Method for the calibration of an implantable sensor
Inventors
Crivelli, Rocco • ROTH, Danillo • Ginggen, Alec
Assignees
Integra Lifesciences Switzerland SARL • DePuy Spine LLC • Integra Lifesciences Corp
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Publication Number
US-11169010-B2
Publication Date
2021-11-09
Expiration Date
Abstract
An implant includes a processor, RF communication circuitry, optical communication circuitry, a power source and a memory, all of which being hermetically sealed within a housing having a transparent window. Sensor readings are transmitted by RF using the RF communication circuitry to a remote reader after receiving interrogation signals from the reader. During calibration of the sensor, corrective coefficients are calculated by comparing actual sensor pressure readings with known pressure readings. The corrective coefficients are transmitted to the memory of the control circuitry using optical communication wherein modulated light is transmitted through the transparent window of the housing to the photo-detector.
Core Innovation
The invention provides a method for calibrating a sensor of an implant before implantation into a body. The sensor is connected to control circuitry including a processor, a radio frequency (RF) communication circuitry, optical communication circuitry including a light-receiving device, a power source and memory, all hermetically sealed within a housing.
The method includes placing the implant into a controlled environment outside of the body and adjusting at least one aspect of the controlled environment to a first known value. The sensor measures the at least one aspect and generates a first sensor reading, which is transmitted from the implant to a remote controller using an RF communication link, and the received sensor reading is compared with the first known value to create a first corrective coefficient.
An optical communication link is created between the remote controller and the control circuitry of the implant before implantation, and the first corrective coefficient is transmitted to memory of the control circuitry using the optical communication link. After calibration and implantation within the body, RF energy from the remote controller is transmitted to the implant in the body to activate the sensor, power at least the processor and RF communication circuitry, read output of the sensor, calculate calibrated sensor data, and extract calibrated sensor data in real time.
A pressure-sensor variant uses a pressure chamber adjusted to a known first pressure value, and optical communication is performed through a transparent window in the hermetically sealed housing.
Claims Coverage
The independent claims are clm-00001 and clm-00013. Each independent claim includes a calibration workflow with pre-implant exposure of a hermetically sealed implant sensor, a controlled environment set to a first known value, derivation of a first corrective coefficient, optical transfer of the coefficient into hermetically sealed implant memory before implantation, and RF energy after implantation to activate the sensor and extract calibrated sensor data in real time.
Pre-implant controlled-environment calibration with corrective coefficient
creating a bore through the base plate; placing the sensor over the bore so that the sensor is exposed to an external atmosphere while being hermetically sealed within the housing; placing said implant into a controlled environment outside of the body; adjusting at least one aspect of said controlled environment to a first known value; allowing said sensor to measure said at least one aspect of said controlled environment and generate a first sensor reading; comparing said received first sensor reading with said first known value of said at least one aspect of said controlled environment to create a first corrective coefficient
Optical coefficient transfer into hermetically sealed implant memory before implantation
creating an optical communication link between said remote controller and said control circuitry of said implant before implantation into the body; transmitting said first corrective coefficient to said memory of said control circuitry using said optical communication link
RF activation and real-time extraction of calibrated sensor data after implantation
implanting said sensor and said implant within said body; transmitting, after calibration and implantation, RF energy from said remote controller to said implant in said body for activating said sensor, powering at least said processor and said RF communication circuitry of said sensor to read output of said sensor and use the first corrective coefficient to calculate calibrated sensor data, and extracting calibrated sensor data in real time from said sensor implanted in said body
Hermetically sealed implant control circuitry with RF and optical communication
wherein said sensor is connected to control circuitry which includes a processor, a radio frequency (RF) communication circuitry, optical communication circuitry including a light-receiving device, a power source and memory, all of which being hermetically sealed within a housing, the sensor is disposed on a base plate
Pressure-sensor calibration using a pressure chamber and transparent window optical link
creating a bore through the base plate; placing the sensor over the bore so that the sensor is exposed to an external atmosphere while being hermetically sealed within the housing; placing said implant into a pressure chamber outside of the body; creating an RF communication link between a remote controller and said RF communication circuitry of said control circuitry, whereby the control circuitry converts RF energy from the remote controller to help power at least the processor and RF communication circuitry; adjusting the pressure within said chamber to a known first pressure value; allowing said sensor to measure said known first pressure of said chamber and generate a first sensor pressure reading; transmitting said first sensor pressure reading from said implant to said remote controller using said RF communication link; comparing said received first sensor pressure reading with said known first pressure value to create a first corrective coefficient; creating an optical communication link between said remote controller and said control circuitry of said implant through said transparent window before implantation into the body; transmitting said first corrective coefficient to said memory of said control circuitry using said optical communication link; allowing said control circuitry to use said first corrective coefficient to adjust said first sensor pressure reading to align with said known first pressure reading for future readings; implanting said sensor and said implant within said body; transmitting, after calibration and implantation within said body, RF energy from said remote controller to said implant in said body for activating said sensor, powering at least said processor and said RF communication circuitry of said sensor to read output of said sensor and use the first corrective coefficient to calculate calibrated sensor data, and extracting calibrated sensor data in real time from said sensor implanted in said body
Across both independent claims, the coverage centers on deriving and storing a first corrective coefficient from a sensor reading in a controlled environment set to a first known value, transferring that coefficient into hermetically sealed implant memory via an optical communication link created before implantation, and then using RF energy after implantation to activate the sensor and extract calibrated sensor data in real time. clm-00013 further specifies calibration of a pressure sensor using a pressure chamber and an optical communication link through a transparent window.
Stated Advantages
Allows the control circuitry to use the first corrective coefficient to adjust future sensor readings to align with the known first value for future readings.
Enables extraction of calibrated sensor data in real time from the sensor implanted in the body.
Avoids transmitting the corrective coefficient to memory through RF by using an optical communication link before implantation.
Documented Applications
Calibrating an implantable sensor before implantation into a body and using the sensor and the implant in the body to compute calibrated sensor data and extract calibrated sensor data in real time.
Calibrating a pressure sensor of an implant before implantation, including calibrating in a pressure chamber outside of the body and later extracting calibrated sensor data in real time after implantation.
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