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1. WO2019057665 - APPARATUS FOR LOCALISING AN ELECTRICAL FIELD

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Claims

An electrophysiology apparatus comprising a high voltage pulsed direct current (DC) supply and at least two catheters configured for endocardial access, each of the at least two catheters including at least one catheter tip and electrode assembly connectable with the high voltage pulsed DC supply to provide the at least two catheters with oppositely charged electroporation electrodes, wherein each of the at least two catheters is configured to be inserted into a different natural lumen or cavity adjacent to a target tissue at an abluminal location such that, in use, the at least two catheters at the different natural lumens or cavities create a peak cumulative electric field at the abluminal location between the oppositely charged electroporation electrodes to effect electroporation of the target tissue.

The electrophysiology apparatus of claim 1 , wherein the electrophysiology apparatus comprises three catheters configured for endocardial access, each of the three catheters including at least one catheter tip and electrode assembly connectable with the high voltage pulsed DC supply to provide selectively at least two of the catheters with oppositely charged electroporation electrodes.

The electrophysiology apparatus of claim 1 or claim 2, wherein each catheter comprises a plurality of catheter tip and electrode assemblies connectable with the high voltage pulsed DC supply to provide the electroporation electrodes.

The electrophysiology apparatus of any one of the preceding claims wherein each catheter tip and electrode assembly comprises at least two electroporation electrodes.

The electrophysiology apparatus of any one of the preceding claims, wherein the electroporation electrodes are operable individually, in selected combinations, or together at the same time.

The electrophysiology apparatus of any one of the preceding claims wherein one or more of the electroporation electrodes are partially insulated

circumferentially to direct the electric field in a desired direction and reduce the effect of the electric field in other directions.

7. The electrophysiology apparatus of any one of the preceding claims, comprising a sheath for electrical field blocking, wherein the sheath is configured to fit over one or more of the catheter tip and electrode assemblies and to have a plurality of openings for selective electric field emission.

8. The electrophysiology apparatus of claim 7, wherein the sheath is adjustable circumferentially or longitudinally upon the one or more catheter tip and electrode assemblies to influence electrical field emission.

9. The electrophysiology apparatus of claim 7 or claim 8, wherein the sheath comprises a metal reinforced polymer.

10. The electrophysiology apparatus of claim 4, wherein one or more of the catheter tip and electrode assemblies comprises an articulated catheter tip portion to allow one of the at least two electroporation electrodes on the catheter tip and electrode assembly to be deflected and re-oriented with respect to another of the at least two electroporation electrodes on the catheter tip and electrode assembly.

11. The electrophysiology apparatus of any one of the preceding claims, wherein the electrodes of each catheter tip and electrode assembly are individually controllable by a controller operable by a user, or by a programmable control system incorporating a controller, wherein said controller selectively controls the pairing of (+) and (-) electrodes of the catheter tip and electrode assemblies according to a switching sequence, and controls the duration of an electrical field pulse delivered by the high voltage pulsed DC supply.

12. The electrophysiology apparatus of any one of the preceding claims, wherein the high voltage pulsed DC supply has an operable range of from 500 to 2000 Volts, and is controllable to deliver an electrical field pulse duration of from 1 microsecond to 1 millisecond.

13. The electrophysiology apparatus of any one of the preceding claims, wherein the electroporation electrodes of respective catheters are positioned within an operational space of maximum width dimension in a range of 4 to 8 cm, and a (+) electrode is spaced from a coupling electrode by at least 2 mm.

14. The electrophysiology apparatus of any one of the preceding claims, wherein one or more of the at least two catheters is configured to effect temperature treatments and comprises an elongate tubular body having a proximal end and a distal end, and internal fluid channels, the distal end of the catheter having spaced electrodes on a side surface, and a recess between the electrodes, wherein the recess houses an inflatable balloon in communication with the internal fluid channels for receiving and venting a temperature control fluid, such as heated or cooled saline circulated under pressure control for selective inflation of the inflatable balloon.

15. The electrophysiology apparatus of any one of the preceding claims, wherein the target tissue comprises ganglionated plexi.

16. A system for carrying out electroporation of tissue comprising an electrophysiology apparatus as claimed in any one of claims 1 to 15 and a controller operably connected to the high voltage pulsed DC supply for selectively controlling the electroporation electrodes according to a switching sequence, and controlling the duration of an electrical field pulse delivered by the high voltage pulsed DC supply.

17. An electrophysiology apparatus according to any one of claims 1 to 15 for use in inhibiting atrial fibrillation of the heart.

18. An electrophysiology apparatus for use in inhibiting atrial fibrillation of the heart, wherein the electrophysiology apparatus comprises a high voltage pulsed direct current supply and at least two catheters configured for endocardial access, each catheter including at least one catheter tip and electrode assembly connectable with the high voltage pulsed DC supply to provide the at least two catheters with oppositely charged electroporation electrodes, wherein in use each of the at least two catheters is inserted into a different natural lumen or cavity adjacent to a target tissue at an abluminal location such that the at least two catheters at the different natural lumens or cavities create a peak cumulative electric field at the abluminal location

between the oppositely charged electroporation electrodes to effect electroporation of the target tissue.

19. The electrophysiology apparatus for use of claim 18, wherein the target tissue comprises ganglionated plexi.

20. The electrophysiology apparatus for use of any one of claims 17 to 19, wherein electroporation is effected in an operational space including the ganglionated plexi and the electroporation electrodes of the at least two catheters have at least 2 mm of spacing therebetween, optionally at least 5 mm of spacing therebetween.

21. The electrophysiology apparatus for use of any one of claims 17 to 20, wherein electroporation is conducted upon aortocaval ganglionated plexi and the electroporation electrodes of the at least two catheters are positioned between the superior vena cava and the aortic root, superior to the right pulmonary artery.

22. The electrophysiology apparatus for use of claim 21 , wherein electroporation is effected in an operational space including the ganglionated plexi and an inferior aspect of the operational space is positioned at least 2 mm above the transverse pericardial sinus, and optionally no more than 20 mm above the transverse pericardial sinus.

23. The electrophysiology apparatus for use of claim 18, wherein electroporation is effected in an operational space including the ganglionated plexi by means of at least three catheters, each of the three catheters including at least one catheter tip and electrode assembly configured for endocardial access comprising electroporation electrodes connectable with the high voltage pulsed DC supply to provide selectively at least two of the catheters with oppositely charged electroporation electrodes, the oppositely charged electroporation electrodes of the at least two catheters having at least 2 mm of spacing therebetween, optionally at least 5 mm of spacing therebetween.

24. The electrophysiology apparatus for use of any one of claims 17 to 23, wherein the electrodes of the respective at least two catheters are selectively controllable to change at least one of applied voltage, pulse duration, coupling between the electroporation electrodes, and charge polarity.

25. The electrophysiology apparatus for use of any one of claims 18 to 24, wherein one or more of the at least two catheters is manipulated to change electrical field direction by means of a fenestrated sheath movable axially and/or rotationally upon the catheter.

26. The electrophysiology apparatus for use of any one of claims 18 to 25, wherein each catheter tip and electrode assembly comprises at least two electroporation electrodes and one or more of the catheter tip and electrode assemblies is manipulated to change electrical field direction by means of the catheter tip and electrode assembly having a flexible portion or articulation point that allows one of the at least two electroporation electrodes on the catheter tip and electrode assembly to be deflected and re-oriented with respect to another of the at least two electroporation electrodes on the catheter tip and electrode assembly.

27. A method of inhibiting atrial fibrillation of the heart by electroporation of target abluminal tissue, the method comprising:

- introducing at least two catheters configured for endocardial access endocardially via a lumen of a natural vessel selected from any of the superior vena cava, the aorta, pulmonary arteries and coronary arteries, to locate the at least two catheters adjacent to the of target abluminal tissue, wherein each of the at least two catheters includes at least one catheter tip and electrode assembly,

- providing a high voltage pulsed direct current supply connected to the catheter tip and electrode assemblies to provide the at least two catheters with oppositely charged electroporation electrodes,

- generating a pulsed electrical field around the catheter tip and electrode assemblies adjacent to the of target abluminal tissue, and

- applying repeated pulses of the electrical field to effect electroporation of the of target abluminal tissue.

28. The method of claim 27, wherein the target abluminal tissue comprises neuronal tissue.

29. The method of claim 28, wherein of target abluminal tissue comprises ganglionated plexi.

30. The method of claim 29, wherein electroporation is effected in an operational space including the ganglionated plexi and the electroporation electrodes of the at least two catheters have at least 2 mm of spacing therebetween, optionally at least 5 mm of spacing therebetween.

31. The method of claim 29 or claim 30, wherein the electroporation is conducted upon aortocaval ganglionated plexi and the electroporation electrodes of the at least two catheters are positioned between the superior vena cava and the aortic root, superior to the right pulmonary artery.

32. The method of claim 31 , wherein electroporation is effected in an operational space including the ganglionated plexi and an inferior aspect of the operational space is positioned at least 2 mm above the transverse pericardial sinus, and optionally no more than 20 mm above the transverse pericardial sinus.

33. The method of claim 29, wherein electroporation is effected in an operational space including the ganglionated plexi by means of at least three catheters, each of the at least three catheters including at least one catheter tip and electrode assembly configured for endocardial access comprising electroporation electrodes connectable with the high voltage pulsed DC supply to provide selectively at least two of the catheters with oppositely charged electroporation electrodes, the oppositely charged electroporation electrodes of the at least two catheters having at least 2 mm of spacing therebetween, optionally at least 5 mm of spacing therebetween.

34. The method of any one of claims 27 to 33, wherein the electrodes of the respective at least two catheters are selectively controllable to change at least one of applied voltage, pulse duration, coupling between the electroporation electrodes, and charge polarity.

35. The method of any one of claims 27 to 34 wherein one or more of the at least two catheters is manipulated to change electrical field direction by means of a fenestrated sheath movable axially and/or rotationally upon the catheter.

36. The method of any one of claims 27 to 35 wherein each catheter tip and electrode assembly comprises at least two electroporation electrodes and one or more of the catheter tip and electrode assemblies is manipulated to change electrical field direction by means of the catheter tip and electrode assembly having a flexible portion or articulation point that allows one of the at least two electroporation electrodes on the catheter tip and electrode assembly to be deflected and re-oriented with respect to another of the at least two electroporation electrodes on the catheter tip and electrode assembly.