Valve implant with integrated sensor and transmitter

• US 10,667,904 B2
• Filed: 03/07/2017
• Issued: 06/02/2020
• Est. Priority Date: 03/08/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marquez, Salvador, Chang, Da-Yu, Woo, Cindy, Yang, Hao-Chung, Dang, Lynn T., Sanguinetti, Javier A., Siemons, Alexander H., Keidar, Yaron, Lin, Virginia Qi, Conklin, Brian S., Bobo, Jr., Donald E.
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/452,617
• Publication Number:
  US 20170258585A1
• Time in Patent Office: 1,183 Days
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/00 Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof

Abstract

Sensor-integrated prosthetic valves that can comprise a variety of features, including a plurality of valve leaflets, a frame assembly configured to support the plurality of valve leaflets and define a plurality of commissure supports terminating at an outflow end of the prosthetic valve, a sensor device associated with the frame assembly and configured to generate a sensor signal, for example, a sensor signal indicating deflection of one or more of the plurality of commissure supports, and a transmitter assembly configured to receive the sensor signal from the sensor device and wirelessly transmit a transmission signal that is based at least in part on the sensor signal.

Claims

1. A prosthetic valve comprising:

a plurality of valve leaflets;

a frame assembly configured to support the plurality of valve leaflets, the frame assembly comprising an outer frame defining arcuate commissure regions and a flexible band comprising commissure support portions configured to fit at least partially within the arcuate commissure regions of the outer frame, the valve leaflets being secured at least in part between the outer frame and the flexible band;

a strain gauge device including one or more conductors applied directly to an outer surface of one of the commissure support portions of the flexible band, the strain gauge device being configured to generate a sensor signal providing a direct measurement of radial deflection of the one of the commissure support portions; and

a transmitter assembly configured to receive the sensor signal from the strain gauge device and wirelessly transmit a transmission signal, wherein the transmission signal is based at least in part on the sensor signal.

2. The prosthetic valve of claim 1, wherein the one or more conductors are disposed in one or more etched channels formed in the one of the commissure support portions of the flexible band.

3. The prosthetic valve of claim 1, wherein the one or more conductors are printed on the outer surface of the one of the commissure support portions of the flexible band.

4. The prosthetic valve of claim 1, further comprising one or more piezoelectric crystals attached to the flexible band and configured to generate power for use by the prosthetic valve.

5. The prosthetic valve of claim 1, wherein the transmitter assembly is configured to receive power wirelessly from an external power supply and transmit the transmission signal using the received power.

6. The prosthetic valve of claim 5, wherein the external power supply comprises a wearable strap configured to be worn around an abdomen of a patient in whom the prosthetic valve is implanted.

7. The prosthetic valve of claim 1, further comprising a piezoresistive sensor device.

8. The prosthetic valve of claim 1, wherein the transmitter assembly comprises an antenna coil wrapped around a stiffening band of the frame assembly.

9. A prosthetic valve comprising:

a plurality of valve leaflets;

a frame assembly configured to support the plurality of valve leaflets, the frame assembly comprising an outer frame defining arcuate commissure regions and a flexible band comprising commissure support portions configured to fit at least partially within the arcuate commissure regions of the outer frame, the valve leaflets being secured at least in part between the outer frame and the flexible band;

a power generator implemented within one of the commissure support portions of the flexible band, the power generator comprising a piezoelectric polymer layer disposed between first and second conductive layers that are sealed within the one of the commissure portions of the flexible band; and

a transmitter assembly configured to wirelessly transmit a transmission signal using power using power generated by the power generator.

10. The prosthetic valve of claim 9, wherein the transmitter assembly includes an electrically conductive coil, wherein the transmitter assembly is further configured to perform said wireless transmission using the coil.

11. The prosthetic valve of claim 9, wherein one or more of the commissure support portions are configured to deflect in response to formation of fluid vortices in a fluid channel in which the prosthetic valve is disposed.