Low profile heart valve and delivery system

• US 9,277,991 B2
• Filed: 12/31/2013
• Issued: 03/08/2016
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (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 A.
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US14/144,916
• Publication Number:
  US 20140114406A1
• Time in Patent Office: 798 Days
• US Class Current: 1/1
• 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 delivery system for endovascularly replacing a heart valve of a patient, comprising:

a replacement heart valve and an 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 sheath, and the anchor is adapted to be foreshortened and to self-expand to a partially expanded configuration outside of the delivery sheath.

2. The delivery system of claim 1 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.

3. The delivery system of claim 1 wherein the plurality of actuation elements are adapted to assume a radially expanded configuration when the anchor is outside of the delivery sheath.

4. The delivery system of claim 1 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 sheath.

5. The delivery system of claim 1 wherein the anchor is adapted to radially expand.

6. The delivery system of claim 1, wherein the expandable anchor comprises a braid.

7. The delivery system of claim 1, wherein the expandable anchor comprises a first anchor locking element and a second anchor locking element, wherein at least one of the first and second anchor locking elements is movable to decrease the distance between the first and second locking elements.

8. The delivery system of claim 7, wherein the first anchor locking element comprises a male interlocking element extending from a skirt region of the anchor and the second anchor locking element comprises a female interlocking element that is adapted to interlock with the male interlocking element.

9. The delivery system of claim 8, wherein the male interlocking element defines an eyelet structured to receive at least one of the plurality of actuation elements therethrough.

10. The delivery system of claim 8, wherein the female interlocking element is located at or near a lip region of the anchor, the lip region located proximal of the skirt region.

11. The delivery system of claim 1, wherein at least one of the plurality of actuation elements comprises a wire extending through an eyelet in a reversible coupling.

12. The delivery system of claim 1, further comprising barb elements protruding from anchor 30.

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

a replacement heart valve and an expandable anchor are adapted to be delivered within a delivery sheath to a vicinity of the heart valve; and

a first actuation element adapted to apply an axial directed force on the replacement heart valve to deploy the anchor after the anchor is outside of the delivery sheath;

wherein the first actuation element is reversibly coupled to the replacement heart valve, and further comprising a second actuation element adapted to apply a proximally directed force on the replacement heart valve to deploy the anchor after the anchor is outside of the delivery sheath.

14. The delivery system of claim 13 wherein the first actuation element is reversibly coupled to the replacement heart valve in both a delivery configuration and an expanded configuration outside of the delivery sheath.

15. The delivery system of claim 13 wherein the first actuation element is reversibly coupled to a proximal end of the replacement heart valve.

16. The delivery system of claim 13 wherein the anchor is adapted to self-expand to a partially expanded configuration outside of the delivery sheath.

17. The delivery system of claim 16, wherein the anchor is adapted to be foreshortened.

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

a replacement heart valve and an expandable anchor are adapted to be delivered within a delivery sheath to a vicinity of the heart valve;

a delivery tool comprising a first delivery tool component and a second delivery tool component, the delivery tool being reversibly coupled to the replacement heart valve, and

wherein the first and second delivery tool components are adapted to apply a distally directed and an axially directed force, respectively, on the replacement heart valve to deploy the anchor after the anchor is outside of the delivery sheath, and the anchor is adapted to be foreshortened and to self-expand to a partially expanded configuration outside of the delivery sheath.

19. The delivery system of claim 18, further comprising a second actuation element adapted to apply a proximally directed force on the replacement heart valve to deploy the anchor after the anchor is outside of the delivery sheath.

20. The delivery system of claim 18, wherein the delivery tool is adapted to simultaneously apply the distally directed and axially directed forces on the replacement heart valve.