Devices, systems and methods for using and monitoring heart valves

Patent metadata

Field	Value
Publication number	US-2017196509-A1
Application number	US-201515320296-A
Country	US
Kind code	A1
Filing date	Jun 25, 2015
Priority date	Jun 25, 2014
Publication date	Jul 13, 2017
Grant date	—

Abstract

Heart valves are provided, comprising a heart valve and a plurality of sensors. Briefly stated, heart valves having sensors, as well as related delivery devices are provided with a number of sensors to monitor the integrity and efficaciousness of the device. Within one embodiment, sensors can be positioned within the heart valve, and/or on one or more surfaces of the heart valve. When the phrase “placed in a heart valve” is utilized, it should be understood to refer to any of the above embodiments, unless the context of the usage implies otherwise. Within certain embodiments, the sensors are of the type that are passive and thus do not require their own power supply.

First claim

What is claimed is:

1 . A heart valve comprising:
a heart valve and one or more sensors positioned within or upon said heart valve.

2 . The heart valve of claim 1 wherein said one or more sensors includes a sensor within the matrix of the heart valve.

3 . The heart valve of claim 1 wherein said one or more sensors includes a sensor within or upon said heart valve.

4 . The heart valve according to any one of claims 1 to 4 wherein said sensor is selected from the group consisting of fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, liquid volume sensors, liquid flow sensors, chemistry sensors, metabolic sensors, accelerometers, mechanical stress sensors and temperature sensors.

5 . The heart valve according to any one of claims 1 to 4 wherein said heart valve is a mechanical heart valve.

6 . The heart valve according to claim 5 wherein said mechanical valve is a ball and cage valve.

7 . The heart valve according to claim 5 wherein said mechanical valve is a tilting disc heart valve.

8 . The heart valve according to any one of claims 1 to 4 wherein said heart valve is a biological heart valve.

9 . The heart valve according to any one of claims 1 to 4 wherein said heart valve is a percutaneous heart valve.

10 . A medical device, comprising a percutaneous heart valve according to claim 9 , and a balloon catheter comprising one or more sensors.

11 . The medical device according to claim 10 wherein said sensor on said balloon catheter is selected from the group consisting of accelerometers, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors.

12 . The medical device according to claim 11 wherein said accelerometer detects acceleration, tilt, vibration, shock and or rotation.

13 . The heart valve according to any one of claims 1 to 9 or medical device according to any one of claim 11 or 12 further comprising:
an electronic processor positioned upon and/or inside the heart valve or medical device that is electrically coupled to sensors.

14 . The heart valve or medical device according to claim 13 wherein the electric coupling is a wireless coupling.

15 . The heart valve or medical device according to claim 13 further including:
a memory coupled to the electronic processor and positioned upon and/or inside the heart valve or medical device.

16 . The heart valve or medical device according to any one of claims 1 to 15 wherein said sensor is a plurality of sensors which are positioned on or within said heart valve, medical device and/or kit at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

17 . The heart valve or medical device according to any one of claims 1 to 15 wherein said sensor is a plurality of sensors which are positioned on or within said heart valve, medical device and/or kit at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

18 . The heart valve or medical device to any one of claims 1 to 17 wherein said sensors are placed randomly within the heart valve or medical device.

19 . The heart valve or medical device according to any one of claims 1 to 18 wherein the one or more of the sensors are placed at specific locations within the heart valve or medical device.

20 . A method comprising:
obtaining data from a sensor positioned at a plurality of locations between on and/or within a heart valve or medical device according to any one of claims 1 to 19 of a subject; storing the data in a memory device located on or within the heart valve or medical device; and transferring the data from the memory to a location outside the heart valve or medical device.

21 . A method according to claim 20 , further comprising the step of analyzing said data.

22 . A method for detecting and/or recording an event in a subject with a heart valve or medical device as provided in any one of claims 1 to 19 , comprising the step of interrogating at a desired point in time the activity of one or more sensors within the heart valve or medical device, and recording said activity.

23 . The method according to claim 22 wherein the step of interrogating is performed by a subject which has an implanted heart valve, and the step of recording is performed on a wearable device.

24 . The method according to any one of claim 22 , or 23 , wherein said recording is provided to a health care provider.

25 . A method for imaging a heart valve or medical device, comprising the steps of
(a) detecting the location of one or more sensors of a heart valve or medical device according to any one of claims 1 to 19 ; and (b) visually displaying the location of said one or more sensors, such that an image of the heart valve or medical device is created.

26 . The method according to claim 25 wherein the step of detecting occurs over time.

27 . The method according to claim 25 or 26 , wherein said visual display shows changes in the positions of said sensors over time, and/or changes in temperature of the sensors or surrounding tissue over time.

28 . The method according to any one of claims 25 to 27 wherein said visual display is a three-dimensional image of said heart valve.

29 . A method for inserting a heart valve or medical device into a subject, comprising the steps of
(a) inserting a heart valve or medical device according to any one of claims 1 to 19 into a subject; and (b) imaging the placement of said heart valve or medical device according to the method of any one of claims 25 to 28 .

30 . A method for examining a heart valve or medical device according to any one of claims 1 to 19 which has been previously inserted into a patient, comprising the step of imaging the heart valve according to the method of any one of claims 25 to 28 .

31 . A method of monitoring a heart valve, medical device, or kit within a subject, comprising:
transmitting a wireless electrical signal from a location outside the body to a location inside the subject's body; receiving the signal at a sensor positioned on a heart valve, medical device, or kit according to any one of claims 1 to 19 located inside the body; powering the sensor using the received signal; sensing data at the sensor; and outputting the sensed data from the sensor to a receiving unit located outside of the body.

32 . The method according to claim 31 wherein said receiving unit is a watch, wrist band, cell phone or glasses.

33 . The method according to claim 31 or 32 wherein said receiving unit is located within a subject's residence or office.

34 . The method according to claims any one of claims 31 to 33 wherein said sensed data is provided to a health care provider.

35 . The method according to any one of claims 31 to 34 wherein said sensed data is posted to one or more websites.

36 . A non-transitory computer-readable storage medium whose stored contents configure a computing system to perform a method, the method comprising:
identifying a subject, the identified subject having at least one wireless heart valve

Assignees

• Canary Medical Inc

Inventors

• Hunter William L

Classifications

• A61F2250/0096

  Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers · CPC title

• A61F2/2472

  Devices for testing · CPC title

• A61B5/0031

  Implanted circuitry · CPC title

• A61B2562/0247

  Pressure sensors · CPC title

• A61B5/02055

  Simultaneously evaluating both cardiovascular condition and temperature · CPC title