Prosthetic aortic valve pacing system

• US 10,543,083 B2
• Filed: 01/08/2018
• Issued: 01/28/2020
• Est. Priority Date: 01/08/2018
• Status: Active Grant

• Current Assignee: E-Valve Systems Limited
• Original Assignee: Rainbow Medical Ltd.
• Inventors: Gross, Yossi
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/864,661
• Publication Number:
  US 20190209302A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/008 Alarm means
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A method of assembling an electronic prosthetic aortic valve is provided. The method includes inserting an electronics component into a valve component, the electronics component including one or more electrodes and a prosthetic-valve coil, and the valve component including a frame and prosthetic leaflets coupled to the frame; and coupling the electronics component to the valve component. Other embodiments are also described.

Claims

1. A method of assembling an electronic prosthetic aortic valve, the method comprising:

inserting an electronics component into a valve component, the electronics component comprising one or more electrodes and a prosthetic-valve coil, and the valve component comprising a frame and prosthetic leaflets coupled to the frame; and

coupling the electronics component to the valve component,

wherein coupling the electronics component to the valve component comprises;

coupling a first portion of the electronics component to an inner surface of the frame; and

coupling a second portion of the electronics component to an external surface of the frame.

2. The method according to claim 1,

wherein the first portion of the electronics component comprises the prosthetic-valve coil and one of the one or more electrodes, and

wherein the second portion of the electronics component comprises a cathode of the one or more electrodes.

3. The method according to claim 2, wherein the electronics component further comprises prosthetic-aortic-valve control circuitry, and wherein the first portion of the electronic component comprises the prosthetic-aortic-valve control circuitry.

4. The method according to claim 3,

wherein the electronics component further comprises an elongate insulated electrical conductor that electrically couples the cathode to the prosthetic-aortic-valve control circuitry, and

wherein coupling the electronics component to the valve component comprises coupling the electronics component to the valve component such that the conductor passes from inside to outside the frame.

5. The method according to claim 4, wherein the valve component further comprises a skirt, and wherein coupling the electronics component to the valve component comprises coupling the electronics component to the valve component such that the conductor passes from inside to outside the frame through the skirt.

6. A method of assembling an electronic prosthetic aortic valve, the method comprising:

inserting an electronics component into a valve component, the electronics component comprising one or more electrodes and a prosthetic-valve coil, and the valve component comprising a frame and prosthetic leaflets coupled to the frame; and

coupling the electronics component to the valve component,

wherein coupling the electronics component to the valve component comprises stitching the electronics component to the valve component.

7. The method according to claim 6, wherein the valve component further comprises a skirt, and wherein coupling the electronics component to the valve component comprises stitching the electronics component to the skirt.

8. Apparatus comprising a prosthetic aortic valve, which comprises:

(a) a plurality of prosthetic leaflets;

(b) a frame, which is shaped so as to define;

(1) an upstream inflow portion,

(2) a downstream outflow portion, and

(3) a constriction portion, which is axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflets are coupled to the constriction portion, and wherein when the prosthetic aortic valve is in an expanded fully-deployed configuration;

(A) free edges of the prosthetic leaflets face toward the downstream outflow portion, and (B) a ring-shaped longitudinal border between the downstream outflow portion and the constriction portion is defined by a downstream-most point of the frame to which the prosthetic leaflets are coupled;

(c) one or more electrodes coupled to the frame; and

(d) a prosthetic-valve coil, which is in non-wireless electrical communication with the one or more electrodes, and which is coupled to the frame no more than 1 mm upstream of the ring-shaped longitudinal border.

9. The apparatus according to claim 8, wherein the prosthetic-valve coil is disposed axially along the downstream outflow portion.

10. The apparatus according to claim 8, wherein at least one of the one or more electrodes is coupled to the upstream inflow portion of the frame.

11. The apparatus according to claim 10, wherein when the prosthetic aortic valve is in the expanded fully-deployed configuration:

the frame has an inflow end at the upstream inflow portion and a downstream outflow end at the downstream outflow portion, and an axial length, measured between the inflow end and the downstream outflow end, and

at least one of the one or more electrodes is coupled to the upstream inflow portion within a distance from the inflow end, the distance equal to 10% of the axial length of the frame.

12. A valve prosthesis system comprising the prosthetic aortic valve according to claim 8, the valve prosthesis system further comprising an external unit, which comprises:

an external-unit coil; and

external-unit control circuitry, which is configured to drive the external-unit coil to wirelessly transfer energy, by inductive coupling, to the prosthetic-valve coil when the prosthetic aortic valve is in the expanded fully-deployed configuration.

13. The valve prosthesis system according to claim 12, wherein the external-unit control circuitry is configured to drive the one or more electrodes to apply a pacing signal.

14. The valve prosthesis system according to claim 12, wherein the external unit comprises a collar configured to be worn around a patient'"'"'s neck, and the external-unit coil is incorporated into the collar.

15. The valve prosthesis system according to claim 8,

wherein the prosthetic aortic valve further comprises prosthetic-aortic-valve control circuitry, which is coupled to the frame and which is in non-wireless electrical communication with the one or more electrodes, and

wherein the prosthetic-valve coil is in non-wireless electrical communication with the prosthetic-aortic-valve control circuitry, such that the prosthetic-valve coil is in non-wireless electrical communication with the one or more electrodes via the prosthetic-aortic-valve control circuitry.

16. The valve prosthesis system according to claim 15, wherein the prosthetic-aortic-valve control circuitry is configured to apply pacing.

17. The valve prosthesis system according to claim 15,

wherein the one or more electrodes comprise a cathode that is coupled to the upstream inflow portion of the frame, and

wherein the prosthetic-aortic-valve control circuitry is configured to drive the cathode to apply a cathodic current.

18. The valve prosthesis system according to claim 17, wherein the prosthetic aortic valve further comprises a skirt coupled to an external surface of the upstream inflow portion of the frame, and wherein the cathode is disposed on an external surface of the skirt.

19. The valve prosthesis system according to claim 15,

wherein the prosthetic leaflets are coupled to the frame at at least first and second commissures that are located at respective first and second angular locations around the frame separated by a first angular offset around the frame when the prosthetic aortic valve is in the expanded fully-deployed configuration, and

wherein the prosthetic-aortic-valve control circuitry is coupled to the frame at a third angular location around the frame that is separated from the first angular location by a second angular offset that equals between 40% and 60% of the first angular offset when the prosthetic aortic valve is in the expanded fully-deployed configuration.

20. The valve prosthesis system according to claim 15, wherein the prosthetic-aortic-valve control circuitry is coupled to the frame inside the frame.

21. The valve prosthesis system according to claim 15, wherein the prosthetic-aortic-valve control circuitry is stitched to the frame.

22. The valve prosthesis system according to claim 15, wherein the prosthetic aortic valve further comprises a skirt coupled to an external surface of the upstream inflow portion of the frame, and wherein the prosthetic-aortic-valve control circuitry is stitched to the skirt.

23. The valve prosthesis system according to claim 15, wherein the prosthetic-aortic-valve control circuitry is configured to (a) use the one or more electrodes to sense a cardiac signal, and (b) drive the prosthetic-valve coil to transmit a wireless signal indicative of the sensed cardiac signal.

24. The valve prosthesis system according to claim 15, wherein the prosthetic aortic valve comprises an electronic implant, which comprises:

the prosthetic-aortic-valve control circuitry; and

a multi-layer protective coating, which comprises the following layers in the following order;

a first inner aluminum oxide (AIOx) film layer deposited on the circuitry; and

a second parylene layer deposited on the first inner AIOx film layer, wherein the prosthetic-aortic-valve control circuitry is not encased in a case.