Simultaneous blood flow and hematocrit sensor

• US 8,172,762 B2
• Filed: 08/31/2007
• Issued: 05/08/2012
• Est. Priority Date: 09/01/2006
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Biomedical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Robertson, Timothy L.
• Primary Examiner(s): Le, Miranda
• Assistant Examiner(s): WEARE, MEREDITH H
• Application Number:
  US11/897,942
• Publication Number:
  US 20080058630A1
• Time in Patent Office: 1,712 Days
• Field of Search: 600504-506
• US Class Current: 600/506
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/14535 for measuring haematocrit

Abstract

Embodiments of the present invention provide blood flow sensors that can be used for measurement of various physiological parameters under a wide array of conditions. In some embodiments, the blood flow sensor can be implanted into a blood vessel and left in place indefinitely and will unobtrusively measure and record data as the patient engages in regular daily activities. The data can later be read out by a clinician using a suitable interface. In other embodiments, the data is collected and analyzed within a data collection device implanted in or attached to the patient'"'"'s body, and the collection device can report to the patient on an ongoing basis or in the form of alerts issued when conditions requiring medical intervention are detected.

Claims

1. An implantable blood flow sensor to generate signals used to simultaneously determine a velocity and hematocrit of flowing blood, the implantable blood flow sensor comprising:

a substrate sized and shaped to be implantable in a blood vessel of a body of a patient;

a pair of current-flow terminals disposed on a top surface of the substrate and arranged to be placed in the flowing blood;

a current source fabricated on the substrate and configured to transfer charge between the pair of current-flow terminals;

at least three sense electrodes disposed on the top surface of the substrate substantially in line with each other between the current-flow terminals with each sense electrode of the at least three sense electrodes separated from a neighboring sense electrode by a distance S, wherein the at least three sense electrodes comprise a first pair of neighboring sense electrodes formed by a first sense electrode and a second sense electrode adjacent to the first sense electrode and a second pair of neighboring sense electrodes formed by the second sense electrode and a third sense electrode adjacent to the second sense electrode; and

a detection circuit fabricated on the substrate, electrically coupled to the at least three sense electrodes, and configured to generate at least a first signal based on a potential difference between the first pair of neighboring sense electrodes and a second signal based on a potential difference between the second pair of neighboring sense electrodes, wherein the velocity of the flowing blood is determined based on a distance between the first pair of neighboring sense electrodes and the second pair of neighboring sense electrodes in addition to a time shift between the first signal and the second signal, and wherein the hematocrit of the flowing blood is determined by counting a number of spikes in the first signal or the second signal, the number of spikes corresponding to red blood cells passing via the first pair of the neighboring sense electrodes or the second pair of the neighboring sense electrodes.

2. The implantable blood flow sensor of claim 1 further comprising:

a transmitter unit coupled to an output node of the detection circuit and configured to transmit the at least first signal and the second signal to a data collector.

3. The implantable blow flow sensor of claim 2 wherein the transmitter unit is configured to transmit via quasi-electrostatic coupling into a conductive tissue of the body of the patient.

4. The implantable blood flow sensor of claim 2 wherein the transmitter is fabricated on the substrate.

5. The implantable blood flow sensor of claim 1 further comprising a power supply unit coupled to the current source, wherein the power supply unit is configured to supply power to the current source and the detection circuit.

6. The implantable blood flow sensor of claim 5 wherein the power supply unit is further configured to receive power via a quasi-electrostatic coupling to a conductive tissue of the body.

7. The implantable blood flow sensor of claim 1 wherein the distance S is set as similar to a size of a red blood cell.

8. The implantable blood flow sensor of claim 7 wherein the distance S is between about 6 and about 8 microns.

9. The implantable blood flow sensor of claim 1, wherein the detection circuit comprises at least two differential amplifiers.

10. A method of measuring a physiological parameter, the method comprising:

implanting a blood flow sensor in a blood vessel in a body of a patient, the blood flow sensor configured to measure and transmit a velocity and hematocrit of flowing blood in the blood vessel, wherein the blood flow sensor comprises;

a substrate sized and shaped to be implantable in the blood vessel;

a pair of current-flow terminals disposed on a to surface of the substrate and arranged to be placed in the flowing blood;

a current source fabricated on the substrate and configured to transfer charge between the pair of current-flow terminals;

at least three sense electrodes disposed on the top surface of the substrate substantially in line with each other between the current-flow terminals with each sense electrode of the at least three sense electrodes separated from a neighboring sense electrode by a distance S, wherein the at least three sense electrodes comprise a first pair of neighboring sense electrodes formed by a first sense electrode and a second sense electrode adjacent to the first sense electrode and a second pair of neighboring sense electrodes formed by the second sense electrode and a third sense electrode adjacent to the second sense electrode; and

a detection circuit fabricated on the substrate, electrically coupled to the at least three sense electrodes, and configured to generate at least a first signal based on a potential difference between the first pair of neighboring sense electrodes and a second signal based on a potential difference between the second pair of neighboring sense electrodes, wherein the velocity of the flowing blood is determined based on a distance between the first pair of neighboring sense electrodes and the second pair of neighboring sense electrodes in addition to a time shift between the first signal and the second signal, and wherein the hematocrit of the flowing blood is determined by counting a number of spikes in the first signal or the second signal, the number of spikes corresponding to red blood cells passing via the first pair of neighboring sense electrodes or the second pair of neighboring sense electrodes;

communicably coupling a data collector to the blood flow sensor, wherein the data collector is implanted in or attached to the body of the patient;

operating the blood flow sensor to measure the velocity and the hematocrit and transmit the velocity and the hematocrit to the data collector; and

processing the velocity and the hematocrit to extract the physiological parameter.

11. The method of claim 10 wherein the blood flow sensor is configured to communicate wirelessly using quasi-electrostatic coupling to a conductive tissue of the body of the patient.

12. The method of claim 11 wherein the data collector comprises a pacemaker can configured to detect quasi-electrostatic signals propagating in the body of the patient.

13. The method of claim 11 wherein the data collector comprises a wearable unit including electrodes attachable to the skin of the patient and configured to detect quasi-electrostatic signals propagating in the body of the patient.

14. The method of claim 10 wherein the blood flow sensor is operated while the patient is away from a medical clinic.

15. The method of claim 10 further comprising:

triggering a remedial action based on the physiological parameter.

16. The method of claim 15 wherein the remedial action includes releasing a medication into the body of the patient.

17. The method of claim 15 wherein the remedial action includes alerting the patient to seek medical attention.