applying the axially directed actuation force on the anchor.

8. The method of claim 1 wherein expanding the anchor comprises foreshortening the anchor.

9. The method of claim 1 wherein applying an axially directed actuation force does not comprise expanding a balloon.

10. The method of claim 1 further comprising:

reversibly coupling the delivery tool to the anchor before the delivering step, and

decoupling the delivery tool from the anchor after the expanding step.

11. The method of claim 1 further comprising locking the anchor in a fully deployed configuration by coupling a first anchor locking element with a second anchor locking element, wherein expanding the anchor comprises moving the first anchor locking element towards the second anchor locking element.

12. A method of endovascularly replacing a heart valve of a patient, comprising:

endovascularly delivering a replacement valve and an expandable anchor within a delivery catheter to a vicinity of the heart valve;

allowing the expandable anchor to self-expand to a partially expanded configuration outside of the delivery catheter; and

further expanding the anchor by applying a non-hydraulic and non-pneumatic actuation force on the anchor with a delivery tool.

13. The method of claim 12 wherein allowing the expandable anchor to self-expand comprises allowing the expandable anchor to radially self-expand.

14. The method of claim 13 wherein further expanding the anchor comprising further radially expanding the anchor.

15. The method of claim 12 wherein further expanding the anchor comprises foreshortening the anchor.

16. The method of claim 12 wherein further expanding the anchor by applying a non-hydraulic and non-pneumatic actuation force on the anchor with a delivery tool comprises applying a distally directed actuation force on the anchor with a first delivery tool component and applying a proximally directed actuation force on the anchor with a second delivery tool component.

17. The method of claim 12 further comprising reversibly coupling the delivery tool and the anchor before the delivering step, and decoupling the delivery tool from the anchor after further expanding the anchor.

18. The method of claim 12 wherein further expanding the anchor occurs after allowing the anchor to self-expand.

19. A method of endovascularly replacing a heart valve of a patient, comprising:

endovascularly delivering a replacement valve and an expandable anchor within a delivery catheter to a vicinity of the heart valve;

expanding the anchor by applying a distally directed actuation force and a proximally directed actuation force on the anchor with a delivery tool.

20. The method of claim 19 wherein expanding the anchor comprises expanding the anchor by applying a distally directed actuation force and a proximally directed actuation force on the anchor with a delivery tool after the anchor is outside of the delivery catheter.

21. The method of claim 19 wherein expanding the anchor comprises radially expanding the anchor.

22. The method of claim 19 wherein applying the distally directed actuation force on the anchor occurs while applying the proximally directed actuation force on the anchor.

23. The method of claim 19 wherein applying a distally directed actuation force on the anchor comprises applying a distally directed actuation force on the anchor with a first delivery tool component and where applying a proximally directed actuation force on the anchor comprises applying a proximally directed actuation force on the anchor with a second delivery tool component.

24. The method of claim 19 further comprising:

reversibly coupling the delivery tool and the expandable anchor before the delivering step, and

decoupling the delivery tool from the expandable anchor after the expanding step.

25. The method of claim 19 further comprising locking the anchor in a fully deployed configuration by coupling a first anchor locking element with a second anchor locking element, wherein expanding the anchor comprises moving the first anchor locking elements towards the second anchor locking element.

26. A delivery system for endovascularly replacing a heart valve of a patient, comprising:

a replacement heart valve disposed within an expandable anchor, wherein the replacement heart valve and the expandable anchor are adapted to be delivered within a delivery catheter to a vicinity of the heart valve;

a delivery tool comprising a plurality of actuation elements wherein the plurality of actuation elements are reversibly coupled to the anchor, and

wherein the plurality of actuation elements are adapted to apply an axially directed force on the anchor to radially expand the anchor after the anchor is outside of the delivery catheter.

27. The delivery system of claim 26 wherein the plurality of actuation elements are reversibly coupled to the anchor in both a delivery configuration and an expanded configuration outside of the delivery catheter.

28. The delivery system of claim 26 wherein the delivery tool comprises a first plurality of actuation elements reversibly coupled to a proximal end of the anchor, wherein the first plurality of actuation elements are adapted to apply a distally directed force on the anchor after the anchor is outside of the delivery catheter.

29. The delivery system of claim 28 wherein the first plurality of actuation elements assume a radially expanded configuration when the anchor is outside of the delivery catheter.

30. The delivery system of claim 28 wherein the delivery tool comprises a second plurality of actuation elements adapted to apply a proximally directed force on the anchor after the anchor is outside of the delivery catheter.

31. The delivery system of claim 30 wherein the second plurality of actuation elements are used to lock a plurality of first anchor locking elements with a plurality of second anchor locking elements to lock the anchor in a fully deployed configuration.

32. The delivery system of claim 26 wherein the expandable anchor comprises a braid.