WO2017041889A2 - Dispositif médical allongé, convenant à une insertion intravasculaire et procédé de fabrication d'un dispositif médical allongé convenant à insertion intravasculaire - Google Patents

Dispositif médical allongé, convenant à une insertion intravasculaire et procédé de fabrication d'un dispositif médical allongé convenant à insertion intravasculaire Download PDF

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Publication number
WO2017041889A2
WO2017041889A2 PCT/EP2016/001512 EP2016001512W WO2017041889A2 WO 2017041889 A2 WO2017041889 A2 WO 2017041889A2 EP 2016001512 W EP2016001512 W EP 2016001512W WO 2017041889 A2 WO2017041889 A2 WO 2017041889A2
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WO
WIPO (PCT)
Prior art keywords
medical device
support arms
electrodes
electrode assembly
electrode
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PCT/EP2016/001512
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English (en)
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WO2017041889A3 (fr
Inventor
Peter Ruppersberg
Original Assignee
Ablacon Inc.
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Publication date
Application filed by Ablacon Inc. filed Critical Ablacon Inc.
Publication of WO2017041889A2 publication Critical patent/WO2017041889A2/fr
Publication of WO2017041889A3 publication Critical patent/WO2017041889A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6858—Catheters with a distal basket, e.g. expandable basket
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6857—Catheters with a distal pigtail shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6859—Catheters with multiple distal splines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A61B2017/00327—Cables or rods with actuating members moving in opposite directions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1435—Spiral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/144—Wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Definitions

  • the present invention relates generally to elongated medical devices suitable for intravascular insertion, comprising a flexible elongated body having a distal portion with a distal end and a proximal portion, a mapping electrode assembly located at the distal portion having a plurality of electrodes, the electrode assembly being configured to have an unexpanded condition, where the electrode assembly is stored at a portion of the elongated body, and to have an expanded condition, where the electrode assembly forms a at least two dimensional mapping screen that has a center of symmetry.
  • Such elongated medical devices suitable for intravascular insertion may be manually or ro- botically steerable catheters for the exploration or treatment of vessels or organs or other body cavities or guide wires for guiding catheters or the like medical apparatuses.
  • the present invention especially relates to an elongated medical device suitable for intravascular insertion with individual features of claim 1 , as well as a method of making an elongated medical devices suitable for intravascular insertion with individual features of the respective independent method claim.
  • Elongated medical devices suitable for intravascular insertion such as catheters, especially ablation catheters, and guide wires for guiding catheters through vessels, organs or other body cavities are e.g. used in the treatment of atrial fibrillation (Afib). Atrial fibrillation is the most frequent arrhythmic disorder of the heart. Blood clotting occurring in the fibrillating atria is one main cause of stroke. In so far, Afib is one of the most important disorders associated with a high fatal risk.
  • Afib has been subject to intensive scientific investigations and is meanwhile largely understood.
  • the pulmonary veins draining into the left atrium are the sources of rapid arrhythmic action potentials which trigger circular excitation patterns (rotors), in the left atrium that induce a high frequency fibri llation through their re-entry mechanism.
  • Those rotors have the character of small action potential cyclones of 2 to 3 cm 2 i n size.
  • the l ikel ihood of occurrence of those rotors and the frequency of pathological action potential generation in the pu lmonary vei ns increases with fibrotic structural changes and certain modifications of ion channel expression patterns i n atrial cells with age.
  • the only potential ly curative treatments for Afib are open heart surgery or catheter ablation of those parts of the atrial wal l tissue which originate, transmit or maintain the pathologic excitation circles.
  • mappi ng catheters are used to first identify circular excitation pat- terns (rotors) i n the left atrium. After identification of rotors, force sensing catheters are used that al low to better control the catheter positioni ng pressure which has an influence on the intensity of ablation. Further, water irrigation tries to keep the endothelial tissue free of lesions and micro-calorimetric sensors try to measure and control the heat i n the tissue.
  • US 8,364,234 discloses a system for sensi ng multiple local electric voltages from endocardial surface of a heart.
  • the system i excludes a first elongate tubular member; a basket assembly having a plural ity of flexible spli nes for guidi ng a plural ity of exposed electrodes, the splines havi ng proximal portions, distal portions and medial portions therei n between; a proximal anchor for securely affixing the proximal portions of the spl i nes; the proximal anchor bei ng secured at the distal end of the first elongate tubular member; a distal tip consisting essential ly of means for only securely affixing the distal portions of the splines wherein at least some of the spl ines i n the radial ly expanded non-spherical shape contain a distal excurvate outward bend disposed at the distal portion of the spl i ne at a location near to the distal tip of the basket assembly to bend the spl ines back towards the s
  • US 7,081 , 1 1 4 B2 discloses a remotely deflectable electrophysiology/ablation catheter of the type i ntended for placing i nto an i nterior passage of the heart is disclosed.
  • the distal end of this elongated tubu lar catheter has a pair of tension/compression members each with a flattened end portion connected to the distal electrode and extendi ng through the catheter casing and attached to a user moveable actuator for effecting the tension/compression thereon for remotely curling the distal end of the catheter.
  • Spaced ri ng electrodes are provided adjacent the distal electrode.
  • a permanent bend is pre-formed in the casing and tension/compression members adjacent the ring electrodes about an axis perpendicular to the elongated tension/compression members. Movement of the remote actuator causes the distal portion of the catheter to curl into a lariat in a plane perpendicular to the axis along the elongated catheter casi ng, thus permitti ng electrical mapping or ablation with the distal and/or ri ng electrodes about the i nner surface of the heart passage into which the lariat is formed and situated.
  • the lariat can achieve a curvature greater than 360 degrees and at a significantly reduced radius to al low insertion of the catheter distal end into passages of reduced dimension.
  • a disadvantage of this catheter is the low resolution of the electrode array when used for mappi ng due to the l imited number of electrodes and due to the relative large distances from electrode to electrode in the radial direction.
  • WO 201 2/09201 6 discloses a medical device having a distal end that is arranged in a spiral configuration having a single spiral arm extending between an elongated part of the device and its distal end, which is formed on the end of the spiral arm.
  • the spiral configuration is general ly planar and contains a number of electrodes for taki ng unipolar or bipolar measurements from a tissue.
  • the diameter of the outermost loop of the spiral configuration is twenty mi ll imeters.
  • the spiral configuration may contain multiple spiral loops. Anyhow, a first disadvantage of this device is that the maximum diameter of the spi ral configuration loops is restricted by the diameter of the vessel, organ or other body cavity the device is to be introduced in.
  • US 201 0/0094274 ⁇ discloses a sensor catheter in the form of an adjustable corkscrew design, with a small number of spiral meridians ending on a blunt non-traumatic end.
  • the meridians may include multiple elements, electrodes or probes.
  • the corkscrew can be advanced or retracted into the sheath by manipulating the shaft, to increase or decrease the corkscrew size and/or probe spacing.
  • a disadvantage of this geometry is that it will be difficult to control because it has a very long free ending. Further, it is almost impossible to judge if it really touches the surface.
  • US 2008/0275367 A1 discloses robotic instrument systems and methods for generating a ge- ometric map of an area of body tissue which is correlated with a tissue characteristic such as tissue compliance or related property.
  • the system comprises a robotically controlled catheter which is controlled by a robotic instrument driver.
  • a force sensor system is provided that generates force signals responsive to a force applied to the distal end of the catheter.
  • a position determination system is also provided which generates position signals responsive to the location of the distal end of the catheter.
  • a computer is configured to receive and process the force signals and position signals to generate a geometric map of an area of body tissue correlated to the tissue compliance of different regions of the body tissue or a tissue characteristic determinable from the tissue compliance.
  • an elongated medical device suitable for intravascular insertion wherein a force sensor is disposed within said flexible elongated body proximate said distal end.
  • a mapping electrode assembly and a force sensor in a single elongated medical device allows for collection of electrophysiological data such as action potential data when the elongated medical device is located in the respective body area, such as the left atrium of the heart, and when a press on force is detected by the force sensor i ndicati ng satisfactory contact with the tissue to be electrophysiological ⁇ mapped by the mappi ng electrode assembly.
  • the force sensor is configured to sense forces appl ied to said distal end, with the distal end bei ng arranged in the center of symmetry of the mapping screen in the expanded condition of the electrode assembly.
  • the elongated medical device also comprises an ablation assembly.
  • the ablation assembly which may e.g. be formed as an ablation electrode assembly for RF (radio frequency) ablation
  • the elongated medical device al lows to perform the whole procedure of localization, exami nation and treatment of atrial fibri l lation rotors with a single de- vice.
  • the correct press on force wi l l be sensed by the force sensor
  • the mapping electrode assembly wil l col lect electrophysiological data to identify rotors and the tip of the device may then be located in the center of such identified rotors.
  • the tissue hosting the rotor may be treated by ablation, e.g. electro- respectively RF ablation by means of the ablation assembly for best results and least harm to the healthy tissue.
  • the plural ity of electrodes is arranged on at least two support arms, the at least two support arms being configured to have an unexpanded condition, where the at least two support arms fit closely along a portion of the elongated body, and to have an expanded condition, where at least a part of each of the at least two support arms project away from the elongated body.
  • At least the central parts of the at least two support arms are wound in a spiral i n the expanded condition of the support arms, formi ng a mappi ng screen that has a spiral structure with at least two spiral arms and with the distal end bei ng located i n the center of symmetry of the spiral structure.
  • the force sensor is located i n the area of the center of symmetry of the spiral structure (and respectively of the mapping electrode assembly) and is configured to sense a force appl ied to said distal end.
  • the advantage of the central disposition of the force sensor i n respect to the spi ral structure is, besides from the before mentioned advantages of a force sensor in general, the easy navigation and positioni ng achieved by this geometry.
  • the force sensor is used to verify that the mapping electrode assembly is touching the inner surface of the atrium.
  • the tip/distal end of the elongated medical device is automatically centered together with the electrode array and so is the force sensor centered.
  • an ablation of the body tissue can be initiated by an ablation tip electrode, thus ablating the center of the rotor structure.
  • the spirally structured electrode assembly according to the invention with at least two spiral arms allows for a relative even distribution of electrodes in a defined area and is fail-safe and inexpensive to produce. Further, the inventive spirally structured electrode assembly allows for an enhanced electrode density, allowing an electrode mapping of larger tissue areas as in the state of the art.
  • the plurality of electrodes is arranged on at least two support arms, each of the support arms having a distal part that is pivotably connected to the distal portion of the medical device proximate said distal end. Due to the pivotable connection of each support arm with the distal portion, every contact of a support arm with a body surface may result in pivoting the respective arm at the pivotable connection such that each arm may flexibly re- spond to a contact with a body surface.
  • the pivotable connection may be realized by disposing hinges in the connecting region between the support arms and the distal portion.
  • the force sensor is formed as an optical force sensor and comprises a light source, an optical sensor and a light beam path in between the light source and the optical sensor.
  • the advantage of the optical sensor is its small instal- lation size coupled with its high precision and high resolution.
  • the light source may preferably be formed as an LED (Light Emitting Diode).
  • the optical sensor may be formed as a camera module, more preferably as a waver-level camera. Such a camera module, especially the waver-level camera allows for a high resolution of the optical force sensor in the range of 0.01 N +/- 0.005 N and a sampling rate of > 25 samplings per second. This sampling rate is identical with the video rate of the waver-level camera. Further, such camera modules, like waver-level cameras, are available in very small sizes, smaller than a match head.
  • An alternative optical sensor may comprise a cmos sensor or an array of photo-diodes.
  • the force sensor / optical force sensor further comprises aperture seg- ments defining an aperture in the light beam path, each aperture segment being coupled to at least one support arm for joined pivot-movement with the at least one support arm and being configured to move in and out of the light beam path to influence reception of light by the optical sensor.
  • the aperture is preferably located closer to or adjacent to the light source.
  • the force sensor data may be analog data or the data may be digitized in the elongated medical device and communicated to the data processing and control unit in the form of digital data.
  • each aperture element is coupled to an end of a distal part of a support arm.
  • every pivot movement of the support arm wil l be di- rectly transmitted to the associated aperture element which will move in a direction out of the light beam path.
  • all aperture elements are of identical shape and size so that they cover the same area. Forces applied to any of the associated support arms are equally weighted such that the same force applied to one or more support arms will result in the same force data output for each individual support arm.
  • the electrode assembly includes a number of 2 plus n support arms, whereby n equals 2 to 30, preferentially 2 to 22, more preferentially 2 to 14.
  • n equals 2 to 30, preferentially 2 to 22, more preferentially 2 to 14.
  • the distal portion of the elongated medical device defines a longitudinal axis
  • the center of symmetry of the spiral structure is located in the longitudinal axis
  • the spirally wound parts of the support arms lie in a plane that intersects the longitudinal axis perpendicularly.
  • the advantage of this arrangement is a 2 to 2 plus n-fold rotation symmetry of the spiral structure with the longitudinal axis as a center of rotation with all electrodes arranged in a plane that is perpendicular to the longitudinal axis.
  • the spiral structure of electrodes is but also flexible, so that when the spiral structure of electrodes is pushed against a body surface, it will follow the topography of the body surface it is in contact with to obtain optimal electrode measurements.
  • the electrodes are located on the central parts of each of the support arms and the electrodes are lying in or are arranged in parallel to the plane, defined by the spiral structure, in the expanded condition of the support arms.
  • the distal parts of the support arms being attached to the distal portion adjacent the distal end and the proximal parts of the support arms being coupled to an axial ly movable member located on an end of the proximal portion facing the distal portion.
  • the axially movable member may be coupled to an actuating mem- ber which could be part of a handle of the elongated medical device.
  • the spirally structured electrode assembly may be easily transferred from its unexpanded condition to its expanded condition and vice versa from its expanded condition to its unexpanded condition.
  • Axially movable thereby means that this member is movable relative to another part of the elongated medical device. So, actually, the other part (distal portion of the elongated body) may be moved and the axially movable member may be static.
  • the axially movable member is adapted to be moved back and forth between a first position and a second position, wherein a movement from the first position to the second position is in direction of the distal portion in order to dislocate the support arms from their unexpanded condition, where the at least two support arms fit closely along a portion of the elongated body, to their expanded condition, where at least the central parts of the at least two support arms are spirally wound and wherein a movement from the second position to the first position is in a direction away from the distal portion in order to dislocate the support arms from their expanded condition back into their unexpanded condition.
  • the axially movable member may be static and the other part (distal portion) of the elongated body to which the distal parts of the support arms are being attached to may be moved.
  • each support arm comprises a strand formed of a shape memory metal and a PCB (Printed Circuit Board) layer, whereby the PCB layer carries the electrodes and the electric lines for contacting the electrodes electrically.
  • the strands are formed out of a shape memory metal, such as e.g. Nitinol, and memorize the spiral arm shape.
  • the PCB ' s on the other hand, passively follow any shape the strands may possess.
  • the PCB ' s at least partially surround or encapsulate the strands, thus protecting the strands.
  • PCB ' s and strands may be connected to each other by material bond- ing, e.g. by gluing or curing.
  • each of the support arms (a number of 8 to 30 electrodes is disposed on each of the support arms. So, advantageously an electrode array of 1 6 electrodes (on a total of two spiral arms) to about 480 electrodes (on a total of sixteen spiral arms) may be achieved. Preferably a number of 8 to 1 8 electrodes is disposed on each of the support arms allowing for an electrode array of 1 6 electrodes (on a total of two spiral arms) to about 288 electrodes (on a total of sixteen spiral arms). Whi le low resolution electrode arrays of only 1 6 electrodes are sti ll possible, the invention allows for high resolution electrode arrays of 256 electrodes and even more up to about 480 electrodes. In a further favorable embodiment of the present invention, the electrodes are gold plated, thus allowing for a high electrode sensitivity coupled with a very good bio-compatibility, avoiding defensive reactions of the immune system of the human or animal body.
  • the surface size of an electrode is between 0,01 mm 2 and 0,25 mm 2 , which allows for an utilization of PCB ' s having a width of less than 1 mm while the electrodes still have a satisfactory impedance of 10 kilo ohm to 1 mega ohm.
  • two adjacent electrodes on an individual support arm are arranged in a distance to each other, wherein this distance is between 2 mm and 9 mm, preferably between 2.5 mm and 4.5 mm. Further advantageously, two adjacent electrodes on two adjacent support arms are arranged in a distance to each other, wherein the distance is between 2 mm and 9 mm, preferentially between 2.5 mm and 4.5 mm.
  • the distance between two adjacent electrodes on an individual support arm and the distance between two adjacent electrodes on two adjacent support arms are equal within a maximum tolerance in a range of up to +/- 1 .5 mm. With these distances a resolution of about 1 to 36 electrodes per cm 2 are achieved.
  • the electrodes on the support arms are electrically connected to at least one electronic element of an electronics unit disposed at the distal portion adjacent the distal end.
  • the electronic element of the electronic unit disposed at the distal portion adjacent the distal end of the elongated body has the advantage, that some processing of the electrode measurement data can already be performed in the elongated medical device. This will reduce noise and the sensitivity to electrical interference.
  • the at least on electronic element is configured to process and digitize analog signals received from the electrodes. Due to this advantageous data processing and digi- talization already in the distal end area of the device, the communication cables or wires needed for communication with the external data processing unit can be reduced in number, hence reduci ng the necessary construction volume and thus reduci ng the diameter of the elongated device even for a higher number of electrodes in the spirally structured electrode array.
  • the at least one electronic element may also digitize ana- log measurement data of the force sensor so that digital force sensing data may be communicated to the data processing and control unit.
  • the at least one electronic element is an ASIC which comprises one or more operational ampl ifiers, at least one multiplexer and at least one analog-digital converter.
  • ASIC application-specific integrated circuit
  • the electronics unit with the at least one electronic element is adapted to be connected to a data processi ng and control unit that is configured to process digitized electrode measurement data and to output data for visual- izi ng and displaying atrial rotors of a patient on a data output unit.
  • the medical device is formed as a catheter for the exploration or treatment of a vessel, organ or other body cavity.
  • This catheter contains one or more of the i nventive features described before.
  • the medical device may be formed as a guide wire for guiding a catheter or the l i ke medical apparatus through a vessel, organ or other body cavity, whereby the guide wire i ncludes one or more of the i nventive features described before.
  • Fig. 1 a is a schematic view of an elongated medical device i n a fi rst embodiment which is a catheter for exploration or treatment of a vessel or organ or other body cavity which i ncludes an electrode assembly for electro-anatomic mapping of cardiac or vessel areas i n a first, un- expanded condition of the electrode assembly;
  • Fig. 1 b is an enlarged view of the distal portion of the elongated medical device of Fig. l a according to the area marked lb in Fig. 1 a;
  • Fig. 1 c is an enlarged view of an area of the proximal portion of the elongated medical device of Fig. 1 a according to the area marked lc in Fig. 1 a;
  • Fig. 1 d is an enlarged view of a proximal end area of the proximal portion of the elongated medical device of Fig. l a connected to a data processi ng and control unit / data output unit;
  • Fig. 2 is a schematic view of the elongated medical device of Fig. 1 a i n a second, expanded condition of the electrode assembly;
  • Fig. 3 is a cut view of the elongated medical device accordi ng to the li ne II I - I I I of Fig. 1 a;
  • Fig. 4 is a cut view of the elongated medical device accordi ng to the l i ne IV - IV of Fig. 2;
  • Fig. 5 is a cut view of the elongated medical device accordi ng to the l i ne V - V of Fig. 8;
  • Fig. 6 is a top view of the elongated medical device according to Fig. 2 in the second, expanded condition of the electrode assembly;
  • Fig. 6a is an enlarged view of an area of the electrode assembly of the elongated medical device of Fig. 6 according to the marking Via in Fig. 6;
  • Fig. 7 is a perspective view on the distal portion of the elongated medical device according to Fig. 2;
  • Fig. 8 is an enlarged perspective view of the distal end area of the elongated medical device of Fig. 2 i n the second, expanded condition of the electrode assembly;
  • Fig. 9 is a detai l of the electrode assembly of the elongated medical device; Fig. 9 is an enlarged detail of the electrode assembly of Fig. 9;
  • Fig. 1 0 is a top view of a further embodiment of the elongated medical device in the second, expanded condition of the electrode assembly;
  • Fig. 1 0a is an enlarged view of an area of the electrode assembly of the elongated medical device of Fig. 1 0 according to the marking Xa in Fig. 1 0;
  • Fig. 1 1 is a top view of a sti ll further embodiment of the elongated medical device in the second, expanded condition of the electrode assembly;
  • Fig. 1 1 a is an enlarged view of an area of the electrode assembly of the elongated medical device of Fig. 1 1 according to the marking Xla in Fig. 1 1 ;
  • Fig. 12 is a top view of a sti ll further embodiment of the elongated medical device in the second, expanded condition of the electrode assembly;
  • Fig. 12a is an enlarged view of an area of the electrode assembly of the elongated medical device of Fig. 12 according to the marking Xlla in Fig. 1 2;
  • Fig. 1 3 is a top view of a still further embodiment of the elongated medical device in the second, expanded condition of the electrode assembly;
  • Fig. 1 3a is an enlarged view of an area of the electrode assembly of the elongated medical device of Fig. 1 3 according to the marking Xllla in Fig. 1 3;
  • Fig. 14a is a representation of an exemplary visual output on the screen of the data output unit
  • Fig. 1 4b is a representation of a further exemplary visual output on the screen of the data output unit
  • Fig. 1 5 is a top view of a still further embodiment of the elongated medical device in the second, expanded condition of the electrode assembly
  • Fig. 1 6a is an enlarged partial cut view through the central distal portion of the elongated medical device of Fig. 1 5;
  • Fig. 1 6b is an enlarged axial view on the central distal portion of the elongated medical device of Fig. 1 5 and 1 6a when no force is applied to any of the support arms;
  • Fig. 1 6c is an enlarged partial cut view through the central distal portion of the elongated medical device of Fig. 15 that corresponds to Fig. 1 6a, wherein in Fig. 16c a force is applied to one of the support arms;
  • Fig. 1 6d is an enlarged axial view on the central distal portion of the elongated medical device of Fig. 1 5 and 1 6c with a force being applied to one of the support arms;
  • Fig. 1 7 is a top view of a still further embodiment of the elongated medical device in the second, expanded condition of the electrode assembly;
  • Fig. 1 8a is a side view of the elongated medical device of Fig. 1 7;
  • Fig. 1 8b is an enlarged axial view on the central distal portion of the elongated medical device of Fig. 1 7 and 18a with a force being applied to two of the support arms.
  • the present invention is directed to an elongated medical device suitable for intravascular insertion, such as a catheter for exploration or treatment of a vessel, organ or other body cavity which includes an electrode assembly for electro-anatomic mapping of cardiac or vessel areas or the like medical apparatus.
  • the medical device has a force sensor which could be formed as a 3D optical force sensor with which contact forces between a distal portion of the medical device and a wall of the vessel, organ or other body cavity can be measured in three dimensions.
  • Such an optical force sensor is e.g. disclosed in the parallel patent application PCT/EP201 5/001 097.
  • the force sensing abi lity may be used periodically to measure the contact forces at certain points, or, alternatively, it may be used to continuously monitor such contact forces to support the operation of the medical device.
  • the electrode assembly may be used to map circular excitation patterns (rotors), e.g. of the left atrium of the heart, as will be described in more detail in the following.
  • an elongated medical device 1 is formed as a combined ablation and mapping catheter, e.g. to be used in the curative treatment of Atrial Fibrillation and other hearth rhythm diseases like Atrial Flutter, Accessory Pathways or Ventricular Tachycardia.
  • the elongated medical device 1 comprises an elongated body 2, which is only partly shown in Figures 1 a and 2.
  • a tip electrode 6 arranged at its distal end 4 as can especially be depicted from Figures 1 b and 8.
  • At least one further electrode which is an annular ground electrode 8 is arranged at the distal portion 3 of the elongated body 2.
  • Tip electrode 6 and ground electrode 8 are electrically isolated from each other and are used for electro-ablation of body tissue, e.g. in the left atrium of the heart, where rotors have been detected and tissue has to be treated.
  • a flexible tube (56) is disposed which is an isolator.
  • a proximal portion 5 of the elongated body 2 is formed as a flexible tube and comprises an outer tube 29 made e.g. of a combination of a woven grid metal-layer and plastic and/or silicone rubber and/or ChronePreneTM and an inner tube 28 e.g. of a combination of a woven grid metal-layer and plastic and/or silicone rubber and/or ChronePreneTM in a radial distance of about 0.2 mm - 0.4 mm .
  • Inside of the inner tube 29 there is an inner shaft-member 24 arranged which fills the inner tube volume of inner tube 28 and which is in sliding relation to inner tube 28.
  • Inner shaft-member 24 may be made e.g.
  • Inner tube 28 and inner shaft-member 24 continue up to the distal portion, while the outer tube 29 ends at an annular steering member 25 which is axially movable.
  • the inner shaft-member 24 member there are arranged a number of channels which include a first channel 23, through which the force sensor cable 22 is guided along the elongated body 2 up to the force sensor 20, second channels 87, through which mapping elec- trode cables 88 and ablation electrode cables 88a are guided along the elongated body 2 up to distal portion 3 with the respective electric components to be contacted, and fluid supply line 1 9 which is formed as a channel as well.
  • the number of channels disposed in the inner shaft-member may vary upon the technical needs and the number of cable to be accommodated.
  • the elongated medical device 1 further comprises a fluid supply line 1 3, which may be connected to a fluid supply 1 7 (see Fig. 1 d).
  • This fluid supply line 1 3 is in fluid-guiding connection to at least one fluid opening 1 8 in the tip electrode 6, through which an irrigation fluid, like e.g. a saline fluid, may flow to the outside of the distal portion 3 of the elongated medical device 1 to irrigate a surrounding portion of the vessel, organ or other body cavity into which the elongated medical device 1 has been introduced. Fluid flow is guided from the fluid supply line 1 3 through the fluid channel 1 9 (see figures 3, 4 and 5) in the elongated body 2. Fluid flow 63 through the fluid supply line 1 3 and the fluid channel 1 9 in the elongated medical device 1 to the at least one fluid opening 1 8 to the outside of the elongated medical device 1 is indicated by arrows 63 in Fig. 8.
  • an irrigation fluid like e.g. a saline fluid
  • Fluid flow may be controlled by the handle 7 or by a control at the fluid supply 1 7. Irrigation fluid will be distributed especially during or after an electro-ablation procedure has been performed.
  • the distal portion houses towards its distal end 4 a force sensor assembly 20 / force sensor, preferably an optical force sensor such as described in co-pending patent application PCT/EP201 5/001 097 of the applicant.
  • the force sensor assembly comprises an elastic element 51 , which is formed as a helical spring that has a metal core and an outer rim, which is formed by an isolating plastic material. By means of the elastic element 51 , a first and a second part of the force sensor are moveably connected with each other, whereby this connection need not be a fixed connection.
  • a handle 7 is disposed which comprises a first handle part 7a and a second handle part 7b. Via the handle 7 electro-ablation using the electrodes 6, 8 can be initiated and also the operation of an electrode assembly 80 / mapping electrode assembly may be controlled.
  • the electrode assembly 80 / mapping electrode assembly is located at the distal portion 3 and comprises in the embodiment of Figures 1 a - 8 eight support arms 81 , whereby it has to be mentioned that the invention requires at least two such support arms 81 .
  • Each support arm 81 has a proximal part 81 a, a distal part 81 b and a central part 81 c between the proximal part 81 a and the distal part 81 b.
  • the distal parts 81 b of each of the support arms 81 are attached to the distal portion 3 adjacent to its distal end 4 and the proximal parts 81 a of the support arms 81 are coupled to a steering member 25 located on an end of the proximal portion 5 that faces the distal portion 3.
  • the support arms 81 are configured to have a first, unexpanded condition UC, in which the support arms 81 are arranged in a close fit along a portion of the elongated body 2, as is best seen in Figures 1 a - 1 c and 3.
  • UC unexpanded condition
  • the steering member 25 located in its first position 60, remote, or in other words in a maximum distance to the distal end 4.
  • the support arms 81 are further configured to have a second, expanded condition EC, in which the central parts 81 c of each of the support arms 81 project away from the elongated body 2 and are spirally wound, forming a spiral structure 83 with eight spiral arms 84 and the distal end 4 being located in a center of symmetry C of the spiral structure 83.
  • Spiral arms 84 essentially correspond to the central parts 81 c of the support arms.
  • the center of symmetry C of the spiral structure 83 lies in a longitudinal axis A which is defined by the distal portion 3 of the elongated medical device 1 .
  • the steering member 25 located in its second position 70, nearby, or in other words in a minimum distance to the distal end 4.
  • the spiral structure 83 with the spiral arms on the other hand define a plane P which intersects the longitudinal axis A essentially perpendicularly.
  • the electrode assembly forms an electrode array of a plurality of electrodes 81 arranged essentially in the plane P.
  • the electrode array in the present embodiment com- prises 8 support arms 81 with each support arm carrying 1 8 electrodes so that the electrode array counts 8 times 1 8 electrodes summing up to a total of 144 electrodes and has a size of about 4.4 cm in diameter which is about 1 5.2 cm 2 .
  • the corresponding spatial resolution is about 1 0 times higher than that of existing electro-mapping technologies.
  • two adjacent electrodes 82 on an individual support arm 81 are arranged in a distance x to each other.
  • This distance x is between 2 mm to 9 mm, preferably between 2.5 mm to 4.5 mm.
  • two adjacent electrodes 82 on two adjacent support arms 81 are arranged in a distance y to each other.
  • This distance y is between 2 mm to 9 mm, preferentially between 2.5 mm to 4.5 mm.
  • Distances x and y are correlated with each other in that the distance x and the distance y are equal within a'maximum tolerance in a range of +/- 0,5 mm.
  • a steering wire 27 is guided between the inner tube 28 and the outer tube 29 between the inner tube 28 and the outer tube 29 between the inner tube 28 and the outer tube 29 there are two guide channels 26 arranged in each of which a steering wire 27 is guided.
  • the steering wires 27 are fixedly connected at one end to the annular steering member 25 and at their respective other end at the first handle part 7a of handle 7.
  • the handle 7a which may be moved away from the second handle part 7b (see movement of first handle part 7a indicated by arrow 9 in Fig. 2), and the steering wires 27 the annular steering member 25 can be moved from its first position 60 towards the distal end 4 of the elongated medical device 1 into its second position 70 (see movement of annular steering member 25 indicated by arrow 10 in Fig. 2), reducing the distance between the annular steering member 25 and the distal end 4.
  • the electrode assembly 80 / mapping electrode assembly and their eight support arms 81 will be transferred from their unexpanded condition UC to their expanded condition EC, opening and expanding the spiral structure 83 of the electrode assembly 81 .
  • this expanded condition EC the electrode assembly is ready for use in mapping circular excitation patterns (rotors), e.g. of the left atrium of the heart.
  • mapping circular excitation patterns rotors
  • a movement of the first handle part 7a in the other direction back towards the second handle part 7b will close and collapse the spiral structure 83 of the electrode assembly 81 , transferring it to the unexpanded condition EC of the electrode assembly 80 / mapping electrode assembly and their eight support arms 81 .
  • each support arm 81 carries a plurality of electrodes 82 (also refer- enced to as mapping electrodes) which are gold-plated for enhanced electro-conductability, as can especially be seen in Fig. 6.
  • electrodes 82 also refer- enced to as mapping electrodes
  • the surface size of an electrode 82 is between 0.01 mm 2 and 0.25 mm 2 .
  • each of the support arms 81 comprises a strand 86 formed of a shape memory metal and a PCB (printed circuit board) layer 85, whereby the PCB layers 85 carry the electrodes 82 and electric lines 89 for contacting the electrodes 82 electrically.
  • the PCB layers 85 at least partially surround the strands 86, which may be formed as Nitinol wires of 0.1 - 0.3 mm diameter, preferentially 0.2 mm diameter.
  • the PCB layers 85 of two support arms 81 merge at their distal part 81 b and both contact an electronic element 91 of an electronic unit 90 which is arranged at the distal portion 3 close to the force sensing assembly 20 (see Fig. 8 in this respect).
  • the electronic unit 90 comprises four electronic elements 91 (see Fig. 5.) which are arranged radially outwardly on the distal end of the inner shaft-member 24.
  • the hull 30 of this part of the distal portion, where the electronic unit 90 is located is again made of a silicone rubber or a ChronePreneTM.
  • each electronic element 91 which are adapted to process and digitize analog signals received from the electrodes 82, are formed as ASIC ' s (application-specific integrated circuits).
  • the ASIC ' s have a size of between 1 x 0.6 to 3 x 1 .8 mm, preferentially 2 x 1 .2 mm, and are located on the PCB layer 85 at the area where two support arms 81 merge together.
  • each electronic element 91 / ASIC comprises a plurality of operational amplifiers 92, preferentially seventy two operational amplifiers 92, at least one multiplexer 93 and at least one analog- digital converter 94.
  • Each of the electrodes 88 is connected via an electric line 89 to a re- spective operational amplifier 92 of the electronic element 91 .
  • the operational amplifiers 92 acquire AC inputs from the electrodes 82 on four wires / electric lines 89 with 1 00 kilo ohm input resistance each and 1 s of time constant. Signals are low pass filtered at 200 Hz and read by the analog multiplexer 93 and through the 14 bit analog-digital converter 94 and forwarded into a serial LVDS digital output signal via mapping electrode cables 88 and data line 12 passing to a three channel serial interface jointly with the force sensor data of force sensing assembly 20.
  • the force sensing assembly 20, the electrode assembly 80 with its electronics unit 90 and with the electronic elements 91 as well as the electrodes 6, 8 are connected via a line 12 with a data processing and control unit 1 5 (see Fig. 1 d), which energizes and controls the force sensor assembly 20 and the electrodes 6, 8.
  • Data processing and control unit 1 5 processes electrode mapping data from the electrode assembly and sensor data received from the force sensor assembly 20 and outputs mapping data and force sensor data via a data output unit 1 6.
  • Line 1 2 may be a ribbon cable, flat conductor, flat flexible cable or the like and combines force sensor cable 22, mapping electrode cables 88 and ablation electrode cables 88a.
  • the data processing and control unit 1 5 is configured to process digitized electrode measurement data and to output data for visualizing circular excitation pattern (rotors) 45 e.g. in the left atrium of a patient's heart on a data output unit 1 6 which will be explained in detail with respect to figures 14a and 14b.
  • Figures 14a and 14b represent exemplary visual outputs on the screen or a sub-zone 14 of the data output unit 1 6.
  • a pre-condition of a meaningful electro-anatomic mapping is that the force sensing assembly 20 of the elongated medical device 1 or catheter has detects a sufficient perpendicular force vector F (see e.g. Fig. 2), indicating that the tip electrode 6 is in sufficient contact with the tissue (not displayed in the Figures) e.g. of the left atrium of the heart.
  • the excitation in response to a pacing stimulus is measured while travelling along the walls of the atrium.
  • the path from one side to the other is around 6 cm and the excitation needs 200 ms for this distance.
  • the "eye of the storm" has a diameter of around 1 cm (circumference of 3 cm).
  • rotor excitation cycles have a period of 200 ms or 300 beats per minute. Since action potentials are about 1 00 ms in duration excitation clusters have a size of about 1 .5 cm.
  • the data output unit 1 6 or monitor display shows the tissue e.g. of the left atrium of the heart as a 3 D object visualized from outside with the atrial septum on the backside.
  • the respective excitation pattern map is put on the surface of this object as texture of electro-anatomic data arrows 40 upon a sufficient perpendicular force vector F.
  • the excitation pat- tern or cluster has a length of about four to five electrode distances x, y.
  • the circular excitation pattern 45 is recorded every 10 ms and visualized on a screen or sub-zone 1 4 of a screen of the data output unit 1 6 or monitor display by means of electro-anatomic data arrows 40.
  • the circular excitation pattern (rotor) 45 travels with a speed of about half an electrode per measurement cycle.
  • the amplitude pattern of the AC signal undergoes a software cluster analysis. Each cluster ' s center of gravity position is determined in each time interval.
  • Electro-anatomic data arrows 40 are displayed on the sub-zone 1 4 of the screen of the data output unit 1 6 indicating the direction of movement of a circular excitation pattern (rotor) 45.
  • the Electro- anatomic data arrows 40 indicate rotors 45 by their circulating behavior which is indicated by circular arrows 41 a and 42 i n Fig. 1 4a, where two active rotors 45 may be identified.
  • the high resolution of the electro-anatomic data arrow map wil l al low to see the excitation path also if the voltage ampl itude is changing in case of fibrosis. Fig.
  • FIG. 1 4b shows the situation after electro-ablation of the rotor 45 i ndicated by circular arrow 41 b has taken place by using the ablation facility (tip electrode 6 and ground electrode 8) of the elongated medical device 1 or catheter.
  • the ablation facility tip electrode 6 and ground electrode 8
  • rotor 45 of Fig. 1 4a has vanished completely as indicated by circular arrow 41 b.
  • I n Fig. 1 a the elongated medical device 1 /catheter is displayed in a condition when it may be introduced into a vessel, organ or other body cavity and when the electrode assembly 80 and the support arms 81 are in thei r unexpanded condition UC.
  • the medical device 1 or catheter wil l be inserted i n the vessel, organ or other body cavity until it reaches the target area, which may e.g. be the left atrium of the heart.
  • the operator may expand the electrode assembly 80 by movi ng first handle part 7a i n di rection of arrow 9, as displayed in Fig. 2.
  • the medical device 1 wil l be pushed with its distal end 4 and respectively with its tip electrode 6 agai nst body tissue exerti ng a force F on the distal end 4.
  • Force F wi l l be measured by the force sensi ng assembly 20 as has been described before.
  • electro-anatomic mappi ng wi l l be started either automatical ly or initiated by the operator as has been explained in detai l above.
  • electro ablation using the tip electrode 6 and ground electrode 8 wil l be i nitiated by the operator as has been explained i n detai l above.
  • the inventive elongated medical device 1 or catheter is a multipurpose device which combines force detection, electro-anatomic mapping and ablation in one device.
  • Figs. 1 0 and 1 0a display a further embodiment of the elongated medical device 1 1 .
  • the embodiment of Figs. 10 and 1 0a differs from the one described in Figs. 1 a to 9 in that the electrode assembly 80 comprises six support arms 81 forming a spiral structure 83 with six spiral arms 84 in the expanded condition EC of the electrode assembly 80 and the support arms 81 .
  • Each of the six support arms 81 carries eighteen electrodes 82.
  • Figs. 1 1 and 1 1 a a further embodiment of the elongated medical device 1 1 0 is shown.
  • the electrode assem- bly 80 comprises twelve support arms 81 forming a spiral structure 83 with twelve spiral arms 84 in the expended condition EC of the electrode assembly 80 and the support arms 81 .
  • Each of the support arms 81 carries eighteen electrodes.
  • Figs. 1 2 and 12a display a further embodiment of the elongated medical device 21 0.
  • the electrode assembly 80 comprises sixteen support arms forming a spiral structure 83 in the expanded condition of the electrode assembly 80 and support arms 81 that has sixteen spiral arms 84, whereby each of the spiral arms 84 carries sixteen electrodes 82.
  • FIGs. 1 3 to 1 3a another embodiment of the elongated medical device 31 0 is shown.
  • FIGs. 1 a to 9 another embodiment of the elongated medical device 31 0 is shown.
  • Figs. 1 3 and 1 3a differs from the ones described in Figs. 1 a to 12a in that the electrode assembly 80 forms a spiral structure 83 in the expanded condition EC of the electrode assembly 80 and the support arms 81 that has eight spiral arms 84 which occupy a square like area in the expanded condition EC.
  • the spiral arms 84 are partly curved and partly linear in the expanded condition EC of the support arms 81 .
  • Figs. 1 5 to 1 6d display a further embodiment of the elongated medical device 1 1 .
  • the electrode assembly 80 comprises four support arms 81 forming a spiral structure 83 with four spiral arms 84 in the expanded condition EC of the electrode assembly 80 and the support arms 81 .
  • Each of the four support arms 81 carries eighteen electrodes 82 which are equally spaced and distributed as had been discussed previously e.g. with reference to Fig. 6a.
  • Tip 6.1 is not formed as a tip electrode in this embodiment. Tip 6.1 could though be realized as a tip electrode if an ablation function of the device is intended.
  • the force sensor 20 of this embodiment is formed as an optical force sensor 20 as can be seen in more detail in Figures 1 6a to 1 6d.
  • the optical force sensor 20 comprises a light source 31 , like an LED, which is mounted on a light source mounting 36 which is fixed to the tip 6.1 .
  • the optical force sensor 20 further comprises an optical receiver / optical sensor 32 such as a camera or a waver level camera on a circuit board 34 mounted at the end of inner tube 28 of the elongated medical device.
  • Optical force sensor 20 with its components is arranged coaxially with the axis A of the distal portion of the elongated medical device. Along the axis A runs a light beam path 33 between the light source 31 and the optical sensor 32.
  • the optical force sensor 20 further comprises aperture elements 39 that define an aperture 38 in the light beam path 33.
  • Each aperture element 39 is coupled to at least one support arm 81 for joined pivot-movement with this support arm 81 .
  • the aperture elements 39 are each coupled to an end 81 d of the distal part 81 b of a support arm 81 .
  • the aperture elements 39 are all of identical shape and size so that they cover the same area.
  • the aperture elements 39 are formed as thin blades.
  • the aperture 38 is preferably located closer to or adjacent to the light source 31 . That is, if the distance between the light source 31 and the optical sensor 32 is 1 00%, than a distance closer to or adjacent to the light source is 0% to 33% of the total distance.
  • the aperture elements 39 are in their closed state, when no force is applied to any of the support arms 81 the aperture elements 39 jointly cover 90% to 1 00% of the aperture 38 in the light beam path 33. Accordingly, 90% to 1 00% of the light beam path 33 are blocked by the closed aperture elements 39. In this closed condition no or only little amount of light may fall onto the optical sensor 32.
  • the support arms 81 are pivotably mounted with their ends 81 d to the inner tube 28 of the elongated medical device.
  • the aperture elements 39 are pivotable together with their respective support arms 81 and accordingly the aperture elements 39 move out of the light beam path 33 when a force F is exerted to their respective support arms 81 as is indicated in Figures 1 6c and 1 6d.
  • a force F is exerted on one of the support arms 81 , e.g. because the support arm 81 is in contact with a body surface, such as an inner surface of an atrial wall (not shown). Mapping electrodes 82 on the respective support arm 81 will accordingly be in contact with the body surface tissue.
  • the aperture element 39 that belongs to the contacting support arm 81 will move out of the light beam path 33 proportionally to the pivot angle of bending and accordingly proportionally to the force F.
  • the aperture element 39 influences reception of light by the optical sensor 32.
  • the force sensor 32 senses forces applied to each of the support arms 81 individually and communicates the force sensing data for each support arm 81 to the data processing and control unit 1 5. Data will be made available for the user via the data output unit 1 6 which connected to the data processing and control unit 1 5. A user may accordingly obtain an information about the contact forces F for each of the support arms 81 individually.
  • the inventive medical device is able to "sense” any touch of any of its support arms independently and quantitatively.
  • the medical device such as a mapping catheter, is able to determine the geometry and angle of a wall it is in contact with and it tells when it feels first contact, how many support arms are touching and if there is full contact.
  • the force sensor data may be analog data or the data may be digitized in the elongated medical device in one or more of the electronic elements 91 and communicated to the data processing and control unit 1 5 in the form of digital data.
  • Forces applied to any of the associated support arms 81 are equally weighted such that the same force applied to one or more support arms 81 will result in the same force data output for each individual support arm.
  • the embodiment of Figs. 1 7 to 18b differs from the one described in Figs. 15 to 1 6d in that the electrode assembly 80 comprises eight support arms 81 forming a "basket" type structure 83.1 where the eight support arms 81 are bend in the expanded condition EC of the electrode assembly 80.
  • Each of the eight support arms 81 carries eight electrodes 82 which are equally spaced and distributed.
  • Tip 6.1 is not formed as a tip electrode in this embodiment. Tip 6.1 could though be realized as a tip electrode if an ablation function of the device is intended.
  • Figs. 1 7 to 18b comprises an optical force sensor 20 as described with reference to Figs. 15 to 1 6d.
  • the force sensor 20 comprises 8 aperture elements 39, each of which disposed at an end 81 d of the distal part 81 b of a support arm 81 .
  • aperture elements could be arranged on a group of support arms. E.g. two support arms could be associated with one and the same aperture element.
  • Fig. 1 8b two of the support arms 81 of the medical device are in contact with body tissue as indicated by reference number 81 F. Accordingly, a force acts on the two support arms 81 F causing the support arms 81 F to bend and the respective two aperture elements 39 to pivot partially out of the light beam path (not indicated in Fig. 1 8b).
  • the underlying optical sensor (not visible in Fig. 1 8b) will receive a respective light signal from the light source 31 indicating the body surface contact and the force effective on the respective two support arms 81 F.
  • the sensed force data will be communicated to the data processing and control unit and will be made available for the user via the data output unit 1 6 which connected to the data processing and control unit 1 5.
  • optical force sensor 20 as described with reference to Figures 1 5 to 1 8b may also be used with any other type of mapping catheter, and also with any type of elongated medical device as described in this application. Further, the optical force sensor may also be configured to measure forces applied to the tip 6.1 or a tip electrode 6 e.g. by sensing changes in the distance between the light source 31 and the optical sensor 32.

Abstract

La présente invention concerne un dispositif médical allongé (1) convenant à une insertion intravasculaire. Ledit dispositif comprend un corps allongé flexible, (2) comprenant une partie distale (3) avec une extrémité distale (4) et une partie proximale (5), et un ensemble d'électrodes de cartographie (80) situé au niveau de la partie distale (3) comprenant une pluralité d'électrodes (82), l'ensemble d'électrodes (80) étant configuré pour avoir un état non expansé (EN), dans lequel l'ensemble d'électrodes (80) est stocké au niveau d'une partie du corps allongé (2), et pour avoir un état déployé (ED), dans lequel l'ensemble d'électrodes (80) forme un écran de cartographie au moins bidimensionnel qui a un centre de symétrie (C), un capteur de force (20) étant disposé à l'intérieur dudit corps allongé flexible (2) à proximité de ladite extrémité distale (4).
PCT/EP2016/001512 2015-09-07 2016-09-07 Dispositif médical allongé, convenant à une insertion intravasculaire et procédé de fabrication d'un dispositif médical allongé convenant à insertion intravasculaire WO2017041889A2 (fr)

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