METHOD AND APPARATUS FOR COMPREHENSIVE ASSESSMENT OF VASCULAR HEALTH

Abstract

Apparatus and methods for comprehensive assessment of vascular health is provided including functional status of the individual, risk factor assessment based on epidemiologic studies, and structural studies of the individual. Functional assessment in accordance with an embodiment of the invention includes generation of information on the status of three compartments: the microvasculature, the macrovasculature and the neurovasculature.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the components of a comprehensive assessment of vascular health.

FIG. 2 depicts functional assessment modules provided in one embodiment of the invention.

FIGS. 3A and B depict contributory factors in a DTM response.

FIGS. 4A and 4B depict the measured components of a DTM response.

FIG. 5 provides a block diagram depicting one embodiment of an entire system level design.

FIG. 6 provides a block diagram depicting one embodiment of DTM Module controller.

FIG. 7 provides a block diagram depicting one embodiment of a Cuff Management Module controller.

FIG. 8 depicts a resident GUI application for operating with the system.

FIG. 9 depicts one embodiment of a DTM Module.

FIG. 10 depicts one embodiment of a DTM sensor.

FIG. 11 depicts one embodiment of a Doppler flow velocity sensor.

FIG. 12 depicts results of measuring the response to reactive hyperemia using a Doppler flow velocity sensor.

FIGS. 13A-C depict Doppler arrays for smart Pulse Wave Form (PWF) analysis.

FIG. 14 graphically depicts the generation of a pulse pressure wave in an artery.

FIG. 15A graphically depicts the oscillatory waveform produced by the pressure wave of arterial flow and reflectance. FIG. 15B graphically depicts the oscillatory waveform produced by the pressure wave of arterial flow and reflectance in a healthy artery. FIG. 15C graphically depicts the oscillatory waveform produced by the pressure wave of arterial flow and reflectance in a stiff artery.

FIG. 16 depicts a set up for measuring pulse wave velocity.

FIG. 17 depicts Doppler signals form brachial and radial arteries overlaid.

FIG. 18A depicts the results of a baseline PWV analysis. FIG. 18B depicts the results of a post reactive challenge PWV analysis.

FIG. 19 depicts IR thermography of two hands during a CLVR response.

FIG. 20 depicts ability of DTM to identify individuals with known CHD as compared with FRE.

FIG. 21 depicts the significant inverse linear relationships observed between DTM parameters and increasing CV risk.

FIG. 22 depicts the predictive ability of DTM and CLVR in relation to Metabolic Syndrome.

FIGS. 23A and B depict suitable designs, among others, for skin temperature sensors.

Claims

1. A modular functional vascular status assessment apparatus, comprising: a CPU in electrical communication with and controlling a plurality of vascular function testing modules including a digital thermal monitoring (DTM) module, a cuff management module, a display or recorder; and a Doppler module comprising at least one Doppler sensor.

2. The apparatus of claim 1, wherein the DTM module comprises a plurality of temperature sensors.

3. The apparatus of claim 1, wherein the cuff management module comprises a plurality of blood pressure cuffs and blood pressure detectors.

4. The apparatus of claim 1, wherein the Doppler module controls a plurality of Doppler sensors.

5. The apparatus of claim 1, wherein at least one Doppler sensor is adapted for measurement of Doppler flow velocity.

6. The apparatus of claim 4, wherein at least two of the plurality of Doppler sensors are adapted to be disposed over a single arterial flow path and at a spaced apart distance sufficient for pulse wave velocity (PWV) measurement and wherein the CPU is programmed to perform PWV analysis.

7. The apparatus of claim 6, further comprising a template or guide for placement of the sensors.

8. The apparatus of claim 7, wherein the template or guide is a bar on which the sensors are slidably mounted.

9. The apparatus of claim 1, wherein at least one Doppler sensor is adapted for pulse wave form (PWF) analyses.

10. The apparatus of claim 4, wherein the plurality of Doppler sensors are disposed in an array.

11. The apparatus of claim 7, wherein the array is affixed to at least one blood pressure cuff.

12. A computer implemented method for assessing cardiovascular risk, comprising: receiving results from one or more vascular functional assessments on an individual;placing the results of the functional assessments into a computational dataset corresponding to the individual;receiving a status for each of a plurality of epidemiologic risk factors;placing the status of each epidemiologic risk factor into the computational dataset corresponding to the individual; andcomputing a combined functional and epidemiologic relative risk for the individual from the dataset corresponding to the individual.

13. The computer implemented method of claim 12, wherein the one or more vascular function assessments include one or more of: DTM, BP, PWV, PWF, DFV, CLVR, and ABI.

14. The computer implemented method of claim 12, wherein the functional assessments include reactive assessments.

15. The computer implemented method of claim 12, wherein the risk factors comprise one or more of traditional and emerging risk factors.

16. The computer implemented method of claim 12, further comprising: receiving results from one or more structural assessments on the individual;placing the results of the one or more structural assessments into the computational dataset corresponding to the individual; andcomputing a combined functional, epidemiologic, and structural relative risk for the individual from the dataset corresponding to the individual.

17. The computer implemented method of claim 16, wherein the structural assessments include determination of pathologic changes including one or more of: increased intima medial thickness, atherosclerotic plaque formation and calcium deposits in at least one vascular bed.

18. The computer implemented method of claim 12, further comprising: receiving results from one or more serologic assays of a status of circulatory progenitor cells on the individual;placing the results of the one or more serologic assays into the computational dataset corresponding to the individual; andcomputing a combined functional, epidemiologic, and serologic relative risk for the individual from the dataset corresponding to the individual.

19. A method of determining a neurovascular status for an individual comprising: locating a blood flow sensor on a test site on the individual and establishing a stable baseline blood flow reading at the site;providing a local vascular or neurovascular stimulant to a body part of the individual that is contralateral to the test site;determining a temperature response to the vasostimulant; andestablishing a neurovascular reactivity assessment for the individual based on a blood flow response at the test site.

20. The method of claim 19, further comprising locating an additional blood flow sensor on a contralateral site corresponding to the test site, the additional blood flow sensor located on a vascular tree directly affected by the local vasostimulant.

21. The method of claim 19, wherein the blood flow sensor detects blood flow by a technique selected from the group consisting of: DTM, skin color, nail capilloroscopy, fingertip plethysmography, forearm plethysmography, oxygen saturation change, laser Doppler flow, ultrasound Doppler flow measurement, near-infrared spectroscopy measurement, wash-out of induced skin temperature, and peripheral arterial tonometry.

22. The method of claim 21, wherein the blood flow sensor is a DTM sensor.

23. A functional vascular status assessment apparatus, comprising: a blood pressure cuff in operable association with at least one Doppler sensor array comprising a plurality of Doppler sensors; anda smart Doppler sensor selector, wherein the selector monitors signals from each sensor of the array and selects a sensor providing a desired signal intensity and frequency for signal analysis.

24. The apparatus of claim 23, further comprising a computer programmed to perform PWF analysis based on the signal selected by the smart Doppler sensor selector.

25. The apparatus of claim 23, wherein at least one Doppler sensor array is affixed to an inside surface of the cuff.

26. The apparatus of claim 25, wherein the Doppler sensor array is disposed essentially circumferentially around in the inside surface of the cuff.

27. The apparatus of claim 23, wherein the Doppler sensors are disposed in a local array.

28. The apparatus of claim 23, wherein the Doppler sensors are disposed in a longitudinal array.

29. A smart Doppler sensor array apparatus adapted for determining maximum Doppler signal from a target cardiovascular system, comprising: at least one Doppler sensor array comprising a plurality of Doppler sensors; anda smart Doppler sensor selector, wherein the selector monitors signals from each sensor of the array and selects a sensor providing a desired signal intensity and frequency for signal analysis.

30. The apparatus of claim 23, wherein sensors comprising the array include sensors resonating at different frequencies providing information at different depths through a tissue.

31. The apparatus of claim 23, wherein sensors comprising the array include sensors positioned at different angles for locating a maximum Doppler blood flow velocity.

32. The apparatus of claim 23, wherein the target cardiovascular system is selected from the group consisting of: carotid, brachial, femoral, aortic and coronary.