Implant

• US 10,195,031 B2
• Filed: 05/03/2016
• Issued: 02/05/2019
• Est. Priority Date: 05/08/2015
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Nasr, Malek, Bortlein, Georg, Ollivier, Jean-Francois, D'Hiver, Philippe
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/572,049
• Publication Number:
  US 20180116799A1
• Time in Patent Office: 1,008 Days
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

An implant for implantation around a circumferential tissue structure in a heart, includes a flexible elongated component having a longitudinal axis and a first distal end portion, a second distal end portion and an intermediate portion extending between the first and second distal end portions, and an inner lumen extending longitudinally between the first and second distal end portions and through the intermediate portion; and a locking member for allowing the first distal end portion to be fixedly connected to the second distal end portion so as to provide the elongated component as a closed loop. The first distal end portion is provided with a first distal opening which connects the inner lumen with an outside of the component. The second distal end portion is provided with a second distal opening which connects the inner lumen with the outside of the component.

Claims

1. An implant for implantation around a circumferential tissue structure in a heart, the implant comprising:

a flexible elongated component which has a longitudinal axis and which has a first distal end portion, a second distal end portion and an intermediate portion extending between the first and second distal end portions, and one inner lumen extending longitudinally between the first and second distal end portions and through the intermediate portion; and

a locking means configured to allow the first distal end portion to be fixedly connected to the second distal end portion so as to provide the elongated component as a closed loop;

wherein the first distal end portion is provided with a first distal opening which connects the one inner lumen with an outside of the component;

wherein the second distal end portion is provided with a second distal opening which connects the inner lumen with the outside of the component;

wherein the intermediate portion is provided with a proximal opening which connects the one inner lumen with the outside of the component, wherein the proximal opening is longitudinally spaced from both the first and second distal openings; and

wherein the first distal end portion is configured to engage into the second distal opening, the locking means comprises a protrusion which radially protrudes from an outside of the first distal end portion, and when the first distal end portion is in engagement in the second distal opening, the protrusion radially engages with an inner portion of the second distal end portion so as to fixedly secure the engagement of the first distal end portion in the second distal opening.

2. The implant according to claim 1, wherein each of the first and second distal openings is a distal end opening provided in a distal frontal end of the corresponding first and second distal end portions.

3. The implant according to claim 1, wherein a longitudinal distance between the proximal opening and the first distal opening is at least substantially equal to a longitudinal distance between the proximal opening and the second distal opening.

4. The implant according to claim 1, wherein the proximal opening has first and second proximal sub-openings, both of which connect the one inner lumen with the outside of the component and which are located adjacent to each other.

5. The implant according to claim 4, wherein the longitudinal distance between the first distal opening and the first proximal sub-opening is at least substantially equal to the longitudinal distance between the second distal opening and the second proximal sub-opening.

6. The implant according to claim 1, wherein the protrusion is formed as an anchor or barb.

7. The implant according to claim 1, wherein at least the inner portion of the second distal end portion is provided in a flexible manner so as to allow the protrusion to radially expand the inner portion and to be longitudinally anchored in the inner portion of the second distal end portion.

8. The implant according to claim 7, further comprising a restricting arrangement, by which a longitudinal movement of the first distal end portion into the second distal opening is restricted.

9. The implant according to claim 8, wherein the restricting arrangement comprises an outer sleeve provided on the second distal end portion, wherein the outer sleeve has a radial strength stronger than the radial strength of the second distal end portion.

10. The implant according to claim 1, wherein an outer surface of the component is treated with a tissue ingrowth promoting material.

11. A system for implanting an implant around a circumferential tissue structure in a heart of a patient, the system comprising:

a flexible elongate continuous guide wire for surrounding the tissue structure, which has a first leg portion with a first free end portion, a second leg portion with a second free end portion, and a loop portion extending between and connecting the first and second leg portions, wherein the loop portion is for distally extending around the tissue structure and the first and second leg portions are for proximally extending from the tissue structure towards an outside of the patient so that the first and second free end portions are accessible for a surgeon, and

an implant including;

a flexible elongated component which has a longitudinal axis and which has a first distal end portion, a second distal end portion and an intermediate portion extending between the first and second distal end portions, and one inner lumen extending longitudinally between the first and second distal end portions and through the intermediate portion; and

a locking means configured to allow the first distal end portion to be fixedly connected to the second distal end portion so as to provide the elongated component as a closed loop;

wherein the first distal end portion is provided with a first distal opening which connects the one inner lumen with an outside of the component;

wherein the second distal end portion is provided with a second distal opening which connects the inner lumen with the outside of the component; and

wherein the intermediate portion is provided with a proximal opening which connects the one inner lumen with the outside of the component, wherein the proximal opening is longitudinally spaced from both the first and second distal openings;

wherein the guide wire is disposable or is disposed in the one inner lumen of the component in a manner so that the loop portion extends between the first and second distal end portions, the first leg portion extends from the loop portion through the first distal opening and through the proximal opening so that the first free portion is proximally exposed from the component, and the second leg portion extends from the loop portion through the second distal opening and through the proximal opening so that the second free end portion is proximally exposed from the component, and

wherein the implant is moveable along the guide wire in a distal direction, with the first and second distal end portions being simultaneously moveable in a distally leading manner on the first and second leg portions onto the loop portion.

12. The system according to claim 11, wherein the proximal opening has first and second proximal sub-openings, both of which connect the one inner lumen with the outside of the component and which are located adjacent to each other.

13. The system according to claim 11, further comprising first and second tubes, wherein the first and second tubes removably extend through the inner lumen of the component, with the first tube extending through the proximal opening and/or the first proximal sub-opening, and with the second tube extending through the proximal opening and/or the second proximal sub-opening, and wherein the first leg portion extends through the first tube and the second leg portion extends through the second tube.

14. The system according to claim 11, further comprising an outer catheter having proximal and distal outer catheter end portions with respective proximal and distal outer catheter openings and an outer catheter lumen, wherein the guide wire, with the implant disposed thereon, is disposable through the outer catheter lumen.

15. The system according to claim 14, further comprising a pusher catheter having distal and proximal pusher catheter end portions with respective distal and proximal pusher catheter openings and a pusher catheter lumen, wherein the pusher catheter is configured so as to be disposable through the outer catheter lumen, and wherein the guide wire is configured so as to be partly disposable through the pusher catheter lumen, and wherein the pusher catheter and the implant are configured such that the implant, disposed on the guide wire which itself is partly disposed in the pusher catheter lumen, can be distally pushed on and along the guide wire through the outer catheter lumen.

16. The system according to claim 15, wherein the pusher catheter is provided with a pusher head provided on the distal pusher catheter opening, the pusher head having a through opening sized so as to allow the first and second leg portions of the guide wire to pass therethrough and to prevent the component to pass therethrough.

17. The system according to claim 16, wherein the through opening comprises first and second sub-through openings which are sized so as to allow the first and second leg portions, respectively, of the guide wire to pass therethrough.

18. The system according to claim 16, wherein the pusher head is rotatable relative to the pusher catheter about a longitudinal axis of the pusher catheter.

19. A method for disposing and forwarding an implant on a guide wire of a system according to claim 11, the method comprising:

threading the first leg portion of the guide wire with its first free end portion into the first distal opening and out through the proximal opening and/or the first proximal sub-opening, threading the second leg portion of the guide wire with its second free end portion into the second distal opening and out through the proximal opening and/or the second proximal sub-opening, and pushing the component on and along the guide wire towards the loop portion thereof to distally approach the first and second distal end portions from opposite direction so as to meet and connect to each other in the loop portion of the guide wire.