Systems and methods for screening for adverse effects of a treatment

• US 6,656,122 B2
• Filed: 10/01/2001
• Issued: 12/02/2003
• Est. Priority Date: 09/29/2000
• Status: Expired due to Fees

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Crutchfield, Kevin, Davidson, John, Fitall, Simon, Mozayeni, Robert
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Jain, Ruby
• Application Number:
  US09/966,367
• Publication Number:
  US 20020077549A1
• Time in Patent Office: 792 Days
• Field of Search: 600/453-456, 600/504-506, 600/513, 600/457, 738/612.5, 514/2
• US Class Current: 600/454
• 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. The present invention further provides an expert system for achieving the above.

Claims

1. A method of screening for adverse effects of a treatment comprising:

applying a treatment to at least one subject;

monitoring cerebrovascular blood flow of the at least one subject after applying the treatment wherein the monitoring step includes generating a plurality of blood flow factor values for at least one cerebrovascular vessel of the at least one subject;

correlating the blood flow factor values; and

identifying adverse effects to cerebrovascular blood flow in the at least one subject arising after applying the treatment.

2. The method of screening for adverse effects of a treatment according to claim 1 wherein quantitative data regarding the cerebrovascular blood flow of the at least one subject is obtained.

3. The method of screening for adverse effects of a treatment according to claim 2 wherein the quantitative data regarding cerebrovascular blood flow comprises mean flow velocity values for at least three cerebrovascular vessels of the at least one subject and systolic acceleration values for at least three cerebrovascular vessels of the at least one subject.

4. The method of screening for adverse effects of a treatment according to claim 3 wherein the quantitative data regarding cerebrovascular blood flow further comprises pulsatility index values for at least three cerebrovascular vessels of the at least one subject.

5. The method of screening for adverse effects of a treatment according to claim 3 wherein the treatment is at least one treatment selected from the group consisting of administering a drug, conducting a procedure, and carrying out a therapy.

6. The method of screening for adverse effects of a treatment according to claim 5 wherein the treatment is administering a drug.

7. The method of screening for adverse effects of a treatment according to claim 3 wherein the at least three cerebrovascular vessels are arteries.

8. The method of screening for adverse effects of a treatment according to claim 7 wherein the at least three cerebrovascular vessels are selected from the group consisting of a common 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, a basilar artery, and branches thereof.

9. The method of screening for adverse effects of a treatment according to claim 7 wherein the at least three cerebrovascular vessels are intracranial vessels.

10. The method of screening for adverse effects of a treatment according to claim 2 wherein ultrasound energy is used to collect the data regarding cerebrovascular health status.

11. The method of screening for adverse effects of a treatment according to claim 10 wherein a Doppler probe is used to collect the data regarding cerebrovascular health status.

12. The method of screening for adverse effects of a treatment according to claim 2 further comprising the steps of:

monitoring cerebrovascular blood flow of the at least one subject before applying the treatment;

correlating blood flow factor values; and

identifying a base cerebrovascular blood flow status in the at least one subject arising before applying the treatment.

13. The method of screening for adverse effects of a treatment according to claim 12 wherein the treatment is administration of a drug.

14. The method of screening for adverse effects of a treatment according to claim 13 wherein the drug is a vasoactive drug.

15. The method of screening for adverse effects of a treatment according to claim 13 wherein the drug is suspected of having vascular activity.

16. The method of screening for adverse effects of a treatment according to claim 2 wherein the at least one subject has a vascular disease or condition that affects vascular function.

17. The method of screening for adverse effects of a treatment according to claim 2 wherein the at least one subject is suspected of having a vascular disease or condition that affects vascular function.

18. The method of screening for adverse effects of a treatment according to claim 1 wherein data regarding cerebrovascular health status comprises a mean flow velocity value for at least three cerebrovascular vessels of the at least one subject and a systolic acceleration value for at least three cerebrovascular vessels of the at least one subject.

19. The method of screening for adverse effects of a treatment according to claim 18 wherein the data regarding cerebrovascular health status further comprises a pulsatility index value for at least three cerebrovascular vessels of the at least one subject.

20. The method of screening for adverse effects of a treatment according to claim 18 wherein the treatment is at least one treatment selected from the group consisting of administering a drug, conducting a procedure, and carrying out a therapy.

21. The method of screening for adverse effects of a treatment according to claim 20 wherein the treatment is administering a drug.

22. The method of screening for adverse effects of a treatment according to claim 18 wherein the at least three cerebrovascular vessels are arteries.

23. The method of screening for adverse effects of a treatment according to claim 22 wherein the at least three cerebrovascular vessels are selected from the group consisting of a common 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, a basilar artery, and branches thereof.

24. The method of screening for adverse effects of a treatment according to claim 22 wherein the at least three cerebrovascular vessels are intracranial vessels.

25. The method of screening for adverse effects of a treatment according to claim 1 wherein ultrasound energy is used to collect the data regarding cerebrovascular health status.

26. The method of screening for adverse effects of a treatment according to claim 25 wherein a Doppler probe is used to collect the data regarding cerebrovascular health status.

27. The method of screening for adverse effects of a treatment on a vessel according to claim 1 further comprising the steps of:

monitoring cerebrovascular blood flow of the at least one subject before applying the treatment;

correlating blood flow factor values; and

identifying a base cerebrovascular blood flow status in the at least one subject arising before applying the treatment.

28. The method of screening for adverse effects of a treatment on a vessel according to claim 27 wherein the treatment is administration of a drug.

29. The method of screening for adverse effects of a treatment on a vessel according to claim 28 wherein the drug is a vasoactive drug.

30. The method of screening for adverse effects of a treatment on a vessel according to claim 28 wherein the drug is suspected of having vascular activity.

31. The method of screening for adverse effects of a treatment according to claim 1 wherein the at least one subject has a vascular disease or a condition that affects vascular function.

32. The method of screening for adverse effects of a treatment according to claim 1 wherein the at least one subject is suspected of having a vascular disease or a condition that affects vascular function.

33. The method of screening for adverse effects of a treatment according to claim 1 wherein the step of correlating blood flow factor values further comprises, in part, inputting the blood flow factor values into a schema.