Expandable member for deploying a prosthetic device

• US 10,076,412 B2
• Filed: 10/12/2015
• Issued: 09/18/2018
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David M., Marchand, Philippe, Wood, Larry L., Bowes, Robert
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Mendoza, Michael
• Application Number:
  US14/880,616
• Publication Number:
  US 20160030164A1
• Time in Patent Office: 1,072 Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

An apparatus and method for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon.

Claims

1. An apparatus for delivering a prosthetic heart valve through the vasculature of a patient comprising:

an elongate shaft having a proximal end and a distal end;

a radially expandable member disposed on the distal end of the shaft, the radially expandable member comprising a generally cylindrical expandable framework, one or more flexible leaflets, and a plurality of connecting struts coupled to the radially expandable member at attachment areas, wherein;

the radially expandable member comprises a distal end portion and a proximal end portion that are movable relative to one another between a first orientation and a second orientation;

in the first orientation the distal end and proximal end portions are a first distance apart, and in the second orientation the distal end and proximal end portions are a second distance apart, the second distance being less than the first distance; and

movement of the distal end and proximal end portions from the first orientation to the second orientation causes the radially expandable member to expand radially outwards from a first configuration to a second configuration;

a screw mechanism connected to the expandable framework of the expandable member;

an actuator that is coupled to the shaft; and

a gear mechanism connected to and positioned distally of the distal end of the shaft, and configured to transfer rotational movement of the actuator to the screw mechanism such that rotation of the actuator causes rotation of the screw mechanism, wherein the screw mechanism is separate from the actuator and operatively coupled to the actuator by the gear mechanism, and further wherein the rotation of the screw mechanism causes the distal end portion and proximal end portion to move from the first orientation to the second orientation, thereby radially expanding the expandable framework.

2. The apparatus of claim 1, wherein the actuator comprises a DC motor.

3. The apparatus of claim 1, wherein the actuator comprises a knob.

4. The apparatus of claim 1, wherein the screw mechanism comprises a threaded rod engaged with a receptacle located on the distal end portion of the radially expandable member.

5. The apparatus of claim 1, wherein the gear mechanism comprises a gear reduction mechanism coupled to the actuator.

6. The apparatus of claim 5, wherein the gear reduction mechanism is configured to increase the output torque of the actuator.

7. The apparatus of claim 1, wherein the actuator is positioned on or around an external handle member positioned at the proximal end of the shaft.

8. The apparatus of claim 7, wherein the actuator is configured to be manually rotated by a user.

9. The apparatus of claim 7, wherein the external handle comprises visual indicia indicating an amount of radial expansion of the radially expandable member.

10. The apparatus of claim 1, wherein the actuator is positioned at the distal end of the shaft.

11. The apparatus of claim 1 wherein the screw mechanism is configured to apply a first longitudinal force to the proximal end portion of the expandable framework and a second longitudinal force to the distal end portion of the expandable framework upon rotation of the screw mechanism, wherein when the screw mechanism is rotated in a first direction, the first longitudinal force and the second longitudinal force extend in respective directions toward each other and cause the expandable framework to radially expand, and wherein when the screw mechanism is rotated in a second direction, opposite the first direction, the first longitudinal force and the second longitudinal force extend in respective directions away from each other and cause the expandable framework to radially collapse.

12. The apparatus of claim 1, further comprising a wire member connected to the connecting struts, such that the radially expandable member is released by pulling the wire member in a proximal direction.

13. The apparatus of claim 1, further comprising an external handle member positioned at the proximal end of the shaft, the handle member comprising visual indicia corresponding to an amount of radial expansion of the expandable member.

14. The apparatus of claim 1 wherein the screw mechanism is configured such that when the screw mechanism is rotated in a first direction, the rotation in the first direction causes the expandable framework to radially expand, and when the screw mechanism is rotated in a second direction, opposite the first direction, the rotation in the second direction causes the expandable framework to radially collapse.

15. The apparatus of claim 1, wherein the gear mechanism is configured to receive an input torque from the actuator and to rotate the screw mechanism at an output torque different than the input torque.

16. The apparatus of claim 1, wherein the gear mechanism is configured to receive an input speed from the actuator and to rotate the screw mechanism at an output speed different than the input speed.