ADJUSTABLE ANNULOPLASTY RING AND SYSTEM

• US 20160256274A1
• Filed: 10/25/2013
• Published: 09/08/2016
• 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
• Granted Patent: US 10,058,427 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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.

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.

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

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

48. 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.

49. The assembly of claim 48, 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

50. 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.

51. The assembly of claim 50, further comprising a control member for controlling the extent of deployment of the pressing element.

52. The assembly of claim 50, comprising a latching mechanism for retaining a state of deployment of the pressing element after adjustment.

53. The assembly of claim 50, comprising a ratchet configured to (i) obstruct relaxing of the pressing element from a current deployment state, and (ii) permit further deployment of the pressing element to a further deployment state beyond the current deployment state.

54. The assembly of claim 53, wherein the ratchet includes a controllable override for allowing relaxing of the pressing element from a current deployment state.

55. The assembly of claim 50, configured to provide a plurality of predetermined different deployment states representing different extents of deployment, and each deployment state is self-retainable by the assembly.

56. The assembly of claim 55, configured to provide four different deployment states including a non-deployed state a first partly deployed state, a second further deployed state, and a third fully deployed state.

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

60. The assembly of claim 1, wherein the at least one deployable pressing element comprises a deflectable blade configured to bow in response to application of mechanical force to at least a portion of the deflectable blade.

61. The assembly of claim 60, wherein the blade is configured to bow in response to application of mechanical force to at least one end of the blade.

62. The assembly of claim 60, wherein the blade has a non-straight shape, when in a non-deployed state, to promote bowing in a direction towards the adjustable ring in response to application of mechanical force,

63. The assembly of claim 60, further comprising a control member, integral with the blade, and extending from the blade in a peripheral direction of the assembly, and the control member is configured for transmission of mechanical force to the blade.

64. The assembly of claim 60, wherein the blade is carried by the support ring and is deflectable to bow towards the adjustable ring.

65. The assembly of claim 64, wherein the support ring comprises a profile shape for controlling the blade state, and the profile shape includes any combination of one or more of:

(I) a curved and/or a convex profile for imparting a partly bowed shape to the blade when in a non-deployed condition;

(ii) a stop profile for restraining one end of the blade against displacement in response to the application of mechanical force, and for allowing pivoting movement of the end of the blade at the stop profile; and

(iii) a retention profile for defining a plurality of different retention positions to which a movable end of the blade may be moved and retained when received by the retention profile.

66. The assembly of claim 65, wherein the retention profile is at least one of a sawtooth profile and a ratchet profile.

67. The assembly of claim 1, wherein the at least one deployable pressing element comprises a fluid-deployable device.

68. The assembly of claim 67, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm;

or

a piston within a cylinder.

69. The assembly of claim 68, wherein the fluid-deployable device is deployable by a fluid selected from:

a gas;

a liquid;

or

a gel.

70. 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.

71. The assembly of claim 70, 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.

72. 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.

73. The assembly of claim 70, wherein the ring assembly is adjustable, after implantation, for adjusting a shape of the annuloplasty ring assembly.

74. The assembly of claim 72, wherein the ring assembly is adjustable, after implantation, for adjusting a shape of the annuloplasty ring assembly.

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

77. The assembly of claim 1, wherein the at least one deployable pressing element comprises a crick configured to extend in response to application of mechanical force to at least a portion of the crick.

78. The assembly of claim 77, wherein the crick comprises two ratchets and two counterratchets, and the ratchets move in the counterratchets into the extended configuration.

79. The assembly of claim 1, wherein the at least one deployable pressing element comprises a pantograph configured to extend, in response to application of mechanical force, to at least a portion of the pantograph.

80. A system comprising:

an adjustable annuloplasty ring assembly of claim 1;

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

a transmission line for coupling the actuator to the ring assembly for transmitting the physical control signal from the actuator to the ring assembly, the transmission line being made at least partly of material that is biodegradable and/or resorbable in the human body,

81. The system of claim 80, wherein the transmission line is made substantially entirely of material that is biodegradable and/or resorbable in the human body.

82. The system of claim 80, wherein the transmission line is a transcatheter comprising a lumen.

83. A system of claim 80, the system comprising:

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

86. The system of claim 80, wherein the physical control signal is selected from:

a mechanical adjustment force;

a fluid control;

a pneumatic control;

or

a hydraulic control.

87. The system of claim 86 comprising:

an actuator for controlling actuation of the plurality of adjusters.

88. The system of claim 86, wherein the system is configured to actuate the plurality of adjusters in at least one predetermined sequence of actuation.

89. The system of claim 86, wherein the ring assembly comprises an anterior portion for fitting near an anterior valve leaflet of a cardiac valve to be treated, a posterior portion opposite the anterior portion for fitting near a posterior valve leaflet, and at least one lateral portion between the posterior and the anterior portions;

and

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.

90. The system of claim 80, 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.

91. The system of claim 80, further 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.

92. The system of claim 90, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm;

or

a piston within a cylinder.

93. The system of claim 90, wherein the controllable actuator is operable to introduce a hardenable fluid to the fluid-deployable device, whereby a state of the device sets when the fluid hardens.

94. The system of claim 90, wherein the fluid is selected from:

a gas;

a liquid;

or

a gel.

6. An adjustable annulopasty 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.

58. The assembly of claim 6, wherein the at east 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.

11. The assembly of claim 8, comprising a ratchet configured to (i) obstruct relaxing of the pressing element from a current deployment state, and (ii) permit further deployment of the pressing element to a further deployment state beyond the current deployment state.

12. The assembly of claim 11, wherein the ratchet includes a controllable override for allowing relaxing of the pressing element from a current deployment state.

13. The assembly of claim 8, configured to provide a plurality of predetermined different deployment states representing different extents of deployment, at each of which the deployment state is self-retainable by the assembly.

14. The assembly of claim 13, configured to provide four different deployment states, including a non-deployed state, a first partly deployed state, a second further deployed state, and a third fully deployed state.

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

16. 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 deflectable blade configured to bow in response to application of mechanical force to at least a portion of the deflectable blade.

17. The assembly of claim 16, wherein the blade is configured to bow in response to application of mechanical force to at least one end of the blade,

18. The assembly of claim 16, wherein the blade has a non-straight shape, when in a non-deployed state, to promote bowing in a direction towards the adjustable ring in response to said application of mechanical force.

19. The assembly of claim 16 further comprising a control member, integral with the blade, and extending from the blade in a peripheral direction of the assembly, the control member configured for transmission of mechanical force to the blade.

20. The assembly of claim 16, wherein the blade is carried by the support ring, and is deflectable to bow towards the adjustable ring.

21. The assembly of claim 20, wherein the support ring comprises a profile shape for controlling the blade state, the profile shape including any combination of one or more of:

(i) a curved and/or a convex profile for imparting a partly bowed shape to the blade when in a non-deployed condition;

(ii) a stop profile for restraining one end of the blade against displacement in response to said application of mechanical force, and optionally for allowing pivoting movement of said end of the blade at the stop profile; and

)

(iii) a retention profile for defining a plurality of different retention positions to which a movable end of the blade may be moved and retained when received by the retention profile.

22. The assembly of claim 21, wherein the retention profile is a sawtooth and/or a ratchet profile.

23. An adjustable annuloplasty ring assembly, the assembly cornpnsing:

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.

24. The assembly of claim 23, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm; and

a piston within a cylinder.

25. The assembly of claim 23 wherein the fluid-deployable device is deployable by fluid selected from:

a gas;

a liquid;

a gel.

27. An annuloplasty ring assembly comprising at least one sensor for sensing a parameter relating to performance of a valve to be treated by the assembly.

28. The assembly of claim 27, wherein the sensor comprises at least one selected from:

a Doppler-effect sensor for sensing blood flow;

a transducer for a Doppler-effect sensor;

an acoustic transducer;

an ultrasound transducer; and

a pressure sensor for sensing blood pressure.

30. The annuloplasty ring assembly of claim 27, wherein the ring assembly is adjustable after implantation for adjusting a shape of the annuloplasty ring assembly.

29. An annuloplasty ring assembly comprising at least one electrode for applying or sensing an electrical signal at the site of the cardiac valve.

75. The assembly of claim 29, wherein the assembly is adjustable, after implantation, for adjusting a shape of the annuloplasty ring assembly.

31. An annuloplasty ring assembly comprising a mechanical interface arranged to receive a prosthetic valve.

32. 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 crick configured to extend in response to application of mechanical force to at least a portion of the crick.

33. The assembly of claim 32, wherein the crick comprises two ratchets and two counterratchets, and the ratchets move in the counterratchets into the extended configuration.

34. 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 pantograph configured to extend in response to application of mechanical force to at least a portion of the pantograph.

35. A system comprising:

an adjustable annuloplasty ring assembly;

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

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 the transmission line being made at least partly of material that is biodegradable and/or resorbable in the human body.

36. The system of claim 35, wherein the transmission line is made substantially entirely of material that is biodegradable and/or resorbable in the human body.

37. The system of claim 35, wherein the transmission line is a transcatheter comprising a lumen.

39. The system of claim 35, wherein the physical control signal is selected from:

a mechanical adjustment force;

a fluid control;

a pneumatic control;

or

a hydraulic control.

84. A system of claim 35, the system comprising:

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

38. A system, comprising:

an adjustable annuloplasty ring assernbly;

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.

85. The system of claim 38, wherein the physical control signal is selected from:

a mechanical adjustment force;

a fluid control;

a pneumatic control;

or

a hydraulic control.

40. 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,

41. The system of claim 40, wherein the system is configured to actuate the plurality of adjusters in at least one predetermined sequence of actuation,

42. The system of claim 40, wherein the ring assembly comprises 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 the anterior portions;

and

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 the anterior portion.

43. The system of claim 40, 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.

44. A system, comprising:

n adjustable annuloplasty ring assembly, having at least one fluid-deployable device for adjusting a shape of at east 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.

45. The system of claim 44, wherein the fluid-deployable device is selected from:

an inflatable bladder;

a movable diaphragm;

or

a piston within a cylinder.

46. The system of claim 44, wherein the controllable actuator is operable to introduce a hardenable fluid to the fluid-deployable device, whereby [[the]] a state of the device becomes set when the fluid hardens.

47. The system of claim 44, wherein the fluid is selected from:

a gas;

a liquid;

or

a gel.