Implantable coaptation assist devices with sensors and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12390331-B2
Application number	US-202318187603-A
Country	US
Kind code	B2
Filing date	Mar 21, 2023
Priority date	Jan 16, 2019
Publication date	Aug 19, 2025
Grant date	Aug 19, 2025

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 method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure directly contacts and displaces a first native leaflet of a native mitral valve of a heart and directly contacts and coapts with a second native leaflet of the native mitral valve during systole; and
interrogating, via an external device, a pressure sensor of the mitral valve repair device to receive pressure data during cardiac cycles of the heart.

2. A method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure displaces a first native leaflet of a native mitral valve of a heart and coapts with a second native leaflet of the native mitral valve during systole;
deploying a fixation member of the mitral valve repair device to a left atrium of the heart such that the fixation member presses against cardiac tissue in the left atrium;
after deploying the fixation member, sliding a pressure sensor of the mitral valve repair device along sutures extending from a delivery system to the fixation member;
coupling the pressure sensor to the deployed fixation member; and
interrogating via an external device, the pressure sensor of the mitral valve repair device to receive pressure data during cardiac cycles of the heart.

3. The method of claim 1 , further comprising:
detecting left ventricular wall movement during the cardiac cycles via an accelerometer and/or strain gauge of the mitral valve repair device.

4. The method of claim 1 , further comprising powering the pressure sensor via the external device.

5. A method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure displaces a first native leaflet of a native mitral valve of a heart and coapts with a second native leaflet of the native mitral valve during systole;
deploying a fixation member of the mitral valve repair device to a left atrium of the heart such that the fixation member presses against cardiac tissue in the left atrium; and
interrogating, via an external device, a pressure sensor of the mitral valve repair device to receive pressure data during cardiac cycles of the heart, wherein the pressure sensor is coupled to the fixation member, and wherein the pressure data comprises a left atrial pressure within the left atrium during the cardiac cycles.

6. The method of claim 1 wherein the pressure sensor is coupled to the coaptation structure, and wherein the pressure data comprises left ventricular pressure within a left ventricle of the heart during the cardiac cycles.

7. The method of claim 5 , wherein:
the pressure sensor is a first pressure sensor coupled to the fixation member, wherein the pressure data is first pressure data; and
the method further comprises interrogating, via the external device, a second pressure sensor of the mitral valve repair device coupled to the coaptation structure to receive second pressure data comprising left ventricular pressure within a left ventricle of the heart during the cardiac cycles.

8. The method of claim 7 wherein the first pressure sensor comprises a first resonant circuit having a first resonant frequency, wherein the second pressure sensor comprises a second resonant circuit having a second resonant frequency substantially different than the first resonant frequency, and wherein interrogating the first pressure sensor and interrogating the second pressure sensor occurs substantially simultaneously.

9. The method of claim 7 wherein interrogating the first pressure sensor and interrogating the second pressure includes sequentially interrogating the first pressure sensor and interrogating the second pressure sensor.

10. A method of claim 1 monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure displaces a first native leaflet of a native mitral valve of a heart and coapts with a second native leaflet of the native mitral valve during systole;
deploying a fixation member of the mitral valve repair device to a left atrium of the heart such that the fixation member presses against cardiac tissue in the left atrium, wherein:
the fixation member comprises a wire mesh structure; and
at least a portion of the wire mesh structure defines an antenna; and

interrogating, via an external device, a pressure sensor of the mitral valve repair device to receive pressure data during cardiac cycles of the heart, wherein interrogating the pressure includes establishing a wireless connection to the pressure sensor via the antenna.

11. A method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure displaces a first native leaflet of a native mitral valve of a heart and coapts with a second native leaflet of the native mitral valve during systole, wherein the coaptation structure comprises a plurality of struts, and wherein at least a portion of one or more of the struts defines an antenna; and
interrogating via an external device, a pressure sensor of the mitral valve repair device to receive pressure data during cardiac cycles of the heart wherein interrogating the pressure includes establishing a wireless connection to the pressure sensor via the antenna.

12. The method of claim 1 wherein:
the coaptation structure has an anterior surface and a posterior surface; and
deploying the coaptation structure includes positioning (a) the posterior surface to engage and displace the first native leaflet and (b) the anterior surface to coapt with the second native leaflet during systole.

13. The method of claim 1 wherein deploying the coaptation structure includes positioning the coaptation structure to remain substantially stationary during the cardiac cycles.

14. The method of claim 1 , further comprising coupling the pressure sensor to the mitral valve repair device before deploying the coaptation structure.

15. A method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure directly contacts and displaces a first native leaflet of a native mitral valve of a heart and directly contacts and coapts with a second native leaflet of the native mitral valve during systole; and
interrogating, via an external device, a sensor of the mitral valve repair device to detect one or more parameters associated with at least one of cardiac function of the heart and functionality of the mitral valve repair device.

16. A method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure displaces a first native leaflet of a native mitral valve of a heart and coapts with a second native leaflet of the native mitral valve during systole; and
interrogating, via an external device, a strain gauge and/or an accelerometer coupled to the coaptation structure to detect movement of the coaptation structure during cardiac cycles.

17. A method of monitoring a native mitral valve, the method comprising:
deploying a coaptation structure of a mitral valve repair device such that the coaptation structure displaces a first native leaflet of a native mitral valve of a heart and coapts with a second native leaflet

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

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2/90

  characterised by a net-like or mesh-like structure · CPC title

• A61B5/686

  Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence) · CPC title

• A61B5/4851

  Prosthesis assessment or monitoring · CPC title

• A61B5/029

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