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WO2025176801A1 - Dispositif de cathéter multifonction orientable - Google Patents

Dispositif de cathéter multifonction orientable

Info

Publication number
WO2025176801A1
WO2025176801A1 PCT/EP2025/054624 EP2025054624W WO2025176801A1 WO 2025176801 A1 WO2025176801 A1 WO 2025176801A1 EP 2025054624 W EP2025054624 W EP 2025054624W WO 2025176801 A1 WO2025176801 A1 WO 2025176801A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
anchor
distal end
coil
shaft
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/EP2025/054624
Other languages
English (en)
Inventor
Marissa A. METCALF
Jesse J. PISCHLAR
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 Ireland Manufacturing ULC
Original Assignee
Medtronic Ireland Manufacturing ULC
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 Ireland Manufacturing ULC filed Critical Medtronic Ireland Manufacturing ULC
Publication of WO2025176801A1 publication Critical patent/WO2025176801A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • 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
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1435—Spiral
    • 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
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • 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
    • 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
    • A61B2034/2053—Tracking an applied voltage gradient
    • 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
    • A61B5/6856—Catheters with a distal loop
    • 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
    • A61B5/6857—Catheters with a distal pigtail shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible

Definitions

  • the present technology is generally related to a steerable multi-function catheter device.
  • Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure.
  • a catheter can include a sensor that is used by a navigation system to track the position of the catheter during the procedure.
  • the catheter can also include one or more other sensors, which can be used to track the progress and other aspects of the procedure. Such sensors and other structures tend to increase the overall diameter of the catheter.
  • the techniques of this disclosure generally relate to a steerable multi-function catheter device.
  • the present disclosure provides a catheter that includes a handle including a manipulator.
  • a catheter shaft extends from the handle to terminate in a distal end portion, and the catheter shaft includes a lumen extending through the shaft.
  • An electrically conductive anchor is at the distal end portion and includes an anchor body configured to provide a sensor signal in response to sensed electrical signal.
  • a steering wire has proximal and distal ends, in which the proximal end is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor.
  • a conductive wire is electrically coupled to the anchor and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire.
  • the disclosure provides a catheter.
  • the catheter includes a handle, a catheter shaft, a coil of electrically conductive wire, and an electrode apparatus.
  • the catheter shaft extends from the handle to terminate in a distal end portion, in which the catheter shaft includes a lumen extending through the catheter shaft.
  • the coil is at the distal end portion of the catheter shaft, and the coil includes a first portion of a first number of windings having a first outer diameter and second portion of a second number of windings having a second outer diameter, the second outer diameter is greater than the first outer diameter, a length of the conductive wire extends from the coil through the lumen and to the handle, and the coil is configured to provide a sensor signal in response to sensed electrical signal.
  • An overmolding encapsulates the first portion of the coil, including a radially outer surface thereof, around the catheter shaft, and at least a radially outer surface of the second portion of the coil is exposed beyond the overmolding.
  • the electrode apparatus includes an electrode and is movable relative to the distal end portion of the catheter shaft.
  • the disclosure provides a system that includes a catheter and a tracking system.
  • the catheter includes a handle including a manipulator.
  • a catheter shaft extends from the handle to terminate in a distal end portion, and the catheter shaft includes a lumen extending through the shaft.
  • An electrically conductive anchor has an anchor body at the distal end portion of the shaft, in which the anchor body defines a first sensor configured to provide a first sensor signal in response to a first sensed signal.
  • a steering wire has proximal and distal ends, in which the proximal end of the steering wire is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor.
  • a second sensor extends from the distal end portion of the shaft and has a known fixed spatial position relative to the anchor body, in which the second sensor is configured to provide a second sensor signal in response to the second sensed signal.
  • the tracking system includes first and second tracking modalities.
  • the first tracking modality is configured to determine a position of the anchor based on the first sensor signal.
  • the second tracking modality is configured to determine a position of the second sensor based on the second sensor signal.
  • FIG. 1 is a perspective view illustrating the distal end portion of a catheter that includes an electrode apparatus.
  • FIG. 2 is a side view illustrating a first example of internal features of the catheter of FIG. 1.
  • FIG. 3 is a side view illustrating a second example of the internal features of the catheter of FIG. 1.
  • FIG. 4 is a side view of an example handle, partially in phantom to show internal part of the handle.
  • FIG. 5 is a side view illustrating an example of variable diameter coil sensor.
  • FIG. 6 is a side view illustrating another example of a variable diameter coil sensor configured as an anchor.
  • FIG. 7 is a side view of a distal end portion of an example catheter illustrating the coil of FIG. 5 at the distal end portion without an overmolding layer.
  • FIG. 8 is a side view of a distal end portion of an example catheter illustrating the coil of FIG. 5 at the distal end portion with the overmolding layer.
  • FIG. 9 is a cross-sectional view of the catheter of FIG. 8 taken along lines 9-9.
  • FIG. 10 is an enlarged view of part of the cross-sectional view of FIG. 9 illustrating the catheter with the overmolding layer removed.
  • FIG. 11 is an enlarged view of part of the cross-sectional view of FIG. 9 with the oveimolding layer.
  • FIG. 12 is a block diagram of a system illustrating an example operating environment for a catheter device.
  • the catheter includes an elongated shaft extending from a handle to terminate in a distal end portion of the shaft.
  • the catheter also includes an anchor at a distal end portion of the shaft.
  • One or more steering wires are coupled to the anchor, and a length of the steering wire(s) extends proximally from the anchor through the shaft to couple to a manipulator of the handle.
  • the manipulator can be configured to adjust the length of the steering wire(s) to deflect a distal end portion of the catheter.
  • a conductive wire is electrically coupled to the anchor.
  • the conductive wire can be coupled directly to the anchor (e.g., by welding, soldering or mechanical coupling) or to the steering wire (e.g., by welding, soldering or inter-wire coupling).
  • the anchor can be configured to sense an electrical signal (e.g., a current or voltage), which can be initiated by one or more sources external to the body and/or within the body.
  • the conductive wire can carry an electrical signal to a location beyond the proximal end of the steering wire in response to the electrical signal sensed by the anchor.
  • a first localization system e.g., configured to perform impedance-based localization
  • the anchor can have a cylindrical body, which can include a coil of electrically conductive wire.
  • a length of the conductive wire can extend from an end of the coil through a lumen of the catheter shaft and be coupled to the handle.
  • the coil can include a first portion having a first number of windings and a first outer diameter and a second portion having a second number of windings and a second outer diameter.
  • the second portion can have a greater outer diameter than the first portion.
  • An overmolding layer can encapsulate the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil be exposed beyond the overmolding.
  • a jacket or jacketing layer (e.g., a tubular sleeve, overmolding, or lamination) 118 can surround the braided layer of the shaft 104 such that the braided layer is sandwiched between the inner and jacket layers.
  • the jacket 118 can extend partially or fully over the length of the shaft 104. In some examples, the jacket 118 is over at least the distal end portion 102 of the shaft 104.
  • the jacket 118 can extend axially a length beyond the distal end 106 of the shaft to terminate in a distal end 120 of the catheter 100 that defines an opening (also referred to as a distal opening of the catheter).
  • one or more apparatuses e.g., an ablation electrode, sensor, probe, etc.
  • the shaft 104 also includes a lumen 108 extending through the shaft 104 between proximal and distal ends thereof.
  • the lumen 108 constitutes a main central lumen that extends axially through the shaft.
  • Various parts and structures can extend through the lumen 108, including being axially movable within such lumen. In some examples there can be more than one lumen extending through the shaft 104, in which various devices or structures can extend. Also, or as an alternative, devices or structures can be axially moveable within respective lumens.
  • the anchor body 112 has a sidewall that can extend axially a length along the shaft 104 and has a radial thickness along its axial length, which can be a fixed or variable thickness.
  • the anchor body 112 includes a coil having a number of windings arranged axially to define the length of the anchor body.
  • a radially outer surface portion of the anchor body 112 can remain exposed and contact bodily fluids during use of the catheter 100.
  • the anchor body 112 includes or is formed of an electrically conductive material and defines an electrode configured to provide a sensor signal in response to sensed electrical signal.
  • the anchor body 112 can define a reference electrode of an impedance-based navigation system.
  • One or more steering wires (also referred to as pull wires or steering cables) 114 can be coupled to the anchor 110 to provide for deflection (e.g., steering) of the catheter 100 responsive to movement of the steering wire(s) relative to the shaft 104.
  • the steering wire(s) 114 are formed of an electrically conductive material, such as stainless steel.
  • one or more steering wires can be formed of electrically insulating (non-conductive) material, such a polymer material.
  • the steering wire(s) are formed of a combination of different types of materials, such as including polymer and metal components (e.g., polymer coated stainless steel wires).
  • the steering wire 114 can extend through the central lumen 108 or through another lumen (e.g., a steering lumen), which extends axially through the shaft.
  • the steering wire 114 has a distal end 116 coupled to the anchor body 112, and a proximal end (not shown) coupled to a manipulator in the handle (not shown - but see, e.g., FIG. 4).
  • the distal end of the steering wire 114 is secured to the anchor.
  • the anchor includes a slot or recess extending partially or fully through a sidewall of the anchor body 112 arranged and configured to receive the distal end of the steering wire 114 therein.
  • the distal end of the steering wire 114 can be secured to a radially outer surface or a radially inner surface of the anchor body 112.
  • the steering wire 114 can be secured to the surface of the anchor body by welding (e.g., laser welding), soldering, brazing or other metallurgical methods of connecting the steering wire and the anchor 110.
  • the distal end of the steering wire 114 can be embedded in and/or mechanically coupled with the anchor 110 (e.g., by a mechanical coupling, fitting or connector).
  • anchors distributed axially along the length of the shaft 104 to provide for deflection of respective shaft segments.
  • steering wires coupled to each of the anchors to provide for deflection of respective shaft segments in directions transverse to the shaft axis according to movement of the respective steering wires relative to the shaft 104.
  • the anchor 110 circumscribes a proximal portion of the jacket 118 near (e.g., spaced proximally) the distal end 106 of the shaft.
  • the jacket 118 thus can extend over a portion (e.g., over the distal end portion 102) of the shaft 104 or the entire axial length of the shaft, and at least a portion of the outer surface of the anchor remains exposed.
  • the jacket 118 can be formed by overmolding one or more layers of a polymer or other suitable pliant insulating and biocompatible material to encapsulate the portion of the shaft 104 that resides radially inward from die jacket 118.
  • the jacket (e.g., overmolding) 118 can be applied to cover portions of the anchor body with an outer diameter less than a given diameter while portion(s) with an outer diameter greater than the given diameter remain exposed through the jacket.
  • the catheter 100 can include one or more other sensors 124 in addition to the anchor 110.
  • the sensor 124 includes a distal sensor portion 126 that extends from the distal end 106 of the catheter shaft.
  • the distal sensor portion 126 extends axially along or adjacent a radially inner sidewall of the outer layer 118 and the distal end of the sensor 124 is spaced at or proximally located from the distal opening 120.
  • One or more wires can extend proximally from the distal sensor portion 126, such as through the central lumen (or another lumen) of the shaft 104, to carry a respective sensor signal based on a detected signal or condition.
  • the sensor 124 has a known fixed spatial position relative to the anchor 110 (also a sensor). The known fixed spatial position can be used, such as for mapping and/or spatial registration, where one or both of the sensor 124 and the anchor 110 are used as sensors for navigation or localization.
  • the senor 124 can be an electromagnetic sensor having a distal sensor portion 126 extending from the distal end portion of the catheter shaft to terminate in a distal end thereof.
  • the electromagnetic sensor 124 can be configured to provide a sensor signal in response to an electromagnetic field provided by a field generator.
  • the distal sensor portion 126 can include a conductive sensor coil around a magnetic core and a conductive link (e.g., a twisted pair of wires) that extends from the coil to carry the sensor signal to processing electronics.
  • the sensor 124 can be a five degree of freedom (5DOF) or six degree of freedom (6DOF) sensor (e.g., commercially available from Northern Digital Inc. of Ontario, Canada).
  • the electromagnetic sensor 124 thus can be configured to provide a sensor signal in response to an electromagnetic field, such as provided by a field generator of a navigational tracking system.
  • an electromagnetic field such as provided by a field generator of a navigational tracking system.
  • Other examples of sensing coils that can be used for determining the location of a catheter or probe inserted into a selected body cavity of a patient response to electromagnetic fields that are consistent with this disclosure would also be known to one of ordinary skill in the art.
  • Other types of electromagnetic sensors and electromagnetic localization methods can also be used to track the catheter 100 in other examples.
  • the catheter 100 includes an electrode apparatus 130 extending from the distal end portion 102.
  • the electrode apparatus 130 can include one or more electrodes 132 distributed over a surface of a substrate (or body) 134.
  • the one or more of the electrodes 132 can be configured to sense of electrical signals, sense electric fields, transmit electrical signals (e.g., electrical signals generated by a generator coupled to the catheter 100) and/or generate electric fields (e.g., via the transmitted electrical signals).
  • the number and type of electrodes in the apparatus 130 can vary according to desired use of the electrode apparatus.
  • the substrate 134 can have any of a variety of shapes and configurations, such as a basket (e.g., having a spherical, teardrop, or ellipsoidal shape), a ring (e.g., a circular or ellipsoidal loop, a spiral or coil shape, a helical shape), or a probe electrode (e.g., having an elongate tubular body with a flat or semi- spherical tip).
  • the electrode apparatus 130 includes a plurality of electrodes 132 distributed along a circular loop body 134 that extends between respective ends thereof, shown at 136 and 138.
  • the ends 136 and 138 of the body 134 can be coupled to elongated rods 140 and 142, respectively, which can be moveable axially within the lumen 108, independently or collectively, such as to adjust the position, size, and/or shape of the apparatus 130.
  • the body 134 can have a solid or hollow core structure, which can carry wires or traces coupled to each of the electrodes 132.
  • the rod 140 can include a lumen through which a guidewire (not shown) can traverse, and the guidewire can have a distal end portion that is independently steerable from the catheter body.
  • the electrode apparatus 130 can be configured according to the electrode in the PULSESELECT® medical device system from Medtronic Inc. of Minnesota, USA. Other types and configurations of electrode apparatuses can be used as the electrode apparatus 130 in other examples.
  • the electrode apparatus 130 can be transitioned between compressed and uncompressed states, and is shown in the uncompressed (e.g., expanded) state in FIGS. 1-3.
  • the expansion can be automatic, such as in response to removal of an external force when the electrode apparatus 130 is moved distally through the lumen and beyond the distal end of the catheter 100.
  • the electrode apparatus 130 can be expandable in response to application of a radially outward force, such as by a balloon or other expansion mechanism.
  • the electrode apparatus 130 can have a generally fixed shape and size in the absence of application of an external force.
  • the materials of the electrode apparatus 130 can be selected according to mechanical properties of the apparatus.
  • the catheter 100 includes conductive wire electrically coupled to the anchor 110 and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire 114, such as by signal processing and/or other circuitry.
  • the external location includes an electrical connector that may be on or external to the catheter 100 and the handle thereof.
  • the electrical connection between the conductive wire, which carries the sensor signal, and the anchor 110 can be implemented according to various example embodiments described herein.
  • the conductive wire can have a distal end that is fixed to and/or extends from the anchor body 112 or it can be coupled to a steering wire that is fixed to and/or extends from the anchor body.
  • FIGS. 2, 3, and 4 are side views of different example embodiments of the distal end portion 102 of the catheter 100 of FIG. 1.
  • FIG. 4 shows an example of the handle that can be used with die catheter of FIG. 3. Accordingly, the description of FIGS. 2, 3, and 4 also refers to die catheter 100 of FIG. 1.
  • the catheter 100 includes a conductive wire 150 having a distal end 152 fixed to the anchor body 112.
  • the conductive wire 150 can extend through the central lumen 108 or through another lumen that extends axially through the shaft 104.
  • the conductive wire 150 can include a conductive wire that forms part of a braided tubular wall of the shaft 104.
  • the conductive wire 150 thus can communicate electrical signals (e.g., representative of sensed electrical signals) fiom the anchor body 112 to a location that is external to the catheter 100, such as to associated sensing and/or processing circuitry.
  • the conductive wire 150 has a proximal termination at a connector or junction, which can be coupled to the associated sensing and/or processing circuitry.
  • FIGS. 3 and 4 illustrate another example of the catheter 100, in which the anchor 110 is configured to enable steering of the distal aid portion 102 by one or more steering wires 114 and to operate as a sensor.
  • Each of the steering wires 114 has a distal end 116 that is coupled to the anchor body 112.
  • a pair of steering wire 114 can be coupled to diametrically opposed sides of the anchor body to provide steering of the distal end portion along a plane.
  • Other numbers of steering wires can be used to provide for steering in less or more directions.
  • the steering wires 114 can extend through the central lumen or other lumen (e.g., steering channels) that extend axially through the shaft 104.
  • a proximal end 154 of die shaft 104 terminates within a handle 160 of the catheter 100.
  • die proximal end 154 of the shaft 104 can be mounted to an internal wall that forms part of a housing of handle 160 to fix die shaft 104 with respect to the handle.
  • the steering wires 114 extend fiom the proximal end 154 of the shaft and are coupled to a manipulator 162.
  • the manipulator 162 can be actuated (e.g., by rotation or translation thereof) in one or more directions to effect steering of the distal aid portion 102 of the catheter.
  • the actuation of the manipulator 162 can be manual or automated (e.g., robotically controlled) or a combination thereof,
  • the type of manipulator and handle design can vary according to user preferences.
  • the conductive wire 150 is coupled to a proximal portion of a given steering wire 114, such as at a location between the manipulator 162 and the proximal end 154 of die shaft.
  • a signal received at the anchor 110 is communicated through the steering wire 114, to die conductive wire 150 and to a location external to the catheter, such as to associated sensing and/or processing circuitry.
  • the conductive wire 150 can have a proximal termination at a connector or electrical junction, which can be coupled to associated sensing and/or processing circuitry (see, e.g., FIG. 12).
  • FIG. 5 is a side view illustrating an example of a variable diameter coil 200.
  • the coil 200 can be formed of a length of a conductive wire 202 that can be wound with respective windings turned on one or more mandrels or other substrates having respective diameters to produce the variable diameter coil 200 having a circular cross- sectional shape.
  • the conductive wire 202 has a thickness, shown as T1.
  • the coil 200 includes a number of windings, shown as proximal and distal winding portions 204 and 206 having a first outer diameter DI , and another number of windings, shown as intermediate winding portion 208, having a second outer diameter D2. In the example of FIG. 5, D2>D1. While three winding portions 204, 206, and 208 are shown in FIG. 5, in other examples, the coil can have any number of two or more winding portions having different outer diameters. Also, each of the winding portions 204, 206 and 208 can have a desired number of windings according to application requirements, and the number of windings in each portion 204, 206 and 208 can be the same or different.
  • One or more lengths 210 of the conductive wire 202 can extend axially from the proximal winding portion 206. Also, or as an alternative, a length of the conductive wire 202 can extend axially from one or more other of the winding portions 204 and/or 208 (not shown, but see, e.g., FIG. 6). In some examples, winding portions with the smaller first outer DI (e.g., proximal winding portion 204 and distal winding portion 206) as well as the length 210 of the wire can be encapsulated by an electrically insulating material, such as a polymer.
  • an electrically insulating material such as a polymer.
  • the winding portion with the larger second outer diameter D2 can remain unencapsulated to expose a radially outer surface of the conductive wire in such winding portion 208.
  • the proximal and distal winding portions 204 and 206 can be embedded within a sidewall of a tubular sleeve (e.g., outer layer 118) and the intermediate winding portion 208 (or at least a radially outer surface extends outwardly from the jacket to remain exposed, such as to enable direct contact with bodily fluid and/or tissue (see, e.g., FIG. 6).
  • the coil 200 can be implemented as a sensor, such as an electromagnetic sensor for detecting an electric field and/or as an electrode sensor for detecting an electrical signal (e.g., an electrophysiological signal or a signal provided by another electrode.
  • the coil 200 can be implemented as an anchor ring of a steerable catheter (e.g., as anchor 110 or the catheter 100), as described herein.
  • the length of conductive wire 210 extending from the coil 200 thus can implement one or more functions, including as a wire to communicate sensor signals from the coil to external circuitry and/or as a steering wire to deflect a portion of a catheter shaft to which the coil is coupled. That is, the coil 200 can be an anchor ring of a catheter that is also used as a reference electrode sensor.
  • FIG. 6 is a side sectional view illustrating an example of part a catheter 250 that includes variable diameter coil 200 of FIG. 5. Accordingly, aspects of the description of FIG. 6 also refer to aspects of the coil 200 described with respect to FIG. 5.
  • two lengths 210 of the conductive wire 202 extend from the coil 200, in which one length of wire extends from the proximal winding portion 206 and the other length of wire extends from the distal winding portion 204.
  • the coil 200 and the two lengths extending therefrom are formed of a single length of the conductive wire 202.
  • the respective lengths 210 extend from opposite ends of the coil 200, which ends can be angularly positioned at diametrically opposed sides of the coil to facilitate passage of the wires axially through the catheter (e.g., within respective lumens).
  • the coil 200 including winding portions 204, 206 and 208, circumscribes an elongated catheter shaft 252 (e.g., the shaft 104).
  • the shaft 252 can extend longitudinally between a distal end 254 and a proximal end (not shown, but see, e.g., end 154 in FIG. 4).
  • the shaft 252 includes a central lumen 256 defined by an inner sidewall of the shaft.
  • the shaft 252 can also include one or more other lumens (e.g., channels) through which the lengths of wire 210 can extend. Alternatively, the lengths of wire 210 can extend through the central lumen.
  • the lengths 210 of conductive wire 202 can be adapted both to carry electric signals responsive to signals sensed by the coil 200 and steer the distal end portion of the catheter shaft 252 based on movement of the lengths of wire relative to the shaft.
  • a number of windings in coil 200 can be mechanically coupled together by support structures 260, such as rods, pins or other couplings affixed to adjacent windings in the axial direction.
  • the support structures 260 can increase the rigidity or stiffness of the proximal and distal winding portions 206 and 204 from which the lengths of wire 210 extend.
  • the support structures 260 can be formed by laser welding two more windings together at locations across the coil 200 to increase the stiffness along the coil.
  • Other support structures can be used to increase the stiffness and resist deflection of the winding portions responsive to axial steering forces being applied to the lengths of wire 210 (e.g., by a manipulator).
  • a jacket or jacketing layer 262 (e.g., a tubular outer sleeve or overmolding) can encapsulate the proximal and distal winding portions 204 and 206 while leaving at least a radially outer surface of the intermediate winding portion 208 exposed.
  • approximately one-half of the larger second outer diameter D2 of the intermediate winding portion 208 can remain exposed outside of the jacket 262. Less or more of the larger diameter intermediate winding portion 208 can remain exposed in other examples.
  • the jacket 262 can be implemented according to the example jacket 118 described herein with respect to FIGS. 1-3.
  • the jacket 262 can be applied as one or more layers of an electrically insulating material (e.g., through an overmolding, injection molding, or other fabrication technique) to define an ovennolding layer around part of the distal end portion of the catheter shaft 252.
  • the distal end 254 of the catheter shaft 252 can extend a distance axially beyond a distal end 266 of the jacket 262.
  • the ovennolding provided by the jacket 262 can provide a mechanical interlock (or interference fit) between outer surface of the catheter 250 and the coil 200.
  • the jacket 262 can also increase the stiffness of the distal end portion of the shaft as well as provide a seal (e.g., a hermetic seal) between the exterior of the catheter and an interior of the catheter through which the lengths of wire 210 can extend to communicate signals to and/or from the coil 200.
  • a seal e.g., a hermetic seal
  • FIGS. 7, 8, 9, 10, and 11 depict various views of part of a catheter 300 that includes the variable diameter coil 200 of FIG. 5 or 6. Accordingly, aspects of the description of FIGS. 7, 8, 9, 10, and 11 may also refer to aspects of the coil described with respect to FIGS. 5 and 6.
  • the catheter 300 includes an elongated catheter shaft 302 of a pliant material to enable deflection of at least the distal end portion of the catheter 300.
  • the shaft 302 includes a central lumen 304 extending through the shaft.
  • the shaft 302 can include a number of other lumens (e.g., channels) 306 through which respective wires or devices can traverse.
  • the coil 200 is disposed around the shaft 302.
  • the coil 200 is configured as an electrode or sensor that includes one or more integrated wires that extend from respective ends of the coils and through a lumen (e.g., lumen 304 or 306) to a proximal end of the shaft.
  • a distal ring 308 can be positioned around the shaft 302 distally of the coil 200.
  • the distal ring 308 has a proximal end that abuts a distal end of the coil 200.
  • a distal end of the ring 308 can be spaced apart from an open distal end of the shaft 302.
  • a jacket (e.g., a jacketing layer, tubular sleeve or overmolding) 310 can encapsulate the smaller diameter proximal and distal winding portions 204 and 206. At least a radially outer surface of the larger diameter winding portion 208 remains exposed (unencapsulated), such as to contact bodily fluid and/or tissue.
  • FIG. 9 is a cross-sectional view of the catheter shown in FIG. 8 showing the mechanical interlock between the jacket 310 and the coil 200.
  • FIGS. 10 and 11 are enlarged sectional views depicting the catheter before and after the jacket 310 is formed on the catheter 300.
  • the jacket 310 can be an electrically insulating (non-conductive) plastic material or resin that is injection molded as an overmolding to secure the coil 200 at a fixed position on the shaft 302.
  • the fixed position of the coil 200 can be known relative to one or more other sensors (e.g., navigation or localization sensors 124) that can also be mounted on the catheter 300.
  • the coil 200 can also be adapted to operate as a steering anchor. In examples when the coil 200 is used as a steering anchor and sensor, each wire 202 that extends from the coil is adapted to function both as a steering wire and as a conductor to communicate electrical signals sensed by the exposed winding portion 208 of the coil.
  • the tracking modality 360 is an electromagnetic tracking system and the tracking modality 362 is an impedance-based tracking system.
  • Examples of a tracking system that can implement multiple tracking modalities to localize a catheter are known to those of ordinary skill in the art. Other tracking modalities can be used in other examples.
  • the tracking system 358 is configured to spatially correlate the respective positions of the sensors 354 and 356, which have a fixed known position relative to each other on the catheter 352. The tracking system 358 can further register the positions of the respective sensors 354 and 356 in a respective spatial domain based on the sensors’ known relative positions and tracking sensor signals provided by the respective sensors.
  • a catheter comprising: a handle including a manipulator; a catheter shaft extending from the handle to terminate in a distal end portion, the catheter shaft including a lumen extending through the shaft; an electrically conductive anchor at the distal end portion and including an anchor body configured to provide a sensor signal in response to sensed electrical signal; a steering wire having proximal and distal ends, in which the proximal end is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor; and a conductive wire electrically couples! to the anchor and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire.
  • the sensor signal is a first sensor signal and the catheter further comprises an electromagnetic sensor having a distal sensor portion extending from the distal end portion of the catheter shaft and having a known fixed spatial position relative to the anchor, the electromagnetic sensor configured to provide a second sensor signal in response to an electromagnetic field.
  • the anchor comprises a ring having a cylindrical body.
  • the cylindrical body of the anchor comprises a coil of the electrically conductive wire, in which a length of the conductive wire extends from the coil through the lumen and into the handle.
  • the catheter of example 8 further comprising an overmolding encapsulating the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil being exposed beyond the overmolding.
  • the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known a fixed position relative to each other electrode when in the ablation electrode apparatus is in the expanded condition.
  • the coil defines an anchor and the length of the conductive wire defines a steering wire that extends into the handle and a distal end of the steering wire is coupled to the manipulator.
  • the coil further comprises a third portion that extends distally from the second portion and has a third outer diameter commensurate with the first outer diameter, the overmolding encapsulating the third portion of the coil.
  • the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known position relative to each other electrode when the ablation electrode apparatus is in the expanded condition.
  • a system comprising: a catheter comprising: a handle including a manipulator; a catheter shaft extending from the handle to terminate in a distal end portion, the catheter shaft including a lumen extending through the shaft; an electrically conductive anchor having an anchor body at the distal end portion of the shaft, wherein the anchor body defines a first sensor configured to provide a first sensor signal in response to a first sensed signal; a steering wire having proximal and distal ends, in which the proximal end of the steering wire is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor; and a second sensor extending from the distal end portion of the shaft and having a known fixed spatial position relative to the anchor body, in which the second sensor is configured to provide a second sensor signal in response to a second sensed signal; a first tracking modality configured to determine a position of the anchor based on the first sensor signal; and a second tracking modality configured to determine a position of the second sensor based on the second sensor signal.
  • the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known position relative to each other electrode when the ablation electrode apparatus is in the expanded condition.
  • the electrical signal includes a plurality of signals supplied by an arrangement of electrodes spaced apart from first sensor
  • the second sensor is an electromagnetic sensor configured to provide the second sensor signal in response to an electromagnetic field.
  • the anchor comprises a ring having a cylindrical body.
  • the cylindrical body of the anchor comprises a coil of the electrically conductive wire, in which a length of the conductive wire extends from the coil through the lumen and into the handle.
  • the catheter further comprises an overmolding encapsulating the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil being exposed beyond the overmolding.
  • the term “couple” may cover connections, communications, or signal paths that enable a functional relationship consistent with this description. For example, if device A generates a signal to control device B to perform an action: (a) in a first example, device A is coupled to device B by direct connection; or (b) in a second example, device A is coupled to device B through intervening component C if intervening component C does not alter the functional relationship between device A and device B, such that device B is controlled by device A via the control signal generated by device A.

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Abstract

Dans un exemple décrit, un cathéter comprend une poignée comprenant un manipulateur. Une tige de cathéter s'étend à partir de la poignée pour se terminer dans une partie d'extrémité distale, et la tige de cathéter comprend une lumière s'étendant à travers la tige. Un ancrage électroconducteur est situé au niveau de la partie d'extrémité distale et comprend un corps d'ancrage conçu pour fournir un signal de capteur en réponse à un signal électrique détecté. Un fil de direction présente des extrémités proximale et distale, l'extrémité proximale étant accouplée au manipulateur, et l'extrémité distale du fil de direction étant accouplée à l'ancrage. Un fil conducteur est électriquement couplé, à l'ancrage et conçu pour transmettre le signal de capteur à un emplacement au-delà de l'extrémité proximale du fil de direction.
PCT/EP2025/054624 2024-02-20 2025-02-20 Dispositif de cathéter multifonction orientable Pending WO2025176801A1 (fr)

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US63/555,664 2024-02-20

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140187894A1 (en) * 2012-12-31 2014-07-03 Biosense Webster (Israel), Ltd. Double loop lasso with single puller wire for bi-directional actuation
US20200015703A1 (en) * 2010-12-30 2020-01-16 Biosense Webster, Inc. Catheter with single axial sensors
US20220032011A1 (en) * 2020-07-29 2022-02-03 Intricon Corporation Microminiature EM Coil Sensor Pull Ring For Catheter
WO2022249012A1 (fr) * 2021-05-28 2022-12-01 Covidien Lp Cathéter déformable avec capteur de localisation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200015703A1 (en) * 2010-12-30 2020-01-16 Biosense Webster, Inc. Catheter with single axial sensors
US20140187894A1 (en) * 2012-12-31 2014-07-03 Biosense Webster (Israel), Ltd. Double loop lasso with single puller wire for bi-directional actuation
US20220032011A1 (en) * 2020-07-29 2022-02-03 Intricon Corporation Microminiature EM Coil Sensor Pull Ring For Catheter
WO2022249012A1 (fr) * 2021-05-28 2022-12-01 Covidien Lp Cathéter déformable avec capteur de localisation

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