WO2015187386A1 - Electrode assembly having an atraumatic distal tip - Google Patents

Electrode assembly having an atraumatic distal tip Download PDF

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Publication number
WO2015187386A1
WO2015187386A1 PCT/US2015/032004 US2015032004W WO2015187386A1 WO 2015187386 A1 WO2015187386 A1 WO 2015187386A1 US 2015032004 W US2015032004 W US 2015032004W WO 2015187386 A1 WO2015187386 A1 WO 2015187386A1
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WO
WIPO (PCT)
Prior art keywords
spline
distal
distal end
electrode assembly
orientation
Prior art date
Application number
PCT/US2015/032004
Other languages
French (fr)
Inventor
Andrew T. MARECKI
Michael C. KOZLOWSKI
Daniel J. Foster
Mary M. Byron
Original Assignee
Boston Scientific Scimed, 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 Boston Scientific Scimed, Inc. filed Critical Boston Scientific Scimed, Inc.
Priority to CN201580030242.8A priority Critical patent/CN106413540A/en
Priority to EP15728975.2A priority patent/EP3151772A1/en
Priority to JP2016569634A priority patent/JP2017522923A/en
Publication of WO2015187386A1 publication Critical patent/WO2015187386A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283Invasive
    • A61B5/287Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6847Arrangements 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
    • A61B5/6852Catheters
    • A61B5/6858Catheters with a distal basket, e.g. expandable basket
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/0016Energy applicators arranged in a two- or three dimensional array
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • A61B2018/00357Endocardium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49002Electrical device making
    • Y10T29/49004Electrical device making including measuring or testing of device or component part

Definitions

  • the present disclosure generally relates to electrode assemblies for use in cardiac procedures and more particularly, to an electrode assembly that may be utilized in a cardiac mapping procedure.
  • Electrophysiology catheters are used in a variety of diagnostic and/or therapeutic medical procedures to diagnose and/or correct conditions such as cardiac arrhythmias, including for example, atrial tachycardia, ventricular tachycardia, atrial fibrillation, and atrial flutter.
  • Cardiac arrhythmias are a leading cause of stroke, heart disease, and sudden death.
  • the physiological mechanism of arrhythmia involves an abnormality in the electrical conduction of the heart.
  • treatment options for patients with arrhythmia that include medication, implantable devices, and catheter ablation of cardiac tissue.
  • the present disclosure generally relates to electrode assemblies for use in cardiac procedures and more particularly, to an electrode assembly that may be utilized in a cardiac mapping procedure.
  • a catheter in a first example, includes an elongate catheter body extending from a proximal end to a distal end.
  • An expandable electrode assembly is disposed at the distal end of the catheter body.
  • the electrode assembly comprises a plurality of flexible splines extending from the distal end of the catheter body to a distal cap.
  • the distal cap comprises a plurality of slots disposed about an outer circumference of the distal cap.
  • the plurality of flexible splines includes at least a first spline comprising a distal end defining a locking feature secured within one of the plurality of slots provided in the distal cap.
  • the expandable electrode assembly is configured to be transitioned between a collapsed configuration suitable for delivery and an expanded configuration. Two or more electrodes are located on the first spline.
  • the distal cap comprises a cylindrical shape defining an interior cavity.
  • the distal cap comprises a rounded tip having an aperture defined therein.
  • a height is greater than a width for each of the slots.
  • a width is greater than a height for each of the slots.
  • the locking feature defined by the distal end of the first spline comprises a first portion having a first width and a second portion having a second width, the first width greater than the second width.
  • the locking feature defined by the distal end of the first spline comprises an aperture formed therein.
  • an adhesive is disposed within the distal cap.
  • the distal cap comprises a rounded distal end and defines an atraumatic distal tip of the catheter.
  • each of the slots are spaced an equal distance from one another about the outer circumference of the distal cap.
  • an actuation member is coupled to the expandable electrode assembly.
  • the locking feature defined by the distal end of the first spline comprises a hook shape.
  • the locking feature defined by the distal end of the first spline comprises an arrowhead shape.
  • the distal cap serves as a distal tip electrode.
  • a catheter in a fifteenth example, includes an elongate catheter body extending from a proximal end to a distal end.
  • An expandable electrode assembly is disposed at the distal end of the catheter body.
  • the electrode assembly comprises a plurality of flexible splines including a first spline extending from the distal end of the catheter body to a distal cap.
  • the distal cap comprises a plurality of slots including a first slot disposed about an outer circumference of the distal cap.
  • the first spline comprises a distal end defining a locking feature secured within the first slot.
  • the expandable electrode assembly is configured to be transitioned between a collapsed configuration suitable for delivery and an expanded configuration. Two or more electrodes are located on the first spline.
  • An actuation member is coupled to the expandable electrode assembly.
  • a method of forming an expandable basket electrode assembly includes forming a flattened spline array comprising two or more flexible splines, a distal end of each spline defining a locking feature; forming a cylindrical spline array from the flattened spline array; positioning a distal cap comprising two or more slots disposed about an outer circumference adjacent a distal end of the cylindrical spline array; separating a first spline from the two or more flexible splines of the cylindrical spline array; rotating the first spline about its major axis from a first orientation to a second orientation; bending the first spline along its minor axis while it is in its second orientation and inserting the distal end into a first slot of the distal cap; and returning the first spline to its original first orientation.
  • the first spline automatically returns from the second orientation to the first orientation.
  • rotating the first spline about its major axis comprises rotating the first spline about 60 degrees to about 120 degrees about its major axis.
  • the method further comprises separating a second spline from the two or more flexible splines of the cylindrical spline array; rotating the second spline about its major axis from the first orientation to the second orientation; inserting the distal end of the second spline while it is in the second orientation into a second slot; and returning the second spline from the second orientation to the first orientation.
  • the method further comprises delivering a potting material into the distal cap.
  • the method further comprises inserting a cylindrical tube, plug, or gasket into the proximal end of the distal cap to occlude the gaps in the cap's slots, proximal to the distal ends of the splines.
  • a method of forming a flexible electrode assembly includes: forming a first flexible printed circuit comprising one or more electrodes on an upper surface of a substrate and forming a second flexible printed circuit comprising one or more electrodes on a lower surface of the substrate to produce a flexible layered sheet; separating the flexible layered sheet into two or more splines extending longitudinally from a proximal end of the flexible layered sheet to a distal end of the flexible layered sheet, wherein the two or more splines are fully separated from one another such that they are not connected and at least one of the splines includes two or more electrodes; inserting a first end of a first spline of the two or more splines into a first slot provided in a distal cap; and inserting a first end of a second spline of the two or more splines into a second slot provided in the distal cap.
  • the substrate comprises a shape memory material.
  • the step of separating the flexible layered sheet into two or more splines comprises laser cutting the flexible layered sheet into two or more splines.
  • the step of separating the flexible layered sheet into two or more splines comprises die cutting the flexible layered sheet into two or more splines.
  • the method further includes securing a second end of the first spline and a second end of the second spline to a distal end of a catheter body to form an expandable electrode assembly, wherein the expandable electrode assembly is capable of transitioning from a collapsed configuration to an expanded configuration.
  • the method further including at least partially rotating the first end of the first spline to facilitate insertion of the first end into the first slot provided in the distal cap and at least partially rotating the first end of the second spline to facilitate insertion of the first end of the second spline into the second slot provided in the distal cap.
  • Figure 1 is a schematic diagram showing a catheter in the context of a system
  • Figures 2A-2B are schematic views of an exemplary catheter
  • Figure 3A is an isometric view of an expandable electrode assembly shown in a collapsed configuration
  • Figure 3B is an isometric view of the expandable electrode assembly of Figure 3A shown in an expanded configuration
  • Figure 4 is a schematic view of an exemplary distal cap
  • Figure 5A is a schematic view of a flattened array of multiple flexible splines
  • Figure 5B is a close-up, schematic view of the distal ends of each of the splines of the flattened array shown in Figure 5A;
  • Figure 6 is a close-up, schematic view of a distal portion of an electrode assembly showing the distal ends of multiple flexible splines engaged with a distal cap;
  • Figure 7 is a schematic view of another exemplary distal cap
  • Figure 8A is a schematic view of another exemplary flattened array of multiple flexible splines
  • Figure 8B is a close-up, schematic view of the distal ends of each of the splines of the flattened array shown in Figure 8A.
  • Figure 9A is a detailed view of a distal portion of an exemplary electrode assembly showing the distal ends of a plurality of flexible splines engaged with a distal cap 170;
  • Figure 9B is a cross-sectional view of the distal portion of the exemplary electrode assembly shown in Figure 9A taken along lines A-A;
  • Figure 10 is a cross-sectional view of the distal portion of another exemplary electrode assembly including a distal cap having a cylindrical plug inserted therein;
  • Figure 1 1 is a flow chart of a method of constructing an exemplary electrode assembly
  • Figure 12 is a schematic view of an exemplary, individual spline being rotated about its major axis and bent about its minor axis such that the distal end of the spline can be engaged within a slot provided in an exemplary distal cap.
  • Figure 1 is a high level, schematic view of an overall system 2 that includes a physician, a patient, catheters, including a mapping catheter 10, and related electrophysiology equipment located within an operating room.
  • a physician 16 introduces the catheter 10 into the vasculature of the patient 1 1 at the patient's leg and advances it along a blood vessel ultimately, entering the patient's heart 12.
  • Other catheters that may be used in the procedure are represented by companion catheter 18.
  • Each catheter 10, 18 is coupled to signal conditioning hardware 20 with appropriate catheter cabling typified by catheter cable 17.
  • the signal conditioning hardware 20 performs various interface functions applicable to the mapping, tracking, and registration procedures that are performed in conjunction with the workstation 24. If the companion catheter 18 is an ablation catheter, then conditioning hardware also forms an interface to an RF ablation unit (not illustrated).
  • the physician looks at a computer display 26.
  • Present on the display 26 is a substantial amount of information.
  • a large window presents an image of the heart chamber 13 along with an image of the catheter 10.
  • the physician will manipulate and control the catheter 10 based in part on the images and other data presented on the display 26.
  • the image 27 seen in FIG. 1 is schematic and depicts the distal array of the deployed catheter 10 occupying a small portion of the heart chamber 13 volume.
  • the representation of the heart chamber 13 may use color, wire frame, or other techniques to depict the structure of the heart chamber 13 and to simultaneously portray electrical activity of the patient's heart. In some cases, it may be useful to display chamber geometry, catheter location, and electrical activity in an integrated fashion on the display 26.
  • the physician will observe the display 26 and interact with the workstation processing unit 24 and the catheters 10 and 18, to direct a medical procedure such as, for example, a cardiac mapping procedure.
  • Figures 2A and 2B are schematic views of an exemplary intravascular catheter 10.
  • the catheter 10 may be used to map electro-anatomical characteristics of the heart in a cardiac mapping procedure.
  • the mapping procedure may be an in-contact mapping or a non-contact mapping procedure.
  • the catheter 10 may be deployed at a target location within a patient's heart, placing multiple electrodes in a known spatial configuration. Electrode stability and the known spatial geometry of the electrodes may improve the accuracy of the mapping device.
  • the catheter 10 may be used in an ablation procedure. These are just some examples.
  • the catheter 10 includes an elongate catheter body 34 extending from a proximal end 38 to a distal end 42.
  • the catheter body 34 may include a lumen (not shown) extending there through, but this is not required in all embodiments.
  • the catheter body 34 may have sufficient flexibility so as to navigate the tortuous pathways of a patient's vasculature system.
  • the catheter 10 can include a handle assembly 46 coupled to the proximal end 38 of the catheter body 34. A physician may manipulate the handle assembly 46 to deliver, steer, rotate, deploy and/or deflect the catheter 10 when performing a medical procedure.
  • the catheter 10 may include an expandable electrode assembly 30 including one or more electrodes that may be used for cardiac mapping or diagnosis, ablation and/or other therapies involving the application of electrical energy to a patient's heart.
  • the handle assembly 46 may include a first actuation mechanism 48 that may be manipulated to transition the expandable electrode assembly 30 from a collapsed configuration (shown in Figure 2 A) suitable for delivery of the catheter 10 to a target location within a patient's body (e.g. the heart) and an expanded configuration (shown in Figure 2B) suitable for use in a diagnostic procedure and/or delivery of a therapy.
  • the actuation mechanism 48 may include a pull wire that may be coupled to the expandable electrode assembly 30 that, when actuated in a proximal direction as indicated by the arrow shown in Figure 2B, causes the expandable electrode assembly 30 to transition from the collapsed configuration to the expanded configuration.
  • the actuation mechanism 48 may include a retractable sheath that, when retracted in a proximal direction as indicated by the arrow shown in Figure 2B, may permit the expandable electrode assembly 30 to self-expand from the collapsed configuration to the expanded configuration.
  • the catheter body 34 may include a deflectable distal portion 52 that a physician may manipulate using a second actuation mechanism 54 provided in the handle assembly 46 to position the electrode assembly 30 nearer or adjacent to tissue of interest.
  • Figures 3 A and 3B show different views of an exemplary expandable electrode assembly 30.
  • the expandable electrode assembly 30 is capable of being transitioned form a generally cylindrical, collapsed configuration suitable for delivery of the catheter 10 and the electrode assembly 30 to a target location within the patient's heart and an expanded configuration suitable for use in a desired cardiac procedure such as, for example, a mapping or ablation procedure.
  • the expandable electrode assembly 30 may include two or more flexible splines 60 which may be capable of being flexed outwardly and away from a longitudinal axis of the electrode assembly 30.
  • an actuation mechanism may be utilized to transition the electrode assembly 30 including the two or more flexible splines 60 from the collapsed configuration ( Figure 3A) to the expanded configuration ( Figure 3B).
  • the flexible splines 60 may be incorporate a shape memory material that may facilitate self-expansion of the flexible splines 60 and consequently, the electrode assembly 30, from the collapsed configuration to the expanded configuration.
  • the flexible splines 60 may be relatively stiff such that the electrode assembly 30 may be expanded into a known, reproducible shape capable of retaining a known spatial geometry when in use which, in some cases, may be aided by the incorporation of a shape-memory material or other stiff polymeric material such as, for example, a nickel-titanium alloy, or a polyimide or PEEK into the flexible splines 60.
  • a shape-memory material or other stiff polymeric material such as, for example, a nickel-titanium alloy, or a polyimide or PEEK
  • the flexible splines 60 may be fabricated such that they are somewhat compliant so as to conform to a surface of a patient's heart when placed into intimate contact with the surface of the patient's heart.
  • the expandable electrode assembly 30 may include a number of electrodes 64 located on each of the flexible splines 60 forming an electrode array.
  • the electrodes 64 may be sensing electrodes.
  • the electrode assembly 30 may include at least some current injecting locator electrodes.
  • the locator electrodes may be positioned diametrically opposed to each other on the meridian of the expanded electrode assembly 30.
  • the electrode assembly 30 may also include a tip electrode which may be used for cardiac stimulation, ablation or as a locator electrode.
  • Each electrode 64 may be electrically connected to the cabling in the handle assembly 46.
  • the signal from each individual electrode may be independently available at the hardware interface 20. This may be achieved by passing a conductor for each electrode through a connection cable extending within the catheter body. As an alternative, the signals may be multiplexed to minimize the number of conductors.
  • the electrodes 64 may have a uniform and symmetrical distribution throughout the expandable electrode assembly 30. In other cases, the electrodes 64 may have an asymmetrical distribution throughout the expandable electrode assembly 30. Certain electrode distributions may be advantageous for non-contact cardiac mapping, while others may be more suited for contact mapping. The number of electrodes 64 distributed throughout the electrode assembly 30 and the stability of the shape of electrode assembly 30, when expanded, may affect the overall performance of the mapping system.
  • the electrodes 64 may be located on the outer surfaces 66 of each or the splines 60, the inner surfaces 68 of each of the splines 60, or both the outer and inner surfaces 66, 68 of each of the flexible splines 60. In some cases, up to sixty-four sensing electrodes 64 may be distributed over and along the various splines 60. Depending upon the application, the electrode assembly 30 may include fewer or greater than sixty-four electrodes. In some cases, the electrodes 64 may form a number of bipolar electrode pairs.
  • the bipolar electrode pairs may be formed between two adjacent electrodes located on the same surface (inner or outer surface) of a spline, between two electrodes located on adjacent splines, or between a first electrode located on an outer surface opposite a second electrode located on an inner surface of a spline.
  • all of the electrodes 64 located on the flexible splines 60 may be paired together to form a plurality of electrode pairs distributed along the length of the individual flexible splines 60. Up to thirty-two bipolar electrode pairs may be distributed throughout the electrode assembly 30 for a total of up to sixty-four electrodes 64 depending upon the overall size and geometry of the electrode assembly 30. However, it is contemplated that the electrode assembly 30 may be configured such that it is capable of carrying fewer or greater than thirty -two bipolar electrode pairs, depending upon the overall size and geometry of the electrode assembly 30 and the desired application.
  • each of the flexible splines 60 may extend from a distal end 42 of the catheter body 34 to a distal cap 70.
  • the distal cap 70 may have a rounded distal end, and may define an atraumatic distal tip of the catheter 10.
  • at least one of the flexible splines 60 may be mechanically interlocked with a corresponding slot provided in the distal cap 70 such that there is a one to one mechanical engagement between the flexible spline 60 and a corresponding slot provided in the cap 70.
  • each of the flexible splines 60 may be mechanically interlocked with a corresponding slot provided in the distal cap 70 such that there is a one to one mechanical engagement between each flexible spline 60 and each slot provided in the cap 70.
  • An adhesive may be utilized to provide a secondary means of securing the each of the flexible splines within each of their respective slots.
  • the distal cap 70 may serve as a tip electrode, but this is not required in all embodiments.
  • Figure 4 is a schematic view of an exemplary distal cap 170 that may be utilized in the construction of an exemplary expandable electrode assembly such as, for example, expandable electrode assembly 30, as described herein.
  • Figure 5A is a schematic view of a flattened array 150 of multiple flexible splines 160 that may be engaged with each of the slots 174 provided in the distal cap 170 to form an electrode assembly 30, and
  • Figure 5B is a close-up, schematic view of the distal ends 178 of each of the splines 160 of the flattened array 150.
  • the distal cap 170 may be machined or laser cut from a metal or suitable plastic such that it has a desired size and shape.
  • the distal cap 170 may be fabricated such that it has a substantially hollow, cylindrical shape, and may include two or more slots 174 spaced an equal distance from one another about an outer circumference of the distal cap 170.
  • each of the slots 174 may have a height h greater than a width w such that they are capable of receiving and retaining a distal end 178 of a respective flexible spline 160 when the distal end 178 of the flexible spline is inserted into the slot 174.
  • the distal end of the distal cap 170 may be rounded such that it provides the catheter 10 with an atraumatic distal tip.
  • the distal cap 170 may include a distal aperture 182, but this is not required.
  • the aperture 182 may facilitate an introduction of an adhesive or other suitable potting material that may be provided as a secondary means of securing the distal ends 178 of each of the flexible splines 160 to the distal cap 170.
  • a cylindrical tube, plug, or gasket may be inserted into the interior cavity of the distal cap to seal any remaining gaps between the splines and the slots subsequent to assembly.
  • the distal end of the distal cap 170 may be solid.
  • the flattened array 150 of multiple flexible splines 160 may be initially fabricated as a flexible, multi-layered sheet including at least one flexible printed circuit bonded to a substrate.
  • the multi- layered sheet includes a first flexible printed circuit bonded to an upper surface of a substrate and a second flexible printed circuit bonded to a lower surface of the same substrate such that each of the flexible splines 160, when formed, have at least one electrode located on an outer surface and at least one electrode located on an inner surface of each of the splines 160.
  • the substrate may include a shape memory material. This is just one example.
  • the flexible multi-layered sheet including the flexible printed circuit is then laser cut or die cut in a direction along its longitudinal axis to form each of the individual, flexible splines 160.
  • the flexible multi-layered sheet including the flexible printed circuit is then laser cut or die cut to separate and form two or more flexible splines.
  • the flexible multi- layered sheet may be fabricated from a dual-sided flexible printed circuit having electrodes located both an upper surface and a lower surface.
  • the various materials used to fabricate the flexible multi-layered sheet from which the flexible splines 160 are formed may be selected such that each of the flexible splines 160 has a desired flexibility profile.
  • the materials used to fabricate the flexible multi-layered sheet from which the flexible splines 160 are formed may be selected such that the flexible splines 160 are capable of some degree of deformation so that they can be twisted, rotated, and/or bent to facilitate insertion of their distal end into a distal cap (e.g. distal cap 170) during construction of an electrode assembly such as, for example, electrode assembly 30.
  • at least one of the layers or substrates of the multi-layered flexible sheet may include a shape memory material such as, for example, Nitinol or another super-elastic material.
  • Incorporation of a Nitinol or super-elastic layer or substrate into the flexible multi- layered sheet from which the flexible splines 160 may be formed may provide the splines 160 with a degree of flexibility and deformation needed such that they can be twisted or rotated about a major axis to facilitate insertion of their distal end into a distal cap (e.g. distal cap 170) during construction of an electrode assembly such as, for example, electrode assembly 30.
  • a distal cap e.g. distal cap 170
  • each of the flexible splines 160 extend from a proximal band 186 to which they are attached or integrally formed with at their proximal ends 196 to a free distal end 178.
  • Two or more tabs 190, 192 may extend from the proximal band 186. Traces on the flexible printed circuit including those connected to the electrodes may terminate to pads bonded on an inner and/or outer surface of the two or more tabs 190, 192.
  • the two or more tabs 190, 192 and may be utilized to couple to the electrode assembly 30 to the distal end 32 of the catheter body 34.
  • both the proximal ends 196 and the distal ends 178 may be detached from one another.
  • the splines 160 may be independent of one another, and may be inserted into the distal cap 170 and distal end 32 of the catheter body 34 either simultaneously or sequentially.
  • Each of the distal ends 178 of the flexible splines 160 may be formed by laser cutting, die cutting or other suitable method such that they define a locking feature 198 that is configured to be inserted into and secured within each of the slots 174 of the distal cap 170.
  • the locking feature 198 may be defined by a geometrical shape having a first portion 202 having a first width and a second portion 204 having a second width. The first width can be greater than the second width.
  • the locking feature 198 may have an arrowhead shape.
  • each of the locking features 198 may include an aperture 201.
  • An adhesive when utilized, may permeate the apertures 201 and may provide a further means of securing the distal ends 178 to the distal cap 170.
  • the material(s) from which the flattened array 150 may be sufficiently deformable such that the locking feature 198 is capable of being deformed for insertion into the corresponding slot 174 of the distal cap 170.
  • the points 200 of the arrowhead shaped locking feature 198 may be capable of bending or folding inward towards a centerline 210 when inserted into a slot 174 of a distal cap 170.
  • the material from which the flexible splines 160 is fabricated may be sufficiently resilient such that the arrowhead-shaped locking feature 198 returns to its unfolded or uncompressed state, mechanically securing the distal end 178 of the flexible spline 160 in the slot 174 such that the distal end 178 of the spline is unable to be disengaged or removed from the slot 174.
  • Figure 6 is a detailed view of a distal portion 220 of an exemplary electrode assembly showing the distal ends 178 of a plurality of flexible splines 160 engaged with the distal cap 170.
  • Figure 7 is a schematic view of another exemplary distal cap 270 that may be utilized in the construction of an exemplary expandable electrode assembly such as, for example, expandable electrode assembly 30, as described herein.
  • Figure 8A is a schematic view of another exemplary flattened array 250 of multiple flexible splines 260 that may be engaged with each of the slots 274 provided in the distal cap 270 to form an electrode assembly
  • Figure 8B is a close-up, schematic view of the distal ends 278 of each of the splines 260 of the flattened array 250.
  • the distal cap 270 may be machined or laser cut from a metal or suitable plastic such that it has a desired size and shape. As shown in Figure 7, the distal cap 270 may be fabricated such that it has a substantially cylindrical shape defining an interior cavity, and may include two or more slots 274. In some cases, the two or more slots 274 may be spaced an equal distance from one another about an outer circumference of the distal cap 270 about the same longitudinal line. In other cases, the distance between the two or more slots 274 may vary.
  • each of the slots 274 may have a width w greater than a height h such that they are capable of receiving and retaining a distal end 278 of a respective flexible spline 260 when the distal end 278 of the flexible spline 260 is inserted into the slot 274.
  • the distal end of the distal cap 270 may be rounded such that it provides the catheter 10 with an atraumatic distal tip.
  • the distal cap 270 may include a distal aperture 282, but this is not required in all embodiments.
  • the aperture 282 may facilitate an introduction of an adhesive or other suitable potting material that may be provided as a secondary means of securing the distal ends 278 of each of the flexible splines 260 to the distal cap 270.
  • the distal end of the distal cap 270 may be solid.
  • a cylindrical tube, plug, or gasket may be inserted into the interior cavity of the distal cap 270 to seal any remaining gaps between the splines 260 and the slots 274.
  • the flattened array 250 of multiple flexible splines 260 may be initially fabricated as a flexible, multi-layered sheet including at least one flexible printed circuit bonded to a substrate.
  • the multi- layered sheet includes a first flexible printed circuit bonded to an upper surface of a substrate and a second flexible printed circuit bonded to a lower surface of the same substrate such that each of the flexible splines 260, when formed, have at least electrode located on an outer surface and at least one electrode located on an inner surface of each of the splines 260.
  • the flexible multi-layered sheet may be fabricated from a dual-sided flexible printed circuit having electrodes located both an upper surface and a lower surface. The flexible multi-layered sheet including the flexible printed circuit(s) is then laser cut or die cut in a direction along its longitudinal axis to form each of the individual, flexible splines 260.
  • the various materials used to fabricate the flexible multi-layered sheet from which the flexible splines 260 are formed may be selected such that each of the flexible splines2 60 has a desired flexibility profile.
  • the materials used to fabricate the flexible multi-layered sheet from which the flexible splines 260 are formed may be selected such that the flexible splines 260 are capable of some degree of deformation so that their distal end can be elastically inserted into a distal cap (e.g. distal cap 70) during construction of an electrode assembly such as, for example, electrode assembly 30.
  • a distal cap e.g. distal cap 70
  • at least one of the layers of the multi-layered flexible sheet may include Nitinol or another super-elastic material.
  • Incorporation of a Nitinol or super-elastic layer or substrate into the flexible multi-layered sheet from which the flexible splines 260 may be formed may provide the splines 260 with a degree of mechanical strength, flexibility and deformation needed such that their distal end can be inserted into a distal cap (e.g. distal cap 270), causing the distal barb 302 to bend inward and then recover to lock the spline in position during construction of an electrode assembly such as, for example, electrode assembly 30.
  • a distal cap e.g. distal cap 270
  • each of the flexible splines 260 extend from a proximal band 286 to which they are attached or integrally formed with at their proximal ends 296 to a free distal end 278.
  • Two or more tabs 290, 292 may extend from the proximal band 286. Traces on the flexible printed circuit including those connected to the electrodes may terminate to pads bonded on an inner and/or outer surface of the two or more tabs 290, 292.
  • the two or more tabs 290, 292 and may be utilized to couple to the electrode assembly 30 to the distal end 42 of the catheter body 34.
  • both the proximal ends 296 and the distal ends 278 may be freely detached from one another.
  • Each of the distal ends 278 of the flexible splines 260 may be formed by laser cutting, die cutting or other suitable method such that they define a locking feature 298 that is configured to be inserted into and secured within each of the slots 274 of the distal cap 270.
  • the locking feature 298 may be defined by a geometrical shape having a first portion 302 having a first width and a second portion 304 having a second width. The first width can be greater than the second width.
  • the locking feature 298 may have a barb or hook shape.
  • the material(s) from which the flattened array 250 may be sufficiently deformable such that the locking feature 298 is capable of being deformed for insertion into the corresponding slot 274 of the distal cap 270.
  • the first portion 302 of the barb or hook shaped locking feature 298 may be capable of bending or flexing inward towards a centerline 310 when inserted into a slot 274 of a distal cap 270.
  • the material from which the flexible splines 260 is fabricated may be sufficiently resilient such that the hook or barbed- shaped locking feature 298 returns to its uncompressed state, mechanically securing the distal end 278 of the flexible spline 260 in the slot 274 such that the distal end 278 of the spline is unable to be disengaged or removed from the slot 274.
  • Figure 9A is a detailed view of a distal portion 320 of an exemplary electrode assembly showing the distal ends 278 of a plurality of flexible splines 160 engaged with the distal cap 170.
  • Figure 9B is a cross-sectional view of the distal portion 320 taken along lines A-A of Figure 9A and shows the first portions 302 of the barb- shaped locking features 298 engaged in the slots 274 of distal cap 270.
  • a cylindrical tube, plug, or gasket 356 may be inserted into the interior cavity 358 of the distal cap 370 to seal any remaining gaps between the splines 360 and the slots 374 subsequent to assembly.
  • Figure 10 is a cross sectional view of a distal portion 370 of an exemplary electrode assembly including a cylindrical tube, plug, or gasket 356.
  • Figure 11 is a flow chart of a method 400 of constructing an expandable electrode assembly using a distal cap and a flexible spline array, as described herein.
  • the method 400 may be automated using appropriate machinery or manually performed by an individual.
  • a flattened spline array may be formed from flexible, multilayered sheet (Block 404).
  • the flexible, multi-layered sheet from which a flattened spline array may be formed may includes at least one flexible printed circuit bonded to a substrate.
  • the multi- layered sheet includes a first flexible printed circuit bonded to an upper surface of a substrate and a second flexible printed circuit bonded to a lower surface of the same substrate such that each of the flexible splines, when formed, have at least electrode located on an outer surface and at least one electrode located on an inner surface of each of the splines.
  • the individual splines may be formed by laser cutting or die cutting the flexible multi-layered sheet in a direction along its longitudinal axis to form the flattened spline array.
  • the flattened spline array includes at least two splines.
  • the flattened spline array including the two or more splines may be rolled into cylindrical shape (Block 408).
  • the flattened spline array may be rolled around a mandrel or other cylindrical member to facilitate formation of the cylindrical shape.
  • a band may also be placed around the array to maintain its cylindrical shape during assembly.
  • a distal cap such as those described herein may be positioned adjacent a distal end of the now cylindrical array such that the distal cap is co-axial with the cylindrical array (Block 412).
  • a first spline may be separated from the other splines of the array (Block 416) and rotated or twisted about its major axis and bent about its minor axis from a first orientation to a second orientation (Block 420).
  • the first spline may be rotated at about 60 to about 120 degrees about its major axis and more particularly, about 90 degrees about its major axis from a first orientation to a second orientation.
  • the spline may also be bent about its minor axis to align with one of the slots in the distal tip 570.
  • the spline should be rotated a sufficient degree of rotation about its major and minor axes such that the distal end of the locking feature is capable of being inserted into a corresponding slot provided in the distal cap.
  • the distal end of the spline including the locking feature may be deformed so as to facilitate insertion of the distal end of the spline into the slot.
  • the distal end of the spline may then be inserted into a slot provided in the distal cap while still in the second orientation (Block 420). Once inserted through the slot, the locking feature may re-assume its un-deformed shape, if applicable.
  • the spline may be returned from its second orientation to its first orientation and lie flat in the slot (Block 428). In some cases, the spline may be manually twisted or rotated in the slot from its second orientation to its first orientation. In other cases, because of the elasticity of some of the materials used to construct the flexible, multilayer sheet from which the spline array is formed, the spline may be configured to automatically return from its second orientation to its first orientation and lie flat in the slot.
  • the spline may be mechanically interlocked with the cap by the locking feature formed at the distal end of the spline.
  • the remaining splines may be engaged with the cap following the same steps outlined by Blocks 416, 420, 424, and 428.
  • the proximal ends of the splines may be banded together, and may be anchored or bonded to a distal portion of the catheter body.
  • the splines may be fully separated from one another such that they are not connected.
  • Each of the distal ends of the separated splines may be inserted into a corresponding slot provided in the distal cap.
  • the distal ends of the separated splines may be mechanically interlocked with the cap by the locking feature formed at the distal end of the spline. Some rotation of the individual splines may be necessary to urge the locking feature into slot after which the spline may lie flat in the slot. The remaining individual splines may be engaged with the cap utilizing the same method.
  • an adhesive may be used to further secure the distal ends of the spline with the cap.
  • the distal cap may include an aperture through which an adhesive or other suitable potting material may be introduced.
  • a cylindrical tube, plug, or gasket may also be inserted into the proximal end of the cap, occluding the gaps proximal to the distal ends of the splines.
  • a sealing material may be provided to seal any gaps between the distal ends of the splines and the slots such that the outer surface of the distal cap is substantially smooth and does not provide a surface onto which blood may collect and thrombi form.

Abstract

A catheter including expandable electrode assembly having a distal cap that mechanically engages a locking feature provided on the distal ends of each of two or more flexible splines forming a portion of the expandable electrode assembly is described. The distal cap defines an atraumatic distal tip of the catheter. The catheter may be used in a cardiac mapping and/or ablation procedure.

Description

ELECTRODE ASSEMBLY HAVING AN
ATRAUMATIC DISTAL TIP
CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. § 1 19 to U.S. Provisional Application Serial No. 62/007,320, filed June 3, 2014, the entirety of which is incorporated herein by reference.
TECHNICAL FIELD
The present disclosure generally relates to electrode assemblies for use in cardiac procedures and more particularly, to an electrode assembly that may be utilized in a cardiac mapping procedure.
BACKGROUND
Electrophysiology catheters are used in a variety of diagnostic and/or therapeutic medical procedures to diagnose and/or correct conditions such as cardiac arrhythmias, including for example, atrial tachycardia, ventricular tachycardia, atrial fibrillation, and atrial flutter. Cardiac arrhythmias are a leading cause of stroke, heart disease, and sudden death. The physiological mechanism of arrhythmia involves an abnormality in the electrical conduction of the heart. There are a number of treatment options for patients with arrhythmia that include medication, implantable devices, and catheter ablation of cardiac tissue.
SUMMARY
The present disclosure generally relates to electrode assemblies for use in cardiac procedures and more particularly, to an electrode assembly that may be utilized in a cardiac mapping procedure.
In a first example, a catheter is disclosed. The catheter includes an elongate catheter body extending from a proximal end to a distal end. An expandable electrode assembly is disposed at the distal end of the catheter body. The electrode assembly comprises a plurality of flexible splines extending from the distal end of the catheter body to a distal cap. The distal cap comprises a plurality of slots disposed about an outer circumference of the distal cap. The plurality of flexible splines includes at least a first spline comprising a distal end defining a locking feature secured within one of the plurality of slots provided in the distal cap. The expandable electrode assembly is configured to be transitioned between a collapsed configuration suitable for delivery and an expanded configuration. Two or more electrodes are located on the first spline.
In addition or alternatively, and in a second example, the distal cap comprises a cylindrical shape defining an interior cavity.
In addition or alternatively, and in a third example, the distal cap comprises a rounded tip having an aperture defined therein.
In addition or alternatively, and in a fourth example, a height is greater than a width for each of the slots.
In addition or alternatively, and in a fifth example, a width is greater than a height for each of the slots.
In addition or alternatively, and in a sixth example, the locking feature defined by the distal end of the first spline comprises a first portion having a first width and a second portion having a second width, the first width greater than the second width.
In addition or alternatively, and in a seventh example, the locking feature defined by the distal end of the first spline comprises an aperture formed therein.
In addition or alternatively, and in an eighth example, an adhesive is disposed within the distal cap.
In addition or alternatively, and in a ninth example, the distal cap comprises a rounded distal end and defines an atraumatic distal tip of the catheter.
In addition or alternatively, and in a tenth example, each of the slots are spaced an equal distance from one another about the outer circumference of the distal cap.
In addition or alternatively, and in an eleventh example, an actuation member is coupled to the expandable electrode assembly.
In addition or alternatively, and in a twelfth example, the locking feature defined by the distal end of the first spline comprises a hook shape.
In addition or alternatively, and in a thirteenth example, the locking feature defined by the distal end of the first spline comprises an arrowhead shape.
In addition or alternatively, and in a fourteenth example, the distal cap serves as a distal tip electrode.
In a fifteenth example, a catheter is disclosed. The catheter includes an elongate catheter body extending from a proximal end to a distal end. An expandable electrode assembly is disposed at the distal end of the catheter body. The electrode assembly comprises a plurality of flexible splines including a first spline extending from the distal end of the catheter body to a distal cap. The distal cap comprises a plurality of slots including a first slot disposed about an outer circumference of the distal cap. The first spline comprises a distal end defining a locking feature secured within the first slot. The expandable electrode assembly is configured to be transitioned between a collapsed configuration suitable for delivery and an expanded configuration. Two or more electrodes are located on the first spline. An actuation member is coupled to the expandable electrode assembly.
In a sixteenth example, a method of forming an expandable basket electrode assembly is disclosed. The method includes forming a flattened spline array comprising two or more flexible splines, a distal end of each spline defining a locking feature; forming a cylindrical spline array from the flattened spline array; positioning a distal cap comprising two or more slots disposed about an outer circumference adjacent a distal end of the cylindrical spline array; separating a first spline from the two or more flexible splines of the cylindrical spline array; rotating the first spline about its major axis from a first orientation to a second orientation; bending the first spline along its minor axis while it is in its second orientation and inserting the distal end into a first slot of the distal cap; and returning the first spline to its original first orientation.
In addition or alternatively, and in a seventeenth example, the first spline automatically returns from the second orientation to the first orientation.
In addition or alternatively, and in an eighteenth example, rotating the first spline about its major axis comprises rotating the first spline about 60 degrees to about 120 degrees about its major axis.
In addition or alternatively, and in a nineteenth example, the method further comprises separating a second spline from the two or more flexible splines of the cylindrical spline array; rotating the second spline about its major axis from the first orientation to the second orientation; inserting the distal end of the second spline while it is in the second orientation into a second slot; and returning the second spline from the second orientation to the first orientation.
In addition or alternatively, and in a twentieth example, the method further comprises delivering a potting material into the distal cap.
In addition or alternatively, and in a twenty-first example, the method further comprises inserting a cylindrical tube, plug, or gasket into the proximal end of the distal cap to occlude the gaps in the cap's slots, proximal to the distal ends of the splines.
In a twenty-second example, a method of forming a flexible electrode assembly is disclosed. The method includes: forming a first flexible printed circuit comprising one or more electrodes on an upper surface of a substrate and forming a second flexible printed circuit comprising one or more electrodes on a lower surface of the substrate to produce a flexible layered sheet; separating the flexible layered sheet into two or more splines extending longitudinally from a proximal end of the flexible layered sheet to a distal end of the flexible layered sheet, wherein the two or more splines are fully separated from one another such that they are not connected and at least one of the splines includes two or more electrodes; inserting a first end of a first spline of the two or more splines into a first slot provided in a distal cap; and inserting a first end of a second spline of the two or more splines into a second slot provided in the distal cap.
In addition or alternatively, and in a twenty-third example, the substrate comprises a shape memory material.
In addition or alternatively, and in a twenty-fourth example, the step of separating the flexible layered sheet into two or more splines comprises laser cutting the flexible layered sheet into two or more splines.
In addition or alternatively, and in a twenty-fifth example, the step of separating the flexible layered sheet into two or more splines comprises die cutting the flexible layered sheet into two or more splines.
In addition or alternatively, and in a twenty-sixth example, the method further includes securing a second end of the first spline and a second end of the second spline to a distal end of a catheter body to form an expandable electrode assembly, wherein the expandable electrode assembly is capable of transitioning from a collapsed configuration to an expanded configuration.
In addition or alternatively, and in a twenty-seventh example, the method further including at least partially rotating the first end of the first spline to facilitate insertion of the first end into the first slot provided in the distal cap and at least partially rotating the first end of the second spline to facilitate insertion of the first end of the second spline into the second slot provided in the distal cap.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
The disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
Figure 1 is a schematic diagram showing a catheter in the context of a system;
Figures 2A-2B are schematic views of an exemplary catheter;
Figure 3A is an isometric view of an expandable electrode assembly shown in a collapsed configuration;
Figure 3B is an isometric view of the expandable electrode assembly of Figure 3A shown in an expanded configuration;
Figure 4 is a schematic view of an exemplary distal cap;
Figure 5A is a schematic view of a flattened array of multiple flexible splines;
Figure 5B is a close-up, schematic view of the distal ends of each of the splines of the flattened array shown in Figure 5A;
Figure 6 is a close-up, schematic view of a distal portion of an electrode assembly showing the distal ends of multiple flexible splines engaged with a distal cap;
Figure 7 is a schematic view of another exemplary distal cap;
Figure 8A is a schematic view of another exemplary flattened array of multiple flexible splines;
Figure 8B is a close-up, schematic view of the distal ends of each of the splines of the flattened array shown in Figure 8A.
Figure 9A is a detailed view of a distal portion of an exemplary electrode assembly showing the distal ends of a plurality of flexible splines engaged with a distal cap 170;
Figure 9B is a cross-sectional view of the distal portion of the exemplary electrode assembly shown in Figure 9A taken along lines A-A;
Figure 10 is a cross-sectional view of the distal portion of another exemplary electrode assembly including a distal cap having a cylindrical plug inserted therein;
Figure 1 1 is a flow chart of a method of constructing an exemplary electrode assembly; and Figure 12 is a schematic view of an exemplary, individual spline being rotated about its major axis and bent about its minor axis such that the distal end of the spline can be engaged within a slot provided in an exemplary distal cap.
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
DETAILED DESCRIPTION
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into an additional embodiment unless clearly stated to the contrary.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may be indicative as including numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.
As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
Figure 1 is a high level, schematic view of an overall system 2 that includes a physician, a patient, catheters, including a mapping catheter 10, and related electrophysiology equipment located within an operating room. A physician 16 introduces the catheter 10 into the vasculature of the patient 1 1 at the patient's leg and advances it along a blood vessel ultimately, entering the patient's heart 12. Other catheters that may be used in the procedure are represented by companion catheter 18. Each catheter 10, 18 is coupled to signal conditioning hardware 20 with appropriate catheter cabling typified by catheter cable 17. The signal conditioning hardware 20 performs various interface functions applicable to the mapping, tracking, and registration procedures that are performed in conjunction with the workstation 24. If the companion catheter 18 is an ablation catheter, then conditioning hardware also forms an interface to an RF ablation unit (not illustrated).
In use, the physician looks at a computer display 26. Present on the display 26 is a substantial amount of information. A large window presents an image of the heart chamber 13 along with an image of the catheter 10. The physician will manipulate and control the catheter 10 based in part on the images and other data presented on the display 26. The image 27 seen in FIG. 1 is schematic and depicts the distal array of the deployed catheter 10 occupying a small portion of the heart chamber 13 volume. The representation of the heart chamber 13 may use color, wire frame, or other techniques to depict the structure of the heart chamber 13 and to simultaneously portray electrical activity of the patient's heart. In some cases, it may be useful to display chamber geometry, catheter location, and electrical activity in an integrated fashion on the display 26. In use, the physician will observe the display 26 and interact with the workstation processing unit 24 and the catheters 10 and 18, to direct a medical procedure such as, for example, a cardiac mapping procedure.
Figures 2A and 2B are schematic views of an exemplary intravascular catheter 10. In some cases, the catheter 10 may be used to map electro-anatomical characteristics of the heart in a cardiac mapping procedure. The mapping procedure may be an in-contact mapping or a non-contact mapping procedure. The catheter 10 may be deployed at a target location within a patient's heart, placing multiple electrodes in a known spatial configuration. Electrode stability and the known spatial geometry of the electrodes may improve the accuracy of the mapping device. Alternatively, the catheter 10 may be used in an ablation procedure. These are just some examples.
As shown in Figures 2A and 2B, the catheter 10 includes an elongate catheter body 34 extending from a proximal end 38 to a distal end 42. In addition, the catheter body 34 may include a lumen (not shown) extending there through, but this is not required in all embodiments. The catheter body 34 may have sufficient flexibility so as to navigate the tortuous pathways of a patient's vasculature system. The catheter 10 can include a handle assembly 46 coupled to the proximal end 38 of the catheter body 34. A physician may manipulate the handle assembly 46 to deliver, steer, rotate, deploy and/or deflect the catheter 10 when performing a medical procedure.
Additionally, as shown in Figures 2A and 2B, the catheter 10 may include an expandable electrode assembly 30 including one or more electrodes that may be used for cardiac mapping or diagnosis, ablation and/or other therapies involving the application of electrical energy to a patient's heart. In some cases, the handle assembly 46 may include a first actuation mechanism 48 that may be manipulated to transition the expandable electrode assembly 30 from a collapsed configuration (shown in Figure 2 A) suitable for delivery of the catheter 10 to a target location within a patient's body (e.g. the heart) and an expanded configuration (shown in Figure 2B) suitable for use in a diagnostic procedure and/or delivery of a therapy. In some cases, the actuation mechanism 48 may include a pull wire that may be coupled to the expandable electrode assembly 30 that, when actuated in a proximal direction as indicated by the arrow shown in Figure 2B, causes the expandable electrode assembly 30 to transition from the collapsed configuration to the expanded configuration. In other cases, the actuation mechanism 48 may include a retractable sheath that, when retracted in a proximal direction as indicated by the arrow shown in Figure 2B, may permit the expandable electrode assembly 30 to self-expand from the collapsed configuration to the expanded configuration. These are just some examples of exemplary actuation mechanisms that may be utilized to facilitate expansion of the expandable electrode assembly 30 when the catheter 10 is in use. In some cases, the catheter body 34 may include a deflectable distal portion 52 that a physician may manipulate using a second actuation mechanism 54 provided in the handle assembly 46 to position the electrode assembly 30 nearer or adjacent to tissue of interest.
Figures 3 A and 3B show different views of an exemplary expandable electrode assembly 30. As shown in Figures 3 A and 3B, the expandable electrode assembly 30 is capable of being transitioned form a generally cylindrical, collapsed configuration suitable for delivery of the catheter 10 and the electrode assembly 30 to a target location within the patient's heart and an expanded configuration suitable for use in a desired cardiac procedure such as, for example, a mapping or ablation procedure.
As shown in Figures 3A and 3B, the expandable electrode assembly 30 may include two or more flexible splines 60 which may be capable of being flexed outwardly and away from a longitudinal axis of the electrode assembly 30. In some cases, as discussed herein, an actuation mechanism may be utilized to transition the electrode assembly 30 including the two or more flexible splines 60 from the collapsed configuration (Figure 3A) to the expanded configuration (Figure 3B). In other cases, the flexible splines 60 may be incorporate a shape memory material that may facilitate self-expansion of the flexible splines 60 and consequently, the electrode assembly 30, from the collapsed configuration to the expanded configuration. The flexible splines 60 may be relatively stiff such that the electrode assembly 30 may be expanded into a known, reproducible shape capable of retaining a known spatial geometry when in use which, in some cases, may be aided by the incorporation of a shape-memory material or other stiff polymeric material such as, for example, a nickel-titanium alloy, or a polyimide or PEEK into the flexible splines 60. Alternatively, depending upon the desired application, the flexible splines 60 may be fabricated such that they are somewhat compliant so as to conform to a surface of a patient's heart when placed into intimate contact with the surface of the patient's heart.
The expandable electrode assembly 30 may include a number of electrodes 64 located on each of the flexible splines 60 forming an electrode array. In many cases, the electrodes 64 may be sensing electrodes. In addition, the electrode assembly 30 may include at least some current injecting locator electrodes. The locator electrodes may be positioned diametrically opposed to each other on the meridian of the expanded electrode assembly 30. The electrode assembly 30 may also include a tip electrode which may be used for cardiac stimulation, ablation or as a locator electrode.
Each electrode 64 may be electrically connected to the cabling in the handle assembly 46. In some cases, the signal from each individual electrode may be independently available at the hardware interface 20. This may be achieved by passing a conductor for each electrode through a connection cable extending within the catheter body. As an alternative, the signals may be multiplexed to minimize the number of conductors.
The electrodes 64 may have a uniform and symmetrical distribution throughout the expandable electrode assembly 30. In other cases, the electrodes 64 may have an asymmetrical distribution throughout the expandable electrode assembly 30. Certain electrode distributions may be advantageous for non-contact cardiac mapping, while others may be more suited for contact mapping. The number of electrodes 64 distributed throughout the electrode assembly 30 and the stability of the shape of electrode assembly 30, when expanded, may affect the overall performance of the mapping system.
The electrodes 64 may be located on the outer surfaces 66 of each or the splines 60, the inner surfaces 68 of each of the splines 60, or both the outer and inner surfaces 66, 68 of each of the flexible splines 60. In some cases, up to sixty-four sensing electrodes 64 may be distributed over and along the various splines 60. Depending upon the application, the electrode assembly 30 may include fewer or greater than sixty-four electrodes. In some cases, the electrodes 64 may form a number of bipolar electrode pairs. The bipolar electrode pairs may be formed between two adjacent electrodes located on the same surface (inner or outer surface) of a spline, between two electrodes located on adjacent splines, or between a first electrode located on an outer surface opposite a second electrode located on an inner surface of a spline. In some cases, all of the electrodes 64 located on the flexible splines 60 may be paired together to form a plurality of electrode pairs distributed along the length of the individual flexible splines 60. Up to thirty-two bipolar electrode pairs may be distributed throughout the electrode assembly 30 for a total of up to sixty-four electrodes 64 depending upon the overall size and geometry of the electrode assembly 30. However, it is contemplated that the electrode assembly 30 may be configured such that it is capable of carrying fewer or greater than thirty -two bipolar electrode pairs, depending upon the overall size and geometry of the electrode assembly 30 and the desired application.
Referring now back to Figures 3 A and 3B, each of the flexible splines 60 may extend from a distal end 42 of the catheter body 34 to a distal cap 70. The distal cap 70 may have a rounded distal end, and may define an atraumatic distal tip of the catheter 10. As will be described in greater detail herein, at least one of the flexible splines 60 may be mechanically interlocked with a corresponding slot provided in the distal cap 70 such that there is a one to one mechanical engagement between the flexible spline 60 and a corresponding slot provided in the cap 70. In some cases, each of the flexible splines 60 may be mechanically interlocked with a corresponding slot provided in the distal cap 70 such that there is a one to one mechanical engagement between each flexible spline 60 and each slot provided in the cap 70. An adhesive may be utilized to provide a secondary means of securing the each of the flexible splines within each of their respective slots. In some cases, the distal cap 70 may serve as a tip electrode, but this is not required in all embodiments.
Figure 4 is a schematic view of an exemplary distal cap 170 that may be utilized in the construction of an exemplary expandable electrode assembly such as, for example, expandable electrode assembly 30, as described herein. Figure 5A is a schematic view of a flattened array 150 of multiple flexible splines 160 that may be engaged with each of the slots 174 provided in the distal cap 170 to form an electrode assembly 30, and Figure 5B is a close-up, schematic view of the distal ends 178 of each of the splines 160 of the flattened array 150.
In many cases, the distal cap 170 may be machined or laser cut from a metal or suitable plastic such that it has a desired size and shape. As shown in Figure 4, the distal cap 170 may be fabricated such that it has a substantially hollow, cylindrical shape, and may include two or more slots 174 spaced an equal distance from one another about an outer circumference of the distal cap 170. In some cases, as shown in Figure 4, each of the slots 174 may have a height h greater than a width w such that they are capable of receiving and retaining a distal end 178 of a respective flexible spline 160 when the distal end 178 of the flexible spline is inserted into the slot 174. The distal end of the distal cap 170 may be rounded such that it provides the catheter 10 with an atraumatic distal tip. In addition, the distal cap 170 may include a distal aperture 182, but this is not required. The aperture 182 may facilitate an introduction of an adhesive or other suitable potting material that may be provided as a secondary means of securing the distal ends 178 of each of the flexible splines 160 to the distal cap 170. In some cases, during construction of any one of the electrode assemblies, as described herein, a cylindrical tube, plug, or gasket may be inserted into the interior cavity of the distal cap to seal any remaining gaps between the splines and the slots subsequent to assembly. Alternatively, the distal end of the distal cap 170 may be solid. Turning now to Figures 5 A and 5B, the flattened array 150 of multiple flexible splines 160 may be initially fabricated as a flexible, multi-layered sheet including at least one flexible printed circuit bonded to a substrate. In some cases, the multi- layered sheet includes a first flexible printed circuit bonded to an upper surface of a substrate and a second flexible printed circuit bonded to a lower surface of the same substrate such that each of the flexible splines 160, when formed, have at least one electrode located on an outer surface and at least one electrode located on an inner surface of each of the splines 160. The substrate may include a shape memory material. This is just one example. The flexible multi-layered sheet including the flexible printed circuit is then laser cut or die cut in a direction along its longitudinal axis to form each of the individual, flexible splines 160. For example, the flexible multi-layered sheet including the flexible printed circuit is then laser cut or die cut to separate and form two or more flexible splines. In other cases, the flexible multi- layered sheet may be fabricated from a dual-sided flexible printed circuit having electrodes located both an upper surface and a lower surface.
The various materials used to fabricate the flexible multi-layered sheet from which the flexible splines 160 are formed may be selected such that each of the flexible splines 160 has a desired flexibility profile. The materials used to fabricate the flexible multi-layered sheet from which the flexible splines 160 are formed may be selected such that the flexible splines 160 are capable of some degree of deformation so that they can be twisted, rotated, and/or bent to facilitate insertion of their distal end into a distal cap (e.g. distal cap 170) during construction of an electrode assembly such as, for example, electrode assembly 30. In some cases, at least one of the layers or substrates of the multi-layered flexible sheet may include a shape memory material such as, for example, Nitinol or another super-elastic material. Incorporation of a Nitinol or super-elastic layer or substrate into the flexible multi- layered sheet from which the flexible splines 160 may be formed may provide the splines 160 with a degree of flexibility and deformation needed such that they can be twisted or rotated about a major axis to facilitate insertion of their distal end into a distal cap (e.g. distal cap 170) during construction of an electrode assembly such as, for example, electrode assembly 30.
In some cases, as shown in Figure 5 A, each of the flexible splines 160 extend from a proximal band 186 to which they are attached or integrally formed with at their proximal ends 196 to a free distal end 178. Two or more tabs 190, 192 may extend from the proximal band 186. Traces on the flexible printed circuit including those connected to the electrodes may terminate to pads bonded on an inner and/or outer surface of the two or more tabs 190, 192. In addition, the two or more tabs 190, 192 and may be utilized to couple to the electrode assembly 30 to the distal end 32 of the catheter body 34. Alternatively, both the proximal ends 196 and the distal ends 178 may be detached from one another. The splines 160 may be independent of one another, and may be inserted into the distal cap 170 and distal end 32 of the catheter body 34 either simultaneously or sequentially.
Each of the distal ends 178 of the flexible splines 160 may be formed by laser cutting, die cutting or other suitable method such that they define a locking feature 198 that is configured to be inserted into and secured within each of the slots 174 of the distal cap 170. Is some cases, the locking feature 198 may be defined by a geometrical shape having a first portion 202 having a first width and a second portion 204 having a second width. The first width can be greater than the second width. For example, as shown in Figures 5A and 5B, the locking feature 198 may have an arrowhead shape. In addition, each of the locking features 198 may include an aperture 201. An adhesive, when utilized, may permeate the apertures 201 and may provide a further means of securing the distal ends 178 to the distal cap 170.
In some cases, the material(s) from which the flattened array 150 may be sufficiently deformable such that the locking feature 198 is capable of being deformed for insertion into the corresponding slot 174 of the distal cap 170. For example, the points 200 of the arrowhead shaped locking feature 198, best viewed in Figure 5B, may be capable of bending or folding inward towards a centerline 210 when inserted into a slot 174 of a distal cap 170. Once inserted into the slot 174, the material from which the flexible splines 160 is fabricated may be sufficiently resilient such that the arrowhead-shaped locking feature 198 returns to its unfolded or uncompressed state, mechanically securing the distal end 178 of the flexible spline 160 in the slot 174 such that the distal end 178 of the spline is unable to be disengaged or removed from the slot 174.
Figure 6 is a detailed view of a distal portion 220 of an exemplary electrode assembly showing the distal ends 178 of a plurality of flexible splines 160 engaged with the distal cap 170.
Figure 7 is a schematic view of another exemplary distal cap 270 that may be utilized in the construction of an exemplary expandable electrode assembly such as, for example, expandable electrode assembly 30, as described herein. Figure 8A is a schematic view of another exemplary flattened array 250 of multiple flexible splines 260 that may be engaged with each of the slots 274 provided in the distal cap 270 to form an electrode assembly, and Figure 8B is a close-up, schematic view of the distal ends 278 of each of the splines 260 of the flattened array 250.
In many cases, as described previously herein, the distal cap 270 may be machined or laser cut from a metal or suitable plastic such that it has a desired size and shape. As shown in Figure 7, the distal cap 270 may be fabricated such that it has a substantially cylindrical shape defining an interior cavity, and may include two or more slots 274. In some cases, the two or more slots 274 may be spaced an equal distance from one another about an outer circumference of the distal cap 270 about the same longitudinal line. In other cases, the distance between the two or more slots 274 may vary. As shown in Figure 7, each of the slots 274 may have a width w greater than a height h such that they are capable of receiving and retaining a distal end 278 of a respective flexible spline 260 when the distal end 278 of the flexible spline 260 is inserted into the slot 274. The distal end of the distal cap 270 may be rounded such that it provides the catheter 10 with an atraumatic distal tip. In addition, the distal cap 270 may include a distal aperture 282, but this is not required in all embodiments. The aperture 282, if provided, may facilitate an introduction of an adhesive or other suitable potting material that may be provided as a secondary means of securing the distal ends 278 of each of the flexible splines 260 to the distal cap 270. Alternatively, the distal end of the distal cap 270 may be solid. In some cases, during construction of the electrode assembly, a cylindrical tube, plug, or gasket may be inserted into the interior cavity of the distal cap 270 to seal any remaining gaps between the splines 260 and the slots 274.
As previously described herein, the flattened array 250 of multiple flexible splines 260 may be initially fabricated as a flexible, multi-layered sheet including at least one flexible printed circuit bonded to a substrate. In some cases, the multi- layered sheet includes a first flexible printed circuit bonded to an upper surface of a substrate and a second flexible printed circuit bonded to a lower surface of the same substrate such that each of the flexible splines 260, when formed, have at least electrode located on an outer surface and at least one electrode located on an inner surface of each of the splines 260. This is just one example. In other cases, the flexible multi-layered sheet may be fabricated from a dual-sided flexible printed circuit having electrodes located both an upper surface and a lower surface. The flexible multi-layered sheet including the flexible printed circuit(s) is then laser cut or die cut in a direction along its longitudinal axis to form each of the individual, flexible splines 260.
The various materials used to fabricate the flexible multi-layered sheet from which the flexible splines 260 are formed may be selected such that each of the flexible splines2 60 has a desired flexibility profile. The materials used to fabricate the flexible multi-layered sheet from which the flexible splines 260 are formed may be selected such that the flexible splines 260 are capable of some degree of deformation so that their distal end can be elastically inserted into a distal cap (e.g. distal cap 70) during construction of an electrode assembly such as, for example, electrode assembly 30. In some cases, at least one of the layers of the multi-layered flexible sheet may include Nitinol or another super-elastic material. Incorporation of a Nitinol or super-elastic layer or substrate into the flexible multi-layered sheet from which the flexible splines 260 may be formed may provide the splines 260 with a degree of mechanical strength, flexibility and deformation needed such that their distal end can be inserted into a distal cap (e.g. distal cap 270), causing the distal barb 302 to bend inward and then recover to lock the spline in position during construction of an electrode assembly such as, for example, electrode assembly 30.
In some cases, as shown in Figure 8A, each of the flexible splines 260 extend from a proximal band 286 to which they are attached or integrally formed with at their proximal ends 296 to a free distal end 278. Two or more tabs 290, 292 may extend from the proximal band 286. Traces on the flexible printed circuit including those connected to the electrodes may terminate to pads bonded on an inner and/or outer surface of the two or more tabs 290, 292. In addition, the two or more tabs 290, 292 and may be utilized to couple to the electrode assembly 30 to the distal end 42 of the catheter body 34. Alternatively, both the proximal ends 296 and the distal ends 278 may be freely detached from one another.
Each of the distal ends 278 of the flexible splines 260 may be formed by laser cutting, die cutting or other suitable method such that they define a locking feature 298 that is configured to be inserted into and secured within each of the slots 274 of the distal cap 270. Is some cases, the locking feature 298 may be defined by a geometrical shape having a first portion 302 having a first width and a second portion 304 having a second width. The first width can be greater than the second width. For example, as shown in Figures 8A and 8B, the locking feature 298 may have a barb or hook shape.
In some cases, the material(s) from which the flattened array 250 may be sufficiently deformable such that the locking feature 298 is capable of being deformed for insertion into the corresponding slot 274 of the distal cap 270. For example, the first portion 302 of the barb or hook shaped locking feature 298 may be capable of bending or flexing inward towards a centerline 310 when inserted into a slot 274 of a distal cap 270. Once inserted into the slot 274, the material from which the flexible splines 260 is fabricated may be sufficiently resilient such that the hook or barbed- shaped locking feature 298 returns to its uncompressed state, mechanically securing the distal end 278 of the flexible spline 260 in the slot 274 such that the distal end 278 of the spline is unable to be disengaged or removed from the slot 274.
Figure 9A is a detailed view of a distal portion 320 of an exemplary electrode assembly showing the distal ends 278 of a plurality of flexible splines 160 engaged with the distal cap 170. Figure 9B is a cross-sectional view of the distal portion 320 taken along lines A-A of Figure 9A and shows the first portions 302 of the barb- shaped locking features 298 engaged in the slots 274 of distal cap 270.
In some cases, during construction of any one of the electrode assemblies, as described herein, a cylindrical tube, plug, or gasket 356 may be inserted into the interior cavity 358 of the distal cap 370 to seal any remaining gaps between the splines 360 and the slots 374 subsequent to assembly. Figure 10 is a cross sectional view of a distal portion 370 of an exemplary electrode assembly including a cylindrical tube, plug, or gasket 356.
Figure 11 is a flow chart of a method 400 of constructing an expandable electrode assembly using a distal cap and a flexible spline array, as described herein. The method 400 may be automated using appropriate machinery or manually performed by an individual. During assembly, a flattened spline array may be formed from flexible, multilayered sheet (Block 404). As described herein, the flexible, multi-layered sheet from which a flattened spline array may be formed may includes at least one flexible printed circuit bonded to a substrate. In some cases, the multi- layered sheet includes a first flexible printed circuit bonded to an upper surface of a substrate and a second flexible printed circuit bonded to a lower surface of the same substrate such that each of the flexible splines, when formed, have at least electrode located on an outer surface and at least one electrode located on an inner surface of each of the splines. The individual splines may be formed by laser cutting or die cutting the flexible multi-layered sheet in a direction along its longitudinal axis to form the flattened spline array. In many cases, the flattened spline array includes at least two splines. Next, the flattened spline array including the two or more splines may be rolled into cylindrical shape (Block 408). In some cases, the flattened spline array may be rolled around a mandrel or other cylindrical member to facilitate formation of the cylindrical shape. A band may also be placed around the array to maintain its cylindrical shape during assembly.
A distal cap such as those described herein may be positioned adjacent a distal end of the now cylindrical array such that the distal cap is co-axial with the cylindrical array (Block 412). A first spline may be separated from the other splines of the array (Block 416) and rotated or twisted about its major axis and bent about its minor axis from a first orientation to a second orientation (Block 420). In some cases, the first spline may be rotated at about 60 to about 120 degrees about its major axis and more particularly, about 90 degrees about its major axis from a first orientation to a second orientation. The spline may also be bent about its minor axis to align with one of the slots in the distal tip 570. The spline should be rotated a sufficient degree of rotation about its major and minor axes such that the distal end of the locking feature is capable of being inserted into a corresponding slot provided in the distal cap. In some cases, as described herein, the distal end of the spline including the locking feature may be deformed so as to facilitate insertion of the distal end of the spline into the slot. These steps are schematically illustrated in Figure 12. Figure 12 shows a spline 560 being twisted or orientated about its major axis 580 and bent about its minor axis 582 such that the distal end 578 may be inserted into slot 574 provided in distal cap 570.
The distal end of the spline may then be inserted into a slot provided in the distal cap while still in the second orientation (Block 420). Once inserted through the slot, the locking feature may re-assume its un-deformed shape, if applicable. In addition, the spline may be returned from its second orientation to its first orientation and lie flat in the slot (Block 428). In some cases, the spline may be manually twisted or rotated in the slot from its second orientation to its first orientation. In other cases, because of the elasticity of some of the materials used to construct the flexible, multilayer sheet from which the spline array is formed, the spline may be configured to automatically return from its second orientation to its first orientation and lie flat in the slot. The spline may be mechanically interlocked with the cap by the locking feature formed at the distal end of the spline. The remaining splines may be engaged with the cap following the same steps outlined by Blocks 416, 420, 424, and 428. The proximal ends of the splines may be banded together, and may be anchored or bonded to a distal portion of the catheter body.
In another case, the splines may be fully separated from one another such that they are not connected. Each of the distal ends of the separated splines may be inserted into a corresponding slot provided in the distal cap. The distal ends of the separated splines may be mechanically interlocked with the cap by the locking feature formed at the distal end of the spline. Some rotation of the individual splines may be necessary to urge the locking feature into slot after which the spline may lie flat in the slot. The remaining individual splines may be engaged with the cap utilizing the same method.
In some cases, an adhesive may be used to further secure the distal ends of the spline with the cap. For example, the distal cap may include an aperture through which an adhesive or other suitable potting material may be introduced. A cylindrical tube, plug, or gasket may also be inserted into the proximal end of the cap, occluding the gaps proximal to the distal ends of the splines. In addition or in alternative to, a sealing material may be provided to seal any gaps between the distal ends of the splines and the slots such that the outer surface of the distal cap is substantially smooth and does not provide a surface onto which blood may collect and thrombi form.
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.

Claims

What is claimed is:
1. A catheter comprising:
an elongate catheter body extending from a proximal end to a distal end;
an expandable electrode assembly disposed at the distal end of the catheter body, the electrode assembly comprising a plurality of flexible splines extending from the distal end of the catheter body to a distal cap;
wherein the distal cap comprises a plurality of slots disposed about an outer circumference of the distal cap;
wherein the plurality of flexible splines include a first spline comprising a distal end defining a locking feature secured within one of the plurality of slots provided in the distal cap, the expandable electrode assembly configured to be transitioned between a collapsed configuration suitable for delivery and an expanded configuration; and
two or more electrodes located on the first spline.
2. The catheter according to claim 1, wherein the distal cap comprises a rounded tip having an aperture defined therein.
3. The catheter according to any one of claims 1 or 2, wherein a height is greater than a width for each of the plurality of slots.
4. The catheter according to any one of claims 1 or 2, wherein a width is greater than a height for each of the plurality of slots.
5. The catheter according to any one of claims 1 through 4, wherein the locking feature defined by the distal end of the first spline comprises a first portion having a first width and a second portion having a second width, the first width greater than the second width.
6. The catheter according to any one of claims 1 through 5, the locking feature defined by the distal end of the first spline comprises an aperture formed therein.
7. The catheter according to any one of claims 1 through 6, further comprising an actuation member coupled to the expandable electrode assembly.
8. The catheter according to any one of claims 1 through 7, wherein the locking feature defined by the distal end of the first spline comprises a hook shape.
9. The catheter according to any one of claims 1 through 7, wherein the locking feature defined by the distal end of the first spline comprises an arrowhead shape.
10. The catheter according to any one of claims 1 through 9, wherein the distal cap serves as a distal tip electrode.
11. A method of forming an expandable basket electrode assembly, the method comprising:
forming a flattened spline array comprising two or more flexible splines, a distal end of each spline defining a locking feature;
forming a cylindrical spline array from the flattened spline array;
positioning a distal cap comprising two or more slots disposed about an outer circumference adjacent a distal end of the cylindrical spline array;
separating a first spline from the two or more flexible splines of the cylindrical spline array;
rotating the first spline about its major axis from a first orientation to a second orientation;
inserting the distal end of the first spline while it is in the second orientation into a first slot of the distal cap; and
returning the first spline from the second orientation to the first orientation.
12. The method according to claim 11, wherein the first spline automatically returns from the second orientation to the first orientation.
13. The method according to any one of claims 1 1 or 12, wherein rotating the first spline about its major axis comprises rotating the first spline about 60 degrees to about 120 degrees about its major axis.
14. The method according to any one of claims 1 1 through 13, further comprising:
separating a second spline from the two or more flexible splines of the cylindrical spline array;
rotating the second spline about its major axis from the first orientation to the second orientation;
inserting the distal end of the second spline while it is in the second orientation into a second slot; and
returning the second spline from the second orientation to the first orientation.
15. The method according to any one of claims 1 1 through 14, further comprising delivering a potting material into the distal cap.
PCT/US2015/032004 2014-06-03 2015-05-21 Electrode assembly having an atraumatic distal tip WO2015187386A1 (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9474467B2 (en) 2008-04-02 2016-10-25 Rhythmia Medical, Inc. Intracardiac tracking system
US9585588B2 (en) 2014-06-03 2017-03-07 Boston Scientific Scimed, Inc. Electrode assembly having an atraumatic distal tip
US9687166B2 (en) 2013-10-14 2017-06-27 Boston Scientific Scimed, Inc. High resolution cardiac mapping electrode array catheter
US9848795B2 (en) 2014-06-04 2017-12-26 Boston Scientific Scimed Inc. Electrode assembly
US10034637B2 (en) 2007-12-28 2018-07-31 Boston Scientific Scimed, Inc. Cardiac mapping catheter
US10758144B2 (en) 2015-08-20 2020-09-01 Boston Scientific Scimed Inc. Flexible electrode for cardiac sensing and method for making

Families Citing this family (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2659898C (en) 2006-08-03 2017-08-29 Christoph Scharf Method and device for determining and presenting surface charge and dipole densities on cardiac walls
EP2094352A4 (en) 2006-12-06 2010-05-19 Cleveland Clinic Foundation Method and system for treating acute heart failure by neuromodulation
ITBA20070049A1 (en) * 2007-06-14 2008-12-15 Massimo Grimaldi CATHETERS FOR ABLATION TRANSCATETER BY PERCUTANEOUS ROUTE OF HEART ARITHMIA THROUGH BIPOLAR RADIOFREQUENCY
EP2252203A2 (en) 2008-01-17 2010-11-24 Christoph Scharf A device and method for the geometric determination of electrical dipole densities on the cardiac wall
WO2012122517A2 (en) 2011-03-10 2012-09-13 Acutus Medical, Inc. Device and method for the geometric determination of electrical dipole densities on the cardiac wall
WO2012145077A1 (en) * 2011-04-22 2012-10-26 Topera, Inc. Method for detection of cardiac rhythm disorders using basket style cardiac mapping catheter
SG11201402610QA (en) 2011-12-09 2014-10-30 Metavention Inc Therapeutic neuromodulation of the hepatic system
JP6316821B2 (en) 2012-08-31 2018-04-25 アクタス メディカル インクAcutus Medical,Inc. Ablation system
CN105358070B (en) 2013-02-08 2018-03-23 阿库图森医疗有限公司 Expandable catheter component with flexible printed circuit board
AU2014318872B2 (en) 2013-09-13 2018-09-13 Acutus Medical, Inc. Devices and methods for determination of electrical dipole densities on a cardiac surface
WO2015148470A1 (en) 2014-03-25 2015-10-01 Acutus Medical, Inc. Cardiac analysis user interface system and method
JP6580068B2 (en) 2014-05-22 2019-09-25 カーディオノミック,インク. Catheter and catheter system for electrical neuromodulation
JP2016007334A (en) * 2014-06-24 2016-01-18 株式会社グッドマン Electrode member for ablation and catheter for ablation
AU2015315570B2 (en) 2014-09-08 2020-05-14 CARDIONOMIC, Inc. Methods for electrical neuromodulation of the heart
WO2016040037A1 (en) 2014-09-08 2016-03-17 CARDIONOMIC, Inc. Catheter and electrode systems for electrical neuromodulation
CN109568786A (en) 2015-01-05 2019-04-05 卡迪诺米克公司 Heart, which is adjusted, promotes method and system
CN107847173B (en) 2015-05-12 2022-08-30 阿库图森医疗有限公司 Ultrasonic sequencing system and method
WO2016183179A1 (en) 2015-05-12 2016-11-17 Acutus Medical, Inc. Cardiac virtualization test tank and testing system and method
WO2016183468A1 (en) 2015-05-13 2016-11-17 Acutus Medical, Inc. Localization system and method useful in the acquisition and analysis of cardiac information
JP2019513032A (en) 2016-03-09 2019-05-23 カーディオノミック,インク. Cardiac contraction stimulation system and method
US10314505B2 (en) * 2016-03-15 2019-06-11 Biosense Webster (Israel) Ltd. Asymmetric basket catheter
US10362991B2 (en) * 2016-04-04 2019-07-30 Biosense Webster (Israel) Ltd. Convertible basket catheter
US20170296251A1 (en) * 2016-04-13 2017-10-19 Biosense Webster (Israel) Ltd. Basket catheter with prestrained framework
US11399759B2 (en) 2016-05-03 2022-08-02 Acutus Medical, Inc. Cardiac mapping system with efficiency algorithm
CN107440788A (en) * 2016-06-01 2017-12-08 四川锦江电子科技有限公司 A kind of ablation catheter and ablating device with interpolar discharge function
US10524859B2 (en) 2016-06-07 2020-01-07 Metavention, Inc. Therapeutic tissue modulation devices and methods
EP3554406A1 (en) 2016-12-19 2019-10-23 Boston Scientific Scimed Inc. Distally-facing electrode array with longitudinally mounted splines
US11246534B2 (en) * 2017-01-23 2022-02-15 Biosense Webster (Israel) Ltd. Basket catheter made from flexible circuit board with mechanical strengthening
EP3664703A4 (en) 2017-09-13 2021-05-12 Cardionomic, Inc. Neurostimulation systems and methods for affecting cardiac contractility
US10905347B2 (en) * 2018-02-06 2021-02-02 Biosense Webster (Israel) Ltd. Catheter with increased electrode density spine assembly having reinforced spine covers
EP3836859A4 (en) 2018-08-13 2022-05-11 Cardionomic, Inc. Systems and methods for affecting cardiac contractility and/or relaxation
US11045628B2 (en) 2018-12-11 2021-06-29 Biosense Webster (Israel) Ltd. Balloon catheter with high articulation
US11850051B2 (en) 2019-04-30 2023-12-26 Biosense Webster (Israel) Ltd. Mapping grid with high density electrode array
WO2020227234A1 (en) 2019-05-06 2020-11-12 CARDIONOMIC, Inc. Systems and methods for denoising physiological signals during electrical neuromodulation
WO2021065875A1 (en) * 2019-09-30 2021-04-08 テルモ株式会社 Medical device
US11517218B2 (en) 2019-12-20 2022-12-06 Biosense Webster (Israel) Ltd. Selective graphical presentation of electrophysiological parameters
US20210378594A1 (en) * 2020-06-08 2021-12-09 Biosense Webster (Israel) Ltd. Features to assist in assembly and testing of devices
CN112022154A (en) * 2020-09-10 2020-12-04 中国科学院半导体研究所 Flexible nerve electrode implantation system for multi-dimensional extraction of neuron signals
WO2022063137A1 (en) * 2020-09-22 2022-03-31 杭州德诺电生理医疗科技有限公司 Left atrial appendage occlusion apparatus
US11918383B2 (en) 2020-12-21 2024-03-05 Biosense Webster (Israel) Ltd. Visualizing performance of catheter electrodes
US20230015298A1 (en) * 2021-07-13 2023-01-19 Biosense Webster (Isreal) Ltd. Ablation electrodes made from electrical traces of flexible printed circuit board
US20230225789A1 (en) * 2022-01-20 2023-07-20 Biosense Webster (Israel) Ltd. Systems and methods for linear spines and spine retention hub for improved tissue contact and current delivery
WO2024044498A1 (en) * 2022-08-25 2024-02-29 6K Inc. Plasma apparatus and methods for processing feed material utilizing a powder ingress preventor (pip)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5893847A (en) * 1993-03-16 1999-04-13 Ep Technologies, Inc. Multiple electrode support structures with slotted hub and hoop spline elements
EP1484026A1 (en) * 2003-06-02 2004-12-08 Biosense Webster, Inc. Catheter for mapping a pulmonary vein
US20090171274A1 (en) * 2007-12-28 2009-07-02 Doron Harlev Non contact mapping catheter
CN203017083U (en) * 2012-12-31 2013-06-26 上海微创电生理医疗科技有限公司 Multi-electrode ablation catheter
US20130172715A1 (en) * 2011-12-30 2013-07-04 Dale E. Just Electrode support structure assemblies

Family Cites Families (132)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1265586A (en) 1984-08-14 1990-02-06 Consiglio Nazionale Delle Ricerche Method and device for quick location of starting site of ventricular arrhythmias
US4674518A (en) 1985-09-06 1987-06-23 Cardiac Pacemakers, Inc. Method and apparatus for measuring ventricular volume
US5231995A (en) 1986-11-14 1993-08-03 Desai Jawahar M Method for catheter mapping and ablation
US4920490A (en) 1988-01-28 1990-04-24 Rensselaer Polytechnic Institute Process and apparatus for distinguishing conductivities by electric current computed tomography
US4840182A (en) 1988-04-04 1989-06-20 Rhode Island Hospital Conductance catheter
US5345936A (en) * 1991-02-15 1994-09-13 Cardiac Pathways Corporation Apparatus with basket assembly for endocardial mapping
US5156151A (en) 1991-02-15 1992-10-20 Cardiac Pathways Corporation Endocardial mapping and ablation system and catheter probe
US5381333A (en) 1991-07-23 1995-01-10 Rensselaer Polytechnic Institute Current patterns for electrical impedance tomography
US5588429A (en) 1991-07-09 1996-12-31 Rensselaer Polytechnic Institute Process for producing optimal current patterns for electrical impedance tomography
US5284142A (en) 1991-12-16 1994-02-08 Rensselaer Polytechnic Institute Three-dimensional impedance imaging processes
US5300068A (en) 1992-04-21 1994-04-05 St. Jude Medical, Inc. Electrosurgical apparatus
US5341807A (en) 1992-06-30 1994-08-30 American Cardiac Ablation Co., Inc. Ablation catheter positioning system
US5782239A (en) * 1992-06-30 1998-07-21 Cordis Webster, Inc. Unique electrode configurations for cardiovascular electrode catheter with built-in deflection method and central puller wire
US5297549A (en) 1992-09-23 1994-03-29 Endocardial Therapeutics, Inc. Endocardial mapping system
USRE41334E1 (en) 1992-09-23 2010-05-11 St. Jude Medical, Atrial Fibrillation Division, Inc. Endocardial mapping system
US6603996B1 (en) 2000-06-07 2003-08-05 Graydon Ernest Beatty Software for mapping potential distribution of a heart chamber
US8728065B2 (en) 2009-07-02 2014-05-20 St. Jude Medical, Atrial Fibrillation Division, Inc. Apparatus and methods for contactless electrophysiology studies
US5662108A (en) 1992-09-23 1997-09-02 Endocardial Solutions, Inc. Electrophysiology mapping system
CA2678625A1 (en) 1992-09-23 1994-03-31 St. Jude Medical, Atrial Fibrillation Division, Inc. Endocardial mapping system
US5553611A (en) 1994-01-06 1996-09-10 Endocardial Solutions, Inc. Endocardial measurement method
US5309910A (en) 1992-09-25 1994-05-10 Ep Technologies, Inc. Cardiac mapping and ablation systems
US5687737A (en) 1992-10-09 1997-11-18 Washington University Computerized three-dimensional cardiac mapping with interactive visual displays
WO1994021170A1 (en) * 1993-03-16 1994-09-29 Ep Technologies, Inc. Flexible circuit assemblies employing ribbon cable
US5476495A (en) 1993-03-16 1995-12-19 Ep Technologies, Inc. Cardiac mapping and ablation systems
JP3423719B2 (en) * 1993-03-16 2003-07-07 ボストン サイエンティフィック リミテッド Multiple electrode support mechanism
US5840031A (en) 1993-07-01 1998-11-24 Boston Scientific Corporation Catheters for imaging, sensing electrical potentials and ablating tissue
IL116699A (en) 1996-01-08 2001-09-13 Biosense Ltd Method of constructing cardiac map
US5391199A (en) 1993-07-20 1995-02-21 Biosense, Inc. Apparatus and method for treating cardiac arrhythmias
US5921982A (en) 1993-07-30 1999-07-13 Lesh; Michael D. Systems and methods for ablating body tissue
US6947785B1 (en) 1993-09-23 2005-09-20 Endocardial Solutions, Inc. Interface system for endocardial mapping catheter
US5713367A (en) 1994-01-26 1998-02-03 Cambridge Heart, Inc. Measuring and assessing cardiac electrical stability
US5469858A (en) 1994-03-15 1995-11-28 Hewlett-Packard Corporation ECG P-QRS-T onset/offset annotation method and apparatus
US5722402A (en) 1994-10-11 1998-03-03 Ep Technologies, Inc. Systems and methods for guiding movable electrode elements within multiple-electrode structures
US5941251A (en) 1994-10-11 1999-08-24 Ep Technologies, Inc. Systems for locating and guiding operative elements within interior body regions
US6690963B2 (en) 1995-01-24 2004-02-10 Biosense, Inc. System for determining the location and orientation of an invasive medical instrument
US6246898B1 (en) 1995-03-28 2001-06-12 Sonometrics Corporation Method for carrying out a medical procedure using a three-dimensional tracking and imaging system
DE19511532A1 (en) 1995-03-29 1996-10-02 Siemens Ag Process for locating electrical cardiac activity
US5577502A (en) 1995-04-03 1996-11-26 General Electric Company Imaging of interventional devices during medical procedures
US5954665A (en) 1995-06-07 1999-09-21 Biosense, Inc. Cardiac ablation catheter using correlation measure
US6001065A (en) 1995-08-02 1999-12-14 Ibva Technologies, Inc. Method and apparatus for measuring and analyzing physiological signals for active or passive control of physical and virtual spaces and the contents therein
US5848972A (en) 1995-09-15 1998-12-15 Children's Medical Center Corporation Method for endocardial activation mapping using a multi-electrode catheter
US5697377A (en) 1995-11-22 1997-12-16 Medtronic, Inc. Catheter mapping system and method
NL1001890C2 (en) 1995-12-13 1997-06-17 Cordis Europ Catheter with plate-shaped electrode array.
JP2000504242A (en) 1996-01-19 2000-04-11 イーピー・テクノロジーズ・インコーポレイテッド Multifunctional electrode structure for electrically analyzing and heating body tissue
DE19622078A1 (en) 1996-05-31 1997-12-04 Siemens Ag Active current localising appts. for heart
US6167296A (en) 1996-06-28 2000-12-26 The Board Of Trustees Of The Leland Stanford Junior University Method for volumetric image navigation
US5971933A (en) 1996-09-17 1999-10-26 Cleveland Clinic Foundation Method and apparatus to correct for electric field non-uniformity in conductance catheter volumetry
JPH10122056A (en) 1996-10-18 1998-05-12 Mitsubishi Heavy Ind Ltd Liquefied fuel carburetor
RU2127075C1 (en) 1996-12-11 1999-03-10 Корженевский Александр Владимирович Method for producing tomographic image of body and electrical-impedance tomographic scanner
US6314310B1 (en) 1997-02-14 2001-11-06 Biosense, Inc. X-ray guided surgical location system with extended mapping volume
US6050267A (en) 1997-04-28 2000-04-18 American Cardiac Ablation Co. Inc. Catheter positioning system
US6839588B1 (en) 1997-07-31 2005-01-04 Case Western Reserve University Electrophysiological cardiac mapping system based on a non-contact non-expandable miniature multi-electrode catheter and method therefor
US6014581A (en) 1998-03-26 2000-01-11 Ep Technologies, Inc. Interface for performing a diagnostic or therapeutic procedure on heart tissue with an electrode structure
US7198635B2 (en) 2000-10-17 2007-04-03 Asthmatx, Inc. Modification of airways by application of energy
US7263397B2 (en) 1998-06-30 2007-08-28 St. Jude Medical, Atrial Fibrillation Division, Inc. Method and apparatus for catheter navigation and location and mapping in the heart
US6226542B1 (en) 1998-07-24 2001-05-01 Biosense, Inc. Three-dimensional reconstruction of intrabody organs
AU4644799A (en) 1998-08-02 2000-03-14 Super Dimension Ltd. Intrabody navigation system for medical applications
US6701176B1 (en) 1998-11-04 2004-03-02 Johns Hopkins University School Of Medicine Magnetic-resonance-guided imaging, electrophysiology, and ablation
US5986126A (en) 1999-01-25 1999-11-16 E. I. Du Pont De Nemours And Company Process for the production of 6-aminocapronitrile and/or hexamethylenediamine
EP1023870B1 (en) 1999-01-28 2004-09-22 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Device for localization of endocardial electrodes
US6556695B1 (en) 1999-02-05 2003-04-29 Mayo Foundation For Medical Education And Research Method for producing high resolution real-time images, of structure and function during medical procedures
US6278894B1 (en) 1999-06-21 2001-08-21 Cardiac Pacemakers, Inc. Multi-site impedance sensor using coronary sinus/vein electrodes
EP1069814A1 (en) 1999-07-16 2001-01-17 Ezio Babini Support device for boards, in particular for printed circuit boards
WO2001006917A1 (en) 1999-07-26 2001-02-01 Super Dimension Ltd. Linking of an intra-body tracking system to external reference coordinates
US6317619B1 (en) 1999-07-29 2001-11-13 U.S. Philips Corporation Apparatus, methods, and devices for magnetic resonance imaging controlled by the position of a moveable RF coil
US6360123B1 (en) 1999-08-24 2002-03-19 Impulse Dynamics N.V. Apparatus and method for determining a mechanical property of an organ or body cavity by impedance determination
US6368285B1 (en) 1999-09-21 2002-04-09 Biosense, Inc. Method and apparatus for mapping a chamber of a heart
US6829497B2 (en) 1999-09-21 2004-12-07 Jamil Mogul Steerable diagnostic catheters
US6298257B1 (en) 1999-09-22 2001-10-02 Sterotaxis, Inc. Cardiac methods and system
US6308093B1 (en) 1999-10-07 2001-10-23 Massachusetts Institute Of Technology Method and apparatus for guiding ablative therapy of abnormal biological electrical excitation
US6892091B1 (en) 2000-02-18 2005-05-10 Biosense, Inc. Catheter, method and apparatus for generating an electrical map of a chamber of the heart
US6400981B1 (en) 2000-06-21 2002-06-04 Biosense, Inc. Rapid mapping of electrical activity in the heart
US6408199B1 (en) 2000-07-07 2002-06-18 Biosense, Inc. Bipolar mapping of intracardiac potentials with electrode having blood permeable covering
US6650927B1 (en) 2000-08-18 2003-11-18 Biosense, Inc. Rendering of diagnostic imaging data on a three-dimensional map
US6631290B1 (en) 2000-10-25 2003-10-07 Medtronic, Inc. Multilayer ceramic electrodes for sensing cardiac depolarization signals
US6807439B2 (en) 2001-04-03 2004-10-19 Medtronic, Inc. System and method for detecting dislodgement of an implantable medical device
US20030018251A1 (en) 2001-04-06 2003-01-23 Stephen Solomon Cardiological mapping and navigation system
US6397776B1 (en) 2001-06-11 2002-06-04 General Electric Company Apparatus for large area chemical vapor deposition using multiple expanding thermal plasma generators
US6773402B2 (en) 2001-07-10 2004-08-10 Biosense, Inc. Location sensing with real-time ultrasound imaging
US6847839B2 (en) 2001-07-30 2005-01-25 The Trustees Of Columbia University In The City Of New York System and method for determining reentrant ventricular tachycardia isthmus location and shape for catheter ablation
US7187964B2 (en) 2001-09-27 2007-03-06 Dirar S. Khoury Cardiac catheter imaging system
GB0123772D0 (en) 2001-10-03 2001-11-21 Qinetiq Ltd Apparatus for monitoring fetal heartbeat
WO2003028801A2 (en) 2001-10-04 2003-04-10 Case Western Reserve University Systems and methods for noninvasive electrocardiographic imaging (ecgi) using generalized minimum residual (gmres)
JP3876680B2 (en) 2001-10-19 2007-02-07 コニカミノルタビジネステクノロジーズ株式会社 Image display device
US6735465B2 (en) 2001-10-24 2004-05-11 Scimed Life Systems, Inc. Systems and processes for refining a registered map of a body cavity
US7184820B2 (en) 2002-01-25 2007-02-27 Subqiview, Inc. Tissue monitoring system for intravascular infusion
DE10210645B4 (en) 2002-03-11 2006-04-13 Siemens Ag A method of detecting and displaying a medical catheter inserted into an examination area of a patient
US20140018880A1 (en) 2002-04-08 2014-01-16 Medtronic Ardian Luxembourg S.A.R.L. Methods for monopolar renal neuromodulation
US7043292B2 (en) 2002-06-21 2006-05-09 Tarjan Peter P Single or multi-mode cardiac activity data collection, processing and display obtained in a non-invasive manner
US6892090B2 (en) 2002-08-19 2005-05-10 Surgical Navigation Technologies, Inc. Method and apparatus for virtual endoscopy
US6957101B2 (en) 2002-08-21 2005-10-18 Joshua Porath Transient event mapping in the heart
US7599730B2 (en) 2002-11-19 2009-10-06 Medtronic Navigation, Inc. Navigation system for cardiac therapies
US6893588B2 (en) 2003-06-23 2005-05-17 Graham Packaging Company, L.P. Nitrogen blow molding to enhance oxygen scavenger shelf-life
US20050033136A1 (en) 2003-08-01 2005-02-10 Assaf Govari Catheter with electrode strip
US7398116B2 (en) 2003-08-11 2008-07-08 Veran Medical Technologies, Inc. Methods, apparatuses, and systems useful in conducting image guided interventions
DE10340546B4 (en) 2003-09-01 2006-04-20 Siemens Ag Method and apparatus for visually assisting electrophysiology catheter application in the heart
US20050054918A1 (en) 2003-09-04 2005-03-10 Sra Jasbir S. Method and system for treatment of atrial fibrillation and other cardiac arrhythmias
WO2005025401A2 (en) 2003-09-09 2005-03-24 Board Of Regents Method and apparatus for determining cardiac performance in a patient with a conductance catheter
US20050107833A1 (en) 2003-11-13 2005-05-19 Freeman Gary A. Multi-path transthoracic defibrillation and cardioversion
US20050154282A1 (en) 2003-12-31 2005-07-14 Wenguang Li System and method for registering an image with a representation of a probe
US20050288599A1 (en) 2004-05-17 2005-12-29 C.R. Bard, Inc. High density atrial fibrillation cycle length (AFCL) detection and mapping system
US7865236B2 (en) 2004-10-20 2011-01-04 Nervonix, Inc. Active electrode, bio-impedance based, tissue discrimination system and methods of use
US7720520B2 (en) 2004-12-01 2010-05-18 Boston Scientific Scimed, Inc. Method and system for registering an image with a navigation reference catheter
US7117030B2 (en) 2004-12-02 2006-10-03 The Research Foundation Of State University Of New York Method and algorithm for spatially identifying sources of cardiac fibrillation
US7869865B2 (en) 2005-01-07 2011-01-11 Biosense Webster, Inc. Current-based position sensing
US7684850B2 (en) 2005-01-07 2010-03-23 Biosense Webster, Inc. Reference catheter for impedance calibration
US7722538B2 (en) 2005-02-10 2010-05-25 Dirar S. Khoury Conductance-imaging catheter and determination of cavitary volume
JP2009500052A (en) 2005-06-20 2009-01-08 アブレーション フロンティアズ,インコーポレーテッド Ablation catheter
US7848787B2 (en) 2005-07-08 2010-12-07 Biosense Webster, Inc. Relative impedance measurement
US7536218B2 (en) 2005-07-15 2009-05-19 Biosense Webster, Inc. Hybrid magnetic-based and impedance-based position sensing
US7610078B2 (en) 2005-08-26 2009-10-27 Boston Scientific Scimed, Inc. System and method of graphically generating anatomical structures using ultrasound echo information
US20080221566A1 (en) 2005-11-29 2008-09-11 Krishnan Subramaniam C Method and apparatus for detecting and achieving closure of patent foramen ovale
US9629567B2 (en) 2006-01-12 2017-04-25 Biosense Webster, Inc. Mapping of complex fractionated atrial electrogram
EP2020914B1 (en) 2006-05-10 2017-03-01 Regents of the University of Minnesota Methods and apparatus of three dimensional cardiac electrophysiological imaging
EP1857141A1 (en) 2006-05-15 2007-11-21 BIOTRONIK CRM Patent AG Method for automatically monitoring the cardiac burden of sleep disordered breathing
US7505810B2 (en) 2006-06-13 2009-03-17 Rhythmia Medical, Inc. Non-contact cardiac mapping, including preprocessing
US7515954B2 (en) 2006-06-13 2009-04-07 Rhythmia Medical, Inc. Non-contact cardiac mapping, including moving catheter and multi-beat integration
US7729752B2 (en) 2006-06-13 2010-06-01 Rhythmia Medical, Inc. Non-contact cardiac mapping, including resolution map
US20080190438A1 (en) 2007-02-08 2008-08-14 Doron Harlev Impedance registration and catheter tracking
US10492729B2 (en) 2007-05-23 2019-12-03 St. Jude Medical, Cardiology Division, Inc. Flexible high-density mapping catheter tips and flexible ablation catheter tips with onboard high-density mapping electrodes
US8538509B2 (en) 2008-04-02 2013-09-17 Rhythmia Medical, Inc. Intracardiac tracking system
US8128617B2 (en) 2008-05-27 2012-03-06 Boston Scientific Scimed, Inc. Electrical mapping and cryo ablating with a balloon catheter
US8137343B2 (en) 2008-10-27 2012-03-20 Rhythmia Medical, Inc. Tracking system using field mapping
US8571647B2 (en) 2009-05-08 2013-10-29 Rhythmia Medical, Inc. Impedance based anatomy generation
US8870863B2 (en) 2010-04-26 2014-10-28 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses, systems, and methods for renal neuromodulation
WO2012092016A1 (en) 2010-12-30 2012-07-05 St. Jude Medical, Atrial Fibrillation Division, Inc. System and method for diagnosing arrhythmias and directing catheter therapies
WO2012145077A1 (en) 2011-04-22 2012-10-26 Topera, Inc. Method for detection of cardiac rhythm disorders using basket style cardiac mapping catheter
EP2792323B1 (en) 2011-08-25 2017-10-04 Covidien LP Systems and devices for treatment of luminal tissue
WO2014110579A1 (en) 2013-01-14 2014-07-17 Boston Scientific Scimed, Inc. Renal nerve ablation catheter
CN103750899B (en) * 2014-01-21 2016-04-27 深圳市惠泰医疗器械有限公司 Multi-electrode basket catheter and preparation method thereof
US9585588B2 (en) 2014-06-03 2017-03-07 Boston Scientific Scimed, Inc. Electrode assembly having an atraumatic distal tip
JP2017516588A (en) 2014-06-04 2017-06-22 ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. Electrode assembly

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5893847A (en) * 1993-03-16 1999-04-13 Ep Technologies, Inc. Multiple electrode support structures with slotted hub and hoop spline elements
EP1484026A1 (en) * 2003-06-02 2004-12-08 Biosense Webster, Inc. Catheter for mapping a pulmonary vein
US20090171274A1 (en) * 2007-12-28 2009-07-02 Doron Harlev Non contact mapping catheter
US20130172715A1 (en) * 2011-12-30 2013-07-04 Dale E. Just Electrode support structure assemblies
CN203017083U (en) * 2012-12-31 2013-06-26 上海微创电生理医疗科技有限公司 Multi-electrode ablation catheter

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10034637B2 (en) 2007-12-28 2018-07-31 Boston Scientific Scimed, Inc. Cardiac mapping catheter
US9474467B2 (en) 2008-04-02 2016-10-25 Rhythmia Medical, Inc. Intracardiac tracking system
US9687166B2 (en) 2013-10-14 2017-06-27 Boston Scientific Scimed, Inc. High resolution cardiac mapping electrode array catheter
US9585588B2 (en) 2014-06-03 2017-03-07 Boston Scientific Scimed, Inc. Electrode assembly having an atraumatic distal tip
US9848795B2 (en) 2014-06-04 2017-12-26 Boston Scientific Scimed Inc. Electrode assembly
US10758144B2 (en) 2015-08-20 2020-09-01 Boston Scientific Scimed Inc. Flexible electrode for cardiac sensing and method for making

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