Spiral catheter for electrophysiological studies and irreversible electroporation of the heart

Abstract

A spiral catheter for electrophysiological studies and irreversible electroporation of the heart, comprising a plastic main conductor (1) connected at one end to an electrical connection (2) from which electrical leads (3) supply the electrodes (4) located at the other end of this conductor (1), wherein the core (5) protruding from the sleeve-shaped main conductor (1) is made of a shape-memory metal alloy and is bent at its end (6) into a conical spiral (7) with a variable number of turns, at least one of which is equipped with sleeve-shaped electrodes (4) mounted on this core (5), which are supplied via insulated electrical leads (3) and separated from each other by non-electrically conductive plastic ring elements (8), wherein the number of electrodes (4) arranged on the full turns of the conical spiral (7) of the cathetera multiple of four and on each full turn of the conical spiral (7) at least four electrodes (4) are arranged at a distance from each other that is the same for the respective turn of the spiral (7).

Description

[0001] The invention relates to a spiral catheter for electrophysiological studies and irreversible electroporation of the heart, which is intended both for electrophysiological studies of the heart (EPS) to accurately assess the type and cause of cardiac arrhythmias in the heart muscle in individuals suspected of having such arrhythmias and those diagnosed with them, and for performing electroporation in the heart using high voltage, with the ability to read and map signals before and after the ablation. Furthermore, this catheter can be used in conjunction with many electrophysiological systems platforms, 3D mapping systems, and pulse generators, in particular high-voltage pulse generators, designed for performing irreversible electroporation of tissues.

[0002] Procedures for treating cardiac arrhythmias involve destroying the areas causing the arrhythmia by ablating the heart muscle tissue with electrical energy, usually by applying alternating current, typically radiofrequency, to one or more ablation electrodes with the power required to effectively alter the target tissue. These electrodes are usually attached to the distal tip or invasive portion of a probe or catheter, which is inserted into the patient's heart via the blood vessels, usually the femoral vein or artery.

[0003] The prior art described below shows that catheters with probes / catheter electrodes are used to treat cardiac arrhythmias, including electrophysiological studies, ablations and cardiac mapping, namely: The electrophysiological catheter known from the description of European Patent EP 2269505 A comprises an elongated body with an elastically deformed distal region, which is predisposed to assume a spring-like shape, and a first group of several electrodes arranged thereon. Each of the first group of electrodes comprises an electrically active area limited to the inner surface of the coil, for use in non-contact electrophysiological studies. The second group of electrodes can also be arranged in the distal region, including alternating with the first group of electrodes, with each of these second group of electrodes having an electrically active area extending to the outer surface of the spring-like shape, for use in contact electrophysiological studies.The distal portion can be deformed into a straight configuration for insertion and navigation within the patient's vascular system, for example, using a guide tube. If the distal portion extends beyond the distal end of the introducer, it assumes a spiral shape. Furthermore, this electrophysiological catheter incorporates a shape-memory material extending across its distal (springy) body. This shape-memory material is a metal wire enclosed within a polymer tube, the posterior end of which is located within a guide tube (introducer).

[0004] International patent application WO 02089687 A discloses a catheter arrangement for the treatment of cardiac arrhythmias, comprising a catheter body and an ablation energy source. The catheter body includes a proximal section, a middle section, and a distal section, the middle section extending from the proximal section and defining the longitudinal axis, and the distal section extending from the middle section and comprising an ablation section and a terminal tip. The ablation section forms a loop with a diameter larger than the outer dimension of the pulmonary vein orifice. The terminal tip extends distally from the ablation section and is configured for localizing the pulmonary vein. Finally, the ablation energy source is connected to the ablation section. In this configuration, upon activation of the energy source, the ablation section ablates the desired disease pattern.In an advantageous embodiment, the ablation section forms a distally tapered spiral, while the end tip has a relatively straight guide section. In this advantageous configuration, the tip easily locates the pulmonary vein and guides the ablation section into a position around the pulmonary vein orifice.

[0005] The description of international patent application WO 2019089199 A, on the other hand, discloses a method for cardiac catheterization using a spiral catheter comprising a flexible, electrically insulated tube and several ablation electrodes arranged on the outer surface of the tube and electrically insulated, as well as several microelectrodes that are also electrically insulated from each other and from the ablation electrodes. Furthermore, this catheter includes a retention element and a shape memory that forces it to form spiral loops.

[0006] Furthermore, the method according to the invention also includes reading bioelectrical signals from the heart using microelectrodes and conducting electrical energy through selected ablation electrodes to cause damage in the heart chamber, as well as reading bioelectrical signals from selected microelectrodes and creating a map of the electrical activity in the heart based on these measurements. Catheterization is performed by inserting a catheter into the heart, the catheter being advanced into the heart chamber through the sheath surrounding the multi-electrode probe. The sheath is retracted to expose the probe. As the sheath is retracted, the exposed probe expands into a spiral configuration, and the electrodes make contact with the surface of the endocardium at multiple points.

[0007] From U.S. patent application US 5374287 A, a defibrillator and a stimulator catheter are known, comprising a flexible, electrically non-conductive probe in which an electrically conductive path is arranged longitudinally. A defibrillation electrode is attached to one end of the probe, which anchors the probe in the cardiac septum and can transmit a portion of the electrical defibrillation pulse sufficient for defibrillating the heart directly from said conductive path into the interior of the septum. The defibrillation pulse is delivered in such a way as to avoid damage to the cardiac tissue immediately adjacent to the defibrillator electrode. In an advantageous embodiment, the defibrillator electrode is spiral-shaped; however, it is also provided that it is a lance.Alternatively, the catheter additionally includes a grounding electrode, an on-demand stimulator electrode, and an additional defibrillator electrode attached to the probe.

[0008] Also known from US patent application 5133365 A is a modified cardiac electrode suitable for use with an automatic implantable cardioverter-defibrillator (AICD). This electrode consists of an elongated, flexible, tubular catheter body made of plastic, pre-shaped to assume the form of a tapered spiral or helix after deformation. The catheter body carries a defibrillation electrode attached to its outer wall and is connected via a cable to a proximal connector for adaptation to the AICD's pulse generator. The improved probe also includes an end electrode for sensing cardiac activity and transmitting information to the AICD's pulse generator to control its operation.The probe according to the present invention is designed for implantation into the endocardium with electrode structures, preferably in the right ventricle, and offers a significantly enlarged electrode surface area in contact with the cardiac tissue, thereby maximizing the energy delivered to the heart during defibrillation. A system based on a non-retractable, non-contact miniature catheter with multiple electrodes is known from US patent application 2004181160 A. This system is used for measuring electrical potentials in the ventricle and for electrophysiological mapping of the heart. This system comprises a non-contact, multi-electrode catheter probe that can be inserted into the blood-filled ventricle without obstructing it.This probe for measuring electrical potentials in the heart chamber comprises: an end part with several electrodes adapted to the shape of a cylindrical spiral, oriented so that it does not touch the endocardial surface of the heart, being placed percutaneously in this heart chamber.

[0009] From international application WO 2018208795 A, an electroporation catheter is known which comprises: several catheter electrodes arranged along the distal end of the electroporation catheter, wherein the several catheter electrodes comprise: several catheter electrodes of a first type designed for use with an electroporation generator during an electroporation procedure; and several catheter electrodes of a second type suitable for use with an electroporation generator during the electroporation procedure and for use with a diagnostic subsystem, wherein each catheter electrode of the second type is adjacent to another catheter electrode of the second type.Preferably, the adjacent second-type catheter electrodes form a pair of second-type catheter electrodes, and the first-type electrodes and the pairs of second-type electrodes are arranged alternately along the electroporation catheter section, with each first-type electrode adjacent to at least one pair of second-type electrodes.

[0010] From the Polish patent description of invention PL 227730 B, an ablation mapping catheter for electrocardiological procedures is described, comprising at least eight diagnostic rings connected via terminals to a generator (or generators) that enable non-fluoroscopic mapping in a three-dimensional electroanatomical system, the diagnostic rings being evenly spaced at the distal end of this electrode. This ablation and mapping catheter includes a control handle, a straight main tube, a distal end ring attached thereto, and diagnostic rings, including distal and proximal rings, as well as two bundles of electrical leads connecting these diagnostic rings and the distal end ring to the electrophysiological system.Furthermore, this catheter is made of an elastic material that allows for easy bending, and its distal end is equipped with a control system located in the catheter's handle and connected to corresponding traction leads. This allows the catheter to be guided into the peripheral venous or arterial vessels (femoral vein / artery) and then through the main vessels to the right or left ventricles of the heart. The catheter's control system allows its rounded distal tip to be bent.

[0011] Polish patent PL 242208 B discloses a spiral catheter for electrophysiological studies and irreversible electroporation of the heart, characterized in that the core of this catheter, projecting from the sleeve-shaped main conductor, is made of a shape-memory metal alloy and is bent into the form of a conical spiral with a variable number of turns, at least one of which is equipped with sleeve electrodes mounted on this core, which are supplied via insulated electrical conductors and separated from each other by ring-shaped plastic elements, wherein the diameter ø1 of the first turn of the spiral is between 5 mm and 30 mm, and the diameter ø2 of the last turn of the spiral is between 10 mm and 31 mm, while the length of each of these electrodes is between 2 mm and 4 mm and the diameter ø is between 1 mm and 3 mm.These electrodes transmit a pulse with an amplitude of 100 to 3000 V in a time of 5 microseconds to 6 milliseconds, and the number of electrodes arranged on the coil of the catheter is between 10 and 65.

[0012] In commonly used catheters for electrophysiological studies and cardiac mapping, electrodes with opposite poles are often positioned too close together. While this is not a major issue when delivering radiofrequency current during thermal ablation, it can be crucial for effective and safe non-thermal ablation using irreversible electroporation. This is because delivering high-voltage current (required for the irreversibility of the electroporation) can lead to potentially dangerous electrical breakdowns between electrodes with opposite polarity, resulting in plasma formation and the risk of burning / thermal ablation of excessively large or unwanted tissue areas, which can endanger health and life.

[0013] The aim of the invention is to develop a spiral catheter design for electrophysiological studies that enables safe, irreversible electroporation of the heart tissue using high-voltage pulses, in which the heart cells die by destabilizing the cell membrane, without the risk of electrical breakdowns between adjacent electrodes of opposite polarity.

[0014] A spiral catheter for electrophysiological studies and irreversible electroporation of the heart, comprising a plastic main conductor connected at one end to an electrical connector from which electrical leads supply power to the electrodes located at the other end of the conductor. The core protruding from the sleeve-shaped main cable is made of a shape-memory metal alloy and is bent at its end into a conical spiral with a varying number of turns, at least one of which is equipped with sleeve electrodes mounted on this core. These electrodes are supplied via insulated electrical leads and are separated from each other by annular, electrically non-conductive plastic elements. The diameter ø1 of the first turn of the spiral is between 5 mm and 30 mm, and the diameter ø2 of the last turn of the spiral is between 10 mm and 31 mm.While the length of each of these electrodes is between 2 mm and 4 mm and the diameter ø is between 1 mm and 3 mm, these electrodes sending a pulse with an amplitude of 100 V to 6000 V in a time of 2 microseconds to 6 milliseconds, it is characterized in that the number of electrodes arranged on the complete turns of the conical spiral of the catheter is a multiple of four, and on each complete turn of the conical spiral at least four electrodes are arranged at equal intervals – for the turn of the spiral concerned – from each other, with the adjacent electrodes having opposite polarity, so that a positive electrode is always adjacent to a negative electrode, with both the positive and the negative electrodes of adjacent turns of the spiral being arranged in a line when viewed from the front of the spiral.

[0015] The conical spiral is advantageous because it is a converging spiral.

[0016] Further advantages arise if the conical spiral is a diverging spiral.

[0017] Further advantages are achieved when a movable three-part shield is attached to the sleeve main conductor, the two outer parts of which are conductive shields, while the third shield arranged in between consists of insulating material, wherein the conductive shields consist entirely of electrically conductive material, or half of electrically conductive material and half of insulating material, or ¼ of these conductive shields of electrically conductive material, and ¾ of insulating material.

[0018] An advantageous electrically conductive material is copper or a copper alloy.

[0019] Further advantages arise when a stabilizing rod made of PTFE-coated stainless steel is installed in the sleeve-shaped main line.

[0020] Further advantages are achieved if the stabilizing rod protrudes from the main tube through the opening in front of the conical spiral, so that this spiral is wound onto the main tube.

[0021] Advantageously, the stabilizing rod, which is arranged in the sleeve-shaped main line, runs through the openings of the sleeve electrodes and the openings of the plastic ring elements of the conical spiral of the catheters.

[0022] Further advantages arise if a control handle is attached at the rear end of the sleeve-shaped main line, in front of the electrically connected terminal, which serves only to bend the tip of the catheter coil.

[0023] An advantage is that the handle of the control unit has a freewheel mechanism, which allows the handle of the control unit to be turned in only one direction.

[0024] Further advantages arise when the sleeve electrodes are equipped with temperature sensors.

[0025] Sleeve electrodes made entirely of electrically conductive material are advantageous.

[0026] Further advantages arise if the sleeve electrodes consist of half electrically conductive material and half electrically non-conductive material.

[0027] Further advantages arise if the sleeve electrodes consist of ¼ of electrically conductive material and ¾ of electrically non-conductive material.

[0028] Platinum, gold or surgical steel are advantageous as electrically conductive materials for the sleeve electrodes (5).

[0029] Further advantages arise if the non-electrically conductive material is PVC or Teflon.

[0030] Further advantages arise if its core is made of nitinol and coated with plastic.

[0031] Advantageously, the number of pins in the connector corresponds to the number of electrical leads supplying the sleeve electrodes, as well as the number of sensors arranged in these electrodes.

[0032] Further advantages arise when the spiral catheter has two turns of a conical spiral and four electrodes are arranged on each turn of the conical spiral.

[0033] Preclinical studies with the spiral catheter according to the invention have shown that the use of a large number of electrodes transmitting high-amplitude pulses results in this catheter delivering significantly higher energy than all currently available and commonly used catheters of this type, thus minimizing the occurrence of unforeseen situations that could endanger the patient's life and health during the procedure. Furthermore, this catheter has the following properties: - After being withdrawn from the vessel wall, the catheter strives for an optimal spiral shape. - the catheter adapts to the shape of the surface on which it is located, depending on the individual anatomical conditions of the heart of different patients; - The catheter can work with many platforms, minimizing the limitations regarding the availability of "single" and "specific" compatible devices.

[0034] The spiral catheter according to the invention is a universal solution that can be used for electrophysiological studies and cardiac mapping, as well as for electroporation procedures in many configurations, in particular for: single- or dual-electrode electroporation, single-electrode interring electroporation, etc. Its simple and flexible design significantly minimizes the risk of cardiac perforation, while the materials used for the electrode construction are relatively readily available, which greatly simplifies their manufacture. Manufacturing the catheter core from nitinol allows it to retain its originally assigned shape and restore it under the influence of suitable external conditions (e.g., changes in the magnetic field or temperature).The use of a movable, three-part sheath in the advantageous embodiment of the catheter according to the invention, in turn, makes it possible to maximize the electrically active surface of the electrode through which the electroporation pulses are delivered. This reduces the risk of complications such as perforation, barotrauma, or the formation of gas bubbles, while the closure of the catheter with a plastic ring element minimizes the risk of mechanical trauma to the tissue. Furthermore, equipping the electrodes with sensors such as thermistors and thermocouples allows for monitoring the temperature of these electrodes, which can increase in certain pulse configurations.

[0035] In contrast to spiral catheters known in the prior art, the device according to the invention, thanks to the arrangement of electrodes with opposite polarity from adjacent spiral turns in a line (viewed from the front of the spiral), does not lead to dangerous electrical breakdowns between electrodes with opposite polarity, the formation of plasma, and thus the risk of excessively large burns and endangerment of health and life. The inclusion of a freewheel in the handle of the control unit allows the handle to be rotated in only one direction, preventing the spiral from rotating in a direction that could perforate the heart with the distal ring / end of the spiral. A further advantage is the audible clicks during rotation of the spiral, which aid in electrode navigation.This can reduce the number of fluoroscopies required, and also makes the operation of the device according to the invention easier for trained operators.

[0036] The subject matter of the invention is illustrated in three exemplary embodiments in the drawing, in which the Fig. 1 to 8 the spiral catheter in the first embodiment, the Fig. 9 to 13 the spiral catheter in the second embodiment and the Fig. 14 show the spiral catheter in the third embodiment, wherein Fig. Figure 1 shows the catheter in the first embodiment in a perspective view with a representation of its coils from the front and from above. Fig. Figure 2 shows the spiral catheter according to this variant in a side view. Fig. Figure 3 shows the main catheter line in cross-section along line AA, Fig. Figure 4 shows an enlarged detail view “B” of the front part of the triple-wound catheter in the first embodiment, Fig. Figure 5 shows the conical converging spiral of the catheter in the first embodiment in a front view, Fig. Figure 6 shows the cross-section BB through the handle of the control unit with visible freewheel, and Fig. 7 and Fig. Figure 8 shows a simplified example of the adaptation of the coil winding profile of the catheter according to the first embodiment to a flat or concave surface of the heart chamber during the procedure in the side view, while the Fig. Figures 9 to 13 show a second embodiment of a spiral catheter for electrophysiological studies and irreversible electroporation of the heart, which has three turns with a diverging spiral profile at its front end, on whose main conductor several conductive sheaths are attached, which are separated from each other by insulating sheaths, wherein Fig. Figure 9 shows the spiral catheter of this variant in a side view, Fig. Figure 10 shows the main catheter line in cross-section along line AA, Fig. Figure 11 shows the spiral catheter in perspective view, Fig. Figure 12 shows the conical, diverging spiral of the catheter in the second embodiment in the front view and Fig. Figure 13 shows the cross-section of the sleeve electrode of the spiral catheter in the second embodiment, wherein one half of the electrode circumference consists of electrically conductive material and the other half of insulating material, and finally Fig. Figure 14 shows a third design variant of the spiral catheter for electrophysiological studies and irreversible electroporation of the heart, which has three turns with a convergent spiral profile at its front end, wound onto the main lead of the catheter, which is additionally equipped with a stabilizing rod that is partially arranged in this lead.

[0037] In the first embodiment, the spiral catheter for electrophysiological studies and irreversible electroporation of the heart has a plastic main tube 1 connected at one end to an electrical connector 2. Electrical leads 3 supply power to the electrodes 4 located at the other end of the tube 1. The core 5, protruding from the sleeve-shaped main tube 1, is made of Ni-nitrile (a shape-memory nickel-titanium alloy) and is surrounded by a plastic sheath 21. At its end 6, the core 5 is bent into a conical, convergent spiral 7 with three turns. Each turn of the spiral 7 is equipped with sleeve-shaped electrodes 4 mounted on the core 5. These electrodes are energized via insulated electrical leads 3 and separated from each other by annular, electrically non-conductive plastic elements 8.The sleeve-shaped electrodes 4 are made entirely of an electrically conductive material 13, namely surgical steel. The diameter ø1 of the first turn of the coil 7 is 30 mm, and the diameter ø2 of the last turn of the coil 7 is 10 mm. The length of each electrode 4 is 4 mm, and the diameter ø is 1 mm. The electrodes 4 emit a pulse with an amplitude of 100 V within 5 microseconds. There are twelve electrodes 4 arranged on the conical coil 7 of the catheter, and four electrodes 4 are arranged at equal intervals on each turn of the conical coil 7. Adjacent electrodes 4 have opposite polarity, so that a positive electrode 4' is always adjacent to a negative electrode 4".

[0038] Both the positive electrodes 4' and the negative electrodes 4" of adjacent turns of the spiral 7 are arranged in a line when viewed from the front of the spiral 7, as shown in Fig. Figure 5 shows that at the rear end of the sleeve-shaped main conductor 1, in front of the electrically connected terminal 2, there is a handle 18, which serves only to bend the end of the probe's spiral 7. The handle of the control unit 18 contains a freewheel 19, which allows the handle of the control unit 18 to rotate in only one direction. The sleeve-shaped electrodes 4 are equipped with temperature sensors 20 in the form of thermocouples. The number of pins in terminal 2 is twenty-four, corresponding to the twelve electrical conductors 3 that supply the twelve sleeve-shaped electrodes 4, as well as the twelve temperature sensors 20 arranged in these electrodes 4.

[0039] In the second embodiment, the spiral catheter for electrophysiological studies and irreversible electroporation of the heart has a plastic main conduit 1 connected at one end to an electrical connector 2. Electrical leads 3 supply power to the electrodes 4 located at the other end of the conduit 1. The core 5, protruding from the sleeve-shaped main conduit 1, is made of Ni-nitrile (a shape-memory nickel-titanium alloy) and is surrounded by a plastic sheath 21. At its end 6, the core 5 is bent into a conical, diverging spiral 7 with three turns. Each turn of the spiral 7 is equipped with sleeve electrodes 4 mounted on the core 5. These electrodes are energized via insulated electrical leads 3 and separated from each other by non-conductive plastic ring elements 8.The sleeve-shaped electrodes 4 consist of half an electrically conductive material 13, namely gold, and half an electrically non-conductive material 12, namely Teflon. The diameter ø1 of the first turn of the spiral 7 is 10 mm, and the diameter ø2 of the last turn of the spiral 7 is 30 mm. The length of each electrode 4 is 2 mm, and the diameter ø is 2 mm. The electrodes 4 emit a pulse with an amplitude of 3000 V within 5 milliseconds. The number of electrodes 4 arranged on the conical spiral 7 of the catheter is twenty-four, and on each turn of the conical spiral 7, eight electrodes 4 are arranged at equal intervals—for that particular turn of the spiral 7. Adjacent electrodes 4 have opposite polarity, so that a positive electrode 4' is always adjacent to a negative electrode 4".Both the positive electrodes 4' and the negative electrodes 4" from adjacent turns of the spiral 7 are arranged in a line, as seen from the front of the spiral 7, as shown in . Fig. Figure 12 shows the sleeve-shaped electrodes 4 equipped with temperature sensors 20 in the form of thermistors. The number of pins in the terminal 2 is forty-eight, corresponding to the twenty-four electrical leads 3 supplying the twenty-four sleeve-shaped electrodes 4, and the twenty-four temperature sensors 20 arranged in these electrodes 4. A sliding three-part sheath 9 is located on the sleeve-shaped main conductor 1. The two outer parts of this sheath form a conductive sheath 10, while the third, insulating sheath 11, located between them, is made of an insulating material 12'. The conductive sheaths 10 are made entirely of an electrically conductive material 13', namely copper. A stabilizing rod 14 made of PTFE-coated stainless steel is located inside the sleeve-shaped main conductor 1.The stabilizing rod 14, which is located in the sleeve main conductor 1, passes through the openings 16 of the sleeve-shaped electrodes 4 and the openings 17 of the plastic ring elements 8 of the conical spiral 7 of the coil.

[0040] In its third embodiment, the spiral catheter for electrophysiological studies and irreversible electroporation of the heart has a plastic main tube 1 connected at one end to an electrical connector 2. Electrical leads 3 supply power to the electrodes 4 located at the other end of the tube 1. A stabilizing rod 14 made of PTFE-coated stainless steel is located inside the sleeve-shaped main tube 1. The stabilizing rod 14 extends through an opening 15 from the main tube 1 in front of the conical spiral 7, so that the spiral 7 is wound around the main tube 1.

[0041] After preparing the patient for electrophysiological studies, a puncture of the femoral vein, femoral artery, radial artery, or brachial artery is performed. A venous or arterial sheath is then inserted into the artery through this puncture using the Seldinger method. A spiral catheter is then inserted through this sheath. Upon contact with the flat surface of the heart, the anterior part of this catheter assumes the shape of a ring with coils arranged within it. If the surface is concave, it assumes the shape of a corresponding cone, as shown in [reference to diagram]. Fig. 6 and Fig. Figure 7 shows the profile adapted to this profile.

[0042] The signals from the individual electrode pairs located on the catheter are received and forwarded as needed to: - the electrophysiological system that enables the visualization, recording and analysis of intracardiac potentials - a stimulator to deliver impulses to the heart, which are used to perform diagnostic maneuvers - a 3D mapping system for reconstructing the catheter and / or the heart chambers - a high-amplitude pulse generator for performing electroporation or cardioversion / defibrillation

[0043] The electroporation process is usually carried out with a programmable generator with a voltage of 100 V to 6000 V, with a pulse duration between 2 and 6 milliseconds, when using an automatic generator with a power of 5 J to 400 J. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] EP 2269505 A

[0003] WO 02089687 A

[0004] WO 2019089199 A

[0005] US 5374287 A

[0007] US 5133365 A

[0008] US 2004181160 A

[0008] WO 2018208795 A

[0009] PL 227730 B

[0010] PL 242208 B

[0011]

Claims

[1] Spiral catheter for electrophysiological studies and irreversible electroporation of the heart with a plastic main conductor (1) which is connected at one end to an electrical connection (2) from which electrical conductors (3) supply the electrodes (4) which are attached at the other end of the conductor (1), wherein the core (5) protruding from the sleeve-shaped main conductor (1) is made of a shape-memory metal alloy and is bent at its end (6) into a conical spiral (7) with a different number of turns, at least one of which is equipped with sleeve-shaped electrodes (4) mounted on this core (5), which are supplied via insulated electrical conductors (3) and are separated from each other by non-electrically conductive plastic ring elements (8), wherein the diameter ø1 of the first turn of the spiral (7) is between 5 mm and 30 mm and the diameter ø2 of the last turn of the spiral (7) is between 10 mm and 31 mm, while the length of each of these electrodes (4) is between 2 mm and 4 mm and the diameter ø is between 1 mm and 3 mm, wherein the electrodes (4) transmit a pulse with an amplitude on the order of 100 V to 6000 V in a time of 2 microseconds to 6 milliseconds, characterized by , that the number of electrodes (4) arranged on the full turns of the conical spiral (7) of the catheter is a multiple of four and that on each full turn of the conical spiral (7) at least four electrodes (4) are arranged at an equal distance from each other for the respective turn of the spiral (7), wherein adjacent electrodes (4) have opposite polarity, such that a positive electrode (4') is always adjacent to a negative electrode (4"), wherein both the positive electrodes (4') and the negative electrodes (4") of adjacent turns of the spiral (7) are arranged in a line as seen from the end face of the spiral (7). [2] Spiral catheter according to claim 1, characterized by , that the conical spiral (7) is a converging spiral. [3] Spiral catheter according to claim 1, characterized by , that the conical spiral (7) is a diverging spiral. [4] Spiral catheter according to claim 1, characterized by, that a movable three-part sheath (9) is attached to the sleeve-shaped main conductor (1), the two outer parts of which form conductive sheaths (10), while the third insulating sheath (11) arranged in between consists of an insulating material (12'), wherein the conductive sheaths (10) consist entirely of an electrically conductive material (13') or half of an electrically conductive material (13') and half of insulating material (12'), or ¼ of these conductive sheaths (10) consist of electrically conductive material (13') and ¾ of insulating material (12'). [5] Spiral catheter according to claim 4, characterized by , that the electrically conductive material (13') is copper or a copper alloy. [6] Spiral catheter according to claim 1, characterized by , that a stabilizing rod (14) made of PTFE-coated stainless steel is arranged in the sleeve-shaped main line (1). [7] Spiral catheter according to claim 6, characterized by , that the stabilizing rod (14) protrudes from the main line (1) through an opening (15) in front of the conical spiral (7), so that the spiral (7) is wound onto the main line (1). [8] Spiral catheter according to claim 6, characterized by , that the stabilizing rod (14) which is arranged in the sleeve-shaped main line (1) extends through the openings (16) of the sleeve-shaped electrodes (4) and the openings (17) of the ring-shaped plastic elements (8) of the conical spiral (7) of the catheter. [9] Spiral catheter according to claim 1, characterized by , that at the rear end of the sleeve-shaped main line (1) in front of the electrically connected connection (2) to it a handle (18) of the control unit is attached, which serves exclusively to bend the tip of the spiral (7) of the catheter. [10] Spiral catheter according to claim 9, characterized by, that a freewheel (19) is arranged in the handle (18) of the control unit, which allows the handle (18) of the control unit to rotate in only one direction. [11] Spiral catheter according to claim 1, characterized by , that the sleeve-shaped electrodes (4) are equipped with temperature sensors (20). [12] Spiral catheter according to claim 1, characterized by , that the sleeve-shaped electrodes (4) consist entirely of electrically conductive material (13). [13] Spiral catheter according to claim 1, characterized by , that the sleeve-shaped electrodes (4) consist of half electrically conductive material (13) and half electrically non-conductive material (12). [14] Spiral catheter according to claim 1, characterized by , that the sleeve-shaped electrodes (4) consist of ¼ of electrically conductive material (13) and of the remaining ¾ of electrically non-conductive material (12). [15] Spiral catheter according to claim 1, characterized by , that the electrical conductive material (13) of the sleeve-shaped electrodes (4) is platinum, gold or surgical steel. [16] Spiral catheter according to claim 14 or 15, characterized by , that the electrically non-conductive material (12) is PVC or Teflon. [17] Spiral catheter according to claim 1, characterized by , that its core (5) consists of nitinol and is provided with a plastic coating (21). [18] Spiral catheter according to claim 1, characterized by , that the number of pins arranged in the terminal (2) corresponds to the number of electrical conductors (3) that supply the sleeve-shaped electrodes (4) and the number of sensors arranged in these electrodes (4). [19] Spiral catheter according to claim 1, characterized bythat it has two turns of a conical spiral (7) and that four electrodes (4) are arranged on each turn of the conical spiral (7).

Images