Devices and methods for predicting and preventing restenosis

• US 8,548,571 B2
• Filed: 12/08/2010
• Issued: 10/01/2013
• Est. Priority Date: 12/08/2009
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: He, Xuanmin, Simpson, John B., Rosenthal, Michael H., Black, John F.
• Primary Examiner(s): Cheng, Jacqueline
• Application Number:
  US12/963,536
• Publication Number:
  US 20110263936A1
• Time in Patent Office: 1,028 Days
• Field of Search: 600/407, 600/425, 600/476, 356/450
• US Class Current: 600/476
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: G06T 2207/10068 Endoscopic image
• CPC Class Codes: G06T 2207/30101 Blood vessel; Artery; Vein; Vascular
• CPC Class Codes: G06T 7/0012 Biomedical image inspection

Abstract

The present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis. Methods of predicting restenosis in a stenosed peripheral artery may include quantitative histology of the vessel. For example, a method of treating a stenosed artery (and particularly a peripheral artery) may include the steps of determining a level of hypercellularity and one or more of the lipid-richness and extent of inflammatory cell inclusion in the tissue. An index of restenosis based on the hypercellularity and lipid richness and/or extent of inflammatory cell inclusion in the tissue may be determined. Systems for treating or preventing restenosis may include one or more imaging modalities for imaging tissue regions and determining the level of hypercellularity and one or more of the degree of lipid-richness and the extent of inflammatory cell inclusion in the tissue region.

Claims

1. A device for determining an enhanced risk of restenosis in an arterial tissue, the device comprising:

an imaging catheter having a sensor configured to image a portion of an artery;

a processor configured to receive images of the artery from the sensor and to detect regions of hypercellularity in the artery by counting or estimating the amount of satellite-to-spindle shaped smooth muscle cells within stroma in the received images, and further configured to detect regions of either or both;

lipid-rich tissue and inflammatory cells in the artery from the received images; and

a display configured to display a modified view of the artery indicating hypercellularity and the one or both of lipid-rich tissue and inflammatory cells in the artery.

2. The device of claim 1, wherein the imaging catheter is an atherectomy catheter.

3. The device of claim 1, wherein the imaging catheter is an OCT imaging catheter and the sensor comprises an OCT imaging sensor.

4. The device of claim 1, wherein the processor and display are configured to operate in real or near-real time.

5. The device of claim 1, wherein the processor comprises detection logic configured to detect the regions of hypercellularity and either or both:

lipid-rich tissue and inflammatory cells in the artery from the received images.

6. The device of claim 1, wherein the display is configured to highlight region of overlap indicating both hypercellularity and either or both:

lipid-rich tissue and inflammatory cells in the artery on the modified view of the artery.

7. The device of claim 1, wherein the processor further comprises index logic configured to determine an index of restenosis based on the degree of hypercellularity and either or both:

the degree of lipid-rich tissue and the degree of inflammatory cells in the artery from a region of the artery in the received images.

8. The device of claim 7, wherein the index logic determines the index of restenosis based on the degree of hypercellularity, the degree of lipid-rich tissue and the degree of inflammatory cells from the region of the artery.

9. The device of claim 7, wherein the display is configured to display the index of restenosis for the region.

10. The device of claim 7, wherein the display is configured to overlay an indicator of the index of restenosis for the region over a view including the region of the artery.

11. A system for indicating an enhanced risk of restenosis in an arterial tissue, the system comprising:

an imaging modality configured to image a region of arterial tissue; and

a processor configured to receive the image of the region of arterial tissue from the imaging modality and to determine a measure of hypercellularity by counting or estimating the amount of satellite-to-spindle shaped smooth muscle cells within stroma and further configured to determine one or both of;

a measure of how lipid-rich the tissue region is and a measure of how many inflammatory cells there are associated with the tissue region; and

index logic configured to determine an index of restenosis for the tissue region based on the measure of hypercellularity and one or both of the measures of how lipid-rich the first tissue region is and the measure of how many inflammatory cells are associated with the first tissue region.

12. The system of claim 11, further comprising an output configured to output the index of restenosis.

13. The system of claim 11, further wherein the index logic is configured to determine an index of restenosis based on the measure of hypercellularity, the measure of how lipid-rich the first tissue region is, and the measure of how many inflammatory cells are associated with the first tissue region.

14. A method of determining an enhanced risk of restenosis in an arterial tissue, the method comprising:

determining a measure of hypercellularity in a first arterial tissue region by counting or estimating the amount of satellite-to-spindle shaped smooth muscle cells within stroma;

determining one or both of;

a measure of how lipid-rich the first tissue region is and a measure of how many inflammatory cells there are associated with the first tissue region;

determining an index of restenosis for the first tissue region based on the measure of hypercellularity and one or both of the measures of how lipid-rich the first tissue region is and the measure of how many inflammatory cells are associated with the first tissue region; and

presenting the index of restenosis for the first tissue region.

15. The method of claim 14, wherein the step of determining an index of restenosis comprises determining the index of restenosis for the first tissue region based on the measure of hypercellularity and the measure of how lipid-rich the first tissue region is and the measure of how many inflammatory cells are associated with the first tissue region.

16. The method of claim 14, wherein the step of presenting comprises displaying an image of the first tissue region with a visual indicator of the index of restenosis.

17. The method of claim 14, further comprising imaging the first tissue region with an imaging modality configured to detect hypercellularity.

18. The method of claim 14, further comprising imaging the first tissue region with an imaging modality configured to detect lipid-rich regions.

19. The method of claim 14, wherein the step of determining a measure of hypercellularity comprises imaging the first region with optical coherence tomography.

20. The method of claim 14, wherein the step of determining a measure of how lipid-rich the first tissue region is comprises estimating the amount or degree of amorphous material containing cholesterol crystals, loosely aggregated necrotic debris and foam cells.

21. The method of claim 14, wherein the step of determining a measure of how many inflammatory cells are associated with the first tissue region comprises counting or estimating clusters of macrophages and lymphocytes.

22. The method of claim 14, further comprising treating the tissue with a marker, dye, or indicator.

23. The method of claim 14, further comprising inserting a stent adjacent to the first arterial tissue region when the index of restenosis indicates a greater likelihood of restenosis.

24. The method of claim 14, further comprising removing the first tissue region from a patient.

25. A method of preventing restenosis in an arterial tissue, the method comprising:

determining an index of restenosis for a first arterial tissue region based on a measure of hypercellularity of the first arterial tissue region, the measure of hypercellularity based upon counting or estimating the amount of satellite-to-spindle shaped smooth muscle cells within stroma, and one or both of a measure of how lipid-rich the first arterial tissue region is and a measure of how many inflammatory cells are associated with the first arterial tissue region; and

inserting a stent adjacent to the first arterial tissue region when the index of restenosis indicates a greater likelihood of restenosis.

26. The method of claim 25, further comprising removing tissue from the first arterial tissue region.

27. The method of claim 26, wherein the step of determining an index comprises imaging the first arterial tissue region in real or near-real time.

28. A device for determining an enhanced risk of restenosis in an arterial tissue, the device comprising:

an imaging catheter having a sensor configured to image a portion of an artery;

a processor configured to receive images of the artery from the sensor and to detect regions of hypercellularity in the artery based on a presence of satellite-to-spindle shaped smooth muscle cells within stroma in the received images, and further configured to detect regions of either or both;

lipid-rich tissue and inflammatory cells in the artery from the received images; and

a display configured to display a modified view of the artery indicating hypercellularity and the one or both of lipid-rich tissue and inflammatory cells in the artery.

29. A method of determining an enhanced risk of restenosis in an arterial tissue, the method comprising:

determining a measure of hypercellularity in a first arterial tissue region by identifying satellite-to-spindle shaped smooth muscle cells within stroma;

determining one or both of;

a measure of how lipid-rich the first tissue region is and a measure of how many inflammatory cells there are associated with the first tissue region;

determining an index of restenosis for the first tissue region based on the measure of hypercellularity and one or both of the measures of how lipid-rich the first tissue region is and the measure of how many inflammatory cells are associated with the first tissue region; and

presenting the index of restenosis for the first tissue region.