Transcatheter prosthetic heart valve delivery device with release features

• US 9,301,839 B2
• Filed: 03/07/2013
• Issued: 04/05/2016
• Est. Priority Date: 04/17/2012
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Stante, Glenn, Barrett, Donna, Duffy, Niall, Yeung, Hubert, Shipley, Adam, Dwork, Joshua
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US13/787,937
• Publication Number:
  US 20130274855A1
• Time in Patent Office: 1,125 Days
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes at least one release feature for releasing the stented prosthetic heart valve from the delivery device.

Claims

1. A delivery device for percutaneously deploying a stented prosthetic heart valve including a stent frame to which a valve structure is attached, the device comprising:

a delivery sheath assembly terminating at a distal end and defining a lumen;

an inner shaft slidably disposed within the lumen; and

a capture assembly for selectively coupling the stented prosthetic heart valve relative to the inner shaft, the capture assembly comprising;

a spindle attached to the inner shaft and including at least one coupling section defining a slot; and

a biasing member positioned in the slot and configured to transition from a deflected condition to a normal condition, wherein the biasing member includes a fixed end and a free end rotatable about the fixed end, a radial projection of the free end relative to a centerline of the inner shaft is greater in the normal condition than in the deflected condition,

wherein the delivery device is configured to provide;

a delivery state in which the delivery sheath assembly retains the stented prosthetic heart valve over the inner shaft and the biasing member in the deflected condition, including a portion of the stented prosthetic heart valve engaged with the at least one coupling section and the biasing member forced to the deflected condition; and

a deployment state in which the distal end of the delivery sheath assembly is withdrawn from covering at least a portion of the capture assembly, wherein the biasing member transitions to the normal condition such that the free end rotates about the fixed end to radially deflect the stent frame, and wherein the biasing member further includes an intermediate region positioned between the free end and the fixed end, wherein the intermediate region projects radially to a greater distance from the centerline than the fixed end in the normal and deflected conditions.

2. The device of claim 1, wherein the spindle includes two coupling sections and wherein the capture assembly includes two biasing members positioned within the two coupling sections.

3. The device of claim 1, wherein the intermediate region forms a hump between the fixed end and the free end.

4. The device of claim 1, wherein a post of the stented prosthetic heart valve is positioned between the biasing member and the outer sheath assembly when the device is in the delivery state.

5. The device of claim 1, further comprising:

an alignment member selectively coupled with the spindle, the alignment member including features to align the spindle with the biasing member.

6. The device of claim 1, further comprising:

a coupling member comprising a spring member positioned between the shaft and the spindle and wherein, in transition from the delivery state to the deployment state, the coupling member moves relative to the at least one coupling section and releases the biasing member from the at least one coupling section.

7. The device of claim 1, wherein the capture assembly includes multiple biasing members connected together at respective fixed ends to a ring, the biasing members positioned with respect to one another in a staggered relationship such that each biasing member extends from the ring and terminates at a free end at a different length from the ring.

8. A system for restoring a defective heart valve of a patient, the system comprising:

a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the stent frame defining a distal region and a proximal region, the proximal region forming at least one post; and

a delivery device, comprising;

a delivery sheath assembly terminating at a distal end and defining a lumen;

an inner shaft slidably disposed within the lumen; and

a capture assembly for selectively coupling the prosthetic heart valve relative to the inner shaft, the capture assembly comprising;

a spindle attached to the inner shaft and including at least one coupling section defining a slot; and

a biasing member positioned in the slot and configured to transition from a deflected condition to a normal condition, wherein the biasing member includes a fixed end and a free end rotatable about the fixed end, a radial projection of the free end relative to a centerline of the inner shaft is greater in the normal condition than in the deflected condition,

wherein the delivery device is configured to provide;

a delivery state in which the delivery sheath assembly retains the prosthetic heart valve over the inner shaft and the biasing member in the deflected condition, including a portion of the prosthetic heart valve engaged with the at least one coupling section and the biasing member forced to the deflected condition; and

a deployment state in which the distal end of the delivery sheath assembly is withdrawn from covering at least a portion of the capture assembly, wherein the biasing member transitions to the normal condition such that the free end rotates about the fixed end to radially deflect the stent frame, and wherein the biasing member further includes an intermediate region positioned between the free end and the fixed end, wherein the intermediate region projects radially to a greater distance from the centerline than the fixed end in the normal and deflected conditions.

9. The system of claim 8, wherein the spindle includes two coupling sections and wherein the capture assembly includes two biasing members positioned within the two coupling sections.

10. The system of claim 8, wherein the intermediate region forms a hump between the fixed end and the free end.

11. The system of claim 8, wherein the at least one post of the prosthetic heart valve is positioned between the biasing member and the outer sheath assembly when the device is in the delivery state.

12. The system of claim 8, further comprising:

an alignment member selectively coupled with the spindle, the alignment member including features to align the spindle with the biasing member.

13. The system of claim 8, further comprising:

a coupling member comprising a spring member positioned between the shaft and the spindle and wherein, in transition from the delivery state to the deployment state, the coupling member moves relative to the at least one coupling section and releases the biasing member from the at least one coupling section.

14. The system of claim 8, wherein the capture assembly includes multiple biasing members connected together at respective fixed ends to a ring, the biasing members positioned with respect to one another in a staggered relationship such that each biasing member extends from the ring and terminates at a free end at a different length from the ring.