DEVICES, SYSTEMS AND METHODS FOR USING AND MONITORING HEART VALVES
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.
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, medical device, or kit according to any one of claims 1 to 19 , each wireless heart valve, medical device, or kit having one or more wireless sensors;
directing a wireless interrogation unit to collect sensor data from at least one of the respective one or more wireless sensors; and
receiving the collected sensor data.
37 . The non-transitory computer-readable storage medium of claim 36 whose stored contents configure a computing system to perform a method, the method further comprising:
identifying a plurality of subjects, each identified subject having at least one wireless heart valve, medical device, or kit, each wireless heart valve, medical device, or kit having one or more wireless sensors;
directing a wireless interrogation unit associated with each identified subject to collect sensor data from at least one of the respective one or more wireless sensors;
receiving the collected sensor data; and
aggregating the collected sensor data.
38 . The non-transitory computer-readable storage medium of claim 36 whose stored contents configure a computing system to perform a method, the method further comprising:
removing sensitive subject data from the collected sensor data; and
parsing the aggregated data according to a type of sensor.
39 . The non-transitory computer-readable storage medium of claim 36 whose stored contents configure a computing system to perform a method, wherein directing the wireless interrogation unit includes directing a control unit associated with the wireless interrogation unit.
40 . The non-transitory computer readable storage medium according to any one of claims 36 to 39 , wherein said heart valve, medical device, or kit is an assembly according to any one of claims 1 to 19 .
41 . The storage medium according to any one of claims 36 to 40 wherein said collected sensor data is received on a watch, wrist band, cell phone or glasses.
42 . The storage medium according to any one of claims 36 to 41 wherein said collected sensor data is received within a subject's residence or office.
43 . The storage medium according to any one of claims 36 to 42 wherein said collected sensed data is provided to a health care provider.
44 . The storage medium according to any one of claims 36 to 43 wherein said sensed data is posted to one or more websites.
45 . The method according to any one of claims 31 to 35 , or storage medium according to any one of claims 36 to 44 , wherein said data is analyzed.
46 . The method or storage medium according to claim 45 wherein said data is plotted to enable visualization of change over time.
47 . The method or storage medium according to claim 45 or 46 wherein said data is plotted to provide a three-dimensional image.
48 . A method for determining degradation of a heart valve, comprising the steps of a) providing to a body passageway of a subject a heart valve according to any one of claims 1 to 7 or 16 to 19 , and b) detecting a change in a sensor, and thus determining degradation of the heart valve.
49 . The method according to claim 48 wherein said sensor is capable of detecting one or more physiological and/or locational parameters.
50 . The method according to claim 48 or 49 wherein said sensor detects contact, fluid flow, pressure and/or temperature.
51 . The method according to any one of claims 48 to 50 wherein said sensor detects a location within the subject.
52 . The method according to any one of claims 48 to 50 wherein said sensor moves and/or is eliminated by the body upon degradation of the heart valve.
53 . The method according to any one of claims 48 to 52 wherein the step of detecting is a series of detections over time.
54 . A method for determining an infection associated with a heart valve, comprising the steps of a) providing to a body passageway of a subject a heart valve according to any one of claims 1 to 19 , wherein said heart valve comprises at least one temperature sensor and/or metabolic sensor, and b) detecting a change in said temperature sensor and/or metabolic sensor, and thus determining the presence of an infection.
55 . The method according to claim 54 wherein the step of detecting is a series of detections over time.
56 . The method according to claim 54 or 55 wherein said change is greater than a 1% change over the period of one hour.
57 . The method according to claims 54 to 56 wherein said change is a continually increasing temperature and/or metabolic activity over the course of 4 hours.