Method of crimping a prosthetic valve

• US 7,895,876 B2
• Filed: 10/05/2006
• Issued: 03/01/2011
• Est. Priority Date: 09/09/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel, Spenser, Benjamin
• Primary Examiner(s): Sullivan; Debra M
• Application Number:
  US11/544,822
• Publication Number:
  US 20070061009A1
• Time in Patent Office: 1,608 Days
• Field of Search: 724/02, 724/16, 724/521, 724/528, 72/310.6, 72/310.1, 72/186, 724/529, 724/821, 724/651, 724/668, 335551-5554
• US Class Current: 72/402
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• 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: B25B 27/10 inserting fittings into hoses
• CPC Class Codes: B30B 7/04 wherein pressing is effected in different directions simultaneously or in turn

Abstract

An improved crimping mechanism and method well-suited for use with stented prosthetic heart valves. The crimping mechanism includes a plurality of jaws configured for linear non-rotational movement toward a central axis. A rotational plate is formed with a plurality of spiral grooves or tracks for engaging the jaws. Rotational movement of the spiral tracks produces linear movement of the jaws. Nesting of the inner ends of the jaws permits each to be acted on along different radial lines while their inner faces move together evenly to reduce the crimping aperture in a smooth fashion. The crimping mechanism is particularly well-suited for use with stented prosthetic heart valves, such as a prosthetic aortic valve, though it can also be applied to other stented heart valves, venous valves, and even stent grafts which tend to be fairly large.

Claims

1. A method of crimping a prosthetic valve, comprising:

providing a prosthetic valve crimping device having a plurality of rotationally constrained but radially movable jaws each having at least one camming member and a radially inner face such that the combination of all the radially inner faces defines a variable sized crimping aperture centered about a central axis, the crimping device further including an actuator connected to move a plurality of cams comprising spiral tracks each centered around the central axis that receive the jaw camming members;

positioning an expandable prosthetic valve within the crimping aperture, the prosthetic valve having an expanded diameter of at least 19 mm;

displacing the actuator such that the moving cams contact the at least one camming member on each jaw and apply radially inward forces to the jaws sufficient to narrow the crimping aperture and crimp the prosthetic valve down to a desired reduced diameter of at least 10 mm less than its expanded diameter; and

removing the crimped prosthetic valve from the crimping aperture and passing it through a prosthetic valve gauge attached to the prosthetic valve crimping device having a throughbore calibrated to the desired reduced diameter to ensure that the prosthetic valve has been crimped to the desired reduced diameter.

2. The method of claim 1, wherein the spiral tracks overlap one another.

3. The method of claim 2, wherein the actuator comprises a handle that rotates about the central axis, and the spiral tracks each extend around the central axis through an angle of at least 360°

, and the method includes rotating the handle at least 270°

.

4. The method of claim 1, wherein the actuator comprises a handle that rotates about the central axis, and the spiral tracks are formed on a rotatable camming plate, and the method comprises rotating the handle to rotate the camming plate.

5. The method of claim 1, wherein each jaw has at least two camming members extending on opposite sides of the jaw in axially opposite directions, wherein the plurality of cams comprises at least one cam on each axial side of the jaws, the method including applying radially inward forces with the at least one cam on each axial side of the jaws contacting the camming members on both sides of the jaws.

6. The method of claim 1, wherein the prosthetic valve comprises a prosthetic heart valve having an expanded diameter of between 19-29 mm, and wherein the method includes reducing the expanded prosthetic heart valve diameter by between about 14-24 mm.

7. The method of claim 1, wherein the prosthetic valve comprises a prosthetic heart valve having a balloon-expandable frame supporting a plurality of flexible leaflets within, the method including positioning the expanded prosthetic heart valve around a balloon on a balloon catheter prior to inserting the prosthetic heart valve into the crimping aperture and crimping the prosthetic heart valve over the balloon.

8. A method of crimping a prosthetic valve, comprising:

providing a disposable, portable crimping system for prosthetic valves, comprising a base, a valve crimper mounted on the base having a plurality of movable jaws defining a crimping aperture of variable diameter, and a prosthetic valve gauge mounted on the base having a tapered throughbore with a minimum diameter calibrated to be the same as a minimum diameter of the crimping aperture;

positioning an expandable prosthetic valve having an expanded diameter of at least 19 mm within the crimping aperture;

actuating the valve crimper jaws to narrow the crimping aperture and crimp the prosthetic valve down to the minimum diameter of at least 10 mm less than the expanded diameter; and

removing the crimped prosthetic valve from the crimping aperture and inserting it into the prosthetic valve gauge to ensure that the prosthetic valve has been crimped to the minimum reduced diameter.

9. The method of claim 8, wherein the prosthetic valve comprises a prosthetic heart valve having an expanded diameter of between 19-29 mm, and wherein the method includes reducing the prosthetic heart valve diameter by between about 14-24 mm.

10. The method of claim 9, wherein the prosthetic heart valve includes a balloon-expandable frame supporting a plurality of flexible leaflets within, the method including positioning the expanded prosthetic heart valve around a balloon on a balloon catheter prior to inserting the prosthetic heart valve into the crimping aperture and crimping the prosthetic heart valve over the balloon.

11. The method of claim 10, wherein the crimping system further includes a balloon gauge mounted on the base having a throughbore, and wherein prior to crimping the prosthetic heart valve the method includes expanding the balloon on the balloon catheter within the balloon gauge throughbore and calibrating the amount of inflation fluid necessary to inflate the balloon within the balloon gauge.

12. The method of claim 8, wherein the crimping system further includes a stop member removably mounted on the valve crimper so as to limit the minimum diameter of the crimping aperture.

13. The method of claim 8, wherein the movable jaws are radially movable relative to a central axis and each jaw has a radially inner face such that the combination of all the radially inner faces defines the variable diameter crimping aperture centered about the central axis, and wherein each jaw has at least one camming member and the valve crimper includes a rotating plate with spiral tracks each centered around the central axis that receive the jaw camming members, and the step of actuating the valve crimper jaws includes rotating the rotating plate to apply force with the spiral tracks to the jaw camming members.

14. The method of claim 8, wherein the movable jaws are radially movable relative to a central axis and each jaw has at least two camming members extending on opposite sides of the jaw in axially opposite directions, and the valve crimper includes two rotating plates, one on each axial side of the jaws, each plate having cam tracks each centered around the central axis which receive the jaw camming members, and the step of actuating the valve crimper jaws includes rotating the rotating plates to apply force with the cam tracks to the jaw camming members.

15. A method of crimping a prosthetic valve, comprising:

providing a prosthetic valve crimping device having a plurality of rotationally constrained but radially movable jaws each having at least one camming member and a radially inner face such that the combination of all the radially inner faces defines a variable sized crimping aperture centered about a central axis, the crimping device further including an actuator connected to move a plurality of cams;

positioning an expandable prosthetic valve within the crimping aperture, the prosthetic valve having an expanded diameter of at least 19 mm; and

displacing the actuator such that the moving cams contact at least one camming member on each jaw and apply radially inward forces to the jaws sufficient to narrow the crimping aperture and crimp the prosthetic valve down to a reduced diameter of at least 10 mm less than its expanded diameter,

wherein the prosthetic valve comprises a prosthetic heart valve having a balloon-expandable frame supporting a plurality of flexible leaflets within, the method including positioning the expanded prosthetic heart valve around a balloon on a balloon catheter prior to inserting the prosthetic heart valve into the crimping aperture and crimping the prosthetic heart valve over the balloon, and

wherein prior to crimping the prosthetic heart valve the method includes expanding the balloon on the balloon catheter within a balloon gauge attached to the crimping device to calibrate the amount of inflation fluid necessary to inflate the balloon within the balloon gauge.

16. A method of crimping a prosthetic valve, comprising:

providing a prosthetic valve crimping device having a plurality of rotationally constrained but radially movable jaws each having at least one camming member and a radially inner face such that the combination of all the radially inner faces defines a variable sized crimping aperture centered about a central axis, the crimping device further including an actuator connected to move a plurality of cams;

positioning an expandable prosthetic valve within the crimping aperture, the prosthetic valve having an expanded diameter of at least 19 mm;

displacing the actuator such that the moving cams contact the at least one camming member on each jaw and apply radially inward forces to the jaws sufficient to narrow the crimping aperture and crimp the prosthetic valve down to a desired reduced diameter of at least 10 mm less than its expanded diameter; and

removing the crimped valve from the crimping aperture and passing it through a prosthetic valve gauge attached to the prosthetic valve crimping device having a throughbore calibrated to the desired reduced diameter to ensure that the prosthetic valve has been crimped to the desired reduced diameter.