WO2011072068A2 - Dispositifs et procédés destinés à prédire et à prévenir la resténose - Google Patents

Dispositifs et procédés destinés à prédire et à prévenir la resténose Download PDF

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WO2011072068A2
WO2011072068A2 PCT/US2010/059559 US2010059559W WO2011072068A2 WO 2011072068 A2 WO2011072068 A2 WO 2011072068A2 US 2010059559 W US2010059559 W US 2010059559W WO 2011072068 A2 WO2011072068 A2 WO 2011072068A2
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tissue
restenosis
measure
index
region
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PCT/US2010/059559
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English (en)
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WO2011072068A3 (fr
Inventor
Xuanmin He
John B. Simpson
Michael H. Rosenthal
John F. Black
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Avinger, Inc.
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Priority to EP10836649.3A priority Critical patent/EP2509498B1/fr
Publication of WO2011072068A2 publication Critical patent/WO2011072068A2/fr
Publication of WO2011072068A3 publication Critical patent/WO2011072068A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0033—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room
    • A61B5/0036—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room including treatment, e.g., using an implantable medical device, ablating, ventilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/005—Devices for introducing or retaining media, e.g. remedies, in cavities of the body for contrast media
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00—Image analysis
    • G06T7/0002—Inspection of images, e.g. flaw detection
    • G06T7/0012—Biomedical image inspection
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/10—Image acquisition modality
    • G06T2207/10068—Endoscopic image
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/30—Subject of image; Context of image processing
    • G06T2207/30004—Biomedical image processing
    • G06T2207/30101—Blood vessel; Artery; Vein; Vascular

Definitions

  • Atherosclerosis is an artery disease believed to arise from endothelial malfunction, accumulation of lipid materials in the intima of artery, inflammatory cell infiltration and reaction, artery wall structure damage, smooth muscle cell proliferation and fibrosis change. These factors may result in artery stenosis and ischemia of supplied organs and severe clinical consequences, such as heart attack in coronary artery stenosis, claudication and critical limb ischemia in occlusive peripheral vascular disease.
  • Atherosclerosis may be treated by atherectomy (e.g., removal of stenosed tissue).
  • atherectomy e.g., removal of stenosed tissue
  • directional atherectomy may use a catheter-based system to excise and retrieve plaque tissue for the transluminal treatment of coronary and peripheral atherosclerotic artery disease.
  • the excision and collection of plaque tissue in directional atherectomy not only leaves behind a large and smooth lumen at the treated artery segment, but may also provide plaque tissue for histopathological analysis and new insights into the mechanism of atherosclerotic progress and variable therapy response.
  • Atherosclerotic stenoses in coronary and peripheral arteries vary widely in presentation and severity.
  • the disease is under-diagnosed and under- treated, amputation rate in the US is staggering at 200,000 per year and recurrence rates following peripheral interventions (atherectomy, angioplasty and stenting) are still high.
  • Baim-Kuntz coronary model of "bigger is better” has been difficult to apply to peripheral vessels because of the diffuse nature of the disease and the large atherosclerotic burden.
  • a high capacity atherectomy system with on-board real-time imaging to guide plaque resection could potentially overcome the disadvantages in current devices and allow the Baim- Kuntz model to be applied to the peripheral vascular space for the first time.
  • histopathological analysis of atherosclerotic artery tissue from patients with cardiovascular disease may be used to predict incidence of restenosis in the artery. More particularly, restenosis of may be predicted based on the histopathological analysis of atherosclerotic tissue (including excised fragments from atherectomy procedures) in patients with atherosclerotic artery disease.
  • the histopathological analysis applied may be quantitative; furthermore, quantitative estimates and ranges are provided which may correlate to restenosis.
  • Applications of the quantitative histological parameters and ranges of values of these parameters are also described.
  • the present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis.
  • a method of treating a stenosed artery may include the steps of determining a level of hypercellularity, and providing a predictive index of restenosis based on the level of hypercellularity and/or the level of lipid-rich tissue, and/or the level of inflammatory cells in the tissue.
  • a method of treating a stenosed artery may include the steps of determining a level of hypercellularity, and providing a predictive index of restenosis based on the level of hypercellularity and/or the level of lipid-rich tissue, and/or the level of inflammatory cells in the tissue.
  • hypercellularity may be provided as a percentage of total tissue or a percentage of hypercellularity, or the level of hypercellularity may be used to provide an indicator of "low/medium/high” or the like.
  • An index indicating the likelihood of restenosis may be provided by combining one or more of these factors.
  • MLD post-interventional minimal lumen diameter
  • Systems including visualization methods such as catheter-based imaging systems using Optical Coherence
  • Tomography are of particular interest.
  • Systems may also be configured for predicting or indicating if restenosis is to occur.
  • Systems or devices may be configured to show
  • the systems may be configured to present quantitative or qualitative estimates in real-time.
  • devices for treating atherosclerosis may be configured for realtime or near real-time imaging of tissue so that the artery may be treated while imaging the tissue.
  • these devices may be used with one more catheters for imaging and treating the tissue.
  • the devices include: 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 processor and to detect regions of hypercellularity in the artery based on 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 one or both of lipid-rich tissue and inflammatory cells in the artery.
  • the device imaging catheter may be any appropriate catheter, including an
  • Atherectomy catheter Steerable catheters, and catheters having more than one imaging modality may be included (or catheters having one imaging modality).
  • the imaging catheter may be an OCT imaging catheter and the sensor comprises an OCT imaging sensor.
  • the device may include any appropriate processor or processors for taking and analyzing images of the arterial tissue or regions of the artery.
  • a processor may be a dedicated or general purpose processor.
  • the processor may be configured in part as a controller for controlling operation of the various components of the system. In some variations a separate controller may be used.
  • the controller may control operation of the analysis and/or the display of images and the resulting identified tissue regions (e.g., showing regions at high risk for restenosis on a display).
  • the processor and display are configured to operate in real or near-real time.
  • the processor may include logic for analyzing and/or controlling the system.
  • a device or system may include detection logic configured to detect regions of hypercellularity and either or both: lipid-rich tissue and inflammatory cells in the artery from the received images.
  • the detection logic may be further configured to estimate, measure or count a degree of hypercellularity and one or both of lipid-richness and/or the amount of inflammatory cells (e.g., macrophages, lymphocytes, etc.) in the tissue region.
  • the device or system may also include index logic for calculating an index that combined (and/or weights) the measures, counts, or estimates of hypercellularity and one or both of lipid-richness and/or the amount of inflammatory cells (e.g., macrophages, lymphocytes, etc.) in the tissue region.
  • index logic may be included with the detection logic, or vice-versa.
  • the display may be a visual display, such as monitor, screen, projection, or the like.
  • the display may be configured to highlight one or more regions 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.
  • the display may overlay an image of the artery or a region of the artery with an indication of the likelihood of restenosis, and my include markers indicating the relative location of the catheter or another device such as an atherectomy catheter or the cutting region of an atherectomy catheter.
  • the indicator of the likelihood of restenosis may be a color (e.g., color intensity or color-coding) or numeric (0 to 100, 0 to 10, 0.00 to 1.00, etc.) or percentage indicator.
  • the processor further may also include 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.
  • 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.
  • the system may display the index of restenosis for the region.
  • the device display may be configured to overlay an indicator of the index of restenosis for the region over a view including the region of the artery.
  • a system may include: 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 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 hypercellularlity 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.
  • the system may also include an output configured to output the index of restenosis.
  • the index logic is configured to determine an index of restenosis based on the measure of hypercellularlity, 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.
  • Methods of treating atherosclerosis based on an estimate of the risk of restenosis as described herein are also provided. Also taught are methods, devices and systems for determining an enhanced risk of restenosis in an arterial tissue, as well as methods, devices and systems for treating and/or preventing restenosis in an arterial tissue.
  • determining an enhanced risk of restenosis in an arterial tissue include the steps of:
  • determining a measure of hypercellularity in a first arterial tissue region determining one or both of: a measure of how lipid-rich the first tissue region is and a measure of how many
  • determining an index of restenosis for the first tissue region based on the measure of hypercellularlity 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.
  • the step of determining an index of restenosis may include determining the index of restenosis for the first tissue region based on the measure of hypercellularlity 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.
  • the step of presenting may include displaying an image of the first tissue region with a visual indicator of the index of restenosis.
  • the method further includes imaging the first tissue region with an imaging modality configured to detect hypercellularity and/or imaging the first tissue region with an imaging modality configured to detect lipid-rich regions.
  • hypercellularity may be determined using an imaging modality such as optical coherence tomography to image the arterial tissue or a region (e.g., the "first region") of the tissue.
  • an imaging modality such as optical coherence tomography to image the arterial tissue or a region (e.g., the "first region") of the tissue.
  • the step of determining a measure of hypercellularity may include counting or estimating the amount of satellite-to-spindle-shaped smooth muscle cells within stroma.
  • determining a measure, estimate or count of hypercellularity may include determining the density of cells (e.g., muscle cells) within the stroma or a region of stroma (e.g., fibrotic stroma rich in proteoglycan materials).
  • the step of determining a measure of how lipid-rich a tissue region is may comprise estimating the amount or degree of amorphous material containing cholesterol crystals, loosely aggregated necrotic debris and foam cells.
  • the step of determining a measure of how many inflammatory cells are associated with the first tissue region may include counting or estimating clusters of macrophages and lymphocytes.
  • the arterial tissue may be treated with a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or indicator, which may help in determining a marker, dye, or
  • the methods described herein may also include the step of inserting a stent adjacent to the first arterial tissue region when the index of restenosis indicates a greater likelihood of restenosis.
  • Other treatment methods may be used as well.
  • tissue additional tissue in some cases
  • tissue may be excited, the arterial region treated locally with one or more drugs or therapies (e.g., ablated, heat-treated, etc.), or the like.
  • tissue e.g., an arterial tissue region
  • tissue may be removed from the patient before or during the procedure, including before or during the estimation of hypercellularity, lipid-richness or the presence of inflammatory cells.
  • it is the removed tissue that is examined; in other variations in is the tissue left behind that is examined; while in still other variations both tissues are examined.
  • a method of preventing restenosis may include: determining an index of restenosis for a first arterial tissue region based on a measure of hypercellularlity of the first arterial tissue region 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.
  • other methods of treating the artery may be used in addition to, or in place of, the insertion of a stent.
  • the method may further include removing of tissue from the first arterial tissue region, either before (to analyze) or after (to treat).
  • the step of determining an index comprises imaging the first arterial tissue region in real or near-real time.
  • FIG. 1 illustrates hypercellular tissue
  • FIG. 2 shows an example of fibrocellular tissue
  • FIG. 3 shows an example of fibrous tissue
  • FIG. 4 shows an example of a lipid-rich region of tissue
  • FIG. 5 illustrates a region of tissue containing inflammatory cells.
  • FIG. 6 shows a thrombus
  • FIG. 7 shows an example of a hemorrhage
  • FIG. 8 illustrates the media portion of arterial tissue.
  • FIG. 9 shows a portion of adventitia tissue
  • FIG. 10 shows an example of a total section area.
  • FIG. 1 1 is a diagram schematically illustrating one method of determining the risk of restenosis.
  • FIG. 12 schematically illustrates one variation of a system for determining the risk of restenosis as described herein.
  • Section I describes the key observation that quantitative histology may be used to predict rates of restenosis in patients undergoing atherectomy. In particular, certain levels of hypercellularity may indicate restenosis. The degree of lipid-rich tissue, as well as the level of inflammatory cells in the tissue may also be combined (individually or together) with the level of hypercellularity or other factor to provide an indication (which may be provided as an index) of the likelihood of restenosis. Section II describes how these observations may be applied. Section I: Quantitative Histology
  • Atherosclerotic tissue fragments were removed from the collection chamber of atherectomy catheter and fixed in 10% buffered formalin, processed through graded alcohols, and xylene, and embedded in paraffin. Tissue sections of 4-6 um thick were cut and stained with hematoxylin and eosin, Masson's trichrome, and elastic van Gieson stains. The stained slides were scanned into digital images using a slide scanner , e.g., ScanScope CS (Aperio, Vista, CA 92081).
  • Hypercellular plaque tissue was characterized by the presence of numerous satellite-to-spindle shaped smooth muscles cells within loose-to-mildly fibrotic stroma rich in proteoglycan materials (see, e.g., Fig. 1).
  • Fibrocellular plaque tissue was consisted of moderate amount of connective tissue and intermediate numbers of smooth muscle cells (Fig. 2).
  • Fibrous plaque tissue was defined by presence of abundant dense connective tissue with sparse cells (Fig. 3).
  • Lipid-rich Lipid rich lesion was defined as an area of amorphous materials containing cholesterol crystals, loosely aggregated necrotic debris or collection of foam cells (Fig. 4).
  • Inflammatory cells Inflammatory cell infiltration was evidence by the presence of clusters of macrophages and lymphocytes (Fig. 5).
  • Thrombus Thrombus was defined as an organized collection of fibrin, platelets and red blood cells (Fig. 6).
  • Hemorrhage was defined as collections of erythrocytes within plaque matrix that were outside of vasa vasorum and that resulted in some distortion of the plaque structure (Fig. 7).
  • Tissue taken from all of the 825 patients was examined as described above. The analysis was performed without any knowledge of the patient outcomes. As part of the analysis, the criterion above were used to quantify the areas of cellular hyperplasia, media, media and adventitia, thrombus and hemorrhage, lipid and inflammatory cells, unidentified fibrocellular, and fibrous tissue, by individually inspecting and drawing the area around each component on over 4000 specimens. The total section area was measured by computer and these values were used to calculate the individual percentages for each component. A summary of the measured components appears in Table 1 , below.
  • variables ending with mm represent the area measurements in square mm while variables ending with area are expressed as percentages of the total section area (for example, for the 825 slides available the square mm of fibrous area (fibareamni2) averaged 3.18 mm and the total section area
  • totalsectionmm2 averaged 9.70 mm 2 so 33.3% of the total section was fibrous tissue as determined by quantitative histology using this system.
  • angiography was available for 692 (83.3%) of the patients.
  • the angiographic restenosis rate was 39.6% (all pts), 37.5% ⁇ de novo pts) and 42.0% (restenosis pts).
  • Stepwise logistic regression was then used to compare MLD post intervention to the quantitative histological parameters seeking to determine if any of the histology findings were independent predictors of restenosis in the de novo patient population.
  • a system e.g., a system for treating atherosclerosis
  • a system may be configured to allow visualization (direct imaging) or an indicator of one or more of any of the factors described above.
  • a system may be configured to provide visualization or an indication of hypercellularity, lipid-rich tissue regions, and/or inflammatory cells.
  • the system may provide an index of one or more of these factors, or a "restenosis index" based on one or more of these factors.
  • the system may provide an image of a tissue region (e.g., a peripheral vessel) that allows visualization of one or more of hypercellularity, lipid-rich tissue and/or inflammatory cells.
  • the system may be configured so that multiple versions of the same image are displayed that are specific for showing one or more of these factors.
  • the system may also include logic that assists the user in identifying or quantifying these factors.
  • a system for treating atherectomy includes one or more visualization modalities that permit visualization one or more of these factors.
  • an optical coherence tomography (OCT) imaging modality may be used.
  • OCT may therefore provide realtime data indicating, for example, multicellularity, lipid content and/or inflammatory cells.
  • An OCT system may be configured to use one or more wavelengths of light (or a band or mixture of wavelengths) that is selective for one or more of these features.
  • Any of the imaging systems described herein may be used in conjunction with one or more markers (e.g., vital dyes, contrast agents, etc.) to help visualize.
  • the OCT may be used in vivo prior to excising the tissue.
  • the tissue may be examined as (or shortly after) it is removed from the vessel.
  • any of the systems described herein may include an atherectomy device such as an atherectomy catheter.
  • the catheter may be guided or controlled based in part of the feedback or guidance from the
  • regions of the tissue exhibiting hypercellularity may be excised more completely or aggressively than other stenotic regions, or may be treated by stenting and/or the application of a local drug agent.
  • OCT Preliminary analysis of human cadaver coronary artery tissue by OCT compared to a routine light microscopic image of the same vessel at the same site suggests that OCT may be configured to distinguish the lipid and fibrous components.
  • OCT variations that may be used include OCT systems having multiple fibers, polarization OCT imaging, multiple/selectable wavelength, birefringence imaging using OCT, combinations of OCT imaging with ultrasound or other tissue-perturbation techniques, or the like.
  • OCT may be used to examine the elastic properties of the tissue which may correspond to the lipid content.
  • Perturbing e.g., vibrating
  • the tissue either directly (mechanically by pushing against the tissue, including inflating a balloon against a region of the tissue and imaging it) or using ultrasound (to vibrate the tissue) may indicate the lipid composition of the tissue region.
  • FIG. 12 shows a schematic diagram of one variation of a system (which may also be integrated in a device) for determining the risk of restenosis.
  • the system/device includes a catheter 1203 using an OCT imaging modality 1205, including a lensing region 1205 at the distal end from which light may exit the side of the catheter for examining a region of arterial wall.
  • the system also includes a processor 1209 connected 1207 to receive images from the OCT subsystem (not shown).
  • the processor may be configured to include or execute detection logic 1213 and/or index logic 1215 to measure, estimate or otherwise determine the extent of hypercellularity and one or both of lipid-richness and/or the presence of inflammatory cells.
  • the system may also include an output 1211, such as a monitor, display, or the like.
  • the output may display the image of the arterial wall (or multiple images) as well as display or indicate regions of hypercellularity and/or regions of high lipid-richness and/or the inflammatory cells.
  • the display shows only region of high-risk for restenosis.
  • the display may be adjustable, and allowing the threshold to adjust the level of risk of restenosis (e.g., changing a threshold above or below which regions of high/low indexes for restenosis are shown).
  • imaging modalities may include ultrasound, angiography (e.g., QVA), CT, MRJ, SPECT, PET/CT, X-ray, etc.
  • Virtually any imaging modality may be used, particularly those that may provide images of vessel regions displaying hypercellularity, lipid-rich tissue, and/or
  • Indication of the hypercellularity, lipid rich tissue, inflammatory cells and/or other factors may be provided in real time, near-real time, or otherwise during the procedure, as mentioned above.
  • Near-real time may refer to a slight delay (e.g., time delayed images) compared to strict real time; for example an image in near-real time may lag by a few seconds or minutes.
  • images illustrating the stenosed tissue regions may be saved for later analysis.
  • the tissue may be removed before the analysis, and correlated with a particular region, or merely with a particular patient.
  • an atherectomy device may be used to remove the tissue, which can then be examined (including by staining, fixation, or other treatments not typically advocated before removal from the patient) for these factors.
  • Any of the systems described herein may be configured to provide automated analysis of these factors.
  • a system for treating atherosclerosis may include logic for analyzing images of the vessel and determine an index of one or more of hypercellularity, lipid-rich membrane, and/or inflammatory cells.
  • An index may be quantitative (e.g., a percentage, or percentage area, or square or cubic area or density).
  • the index may be qualitative (e.g., "high", “medium”, “low”, etc.).
  • An index for the risk of restenosis may also be provided, based on the predictive risks described above.
  • an index of restenosis may be provided based (weighted heavily) on the degree or extent of very active (e.g., hypercellularity) tissue when there is a significant increase in lipid-rich tissue and/or inflammatory cells.
  • the system may include image analysis logic configured to examine one or more of the features described above.
  • Logic may include computer-executable code (software), hardware, firmware, or any combination of these.
  • detection and/or index logic may be executable on or as part of a computer processor (e.g., microprocessor) that is either a general -purpose processor, a distributed processor, or a dedicated processor (or processors).
  • the system provides images that are colored, highlighted, or otherwise marked to indicate regions displaying some threshold (typically correlating to an enhanced risk for restenosis) based on one or more of the factors described herein. Multiple images may be displayed and/or marked, or a single composite (e.g., "high risk" for restenosis) image may be provided.
  • FIG. 1 1 illustrates one variation of a method determining (and treating) restenosis.
  • a method of determining a risk of restenosis as described herein may include the steps of determining from the tissues of a vessel if the tissue is hypercellular. The method may also include determining if the tissue is lipid-rich and/or the extent of inflammatory cells in the tissue. Determining if the tissue is hypercellular, lipid-rich and/or the extent of inflammatory cells may include determining a quantitative measure of the extent of
  • tissue may be visualized and these determinations may be made by a visual means, or the determinations may be made without presenting an image of the tissue.
  • Determining if a tissue is hypercellular may also include determining the density of cells per unit area, or the density of a marker for cells (e.g., nuclei, cell membranes, etc.).
  • a determination of hypercellular tissue may mean simply presenting an image of the tissue in a modality that allows visualization of hypercellular tissue.
  • determining if a tissue is hypercellular may mean displaying an OCT image taken with a wavelength or plurality of wavelengths that permit visualization of hypercellularity (or a birefringent image, a polarized OCT image, etc.). Regions of relative hypercellularity may be marked or unmarked on the image.
  • the determination steps described may include adding a marker, dye, or indicator of the factor to be evaluated (e.g., cellularity, lipid content, inflammatory cell, etc.).
  • the determining step may also include perturbing the tissue so that the factor to be evaluated may be more readily determined using a particular methodology that benefits from this perturbation (e.g., by changing the temperature of the tissue, by vibrating the tissue, by irradiating the tissue, etc.).
  • the method includes the steps of imaging a region of arterial tissue (e.g., arterial wall tissue or a depth through a region of arterial wall) 1100. This region is then examined to determine the extent of hypercellularity (e.g., estimating/counting/measuring the extent of hypercellularity) 1102. The same region is examined to determine either: (1) the extent of lipid-richness 1 106; (2) the presence of inflammatory cells 1 108; or (3) both 1 104. From these estimates (1 102 and 1 108, 1105 or 1 104) an index reflecting the likelihood of restenosis may be determined 1 1 10.
  • a region of arterial tissue e.g., arterial wall tissue or a depth through a region of arterial wall
  • This region is then examined to determine the extent of hypercellularity (e.g., estimating/counting/measuring the extent of hypercellularity) 1102.
  • the same region is examined to determine either: (1) the extent of lipid-richness 1 106; (2) the presence of inflammatory cells 1 108; or (3) both 1
  • the tissue may be treated to prevent restenosis or to mitigate the effects of restenosis 1 1 12.
  • the magnitude of the index of restenosis may be used to predict the likelihood of restenosis.
  • one or more thresholds e.g., confidence intervals
  • confidence intervals and/or thresholds may be determined experimentally (e.g., from population studies) or theoretically, e.g., extrapolated from data such as that shown herein.
  • Methods of determining a risk of restenosis may also include determining an index of restenosis based on the determination of one or more of the factors mentioned herein, including hypercellularity, lipid content, and/or inflammatory cells.
  • the index may be presented for the patient as a whole (a global index) or for specific regions mapped to the patients anatomy (e.g., within the vessels).
  • a method of determining a risk of restenosis may be present as an image or series of images of the subject's vessel lumen, indicating regions of greater and/or lesser risk. Any of the imaging modalities described herein may be used in the determining steps mentioned above.
  • the methods of determining the risk of restenosis may also include the step of inserting a device configured to help determine the risk of restenosis (e.g., a catheter, probe, etc.) within the vessel.
  • a device configured to help determine the risk of restenosis (e.g., a catheter, probe, etc.) within the vessel.
  • the method may include determining the risk non-invasively, using one or more imaging modalities from outside of a patient.
  • any of the methods described herein typically include the step of determining if a tissue (e.g., peripheral vascular tissue) is one or more of hypercellular, lipid-rich and/or includes inflammatory cells. Any of these determining steps may also include
  • determining the extent to which the tissue is hypercellular, lipid-rich and/or includes in inflammatory cells For example, a measure of hypercellular, lipid-richness and/or density of inflammatory cells may be compared to a standard or metric for these factors, based on the experimental data described above. The measure may be +/- some percentage of a threshold value (e.g., within +/- 1 %, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30%, 50%, etc. of a threshold value indicated from the experimental data).
  • a threshold value e.g., within +/- 1 %, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30%, 50%, etc. of a threshold value indicated from the experimental data.
  • a method of treating atherosclerosis typically includes the step of determining if a tissue (e.g., peripheral vascular tissue) is one or more of hypercellular, lipid-rich and/or includes inflammatory cells as mentioned above. This (these) determining steps may include any of the variations described above.
  • the method of treating atherosclerosis may also include the step of removing tissue from the vessel. This removing step may be performed before, during or after the determining step(s).
  • the method of treating atherosclerosis also includes the step of treating regions of the vessel that have a higher risk for restenosis (as suggested by the determination of one or more of hypercellularity, lipid richness and/or inflammatory cells) more aggressively than regions of lower risk.
  • regions of de novo atherectomy lesions having a higher hypercellularity and/or risk of restenosis may be treated with a drug eluting stent while atherectomy alone or atherectomy with a bare metal stent could be advised for less cellular lesions.
  • the method of treating atherosclerosis may include the step of providing a pharmacological agent if it is determined that the subject is at greater risk for restenosis. For example, based on a subject's overall risk of restenosis, the subject may be given anticoagulants (e.g., clopidogrel (Plavix), etc.), or drugs that prevent excessive cell division (e.g., within the lumen), or the like.
  • anticoagulants e.g., clopidogrel (Plavix), etc.
  • drugs that prevent excessive cell division e.g., within the lumen
  • the data describe above may also be interpreted to suggest that good results may be achieved by getting the best possible luminal gain with any intervention (atherectomy, stent, etc.) even to the extent of resecting media and adventitia with atherectomy, as long as the vessel is not perforated.

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Abstract

La présente invention concerne des procédés et des dispositifs destinés à prédire la resténose, et à traiter l'athérosclérose afin de prévenir ou de réduire l'incidence de la resténose. Les procédés de prédiction de la resténose dans une artère périphérique sténosée peuvent comprendre une histologie quantitative du vaisseau. Par exemple, un procédé de traitement d'une artère sténosée (et en particulier une artère périphérique) peut comprendre l'étape consistant à déterminer un taux d'hypercellularité et un ou plusieurs parmi la richesse en lipides et l'étendue de l'inclusion des cellules inflammatoires dans les tissus. Un indice de resténose basé sur l'hypercellularité et la richesse en lipides et/ou l'étendue de l'inclusion des cellules inflammatoires dans les tissus peut être déterminé. Des systèmes destinés à traiter ou à prévenir la resténose peuvent comprendre un ou plusieurs parmi des modes d'imagerie pour prendre des images des régions de tissus et déterminer le taux d'hypercellularité et un ou plusieurs parmi le degré de richesse en lipides et l'étendue de l'inclusion des cellules inflammatoires dans la région tissulaire.
PCT/US2010/059559 2009-12-08 2010-12-08 Dispositifs et procédés destinés à prédire et à prévenir la resténose WO2011072068A2 (fr)

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US8548571B2 (en) 2013-10-01
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