IMPLANT FOR TREATMENT OF A HEART VALVE, IN PARTICULAR A MITRAL VALVE, MATERIAL INCLUDING SUCH AN IMPLANT, AND MATERIAL FOR INSERTION THEREOF

• US 20100292785A1
• Filed: 04/14/2008
• Published: 11/18/2010
• Est. Priority Date: 04/20/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Seguin, Jacques, Lecointe, Bruno, Nguyen, Than
• Granted Patent: US 9,237,886 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

This implant (1) is formed by a helically wound wire (2). According to the invention, it has dimensions such that it is able to be screwed into the wall of the annulus (103) and/or into the cardiac wall (101) adjoining this annulus (103) such that a portion of said annulus (103) and/or of said wall (101) is located in the perimeter of the implant (1); and it comprises at least one first coil able, during said screwing of the implant (1), to insert itself into said wall while having a first dimension and at least one second coil having a second dimension, or adopting this second dimension after implantation, said second dimension being smaller than the first dimension such that the implant (1), once inserted, enables contraction of said wall portion located in the perimeter of this implant (1).

Claims

1. - Implant (1) for treating a heart valve, in particular a mitral valve of a heart, made up of a helically wound wire (2), characterized in that:

it has dimensions such that it can be screwed into the wall of the annulus (103) and/or into the cardiac wall (101) adjoining this annulus (103) so that a portion of said annulus (103) and/or of said wall (101) is located in the perimeter of the implant (1); and

the implant (1) comprises at least one first coil able, upon screwing of the implant (1), to insert itself into said wall while having a first dimension and at least one second coil having a second dimension, or adopting this second dimension after implantation, said second dimension being smaller than the first dimension such that the implant (1), once inserted, allows contraction of said wall portion located in the perimeter of this implant (1).

2. - Implant (1) according to claim 1, characterized in that said first coil(s) are located, in the direction of screwing of the implant (1), in front of said second coil(s).

3. - Implant (1) according to claim 1 or claim 2, characterized in that its coils have a non-circular shape, in particular oval or elliptical.

4. - Implant (1) according to one of claims 1 to 3, characterized in that the wire (2) constituting the implant (1) is in a shape memory material, defining, in a first state, coils having said first dimension and, in a second state, coils having said second dimension.

5. - Implant (1) according to one of claims 1 to 4, characterized in that the front end (5) of the wire (2) which constitutes it is pointed or sharp.

6. - Implant (1) according to one of claims 1 to 5, characterized in that the wire which constitutes it has a same structure along its entire length.

7. - Implant (1) according to one of claims 1 to 5, characterized in that the wire constituting it comprises portions in a first material and portions in a second material different from the first material.

8. - Implant (1) according to one of claims 1 to 7, characterized in that the wire which constitutes it comprises portions having different structures, for example solid, resistant portions and portions having a thinner cross-section able to break in case of exertion on the implant of stresses directed radially outwardly.

9. - Implant (1) according to one of claims 1 to 8, characterized in that it comprises radiopaque markers enabling its visualization through the body of the patient, in particular markers making it possible to visualize the angular orientation of the implant when the latter comprises non-circular coils.

10. - Implant (1) according to one of claims 1 to 9, characterized in that it comprises means ensuring its anchoring in the tissue with regard to screwing or unscrewing.

11. - Material including the implant according to one of claims 1 to 10, characterized in that it comprises means (40) making it possible to connect at least two adjacent implants (1) inserted in an annulus (103), so as to achieve a contraction of the wail of the annulus (103) located between the implants (1), in addition to the contraction done by the implants (1) themselves.

12. - Material according to claim 11, characterized in that said means comprise wires (40) in a material able to be twisted, in particular in a metallic material, connected to the proximal parts of the implants (1), these wires (40) being engaged in a same catheter (41) then being twisted to bring the two implants (1) closer together.

13. - Material including the implant according to one of claims 1 to 10, characterized in that it comprises curved connection means able to connect at least two implants, these connection means being able to go from a first bend, which they have before implantation, to a smaller or rectilinear bend, which they have after implantation.

14. - Material including the implant according to one of claims 1 to 10, characterized in that it comprises connection means able to connect at least two implants, these connection means being able to go, via shape memory, from an elongated shape before implantation to a shortened shape after implantation, in order to achieve a contraction of the valvular annulus due to the implants being brought closer together.

15. - Material for inserting the implant (1) according to one of claims 1 to 10, or the material including this implant according to one of claims 11 to 14, characterized in that it includes at least one catheter (11) able to deliver the implant (1), means (16) for moving the implant (1) longitudinally in relation to this catheter (11) and means (14, 15, 16) for driving the implant (1) in rotation along the axis of the implant (1).

16. - Material according to claim 15, characterized in that the longitudinal movement means comprise a push-rod (16) slidingly engaged in the catheter (11).

17. - Material according to claim 15 or claim 16, characterized in that the means for driving in rotation comprise a wire (14) connected separably to the rear end of the implant (1).

18. - Percutaneous intervention method for performing the treatment of a heart valve, in particular to perform an annuloplasty, i.e. a reduction of a distension of the valvular annulus (103), or a strengthening of the annulus (103) of a normal valve;

characterized in that it comprises steps consisting of;

using the implant (1) according to one of claims 1 to 10 and the material according to one of claims 15 to 17;

bringing the distal opening of the catheter (11) comprised by the material across from the area designed to receive the implant (1);

moving the implant (1) forward in relation to the catheter (11) while driving this implant (1) in rotation along its axis, in order to achieve screwing of the implant (1) into the annulus (103) of the valve to be treated and/or the cardiac wall adjoining this annulus (103);

if necessary, repeating the preceding steps so as to insert as many implants (1) as necessary to perform the desired annuloplasty and/or strengthening of the annulus (103).

19. - Intervention method according to claim 18, characterized in that the step consisting of bringing the distal opening of the catheter (11) across from the area designed to receive the implant (1) is done by approaching the valve from one or the other of the sides of this valve, in particular, involving the treatment of a mitral valve, either using a ventricular approach or an auricular approach.