US-12623083-B2 - System and method for intra-body communication of sensed physiologic data

US12623083B2US 12623083 B2US12623083 B2US 12623083B2US-12623083-B2

Abstract

A system for collecting real-time on-demand measurements. The system includes an implantable sensor that has a power source, a sensing circuit, a communications circuit, a memory, and one or more processors. The sensing circuit senses a physiologic parameter of interest (PPOI) and generates signals indicative of the PPOI. The communications circuit communicates with at least one of an implantable medical device (IMD) or an external device (ED). The one or more processors execute program instructions stored in the memory to collect real-time on-demand measurements by activating the sensing circuit to generate the signals indicative of the PPOI, converting the signals to physiologic data indicative of the PPOI, storing the physiologic data in the memory, and directing the communications circuit to transmit the physiologic data to the at least one of the IMD or the ED.

Inventors

Jin-woo Park
Dean P. Andersen
Michael Fonseca

Assignees

TC1 LLC

Dates

Publication Date: 20260512
Application Date: 20220818

Claims (20)

1 . A system for collecting real-time on-demand measurements, the system comprising: an implantable medical device (IMD) configured to be implanted in a patient, the IMD configured to sense and analyze a first type of patient data; and an implantable sensor comprising: a housing configured to be implanted in a blood vessel of a patient; a power source; a sensing circuit configured to sense a physiologic parameter of interest (PPOI) and to generate signals indicative of the PPOI; a communications circuit configured to communicate with the IMD and an external device (ED); a memory configured to store program instructions; and one or more processors coupled to the memory, wherein the housing holds the power source, the sensing circuit, the communications circuit, the memory, and the one or more processors, wherein the program instructions are executable by the one or more processors to: receive a data collection instruction from the IMD; responsive to receiving the data collection instruction, collect real-time on-demand measurements for a second type of patient data by (i) activating the sensing circuit to generate the signals indicative of the PPOI; (ii) converting the signals to physiologic data indicative of the PPOI; and (iii) storing the physiologic data in the memory over a collection period, wherein the second type of patient data differs from the first type of patient data; and direct the communications circuit to transmit at least some of the physiologic data stored in the memory to at least one of the IMD or the ED at first times or intervals according to a predetermined data transmission schedule.
2 . The system of claim 1 , wherein the memory is configured to store a data collection schedule, and the one or more processors are further configured to collect the measurements based on the data collection schedule in real-time.
3 . The system of claim 1 , wherein the power source is configured to store an amount of energy to supply the sensing circuit, the communications circuit, and the one or more processors for at least a predetermined number of data collection operations and radiofrequency (RF) communication sessions, the data collection operations and RF communication sessions performed without any external energy delivery.
4 . The system of claim 1 , wherein the communications circuit further comprises a radiofrequency (RF) antenna configured to communicate with the IMD utilizing RF communications signals.
5 . The system of claim 1 , wherein the housing includes a first housing portion at a first end of the sensor, a second housing portion at a second end of the sensor opposite the first end, and a flexible cable disposed between and connected to the first and second housing portions, the sensor including a first electrode of the communications circuit held by the first housing portion and a second electrode of the communications circuit held by the second housing portion, the first electrode electrically coupled to the second electrode via the flexible cable, wherein the one or more processors are configured to direct the communications circuit to transmit the physiologic data by applying voltage bursts to the first and second electrodes to create a polarized electric field around the sensor.
6 . The system of claim 1 , wherein the one or more processors are configured to remain in a sleep mode until transitioning to a wake mode in response to receiving a wake-up instruction from a clock of the implantable sensor, the one or more processors configured to perform at least one of the activating, converting, storing, and directing operations when in the wake mode.
7 . The system of claim 1 wherein the sensing circuit is configured to sense, as the PPOI, at least one of pressure, temperature, respiration, or a body generated analyte (BGA), wherein the signals generated by the sensing circuit represent electrical signals, for which at least one of voltage, current, capacitance, inductance or resistance varies based on a level of the PPOI.
8 . The system of claim 1 , wherein the power source includes a secondary battery, the secondary battery electrically connected to one of (i) the IMD via a direct wired connection to receive electrical power from the IMD or (ii) an energy harvesting unit of the sensor, the energy harvesting unit comprising a coil configured to inductively connect to an external recharge device to transfer electrical power from the external recharge device to the secondary battery via the energy harvesting unit.
9 . The system of claim 1 , wherein the one or more processors are configured to collect the measurements at second times or intervals according to a predetermined data collection schedule, stored in the memory of the sensor, to store the physiologic data in the memory over the collection period, and wherein the second times or intervals of the data collection schedule are more frequent than the first times or intervals of the data transmission schedule.
10 . The system of claim 1 , wherein the housing of the implantable sensor includes one or more loop wires that extend from the housing for anchoring the implantable sensor to the blood vessel of the patient.
11 . The system of claim 1 , wherein the implantable sensor is a pressure sensor and the PPOI is blood pressure; and wherein the IMD includes sensing circuitry coupled to electrodes and configured to sense electrical cardiac activity data, a processor that, when executing program instructions, is configured to analyze the cardiac activity data.
12 . The system of claim 1 , wherein the processor of the IMD is configured to analyze the physiologic data and based thereon change a therapy delivered by the IMD.
13 . The system of claim 1 , wherein the communications circuit is configured to wirelessly communicate with the IMD and the ED utilizing at least one of radio frequency wireless communication or conductive communication.
14 . The system of claim 1 , wherein the processor of the IMD is configured to determine whether the physiologic data indicates a change that prompts a modification of treatment provided by the IMD.
15 . The system of claim 14 , wherein the processor is further configured to modify at least one parameter of the therapy provided by the IMD based on the determination.
16 . A method comprising: sensing and analyzing a first type of patient data utilizing an implantable medical device (IMD) implanted in a patient; and receiving, via a communications circuit of an implantable sensor implanted within the patient, a data collection instruction communicated by the IMD, wherein the implantable sensor includes a housing configured to be implanted in a blood vessel of the patient; collecting real-time on-demand measurements for a second type of patient data via the implantable sensor in response to receiving the data collection instruction, wherein the collecting operation comprises (i) activating a sensing circuit of the implantable sensor to sense a physiologic parameter of interest (PPOI) and generate signals indicative of the PPOI, the sensing circuit powered by a power source onboard the implantable sensor; (ii) converting the signals to physiologic data indicative of the PPOI via one or more processors of the implantable sensor; and (iii) storing the physiologic data in a memory of the implantable sensor, wherein the second type of patient data differs from the first type of patient data, wherein the housing holds the power source, the sensing circuit, the communications circuit, the memory, and the one or more processors; and directing the communications circuit of the implantable sensor to transmit at least some of the physiologic data stored in the memory to at least one of the IMD or an external device (ED) outside of the patient in response to receiving the data collection instruction.
17 . The method of claim 16 , further comprising collecting the real-time on-demand measurements via the implantable sensor at first times or intervals according to a predetermined data collection schedule stored in the memory in addition to collecting the real-time on-demand measurements in response to receiving the data collection instruction.
18 . The method of claim 17 , further comprising directing the communications circuit to transmit radiofrequency (RF) communications signals comprising the physiologic data stored in the memory to the at least one of the IMD or the ED at second times or intervals according to a predetermined data transmission schedule, in addition to directing the communications circuit to transmit the at least some of the physiologic data to the at least one of the IMD or the ED on-demand in response to receiving the data collection instruction.
19 . The method of claim 18 , wherein the first times or intervals of the data collection schedule are more frequent than the second times or intervals of the data transmission schedule.
20 . The method of claim 16 , further comprising assembling the implantable sensor to include, as the housing, a first housing portion, a second housing portion, and a flexible cable disposed between and connected to the first and second housing portions, the assembling operation comprising: installing a first electrode of the communications circuit to the first housing portion; installing a second electrode of the communications circuit to the second housing portion; and electrically coupling the first electrode to the second electrode via the flexible cable, wherein the directing operation to direct the communications circuit of the sensor to transmit the physiologic data comprises applying voltage bursts to the first and second electrodes to create a polarized electric field around the sensor.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63/262,115, filed Oct. 5, 2021. The subject matter of the provisional application is expressly incorporated herein by reference in its entirety. BACKGROUND Embodiments of the present disclosure generally relate to methods and devices for communications between implanted sensors, other implanted medical devices within a patient, and external devices outside a patient. Passive implantable medical sensors are currently available to monitor certain physiologic conditions, such as blood pressure. One example is a pulmonary arterial (PA) pressure sensor. However, passive implantable medical sensors require active patient participation in order to collect the physiologically relevant data and to make the data available to a clinician. For example, PA pressure sensors utilize an external device, outside of the patient body, for supplying energy to the sensors to power the generation and communication of the physiological data. Consequently, the system requires initial patient training and periodic reminders for the patient to utilize the external device for data collection and communication. The physiologic data is analyzed to improve the patient outcome, such as by modifying a treatment of the patient based on the physiologic data generated by the sensor. The current mechanism, which depends on external devices to power and communicate with the implantable sensor, requires large and highly specialized circuitry within the external device. The circuitry is not available nor easy to integrate in a typical implantable device, such as a pacemaker or cardiac resynchronization therapy (CRT) device. Because user interaction may be required to utilize the external device to activate the passive sensor, the sensor operation may be dependent on patient cooperation and attentiveness. In effect, a sensor may only collect data when it is convenient for the patient, so there may be significant delays between a time at which a physiologic condition of the patient changes and a time in which physiologic data generated by the passive implantable medical sensor indicating that change is communicated for analysis and updating the treatment of the patient based on the change. The physiologically relevant data, that is collected by passive sensor, may not be readily available to other implanted devices such as pacemakers and CRT devices, so the real-time treatment parameter update is not possible. Furthermore, the size of the passive implantable medical sensors may be limited due to target implant locations within the patient, such as within blood vessels. Due to the size constraint, even if the sensors have an onboard battery, the battery may not be large enough to store sufficient charge to power the physiological data generation and conventional communication operations for an extended period of time. A need remains for a system and method of communicating sensed physiologic data from an implantable medical sensor for real-time analysis and modification of patient treatment to improve patient outcome, without relying on active patient cooperation or an external energy source to power the sensor at the time of data collection and transmission. SUMMARY In accordance with an embodiment, methods, devices and systems are provided that enable implantable sensors such as PA pressure sensors to transmit measured data directly to other implantable medical devices to be analyzed for real-time therapy optimization and disease state diagnosis. The other implantable medical devices may include cardiac resynchronization therapy (CRT) devices, blood glucose monitors, implantable cardiac monitoring devices (ICM), implantable cardioverter defibrillators (ICD), and the like. In accordance with embodiments herein, an implantable sensor measures a physiologic parameter and generates physiologic data indicative of a value of the physiologic parameter. The sensor transmits the measured physiologic data to a second device, implanted or external, through intra-body communication. The communication mechanism may be radio-frequency (RF), direct wired connection, or wireless conductive communication. The physiologic data is analyzed by the second device, such as an implanted CRT device, a bedside monitoring device, a remote server, or the like, to enhance the therapy delivered to the patient based on the physiologic data. Additionally or alternatively, the physiologic data can be sent from the sensor to a second implantable medical device (IMD) within the patient, such as a CRT device, which transmits the physiologic data externally to an external device outside of the patient. The external device may be a web-enabled device such as a bedside monitor, a hand-held smartphone, a wearable device, or the like, which can store the data in a database and/or communicate the data via a network to a remote server. The implantable sensor includes an onbo