CRIMPING APPARATUS FOR CRIMPING PROSTHETIC VALVE WITH PROTRUDING ANCHORS

• US 20150336150A1
• Filed: 05/08/2015
• Published: 11/26/2015
• Est. Priority Date: 05/22/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Peterson, Matthew A., Taft, Robert C., Marr, Devin H., Ma, Minh T., Yi, Seung-Beom, Silva, Ryan
• Granted Patent: US 9,757,232 B2
• Time in Patent Office: 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: B21D 11/08 Bending by altering the thickness of part of the cross-section of the work B21D11/06 takes precedence
• CPC Class Codes: B21D 37/00 Tools as parts of machines covered by this subclass forms or constructions of tools uniquely adapted for particular operations, see the relevant groups for the operations
• CPC Class Codes: B21D 39/048 using presses for radially crimping tubular elements

Abstract

Embodiments of an apparatus, and a method for crimping expandable stents or prosthetic valves having a radially expandable and compressible annular body and one or more protruding anchors extending from the body using the apparatus, where the apparatus comprise a housing, a plurality of circumferentially arranged nesting jaws, and an actuator configured to move the jaws radially inwardly to reduce the size of the crimping aperture, thereby radially compressing the annular body of the prosthetic valve or stent. In particular embodiments, a selected set of the jaws, each having a front side and a recessed portion in its front side adjacent to its inner end. The recessed portions of the selected jaws collectively are sized and shaped to receive the one or more anchors of the prosthetic valve when the annular body is positioned within the crimping aperture.

Claims

1. A prosthetic valve crimping apparatus for crimping a prosthetic valve comprising a radially expandable and compressible annular body and two or more protruding anchors extending from the body, the apparatus comprising:

a housing;

a plurality of circumferentially arranged nesting jaws that are radially movable within the housing, each jaw having an inner end that has a partial crimping surface which combines with the same on the other jaws to form a crimping aperture of variable diameter;

a selected set of the jaws each having a front side and a recessed portion in its front side adjacent to its inner end, wherein the recessed portions of the selected jaws collectively are sized and shaped to receive the anchors of the prosthetic valve when the annular body is positioned within the crimping aperture; and

an actuator configured to move the jaws radially inwardly to reduce the size of the crimping aperture, thereby radially compressing the annular body of the prosthetic valve.

2. The apparatus of claim 1, wherein the selected set of the jaws comprises all of the jaws.

3. The apparatus of claim 1, wherein the selected set of the jaws comprises a plurality of groups of jaws that are evenly spaced circumferentially around the crimping aperture.

4. The apparatus of claim 1, wherein the selected set of the jaws comprises two groups of jaws on opposing sides of the crimping aperture.

5. The apparatus of claim 1, wherein the recessed portion of each of the selected jaws is defined by a surface that extends from the front side of the jaw toward back side of the jaw, and wherein an angle between the partial crimping surface and the surface of the recessed portion is between from about 5 to about 85 degrees.

6. The apparatus of claim 5, wherein the angle is between from about 10 to about 70 degrees.

7. The apparatus of claim 1, further comprising a plurality of slidable shielding members disposed within the recessed portions of the selected jaws, each shielding member being sized and shaped to engage one of the anchors of the prosthetic valve when the annular body is positioned within the crimping aperture, each shielding member being configured to move radially inwardly when the actuator is actuated to move the jaws radially inwardly.

8. The apparatus of claim 7, wherein the plurality of shielding members comprise two shielding members on diametrically opposing sides of the crimping aperture.

9. A method for crimping a prosthetic valve comprising a radially expandable and compressible annular body and two or more protruding anchors extending from the body, the method comprising:

placing the annular body in a crimping aperture formed by a plurality of circumferentially arranged jaws;

locating the protruding anchors in recessed portions of a selected set of the jaws, the recessed portions being formed in the front sides of the jaws of the selected set of the jaws, the recessed portions being outside of the crimping aperture; and

crimping the annular body with the jaws.

10. The method of claim 9, wherein the jaws are radially movable, and crimping the annular body comprises moving the jaws radially inwardly against the annular body.

11. The method of claim 9, wherein locating the protruding anchors in the recessed portions comprises placing each protruding anchor against a slidable shielding member disposed in the recessed portions.

12. The method of claim 9, wherein the annular body has an outer surface, and the protruding anchors and the outer surface of the annular body define an angle therebetween, and the act of locating the protruding anchors in the recessed portions of the selected set of jaws comprises positioning the protruding members relative to the annular body such that such that the angle between the protruding anchors and the outer surface of the annular body is less than about 90 degrees.

13. The method of claim 12, wherein the angle is between from about 10 to about 70 degrees.

14. The method of claim 9, further comprising loading the prosthetic valve onto a delivery device after crimping.

15. The method of claim 14, wherein the act of loading the prosthetic valve onto a delivery device comprises inserting the annular body into an inner sheath of the delivery device and inserting the anchors into an outer sheath of the delivery device, the outer sheath extending coaxially over the inner sheath.

16. The method of claim 9, further comprising inserting a portion of a crimping accessory tool into space between the annular body and leaflets supported inside of the annular body before the act of crimping the annular body with the jaws.

17. A prosthetic valve crimping apparatus for crimping a prosthetic valve comprising a radially expandable and compressible annular body and two or more protruding anchors extending from the body, the apparatus comprising:

crimping means for crimping the annular body to a radially compressed state while retaining the anchors of the prosthetic valve at an angle less than about 90 degrees relative to the annular body such that a crimping force is applied only to the annular body; and

actuating means for moving the crimping means radially inwardly, thereby crimping the annular body without crimping the protruding anchors.

18. The apparatus of claim 17, wherein the crimping means comprises a plurality of circumferentially arranged jaws defining a variable crimping aperture for receiving the annular body of the prosthetic valve.

19. The apparatus of claim 18, wherein a selected set of the jaws each has a front side, an inner end and a recessed portion in the front side adjacent to the inner end, and wherein the recessed portions collectively are sized and shaped to receive the anchors at an angle of less than 90 degrees relative to the annular body.

20. The apparatus of claim 18, further comprising means for preventing the protruding anchors from contacting the jaws during crimping.