Spiral catheter for electrophysiological studies and irreversible cardiac electroporation

Abstract

Spiral catheter for electrophysiological studies and irreversible cardiac electroporation having a plastic main conductor (1) connected at one end to an electrical connector (2), from which electrodes (4) placed at the other end of said conductor (1) are powered via electrical wires (3), and a core (5) protruding from the sleeve-shaped main conductor (1) is made of an alloy of metals preserving shape memory and at its end (6) is bent into the shape of a conical spiral (7) with a varied number of turns, at least one of which is equipped with the sleeve electrodes (4) placed on said core (5) and powered by the insulated electrical wires (3) and separated from each other by plastic ring elements (8) that do not conduct electric current, wherein the number of the electrodes (4) arranged on full turns of the conical spiral (7) of the catheter is a multiple of four and on each full turn of the conical spiral (7) at least four electrodes (4) are arranged at an equal distance from each other for a given turn of the spiral (7).

Description

[0001] Spiral catheter for electrophysiological studies and irreversible cardiac electroporation

[0002] The subject of the invention is a spiral catheter for electrophysiological studies and irreversible cardiac electroporation, used for both conducting of electrophysiological studies of a heart (electrophysiology studies - EPS) allowing for precise evaluation of a type of heart rhythm disorders and their source in the heart muscle by people with suspected heart rhythm disorders and diagnosed heart arrhythmia, as well as for performing electroporation in the heart using high voltage with the possibility of reading signals before and after ablation and mapping, and moreover this catheter can be used with multiple platforms of electrophysiological systems, 3D mapping systems and pulse generators, especially high-voltage ones designed for irreversible tissue electroporation.

[0003] Cardiac arrhythmia treatment procedures involve the destruction of the arrhythmia-causing areas by ablation of the heart muscle tissue with electrical energy, which is usually accomplished by applying an alternating current, usually radiofrequency, to one or more ablation electrodes at a power sufficient to effectively alter the target tissue. These electrodes are typically mounted on the distal tip or portion of an invasive probe or catheter that is inserted into the patient's heart through a blood vessel, usually a femoral vein or artery.

[0004] The state of the art cited below shows that catheters with catheter probes / electrodes are used to treat cardiac arrhythmias, including electrophysiological studies of ablation and cardiac mapping, namely:

[0005] Known from the European patent description EP 2269505 A an electrophysiology catheter includes an elongate catheter body having an elastically-deformable distal region predisposed to assume a spiral shape and a first plurality of electrodes disposed thereon. Each of the first plurality of electrodes includes an electrically active region limited to the inner surface of the spiral shape for use in non-contact electrophysiology studies. A second plurality of electrodes may also be disposed on the distal region interspersed including alternating with the first plurality of electrodes, with each of the second plurality of electrodes having an electrically active region extending into the outer surface of the spiral shape for use in contact electrophysiology studies. The distal region may be deformed into a straight configuration for insertion into and navigation through the patient's vasculature, for example via use of a tubular introducer. As the distal region deploys beyond the distal end of the introducer, it resumes the spiral shape. Furthermore, the electrophysiology catheter comprises a shape memory material extending through a distal (spring) region of the body thereof, the shape memory material comprising a metal wire, a portion of which is enclosed in a polymer tube, the rear end of which is disposed in a tubular guide (introducer).

[0006] From the patent description of international patent application of the invention WO 02089687 A it is known a catheter assembly for treatment of cardiac arrhythmia, which includes a catheter body and an ablative energy source. The catheter body includes a proximal portion, an intermediate portion, and a distal portion, wherein the intermediate portion extends from the proximal portion and defines a longitudinal axis and the distal portion extends from the intermediate portion and includes an ablation section and a tip. The ablation section forms a loop defining a diameter greater than an outer dimension of a pulmonary vein ostium. The tip extends distally from the ablation section and is configured to locate a pulmonary vein. Finally, the ablative energy source is associated with the ablation section. With this configuration, upon activation of the energy source, the ablation section ablates a desired lesion pattern. In one preferred embodiment, the ablation section forms a distally decreasing radius helix, whereas the tip includes a relatively linear leader section. With this one preferred configuration, the tip readily locates a pulmonary vein and guides the ablation section to a seated relationship about a pulmonary vein ostium.

[0007] On the other hand the patent description of international patent application of the invention WO 2019089199 A discloses a method of medical catheterization using a spiral catheter having a flexible, electrically insulated tube and a plurality of ablation electrodes disposed on the external surface of the tube in electrical isolation from one another and a plurality of microelectrodes in electrical isolation from one another and from the ablation electrodes. Moreover the catheter has a shape memory that urges the probe to form spiral loops. Moreover the method according to the invention comprises reading bioelectrical signals from the heart with the microelectrodes; and conducting electrical energy through selected ones of the ablation electrodes to produce a lesion in the chamber of the heart and taking bioelectric readings from selected ones of the microelectrodes and preparing a map of electrical activity in the heart based on the readings. Catheterization is performed by inserting a catheter into the heart, sliding the catheter through a sheath that surrounds a multi -el ectrode probe into the heart chamber. The sheath is retracted to expose the probe. As the sheath is retracted, the exposed probe expands into a spiral configuration, and the electrodes contact the endocardial surface of the ventricle at multiple contact points.

[0008] From the american patent application US 5374287 A it is known a defibrillator and demand pacer catheter having electrically nonconductive probe having an electrically conductive pathway longitudinally disposed therein. Attached to one end of the probe is a defibrillator electrode capable of anchoring the probe to the septum of a heart and of transmitting from said conductive pathway directly to the interior of the septum a portion of an electrical defibrillation pulse sufficient to defibrillate the heart. The defibrillation pulse is delivered in such a manner so as to avoid injuring the heart tissue immediately adjacent to the defibrillator electrode. In the preferred embodiment, the defibrillator electrode is helical; however, it is also envisioned as being a lance. Alternatively, the catheter further comprises a ground electrode, a demand pacer electrode, and a supplemental defibrillator electrode attached to the probe.

[0009] Also from the american patent application US 5133365 A it is known an improved electrocardial lead for use with an automatic implantable cardioverter / defibrillator (AICD) comprises an elongated, flexible, plastic tubular catheter body which is preformed so that when unconstrained, it assumes the shape of a tapered spiral or helix. The catheter body supports a defibrillating electrode attached to the exterior wall of the catheter body and is connected by a suitable cable to a proximal connector for mating with the AICD pulse generator. The improved lead also includes a tip electrode for sensing cardiac activity and providing information to the AICD pulse generator for controlling its operation. The lead of the present invention is intended for endocardial emplacement with the electrode structures predominantly in the right ventrical and provides substantially increased electrode surface area in contact with heart tissue as compared to prior art endocardial defibrillating leads and, thus, maximizing the energy delivered to the heart during defibrillation.

[0010] From the american patent application US 2004181160 A it is known a system based on a non-extendable, spiral-shaped non-contact, multi -el ectrode miniature catheter probe, which is used for determining electrical potentials on an endocardial surface of a heart. The system includes a spiral-shaped non-contact, multi-electrode catheter probe, a plurality of electrodes disposed on an end portion thereof, means for determining endocardial potentials based on electrical potentials measured by the catheter probe, a matrix of coefficients that is generated based on a geometric relationship between the probe surface, and the endocardial surface. This system comprises a non-contact multi-electrode catheter probe which can be inserted into a heart cavity filled with blood without covering it. This probe for measuring electrical potentials in the heart cavity comprises: a tip portion with a plurality of electrodes adapted to the shape of a cylindrical spiral, which is positioned so as not to contact the endocardial surface of the heart, which is placed percutaneously in said heart cavity.

[0011] It is known from the international patent application WO 2018208795 A catheter for electroporation includes a plurality of catheter electrodes disposed along a portion of a distal end of the electroporation catheter, wherein the plurality of catheter electrodes includes a plurality of first type catheter electrodes adapted for use with an electroporation generator during an electroporation procedure and a plurality of second type catheter electrodes adapted for use with an electroporation generator during an 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, adjacent catheter electrodes of the second type form a pair of catheter electrodes of the second type, and the catheter electrodes of the first type and the pair of catheter electrodes of the second type are alternately disposed along a portion of the electroporation catheter, wherein each catheter electrode of the first type is adjacent to at least one pair of catheter electrodes of the second type.

[0012] It is known from the polish patent description PL 227730 B an ablationmapping catheter used for electrocardiological procedures comprising at least eight diagnostic rings connected via connections to a generator (generators) which enable non-fluoroscopic mapping in a three-dimensional electroanatomical system, wherein the diagnostic rings are evenly distributed at the distal end of said electrode. This ablation-mapping catheter comprises a control handle, a straight main cable, a distal end ring mounted thereon and diagnostic rings, including distal and proximal ones, and two bundles of electrical cables connecting these diagnostic rings and the distal end ring with the electrophysiological system. In addition, this catheter is made of a flexible material enabling it to be easily bent, and the distal end is equipped with a control system located in the handle of said catheter and connected by appropriate cables, wherein this catheter is introduced into the peripheral venous or arterial vessels (femoral vein / artery) of the patient and then guided through the main vessels to the right or left chambers of the heart. The control system of this catheter allows for bending of its rounded distal tip.

[0013] It is known from the polish patent description PL 242208 B a spiral catheter for electrophysiology studies and irreversible electroporation within the heart, which is characterized in that the coreof the catheter protruding from the sleeve main conduit is made of a shape-retaining metal alloy and is bent in the shape of a conical spiral with a different number of coils, at least one of which is equipped with sleeve electrodes imposed on this core, supply through insulated electric wires and separated from each other with plastic ring elements, where the diameter ol of the first coil of the spiral is from 5 mm to 30 mm, and the diameter o2 of the last coil of the spiral is from 10 mm to 31 mm, while the length of each of these electrodes is from 2 mm to 4 mm, and the diameter o is from 1 mm to 3 mm, and these electrodes send a pulse with an amplitude of 100- 3000V in time and from 5 microseconds to 6 milliseconds, and the number of electrodes distributed on the spiral of the catheter ranges from 10 to 65 pieces.

[0014] In commonly known catheters used for electrophysiological studies and cardiac mapping, electrodes with opposite polarities are often too close to each other. While this is not very important in the case of radiofrequency current delivery during thermal ablation, it can be crucial for effective and safe nonthermal ablation by irreversible electroporation. This is because during the delivery of high voltage current (which is necessary to ensure the irreversibility of the electroporation performed), prospective dangerous electrical breakdowns can occur between electrodes with opposite polarity, plasma formation, and thus the risk of buming / thermal ablation of too large or undesirable tissue areas, which can pose a threat to health and life.

[0015] The aim of the invention is to develop a design of a spiral catheter for electrophysiological studies that will enable patient-safe, irreversible electroporation of heart tissue using high-voltage electrical impulses, as a result of which heart cells die as a result of destabilization of the cell membrane, without the risk of electrical breakdowns between adjacent electrodes of opposite polarity.

[0016] Spiral catheter for electrophysiological studies and irreversible cardiac electroporation having a plastic main conductor connected at one end to an electrical connector, from which electrodes placed at the other end of said conductor are powered via electrical wires, and a core protruding from the sleeveshaped main conductor is made of an alloy of metals preserving shape memory and at its end is bent into the shape of a conical spiral with a varied number of turns, at least one of which is equipped with the sleeve electrodes placed on said core and powered by the insulated electrical wires and separated from each other by plastic ring elements that do not conduct electric current, wherein the diameter ol of the first turn of the spiral is from 5 mm to 30 mm, and the diameter 02 of the last turn of the spiral is from 10 mm to 31 mm, while the length of each of these electrodes is from 2 mm to 4 mm, and the diameter 0 is from 1 mm to 3 mm, wherein these electrodes transmit a pulse with an amplitude of 100V to 6000V in a time of 2 microseconds to 6 milliseconds, is characterized by that the number of the electrodes arranged on full turns of the conical spiral of the catheter is a multiple of four and on each full turn of the conical spiral at least four electrodes are arranged at an equal distance from each other for a given turn of the spiral, wherein adjacent electrodes have opposite polarity, so that a positive electrode is always adjacent to a negative electrode, wherein both the positive electrodes and the negative electrodes from adjacent turns of the spiral are arranged in one line, viewed from the front of the spiral.

[0017] Preferably the conical spiral is a tapered spiral.

[0018] Other benefits are obtained, if the conical spiral is a divergent spiral.

[0019] Further benefits are obtained, if on the sleeve-shaped main conductor a three-part cover is slidably placed, the two outermost parts of which are conductive covers, and the third insulating cover placed between them is made of an insulating material, wherein the conductive covers are made entirely of an electrically conductive material or half of them are made of an electrically conductive material and half of them are made of an insulating material or 14 of these conductive covers are made of an electrically conductive material, and3 / 4 of them are made of an insulating material.

[0020] Preferably the electrically conductive material is copper or copper alloy.

[0021] Other benefits are obtained, if in the sleeve-shaped main conductor there is placed a stabilizing rod made of PTFE coated stainless steel.

[0022] Further benefits are obtained, if the stabilizing rod comes out of the main conductor through an aperture before the conical spiral so that the spiral is wound around the main conductor.

[0023] Preferably the stabilizing rod placed in the sleeve-shaped main conductor, passes through holes of the sleeve electrodes and holes of the plastic ring elements of the conical spiral of the catheter.

[0024] Other benefits are obtained, if at the rear end of the sleeve-shaped main conductor, before the electrically connected connector, there is a controller handle which is used only to bend the tip of the spiral of the catheter.

[0025] Preferably in the controller handle there is placed a freewheel, which allows turning the controller handle only in one direction.

[0026] Further benefits are obtained, if the sleeve electrodes are equipped with temperature sensors.

[0027] Preferably the sleeve electrodes are made entirely of an electrically conductive material.

[0028] Other benefits are obtained, if the sleeve electrodes in half of their circumference are made of an electrically conductive material and in half of their circumference of a material that does not conduct electrical current.

[0029] Further benefits are obtained, if the sleeve electrodes in 14 of their circumference are made of an electrically conductive material and in the rest3A of their circumference of a material that does not conduct electrical current.

[0030] Preferably electrically conductive material of the sleeve electrodes (5) is platinum, gold or surgical steel. Other benefits are obtained, if the material that does not conduct electrical current is PVC or teflon.

[0031] Further benefits are obtained, if its core is made of nitinol and is covered with a plastic coating.

[0032] Preferably the number of pins placed in the connector corresponds to the number of the electrical wires powering the sleeve electrodes and the number of sensors placed in these electrodes.

[0033] Other benefits are obtained, if has two turns of the conical spiral and on each turn of the conical spiral are four electrodes.

[0034] Preclinical tests of the spiral catheter according to the invention have shown that the use of a large number of electrodes transmitting high-amplitude impulses means that the catheter delivers much higher energy than any available and currently commonly used catheters of this type, which minimizes the occurrence of unforeseen situations in the patient during the procedure that threaten his life and health, and in addition, the catheter:

[0035] - after sliding out of the vascular sheath, it tends to obtain an optimal spiral shape;

[0036] - adapts to the shape of the surface in which it is located depending on the individual anatomical conditions of the heart in different patients;

[0037] - has the ability to work with many platforms, which minimizes the limitations associated with the availability of an "only" and "specific" cooperating hardware.

[0038] The spiral catheter according to the invention is a universal solution that can be used both for electrophysiological studies and heart mapping, as well as for electroporation procedures in many configurations, especially such as: single- or double-electrode electroporation, single-electrode-interannual electroporation, etc., and its simple and flexible design significantly minimizes the risk of heart perforation, while the materials used to build the electrodes are relatively easily available, which significantly facilitates their production, and the fact that the catheter’s core is made of nitinol allows for remembering its original shape and its reconstruction under the influence of appropriate external conditions (e.g. changes in the magnetic field or temperature). In turn, the use of the three-part cover in a preferred embodiment of the catheter according to the invention allows for maximization of the electrically active surface of the electrode through which electroporation pulses are delivered, which minimizes the risk of complications such as punctures, barotrauma or the formation of gas bubbles, while the end of the catheter with the plastic ring element minimizes the risk of mechanical traumatization of the tissue. In addition, providing the electrodes with sensors such as thermistors and thermocouples allows for control of the temperature of these electrodes, which may increase in some pulse configurations.

[0039] Unlike spiral catheters known in state of the art, in the device according to the invention, thanks to the arrangement of electrodes of opposite polarity from adjacent turns of the spiral in one line, when viewed from the front of the spiral, there is no dangerous electrical breakdown between the electrodes of opposite polarity, no plasma formation, and thus no risk of burning too large areas and a threat to health and life. Thanks to the placement of the freewheel in the controller handle, it is possible to rotate the controller handle in one direction only, which prevents the spiral from rotating in the direction that could perforate the heart with the most distal ring / tip of the spiral. An additional advantage is the audible clicks during the rotation of the spiral, which are helpful in navigating the electrode. This allows the amount of required fluoroscopy to be reduced, and it also makes it easier for trained operators to operate the device according to the invention.

[0040] The subject of the invention in three embodiments is depicted in the drawing, where figures 1 to 8 show a spiral catheter in a first embodiment, figures 9 to 13 show a spiral catheter in a second embodiment, and figure 14 shows a spiral catheter in a third embodiment, wherein fig. 1 shows the catheter in the first embodiment in a perspective view showing its turns from the front and from above, fig. 2 shows the spiral catheter of this type in a side view, fig. 3 - a main conductor of the catheter in a cross section along the line A-A, fig. 4 - enlarged detail "B" of a front part of the three-turn catheter in the first embodiment, fig. 5 shows the conical tapered spiral of the catheter in the first embodiment in a front view, fig. 6 shows a cross section B-B through a controller handle with a freewheel shown, while fig. 7 and fig. 8 show a simplified example of an adaptation of a profile of the coils of the catheter according to the first embodiment to a flat or concave surface of the heart cavity during the procedure performed in a side view, whereas fig. 9 - 13 show a second version of the spiral catheter for electrophysiological studies and irreversible cardiac electroporation, having three turns with a divergent spiral profile at its front end, on the main conductor of which several conductive sleeve-shaped covers are mounted, separated from each other by insulating sleeve-shaped covers, wherein fig. 9 shows the spiral catheter of this type in a side view, fig. 10 - a main conductor of the catheter in a cross section along the line A-A, fig. 11 the spiral catheter in a perspective view, fig. 12 shows the conical divergent spiral of the catheter in the second embodiment in a front view, a fig. 13 - a cross section of a sleeve electrode of the spiral catheter in the second embodiment, wherein half of a circumference of the electrode is made of an electrically conductive material and the second half of its circumference of a material that does not conduct electrical current and the last fig. 14 shows the third embodiment of a spiral catheter for electrophysiological studies and irreversible cardiac electroporation having three turns with a tapered spiral profile at its front end wound on a main conductor of the catheter additionally equipped with a stabilizing rod placed partially in this conductor, in a front view.

[0041] Spiral catheter for electrophysiological studies and irreversible cardiac electroporation in the first embodiment has a plastic main conductor 1 connected at one end to an electrical connector 2, from which electrodes 4 placed at the other end of said conductor 1 are powered via electrical wires 3. A core 5 protruding from the sleeve-shaped main conductor 1 is made of nitinol (an alloy of metallic nickel and titanium preserving shape memory) and is covered with a plastic coating 21. The core 5 at its end 6 is bent into the shape of a conical tapered spiral 7 with three turns, each of which turns is equipped with the sleeve electrodes 4 placed on said core 5 and powered by the insulated electrical wires 3 and separated from each other by plastic ring elements 8 that do not conduct electric current. The sleeve electrodes 4 are made entirely of an electrically conductive material 13, which is surgical steel. The diameter ol of the first turn of the spiral 7 is 30 mm, and the diameter o2 of the last turn of the spiral 7 is 10 mm. The length of each of these electrodes 4 is 4 mm, and the diameter o is 1 mm. These electrodes 4 transmit a pulse with an amplitude of 100V in a time of 5 microseconds. The number of the electrodes 4 arranged on the conical spiral 7 of the catheter is twelve and on each turn of the conical spiral 7 four electrodes 4 are arranged at an equal distance from each other for a given 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 one line, viewed from the front of the spiral 7, what is shown in the fig. 5. At the rear end of the sleeve-shaped main conductor 1, before the electrically connected connector 2, there is a controller handle 18 which is used only to bend the tip of the spiral 7 of the catheter. In the controller handle 18 there is placed a freewheel 19, which allows turning the controller handle 18 only in one direction. The sleeve electrodes 4 are equipped with temperature sensors 20 in the form of thermocouples. The number of pins placed in the connector 2 is twenty four and corresponds to the number of the twelve electrical wires 3 powering the twelve sleeve electrodes 4 and the number of twelve temperature sensors placed in these electrodes 4.

[0042] Spiral catheter for electrophysiological studies and irreversible cardiac electroporation in the second embodiment has a plastic main conductor 1 connected at one end to an electrical connector 2, from which electrodes 4 placed at the other end of said conductor 1 are powered via electrical wires 3. A core 5 protruding from the sleeve-shaped main conductor 1 is made of nitinol (an alloy of metallic nickel and titanium preserving shape memory) and is covered with a plastic coating 21. The core 5 at its end 6 is bent into the shape of a conical divergent spiral 7 with three turns, each of which turns is equipped with the sleeve electrodes 4 placed on said core 5 and powered by the insulated electrical wires 3 and separated from each other by plastic ring elements 8 that do not conduct electric current. The sleeve electrodes 4 in half of their circumference are made of an electrically conductive material 13, which is gold and in half of their circumference of a material 12 that does not conduct electrical current, which is teflon. The diameter ol of the first turn of the spiral 7 is 10 mm, and the diameter o2 of the last turn of the spiral 7 is 30 mm. The length of each of these electrodes 4 is 2 mm, and the diameter o is 2 mm. The electrodes 4 transmit a pulse with an amplitude of 3000V in a time of 5 microseconds. The number of the electrodes 4 arranged on the conical spiral 7 of the catheter is twelve and on each turn of the conical spiral 7 four electrodes 4 are arranged at an equal distance from each other for a given 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 one line, viewed from the front of the spiral 7, what is shown in the fig. 12. The sleeve electrodes 4 are equipped with temperature sensors 20 in the form of thermistors. The number of pins placed in the connector 2 is forty eight and corresponds to the number of the twenty four electrical wires 3 powering the twenty four electrodes 4 and the number of twenty four temperature sensors placed in these electrodes 4. On the sleeve-shaped main conductor 1 a three-part cover 9 is slidably placed, the two outermost parts of which are conductive covers 10, and the third insulating cover 11 placed between them is made of an insulating material 12'. The conductive covers 10 are made entirely of an electrically conductive material 13’, which is copper. In the sleeve- shaped main conductor 1 there is placed a stabilizing rod 14 made of PTFE coated stainless steel. The stabilizing rod 14 placed in the sleeve-shaped main conductor 1, passes through holes 16 of the sleeve electrodes 4 and holes 17 of the plastic ring elements 8 of the conical spiral 7 of the catheter.

[0043] Spiral catheter for electrophysiological studies and irreversible cardiac electroporation in the third embodiment has a plastic main conductor 1 connected at one end to an electrical connector 2, from which electrodes 4 placed at the other end of said conductor 1 are powered via electrical wires 3. In the sleeve-shaped main conductor 1 there is placed a stabilizing rod 14 made of PTFE coated stainless steel. The stabilizing rod 14 comes out of the main conductor 1 through an aperture 15 before the conical spiral 7 so that the spiral 7 is wound around the main conductor 1.

[0044] After prior preparation of the patient for electrophysiological examination, a puncture of the femoral vein, femoral artery, radial artery or brachial artery is performed, and then through this puncture a venous or arterial sheath is introduced into the artery using the Seidinger method, through which a spiral catheter is introduced, the front part of which, when in contact with the flat part of the heart surface 22, takes the form of a ring with tuma placed inside it or, in the case of a concave surface 23, takes the form of a corresponding cone as shown in Fig. 6 and Fig. 7 adapted to this profile.

[0045] Signals from individual pairs of electrodes placed on the catheter are received and transmitted, depending on the need, to:

[0046] - an electrophysiological system that enables imaging, recording and analysis of intracardiac potentials

[0047] - a pacemaker to deliver impulses stimulating the heart to perform diagnostic maneuvers

[0048] - a 3D mapping system to reconstruct the catheter and / or heart chambers

[0049] - a high-amplitude pulse generator to perform electroporation or cardioversion / defibrillation The electroporation process is usually carried out using a programmable generator with a voltage range from 100 V to 6000 V, with a pulse duration ranging from 2 microseconds to 6 milliseconds, while in the case of an automatic generator, the power ranges from 5 J to 400 J.

Claims

Patent claims1. Spiral catheter for electrophysiological studies and irreversible cardiac electroporation having a plastic main conductor (1) connected at one end to an electrical connector (2), from which electrodes (4) placed at the other end of said conductor (1) are powered via electrical wires (3), and a core (5) protruding from the sleeve-shaped main conductor (1) is made of an alloy of metals preserving shape memory and at its end (6) is bent into the shape of a conical spiral (7) with a varied number of turns, at least one of which is equipped with the sleeve electrodes (4) placed on said core (5) and powered by the insulated electrical wires (3) and separated from each other by plastic ring elements (8) that do not conduct electric current, wherein the diameter ol of the first turn of the spiral (7) is from 5 mm to 30 mm, and the diameter o2 of the last turn of the spiral (7) is from 10 mm to 31 mm, while the length of each of these electrodes (4) is from 2 mm to 4 mm, and the diameter o is from 1 mm to 3 mm, wherein these electrodes (4) transmit a pulse with an amplitude of 100V to 6000V in a time of 2 microseconds to 6 milliseconds, characterized in that the number of the electrodes (4) arranged on full turns of the conical spiral (7) of the catheter is a multiple of four and on each full turn of the conical spiral (7) at least four electrodes (4) are arranged at an equal distance from each other for a given turn of the spiral (7), wherein adjacent electrodes (4) have opposite polarity, so that a positive electrode (4') is always adjacent to a negative electrode (4"), wherein both the positive electrodes (4') and the negative electrodes (4") from adjacent turns of the spiral (7) are arranged in one line, viewed from the front of the spiral (7).

2. Spiral catheter according to claim 1, characterized in that the conical spiral (7) is a tapered spiral.

3. Spiral catheter according to claim 1, characterized in that the conical spiral (7) is a divergent spiral.

4. Spiral catheter according to claim 1, characterized in that on the sleeve-shaped main conductor (1) a three-part cover (9) is slidably placed, the two outermost parts of which are conductive covers (10), and the third insulating cover (11) placed between them is made of an insulating material (12'), wherein the conductive covers (10) are made entirely of an electrically conductive material (13’) or half of them are made of an electrically conductive material (13’) and half of them are made of an insulating material (12’) or 14 of these conductive covers (10) are made of an electrically conductive material (13’), and3 / 4 of them are made of an insulating material (12’).

5. Spiral catheter according to claim 4, characterized in that the electrically conductive material (13’) is copper or copper alloy.

6. Spiral catheter according to claim 1, characterized in that in the sleeve-shaped main conductor (1) there is placed a stabilizing rod (14) made of PTFE coated stainless steel.

7. Spiral catheter according to claim 6, characterized in that the stabilizing rod (14) comes out of the main conductor (1) through an aperture (15) before the conical spiral (7) so that the spiral (7) is wound around the main conductor (1).

8. Spiral catheter according to claim 6, characterized in that the stabilizing rod (14) placed in the sleeve-shaped main conductor (1), passes through holes (16) of the sleeve electrodes (4) and holes (17) of the plastic ring elements (8) of the conical spiral (7) of the catheter.

9. Spiral catheter according to claim 1, characterized in that at the rear end of the sleeve-shaped main conductor (1), before the electrically connectedconnector (2), there is a controller handle (18) which is used only to bend the tip of the spiral (7) of the catheter.

10. Spiral catheter according to claim 9, characterized in that in the controller handle (18) there is placed a freewheel (19), which allows turning the controller handle (18) only in one direction.

11. Spiral catheter according to claim 1, characterized in that the sleeve electrodes (4) are equipped with temperature sensors (20).

12. Spiral catheter according to claim 1, characterized in that the sleeve electrodes (4) are made entirely of an electrically conductive material (13).

13. Spiral catheter according to claim 1, characterized in that the sleeve electrodes (4) in half of their circumference are made of an electrically conductive material (13) and in half of their circumference of a material (12) that does not conduct electrical current.

14. Spiral catheter according to claim 1, characterized in that the sleeve electrodes (4) in 14 of their circumference are made of an electrically conductive material (13) and in the rest3 / 4 of their circumference of a material (12) that does not conduct electrical current.

15. Spiral catheter according to claim 1, characterized in that electrically conductive material (13) of the sleeve electrodes (4) is platinum, gold or surgical steel.

16. Spiral catheter according to claim 14 or 15, characterized in that the material (12) that does not conduct electrical current is PVC or teflon.

17. Spiral catheter according to claim 1, characterized in that its core (5) is made of nitinol and is covered with a plastic coating (21).

18. Spiral catheter according to claim 1, characterized in that the number of pins placed in the connector (2) corresponds to the number of the electrical wires (3) powering the sleeve electrodes (4) and the number of sensors placed in these electrodes (4).

19. Spiral catheter according to claim 1, characterized in that has two turns of the conical spiral (7) and on each turn of the conical spiral (7) are four electrodes (4).

Images