DEVICE FOR CARDIAC ELECTROPHYSIOLOGY PROCEDURE

Abstract

A cardiac electrophysiology device part of a catheter device or of a cardiac implantable device comprising a plurality of electrodes which are connected via a selector switch over a resistor to a neutral electrode. Voltage and current at one of the electrodes are measured to set the site and the timing of channelling current out from the heart optionally by the electrophysiology therapy.

Claims

1. A cardiac electrophysiology device comprising: at least one or at least two active electrodes (121, 122, 123, 124), a neutral electrode (170), a sensor device (160) comprising voltage (161) and current (162) meters, the sensor device being connected to the neutral electrode (170), and being configured to measure the instantaneous voltage and current, wherein the improvement comprises the measurement and output of the value of the instantaneous differential resistance, a first selector switch (156) connected to at least one active electrodes and further connected to the sensor device (160), the first selector switch (156) being configured to electrically connect the sensor device (160) to at least one active electrode. characterised in that the cardiac electrophysiology device further comprises: a resistor (151) having a fixed value in the range of 0.10 ohm to 2 mega ohm or being adjustable within a part of said range, the resistor being connected to the neutral electrode, a second selector switch (155) connected to at least one active electrodes and further connected to the resistor (151), the second selector switch (155) being configured to electrically connect the resistor (151) to at least one active electrode.

2. A catheter device (110) comprising the cardiac electrophysiology device of claim 1 and a mapping catheter characterised in that the mapping catheter is preferably multipolar. characterised in that the mapping catheter has, but not limited to, a linear, circular, grid, mesh, orthogonal close unipolar, basket or a balloon three dimensional architecture. characterised in that the mapping catheter is an open irrigated catheter, wherein the improvement comprises that: the mapping catheter is flushed with an ink, wherein that provides the electrophysiology therapy to the arrhythmic substrate. characterised in that the mapping catheter is optionally chosen to be suitable to have as many as active electrodes at the distal end as needed to cover at least the full extent of the arrhythmic substrate given that for certain arrhythmias the arrhythmic substrate involves a whole cardiac structure as for instance a cardiac chamber and given that for certain arrhythmias the arrhythmic substrate involves a region of the epicardial aspect of the heart. further on characterised in that the catheter device (110) comprises a distal end (120) connected by a flexible shaft (140) to a proximal end (130), the distal end (120) of the catheter device (110) comprises the active electrodes, each of the active electrodes is connected via a plurality of low resistive wires (125) to at least one connector at the proximal end (130), the flexible shaft (140) comprises at least one flexible wire (141) formed of a superplastic material and shaped to bias the distal end (120) in at least one orientation in response to the movement of an operating element (181) of the catheter device (110). wherein the improvement comprises that: the catheter device (110) has a handle (180) configured to control the control unit (150), wherein the improvement further comprises that: the handle (180) has an operating element (181) for triggering different measurement functions of the control unit (150) or measurement of the sensor device (160). further on characterised in that the neutral electrode (170) is configured to be attached to a patient (400).

3. A control unit (150), an operating modus of the control unit (150), wherein said operating modus is a mapping modus of the control unit which provides the electronic mapping of the arrhythmic substrate comprising a plurality of steps: to set and change the setting of the value of the resistor (151) so that the current can be recorded by the sensor device (160) and may be configured to be maximal; to process a set of measurement data provided from the sensor device (160) wherein the improvement comprises the measurement of the value of the instantaneous differential resistance, wherein the control unit is configured to display the set of measurement data at a display; to control the first selector switch (156) and the second selector switch (155) during mapping, optionally but not necessarily dependent on the cardiac signal, wherein the setting of the second selector switch and the setting of the first selector switch may be set to be different so that the sensor device is said to operate in a bipolar mode and wherein the setting of the second selector switch and the setting of the first selector switch may be set to be the same so that the sensor device is said to operate in an unipolar mode; to set and to change the setting of the second selector switch (155), such that the resistor (151) is sequentially connected to a plurality of selected active electrodes in a bipolar mode if the value of the differential resistance provided by the sensor device is or turns negative during mapping, wherein this may indicate that the selected active electrode according to the setting of the first selecting switch is approaching or in electromechanical coupling to the arrhythmic substrate; to set and to change the setting of the second selector switch (155), such that the resistor (151) is sequentially connected to a plurality of selected active electrodes in a bipolar mode provided that the value of the differential resistance provided by the sensor device is and remains negative regardless of the setting of the second selector switch (155), wherein this may indicate stability of the selective active electrode according to the setting of the first selector switch in stabile electromechanical coupling to the arrhythmic substrate; to alter the setting of the first selector switch (156) to the selective active electrode most suitable according to the three dimensional architecture of the mapping catheter for the electrophysiology therapy, preferably but not limited to one of the tip or central electrodes of the mapping catheter, provided that the selective active electrode most suitable according to the three dimensional architecture of the mapping catheter for the electrophysiology therapy is now set by mapping manoeuvres in stable electromechanical coupling with the arrhythmic substrate, wherein the stability of the selective active electrode now in electromechanical coupling with the arrhythmic substrate and according to the new setting of the first selector switch is provided and may allow the electrophysiology therapy, wherein the value of the differential resistance provided by the sensor device (160) turns equal or greater than zero during the electrophysiology therapy; to change the setting of the second selector switch to a plurality of positions in a bipolar mode, provided that the value of the differential resistance provided by the sensor device is and remains equal or greater than zero despite changing the setting of the second selector switch to a plurality of positions in a bipolar mode, wherein this may allow the discontinuation of the electrophysiology therapy, wherein the entire sequence above may be repeated through mapping manoeuvres to map point by point the entire arrhythmic substrate; to automatically change the setting of the second selector switch (155), such that the neutral electrode (170) is sequentially connected via the resistor (151) to a plurality of active electrodes in a bipolar mode if the value of the differential resistance provided by the sensor device has a specific value, either negative, zero or positive; to automatically set and change the setting of the first selector switch and of the second selector switch in a bipolar or in an unipolar mode during mapping at a customised switching rate.

4. A therapy of an arrhythmia comprising the following steps: the passage of a staining ink through the internal lumen of the mapping catheter connected to the catheter device (110) or optionally through the internal lumen od an additional mapping catheter suitable positioned in electromechanical coupling to the arrhythmic substrate only for the therapy; the delivery of the staining ink to the arrhythmic substrate; the ink staining of the arrhythmic substrate with the staining ink, wherein the therapy is an electrophysiology therapy (EPT) and not an ablation of the arrhythmic substrate, wherein the electrophysiology therapy (EPT) restores the electronic properties of the arhythmic substrate, wherein the staining ink is a potentiometric ink, wherein the staining ink is an organic semiconductor ink, wherein the staining ink is a lipophilic or oxidised lipophilic ink wherein the staining ink is configured to be a straight-chain or a branched-chain carbohydrate, a carbocycle or heterocycle containing ink, wherein the staining ink is a polymeric ink, wherein the staining ink is a conductive polymeric ink, wherein the staining ink is a magnetic ink, wherein the staining ink is a combination of the above staining inks, wherein the staining ink is chosen to be dissolvable, wherein the staining ink contains soluble graphene, wherein the staining ink non.invasively integrates into the arrhythmic substrate wherein the dissolvable staining ink is conformal with the arrhythmic substrate.

5. The therapy of claim 4 further on characterised in that the therapy implies the navigation of the staining ink in small amounts in close proximity to the arrhythmic substrate, wherein the therapy represents a magnetic conformal staining of the arrhythmic substrate with the staining ink.

6. The therapy of any claim 4-5 characterised in that the electrophysiology therapy (EPT) is provided by any from the catheter device (110), the control unit (150) and the mapping modus of the control unit (150).

7. The therapy of any claim 4-5 characterised in that the electrophysiology therapy (EPT) is provided by a conventional magnetically guidable catheter. characterised in that the electrophysiology therapy (EPT) is provided by a conventional magnetically guidable catheter and by any from the electrophysiology catheter, the control unit (150), the mapping modus of the control unit (150). characterised in that the electrophysiology therapy (EPT) is provided by a dedicated catheter device exhibiting magnetic properties and designed to be magnetically guidable in the magnetic field independently from the magnetic properties exhibiting staining ink, which catheter device is provided and configured for the electrophysiology therapy (EPT). characterised in that the electrophysiology therapy (EPT) is provided by a dedicated catheter device exhibiting magnetic properties and designed to be magnetically guidable in the magnetic field independently from the magnetic properties exhibiting staining ink, which catheter device is provided and configured for the electrophysiology therapy (EPT); any from the electrophysiology device, the control unit (150), the mapping modus of the control unit (150).

8. The therapy of any claim 4-7 characterised in that at the end of the electrophysiology therapy (EPT), the value of the differential resistance at the level of the arrhythmic substrate previously responsible for the mechanism of the previous arrhythmia is and remains equal or greater that zero, wherein that indicates the end of the successful EPT.

9. The therapy of any claim 4-8 characterised in that the therapy is an electrophysiology therapy (EPT) which provides in another embodiment an alternative current path inside the heart when a heart block is present, which reverses said heart block and substitutes in another embodiment the pace function of a cardiac implantable device. wherein said therapy is an electrophysiology therapy (EPT) of said heart block and not an ablation of said heart block.

10. The cardiac electrophysiology device of claim 1 characterised in that the device is part of a cardiac implantable device or of an implantable lead, wherein the cardiac implantable device is a cardiac pacemaker, a cardiac defibrillator or a contractility modulation device and wherein the neutral electrode is configured to be part of the housing of the cardiac implantable device or a floating electrode.

11. The cardiac electrophysiology device of claim 10 characterised in that the electrophysiology device senses an arrhythmia according to the sensing algorithms of a cardiac pacemaker or defibrillator. characterised in that the electrophysiology device detects an arrhythmia according to the detection algorithms of a cardiac pacemaker or defibrillator. further on characterised in that the electrophysiology device receives input data from the sensor device 160, wherein the inputted data is configured to be the instantaneous value of the differential resistance.

12. The electrophysiology device of claim 11 further on characterised in that the electrophysiology device defines an arrhythmia or a predisposition to an arrhythmia whenever the inputted value of the instantaneous differential resistance is or turns negative. further on characterised in that the electrophysiology device interrupts the arrhythmia wherein the interruption of the arrhythmia occurs primarily by channelling current out from the heart by setting and changing the setting of the value of the resistor (151) and first and/or second selector switch until the arrhythmia terminates and wherein the setting and the change of the setting of the value of resistor (151) and of first and/or second selector switch is accomplished in either an unipolar or a bipolar mode, wherein the setting and the change of setting of the value of the resistor (151) in either an unipolar or a bipolar mode is configured in such a way that the current dissipation recorded by the sensor device (160) is maximal, wherein the interruption of the arrhythmia may occur by remote sensing of the arrhythmia.

13. The electrophysiology device of claim 12 further on characterised in that the device improves the mechanical performance of the heart muscle provided that the rhythm of said heart is either a spontaneous rhythm or a paced rhythm, wherein the improvement of the mechanical contractility or the contractility modulation is provided by primarily channeling current out from the heart whenever a predisposition of an arrhythmia in the absence of an arrhythmia is defined.

14. The electrophysiology device of any claim 10-13 further on characterised in that the electrophysiology device is a compound of a cardiac implantable device (CID), wherein the cardiac implantable device (CID) is neither a pacemaker, nor a defibrillator, nor a contractility modulation device.

Description

DESCRIPTION OF DRAWINGS

[0064] In the following, the invention will be described by way of example, without limitation of the general inventive concept, on examples of embodiment with reference to the drawings.

[0065] FIG. 1 shows a catheter device.

[0066] FIG. 2 shows a schematic diagram of the electrophysiology device-catheter device assembly.

[0067] FIG. 3 shows a sectional view of the heart with a catheter.

[0068] FIG. 4 shows the VI (voltage-current) electronic distribution at the level of the arrhythmic substrate;

[0069] FIG. 4.1 depicts the co-existence of more than one NDR domains in more that one voltage or current ranges available to the arrhythmic substrate.

[0070] FIG. 1 shows a catheter device 110 with a handle 180. The catheter 110 is divided into three parts. The catheter 110 has a proximal end 130 a flexible shaft 140 and a distal end 120.

[0071] The distal end has a plurality of electrodes 121, 122, 123, 124.

[0072] The handle 180 has two operating elements 181, 182 to control the function of the catheter or the catheter device. In this configuration, the handle 180 can be configured to control the distal end 120 of the catheter 110 via the operating element 181. The handle 180 can be further configured to trigger different measurement functions of the catheter device, respectively of the control unit or the sensor device via the operating elements 182. The handle 180 can have at least one electrical connection for connecting the handle to the catheter device 110 and a connection to the ink can.

[0073] FIG. 2 shows a schematic diagram of the electrophysiology device-catheter device assembly. It has at its distal end 120 a plurality of electrodes 121, 122, 123 and 124. Although here four electrodes are shown, the catheter device may have any number of electrodes between 2 and 20, preferably between 6 and 16 disposed on the mapping catheter, according to the specific geometry of the mapping catheter. These electrodes are connected via low resistive wires 125 in the catheter and a connector 131 to a control unit 150. The control unit comprises a second selector switch 155 connected to the electrodes and a resistor 151. It is not necessary that the selector switch is connected to all electrodes. Two electrodes or more are sufficient. The resistor may be a fixed or a variable resistor. It preferably is in the range from 0.10 to 2 mega ohm. The control unit comprises a first selector switch 156 connected to the electrodes and a sensor device 160. The sensor device may be a voltage or current meter. The term voltage or current meter includes all devices which are able to measure voltages and currents. This includes amplifiers and analog/digital converters which may provide digital information to a computer. It is not necessary that the selector switch is connected to all electrodes. Two electrodes or more may be sufficient.

[0074] A neutral electrode is connected to the resistor and/or sensor device.

[0075] This neutral electrode 170 allows current from the heart 200 of the patient to flow back to the body. For attaching the neutral electrode 170 to a patient, the neutral electrode 170 may have an adhesive surface.

[0076] FIG. 3 shows a heart 200 in detail. An additional mapping catheter 360 can be used; the ink staining of the arrhythmic substrate is provided and displayed.

[0077] FIG. 4 shows the VI (voltage-current) electronic distribution at the level of the arrhythmic substrate. Both the N-shaped and the S-shaped VI distributions are shown. An arrhythmia is present when the arrhythmic substrate has a NDR behaviour and is absent whenever the arrhythmic substrate has a non-NDR behaviour. Typically, an increasing voltage applied to the substrate triggers an arrhythmia at point 1 or 3, and terminates a given arrhythmia at point 2 and respectively 3 and, vice versa, a decreasing voltage applying to the substrate, triggers an arrhythmia at point 2 or 4 and further on terminates the given arrhythmia at point 1 or 4.

[0078] Although the invention has been illustrated and described in detail by the embodiments explained above, it is not limited to these embodiments. Other variations may be derived by the skilled person without leaving the scope of the attached claims.

[0079] In addition, numerical values may include the exact value as well as an usual tolerance interval, unless this is explicitly excluded.

[0080] Features shown in the embodiments, in particular in different embodiments, may be combined or substituted without leaving the scope of the invention.

LIST OF REFERENCE NUMERALS

[0081] 110 catheter device [0082] 120 distal end [0083] 121-124 electrodes [0084] 125 low resistive wires [0085] 130 proximal end [0086] 131 connectors [0087] 140 flexible shaft [0088] 141 flexible wire [0089] 150 control unit [0090] 151 resistor [0091] 156 first selector switch [0092] 155 second selector switch [0093] 160 sensor device [0094] 161 voltage meter [0095] 162 current meter [0096] 170 neutral electrode [0097] 180 handle [0098] 181 operating element [0099] 182 operating element [0100] 200 heart [0101] 300 stained ink [0102] 310 tip assembly [0103] 360 additional mapping catheter

[0104] Keywords [0105] electrophysiology therapy (EPT), staining ink, conformal, magnetic, [0106] negative (differential) resistance, current channelling out, arrhythmic substrate cardiac mapping (mapping), electronic mapping, three dimensional mapping, magnetic mapping electrophysiology device, catheter device, control unit electrophysiology procedure