Safety systems for expansion of prosthetic heart valves

• US 10,548,728 B2
• Filed: 12/02/2016
• Issued: 02/04/2020
• 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.
• Primary Examiner(s): Herbermann, Erich G
• Application Number:
  US15/368,335
• Publication Number:
  US 20170135814A1
• Time in Patent Office: 1,159 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 2/2433 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

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.

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 a valve annulus;

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

a balloon catheter extending through the handle shaft lumen and having a balloon on a distal end sized to pass within the expandable frame of the heart valve, the balloon catheter having a proximal end located at the handpiece in fluid communication with a fluid inflation system connector, the balloon catheter being axially movable relative to the handle shaft and handpiece between a retracted position and a distally advanced position in which the balloon is located within the expandable frame of the heart valve; and

a safety member on the handpiece covering the fluid inflation system connector and thus preventing coupling of a mating connector of a fluid source thereto and thus expansion of the balloon when the balloon catheter is in the retracted position, further including a thumb plate connected to move the balloon catheter such that when the thumb plate is displaced distally the balloon catheter is moved between the retracted position and the distally advanced position which exposes the fluid inflation system connector from within the safety member so as to permit coupling of the mating connector of the fluid source thereto.

2. The system of claim 1, further including a valve holder attached to the heart valve, and an adapter on the distal end of the handle shaft attaches to the valve holder, wherein the heart valve has a labeled size and the expandable frame has a related diameter in its expanded state, and the adapter has a mating structure that matches complementary mating structure on the valve holder to ensure that only a properly-sized balloon catheter can be used with a particular size of heart valve.

3. 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.

4. The system of claim 1, wherein the fluid inflation system connector is a luer connector.

5. The system of claim 1, wherein the fluid inflation system connector is a luer connector, and wherein the safety member comprises a safety guard having a stationary part on 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 the thumb plate, 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 the mating connector of the fluid source thereto, and wherein distal movement of the balloon catheter exposes the luer connector from within the luer guard to permit coupling of the mating connector.

6. The system of claim 5, further including cooperating structures on the stationary and movable parts that prevent axial balloon catheter advancement until the cooperating structures are disengaged.

7. The system of claim 1, wherein the fluid inflation system connector is a luer connector, and wherein the safety member comprises a stationary part fixed to the handpiece having the luer connector on its proximal end and a coiled flexible tube within the safety member fluidly connecting the luer connector to the proximal end of the balloon catheter, and the safety member further comprises a movable cover having the thumb plate arranged to slide distally over the stationary part from the retracted position that extends over the luer connector and prevents attachment of a fluid supply thereto toward the distally advanced position which exposes the luer connector to permit coupling of the mating connector, the movable cover being engaged to move the balloon catheter towards the distally advanced position.

8. The system of claim 7, wherein the thumb plate enables axial movement of the movable cover in a one-handed operation, and wherein an inner shoulder of the movable cover engages a portion of the balloon catheter and simultaneously pushes it distally from the retracted position to the distally advanced position.

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

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

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

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

a handle shaft having a handpiece on a proximal end, the valve holder being attached to a distal end of the handle shaft, the handle shaft and handpiece defining a handle lumen;

a balloon catheter having a balloon received within the handle lumen and a proximal fluid inflation system connector for attaching a fluid fill tube to inflate the balloon, the balloon catheter having a balloon displacer at the handpiece for manually displacing the balloon catheter relative to the handle shaft, wherein the balloon displacer has two primary positions relative to the handpiece a retracted position wherein the balloon displacer is spaced from a stop on the handpiece and a distally advanced position where the balloon displacer engages the stop on the handpiece and the balloon extends distally to a position within the expandable frame; and

a safety member on the handpiece including a connector guard that covers the fluid inflation system connector and prevents coupling of a mating connector of a fluid source thereto, and prevents inflation of the balloon when the balloon displacer is in the retracted position, and the fluid inflation system connector is automatically separated from the connector guard when the balloon displacer is advanced distally from the retracted position.

10. The system of claim 9, wherein the fluid inflation system connector is a luer connector, and wherein the safety member comprises a safety guard fixed to a proximal end of the handpiece, and wherein an elongated arm on the safety guard terminates in the connector guard that receives the luer connector in the retracted position of the balloon displacer, and wherein distal movement of the balloon displacer moves the luer connector away from the connector guard to expose the luer connector and permit coupling of the mating connector.

11. The system of claim 10, further including cooperating structures on the safety guard and balloon displacer that prevent axial balloon catheter advancement until the cooperating structures are disengaged.

12. 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 a valve 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;

a balloon catheter extending through the handle shaft lumen and having a balloon 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 in fluid communication with a fluid inflation system connector for balloon inflation, the balloon catheter being axially movable relative to the handle shaft between a retracted position and a distally advanced position in which the balloon is located within the expandable frame of the heart valve, wherein in the retracted position of the balloon catheter the fluid inflation system connector is covered by a connector guard that is coupled to move axially with the balloon catheter and prevents balloon inflation prior to axial movement of the balloon catheter from its retracted position and wherein relative movement between the fluid inflation system connector and the connector guard uncovers the fluid inflation system connector to permit coupling of a mating luer connector.

13. The system of claim 12, 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.

14. The system of claim 12, wherein the connector guard forms a part of a safety guard affixed to a proximal end of the handpiece and the fluid inflation system connector is attached to the proximal end of the balloon catheter, and wherein distal movement of the balloon catheter separates the fluid inflation system connector from the connector guard to permit coupling of the mating luer connector.

15. The system of claim 14, further including cooperating structures on the balloon catheter and handpiece that prevent distal balloon catheter advancement until the cooperating structures are disengaged.