Adjustable annuloplasty ring and system

• US 10,058,427 B2
• Filed: 10/25/2013
• Issued: 08/28/2018
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Kephalios S.A.S. (Affluent Medical SA)
• Original Assignee: Kephalios S.A.S. (Affluent Medical SA)
• Inventors: Hayoz, Daniel
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/031,321
• Publication Number:
  US 20160256274A1
• Time in Patent Office: 1,768 Days
• Field of Search: 623 238- 24
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

An adjustable annuloplasty ring assembly (10) comprises a support ring (30), an adjustable ring (32) nested at least partly within the support ring, and at least one deployable pressing element (34) for deforming the adjustable ring using the support ring (30) as support. Plural pressing elements (34) may be used at different positions around rings. Each pressing element (34) may have a variable extents of deployment, to vary the extent of deformation of the adjustable ring at the position of the pressing element. Each pressing element may comprise a deflectable blade (40), and the state of the blade may be retained by a ratchet (50). The pressing elements may be operated in a predetermined controlled sequence.

Claims

1. An adjustable annuloplasty ring assembly comprising:

a support ring,

an adjustable ring nested at least partly within the support ring, and

a plurality of pressing elements at different positions around an interface between the support ring and the adjustable ring, each pressing element deployable to deform the adjustable ring inwardly using the support ring as a support, for adjusting the shape of the adjustable ring the at least one deployable pressing element comprises a fluid-deployable device.

2. The assembly of claim 1, wherein each pressing element is deployable to deform the adjustable ring inwardly with respect to the support ring at the respective position of the pressing element.

3. The assembly of claim 1, wherein each pressing element is deployable individually.

4. The assembly of claim 1, wherein there are three deployable pressing elements.

5. The assembly of claim 1, wherein the assembly comprises an anterior portion for fitting near an anterior native cardiac valve leaflet, a posterior portion opposite the anterior portion and for fitting near a posterior native cardiac valve leaflet, and at least one lateral portion between the posterior and the anterior portions;

the plurality of deployable pressing elements comprise at least one pressing element associated at least partly with the lateral portion, and at least one pressing element associated with the posterior and/or the anterior portions.

11. The assembly of claim 1, wherein the at least one pressing element is carded by the support ring.

15. The assembly of claim 1, further comprising a flexible cover for covering at least partly at least one of the rings.

24. The assembly of claim 1, wherein at least a portion of the at least one deployable pressing element is configured to remain, in use during deployment of the pressing element, generally at a predetermined position along a periphery of at least one of the rings.

25. The assembly of claim 24, wherein the at least one deployable pressing element is configured to remain, in use during deployment of the pressing element, generally at a predetermined position along a periphery of at least the support ring.

26. The assembly of claim 1, wherein the at least one pressing element is controllable to have a variable extent of deployment at the position of the pressing element, to define a variable deformation of the adjustable ring with respect to the support ring.

27. The assembly of claim 26, further comprising a control member for controlling the extent of deployment of the pressing element.

28. The assembly of claim 26, comprising a latching mechanism for retaining a state of deployment of the pressing element after adjustment.

29. The assembly of claim 5, wherein the at least one pressing element is carried by the support ring.

32. The assembly of claim 1, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm;

or

a piston within a cylinder.

33. The assembly of claim 32, wherein the fluid-deployable device is deployable by a fluid selected from:

a gas;

a liquid;

or

a gel.

34. The assembly of claim 1, and comprising at least one sensor for sensing a parameter relating to performance of a valve to be treated by the assembly.

35. The assembly of claim 34, wherein the sensor comprises at least one sensor selected from:

a Doppler-effect sensor for sensing blood flow;

a transducer for a Doppler-effect sensor;

an acoustic transducer;

an ultrasound transducer;

or

a pressure sensor for sensing blood pressure.

36. The assembly of claim 1, and comprising at least one electrode for applying or sensing an electrical signal at a site of the cardiac valve.

37. The assembly of claim 34, wherein the ring assembly is adjustable, after implantation, for adjusting a shape of the annuloplasty ring assembly.

38. The assembly of claim 36, wherein the ring assembly is adjustable, after implantation, for adjusting a shape of the annuloplasty ring assembly.

39. The assembly of claim 1, wherein the assembly is adjustable, after implantation, for adjusting a shape of the annuloplasty ring assembly.

40. The assembly of claim 1, comprising a mechanical interface arranged to receive a prosthetic valve.

6. An adjustable annuloplasty ring assembly, the assembly comprising:

a support ring,

an adjustable ring nested at least partly within the support ring, and

at least one pressing element deployable to deform the adjustable ring by using the support ring as a support, for adjusting the shape of the adjustable ring,

wherein at least a portion of the at least one deployable pressing element is configured to remain, in use during deployment of the pressing element, generally at a predetermined position along a periphery of at least one of the rings.

7. The assembly of claim 6, wherein the at least one deployable pressing element is configured to remain, in use during deployment of the pressing element, generally at a predetermined position along a periphery of at least the support ring.

30. The assembly of claim 6, wherein the at least one pressing element is carried by the support ring.

8. An adjustable annuloplasty ring assembly, the assembly comprising:

a support ring,

an adjustable ring nested at least partly within the support ring, and

at least one pressing element deployable to deform the adjustable ring by using the support ring as a support, for adjusting the shape of the adjustable ring,

wherein the at least one pressing element is controllable to have a variable extent of deployment at the position of the pressing element, to define a variable deformation of the adjustable ring with respect to the support ring.

9. The assembly of claim 8, further comprising a control member for controlling the extent of deployment of the pressing element.

10. The assembly of claim 8, comprising a latching mechanism for retaining a state of deployment of the pressing element after adjustment.

31. The assembly of claim 8, wherein the at least one pressing element is carried by the support ring.

12. An adjustable annuloplasty ring assembly, the assembly comprising:

a support ring,

an adjustable ring nested at least partly within the support ring, and

at least one pressing element deployable to deform the adjustable ring by using the support ring as a support, for adjusting the shape of the adjustable ring,

wherein the at least one deployable pressing element comprises a fluid-deployable device.

13. The assembly of claim 12, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm; and

a piston within a cylinder.

14. The assembly of claim 12 wherein the fluid-deployable device is deployable by fluid selected from:

a gas;

a liquid;

a gel.

16. A system comprising:

an adjustable annuloplasty ring assembly;

an actuator for generating a physical control signal for transmission to the ring assembly;

a transmission line for coupling the actuator to the ring assembly for transmitting the physical control signal from the actuator to the ring assembly; and

a releasable coupling for releasably coupling the transmission line to the ring assembly.

17. The system of claim 16, wherein the physical control signal is selected from:

a mechanical adjustment force;

a fluid control;

a pneumatic control;

or

a hydraulic control.

18. A system comprising:

an adjustable annuloplasty ring assembly having a plurality of actuatable adjusters for adjusting a shape of at least a portion of the ring assembly after implantation in the body; and

an actuator for controlling actuation of the plurality of adjusters,

wherein the ring assembly comprised an anterior portion for fitting near an anterior valve leaflet of a cardiac valve to be treated, a posterior portion opposite the anterior portion and for fitting near a posterior valve leaflet, and at least one lateral portion between the posterior and anterior portions; and

wherein the system is configured for actuation of at least one adjuster associated with the lateral portion, before actuation of an adjuster associated with the posterior and/or anterior portion.

19. The system of claim 18, wherein the system is configured to actuate the plurality of adjusters in at least one predetermined sequence of actuation.

20. The system of claim 18, wherein the system is configured to control an order of actuation of the adjusters in such a manner as to provide reinforcement of a mitral valve without provoking onset of substantial systolic anterior motion (SAM) of the anterior mitral valve leaflet.

21. A system comprising:

an adjustable annuloplasty ring assembly having at least one fluid-deployable device for adjusting a shape of at least a portion of the ring assembly after implantation in the body; and

a controllable actuator for controlling flow of fluid to and/or from the fluid-deployable device.

22. The system of claim 21, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm;

or

a piston within a cylinder.

23. The system of claim 21, wherein the fluid is selected from:

a gas;

a liquid;

or

a gel.