Methods and apparatus for characterizing lesions in blood vessels and other body lumens

• US 6,782,289 B1
• Filed: 09/26/2000
• Issued: 08/24/2004
• Est. Priority Date: 10/08/1999
• Status: Expired due to Fees

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Strauss, H. William
• Primary Examiner(s): Wolfe, Willis R.
• Assistant Examiner(s): Hoang, Johnny H.
• Application Number:
  US09/670,412
• Time in Patent Office: 1,428 Days
• Field of Search: 600/431, 600/436, 600/407
• US Class Current: 600/436
• CPC Class Codes: A61B 5/02755 Radioactive tracers
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61K 51/0491 Sugars, nucleosides, nucleotides, oligonucleotides, nucleic acids, e.g. DNA, RNA, nucleic acid aptamers
• CPC Class Codes: A61K 51/1018 against material from animals or humans

Abstract

Methods, devices, and kits, for assessing luminal lesions are provided. The subject devices comprise an intraluminal detector capable of sensing radioactive or other labels. In the subject methods, a detectable marker is introduced to a body lumen, either into the lumen itself or systemically in patient circulation, and localizes at a lesion. The detector is introduced into the body lumen and the distribution of a localized marker detected in situ. The information is useful for a number of purposes including the identification of unstable plaque in patients suffering from atherosclerotic disease.

Claims

1. A method for identifying or assessing a luminal lesion, said method comprising:

introducing a first detectable marker into a body lumen, wherein said first detectable marker localizes at a lesion comprising a material which preferentially binds or incorporates the first detectable marker;

introducing a detector into the body lumen; and

detecting the first detectable marker localized at said lesion using the detector.

2. A method as in claim 1, wherein introducing said first detectable marker comprises introducing a radioactive marker.

3. A method as in claim 2, wherein introducing the radioactive marker comprises introducing a radioisotope which emits beta (β

) radiation.

4. A method as in claim 1, wherein introducing the detectable marker comprises systemic introduction of the marker.

5. A method as in claim 1, wherein introducing the detectable marker comprises local introduction through the detector.

6. A method as in claim 1, wherein introducing the first detectable marker comprises systemic injection into a patient'"'"'s vasculature.

7. A method as in claim 1, wherein introducing the detector comprises percutaneous introduction of a catheter into the body lumen, wherein the catheter comprises the detector.

8. A method as in claim 1, wherein introducing the detector comprises surgically accessing the body lumen to create an access passage and advancing the catheter through the passage into the body lumen, wherein the catheter comprises the detector.

9. A method as in claim 1, wherein detecting the first detectable marker localized at said lesion, comprises detecting the first detectable marker within 5 cm of a detection surface of the detector.

10. A method as in claim 1, wherein the marker emits beta (β

) radiation and the detector detects beta (β

) radiation.

11. A method as in claim 1, wherein detecting the first detectable localized marker comprises scanning a segment of the lesion having a length of at least 3 cm.

12. A method as in claim 11, wherein detecting the first detectable localized marker comprises scanning a segment of the lesion having a length of at least 4 cm.

13. A method as in claim 11, wherein scanning the segment comprises positioning said detector having a detection surface and scanning while the detector remains stationary in the body lumen.

14. A method as in claim 11, wherein scanning the segment comprises positioning said detector and repositioning the detector to scan the entire segment.

15. A method as in any of claim 1, wherein detecting the localized marker comprises isotropically detecting marker disposed about a periphery of the body lumen.

16. A method as in claim 1, further comprising:

introducing a second detectable marker to the body lumen, wherein said second detectable marker localizes at a lesion comprising a second material which preferentially binds the second detectable marker; and

detecting the second detecting marker.

17. A method as in claim 16, wherein the second detectable marker is detected using the same detector as detected the first detectable marker.

18. A method as in claim 16, wherein the second detectable marker is detected using a second detector.

19. A method as in claim 1, wherein the body lumen is selected from a blood vessel, a ureter, a urethra, an esophagus, a cervix, a uterus or a bladder.

20. A method as in claim 1, wherein said first detectable marker is a fluorescent marker.

21. A method for assessing stability of an intravascular lesion, said method comprising:

introducing a radiolabeled substance into a blood vessel, wherein the radiolabeled substance is selectively incorporated into plaque which is at increased risk of rupture;

introducing a detector into the blood vessel; and

determining to which degree the radiolabeled substance has been incorporated into a lesion, whereby an assessment of lesion stability may be made.

22. A method as in claim 21, wherein introducing the radiolabeled substance comprises introducing a radioisotope which emits beta (β

) radiation.

23. A method as in claim 21, wherein introducing radiolabeled substance comprises systemic introduction of the marker.

24. A method as in claim 21, wherein introducing the radiolabeled substance comprises local introduction through the detector.

25. A method as in claim 21, wherein introducing the radiolabeled substance comprises systemic injection into a patient'"'"'s vasculature.

26. A method as in claim 21, wherein introducing the detector comprises percutaneous introduction of a catheter into the blood vessel, wherein the catheter comprises the detector.

27. A method as in claim 21, wherein introducing the detector comprises surgically accessing the blood vessel to create an access passage and advancing the catheter through the passage into the blood vessel, wherein the catheter comprises the detector.

28. A method as in claim 21, wherein determining the degree of incorporation comprises detecting radiolabeled substance within 5 cm of a detection surface of the detector.

29. A method as in claim 28, wherein the radiolabeled substance emits beta (β

) radiation and the detector detects beta (β

) radiation.

30. A method as in claim 21, wherein determining the degree of incorporation comprises scanning a segment of the lesion having a length of at least 3 cm.

31. A method as in claim 30, wherein determining the degree of incorporation comprises scanning a segment of the lesion having a length of at least 4 cm.

32. A method as in claim 30, wherein scanning the segment comprises positioning the detector having a detection surface and scanning while the detector remains stationary in the body lumen.

33. A method as in claim 30, wherein scanning the segment comprises positioning the detector and repositioning the detector to scan the entire segment.

34. A method as in claim 21, wherein determining the degree of incorporation comprises isotropically detecting marker disposed about a periphery of the body lumen.

35. A method as in claim 21, further comprising:

introducing a second radiolabeled substance to the blood vessel, wherein said second radiolabeled substance localizes at a lesion comprising a second material which preferentially binds the lesion; and

detecting the second radiolabeled substance.

36. A method as in claim 35, wherein the second radiolabeled substance is detected using the same detector as detected the first radiolabeled substance.

37. A method as in claim 35, wherein the second radiolabeled substance is detected using a second detector.