WO2021198205A1 - A process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor - Google Patents
A process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor Download PDFInfo
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- WO2021198205A1 WO2021198205A1 PCT/EP2021/058201 EP2021058201W WO2021198205A1 WO 2021198205 A1 WO2021198205 A1 WO 2021198205A1 EP 2021058201 W EP2021058201 W EP 2021058201W WO 2021198205 A1 WO2021198205 A1 WO 2021198205A1
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- internal organ
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0507—Electrodes for the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0507—Electrodes for the digestive system
- A61N1/0514—Electrodes for the urinary tract
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
- A61N1/0597—Surface area electrodes, e.g. cardiac harness
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N2001/0585—Coronary sinus electrodes
Definitions
- the present invention relates to a process of treatment of internal organ oedema using an electrical current delivering electrode system comprising two electrodes to be positioned at two places on or close to the internal organ or in liquid carrying vessels as part of the organ or in the internal organ as well as a device for the reduction up to removal outside of internal organ oedema and a system, therefor.
- organs Primary or secondary disease of an organ, acute or chronic infections or a reduced blood supply to organs are often associated with oedema of the affected organ, which can severely impair the function of the organ. In the heart, this is particularly evident in the form of a restriction of the pumping function, which has an effect on all organs of the body.
- internal organ oedema relate to myocardial oedema as described in the following prior art articles but also to kidney oedema or liver oedema to name specific internal organs.
- Reduced pumping function of the heart typically leads to a congestion of blood in other dependent organs (e.g. liver, kidney), which impresses as oedema in these organs.
- Organ oedema in these organs depends on the severity of the heart dysfunction. Organ oedema can also occur independently of a reduced pumping function of the heart in organ-specific diseases (e.g. diseases of the kidney or liver), such as nephrotic syndrome or inflammation of the liver.
- organ-specific diseases e.g. diseases of the kidney or liver
- CMR cardiac magnetic resonance
- a liquid carrying vessel can be a blood vessel or a vessel of the lymphatic system or one of the two main cavities (right or left ventricular cavity) of the heart.
- the electrodes are positioned on or near by or in the heart at positions taken from the group comprising inside the right ventricle, inside the coronary sinus, on the outside of the left ventricle and/or on the outside of the right ventricle. Regardless of where the electrodes are placed (for example even subcutaneously or outside the human body), it is only relevant that the current flows through the affected organ.
- the electrode according to the invention for reducing oedema of internal organs through application of an electrical current comprises an electrode support and at least one electrically conductive electrode surface which is embedded in the electrode support, wherein the electrode surface is connected to a control and power supply unit by way of electric lines.
- the predetermined current density on the electrode can be maintained by controlling/regulating the current or the voltage.
- the current density can be maintained, in particular, for a time period starting from several minutes up to days, i.e. longer than 24 hours. Subsequently, it is possible but not necessary to provide a direct current having the opposite polarity.
- the direct current application provides electro-osmosis or an osmotic like effect which generates the secretion of water droplets usually at the cathode, however, depending on the composition of the liquid (electrical charge carriers in the liquid) to be removed, the liquid can also be secreted at the anode.
- the electroosmosis or electroosmosis-like effect can also affect the lymphatic system in the sense that increased lymph is drained from the organ tissues (interstitium) via the lymphatic system, thus reducing oedema.
- such a one-way valve is a diaphragm valve having a valve diaphragm.
- the process of reduction of the internal oedema applies steps for controlling the current density (J) on the electrode according to the present invention wherein the current (I) flowing through the electrode is regulated in such a way that a current density (J) provided within a predetermined interval for the electrode surface is maintained. Alternatively, the current density (J) is maintained around a predetermined value for the electrode surface.
- a treatment-specific current density can be set, which is particularly advantageous since providing a predetermined electroosmotic effect.
- a control unit can achieve that the current density on each electrode part is maintained in such a predetermined interval.
- Each electrode according to the invention can be used as a current-feeding or current receiving electrode, wherein the cathode is the electrode where the maximum water is gathered and conducted away. Therefore, an important reduction effect of the internal oedema happens where the anode provides the water-reduced area.
- the process of treatment of internal organ oedema can comprise different current delivering electrode systems.
- the always comprise two electrodes and a control unit.
- the two electrodes are to be positioned at two places in relation to the internal organ to be treated and the electrodes are connected to the control unit.
- the control unit is then adapted to deliver an electric current to induce electro-osmosis.
- two patch electrodes which can be one-surface electrodes or comprises a plurality of separated segments. Then the patch electrodes are mounted on the outer surface of the internal organ, which can be heart, kidney or liver. Mounted can comprise positioning or attaching. It is also possible to position the patch electrodes just subcutaneously or on the outside of the skin of the patient.
- the electrodes are positioned extracorporally, preferably in physical contact to the skin of a patient.
- a place on the outer surface of an internal organ may also include a place on the external skin surface and/or the outer surface of an internal organ may include the external skin surface.
- myocardial oedema plays a crucial role in the further course of the disease in patients with fresh myocardial infarction or acute myocarditis.
- a myocardial infarction or myocarditis that cannot be controlled because of myocardial oedema has an increased likelihood of fatal consequences.
- electrodes are envisaged herein that apply the current with its inherent field or the electric field transdermally (with physical contact to the skin).
- the electrodes of the present invention and/or the electrode assembly system of the present invention are adapted to allow an extracorporal application thereof.
- the size of the electrodes of the present invention may be selected depending on the size of the person to be treated.
- the electrodes to be applied extracorporally are patch electrodes.
- patch electrodes having a size in the range of from 2 by 2 cm (for babies or infants) up to 30 by 40 cm (for adults), and/or a surface area of from 4 cm 2 to 1200 cm 2 , or any size or surface area in between may be employed.
- electrodes of different shapes or forms may be used, comprising round, elliptical, square, rectangular and freeform.
- the electrodes contacting the skin are electrically conductive allowing electrical current to flow. In one embodiment of the present invention, at least one or all electrodes contacting the skin is/are electrically insulated allowing an electrical field to be generated without any current flow.
- a gel or other liquid with high conductivity may be applied between the extracorporally applied electrode and the skin, similar to substances used for external defibrillation.
- one embodiment of the present invention features adhesive electrodes which may be reversibly and directly fixed to the skin surface, preferably wherein the adhesive itself has a favorable resistance behavior.
- the electrically conductive surface of the extracorporal electrode(s) is designed to be deformable so that the electrode(s) can adapt to the body contours.
- the electrically conductive electrode surface may be connected via an electrical energy conducting cable to a device that can generate and deliver the corresponding currents and voltages.
- a patch electrode is combined with a coil electrode, wherein the patch electrode is positioned on the outer surface of the internal organ, wherein the coil electrode is positioned in a liquid carrying vessel of the internal organ. Then the current is flowing through the organ between the electrode in the blood or lymphatic duct vessel and the outside of the organ.
- the patch electrode is positioned for the heart on the epicardial side of the heart and wherein the coil electrode is positioned for the heart inside the ventricular cavity.
- the patch electrode is positioned for the kidney on the outer side opposite to the renal artery and renal vein and wherein the coil electrode is positioned inside the renal artery and renal vein or the renal pelvis.
- a process of treatment of internal organ oedema can also use two coil electrodes, wherein the two coil electrodes are positioned in different liquid carrying vessels within the same internal organ. Then the current flow is restricted between the core parts of the organ where the coil electrodes are positioned.
- one of the two coil electrodes can be placed in the coronary sinus and the other of the two electrodes can be positioned in the right or left ventricular cavity.
- the internal organ oedema to be treated can be a myocardial oedema or an oedema of the kidney or an oedema of the liver.
- the electro-osmosis is generated for a reduction up to a removal of the internal organ oedema.
- the electroosmotic effect comprises an accumulation of oedema fluid at the electrodes to be carried away from the electrodes. Additionally, said electroosmotic effect is to drain an accumulation of oedema fluid from the tissue (interstitium) of an organ by stimulating the lymphatic system of the corresponding organ to more rapidly remove the accumulated oedema fluid.
- the current delivered to the electrodes and flowing through the organ can be preferably a direct current.
- the direct current can be an amplitude modulated direct current, i.e. a direct current wherein the intensity of current is modulated around an average value.
- the control unit can be configured to switch the polarity of the direct current in predetermined time intervals.
- Such predetermined time intervals can comprise intervals between 1 hour and 7 days.
- the entire process can comprise a treatment time of several days up to several months.
- an electric current flowing between two electrodes is accompanied by electrolysis generating a pH shift in the area of the interface between electrode conducting surface and tissue and creation of gas. Since the current density is small and the electrodes are preferably made of platinum or a platinum iridium alloy (or another metal from the electrochemical series with high positive electrical voltage), the effects are limited. It is even so that the shift of the pH towards alkaline can have a beneficial effect on the tissue as inflamed tissue often has a pathological (acid) pH value.
- the gas generation is effected at the anode which is preferably in the flowing blood (in the blood vessel). The liquid is capable to dissolve the gas.
- the generated gas is especially CI2 which - immediately after its formation, forms bonds that are physiological and therefore harmless.
- the existence of an electrolysis effect, even if small, is a difference between any application of AC currents to internal organs.
- the invention further comprises an electrode assembly comprising two electrodes and a control circuit, wherein the first and second electrodes are electrically connected to the control circuit, wherein the control unit is adapted to establish a direct current flow between the first and the second electrode.
- the electrode assembly has preferably a control unit being adapted to switch the polarity of the current flow between the first and second electrodes.
- the electrode assembly can comprise two patch electrodes to be positioned opposite one the other of the internal organ so that the current flow between the first and second electrodes is traversing the internal organ.
- the electrode assembly can have a mixed lay-out with one coil electrode and a patch electrode, wherein the coil electrode is to be positioned inside a liquid vessel of the internal organ and the patch electrode is to be positioned outside of the internal organ so that the current flow between the first and second electrodes is traversing the internal organ oedema part.
- the electrode assembly can have two coil electrodes to be positioned both inside in different liquid vessels of the internal organ so that the electric current flow between the first and second electrode is traversing through the internal organ oedema part especially between the two liquid vessels.
- the control unit of the electrode assembly can be adapted to control the strength of the current flowing between the first and second electrodes to control the strength of the electric current flow through the place of the internal organ oedema over time.
- Fig. 1 shows a two internal electrode disposition (two internal coil electrodes) of electrodes in the heart as internal organ;
- Fig. 2 shows a mixed (one internal coil electrode, one external patch electrode) disposition of electrodes in and outside the heart;
- Fig. 3 shows a two external electrodes (external patches with segmented electrodes) disposition of electrodes on external heart surfaces according to the invention during use;
- Fig. 4 shows an electrode according to the invention comprising a one-way valve
- Fig. 5 shows a two external electrodes (external patches with single electrodes) disposition of electrodes on external kidney surfaces according to the invention during use;
- Fig. 6 shows a mixed (one internal coil electrode, one external patch electrode) disposition of electrodes in and outside the kidney.
- FIG. 1 shows a schematic representation of a heart 10 with an electrode assembly 20 according to a first illustrative embodiment of the invention.
- the implantable direct-current electrode assembly 20 comprises two implantable electrodes 30 and 40 and a control circuit 50, usually arranged in a separate housing in which the battery for the power supply is likewise provided.
- the two electrodes 30 and 40 are connected to the control circuit 50 via two single conductor cables 51 and 52.
- the control circuit 50 is designed to establish a potential difference between the two electrodes 30 and 40, such that a direct current can flow between these electrodes 30 and 40.
- One electrode 30 is a ventricular electrode, provided for positioning in the right ventricle, and is designed as a coil electrode. It is therefore designated below as a ventricular coil electrode 30.
- the length of the ventricular coil electrode 30, defined by the one conductive metallic sheath surface or coil surface defining a sheath, is ca. 4 to 10 centimeters and is designed to fill as far as possible the entire length of the right ventricle after passage through the right cardiac tricuspid valve.
- the ventricular coil electrode 30 is placed loosely into the right ventricle, but it can touch the wall of the right ventricle.
- the electrode To prevent the electrode from falling into the outflow tract of the right ventricle (pulmonary valve), it is anchored actively (by screw) with its tip or passively with barbs in the tip of the right ventricle which hook into the trabecular meshwork of the right ventricle and thus fix the electrode tip.
- the electrode 30 seems to float freely in the right ventricle. However, this is only apparently the case, because the figures are schematic two-dimensional depictions. Generally, the electrode 30 will nestle on the wall of the ventricle; in the depiction in Fig. 2, this could be the posterior wall, which is not visible there. The electrode 30 is flexible in order to adopt these gentle curvatures, which amount to less than 30 degrees with respect to the longitudinal axis.
- the other electrode 40 of Fig. 1 is a coronary sinus electrode, provided for positioning in the coronary sinus, and is likewise designed as a coil electrode.
- This coronary sinus coil electrode 40 has a smaller diameter than the ventricular coil electrode 30 since it is intended to be advanced far into the coronary sinus in order then to come to lie in the narrowing end region there.
- This electrode thus lies at a position substantially predefined by the vessel walls, which position the operating surgeon otherwise establishes by advancing it in the longitudinal direction.
- the electrode 30 can be the cathode for a predetermined time of between a few minutes and up to chronically, whereby the direction of the current is predefined.
- the control circuit can then change the direction of the current after a correspondingly predetermined time, whereby the electrode 40 becomes the cathode.
- the current strength can also change, since the resistance between the two electrodes 30 and 40 is dependent on the direction of the current.
- control device controls the current strength at a uniform predetermined value.
- the DC current can have a constant value or can be amplitude modulated with a modulation height of e.g. +-10% to +-25% of the average DC value.
- Fig. 2 shows a schematic representation of a heart 10 with an electrode assembly 120 according to a second illustrative embodiment of the invention.
- the implantable direct- current electrode assembly 120 comprises two implantable electrodes 30 and 140 and also a control circuit 50.
- the control circuit 50 can be designed in the same way as described in Fig. 1.
- the two electrodes 30 and 140 are also connected to the control circuit 50 via two single-conductor cables 51 and 52.
- the control circuit 50 is also designed here to establish a potential difference between the two electrodes 30 and 140, such that a direct current can flow between these electrodes 30 and 140 for a predetermined time of several minutes, e.g. 5 minutes, to several days, e.g. 3 days or even chronically.
- One electrode 30 is once again a ventricular electrode, provided for positioning in the right ventricle, and is designed as a coil electrode. It is therefore also designated here as a ventricular coil electrode 30.
- the length of the ventricular coil electrode 30, defined by the one conductive metallic sheath surface or coil surface defining a sheath, is ca. 4 to 10 centimeters and is designed to fill as far as possible the entire length of the right ventricle in the longitudinal axis after passage through the right cardiac valve (tricuspid valve).
- the ventricular coil electrode 30 is placed loosely into the right ventricle, is passively anchored at the distal end and can bear on the wall of the ventricle or on the septum. To prevent the electrode from falling into the outflow tract of the right ventricle (pulmonary valve), it is anchored actively (by screw) with its tip or passively with barbs in the tip of the right ventricle.
- the other electrode 140 is a surface electrode (patch electrode), provided for positioning on the epicardium, the pericardium or close to the epicardium (e. g. even subcutaneously). It can be designed, for example, according to the teaching of US 2008/0195163 A1. This surface electrode 140 is applied to the left side of the myocardium, epicardially opposite the right ventricle.
- a direct current then flows according to the arrows 155 through the myocardium.
- This flow of current is symbolized here by two arrows which essentially show the approximate current flow direction, since the flow of current here fans out from a substantially longitudinally dimensional face of the substantially longitudinally oriented surface of the coil electrode 30 toward the surface electrode 140 and thus sweeps across a fan.
- the direct current flows through a prism; that is to say proceeding from an edge (of the prism) to its base on the patch electrode.
- a prism is by definition a geometric body whose side edges are parallel and of equal length and which has a polygon as base. It arises from parallel displacement of a plane polygon along a straight line not lying in this plane and is therefore a special polyhedron.
- the straight line is predefined by the longitudinal axis of the coil electrode 30, and the polygon is a triangle with the apex at the coil electrode 30 and with a base that corresponds to the width of the surface electrode (patch electrode) 140. If these side edges 141 of the surface electrode 140 do not come to lie parallel to the orientation of the coil electrode, it is a rotated prism.
- the two electrodes 30 and 140 define a not inconsiderable spatial body which guarantees that the direct current emitted by the control circuit 50 flows through a likewise not inconsiderable sub region of the left cardiac muscle and to a slightly lesser extent also of the right cardiac muscle.
- Describing the geometry of the body through which the current flows as a prism is an approximation, since it can be assumed from this that the electrode does not float freely but is instead passively fixed at its distal tip and then bears on the wall of the ventricle.
- the boundary lines of the body are then certainly not straight but curved, and the defined body is then obtained only approximately as a prism. Of importance, however, is the narrow "edge" on the one side formed by the coil electrode, and the "broad bottom face" on the other side which is formed by the patch electrode.
- Fig.3 shows two patch electrodes 240 and 340 which are connected with lines 51 and 52 to a control and power supply unit 50.
- each patch electrode 240 and 340 as such is a segmented electrode 240 or 340.
- each electrode 240 or 340 is or comprises a plurality of electrode segments 241 or 341 which are shown as smaller rectangles in Fig. 3.
- an electrode surface of a patch electrode 240 or 340 which is 100 square centimeters in size in total, and a direct current I of 1 milliampere, the current density is 0.01 milliamperes per square centimeter. If the electrode surface (here a plurality of the electrode segments 241 or 341 detaches from the tissue, e.g.
- the organ 10 can be a heart, it is also possible that the organ 10 is a kidney with applied electrodes 240 and 340. In other embodiments it could be a liver.
- the electrode 1 optionally comprises at least one one-way valve 70 which essentially comprises an opening 72 and a diaphragm 73 covering the opening 72 on the far side of the internal organ.
- a schematic sectional view of the one-way valve 70 is depicted in Fig. 4.
- the diaphragm is made from silicone, for example.
- the one-way valve 70 is situated within the electrode surface 75.
- the apparatus as described in connection with Fig. 1, 2 or 3 delivers an electric current, e.g. a direct current, to the internal organ, here the heart. This electric current, e.g. a direct current, acts immediately or at least extremely fast on the internal organ, here the heart.
- the electric current mainly causes ion movement (electrokinesis), i.e. the migration of negatively charged anions (e.g. CI-, CO2- etc.) to the anode and of positively charged cations (e.g. Na+. Mg++.etc.) to the cathode.
- electro-chemical reactions occur on metals (electrodes, but also metallic foreign bodies).
- a migration of protein fractions (electrophoresis) and a shift of water in the direction of the cathode (electro-osmosis) takes place in the applied direct current field.
- the electroosmosis or electroosmosis-like effect induced by the applied current field supports and enhances drainage through the lymphatic system.
- the effect is as such independent from the application with two internal coil electrodes, one coil electrode and one patch electrode or two patch electrodes applied on opposite parts of the internal organ like the on the left and the right ventricle.
- FIG. 1 Although the drawings only show the heart in the application, similar coil electrodes can be used for the treatment of a liver and/or a kidney. This can be used in blood vessels or the lymphatic system. Flat electrodes can be positioned on or near the liver or kidney with the flat electrodes on mainly opposite sides of the organ, so that the current passes through the organ. This can also be done subcutaneously or from the exterior of the human body.
- the average of patients included in the study reported therein is a New York Heart Association (NYHA) Class III non-ischemic patient in the age group of 29 to 67 years, with a body mass index of 22.5 to 35.9 and a history of heart failure, and in particular with a significantly reduced left ventricular ejection fraction (LVEF) and a 6 minute walk under about 250 m.
- NYHA New York Heart Association
- LVEF left ventricular ejection fraction
- 6 min walk test or “6MWT” has been developed by the American Thoracic Society as a reliable indicator in the form of a sub-maximal exercise test for assessing aerobic capacity and endurance, wherein the walking distance covered over a time of 6 minutes by the patient is used as the outcome by which to compare changes in performance capacity.
- Fig. 5 shows a two external electrodes (external patches with single electrodes) disposition of electrodes on external kidney surfaces according to the invention during use.
- Ureters 12 connect the kidneys 11 with the bladder of the person.
- a patch electrode 440 is positioned on the outside of one kidney 11.
- a second patch electrode 440' (with an identical outlay to the first patch electrode 440) is positioned on the opposite side of the kidney 11. Therefore, the core part of the kidney with its renal pyramids 17, renal calix 16 and the renal pelvis 18 is positioned between the two patches 440 and patches 440'.
- the flat electrode patches 440 and 440' are connected with a control unit 50, not shown in Fig. 5, via connection lines 51 and 52, respectively.
- the supply lines 51 and 52 provide a current flow between the flat electrode patches 440 and 440' which current then effectively flows through the mentioned parts of the kidney to reduce the oedema through electro osmotic effects.
- the electrode patches 440 and 440' are shown as single electrodes but can also be segmented electrodes as shown in Fig. 3.
- Fig. 6 shows a mixed (one internal coil electrode, one external patch electrode) disposition of electrodes in and outside the kidney.
- the kidney 11 is shown with its renal pyramids 17, renal calix 16 and the renal pelvis 18.
- the aorta renalis 14 and vena renalis 15 are shown as well.
- a first external electrode 440 is connected via line 51 to a control unit 50 (not shown).
- a renal coil electrode 540 is positioned in the vena renalis 15 to allow a current flow between this electrode 540 and said external patch electrode 440.
- the connection of the renal coil electrode 540 to the control unit 50 is effected via the catheter line 53 used to position the renal coil electrode 540.
- the coil electrode could in other embodiments also positioned in the renal lymphatic system.
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Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/995,100 US12357813B2 (en) | 2020-03-30 | 2021-03-29 | Process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor |
| US19/243,593 US20250312592A1 (en) | 2020-03-30 | 2025-06-19 | Process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063001780P | 2020-03-30 | 2020-03-30 | |
| EP20166881 | 2020-03-30 | ||
| US63/001,780 | 2020-03-30 | ||
| EP20166881.1 | 2020-03-30 |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US17/995,100 A-371-Of-International US12357813B2 (en) | 2020-03-30 | 2021-03-29 | Process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor |
| US19/243,593 Continuation US20250312592A1 (en) | 2020-03-30 | 2025-06-19 | Process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor |
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| Publication Number | Publication Date |
|---|---|
| WO2021198205A1 true WO2021198205A1 (en) | 2021-10-07 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2021/058201 Ceased WO2021198205A1 (en) | 2020-03-30 | 2021-03-29 | A process for treatment of internal organ oedema using an electric current delivering electrode system and system therefor |
| PCT/EP2021/058198 Ceased WO2021198203A1 (en) | 2020-03-30 | 2021-03-29 | An electric field or electric voltage delivering electrode system for the treatment of internal organ oedema |
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|---|---|---|---|
| PCT/EP2021/058198 Ceased WO2021198203A1 (en) | 2020-03-30 | 2021-03-29 | An electric field or electric voltage delivering electrode system for the treatment of internal organ oedema |
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| US (3) | US20230148130A1 (https=) |
| EP (2) | EP4647112A3 (https=) |
| JP (2) | JP2023520026A (https=) |
| CN (1) | CN115916324A (https=) |
| AU (1) | AU2021247476B2 (https=) |
| BR (1) | BR112022019740A2 (https=) |
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| IL (1) | IL296705A (https=) |
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- 2021-03-29 IL IL296705A patent/IL296705A/en unknown
- 2021-03-29 JP JP2022559833A patent/JP2023520026A/ja active Pending
- 2021-03-29 WO PCT/EP2021/058201 patent/WO2021198205A1/en not_active Ceased
- 2021-03-29 BR BR112022019740A patent/BR112022019740A2/pt unknown
- 2021-03-29 EP EP25203936.7A patent/EP4647112A3/en active Pending
- 2021-03-29 US US17/995,098 patent/US20230148130A1/en active Pending
- 2021-03-29 CA CA3174083A patent/CA3174083A1/en active Pending
- 2021-03-29 WO PCT/EP2021/058198 patent/WO2021198203A1/en not_active Ceased
- 2021-03-29 CN CN202180039051.3A patent/CN115916324A/zh active Pending
- 2021-03-29 AU AU2021247476A patent/AU2021247476B2/en active Active
- 2021-03-29 ES ES21714220T patent/ES3053234T3/es active Active
- 2021-03-29 US US17/995,100 patent/US12357813B2/en active Active
- 2021-03-29 EP EP21714220.7A patent/EP4126192B1/en active Active
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2022
- 2022-10-27 ZA ZA2022/11745A patent/ZA202211745B/en unknown
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2025
- 2025-06-19 US US19/243,593 patent/US20250312592A1/en active Pending
- 2025-11-21 JP JP2025202106A patent/JP2026032107A/ja active Pending
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Also Published As
| Publication number | Publication date |
|---|---|
| WO2021198203A1 (en) | 2021-10-07 |
| EP4126192B1 (en) | 2025-09-24 |
| CA3174083A1 (en) | 2021-10-07 |
| IL296705A (en) | 2022-11-01 |
| EP4126192A1 (en) | 2023-02-08 |
| US20250312592A1 (en) | 2025-10-09 |
| ES3053234T3 (en) | 2026-01-20 |
| JP2023520026A (ja) | 2023-05-15 |
| US12357813B2 (en) | 2025-07-15 |
| AU2021247476A1 (en) | 2022-12-08 |
| AU2021247476B2 (en) | 2025-12-18 |
| EP4126192C0 (en) | 2025-09-24 |
| EP4647112A3 (en) | 2026-01-07 |
| US20230148130A1 (en) | 2023-05-11 |
| JP2026032107A (ja) | 2026-02-25 |
| BR112022019740A2 (pt) | 2022-12-06 |
| EP4647112A2 (en) | 2025-11-12 |
| CN115916324A (zh) | 2023-04-04 |
| US20230149707A1 (en) | 2023-05-18 |
| ZA202211745B (en) | 2026-01-28 |
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