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WO2025146581A1 - Système d'ablation par champ pulsé haute tension - Google Patents

Système d'ablation par champ pulsé haute tension Download PDF

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Publication number
WO2025146581A1
WO2025146581A1 PCT/IB2024/062216 IB2024062216W WO2025146581A1 WO 2025146581 A1 WO2025146581 A1 WO 2025146581A1 IB 2024062216 W IB2024062216 W IB 2024062216W WO 2025146581 A1 WO2025146581 A1 WO 2025146581A1
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WO
WIPO (PCT)
Prior art keywords
electrodes
circuit
switches
medical system
switching circuit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/062216
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English (en)
Inventor
Steven J. Fraasch
Lars M. MATTISON
Vinicius BINOTTI
Sara A. FRANTZ
Bryce W. BUNKERS
Kevin D. GOLLON
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Medtronic Inc
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Medtronic Inc
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Publication of WO2025146581A1 publication Critical patent/WO2025146581A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B18/1206—Generators therefor
    • 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
    • A61B18/1206—Generators therefor
    • A61B18/1233—Generators therefor with circuits for assuring patient safety
    • 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
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00613—Irreversible electroporation
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/124—Generators therefor switching the output to different electrodes, e.g. sequentially
    • 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

Definitions

  • PFA allows for very brief periods of therapeutic energy delivery, e.g., milliseconds to microseconds in duration. In many cases, PFA does not cause collateral damage to non- targeted tissue as frequently or severely as thermal ablation.
  • SUMMARY [0004] Disclosed herein are, among other things, various examples, aspects, features, and embodiments of a medical system capable of delivering high-voltage PFA signals to a treatment site in a first operating mode and collecting electrogram (EGM) or mapping/navigation signals from the treatment site in a second operating mode.
  • the medical system includes a switching circuit capable of reducing cross- modal interference between the medical system components used in different operating modes, such as the interference to EGM signals from the high voltage PFA delivery system.
  • the medical system includes a fault protection circuit that inhibits delivery of PFA waveforms to the treatment site when a potentially damaging shoot-through or vertical current in the PFA-waveform generator exceeds a safe level.
  • a shoot-through or vertical current occurs when two switching devices in the same side of an H-bridge circuit are on at the same time.
  • Atty Ref. No. A0011026WO01 [0005]
  • One example provides a medical system including an H-bridge circuit configured to generate a pulsed voltage waveform between first and second load terminals thereof.
  • the medical system also includes a switching circuit connected to the first and second load terminals, the switching circuit being configurable to route the pulsed voltage waveform from the H-bridge circuit to a first selected set of a plurality of electrodes of an ablation device and being further configurable to route collected signals from a second selected set of the plurality of electrodes to a receiving circuit.
  • the medical system also includes an electronic controller configured to cause the switching circuit to switch between a first routing configuration corresponding to a first operating mode and a second routing configuration corresponding to a second operating mode. In the first routing configuration, the first selected set of the plurality of electrodes is electrically connected to receive the pulsed voltage waveform from the H-bridge circuit via the switching circuit.
  • Another example provides a signal-routing method including, with an electronic controller, controlling routing configurations of a switching circuit connected to first and second load terminals of an H-bridge circuit, the switching circuit being configurable to route a pulsed voltage waveform from the H-bridge circuit to a first selected set of a plurality of electrodes of an ablation device and being further configurable to route collected signals from a second selected set of the plurality of electrodes to a receiving circuit.
  • the controlling includes producing a first routing configuration by configuring the switching circuit to electrically connect the first set of electrodes to receive the pulsed voltage waveform from the H-bridge circuit via the switching circuit.
  • the controlling also includes producing a second routing configuration by configuring the switching circuit to electrically disconnect the plurality of electrodes and the receiving circuit from the H-bridge circuit.
  • a medical system including an H-bridge circuit configured to apply a pulsed voltage waveform to an ablation device, the H-bridge circuit including a first branch connected between a first power supply rail and a second power supply rail and a second branch connected between the first power supply rail and the second power supply rail.
  • the medical system also includes a fault protection circuit Atty Ref. No. A0011026WO01 electrically coupled to the H-bridge circuit and configured to detect a fault condition when a shoot-through current flowing through the first branch or the second branch exceeds a threshold value.
  • FIG.4 is a circuit diagram illustrating an electrical circuit configured to connect the H-bridge circuit of FIG.3 to various components of the medical system of FIG.1 according to some examples.
  • FIG.5 is a circuit diagram illustrating a fault protection circuit used in conjunction with the electrical circuit of FIG.4 according to some examples.
  • Atty Ref. No. A0011026WO01 Atty Ref. No. A0011026WO01
  • FIG.6 is a circuit diagram illustrating a signal-routing circuit used in the medical system of FIG.1 according to some examples.
  • FIG.7 is a flowchart illustrating a power-on self-test (POST) performed in the medical system of FIG.1 according to some examples.
  • POST power-on self-test
  • FIG.8 is a flowchart illustrating a fault protection method implemented in the medical system of FIG.1 according to some examples.
  • FIG.9 is a flowchart illustrating a signal-routing method implemented in the medical system of FIG.1 according to some examples.
  • DETAILED DESCRIPTION [18]
  • PFA can be performed in an open chest procedure or with the use of minimally invasive techniques. Vectoring of the electrode polarity has certain advantages in terms of obtaining greater lesion depths and widening or narrowing the area for electrical field transfer.
  • the tracking and navigation system 140 When present, the tracking and navigation system 140 is typically used for guiding a medical procedure. In the example shown, the tracking and navigation system 140 is coupled to the medical apparatus 120. In some other examples, the tracking and navigation system 140 is integrated into the medical apparatus 120. The tracking and navigation system 140 is designed to help visualize the real-time position and orientation of catheters, ablation devices, and/or auxiliary devices within the patient’s body, e.g., to increase the accuracy of targeted ablation and reacquisition of pacing sites for re-ablation.
  • a visual representation of the ablation device 110 or auxiliary device is displayed on an Atty Ref. No. A0011026WO01 anatomical map, e.g., to provide spatial and anatomic context for visualizing the electrode locations.
  • Such visual representations can be generated, e.g., using the processor 124 or another processing device coupled to or integrated into the medical apparatus 120 or the tracking and navigation system 140.
  • the ablation device 110 includes an actuation mechanism 116, e.g., a knob, a lever, a handle, or other suitable mechanism for moving, deflecting, steering, reconfiguring, and otherwise manipulating the ablation device 110 or relevant portions thereof within the patient’s anatomy.
  • the actuation mechanism 116 can be controlled by an operator based on a location of the distal portion of the ablation device 110 and the overall objective of the medical procedure. In some examples, the operator controls the actuation mechanism 116 with the aid of the above-mentioned visual representations generated with the tracking and navigation system 140, e.g., based in part on the signals received from one or more sensors 114 of the ablation device 110.
  • FIG.2 graphically illustrates an electrical waveform 202 that can be generated with the signal generator 122 according to some examples.
  • the electrical waveform 202 includes a sequence of biphasic pulses 210, each including a respective positive pulse 222 and a respective negative pulse 224.
  • each pulse 222, 224 has an absolute amplitude value ⁇ V 0 and a pulse width T p , where V 0 is a constant.
  • a negative pulse 224 follows a positive pulse 222 within each respective biphasic pulse 210, it is to be understood that it is contemplated that in other examples these may be understood to be reversed (e.g., the positive pulse following the negative pulse within a given biphasic pulse) as the “positive” and “negative” aspect of these pulses are primarily discussed in this way to illustrate the opposing nature of a biphasic pulse from the perspective of the tissue (e.g., opposing pulses from electrodes resulting in net neutral charge).
  • Both the scaling factor ⁇ and the pulse width T p are selectable and controllable via the electronic controller 123.
  • a relatively large value of ⁇ may be used to obtain a therapeutic waveform 202 whereas a relatively small value of ⁇ may be used to obtain a non-therapeutic waveform 202.
  • the time delay between the positive pulse 222 and the negative pulse 224 of the same biphasic pulse 210 is d 1 .
  • the parameter d 1 is often referred to as the interphase Atty Ref. No. A0011026WO01 delay.
  • the time delay between two consecutive biphasic pulses 210 in the waveform 202 is d 2 .
  • the parameter d 2 is often referred to as the inter-pulse delay.
  • the waveform 202 has N biphasic pulses 210, where N is a positive integer.
  • the parameters N, d 1 , d 2 , and T w of the waveform 202 are also selectable and controllable via the electronic controller 123.
  • one or more of the following considerations are applied when configuring the signal generator 122 for delivery of therapeutic waveforms: i. Biphasic waveforms, such as the waveform 202, are characterized by an approximately zero net charge applied to the targeted tissue, which is beneficial for many treatment scenarios. ii.
  • the value of ⁇ V 0 is selected to produce an electric field strength greater than approximately 350V/cm in the vicinity of the corresponding electrodes 112. This electric field strength corresponds to the irreversible electroporation threshold of a specific targeted tissue, in this example, cardiac myocytes.
  • the value of ⁇ V 0 may differ for different ablation applications targeting different tissues. These electric field strengths can typically be produced with an applied voltage in the range from approximately 1 kV to approximately 4 kV.
  • the pulse width T p is typically selected to be on the order of microseconds to avoid leakage currents associated with the change of polarity, significant heat generation, and/or unwanted stimulation of muscle or nerve cells.
  • Biphasic pulses 210 may be delivered in trains.
  • Pulse trains are typically delivered within a relatively short time interval, e.g., shorter than 200ms, to fit into the refractory period of the surrounding myocardium. The inter-pulse delay can be adjusted to achieve a desired train duration. Atty Ref. No. A0011026WO01 vii.
  • Therapeutic pulses are vectored between the electrodes that are selected to produce a therapeutic electric field strength into the targeted volume of tissue.
  • FIG.3 is a circuit diagram illustrating an H-bridge circuit 300 used in the signal generator 122 according to some examples.
  • the H-bridge circuit 300 includes four power switches (labeled Q1, Q2, Q3, and Q4, respectively) connected between a positive power supply rail +HV and a negative power supply rail ⁇ HV as indicated in FIG.3.
  • An electrical load e.g., including the ablation device 110, is connected between load terminals L1, L2 located at the center of the H-like structure of the circuit 300. When the power switches Q1 and Q4 are closed and the power switches Q2 and Q3 are open, a positive voltage is applied across the load.
  • the power switches Q1, Q2, Q3, and Q4 are implemented using bipolar transistors, FET transistors, insulated-gate bipolar transistors (IGBTs), vacuum relays, and other suitable power-switching elements.
  • IGBTs insulated-gate bipolar transistors
  • the control circuit 440 can selectively open and close the electrical paths between the patient load 410 and the EGM load 490 via the corresponding control signals applied to the third and fourth relays 480C, 480D.
  • a first resistor R1 is electrically coupled between (i) the load terminal L1 and (ii) the line including the first relay 480A and the third relay 480C.
  • a second resistor R2 is electrically coupled between (i) the load terminal L2 and (ii) the line including the second relay 480B and the fourth relay 480D.
  • a third resistor R3 is electrically coupled between the power supply rail +HV and the first transistor switch Q1.
  • a fourth sensing resistor R4 is electrically coupled between the second transistor switch Q2 and the power supply rail ⁇ HV.
  • a fifth resistor R5 is electrically coupled between the power supply rail +HV and the third transistor switch Q3.
  • a sixth resistor R6 is electrically coupled between the fourth transistor switch Q4 and the power supply rail ⁇ HV.
  • the resistors R3, R4, R5, and R5 are the current-sensing resistors electrically coupled to the fault protection circuit 500 as described in more detail below. Atty Ref. No. A0011026WO01 [39]
  • the electrical circuit 400 In a first mode of operation, the electrical circuit 400 is configured to deliver high- voltage pulses to the patient load 410.
  • the electrical circuit 400 is configured to collect EGM signals from the EGM load 490.
  • the patient load 410 and the EGM load 490 may be connected to the electrical circuit 400 via the same catheter or via different respective catheters.
  • the control circuit 440 is configured to switch the electrical circuit 400 to one signal pathway to deliver high-voltage (e.g., 4 kV) PFA energy and is further configured to switch the electrical circuit 400 to a different signal pathway to route collected EGM signals to an electrophysiological (EP) recorder (not explicitly shown in FIG.4, e.g., see FIG.6).
  • EP electrophysiological
  • the fault protection circuit 500 is connected to the control circuit 440 and is configured to sense voltages across resistors R51, R52, each of which represents (e.g., via a current or voltage follower) a respective one of the resistors R3, R4, R5, and R6 (also see FIG.4). Based on the sensed voltages, a shoot-through fault can be detected by the control circuit 440 as described below.
  • the fault protection circuit 500 includes a differential amplifier 510 connected across the serially connected resistors R51, R52 such that a first end of the resistor series is connected to a non-inverting (+) input of the differential amplifier 510, and a second end Atty Ref. No.
  • A0011026WO01 of the resistor series is connected to an inverting ( ⁇ ) input of the differential amplifier 510.
  • Resistors R53-R56 are connected between the resistors R51, R52 and the differential amplifier 510 to provide a suitable voltage gain such that the fault protection circuit 500 has a desired sensitivity to shoot-through currents.
  • An output signal 512 of the differential amplifier 510 is electrically coupled to the non-inverting (+) input of a first comparator 530 and to the inverting ( ⁇ ) input of a second comparator 540.
  • the fault protection circuit 500 also includes a digital-to-analog converter (DAC) 550 configured to provide reference voltages Vout, ⁇ Vout to the inverting ( ⁇ ) input of the comparator 530 and the non-inverting (+) input of comparator 540.
  • the DAC 550 generates reference voltages Vout, ⁇ Vout in response to digital values thereof received, via a control signal 564, from the control circuit 440.
  • the first comparator 530 is used to detect a positive shoot-through current, for example, when the corresponding current is flowing from the first end to the second end of the resistor series.
  • the second comparator 540 is similarly used to detect a negative shoot-through current, for example, when the corresponding current is flowing from the second end to the first end of the resistor series.
  • a current flows across the resistors R51, R52
  • the voltage drop across the resistors is amplified by the differential amplifier 510, and the corresponding amplified signal 512 proportional to the voltage drop is provided to the inputs of the comparators 530 and 540.
  • an output signal 532 of the first comparator 530 switches states (for example, from low to high) when the signal 512 exceeds the reference voltage Vout.
  • a distal portion 636 of the catheter 110 has nine electrodes 112, which are labeled 112 1 -112 9 .
  • the electrodes 112 1 -112 9 are used to deliver PFA waveforms to the treatment site.
  • the electrodes 112 1 -112 9 are used to collect MAP/NAV or EGM signals from the treatment site.
  • the catheter 110 also includes an elongated body 634 to enable placement of the electrodes 112 in proximity to the treatment site of the patient.
  • the electrodes 112 1 -112 9 are located on the carrier arm 640. Each one of the electrodes 112 1 -112 9 is electrically connected, via a dedicated electrical wire of an electrical bus 632 disposed within the corresponding lumen of the elongated body 634, to Atty Ref. No. A0011026WO01 a multi-pin connector 630 located at the proximal portion 628 of the catheter 110. The multi-pin connector 630 is further electrically connected to the switching circuit 620 as indicated in FIG.6. [47] In the example shown, the switching circuit 620 includes twenty-seven switches, which are labeled K1-K27.
  • the number of switches in the switching circuit 620 corresponds to the number or electrodes 112 in the matching ablation device 110, with three switches per electrode. Based on the provided description, a person of ordinary skill in the pertinent art will be able to make and use additional embodiments of the switching circuit 620 compatible with other ablation devices 110 having other (than nine) numbers of electrodes 112, without any undue experimentation.
  • the switching circuit 620 has the corresponding dedicated switches K1, K10, and K19.
  • the switching circuit 620 has the corresponding dedicated switches K2, K11, and K20, and so on.
  • the switching circuit 620 has the corresponding dedicated switches K9, K18, and K27.
  • the states (OPEN or CLOSED) of individual switches K1-K27 are independently controllable via control signals 618 generated by the control circuit 440 or other suitable circuit of the electronic controller 123.
  • the switch Kn When in the CLOSED state, the switch Kn electrically connects the electrode 112 n to the load terminal L1 of the H-bridge circuit 300.
  • the switch K(n+18) electrically connects the electrode 112 n to the load terminal L2 of the H-bridge circuit 300.
  • the switch K(n+9) When in the CLOSED state, the switch K(n+9) electrically connects the electrode 112 n to the signal-receiving circuit 610.
  • all switches K(n+9) are switched to the OPEN state.
  • the electrodes 112 1 -112 9 are sorted into three non- overlapping sets based on the intended PFA delivery configuration. For an electrode 112 n belonging to the first set, the switch Kn is switched to the CLOSED state, and the switch K(n+18) is switched to the OPEN state. For an electrode 112 n belonging to the second set, the switch Kn is switched to the OPEN state, and the switch K(n+18) is switched to the Atty Ref. No.
  • both of the switches Kn and K(n+18) are switched to the OPEN state.
  • At least one of the first and second sets is a nonempty set.
  • the third set can be empty.
  • At least some of the first, second, and third sets can be dynamically changed during the first operating mode, e.g., to enable PFA delivery via different respective sets of the electrodes 112 1 -112 9 .
  • all switches Kn and K(n+18) are switched to the OPEN state.
  • This switch configuration beneficially electrically isolates the electrodes 112 1 -112 9 and the signal-receiving circuit 610 from the high voltages of and the noise induced by the H-bridge circuit 300.
  • One or more switches K(n+9) are switched to the CLOSED state to enable transmission of the signals picked up at the treatment site by the corresponding one or more electrodes 112 n to the signal- receiving circuit 610.
  • the remaining switches K(n+9) are switched to the OPEN state.
  • the sets of the switches K(n+9) that are in the OPEN state and the CLOSED state can be dynamically changed to enable the signal-receiving circuit 610 to receive signals from different sets of the electrodes 112 1 -112 9 at different times during the second operating mode.
  • FIG.7 is a flowchart illustrating a power-on self-test (POST) 700 performed in the medical system 100 according to some examples.
  • the POST 700 can be performed, e.g., using the fault protection circuit 500.
  • the POST 700 includes the electronic controller 123 setting one or more POST thresholds (in a block 702).
  • the POST thresholds are represented by the digital values of Vout and ⁇ Vout communicated by the control circuit 440 to the DAC 550.
  • the DAC 550 applies the corresponding voltages to the first comparator 530 and the second comparator 540, respectively.
  • the POST 700 also includes the electronic controller 123 operating the power supply 450 to apply suitable voltages to the power rails +HV and ⁇ HV of the H-bridge circuit 300 (in a block 704). Operations of the block 704 further include the control circuit 440 switching the power switches Q1, Q2, Q3, and Q4 of the H-bridge circuit 300 to generate a test waveform between the load terminals L1, L2. In some examples, the test Atty Ref. No. A0011026WO01 waveform includes or is the waveform 202. In some other examples, a different suitable test waveform can also be used in the block 704. [55] The POST 700 also includes the electronic controller 123 determining (in a decision block 706) whether a fault condition is present.
  • FIG.8 is a flowchart illustrating a fault protection method 800 carried out in the medical system 100 according to some examples.
  • the method 800 can be implemented, e.g., using the fault protection circuit 500.
  • the method 800 includes the electronic controller 123 receiving a user input requesting PFA delivery (in a block 802).
  • the method 800 also includes the electronic controller 123 operating the H-bridge circuit 300 to deliver a portion of the corresponding Atty Ref. No. A0011026WO01 PFA waveform to the ablation device 110 (in a block 804).
  • the method 800 further includes the electronic controller 123 determining (in a decision block 806) whether a fault condition is present.
  • the electronic controller 123 detects the presence of a fault condition when the control circuit 440 determines that the magnitude of shoot- through currents through at least one of the vertical branches 302, 304 of the H-bridge circuit 300 is too large. This determination is made based on the output signals 532, 542 of the comparators 530 and 540 generated in the fault protection circuit 500 in response to the portion of the waveform delivered the block 804 and based on applicable threshold voltage(s) applied to the comparators 530 and 540 as described above in reference to FIG. 5.
  • the processing of the method 800 is directed to operations of a block 808.
  • Operations of the block 808 include the control circuit 440 generating one or more control signals 562 configured to inhibit or stop the H-bridge circuit 300 from delivering the PFA waveform 202 to the ablation device 110, e.g., by changing the states of the power switches Q1, Q2, Q3, and Q4 and/or of the relays 480A, 480B. The method 800 is thereafter terminated.
  • Operations of the block 810 include the electronic controller 123 determining whether the PFA delivery is completed.
  • FIG.9 is a flowchart illustrating a signal-routing method 900 implemented in the medical system 100 according to some examples.
  • the method 900 can be implemented, e.g., using the switching circuit 620.
  • the method 900 includes the electronic controller 123 determining whether the medical system 100 is to be operated in a first operating mode or in a second operating mode (in a decision block 902). In the first operating mode, the medical system 100 is Atty Ref. No.
  • A0011026WO01 configured to deliver high-voltage pulses to the ablation device 110.
  • the medical system 100 is configured to collect EGM or MAP/NAV signals from the ablation device 110.
  • the completion determination in the decision block 902 is made based on the user input or based on the applicable programmatic script that specifies different operating modes for different periods of time.
  • the processing of the method 900 is directed to operations of a block 904.
  • Operations of the block 904 include the electronic controller 123 generating an set of control signals 618 for the switches K1-K27 of the switching circuit 620 to connect the first and second sets of the electrodes 112 n of the ablation device 110 to the load terminals L1 and L2, respectively, of the H-bridge circuit 300.
  • the control signals 618 generated by the electronic controller 123 in the block 904 also cause all switches K(n+9) to be in the OPEN state to electrically isolate the signal-receiving circuit 610 from the ablation device 110.
  • Operations of the block 904 also include the electronic controller 123 switching the power switches Q1-Q4 of the H-bridge circuit 300 to deliver a PFA waveform to the connected electrodes 112 n of the ablation device 110.
  • Operations of the block 906 include the electronic controller 123 generating another set of control signals 618 for the switching circuit 620 to isolate the ablation device 110 from the H-bridge circuit 300 by placing the switches Kn and K(n+18) in the OPEN state.
  • the control signals 618 generated by the electronic controller 123 in the block 906 also cause some of the switches K(n+9) to be in the CLOSED state to enable the signal-receiving circuit 610 to collect EGM or MAP/NAV signals from the corresponding electrodes 112 n of the ablation device 110.
  • the method 900 also includes the electronic controller 123 determining whether the medical system 100 is to continue with operations of one of the first and second operating modes (in a decision block 908).
  • the electronic controller 123 determines Atty Ref. No. A0011026WO01 that the operations will continue (“Yes” at the decision block 908), the processing of the method 900 is looped back to the block 902.
  • the method 900 is terminated.
  • a medical system comprising: an H-bridge circuit configured to generate a pulsed voltage waveform between first and second load terminals thereof; a switching circuit connected to the first and second load terminals, the switching circuit being configurable to route the pulsed voltage waveform from the H-bridge circuit to a first selected set of a plurality of electrodes of an ablation device and being further configurable to route collected signals from a second selected set of the plurality of electrodes to a receiving circuit; and an electronic controller configured to control routing configurations of the switching circuit, wherein, in a routing configuration corresponding to a first operating mode, the first set of electrodes is electrically connected to receive the pulsed voltage waveform from the H-bridge circuit via the switching circuit; and wherein, in a routing configuration corresponding to a second operating mode, the plurality of electrodes and the receiving circuit are electrically disconnected by the switching circuit from
  • the switching circuit includes three respective switches per electrode of the plurality of electrodes.
  • the switching circuit includes a plurality of first switches and a plurality of second switches; wherein each of the first switches is switchable by the electronic controller to selectively connect and disconnect a respective electrode of the plurality of electrodes to and from the first load terminal; and wherein each of the second switches is switchable by the electronic controller to selectively connect and disconnect a corresponding electrode of the plurality of electrodes to and from the second load terminal.
  • the switching circuit further includes a plurality of third switches, wherein each of the third switches is switchable by Atty Ref. No.
  • a signal-routing method comprising: with an electronic controller, controlling routing configurations of a switching circuit connected to first and second load terminals of an the H-bridge circuit, the switching circuit being configurable to route a pulsed voltage waveform from the H-bridge circuit to a first selected set of a plurality of electrodes of an ablation device and being further configurable to route collected signals from a second selected set of the plurality of electrodes to a receiving circuit, the controlling including: producing a first routing configuration by configuring the switching circuit to electrically connect the first set of electrodes to receive the pulsed voltage waveform from the H-bridge circuit via the switching circuit; and producing a second routing configuration by configuring the switching circuit to electrically disconnect the plurality of electrodes and the receiving circuit from the H-bridge circuit.
  • the switching circuit includes three respective switches per electrode of the plurality of electrodes.
  • the switching circuit includes a plurality of first switches and a plurality of second switches; wherein each of the first switches is switchable by the electronic controller to selectively connect and disconnect a respective electrode of the plurality of electrodes to and from the first load terminal; and wherein each of the second switches is switchable by the electronic controller to selectively connect and disconnect a corresponding electrode of the plurality of electrodes to and from the second load terminal.
  • the switching circuit further includes a plurality of third switches, wherein each of the third switches is Atty Ref. No.
  • the receiving circuit is a part of a mapping and navigation system or a part of an electrophysiological recorder.
  • the ablation device is a catheter including an electrical bus disposed in an elongated body thereof and configured to separately connect each electrode of the plurality of electrodes to the switching circuit.
  • a medical system comprising: an H-bridge circuit configured to apply a pulsed voltage waveform to an ablation device, the H-bridge circuit including a first branch connected between a first power supply rail and a second power supply rail and a second branch connected between the first power supply rail and the second power supply rail; a fault protection circuit electrically coupled to the H-bridge circuit and configured to detect a fault condition when a shoot-through current flowing through the first branch or the second branch exceeds a threshold value; and an electronic controller configured to inhibit the medical system from delivering the pulsed voltage waveform to the ablation device in response to the fault condition being detected.
  • the first branch includes a first power switch, a first resistor configured to sense a first electrical current flowing through the first power switch, a second power switch serially connected with the first power switch, and a second resistor configured to sense a second electrical current flowing through the second power switch; and wherein the second branch includes a third power switch, a third resistor configured to sense a third electrical current flowing through the third power switch, a fourth power switch serially connected with the third power switch, and a fourth resistor configured to sense a fourth electrical current flowing through the fourth power switch.
  • the fault protection circuit is electrically coupled to the first, second, third, and fourth resistors and is configured to Atty Ref. No.
  • the fault protection circuit comprises: a differential amplifier configured to generate an output signal proportional to a difference between a selected pair of the sensed first, second, third, and fourth electrical currents; a comparator configured to compare a voltage of the output signal with a threshold voltage; and a control circuit configured to detect the fault condition based on the comparison.
  • a fault protection method for a medical system comprising: with an H-bridge circuit, applying a pulsed voltage waveform to an ablation device, the H-bridge circuit including a first branch connected between a first power supply rail and a second power supply rail and a second branch connected between the first power supply rail and the second power supply rail; with a fault protection circuit electrically coupled to the H-bridge circuit, detecting a fault condition when a shoot- through current flowing through the first branch or the second branch exceeds a threshold value; and with an electronic controller, inhibiting the medical system from delivering the pulsed voltage waveform to the ablation device in response to the fault condition being detected.
  • the phrase “if it is determined” or “if [a stated condition] is detected” may be construed to mean “upon determining” or “in response to determining” or “upon detecting [the stated condition or event]” or “in response to detecting [the stated condition or event].”
  • the drawings which are not to scale, are illustrative only and are used in order to explain, rather than limit the disclosure.
  • the use of terms such as height, length, width, top, bottom, is strictly to facilitate the description of the embodiments and is not intended to limit the embodiments to a specific orientation.
  • height does not imply only a vertical rise limitation, but is used to identify one of the three dimensions of a three-dimensional structure as shown in the figures.
  • Couple refers to any manner known in the art or later developed in which energy is allowed to be transferred between two or more elements, and the interposition of one or more additional elements is contemplated, although not required. Conversely, the terms “directly coupled,” “directly connected,” etc., imply the absence of such additional elements.
  • processors may be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software.
  • the functions may be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which may be shared.
  • processor or “controller” should not be construed to refer exclusively to hardware capable of executing software, and may implicitly include, without limitation, digital signal processor (DSP) hardware, network processor, application specific integrated circuit (ASIC), field programmable gate array (FPGA), read only memory (ROM) for storing software, random access memory (RAM), and nonvolatile storage. Other hardware, conventional and/or custom, may also be included.
  • DSP digital signal processor
  • ASIC application specific integrated circuit
  • FPGA field programmable gate array
  • ROM read only memory
  • RAM random access memory
  • nonvolatile storage Other hardware, conventional and/or custom, may also be included.
  • any switches shown in the figures are conceptual only. Their function may be carried out through the operation of program logic, through dedicated logic, through the interaction of program control and dedicated logic, or even manually, the particular technique being selectable by the implementer as more specifically understood from the context. Atty Ref. No.
  • circuitry also covers an implementation of merely a hardware circuit or processor (or multiple processors) or portion of a hardware circuit or processor and its (or their) accompanying software and/or firmware.
  • circuitry also covers, for example and if applicable to the particular claim element, a baseband integrated circuit or processor integrated circuit for a mobile device or a similar integrated circuit in server, a cellular network device, or other computing or network device.
  • Example 1 A medical system, comprising: an H-bridge circuit configured to generate a pulsed voltage waveform between first and second load terminals thereof; a switching circuit connected to the first and second load terminals, the switching circuit being configurable to route the pulsed voltage waveform from the H-bridge circuit Atty Ref. No.
  • A0011026WO01 to a first selected set of a plurality of electrodes of an ablation device and being further configurable to route collected signals from a second selected set of the plurality of electrodes to a receiving circuit; and an electronic controller configured to cause the switching circuit to switch between a first routing configuration corresponding to a first operating mode and a second routing configuration corresponding to a second operating mode, wherein, in the first routing configuration, the first selected set of the plurality of electrodes is electrically connected to receive the pulsed voltage waveform from the H- bridge circuit via the switching circuit; and wherein, in the second routing configuration, the plurality of electrodes and the receiving circuit are electrically disconnected by the switching circuit from the H-bridge circuit.
  • Example 3 The medical system of Example 1, wherein the switching circuit includes a plurality of first switches and a plurality of second switches; wherein each of the first switches is switchable by the electronic controller to selectively connect and disconnect a respective electrode of the plurality of electrodes to and from the first load terminal; and wherein each of the second switches is switchable by the electronic controller to selectively connect and disconnect a corresponding electrode of the plurality of electrodes to and from the second load terminal.
  • Example 4 Example 4.
  • Example 5 The medical system of Example 1, wherein the switching circuit further includes a plurality of third switches; and wherein each of the third switches is switchable by the electronic controller to selectively connect and disconnect an associated electrode of the plurality of electrodes to and from the receiving circuit.
  • Example 5 The medical system of Example 1, wherein the receiving circuit is a part of a mapping and navigation system or a part of an electrophysiological recorder.
  • Example 6 The medical system of Example 1, wherein the ablation device is a catheter including an electrical bus disposed in an elongated body thereof and Atty Ref. No. A0011026WO01 configured to separately connect each electrode of the plurality of electrodes to the switching circuit.
  • Example 7 Example 7.
  • Example 8 The medical system of Example 1, wherein the H-bridge circuit comprises: a first branch connected between a first power supply rail and a second power supply rail, the first branch including a first power switch, a first resistor configured to sense a first electrical current flowing through the first power switch, a second power switch serially connected with the first power switch, and a second resistor configured to sense a second electrical current flowing through the second power switch; and a second branch connected between the first power supply rail and the second power supply rail, the second branch including a third power switch, a third resistor configured to sense a third electrical current flowing through the third power switch, a fourth power switch serially connected with the third power switch, and a fourth resistor configured to sense a fourth electrical current flowing through the fourth power switch.
  • Example 8 Example 8
  • Example 7 further comprising a fault protection circuit electrically coupled to the first, second, third, and fourth resistors and configured to detect a fault condition based on the sensed first, second, third, and fourth electrical currents.
  • Example 9 The medical system of Example 8, wherein the electronic controller is further configured to inhibit the medical system from delivering the pulsed voltage waveform to the ablation device in response to the fault condition being detected.
  • Example 10 The medical system of Example 8, wherein the fault condition is detected when a shoot-through current flowing through the first branch or the second branch exceeds a threshold value.
  • the fault protection circuit comprises: a differential amplifier configured to generate an output signal proportional to a difference between a selected pair of the sensed first, second, third, and fourth electrical currents; a comparator configured to compare a voltage of the output signal with a threshold voltage; and a control circuit configured to detect the fault condition based on the comparison.
  • a differential amplifier configured to generate an output signal proportional to a difference between a selected pair of the sensed first, second, third, and fourth electrical currents
  • a comparator configured to compare a voltage of the output signal with a threshold voltage
  • a control circuit configured to detect the fault condition based on the comparison.
  • a signal-routing method comprising: with an electronic controller, controlling routing configurations of a switching circuit connected to first and second load terminals of an the H-bridge circuit, the switching circuit being configurable to route a pulsed voltage waveform from the H-bridge circuit to a first selected set of a plurality of electrodes of an ablation device and being further configurable to route collected signals from a second selected set of the plurality of electrodes to a receiving circuit, the controlling including: producing a first routing configuration by configuring the switching circuit to electrically connect the first selected set of the plurality of electrodes to receive the pulsed voltage waveform from the H-bridge circuit via the switching circuit; and producing a second routing configuration by configuring the switching circuit to electrically disconnect the plurality of electrodes and the receiving circuit from the H-bridge circuit.
  • Example 13 The signal-routing method of Example 12, wherein the switching circuit includes three respective switches per electrode of the plurality of electrodes.
  • Example 14 The signal-routing method of Example 13, wherein the switching circuit includes a plurality of first switches and a plurality of second switches; wherein each of the first switches is switchable by the electronic controller to selectively connect and disconnect a respective electrode of the plurality of electrodes to and from the first load terminal; and wherein each of the second switches is switchable by the electronic controller to selectively connect and disconnect a corresponding electrode of the plurality of electrodes to and from the second load terminal.
  • Example 15 Example 15
  • Example 14 The signal-routing method of Example 14, wherein the switching circuit further includes a plurality of third switches; and wherein each of the third switches is switchable by the electronic controller to selectively connect and disconnect an associated electrode of the plurality of electrodes to and from the receiving circuit.
  • Example 16 The signal-routing method of Example 12, wherein the receiving circuit is a part of a mapping and navigation system or a part of an electrophysiological recorder. Atty Ref. No. A0011026WO01
  • Example 17 The signal-routing method of claim 12, wherein the ablation device is a catheter including an electrical bus disposed in an elongated body thereof and configured to separately connect each electrode of the plurality of electrodes to the switching circuit.
  • Example 18 Example 18
  • a medical system comprising: an H-bridge circuit configured to apply a pulsed voltage waveform to an ablation device, the H-bridge circuit including a first branch connected between a first power supply rail and a second power supply rail and a second branch connected between the first power supply rail and the second power supply rail; a fault protection circuit electrically coupled to the H-bridge circuit and configured to detect a fault condition when a shoot-through current flowing through the first branch or the second branch exceeds a threshold value; and an electronic controller configured to inhibit the medical system from delivering the pulsed voltage waveform to the ablation device in response to the fault condition being detected.
  • Example 18 The medical system of Example 18, wherein the first branch includes a first power switch, a first resistor configured to sense a first electrical current flowing through the first power switch, a second power switch serially connected with the first power switch, and a second resistor configured to sense a second electrical current flowing through the second power switch; and wherein the second branch includes a third power switch, a third resistor configured to sense a third electrical current flowing through the third power switch, a fourth power switch serially connected with the third power switch, and a fourth resistor configured to sense a fourth electrical current flowing through the fourth power switch.
  • Example 20 Example 20.
  • Example 21 The medical system of Example 19, wherein the fault protection circuit is electrically coupled to the first, second, third, and fourth resistors and is configured to detect the fault condition based on the sensed first, second, third, and fourth electrical currents.
  • the fault protection circuit comprises: a differential amplifier configured to generate an output signal proportional to a difference between a selected pair of the sensed first, second, third, and fourth electrical currents; a comparator configured to compare a voltage of the output Atty Ref. No. A0011026WO01 signal with a threshold voltage; and a control circuit configured to detect the fault condition based on the comparison.
  • Example 22 Example 22.
  • a fault protection method for a medical system comprising: with an H-bridge circuit, applying a pulsed voltage waveform to an ablation device, the H-bridge circuit including a first branch connected between a first power supply rail and a second power supply rail and a second branch connected between the first power supply rail and the second power supply rail; with a fault protection circuit electrically coupled to the H-bridge circuit, detecting a fault condition when a shoot- through current flowing through the first branch or the second branch exceeds a threshold value; and with an electronic controller, inhibiting the medical system from delivering the pulsed voltage waveform to the ablation device in response to the fault condition being detected.

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Abstract

Un système médical est configuré pour fournir des signaux d'ablation par champ pulsé (PFA) haute tension à un site de traitement dans un premier mode de fonctionnement et collecter des signaux d'électrogramme (EGM) ou de mappage/navigation à partir du site de traitement dans un second mode de fonctionnement. Dans certains exemples, le système médical comprend un circuit de commutation pouvant réduire une interférence intermodale entre les composants de système médical utilisés dans différents modes de fonctionnement. Dans certains exemples supplémentaires, le système médical comprend un circuit de protection contre les défauts qui inhibe la distribution de formes d'onde PFA au site de traitement lorsqu'un courant de traversée dans le générateur de forme d'onde PFA dépasse un niveau sûr.
PCT/IB2024/062216 2024-01-04 2024-12-04 Système d'ablation par champ pulsé haute tension Pending WO2025146581A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210022794A1 (en) * 2018-02-08 2021-01-28 Farapulse, Inc. Method and apparatus for controlled delivery of pulsed electric field ablative energy to tissue
US20210038283A1 (en) * 2017-01-27 2021-02-11 Medtronic, Inc. Methods of ensuring pulsed field ablation generator system electrical safety
US20210161592A1 (en) * 2019-12-03 2021-06-03 Biosense Webster (Israel) Ltd. Pulse Generator for Irreversible Electroporation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210038283A1 (en) * 2017-01-27 2021-02-11 Medtronic, Inc. Methods of ensuring pulsed field ablation generator system electrical safety
US20210022794A1 (en) * 2018-02-08 2021-01-28 Farapulse, Inc. Method and apparatus for controlled delivery of pulsed electric field ablative energy to tissue
US20210161592A1 (en) * 2019-12-03 2021-06-03 Biosense Webster (Israel) Ltd. Pulse Generator for Irreversible Electroporation

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