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WO2025074181A1 - Capteur électromagnétique et d'impédance intégré pour cathéters - Google Patents

Capteur électromagnétique et d'impédance intégré pour cathéters Download PDF

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Publication number
WO2025074181A1
WO2025074181A1 PCT/IB2024/058896 IB2024058896W WO2025074181A1 WO 2025074181 A1 WO2025074181 A1 WO 2025074181A1 IB 2024058896 W IB2024058896 W IB 2024058896W WO 2025074181 A1 WO2025074181 A1 WO 2025074181A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical apparatus
electrode
electrical wire
sensor
distal portion
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.)
Pending
Application number
PCT/IB2024/058896
Other languages
English (en)
Inventor
Jesse J. PISCHLAR
Ben W. Herberg
Disha MISHRA
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.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025074181A1 publication Critical patent/WO2025074181A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining 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
    • A61B5/062—Determining 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 magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • 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
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems

Definitions

  • the present disclosure relates to methods, systems, and devices for improving navigation and positioning of catheters.
  • a catheter for performing pulsed field ablation has an integrated electromagnetic (EM) and impedance sensor in which at least one element is used to support both position and shape tracking.
  • EM electromagnetic
  • impedance sensor in which at least one element is used to support both position and shape tracking.
  • the element sharing enables the footprint of the distal portion of the catheter to remain relatively small even with a new capability having been added thereto.
  • One example provides a medical apparatus including an elongated body passable through patient’s vasculature and having a distal portion and a proximal portion in mechanical and electrical communication with each other.
  • the medical apparatus also includes an EM sensor located in the distal portion and electrically connected through the elongated body to the proximal portion using a first electrical wire, a second electrical wire, and a third electrical wire.
  • the EM sensor includes a first electrode and an EM coil having a magnetic core.
  • the first electrode is electrically connected to the proximal portion via the first electrical wire.
  • the EM coil is electrically connected to the proximal portion via the second electrical wire and the third electrical wire.
  • the medical apparatus also includes a carrier arm mechanically connected to the distal portion and having a plurality of second electrodes mounted thereon. The plurality of second electrodes is electrically connected to the proximal portion via an electrical bus disposed within the elongated body.
  • the carrier arm also has a plurality of first electrodes mounted thereon and electrically connected to the proximal portion via an electrical bus disposed within the elongated body.
  • the medical apparatus also includes a coil-shaped electrode wound around a section of the carrier arm adjacent to the first end and electrically connected to the proximal portion via a third electrical wire disposed within the elongated body.
  • the above medical apparatus is configured to (i) determine a position of the EM sensor with respect to patient’s anatomy based on a voltage between the first electrical wire and the second electrical wire generated by the EM sensor in response to an external magnetic field; (ii) determine the position of the coil-shaped electrode based on a signal from the coil-shaped electrode detected via the third electrical wire in response to periodic currents driven through a patient’s body with a plurality of second electrodes; and (iii) determine positions of the plurality of first electrodes with respect to the patient’s anatomy based on signals from the plurality of first electrodes detected via the electrical bus and further based on a coordinate system established based on the positions of the EM sensor and the coil-shaped electrode.
  • FIG. 2 illustrates a side view of an EM sensor that can be used in the medical system of FIG. 1 according to one example.
  • FIG. 3 illustrates a side view of an EM sensor that can be used in the medical system of FIG. 1 according to another example.
  • FIGS. 4A-4B show three-dimensional (3D) perspective views illustrating a modification of the EM sensor of FIG. 3 according to one example.
  • FIG. 5 shows a 3D perspective view illustrating an EM-sensor assembly that can be used in the medical system of FIG. 1 according to one example.
  • FIG. 6 shows a 3D perspective view illustrating the distal portion of a catheter used in the medical system of FIG. 1 according to one example.
  • FIG. 7 shows a 3D perspective view illustrating the distal portion of a catheter used in the medical system of FIG. 1 according to another example.
  • FIG. 8 shows a 3D perspective view illustrating the distal portion of a catheter used in the medical system of FIG. 1 according to yet another example.
  • FIG. 9 shows a 3D perspective view illustrating the distal portion of a catheter used in the medical system of FIG. 1 according to yet another example.
  • FIG. 10 is a schematic diagram illustrating a cross-sectional side view of a section of the carrier arm used in a catheter of the medical system of FIG. 1 according to one example.
  • FIG. 11 is a block diagram illustrating impedance -based mapping operations implemented in the medical system of FIG. 1 according to one example.
  • FIG. 12 is a flowchart illustrating a mapping and navigation method implemented in the medical system of FIG. 1 according to one example.
  • Some embodiments disclosed herein are directed to fluoro-free navigation of catheters to their targeted locations within the patient’s body. Although example embodiments are described herein below in reference to catheters typically used for cardiac mapping and ablation, various embodiments are not so limited. Based on the provided description, a person of ordinary skill in the pertinent art will be able to make and use additional embodiments suitable for other types of catheters without any undue experimentation.
  • an EM-sensor modification directed at providing such added capability includes extending the magnetic core of the EM sensor beyond the insulative EM-sensor potting, thereby subjecting an electrically conducting surface of the magnetic core to patient’s blood and providing an electrically conductive path between the magnetic core and the navigation system.
  • the electrically conducting surface is plated with a suitable biocompatible material that is different from the material used to form the bulk of the magnetic core.
  • the distal portion 101 of the catheter 102 has electrodes 118 used for therapeutic interaction with the selected treatment site in or on the patient’s body.
  • the electrodes 118 deliver energy, for example, PFA energy, electroporation energy, non-therapeutic pulses and waveforms, and/or other transferred energy, to the treatment site.
  • the catheter 102 also includes an elongated body 104 to enable placement of the electrodes 118 in proximity to the treatment site of the patient for performing diagnosis, collecting EGM signals, determining the degree of contact with the tissue, and/or delivering treatment.
  • the elongated body 104 has a proximal portion 106, is connected to the distal portion 101, and typically includes one or more lumens that provide mechanical, electrical, and/or fluid communication between the proximal portion 106 and the distal portion 101.
  • the elongated body 104 has a central or guidewire lumen for hosting a shaft 132 and a carrier arm 128 in a retracted position.
  • the shaft 132 is longitudinally movable within and with respect to the outer shaft of the catheter 102. In operation, longitudinal movement of the shaft 132 is used to cause the carrier arm 128 to transition between at least a first (e.g., substantially linear) configuration and a second (e.g., looped) configuration.
  • a first e.g., substantially linear
  • a second e.g., looped
  • the proximal portion 106 typically includes or is connected to a handle (not explicitly shown in FIG. 1) that can be used to manipulate the catheter 102. Additionally, the proximal portion 106 includes an electrical connector 108 for electrically connecting various circuit elements of the distal portion 101 to pertinent circuitry of the system 100 that is external to the catheter 102. As an example, three corresponding electrical connections are explicitly shown in FIG.
  • the mapping and navigation module 150 is typically used for guiding a medical treatment procedure.
  • the medical device 110 is coupled to the electronic controller 160 through the mapping and navigation module 150.
  • both the medical device 110 and the mapping and navigation module 150 are directly coupled to the electronic controller 160.
  • the mapping and navigation module 150 is designed to help visualize the real-time position and orientation of the distal portion 101 of the catheter 102 within the patient’s body, e.g., to increase the accuracy of targeted ablation and reacquisition of pacing sites for re-ablation.
  • the reference electrode 122 and the electrodes 118 are surrounded by patient’s blood, which provides electrically conducive paths between the electrodes 118, the reference electrode 122, and other electrodes, which can be placed on the skin of the patient or introduced into the patient’s body using another catheter (e.g., see FIG. 11).
  • Impedances of various conductive paths can be measured with the electronic controller 160 appropriately operating the generator 140 and the mapping and navigation module 150. Based on the measured impedances, the electronic controller 160 determines the positions of the reference electrode 122 and the individual ones of the electrodes 118.
  • the presence of the cylindrical core 220 in the center of the EM coil 210 significantly increases the sensitivity of the EM sensor 200 to magnetic fields and, as such, improves the precision with which the position of the distal portion 101 can be tracked in the system 100.
  • Both the EM coil 210 and the magnetic core 220 are fully encapsulated by a potting material (e.g., a polymer) 230.
  • the potting 230 causes the magnetic core 220 of the EM sensor 200 to be electrically floating, as the magnetic core 220 does not have a direct electrical connection to any other circuit elements of the medical device 110.
  • FIG. 3 illustrates a side view of an EM sensor 300 that can be used in the catheter 102 according to another example.
  • the EM sensor 300 represents a modification of the EM sensor 200 illustrated in FIG. 2, with the modification being directed at integrating the reference electrode 122 into the EM sensor.
  • the incorporation of the reference electrode 122 into the EM sensor 300 provides for an additional functionality substantially without increasing the footprint of the resulting modified EM sensor 300 compared to that of the EM sensor 200 illustrated in FIG. 2.
  • the surface 122 of the distal end 306 of the cylindrical core 220 in the EM sensor 300 is unmodified and comprises substantially the same material as the bulk of the cylindrical core 220.
  • the surface 122 is covered by a thin film of an electrically conducting material.
  • the material for the thin film is selected from the group consisting of platinum-iridium alloy, gold, titanium, MP35N, 35NLT, austenitic stainless steel, and tantalum.
  • MP35N refers to a vacuum induction melted (VIM), vacuum arc re-melted (VAR) superalloy with cobalt, nickel, chromium, and molybdenum as its primary alloying elements.
  • FIGS. 4A-4B show 3D perspective views illustrating a modification of the EM sensor 300 according to one embodiment. More specifically, FIG. 4A shows a 3D perspective view of the embodiment of the EM sensor 300 illustrated in FIG. 3, with the corresponding labeling.
  • FIG. 4B shows a 3D perspective view of a modified EM sensor 300a in which an electrically conducting cap 402 is attached to the exposed distal end 306 of the magnetic core 220.
  • the cap 402 has a larger diameter than the magnetic core 220 and, as such, increases the effective surface area of the exposed distal end 306 of the magnetic core serving as the reference electrode 122.
  • the use of a reference electrode 122 having a relatively large surface area is beneficial, e.g., because the corresponding measured impedance signals tend to have a higher signal-to-noise ratio (SNR) with a larger area of the electrodes used for the measurements.
  • SNR signal-to-noise ratio
  • FIG. 6 shows a 3D perspective view illustrating the distal portion 101 of the catheter 102 according to one example.
  • the distal portion 101 includes the EM sensor 300 described above in reference to FIG. 3.
  • the EM sensor 300 is located in a distal-end section 610 of the elongated body 104 and is oriented parallel to the shaft 132.
  • the distal end 306 of the magnetic core 220 of the EM sensor 300 protrudes through an end face 612 of the distal-end section 610 as indicated in FIG. 6 and, as such, is exposed to patient’s blood when the illustrated distal portion 101 is deployed in the patient’s body.
  • the blood-exposed surface of the distal end 306 of the magnetic core 220 is operated as the reference electrode 122 as explained above.
  • FIG. 9 shows a 3D perspective view illustrating the distal portion 101 of the catheter 102 according to yet another example.
  • the distal portion 101 illustrated in FIG. 9 is generally similar to the distal portion 101 illustrated in FIG. 6.
  • the distal portion 101 illustrated in FIG. 9 includes the EM sensor 200 described above in reference to FIG. 2, whereas the distal portion 101 illustrated in FIG. 6 includes the EM sensor 300 described above in reference to FIG. 3.
  • the reference electrode 122 is implemented in the distal portion 101 illustrated in FIG. 9 using an electrical coil 910, which is described in more detail below in reference to FIG. 10.
  • the electrical coil 910 is wound around a section of the carrier arm 128 adjacent to the end face 612 of the distal-end section 610 and is electrically connected to the electrical connection 146 using an electrical lead wire 908 (also see FIG. 1). Due to its position, the electrical coil 910 is exposed to patient’s blood when the distal portion 101 is deployed in the patient’s body.
  • FIG. 12 is a flowchart illustrating a mapping and navigation method 1200 implemented in the system 100 according to one example.
  • the method 1200 includes positioning the distal portion 101 of the catheter 102 adjacent to the tissue targeted for therapy (in a block 1202).
  • the method 1200 also includes independently determining the position of the reference electrode 112 using impedance-based navigation (in a block 1206).
  • operations of the block 1206 include: (i) driving sine- wave currents of three different respective frequencies from one patch to another in the three pairs 71/72, 73/74, and 75/76 of electrode patches; and (ii) determining the position of the reference electrode 122 based on three frequency-demodulated voltages measured between the reference electrode 122 and the surface patch electrode 90, e.g., as illustrated in FIG. 11.
  • the method 1200 also includes crossregistering the coordinate systems corresponding to EM- and impedance -based navigation (in a block 1208). The cross-registration is performed in the block 1208 using the EM-based measurements of the position of the reference electrode 122 obtained in the block 1204 and the independent impedance -based measurements of the same position of the reference electrode 122 obtained in the block 1206.
  • the medical apparatus is configured to: determine a position of the first electrode with respect to patient’s anatomy based on a voltage between the second electrical wire and the third electrical wire generated by the EM coil in response to an external magnetic field; independently determine the position of the first electrode based on a signal from the first electrode detected via the first electrical wire in response to periodic currents driven through a patient’s body with a plurality of third electrodes; and determine positions of the plurality of second electrodes with respect to the patient’s anatomy based on signals from the plurality of second electrodes detected via the electrical bus and further based on a coordinate system cross-referenced based on the twice-determined position of the first electrode.
  • a surface of the distal end is covered by a film of an electrically conducting material that is different from a bulk ferromagnetic material of the magnetic core.
  • the first electrode further comprises an end cap attached to the metal tube.
  • the first electrically conducting material is selected from the group consisting of silver, copper, nickel, and aluminum; and wherein the second electrically conducting material is selected from the group consisting of platinum-iridium alloy, gold, titanium, MP35N, 35NLT, austenitic stainless steel, and tantalum.
  • processors may be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software.
  • the functions may be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which may be shared.
  • circuitry also covers an implementation of merely a hardware circuit or processor (or multiple processors) or portion of a hardware circuit or processor and its (or their) accompanying software and/or firmware.
  • circuitry also covers, for example and if applicable to the particular claim element, a baseband integrated circuit or processor integrated circuit for a mobile device or a similar integrated circuit in server, a cellular network device, or other computing or network device.
  • Example 2 The medical apparatus of Example 1 , wherein the medical apparatus is configured to: determine a position of the EM sensor with respect to patient’s anatomy based on a voltage between the second electrical wire and the third electrical wire generated by the EM coil in response to an external magnetic field; independently determine the position of the first electrode based on a signal from the first electrode detected via the first electrical wire in response to periodic currents driven through a patient’s body with a plurality of third electrodes; and determine positions of the plurality of second electrodes with respect to the patient’s anatomy based on signals from the plurality of second electrodes detected via the electrical bus and further based on a coordinate system established based on the position of the EM sensor and the independently determined position of the first electrode.
  • Example 5 The medical apparatus of Example 3, wherein a surface of the distal end is covered by a film of an electrically conducting material that is different from a bulk ferromagnetic material of the magnetic core.
  • Example 6 The medical apparatus of Example 5, wherein the electrically conducting material is selected from the group consisting of platinum-iridium alloy, gold, titanium, MP35N, 35NLT, austenitic stainless steel, and tantalum.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
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  • Human Computer Interaction (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Robotics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne des procédés et un appareil pour réaliser des interventions médicales d'ablation. Selon un exemple, un cathéter pour effectuer une ablation par champ pulsé comprend un capteur électromagnétique et d'impédance intégré dans lequel au moins un élément est utilisé pour prendre en charge un suivi à la fois de la position et de la forme. Le partage d'élément permet à la partie distale du cathéter de conserver une aire relativement petite même en tenant compte de l'ajout d'une nouvelle capacité à celle-ci.
PCT/IB2024/058896 2023-10-05 2024-09-12 Capteur électromagnétique et d'impédance intégré pour cathéters Pending WO2025074181A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363588163P 2023-10-05 2023-10-05
US63/588,163 2023-10-05

Publications (1)

Publication Number Publication Date
WO2025074181A1 true WO2025074181A1 (fr) 2025-04-10

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PCT/IB2024/058896 Pending WO2025074181A1 (fr) 2023-10-05 2024-09-12 Capteur électromagnétique et d'impédance intégré pour cathéters

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180214215A1 (en) * 2015-07-30 2018-08-02 St. Jude Medical International Holding S.À R.L. Roll-sensing sensor assembly
US20180228393A1 (en) * 2017-02-15 2018-08-16 Biosense Webster (Israel) Ltd. Electrophysiologic device construction
EP3753487A1 (fr) * 2019-06-19 2020-12-23 Biosense Webster (Israel) Ltd Rendu de sonde à bras multiples
US20220370121A1 (en) * 2021-05-20 2022-11-24 Biosense Webster (Israel) Ltd. Tissue puncture using high articulation microcatheter and electrically active guidewire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180214215A1 (en) * 2015-07-30 2018-08-02 St. Jude Medical International Holding S.À R.L. Roll-sensing sensor assembly
US20180228393A1 (en) * 2017-02-15 2018-08-16 Biosense Webster (Israel) Ltd. Electrophysiologic device construction
EP3753487A1 (fr) * 2019-06-19 2020-12-23 Biosense Webster (Israel) Ltd Rendu de sonde à bras multiples
US20220370121A1 (en) * 2021-05-20 2022-11-24 Biosense Webster (Israel) Ltd. Tissue puncture using high articulation microcatheter and electrically active guidewire

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