METHOD FOR DETECTING AND TREATING VARIATIONS IN FLUID

• US 20150223722A1
• Filed: 04/20/2015
• Published: 08/13/2015
• Est. Priority Date: 01/19/2012
• Status: Active Grant

• Current Assignee: Cerebrotech Medical Systems, Inc.
• Original Assignee: Cerebrotech Medical Systems, Inc.
• Inventors: WYETH, Richard Warren, LEVINSON, Mitchell Elliott
• Granted Patent: US 10,335,054 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 2562/182 Electrical shielding, e.g. using a Faraday cage
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 2576/026 for the brain
• CPC Class Codes: A61B 5/0037 Performing a preliminary scan, e.g. a prescan for identifying a region of interest
• CPC Class Codes: A61B 5/0042 for the brain
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/0522 Magnetic induction tomography
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7225 : Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7246 : using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7257 : using Fourier transforms
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A diagnostic method for monitoring changes in a fluid medium in a patient'"'"'s head. The method includes positioning a transmitter at a first location on or near the patient'"'"'s head, the transmitter generates and transmits a time-varying magnetic field into a fluid medium in the patient'"'"'s head responsive to a first signal; positioning a receiver at a second location on or near the patient'"'"'s head offset from the transmitter, the receiver generates a second signal responsive to a received magnetic field at the receiver; transmitting a time-varying magnetic field into the fluid medium in the patient'"'"'s head in response to the first signal; receiving the transmitted magnetic field; generating the second signal responsive to the received magnetic field; and determining, a phase shift between the transmitted magnetic field and the received magnetic field for a plurality of frequencies of the transmitted time-varying magnetic field.

Claims

1. A diagnostic method for monitoring changes in a fluid medium in a patient'"'"'s head, the method comprising:

positioning a transmitter at a first location on or near the patient'"'"'s head, wherein the transmitter is configured to generate and transmit a time-varying magnetic field into a fluid medium in the patient'"'"'s head responsive to a first signal;

positioning a receiver at a second location on or near the patient'"'"'s head offset from the transmitter and configured to generate a second signal responsive to a received magnetic field at the receiver;

transmitting from the transmitter a time-varying magnetic field into the fluid medium in the patient'"'"'s head in response to the first signal;

receiving at the receiver the transmitted magnetic field;

generating with the receiver the second signal responsive to the received magnetic field; and

determining, using a processing unit coupled with at least the receiver, a phase shift between the transmitted magnetic field and the received magnetic field for a plurality of frequencies of the transmitted time-varying magnetic field;

wherein

at least one of the transmitter or the receiver comprises a shielded transmission line, and wherein the shielded transmission line comprises a strip line on a printed circuit board coupled between two grounded planes and has a loop shape.

2. The diagnostic method of claim 1, wherein the shielded transmission line comprises a first conductor that at least partially encloses a second conductor, and the second conductor provides an output signal responsive to a varying magnetic field.

3. The diagnostic method of claim 2, wherein the first conductor forms a Faraday cage around the second conductor.

4. The diagnostic method of claim 1, further comprising a plurality of vias between the two grounded planes.

5. The diagnostic method of claim 1, wherein the loop shape of the shielded transmission line has a diameter of approximately one inch.

6. The diagnostic method of claim 1, wherein the shielded transmission line comprises a single turn loop.

7. The diagnostic method of claim 1 wherein the shielded transmission line comprises a first loop positioned in a first layer of a printed circuit board, and wherein at least one of the transmitter or the receiver further comprises a second loop positioned in a second layer of the printed circuit board and formed using strip line, wherein leads from both the first and second loops are coupled to a differential amplifier.

8. The diagnostic method of claim 7, wherein the printed circuit board further comprises a plurality of grounded shielding planes positioned above and below the shielded transmission line in the printed circuit board.

9. The diagnostic method of claim 8, wherein the grounded shielding planes each define a circular void, with an internal diameter of the circular void being smaller than an internal diameter of the shielded transmission line.

10. The diagnostic method of claim 1, further comprising balancing an output of at least one of the transmitter or the receiver, using a balun coupled to the shielded transmission line.

11. The diagnostic method of claim 1, further comprising balancing an output of the shielded transmission line to effectively provide a 50 ohm output impedance.

12. The diagnostic method of claim 1, further comprising converting at least one of the first signal or the second signal from an analog signal to a digital signal, using at least one of a first analog to digital converter coupled to the transmitter and positioned proximate the transmitter or a second analog to digital converter coupled to the receiver and positioned proximate the receiver.

13. The diagnostic method of claim 12, wherein the first analog to digital converter and the transmitter are coupled to a single printed circuit board.

14. The diagnostic method of claim 12, further comprising generating a sampling signal, using a sampling signal generator, the sampling signal having a frequency to under-sample the transmitted and received magnetic fields.

15. The diagnostic method of claim 14, further comprising:

averaging, with the processing unit, a plurality of respective samples of the transmitted and received magnetic fields; and

determining the phase shift between the averaged transmitted magnetic fields and the averaged received magnetic fields.

16. The diagnostic method of claim 12, further comprising generating a sampling signal to coherently sample the transmitted and received magnetic fields.

17. The diagnostic method of claim 16, further comprising:

calculating a fast Fourier transform of samples of the transmitted and received magnetic fields; and

determining the phase shift by comparing phase components of the calculated respective fast Fourier transforms.

18. The diagnostic method of claim 1, wherein the transmitter is a first transmitter and the time-varying magnetic field is a first time-varying magnetic field, further comprising transmitting, from a second transmitter, a second time-varying magnetic field into the medium responsive to a third signal, the second transmitter being offset from the first transmitter.

19. The diagnostic method of claim 18, wherein a first frequency of the first time-varying magnetic field generated and transmitted by the first transmitter is different from a second frequency of the second time-varying magnetic field generated and transmitted by the second transmitter.

20. The diagnostic method of claim 1, wherein the receiver is a first receiver, further comprising generating, using a second receiver, a third signal responsive to a received magnetic field at the second receiver, the second receiver being offset from the first receiver.

21. The diagnostic method of claim 20, further comprising triangulating, using the processing unit, a location of a change in fluid responsive to the received magnetic field at the first and second receivers.

22. The diagnostic method of claim 1, further comprising using the processing unit to reduce errors in the determined phase shift resulting from movement of the transmitter, the receiver, or a patient.

23. The diagnostic method of claim 22, further comprising:

detecting motion of the transmitter or the receiver, using an accelerometer coupled to the transmitter or to the receiver; and

excluding data, using the processing unit, corresponding to periods of time wherein the accelerometer detects significant motion of the transmitter or receiver.

24. The diagnostic method of claim 22, further comprising using the processing unit to exclude data corresponding to periods of time during which the determined phase shift between the transmitted magnetic field and the received magnetic field is such that it is unlikely the result of biological changes within the medium.

25. The diagnostic method of claim 22, further comprising:

taking an air scan, using the transmitter and receiver, before positioning the transmitter or the receiver on or near the patient'"'"'s head; and

performing an initialization step, using the processing unit, responsive to the air scan.

26. The diagnostic method of claim 1, wherein the receiver is a first receiver, further comprising generating a third signal, using a second receiver positioned proximate the transmitter, responsive to the transmitted magnetic field and indicative of the phase of the magnetic field proximate the transmitter.

27. The diagnostic method of claim 26, wherein the second receiver is concentric within the first receiver.

28. The diagnostic method of claim 1, further comprising:

using a first FPGA (Field Programmable Gate Array) to synthesize the first signal;

using a second FPGA to collect and average a first plurality of samples from the second signal and a second plurality of samples representative of the phase of the transmitted magnetic field;

using a third FPGA to determine a phase measurement based on the averaged first and second plurality of samples; and

using a microcontroller, coupled to the first, second, and third FPGAs, to control the first, second, and third FPGAs.

29. The method of claim 1, further comprising:

administering mannitol to the patient to reduce intracerebral pressure by reducing an amount of fluid in the brain; and

repeating the transmitting, receiving, generating and determining steps after administering the mannitol.

30. The method of claim 1, further comprising:

administering a therapeutic agent to the patient; and

repeating the transmitting, receiving, generating and determining steps after administering the therapeutic agent; and

determining how to treat the patient with the therapeutic agent, based on the determining step.

35. The diagnostic method of claim 30, further comprising stabilizing the transmitter and receiver on the patient'"'"'s head using stabilizers coupled with the transmitter and receiver.

36. The diagnostic method of claim 35, further comprising molding the stabilizers to the patient'"'"'s head to hold the transmitter and receiver in place.

31. A diagnostic method for monitoring fluid changes in a patient, the method comprising:

placing a headset on the patient'"'"'s head, wherein the headset comprises;

a transmitter;

a receiver coupled with the headset such that it is offset from the transmitter when the headset is applied to the patient'"'"'s head;

receiving, in the transmitter, a first signal from a processing unit coupled with the headset;

generating and transmitting, from the transmitter, a time-varying magnetic field into the patient'"'"'s head, responsive to the first signal;

receiving the magnetic field in the receiver;

generating, using the receiver, a second signal responsive to the received magnetic field at the receiver; and

determining, using the processing unit, a phase shift between the transmitted magnetic field and the received magnetic field for a plurality of frequencies of the transmitted time-varying magnetic field;

wherein at least one of the transmitter or the receiver comprises a shielded transmission line,

wherein the shielded transmission line comprises a strip line on a printed circuit board coupled between two grounded planes, and the shielded transmission line has a lowest natural resonant frequency above 200 MHz.

32. The method of claim 31, further comprising:

administering a therapeutic agent to the patient; and

repeating the transmitting, receiving, generating and determining steps after administering the therapeutic agent; and

determining how to treat the patient with the therapeutic agent, based on the determining step

33. The method of claim 31, further comprising:

administering mannitol to the patient to reduce intracerebral pressure by reducing an amount of fluid in the brain; and

repeating the transmitting, receiving, generating and determining steps after administering the mannitol

34. The diagnostic method of claim 31, wherein the headset comprises an elastic headband.

37. A method for monitoring intracranial fluid in a patient, the method comprising:

transmitting a first time-varying magnetic field from a transmitter toward a receiver, wherein the transmitter and the receiver are coupled to the patient'"'"'s head via a headset, the first time-varying magnetic field comprising a first plurality of frequencies that are harmonics of a first fundamental frequency, and wherein all of the first plurality of frequencies are simultaneously transmitted;

receiving the first magnetic field with the receiver; and

determining a phase shift between the transmitted magnetic field and the received magnetic field for each of the plurality of frequencies.

38. The method of claim 37, further comprising converting the received magnetic fields with an analog to digital converter coupled directly with the headset at or near the receiver.

39. The method of claim 38, further comprising converting the transmitted magnetic fields with an analog to digital converter coupled directly with the headset at or near the transmitter.

40. The method of claim 37, further comprising generating a signal, via the processor, if it is determined that the change has occurred.

41. The method of claim 37, wherein the first and second magnetic fields are in a frequency range of about 20 MHz to about 300 MHz.

42. The method of claim 37, further comprising, before transmitting the first time-varying magnetic field, initiating the headset by transmitting a calibration magnetic field from the transmitter to the receiver while the headset is not coupled with the patient.

43. The method of claim 37, wherein at least one of the transmitter or the receiver comprises a loop formed using strip line on a printed circuit board, wherein the loop has a diameter of approximately one inch and is a single turn loop.

44. The method of claim 37, further comprising:

detecting motion of the patient with a motion detection member;

transmitting a signal to the processor based on the detected motion; and

distinguishing, using the processor, the comparison of the new and baseline phase shifts from the detected motion of the patient.

45. The method of claim 37, further comprising:

calculating, with the processor, a fast Fourier transform of samples of the transmitted and received magnetic fields; and

determining the first and second phase shifts by comparing phase components of the calculated respective fast Fourier transforms.

46. The method of claim 37, wherein coupling the headset with the patient'"'"'s head comprises positioning an elastic headband on the head, wherein the transmitter and the receiver are mounted to the elastic headband, and wherein a spacer is coupled with each of the transmitter and receiver so as to be disposed between the transmitter and receiver and the patient'"'"'s head when the headband is positioned on the head.

47. A method as in claim 37, further comprising repeating the steps multiple times over time to monitor the fluid over time.

48. A method as in claim 37, further comprising recommending a treatment, based on the generation of the signal.

49. The method of claim 48, wherein recommending the treatment comprises recommending an amount of mannitol to be delivered to the patient to reduce an amount of intracranial fluid.

50. The method of claim 37, further comprising:

administering mannitol to the patient to reduce intracerebral pressure by reducing an amount of fluid in the brain; and

repeating the steps after administering the mannitol.

51. The method of claim 37, further comprising:

administering a therapeutic agent to the patient; and

repeating the transmitting, receiving, generating and determining steps after administering the therapeutic agent; and

determining how to treat the patient with the therapeutic agent, based on the determining step.