Electromedical implantable or extracorporeally applicable device for the treatment or monitoring of organs, and methods for therapeutic organ treatment

Abstract

The invention relates to an electromedical implantable or extracorporeally applicable device for treating and monitoring organs as well as a method for therapeutic organ treatment. The aim of the invention is to create an electromedical implantable or externally applicable device which allows healing processes to be excited in diseased organs. Said aim is achieved by an electromedical implantable or extracorporeally applicable device for treating and monitoring organs, comprising a programmable generator and receiver unit which generates and receives electrical microcurrents and electromagnetic power and is connected in a conducting manner to electrodes, a telemetry unit that is integrated into the generator and receiver unit and is provided with a transmitter and a receiver for exchanging data with extracorporeal devices, and a power supply unit.

Claims

1. An implantable electromedical device for organ treatment and organ monitoring, comprising a power supply unit; two electrodes configured to be positioned on the liver; a programmable generator and receiver unit that generates and receives electric microcurrents and electromagnetic energy and is electrically connected to the two electrodes; and an integrated telemetry unit integrated in the programmable generator and receiver unit and being equipped with a transmitter and receiver for data exchange with extracorporeal devices, wherein the programmable generator and receiver unit generates and receives electric direct microcurrents in the range of 0.001 mA to 10 mA and electromagnetic energy, and is electrically connected to the two electrodes for delivering said electric and electromagnetic energy to organ tissue of the liver or extracellular areas of the liver, wherein the two electrodes are designed as patch electrodes, and wherein the two electrodes further comprise permanent magnets.

2. The device according to claim 1, wherein one or more of the power supply unit, the telemetry unit and the generator and receiver unit are arranged partially or completely extracorporeally.

3. The device according to claim 1, wherein the two electrodes are designed to pick up signals from liver tissue and transmit said signals to the programmable generator and receiver unit.

4. The device according to claim 1, further comprising sensors for detecting movements of the wall of the liver, wherein the sensors are integrated into the two electrodes and configured to attach directly to the liver.

5. An implantable electromedical device for organ treatment and organ monitoring, comprising a power supply unit; two electrodes configured to be positioned on the liver; a programmable generator and receiver unit that generates and receives electric microcurrents and electromagnetic energy and is electrically connected to the two electrodes; an integrated telemetry unit integrated in the programmable generator and receiver unit and being equipped with a transmitter and receiver for data exchange with extracorporeal devices, and sensors for detecting movements of the wall of the liver, wherein the programmable generator and receiver unit generates and receives electric direct microcurrents in the range of 0.001 mA to 10 mA and electromagnetic energy, and is electrically connected to the two electrodes for delivering said electric and electromagnetic energy to organ tissue of the liver or extracellular areas of the liver, wherein the two electrodes are designed as patch electrodes, and wherein the sensors are integrated into the two electrodes and configured to attach directly to the liver.

6. The device according to claim 5, wherein the two electrodes further comprise small coils connected with the programmable generator and receiver unit for generating a magnetic field for delivery to the organ tissue of the liver or extracellular areas of the liver.

7. The device according to claim 5, wherein one or more of the power supply unit, the telemetry unit and the generator and receiver unit are arranged partially or completely extracorporeally.

8. The device according to claim 5, wherein the two electrodes are designed to pick up signals from liver tissue and transmit said signals to the programmable generator and receiver unit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The present invention is explained in greater detail below on the basis of exemplary embodiments and drawings, in which

(2) FIG. 1 shows an arrangement of an implanted variant in the heart area in a view from the front,

(3) FIG. 2 shows an arrangement of an implantable variant in a view from the side,

(4) FIG. 3 shows an external variant of the inventive device in a view from the front and

(5) FIG. 4 shows an external variant of the system in a view from the rear.

DETAILED DESCRIPTION

(6) Heart failure is characterized in that the physiological ability of the heart to pump blood is limited. At the start of the disease, this effect is manifested only under exertion conditions. In an advanced stage of the disease, it can be observed even under resting conditions.

(7) A generally accepted classification of stages of heart failure is the classification of the NYHA (New York Heart Association), which divides heart failure into four stages.

(8) The goal of the treatment of heart failure is to improve the function of the heart and/or to maintain the impaired function as long as possible.

(9) In an early stage, it is treated with medication, but in an advanced stage, so-called resynchronization treatment through biventricular pacing is often used today. The treatment of choice in the late stage is a heart transplant and/or implanting a cardiac support system or an artificial heart system.

(10) Treatment with an electric microcurrent or with electromagnetic energy is a novel method of treating heart failure. This treatment may be used in all stages of heart failure. The microcurrent or electromagnetic energy can be applied in various ways, e.g., as shown in FIGS. 1, 2, 3 and 4.

(11) Essentially the current is administered internally via an anterior electrode 4 and a posterior electrode 5, which directly surround the heart 2 of a patient 1, or administered externally via electrodes placed on the skin in the area of the heart. Magnetic energy can be applied without direct contact with skin.

(12) Direct internal application is performed as follows:

(13) The anterior and posterior electrodes 4 and 5, which directly surround the heart 1, are positioned around the heart 1. This may be accomplished by opening the chest through a median sternotomy, through a lateral access or during heart surgery, which is being performed for the reasons (e.g., bypass surgery, heart valve operation, implantation of a heart support system, in a heart transplant, etc.).

(14) FIGS. 1 and 2 show a patient 1 with an implanted generator and receiving part 3, with an implanted telemetry unit 6 and a power supply unit 7 in a schematic diagram, whereas FIGS. 3 and 4 show the generator and receiving part 3, the telemetry unit 6 and the power supply unit 7 situated outside of the patient 1.

(15) The anterior electrode 4 and the posterior electrode 5 are each made of a highly flexible plastic (e.g., silicone) with an electrically conducting side which faces the heart side. For application of electromagnetic energy, electrodes containing permanent magnets or small coils capable of building up a magnetic field are used. Corresponding electrodes are used for application of electric fields.

(16) The electrodes are then electrically connected to an implant which is placed in a thoracic or abdominal pocket in a procedure comparable to that used with a pacemaker.

(17) Another option for the positioning of the electrodes consists of a sub-xyphoid access to the heart, which makes opening the chest superfluous. With this access, the electrodes can be positioned intrapericardially or extrapericardially. This access is preferred for patients who must not undergo any further heart surgery and have no pericardial adhesions. With this form of access, the implant, generating the required electric signals, is preferably placed in an abdominal pocket.

(18) Another option for applying microcurrents to the heart consists of transvenous electrodes. Electrodes that are used for stimulation or defibrillation are preferred. If implantable mono- or biventricular pacemakers or defibrillators that are provided with a microcurrent generator are used, then the same electrodes may be used for microcurrent application and for stimulation or defibrillation.

(19) In external application of microcurrent or electromagnetic energy, electrically conducting electrodes are brought into direct electric contact with the skin. The electrodes are positioned in such a way that the largest possible area of the heart is influenced by microcurrent. This may be accomplished by electrodes that are positioned only frontally or by electrodes that are additionally positioned dorsally. Magnetic electrodes or electrodes for electric fields may also be used without direct skin contact.

(20) After placement of the electrodes, the generator 3 is activated via the telemetry 6, which is provided in the implant (FIGS. 1 and 2) and the corresponding current form is selected. The success of the procedure is monitored by regular monitoring of the contractility of the myocardium, the function (ejection fraction) of the heart, the size of the right and left ventricles and the rate of movement of the wall with the help of echocardiography. The duration of treatment will depend on the improvement achieved as measured by echocardiography. The method should be used until no further improvement in the heart can be observed after optimization of the amperage, current form and frequency.

(21) For patients following a heart transplant, the application of microcurrent or electromagnetic energy may be utilized to diminish rejection reactions. This method is used in the same way as in patients with heart failure as described above.

(22) This method may also be used in the same way as described above to treat liver diseases, lung diseases and renal diseases associated with a loss of function or fibrosis of the organ.

LIST OF REFERENCE NUMERALS

(23) 1 patient 2 heart 3 generator and receiver part 4 anterior electrode 5 posterior electrode 6 telemetry unit 7 power supply unit