Leaflet engagement elements and methods for use thereof

• US 7,748,389 B2
• Filed: 10/21/2004
• Issued: 07/06/2010
• 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: Gleshlider, Robert A., Morejohn, Dwight P., Brandt, Brian D., Salahieh, Amr, Saul, Tom
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): STRASZHEIM, REBECCA L
• Application Number:
  US10/972,287
• Publication Number:
  US 20050137698A1
• Time in Patent Office: 2,084 Days
• Field of Search: 623/1.28, 623/1.24, 623/1.26, 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19, 623/2.38, 623/2.39, 623/2.4
• US Class Current: 128/898
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2250/006 modular

Abstract

The present invention relates to apparatus for methods for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes an expandable anchor with leaflet engagement elements on the proximal end of the anchor and a replacement valve. The leaflet engagement elements can be used to prevent distal migration and insure proper positioning of the apparatus.

Claims

1. A method for endovascularly replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable anchor and a replacement valve to a vicinity of the native heart valve, wherein leaflet engagement elements extend distally from a proximal region of the anchor;

sandwiching native valve leaflets between the distally extending leaflet engagement elements and the anchor; and

expanding the anchor from a collapsed delivery configuration to an expanded configuration;

positioning a proximal end of the anchor further from a left ventricle than a distal end of the anchor,

wherein the replacement valve allows the flow of blood through the replacement valve in a first configuration and prevents the flow of blood through the valve in a second configuration.

2. A method for endovascularly replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable anchor and a replacement valve to a vicinity of the native heart valve, wherein leaflet engagement elements extend distally from a first end of the anchor;

sandwiching native valve leaflets between the distally extending leaflet engagement elements and the anchor; and

expanding the anchor from a collapsed delivery configuration to an expanded configuration;

positioning the first end of the anchor further from a left ventricle than a second end of the anchor,

wherein the replacement valve allows the flow of blood through the replacement valve in a first configuration and prevents the flow of blood through the valve in a second configuration.

3. A method for endovascularly replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable anchor and a replacement valve to a vicinity of the native heart valve, wherein leaflet engagement elements extend distally from a proximal end of the anchor;

sandwiching native valve leaflets between the distally extending leaflet engagement elements and the anchor; and

expanding the anchor from a collapsed delivery configuration to an expanded configuration to secure the anchor within the native heart valve;

positioning the proximal end of the anchor further from a left ventricle than a distal end of the anchor,

wherein the replacement valve allows the flow of blood through the replacement valve in a first configuration and prevents the flow of blood through the valve in a second configuration.

4. The method of claim 3 wherein expanding the anchor from a collapsed delivery configuration to an expanded configuration comprises allowing the anchor to self-expand to thereby sandwich the native valve leaflets between the distally extending leaflet engagement elements and the anchor.

5. The method of claim 3 wherein the leaflet engagement elements extend generally parallel to the longitudinal axis of the expandable anchor when the anchor is in the expanded configuration.

6. The method of claim 3 wherein the expandable anchor and the replacement valve are delivered as two separate elements, the method further comprising deploying the expandable anchor and the replacement valve in the vicinity of the native heart valve in two different steps.

7. The method of claim 6 further comprising engaging the expandable anchor and the replacement valve after they are deployed in the vicinity of the native heart valve to secure the replacement heart valve to the expandable anchor.

8. The method of claim 7 wherein the replacement heart valve comprises an expandable support structure and replacement valve leaflets, and wherein engaging the expandable anchor and the replacement valve in the vicinity of the native heart valve comprises coupling the expandable anchor and the expandable support structure to secure the replacement heart valve to the expandable anchor.