Device for the deployment of a system of guide wires within a cardiac chamber for implanting a prosthetic heart valve

• US 10,327,901 B2
• Filed: 05/18/2015
• Issued: 06/25/2019
• Est. Priority Date: 11/20/2012
• Status: Active Grant

• Current Assignee: InnovHeart s.r.l.
• Original Assignee: InnovHeart s.r.l.
• Inventors: Righini, Giovanni, Zanon, Sarah
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US14/714,420
• Publication Number:
  US 20150245910A1
• Time in Patent Office: 1,499 Days
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A prosthetic system for heart valve replacement comprises an annular support structure within which a valved prosthetic body can be expanded until it meets opposition. The annular support is provided in ring segments having terminal connectors for forming, in the condition of use of the prosthetic system, a stable and durable annular structural continuity capable of withstanding the opposition exerted by the valved prosthetic body. The prosthetic system is deployed using guide wires within a cardiac chamber guided through an introducer catheter having through lumens, within which at least two first guide catheters are positioned. These guide catheters have respective deflected or deflectable distal ends adapted to emerge from the distal end of the introducer catheter to convey and direct the distal ends of respective guide wires, placed within the guide catheters, towards a capture member of a capture system which is provided within the introducer catheter.

Claims

1. An annular support prosthetic system for heart valve replacement comprising:

said annular support prosthetic system designed for deployment by one or more guide wires within a cardiac chamber utilizing an introducer catheter having at least a first main through lumen and at least a second through lumen;

said introducer catheter having the first main through lumen designed to be placed with at least two first guide catheters having respective deflected or deflectable distal ends that are adapted to emerge from the distal end of the introducer catheter to convey and direct the distal ends of respective one or more guide wires placed within the guide catheters towards a capture member of a capture system which is provided within the second through lumen of the introducer catheter and can be selectively drawn out of and retracted into the interior thereof;

the capture member being provided with a distal gripper for capturing the distal ends of the one or more guide wires and drawing the one or more guide wires into the introducer catheter;

wherein the second through lumen comprises a rectilinear portion and a curvature with respect to the axis of advance of the first main through lumen, and terminates in a distal orifice located on the lateral surface of the introducer catheter.

2. A prosthetic system for heart valve replacement according to claim 1, wherein each of the first guide catheters has characteristics of torsional rigidity.

3. A prosthetic system for heart valve replacement according to claim 1, wherein each of the first guide catheters accommodates and guides internally a respective second guide catheter having a torsionally rigid distal portion which is deflected or deflectable and is adapted to emerge from the distal end of the respective first guide catheter so as to guide and direct the distal end of the respective one or more guide wires.

4. A prosthetic system for heart valve replacement according to claim 3, further comprising a controlled deflection mechanism for one or more of the second guide catheters.

5. A prosthetic system for heart valve replacement according to claim 1, wherein the gripper of the capture member emerges selectively in a position spaced apart from the distal end of the introducer catheter.

6. A prosthetic system for heart valve replacement according to claim 1, wherein the gripper of the capture member comprises an automatically expanding collapsible structure retained selectively in a collapsed configuration by a retractable control sheath.

7. A prosthetic system for heart valve replacement according to claim 6, wherein the collapsible structure comprises a plurality of mesh elements which in the expanded configuration are adapted to trap the ends of the one or more guide wires without creating resistance to the blood flow.

19. A method for implanting a prosthetic system for heart valve replacement comprising positioning the guide wires using the annular support prosthetic system according to claim 1, inserting and positioning ring segments, separately, around the native heart valve, providing annular structural continuity using a connector present on the segments, so as to surround the native heart valve, and expanding a prosthetic valved body within the native heart valve until the prosthetic valved body is opposed by the annular support prosthetic system, in such a way that leaflets of the native heart valve are secured between the ring segments.

8. A method for implantation of a prosthetic system to replace a heart valve, comprising the steps:

providing a multiple component annular support structure that is designed to be coupled together resulting in a single annular support structure, to be implanted with a valved prosthetic body within a mitral valve body;

positioning an introducer catheter with a distal end thereof close to the area of implantation of the prosthetic system;

advancing first guide catheters along the axis of the introducer catheter to a desired position, said first guide catheters having a deflected distal portion;

orientating the deflected distal portion of the first guide catheters in opposite directions lying substantially on the same plane;

causing the ends of corresponding guide wires to emerge from the inside of the first guide catheters;

drawing out a capture member having one or more grippers;

preparing said one or more grippers for capturing the ends of the guide wires;

directing the ends of the guide wires towards the one or more grippers;

capturing the guide wires with the one or more grippers and then drawing the guide wires into the introducer catheter by retracting the capture member; and

inserting the multiple component annular support structure over the guide wires.

9. A method according to claim 8, wherein the method comprises the further step of advancing second guide catheters to move respective distal ends thereof out of the deflected distal portion of the first guide catheters and guiding the second guide catheters so as to position the second guide catheters substantially in the proximity of the drawn-out capture member, in order to direct the distal ends of the respective guide wires towards the capture member.

10. A prosthetic system for heart valve replacement, comprising:

a multiple component annular support structure within which a prosthetic valved body can be expanded until the valved body meets opposition;

the annular support structure being provided in two or more ring segments having a terminal connector;

wherein the two or more ring segments are interconnected by a connection system comprising pins adapted to engage in corresponding holes; and

wherein solely engagement of the pins into the holes withstands the opposition exerted by the prosthetic valved body, and engagement of the pins into the holes results in the annular support structure that is stable, durable, and continuous.

11. A prosthetic system according to claim 10, wherein there are two ring segments and each end of one of the two ring segments is provided with the pins and each opposing end of the other one of the two ring segments is provided with the hole designed to receive the pins of the other one of the two ring segments.

12. A prosthetic system according to claim 10, wherein the two or more ring segments are deformable to provide a smaller overall radial dimension, adapted to allow the insertion of the segments by a catheter for conveyance thereof towards a heart valve implantation site.

13. A prosthetic system according to claim 10, wherein each of the two or more ring segments can be inserted separately into a cardiac chamber, where the terminal connector provides annular structural continuity after positioning of the segments.

14. A prosthetic system according to claim 10, wherein the annular support structure formed by connection of the two or more ring segments has predetermined shapes and dimensions, substantially coinciding with the anatomy of the annulus of the heart valve, so as to be capable of surrounding the valve in a continuous manner.

15. A prosthetic system according to claim 10, wherein each of the two or more ring segments is suitable for being supported by arms of a corresponding positioning and support device.

16. A prosthetic system according to claim 10, wherein each of the two or more ring segments is internally hollow to allow the passage of at least one guide wire.

17. A prosthetic system according to claim 16, wherein each of the two or more ring segments is an elongate tubular structure, bendable into two substantially identical portions, an aperture being provided in the vicinity of the halfway point of the elongate tubular structure, substantially in the area of bending of the ring segments, for the emergence of the at least one guide wire.

18. A prosthetic system according to claim 16, wherein the at least one guide wire comprises a plurality of guide wires that each emerge from the ends of each of the two or more ring segments, substantially at the positions of the terminal connector.