Device for the Deployment of a System of Guide Wires Within a Cardiac Chamber for Implanting a Prosthetic Heart Valve

• US 20150245910A1
• Filed: 05/18/2015
• Published: 09/03/2015
• 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
• Granted Patent: US 10,327,901 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 meet opposition. The annular support is provided in two or more ring segments having terminal connection means 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 two or more 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 a first main 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 guide wires placed within the guide catheters towards a capture member of a capture system which is provided within the secondary lumen of the introducer catheter and can be selectively drawn out of and retracted into the interior thereof;

the capture member being provided with distal gripping means for capturing the distal ends of the guide wires and drawing them into the introducer catheter;

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

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

3. A prosthetic system for heart valve replacement device 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 guide wire.

4. A prosthetic system for heart valve replacement device according to claim 1, further comprising a controlled deflection mechanism for one or more of the guide catheters.

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

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

7. A prosthetic system for heart valve replacement device according to claim 1, wherein the collapsible structure comprises a plurality of mesh elements which in the expanded configuration are adapted to trap the ends of the guide wires without creating resistance to the blood flow.

19. A method for implanting a prosthetic system for heart valve replacement, including an annular support structure according to any one of the preceding claims, comprising the steps of inserting and positioning ring segments, separately, around the native heart valve, providing annular structural continuity using the connection means present on the segments, so as to surround the native heart valve, and expanding a prosthetic valved body within the heart valve until it is opposed by the annular support, in such a way that the leaflets of the native valve are secured between the two structures.

8. A method for the 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 its distal end close to the area of implantation of the prosthetic system;

advancing one or more guide catheters along the axis of the introducer catheter to a desired position, said one or more 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 guide catheters;

drawing out a capture member having one or more gripping means;

preparing said gripping means for capturing the ends of the guide wires;

directing the ends of the guide wires towards the gripping means; and

,

capturing them with the gripping means and then drawing them into the introducer catheter by retracting the capture member.

9. A method according to claim 8, where the method comprising the further step of advancing the second guide catheters to move their respective distal ends out of the deflected distal ends of the first guide catheters and guiding them so as to position them substantially in the proximity of the drawn-out capture member, in order to direct the distal ends of the respective guide wires towards this 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 it meets opposition;

the annular support structure being provided in two or more ring segments having terminal connection means;

wherein the two or more ring segments are interconnected by means of a connection system comprising pins adapted to engage in corresponding holes, resulting in a stable and durable continuous annular structure capable of withstanding the opposition exerted by the valved prosthetic body.

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

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 means of a catheter for their conveyance 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 connection means provide the annular structural continuity after the positioning of the segments.

14. A prosthetic system according to claim 10, wherein the annular structure formed by the 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 segment in the bent configuration, for the emergence of at least one guide wire.

18. A prosthetic system according to claim 16, wherein guide wires emerge from the ends of each of the two or more ring segments, substantially at the positions of the terminal connection means.

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

an annular support structure within which a prosthetic valved body can be expanded until it meets opposition;

the annular support being provided in two or more ring segments having terminal connection means for forming, in the condition of use of the prosthetic system, a stable and durable continuous annular structure capable of withstanding the opposition exerted by the valved prosthetic body;

wherein there are two segments and each end of one of the two segments is provided with a pin structure and each opposing end of the other segment is provided with a hole designed to receive the pin structure of the other segment.