Systems and methods for using dynamic vascular assessment to improve vascular stent placement, application, design and marketing

• US 7,604,599 B2
• Filed: 01/12/2004
• Issued: 10/20/2009
• Est. Priority Date: 09/29/2000
• Status: Expired due to Fees

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Mozayeni, B. Robert, Fitall, Simon, Crutchfield, Kevin E.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Rozanski; Michael T
• Application Number:
  US10/755,208
• Publication Number:
  US 20050038342A1
• Time in Patent Office: 2,108 Days
• Field of Search: 600453-457, 600/500, 600504-506, 600/513, 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 5/411 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 8/0808 for diagnosis of the brain
• 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

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 is applicable as both a system and method for monitoring and improving the design, performance, marketing and use of vascular stents. In particular, the invention enables DVA-assisted stenting procedures, including both pre-operative and post-operative management.

Claims

1. A method of assisting a stenting procedure in a human or an animal, comprising the steps of:

obtaining a first set of intracranial blood flow data from a patient;

generating blood flow factor values from said first set of blood flow data, the blood flow factor values including at least a value for mean blood flow velocity and a value for systolic acceleration;

correlating said blood flow factor values;

assessing blood flow based upon said correlated blood flow factor values; and

inserting a stent at a location within a lumen, the location being based upon the assessed blood flow.

2. The method of claim 1, wherein said stent is expanded in stages.

3. The method of claim 1, wherein said steps of obtaining a first set of blood flow data, generating at least two blood flow factor values from said first set of blood flow data, correlating said at least two blood flow factor values and assessing blood flow at least on said correlated blood flow factor values occur before inserting the stent.

4. The method of claim 1, further comprising performing the steps of obtaining a second set of blood flow data, generating at least two blood flow factor values from said second set of blood flow data, correlating said at least two blood flow factor values and assessing blood flow at least on said correlated blood flow factor values after inserting the stent.

5. The method of claim 1, wherein said blood flow factor values also include at least one of 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.

6. The method of claim 5, further comprising the step of correlating at least three blood flow factor values.

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

8. The method of claim 7, wherein said emissive and reflective wave technology includes ultrasound technology.

9. The method of claim 8, wherein said ultrasound technology includes Doppler technology.

10. The method of claim 8, wherein said ultrasound technology includes thin wire intravascular ultrasound technology.

11. The method of claim 7, wherein said emissive and reflective wave technology includes laser technology.

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

13. The method 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.

14. The method 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.

15. The method of claim 1, further comprising the step of designing a stent.

16. The method of claim 15, further comprising the step of infusing a stent with at least one chemical composition.

17. The method of claim 15, further comprising the step of coating a stent with at least one chemical composition.

18. The method of claim 15, further comprising the step of inserting the blood flow factor values into a schema.

19. The method of claim 1, wherein the step of assessing blood flow based upon said correlated blood flow factor values includes evaluating the patient'"'"'s anticipated reaction to a proposed treatment approach.