Method for detecting early atherosclerosis and vascular damage using radioactive tracers and intravascular radiation detection devices

• US 6,295,680 B1
• Filed: 05/07/1999
• Issued: 10/02/2001
• Est. Priority Date: 07/05/1998
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Lederman, Robert J., Wahl, Richard L.
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): ROBINSON, DANIEL LEON
• Application Number:
  US09/306,976
• Time in Patent Office: 879 Days
• Field of Search: 600/431, 600/436, 600/407, 600/1-8
• US Class Current: 600/431
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00079 Radioactivity
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 6/425 using detectors specially adapted to be used in the interior of the body
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/503 for diagnosis of the heart
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 6/508 for non-human patients

Abstract

A method and apparatus for detecting and optionally treating metabolically unstable or active atherosclerotic plaque is provided. The patient is given an I.V. solution containing a radioactive tracer which specifically accumulates in these plaques. A miniaturized radiation detector for local radioactivity imaging and detection is applied directly within the arterial lumen. The radiation detector identifies and differentiates the active, unstable plaque from the inactive, stable plaque. Treatment may optionally be provided through any of three forms, including opening the vessel by mechanical expansion, removing the plaque by mechanical ablation, or delivering a metabolism-altering agent to the affected site.

Claims

1. A method for use in detecting focal accumulation of radiopharmaceutical agents within an arterial lumen of a patient, the method comprising the steps of:

creating a bloodless field within the vessel of investigation by blocking off the affected vessel proximally and distally with respect to a site and flushing out a quantity of infiltrated blood;

injecting into the patient a solution containing a radioactive tracer which specifically accumulates in metabolically active plaque;

forming a miniaturized radiation detector and readout for local radioactivity imaging and detection;

inserting said radiation detector into a blood vessel of the patient;

interpreting information produced by said readout; and

treating said metabolically active plaque.

2. A method for use in detecting focal accumulation of radiopharmaceutical agents within an arterial lumen of a patient, the method comprising the steps of:

injecting into the patient a solution containing a radioactive tracer which specifically accumulates in metabolically active plaque;

forming a miniaturized radiation detector and readout for local radioactivity imaging and detection;

inserting said radiation detector into a blood vessel of the patient;

characterizing the radioactivity to ascertain whether the atherosclerotic plaques as active, unstable, or vulnerable;

quantifying a concentration of said atherosclerotic plaque by comparing a ratio of abnormal-to-normal metabolic activity; and

treating said metabolically active plaque according to its characterization.

3. The method of detecting of claim 2 wherein treating further comprises expanding a balloon catheter within an affected area of said blood vessel to increase an inside diameter of said blood vessel.

4. The method of detecting of claim 2 wherein treating further comprises mechanically removing said atherosclerotic plaque within an affected area of said blood vessel to reduce said atherosclerotic plaque within said blood vessel.

5. The method of detecting of claim 2 wherein treating further comprises delivering a metabolic altering agent to an affected area of said blood vessel to reduce said atherosclerotic plaque within said blood vessel.

6. A method for use in detecting focal accumulation of radiopharmaceutical agents within an arterial lumen of a patient, the method comprising the steps of:

injecting into the patient a solution containing a radioactive tracer which specifically accumulates in metabolically active plaque;

forming a miniaturized radiation detector and readout for local radioactivity imaging and detection;

inserting said radiation detector into a blood vessel of the patient;

detecting nuclear particles within the pathological tissue;

differentiating the pathological tissue of interest from any background radiation;

isolating the volume of pathological tissue of interest from the larger pool of background radioactivity;

reading the level of radioactivity along a vessel wall;

quantifying a concentration of said atherosclerotic plaque;

characterizing the radioactivity to ascertain whether the atherosclerotic plaques as active, unstable, or vulnerable; and

treating said metabolically active plaque according to its characterization.

7. The method of detecting of claim 6 wherein injecting further comprises the injection of a radioactive tracer such as 18-FDG or similar radioactive tracer.

8. The method of detecting of claim 6 wherein injecting further comprises creating a bloodless field within the vessel of investigation by blocking off the affected vessel proximally and distally with respect to the site and flushing out the infiltrated blood through the use of saline.

9. The method of detecting of claim 6 wherein reading further comprises withdrawing the catheter in incremental amounts and taking a reading at each increment.

10. The method of detecting of claim 6 wherein inserting further comprises inserting said catheter to an extreme distal position from a point of epidermal insertion, said extreme distal position being the furthest location from the epidermal insertion point at which a reading will be desired.

11. The method of detecting of claim 6 wherein treating further comprises expanding a balloon catheter within an affected area of said blood vessel to increase an inside diameter of said blood vessel.

12. The method of detecting of claim 6 wherein treating further comprises mechanically removing said atherosclerotic plaque within an affected area of said blood vessel to reduce said atherosclerotic plaque within said blood vessel.

13. The method of detecting of claim 6 wherein treating further comprises delivering a metabolic altering agent to an affected area of said blood vessel to reduce said atherosclerotic plaque within said blood vessel.

14. The method of detecting of claim 6 wherein quantifying a concentration of said atherosclerotic plaque further comprises comparing a ratio of abnormal-to-normal metabolic activity.