Systems and methods for investigating intracranial pressure

• US 7,104,958 B2
• Filed: 05/21/2003
• Issued: 09/12/2006
• Est. Priority Date: 10/01/2001
• Status: Expired due to Fees

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Davidson, John B., Lall, Rakesh, Mozayeni, B. Robert, Crutchfield, Kevin, Fitall, Simon
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US10/442,194
• Publication Number:
  US 20040049105A1
• Time in Patent Office: 1,210 Days
• Field of Search: 600453-457, 600/500, 600504-506, 600/513, 738/612.5
• US Class Current: 600/454
• 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 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/4088 Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• 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 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 8/0808 for diagnosis of the brain
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: G01S 15/8979 Combined Doppler and pulse-echo imaging systems
• 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

The invention relates to systems and methods for assessing blood flow in single or multiple vessels and segments, for assessing vascular health, for conducting clinical trials, for screening therapeutic interventions for effect, for assessing risk factors, for evaluating intracranial pressure and for analyzing the results in a defined manner. The invention enables direct monitoring of therapies, substances and devices on blood vessels, especially those of the cerebral vasculature. Relevant blood flow parameters include mean flow velocity, systolic acceleration, and pulsatility index. Measurement and analysis of these parameters, and others, provides details regarding the vascular health of individual and multiple vessels and a global analysis of an individual'"'"'s overall vascular health. The invention can track the onset, progression and treatment efficacy in an individual experiencing increased intracranial pressure, or can help identify underlying vulnerabilities of the vascular system to normal pressures, associated with and manifested as hydrocphalus or dementia.

Claims

1. A method of assessing intracranial pressure related to at least one of hydrocephalus and dementia in a human or an animal, comprising the steps of:

obtaining a first set of intracranial blood flow data;

generating at least two blood flow factor values from said first set of intracranial flow data;

correlating said at least two blood flow factor values; and

assessing intracranial pressure based at least on said correlated blood flow factor values;

wherein said at least two blood flow factor values include at least one of a mean flow velocity value, a systolic acceleration value, a pulsatility index value, a natural logarithm of systolic acceleration value, a peak systolic velocity value, an end diastolic velocity value, a peak systolic time value, an end diastolic time value, an acceleration/mean flow velocity index value, a velocity/impedance index value and an acceleration/impedance index value.

2. The method of assessing intracranial pressure of claim 1, further comprising the step of correlating at least three blood flow factor values.

3. The method of assessing intracranial pressure of claim 1, wherein said step of obtaining intracranial blood flow data comprises use of emissive and reflective wave technology.

4. The method of assessing intracranial pressure of claim 3, wherein said emissive and reflective wave technology includes ultrasound technology.

5. The method of assessing intracranial pressure of claim 4, wherein said ultrasound technology includes Doppler technology.

6. The method of assessing intracranial pressure of claim 3, wherein said emissive and reflective wave technology includes laser technology.

7. The method of assessing intracranial pressure of claim 1, further comprising the step of generating a reference data set of correlated blood flow factor values.

8. The method of assessing intracranial pressure of claim 1, further comprising the step of supplementing a reference data set of correlated blood flow factor values with additional correlated blood flow factor values and data.

9. The method assessing intracranial pressure of claim 1, further comprising the step of comparing said correlated blood flow factor values with a reference data set of correlated blood flow factor values.

10. The method of assessing intracranial pressure of claim 1, further comprising the step of diagnosing a subject suffering or suspected of suffering from a condition characterized by increased intracranial pressure based at least on said step of assessing intracranial pressure.

11. The method of assessing intracranial pressure of claim 10, wherein said step of diagnosing includes diagnosing said subject as suffering from a form of hydrocephalus.

12. The method of assessing intracranial pressure of claim 11, wherein said form of hydrocephalus is normal pressure hydrocephalus.

13. The method of assessing intracranial pressure of claim 10, wherein said step of diagnosing includes diagnosing said subject as suffering from dementia.

14. The method of assessing intracranial pressure of claim 1, wherein said method comprises part of a treatment regimen for a subject suffering or suspected of suffering from a condition characterized by increased intracranial pressure.

15. The method of assessing intracranial pressure of claim 14, wherein said method comprises monitoring the efficacy of a treatment regimen of a subject suffering from or suspected of suffering from a condition characterized by increased intracranial pressure.

16. The method of assessing intracranial pressure of claim 14, wherein said condition characterized by increased intracranial pressure comprises a form of hydrocephalus.

17. The method of assessing intracranial pressure of claim 14, wherein said condition characterized by increased intracranial pressure comprises normal pressure hydrocephalus.

18. The method of assessing intracranial pressure of claim 17, wherein said treatment regimen comprises at least the use of a shunt.

19. The method of assessing intracranial pressure claim 18, wherein said shunt is a programmable shunt.

20. The method of assessing intracranial pressure of claim 1, wherein said method is used as part of the development and improvement of shunt technology.

21. The method of assessing intracranial pressure of claim 1, further comprising the step of programming or reprogramming a shunt based at least on said step of assessing intracranial pressure based at least on said correlated blood flow factor values.

22. The method of assessing intracranial pressure of claim 21, wherein said screening of a subject occurs as part of a admission procedure to a health care facility.

23. The method of assessing intracranial pressure of claim 21, wherein said screening of a subject occurs as part of a monitoring protocol at health care facility.

24. The method of assessing intracranial pressure of claim 1, wherein said method is used to screen a subject for increased intracranial pressure.

25. The method of assessing intracranial pressure of claim 1, further comprising the step of inserting the blood flow factor values into a schema.

26. A method of assessing hydrocephalus in a human or an animal, comprising the steps of:

obtaining a first set of intracranial blood flow data;

generating at least two blood flow factor values from said first set of intracranial flow data;

correlating said at least two blood flow factor values; and

assessing intracranial pressure based at least on said correlated blood flow factor value;

wherein said at least two blood flow factor values include at least one of a mean flow velocity value, a systolic acceleration value, a pulsatility index value, a natural logarithm of systolic acceleration value, a peak systolic velocity value, an end diastolic velocity value, a peak systolic time value, an end diastolic time value, an acceleration/mean flow velocity index value, a velocity/impedance index value and an acceleration/impedance index value.

27. A method of assessing dementia in a human or an animal, comprising the steps of:

obtaining a first set of intracranial blood flow data;

generating at least two blood flow factor values from said first set of intracranial flow data;

correlating said at least two blood flow factor values; and

assessing intracranial pressure based at least on said correlated blood flow factor values;

wherein said at least two blood flow factor values include at least one of a mean flow velocity value, a systolic acceleration value, a pulsatility index value, a natural logarithm of systolic acceleration value, a peak systolic velocity value, an end diastolic velocity value, a peak systolic time value, an end diastolic time value, an acceleration/mean flow velocity index value, a velocity/impedance index value and an acceleration/impedance index value.