Surgical methods of replacing prosthetic heart valves

• US 10,456,251 B2
• Filed: 03/11/2019
• Issued: 10/29/2019
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Wood, Larry L., Bourang, Henry, Bakis, George, Spenser, Benjamin, Benichou, Netanel, Bash, Assaf, Keidar, Yaron
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/298,616
• Publication Number:
  US 20190201195A1
• Time in Patent Office: 232 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

Claims

1. A surgical method of implanting a two-stage prosthetic heart valve in a native heart valve annulus of a patient, comprising:

providing an expandable anchoring member having a generally tubular expandable body with a proximal end and a distal end, the anchoring member being configured to be constricted to a contracted anchoring member and configured to be enlarged to an expanded anchoring member sized to contact the heart valve annulus;

providing a non-expandable/non-collapsible prosthetic valve member having a peripheral sewing ring on an inflow end and one-way leaflets configured to permit flow in an outflow direction through the valve member;

preparing the patient for surgery by placing him/her on cardiopulmonary bypass;

creating a direct access pathway to the heart valve annulus that permits direct naked eye vision of the heart valve annulus;

delivering the anchoring member to a position within the heart valve annulus and with the proximal end directed toward an outflow side of the annulus;

enlarging the anchoring member to the expanded anchoring member and into contact with the heart valve annulus;

delivering the valve member to the expanded anchoring member such that the one-way leaflets permit flow toward the outflow side of the annulus; and

coupling the sewing ring to the expanded anchoring member.

2. The method of claim 1, wherein the step of delivering the valve member includes positioning the sewing ring at the proximal end of the expanded anchoring member, and the step of coupling comprises coupling the sewing ring to the proximal end of the expanded anchoring member.

3. The method of claim 2, wherein the sewing ring and the proximal end of the expanded anchoring member are provided with mating connectors, and the step of coupling comprises axially displacing the valve member toward the expanded anchoring member so that the mating connectors engage.

4. The method of claim 3, wherein the mating connectors on the sewing ring comprise protruding members and the mating connectors on the proximal end of the expanded anchoring member comprise posts extending in a proximal direction each slotted so as to form a capture portion configured to receive and capture the protruding members.

5. The method of claim 2, wherein the sewing ring and the proximal end of the expanded anchoring member are provided with mating connectors, and the step of coupling comprises rotating the valve member relative to the expanded anchoring member so that the mating connectors engage.

6. The method of claim 5, wherein the mating connectors have mating threads.

7. The method of claim 5, wherein the mating connectors on the sewing ring comprise protruding members and the mating connectors on the proximal end of the expanded anchoring member comprise posts extending in a proximal direction each slotted so as to form a capture portion configured to receive and capture the protruding members.

8. The method of claim 2, wherein the expandable anchoring member is a first expandable anchoring member and further including a second expandable anchoring member, and the step of coupling includes enlarging the second expandable anchoring member on an opposite side of the sewing ring from the first expanded anchoring member to capture the sewing ring therebetween.

9. The method of claim 2, wherein the proximal end of the expanded anchoring member is provided with bendable connectors, and the method includes causing the connectors to bend inward and engage the sewing ring.

10. The method of claim 9, wherein the step of causing the connectors to bend inward comprises actuating a bending tool that is removed from the implantation site thereafter.

11. The method of claim 2, wherein the step of coupling comprises providing an adapter sized to surround the valve member and seat on the sewing ring and coupling the adapter to the proximal end of the expanded anchoring member.

12. The method of claim 11, wherein the adapter includes a plurality of connectors adapted to engage and couple the adapter directly to the sewing ring, and the step of coupling includes causing the connectors to engage the sewing ring.

13. The method of claim 11, wherein the proximal end of the expanded anchoring member has a series of tabs that project inwardly configured to mate with exterior threading on the adapter.

14. The method of claim 11, wherein the adapter includes a plurality of connectors spaced around a circumference thereof, and the proximal end of the expanded anchoring member has a plurality of mating connectors spaced around a circumference thereof, and the step of coupling the adapter to the expanded anchoring member comprises displacing the adapter toward the expanded anchoring member to engage pairs of the mating connectors thereon.

15. The method of claim 14, further including aligning the adapter and the expanded anchoring member by passing a guide suture through each pair of mating connectors.

16. The method of claim 1, wherein the step of delivering the valve member includes positioning the sewing ring within the expanded anchoring member and the step of coupling comprises coupling the sewing ring to a feature on an inner wall of the expanded anchoring member.

17. The method of claim 16, wherein the expanded anchoring member has a flared outflow end larger than an inflow end thereof, and the step of delivering the valve member includes positioning the sewing ring within the outflow end of the expanded anchoring member.

18. The method of claim 16, wherein the anchoring member comprises a suture-permeable fixation ring attached thereto, wherein the step of coupling comprises connecting sutures between the sewing ring and the fixation ring.

19. The method of claim 16, wherein the expanded anchoring member has an inwardly-directed circumferential member defining a groove that extends at least partially around the circumferential member and is sized to receive the sewing ring.

20. The method of claim 16, wherein the expanded anchoring member has a row of lower prongs that project inward from the body and a row of upper prongs that extend inward from the body axially spaced from the row of lower prongs, wherein the step of coupling includes positioning the sewing ring between the lower and upper prongs.

21. The method of claim 1, wherein the step of creating a direct access pathway comprises performing open-heart surgery.

22. The method of claim 1, wherein the step of enlarging the anchoring member comprises balloon-expanding the anchoring member.

23. The method of claim 1, further including:

providing a valve dilator/delivery tube having an exterior diameter sized to dilate a heart valve annulus;

positioning the valve member and anchoring member within the valve dilator/delivery tube;

advancing the valve dilator/delivery tube therewithin to the heart valve annulus;

dilating the heart valve annulus with the valve dilator/delivery tube;

expulsing the anchoring member from the valve dilator/delivery tube and performing the step of enlarging; and

expulsing the valve member from the valve dilator/delivery tube and performing the step of coupling.