EP1326531A4 - Detecteur d'emission radioactive equipe d'un systeme detecteur de position et utilisation dudit detecteur d'emission dans des systemes medicaux et procedures medicales - Google Patents

Detecteur d'emission radioactive equipe d'un systeme detecteur de position et utilisation dudit detecteur d'emission dans des systemes medicaux et procedures medicales

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Publication number
EP1326531A4
EP1326531A4 EP01951883A EP01951883A EP1326531A4 EP 1326531 A4 EP1326531 A4 EP 1326531A4 EP 01951883 A EP01951883 A EP 01951883A EP 01951883 A EP01951883 A EP 01951883A EP 1326531 A4 EP1326531 A4 EP 1326531A4
Authority
EP
European Patent Office
Prior art keywords
coordinates
detector
count rate
position tracking
positional information
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Withdrawn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
EP01951883A
Other languages
German (de)
English (en)
Other versions
EP1326531A2 (fr
Inventor
Yoav Kimchy
Roni Amrami
Yona Bouskila
Udi Antebi
Nick Sidorenko
David Gal Ben
Yoel Zilberstein
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.)
Biosensors International Group Ltd
Original Assignee
V Target Technologies Ltd
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
Priority claimed from US09/641,973 external-priority patent/US8489176B1/en
Priority claimed from US09/727,464 external-priority patent/US7826889B2/en
Application filed by V Target Technologies Ltd filed Critical V Target Technologies Ltd
Publication of EP1326531A2 publication Critical patent/EP1326531A2/fr
Publication of EP1326531A4 publication Critical patent/EP1326531A4/fr
Withdrawn legal-status Critical Current

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01TMEASUREMENT OF NUCLEAR OR X-RADIATION
    • G01T1/00Measuring X-radiation, gamma radiation, corpuscular radiation, or cosmic radiation
    • G01T1/16Measuring radiation intensity
    • G01T1/161Applications in the field of nuclear medicine, e.g. in vivo counting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/064Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/415Evaluating particular organs or parts of the immune or lymphatic systems the glands, e.g. tonsils, adenoids or thymus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/418Evaluating particular organs or parts of the immune or lymphatic systems lymph vessels, ducts or nodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/40Arrangements for generating radiation specially adapted for radiation diagnosis
    • A61B6/4057Arrangements for generating radiation specially adapted for radiation diagnosis by using radiation sources located in the interior of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/42Arrangements for detecting radiation specially adapted for radiation diagnosis
    • A61B6/4208Arrangements for detecting radiation specially adapted for radiation diagnosis characterised by using a particular type of detector
    • A61B6/4258Arrangements for detecting radiation specially adapted for radiation diagnosis characterised by using a particular type of detector for detecting non x-ray radiation, e.g. gamma radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/50Apparatus 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
    • A61B6/507Apparatus 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 determination of haemodynamic parameters, e.g. perfusion CT
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/52Devices using data or image processing specially adapted for radiation diagnosis
    • A61B6/5211Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data
    • A61B6/5229Devices 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
    • A61B6/5235Devices 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 the same or different ionising radiation imaging techniques, e.g. PET and CT
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/52Devices using data or image processing specially adapted for radiation diagnosis
    • A61B6/5211Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data
    • A61B6/5229Devices 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
    • A61B6/5247Devices 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/392Radioactive markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/055Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/02Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A61B6/03Computed tomography [CT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/02Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A61B6/03Computed tomography [CT]
    • A61B6/037Emission tomography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12Arrangements for detecting or locating foreign bodies

Definitions

  • the present invention relates to a radioactive emission detector equipped with a position tracking system. More particularly, the present invention relates to the functional integration of a radioactive emission detector equipped with a position tracking system as above with medical imaging modalities and/or with guided minimally-invasive surgical instruments. The present invention is therefore useful for calculating the position of a concentrated radiopharmaceutical in the body in positional context of imaged portions of the body, which information can be used, for example, for performing an efficient minimally invasive surgical procedure.
  • the present invention further relates to a surgical instrument equipped with a position tracking system and a radioactive emission detector for fine in situ localization during resection and/or biopsy procedures, which surgical instrument is operated in concert with other aspects of the invention.
  • minimally invasive surgical procedures cause little blunt trauma or blood loss and minimize the risk of infection by maintaining the body's natural barriers to infection substantially intact.
  • Minimally invasive surgical procedures result in faster recovery and cause fewer complications than conventional, open, surgical procedures.
  • Minimally invasive surgical procedures such as laparoscopic, endoscopic, or cystoscopic surgeries, have replaced more invasive surgical procedures in all areas of surgical medicine. Due to technological advancements in areas such as fiber optics, micro-tool fabrication, imaging and material science, the physician performing the operation has easier-to-operate and more cost effective tools for use in minimally invasive procedures.
  • there still exist a host of technical hurdles that limit the efficacy and increase the difficulty of minimally invasive procedures some of which were overcome by the development of sophisticated imaging techniques.
  • the present invention offers a yet further advantage in this respect.
  • Radionuclide imaging is one of the most important applications of radioactivity in medicine.
  • the purpose of radionuclide imaging is to obtain a distribution image of a radioactively labeled substance, e.g., a radiopharmaceutical, within the body following administration thereof to a patient.
  • radiopharmaceuticals include monoclonal antibodies or other agents, e.g., f ⁇ brinogen or fiuorodeoxyglucose, tagged with a radioactive isotope, e.g., technetium, 6 gallium, ° thallium, indium, iodine, iodine and fluorine, which may be administered orally or intravenously.
  • the radiopharmaceuticals are designed to concentrate in the area of a tumor, and the uptake of such radiopharmaceuticals in the active part of a tumor, or other pathologies such as an infl nimation, is higher and more rapid than in the tissue that neighbors the tumor. Thereafter, a radiation emission detector, typically an invasive detector or a gamma camera (see below), is employed for locating the position of the active area.
  • a radiation emission detector typically an invasive detector or a gamma camera (see below)
  • Another application is the detection of blood clots with radiopharmaceuticals such as ACUTECT from Nycomed Amersham for the detection of newly formed thrombosis in veins, or clots in arteries of the heart or brain, in an emergency or operating room.
  • Yet other applications include radioimaging of myocardial infarct using agents such as radioactive anti-myosin antibodies, radioimaging specific cell types using radioactively tagged molecules (also known as molecular imaging), etc.
  • the distribution image of the radiopharmaceutical in and around a tumor, or another body structure is obtained by recording the radioactive emission of the radiopharmaceutical with an external radiation detector placed at different locations outside the patient.
  • the usual preferred emission for such applications is that of gamma rays, which emission is in the energy range of approximately 20-511 KeV.
  • beta radiation and positrons may also be detected.
  • the first attempts at radionuclide "imaging" were in the late 1940's. An array of radiation detectors was positioned mechanically on a matrix of measuring points around the head of a patient. Alternatively, a single detector was positioned mechanically for separate measurements at each point on the matrix. A significant advance occurred in the early 1950's with the introduction of the rectilinear scanner by Ben Cassen. With this instrument, the detector was scanned mechanically in a predetermined pattern over the area of interest.
  • the first gamma camera capable of recording all points of the image at one time was described by Hal Anger in 1953.
  • Anger used a detector comprised of a Nal(Tl) screen and a sheet of X-ray film.
  • Anger replaced the film screen with a photomultiplier tube assembly.
  • the Anger camera is described in Hal O. Anger, "Radioisotope camera in Hine GJ", Instrumentation in Nuclear Medicine, New York, Academic Press 1967, chapter 19.
  • U.S. Patent No. 4,959,547 to Carroll et al. describes a probe used to map or provide imaging of radiation within a patient.
  • the probe comprises a radiation detector and an adjustment mechanism for adjusting the solid angle through which radiation may pass to the detector, the solid angle being continuously variable.
  • the probe is constructed so that the only radiation reaching the detector is that which is within the solid angle. By adjusting the solid angle from a maximum to a minimum while moving the probe adjacent the source of radiation and sensing the detected radiation, one is able to locate the probe at the source of radiation.
  • the probe can be used to determine the location of the radioactivity and to provide a point-by-point image of the radiation source or data for mapping the same.
  • U.S. Patent No. 5,246,005 to Carroll et al. describes a radiation detector or probe, which uses statistically valid signals to detect radiation signals from tissue.
  • the output of a radiation detector is a series of pulses, which are counted for a predetermined amount of time.
  • At least two count ranges are defined by circuitry in the apparatus and the count range which includes the input count is determined.
  • an audible signal is produced which is audibly discriminable from the audible signal produced for every other count range.
  • the mean values of each count range are chosen to be statistically different, e.g., 1, 2, or 3 standard deviations, from the mean of adjacent lower or higher count ranges.
  • the parameters of the audible signal such as frequency, voice, repetition rate, and/or intensity are changed for each count range to provide a signal which is discriminable from the signals of any other count range.
  • U.S. Patent No. 5,475,219 to Olson describes a system for detecting photon emissions wherein a detector serves to derive electrical parameter signals having amplitudes corresponding with the detected energy of the photon emissions and other signal generating events.
  • Two comparator networks employed within an energy window, which define a function to develop an output, L, when an event-based signal amplitude is equal to or above a threshold value, and to develop an output, H, when such signal amplitude additionally extends above an upper limit.
  • This discriminator circuit is an asynchronous, sequential, fundamental mode discriminator circuit with three stable states.
  • U.S. Patent Nos. 5,694,933 and 6,135,955 to Madden et al. describe a system and method for diagnostic testing of a structure within a patient's body that has been provided with a radioactive imaging agent, e.g., a radiotracer, to cause the structure to produce gamma rays, associated characteristic x rays, and a continuum of Compton-scattered photons.
  • the system includes a radiation receiving device, e.g., a hand-held probe or camera, an associated signal processor, and an analyzer.
  • the radiation receiving device is arranged to be located adjacent the body and the structure for receiving gamma rays and characteristic X-rays emitted from the structure and for providing a processed electrical signal representative thereof.
  • the processed electrical signal includes a first portion representing the characteristic X-rays received and a second portion representing the gamma rays received.
  • the signal processor removes the signal corresponding to the Compton-scattered photons from the electrical signal in the region of the full-energy gamma ray and the characteristic X-ray.
  • the analyzer is arranged to selectively use the X-ray portion of the processed signal to provide near-field information about the structure, to selectively use both the X-ray and the gamma-ray portions of the processed signal to provide near-field and far-field information about the structure, and to selectively use the gamma-ray portion of the processed signal to provide extended field information about the structure.
  • U.S. Patent No. 5,732,704 to Thurston et al. describes a method for identifying a sentinel lymph node located within a grouping of regional nodes at a lymph drainage basin associated with neoplastic tissue wherein a radiopharmaceutical is injected at the situs of the neoplastic tissue. This radiopharmaceutical migrates along a lymph duct towards the drainage basin containing the sentinel node.
  • a hand-held probe with a forwardly disposed radiation detector crystal is maneuvered along the duct while the clinician observes a graphical readout of count rate amplitudes to determine when the probe is aligned with the duct.
  • the region containing the sentinel node is identified when the count rate at the probe substantially increases.
  • the probe is maneuvered utilizing a sound output in connection with actuation of the probe to establish increasing count rate thresholds followed by incremental movements until the threshold is not reached and no sound cue is given to the surgeon.
  • the probe detector will be in adjacency with the sentinel node, which then may be removed.
  • U.S. Patent No. 5,857,463 to Thurston et al. describes further apparatus for tracking a radiopharmaceutical present within the lymph duct and for locating the sentinel node within which the radiopharmaceutical has concentrated.
  • a smaller, straight, hand-held probe is employed carrying two hand actuable switches.
  • the probe is moved in an undulatory manner, wherein the location of the radiopharmaceutical-containing duct is determined by observing a graphics readout.
  • a switch on the probe device is actuated by the surgeon to carry out a sequence of squelching operations until a small node locating region is defined.
  • U.S. Patent Nos. 5,916,167 to Kramer et al. and 5,987,350 to Thurston describe surgical probes wherein a heat-sterilizable and reusable detector component is combined with a disposable handle and cable assembly.
  • the reusable detector component incorporates a detector crystal and associated mountings along with preamplifier components.
  • U.S. Patent No. 5,928,150 to Call describes a system for detecting emissions from a radiopharmaceutical injected within a lymph duct wherein a hand-held probe is utilized.
  • a hand-held probe When employed to locate sentinel lymph nodes, supplementary features are provided including a function for treating validated photon event pulses to determine count rate level signals.
  • the system includes a function for count-rate based ranging as well as an adjustable thresholding feature.
  • a post-threshold amplification circuit develops full-scale aural and visual outputs.
  • U.S. Patent Nos. 5,932,879 and 6,076,009 to Raylman et al. describe an intraoperative system for preferentially detecting beta radiation over gamma radiation emitted from a radiopharmaceutical.
  • the system has ion-implanted silicon charged-particle detectors for generating signals in response to received beta particles.
  • a preamplifier is located in proximity to the detector filters and amplifies the signal.
  • the probe is coupled to a processing unit for amplifying and filtering the signal.
  • U.S. Patent No. 6,144,876 to Bouton describes a system for detecting and locating sources of radiation, with particular applicability to interoperative lymphatic mapping (ILM) procedures.
  • ILM interoperative lymphatic mapping
  • the scanning probe employed with the system performs with both an audible as well as a visual perceptive output.
  • a desirable stability is achieved in the readouts from the system through a signal processing approach which establishes a floating or dynamic window analysis of validated photon event counts.
  • This floating window is defined between an upper edge and a lower edge.
  • the values of these window edges vary during the analysis in response to compiled count sum values. In general, the upper and lower edges are spaced apart a value corresponding with about four standard deviations.
  • count sums are collected over successive short scan intervals of 50 milliseconds and the count segments resulting therefrom are located in a succession of bins within a circular buffer memory.
  • the count sum is generated as the sum of the memory segment count values of a certain number of the bins or segments of memory. Alteration of the floating window occurs when the count sum either exceeds its upper edge or falls below its lower edge.
  • a reported mean, computed with respect to the window edge that is crossed, is developed for each scan interval which, in turn, is utilized to derive a mean count rate signal.
  • the resulting perceptive output exhibits a desirable stability, particularly under conditions wherein the probe detector is in a direct confrontational geometry with a radiation source.
  • U.S. Patent No. 5,846,513 teaches a system for detecting and destroying living tumor tissue within the body of a living being.
  • the system is arranged to be used with a tumor localizing radiopharmaceutical.
  • the system includes a percutaneously insertable radiation detecting probe, an associated analyzer, and a percutaneously insertable tumor removing instrument, e.g., a resectoscope.
  • the radiation detecting probe includes a needle unit having a radiation sensor component therein and a handle to which the needle unit is releasably mounted.
  • the needle is arranged to be inserted through a small percutaneous portal into the patient's body and is movable to various positions within the suspected tumor to detect the presence of radiation indicative of cancerous tissue.
  • the probe can then be removed and the tumor removing instrument inserted through the portal to destroy and/or remove the cancerous tissue.
  • the instrument not only destroys the tagged tissue, but also removes it from the body of the being so that it can be assayed for radiation to confirm that the removed tissue is cancerous and not healthy tissue.
  • a collimator may be used with the probe to establish the probe's field of view.
  • the main limitation of the system is that once the body is penetrated, scanning capabilities are limited to a translational movement along the line of penetration.
  • An effective collimator for gamma radiation must be several mm in thickness and therefore an effective collimator for high energy gamma radiation cannot be engaged with a fine surgical instrument such as a surgical needle.
  • beta radiation is absorbed mainly due to its chemical reactivity after passage of about 0.2-3 mm through biological tissue.
  • the system described in U.S. Patent No. 5,846,513 cannot efficiently employ high energy gamma detection because directionality will to a great extent be lost and it also cannot efficiently employ beta radiation because too high proximity to the radioactive source is required, whereas body tissue limits the degree of maneuvering the instrument.
  • CT computerized tomography
  • X-ray fluoroscopy X-ray fluoroscopy
  • MRI magnetic resonance imaging
  • optical endoscopy mammography or ultrasound which distinguish the borders and shapes of soft tissue organs or masses.
  • medical imaging is the first step in preventing the spread of cancer through early detection and in many cases medical imaging makes it possible to cure or eliminate the cancer altogether via subsequent treatment.
  • radioactivity tagged materials generally known as radiopharmaceuticals, which are administered orally or intravenously and which tend to concentrate in such areas, as the uptake of such radiopharmaceuticals in the active part of a tumor is higher and more rapid than in the neighboring tumor tissue.
  • a radiation emission detector typically an invasive detector
  • Medical imaging is often used to build computer models which allow doctors to, for example, guide exact radiation in the treatment of cancer, and to design minimally-invasive or open surgical procedures.
  • imaging modalities are also used to guide surgeons to the target area inside the patient's body, in the operation room during the surgical procedure.
  • Such procedures may include, for example, biopsies, inserting a localized radiation source for direct treatment of a cancerous lesion, known as brachytherapy (so as to prevent radiation damage to tissues near the lesion), injecting a chemotherapy agent into the cancerous site or removing a cancerous or other lesions.
  • brachytherapy sinotherapy
  • the aim of all such procedures is to pin-point the target area as precisely as possible in order to get the most precise biopsy results, preferably from the most active part of a tumor, or to remove such a tumor in its entirety on the one hand with minimal damage to the surrounding, non affected tissues, on the other hand.
  • prior art radiation emission detectors and/or biopsy probes while being suitable for identifying the location of the radiation site, they leave something to be desired from the standpoint of facilitating the removal or other destruction of the detected cancerous tissue with minimum invasion of the patient.
  • the combination of modalities can reduce the margin of error in positioning such tumors.
  • the possibility of demonstrating the position of the active part of a tumor superimposed on a scan from an imaging modality that shows the organ or tumor, coupled with the possibility to follow a surgical tool in reference to the afflicted area during a surgical procedure will allow for a more precise and controlled surgical procedures to take place, minimizing the aforementioned problems.
  • the present invention addresses these and other issues which are further elaborated hereinbelow, and offers the physicians and patients more reliable targeting, that in turn will result in less invasive and less destructive surgical procedures and less cases of mistaken diagnosis.
  • a system for calculating a position of a radioactivity emitting source in a system-of-coordinates comprising (a) a radioactive emission detector; (b) a position tracking system being connected to and/or communicating with the radioactive emission detector; and (c) a data processor being designed and configured for receiving data inputs from the position tracking system and from the radioactive emission detector and for calculating the position of the radioactivity emitting source in the system-of-coordinates.
  • a system for calculating a position of a radioactivity emitting source in a system-of-coordinates comprising (a) at least two radioactive emission detectors; (b) a position tracking system being connected to and/or communicating with at least two radioactive emission detectors; and (c) a data processor being designed and configured for receiving data inputs from the position tracking system and from the at least two radioactive emission detectors and for calculating the position of the radioactivity emitting source in the system-of-coordinates.
  • a method for defining a position of a radioactivity emitting source in a system-of-coordinates comprising the steps of (a) providing a radioactive emission detector being connected to or communicating with a position tracking system; and (b) monitoring radioactivity being emitted from the radioactivity emitting source, while at the same time, monitoring the position of the radioactive emission detector in the system-of-coordinates , thereby defining the position of the radioactivity emitting source in the system-of-coordinates.
  • a method for defining a position of a radioactivity emitting source in a system-of-coordinates comprising the steps of (a) providing at least one radioactive emission detector being connected to or communicating with a position tracking system; and (b) monitoring radioactivity being emitted from the radioactivity emitting source, while at the same time, monitoring the position of the at least one radioactive emission detector in the system-of-coordinates, thereby defining the position of the radioactivity emitting source in the system-of-coordinates.
  • a system for calculating a position of a radioactivity emitting source in a first system-of-coordinates and further of projecting the position of the radioactivity emitting source onto a second system-of-coordinates comprising (a) a radioactive emission detector; (b) a position tracking system being connected to and/or communicating with the radioactive detector; and (c) a data processor being designed and configured for (i) receiving data inputs from the position tracking system and from the radioactive emission detector; (ii) calculating the position of the radioactivity emitting source in the first system-of-coordinates; and (iii) projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a system for calculating a position of a radioactivity emitting source in a first system-of-coordinates and further of projecting the position of the radioactivity emitting source onto a second system-of-coordinates comprising (a) at least two radioactive emission detectors; (b) a position tracking system being connected to and/or communicating with the at least two radioactive emission detectors; and (c) a data processor being designed and configured for (i) receiving data inputs from the position tracking system and from the at least two radioactive emission detectors; (ii) calculating the position of the radioactivity emitting source in the first system-of-coordinates; and (iii) projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a method for calculating a position of a radioactivity emitting source in a first system-of-coordinates and for projecting the position of the radioactivity emitting source onto a second system-of-coordinates comprising the steps of (a) providing a radioactive emission detector being connected to or communicating with a position tracking system; and (b) monitoring radioactivity being emitted from the radioactivity emitting source, while at the same time, monitoring the position of the radioactive emission detector in the first system-of-coordinates, thereby defining the position of the radioactivity emitting source in the first system-of-coordinates and projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a method for calculating a position of a radioactivity emitting source in a first system-of-coordinates and for projecting the position of the radioactivity emitting source onto a second system-of-coordinates comprising the steps of (a) providing at least one radioactive emission detector being connected to or communicating with a position tracking system; and (b) monitoring radioactivity being emitted from the radioactivity emitting source, while at the same time, monitoring the position of the at least one radioactive emission detector in the first system-of-coordinates, thereby defining the position of the radioactivity emitting source in the first system-of-coordinates and projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a system for calculating a position of a body component and a position of a radiopharmaceutical uptaking portion of the body component within a subject comprising (a) a two-dimensional (projectional or cross-sectional) or a three-dimensional (consequtive cross-sectional) imaging modality being connected to and/or communicating with a first position tracking system for calculating the position of the body component in a first system-of-coordinates; (b) a radioactive emission detector being connected to and/or communicating with a second position tracking system for tracking a position of the radiophamiaceutical uptaking portion of the body component in a second system-of-coordinates; and (c) at least one data processor being designed and configured for receiving data inputs from the three-dimensional imaging modality, the first position tracking system, the radioactive emission detector and the second position tracking system and calculating the position of the body component and the position of the radiopharmaceutical uptaking portion of the body component in a subject
  • a method for calculating a position of a body component and a position of a radiopharmaceutical uptaking portion of the body component within a subject comprising the steps of (a) providing a two-dimensional or a three-dimensional imaging modality being connected to and/or communicating with a first position tracking system and calculating the position of the body component in a first system-of-coordinates; (b) providing a radioactive emission detector being connected to and/or communicating with a second position tracking system and tracking a position of the radiopharmaceutical uptaking portion of the body component in a second system-of-coordinates; and (c) receiving data inputs from the three-dimensional imaging modality, the first position tracking system, the radioactive emission detector and the second position tracking system and calculating the position of the body component and the position of the radiopharmaceutical uptaking portion of the body component in a common system-of-coordinates.
  • a system for performing an intrabody surgical procedure on a radiopharmaceutical uptaking portion of a body component within a subject comprising (a) a radioactive emission detector being connected to and/or communicating with a first position tracking system for tracking a position of the radiopharmaceutical uptaking portion of the body component in a first system-of-coordinates; (b) a surgical instrument being connected to and/or communicating with a second position tracking system for tracking a position of the surgical instrument in a second system-of-coordinates; and (c) at least one data processor being designed and configured for receiving data inputs from the first position tracking system, the radioactive emission detector and the second position tracking system and for calculating the position of the surgical instrument and the radiopharmaceutical uptaking portion of the body component in a common system-of-coordinates.
  • a method for performing an intrabody surgical procedure on a radiopharmaceutical uptaking portion of a body component within a subject comprising the steps of (a) providing a radioactive emission detector being connected to and/or communicating with a first position tracking system and tracking a position of the radiopharmaceutical uptaking portion of the body component in a first system-of-coordinates; (b) providing a surgical instrument being connected to and/or communicating with a second position tracking system and tracking a position of the surgical instrument in a second system-of-coordinates while performing the intrabody surgical procedure; and (c) receiving data inputs from the first position tracking system, the radioactive emission detector and the second position tracking system and calculating the position of the surgical instrument and the radiopharmaceutical uptaking portion of the body component in a common system-of-coordinates while performing the intrabody surgical procedure.
  • the second system-of-coordinates serves as the common system-of-coordinates and therefore the position of the radiopharmaceutical uptaking portion of the body component in the first system-of-coordinates is projected onto the second system-of-coordinates.
  • the first system-of-coordinates serves as the common system-of-coordinates and therefore the position of the surgical instrument in the second system-of-coordinates is projected onto the first system-of-coordinates.
  • the second system-of-coordinates, the first system-of-coordinates and the common system-of-coordinates are a single system-of-coordinates.
  • the first system-of-coordinates, the second system-of-coordinates and the common system-of-coordinates are each a separate system-of-coordinates and therefore the position of the surgical instrument in the second system-of-coordinates and the position of the radiopharmaceutical uptaking portion of the body component in the first system-of-coordinates are both projected onto the common system-of-coordinates.
  • the first position tracking system and the second position tracking system are a single position tracking system.
  • an image presentation device serves for visual co-presentation of the position of the surgical instrument and the radiopharmaceutical uptaking portion of the body component.
  • the radioactive emission detector is selected from the group consisting of a narrow angle radioactive emission detector, a wide angle radioactive emission detector, a plurality of individual narrow angle radiation emission detectors and a spatially sensitive radioactivity detector, such as a gamma camera employed in nuclear imaging.
  • the first and the second position tracking systems may include, but are not limited to, any combination of an articulated arm position tracking system, an accelerometers based position tracking system, a potentiometers based position tracking system, a sound wave based position tracking system, a radio frequency based position tracking system, a magnetic field based position tracking system and an optical (e.g., optical encoder) based position tracking system.
  • the surgical instrument may include, but is not limited to, any combination of laser probe, cardiac catheter, angioplasty catheter, endoscopic probe, biopsy needle, ultrasonic probe, fiber optic scopes, aspiration tubes, laparoscopy probe, thermal probe and suction/irrigation probe.
  • the radiopharmaceutical may include, but is not limited to, 131 I, 67 Ga (which may be administered as Ga-citrate), 99M Tc methoxyisobutyl isonitrile, 201 T1C1, 18 F-fluorodeoxy glucose, 125 I-fibrinogen and l ⁇ In-octreotide, to name a few.
  • the two- or three-dimensional imaging modality is connected to and/or communicating with a third position tracking system and is used for calculating the position of a body component in a third system-of-coordinates.
  • data inputs are received from the two- or three-dimensional imaging modality and the third position tracking system and are used for calculating the position of the surgical instrument and the position of the radiopharmaceutical uptaking portion of a body component and the position of the body component in a common system-of-coordinates.
  • the first position tracking system, the second position tracking system and the third position tracking system are a single position tracking system.
  • the position of the surgical instrument, the radiopharmaceutical uptaking portion of the body component and the body component are co-represented by a visual presentation device.
  • each of the first, the second and the third position tracking system is independently selected from the group consisting of an articulated arm position tracking system, an accelerometers based position tracking system, a sound wave based position tracking system, a radio frequency based position tracking system, a magnetic field based position tracking system and an optical based position tracking system.
  • the second system-of-coordinates serves as the common system-of-coordinates and therefore the position of the radiopharmaceutical uptaking portion of the body component in the first system-of-coordinates and the position of the body component in the third system-of-coordinates are projected onto the second system-of-coordinates.
  • the first system-of-coordinates serves as the common system-of-coordinates and therefore the position of the surgical instrument in the second system-of-coordinates and the position of the body component in the third system-of-coordinates are projected onto the first system-of-coordinates.
  • the third system-of-coordinates serves as the common system-of-coordinates and therefore the position of the surgical instrument in the second system-of-coordinates and the position of the radiopharmaceutical uptaking portion of the body component in the first system-of-coordinates are projected onto the third system-of-coordinates.
  • the second system-of-coordinates, the first system-of-coordinates, the third system-of-coordinates and the common system-of-coordinates are a single system-of-coordinates.
  • the second system-of-coordinates, the first system-of-coordinates, the third system-of-coordinates and the common system-of-coordinates are each a separate system-of-coordinates and therefore the position of the surgical instrument in the second system-of-coordinates and the position of the radiopharmaceutical uptaking portion of the body component in the first system-of-coordinates and the position of the body component in the third system-of-coordinates are all projected onto the common system-of-coordinates.
  • a system for generating a two- or three-dimensional image of a radioactivity emitting source in a body comprising (a) a radioactive emission detector; (b) a position tracking system being connected to and/or communicating with the radioactive emission detector; and (c) a data processor being designed and configured for receiving data inputs from the position tracking system and from the radioactive emission detector and for generating the two- or three-dimensional image of the radioactivity emitting source.
  • a method of generating a two- or three-dimensional image of a radioactivity emitting source in a body comprising (a) scanning the body with a radioactive emission detector; (b) using a position tracking system being connected to and/or communicating with the radioactive emission detector for determining a position in a two- or three-dimensional system of coordinates of the radioactive emission detector; and (c) data processing inputs from the position tracking system and from the radioactive emission detector for generating the two- or three-dimensional image of the radioactivity emitting source.
  • a system for performing an intrabody surgical procedure on a radiopharmaceutical uptaking portion of a body component within a subject comprising a surgical instrument being connected to and/or communicating with a position tracking system for tracking a position of the surgical instrument in a system-of-coordinates, the surgical instrument including a radioactive emission detector coupled thereto for monitoring the radiopharmaceutical in situ.
  • radioactive emission detector is sensitive to beta radiation and/or positron radiation.
  • it is sensitive to low energy (10 - 30 KeV) or gamma radiation.
  • the surgical instrument preferably includes a tissue resecting mechanism and/or a tissue sampling mechanism, such as an aspiration mechanism.
  • a system for calculating a position of a radioactivity emitting source in a system-of-coordinates comprising (a) a surgical instrument designed and constructed for invading a body of a subject, the surgical instrument including a radioactive emission detector connected thereto or integrated therein; (b) a position tracking system being connected to and/or communicating with the surgical instrument; and (c) a data processor being designed and configured for receiving data inputs from the position tracking system and from the radioactive emission detector and for calculating the position of the radioactivity emitting source in the system-of-coordinates.
  • a system for calculating a position of a radioactivity emitting source in a first system-of-coordinates and further of projecting the position of the radioactivity emitting source onto a second system-of-coordinates comprising (a) a surgical instrument designed and constructed for invading a body of a subject, the surgical instrument including a radioactive emission detector connected thereto or integrated therein; (b) a position tracking system being connected to and/or communicating with the surgical instrument; and (c) a data processor being designed and configured for (i) receiving data inputs from the position tracking system and from the radioactive emission detector;
  • a method for calculating a position of a radioactivity emitting source in a first system-of-coordinates and for projecting the position of the radioactivity emitting source onto a second system-of-coordinates comprising the steps of (a) providing a surgical instrument designed and constructed for invading a body of a subject, the surgical instrument including a radioactive emission detector connected thereto or integrated therein, the surgical instrument being connected to or communicating with a position tracking system; and (b) monitoring radioactivity being emitted from the radioactivity emitting source, while at the same time, monitoring the position of the radioactive emission detector in the first system-of-coordinates, thereby defining the positions of the radioactivity emitting source and of the surgical instrument in the first system-of-coordinates and projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a system for calculating a position of a body component and a position of a radiopharmaceutical uptaking portion of the body component within a subject comprising (a) a two- or three-dimensional imaging modality being connected to and/or communicating with a first position tracking system for calculating the position of the body component in a first system-of-coordinates; (b) a surgical instrument designed and constructed for invading the body, the surgical instrument including a radioactive emission detector connected thereto or integrated therein, the surgical instrument being connected to and/or communicating with a second position tracking system for tracking a position of the radiopharmaceutical uptaking portion of the body component in a second system-of-coordinates; and (c) at least one data processor being designed and configured for receiving data inputs from the three-dimensional imaging modality, the first position tracking system, the radioactive emission detector and the second position tracking system and calculating the position of the body component, the position of the radiopharmaceutical uptaking portion of
  • a method for calculating a position of a body component and a position of a radiopharmaceutical uptaking portion of the body component within a subject comprising the steps of (a) providing a two- or three-dimensional imaging modality being connected to and/or communicating with a first position tracking system and calculating the position of the body component in a first system-of-coordinates; (b) providing a surgical instrument designed and constructed for invading the body, the surgical instrument including a radioactive emission detector connected thereto or integrated therein, the surgical instrument being connected to and/or communicating with a second position tracking system for tracking a position of the radiopharmaceutical uptaking portion of the body component in a second system-of-coordinates; and (c) receiving data inputs from the two- or three-dimensional imaging modality, the first position tracking system, the radioactive emission detector and the second position tracking system and calculating the position of the body component, the position of the surgical instrument and the position of the radiopharmac
  • the present invention seeks to improve and expand upon generation of one, two- or three-dimensional images of radioactivity emitting sources. Specifically, the present invention seeks to provide an improved method and system for imaging and guiding a diagnostic or therapeutic instrument towards a target region inside the patient's body, particularly by means of a nuclear radiation detector with a position tracking system.
  • a radiation probe is housed in a collimator and attached to a position tracking system. As the probe moves in two- or three-dimensional space about the patient being examined, data is collected and an image of the radiation patterns emanating from within the patient are mapped.
  • One advantage of a two- or three-dimensional scan is that higher safety and accuracy are achieved through a greater number of directional searches and in turn a better localization of the radiation source.
  • the invention enables mapping radiation source regions and surrounding uncertainty regions.
  • One way of accomplishing this is by means of a feedback system that employs statistical analysis to determine the bounds of an uncertainty region, and which guides medical personnel to conduct additional scans in these uncertainty regions to improve accuracy, reduce error, and hence minimize the bounds of the uncertainty regions.
  • the present invention successfully addresses the shortcomings of the presently known configurations by providing a radioactive emission detector per se and/or integrated in a surgical instrument connected to or communicating with a position tracking system and the use thereof in a variety of systems and methods used for medical imaging and/or medical procedures.
  • the present invention has many other applications in the direction of therapeutics, such as, but not limited to, implanting brachytherapy seeds, ultrasound microwave radio-frequency cryotherapy and localized radiation ablations.
  • Implementation of the methods and systems of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof.
  • several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof.
  • selected steps of the invention could be implemented as a chip a circuit.
  • selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable algorithms.
  • selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.
  • FIG. 1 is a black box diagram of a system according to the teachings of the present invention.
  • FIG. 2 is a perspective view of an articulated arm which serves as a position tracking system shown carrying a radioactive emission detector in accordance with the teachings of the present invention
  • FIG. 3 is a schematic depiction of a radioactive emission detector carrying a pair of three coaxially aligned accelerometers which serve as a position tracking system in accordance with the teachings of the present invention
  • FIG. 4 is a schematic presentation of a radioactive emission detector communicating with yet another type of a position tracking system in accordance with the teachings of the present invention
  • FIG. 5 is a simplified cross-sectional view of a narrow or wide angle radioactive emission detector used to implement an embodiment of the present invention
  • FIG. 6 is a presentation of a scanning protocol which can be effected with the detector of Figure 5;
  • FIG. 7 is a simplified cross-sectional view of a spatially sensitive radioactive emission detector, e.g., a gamma camera, used to implement another embodiment of the present invention.
  • a spatially sensitive radioactive emission detector e.g., a gamma camera
  • FIG. 8 is a presentation of a scanning protocol which can be effected with the detector of Figure 7;
  • FIG. 9 demonstrates a system in accordance with the teachings of the present invention which employs four position tracking systems for co-tracking the positions of a patient, a radioactive emission detector, an imaging modality and a surgical instrument;
  • FIG. 10 demonstrates the use of a pair of radiation emission detectors connected therebetween via a connector, preferably a flexible connector or a flexible connection to the connector according to the present invention
  • FIG. 11 is a schematic diagram of a surgical instrument and accompanying system elements according to the teachings of the present invention.
  • FIG. 12 is a simplified pictorial illustration of an imaging system constructed and operative in accordance with a preferred embodiment of the present invention, including a radiation probe and position sensor, position tracking system, medical imaging system and coordinate registration system;
  • FIG. 13 is a simplified pictorial illustration of a single dimension image formation with a nuclear radiation probe attached to a position tracking system of the system of Figure 12, in accordance with a preferred embodiment of the present invention
  • FIG. 14 is a simplified pictorial plot of detecting a radiation point source with the nuclear radiation probe of the system of Figure 12, without further processing, in accordance with a preferred embodiment of the present invention
  • FIG. 15 is a simplified flow chart of an averaging algorithm used in the imaging system of Figure 12, in accordance with a preferred embodiment of the present invention
  • FIG. 16 is a simplified pictorial plot of detecting a radiation point source with the nuclear radiation probe of the system of Figure 12, with averaging processing, in accordance with a preferred embodiment of the present invention
  • FIGS. 17 and 18 are simplified pictorial illustrations of hot cross and hot bar phantom images, respectively, of images produced by a gamma radiation probe of the system of Figure 12;
  • FIG. 19 is a simplified flow chart of a minimizing algorithm used in the imaging system of Figure 12, in accordance with a preferred embodiment of the present invention.
  • FIG. 20 is a simplified pictorial plot of detecting a radiation point source with the nuclear radiation probe of the system of Figure 12, with minimizing processing, in accordance with a preferred embodiment of the present invention
  • FIG. 21 is a simplified pictorial illustration of an image reconstruction system constructed and operative in accordance with a preferred embodiment of the present invention, which produces a combined image made up of medical images, the position of the peak radiation location and the location of a therapeutic instrument;
  • FIG. 22 is a simplified flow chart of a radiation map reconstruction algorithm, in accordance with a preferred embodiment of the present invention.
  • FIGs. 23 A and 23B are illustrations of radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of an autonomous adenoma of a thyroid;
  • FIGs. 24A and 24B are illustrations of radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of suspected Paget's disease of a humerus;
  • FIGs. 25A and 25B are illustrations of radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of chronic osteomyelitis;
  • FIGs. 26A and 26B are illustrations of radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of skeletal metastasis from medulloblastoma.
  • FIGs. 27A-G demonstrate the operation of an algorithm provided by the present invention for estimating the distribution of radiation sources in a control volume.
  • the present invention is of a radioactive emission detector equipped with a position tracking system which can be functionally integrated with medical two- or three-dimensional imaging modalities and/or with guided minimally-invasive or other surgical tools.
  • the present invention can be used for calculating the position of a concentrated radiopharmaceutical in the body in positional context of imaged portions of the body, which information can be used, for example, for performing an efficient and highly accurate minimally invasive surgical procedure.
  • radioactive materials to tag physiologically active tissue within the body of a patient, for determining the tissue's localization and demarcation by radioactive emission detectors has been disclosed in the medical literature for at least forty years. Significant developments in the localization and demarcation of tissue bearing radioactive isotope tags for diagnostic and/or therapeutic purposes have occurred since that time.
  • radiopharmaceuticals tend to localize in particular tissue or cell type, whereas uptake or binding of the specific radiopharmaceutical is increased in more "physiologically active" tissue such as the active core of a cancerous tissue, so that the radiation emitted following nuclear disintegrations of the isotope can be detected by a radiation detector to better allocate the active portion of a tumor.
  • radiation may be, for example, ⁇ , ⁇ " , ⁇ + and/or ⁇ radiation.
  • radioactive substances are used to determine the level of flow of blood in blood vessels and the level of perfusion thereof into a tissue, e.g., coronary flow and myocardial perfusion.
  • Figure 1 illustrates a system for calculating a position of a radioactivity emitting source in a system-of-coordinates, in accordance with the teachings of the present invention, which system is referred to hereinbelow as system 20.
  • System 20 includes a radioactivity emission detector 22.
  • System 20 according to the present invention further includes a position tracking system 24.
  • System 24 is connected to and/or communicating with radioactive emission detector 22 so as to monitor the position of detector 22 in a two- or three-dimensional space defined by a system-of-coordinates 28 in two, three or more, say four, five or preferably six degrees-of-freedom (x, y, z, p, ⁇ and ⁇ ).
  • System 20 further includes a data processor 26.
  • Data processor 26 is designed and configured for receiving data inputs from position tracking system 24 and from radioactive emission detector 22 and, as is further detailed below, for calculating the position of the radioactivity emitting source in system-of-coordinates 28.
  • system-of-coordinates and "three-dimensional space” are used herein interchangeably.
  • detectors 22 are preferably connected there between via a connector 29.
  • Connector 29 is preferably flexible. In the alternative, the connections of detectors 22 to connector 29 provide the required flexibility.
  • Position tracking systems per se are well known in the art and may use any one of a plurality of approaches for the determination of position in a two- or three-dimensional space as is defined by a system-of-coordinates in two, three and up to six degrees-of-freedom.
  • Some position tracking systems employ movable physical connections and appropriate movement monitoring devices (e.g., potentiometers) to keep track of positional changes.
  • movement monitoring devices e.g., potentiometers
  • Such systems once zeroed, keep track of position changes to thereby determine actual positions at all times.
  • One example for such a position tracking system is an articulated arm.
  • Figure 2 shows an articulated arm 30 which includes six arm members 32 and a base 34, which can therefore provide positional data in six degrees-of-freedom.
  • Monitoring positional changes may be effected in any one of several different ways. For example, providing each arm member 32 with, e.g., potentiometers or optical encoders 38 used to monitor the angle between adjacent arm members 32, to thereby monitor the angular change of each such arm member with respect to adjacent arm members, so as to determine the position in space of radioactive emission detector 22, which is physically connected to articulated a ⁇ n 30.
  • FIG. 3 other position tracking systems can be attached directly to radioactive emission detector 22 in order to monitor its position in space.
  • An example of such a position tracking system is an assortment of three triaxially (e.g., co-orthogonally) oriented accelerometers 36 which may be used to monitor the positional changes of radioactive emission detector 22 with respect to a space.
  • a pair of such assortments as is specifically shown in Figure 3, can be used to determine the position of detector 22 in six-degrees of freedom.
  • FIG. 4 and 10 other position tracking systems re-determine a position irrespective of previous positions, to keep track of positional changes.
  • Such systems typically employ an array of receivers/transmitters 40 which are spread in known positions in a three-dimensional space and transmitter(s)/receiver(s) 42, respectively, which are in physical connection with the object whose position being monitored. Time based triangulation and/or phase shift triangulation are used in such cases to periodically determine the position of the monitored object, radioactive emission detector 22 in this case.
  • Radioactive emission detectors are well known in the art and may use any one of a number of approaches for the determination of the amount of radioactive emission emanating from an object or portion thereof.
  • detectors typically include substances which when interacting with radioactive decay emitted particles emit either electrons or photons in a level which is proportional over a wide linear range of operation to the level of radiation impinging thereon. The emission of electrons or photons is measurable and therefore serves to quantitatively determine radiation levels.
  • Solid-state detectors in the form of N-type, P-type, PIN-type pixellated or unpixellated include, for example, Ge, Si, CdTe, CdZnTe, CdSe, CdZnSe, Hgl 2, TlBrl, GaAs, Inl, GaSe, Diamond, TlBr, PbI 25 InP, ZnTe, HgBrl, a-Si, a-Se, BP, GaP, CdS, SiC, AlSb, PbO, Bil 3 and ZnSe detectors.
  • Gas (e.g., C0 2 CH 4 ) filled detectors include ionization chamber detectors, proportional chamber detectors and geiger chamber detectors.
  • Scintillation detectors include organic scintillators crystals and liquids, such as C 14 H ⁇ 0 , C ⁇ H ⁇ 2 , C 10 H 8j etc., Plastics, NE102A, NE104, NE110, Pilot U and inorganic scintillators, such as Nal, Csl, BGO, LSO, YSO, BaF, ZnS, ZnO, CaW0 4 and CdW0 4 . Also known are scintillation fiber detectors.
  • Scintillator coupling include photomultiplier tube (PMT) of the following types: side-on type, head-on type, hemispherical type, position sensitive type, icrochannel plate-photomultiplier (MCP-PMTs) and electron multipliers, or photodiodes (and photodiodes arrays), such as Si photodiodes, Si PIN photodiodes, Si APD, GaAs(P) photodiodes, GaP and CCD.
  • PMT photomultiplier tube
  • MCP-PMTs icrochannel plate-photomultiplier
  • electron multipliers or photodiodes (and photodiodes arrays), such as Si photodiodes, Si PIN photodiodes, Si APD, GaAs(P) photodiodes, GaP and CCD.
  • Figure 5 shows a narrow angle or wide angle radioactive emission detector 22'.
  • Narrow or wide angle radioactive emission detector 22' includes a narrow slit (collimator) so as to allow only radiation arriving from a predetermined angular direction (e.g., 1 ° - 280 ° - wide angle, preferably 1 ° - 80 ° - narrow angle) to enter the detector.
  • Narrow or wide angle radioactive emission detectors especially suitable for the configuration shown in Figure 10 are manufactured, for example, by Neoprobe, Dublin, Ohio (www.neoprobe.com), USA, Nuclear Fields, USA (www.nufi.com) IntraMedical Imaging, Los Angeles, CA, USA (www.gammaprobe.com).
  • such a detector is typically used to measure radioactivity, point by point, by scanning over the surface of a radioactive object from a plurality of directions and distances. In the example shown, scans from four different directions are employed. It will be appreciated that if sufficient radioactivity records are collected from different angles and distances, and the orientation and position in space of detector 22' is simultaneously monitored and recorded during such scans, a three-dimensional model of a radioactive region can be reconstituted and its position in space determined. If two or more detectors are co-employed, as shown in the configuration of Figure 10, the results may be collected faster.
  • FIG. 7 shows another example of a radioactive emission detector, a spatially sensitive (pixelated) radioactive emission detector 22" (such as a gamma camera).
  • Detector 22" in effect, includes an array of multitude narrow angle detector units 23.
  • Such an arrangement is used in accordance with the teachings of the present invention to reduce the amount of measurements and angles necessary to acquire sufficient data so as to reconstitute a three-dimensional model of the radioactive object.
  • Examples of spatially sensitive radioactive emission detectors employed in a variety of contexts are disclosed in, for example, U.S. Pat. Nos. 4,019,057; 4,550,250; 4,831,262; and 5,521,373; which are incorporated by reference as if set forth herein.
  • An additional example is the COMPTON detector
  • Figure 8 shows a scan optionally made by spatially sensitive radioactive emission detector 22" (such as a gamma camera).
  • a radioactive emmission detector of particular advantages for use in context of the present invention is the Compton gamma probe, since, in the
  • Compton gamma probe spatial resolution is independent of sensitivity and it appears possible to exceed the noise equivalent sensitivity of collimated imaging systems especially for systems with high spatial resolution.
  • the Compton probe is a novel type of gamma-probe that makes use of the kinematics of Compton scattering to construct a source image without the aid of mechanical collimators.
  • Compton imaging telescopes were first built in the 1970s for astronomical observations [V. Schoenfelder et al., Astro-physical Journal 217 (1977) 306]. The first medical imaging laboratory instrument was proposed in the early 1980s [M. Singh, Med. Phys. 10 (1983) 421].
  • the potential advantages of the Compton gamma probe include higher efficiency, 3-D imaging without detector motion, and more compact and lightweight system.
  • the Compton gamma probe high-energy gamma rays are scattered from a first detector layer (or detectors array) into a second detector layer array. For each gamma, the deposited energy is measured in both detectors. Using a line drawn between these two detectors, the Compton scattering equation can be solved to determine the cone of possible direction about this axis on which the gamma ray must have entered the first detector. The intersection of cones from many events is then developed to locate gamma ray sources in the probe's f ⁇ eld-of-view. Obviously only coincident events are considered, and the more accurately their energy can be determined, the less uncertainty there is in the spatial angle of the arrival cone.
  • the probe's electronic system is combining coincidence measurements across many detectors and detectors layers with a very good energy resolution.
  • the choice of the geometry and the material of the first layer detector plays a major role in the system imaging capability and depends on (i) material efficiency of single Compton events, in relation to other interactions; (ii) detector energy resolution; and (iii) detector position resolution.
  • the overall angular resolution results from the combination of two components, related to the energy resolution and to the pixel volume of the detector.
  • connecting a radioactive emission detector to a position tracking system permits simultaneous radioactivity detecting and position tracking at the same time. This enables the accurate calculation of the shape, size and contour of the radiating object and its precise position in a three-dimensional space.
  • the present invention thus provides a method for defining a position of a radioactivity emitting source in a system-of-coordinates.
  • the method is effected by (a) providing a radioactive emission detector which is connected to or communicating with a position tracking system; and (b) monitoring radioactivity emitted from the radioactivity emitting source, while at the same time, monitoring the position of radioactive emission detector in the system-of-coordinates, thereby defining the position of the radioactivity emitting source in the system-of-coordinates.
  • system 20 of the present invention can be used for calculating a position of a radioactivity emitting source in a first system-of-coordinates 28 and further for projecting the position of the radioactivity emitting source onto a second system-of-coordinates 28'.
  • the system includes radioactive emission detector 22, position tracking system 24 which is connected to and/or communicating with radioactive emission detector 22, and data processor 26 which is designed and configured for (i) receiving data inputs from position tracking system 24 and from radioactive emission detector 22; (ii) calculating the position of the radioactivity emitting source in the first system-of-coordinates; and (iii) projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a method for calculating a position of a radioactivity emitting source in a first system-of-coordinates and for projecting the position of the radioactivity emitting source onto a second system-of-coordinates is also offered by the present invention.
  • This method is effected by (a) providing a radioactive emission detector being connected to or communicating with a position tracking system; and (b) monitoring radioactivity being emitted from the radioactivity emitting source, while at the same time, monitoring the position of the radioactive emission detector in the first system-of-coordinates, thereby defining the position of the radioactivity emitting source in the first system-of-coordinates and projecting the position of the radioactivity emitting source onto the second system-of-coordinates.
  • a radioactive emission detector and a position tracking system connected thereto and/or communicating therewith allows a suitable data processor to generate a two- or three-dimensional image of the radioactivity emitting source.
  • An algorithm can be used to calculate image intensity based on, for example, a probability function which averages radiation counts and generates an image in which the shorter the time interval between radioactive counts, the brighter the image and vise versa, while down-compensating when a location is re-scanned.
  • a free-hand scanning with a directional detector can be employed for this purpose.
  • the detector when scanning a body area with the detector, the detector is made to follow a three-dimensional surface which defines the body curvature and in effect is used also as a position tracking pointer.
  • This information can be used to define the position of the radioactive source with respect to the outer surface of the body, so as to create a three-dimensional map of both the radioactive source and of the body curvature.
  • This approach can also be undertaken in open surgeries, such as open chest surgeries so as to provide the surgeon in real time with information concerning the functionality of a tissue.
  • the radioactive emission detector which can be used in context of the present invention can be a beta emission detector, a gamma emission detector, a positron emission detector or any combination thereof.
  • a detector that is sensitive to both beta (and/or positron) and gamma emission can be used to improve localization by sensing for example gamma emission distant from the source and sensing beta or positrons emission closer to the source.
  • a beta detector is dedicated for the detection of either electrons from sources such as
  • a gamma detector can be designed as a single energy detector or as a detector that can distinguish between different types of energies, using the light intensity in the scintilator as a relative measure of the gamma energy. Also, the detector can be designed to utilize coincidence detection by using detectors facing one another (180 degrees) with the examined organ or tissue in-between.
  • the radiation detector can have different collimators with different diameters. A large bore will be used for high sensitivity with lower resolution while a small bore collimator will have higher resolution at the expense of lower sensitivity.
  • Another possibility is to have a the collimator moving or rotating with the opening eccentric so that a different solid angle is exposed to the incoming photons at any one time, thus gathering the photons from overlapping volumes at different time intervals.
  • the rest of the image processing is similar if the probe moves or if the collimator eccentric opening moves.
  • System 20 of the present invention can be used in concert with other medical devices, such as, but not limited to, any one of a variety of imaging modalities and/or surgical instruments.
  • Imaging modalities are well known in the art, the main modalities that serve for two- (projectional or cross sectional) or three- (cosequtive cross sectional) dimensional imaging are a fluoroscope, a computerized tomography scanner, a magnetic resonance imager an ultrasound imager and an optical camera.
  • Medical images taken of the human body are typically acquired or displayed in three main orientations (i) coronal orientation: in a cross section (plane), for example, across the shoulders, dividing the body into front and back halves; (ii) sagittal orientation: in a cross section (plane), for example, down the middle, dividing the body into left and right halves; and (iii) axial orientation: in a cross section (plane), perpendicular to the long axis of the body, dividing the body into upper and lower halves.
  • Oblique views can also be acquired and displayed.
  • X-ray imaging Various types of X-ray imaging are central to diagnosis of many types of cancer.
  • Conventional X-ray imaging has evolved over the past 100 years, but the basic principal is still the same as in 1895, when first introduced.
  • An X-ray source is turned on and X-rays are radiated through the body part of interest and onto a film cassette positioned under or behind the body part.
  • the energy and wavelength of the X-rays allows them to pass through the body part and create the image of the internal structures like bones.
  • the X-rays pass through the hand, for instance, they are attenuated by the different density tissues they encounter. Bone attenuates a great deal more of the X-rays than the soft tissue sorounding it because of its grater density.
  • X-ray imaging results in a projection of the integrated density of column-voxels defined by the X-rays as they pass through the body.
  • Fluoroscopy is a method based on the principals of film X-ray that is useful for detecting disorders and tumors in the upper gastro-intestinal (GI) system (for example, the stomach and intestines).
  • GI gastro-intestinal
  • Fluoroscopic imaging yields a moving X-ray picture. The physician can watch the screen and see an image of the patient's body (for example the beating heart). Fluoroscopic technology improved greatly with the addition of television cameras and fluoroscopic "image intensifiers".
  • Computed Tomography is based on the X-ray principal, where the film is replaced by a detector that measures the X-ray profile. Inside the covers of the CT scanner is a rotating frame which has an X-ray tube mounted on one side and the detector mounted on the opposite side. A fan beam of X-ray is created as the rotating frame spins the X-ray tube and detector around the patient. Each time the X-ray tube and detector make a 360° rotation, an image or "slice” has been acquired. This "slice” is collimated to a thickness between 1 mm and 10 mm using lead shutters in front of the X-ray tube and X-ray detector.
  • the detector takes numerous profiles of the attenuated X-ray beam. Typically, in one 360° lap, about 1,000 profiles are sampled. Each profile is subdivided spatially by the detectors and fed into about 700 individual channels. Each profile is then backwards reconstructed (or "back projected") by a dedicated computer into a two-dimensional image of the "slice" that was scanned.
  • the CT gantry and table have multiple microprocessors that control the rotation of the gantry, movement of the table (up/down and in/out), tilting of the gantry for angled images, and other functions such as turning the X-ray beam on an off.
  • the CT contains a slip ring that allows electric power to be transferred from a stationary power source onto the continuously rotating gantry.
  • the innovation of the power slip ring has created a renaissance in CT called spiral or helical scanning.
  • spiral CT acquires a volume of data with the patient anatomy all in one position. This volume data set can then be computer-reconstructed to provide three-dimensional models such as of complex blood vessels like the renal arteries or aorta. Spiral CT allows the acquisition of CT data that is perfectly suited for three-dimensional reconstruction.
  • MR Imaging is superior to CT in detecting soft tissue lesions such as tumors as it has excellent contrast resolution, meaning it can show subtle soft-tissue changes with exceptional clarity. Thus, MR is often the method of choice for diagnosing tumors and for searching for metastases.
  • MR uses magnetic energy and radio waves to create single or consequtive cross-sectional images or "slices" of the human body.
  • the main component of most MR systems is a large tube shaped or cylindrical magnet.
  • the strength of the MR systems magnetic field is measured in metric units called "Tesla". Most of the cylindrical magnets have a strength between 0.5 and 1.5 Tesla and most of the open or C-shaped magnets have a magnetic strength between 0.01 and 0.35 Tesla.
  • Each total MR examination typically is comprised of a series of 2 to 6 sequences.
  • An "MR sequence” is an acquisition of data that yields a specific image orientation and a specific type of image appearance or "contrast".
  • MR sequence is an acquisition of data that yields a specific image orientation and a specific type of image appearance or "contrast”.
  • a radio signal is turned on and off, and subsequently the energy which is absorbed by different atoms in the body is echoed or reflected back out of the body.
  • These echoes are continuously measured by "gradient coils” that are switched on and off to measure the MR signal reflecting back.
  • the net magnetization vector rotate from a longitudinal position a distance proportional to the time length of the radio frequency pulse.
  • Radio frequency coils are the "antenna" of the MRI system that broadcasts the RF signal to the patient and/or receives the return signal.
  • RF coils can be receive-only, in which case the body coil is used as a transmitter; or transmit and receive (transceiver).
  • Surface coils are the simplest design of coil. They are simply a loop of wire, either circular or rectangular, that is placed over the region of interest.
  • a digital computer reconstructs these echoes into images of the body.
  • a benefit of MRI is that it can easily acquire direct views of the body in almost any orientation, while CT scanners typically acquire cross-sectional images perpendicular or nearly perpendicular to the long body axis.
  • Ultrasound imaging is a versatile scanning technique that uses sound waves to create images of organs or anatomical structures in order to make a diagnosis.
  • the ultrasound process involves placing a small device called a transducer, against the skin of the patient near the region of interest, for example, against the back to image the kidneys.
  • the ultrasound transducer combines functions of emitting and receiving sound. This transducer produces a stream of inaudible, high frequency sound waves which penetrate into the body and echo off the organs inside.
  • the transducer detects sound waves as they echo back from the internal structures and contours of the organs. Different tissues reflect these sound waves differently, causing a signature which can be measured and transformed into an image.
  • These waves are received by the ultrasound machine and turned into live pictures with the use of computers and reconstruction software.
  • Ultrasound scanning has many uses, including: diagnosis of disease and structural abnormalities, helping to conduct other diagnostic procedures, such as needle biopsies etc.
  • imaging modalities either inherently include (e.g., fluoroscope, CT, MRI) and/or are integrated with position-tracking-systems, which enable the use of such systems to reconstruct three-dimensional image models and provide their position in a three-dimensional space.
  • an optical camera can be used to generate three-dimensional imagery date according to the present invention by imaging a body from a plurality (at least two) directions. This type of imaging is especially applicable in open chest surgeries or other open surgeries.
  • Software for calculating a three-dimensional image from a pair of stereoscopic images is well known in the art.
  • three-dimensional imaging modality refers to any type of imaging equipment which includes software and hardware for generating a three-dimensional image.
  • Such an equipment can generate a three-dimensional image by imaging successive cross-sections of a body, e.g., as if viewed from a single direction.
  • such an equipment can generate a three-dimensional image by imaging a body from different angles or directions (typically two angles) and thereafter combining the data into a three-dimensional image.
  • Surgical instruments are also well known in the art and may use any one of a plurality of configurations in order to perform minimally-invasive surgical procedures. Examples include laser probes, cardiac and angioplastic catheters, endoscopic probes, biopsy needles, aspiration tubes or needles, resecting devices, ultrasonic probes, fiber optic scopes, laparoscopy probes, thermal probes and suction irrigation probes. Examples of such surgical instruments employed in a variety of medical contexts are disclosed in, for example, U.S. Pat. Nos.
  • surgical instruments are integrated with position-tracking-systems, which enable to monitor the position of such instruments while placed in and guided through the body of a treated patient.
  • the surgical instrument is equipped with an additional radioactive emission detector attached thereto or placed therein.
  • This additional detector is used, according to preferred embodiments of the invention, to fine tune the location of radioactive emission from within the body, and in closer proximity to the radioactive source. Since the surgical tool is preferably connected to or communicating with a position-tracking system, the position of the additional detector can be monitored and its readouts used to fine tune the position of the radioactive source within the body.
  • At least one extracorporeal detector and an intracorporeal detector are used in concert to determine the position of a radioactive source in the body in highest precision.
  • the extracorporeal detector provides the general position of the source and is used for directing the surgical instrument thereto, whereas the intracorporeal detector is used for reassuring prior to application of treatment or retrieval of biopsy that indeed the source was correctly targeted at the highest precision.
  • intracorporeal detector While according to a presently preferred embodiment of the invention two detectors, one extracorporeal and one intracorporeal, are employed as described above, for some applications a single intracorporeal detector may be employed, which detector is attached to or integrated with a surgical instrument whose position is tracked.
  • intracorporeal and extracorporeal detectors calls for careful choice of the radioactive isotope employed with the radiopharmaceutical.
  • the extracorporeal detector can be constructed with a suitable collimator for handling strong radiation, such as gamma radiation
  • the intracorporeal detector is miniature by nature and is limited in design and construction by the construction of the surgical instrument with which it is employed.
  • Electron (beta) and positron radiation are characterized by: (i) they highly absorbed by biological tissue as they are of lower energy and higher chemical reactivity; and (ii) they are readily collimated and focused by thin metal collimators. It is also possible to use low energy gamma radiation (10 - 30 KeV) for intracorporal applications since the collimation of these gamma photons can be achieved with thin layers of Tantalum or Tungsten.
  • the radio pharmaceutical of choice is selected to emit both gamma and beta and/or positron radiation, whereas the extracorporeal detector is set to detect the high energy gamma radiation, whereas the intracorporeal detector is set to detect the low energy gamma, beta and/or positron radiation.
  • Isotopes that emit both high energy gamma and/or low energy gamma, beta and/or positron radiation and which can be used per se or as a part of a compound as radiopharmaceuticals include, without limitation, 18 F, m In and 123 I in radiopharmaceuticals, such as, but not limited to, 2-[ 18 F]fluoro-2-deoxy-D-glucose ( 18 FDG), ⁇ In-Pentetreotide ([ 111 In-DTPA-D-Phe 1 ]-octreotide), L-3-[ 123 I]-Iodo-alpha-methyl-tyrosine (IMT), 0-(2-[ 18 F]fluoroethyl)-L-tyrosine (L-[ 18 F]FET), m In-Capromab Pendetide (CYT-356, Prostascint) and m In-Satumomab Pendetide (Oncoscint).
  • FIG. 11 illustrates a system in accordance with this aspect of the present invention.
  • a surgical instrument 100 is shown connected to a resection/aspiration control element 102 as well known in the art.
  • Surgical instrument 100 includes a radioactive emission detector 104, which has a collimator 106 for collimating low energy gamma, beta and/or positron radiation.
  • detector 104 may be translated within instrument 100.
  • a position tracking system having one element thereof 110 attached to instrument 100 and another element thereof 112 at a fixed location serves to monitor the position of instrument 100 at all times in two, three and up to six degrees of freedom.
  • a processor 116 communicates with a counter 114 for counting low energy gamma, beta and/or positron radiation. All the data is communicated to, and processed by, a processor 116. The 2D or 3D data may be projected and displayed along with
  • a real or virtual image of the surgical instrument itself may also be co-displayed.
  • Examples of commercially available radiation emission detectors that can fit inside, for example, a biopsy needle include scintillating plastic optical fibers like S101 and SI 04, manufactured by PPLASTIFO or an optical fiber communicating with a scintillator (either detector paint or scintillation crystal) at the fiber edge.
  • the level of detected radiation can be reported visually or by an audio signal, as is well known in the art.
  • a surgical instrument equipped with a radiation emission detector and which is connected to and/or communicating with a position tracking system forms one embodiment of this aspect of the present invention.
  • Such a design acting in concert with either conventional imaging modalities and/or extracorporeal radiation emission detectors form other embodiments of this aspect of the invention.
  • a surgical instrument equipped with a radiation emission detector and which is connected to and/or communicating with a position tracking system serves for in situ fine tuning of a radioactive source in the body.
  • FIG. 9 An example to this desired outcome is shown in Figure 9.
  • four independent position tracking systems 50, 52, 54 and 56 are used to track the positions of a patient 58, an imaging modality 60, a radioactive emission detector 62 and a surgical instrument 64 in four independent systems-of-coordinates 66, 68, 70 and 72, respectively. If the patient is still, no tracking of the patient's position is required.
  • any subset or all of the position tracking systems employed may be integrated into one or more common position tracking systems, and/or that any subset or all of the position tracking systems employed may share one or more systems-of-coordinates, and further that any positional data obtained by any of the position tracking systems described in any of the systems-of coordinates may be projected to any other system of coordinates or to an independent (fifth) system of coordinates 74.
  • the system of coordinates is a dynamic system of coordinates which takes into account the chest breathing movements of the patient during the procedure.
  • the raw data collected by detector 62 is recorded and, as indicated at 78, the position and the radioactive data records are used to generate a three-dimensional model of a radiopharmaceutical uptaking portion of a body component of the patient.
  • the imagery data collected by imaging modality 60 is recorded and the position and the imagery data records are used to generate a three-dimensional model of the imaged body component of the patient. All the data collected is then fed into a data processor 82 which processes the data and, as indicated at 84, generates a combined or superimposed presentation of the radioactive data and the imagery data, which is in positional context with patient 58 and surgical instrument 64. Instrument 64, which by itself can be presented in context of the combined presentation, may then be used to perform the procedure most accurately.
  • Processor 82 may be a single entity or may include a plurality of data processing stations which directly communicate with, or even integral to, any one or more of the devices described.
  • the present invention provides a major advantage over prior art designs because it positionally integrates data pertaining to a body portion as retrieved by two independent imaging techniques, conventional imaging and radioactive imaging, to thereby provide a surgeon with the ability the fine point the portion of the body to be sampled or treated.
  • two independent imaging techniques conventional imaging and radioactive imaging
  • subsets of the devices described in Figure 9 may be used as stand-alone systems.
  • a combination of detector 62 with its position-tracking system and instrument 64 with its position-tracking-system may in some instances be sufficient to perform intrabody procedures.
  • a combination of detector 62 position-tracking-system and modality 60 position-tracking-system are sufficient.
  • Imaging system 200 preferably includes a radiation probe 202, such as the narrow angle radioactive emission detector 22' described hereinabove with reference to Figures 5 and 10.
  • a position sensor 204 is provided for sensing the position of radiation probe 202.
  • Position sensor 204 may be physically attached to radiation probe 202, or may be distanced therefrom.
  • Position sensor 204 transmits the sensed position data to a position tracking system 206.
  • Position tracking system 206 may be a system like position tracking system 24, described hereinabove with reference to Figure 1, and position sensor 204 may be any kind of sensor applicable for such position tracking systems.
  • Another method which can be used to locate the source of radiation emission is by using a small hand held gamma camera 205 (such as the DigiRad 2020tc Imager TM, 9350 Trade Place, San Diego, California 92126-6334, USA), attached to position sensor 204.
  • Position tracking system 206 enables radiation probe 202 to freely scan back and forth in two- or three-dimensions over the area of interest of the patient, preferably incrementing a short distance between each scan pass. Position tracking system 206 tracks the position of radiation probe 202 with respect to a position tracking coordinate system, such as X p , Y p and Z p with an origin O p .
  • Imaging system 200 also includes a medical imaging system 208, such as, but not limited to, computed or computerized tomography (CT), magnetic resonance imaging (MRI), ultrasound imaging, positron emission tomography (PET) and single photon emission computed tomography (SPECT), for example.
  • Medical imaging system 208 provides images of a patient 209 with respect to a medical imaging coordinate system, such as X m , Y m and Z m; with an origin O m .
  • Imaging system 200 also includes a coordinate registration system 210, such as that described in U.S. Patent Application No. 09/610,490, the disclosure of which is incorporated herein by reference.
  • Coordinate registration system 210 is adapted to register the coordinates of the position tracking coordinate system with those of the medical imaging coordinate system.
  • Position tracking system 206, medical imaging system 208 and coordinate registration system 210 are preferably in wired or wireless communication with a processing unit 212 (also referred to as a data processor 212).
  • a clinician/physician/surgeon may move or scan radiation probe 202 about a target area under examination.
  • a physiological activity map of the target area is obtained by measuring the radiation count rate with radiation probe 202, and by correlating the count rate with the count rate direction with position tracking system 206, which follows the motion of the moving or scanning radiation probe 202.
  • Figure 13 illustrates image formation with radiation probe 202, in accordance with a preferred embodiment of the present invention.
  • the example shown in Figure 13 is for a single dimension image formation, but it is readily understood that the same principles hold true for any other dimensional image formation.
  • radiation probe 202 may be a gamma ray detector probe that comprises a collimator 211 and radiation detector 213. Gamma rays are projected through the probe collimator 211 onto radiation detector 213, which produces electronic signals in accordance with the radiation detected.
  • Radiation probe 202 sends pulses to a probe counter 215 which may include a pulse height analyzer circuit (not shown). The pulse height analyzer circuit analyzes the electronic signals produced by radiation detector 213. If the electronic signals are within a selected energy window, the level of radiation, i.e., number of radiation counts, is counted by probe counter 215.
  • suitable radiation detectors include a solid state detector (SSD) (CdZnTe, CdTe, Hgl, Si, Ge, and the like), a scintillation detector (Nal(Tl), LSO, GSO, Csl, CaF, and the like), a gas detector, or a scintillating fiber detector (SI 01, SI 04, and the like), for example.
  • SSD solid state detector
  • CdZnTe, CdTe, Hgl, Si, Ge, and the like a scintillation detector
  • Nal(Tl) LSO, GSO, Csl, CaF, and the like
  • gas detector or a scintillating fiber detector (SI 01, SI 04, and the like), for example.
  • the position sensor 204 associated with the radiation probe 202 senses the position of radiation probe 202, and position tracking system 206 calculates and monitors the motion of radiation probe 202 with respect to the position tracking coordinate system.
  • the motion is calculated and monitored in two, three and up to six dimensions - the linear directions of the X, Y and Z axes as well as rotations about the X, Y and Z axes (i.e., rotational angles p, ⁇ and ⁇ , respectively).
  • Suitable position tracking systems include a measurement mechanical arm (FaroArm, http://www.faro.com/products/faroarm.asp), optical tracking systems (Northern Digital Inc., Ontario, Canada NDI-POLARIS passive or active systems), magnetic tracking systems (NDI-AURORA), infrared tracking systems (E-PEN system, httpJ/www.e-pen.com), and ultrasonic tracking systems (E-PEN system), for example.
  • Processing unit 212 combines the radiation probe count rate from probe counter 215 together with the positional information from position tracking system 206, and uses an imaging software algorithm 217 to form a two-dimensional or three-dimensional radiotracer-spread image of the target area inside the patient's body.
  • the spatial probe positions together with the spatial count rates may be stored in memory or displayed on a computer monitor 214 as a pattern of marks corresponding to the spatial and count rate position.
  • Figure 14 illustrates a single-dimensional, unprocessed simulation of a radiation point source 218 (Figure 13), 30 mm deep inside the human body, detected by using a 10 mm nuclear radiation probe 202 coupled to position tracking system 206.
  • the graph of Figure 14 indicates to a physician that there is a peak count rate of about 500 in the probe position of about 50 mm.
  • the imaging software algorithm 217 employs an averaging process to refine the curve of Figure 14. This averaging process will now be described with reference to Figure 15.
  • Probe counter 215 feeds probe count rate information N(Xc, Ye, Zc, p, ⁇ , ⁇ ) to processing unit 212 (step 301).
  • Position sensor 204 feeds probe position information (Xc, Ye, Zc, p, ⁇ , ⁇ ) to processing unit 212 (step 302).
  • Probe parameters (such as its physical size, dx, dy, dz) are also input into processing unit 212 (step 303).
  • Processing unit 212 finds all the voxels (i.e., volume pixels) that represent the probe volume in the processing unit memory (step 304), i.e., Xc+dx, Yc+dy, Zc+dz. Processing unit 212 calculates the number of times that the calculation process has been done in each voxel from the beginning of the image formation (step 305), i.e., M(Xc+dx, Yc+dy, Zc+dz). Processing unit 212 then calculates the new average count rate values in each voxel (step 306), in accordance with the formula:
  • N(Xc+dx, Yc+dy, Zc+dz) [N(Xc+dx, Yc+dy, Zc+dz) + N(Xc, Ye, Zc, p, ⁇ , ⁇ ) ] /
  • Processing unit 212 then corrects the display image that represents the perceived voxels at N(Xc+dx, Yc+dy, Zc+dz) (step 307). The algorithm then repeats itself for the next probe position (step 308).
  • Figures 17 and 18 respectively show examples of a hot cross phantom image and a hot 4.77 mm bar phantom image, produced by a gamma radiation probe coupled with position tracking system 206 and the averaging algorithm of Figure 15.
  • the position tracking system used was the Ascension miniBIRD, commercially available from Ascension Technology Corporation, P.O. Box 527, Burlington, Vermont 05402 USA
  • the imaging software algorithm 217 may employ a minimizing process to refine the curve of Figure 14 as is now described with reference to Figure 19.
  • Probe counter 215 feeds probe count rate information N(Xc, Yc, Zc, p, ⁇ , ⁇ ) to processing unit 212 (step 401).
  • Position sensor 204 feeds probe position information (Xc, Yc, Zc, p ⁇ , ⁇ ) to processing unit 212 (step 402).
  • Probe parameters (such as its physical size, dx, dy, di) are also input into processing unit 212 (step 403).
  • Processing unit 212 finds all the voxels that represent the probe volume in the processing unit memory (step 404), i.e., Xc+dx, Yc+dy, Zc+dz. From the voxels that represent the probe volume in the processing unit memory, processing unit 212 finds those that have a higher count rate value N(Xc+dx, Yc+dy, Zc+dz) than the inputted probe count rate N(Xc, Yc, Zc, p ⁇ , ⁇ ) (step 405).
  • Processing unit 212 then changes the higher count rate voxels to that of inputted probe count rate N(Xc, Yc, Zc, p, ⁇ , ⁇ ) (step 406), and corrects the display image at the higher count rate voxels N(Xc+dx, Yc+dy, Zc+dz) (step 407).
  • the algorithm then repeats itself for the next probe position (step 408).
  • the resulting graph of the minimizing algorithm of Figure 19, as applied to the example of Figure 14, is shown in Figure 20.
  • Figures 27A and 27B illustrate a radiation sensor 600, preferably generally shaped as a tube collimator.
  • Radiation quanta 602 are registered by the radiation sensor 600, as described hereinabove, thereby providing the average number of quanta per unit time.
  • the radiation sensor 600 may be moved around a volume of interest 604.
  • the position of the sensor 600 and its direction (as well as the position of the investigated volume 604) are assumed to be known at any given moment ( Figure 27A).
  • the tube collimator is preferably provided with a plane circular detector
  • the quanta detector 606 is preferably disposed on a rear end 608 of the tube and radiation quanta can reach the detector 606 only through an open front end 610 of the tube ( Figure 27B)
  • Figure 27C illustrates a system of coordinates (x, y, z) with the origin O in the center of the radiation sensor 600, the (x, y) plane being the plane of the detector, and the z axis being in the center of the collimator tube.
  • the geometry parameters of the collimator tube - height h and radius p - are known.
  • the radiation sources are distributed in a rectangular region V in a plane. Two systems of coordinates are considered. The first one is the sensor coordinate system (x, y, z) corresponding to the sensor
  • the second one is the radiation source coordinate system (u, v, w) corresponding to the radiation sources plane (u, v).
  • the radiation sources are considered to be distributed in accordance with the distribution function I(Q) ) in some bounded, given rectangle V on the plane (u, v).
  • I(Q) I(u, v) is the unknown and sought-for radiation (or radiation intensity) distribution function defined in V.
  • the function I(Q) will be considered to be given from some finite dimensional space H of functions defined in V. In other words, the function I(Q) itself will not be estimated but rather some finite dimensional approximation of the distribution I(Q).
  • the space H is naturally isomorphic to the m-dimensional space of n x n matrixes (with its natural scalar product ⁇ •,•>).
  • the eigenvector decomposition of the operator M may be used: Let ⁇ ⁇ 2 , ... , ⁇ m be eigenvectors of operator M: H -» H corresponding to eigenvalues ⁇ i > ⁇ 2 ⁇ ... > ⁇ m > 0.
  • R be some natural number, 1 ⁇ R ⁇ m ( R is the "regularization parameter" ).
  • H (R) be the subspace of the space H spanned by the first R eigenvectors ⁇ l3 ... , ⁇ R .
  • the regularized estimate ⁇ R may be obtained as follows:
  • Figure 27F illustrates an advantageous irregular cell subdivision, in accordance with a preferred embodiment of the present invention.
  • the large cells which have an intensity larger than some threshold, are subdivided into 4 equal subcells (or 8 subcells in the 3D case).
  • a suitable threshold may be obtained by taking the average intensity (of all large cells) minus two (or three) sigmas (standard deviation), for example. Measurements and estimations are made in these subdivisions as described hereinabove.
  • the 3D problem may be treated in the same way as the 2D case, the only difference being that instead of rectangle V, there is a parallelepiped V (Figure 27D). Accordingly, the cells in each subdivision are also parallelepipeds.
  • the algorithms described hereinabove may be used for a variety of imaging systems.
  • the algorithms may be used with single radiation detector probe, an array of radiation detector probes, large gamma cameras of various design, such as multi head cameras, general purpose cameras, and automatic white balance (AWB) scanners.
  • the algorithms are suitable for SPECT and planar imaging, and may be used for all types of isotopes of with any type of photon energy.
  • the algorithms described hereinabove may be used to predict the location of the radiation source and the uncertainty region (based on the system measurement errors) in the vicinity of the radiation source.
  • the algorithms also guide the user to perform additional measurements to minimize the uncertainty region according to the requirements of the system operator.
  • the algorithms thus comprise a feedback system that employs analysis to determine the bounds of an uncertainty region about the radiation source, and which guides medical personnel to conduct additional scans in these uncertainty regions to improve accuracy, reduce error, and hence minimize the bounds of the uncertainty regions.
  • FIG. 21 illustrates an image reconstruction system 450, constructed and operative in accordance with a preferred embodiment of the present invention.
  • Image reconstruction system 450 produces a combined image 451 made up of the images coming from the medical imaging system 208 with the position of the peak radiation location (and its uncertainty area) from processing unit 212, together with the location of a therapeutic instrument 452, such as a biopsy needle.
  • the combined image 451 allows the physician to better assess the relative position of therapeutic instrument 452 in relation to the anatomical image (from medical imaging system 208) and the position of the radioactive area as inferred by the radiation detection algorithm.
  • Figure 22 illustrates a flow chart of a radiation map reconstruction algorithm, in accordance with a preferred embodiment of the present invention.
  • Deconvolution methods are often used in image processing procedures. Examples of such deconvolution methods are described in US Patent 6,166,853 to Sapia et al., the disclosure of which is incorporated herein by reference. (However, it is appreciated that these are just examples and the present invention is not limited to the deconvolution methods mentioned in US Patent 6,166,853)
  • light or other electromagnetic wave energy
  • the acquired image is a result of a convolution of the source object's light with the aperture of the imaging system.
  • a system transfer-function may be generally obtained directly by taking the Fourier transform of the aperture.
  • a point- spread- function is an expression used to describe the convolutional blurring in two-dimensions.
  • the PSF physically results from imaging a point source.
  • the Fourier transform of the PSF is the system transfer-function, which is obtained by convolving the system transfer-function with a Dirac-delta function.
  • a point source is the physical equivalent of a Dirac-delta function, and, in the frequency domain, the Dirac-delta function is a unity operator across the spectrum. Therefore, the Fourier transform of the PSF should be the Fourier transform of the aperture.
  • the PSF contains noise and blurring due to other effects such as aberrations.
  • the PSF contribution to the overall blurriness may be diminished or eliminated by deconvolution.
  • the transfer function of the radiation detector may be determined by taking the Fourier transform of the aperture of the detector, and taking into account the noise and blurring due to other effects such as aberrations (step 500).
  • An example of a transfer function may be a normal distribution.
  • the deconvolution of the transfer function may be determined (step 502).
  • the count readings of each spatial location of the detector constitute the sum of radiation counts from all the voxels (or pixels in the case of two-dimensional maps, the term "voxel" being used herein to include both pixels and voxels) within the detector's field of view. At least one voxel, or preferably each such voxel, may be assigned a count value based on the deconvolution of the unique transfer function of the radiation detector in use (step 504). An additional mathematical procedure may treat the various values that each voxel receives due to the multiple readings from viewpoints of different detectors (step 506).
  • This treatment may constitute for example a simple algebraic average, minimum value or reciprocal of averaged reciprocals in order to produce a single value of readings in each voxel.
  • the deconvolution is then used to reconstruct the voxels of the radiation map with diminished or no blurriness (step 508).
  • the algorithms described herein are applicable not only to the analysis of readings obtained using a directional radioactivity detector, rather they also apply for spatially sensitive (pixelated) radioactivity detectors.
  • the readings of each pixel are algorithmically treated as described herein like for a directional radioactivity detector.
  • the motivation behind using a spatially sensitive detector is to save on measurement time by receiving readings from a multitude of directions in parallel. This, in essence, creates a number of overlapping low resolution images which can then be processed to form a high resolution image.
  • the spatially sensitive detector can be scanned to improve even further the resolution using the algorithms described hereinabove.
  • each pixel can be seen as a separate detector with an angle of acceptance dictated by the geometry of a segmented collimator employed thereby.
  • Each of the pixels occupies a different position in space and hence can be seen as a new position of a single directional probe by the algorithm described herein. It is also possible, like with the directional detector, to scan the whole set of pixels by scanning the spatially sensitive detector and to acquire a new set of data points from the new position.
  • a super resolution algorithm can be employed to generate an image of higher resolution.
  • Suitable super resolution algorithms are described in, for example, J. Acoust. Soc. Am., Vol. 77, No. 2, February 1985 Pages 567 - 572; Yokota and Sato, IEEE Trans. Acoust. Speech Signal Process. (April 1984); Yokota and Sato, Acoustical Imaging (Plenum, New York, 1982, Vol. 12; H. Shekarforoush and R. Chellappa, "Data-Driven Multi-channel Super-resolution with Application to Video Sequences", Journal of Optical Society of America-A, vol. 16, no. 3, pp. 481-492, 1999; H.
  • FIGS. 23 A and 23B illustrate radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of an autonomous adenoma of a thyroid of a 58 year-old male.
  • Figures 24A and 24B illustrate radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of suspected Paget's disease of a humerus in an 89 year-old female.
  • Figures 25A and 25B illustrate radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of chronic osteomyelitis in a 19 year-old female.
  • Figures 26A and 26B illustrate radiolabeled patterns observed in images produced by the system of the invention and by a conventional gamma camera, respectively, of skeletal metastasis from medulloblastoma in an 18 year-old male.
  • the system and method of the present invention can find uses for screening for cancer and/or directing invasive diagnosis (biopsies) either from outside the body or by way of endoscopic approach.
  • biopsies include, but are not limited to, lung cancer biopsy, breast cancer biopsy, prostate cancer biopsy, cervical cancer biopsy, liver cancer biopsy, lymph node cancer biopsy, thyroid cancer biopsy, brain cancer biopsy, bone cancer biopsy, colon cancer biopsy, gastro intestine cancer endoscopy and biopsy, endoscopic screening for vaginal cancer, endoscopic screening for prostate cancer (by way of the rectum), endoscopic screening for ovarian cancer, (by way of the vagina), endoscopic screening for cervical cancer (by way of the vagina), endoscopic screening for bladder cancer (by way of the urinary track), endoscopic screening for bile cancer (by way of the gastrointestinal track), screening for lung cancer, screening for breast cancer, screening for melanoma, screening for brain cancer, screening for lymph cancer, screening for kidney cancer, screening for gastro intestinal cancer (from the outside).
  • the radiation detector can be combined and packaged together with a small RF coil for the transmission and reception or reception only of the MRI signals in a rectal probe configuration for prostate diagnosis and treatment or any other close confinement position such as the vagina, airways, the uper portion of the gastrointestinal track, etc)
  • Procedures known as directing localized treatment of cancer can also benefit from the system and method of the present invention.
  • Examples include, but are not limited to, intra tumoral chemotherapy, intra tumoral brachytherapy, intra tumoral cryogenic ablation, intra tumoral radio frequency ablation, intra tumoral ultrasound ablation, and intra tumoral laser ablation, in cases of, for example, lung cancer, breast cancer, prostate cancer, cervical cancer, liver cancer, lymph cancer, thyroid cancer, brain cancer, bone cancer, colon cancer (by way of endoscopy through the rectum), gastric cancer (by way of endoscopy through the thorax), thoracic cancer, small intestine cancer (by way of endoscopy through the rectum or, by way of endoscopy through the thorax), bladder cancer, kidney cancer, vaginal cancer and ovarian cancer.
  • the following procedures can take advantage of the present invention wherein the method and system can be used to assess tissue perfusion, tissue viability and blood flow intra operatively during PTCA procedure (balloon alone or in conjunction with the placement of a stent), in cases of cardiogenic shock to asses damage to the heart, following myocardial infarct to asses damage to the heart, in assessing heart failure condition tissue in terms of tissue viability and tissue perfusion, in intra vascular tissue viability and perfusion assessment prior to CABG operation.
  • the radioactivity detector can be mounted on a catheter that is entered through the blood vessels to the heart to evaluate ischemia from within the heart in order to guide ablation probes or another type of treatment to the appropriate location within the heart.
  • a radioactivity detector as described herein can be used to asses and differentiate between new clots and old clots.
  • the radioactivity detector can be placed on a very small caliber wire such as a guide wire that is used during PTCA in order to image intrabloodvessel clots.
  • Intrabloodvessel clots can be searched for in the aortic arc as clots therein are responsible for about 75 % of stroke cases.
  • tissue viability and blood flow intra operatively can also be employed in the following: during CABG operation to asses tissue viability, to mark infarct areas, during CABG operations to asses the success of the re vascularization.
  • the present invention has many other applications in the direction of therapeutics, such as, but not limited to, implanting brachytherapy seeds, ultrasound microwave radio-frequency cryotherapy and localized radiation ablations. It will be appreciated that many other procedures may also take advantage of the present invention.

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Abstract

L'invention concerne un système pour calculer une position d'une source émettrice de radioactivité dans un système de coordonnées. Ce système de calcul comprend (a) un détecteur d'émission radioactive, (b) un système détecteur de position relié au et/ou communiquant avec ledit détecteur d'émission radioactive et (c) une unité de traitement de données conçue et configurée pour recevoir des entrées de données, en provenance du système détecteur de position et du détecteur d'émission radioactive, et pour calculer la position de la source émettrice de radioactivité dans un système de coordonnées.
EP01951883A 2000-08-21 2001-07-11 Detecteur d'emission radioactive equipe d'un systeme detecteur de position et utilisation dudit detecteur d'emission dans des systemes medicaux et procedures medicales Withdrawn EP1326531A4 (fr)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US727464 1985-04-26
US641973 2000-08-21
US09/641,973 US8489176B1 (en) 2000-08-21 2000-08-21 Radioactive emission detector equipped with a position tracking system and utilization thereof with medical systems and in medical procedures
US71416400A 2000-11-17 2000-11-17
US09/727,464 US7826889B2 (en) 2000-08-21 2000-12-04 Radioactive emission detector equipped with a position tracking system and utilization thereof with medical systems and in medical procedures
US28604401P 2001-04-25 2001-04-25
US286044P 2001-04-25
PCT/IL2001/000638 WO2002016965A2 (fr) 2000-08-21 2001-07-11 Detecteur d'emission radioactive equipe d'un systeme detecteur de position et utilisation dudit detecteur d'emission dans des systemes medicaux et procedures medicales
US714164 2003-11-13

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CN1469720A (zh) 2004-01-21
IL154323A0 (en) 2003-09-17
AU2001272727A1 (en) 2002-03-04
WO2002016965A2 (fr) 2002-02-28

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