# US 11,998,348 B2 · Devices, systems and methods for using and monitoring heart valves > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,348 B2 - Document ID: US11998348B2 - Status: Granted - Kind: B2 - Application number: 16/777,713 - Filed: 2020-01-30 - Published: 2020-08-27 - Granted: 2024-06-04 - Earliest claimed: 2014-06-25 - Assignees: Canary Medical Switzerland AG - Applicants: Canary Medical Inc. - Inventors: William L. Hunter - Web page: https://patentgrep.com/patent/US11998348B2 ## CPC - A61B 5/4851: {Prosthesis assessment or monitoring} - A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet} - A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network} - A61B 5/0028: {Body tissue as transmission medium, i.e. transmission systems where the medium is the human body} - A61B 5/0031: {Implanted circuitry} - A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature} - A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)} - A61B 5/6869: {Heart} - A61F 2/2472: {Devices for testing} - G16B 40/00: ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding - G16B 40/10: Signal processing, e.g. from mass spectrometry [MS] or from PCR - G16H 40/67: for remote operation - A61B 5/0215: by means inserted into the body - A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)} - A61B 5/1102: {Ballistocardiography} - A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)} - A61B 2560/0219: of externally powered implanted units - A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches - A61B 2562/0247: Pressure sensors - A61B 2562/0261: Strain gauges - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2/2433: {using balloon catheter} - A61F 2250/0002: for data transfer - A61F 2250/0096: Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers - G16H 40/63: for local operation - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract Heart valves are provided, comprising a heart valve and a plurality of sensors. ## Claims ### Claim 1 A medical device, comprising a percutaneous heart valve comprising: a support frame, a valve surrounded by the support frame, the value comprising a plurality of leaflets, one or more contact sensors on the support frame, one or more accelerometers on the support frame, one or more pressure sensors positioned within or upon a first side of at least one of the plurality of leaflets, and a balloon catheter comprising: a balloon, one or more contact sensors on the balloon, and one or more accelerometers on the balloon. ### Claim 2 (depends on 1) The medical device according to claim 1, further comprising at least one additional sensor on the balloon selected from the group consisting of pressure sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. ### Claim 3 (depends on 1) The medical device according to claim 1 wherein each of the accelerometer on the support frame and the accelerometer on the balloon detects acceleration, tilt, vibration, shock and or rotation. ### Claim 4 (depends on 1) The medical device according to claim 1 further comprising: an electronic processor positioned upon and/or inside the heart valve or balloon catheter, where the electronic processor is electrically coupled to each of the one or more contact sensors on the support frame, the one or more accelerometers on the support frame, the one or more pressure sensors positioned within or upon the first side of at least one of the plurality of leaflets, the one or more contact sensors on the balloon, and the one or more accelerometers on the balloon. ### Claim 5 (depends on 4) The medical device according to claim 4 wherein the electric coupling is a wireless coupling. ### Claim 6 (depends on 4) The medical device according to claim 4 further including: a memory coupled to the electronic processor and positioned upon and/or inside the heart valve or balloon catheter. ### Claim 7 (depends on 1) The medical device according to claim 1 wherein: the one or more contact sensors on the support frame and the one or more accelerometers on the support frame are positioned on the support frame at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter, the one or more pressure sensors within or upon the first side of at least one of the plurality of leaflets are positioned on the leaflet at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter, and the one or more contact sensors on the balloon and the one or more accelerometers on the balloon are positioned on the balloon at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter. ### Claim 8 (depends on 1) The medical device according to claim 1, further comprising at least one additional sensor on the support frame, the additional sensor selected from the group consisting of pressure sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. ### Claim 9 (depends on 1) The medical device according to claim 1, further comprising at least one additional sensor on one of the plurality of leaflets, the additional sensor selected from the group consisting of accelerometers, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. ### Claim 10 (depends on 1) The medical device according to claim 1, wherein the balloon catheter further comprises a catheter that carries the balloon, and further comprising at least one additional sensor on the catheter, the additional sensor selected from the group consisting of accelerometers, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. ### Claim 11 (depends on 1) The medical device of claim 1, further comprising one or more pressure sensors positioned within or upon a second side of at least one of the plurality of leaflets, where the second side is opposite the first side. ### Claim 12 (depends on 1) A method comprising: obtaining data from a sensor positioned at a plurality of locations between on and/or within a heart valve and/or balloon catheter according to claim 1 of a subject; storing the data in a memory device located on or within the heart valve or balloon catheter; and transferring the data from the memory to a location outside the heart valve or balloon catheter. ### Claim 13 (depends on 12) A method according to claim 12, further comprising the step of analyzing said data. ### Claim 14 (depends on 1) A method for detecting and/or recording an event in a subject with a medical device as provided in claim 1, comprising the step of interrogating at a desired point in time the activity of one or more sensors within the heart valve or balloon catheter, and recording said activity. ### Claim 15 (depends on 14) The method according to claim 14 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. ### Claim 16 (depends on 14) The method according to claim 14, wherein said recording is provided to a health care provider. ### Claim 17 (depends on 1) A method for imaging a medical device according to claim 1 that has been placed inside of a patient, comprising the steps of (a) detecting the location of one or more sensors of the heart valve or balloon catheter; and (b) visually displaying the location of said one or more sensors, such that an image of the medical device is created. ### Claim 18 (depends on 17) The method according to claim 17 wherein the step of detecting occurs over time. ### Claim 19 (depends on 17) The method according to claim 17 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. ### Claim 20 (depends on 1) A method for inserting a medical device into a subject, comprising the steps of (a) inserting a medical device according to claim 1 into a subject; and (b) imaging the placement of said medical device according to a method comprising (i) detecting the location of one or more sensors of the heart valve or the balloon catheter; and (ii) visually displaying the location of said one or more sensors, such that an image of the heart valve or balloon catheter is created. ### Claim 21 (depends on 1) A method of monitoring a medical device 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 medical device according to claim 1 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.