EP3071103A1 - Localisation d'un cathéter intraluminal - Google Patents

Localisation d'un cathéter intraluminal

Info

Publication number
EP3071103A1
EP3071103A1 EP14862247.5A EP14862247A EP3071103A1 EP 3071103 A1 EP3071103 A1 EP 3071103A1 EP 14862247 A EP14862247 A EP 14862247A EP 3071103 A1 EP3071103 A1 EP 3071103A1
Authority
EP
European Patent Office
Prior art keywords
catheter
sensor
vessel
imaging
image data
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP14862247.5A
Other languages
German (de)
English (en)
Inventor
Nathaniel J. Kemp
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Philips Image Guided Therapy Corp
Original Assignee
Volcano Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Volcano Corp filed Critical Volcano Corp
Publication of EP3071103A1 publication Critical patent/EP3071103A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/02—Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/486—Diagnostic techniques involving generating temporal series of image data
    • A61B6/487—Diagnostic techniques involving generating temporal series of image data involving fluoroscopy
    • 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
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/44—Constructional features of apparatus for radiation diagnosis
    • A61B6/4417—Constructional features of apparatus for radiation diagnosis related to combined acquisition of different diagnostic modalities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/50—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications
    • A61B6/504—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications for diagnosis of blood vessels, e.g. by angiography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/52—Devices using data or image processing specially adapted for radiation diagnosis
    • A61B6/5211—Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data
    • A61B6/5229—Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data combining image data of a patient, e.g. combining a functional image with an anatomical image
    • A61B6/5247—Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data combining image data of a patient, e.g. combining a functional image with an anatomical image combining images from an ionising-radiation diagnostic technique and a non-ionising radiation diagnostic technique, e.g. X-ray and ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/40—Arrangements for generating radiation specially adapted for radiation diagnosis
    • A61B6/4007—Arrangements for generating radiation specially adapted for radiation diagnosis characterised by using a plurality of source units
    • A61B6/4014—Arrangements for generating radiation specially adapted for radiation diagnosis characterised by using a plurality of source units arranged in multiple source-detector units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/44—Constructional features of apparatus for radiation diagnosis
    • A61B6/4429—Constructional features of apparatus for radiation diagnosis related to the mounting of source units and detector units
    • A61B6/4435—Constructional features of apparatus for radiation diagnosis related to the mounting of source units and detector units the source unit and the detector unit being coupled by a rigid structure
    • A61B6/4441—Constructional features of apparatus for radiation diagnosis related to the mounting of source units and detector units the source unit and the detector unit being coupled by a rigid structure the rigid structure being a C-arm or U-arm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/481—Diagnostic techniques involving the use of contrast agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4416—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction

Definitions

  • the present invention generally relates to intraluminal procedures, and, more particularly, to tracking a catheter during diagnostic and/or interventional treatment procedures.
  • vascular diseases including vessel lumen narrowing, usually due to atherosclerotic plaque, can lead to reduced blood flow to a heart muscle, angina (chest pain) and ultimately myocardial infarction (a heart attack).
  • interventional treatments of cardiovascular disease are presently available to identify and treat such narrowing of a vessel lumen. Examples of such treatments include balloon angioplasty and/or deployment of stents. Diagnostic imaging is utilized to identify the extent and/or type of blockages within vessels prior to and/or during the treatment of such blockages. Diagnostic imaging enables doctors to ensure proper treatment of diseased vessels and verify the efficacy of such treatment.
  • a first manner of diagnostic imaging involves generating a radiological image of a stream flowing through a blood vessel's lumen.
  • the purpose of generating an image of such flow is to identify blockages within diseased blood vessels that restrict blood flow.
  • the extent of a vessel's lumen is traditionally imaged using angiography, which involves rendering a two-dimensional view of one or more vessels within a portion of a patient's vasculature through which radiopaque contrast media has been injected.
  • the two-dimensional angiographic image can also be viewed real time by fluoroscopy. Fluoroscopy is used by physicians primarily to visually guide diagnostic and therapeutic catheters and/or guidewires through vessels.
  • Intravascular catheters may include radiopaque markers that are viewable on a fluoroscope, thereby enabling a physician to track the location/path of such catheters as they are inserted within and/or withdrawn from patients.
  • the second manner of intravascular imaging generally includes imaging the vessel itself using a catheter-mounted intravascular probe.
  • Intravascular imaging of blood vessels provides a variety of information about the vessel including, but not limited to, the cross-section of the lumen, the thickness of deposits on a vessel wall, the diameter of the non-diseased portion of a vessel, the length of diseased sections, and the makeup of the atherosclerotic plaque on the wall of the vessel.
  • IVUS intravascular ultrasound
  • MRI magnetic resonance imaging
  • OCT optical coherence tomography
  • thermography catheters and palpography catheters have also been demonstrated to generate vessel image data via intravascular probes.
  • Other catheter modalities include infrared or near- infrared imaging.
  • these intravascular catheter-mounted probes are moved along a vessel (e.g., via pullback mechanism) in the region where imaging is desired. As the probe passes through an area of interest, sets of image data are obtained that, correspond to a series of "slices" or cross-sections of the vessel, the lumen, and surrounding tissue.
  • Each method of imaging vessels described above provides advantages, but also suffers from drawbacks. For example, while providing a means for identifying severe blockages in a vessel, as well as monitoring of devices in real time, angiography and fluoroscopy methods lack the ability to provide detailed information about the vessel, due in part to the incomplete nature of angiographic image data. Although intravascular imaging probes provide rich intravascular information, such as vessel wall composition, such a method generally lacks spatial orientation.
  • some current vascular imaging systems use both imaging modalities simultaneously to diagnose and treat a patient. More specifically, some current systems are configured to co-register data obtained from both modalities to provide a comprehensive picture of the coronaries for interventional cardiologists. Co-registration systems and methods are described, for example, in U.S. Pub. 2006/0241465; and U.S. Pub. 2007/0038061, the contents of each of which are hereby incorporated by reference in their entirety.
  • a patient' s vasculature is defined by a super- fine network of very small veins and arteries that branch extensively.
  • accurate and robust tracking of catheters and transducers employed during image-guided coronary intervention is critical to improve the clinical workflow and procedure outcome.
  • a catheter-based intravascular imaging scan e.g., IVUS, OCT, etc.
  • angiogram/fluoro/X-ray scan it is important to be able to detect features of the imaging catheter in the X-ray image.
  • existing co-registration systems and methods are somewhat limited in their ability to provide accurate tracking of imaging catheters and transducers.
  • imaging catheters are typically constructed with radiopaque markers located at certain positions along the imaging region of the catheter body. Radiopaque markers are generally positioned near a distal catheter tip, including the sensor region which can translate longitudinally during a "pullback" image capture.
  • the vessel When performing OCT pullback image capture, for example, the vessel is typically flushed with radiopaque contrast media, resulting in the entire lumen of the vessel to become radiopaque, thereby obscuring the markers built into the catheter and/or transducer. Flushing of the vessel can make it particularly difficult for automated image processing software (or even the human eye) to track and visualize the location of the catheter. Since treating a plaque buildup requires precise positioning of the catheter and avoiding damage to the walls of the vessels, inaccurate tracking of catheter and/or transducer positions in relation to the vessel may render much of the vasculature off-limits to existing procedures.
  • the invention generally provides systems and methods for tracking one or more portions of a catheter within a vessel during diagnostic and/or interventional treatment procedures based, at least in part, on one or more distinguishing features of the catheter.
  • a sensor e.g., an imaging probe
  • the sensor during translation of a sensor (e.g., an imaging probe) within a catheter, the sensor generally translates longitudinally along a length of the catheter when acquiring endoluminal data.
  • the translation can be a pullback of the sensor.
  • the translation of the sensor results in an interior volume, or negative space, remaining within the catheter sheath.
  • the negative space may serve as a distinguishing feature used in determining the location of one or more portions of the catheter, including the sensor itself, particularly in the presence of a contrast media flushed within the vessel.
  • contrast media may be administered to the vessel to allow the capture of image data of the vessel.
  • the contrast media may be radiopaque and allows the capture of angiographic images.
  • the negative space of the catheter may have radiolucent qualities.
  • the term "radiolucent” as used herein generally refers to the quality of being almost transparent to electromagnetic radiation, particularly x-rays and fluoroscopy.
  • radiopaque contrast media is administered to the vessel to allow the capture of angiographic images which may be co-registered with the endoluminal data to provide enhanced visualization of the intraluminal procedure and to further assist in visualization and manipulation of the sensor within the vessel.
  • the radiolucent negative space within the catheter provides a relatively low attenuation of X-irradiation, such that the negative space has a different appearance (e.g., a lighter color) than the surrounding tissue and/or catheter structures.
  • the position of one or more portions of the catheter can be tracked based on the negative space in relation thereto. More specifically, particular attributes of the negative space, including, but not limited to, shape, geometry, and dimensions, may be used to determine the position of the sensor. For example, the position of the sensor may be determined based on the length of the negative space (e.g., the length of the negative space is approximately equal to the length the sensor moved during a pullback, for example).
  • the present invention provides a more accurate system and method of tracking one or more portions of a catheter (e.g., an imaging probe) during angiography procedures in a co-registration system.
  • a physician using this system will be able to continue to use co-registration systems when performing intraluminal procedures without the drawbacks associated with current systems and methods relying solely on radiopaque markers, which provide little clarity and inaccurate positioning.
  • Physicians using systems and methods of the present invention are able to locate specific structures of interest and return to those structures with less effort, as systems and methods of the present invention help overcome the challenges involved with detecting the transducer shadow directly inside a fully flushed vessel. Accordingly, the procedure will take less time, and the patient and the physician will be exposed to less x-ray radiation.
  • tracking one or more portions of a catheter based on systems and methods of the present invention will reduce the amount of radiopaque markers that would otherwise be required.
  • a system includes sensor positioned within a catheter and operable to capture endoluminal data of a vessel and an extraluminal imaging modality operable to capture extraluminal image data of the vessel.
  • the system also includes at least one processor configured to receive the endoluminal data during translation of the sensor within the catheter during endoluminal data capture, receive the extraluminal image data of the vessel during the translation of the sensor, co-register the endoluminal data with the extraluminal image data, and detect a radiolucent feature of the catheter in the presence of a radiopaque contrast media.
  • the radiolucent feature is a section of the catheter having an interior volume, or negative space, devoid of the sensor resulting from the translation of the sensor.
  • the at least one processor is further configured to identify attributes of the negative space and further determine a position of the sensor, at least in part, on the identified attributes.
  • a method includes acquiring endoluminal data of a vessel with a sensor positioned within a catheter, acquiring extraluminal image data of the vessel with an extraluminal imaging modality, and co-registering the endoluminal data with the extraluminal image data.
  • the method further includes detecting a radiolucent feature of the catheter in the presence of a radiopaque contrast media.
  • the radiolucent feature is a section of the catheter having an interior volume, or negative space, devoid of the sensor, generally resulting from translation of the sensor during endoluminal data acquisition.
  • the method further includes identifying attributes of the negative space and determining a position of the sensor based, at least in part, on the identified attributes of the negative space.
  • FIG. 1 is a schematic illustration of a system for implementing catheter image co- registration consistent with the present disclosure.
  • FIG. 2 is a graphical illustration of a three dimensional length of artery, including a highly diseased segment.
  • FIG. 3 is a graphical illustration of a portion of the artery depicted in FIG. 2 with a longitudinal section removed along lines 2 to illustratively depict different elements of atherosclerotic plaque.
  • FIG. 4 is a graphical illustration of the artery from FIGS. 2 and 3 wherein an imaging catheter consistent with the present disclosure has been inserted in the artery.
  • FIG. 5 is detailed view of a section of the artery depicted in FIG. 4 including the imaging catheter in the artery.
  • FIG. 6 is an enlarged view of a distal section of the imaging catheter of FIG. 5 illustrating a pullback operation of the imaging element.
  • FIG. 7 is a diagram of components of an OCT system consistent with the present disclosure.
  • FIG. 8 is a block diagram illustrating a detailed view of an OCT imaging engine of the OCT system of FIG. 7.
  • FIG. 9 is a schematic of an OCT patient interface module consistent with the present disclosure.
  • FIG. 10 illustrates a pattern that an OCT imaging fiber traces during a pullback operation consistent with the present disclosure.
  • FIG. 11 illustrates a pattern of scan lines produced by an imaging operation of the OCT imaging catheter consistent with the present disclosure
  • FIG. 12 is a display of an angiogram of the artery from which the OCT image originated prior to image processing consistent with the present disclosure.
  • FIG. 13 is a display of the angiogram of the artery of FIG. 12 post image processing illustrating the identified radiolucent feature of the catheter.
  • a method and system are described by way of example herein below including image data acquisition equipment and data/image processors that generate views on a single display that simultaneously provides positional information and intravascular images associated with an imaging probe (e.g., an IVUS transducer probe) mounted upon a flexible elongate member (e.g, a catheter, guidewire, etc.).
  • an imaging probe e.g., an IVUS transducer probe
  • a flexible elongate member e.g, a catheter, guidewire, etc.
  • a system consistent with the present disclosure is configured to accurately track the position of an intravascular imaging catheter within a vessel during diagnostic and/or interventional treatment procedures based, at least in part, on radiolucent features of the catheter.
  • FIG. 1 an exemplary system is schematically depicted for carrying out the present invention in the form of co-registration of angiogram/fluoroscopy and
  • the radiological and ultrasound image data acquisition subsystems are generally well known in the art.
  • a patient 10 is positioned upon an angiographic table 12.
  • the angiographic table 12 is arranged to provide sufficient space for the positioning of an angiography/fluoroscopy unit c-arm 14 in an operative position in relation to the patient 10 on the table 12.
  • Radiological image data acquired by the angiography/fluoroscopy c-arm 14 passes to an angiography/fluoroscopy processor 18 via transmission cable 16.
  • the angiography/fluoroscopy processor 18 converts the received radiological image data received via the cable 16 into angiographic/fluoroscopic image data.
  • the angiographic/fluoroscopic ("radiological") image data is initially stored within the processor 18.
  • an imaging catheter 20 such as an IVUS catheter
  • a diagnostic probe 22 in particular an IVUS probe
  • a radiopaque material located near the probe 22 provides indicia of a current location of the probe 22 in a radiological image.
  • the diagnostic probe 22 generates ultrasound waves, receives ultrasound echoes representative of a region proximate the diagnostic probe 22, and converts the ultrasound echoes to corresponding electrical signals.
  • the corresponding electrical signals are transmitted along the length of the imaging catheter 20 to a proximal connector 24.
  • IVUS versions of the probe 22 come in a variety of configurations including single and multiple transducer element arrangements.
  • an array of transducers is potentially arranged: linearly along a lengthwise axis of the imaging catheter 20, curvilinearly about the lengthwise axis of the catheter 20, circumferentially around the lengthwise axis, etc.
  • the proximal connector 24 of the catheter 20 is communicatively coupled to a catheter image processor 26.
  • the catheter image processor 26 converts the signals received via the proximal connector 24 into, for example, cross- sectional images of vessel segments.
  • the catheter image processor 26 generates longitudinal cross-sectional images corresponding to slices of a blood vessel taken along the blood vessel's length.
  • the IVUS image data rendered by the catheter image processor 26 is initially stored within the processor 26.
  • the type of diagnostic imaging data acquired by the diagnostic probe 22 and processed by the catheter image processor 26 varies in accordance with alternative embodiments of the invention.
  • the diagnostic probe 22 is equipped with one or more sensors (e.g., Doppler and/or pressure) for providing hemodynamic information (e.g., blood flow velocity and pressure)—also referred to as functional flow measurements.
  • hemodynamic information e.g., blood flow velocity and pressure
  • functional flow measurements are processed by the catheter image processor 26.
  • image is intended to be broadly interpreted to encompass a variety of ways of representing vascular information including blood pressure, blood flow velocity/volume, blood vessel cross-sectional composition, shear stress throughout the blood, shear stress at the blood/blood vessel wall interface, etc.
  • a co-registration processor 30 receives IVUS image data from the catheter image processor 26 via line 32 and radiological image data from the radiological image processor 18 via line 34. Alternatively, the communications between the sensors and the processors are carried out via wireless media.
  • the co-registration processor 30 renders a co-registration image including both radiological and IVUS image frames derived from the received image data.
  • indicia e.g., a radiopaque marker artifact
  • the co-registration processor 30 initially buffers angiogram image data received via line 34 from the radiological image processor 18 in a first portion 36 of image data memory 40.
  • IVUS and radiopaque marker image data received via lines 32 and 34 is stored within a second portion 38 and a third portion 42, respectively, of the image data memory 40.
  • the individually rendered frames of stored image data are appropriately tagged (e.g., time stamp, sequence number, etc.) to correlate IVUS image frames and corresponding radiological (radiopaque marker) image data frames.
  • the hemodynamic data is stored within the second portion 38.
  • markers can be placed on the surface of the patient or within the vicinity of the patient within the field of view of the angiogram/fluoro scope imaging device. The locations of these markers are then used to position the radiopaque marker artifact upon the angiographic image in an accurate location.
  • the co-registration processor 30 renders a co-registration image from the data previously stored within the first portion 36, second portion 38 and third portion 42 of the image data memory 40.
  • a particular IVUS image frame/slice is selected from the second portion 38.
  • the co-registration processor 30 identifies fluoroscopic image data within the third portion 42 corresponding to the selected IVUS image data from the second portion 38. Thereafter, the co-registration processor 30 superimposes the fluoroscopic image data from the third portion 42 upon the angiogram image frame retrieved from the first portion 36. Thereafter, the co-registered radiological and IVUS image frames are simultaneously displayed, along- side one another, upon a graphical display device 50.
  • the co-registered image data frames driving the display device 50 are also stored upon a long-term storage device 60 for later review in a session separate from a procedure that acquired the radiological and IVUS image data stored in the image data memory 40.
  • the system depicted in FIG. 1 may be used to perform on a patient any number of medical sensing procedures such as intravascular ultrasound (IVUS), angiography, virtual histology (VH), forward looking IVUS (FL-IVUS), intravascular photoacoustic (IVPA) imaging, a fractional flow reserve (FFR) determination, a coronary flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography (CT), intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intravascular palpography, transesophageal ultrasound (TEE), thermography, magnetic resonance imaging (MRI), micro- magnetic resonance imaging (mMRI or ⁇ 3 ⁇ 4 ⁇ ), or any other medical sensing modalities known in the art.
  • the system may be used to perform one or more treatment or therapy procedures on a patient such as radiofrequency ablation (RFA), cryotherapy, atherectomy or any other medical treatment procedure known in the art.
  • RFID radiofrequency ablation
  • cryotherapy cryotherapy
  • any target can be imaged by methods and systems of the invention including, for example, bodily tissue.
  • systems and methods of the invention image within a lumen of tissue.
  • Various lumen of biological structures may be imaged including, but not limited to, blood vessels, vasculature of the lymphatic and nervous systems, various structures of the gastrointestinal tract including lumen of the small intestine, large intestine, stomach, esophagus, colon, pancreatic duct, bile duct, hepatic duct, lumen of the reproductive tract including the vas deferens, vagina, uterus and fallopian tubes, structures of the urinary tract including urinary collecting ducts, renal tubules, ureter, and bladder, and structures of the head and neck and pulmonary system including sinuses, parotid, trachea, bronchi, and lungs.
  • FIG. 2 is a graphical illustration of a three dimensional length of artery 100, including a highly diseased segment.
  • a diseased artery 100 with a lumen 102 is shown. Blood flows through the artery 100 in a direction indicated by arrow 104 from proximal end 106 to distal end 108.
  • a stenotic area 110 is seen in the artery 100.
  • FIG. 3 shows a sectioned portion of the stenotic area 110 of the artery 100.
  • An artery wall 112 consists of three layers, an intima 114, a media 116 and an adventitia 118.
  • An external elastic lamina (EEL) 120 is the division between the media 116 and the adventitia 118.
  • EEL external elastic lamina
  • a stenosis 122 is located in the artery 100 and limits blood flow through the artery 100.
  • a flap 124 is shown at a high stress area 126 of the artery 100.
  • Proximal to the stenosis 122 is an area of vulnerability 128, including a necrotic core 130. A rupture commonly occurs in an area such as the area of vulnerability 128.
  • FIG. 4 illustratively depicts an imaging catheter 132 having a distal end 134 that is inserted into the stenotic area 110 of the artery 100.
  • the imaging catheter 132 is inserted over a guidewire 136, which allows the imaging catheter 132 to be steered to the desired location in the artery 100.
  • the imaging catheter 132 includes an imaging sensor 138 for imaging the diseased portions and normal portions of the artery 100.
  • the imaging sensor 138 is, for example, a rotating ultrasound transducer, an array of ultrasound transducer elements such as phased array/cMUT, an optical coherence tomography (OCT) probe, a spectroscopy probe, angioscopy, or other type of imaging sensor for capturing endoluminal image data.
  • OCT optical coherence tomography
  • spectroscopy probe angioscopy
  • angioscopy or other type of imaging sensor for capturing endoluminal image data.
  • a tapered tip 140 Distal to the imaging sensor 138 is a tapered tip 140 which allows the imaging catheter 132 to easily track over the guidewire 136, especially in challenging tortuous, stenotic or occluded vessels.
  • the tapered tip 140 may be closed end.
  • the imaging catheter 132 can be pulled back or inserted over a desired length of the vessel, obtaining imaging information along this desired length, and thereafter creating a volumetric model of the vessel wall, including the diseased and normal portions, from a set of circumferential cross-section images obtained from the imaging information.
  • Some technologies, such as IVUS, allow for the imaging of flowing blood and thrombus.
  • FIG. 6 is an enlarged view of a distal section of the imaging catheter 132 of FIG. 5 illustrating a pullback operation of the imaging sensor 138.
  • images of the lumen 102 of the vessel 100 may be captured by the imaging sensor 138 via a pullback method.
  • the imaging sensor 138 and driveshaft 140 coupled thereto may pulled (and/or rotated) through the catheter sheath 142, as indicated by arrow 144, from a first position within the sheath 146, indicated by the phantom outline at arrow 146.
  • an interior volume 148, or "negative space" of the catheter sheath 142 remains where a portion of the imaging sensor 138 once was prior to pullback.
  • one or more portions of the imaging catheter 132 may include one or more radiopaque elements.
  • the term "radiopaque” generally refers to the quality of being visible in a radiological image (e.g., x-ray photograph) and under fluoroscopy.
  • the imaging sensor 138 may include a radiopaque element or marker 141.
  • the driveshaft 140, as well as guidewire 136 may also include radiopaque markers positioned thereon.
  • the radiopaque marker 141 is viewable on a fluoroscope, thereby enabling a physician to track the location/path of such catheters as they are inserted within and/or withdrawn from patients.
  • the negative space 148 left within the catheter sheath 142 during pullback may serve as a radiolucent feature.
  • the term "radiolucent" as used herein generally refers to the quality of being almost transparent to electromagnetic radiation, particularly x-rays and fluoroscopy. Accordingly, during fluoroscopy, the negative space 148 is capable of providing a low enough attenuation of X-irradiation such that body structures such as coronary arteries imaged with intraluminal contrast material may be visualized through the catheter without significant degradation in image quality so as to make the image uninterpretable with respect to luminal irregularities, angioplasty outcome, thrombus formation, or vessel occlusion.
  • the location of one or more portions of the catheter 132 may be accurately tracked based, at least in part on, the radiolucent negative space 148 during image-guided coronary intervention when using co-registration of a catheter- based intravascular imaging scan (e.g., IVUS, OCT, etc.) with an angiogram/fluoro/X-ray scan.
  • a catheter- based intravascular imaging scan e.g., IVUS, OCT, etc.
  • the invention provides a system for co-registering OCT captured images with angiogram/fluoro/X-ray scan.
  • OCT systems are employed in diverse applications such as art conservation and diagnostic medicine, e.g., ophthalmology.
  • OCT is also used in interventional cardiology, for example, to help diagnose coronary artery disease.
  • OCT systems and methods are described in U.S. Pub. 2011/0152771; U.S. Pub. 2010/0220334; U.S. Pub. 2009/0043191; U.S. Pub. 2008/0291463; and U.S. Pub. 2008/0180683, the contents of each of which are hereby incorporated by reference in their entirety.
  • a light source delivers a beam of light to an imaging device to image target tissue.
  • an optical amplifier Within the light source is an optical amplifier and a tunable filter that allows a user to select a wavelength of light to be amplified.
  • Wavelengths commonly used in medical applications include near-infrared light, for example between about 800 nm and about 1700 nm.
  • a common beam path system sends all produced light through a single optical fiber to generate a reference signal and a sample signal whereas a differential beam path system splits the produced light such that a portion of the light is directed to the sample and the other portion is directed to a reference surface.
  • Common beam path interferometers are further described for example in U.S. Pat. 7,999,938; U.S. Pat. 7,995,210; and U.S. Pat. 7,787,127, the contents of each of which are incorporated by reference herein in its entirety.
  • differential beam path interferometer In a differential beam path system, amplified light from a light source is input into an interferometer with a portion of light directed to a sample and the other portion directed to a reference surface. A distal end of an optical fiber is interfaced with a catheter for interrogation of the target tissue during a catheterization procedure. The reflected light from the tissue is recombined with the signal from the reference surface forming interference fringes (measured by a photovoltaic detector) allowing precise depth-resolved imaging of the target tissue on a micron scale.
  • Exemplary differential beam path interferometers are Mach-Zehnder interferometers and Michelson interferometers. Differential beam path interferometers are further described for example in U.S. Pat. 7,783,337; U.S. Pat. 6,134,003; and U.S. Pat. 6,421,164, the contents of each of which are incorporated by reference herein in its entirety.
  • FIG. 7 presents a high-level diagram of a differential beam path OCT system according to certain embodiments of the invention.
  • a light beam is delivered to the vessel lumen via a fiber-optic based imaging catheter 826.
  • the imaging catheter is connected through hardware to software on a host workstation.
  • the hardware includes an imagining engine 859 and a handheld patient interface module (PIM) 839 that includes user controls.
  • PIM 839 handheld patient interface module
  • the proximal end of the imaging catheter is connected to PIM 839, which is connected to an imaging engine as shown in FIG. 8.
  • FIG. 8 gives a detailed view of components of imaging engine 859 (e.g., a bedside unit).
  • Imaging engine 859 houses a power supply 849, light source 827, interferometer 931, and variable delay line 835 as well as a data acquisition (DAQ) board 855 and optical controller board (OCB) 854.
  • DAQ data acquisition
  • OBC optical controller board
  • a PIM cable 841 connects the imagine engine 859 to the PIM 839 and an engine cable 845 connects the imaging engine 859 to the host workstation.
  • FIG. 9 shows light path in a differential beam path system according to an exemplary embodiment of the invention.
  • Light for image capture originates within the light source 827. This light is split between an OCT interferometer 905 and an auxiliary, or "clock",
  • interferometer 911 Light directed to the OCT interferometer is further split by splitter 917 and recombined by splitter 919 with an asymmetric split ratio. The majority of the light is guided into the sample path 913 and the remainder into a reference path 915.
  • the sample path includes optical fibers running through the PIM 839 and the imaging catheter 826 and terminating at the distal end of the imaging catheter where the image is captured.
  • Typical intravascular OCT involves introducing the imaging catheter into a patient' s target vessel using standard interventional techniques and tools such as a guide wire, guide catheter, and angiography system. Rotation is driven by spin motor 861 while translation is driven by pullback motor 865.
  • FIG. 10 describes the motion for image capture defined by rotation and translation.
  • Blood in the vessel is temporarily flushed with a clear solution for imaging.
  • Detection of the flushing triggers, via the PJJV1 or control console, the imaging core of the catheter to rotate 1002, pullback, or both while collecting image data that it delivers to the console screen.
  • the inner core uses light provided by the imaging engine, the inner core sends light into the tissue in an array of A scan lines as illustrated in FIG. 11 and detects reflected light.
  • FIG. 11 shows the positioning of A scans with in a vessel. Each place where one of A scans Al l, A12,... A(N) intersects a surface of a feature within vessel 1006 (e.g., a vessel wall) coherent light is reflected and detected.
  • Catheter 826 translates along axis A being pushed or pulled by pullback motor 865.
  • variable delay line (VDL) 925 on the reference path uses an adjustable fiber coil to match the length of reference path to the length of sample path.
  • the reference path length may adjusted by a stepper motor translating a mirror on a translation stage under the control of firmware or software.
  • the free-space optical beam on the inside of the VDL 925 experiences more delay as the mirror moves away from the fixed input/output fiber.
  • the combined light from the splitter is split into orthogonal polarization states, resulting in RF-band polarization-diverse temporal interference fringe signals.
  • the interference fringe signals are converted to photocurrents using PIN photodiodes on the OCB 851 as shown in FIG. 8.
  • the interfering, polarization splitting, and detection steps are done by a polarization diversity module (PDM) on the OCB.
  • PDM polarization diversity module
  • Signal from the OCB is sent to the DAQ 855, shown in FIG. 8.
  • the DAQ includes a digital signal processing (DSP) microprocessor and a field programmable gate array (FPGA) to digitize signals and communicate with the host workstation and the PIM.
  • the FPGA converts raw optical interference signals into meaningful OCT images.
  • the DAQ also compresses data as necessary to reduce image transfer bandwidth to 1 Gbps (e.g., compressing frames with a lossy compression JPEG encoder).
  • a set of A scans generally define a B scan.
  • the data of all the A scan lines together represent a three-dimensional image of the tissue.
  • the data of the A scan lines generally referred to as a B scan can be used to create an image of a cross section of the tissue, sometimes referred to as a tomographic view.
  • the data of the A scan lines is processed according to systems and methods of the inventions to generate images of the tissue. By processing the data appropriately (e.g., by fast Fourier transformation), a two-dimensional image can be prepared from the three dimensional data set.
  • Systems and methods of the invention provide one or more of a tomographic view, ILD, or both.
  • a system consistent with the present disclosure is configured to co-register the OCT data with angiographic/fluoro data.
  • Image co-registration software provides the capability to combine angiography, OCT, and displacement information on one display with multiple views or displays with multiple views of the three dimensional volume around the physiology of interest.
  • Co-registering angiography with OCT images may include segmenting the three-dimensional image data.
  • the displayed co-registered image data may be used for guidance in performing percutaneous coronary intervention (PCI) for coronary arteries.
  • PCI percutaneous coronary intervention
  • the methods may include imaging a portion of the vasculature of the subject using the image collector, e.g., as part of an imaging catheter, imaging the subject to determine the location of the radiopaque label co-located with an image collector, e.g., using angiography, and locating the position of the intravascular image, based, at least in part, on the position of the radiopaque label in relation to the radiolucent features of the catheter in an angiogram
  • FIG. 12 is an angiogram 1100 of a coronary artery from which an OCT image originated, prior to image processing consistent with the present disclosure.
  • radiopaque contrast media may be administered and angiographic images may be taken.
  • Angiography may be performed, for example, using one or more fluoroscopes, each mounted on a c-arm. Where multiple fluoroscopes are used, for example, to achieve higher accuracy and/or to further constrain co-registration, each may be positioned at a unique angle. The angle between the two fluoroscopic sequences may be between 30 degrees and 90 degrees.
  • the fluoroscope image sequence(s) may be two-dimensional.
  • the real time image of the vasculature is typically displayed on a monitor during the intravascular procedure so that the technician or physician can watch the manipulation of the guidewire or catheter in real time.
  • the angiogram may be processed with software and displayed on a computer, or the image may be a closed circuit image of a scintillating surface combined with a visibly fluorescent material.
  • Newer fluoroscopes may use flat panel (array) detectors that are sensitive to lower doses of x-ray radiation and provide improved resolution over more traditional scintillating surfaces.
  • FIG. 13 illustrates the angiogram of FIG. 12 post image processing to better enable the tracking of the imaging transducer during an OCT pullback procedure, particularly when used in a co-registration system.
  • some imaging catheters do not have the inside of their sheaths 142 purged with contrast media during angiographic image capture.
  • the negative space 148 remaining within the catheter sheath 142 may be radiolucent (e.g., filled with, for example, air or saline).
  • the radiolucent negative space 148 generally creates a negative space in the X-ray image.
  • Image processing devices consistent with the present disclosure may be configured to detect the negative space and further determine the location of one or more portions of the catheter, particularly the imaging sensor 138, based on the dimensions (e.g., shape, size, etc.) of the negative space 148.
  • image tagging software can be used to automatically detect radiolucent features, which will generally appear as portions along the vessel and catheter having a lighter color than the rest of the image.
  • the image tagging software can further determine the location of at least the imaging sensor 138 based on the dimensions (e.g., length) of the negative space 148.
  • the negative space 148 results from pullback of the transducer 138 along a length of the catheter 132. Accordingly, the length of the negative space 148 resulting from pullback may be approximately equal to the length the transducer 138 moved along the catheter 132.
  • image tagging software may be used to automatically identify the location of the radiopaque marker which may appear as a small spot having a darker color than other portions of the rest of the image.
  • systems and methods consistent with the present invention are not limited to the use of radiopaque contrast media when tracking the position of one or more portions of the catheter, including the imaging sensor.
  • other types of contrast media may be administered to the vessel depending on the type of sensor, as well as extraluminal imaging modality, being used.
  • microbubbles may be utilized for contrast-enhancement purposes, such as contrast enhancement of a carotid artery lumen-wall interface.
  • systems and methods consistent with the present invention may include non-imaging sensors for capturing various attributes of the lumen, such as, for example, a fractional flow reserve (FFR) probe for measuring pressure within the vessel.
  • FFR fractional flow reserve
  • a physician using such this system will be able to locate specific structures of interest and return to those structures with less effort, as systems and methods of the present invention help overcome the challenges involved with detecting the transducer shadow directly inside a fully flushed vessel. Accordingly, the procedure will take less time, and the patient and the physician will be exposed to less x-ray radiation. Furthermore, tracking one or more portions of an imaging catheter based on systems and methods of the present invention will reduce the amount of radiopaque markers that would otherwise be required.
  • Computer systems or machines of the invention include one or more processors (e.g., a central processing unit (CPU) a graphics processing unit (GPU) or both), a main memory and a static memory, which communicate with each other via a bus.
  • processors e.g., a central processing unit (CPU) a graphics processing unit (GPU) or both
  • main memory e.g., a main memory
  • static memory e.g., a static memory, which communicate with each other via a bus.
  • a computer device generally includes memory coupled to a processor and operable via an input/output device.
  • Exemplary input/output devices include a video display unit (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)).
  • Computer systems or machines according to the invention can also include an alphanumeric input device (e.g., a keyboard), a cursor control device (e.g., a mouse), a disk drive unit, a signal generation device (e.g., a speaker), a touchscreen, an accelerometer, a microphone, a cellular radio frequency antenna, and a network interface device, which can be, for example, a network interface card (NIC), Wi-Fi card, or cellular modem.
  • NIC network interface card
  • Wi-Fi card Wireless Fidelity
  • Memory can include a machine-readable medium on which is stored one or more sets of instructions (e.g., software), data, or both embodying any one or more of the methodologies or functions described herein.
  • the software may also reside, completely or at least partially, within the main memory and/or within the processor during execution thereof by the computer system, the main memory and the processor also constituting machine-readable media.
  • the software may further be transmitted or received over a network via the network interface device.
  • machine-readable medium can in an exemplary embodiment be a single medium
  • the term "machine-readable medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions.
  • the term “machine-readable medium” shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by the machine and that cause the machine to perform any of the methodologies of the present invention.
  • machine-readable medium shall accordingly be taken to include, but not be limited to, solid-state memories (e.g., subscriber identity module (SIM) card, secure digital card (SD card), micro SD card, or solid-state drive (SSD)), optical and magnetic media, and any other tangible storage media.
  • SIM subscriber identity module
  • SD card secure digital card
  • SSD solid-state drive
  • computer memory is a tangible, non-transitory medium, such as any of the foregoing, and may be operably coupled to a processor by a bus.
  • Methods of the invention include writing data to memory— i.e., physically transforming arrangements of particles in computer memory so that the transformed tangible medium represents the tangible physical objects— e.g., the arterial plaque in a patient's vessel.

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Abstract

L'invention concerne de manière générale l'imagerie intraluminale et des procédés de localisation d'une ou plusieurs portions d'un cathéter pendant des procédés de diagnostic et/ou de traitement d'intervention basés, au moins en partie, sur un élément translucide aux rayons X du cathéter. L'invention concerne des systèmes et des procédés de co-enregistrement pour l'imagerie intraluminale dans lesquels un volume d'espace négatif translucide aux rayons X à l'intérieur du cathéter, produit par translation d'un capteur à l'intérieur du cathéter, est utilisé pour localiser l'emplacement d'une ou plusieurs portions du cathéter, en particulier le capteur. Ainsi, lorsqu'un vaisseau est injecté par le milieu de contraste radio-opaque pendant l'angiographie, le système permet d'améliorer le procédé de localisation de l'emplacement du capteur, qui serait sinon difficile à déterminer avec des procédés classiques.
EP14862247.5A 2013-11-18 2014-11-18 Localisation d'un cathéter intraluminal Withdrawn EP3071103A1 (fr)

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