Intracardiac device for restoring the functional elasticity of the cardiac structures, holding tool for the intracardiac device, and method for implantation of the intracardiac device in the heart

• US 8,337,390 B2
• Filed: 07/30/2008
• Issued: 12/25/2012
• Est. Priority Date: 07/30/2008
• Status: Active Grant

• Current Assignee: Cube Corporation (Babcock International Group PLC)
• Original Assignee: Cube Corporation (Babcock International Group PLC)
• Inventors: Ferrazzi, Paolo
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US12/219,883
• Publication Number:
  US 20100030014A1
• Time in Patent Office: 1,609 Days
• Field of Search: 600/16, 600/17, 600/18, 600/36, 600/37, 606/1, 128/897, 128/898, 128/899, 623/1.26, 623/2.11, 623/2.36, 139/50
• US Class Current: 600/37
• 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
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands

Abstract

An intracardiac device for restoring the functional elasticity of the cardiac structures, in particular for the treatment of cardiomyopathies and or valvulopathies, by storing energy from the cardiac structures and ceding energy to the cardiac structures during the cardiac cycle, has an elongated shape, is at least partially wound in coils and is attachable to a cardiac structure; the coils are selected in material, number and dimension so as to allow an elastic elongation of the intracardiac device higher than 10% of the rest length of the intracardiac device and are exposed, in use, to the blood flow.

Claims

1. An intracardiac device for restoring functional elasticity of cardiac structures, in particular for the treatment of cardiomyopathies and valvulopathies, storing energy from the cardiac structures and ceding energy to the cardiac structures during the cardiac cycle;

wherein the intracardiac device comprises an elongated shape and includes an elongated member formed from metal spring wire;

the elongated member being at least partially wound in coils that extend circumferentially, along a given section, and is attachable to a cardiac structure;

wherein said coils are selected in material, number, and dimension to permit elastic elongation of the intracardiac device higher than 10% of the rest length of the intracardiac device during use, and are adapted to be exposed to blood flow during use; and

wherein the device further comprises at least one member directly attachable to the cardiac structure and attached to the elongated member, and the at least one member has an elongated shape and is arranged alongside and along the elongated member and is extendable up to a maximum length in order to limit extension of the elongated member within a given percentage of the rest length of the elongated member, and the attachable member includes a metal mesh tube intersecting with said coils;

the metal mesh tube being extendable.

2. The device according to claim 1, wherein said coils are selected in material, number and dimension to permit elastic elongation of the intracardiac device between 10% and 50% of the rest length of the intracardiac device.

3. The device according to claim 1, wherein said coils are selected in material, number and dimension to permit elastic contraction of the intracardiac device, less than 5% the rest of the length of the intracardiac device.

4. The device according to claim 1, wherein the attachable member is attached to the elongated member leaving said coils at least partially freely exposed to blood flow during use.

5. The device according to claim 1, wherein the elongated member and the attachable member are ring-shaped;

each coil of the elongated member being partially embedded in the material of the attachable member.

6. The device according to claim 1, wherein the metal mesh tube forms a closed ring.

7. The device according to claim 1, wherein said coils define at least one helical spring;

each coil being set at a distance from the adjacent coil in order to permit elastic compression deformation and elastic traction deformation.

8. The device according to claim 1, wherein the attachable member comprises a support structure realized in a material selected from one of the following:

Metal;

Silicone;

Polyurethane;

polyethylene terephthalate;

ePTFE.

9. The device according to claim 8, wherein the attachable member comprises a composite structure comprising the said support structure and a covering in an attachable material;

the covering being realized in a material selected from one of the following;

polyethylene terephthalate;

ePTFE;

Pericardial material;

Metal.

10. A holding tool of an intracardiac device for restoring functional elasticity of cardiac structures, in particular for the treatment of cardiomyopathies and valvulopathies, storing energy from the cardiac structures and ceding energy to the cardiac structures during the cardiac cycle;

wherein the device has an elongated shape and comprises an elongated member formed from metal wire for forming springs, at least partially, wound in coils along a given section and attachable to a cardiac wall;

said coils being selected in material, number, and dimension to permit elastic elongation of the intracardiac device higher than 10% of the rest length of the intracardiac device;

the holding tool comprising a frame;

a holding unit mounted in a mobile manner on said frame and having a variable configuration in order to maintain the intracardiac device in the rest configuration and in an extended configuration in relation to the rest configuration; and

a driving member of the holding unit comprising elements arranged to engage and hold the holding unit respectively in a first stable position to support the intracardiac device in the rest configuration, and in a second stable position to support the intracardiac device in the extended configuration;

the frame comprising a plate having an aperture formed therein with radial slots extending outwardly from edges of the aperture, and wherein the holding unit comprises a plurality of radially movable segments each including an internal face and an external structure with an undercut area in which the intracardiac device is retained, and wherein the driving member is arranged with a plurality of external surfaces equal to the number of internal faces to progressively move the intracardiac device from its rest configuration into an expanded configuration for suturing into position with the heart, and to then retract the plurality of segments leaving the intracardiac device within the heart in a rest configuration.

11. An intracardiac device for restoring functional elasticity of cardiac structures, in particular for the treatment of cardiomyopathies and valvulopathies, storing energy from the cardiac structures, and ceding energy to the cardiac structures during the cardiac cycle;

wherein the intracardiac device comprises an elongated shape and includes an elongated member formed from metal spring wire;

the elongated member being at least partially wound in coils that extend circumferentially, along a given section, and is attachable to a cardiac structure;

wherein said coils are selected in material, number, and dimension to permit elastic elongation of the intracardiac device higher than 10% of the rest length of the intracardiac device during use, and are adapted to be exposed to blood flow during use, and

wherein the elongated member is wound in coils on a plurality of sections to form a plurality of helical springs;

the device further comprising a plurality of attachable members, which are attached to the elongated member, alternates with the helical springs, and encase the elongated member at least partially.

12. The device according to claim 11, wherein the said coils are selected in material, number, and dimension to permit elastic elongation of the intracardiac device between 10% and 50% of the rest length of the intracardiac device.

13. The device according to claim 11, wherein the said coils are selected in material, number, and dimension to permit elastic elongation of the intracardiac device less than 5% of the rest length of the intracardiac device.

14. The device according to claim 11, wherein the attachable member includes a metal mesh tube intersecting with said coils;

the metal mesh tube being extendable.

15. The device according to claim 11, wherein the plurality of attachable members are attached to one another.

16. The device according to claim 11, wherein the attachable member comprises a support structure realized in a material selected from one of the following:

Metal;

Polyethylene terephthalate;

ePTFE;

Pericardial material.

17. The device according to claim 16, wherein the attachable member comprises a composite structure comprising the said support structure and a covering in an attachable material;

the covering being realized in a material selected from one of the following;

Metal;

Silicone;

Polyurethane;

Polyethylene terephthalate;

ePTFE.

18. An intracardiac device for restoring functional elasticity of cardiac structures, in particular for the treatment of cardiomyopathies and valvulopathies, by storing energy from the cardiac structures and ceding energy to the cardiac structures during the cardiac cycle;

the intracardiac device comprising an elongated shape and including an elongated member formed from metal spring wire;

the elongated member being at least partially wound in coils that extend along a given section and being attachable to a cardiac structure;

wherein said coils are selected in material, number, and dimension to permit elastic elongation of the intracardiac device higher than 10% of the rest length of the intracardiac device during use, and are adapted to be exposed to blood flow during use; and

wherein the device further comprises at least one member directly attachable to the cardiac structure and attached to the elongated member, the at least one member has an elongated shape and is arranged alongside and along the elongated member and is extendable up to a maximum length in order to limit extension of the elongated member within a given percentage of the rest length of the elongated member, and the attachable member includes a metal mesh tube intersecting with said coils;

the metal mesh tube being extendable.

19. The device as in claim 18 wherein the coils are inserted in the mesh of the tube in order to join the metal mesh tube to the elongated structure.