Systems and methods for assessing vascular effects of a treatment

• US 6,740,038 B2
• Filed: 10/01/2001
• Issued: 05/25/2004
• Est. Priority Date: 09/29/2000
• Status: Expired due to Fees

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Davidson, John, Crutchfield, Kevin, Fitall, Simon, Mozayeni, Robert
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Jung, William C.
• Application Number:
  US09/966,359
• Publication Number:
  US 20020099291A1
• Time in Patent Office: 967 Days
• Field of Search: 600/437-472
• US Class Current: 600/438
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: G01S 15/8915 using a transducer array
• CPC Class Codes: G01S 15/8979 Combined Doppler and pulse-echo imaging systems
• CPC Class Codes: G01S 7/52036 using analysis of echo signal for target characterisation
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• 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
• CPC Class Codes: G16H 70/60 relating to pathologies

Abstract

The present invention relates generally to systems and methods for assessing blood flow in blood vessels, for assessing vascular health, for conducting clinical trials, for screening therapeutic interventions for adverse effects, and for assessing the effects of risk factors, therapies and substances, including therapeutic substances, on blood vessels, especially cerebral blood vessels, all achieved by measuring various parameters of blood flow in one or more vessels and analyzing the results in a defined matter. The relevant parameters of blood flow include mean flow velocity, systolic acceleration, and pulsatility index. By measuring and analyzing these parameters, one can ascertain the vascular health of a particular vessel, multiple vessels and an individual. Such measurements can also determine whether a substance has an effect, either deleterious or advantageous, on vascular health. In one of many embodiments, the present invention further provides an expert system for achieving the above.

Claims

1. A method of assaying the efficacy of a treatment, the method of assaying comprising the steps of:

collecting physiological information regarding cerebrovascular health status of a number of individuals serving as patients in a clinical trial before application of a treatment;

grouping the patients into at least two groups of patients such that patients with a similar cerebrovascular health status are grouped together;

applying a treatment to the at least two groups of patients;

monitoring outcomes of the treatment for each of the at least two groups of patients;

collecting physiological information regarding cerebrovascular health status of the number of individuals serving as patients in the clinical trial after application of the treatment;

correlating the physiological information regarding cerebrovascular health status of the number of individuals serving as patients in the clinical trial collected before application of the treatment;

correlating said physiological information regarding cerebrovascular health status of the number of individuals serving as patients in the clinical trial collected after application of the treatment; and

determining the efficacy of the treatment based on the outcomes of the treatment for each of the at least two groups of patients based at least on a comparison of the correlated said physiological information regarding cerebrovascular health status of the number of individuals serving as patients in a clinical trial collected before application of the treatment with the correlated said physiological information regarding cerebrovascular health status of the number of individuals serving as patients in a clinical trial collected after application of the treatment.

2. The method of assaying the efficacy of a treatment according to claim 1, wherein said physiological information regarding cerebrovascular health status comprises a mean flow velocity value for at least three cerebrovascular vessels of the individuals and a systolic acceleration value for at least three cerebrovascular vessels of the individuals.

3. The method of assaying the efficacy of a treatment according to claim 2, further comprising calculating a pulsatility index value for at least three cerebrovascular vessels of the individuals.

4. The method of assaying the efficacy of a treatment according to claim 2, wherein the assaying occurs as a part of a clinical trail.

5. The method of assaying the efficacy of a treatment according to claim 4, wherein the clinical trial is investigating sleep disorders.

6. The method of assaying the efficacy of a treatment according to claim 4, wherein the clinical trial is investigating hydrocephalus.

7. The method of assaying the efficacy of a treatment according to claim 2, wherein the treatment is at least one of administering a drug, conducting a procedure, and carrying out a therapy.

8. The method of assaying the efficacy of a treatment according to claim 7, wherein the treatment is administering a drug.

9. The method of assaying the efficacy of a treatment according to claim 8, wherein the drug is a statin.

10. The method of assaying the efficacy of a treatment according to claim 8, wherein the statin is atorvastatin calcium.

11. The method of assaying the efficacy of a treatment according to claim 2, wherein the at least three cerebrovascular vessels are arteries.

12. The method of assaying the efficacy of a treatment according to claim 11, wherein the arteries are selected from the group of a carotid artery, an internal carotid artery, an external carotid artery, a middle cerebral artery, an anterior cerebral artery, a posterior cerebral artery, an anterior communicating artery, a posterior communicating artery, a vertebral artery, and branches thereof.

13. The method of assaying the efficacy of a treatment according to claim 12, wherein the at least three vessels are intracranial vessels.

14. The method of assaying the efficacy of a treatment according to claim 1, wherein ultrasound energy is used to collect the data regarding cerebrovascular health status.

15. The method of assaying the efficacy of a treatment according to claim 14, wherein a Doppler probe is used to collect the data regarding cerebrovascular health status.

16. A method of determining the effects of a treatment on a vessel comprising the application of the method according to claim 1 before and after administration of a treatment.

17. The method of determining the effects of a treatment on a vessel according to claim 16, wherein the treatment is administration of a drug.

18. The method of determining the effects of a treatment on a vessel according to claim 17, wherein the drug is a vasoactive drug.

19. The method of determining the effects of a treatment on a vessel according to claim 17, wherein the drug is suspected of having vascular activity.

20. The method of assaying the efficacy of a treatment according to claim 1, wherein the individuals have a vascular disease or a condition that affects vascular function.

21. The method of assaying the efficacy of a treatment according to claim 1, wherein the individuals are suspected of having a vascular disease or a condition that affects vascular function.

22. The method of assaying the efficacy of a treatment according to claim 1, wherein the individuals are analyzed at a time of normal health and at a time of abnormal health.

23. A method of selecting subjects for a clinical trial comprising the steps of:

collecting physiological information regarding cerebrovascular health status of a number of individuals being considered as subjects for a clinical trial;

correlating the collected physiological information regarding cerebrovascular health status of the individuals being considered for the clinical trial; and

selecting subjects for the clinical trial based at least on the correlated physiological information regarding cerebrovascular health;

wherein subjects selected for participation in the clinical trial have no more than statistically insignificant variations in cerebrovascular health status; and

wherein the data regarding cerebrovascular health status comprises multi-vessel, multi-parameter measurements of cerebral blood flow.

24. The method of selecting subjects for a clinical trial according to claim 23, wherein said physiological information regarding cerebrovascular health comprises a mean flow velocity value for at least three cerebrovascular vessels of the individuals and a systolic acceleration value for at least three cerebrovascular vessels of the individuals.

25. The method of selecting subjects for a clinical trial according to claim 24, further comprising a pulsatility index value for at least three cerebrovascular vessels of the individuals.

26. The method of selecting subjects for a clinical trial according to claim 25, wherein the subjects are divided into at least two groups.

27. The method of selecting subjects for a clinical trial according to claim 26, wherein at least one of the at least two groups is a control group.