Optical power modulation vital sign detection method and measurement device

• US 7,822,299 B2
• Filed: 11/21/2007
• Issued: 10/26/2010
• Est. Priority Date: 01/31/2007
• Status: Expired due to Fees

• Current Assignee: Tarilian Laser Technologies, Limited (Huma Therapeutics Ltd.)
• Original Assignee: Tarilian Laser Technologies, Limited (Huma Therapeutics Ltd.)
• Inventors: Pongratz, Troy, Borgos, Thomas A., Borgos, John A.
• Primary Examiner(s): HEALY, BRIAN
• Application Number:
  US11/944,092
• Publication Number:
  US 20080183053A1
• Time in Patent Office: 1,070 Days
• Field of Search: 600/485, 600/490, 600/495, 600/499, 600/500, 600/504, 600/534, 600/595, 600/493, 600/497, 600/503, 600/336, 600/301, 600/481, 385/12, 385/13, 385/88, 385/89, 385/14, 385/92, 385/1, 385/4, 385/5, 250/227.11, 250/227.14, 250/231.19
• US Class Current: 385/12
• CPC Class Codes: A61B 2562/0266 Optical strain gauges
• 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 5/0082 adapted for particular medical purposes
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/02225 using the oscillometric method
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: G01D 5/35345 using Amplitude variations to detect the measured quantity

Abstract

A vital sign measurement device includes a sensor fixation device, a sensor frame held by the sensor fixation device, an optical sensing system 104 held by the sensor frame, and an output unit. The sensor fixation device is adapted to be placed against an anatomical location of a subject, within which is an artery. The optical sensing system 104 includes an optical waveguide, an optical source device to supply optical energy to the optical waveguide, and an optical detector to detect an amount of optical energy exiting the optical waveguide. The optical sensing system 104 is adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of light exiting the optical waveguide. The output unit is configured to receive a signal indicative of the amount of light exiting the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

Claims

1. A non-invasive vital sign measurement device comprising:

a sensor fixation device adapted to be placed against an external skin surface of an anatomical location of a subject, within which is an artery;

a sensor frame held by the sensor fixation device, the sensor frame adapted to be held against the external skin surface by the sensor fixation device,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

2. The vital sign measurement device of claim 1, wherein the sensor fixation device is a cuff comprising an inflatable bladder adapted to apply pressure to the limb when inflated and thereby compress the artery within the limb.

11. The vital sign measurement device of claim 1, further comprising a pressure sensor to detect a pressure applied to the anatomical location, wherein the output unit receives a pressure input indicative of the pressure applied to the anatomical location from the pressure sensor, and wherein the output unit generates the vital sign using the signal indicative of the optical signal received and the pressure input.

12. The vital sign measurement device of claim 1, wherein the anatomical location of the subject is an upper arm, and the sensor frame is configured on the sensor fixation device so that the optical sensing system is positioned to sense movement due to a pulse of a brachial artery resulting in the compression or flexing of at least a portion of the compressible optical waveguide.

13. The vital sign measurement device of claim 1, wherein the optical waveguide comprises an elastomer.

14. The vital sign measurement device of claim 13, wherein the elastomer is selected from the group consisting of polysiloxane, polyurethane, polybutadine rubber, and combinations thereof.

15. The vital sign measurement device of claim 1, further comprising a waveguide support structure comprising a non-compliant surface, the waveguide support structure supporting at least a portion of the optical waveguide.

17. The vital sign measurement device of claim 1, further comprising a flexible and incompressible support surface that supports the optical waveguide over substantially all of its length.

19. The vital sign measurement device of claim 17, wherein the optical source device and the optical detector are mounted on the surface of the waveguide support surface.

22. The vital sign measurement device of claim 1, wherein the optical sensing system is configured to detect optical signals representative of a series of arterial pulses and the output unit is adapted to determine a pulse waveform for each of the series of arterial pulses.

24. The vital sign measurement device of claim 1, wherein the optical detector is optically coupled to optical waveguide such that the optical detector receives substantially of the optical energy from the optical source that does not escape from the sides of the optical waveguide.

25. The vital sign measurement device of claim 1, wherein the vital sign is at least one of a heart rate, an arterial pulse waveform, a systolic blood pressure, a diastolic blood pressure, a mean arterial blood pressure, a pulse pressure, and an arterial compliance.

33. The vital sign measurement device of claim 1, wherein the sensor fixation device is not inflatable.

34. The vital sign measurement device of claim 33, wherein the sensor fixation device is an adhesive bandage.

35. The vital sign measurement device of claim 33, wherein the sensor is an elastic cuff.

3. A vital sign measurement device comprising:

a cuff comprising an inflatable bladder adapted to be placed against the limb, within which is an artery, and adapted to apply pressure to the limb when inflated and thereby compress the artery within the limb;

a sensor frame held by the cuff, wherein the sensor frame is attached to the cuff at a location that is not coincident with any part of the inflatable bladder, and further wherein the sensor frame is adapted to be held in opposition to the limb by its attachment to the cuff such that the pressure applied to the limb by the sensor frame is substantially equal to the pressure applied to the limb by the surrounding cuff when the inflatable bladder is inflated,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

4. A vital sign measurement device comprising:

a sensor fixation device adapted to be placed against an anatomical location of a subject, within which is an artery;

a sensor frame held by the sensor fixation device,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide;

a sensor pad within the sensor frame which is positionable adjacent to the anatomical location, wherein movement of the sensor pad results in compression or flexing of the compressible optical waveguide, and modulating movement of the sensor pad results in modulating compression or flexing of the optical waveguide; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

5. The vital sign measurement device of claim 4, wherein the sensor pad is positioned at a midpoint of the sensor fixation device.

6. The vital sign measurement device of claim 4, wherein the sensor pad is positioned at a distal location of the sensor fixation device.

7. The vital sign measurement device of claim 4, further comprising a load spring attached to at least a portion of the sensor frame and also supporting the sensor pad, and configured to counter at least some of the pressure exerted against the sensor pad at the anatomical location of a subject.

8. The vital sign measurement device of claim 7, wherein the load spring is adapted to provide a maximum displacement of the sensor pad between 0.5 and 3 millimeters at a maximum pressure.

9. The vital sign measurement device of claim 4, wherein the sensor pad is configured such that pulsatile tensioning of the sensor fixation device does not produce pulsatile movement of the sensor pad, whereas pulsatile opening of the artery within the anatomical location produces a pulsatile movement of the sensor pad.

10. The vital sign measurement device of claim 4, wherein the compression and flexing of the optical waveguide at the position of maximum contact pressure causes a reduction of 50-70% in the total amount of light exiting the optical waveguide.

16. A vital sign measurement device comprising:

a sensor fixation device adapted to be placed against an anatomical location of a subject, within which is an artery;

a sensor frame held by the sensor fixation device,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide;

a waveguide support structure comprising a non-compliant surface, the waveguide support structure supporting at least a portion of the optical waveguide, wherein the optical sensing system is further adapted to cause a flexural deformation in an unsupported portion of the optical waveguide in response to an arterial pulse; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

18. A vital sign measurement device comprising:

a sensor fixation device adapted to be placed against an anatomical location of a subject, within which is an artery;

a sensor frame held by the sensor fixation device,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide;

a flexible and incompressible support surface that supports the optical waveguide over substantially all of its length, wherein the waveguide support surface is a flexible electronic circuit board, to which the waveguide is bonded with a flexible elastomer adhesive; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

20. A vital sign measurement device comprising:

a sensor fixation device adapted to be placed against an anatomical location of a subject, within which is an artery;

a sensor frame held by the sensor fixation device,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide;

a flexible and incompressible support surface that supports the optical waveguide over substantially all of its length;

a support return element which is configured within the support surface and adapted to oppose the flexing of the support surface; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal.

21. The vital sign measurement device of claim 20, further comprising a sensor pad within the sensor frame which is positionable adjacent to the anatomical location, wherein movement of the sensor pad results in compression or flexing of the compressible optical waveguide, and modulating movement of the sensor pad results in modulating compression or flexing of the optical waveguide, wherein the support return element is adapted to provide an increasing contact pressure between the sensor pad and the optical waveguide as the sensor pad moves from a rest position to a position of maximum displacement, with the optical waveguide adapted such that said increasing contact pressure causes a decreasing amount of light exiting the second end of the optical waveguide.

23. A vital sign measurement device comprising:

a sensor fixation device adapted to be placed against an anatomical location of a subject, within which is an artery;

a sensor frame held by the sensor fixation device,

an optical sensing system held by the sensor frame and comprising an optical waveguide, an optical source device to supply optical energy to a first end of the optical waveguide, and an optical detector to detect an amount of optical energy exiting the second end of optical waveguide, the optical sensing system adapted to sense an arterial pulse from the compression or flexing of at least a portion of the optical waveguide resulting in reduction of the amount of optical energy exiting the second end of the optical waveguide; and

an output unit configured to receive a signal indicative of the amount of light exiting the second end of the optical waveguide and to generate a measure of the vital sign based at least in part on the received signal, wherein the optical sensing system is adapted to sense the pulsatile opening of the artery by the compression and flexing of the compressible optical waveguide resulting in a pulsatile decrease in an amount of detected light.

26. A method of non-invasively measuring a vital sign in a subject, the method comprising:

transmitting optical energy into a first end of an optical waveguide, the optical waveguide positioned with a sensor frame, the sensor frame positioned against an external skin surface of an anatomical location of a subject, within which is an artery, the optical waveguide positioned to compress or flex in response to an arterial pulse;

detecting, using an optical detector held by the sensor frame, an amount of optical energy exiting a second end of the optical waveguide and generating therefrom a signal indicative of optical energy received, the amount of optical energy exiting the second end of the optical waveguide changing in response to an arterial pulse; and

generating a measure of the vital sign using the generated signal indicative of the optical energy exiting the second end of the optical waveguide.

27. The method of claim 26, wherein the vital sign is at least one of a heart rate, an arterial pulse waveform, a systolic blood pressure, a diastolic blood pressure, a mean arterial blood pressure, a pulse pressure, and an arterial compliance.

28. The method of claim 26, wherein the sensor frame is held by a sensor fixation device, the method further comprising:

applying a pressure to the anatomical location of the subject with the sensor fixation device.

29. The method of claim 28, the method further comprising:

varying the pressure applied to the anatomical location with the sensor fixation device over a period of time; and

determining a series of pulse characteristics for arterial pulses during the period of time from changes in the amount of optical energy exiting the second end of the optical waveguide over the period of time, wherein the generated measure of the vital sign is based on the series of pulse characteristics during the period of time.

30. The method of claim 28, further comprising

obtaining a measured blood pressure measurement;

obtaining an initial pulse characteristic, at an initial time, and a subsequent pulse characteristic, at a subsequent time, using an input indicative of the amount of optical energy exiting the second end of the optical waveguide, wherein the measured blood pressure measurement was obtained at a measurement time closer to the initial time than to the subsequent time, wherein the generated measurement of the vital sign is based on the measured blood pressure measurement, the initial pulse characteristic, and the subsequent pulse characteristic.

31. The method of claim 30, wherein the initial pulse characteristic and the subsequent pulse characteristics comprise pulse amplitudes.

32. A method of non-invasively measuring a subject'"'"'s blood pressure, the method comprising:

positioning an optical power modulation sensor a against an external skin surface of an anatomical location of a subject, the anatomical location comprising an artery, the optical power modulation sensor comprising an optical waveguide adapted to be compressed or flexed in response to an arterial pulse detected from the external skin surface, the compression or flexing of the optical waveguide resulting in a reduction in the amount of light transmitted to an end of the optical waveguide;

transmitting a light through the optical waveguide;

applying a varying pressure to an anatomical location of a subject;

detecting at least one arterial pulse waveform with the optical power modulation sensor as a function of the applied and varied pressure, the at least one arterial pulse waveform being detected from the amount of light exiting the end of the optical waveguide; and

determining a systolic blood pressure and a diastolic blood pressure based on the at least one detected arterial pulse waveform as a function of the applied and varied pressure.