METHODS FOR ENSURING SAFE AND RAPID DEPLOYMENT OF PROSTHETIC HEART VALVES
First Claim
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; and
actuating the expandable member to convert the expandable frame from its contracted state to its expanded state.
1 Assignment
0 Petitions
Accused Products
Abstract
Methods of quickly and easily implanting a quick-connect heart valve prosthesis during a surgical procedure are 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.
3 Citations
20 Claims
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1. A method of delivery and implant of a prosthetic heart valve at a valve annulus, comprising:
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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; and actuating the expandable member to convert the expandable frame from its contracted state to its expanded state. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of delivery and implant of a prosthetic heart valve at a valve annulus, comprising:
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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. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A method of delivery and implant of a prosthetic heart valve at a valve annulus, comprising:
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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 pas the valve leaflets and is located within the expandable frame; and actuating the expandable member to convert the expandable frame from its contracted state to its expanded state. - View Dependent Claims (15, 16, 17, 18, 19, 20)
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Specification