Injectable hemodynamic monitoring devices, systems and methods
Inventors
Garza, Aimee • Sewell, Tanzania
Assignees
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Publication Number
US-11452497-B2
Publication Date
2022-09-27
Expiration Date
Abstract
An implantable sensor system using one or more sensor implants comprised of micro-electrical mechanical system (MEMS) sensors for the accurate and continuous measurement of physiological hemodynamic signals such as diastolic and systolic blood pressure. Sensor implants are configured to be subcutaneously injected to a placement site adjacent a blood vessel. In some embodiments, sensors comprise micromachined ultrasonic transducers.
Core Innovation
The invention provides a hemodynamic monitoring method in which a sensor implant is subcutaneously placed in tissue adjacent a target blood vessel. The sensor implant generates a data stream during a sensing period, and the data stream is transmitted to a computing device configured to determine pulse wave velocity of the target blood vessel and blood pressure for the patient.
The invention generates the data stream using ultrasound pulse echoes representing inner and outer walls of the target blood vessel at first and second sensing locations with first and second ultrasound sensors. Changes in target blood vessel diameter at the sensing locations are detected based on the pulse echoes, and a time between detecting diameter changes is measured.
In additional implementations, the data stream generates change data at the first and second locations, represents a distance between the locations, and represents a time difference between the detected diameter changes. The sensor implant can further include an accelerometer and a temperature sensor, and sensor placement and measurement are correlated with sensor orientation, where distance-related information between sensing locations varies based on orientation of the implant with respect to the vessel.
Claims Coverage
The identified independent claims cover hemodynamic monitoring using a subcutaneous sensor implant adjacent a target blood vessel to generate and transmit a data stream for determining pulse wave velocity and blood pressure, with ultrasound pulse-echo sensing and time/distance correlation at first and second sensing locations.
Subcutaneous sensor implant for PWV and blood pressure
Subcutaneously placing a sensor implant in tissue adjacent a target blood vessel; generating a data stream from which pulse wave velocity during a sensing period can be determined; and transmitting the data stream to a computing device configured to determine pulse wave velocity for the target blood vessel and blood pressure for the patient using the data stream.
Ultrasound pulse echoes at two sensing locations
Generating and receiving pulse echoes representing inner and outer walls of the target blood vessel at first and second sensing locations with first and second ultrasound sensors; detecting changes in target blood vessel diameter at the first and second sensing locations based on the pulse echoes; and measuring a time between detecting of a change in target blood vessel diameter at the first sensing location and at the second sensing location.
Diameter-change data stream with distance and time difference
Generating data representative of a change in target blood vessel diameter at a first location and at a second location; generating data representative of a distance between the first location and the second location; and generating data representative of a time difference between the change in target blood vessel diameter at the first location and the second location.
Unitary implant with ultrasound sensors, accelerometer, and temperature sensor
Providing a unitary sensor implant comprising first and second spaced apart ultrasound transducers, an accelerometer and a temperature sensor; and generating the data stream by generating and receiving pulse echoes representing inner and outer walls at a first sensing location with the first ultrasound transducer and at a second sensing location with the second ultrasound transducer, detecting changes in diameter, measuring a time between detecting diameter changes, detecting patient movement or changes in patient position with the accelerometer, and detecting patient temperature with the temperature sensor.
Fixed-distance ultrasound sensing with cardiac cycle pulse timing and movement transmission
Subcutaneously placing a sensor implant including first and second ultrasound sensors spaced apart at fixed distance; receiving an ultrasound imaging signal depicting imaging at a first sensing location and detecting a cardiac cycle pulse in the first imaging signal; receiving an ultrasound imaging signal depicting imaging at a second sensing location and detecting the cardiac cycle pulse in the second imaging signal; determining the sensing distance based on the fixed distance and the first and second imaging signals; measuring time between detection of the cardiac cycle pulse at the first and second sensing locations; detecting patient movement during a timeframe encompassing the detecting at the first and second sensing locations; and transmitting a signal containing data representing the detected patient movement, determined sensing distance, and measured time for receipt at a computing device outside a patient's body configured to determine patient blood pressure during the timeframe.
Orientation-dependent sensing distance and transmitted correlated data stream
Placing the sensor implant at a placement location outside a target blood vessel within about 2 mm to about 50 mm of the target blood vessel, the implant comprising at least one sensor configured to detect changes in vessel diameter at first and second spaced apart sensing locations along the vessel, wherein a distance between the first and second sensing locations varies based on orientation of the implant with respect to the vessel; detecting vessel diameter at the first and second sensing locations; generating a data stream correlated to a sensing period comprising data representative of change in vessel diameter at the first and second sensing locations, data representative of the distance between the first and second sensing locations, data representative of a time difference between the changes, data representative of patient movement or change in position, and data representative of vessel inner and outer diameter; and transmitting the data stream to an external system whereby the data stream is accessible by a computing device to determine pulse wave velocity for the vessel and patient blood pressure during the sensing period based on the data stream.
Across the independent claims, the core inventive coverage centers on subcutaneous placement of a sensor implant adjacent a target blood vessel, generation of a data stream from ultrasound-based sensing of vessel diameter changes at first and second sensing locations, and transmission of the data stream to a computing device to determine pulse wave velocity and blood pressure, with further inventive constraints including unitary sensor composition, fixed-distance sensing with cardiac cycle pulse timing and movement transmission, and orientation-dependent distance correlation for sensing locations.
Stated Advantages
Enables determining pulse wave velocity for a target blood vessel and blood pressure for a patient using a subcutaneously placed sensor implant and a transmitted data stream.
Documented Applications
Hemodynamic monitoring for continuous blood pressure monitoring by subcutaneous placement of a MEMS-based sensor implant adjacent a target blood vessel, generating and transmitting a data stream for computation of pulse wave velocity and blood pressure.
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