EP1006905A1 - Catheter orientable avec pointe a electrode rotative et procede d'utilisation - Google Patents

Catheter orientable avec pointe a electrode rotative et procede d'utilisation

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Publication number
EP1006905A1
EP1006905A1 EP97915234A EP97915234A EP1006905A1 EP 1006905 A1 EP1006905 A1 EP 1006905A1 EP 97915234 A EP97915234 A EP 97915234A EP 97915234 A EP97915234 A EP 97915234A EP 1006905 A1 EP1006905 A1 EP 1006905A1
Authority
EP
European Patent Office
Prior art keywords
electrode
impedance
tip
tip electrode
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97915234A
Other languages
German (de)
English (en)
Inventor
Leslie Organ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Taccor Inc
Original Assignee
Taccor 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 Taccor Inc filed Critical Taccor Inc
Publication of EP1006905A1 publication Critical patent/EP1006905A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • 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
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • 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
    • A61B2018/00184—Moving parts
    • A61B2018/00202—Moving parts rotating
    • A61B2018/00208—Moving parts rotating actively driven, e.g. by a motor
    • 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
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1861—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter

Definitions

  • This invention relates to an improved catheter which can be used both for applying a radio frequency (RF) ablation current to a body part, and for electrogram recording.
  • the invention also relates to a method of applying an RF ablation current and a method of electrogram recording.
  • An important application of the invention is in the field of cardiology.
  • a healthy heart is normally caused to contract and relax in an orderly fashion by a spreading wave of electrical excitation originating from the sinoatrial (SA) node in the right upper atrium.
  • SA sinoatrial
  • AV atrio ventricular
  • the AV node then relays the wave over specialized cardiac fibers known as the bundle of His, to the ventricles.
  • the cardiac fibers over which the impulses are conducted have a refractory period, so that once stimulated they cannot be restimulated for a short time period. This normally serves as a protective mechanism.
  • some people are born with an accessory pathway of cardiac fibers extending from the ventricle near the area of the AV node back to the atrium.
  • the accessory pathway allows the excitation wave from the AV node to retrograde or travel back to the atrium.
  • the retrograde wave if it reaches the atrium just after the end of a refractory period, it can then travel back to the AV node, stimulating the AV node prematurely and producing an oscillatory loop.
  • Various other mechanisms e.g. partial damage to atrial or ventricular heart muscle, can also result in an oscillatory loop.
  • the oscillatory loop causes abnormally rapid heart action (tachycardia). This is usually self limiting, but in cases where it is not, it may be fatal. Therefore the condition requires treatment.
  • Tachycardia and other arrhythmias have sometimes been treated with medication.
  • medication is not always effective and may have serious side effects.
  • a second method of treating the condition has been open heart surgery, to cut the tissue (e.g. the accessory pathway) which forms part of the feedback loop, thus opening the feedback loop.
  • open heart surgery is a serious and costly operation.
  • cardiologists have attempted to deal with the condition by inserting catheters containing electrodes into the interior of the heart. They have attempted to locate the accessory pathway or other tissue in question and then to apply RF energy to ablate the tissue by coagulation.
  • the catheters are pushable and steerable, and are guided to the approximate location by x-rays for general guidance, and then by the use of electrograms to the exact location for fine localization.
  • the fibers known as the bundle of His, emanating from the AV node are close to the accessory pathway, so cardiologists often look for electrograms with His activity to determine that the catheter is close to the accessory pathway.
  • Numerous catheters have been designed to perform the above functions. Examples are shown in U.S. patent 5,242,441 to Avitall, U.S. patent 5,125,896 to Hojeibane, and U.S. patent 5,190,050 to Nitzsche. Various designs compete on the basis of which is more easily steerable.
  • the invention provides a catheter comprising:
  • said tip electrode having a conductive portion and an insulated portion
  • a first control extending from said handle through said shaft and connected to said distal end and being operable for bending said distal end relative to said shaft
  • a second control extending from said handle through said shaft to said tip electrode and being operable for axially rotating said tip electrode, so that said conductive portion of said tip electrode may be placed against tissue and said insulated portion may be oriented to face a patient's bloodstream.
  • the invention provides a method of positioning a catheter in a desired manner over selected tissue within a patient, said catheter having a handle, a longitudinally elongated shaft connected to said handle, a bendable distal end connected to said shaft, a first control connected to said distal end for bending said distal end relative to said shaft to steer said catheter, an axially rotatable electrode on said distal end, and a second control connected to said electrode for axially rotating said electrode, said electrode having a conductive portion and an insulated portion, said method comprising:
  • Fig. 1 is a top plan view of a catheter according to the invention
  • Fig. 2 is a side view of the catheter of Fig. 1;
  • Fig. 3 is a side view of a portion of the distal end of the catheter of Fig. 1;
  • Fig. 4 is a view similar to that of Fig. 3 but with the pull wires included;
  • Fig. 5 is a top plan view of the portion of Fig. 4;
  • Fig. 6 is an enlarged view of the tip of the catheter of Fig. i;
  • Fig. 7 is a side sectional view of the distal end of the catheter of Fig. 1;
  • Fig. 8 is a top plan sectional view of the distal end of the catheter of Fig. 1;
  • Fig. 8A shows a modification of the arrangement of Figs. 7 and 8;
  • Fig. 9 is a cross-sectional view of the distal end of the catheter of Fig. 1, taken along lines 9-9 of Fig. 8;
  • Fig. 10 is a cross-sectional view of the catheter of Fig. 1, taken along lines 10-10 of Fig. 8;
  • Fig. 11 is a cross-sectional view of the shaft of the catheter of Fig. 1;
  • Fig. 12 is a diagrammatic top plan view, partly in section, of the handle for the catheter of Fig. 1;
  • Fig. 13 is a side view, partly in section, of the handle of Fig. 12;
  • Fig. 14 is a diagrammatic view of a computer display and control for the catheter of Fig. 1;
  • Fig. 15 is a graph showing variation of impedance versus rotation angle of the catheter tip
  • Fig. 16 is a top plan view of a modified handle for the catheter of Fig 1;
  • Fig. 17 is a side sectional view of the handle of Fig. 16;
  • Fig. 18 shows a visual control display for the catheter of Fig. 1;
  • Fig. 19 is a side view of a modified ring electrode for the catheter of Fig. 1;
  • Fig. 20 is a plot showing variation of impedance with heartbeat.
  • Fig. 21 is a diagrammatic view of a modification of the computer display and control shown in Fig. 14.
  • An ablation catheter according to the invention is shown generally at 10 in Figs. 1 and 2.
  • Catheter 10 has three sections, namely a control handle 12, a shaft 14, and a distal or free end 16.
  • the shaft 14 may typically be about 100 cm long and the distal end 16 may typically be about 8 cm long.
  • the distal end 16 typically contains four platinum- iridium alloy electrodes, namely a tip electrode 18 (which may be e.g. 4 mm long) and three ring electrodes 20.
  • the ring electrodes are typically 1.5 mm long, with 2.5 mm spacing between their edges. However all dimensions mentioned can be varied as required.
  • Both the shaft 14 and the distal end 16 typically have an outside diameter of 7 French (2.34 mm) so that they can be guided through blood vessels into the heart.
  • the handle 12 contains a J-bending control knob 22 and an axial rotation control knob 24. Using knob 22 the distal end 16 can be deflected laterally into a J-shape (as shown in dotted lines in Fig. 1) to assist in steering the catheter toward a desired location.
  • a portion of the tip 18 of the catheter is insulated, and the axial rotation control knob 24 is used to rotate the tip, to bring the bare (uninsulated) portion of the tip against the heart wall and the insulation toward the bloodstream once a desired location has been reached.
  • the catheter distal end 16 is shown in more detail in Figs. 3 to 10 inclusive.
  • Middle ribbon 32 is larger than ribbons 30, 34 and thus has a projecting proximal end 36 and a projecting distal end 38.
  • Central ribbon 32 is also welded on each side to the proximal ends of upper ribbon 30 and lower ribbon 34, the weld locations being indicated at 40.
  • the ribbons are not connected to each other except at the welds 40, so that they may slide at their distal ends.
  • the ribbons thus determine a preferred bending direction (in a plane orthogonal to their flat surfaces) for the distal end 16 (i.e. J-bending).
  • the projecting proximal end 36 of the middle ribbon 32 narrows into an elongated tab 42 (Fig. 5) which inserts into a stainless steel coil 44 (Figs. 7 and 8).
  • Three retainer rings 46, 48, 50 are attached (welded) to the ribbon assembly. Rings 46, 48 are attached to the upper ribbon 30 while ring 50 is attached to the projecting distal end 38 of middle ribbon 32.
  • the rings 46, 48, 50 form a guide channel for a stainless steel torque wire 52 (Figs. 7 to 10) which is coated with polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • the use of the rings results in minimal friction and column stiffness and yet allows free rotation of wire 52 as torque is applied to it (as will be described) to produce axial tip rotation.
  • a length of polyimide or similar tubing 51 (Fig. 8A), attached e.g. by glue to upper ribbon 30, can be used in place of rings 46, 48, 50 to provide similar benefits.
  • Torque wire 52 also serves as an electrical connection to the tip electrode 18.
  • the extent of tip rotation is made sufficient to bring the insulated portion (to be described) of the tip 18 to face the blood and then slightly beyond, regardless of the starting position of the tip and its direction of rotation.
  • Figs. 6 to 8 inclusive As shown in Fig. 6, the tip electrode 18 is partially covered with an electrically insulating coating 56 (typically a polyimide coating), which coats more than 50% of the electrode surface.
  • an electrically insulating coating 56 typically a polyimide coating
  • the arc describing the lateral edges of the bare portion 58 will be less than 180° and is typically between 90° and 120°. However it can be less than 90°.
  • the shape of the bare area may be modified, e.g. hourglass instead of rectangular.
  • the tip 18 is generally bullet shaped but at its proximal end includes a reduced diameter proximally extending portion 60 (Figs. 7, 8) having a circumferential groove 62 therein.
  • the groove 62 retains a sealing ring 64 made of silicone.
  • An outer silicone sleeve 66 which forms a jacket for the catheter distal end, is pushed over sealing ring 64 to abut the proximal end of tip 18 and is then glued in position to provide a fluid tight seal against the tip 18.
  • the tip 18 also includes a central channel 68 in which the torque wire 52 is firmly soldered.
  • Central channel 68 also houses a thermocouple heat sensor 72 (Fig. 7) , from which lead wires 73 protrude. Alternatively, a thermistor heat sensor could be used.
  • the ring electrodes 20 (not shown in Figs. 7 and 8 for simplicity) are glued to the outer silicone sleeve 66, and indent the sleeve so that their outer surfaces form a relatively smooth surface with that of the outer sleeve.
  • ring electrode wires 74 (Fig. 9) which have been threaded through sleeve 66 and out appropriately positioned holes (not shown) in the sleeve are soldered to the ring electrodes.
  • the wires 74 are pulled from the handle end of the sleeve leaving some slack in the wires 74 (as in thermocouple wires 73) to allow for bending and rotation. This operation is of course performed before the tip electrode 18 is attached.
  • PTFE coated pull wires 76, 78, 80, 82 are provided, each terminating in an enlarged disk 76a, 78a, 80a, 82a.
  • the enlarged disks are welded to the projecting distal end 38 of the middle stainless steel ribbon 32.
  • Two pull wires are located on each side of the ribbon assembly as best shown in cross section in Fig. 9.
  • the pull wires 76- 82 serve to bend the assembly of ribbon 30, 32, 34, and hence the catheter distal end 16, in either of its two preferred directions for bending. It will be apparent that the bending will be in a J-shape.
  • torque wire 52 tapers in diameter at its distal end to provide increased flexibility to permit easier lateral deflection of the distal end 16 of the catheter.
  • the pull wires 76-82, the tab section 42 of middle stainless steel ribbon 32, and the torque wire 52 are all inserted into the end of the stainless steel coil 44.
  • the pull wires 76-82, the ribbon assembly 30, 32, 34 and the torque wire 52 are held together adjacent the catheter distal end 16 with three layers of material (which for clarity are not shown in Figs. 7 and 8). These layers consist of an inner layer of PTFE shrink tubing 86, a middle wrapping 88 of aramid fiber to provide strength against tearing during bending, and an outer layer of PTFE shrink tubing 90.
  • the three layer covering extends distally about 0.025 inch beyond the ribbon assembly 30, 32, 34 and extends proximally to butt against the end of the stainless steel coil 44.
  • thermocouple wires 73 and ring electrode wires 74 Located between the outer PTFE shrink tubing 90 and the silicone outer sleeve 66 are the thermocouple wires 73 and ring electrode wires 74 (Fig. 9).
  • a polyimide sleeve 92 shown in Figs. 7 and 8 and in cross section in Fig. 10, bridges the junction of the catheter shaft 14 with the distal end 16, for reinforcing purposes.
  • the sleeve 92 extends over the proximal end of the three layers 86, 88, 90 (which as mentioned are for clarity not shown in Figs. 7, 8).
  • the proximal end 94 of thin silicone sleeve 66 extends over a recessed area 95 of the catheter outer shaft wall 96 (which wall is described below).
  • Fig. 10 which is a cross section close to the junction of the shaft 14 with the catheter distal end 16, shows the tab section 42 of the middle stainless steel ribbon 32 inside the stainless steel coil 44.
  • the outer shaft wall 96 (Figs. 10 and 11) is constructed of a stainless steel braid coated with a polyether block amide (PEBA)/ nylon compound. This construction confers pushability and column stiffness to the shaft 14, while still allowing shaft flexibility.
  • Wall 96 is fixed to the handle 12 and extends to a position over sleeve 92 (Fig. 7), to abut and support proximal end 94 of silicone sleeve 66 as described above.
  • Stainless steel coil 44 runs from inside the catheter handle 12, where it is rigidly fixed, along the entire length of the shaft
  • the distal end of the stainless steel coil 44 is the point against which the pull wires 76-82 produce the lateral bending of the catheter distal end 16.
  • thermocouple wires 73 and ring electrode wires 74 are located between the stainless steel coil 44 and the outer shaft wall 96.
  • the four pull wires 76-82 and the torque wire 52 are as mentioned contained within the coil 44.
  • the J-bending control knob 22 includes a fluted or ridged shaft 98 rotatably mounted on handle wall 100 and having an interior shaft portion 102.
  • the pull wires 76-82 are secured as shown to projections 104 from the interior shaft portion 102, so that turning of the knob 22 produces equal winding and unwinding of pull wire pairs.
  • the resultant J-bending of the catheter distal end 16 is maintained with a locking lever 106.
  • Lever 106 is adapted to slide forwardly in slots 107, 108 in the handle wall 100, to engage with the fluted or ridged control knob shaft 98. Locking lever 106 is then locked in position in the laterally extending portion 109 of slots 107 (which is L-shaped) to maintain the selected bend.
  • a wire bundle 110 consisting of the thermocouple wires 73 and ring electrode wires 74, extends through the handle 12 and terminates in a male electrical connector 112 which may be connected by an appropriate female conductor and cable 113 to a computer based instrument 114 (Fig. 14).
  • Torque wire 52 passes through an axial opening 115 in the acrylic (non-electrically conductive) shaft 116 of axial rotation control knob 24. Torque wire 52 is fixed to shaft 116 by a set screw 116a.
  • torque wire 52 After passing through shaft 116, torque wire 52 terminates in a metal pin 117 which rotates within a fixed socket 118 which in turn is attached to the electrical connector 112. Electrical continuity of torque wire 52 is preserved in this manner, but other suitable methods of providing a rotating electrical connection may be provided.
  • Ablation current typically 500 KHz
  • RF radio frequency
  • the tip electrode 18 can be rotated through a considerable angle, essentially without altering the location of the tip electrode. In other words, if the tip electrode 18 is over particular tissue section, it will normally remain there even when the tip electrode 18 is rotated. The rotation does twist silicone sleeve 66, which is flexible and resilient for this purpose.
  • the Computer Instrument 114
  • Instrument 114 contains, in addition to the RF section 119, an impedance section 200.
  • Impedance section 200 is conventional and generates a 50 KHz excitation current required to measure the impedance. It also produces an impedance measurement which is transmitted to a computer section 146 containing a CPU (not shown).
  • Switch 119a allows the user to add RF current to the tip electrode to begin lesion making. However, impedance monitoring continues during application of the RF current, because a high frequency blocking filter 202 is located after the impedance section to filter out the RF current.
  • Instrument 114 also includes a standard electrogram amplifier 204 which is connected through a high frequency blocking filter 206 directly to leads 52, 74.
  • Amplifier 204 receives the electrogram signals (whose frequency spectrum is all under 1 KHz, and mostly under 500 Hz), and amplifies these signals, and transmits them to the computer section 146 for recording and display.
  • Filter 206 removes the higher frequencies of the impedance current and the ablation current.
  • the electronic signals and the impedance can be, and preferably are, monitored simultaneously, e.g. on monitor 147. (Note that the impedance section 200 need not be protected from the electrogram signals because their upper frequency limit (1 KHz) is appreciably lower than the 50 KHz used by the impedance section.)
  • instrument 114 includes a conventional thermocouple section 208 connected to thermocouple leads 73.
  • Section 208 receives the thermocouple current, amplifies it, and transmits an appropriate signal to computer section 146 for recording and display. The use of the catheter 10 will now be described.
  • Fig. 15 shows a curve 120 of impedance (on the vertical axis) versus tip angle rotation (on the horizontal axis), for various angles of rotation of the catheter tip electrode 18. Shown above the plot in Fig. 15 are representations 121a to 121d of the catheter tip electrode 18 showing the bare (uninsulated) portion 58 of the tip in various positions with respect to the myocardial wall 122. The impedance shown is that between a reference electrode (not shown) connected to the patient and the wire 52 connected to the tip electrode 18.
  • the impedance shown at 124, 125 is relatively low since blood is more conductive than myocardium.
  • the impedance reaches a peak as indicated at 126. Therefore the rotational position of the bare portion 58 of the catheter can be readily determined.
  • the impedance reaches a peak, then (assuming the catheter has been properly positioned over the arrhythmic pathway), RF energy can be efficiently and reliably applied to form the desired lesion.
  • the impedance between catheter tip electrode 18 and the reference electrode can be continually read on a graphic display such as that shown in Fig. 15.
  • a graphic display such as that shown in Fig. 15.
  • the physician rotates the catheter tip using knob 24, meanwhile watching the display of Fig. 15, until the impedance has reached a peak.
  • Impedance can also be displayed numerically or as a rising bar graph or other increasing graphical display. It can also be input to an audio source whose frequency increases as impedance increases, or can be displayed in any other desired manner.
  • RF power is applied to the tip electrode 18 when impedance is greatest.
  • potentiometers may be connected to knobs 22, 24 as shown in Figs. 16, 17, where double primed reference numerals indicate parts corresponding to those of Figs. 1 to 13.
  • a spur gear 130 is formed on the end of shaft 116 " of the axial rotation knob 24 " .
  • Gear 130 drives a gear 132 on the shaft of potentiometer 134 mounted on wall 100 " .
  • Potentiometer 134 has two leads 136 connected to connector 112 " .
  • a semi-circular ring gear 138 is formed on interior shaft portion 102 " of J-bending central knob 22 " .
  • Gear 138 drives a bevel gear 140 connected to the shaft of a second potentiometer 142 having leads 143 connected to connector 112 " .
  • the resistances of the potentiometers 134, 142 will indicate the axial rotation position of tip electrode 18 and the degree of J-bending of distal catheter end 16, respectively.
  • the relationship between the position of knob 24 and rotation of the tip electrode is not linear because friction on torque wire 52 within the distal catheter end 16 increases as J- bending increases.
  • one unit of rotation of knob 24 produces approximately one unit of axial rotation of the tip electrode 18.
  • the catheter distal end is bent into a J-shape, there are significant torque losses and it may take (for example) two units of rotation of knob 24 to produce one unit of tip rotation.
  • the actual relationships can be determined after the catheter has been manufactured, and can then be provided in the form of a look-up table in the read-only memory (ROM) 144 of the computer section 146 of the computer based instrument 114.
  • the look-up table provides to the CPU in the computer section 146 the data representative of the actual degree of axial rotation, so that true tip rotation may be displayed graphically and /or numerically on a monitor 147.
  • the tip electrode 18 may be displayed in cross-section as icon 150 with an arrow 152 indicating the number of degrees of rotation of the uninsulated portion 58 from a reference (unrotated) position 154 marked as 0°.
  • the tip can as mentioned be rotated in either direction from the 0° position.
  • the impedance display consists of a shaded bar 162 which rises and falls as the impedance varies, with an ohm scale beside it on the vertical axis, and with the numeric value of the impedance at any given time displayed at 164.
  • the operator of the catheter can see exactly how far the tip electrode 18 has been rotated from its 0° or reference position, and at the same time can see from display 160 (by rotating the tip electrode 18 back and forth) when the impedance reaches a peak.
  • the graphic display of Fig. 18 can also include a display 168 showing the amount of J-bending. This is indicated by an icon 170 representing the catheter distal end 16 and showing the amount of J- bending in the distal end 16. The amount of J-bending to the left or right is reproduced in the icon, with the alphanumeric value and the direction of bending displayed at 172.
  • An alternative or additional form of display for the rotational position of the tip electrode 18 is shown as icon 174 in Fig. 18.
  • the icon 174 is simply one of the displays 121a to 121d from Fig. 15 and displays the rotational relationship of the tip 18 relative to the tissue wall 122. As the impedance rises or falls, the displayed position of the tip 18 rotates.
  • Such display can be generated by the computer instrument 114, which can be programmed to rotate the representation of tip 18 dependent on whether the impedance (indicated by graph 120) is at a peak or valley, or between those two extremes.
  • the orientation of the insulated portion 56 can be determined by the program from whether the impedance rises or falls when the tip is rotated clockwise or counterclockwise.
  • the impedance is normally measured between the tip electrode 18 and a reference electrode connected elsewhere to the patient, the impedance can if desired be measured between the tip electrode 18 and any of the ring electrodes 20. However it is preferred to use a larger reference electrode located elsewhere on the patient for more consistent results.
  • the catheter described is particularly useful for ablation purposes, it may also be used simply for monitoring purposes, to detect signals from any of its electrodes (to record electrograms), i.e. it may be used as a diagnostic catheter.
  • Diagnostic catheters are normally identical to ablation catheters except that the tip electrode 18 is shorter (e.g. only 2 mm long) in a diagnostic catheter. There may also be more than four electrodes. In diagnostic mode electrograms may be recorded between the tip electrode 18 and a reference electrode, or between the tip electrode 18 and any of the ring electrodes 20, or between any ring electrode and any other ring electrode or a reference electrode.
  • one or all of the ring electrodes 20 may be partially insulated, such insulation being shown at 176 in Fig. 19.
  • the arcuate extent of the uninsulated portion 178 may have the same range as the uninsulated portion 58 of the catheter tip electrode 18.
  • a four channel read-out can be displayed on a multichannel monitor or on monitor 147. If one of the ring electrodes 20, for example, begins picking up an electrogram feature of interest, indicating that such ring electrode is over a desired site, then the catheter as a whole, or simply that ring electrode, can be switched to impedance mode. Alternatively as mentioned, by use of the electronic filtering described, impedance and electrograms can be monitored simultaneously.
  • the frequency spectrum for the electrogram is under 1 KHz, while the impedance excitation current is 50 KHz, filtering suffices in each section to remove unwanted signal.
  • impedance mode the impedance is read between the catheter electrode in question and the reference electrode (or between each catheter electrode and the reference electrode if all four channels are switched to impedance mode).
  • the impedance between the selected ring and the reference electrode is displayed, or four channels of impedance can be displayed, between each catheter electrode and the reference electrode.
  • the catheter distal end 16 is then rotated to bring the uninsulated portion 178 of the ring in question as fully as possible against the tissue wall, at which time the impedance will be a maximum and the signal being picked up by the ring in question will be optimized in size and quality, i.e. more detail will be visible in the wave form of the electrogram signal.
  • the increase in size and detail of the electrogram signal as the catheter is rotated confirm the information from the impedance signal that the uninsulated portion 178 is fully against the tissue wall.
  • the electrogram signal from tip electrode 18 will show an increase in size and quality when the tip is rotated so that its uninsulated portion is fully against the tissue wall, and this will constitute confirmation that the tip has been rotated to the correct position.
  • one channel of impedance and four channels of electrograms can be displayed simultaneously (where only the tip is partially insulated), or (where the rings are also partially insulated) several impedance channels (up to four) and up to four channels of electrograms can all be simultaneously displayed.
  • tip rotation For a diagnostic catheter a major advantage of tip rotation is that the signal detected can be optimized. In all cases the use of impedance readings allows the operator to rotate the distal end to the desired axial position. Rotation is realized best with tip electrode 18, and progressively less with ring electrodes 20 as their distance from the tip increases since their rotation is produced by twisting of the outer silicone sleeve 66, to which they are attached.
  • Impedance readings are dependent on waveform frequency and current magnitude. (The current magnitude dependence can be eliminated if a tetrapolar impedance measurement system is used, but this would be difficult within the body.)
  • the 50 KHz waveform from impedance section 200 is supplied at a constant current level by constant current source 200a to prevent variations in impedance due to current magnitude, thereby making this system more accurate. This can be useful during RF ablations using ablation catheters with either insulated or non- insulated electrode tips where changes in impedance will be followed or observed as a method of determining whether or not a satisfactory lesion has been produced.
  • the heating from RF current produces an initial liquefaction of tissue, causing a slight decrease in impedance (e.g.
  • the initial fall in impedance is an important signal that good lesion formation will follow, indicating the desirability of monitoring impedance before application of the RF current because the decrease is often small and could be missed if no pre-lesion value was available.
  • Current use is to obtain impedance measurements only during lesion making by taking the ratio of rms (root-mean-square) RF voltage to rms RF current. Typically, RF current changes during lesion making ⁇ this factor itself affecting impedance readings — and therefore is likely to obscure the initial true fall in impedance.
  • impedance measuring current is supplied at a different frequency (e.g. 50 KHz) from the ablation current (e.g. 500 KHz), and because of the filter 202, impedance can be monitored both before and during the lesion making process, as described above.
  • a different frequency e.g. 50 KHz
  • the ablation current e.g. 500 KHz
  • the impedance as measured by the impedance section 200 and transmitted to the computer section 146 will be subject to variability.
  • This variability has two components. One component is due to the motion or beating of the heart. It is found that the measured impedance will vary as the heart wall moves with each beat. A typical variation is shown in Fig. 20, which is a plot of impedance against time. In Fig. 20, curve 300 shows the impedance measured by impedance section 200 as varying (typically) between 200 and 220 ohms as the heart beats. It is assumed that the heart is beating at the rate of 90 beats per minute, so the time between each peak in curve 300 is .667 seconds.
  • One method is to measure and display impedance only at the peaks 302 of curve 300. This can be accomplished by using a conventional electronic peak detector (not shown). Alternatively, and preferably, the impedance section 200 can sample the impedance at a frequency much higher than the heartbeat, e.g. 10 times per second. These impedance measurements are directed to a peak detection software function indicated at 304 in Fig. 21 (where corresponding reference numerals indicate parts corresponding to those of Fig. 14). The peak detection software function 302 causes the display monitor 147 to display only the peak impedances.
  • Another alternative is simply to display impedance at the occurrence of the troughs 306, using a trough detector software function as indicated at 308 in Fig. 21. Peak and trough detector software functions are well known to those skilled in the art.
  • the time of the impedance measurement, or of an impedance display can be synchronized with an event within the heart cycle.
  • the R wave of the electrocardiogram generally the largest wave in the electrocardiogram
  • the time of the impedance measurement can be synchronized with a cardiac-related non-electrical event, for example the pressure wave recorded in an arterial catheter, or with pulse or volume change recorded by various means on the body surface, or by changes in optical density recorded at the fingertip (or by using other suitable synchronizing events).
  • a cardiac-related non-electrical event for example the pressure wave recorded in an arterial catheter, or with pulse or volume change recorded by various means on the body surface, or by changes in optical density recorded at the fingertip (or by using other suitable synchronizing events).
  • the second component of impedance variation can be caused by respiratory motion. This is a much slower variation than that caused by movement of the beating heart, although the two components are superimposed together.
  • the reason for impedance variation due to respiratory motion is that impedance is typically measured between the catheter tip (in contact with the heart wall) and a distant, large reference electrode. A common position for this reference electrode is against the trunk or abdomen. The current used for measuring tip impedance must therefore flow through at least part of the lungs in order to reach the reference electrode. The impedance of this pathway varies as the air content of the lungs changes during respiration, becoming maximum at peak inspiration.
  • the impedance variability caused by respiratory motion can be eliminated in various ways.
  • One preferred way is to measure the impedance between the tip electrode 18 and one of the ring electrodes 20. This limits the current used for measuring impedance to a local circuit, avoiding its flow through the lungs and thereby eliminating this source of variability.

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Abstract

Cathéter utilisable p. ex. pour des ablations dans le myocarde. Ce cathéter possède un manche, une tige, et une extrémité distale pouvant être pliée en forme de J, contenant une pointe électrode et des électrodes annulaires. La pointe électrode est rotative axialement et présente des parties isolées et des parties non isolées. Lorsque la pointe électrode tourne, on observe l'impédance entre l'électrode et un seuil de référence. Lorsque l'impédance atteint un maximum, cela indique que la partie non isolée est en contact avec le tissu et que la partie isolée fait face au flux sanguin. Un électrogramme peut être relevé à partir de l'électrode, ou un courant d'ablation peut être appliqué à cette dernière. Ce cathéter permet de réduire les court-circuitages du signal ou du courant occasionnés par le sang.
EP97915234A 1997-04-11 1997-04-11 Catheter orientable avec pointe a electrode rotative et procede d'utilisation Withdrawn EP1006905A1 (fr)

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PCT/CA1997/000243 WO1998046149A1 (fr) 1997-04-11 1997-04-11 Catheter orientable avec pointe a electrode rotative et procede d'utilisation

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EP1006905A1 true EP1006905A1 (fr) 2000-06-14

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US11844691B2 (en) 2013-01-24 2023-12-19 Cardiovalve Ltd. Partially-covered prosthetic valves
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