Method of using a retrievable heart valve anchor with a sheath

• US 8,603,160 B2
• Filed: 12/23/2003
• Issued: 12/10/2013
• 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: Salahieh, Amr, Brandt, Brian D., Morejohn, Dwight P., Haug, Ulrich R., Dueri, Jean-Pierre, Valencia, Hans F., Geshlider, Robert A., Krolik, Jeff
• Primary Examiner(s): Pellegrino, Brian E.
• Application Number:
  US10/746,285
• Publication Number:
  US 20050137689A1
• Time in Patent Office: 3,640 Days
• Field of Search: 606/99, 623/2.11, 623/2.14, 623/2.17, 623/1.23, 623/1.26, 623/1.36, 623/900, 623/1.11, 623/904
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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 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

A method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor in an unexpanded configuration within a catheter to a vicinity of the heart valve; deploying the anchor from the catheter; expanding the anchor to contact tissue at an anchor site; and retrieving the anchor into the catheter. The invention also includes an apparatus for endovascularly replacing a heart valve, including: a catheter; a replacement valve configured to be disposed within the catheter for delivery to a vicinity of the heart valve; and an expandable anchor configured to be disposed within the catheter for delivery to a vicinity of the heart valve, to be deployed from the catheter, to be expanded to contact tissue at an anchor site and to be retrieved back into the catheter after having been expanded.

Claims

1. A method for endovascularly positioning a replacement heart valve of a patient, the method comprising:

endovascularly delivering to a vicinity of the patient'"'"'s heart valve a replacement heart valve comprising replacement leaflets coupled to an expandable anchor, the expandable anchor in an unexpanded configuration within a sheath, wherein the expandable anchor comprises a skirt region opposite a lip region;

releasing the anchor from the sheath;

deploying the anchor at a first position by applying at least one of a distally directed force to the lip region of the anchor with a plurality of tubes and simultaneously a proximally directed force to the skirt region of the anchor with a plurality of wires after the anchor is completely out of the delivery sheath, wherein the applied forces are non-hydraulic and non-pneumatic actuation forces;

retrieving the anchor into the sheath after the deploying at a first position step; and

repositioning the valve by releasing the anchor from the sheath and deploying the anchor at a second position.

2. The method of claim 1 wherein the retrieving step comprises contracting the anchor.

3. The method of claim 2 wherein the contracting step comprises applying an actuation force on the anchor.

4. The method of claim 3 wherein the applying step comprises applying a proximally directed force on the anchor.

5. The method of claim 2 wherein the anchor comprises a skirt region opposite a lip region, the contracting step comprising contracting the anchor'"'"'s skirt region apart from the anchor'"'"'s lip region.

6. The method of claim 1 wherein the anchor comprises a skirt region opposite a lip region, the deploying step comprising expanding the anchor'"'"'s skirt region apart from the anchor'"'"'s lip region.

7. The method of claim 1 wherein the delivering step comprises endovascularly delivering the replacement heart valve within a sheath having a diameter no more than 21 french.

8. The method of claim 1 wherein the replacement heart valve is an aortic valve, the delivering step comprising endovascularly delivering the replacement heart valve along a retrograde approach.

9. The method of claim 1 wherein releasing the anchor from the sheath comprises expanding the anchor from the unexpanded configuration to a partially deployed configuration outside of the sheath when the valve is completely outside of the sheath.

10. The method of claim 1 wherein the tubes and wires are reversibly coupled to the anchor, and applying at least one of a distally directed and proximally directed non-hydraulic and non-pneumatic actuation force on the anchor comprises applying at least one of a distally directed and proximally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a first plurality of actuation elements which are reversibly coupled to the replacement heart valve.

11. The method of claim 10 wherein the tubes and wires are reversibly coupled to the anchor, and applying at least one of a distally directed and proximally directed non-hydraulic and non-pneumatic actuation force on the anchor comprises applying a distally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a first plurality of actuation elements which are reversibly coupled to the replacement heart valve and a proximally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a second plurality of actuation elements which are reversibly coupled to the replacement heart valve.

12. The method of claim 1 wherein the deploying step comprises expanding the replacement heart valve from a partially expanded configuration to a fully deployed configuration when the valve is completely out of the sheath.

13. The method of claim 1 wherein the deploying step comprises shortening the replacement heart valve from a partially deployed configuration to a fully deployed configuration when the valve is completely out of the sheath.