Infusion balloon catheter for tissue ablation
By utilizing the permeable membrane and fluid chamber design of the catheter device, combined with vasoactive substances, the problems of thermal effects and selectivity in tissue ablation are solved, achieving efficient and safe cardiac tissue ablation.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- STOCKCART GAME M BE HER
- Filing Date
- 2026-01-19
- Publication Date
- 2026-07-21
AI Technical Summary
There is a need for improvement in the thermal effect and tissue selectivity of existing tissue ablation devices, especially in cardiac tissue ablation, where traditional methods pose risks and time consumption problems.
A catheter device was designed that employs a fluid-permeable membrane structure. A virtual electrode is formed on the membrane by a conductive fluid to reduce thermal effects. Selective tissue ablation is achieved through the precise layout of the fluid chamber and the electrode. Vasoactive substances are combined to adjust conductivity and reduce energy input to non-target tissues.
This approach reduces thermal effects during tissue ablation, improves tissue selectivity and ablation efficiency, reduces the impact on non-target tissues, and also reduces treatment time and risks.
Smart Images
Figure CN122423948A_ABST
Abstract
Description
Technical Field
[0001] The present invention generally relates to an application device, particularly to a catheter device, and to a system and method having such a device for tissue ablation. Background Technology
[0002] Treating tissues with electrical energy, such as high-frequency (HF) current or pulsed electric fields, is a well-established clinical technique. In HF ablation, an applicator is inserted into the tissue and a high-frequency current is generated. In pulsed field ablation (PFA), short, high-voltage electrical pulses are applied to the tissue along with the associated high electric field intensity. This application method is classified as a non-thermal procedure because it is based on delivering short pulses with high voltage amplitudes that generate localized strong electric fields ranging from several kilovolts per centimeter between each effective electrode pair. This field intensity causes temporary pores to form in the cell membrane. If the electric field exceeds a specific threshold required to form pores in the lipid bilayer of the cell membrane, and the tissue is exposed to this field for more than a critical period, the cells die due to apoptosis (a form of programmed cell death).
[0003] In treating arrhythmias such as atrial fibrillation, an applicator is used. This applicator is usually a catheter with electrodes mounted on a so-called cup structure, a balloon, or a ring electrode mounted on a tube. Summary of the Invention
[0004] This invention falls within the scope of minimally invasive medical surgery, with a particular focus on ablation techniques. Specifically, it emphasizes the use of high-frequency ablation (HF) and irreversible electroporation (IRE) electrical energy delivery, known as pulsed field ablation (PFA). IRE is an advanced method used in interventional medicine for targeted tissue therapy. This technique has made significant progress in medical treatment and, with particular considerations of tissue selectivity, reduced treatment time, and minimized risks associated with traditional treatments, has been specifically applied to the ablation of cardiac tissue.
[0005] According to prior art, US Patent 11,690,671 B1 is known, which relates to a tissue ablation catheter with an insulator between inner and outer electrodes. The device discloses electrodes biased at a distal end. The material between the inner and outer electrodes is an insulator. This catheter is configured to generate an electric field that bends around the tip of the catheter.
[0006] There is currently a need for improved application devices (especially catheter devices) and associated systems and methods for tissue ablation.
[0007] Therefore, an application device is proposed, particularly the catheter device according to technical solution 1, the system according to technical solution 12, and the method according to technical solution 18.
[0008] According to the first aspect, an application device is proposed. The application device can particularly be configured as a catheter device. The application device (especially a catheter device) specified herein is generally referred to simply as a device. The device is particularly suitable for use in surgical procedures.
[0009] The (application) device has a shaft adapted to receive at least one conductive fluid, particularly for conveying it from a proximal end to a distal end of the shaft. The device has at least one first electrode disposed on a first section of the shaft. The device has at least one first pair of counter electrodes. The device has a first wire connected to the at least one first electrode and the at least one first pair of electrodes. The first wire is adapted to transmit an electrical signal to be received to the at least one first electrode and the at least one first pair of electrodes. The device has at least one first membrane, particularly an electrically insulating membrane. The at least one first membrane is adapted to: seal the first section of the shaft in a fluid-impermeable manner (particularly a liquid-impermeable manner), and form a first internal space between the at least one first membrane and the first section of the shaft. The first section of the shaft is adapted to convey the at least one conductive fluid into the internal space. The first wall of the at least one first membrane is adapted to be at least partially permeable to the fluid, particularly permeable to liquids.
[0010] One advantage of the device is that it achieves an electrical connection with the fluid, allowing at least partially fluid-permeable membranes to focus voltage pulses transmitted at one / or said (e.g., at least one first) electrode, creating so-called "virtual electrodes" at locations where conductive fluid emerges from the membrane. Simultaneously, the emerging fluid selectively reduces thermal effects on the tissue. Furthermore, the complexity is reduced because only one electrical connection is required.
[0011] It has the following advantages: on the one hand, conductive fluids such as perfusion fluids can reduce thermal effects; at the same time, the membrane can ensure tissue contact and the associated occlusion.
[0012] The conductive fluid may have a first and / or a second conductive fluid, or be formed as a first and / or a second conductive fluid. The shaft of the device may be adapted to receive the first and / or the second conductive fluid. The first section of the shaft may be adapted to deliver the first and / or the second conductive fluid into the internal space.
[0013] The at least one first membrane, particularly the first wall, may have at least one first perforation from which the first and / or second conductive fluid may seep out.
[0014] The first segment may be located between the distal end and the proximal end.
[0015] The device may have at least one second electrode. The at least one first and / or second electrode may be disposed on the second and / or first segment of the shaft and connected to the first wire.
[0016] The second segment may be disposed between the first segment and the proximal end.
[0017] The device may have at least one second membrane, particularly an electrically insulating membrane. The at least one second membrane may be adapted to close the second section of the shaft, thereby sealing the shaft end in a fluid-impermeable, particularly liquid-impermeable, manner and forming a second internal space between the at least one second membrane and the second section of the shaft.
[0018] The second section of the shaft may be adapted to deliver one or more conductive fluids, particularly the first and / or second conductive fluids, into the second internal space. The second wall of the at least one second membrane may be adapted to be permeable to fluids, particularly liquids.
[0019] The at least one second membrane, particularly the second wall, may have at least one second perforation from which the first and / or second conductive fluid may seep.
[0020] The first and / or second internal space may have at least one first fluid chamber and / or one second fluid chamber. The at least one first and / or second fluid chamber may be adapted to enclose the first and / or second segment of the shaft in a fluid-impermeable manner, or to be connected to the first and / or second segment of the shaft in a fluid-impermeable manner. The at least one first fluid chamber may be adapted to deliver the or a first conductive fluid to at least a first portion of the inner surface of the first and / or second membrane. The at least one second fluid chamber may be adapted to deliver the or a second conductive fluid to at least a second portion of the inner surface of the first and / or second membrane. The first and / or second fluid chamber may include the at least one first and / or at least one second electrode. The at least one first and / or second electrode may be disposed on the first and / or second portions of the first or second segment of the shaft.
[0021] The at least one first fluid chamber may be connected in a fluid-impermeable manner to at least one first portion of the inner surface of the at least one first and / or the at least one second membrane. The at least one second fluid chamber may be connected in a fluid-impermeable manner to at least one second portion of the inner surface of the at least one first and / or the at least one second membrane.
[0022] The at least one first and / or second fluid chamber may occupy / cover any angular region between 45° and 360° (around the longitudinal axis of the first and / or second membrane). The at least one first and / or second fluid chamber may each occupy / cover any angular region, such that the total angular region of the two fluid chambers is between 45° and 360° (e.g., the first angular region is 90°, the second angular region is 180°, and the total angular region is 270°).
[0023] Forming one or more fluid chambers has the advantage that only specific points of the tissue receive energy by means of energy application. Therefore, it prevents the unnecessary injection of energy into tissue that should not be ablated.
[0024] The at least one first electrode, the at least one second electrode, the at least one first, second, and third (see below) electrode pairs and / or the membrane, particularly the at least one first and / or second perforation, may have a bioabsorbable material that is particularly soluble in body fluids, or may be covered with a bioabsorbable material that is particularly soluble in body fluids, or may be covered with a corresponding material layer.
[0025] The at least one first membrane may be disposed between the distal end and the proximal end of the shaft. The at least one second membrane may be disposed between the at least one first membrane and the proximal end of the shaft. The at least one first membrane and / or the at least one second membrane may be formed as a balloon.
[0026] The device may also have at least one containment structure. The at least one containment structure can seal the second section of the shaft in a fluid-impermeable, particularly liquid-impermeable, manner. The at least one containment structure can be adapted to restrict or impede the leakage of the conductive fluid along the propagation direction from the first wall, particularly from the at least one first perforation, and / or to allow it to move or be movable along the shaft. The at least one containment structure can be disposed between the at least one first membrane and the proximal end. The at least one containment structure can be adapted to seal the shaft end in a fluid-impermeable manner.
[0027] The device may have a discharge port / outlet. The discharge port may be disposed on or integrated into the shaft. The discharge port may be disposed on the shaft between the at least one first membrane and the at least one inhibition structure, or between the at least one first membrane and the at least one second membrane. The discharge port may be adapted to discharge conductive fluid that has seeped from the first wall (particularly from the at least one first perforation) and / or from the second wall (particularly from the at least one second perforation) into, for example, the shaft. The shaft may be adapted to transport the discharged conductive fluid to, for example, the proximal end or discharge it outside the shaft via the proximal end. The shaft may have a discharge line disposed within the shaft and connected to the discharge port.
[0028] At least one first pair of electrodes, at least one second pair of electrodes, and / or at least one third pair of electrodes may be provided. For example, at least one first pair of electrodes, at least one second pair of electrodes, and / or at least one third pair of electrodes may be provided at the following locations: between the distal end and the at least one first membrane, or between the at least one first membrane and the proximal end, or between the at least one first membrane and the at least one second membrane, or between the at least one second membrane and the proximal end, or disposed between the at least one first membrane and the at least one suppression structure. The at least one first pair of electrodes, at least one second pair of electrodes, and / or at least one third pair of electrodes may be disposed adjacent to each other or separately from each other. The at least one first pair of electrodes, at least one second pair of electrodes, and / or at least one third pair of electrodes may be formed as the main electrodes.
[0029] The at least one first perforation and / or the at least one second perforation may be formed as at least one perforation line. The at least one perforation line may be oriented along the longitudinal axis of the first and / or second membrane, particularly starting from the outer periphery of the middle / center of the membrane, or starting from the first or second end of the first and / or second membrane, extending along the longitudinal axis to the second or first end of the first and / or second membrane.
[0030] The at least one first perforation and / or the at least one second perforation may be formed as a plurality of perforation lines, each perforation line being oriented along the longitudinal axis of the first and / or second membrane, particularly starting from the middle / central periphery of the first and / or second membrane, or starting from the first or second end of the first and / or second membrane, extending along the longitudinal axis to the second and / or first end of the first and / or second membrane. The at least one first perforation and / or the at least one second perforation may be formed as at least one perforation line, or multiple perforation lines or multiple perforations, which may be arranged or distributed particularly along or across the middle / central periphery of the first and / or second membrane.
[0031] The at least one first and / or second portion of the interior surface may (e.g., only) correspond to the at least one first perforation and / or the at least one second perforation. The at least one first and / or second portion of the interior surface may (e.g., only) correspond to the at least one perforation line. The at least one portion of the interior may (e.g., only) correspond to one or more of the plurality of perforation lines.
[0032] The at least one first and / or second portion of the inner surface may correspond to the entire area of the inner surface, which is formed or extends from the first end of the first or second membrane, particularly along the longitudinal axis of the first and / or second membrane, toward the central / central periphery. The at least one first and / or second portion of the interior surface may correspond to a region of the inner surface, which is formed or extends from the first end of the first or second membrane to the second end of the corresponding membrane.
[0033] The first and / or second section may have a filling port, wherein the first and / or second internal space may be filled or has been filled with the conductive fluid via the proximal end. The first and / or second section may have a vent opening, wherein the first and / or second internal space may be vented or vented via the proximal end.
[0034] The shaft may have an exhaust line disposed in the shaft and connected to the exhaust port. The shaft may also have a first and / or a second filling line disposed in the shaft and connected to the filling port.
[0035] The first and / or second membranes may each have a first end and / or a second end. In the vertically oriented (outside the body) longitudinal axis of the device, the internal space can be vented when filled with a conductive liquid. The internal space can be vented when the device is vertically oriented / held and filled with a conductive liquid.
[0036] The device, the first section and / or the second section, and / or the exterior of the first and / or second membrane may have fluid pressure measurement sensors and / or fluid flow measurement sensors. Each of the fluid pressure measurement sensors and / or the fluid flow measurement sensors may be adapted to provide measurement data. The measurement data may be read via a second wire provided or disposed in the shaft.
[0037] It has the following advantages: when the device is located in a patient's internal cavity, fluid pressure can be measured in different areas of the device, thereby allowing for a more accurate determination of the degree of obstruction and the patient's workload. Fluid supply can be adjusted based on the degree of obstruction.
[0038] The first and / or second wires may be electrically insulated from the conductive fluid.
[0039] The proximal end of the shaft may have an operating unit. The operating unit may have inflow and outflow connections. The inflow and outflow connections may be adapted to deliver a conductive fluid to be received into the shaft, particularly to fill the one or more internal spaces with one or more of the conductive fluid to be received. The inflow and outflow connections may also be adapted to deliver seeping and draining conductive fluid to the outside of the shaft.
[0040] The operating unit may have an electrical connection to the first and / or second wires. The electrical connection may be adapted to transmit an electrical signal to be received to the first wire, and / or to receive and continue transmitting electrical signals, particularly measurement data from the fluid pressure sensor and / or fluid flow sensor, via the second wire.
[0041] The operating unit may have an inlet opening specifically formed as a hemostatic valve. The inlet opening may be adapted to receive a guide wire. The guide wire may pass through or exit at an outlet at the distal end of the shaft.
[0042] According to a second aspect, a system for tissue ablation is proposed. The system includes at least one device according to the first aspect, at least one signal generator device connected to or connectable to said device, at least one control and evaluation unit connected to or connectable to said device and / or signal generator device, and / or at least one fluid supply unit connected to or connectable to said device and / or control and evaluation unit.
[0043] The fluid supply unit is adapted to provide at least one or both first and second conductive fluids.
[0044] The control and evaluation unit can be adapted to set the volumetric flow rate of the fluid supply unit specifically according to user settings. The fluid supply unit can supply the (or first and / or second) conductive fluid according to the settings, and measure the fluid pressure and / or fluid flow rate by means of a fluid pressure measurement sensor and / or a fluid flow measurement sensor.
[0045] It has the following advantages: on the one hand, the thermal effect can be reduced by using a conductive fluid (such as an infusion fluid), and at the same time, the membrane can also ensure tissue contact and blockage connected to it, and the dynamic pressure can also be quantified.
[0046] The control and evaluation unit is adapted to determine and output a measure of positive fit between the membrane (particularly at least one perforation) and the tissue to be ablated, based on measured fluid pressure and / or fluid flow rate. The measure of positive fit can be expressed as a percentage coverage, such as 80% coverage. The measure of positive fit can also be expressed as the amount of recirculation in milliliters per minute (particularly milliliters per minute) and / or as a percentage coverage.
[0047] The (first and / or second) conductive fluid may be formed as a conductive liquid and / or a conductive liquid active substance, particularly, it may have a vasoactive substance or be formed as such a substance, especially (liquid) histamine, which alters the conductivity of tissue upon contact, particularly increasing or decreasing the conductivity. Vasoactive substances may act by means of vasodilation or vasoconstriction.
[0048] It has the following advantages: the tissue section to be ablated comes into contact with an active material that increases conductivity. Therefore, the ablation process can be configured more effectively, wherein tissue sections that do not require ablation and are adjacent to the tissue section to be ablated can have their conductivity reduced by a conductivity-reducing material, thereby reducing the energy input during the ablation process.
[0049] The conductive fluid, particularly the vasoactive substance, may contain bradykinin, serotonin, betahistine, acetylcholine, dopamine, norepinephrine, angiotensin II, and / or catecholamines, or may be formed as these substances themselves or in combination thereof.
[0050] The signal generator device may have a first signal generator for generating radio frequency (RF) signals and a second signal generator for generating signals for pulse field ablation.
[0051] The control and evaluation unit is adapted to activate the first signal generator and / or the second signal generator to deliver signals.
[0052] According to a third aspect, a method is proposed for tissue ablation or for delivering electrical energy to tissue for ablation, particularly irreversible ablation. The method includes providing a system. The system has an application device according to the first aspect.
[0053] The system has a signal generator device that is connected to or can be connected to the application device. The system has a control and evaluation unit that is connected to or can be connected to the application device and / or the signal generator device. The system has a fluid supply unit that is connected to or can be connected to the application device and / or the control and evaluation unit, the fluid supply unit being adapted to provide a conductive fluid, such as a vasoactive substance.
[0054] The method may include introducing an application device into a patient's internal cavity up to the site of tissue to be ablated. The method may include setting the control and assessment unit to set the volumetric flow rate, or setting the volumetric flow rate at the control and assessment unit. The method further includes activating the control and assessment unit to generate an electrical signal.
[0055] The conductive fluid may contain a vasoactive substance. The method may include precisely positioning the application device relative to the tissue portion to be ablated. The method may include delivering an electrical signal. The method may include delivering a vasoactive substance. The method may include removing the application device from a patient's internal cavity.
[0056] The method may include bringing the application device into contact with the tissue. The method may include applying the conductive fluid, such as a vasoactive substance. Upon application, activation of the control and evaluation unit may occur directly to generate an electrical signal.
[0057] The application device is adapted to transmit the electrical signal to be received and the vasoactive substance to be received (especially liquid substances, especially histamine) to the tissue and / or into the tissue.
[0058] According to the fourth aspect, a method for tissue ablation (particularly irreversible ablation) or for delivering electrical energy to tissue is proposed. The method includes providing a system. The system has an apparatus according to the first aspect, a signal generator device connected to or connectable to the apparatus, a control and evaluation unit connected to or connectable to the apparatus and / or the signal generator device, and a fluid supply unit connected to or connectable to the apparatus and / or the control and evaluation unit.
[0059] The application device is adapted to transmit an electrical signal to be received and a vasoactive substance to be received, particularly a liquid substance, particularly histamine, to the tissue and / or into the tissue. A fluid supply unit is adapted to provide the vasoactive substance.
[0060] The method includes bringing the application device into contact with the tissue. The method includes applying the vasoactive substance. The method includes activating the control and evaluation unit to generate an electrical signal.
[0061] The method may include setting the control and evaluation device to set the volumetric flow rate. After application, the method may include directly activating the control and evaluation unit to generate an electrical signal.
[0062] The method may include introducing the device into a patient's internal cavity up to the tissue portion to be ablated. The method may include setting a volumetric flow rate at a fluid supply unit or a control and assessment unit. The method may include activating the control and assessment unit to generate an electrical signal.
[0063] Based on the following description, experts can further understand other features, characteristics, advantages, and possible modifications, with reference to the accompanying drawings. Attached Figure Description
[0064] Figure 1 A schematic diagram of an embodiment variation with a membrane is shown.
[0065] Figure 1a A schematic diagram of an embodiment variant with a membrane and two fluid chambers is shown.
[0066] Figure 1b A schematic diagram of an embodiment variant with a membrane and a fluid chamber is shown.
[0067] Figure 2 A schematic diagram of another variation of the embodiment with two membranes is shown.
[0068] Figure 3 A schematic diagram of an embodiment variant with an operating unit is shown.
[0069] Figure 4 A schematic diagram of an embodiment variant with a drain outlet is shown.
[0070] Figure 5 A schematic diagram of an embodiment variation with a suppression element is shown.
[0071] Figure 6 A schematic diagram of an embodiment variation with field modes during the ablation process is shown.
[0072] Figure 7 The method for delivering electrical energy to an organization is shown.
[0073] Figure 8 The method for irreversible ablation is shown. Detailed Implementation
[0074] In the accompanying drawings described below, in each case, the application device is formed as an example of a catheter device.
[0075] Figure 1A schematic diagram of an embodiment variation of an application device is shown, which in the illustrated example is formed as a conduit device and is therefore described accordingly, having a membrane 100. The depicted variation has a shaft 101, which has a proximal end 120 and a distal end 121. A first electrode 103 is disposed on a first section of the shaft 101. The first electrode 103 is sealed by the membrane 100 in a fluid-impermeable manner. In other words, the first end 122 and the second end 123 of the membrane are connected to the shaft 101 in a fluid-impermeable manner. If the membrane 100 seals the first section of the shaft 101, a first internal space is formed between the membrane 100 and the shaft 101. The membrane 100 has at least a single perforation 102, which, in the illustrated variation, is formed as a plurality of perforated lines. One of the plurality of perforated lines is marked with 110 and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of the membrane 100. Each perforated line originates at the central outer periphery of the membrane 100 and, in the illustrated variant, terminates at a second end 123 of the membrane 100. In addition to the first electrode 103, two other counter electrodes 104a, 104b are disposed on a shaft 101 outside the first internal space. The proximal end 120 of the shaft 101 is adapted to receive conductive fluid and deliver it to the distal end 121 of the shaft 101. A first section of the shaft 101 is adapted to deliver conductive fluid into the first internal space. The first internal space is filled with the conductive fluid. The conductive fluid seeps out from the plurality of perforated lines. If an electrical signal is applied between the first electrode 103 and the counter electrodes 104a or 104b, the signal is better directed to the tissue to be ablated due to the seeped conductive fluid. Figure 6 There is a more detailed explanation in the text.
[0076] Figure 1aA schematic diagram of a variant of one embodiment is shown, comprising a membrane 600 and two fluid chambers 607a, 607b. The depicted variant includes a shaft 601 having a proximal end 620 and a distal end 621. In each case, a separate electrode 603 is disposed on a portion of a first segment of the shaft 601. The electrode 603 is sealed by the membrane 600 in a fluid-impermeable manner. In other words, a first end 622 and a second end 623 of the membrane are connected to the shaft 601 in a fluid-impermeable manner. If the membrane 600 seals the first segment of the shaft 601, a first internal space is formed between the membrane 600 and the shaft 601. The membrane 600 has at least a single perforation 602, which, in the illustrated variant, is formed as a plurality of perforated lines. One of the plurality of perforated lines is indicated by 610 and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of the membrane 600. Each perforated line originates at the central outer periphery of the membrane 600 and terminates at the second end 623 of the membrane 600 in the depicted variant. In addition to electrode 603, two electrodes 604a and 604b are disposed on a shaft 601 outside the first internal space. The proximal end 620 of shaft 601 is adapted to receive a first conductive fluid and transport it to the distal end 621 of shaft 601.
[0077] The internal space has first and second fluid chambers 607a and 607b. Each of the fluid chambers 607a and 607b is connected in a fluid-impermeable manner to a portion of a first section of the shaft 601, on which one of the electrodes 603 is disposed. The first fluid chamber 607a is connected in a fluid-impermeable manner to a first portion of the inner surface 600a of the membrane 600. The second fluid chamber 607b is connected in a fluid-impermeable manner to a second portion of the inner surface 600b of the membrane 600. The two fluid chambers 607a and 607b are disposed opposite to each other. In other words, a first conductive fluid is flushed into the fluid chambers 607a and 607b via the first section of the shaft 601, while the fluid chambers 607a and 607b only deliver the conductive fluid to their respective portions of the surface.
[0078] The first and second surfaces 600a and 600b correspond to the regions on the inner surface of the membrane 600 extending from the first end 622 to the second end 623 of the membrane 600. Therefore, not all perforations in the membrane 600 are filled with conductive fluid. This is evident in... Figure 1a The cross-sectional view in the upper left corner shows this again. It should be noted that the two fluid chambers 607a and 607b are positioned on either side of the vertical axis Az. A portion of the surface of the membrane 600 across the vertical axis Az (not shown) does not contact the fluid chambers 607a and 607b. Therefore, during ablation application, only the tissue portions corresponding to the two partial surfaces 600a and 600b of the membrane 600 are ablated.
[0079] In an alternative variation of this embodiment, the two fluid chambers 607a and 607b can be positioned at any location along the inner surface of the membrane 600, depending on the intended use. For example, the two fluid chambers 607a and 607b can be adjacent to each other. In the illustrated variation, each of the two fluid chambers covers an angular region of approximately 90° (see cross-sectional view), and together they cover an angular region of approximately 180°. Alternatively, depending on the composition of the tissue to be ablated, each fluid chamber 607a and 607b can occupy any angular region, such that the two fluid chambers 607a and 607b are formed within a total angular region of approximately 45° to 360° (a first angular region of approximately 90°, a second angular region of approximately 180°, and a total angular region of approximately 270°).
[0080] Alternatively, one fluid chamber may be filled with a first conductive fluid, while the second fluid chamber may be filled with a second conductive fluid.
[0081] Alternatively, one or two additional fluid chambers may be provided in the internal space. The first and second fluid chambers may be filled with a first conductive fluid, while the two additional fluid chambers may be filled with a second conductive fluid via a first shaft.
[0082] Alternatively, the fluid chamber can be filled first with a first conductive fluid, and then filled with a second conductive fluid.
[0083] The first conductive fluid is formed as an example of a vasoactive liquid that specifically increases conductivity, while the second conductive fluid is formed as an example of a vasoactive liquid that specifically decreases conductivity.
[0084] Figure 1bA schematic diagram of an embodiment variant with a membrane and a fluid chamber 607 is shown. The depicted variant has a shaft 601, which has a proximal end 620 and a distal end 621. A first electrode 603a and a second electrode 603b are respectively disposed on a portion of a first section of the shaft 601. The first electrode 603a and the second electrode 603b are sealed by a membrane 600 in a fluid-impermeable manner. In other words, a first end 622 and a second end 623 of the membrane 600 are connected to the shaft 601 in a fluid-impermeable manner. If the membrane 600 seals the first section of the shaft 601, a first internal space is formed between the membrane 600 and the shaft 601. The membrane 600 has at least a first single perforation 602a, which, in the depicted variant, is formed as a plurality of perforated lines. One of the plurality of perforated lines is indicated by 610a and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of the membrane 600. Each perforated line 610a begins at the outer periphery of the center of the membrane 600 and, in the depicted variant, terminates at the second end 623 of the membrane 600. In addition to the first and second electrodes 603a, 603b, two counter electrodes 604a, 604b are disposed outside the first internal space on the shaft 601. The proximal end 620 of the shaft 601 is adapted to receive the first conductive liquid and transport it to the distal end 621 of the shaft 601.
[0085] The internal space has first and second fluid chambers 607a and 607b. These chambers are formed by a fluid-impermeable partition membrane 607 within the internal space. The partition membrane 607 divides the internal space into two fluid chambers 607a and 607b of approximately equal size.
[0086] The relevant fluid chambers 607a and 607b can be filled via the first and / or second portions of the section. Here, either or both of the two fluid chambers 607a and 607b can be filled. In the depicted variant, the first fluid chamber 607a is used as an example for filling.
[0087] The first fluid chamber 607a is connected to the first portion of the first section of the shaft 601 in a fluid-impermeable manner, and a first electrode 603a is disposed thereon. The separation membrane 607 is sealed to the shaft and the interior of the membrane 600 in a fluid-impermeable manner. In other words, the first conductive fluid is flushed into the first fluid chamber 607a through the first portion of the section of the shaft 601, and the first fluid chamber 607a then delivers the first conductive fluid to the surface of the first portion.
[0088] In other words, the first conductive liquid is flushed into the first fluid chamber 607a via the first section of the shaft 601, and the fluid chamber 607a delivers the conductive liquid only to the first part of the surface.
[0089] The first portion of the surface corresponds to the entire area of the inner surface of the membrane 600, extending from the second end 623 of the membrane 600 to the outer periphery of the center of the membrane 600. In other words, the first fluid chamber 607a covers an angular region of 360° around the longitudinal axis of the membrane.
[0090] Alternatively, the first portion of the surface may correspond to multiple perforated lines. Alternatively, the first portion of the surface may correspond to only one of the multiple perforated lines, or to any (adjacent or next-adjacent) selection of the perforated lines. Alternatively, an additional fluid chamber may be provided that delivers a first or second conductive fluid to the second portion of the surface, particularly to another option of the perforated lines, or to a single perforated line that is not on the first portion of the surface.
[0091] In a variant with a first and an additional fluid chamber, each fluid chamber may occupy any angular region around the longitudinal axis of the membrane, such that the two fluid chambers generate a total angular region (180° for the first angular region, 180° for the second angular region, and 360° for the total angular region) between 45° and 360°.
[0092] In a variation of one embodiment, an additional fluid chamber may be perfused via a first shaft with a second conductive fluid, while the first fluid chamber is perfused with a first conductive liquid. As an example, the first conductive fluid is formed as a vasoactive fluid, and as an example, the second conductive fluid is formed as a liquid with reduced conductivity.
[0093] Figure 2 A schematic diagram of another variation of an embodiment of a catheter device having two membranes 200a and 200b is shown. The depicted variation has a shaft 201, which has a proximal end 220 and a distal end 221. A first electrode 203a is disposed on a first section of the shaft 201. The first section is sealed by the membrane 200a in a fluid-impermeable manner. In other words, the first and second ends of the membrane 200a are connected to the shaft 201 in a fluid-impermeable manner. If the membrane 200a seals the first section of the shaft 201, a first internal space is formed between the membrane 200a and the shaft 201. The membrane 200a has at least one single perforation 202a, which, in the depicted variation, is formed as a plurality of perforated lines. One of the plurality of perforated lines is indicated by 210a and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of the membrane 200a. Each perforation line begins at the outer periphery of the center of membrane 200a and, in the depicted variant, terminates at the first end of membrane 200a.
[0094] A second electrode 203b is disposed on a second segment of shaft 201. This second segment is sealed by membrane 200b in a fluid-impermeable manner. In other words, the first and second ends of membrane 200b are connected to shaft 201 in a fluid-impermeable manner. If membrane 200b seals the second segment of shaft 201, a second internal space is formed between membrane 200b and shaft 201. Membrane 200b has at least one single perforation 202b, which, in the depicted variant, is formed as a plurality of perforated lines. One of these perforated lines is indicated by 210b and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of membrane 200b. Each perforated line originates at the central outer periphery of membrane 200b and, in the depicted variant, terminates at the second end of membrane 200b.
[0095] In addition to the first electrode 203a and the second electrode 203b, three counter electrodes 204a, 204b, and 204c are disposed outside the first and second internal spaces on the shaft 201. The proximal end 220 of the shaft 201 is adapted to receive conductive fluid and transport it to the distal end 221 of the shaft 201. The shaft 201 has walls. In a first section of the shaft 201, the wall has a first filling port (not depicted) through which conductive fluid is transported to the first internal space. The first internal space is filled with conductive fluid. In a second section of the shaft 201, the wall has a second filling port (not depicted) through which conductive fluid is transported to the second internal space. The second internal space is filled with conductive fluid. The conductive fluid permeates from multiple perforated lines in each membrane 200a, 200b.
[0096] In the depicted variant, when the device is introduced into an internal cavity (not depicted), an intermediate space is formed between the first and second membranes 200a, 200b and the tissue wall (not depicted) surrounding the device. If conductive fluid seeps out from the plurality of perforated lines 202a, 202b, this intermediate space is filled with conductive fluid and comes into contact with the tissue wall.
[0097] If an electrical signal is applied between the first electrode 203a and the counter electrode 204b, the guidance of the field lines into the tissue to be ablated will be improved due to the permeated conductive fluid. Figure 6 There is a more detailed explanation in the text.
[0098] To reduce the load on the internal cavities, in the depicted variant, a drain or discharge port 209 is provided on the shaft 201. Conductive fluid exits from the intermediate space via the drain port 209 and is delivered into the interior of the shaft 201. A discharge line 208 is provided in the shaft, through which the conductive fluid in the intermediate space is delivered to the proximal end 220 of the shaft 201.
[0099] Figure 3A schematic diagram of a variant of an embodiment having an operating unit 307 is shown. The depicted variant has a shaft 305, which has a proximal end 320 and a distal end 321. A first electrode 301 is disposed on a first segment of the shaft 305. The first segment is sealed by a membrane 300 in a fluid-impermeable manner. In other words, the first and second ends of the membrane 300 are connected to the shaft 305 in a fluid-impermeable manner. If the membrane 300 seals the first segment of the shaft 305, a first internal space is formed between the membrane 300 and the shaft 305. The membrane 300 has at least one single perforation, which, in the depicted variant, is formed as a plurality of perforations 302. The plurality of perforations 302 are distributed along the outer periphery of the middle portion of the membrane 300. In addition to the first electrode 301, a counter electrode 306 is disposed outside the first internal space of the shaft 305.
[0100] The proximal end 320 of shaft 305 has an operating unit 307 and an inflow and outflow connection 310, through which conductive fluid is delivered to the shaft and reaches membrane 300 in the depicted variant.
[0101] In the depicted variant, the operating unit 307 has an electrical connection 308 that connects to a wire (not shown) disposed in the shaft. The wire is connected to a first electrode 301 and a counter electrode 306.
[0102] The operating unit 307 has an inlet opening 309 forming a hemostasis valve, through which a guide wire can be introduced into the shaft 305 and all the way to the distal end 321. The distal end 321 has an outlet opening 311 through which the guide wire can be exited from the distal end 321.
[0103] In the first section of shaft 305, in addition to the first electrode, at least one filling port 304 is provided, which is connected to the interior of shaft 305. Conductive fluid enters the first internal space through the filling port and fills it. In addition to the first electrode, at least one exhaust port 303 is also provided in the first section of shaft 305, which is connected to the interior of shaft 305. When the first internal space is filled with conductive fluid, the exhaust port discharges air from the first internal space.
[0104] The conductive fluid seeps out from the multiple perforations 302.
[0105] Figure 4A schematic diagram of an embodiment variant with an exhaust port 405a and a filling port 405b is shown. The depicted variant shows a shaft 401, which in turn has a proximal end 420 and a distal end 421. A first electrode 403 is disposed on a first segment of the shaft 401. The first segment is sealed by a membrane 400 in a fluid-impermeable manner. In other words, a first end 122 and a second end 123 of the membrane are connected to the shaft in a fluid-impermeable manner. If the membrane 400 seals the first segment of the shaft 401, a first internal space is formed between the membrane 400 and the shaft 401. The membrane 400 has at least one single perforation 402, which, in the depicted variant, is formed as a plurality of perforated lines. One of the plurality of perforated lines is indicated by 410 and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of the membrane 400. In the depicted variant, each perforated line begins at the outer periphery of the center of the membrane 400 and terminates at a second end of the membrane 400.
[0106] In addition to the first electrode 403, two counter electrodes 404a and 404b are disposed outside the first internal space on the shaft 401. The proximal end 420 of the shaft 401 is adapted to: receive conductive fluid, in the depicted variant, the conductive fluid being formed as a conductive liquid; and to transport the conductive fluid to the distal end 421 of the shaft 401. A first section of the shaft 401 is adapted to transport the conductive liquid to the first internal space via a filling port 405b in the wall of the shaft 401. The first internal space is filled with conductive fluid and flushes the first electrode 403. The conductive fluid seeps out from the plurality of perforated lines. If an electrical signal is applied between the first electrode 403 and the counter electrode 404a, the electric field lines are better guided into the tissue to be ablated due to the seeped conductive fluid, which in Figure 6 There is a more detailed explanation in the text.
[0107] An exhaust port 405a and a filling port 405b are respectively provided on the first section of the membrane 400. If the device is held in a vertical position and conductive fluid is delivered to the first internal space through the filling port, air can escape through the exhaust port—the membrane 400 is vented.
[0108] Figure 5 A schematic diagram of an embodiment variant with suppression element 500b is shown.
[0109] The depicted variant has a shaft 501, which in turn has a proximal end 520 and a distal end 521. A first electrode 505 is disposed on a first segment of the shaft 501. The first segment is sealed in a fluid-impermeable manner by a membrane 500a. In other words, the first and second ends of the membrane 500a are connected to the shaft 501 in a fluid-impermeable manner. If the membrane 500a seals the first segment of the shaft 501, a first internal space is formed between the membrane 500a and the shaft 501. The membrane 500a has at least one single perforation 503, which, in the depicted variant, is formed as a plurality of perforated lines. One of the plurality of perforated lines is marked with 510 and a dashed line. Each of the plurality of perforated lines is oriented along the longitudinal axis of the membrane 500a. In the depicted variant, each perforated line begins at the outer periphery of the center of the membrane 500a and terminates at the first end of the membrane 500a.
[0110] In addition to the first electrode 505, two counter electrodes 504a and 504b are also disposed outside the first internal space on the shaft 501. The proximal end 520 of the shaft 501 is adapted to receive conductive fluid and transport it to the distal end 521 of the shaft 501. A first section of the shaft 501 is adapted to transport conductive fluid into the first internal space. The first internal space is filled with conductive fluid. The conductive fluid seeps out from the plurality of perforated lines.
[0111] The suppression structure 500b is disposed on the second section of shaft 501.
[0112] In the depicted variant, when the device is introduced into a body cavity (not shown), an intermediate space is formed between the first membrane 500a, the inhibition structure 500b, and the tissue wall adjacent to the device (not shown). If conductive fluid seeps from the plurality of perforated lines, the intermediate space is filled with the conductive fluid and comes into contact with the tissue wall. The inhibition structure is movable along its axis, thereby allowing the amount of tissue surface in the body cavity in contact with the conductive fluid to be set.
[0113] When the intermediate space is filled with conductive fluid, the inhibition structure can prevent the conductive fluid that has seeped out from the multiple perforated lines from spreading along the axis of the body cavity.
[0114] If an electrical signal is applied between the first electrode 505 and the counter electrode 504b, the fieldline guidance into the tissue to be ablated will be improved due to the exudated conductive fluid. Figure 6 There is a more detailed explanation in the text.
[0115] Figure 6 A schematic diagram of an embodiment variation having field mode 511 during ablation is shown. In the depicted application, Figure 5The device is introduced into a cavity G within the tissue. The device is connected to a signal generator device (not shown). The signal generator device is connected to a control and evaluation unit (not shown). A fluid supply unit (not shown) is connected to the device and the control and evaluation unit and is adapted to provide conductive fluid.
[0116] The control and evaluation unit is adapted to set the volumetric flow rate of the fluid supply unit, specifically based on user settings on the control and evaluation unit. Thus, the first internal space is filled with conductive fluid, which seeps out from multiple perforated lines. The intermediate space filled with conductive fluid... Figure 6 The diagram is shaded (a diagonal dashed line from the wall of the internal cavity to the opposite wall of the internal cavity). If an electrical signal is now applied between the first electrode 505 and the counter electrode 504b, a field line distribution is generated, of which one field line 511 is depicted as an example. Because the conductive fluid is in direct contact with the tissue G and the signal path is merged via the conductive fluid, the field lines penetrate deeper into the tissue while the tissue to be ablated cools.
[0117] Alternatively, the intermediate space can be perfused with a liquid active substance such as histamine. Histamine acts in tissues and increases their conductivity. Subsequently, the user can configure the control and evaluation unit to supply a second conductive fluid, which may be supplied by or should be supplied by the fluid supply unit. The second conductive fluid displaces the liquid active substance from the internal and intermediate spaces of the membrane 500.
[0118] If an electrical signal is now applied between the first electrode 505 and the counter electrode 504b, another field line distribution result is produced (not shown). Because the second conductive fluid is in direct contact with the tissue G, and the signal path is merged via the conductive fluid, and the tissue conductivity has been increased by the liquid active material beforehand, the field lines can penetrate deeper into the tissue compared to the case where no active material was applied beforehand, while simultaneously cooling the tissue to be ablated.
[0119] Figure 7A method for delivering electrical energy to tissue is shown. The method includes a delivery system (step S10). The system is equipped with an application device adapted to deliver an electrical signal to be received and a vasoactive substance to be received, particularly a liquid substance, particularly histamine, to the tissue. The system has a signal generator device connected to or connectable to the application device. The system has a control and evaluation unit connected to or connectable to the application device and / or the signal generator device. The system has a fluid supply unit connected to or connectable to the application device and / or the control and evaluation unit, the fluid supply unit being adapted to deliver the vasoactive substance. The method includes contacting the application device with the tissue (step S20). The method includes setting (step S30) the control and evaluation unit to set a volumetric flow rate. The method includes applying (step S40) the vasoactive substance. The method includes activating (step S50) the control and evaluation unit to generate an electrical signal.
[0120] Figure 8 A method for irreversible ablation is shown, comprising the following steps: providing (step S100) a system having: an apparatus as described herein, a signal generator apparatus connected to or connectable to the apparatus, a control and evaluation unit connected to or connectable to the apparatus and / or the signal generator apparatus, and a fluid supply unit connected to or connectable to the apparatus and / or the control and evaluation unit, the fluid supply unit being adapted to provide a conductive fluid; introducing the apparatus (step S200) into a patient's internal cavity until reaching the tissue segment to be ablated; setting (step S300) the volumetric flow rate at the fluid supply unit; and activating (step S400) the control and evaluation unit to generate an electrical signal.
Claims
1. An application device, particularly a catheter device, for example for use in surgery, comprising: - Axis (101; 201), which is adapted to receive at least one conductive fluid. - At least one first electrode (103; 203a) is disposed on a first segment of the shaft. - At least one first pair of electrodes (104b; 204b). - A first wire, connected to the at least one first electrode (103; 203a) and the at least one first pair of electrodes (104b; 204b), is adapted to transmit an electrical signal to be received to the at least one first electrode (103; 203a) and the at least one first pair of electrodes (104b; 204b). - At least one first membrane (100; 200a) is adapted to: - Close the first section of the shaft. - The shaft (101; 201) is end-sealed in a fluid-impermeable manner, and - A first internal space is formed between the at least one first membrane (100; 200a) and the first segment of the shaft. in, The first section of the shaft is adapted to deliver the at least one conductive fluid into the interior space, wherein the first wall of the at least one first membrane (100) is adapted to be at least partially fluid-permeable.
2. The apparatus according to claim 1, wherein The at least one first membrane, particularly the first wall, has at least one first perforation (102; 202a), and the conductive fluid can permeate from the at least one first perforation (102; 202a), and / or The device also has: - At least one second electrode (203b) is disposed on a second segment of the shaft and connected to the first wire, and / or - At least one second membrane (200b), which specifically has at least one second perforation (210b), and is adapted to - Close the second section of the shaft (101; 201), - Seal the ends of the shafts (101; 201) in a fluid-impermeable manner, and - A second internal space is formed between the at least one second membrane (200b) and the second segment of the shaft, and / or in, The second section of the shaft is adapted to deliver the conductive fluid into the second interior space, wherein the second wall of the at least one second membrane is adapted to be fluid-permeable, and / or - wherein the conductive fluid permeates or is permeable from the at least one second perforation (202b) of the at least one second membrane, and / or - wherein the shaft (101; 201) has a distal end and a proximal end, and at least one first membrane (100; 200a) is disposed between the distal end (121; 221) and the proximal end (120; 220), and / or at least one second membrane (200b) is disposed between the at least one first membrane (200a) and the proximal end (220).
3. The apparatus according to claim 1 or 2, wherein, The device also has: - At least one inhibition structure (500b) that closes the second portion of the shaft in a fluid-impermeable manner, adapted to prevent or limit the leakage of the conductive fluid from the first wall, in particular from the at least one first perforation, in the direction of propagation, and / or movable or mobile along the shaft, wherein the at least one inhibition structure (500b) is disposed between the at least one first membrane (503) and the proximal end (520).
4. The apparatus according to any of the preceding claims, comprising: A discharge port (209), disposed on a shaft (201) between the at least one first membrane (500a) and the at least one inhibition structure (500b), or between the at least one first membrane (200a) and the at least one second membrane (220b), is adapted to discharge the conductive fluid seeping from the first wall, particularly from the at least one first perforation (202a), and / or from the second wall, particularly from the at least one second perforation (202b), wherein the shaft (201) is adapted to discharge the discharged conductive fluid, particularly to / via the conductive fluid at the proximal end (220), out of the shaft (201); and / or - in, At least one first pair of electrodes and / or at least one second pair of electrodes and / or at least one third pair of electrodes are disposed between the distal end and the at least one first membrane, or between the at least one first membrane and the proximal end, or between the at least one first membrane and the at least one second membrane, or between the at least one second membrane and the proximal end, or between the at least one first membrane and the at least one inhibitory structure; and / or - The at least one first pair of electrodes and / or the second pair of electrodes and / or the third pair of electrodes are formed as the main electrodes.
5. The apparatus according to any of the preceding claims, wherein, The at least one first perforation (102, 202a) and / or the at least one second perforation (202b) are formed as follows: - At least one perforation line (110; 210a) oriented along the longitudinal axis of the membrane (100; 200a; 200b), particularly starting from the middle / outer periphery of the membrane and extending longitudinally toward the first or second end of the membrane; and / or - Multiple perforation lines, each perforation line oriented along the longitudinal axis of the membrane, particularly starting from the middle / outer periphery and moving longitudinally toward the first or second end of the membrane; and / or - Multiple perforations (302) are provided or distributed along or across the membrane, particularly the middle / central periphery of the membrane.
6. The apparatus according to any of the preceding claims, wherein, The first and / or second segment has a filling port (304), wherein the first and / or second internal space is filled with the conductive fluid via the proximal end.
7. The apparatus according to any of the preceding claims, wherein, The first and / or second section has an exhaust port (405a), and / or the shaft has an exhaust line disposed in the shaft and connected to the exhaust port.
8. The apparatus according to any of the preceding claims, wherein, The device, the first section and / or the second section and / or the first membrane and / or the second membrane, have fluid pressure measurement sensors and / or fluid flow measurement sensors on their exterior, each sensor being adapted to provide measurement data, wherein the measurement data can be read via a second wire provided or disposed in the shaft.
9. The apparatus according to any of the preceding claims, wherein, The proximal end (320) of the shaft (305) has an operating unit (307), which further has: - Inflow and outflow connection (310), which is adapted to deliver a conductive fluid to be received into the shaft, in particular to fill the one or more internal spaces with one / the conductive fluid to be received, and to deliver the conductive fluid that has seeped out and been discharged from the shaft. and / or - An electrical connection (308) to the first and / or second wires, the connection being adapted to transmit an electrical signal to be received to the first wire via the second wire, and / or to receive and transmit electrical signals, particularly measurement data from the fluid pressure measurement sensor and / or fluid flow measurement sensor; and / or - An injector opening (309), which is specifically formed as a hemostatic valve, is adapted to receive a guide wire.
10. The apparatus according to any of the preceding claims, wherein, The first and / or second internal space has at least one first fluid chamber adapted to seal the first and / or second section of the shaft in a fluid-impermeable manner and to deliver the conductive fluid to at least a portion of the inner surface of the first and / or second membrane.
11. The apparatus according to any one of the preceding claims, wherein, The at least one first electrode, the at least one second electrode, the at least one first pair of electrodes, the second pair of electrodes, the third pair of electrodes, the at least one first membrane and / or the at least one second membrane, particularly the at least one first perforation and / or the second perforation, have a bioabsorbable material that is particularly soluble in body fluids, or are covered with a bioabsorbable material that is particularly soluble in body fluids, or are covered with a corresponding material layer.
12. A system for ablating tissue, comprising: - At least one device according to any one of claims 1 to 11, - At least one signal generator device that is connected to or can be connected to the device. - At least one control and evaluation unit, which is connected to or can be connected to the device and / or signal generator unit, and - At least one fluid supply unit, which is connected to or can be connected to the device and / or control and evaluation unit, and is adapted to provide conductive fluid.
13. The system according to claim 12, wherein, The control and evaluation unit is adapted to set the volumetric flow rate of the fluid supply unit, wherein the fluid supply unit is adapted to provide the conductive fluid according to the setting, and to measure the fluid pressure and / or fluid flow rate by means of the fluid pressure measurement sensor and / or the fluid flow sensor.
14. The system according to claim 13, wherein, The control and evaluation unit is adapted to determine and output a measure of positive fit between the membrane, particularly the at least one perforation, and the tissue to be ablated, based on measured fluid pressure and / or fluid flow rate.
15. The system according to any one of claims 12 to 14, wherein, In particular, the first and / or second conductive fluids are formed into conductive liquids and / or conductive liquid active substances, especially histamine, whose conductivity changes when they come into contact with tissues, particularly increasing or decreasing.
16. The system according to any one of claims 12 to 15, wherein, The signal generator device has a first signal generator for generating radio frequency (RF) signals and a second signal generator for generating signals for pulse field ablation.
17. The system according to claim 16, wherein, The control and evaluation unit is adapted to activate the first signal generator and / or the second signal generator to transmit signals.