Implantable bio-pressure transponder

• US 10,244,954 B2
• Filed: 10/28/2014
• Issued: 04/02/2019
• Est. Priority Date: 10/28/2013
• Status: Active Grant

• Current Assignee: Arkis BioSciences, Inc. (Integra LifeSciences Holdings Corporation)
• Original Assignee: Arkis BioSciences, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: Seaver, Chad E., Killeffer, James A., Arnott, James C.
• Primary Examiner(s): Eiseman, Adam J
• Application Number:
  US14/525,270
• Publication Number:
  US 20150119752A1
• Time in Patent Office: 1,617 Days
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2206/11 Laminar flow
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

An implantable subcutaneous device to measure internal body pressure and wirelessly transmit information corresponding to the measured internal body pressure, including a pressure sensor to sense pressure of a particular region of a body of a patient and output a pressure signal corresponding to the sensed pressure, an encoder to receive the pressure signal and encode a signal to produce a sensor information signal to be transmitted to an ex vivo receiver, a transceiver to receive the sensor information signal from the encoder and transmit the sensor information signal to the ex vivo receiver, and a biocompatible housing in which to enclose the pressure sensor, encoder, and transceiver.

Claims

1. An implantable subcutaneous device to measure internal body pressure and wirelessly transmit information corresponding to the measured internal body pressure, comprising:

a pressure sensor configured to sense an inlet pressure of a particular region of a body of a patient via an inlet pressure port, and to sense a reference pressure of a reference chamber via a reference pressure port, wherein the pressure sensor is configured to selectively sense the inlet pressure and the reference pressure so as to compare the reference pressure to the inlet pressure to generate a calibrated inlet pressure signal;

an encoder configured to receive the calibrated inlet pressure signal and encode the calibrated inlet pressure signal to produce a sensor information signal;

a transceiver configured to receive the sensor information signal from the encoder and transmit the sensor information signal to an ex vivo receiver; and

a biocompatible housing configured to enclose the pressure sensor, encoder, and transceiver, wherein;

the encoder includes a sweep generator unit, an oscillator, and a signal delay unit, the sweep generator unit outputs a ramp signal to be compared to the calibrated inlet pressure signal, and the signal delay unit is connected to the sweep generator and the oscillator to delay starting of the oscillator and the sweep generator for a sufficient amount of time to facilitate settling of the pressure sensor.

2. The device of claim 1, further comprising a catheter extending from the inlet pressure port to the particular region of the body of the patient through which body fluid may flow to the pressure sensor.

3. The device of claim 2, further comprising a shunt distal catheter configured to receive the body fluid received through the catheter extending to the particular region of the body of the patient to drain the body fluid to a remote collection site.

4. The device of claim 3, further comprising a T-connection configured to connect the shunt distal catheter to the inlet pressure port to receive the body fluid from the catheter extending to the particular region of the body of the patient.

5. The device of claim 1, wherein the reference chamber comprises a fluid containing body coupled to the reference pressure port such that a pressure on a fluid in the fluid containing body is transferred to the pressure sensor.

6. The device of claim 5, further comprising a structural support provided to the fluid containing body to prevent incidental pressures incident to the fluid containing body.

7. The device of claim 5, wherein the fluid containing body is configured to extend inwardly to an internal location in the patient to provide in vivo calibration of the pressure sensor.

8. The device of claim 1, further comprising an antenna configured to be external to the biocompatible housing and in electrical communication with the transceiver to transmit the sensor information signal.

9. The device of claim 1, further comprising a power supply unit to provide power to the device, and to receive power from the transceiver that is induced from an ex vivo induction unit.

10. The device of claim 1, further comprising:

a power transceiver; and

a power supply unit to receive power from the power transceiver that is induced from an ex vivo induction unit, and to provide power to the device.

11. The device of claim 1, wherein the encoder further includes a comparator to compare the calibrated inlet pressure signal to the ramp signal to generate a stop signal in response to the ramp signal being equal to the calibrated inlet pressure signal.

12. The device of claim 1, wherein the oscillator outputs the sensor information signal such that an oscillator output is generated until the ramp signal reaches a level of the calibrated inlet pressure signal, and is stopped in response to the ramp signal becoming equal to or greater than the calibrated inlet pressure signal, during each cycle of the ramp signal so that the oscillator output is proportional in time relative to pressure incident on the pressure sensor.

13. The device of claim 1, wherein the pressure sensor supplies the calibrated inlet pressure signal in proportion to the reference pressure by means of piezo-resistance, capacitive or inductive reactance, or optical interferometry.

14. The device of claim 1, wherein the ex vivo receiver is configured to transmit the reference pressure to pressure sensor.

15. The device of claim 1, wherein the calibrated inlet pressure signal is based on a proportion of the inlet pressure to the reference pressure.

16. The device of claim 15, wherein the reference chamber is sealed and external from the inlet port.

17. The device of claim 1, wherein the pressure sensor selectively senses the reference pressure at predetermined times.

18. The device of claim 1, wherein the encoder is configured to temporally encode the calibrated inlet pressure signal using pulse width modulation (PWM) to produce a temporally encoded sensor information signal.

19. The device of claim 18, wherein the temporally encoded sensor information signal modulates an alternating current signal to encode inlet pressure information into a carrier frequency selected to enhance transcutaneous electromagnetic transmission.

20. A system to measure internal body pressure and wirelessly transmit information corresponding to the measured internal body pressure to be displayed at a location external to a patient, the system comprising:

an implantable subcutaneous device comprising;

a pressure sensor configured to sense an inlet pressure of a particular region of a body of a patient via an inlet pressure port, and to sense a reference pressure of a reference chamber via a reference pressure port, wherein the pressure sensor is configured to selectively sense the inlet pressure and the reference pressure so as to compare the reference pressure to the inlet pressure to generate a calibrated inlet pressure signal,

an encoder configured to receive the calibrated inlet pressure signal and encode the calibrated inlet pressure signal to produce a sensor information signal, the encoder further comprising a sweep generator unit, an oscillator, and a signal delay unit, the sweep generator unit outputs a ramp signal to be compared to the calibrated inlet pressure signal, and the signal delay unit is connected to the sweep generator and the oscillator to delay starting of the oscillator and the sweep generator for a sufficient amount of time to facilitate settling of the pressure sensor,

an internal transceiver configured to receive the sensor information signal from the encoder and transmit the sensor information signal to an ex vivo location, and

a biocompatible housing configured to enclose the pressure sensor, encoder, and transceiver;

an ex vivo transceiver to receive the sensor information signal transmitted from the internal transceiver of the subcutaneous device;

a demodulator to decode the sensor information signal received by the ex vivo transceiver; and

a display unit to display information corresponding to the pressure sensed by the pressure sensor.

21. The system of claim 20, further comprising a communications means through which the internal transceiver and ex vivo transceiver communicate.

22. The system of claim 21, wherein the communications means includes respective antennas provided to the internal and ex vivo transceivers.

23. The system of claim 20, wherein the ex vivo transceiver supplies power to the internal transceiver of the subcutaneous device through induction.

24. The system of claim 20, wherein the implantable subcutaneous device further comprises a power transceiver to receive power through induction from the ex vivo transceiver or other ex vivo device to power the implantable subcutaneous device.

25. The system of claim 24, wherein the internal transceiver is configured as a first antenna, and the power transceiver is configured as a second antenna.

26. The system of claim 20, wherein the encoder uses the received calibrated inlet pressure signal to modulate a communications alternating current frequency by means of pulse width modulation to produce the sensor information signal.

27. An implantable pressure sensor system for the measurement of fluid pressures within a body, the system comprising:

a pressure sensor configured to produce a calibrated inlet pressure signal proportionate to a sensed inlet pressure, the pressure sensor being configured to sense the inlet pressure via an inlet pressure port, and to sense a reference pressure of a reference chamber via a reference pressure port, wherein the pressure sensor is configured to selectively sense the inlet pressure and the reference pressure so as to compare the reference pressure to the inlet pressure to generate the calibrated inlet pressure signal;

encoding circuitry configured to receive the calibrated inlet pressure signal from the pressure sensor and to modulate a communications alternating current frequency to produce a sensor information signal;

a sweep generator unit, an oscillator, and a signal delay unit, the sweep generator unit outputs a ramp signal to be compared to the calibrated inlet pressure signal, and the signal delay unit is connected to the sweep generator and the oscillator to delay starting of the oscillator and the sweep generator for a sufficient amount of time to facilitate settling of the pressure sensor; and

a telemetry unit configured to receive electromagnetic transcutaneous powering and to transmit the sensor information signal to a receiver unit external to the body;

wherein the pressure sensor, encoding circuitry, sweep generator unit, oscillator, signal delay unit, and telemetry unit are configured to be implanted in a subcutaneous manner in the body.

28. The system of claim 27, wherein the sensor information signal is modulated by amplitude, frequency, phase, or temporally to encode information proportional to the calibrated inlet pressure signal.

29. The system of claim 27, wherein the pressure sensor is a differential pressure sensor configured to measure a desired body pressure, and the reference pressure port is used to detect a predetermined or predictable offset pressure for measuring desired in-vivo fluid pressure and to calibrate the pressure sensor.

30. The system of claim 27, wherein the pressure sensor includes a sealed calibrated pressure signal reference chamber in which the calibrated inlet pressure signal is proportional to a pre-determined pressure reference of the reference chamber.

31. The system of claim 30, wherein the reference chamber is substantially a vacuum.

32. The system of claim 30, wherein the reference chamber contains a gas.

33. The system of claim 30, where the reference chamber contains a liquid.