SYSTEMS AND METHODS FOR ENSURING SAFE AND RAPID DEPLOYMENT OF PROSTHETIC HEART VALVES

• US 20130245751A1
• Filed: 03/12/2013
• Published: 09/19/2013
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Phung, Andrew, Yambao, August R., Kalam, Faisal, Brunnett, William C., Pintor, Rafael, Scott, Michael J.
• Granted Patent: US 9,125,741 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: G06F 18/2148 characterised by the process organisation or structure, e.g. boosting cascade
• CPC Class Codes: G06F 40/169 Annotation, e.g. comment data or footnotes
• CPC Class Codes: G06N 3/08 Learning methods
• CPC Class Codes: G06V 10/25 Determination of region of interest [ROI] or a volume of interest [VOI]

Abstract

A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve may include a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A system and method for deployment includes an integrated handle shaft and balloon catheter. A safety member disposed between the balloon catheter and handle shaft prevents premature catheter advancement prior to heart valve placement at the annulus, and also may prevent premature balloon inflation prior to full catheter advancement.

Claims

1. A system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve having an expandable frame, the frame having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the annulus;

a valve holder attached to the heart valve and having a bore;

an elongated handle shaft attached to a proximal end of the valve holder and having a lumen, a proximal end of the handle shaft having a handpiece;

an expansion catheter extending through the handle shaft lumen and having an expandable member on a distal end sized to pass through the bore of the valve holder and a proximal end projecting proximally from out of the handpiece, the expansion catheter being axially movable relative to the handle shaft between a retracted position and an advanced position in which the expandable member is located within the expandable frame of the heart valve; and

a safety member engaged between the expansion catheter and the handle shaft and preventing distal movement of the expansion catheter from its retracted position.

2. The system of claim 1, wherein the heart valve has an inner frame assembly defining a non-expandable, non-collapsible orifice, the expandable frame extending from an inflow end thereof.

3. The system of claim 1, wherein the expansion catheter is a balloon catheter and the expandable member is a balloon.

4. The system of claim 1, wherein the safety member comprises a locking clip that snaps onto the handpiece and proximal end of the expansion catheter, the locking clip preventing relative balloon catheter handpiece movement prior to removal.

5. The system of claim 4, wherein the expansion catheter is a balloon catheter and the expandable member is a balloon, and wherein a proximal end of the balloon catheter has a luer connector, the locking clip covering the luer connector and preventing balloon inflation prior to removal.

6. The system of claim 1, wherein the expansion catheter is a balloon catheter and the expandable member is a balloon, and a proximal end of the balloon catheter has a luer connector, and wherein the safety member comprises a safety guard that snaps onto a proximal end of the balloon catheter and has a toggle lever that pivots to a position between the balloon catheter and the proximal end of the handpiece, wherein outward pivoting of the toggle lever permits distal movement of the balloon catheter, and distal movement of the balloon catheter and attached safety guard enables removal of the safety guard so as to prevent balloon inflation prior to distal movement of the balloon catheter.

7. The system of claim 1, wherein the safety member comprises a safety guard having a stationary part that snaps onto a proximal end of the handpiece and a movable part that forms the proximal end of the balloon catheter and has the luer connector, and wherein an elongated arm on the stationary part terminates in a luer guard that receives the luer connector in the retracted position of the balloon catheter and prevents coupling of a mating luer connector of a fluid source thereto, wherein distal movement of the balloon catheter and movable part exposes the luer connector to permit coupling of a mating luer connector.

8. The system of claim 7, further including cooperating structures on the stationary and movable parts that prevent direct axial balloon catheter advancement until the cooperating structures are disengaged.

9. A system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve having an inner frame assembly defining a non-expandable, non-collapsible orifice, the heart valve further including an expandable frame extending from an inflow end thereof, the expandable frame having a contracted state for delivery to an implant position and an expanded state;

a valve holder attached to the heart valve and having a bore;

an integrated assembly of a handle shaft and balloon catheter, including;

a handle shaft having a handpiece on a proximal end and a distal adapter configured to mate with a proximal end of the valve holder, wherein the axial positions of the handpiece and adapter are fixed, the handle shaft and handpiece defining a handle lumen;

a balloon catheter having a balloon received within the handle lumen and the catheter having a proximal balloon displacer for manually displacing the catheter relative to the handle lumen and a proximal luer connector for attaching a fluid fill tube to inflate the balloon, wherein the balloon catheter has two primary positions relative to the handpiece—

a retracted position wherein the balloon displacer is spaced from the handpiece and the balloon resides partly within the handle shaft adapter and an advanced position where the balloon displacer engages the handpiece and the balloon extends distally from the handle shaft adapter and is positioned within the expandable frame; and

a safety member engaged between the balloon catheter and the handpiece and preventing distal movement of the balloon catheter from its retracted position.

10. The system of claim 9, wherein the safety member comprises a locking clip that snaps onto the handpiece and the proximal end of the balloon catheter, the locking clip covering the luer connector and preventing relative movement between the balloon catheter and handpiece prior to removal.

11. The system of claim 9, wherein the locking clip covers the luer connector and prevents balloon inflation prior to removal.

12. The system of claim 9, wherein the safety member comprises a safety guard that snaps onto a proximal end of the balloon catheter and has a toggle lever that pivots to a position between the balloon catheter and the proximal end of the handpiece, wherein outward pivoting of the toggle lever permits distal movement of the balloon catheter, and distal movement of the balloon catheter and attached safety guard enables removal of the safety guard so as to prevent balloon inflation prior to distal movement of the balloon catheter.

13. The system of claim 9, wherein the safety member comprises a safety guard having a stationary part that snaps onto a proximal end of the handpiece and a movable part that forms the proximal end of the balloon catheter and has the luer connector, and wherein an elongated arm on the stationary part terminates in a luer guard that receives the luer connector in the retracted position of the balloon catheter and prevents coupling of a mating luer connector of a fluid source thereto, wherein distal movement of the balloon catheter and movable part exposes the luer connector to permit coupling of a mating luer connector.

14. The system of claim 13, further including cooperating structures on the stationary and movable parts that prevent direct axial balloon catheter advancement until the cooperating structures are disengaged.

15. A method of delivery and implant of a prosthetic heart valve, comprising:

providing a delivery system including a handle shaft having a lumen therethrough, and wherein an expansion catheter extends through the handle shaft and has an expandable member on a distal end and a proximal end projecting proximally from out of the handle shaft, the expansion catheter being capable of linear movement relative to the handle shaft;

providing a heart valve including a prosthetic valve having an expandable frame, the frame having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the annulus, the heart valve being mounted on the distal end of the handle shaft;

advancing the delivery system so that the heart valve with the frame in its contracted state is located at an implant position adjacent the annulus;

displacing a safety member from engagement between a portion of the expansion catheter that projects from the handle shaft and a proximal end of the handle shaft, the safety member preventing distal movement of the expansion catheter relative to the handle shaft prior to displacement;

displacing the expansion catheter distally so that the expandable member is located within the heart valve frame; and

expanding the expandable member to expand the frame.

16. The method of claim 15, wherein the safety member comprises a locking clip that snaps onto the handpiece and proximal end of the expansion catheter, the locking clip and preventing relative balloon catheter handpiece movement prior to removal, the method including removing the locking clip prior to the step of displacing the expansion catheter distally.

17. The method of claim 16, wherein the expansion catheter is a balloon catheter and the expandable member is a balloon, and wherein a proximal end of the balloon catheter has a luer connector, the locking clip covering the luer connector and preventing balloon inflation prior to removal, the method including removing the locking clip prior to the step of displacing the expansion catheter distally and displacing the expansion catheter distally prior to inflating the balloon.

18. The method of claim 15, wherein the expansion catheter is a balloon catheter and the expandable member is a balloon, and a proximal end of the balloon catheter has a luer connector, and wherein the safety member comprises a safety guard that snaps onto a proximal end of the balloon catheter and has a toggle lever that pivots to a position between the balloon catheter and the proximal end of the handpiece, wherein outward pivoting of the toggle lever permits distal movement of the balloon catheter, and distal movement of the balloon catheter and attached safety guard enables removal of the safety guard so as to prevent balloon inflation prior to distal movement of the balloon catheter, the method including pivoting outward the toggle lever prior to the step of displacing the expansion catheter distally and displacing the expansion catheter distally and removing the safety guard prior to inflating the balloon.

19. The method of claim 15, wherein the safety member comprises a safety guard having a stationary part that snaps onto a proximal end of the handpiece and a movable part that forms the proximal end of the balloon catheter and has the luer connector, and wherein an elongated arm on the stationary part terminates in a luer guard that receives the luer connector in the retracted position of the balloon catheter and prevents coupling of a mating luer connector of a fluid source thereto, wherein distal movement of the balloon catheter and movable part exposes the luer connector to permit coupling of a mating luer connector, the method including advancing the balloon catheter and movable part prior to inflating the balloon.

20. The method of claim 19, further including cooperating structures on the stationary and movable parts that prevent direct axial balloon catheter advancement until the cooperating structures are disengaged, the method including disengaging the cooperating structures prior to the step of displacing the balloon catheter distally.