WO2022120462A1 - Cathéter d'imagerie utilisant des propriétés électriques de tissus - Google Patents

Cathéter d'imagerie utilisant des propriétés électriques de tissus Download PDF

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Publication number
WO2022120462A1
WO2022120462A1 PCT/CA2021/051692 CA2021051692W WO2022120462A1 WO 2022120462 A1 WO2022120462 A1 WO 2022120462A1 CA 2021051692 W CA2021051692 W CA 2021051692W WO 2022120462 A1 WO2022120462 A1 WO 2022120462A1
Authority
WO
WIPO (PCT)
Prior art keywords
imaging catheter
catheter device
electrically conductive
tissues
cells
Prior art date
Application number
PCT/CA2021/051692
Other languages
English (en)
Inventor
Gholamreza MIRSHEKARI
Original Assignee
Mirshekari Gholamreza
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 CA3107032A external-priority patent/CA3107032A1/fr
Application filed by Mirshekari Gholamreza filed Critical Mirshekari Gholamreza
Publication of WO2022120462A1 publication Critical patent/WO2022120462A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0536—Impedance imaging, e.g. by tomography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6853—Catheters with a balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts

Definitions

  • the present invention relates to the field of medical imaging and more particularly to catheters adopted for intracorporeal imaging of body cells, tissues or organs.
  • Endovascular procedures usually use x-ray fluoroscopy to help navigate through the body and deliver endovascular devices and drugs to designated sites in the body.
  • This technique poses the risk of exposure to x-ray to the patient and the physician and the risk of contrast agents administration to the patient.
  • physicians desire to have an intracorporeal mean to have a detailed picture of different tissues presented in the sites of intervention in the body.
  • intracorporeal devices incorporating optical coherence tomography (OCT) or acoustic energy to generate images form within the body.
  • OCT optical coherence tomography
  • EIT Electrical impedance tomography
  • an imaging catheter device comprising: an elongated and hollow body extending between a proximal end and a distal end along longitudinal axis, at least two electrically conductive elongated bodies secured to at least the distal end of the elongated and hollow body and extending longitudinally along at least a portion of the elongated and hollow body, with the electrically conductive elongated bodies capable of sending or receiving electrical current into or from targeted tissues, cells and organs in contact with the distal end of the electrically conductive elongated bodies.
  • the distal end of the electrically conductive bodies in the imaging catheter device may be used as electrodes to create an impedance map of at least a portion of tissues, cells and organs inside a living body by electrical impedance tomography (EIT).
  • EIT electrical impedance tomography
  • the electrically conductive bodies extended to the distal end of the imaging catheter device allow for creating what is known by those skilled in the art as forward-looking electrical impedance tomography images.
  • the imaging catheter device can be used as a forward-looking guiding catheter therein guide wire or other medical devices can pass therethrough.
  • the imaging catheter device may be used to help better target a crossing, or atherectomy device.
  • the imaging catheter device may be used to help better deliver a balloon catheter or a stent.
  • the distal end of the electrically conductive bodies may be arranged in a, including, but not limited to, a circular pattern therein any subset thereof may be used to inject current or apply voltages, or measure current, voltage, or any other electrical properties of the tissues, cells or organs.
  • the distal end of some or all of the electrically conductive bodies may be on a distal surface of the imaging catheter device perpendicular to the longitudinal axis.
  • the distal end of some or all of the electrically conductive bodies may be on a distal surface of the imaging catheter device parallel to the longitudinal axis.
  • the distal end of some or all of the electrically conductive bodies may be on a distal surface of the imaging catheter device having any arbitrary angle with respect to the longitudinal axis.
  • the distal end of some or all of the electrically conductive bodies may be on more than one distal surfaces of the imaging catheter device having different angles with respect to the longitudinal axis.
  • the measurements of the electrical properties of the tissues, cells, or organs at the distal end of the imaging catheter device may be processed to reconstruct a two-dimensional image of the tissues, cells, or organs at the distal end of the imaging catheter device.
  • the measurements of the electrical properties of the tissues, cells or organs at the distal end of the imaging catheter device may be processed to reconstruct a three-dimensional tomographic image of the tissues, cells, or organs at the distal end of the imaging catheter device.
  • the materials or the construction of the imaging catheter device allows the whole or a portion thereof to be flexible to bending.
  • At least one of the electrically conductive bodies secured at distal end can be pulled from the proximal end to impose a bend in at least a portion of the imaging catheter device.
  • the angular arrangement of electrically conductive bodies can be changed in at least one selected region of the imaging catheter device to nullify the bending therein.
  • the imaging catheter system may comprise disposable components or reusable components.
  • the imaging catheter system may comprise components designated to be used in sterile held or components designated to be used in non-sterile held.
  • the disposable components may comprise, including, but not limited to, the imaging catheter device, proximal access ports, intermediate electronics, distal end bending and manipulation mechanisms and means of communication with reusable components.
  • the access to the hollow body of the imaging catheter device may be from a port at the proximal end thereof.
  • the access to the hollow body of the imaging catheter device may be from a port anywhere on the circumferential surface thereof. This later type of access is known by those skilled the art as the rapid exchange.
  • the reusable components may comprise, including, but not limited to, a console that comprises at least electronics to process the measurements and reconstruct images and a display to view the images.
  • the three-dimensional images generated by the system may be viewed using any three-dimensional visualization methods and equipment.
  • arti ti ci al intelligence and machine learning algorithms may be implemented to reconstruct the image from the electrical measurements.
  • additional electrically conductive bodies that are not secured to the distal end of the elongated hollow body may also be used to inject current or apply voltages, or measure current, voltage, or any other electrical properties of the tissues, cells, or organs.
  • the distal end of the electrically conductive bodies may not be in direct contact with tissues, cells, or organs and a dielectric layer between them provides a capacitive coupling.
  • multitude of parallel electronics circuits may perform parallel measurements and computations.
  • FIG. 1 illustrates an imaging catheter device distal end comprising elongated hollow body and multitude of electrically conductive bodies integrated longitudinally in the elongated hollow body’s wall, in accordance with one embodiment.
  • FIG. 2 illustrates a front view of the imaging catheter device distal end comprising multitude of conductor bodies distal ends, in accordance with one embodiment.
  • Fig. 3a illustrates front view of the imaging catheter device distal end injecting a three-dimensional current held into the tissues, cells or organs inside a body.
  • Fig. 3b illustrates side view of imaging catheter device distal end injecting a three-dimensional current held into the tissues, cells or organs inside a body.
  • Fig. 4a illustrates an imaging catheter device distal end therein some or all of the distal ends of the conductor bodies are located on the front surface thereof, in accordance with one embodiment.
  • Fig. 4b illustrates an imaging catheter device distal end therein some or all of the distal ends of the conductor bodies are located on the circumferential surface thereof, in accordance with one embodiment.
  • Fig. 4c illustrates an imaging catheter device distal end therein some or all of the distal ends of the conductor bodies are located on angled or round surface thereof, in accordance with one embodiment.
  • Fig. 4d illustrates an imaging catheter device distal end therein some or all of the distal ends of the conductor bodies are extended on multiple distal surfaces thereof, in accordance with one embodiment.
  • FIG. 5 illustrates an imaging catheter device therein all or distal region thereof can be bent by applying pull forces to the proximal ends of the electrically conductive bodies, in accordance with an embodiment.
  • Fig. 6 illustrates a catheter device therein bending and non-bending regions are created by arranging the electrically conductive bodies in radially asymmetric or symmetric configurations, in accordance with one embodiment.
  • FIG. 7 is a diagram illustrating an imaging catheter system architecture comprising disposable and reusable components, in accordance with one embodiment.
  • Fig. 8 illustrates an imaging catheter device therein the access port to the lumen is located on the circumferential surfaces thereof, in accordance with an embodiment.
  • Fig. 9 illustrates an imaging catheter device distal end having multiple lumens, multiple concentric array of conductive bodies and an additional electrically conductive body free to move along a lumen.
  • Fig. 10 illustrates an imaging catheter device distal end therein dielectric layer provides capacitive coupling between conductive bodies and the tissues, cells, or organs, in accordance with one embodiment.
  • Fig. 11 illustrates a block diagram of an electronics architecture that could be used to inject current and measure electrical voltages in an electrical impedance tomography system, in accordance with one embodiment.
  • Fig. 1 illustrates one embodiment of the imaging catheter device comprising an elongated body 101 that can have at least one lumen 104 and a distal end 103. At least two elongated electrically conductive bodies 102 extending to, including, but not limited to, the distal end 103 of elongated hollow body 101 between inner surface 106 and outer surface 107. [0051] The elongated electrically conductive bodies 102 have exposed surface 105 at the distal end 103 therein the electrically conductive body can be in contact with the tissues, cells, fluids, or organs in the body.
  • the exposed surface 105 may include an additional layer or segment of electrically conductive material to enhance, including, but not limited to, its electrical performance, durability, or corrosion resistance.
  • Fig. 2 illustrates the view perpendicular to the longitudinal axis of one embodiment of the imaging catheter device.
  • electrically conductive bodies 201 are distributed in a known pattern 202 between inner surface 207 and the outer surface 208 of the distal end of the imaging catheter device.
  • any two elongated conductive bodies 204 and 203 may be selected to inject AC or DC electrical current through the tissue, cells, or organs in contact with imaging catheter distal end and any two elongated conductive bodies 206 and 205, including the same elongated conductive bodies selected to inject electrical current 204 and 203, may be selected to measure voltage.
  • the current or voltages measurements may be used to map, including, but not limited to, the electrical impedance of the tissue, cells, or organs in contact with the distal end of the imaging catheter device.
  • FIG. 3 illustrates the injected three-dimensional current field 306 in proximity of the distal end 309 of an embodiment of the imaging catheter device 301.
  • Fig. 3a is the view perpendicular to the longitudinal axis of the distal end of the imaging catheter device 301 and
  • Fig. 3b is the view parallel to the longitudinal axis of the distal end of the imaging catheter device 301.
  • the periodic or non-periodic electric current or potential field 306 of any temporal form may be injected in the tissues, cells, or organs in proximity of the distal end 309 of the imaging catheter device 301 using selected distal ends 304 and 305 of the elongated electrically conductive bodies 302 and 303 and voltages or currents are measured across same path 306 or different selected paths 307 and 310.
  • the path 307 passes through area 308 with different electrical properties, thus the voltage or current measurement through this path would be different from what is expected from an electrically homogeneous medium. These variations in voltages or currents may be used to calculate the location of the tissue with different electrical properties 308.
  • the measured voltages or currents may be processed to reconstruct two-dimensional image or three-dimensional tomographic image of the tissues, cells, or organs at the distal face 309 of the imaging catheter device 301.
  • FIG. 4 illustrates embodiments of the imaging catheter device distal end, including, but not limited to four exemplary configurations of the distal face of the elongated hollow body and the distal ends of the elongated electrically conductive bodies.
  • Fig. 4a illustrates one embodiment therein the distal ends of some or all of the electrically conductive bodies 401 are exposed at the distal surface 402 of the elongated hollow body perpendicular to the longitudinal axis of the elongated hollow body.
  • Fig. 4b illustrates one embodiment therein the distal ends of some or all of the electrically conductive bodies 408 are exposed at the distal circumferential surface 403 of the elongated hollow body parallel to the longitudinal axis of the elongated hollow body.
  • Fig. 4c illustrates one embodiment therein the distal ends of some or all of the electrically conductive bodies 409 are exposed at the distal tapered or curved surface 404 of the elongated hollow body.
  • Fig. 4d illustrates one embodiment therein the distal ends of some or all of the electrically conductive bodies 410 are exposed at some or all of: the distal surface 405 of the elongated hollow body perpendicular to the longitudinal axis of the elongated hollow body, the distal circumferential surface 407 of the elongated hollow body parallel to the longitudinal axis of the elongated hollow body and the distal tapered or curved surface 406 of the elongated hollow body.
  • Fig. 4 represents four possible examples of the distal end configurations, it is to be understood that these examples are not to be regarded as restrictive.
  • Fig. 5 illustrates an embodiment therein the imaging catheter device is flexible to bending at least in its distal region 501.
  • the distal ends 504 and 505 of the selected elongated electrically conductive bodies 502 and 503 are secured to the distal end 506 of the imaging catheter device and are free to be pulled from the proximal end.
  • pulling the proximal ends of the elongated conductive bodies 502 and 503 with different forces 508 and 507 causes the flexible region 501 of the imaging catheter device to flex.
  • This feature is known to those skilled in that art as articulation-by-tendons of the distal end where herein some or all of the the electrically conductive bodies may additionally serve as tendons.
  • Fig. 6 illustrates an embodiment therein the articulation of the imaging catheter device can be limited to a selected region 603 when the elongated conductive bodies 604 and 605 are pulled by force 607 and 608 from the proximal end.
  • the imaging catheter device may have regions of articulating 603, non-articulating 601 and transition 602.
  • the selected elongated conductive bodies 604 and 605 are located on one side of lumen 606 thus puling them causes the imaging catheter device to bend in this region.
  • the non-articulating region 601 as shown in Fig. 6b, the selected elongated conductive bodies 604 and 605 are located on the opposite sides of each other with respect to the lumen 606, thus pulling them does not cause the imaging catheter device to bend in this region.
  • the transition region 602 is where the selected elongated conductive bodies 604 and 605 are reconfigured from the articulating 603 to the non-articulating 601 configuration.
  • Some or all of the electrically conductive bodies may serve additional purpose of braiding along the imaging catheter device for mechanical reinforcement.
  • Fig. 7 illustrates an exemplary architecture of the imaging catheter system. It should be understood that this example is not to be regarded as restrictive to other possible architectures of the system.
  • the system may be divided into disposable components and reusable components.
  • the disposable components may include, but not limited to: the imaging catheter device distal section 710, the imaging catheter device proximal section 711, the imaging catheter device intermediate electronics and their housing 701 and the communication cables 704.
  • the reusable components may include, but not limited to: console 707 that process the measurements and display the reconstructed image on a display 708 or a three-dimensional visualization system 709 through a communication mean 711.
  • the imaging catheter device represented in Fig. 7 may have at least one proximal port 703 that can be used to insert a guide wire, balloon catheter, stent or any other medical device 705 in the imaging catheter device lumen extending from the port 703 to the distal end 702 of the imaging catheter device.
  • the imaging catheter device represented in Fig. 7 may have at least one proximal mean 706 to articulate the distal end of the imaging catheter device.
  • FIG. 8 illustrates one embodiment of the imaging catheter device therein the access to the lumen of the catheter is through what is known to those skilled in the art as a rapid exchange port 804.
  • This embodiment comprises an imaging catheter device distal section 803 and intermediate electronics and their housing 801.
  • the access to the lumen of the catheter is through a rapid exchange port 804 located on the circumferential surface of the distal section of the imaging catheter device.
  • a guide wire, balloon catheter, stent or any other medical device 805 can be delivered to the distal end of the catheter 802 through the rapid exchange port 804.
  • Fig. 9 illustrates one embodiment of the imaging catheter device distal end 901 therein the distal end of additional electrically conductive bodies 906, that are free to move, used to inject current or voltages, or measure current, voltage or other electrical properties of the tissues, cells or organs.
  • the additional free-to-move electrically conductive bodies can be a medical wire, or an integrated, or accessory part of the imaging catheter device.
  • the imaging catheter device represented in Fig. 9 may have multiple lumens 904 and 905.
  • the distal end of the electrically conductive bodies can be arranged in multiple concentric or non-concentric configurations 902 and 903.
  • Fig. 10 illustrates one embodiment of the imaging catheter device therein dielectric layers 1003 and 1004 is integrated at the distal ends of the electrically conductive bodies 1002 to electrically isolate the distal ends of the electrically conductive bodies form the surrounding tissues, cells and organs inside the body and provide capacitive coupling between the distal end of the electrically conductive bodies and tissues, cells and organs inside the body.
  • FIG. 11 illustrates a block diagram of one embodiment of the electronics architecture to inject voltage or current to and measure voltage or current from multitude of electrically conductive bodies 1106.
  • any individual electrically conductive body 1106 is connected to its own analog-to-digital converter 1101 through the discretionary patient protection circuits 1105.
  • Any electrically conductive body 1106 can selectively be connected to the digital-to-analog converters 1102 or the return line 1103 through analog switches 1104.
  • the digital-to-analog converters 1102 in the embodiment of Fig. 11 can inject a DC, periodic or finite duration (pulse) waveforms of any shape.
  • Multitude of digital-to-analog converters can inject different waveforms selectively to some or all of the electrically conductive bodies.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Radiology & Medical Imaging (AREA)
  • Endoscopes (AREA)

Abstract

Est décrit, un dispositif cathéter destiné à être utilisé dans la création, comprenant, mais sans y être limité, des images en vision frontale de tissus, de cellules et d'organes à l'intérieur d'un corps vivant en mesurant au moins une propriété électrique de ces derniers. Le dispositif comprend au moins un corps allongé et creux s'étendant entre une extrémité proximale et une extrémité distale le long d'un axe longitudinal, au moins deux corps allongés électriquement conducteurs fixés au corps allongé et creux et s'étendant longitudinalement le long d'au moins une partie du corps allongé et creux, les corps allongés électriquement conducteurs étant aptes à envoyer ou à recevoir du courant électrique dans des tissus, des cellules et des organes ciblés ou à partir de ces derniers.
PCT/CA2021/051692 2020-12-10 2021-11-25 Cathéter d'imagerie utilisant des propriétés électriques de tissus WO2022120462A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202063124038P 2020-12-10 2020-12-10
US63/124,038 2020-12-14
CA3,107,032 2021-01-25
CA3107032A CA3107032A1 (fr) 2020-12-10 2021-01-25 Catheter d'imagerie utilisant des caracteristiques electriques de tissu

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WO2022120462A1 true WO2022120462A1 (fr) 2022-06-16

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5109870A (en) * 1988-10-25 1992-05-05 Forschungsgesellschaft Fur Biomedizinische Technik E.V. Apparatus for and method of motility and peristalsis monitoring
US20110306867A1 (en) * 2010-06-13 2011-12-15 Venugopal Gopinathan Methods and Systems for Determining Vascular Bodily Lumen Information and Guiding Medical Devices
WO2020007991A1 (fr) * 2018-07-04 2020-01-09 Navix International Limited Système et procédé d'imagerie basée sur la conductivité

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5109870A (en) * 1988-10-25 1992-05-05 Forschungsgesellschaft Fur Biomedizinische Technik E.V. Apparatus for and method of motility and peristalsis monitoring
US20110306867A1 (en) * 2010-06-13 2011-12-15 Venugopal Gopinathan Methods and Systems for Determining Vascular Bodily Lumen Information and Guiding Medical Devices
WO2020007991A1 (fr) * 2018-07-04 2020-01-09 Navix International Limited Système et procédé d'imagerie basée sur la conductivité

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