Implantable coaptation assist devices with sensors and associated systems and methods

Patent metadata

Field	Value
Publication number	US-11633281-B2
Application number	US-202016745246-A
Country	US
Kind code	B2
Filing date	Jan 16, 2020
Priority date	Jan 16, 2019
Publication date	Apr 25, 2023
Grant date	Apr 25, 2023

Abstract

Coaptation assist device for repairing cardiac valves and associated systems and methods are disclosed herein. A coaptation assist device configured in accordance with embodiments of the present technology can include, for example, a fixation member configured to press against cardiac tissue proximate to a native valve annulus, and a stationary coaptation structure extending away from the fixation member. The coaptation structure can include an anterior surface configured to coapt with a first native leaflet during systole and a posterior surface configured to displace at least a portion of a second native leaflet. The device also includes at least one sensor configured to detect parameters associated with at least one of cardiac function and device functionality. The sensors can be pressure sensors configured to detect left atrial pressure and/or left ventricular pressure.

First claim

We claim:

1. A coaptation assist device for repairing a mitral valve, the coaptation assist device comprising:
an atrial fixation member configured to press against cardiac tissue proximate to a native mitral annulus;
a coaptation structure extending away from the atrial fixation member and radially inward from the atrial fixation member, the coaptation structure comprising an anterior surface configured to coapt with a first native leaflet during systole and a posterior surface configured to displace at least a portion of a second native leaflet, wherein the coaptation structure is substantially stationary during cardiac cycles; and
a sensor affixed to a portion of the coaptation assist device and configured to detect one or more parameters associated with at least one of cardiac function and device functionality.

2. The coaptation assist device of claim 1 wherein:
the sensor is a first pressure sensor coupled to the atrial fixation member and configured to detect left atrial pressure during cardiac cycles; and
the coaptation assist device further comprises a second pressure sensor coupled to the coaptation structure and configured to detect left ventricular pressure during cardiac cycles.

3. The coaptation assist device of claim 1 wherein:
the sensor is a first capacitive pressure sensor coupled to the atrial fixation member and configured to detect left atrial pressure during cardiac cycles, the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; and
the coaptation assist device further comprises a second capacitive pressure sensor coupled to the coaptation structure and configured to detect left ventricular pressure during cardiac cycles, the second capacitive pressure sensor having a second LC circuit with a second resonant frequency substantially different from the first resonant frequency,
wherein the first and second LC circuits are configured to be interrogated simultaneously by an external device without interfering with each other.

4. The coaptation assist device of claim 1 wherein:
the fixation member comprises a wire mesh structure, and wherein at least a portion of the wire mesh structure is electroplated; and
the sensor comprises a capacitive pressure sensor attached to the wire mesh structure of the fixation member, wherein the wire mesh structure defines an antenna of the capacitive pressure sensor for transmitting and receiving signals to and from an external device.

5. The coaptation assist device of claim 1 wherein:
the coaptation structure comprises a plurality of struts, and wherein at least a portion of the struts are electroplated; and
the sensor comprises a capacitive pressure sensor attached to the struts of the coaptation structure, wherein the struts defines an antenna of the capacitive pressure sensor for transmitting and receiving signals to and from an external device.

6. The coaptation assist device of claim 1 wherein:
the fixation member comprises an atrial edge region; and
the sensor is a capacitive pressure sensor affixed to the atrial edge region, wherein the capacitive pressure sensor comprises a capacitive element and an inductive element, the inductive element is a coil extending along the atrial edge region and configured to be stimulated by an external energy source.

7. The coaptation assist device of claim 1 wherein:
the fixation member comprises an electroplated mesh structure; and
the sensor is a capacitive pressure sensor affixed to the fixation member, wherein the capacitive pressure sensor comprises a capacitive element and an inductive element, the electroplated mesh structure defines the inductive element.

8. The coaptation assist device of claim 1 wherein the sensor comprises a self-contained pressure sensor attached to an anterior surface of the fixation member.

9. The coaptation assist device of claim 1 , further comprising a power storage element operably coupled to the sensor and configured to store energy until the power storage element has sufficient energy to detect measurements and transmit the detected measurements to an internal device.

10. The coaptation assist device of claim 1 wherein the sensor comprises an accelerometer coupled to the coaptation structure and configured to detect movement of the coaptation structure during cardiac cycles.

11. The coaptation assist device of claim 1 wherein the coaptation structure comprises a plurality of struts that define a chamber, and wherein, before device delivery, the sensor is positioned freely within the chamber.

12. The coaptation assist device of claim 1 , further comprising:
an appendage extending from a posterior portion of the coaptation structure, the appendage comprises a flexible frame biased outwardly away from the coaptation structure and configured to contact a left ventricular wall; and
wherein the sensor comprises an accelerometer attached to the appendage to detect movement of the left ventricular wall.

13. The coaptation assist device of claim 1 wherein the sensor comprises at least one of an accelerometer and a strain gauge configured to detect cardiac wall movement.

14. The coaptation assist device of claim 1 wherein the sensor comprises a microphone configured to detect acoustic signals during cardiac cycles.

15. The coaptation assist device of claim 1 wherein the sensor comprises at least one flow sensor coupled to an atrial-facing surface of the coaptation structure and configured to measure flow patterns throughout cardiac cycles.

16. A heart valve repair and monitoring system, comprising:
a valve repair device comprising—
a coaptation structure comprising an anterior surface configured to coapt with a first native leaflet during systole and a posterior surface configured to displace at least a portion of a second native leaflet; and
a fixation member coupled to the coaptation structure and configured to anchor the coaptation structure proximate to a native heart valve annulus, wherein the coaptation structure remains substantially stationary relative to the fixation member during cardiac cycles; and
a pressure sensor configured to detect pressure during cardiac cycles; and

an external stimulation-detection device configured to interrogate the pressure sensor to wirelessly receive detected data.

17. The heart valve repair and monitoring system of claim 16 wherein the external stimulation-detection device is configured to power the pressure sensor.

18. The heart valve repair and monitoring system of claim 16 wherein:
the pressure sensor is a first capacitive pressure sensor coupled to the fixation member and configured to detect left atrial pressure during cardiac cycles, the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; and
the valve repair device further comprises a second capacitive pressure sensor coupled to the coaptation structure and configured to detect left ventricular pressure during cardiac cycles, the second capacitive pressure sensor having a second LC circuit with a second resonant frequency substantially different from the first resonant frequency,
wherein the first and second LC circuits are configured to be interrogated simultaneously by an external device without interfering with each other.

19. The heart valve repair and monitoring system of claim 18 wherein:
the first capacitive pressure sensor comprises a first LC circuit with a first resonant frequency;
the second capacitive pressure sensor comprises a second LC circuit with a second resonant frequency s

Assignees

• Half Moon Medical Inc
• Medtronic Inc

Inventors

• Kappetein Arie Pieter
• Fann James I
• Gifford Iii Hanson S
• Mclean Matthew
• Krishnamurthy Gaurav
• Zimmerman Neil

Classifications

• A61F2/2463 Primary

  Implants forming part of the valve leaflets · CPC title

• A61B5/0538

  invasively, e.g. using a catheter · CPC title

• A61B5/029

  Measuring blood output from the heart, e.g. minute volume · CPC title

• A61B5/0215

  by means inserted into the body · CPC title

• A61B5/0031

  Implanted circuitry · CPC title