SPRING-LOADED CATHETER FOR AN ELECTROPHYSIOLOGY (EP) STUDY AND IRREVERSIBLE ELECTROPORATION WITHIN THE HEART

Abstract

A spring-loaded catheter for electrophysiology studies and irreversible electroporation within the heart, comprises core of catheter protruding from sleeve main conduit is made of shape-retaining metal alloy and is bent in shape of conical spiral with 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 diameter Ø1 of first coil of spiral is 5 mm to 30 mm, and diameter Ø2 of last coil of spiral is 10 mm to 31 mm, while length of each of these electrodes is 2 mm to 4 mm, and diameter Ø is from 1 mm to 3 mm, and these electrodes send pulse with amplitude of 100-3000V in time and 5 microseconds to 6 milliseconds, and number of electrodes distributed on spiral of catheter ranges 10 to 65 pieces.

Claims

1. A spring-loaded catheter for electrophysiology studies and irreversible electroporation within the heart has a plastic main conduit connected at one end to an electrical connector, from which electrodes located at the other end of the conduit are supplied via electric wires, characterized by the fact that the core protruding from the main sleeve conduit is made of a metal alloy that retains shape memory and is bent in the shape of a conical spiral with a different number of coils, at least one of which is equipped with overlapping on this core, sleeve electrodes fed through insulated electric wires and separated from each other by plastic ring elements, where the diameter Ø1 of the first coil of the spiral ranges from 5 mm to 30 mm, and the diameter Ø2 of the last coil of the spiral amounts to 10 mm to 31 mm, while the length of each of these electrodes is from 2 mm to 4 mm, and the diameter Ø is from 1 mm to 3 mm, where the electrodes which send a pulse with an amplitude of 100-3000V in time and from 5 microseconds to 6 milliseconds, and the number of electrodes located on the catheter spiral is from 10-65 pieces.

2. The spring-loaded catheter according to claim 1, characterized in that the conical spiral is a tapering spiral.

3. The spring-loaded catheter according to claim 1, characterized in that the conical spiral is a divergent spiral.

4. The spring-loaded catheter of claim 1, characterized in that the maximum number of coils of the spiral in the catheter is 5 coils and the number of sleeve electrodes arranged on the coils of the spiral is 65.

5. The spring-loaded catheter according to claim 1, characterized in that the two terminal coils of the conical spiral have 15 sleeve electrodes separated by plastic ring elements, and the central coil of the spiral is covered with a plastic sheath protecting the core together with electric wires supplying current to the sleeve electrodes of the coil.

6. The spring-loaded catheter according to claim 1, characterized in that three-part sheath is slidably placed on the sleeve main conduit, the two terminal parts of which are conductive sheaths, and the third sheath placed between them is made of insulating material, the conductive sheaths are made entirely of electrically conductive material or are in half made of electrically conductive material and in half of insulating material or ¼ of these sheaths are made of electrically conductive material, and ¾ of insulating material.

7. The spring-loaded catheter according to claim 6, characterized in that the electrically conductive material is copper or a copper alloy.

8. The spring-loaded catheter according to claim 1, characterized in that the stabilizing rod made of PTFE-coated stainless steel is inserted into the sleeve main conduit.

9. The spring-loaded catheter of claim 8, characterized in that the stabilizing rod exits the main conduit through the opening in front of the conical spiral so that the spiral is wound around the main conduit.

10. The spring-loaded catheter according to claim 8, characterized in that the stabilizing rod, placed in the sleeve main conduit, passes through the holes of the sleeve electrodes and the holes of the plastic ring elements of the conical spiral of the catheter.

11. The spring-loaded catheter according to claim 1, characterized in that it ends with a sleeve electrode.

12. The spring catheter according to claim 1, characterized in that it terminates with a plastic annular element.

13. The spring-loaded catheter according to claim 1, characterized in that at the rear end of the sleeve main conduit, a driver handle is provided in front of the electrically connected connector for bending only the end of the catheter spiral.

14. The spring-loaded catheter according to claim 1, characterized in that the sleeve electrodes are provided with thermistors.

15. The spring-loaded catheter according to claim 1, characterized in that the sleeve electrodes are provided with thermocouples.

16. The spring-loaded catheter according to claim 1, characterized in that the sleeve electrodes are entirely made of electrically conductive material.

17. The spring-loaded catheter according to claim 1, characterized in that half of the diameter of the sleeve electrodes are made of electrically conductive material and half of electrically non-conducting material.

18. The spring-loaded catheter according to claim 1, characterized in that the sleeve electrodes in ¼ of their diameters are made of electrically conductive material, and in other ¾ of non-conductive material.

19. The spring-loaded catheter according to claim 1, characterized in that the electrically conductive material of the sleeve electrodes is platinum, gold or surgical steel and the electrically non-conductive material is PVC or Teflon.

20. The spring-loaded catheter according to claim 1, characterized in that its core is made of nitinol and is covered with a plastic sheath.

21. The spring-loaded catheter according to claim 1, characterized in that the number of pins placed in the connector corresponds to the number of electric wires supplying the sleeve electrodes and the number of sensors placed in these electrodes.

Description

BRIEF DESCRIPTION OF FIGURES

[0029] The subject of the invention in eight variants of its implementation is shown in FIGS. 1-31, in which FIG. 1-7 show a first embodiment of a spring-loaded catheter for electrophysiology and cardiac irreversible electroporation having three coils with a converging spiral profile at the front end;

[0030] FIG. 1 is a top view of the first embodiment of catheter;

[0031] FIG. 2 is a front view of a spring-loaded catheter of this embodiment;

[0032] FIG. 3 is a cross sectional view of the catheter main conduit along A-A line;

[0033] FIG. 4 is the same first embodiment of the catheter with a perspective view of the coils from the posterior and lateral sides;

[0034] FIG. 5—the same first embodiment of the catheter in the side view from its connector side;

[0035] FIG. 6—the same first embodiment of the catheter in a perspective view with its coils from the anterior side and from above;

[0036] FIG. 7—enlarged “B” detail of the anterior part of the three-coil catheter;

[0037] FIGS. 8-10 show a second embodiment of a spring-loaded catheter for electrophysiology studies and cardiac irreversible electroporation with two coils with a divergent spiral profile at its front end, whereby

[0038] FIG. 8 is a perspective view of the second embodiment of the spring-loaded catheter with the coils seen from the posterior and lateral sides;

[0039] FIG. 9—the spring-loaded catheter in a front view;

[0040] FIG. 10—the main conduit of the catheter in a cross-section along the C-C line;

[0041] FIGS. 11-13 show a third embodiment of a spring-loaded catheter for electrophysiology and cardiac irreversible electroporation having five coils with a divergent spiral profile at its front end, while

[0042] FIG. 11 shows the same third embodiment of the spring-loaded catheter with a side and back view of the coils;

[0043] FIG. 12—the spring-loaded catheter in front view;

[0044] FIG. 13—main conduit of the catheter in cross-section along the D-D line;

[0045] FIGS. 14-16—show a fourth embodiment of the spring-loaded catheter for electrophysiology study and cardiac irreversible electroporation with three coils at its front end with a profile of a convergent spiral, the middle of which is a plastic coil devoid of annular electrodes, while

[0046] FIG. 14 shows the same fourth embodiment of the spring-loaded catheter with a perspective view of the coils from the side and back in a perspective view;

[0047] FIG. 15—the front view of the spring-loaded catheter;

[0048] FIG. 16—the main conduit of the catheter in cross-section along the E-E line;

[0049] FIGS. 17-21 show a fifth embodiment of a spring-loaded catheter for electrophysiology study and cardiac irreversible electroporation having at its front end an incomplete coil with a profile forming part of a converging spiral and at the other end a controller equipped with a handle and an electrical connector;

[0050] FIG. 17 is a perspective view of a spring-loaded catheter according to this embodiment;

[0051] FIG. 18 is a front view of the same spring-loaded catheter;

[0052] FIG. 19 is a cross section of the main catheter conduit along the F-F line;

[0053] FIG. 20—the same fifth embodiment of the catheter in a view from its connector side;

[0054] FIG. 21—enlarged “G” detail of the spring end of the catheter;

[0055] FIGS. 22-28 show the sixth embodiment of the spring-loaded catheter for electrophysiology study and cardiac irreversible electroporation with three coils with a converging spiral profile at its end, while

[0056] FIG. 22 shows a spring-loaded catheter according to this embodiment, on the main conduit of which several conductive sheaths are mounted, separated from each other by insulating sleeve sheaths in a perspective view;

[0057] FIG. 23—the same catheter after sliding on the coils of its spiral conductive sleeve sheaths and a sleeve insulating sheath mounted on the middle coil in the perspective view;

[0058] FIG. 24—the same, sixth embodiment of catheter in the side view from its connection;

[0059] FIG. 25—a triple coil of the same catheter in a vertical section along the H-H line;

[0060] FIG. 26—enlarged “J” detail sheaths of the coils of the catheter spiral in section along the H-H line, representing the first embodiment thereof in FIG. 24;

[0061] FIG. 27—the same enlarged “J” detail of the sheath of one of the coils of the catheter spiral in section along the line H-H in FIG. 24, constituting the second embodiment of its implementation, and

[0062] FIG. 28—the same enlarged “J” detail of the sheath of one of the coils of the catheter spiral in section along the H-H line, in FIG. 24, a third embodiment thereof,

[0063] FIG. 29—shows a seventh embodiment of the spring-loaded catheter for electrophysiology study and cardiac irreversible electroporation having at its front end three coils with a convergent spiral profile wound on the main conduit of the catheter, additionally equipped with a stabilizing rod partially located in the conduit, in front view;

[0064] FIG. 30—three coils of the catheter spiral wound on the main conduit according to the seventh variant its execution along the K-K line;

[0065] FIG. 31 shows the eighth embodiment of the spring-loaded catheter for electrophysiology studies and irreversible electroporation of the heart, having at its front end three coils with a spiral profile converging with the main stabilizing bar placed additionally in them and in the conduit in the front view;

[0066] FIG. 32 is a front view of an embodiment of one of the plurality of annular electrodes provided with a conductor for electric current and a thermistor;

[0067] FIG. 33 is an axial section view of the same annular electrode along the L-L line, front view of one of the plurality of ring electrodes;

[0068] FIG. 34 shows an example of manufacturing one of many ring electrode from front view

[0069] FIG. 35—the same electrode cross-section along the M-M line made of a homogeneous electrically conductive material;

[0070] FIG. 36—the same electrode cross-section along the M-M line, where one half of it is made of electrically conductive material and the other half is made of insulating material;

[0071] FIG. 37—the same electrode in the cross-section along the M-M line, where ¾ of the electrode is made of insulating material, and ¾ of conductive material;

[0072] FIGS. 38-39—show a simplified example of the adaptation of the spiral profile of the catheter to a flat or concave side view of the surface of the heart cavity during the procedure, and

[0073] FIG. 40—shows an example of insertion of a spring-loaded catheter into the heart cavity in a simplified perspective view.

EXAMPLE 1

[0074] The spring-loaded catheter for electrophysiology studies and cardiac irreversible electroporation according to the first embodiment (FIGS. 1-7) is a plastic main conduit 1 made of a thermoplastic elastomer with a sleeve profile, with a core 2 made of nitinol (an alloy of metallic nickel with titanium showing shape memory effect) inside, covered with an insulating, plastic coating 3, where forty-three sleeve electrodes 5, separated by plastic non-conductive ring elements 6, are placed on the end 4 of the core 2 protruding from the main conduit 1.

[0075] The end 4 of the core is bent in the shape of a conical spiral 7 with a length L=17 mm, forming three coils 8, 9 and 10, so that the first coil 8 has a diameter Ø1 equal to 30 mm, and the last coil 10 has a diameter Ø2 equal to 10 mm and finished with a sleeve electrode 5. Each of the electrodes 5 is entirely made of a homogeneous electrically conductive material 11—surgical steel and has a length d=2 mm and a diameter Ø=1 mm, as shown in FIGS. 34 and 35.

[0076] Inside the main conduit 1, between its inner surface and the outer surface of the cover 3 of the core 2, there are placed forty-three electric wires 12, made of copper with a diameter of 0.02 mm, surrounded and laminated with the sheath 13, the front ends of which are electrically connected to the corresponding sleeve electrodes 5, the end 4 of the core 2 and the electric wires 12 pass through the holes 14 of the electrodes 5 and the through holes 15 of the plastic annular elements 6 so that the core 2 passes through all the sleeve electrodes 5, while one electric conductor 12 is led to only one sleeve electrode 5.

[0077] In turn, the rear end of the main conduit 1 is electrically connected to a connector 16, for example of the Redel type, provided with forty pins, not shown, to which an electric current is supplied from an adapter also not shown providing high-amplitude electrical pulses, where the length of the entire of the spring-loaded catheter was 1.2 m.

EXAMPLE 2

[0078] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according to the second embodiment (FIGS. 8-10) is similar to the embodiment described in the first example, the difference being that in the latter embodiment, the front end 4 of the core 2 protruding from the main conduit 1 covered with an insulating, plastic coating 3 made of thermoplastic rubber is provided with twenty sleeve electrodes 5 separated by plastic ring elements 6 connected with twenty electric conductors 12 with a diameter of 0.2 mm, and it is bent into the shape of a conical divergent spiral 17 with length L=15 mm, forming two coils 18 and 19, with coil 18 having a diameter Ø1 equal to 5 mm and coil 19 having a diameter Ø2 equal to 31 mm. Moreover, in the embodiment, the electrodes 5 have a length d=4 mm, a diameter Ø=3 mm and are made of two materials such that one half of each is electrically conductive 11, platinum, and the other half is non-conductive PVC type as shown in FIGS. 34 and 36.

EXAMPLE 3

[0079] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according to the third embodiment (FIGS. 11-13) is similar to the embodiment described in the first example, the difference being that in the third embodiment the front end 4 of the core 2 protruding from the main conduit 1 is provided with sixty-five sleeve electrodes 5, connected to sixty-five electric conductors 12, and is bent in the shape of a conical divergent spiral 21, forming five coils, the diameter Ø1 of the first coil 22 is 15 mm and the diameter Ø6 of the last coil 23 is 20 mm, wherein ¾ of the diameter of each of the sleeve electrodes 5 is non-conductive material 20—Teflon and ¼ of the electrically conductive material 11 is gold as shown in FIGS. 34 and 37, and the length of the entire spring-loaded catheter is 1.6 m.

EXAMPLE 4

[0080] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according to the fourth embodiment (FIGS. 14-16), it is similar to the embodiment described in the first embodiment, the difference between them being that in the fourth embodiment, the front end 4 of the core 2 protruding from the main conduit 1 is bent into the shape of the conical spiral 24, forming three coils 25, 26 and 27. Each of the coils 25 and 27 has fifteen sleeve electrodes 5 separated by plastic ring elements 6, and the coil 26, covered with a plastic coating 3, constitutes the core 2 with electric conductors 12 supplying electricity to sleeve electrodes 5 of coil 27.

EXAMPLE 5

[0081] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according to the fifth embodiment (FIG. 17-21), it is similar to the version of its embodiment described in the first example, the difference between them being that in the fifth embodiment, the front end 4 of the core 2 protruding from the body 1 is bent into a shape of the conical convergent spiral 28 forming one incomplete coil 29, formed by fourteen sleeve electrodes 5 connected by fourteen electric wires 12, equipped with thermistors 30 also connected by fourteen electric wires 12 with pins placed in connector 16, the initial diameter Ø1 of coil is 25 mm and the final diameter Ø2 is 10 mm, and the spiral 28 ends with an annular element 6. On the rear end of the sleeve main conduit 1, in front of the electrically connected connector 16, there is a driver handle 31, serving only to bend the end of the catheter spiral, which improves its steerability, the overall length of the catheter being 1.0 m.

[0082] In another embodiment of a fifth type catheter not shown on the figures, the number of sleeve electrodes 5 was ten.

EXAMPLE 6

[0083] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according to the sixth embodiment (FIGS. 22-28) is similar to the embodiment described in the first example, and the difference between them was that in the sixth embodiment, a sheath 32, which consists of electrically conductive sheaths 33 additionally mounted on the main sleeve conduit 1, made entirely of copper or its alloy (as shown in FIGS. 22 and 25) separated by an insulating plastic coating 34, with the end of sheath 32 is not electrically connected to prevent electric shock during operation of the catheter. When necessary, during treatment, sheath 32 slides over spiral-shaped sleeve electrodes 5 (as shown in FIG. 23), allowing a pulse to be transmitted between the two portions of the conductive sheath 33, increasing the effective surface area of the spring-loaded catheter.

[0084] In the embodiment of the conductive sheath 33 shown in FIG. 27, according to the sixth embodiment the conductive sheath 33 was made in half of electrically conductive material 11′ and in half of insulating material 20′, and in the example shown in FIG. 28 only ¼ of the sheath was electrically conductive 11′, and ¾ of electrically non-conducting insulating material 20′.

EXAMPLE 7

[0085] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according the seventh embodiment (FIGS. 29 and 30), is similar to the embodiment described in the first example, the difference between them being that in the seventh embodiment, a stabilizing rod 36 made of stainless steel is additionally placed inside the main conduit 1 covered with PTFE material, its conical spiral 37 is wound on the sleeve main conduit 1, and the stabilizing rod 36 extends from the main conduit 1 through the opening 38 and does not pass through sleeve electrodes 5 and plastic annular elements 6.

EXAMPLE 8

[0086] The spring-loaded catheter for an electrophysiology study and irreversible electroporation within the heart according to the eighth embodiment (FIG. 38) is similar to the embodiment described in the seventh embodiment, the difference between them is that in the eighth embodiment, the stabilizing rod 36 located in the sleeve main conduit 1 also passes through the sleeve electrodes 5 and plastic ring pieces of 6 conical spiral 39.

[0087] The additional stabilizing bar 36 described in Examples 7 and 8 is a stabilizing element for the spiral 38 and 39 allows the catheter according to the invention to access very narrow veins in the human heart.

[0088] In other embodiments of the spring-loaded catheter for an electrophysiology study and cardiac irreversible electroporation (not shown), the sleeve electrodes 5 had thermocouples embedded inside them, and the core 2 was made of shape memory metal alloys such as Cu—Al and Cu—Zn—Al alloys.

[0089] After the patient is prepared for electrophysiology study, puncture of the femoral vein, femoral artery, radial artery or brachial artery is performed, and through the puncture, using the Seldinger method, a venous or arterial sheath is inserted into the artery, 43 through which a spring-loaded catheter is inserted, the front of which is the part which in case of contact with the flat part of the heart surface 41 takes the form of a ring with coils arranged therein, or in case of the concave surface 42 takes the form of a corresponding cone as shown in FIGS. 38 and 39 adapted to the profile.

[0090] Signals from individual pairs of electrodes placed on the catheter are received and transmitted, depending on the need, to: [0091] an electrophysiology system that enables imaging, recording and analysis of intracardiac potentials [0092] a stimulator to deliver pulses that stimulate the heart to perform diagnostic manoeuvres [0093] 3D mapping system to reconstruct the catheter and/or the heart cavities [0094] high amplitude pulse generator for electroporation or cardioversion/defibrillation

[0095] The electroporation process is usually carried out using a programmable generator with a voltage of 100-3000V, the pulse duration is from 5 microseconds to 6 milliseconds, while in case of using an automatic generator with a power of 5 J to 400 J.