Low Profile Heart Valve and Delivery System

• US 20120016471A1
• Filed: 09/22/2011
• Published: 01/19/2012
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Brandt, Brian D., Morejohn, Dwight P., Haug, Ulrich R., Dueri, Jean-Pierre, Valencia, Hans F., Geshlider, Robert A., Krolik, Jeff
• Granted Patent: US 8,623,076 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 heart valve comprising a replacement valve and an expandable anchor within a delivery sheath to a vicinity of the heart valve; and

deploying the anchor by applying at least one of a distally directed and proximally directed non-pneumatic and non-hydraulic actuation forces on the replacement heart valve with a delivery tool after the anchor is completely outside of the delivery sheath.

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

3. The method of claim 1 wherein applying at least one of a distally directed and proximally directed non-pneumatic and non-hydraulic force on the replacement heart valve with a delivery tool comprises applying a distally directed non-pneumatic and non-hydraulic actuation force and a proximally directed non-pneumatic and non-hydraulic actuation force on the replacement heart valve with a delivery tool.

4. The method of claim 3 wherein applying a distally directed non-pneumatic and non-hydraulic actuation force on the replacement heart valve comprises applying a distally directed non-pneumatic and non-hydraulic actuation force on the replacement heart valve with a first delivery tool component and wherein applying a proximally directed non-pneumatic and non-hydraulic actuation force on the replacement heart valve comprises applying a proximally directed non-pneumatic and non-hydraulic actuation force on the replacement sent valve with a second delivery tool component.

5. The method of claim 1 wherein applying at least one of a distally directed and proximally directed non-pneumatic and non-hydraulic force on the replacement heart valve with a delivery tool comprises applying a proximally directed non-pneumatic and non-hydraulic actuation force on the replacement heart valve.

6. The method of claim 1 wherein applying only non-radially directed actuation forces on the replacement heart valve with a delivery tool comprises applying only distally directed actuation forces on the replacement heart valve.

7. The method of claim 1 further comprising allowing the anchor to self-expand to a partially expanded configuration outside of the delivery sheath before deploying the anchor by applying at least one of a distally directed and proximally directed non-pneumatic and non-hydraulic force on the replacement heart valve.

8. The method of claim 1 wherein deploying the anchor foreshortens the anchor.

9. The method of claim 1 wherein applying only non-radially directed actuation forces does not comprise expanding a balloon.

10. The method of claim 1 further comprising:

maintaining a reversible coupling between the delivery tool and the replacement heart valve during the delivering step, and

decoupling the delivery tool from the replacement heart valve after the deploying 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 deploying the anchor comprises moving the first anchor locking element towards the second anchor locking element.

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

a replacement heart valve and the expandable anchor are adapted to be delivered within a delivery sheath 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 replacement heart valve, and

wherein the plurality of actuation elements are adapted to apply an axially directed force on the replacement heart valve to deploy the anchor after the anchor is outside of the delivery catheter.

13. The delivery system of claim 12 wherein the plurality of actuation elements are reversibly coupled to the replacement heart valve in both a delivery configuration and an expanded configuration outside of the delivery sheath.

14. The delivery system of claim 12 wherein the delivery tool comprises a first plurality of actuation elements reversibly coupled to a proximal end of the replacement heart valve, wherein the first plurality of actuation elements are adapted to apply a distally directed force on the replacement heart valve after the anchor is outside of the delivery catheter.

15. The delivery system of claim 14 wherein the first plurality of actuation elements assume a radially expanded configuration when the anchor is outside of the delivery catheter.

16. The delivery system of claim 14 wherein the delivery tool comprises a second plurality of actuation elements adapted to apply a proximally directed force on the replacement heart valve after the anchor is outside of the delivery catheter.

17. The delivery system of claim 16 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.

18. The delivery system of claim 12 wherein the expandable anchor comprises a braid.

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

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

deploying the anchor after the anchor is outside of the delivery sheath without applying a radially directed force on the anchor.

20. The method of claim 19 wherein the deploying step comprises applying at least one of a distally directed force on the replacement heart valve and a proximally directed force on the replacement heart valve with a delivery tool.