Methods for ensuring safe and rapid deployment of prosthetic heart valves

1. A method of delivery and implant of a prosthetic heart valve at a valve annulus, comprising:

providing a delivery system including:

a handle shaft having a lumen therethrough; and

an expansion catheter extending through the handle shaft having 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 expandable 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 distal end of the handle shaft so that the heart valve with the expandable 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 expandable frame;

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 having a stationary part that snaps onto a proximal end of a handpiece at the proximal end of the handle shaft 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; and

expanding the balloon to convert the expandable frame from its contracted state to its expanded state.

2. The method of claim 1 , wherein the heart valve mounts to a valve holder attached to the distal end of the handle shaft, the valve holder having a bore, and wherein the balloon is sized to pass through the bore of the valve holder.

3. The method of claim 1 , 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.

4. The method of claim 1 , wherein the heart valve has an inner non-expandable, non-collapsible support structure for flexible leaflets, the expandable frame extending from an inflow end of the support structure.

5. A method of delivery and implant of a prosthetic heart valve at a valve annulus, comprising:

providing a delivery system including:

an elongated handle shaft having a lumen therethrough and a handpiece on the proximal end of the handle shaft;

a balloon catheter extending through the handle shaft lumen having a balloon on a distal end and a proximal end projecting proximally from out of the handle shaft with a luer connector for balloon inflation, the balloon catheter being capable of axial movement relative to the handle shaft; and

a safety member removably engaged between the balloon catheter and the handle shaft and covering the luer connector to prevent balloon inflation prior to removal;

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 and the balloon catheter being axially movable relative to the handle shaft between a retracted position and an advanced position in which the balloon is located within the expandable frame of the heart valve;

advancing the distal end of the handle shaft so that the heart valve with the frame in its contracted state is located at an implant position adjacent the annulus;

displacing the safety member from engagement between the balloon catheter and the handle shaft to expose the luer connector;

attaching a source of fluid to the luer connector;

displacing the balloon catheter distally to its advanced position; and

inflating the balloon to expand the expandable frame.

6. The method of claim 5 , wherein the heart valve mounts to a valve holder attached to the distal end of the handle shaft, the valve holder having a bore, and wherein the balloon is sized to pass through the bore of the valve holder.

7. The method of claim 5 , wherein the heart valve has an inner non-expandable, non-collapsible support structure for flexible leaflets, the expandable frame extending from an inflow end of the support structure.

8. The method of claim 5 , wherein the safety member comprises a locking clip that snaps onto the handpiece at the proximal end of the handle shaft and to the proximal end of the balloon catheter, the locking clip preventing relative balloon catheter and handpiece movement prior to removal.

9. The method of claim 5 , wherein the safety member comprises a safety guard having a stationary part that snaps onto a proximal end of the handpiece at the proximal end of the handle shaft 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.

10. The method of claim 9 , further including cooperating structures on the stationary and movable parts that prevent direct axial balloon catheter advancement until the cooperating structures are disengaged.

11. The method of claim 5 , wherein the safety member comprises a safety guard that snaps onto the proximal end of the balloon catheter and has a toggle lever that pivots to a position between the balloon catheter and the handle shaft, 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.

12. A method of delivery and implant of a prosthetic heart valve at a valve annulus, comprising:

providing a delivery system including:

a handle shaft having a lumen therethrough; and

an expansion catheter extending through the handle shaft having 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 prosthetic valve having a non-expandable, non-collapsible support structure for flexible leaflets and an expandable frame extending from an inflow end of the support structure, the expandable 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 to a valve holder attached to the distal end of the handle shaft so that the expandable frame extends distally therefrom, the valve holder having a bore, and wherein the expandable member is sized to pass through the bore of the valve holder;

advancing the distal end of the handle shaft so that the heart valve with the expandable 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 passes through the valve holder and past the valve leaflets and is located within the expandable frame;

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 having a stationary part that snaps onto a proximal end of a handpiece at the proximal end of the handle shaft 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; and

expanding the balloon to convert the expandable frame from its contracted state to its expanded state.

13. The method of claim 12 , further including cooperating structures on the stationary and movable parts that prevent direct axial balloon catheter advancement until the cooperating structures are disengaged.