WO2010129661A1 - Irrigated ablation catheter with multiple segmented ablation electrodes - Google Patents

Irrigated ablation catheter with multiple segmented ablation electrodes Download PDF

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Publication number
WO2010129661A1
WO2010129661A1 PCT/US2010/033706 US2010033706W WO2010129661A1 WO 2010129661 A1 WO2010129661 A1 WO 2010129661A1 US 2010033706 W US2010033706 W US 2010033706W WO 2010129661 A1 WO2010129661 A1 WO 2010129661A1
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WIPO (PCT)
Prior art keywords
segmented
electrode
ablation
electrodes
ablation electrodes
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Ceased
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PCT/US2010/033706
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English (en)
French (fr)
Inventor
Cary Hata
Thu Xuan Tran
Alan De La Rama
Tho Hoang Nguyen
Irvin John Narciso
Peter C. Chen
Hanh Ngoc Do
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St Jude Medical LLC
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St Jude Medical LLC
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Priority to JP2012509944A priority Critical patent/JP5539498B2/ja
Priority to EP10717430.2A priority patent/EP2429436B1/en
Priority to EP22200946.6A priority patent/EP4137084B1/en
Publication of WO2010129661A1 publication Critical patent/WO2010129661A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • 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
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • 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
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • 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
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2201/00—Properties
    • C08L2201/12—Shape memory

Definitions

  • the present invention relates generally to catheter devices, and more specifically to irrigated catheter devices with multiple segmented ablation segments.
  • Catheters are flexible, tubular devices that are widely used by physicians performing medical procedures to gain access into interior regions of the body.
  • Certain types of catheters are commonly referred to as irrigated catheters that deliver fluid to a target site in an interior region of the body.
  • Such irrigated catheters may deliver various types of fluid to the patient, including, for example, medications, therapeutic fluids, and even cooling fluids for certain procedures wherein heat is generated within targeted areas of the body.
  • ablation catheters are sometimes used to perform ablation procedures to treat certain conditions of a patient.
  • a patient experiencing arrhythmia may benefit from ablation to prevent irregular heart beats caused by arrhythmogenic electrical signals generated in cardiac tissues.
  • ablation catheters are known, and may include one or more ablation electrodes supplying RF (radiofrequency) energy to targeted tissue.
  • RF radiofrequency
  • a catheter tip having one or more ablation electrodes may be positioned over the targeted tissue.
  • the ablation electrodes may deliver RF energy, for example, supplied from a generator, to create sufficient heat to damage the targeted tissue. By damaging and scarring the targeted tissue, aberrant electrical signal generation or transmission may be interrupted.
  • irrigation features may be provided in ablation catheters to supply cooling fluid in the vicinity of the ablation electrodes to prevent overheating of tissue and/or the ablation electrodes.
  • Open ablation catheters use the inner cavity of the ablation catheter tip as a manifold to distribute saline solution, or other irrigation fluids known to those skilled in the art, to one or more passageways leading to an orifice. This lowers the temperature of the ablation catheter tip by bringing the outer surface of the ablation electrode in contact with the cool irrigation fluid and dilute the blood around the electrode to prevent blood coagulation.
  • an irrigated catheter ablation apparatus comprises an elongated body having a distal end, a proximal end, and at least one fluid lumen extending longitudinally therein; and a plurality of segmented ablation electrodes on a distal portion of the elongated body.
  • the plurality of segmented ablation electrodes are spaced from the proximal end and from the distal end of the elongated body by electrically nonconductive segments.
  • the plurality of segmented ablation electrodes are spaced from each other longitudinally by electrically nonconductive segments.
  • an edge is formed between an electrode end of the segmented ablation electrode and a nonconductive segment end of the electrically nonconductive segment.
  • a plurality of elution holes are disposed adjacent to the edges which are between the electrode ends of the segmented ablation electrodes and the nonconductive segment ends of the electrically nonconductive segments.
  • a plurality of ducts establish fluid communication between the elution holes and the at least one fluid lumen.
  • the plurality of elution holes may be disposed in the plurality of electrically nonconductive segments.
  • the plurality of elution holes may be disposed in the plurality of segmented ablation electrodes.
  • the plurality of segmented ablation electrodes may include at least one of a coil ring electrode having gaps in a coil to permit fluid flow therethrough or a ring electrode having gaps cut into the ring electrode to permit fluid flow therethrough.
  • a tip electrode is disposed at the distal end of the elongated body The tip electrode has a proximal end which meets a nonconductive segment end of one of the electrically nonconductive segments at a tip electrode edge.
  • At least one tip electrode edge elution hole is disposed adjacent to the tip electrode edge and being in fluid communication with the at least one fluid lumen.
  • the tip electrode may be an ablation tip electrode.
  • the at least one tip electrode edge elution hole is disposed in the tip electrode.
  • At least some of the ducts are substantially perpendicular to the at least one fluid lumen.
  • the distal portion of the elongated body includes a material which is preformed into a substantially closed loop having the plurality of longitudinally spaced segmented ablation electrodes and the electrically nonconductive segments.
  • one or more conducting wires coupled with and supplying RF energy to the plurality of segmented ablation electrodes, the RF energy being one of unipolar RF energy or bipolar RF energy.
  • One or more conducting wires are coupled with the plurality of segmented ablation electrodes.
  • An energy source supplies energy via the one or more conducting wires to the plurality of segmented ablation electrodes.
  • a controller is configured to control the energy source to supply energy to the plurality of segmented ablation electrodes in one of an independent manner, a sequential manner, or a simultaneous manner.
  • a plurality of temperature sensors are disposed on and in contact with the plurality of segmented ablation electrodes at the electrode ends.
  • each of a plurality of temperature sensors is disposed on and in contact with a respective segmented ablation electrode at a location situated between the electrode ends.
  • a controller is configured to control the energy source to supply energy to the plurality of segmented ablation electrodes based on signals received from the plurality of temperature sensors so as to control temperatures of the plurality of segmented ablation electrodes.
  • a method of ablating tissue with an irrigated catheter comprises directing fluid through a plurality of elution holes disposed adjacent to the edges which are between the electrode ends of the segmented ablation electrodes and the nonconductive segment ends of the electrically nonconductive segments; and supplying energy to the plurality of segmented ablation electrodes to ablate tissue.
  • the distal portion of the elongated body includes a material which is preformed into a substantially closed loop having the plurality of longitudinally spaced segmented ablation electrodes and the electrically nonconductive segments.
  • the substantially closed loop is placed around at least one vessel ostium in a chamber of a patient to ablate the tissue on a chamber wall of the chamber around the at least one vessel ostium.
  • the at least one vessel ostium comprises at least one pulmonary vein.
  • the substantially closed loop may be placed within a vessel of a patient to denervate nerves within and around a vessel wall of the vessel.
  • Denervation is defined herein as partially or totally blocking nerve conduction Denervation may be achieved by stimulating, or overstimulating, or ablating the nerves.
  • the vessel comprises a renal artery or a renal vein.
  • FIG. 1 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 2 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 3 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 4 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 5 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention. [0019] FIG.
  • FIG. 6 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 7 is an elevational view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 8 is a transverse sectional view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 9 is a longitudinal sectional view of a distal portion of an irrigated ablation catheter according to an embodiment of the present invention.
  • FIG. 10 is a longitudinal sectional view of a distal portion of an irrigated ablation catheter showing a temperature sensor located at an edge of an electrode according to an embodiment of the present invention
  • FIG. 1 1 is a perspective view of a distal portion of an irrigated ablation catheter having a preformed loop shape.
  • FIG. 12 is an elevational view of an irrigated ablation catheter showing a handle for manipulating the shape of a distal portion of the catheter.
  • FIG. 13 is another elevational view of the irrigated ablation catheter of FIG. 12
  • FIG. 14 is a system installation diagram of an RF ablation system with an irrigated ablation catheter.
  • FIG. 15 is a block diagram of the RF ablation system of FIG 14
  • FIG. 16 is a flow diagram of the software program for the RF ablation system of FIG 14
  • FIG. 17 shows schematic diagrams of ablation patterns around at least one vessel ostium
  • relative orientation and placement terminology such as the terms horizontal, vertical, left, right, top and bottom, is used. It will be appreciated that these terms refer to relative directions and placement in a two dimensional layout with respect to a given orientation of the layout. For a different orientation of the layout, different relative orientation and placement terms may be used to describe the same objects or operations.
  • Exemplary embodiments of the invention provide apparatuses, methods and computer programs for ablation or denervation using an irrigated catheter device with multiple segmented ablation segments
  • FIG. 1 is an elevational view of a distal portion of an irrigated ablation catheter 10 according to an embodiment of the present invention.
  • the catheter 10 has an elongated body with a proximal end 124 (see FIG.
  • a tip electrode 14 is disposed at the distal end 12. The tip electode
  • the tip electrode 14 may be an ablation tip electrode.
  • the tip electrode 14 has irrigation holes
  • a plurality of segmented ablation electrodes 16 are spaced from the proximal end and the distal end 12 by electrically nonconductive segments 18, and they are spaced from each other longitudinally by electrically nonconductive segments 18.
  • the electrically nonconductive segments 18 may be made of a thermoplastic material.
  • a plurality of elution holes 22 are disposed adjacent to the edges 20.
  • adjacent to the edge 20 means very near or substantially abutting the edge 20, such that the distance between a specific elution hole 22 and the edge 20 to which it is "adjacent” is at least an order of magnitude smaller than the distance between that elution hole 22 and the next edge 20 or the distal end 12 or the proximal end of the elongated body.
  • a plurality of ducts 24 establish fluid communication between the elution holes 22 and the fluid lumen 13.
  • the tip electrode 14 has a proximal end which meets a nonconductive segment end of one of the electrically nonconductive segments 18 at a tip electrode edge 30.
  • the elution holes 22 are disposed in the electrically nonconductive segments 18. For each of the edges 20, at least one of the elution holes 22 is disposed adjacent the edge 20. In FIG. 1 , multiple (e.g., four) elution holes 22 are spaced around a circumference adjacent the edge 20.
  • the ducts 24 may be substantially perpendicular to the fluid lumen 13, as seen in FIG. 1.
  • FIG. 2 shows a distal portion of another irrigated ablation catheter 28 which is similar to the catheter 10 of FIG. 1 .
  • the tip electrode 29 has a proximal end which meets a nonconductive segment end of one of the electrically nonconductive segments 18 at a tip electrode edge 30.
  • At least one tip electrode edge elution hole 32 is disposed adjacent to the tip electrode edge 30 and is in fluid communication with the fluid lumen 13 (see FIG. 1 ).
  • the tip electrode edge elution holes 32 are spaced around a circumference adjacent the tip electrode edge 30, and are disposed in the tip electrode 29
  • the tip electrode edge elution holes 32 may be disposed in the electrically nonconductive segment 18.
  • FIG. 3 shows a distal portion of another irrigated ablation catheter 36 which is similar to the catheter 10 of FIG. 1 but does not have a tip electrode at the distal end 12.
  • FIG. 4 shows a distal portion of another irrigated ablation catheter 40 which is similar to the catheter 10 of FIG. 1 .
  • a tip electrode 14 is disposed at the distal end 12 and has irrigation holes 15 .
  • the segmented ablation electrodes in FIG. 4 are coil ring electrodes 42 which are spaced from the proximal end and the distal end 12 by electrically nonconductive segments 44, and the electrodes 42 are spaced from each other longitudinally by electrically nonconductive segments 44.
  • An edge 46 is formed between an electrode end of the segmented ablation electrode 42 and a nonconductive segment end of the electrically nonconductive segment 44.
  • FIG. 5 shows a distal portion of another irrigated ablation catheter 50 which is similar to the catheter 40 of FIG 4.
  • the tip electrode 52 has a proximal end which meets a nonconductive segment end of one of the electrically nonconductive segments 44 at a tip electrode edge 54.
  • At least one tip electrode edge elution hole 56 is disposed adjacent to the tip electrode edge 54 and is in fluid communication with the fluid lumen 13 (see FIG. 1 ).
  • the tip electrode edge elution holes 56 are spaced around a circumference adjacent the tip electrode edge 54, and are disposed in the tip electrode 52.
  • the tip electrode edge elution holes 56 may be disposed in the electrically nonconductive segment 44.
  • FIG. 6 shows a distal portion of another irrigated ablation catheter 58 which is similar to the catheter 40 of FIG. 4 but does not have a tip electrode at the distal end 12.
  • FIG. 7 shows a distal portion of another irrigated ablation catheter 60 which is similar to the catheter 58 of FIG. 6 but has a tip electrode 61 at the distal end 12.
  • the catheter 60 includes flexible ring electrodes 62 having gaps cut into a cylindrical sheet to allow fluid to flow out.
  • One of the flexible ring electrodes 62 also forms the tip electrode 61.
  • elution holes in fluid communication with the fluid lumen 13 via the ducts 24 are provided in a portion of the elongated body underneath the flexible ring electrodes 62, and the fluid flows through the elution holes and the gaps in the electrodes 62.
  • the gaps may be laser cut into the cylindrical sheets of the electrodes 62.
  • the flexible ring electrodes 62 are spaced from the proximal end of the elongated body by an electrically nonconductive segment 64, and the electrodes 62 are spaced from each other longitudinally by electrically nonconductive segments 64.
  • 66 is formed between an electrode end of the segmented ablation electrode 62 and a nonconductive segment end of the electrically nonconductive segment 64.
  • the gaps are elongated gaps in a corrugated pattern.
  • an elongated gap preferably has a length that is at least about 3 times the width of the gap, more preferably at least about 5 times, and most preferably at least about 10 times.
  • the gaps may be linear or curvilinear instead of corrugated.
  • the gaps may be spiral gaps that extend in a helical pattern in the longitudinal direction or transverse gaps that are spaced from each other in the longitudinal direction.
  • a transverse gap may extend less than 360 degrees or may extend the full 360 degrees.
  • a biasing element such as an inner coil may be provided within the elongated body. Examples of flexible ring electrodes with elongated gaps can be found, for example, in US2008/0294158 and WO/2008/147599, the entire disclosures of which are incorporated herein by reference.
  • FIG. 8 is a transverse sectional view of a distal portion of an irrigated ablation catheter, which may be any of the catheters shown in FIGS. 1 -7.
  • FIG. 8 shows four ducts 24 connected to the fluid lumen 13. Additional lumens are provided for conducting wires 70 for supplying energy to the electrodes, one or more preshaping wires 72 made of a material such as Nitinol to provide a preformed shape for the distal portion of the catheter, one or more activation wires 74 for manipulating the distal portion (e.g., bidirectional bending and/or loop size adjusting), and a plurality of temperature sensor lines 76.
  • FIG. 9 is a longitudinal sectional view of a distal portion of an irrigated ablation catheter showing the fluid lumen 13, conducting wires 70, preshaping wires 72, activation wires 74, and temperature sensor lines 76.
  • FIG. 10 is a longitudinal sectional view of a distal portion of an irrigated ablation catheter showing temperature sensors 80 located at edges 102, 104 of an electrode 100. For clarity, elution holes and corresponding ducts are omitted in FIG. 10.
  • the edges 102, 104 are where the electrode 100 abuts the underlying, electrically nonconductive support body 106
  • the temperature sensors 80 are disposed on and in contact with the segmented ablation electrode 100 at the electrode ends substantially abutting the edges 102, 104.
  • RF current densities are high at the edges 102, 104, because the electrically conductivity is discontinuous at the edges 102, 104.
  • the resulting rise in current density at the electrode edges 102, 104 generates localized regions of increased power density and hence regions of higher temperatures.
  • FIG. 1 1 is a perspective view of a distal portion of an irrigated ablation catheter having a preformed loop shape.
  • the one or more preshaping wires 72 includes a material such as Nitinol so that the distal portion is preformed into a substantially closed loop with the distal tip 1 10 having a plurality of longitudinally spaced segmented ablation electrodes 1 12 and electrically nonconductive segments 1 14.
  • FIGS 12 and 13 are elevational views of an irrigated ablation catheter 120 showing a handle 122 connected to a proximal end 124 of the elongated body 125 for manipulating the shape of a distal portion of the catheter 120 near the distal end 126.
  • the distal portion of the catheter 120 includes a loop 128 having segmented ablation electrodes (see FIG. 1 1 ).
  • the handle 122 includes a first roller 130 for changing the size of the loop 128, and a second set of rollers or sliders 132 for bidirectional bending of the elongated body 125.
  • FIG. 14 is a system installation diagram of an RF ablation system with an irrigated ablation catheter.
  • the system includes a catheter 201 with multiple electrodes, a connecting cable 202, an RF generator 203, an EKG connecting cable 204, and a DIP (Dispersive Indifferent Patch) electrode device 205 that is connected to the RF generator 203 through an isolated patient connector 208
  • the DIP electrode device 205 is placed under a patient, during an ablation procedure, to provide a closed-loop circuit of the RF energy delivery system.
  • the catheter 201 has a plurality of electrodes 206 and a plurality of temperature sensing elements. Each temperature sensing element is located at the proximity of each of the electrodes 206.
  • the catheter 201 is connected to the RF generator 203 through the connecting cable 202.
  • Each of the insulated temperature wires and the conducting wires of the catheter 201 are secured to a connector 207 contact pin of the catheter 201. Therefore, the measured temperature data from each of the multiple electrodes is relayed to a control mechanism located in the CPU board 214 (FIG 15) of the RF generator 203. In the meantime, the RF energy output is delivered through each of the conducting wires to a respective individual electrode on the catheter 201.
  • the control mechanism of the CPU board 214 also controls the operation of an irrigation pump 215 which is used to pump irrigation fluid to the irrigated catheter 201 .
  • the EKG connecting cable 204 is used to transmit the intracardiac electrical signal to an external EKG monitor 220 (FIG. 15) to display the intracardiac electrical signal sensed and returned by each of the electrodes 206.
  • an external EKG monitor 220 FIG. 15
  • An optional footswitch 21 1 is also provided for the user's convenience Either the footswitch 21 1 or a button 238 on the front panel of the RF generator 203 can be used to start and stop the RF energy delivery.
  • FIG. 15 is a block diagram of the RF ablation system of FIG 14, to provide RF energy delivery through an RF splitter to each of the multiple electrodes of the ablation catheter 201.
  • the power supply source 212 is connected to the RF generator 203 having the RF board 213 and the CPU board 214.
  • a software program becomes an integral portion of the CPU board 214.
  • a catheter 201 that has multiple electrodes has a plurality of temperature sensing elements 216. Each temperature sensing element 216 is associated with one of the electrodes 206.
  • the measured temperature data is relayed to the software program inside the CPU board 214.
  • the data from the CPU board 214, such as power, temperature, impedance, and time, is then displayed via a display board 221.
  • the command or instruction is issued from the CPU board 214 to the RF board 213 to control the RF energy output.
  • An RF splitter 222 is employed to split the RF energy in order to deliver it to one or more of the conducting wires, wherefrom thereafter the RF energy output is relayed to the corresponding electrode or electrodes.
  • a digital control signal 217 from the CPU board 214 to the RF splitter 222 controls the manner in which the RF energy is delivered to the one or more conducting wires.
  • the RF energy may be delivered in an independent manner, or a sequential manner, or a simultaneous manner
  • the conducting wires which deliver the RF energy to the multiple electrodes of the catheter 201 also carry a low-frequency EKG signal which is sensed and returned by each of the multiple electrodes
  • a low-pass filter 219 is used to allow only the EKG signal to pass to the EKG monitor 220 for real-time display.
  • FIG. 16 is a flow diagram of the software program for the RF ablation system of FIG 14.
  • the major steps in the software program include: "Set ablation mode” block 223, "Set parameters” block 224, "Turn pump on” block 226, “Start ablation” block 228, "Is temp within limit 7 " block 230 and "Ablate until time is up” block 232.
  • the ablation mode 223 includes one of the modes: a simultaneous mode, a sequential mode, a random-order mode, or a combination of the above.
  • the "Set parameters” block 224 includes setting the power limit, the temperature limit, the impedance limit, and the time limit.
  • the power limit 224 is initially set at a relatively low value for safety reasons. An example would be to set the initial power limit at 15 watts.
  • the power limit can be raised in appropriate increments until a final power limit of the RF generator is reached.
  • One example for the final power limit would be 150 watts.
  • the temperature limit is set for a range, which is appropriate for the ablative lesion.
  • One example would be to set the ablation temperature limit as 67.5°C ⁇ 2.5°C.
  • the "time is up" is a predetermined time duration for ablating any of the electrodes.
  • One example would be to set the time limit for electrode no. 1 as 30 seconds. More details of operating the system can be found in U.S. Patent No. 5,954,719, which is incorporated herein by reference in its entirety.
  • the RF energy may be unipolar RF energy or bipolar RF energy depending on the configuration.
  • the control mechanism or controller on the CPU board 214 of the RF generator 203 is configured to control the energy source to supply energy to the plurality of segmented ablation electrodes in an independent manner (control energy to each electrode independently), a sequential manner (control energy to the electrodes in a preset sequence), or a simultaneous manner (control energy to the electrodes simultaneously).
  • the controller may be configured to control the energy source to supply energy to the segmented ablation electrodes based on signals received from the temperature sensors so as to control temperatures of the segmented ablation electrodes. Controlling the temperatures of the electrodes by regulating the supply of energy to the electrodes is also described, for instance, in U.S. Patent No. 6,346,104, which is incorporated herein by reference in its entirety.
  • FIG. 17 shows schematic diagrams of ablation patterns around at least one vessel ostium 300.
  • the loop 128 of the catheter in FIG. 12 can be placed around at least one vessel ostium in a chamber of a patient to ablate the tissue on a chamber wall of the chamber around the at least one vessel ostium.
  • FIG. 17(a) shows an ablation pattern around each vessel ostium 300.
  • FIG. 17(b) shows an ablation pattern around two vessel ostia 300.
  • FIG. 17(c) shows an ablation pattern around four vessel ostia 300.
  • Each vessel ostium may be a pulmonary vein for pulmonary vein isolation. See, e.g., U.S. Patent No. 6,325,797, which is incorporated herein by reference in its entirety.
  • Another application is for ablating renal sympathetic nerves in therapeutic renal sympathetic denervation to achieve reductions of blood pressure in patients suffering from renal sympathetic hyperactivity associated with hypertension and its progression.
  • the catheter will be sized differently for ablating or denervating nerves located within and around different vessels and walls. For example, the size of the catheter for ablating renal sympathetic nerves is typically smaller than that for ablating around a pulmonary vein.

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US11395694B2 (en) 2022-07-26
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