MXPA06003534A - An apparatus for the emission of a combined flux of electrons and electromagnetic radiations particularly suitable for the treatment of the atheromatous disease - Google Patents

Abstract

An apparatus for the emission of a combined flux of electrons and electromagnetic radiations particularly suitable for the treatment of the atheromatous disease comprising:two electric circuits (2, 2âÇÖ) with opposed polarity, each supplying a direct current with a voltage comprised between 4,000 and 80,000 V and an intensity comprised between 0.05 and 0.5 mA;two outputs (8, 8âÇÖ);two plate terminal wires (9, 9âÇÖ), each of them (9, 9âÇÖ) being provided with at least one bundle of pointed wire elements (11, 11âÇÖ), and means suitable for the identification of the coronary vessel corresponding to the stenosis or lesion to be treated and with control and drive means of said plate terminal wires so that the combined flux of electrons and electromagnetic radiations emitted is directed in a concentric and accurately targeted way towards said coronary vessel.

Description

APPARATUS FOR THE EMISSION OF COMBINED FLOW OF ELECTRONS AND ELECTROMAGNETIC RADIATIONS PARTICULARLY SUITABLE FOR THE TREATMENT OF ATEROMATOSES DISEASES FIELD OF THE INVENTION The present invention relates to an apparatus for the emission of a combined flow of electrons and electromagnetic radiation particularly suitable for the treatment of atheromatous diseases. More particularly, the present invention relates to an apparatus for the emission of a combined flow of electrons and electromagnetic radiation particularly suitable for the treatment of atheromatous disease wherein the stenosis or narrowing of the artery is no more than 75%. BACKGROUND OF THE INVENTION As is known, atheromatous disease or atheromasia is the leading cause of death in industrialized countries. The disease is due to numerous degenerative lesions or atheromas of the arteries that reduce the lumen of the arterial vessels. The atheroma, in the intimate wall of the blood vessels, is constituted by a degenerative fatty plaque that evolves in ulceration and later covers thrombi. As is known, the atheromatous plaque causes the Ref .: 171372 ischemia of the affected organ. A consolidated and extensive trial carried out on the atheromatous plaque in patients with atheromasia led to the definition of the stenosis limit within which atheromasia can only be treated with medications. The defined limit corresponds to 75%; therefore, atheromasia - with a stenosis which is no greater than 75% can be treated pharmaceutically; while those that have a percentage of stenosis greater than 75% are treated by invasive techniques such as angioplasty with or without stenting, and surgical revascularization with bypass. For the purposes of the present invention, the percentage of stenosis and the limit of stenosis are determined by non-invasive methods such as color Doppler echocardiography and CT angiography and by invasive methods such as arteriography, as described in: 1) ACC / AHA Guidelines for Percutaneous Coronary Intervention (Revision of the 1993 PTCA Guidelines); 2) ACC / AHA Guidelines for Coronary Artery Bypass Graft Surgery; 3) 'ACC / AHA 2002 Guideline Update for the Management of Patients With Chronic Stable Angina. The pharmacological treatment, based on the use of many drugs for atheromasia with stenosis no greater than 75%, is not free of inconveniences although it is currently used with satisfactory results. One of these drawbacks is that, in some cases, the effectiveness of the treatment does not last; the treated plaques are formed again and once again reduce the blood flow (restenosis). Although this drawback can be resolved with the continued use of the medication, this involves a continual dependence on the same medication. Another drawback is due to the harmful action of these drugs, - when considering the digestive tract, for the health of the patients, particularly - they are "ingested for prolonged periods." In addition, pharmacological treatment does not satisfactorily resolve atheromatous disease in all patients. BRIEF DESCRIPTION OF THE INVENTION The objective of the present invention is to eliminate the drawbacks mentioned above in the treatment of atheromatous disease with a stenosis of not more than 75%, more particularly, the objective of the present invention is effective prevention and / or treatment of atheromatous disease with a -stenosis no greater than 75% without using pharmacological treatments and in a non-invasive manner.

A further objective of the present invention is to provide a means to allow the modulation of stenosis in patients affected by atheromatous disease with values below 40% using techniques which are different from the pharmacological or invasive ones. In its most general aspect, the present invention allows to achieve this and other purposes that result from the following description using a combined flow of electrons and electromagnetic radiations that are obtained by supplying a direct current with a voltage comprised between -4, -000- -8O -., - 0-00 V -_y -._ an intensity comprised "between 0.05 and 0.5 mA to two groups of pointed wire elements, one of which is connected to a circuit with positive polarity ( +) and the other is connected to a circuit with negative polarity (-) and direct the flow in a targeted manner towards the part of the body that corresponds to the stenosis or lesion.The flow is directed and concentrated to the coronary vessel that corresponds to the stenosis or lesion that is going to be treated, the flow can be continuous, intermittent or a pulse flow; According to the tests, intermittent flow is allowed because it has been shown to be the most effective in the treatment of atheromatous disease. Therefore, the objective of the present invention, first of all, is an apparatus for the emission of a combined flow of electrons and electromagnetic radiations, comprising: a. two electric circuits with opposite polarity, one circuit with positive polarity (+) and the other with negative polarity (-) fed by the same alternating current distribution network (for example 22OV), each circuit comprises an electrical or electronic device that transforms the alternating current of the distribution network in direct current and supplies a direct current with a voltage between 4,000 and 80,000 V and an intensity - .. included..between.0.0.-05.and..0_.5. mA; . "~ ~ b: two outputs," one of which- is connected to the circuit with positive polarity (+) and the other connected to the negative polarity (-); c. two wires with plate terminal, each of them is provided with at least one set of pointed wire elements, one wire is connected to the output of said circuit with positive polarity (+) and the other is connected to the output of the circuit with negative polarity (-); d. means for identifying the coronary vessel corresponding to the stenosis or lesion, and e. means for controlling and driving the plate terminal wires in such a way that the combined flow of electrons and electromagnetic radiations - emitted is directed towards a concentric and precise target towards the coronary vessel. The means for identifying the coronary vessel to be treated can be constituted by a thoracic grid support where a map of the coronary tree obtained by a chest radiograph and a coronary angiography examination is configured. The thoracic support is placed and fixed to the patient's body. For each single patient, a map of the coronary tree is formed on the thoracic support by measurement on which the vessels to be treated are presented along with the coordinates of the axis of the coordinates and the axis of the abscissas to establish the measurements goniometric A means for controlling and driving the terminal wires in the plate can be a traditional lighting means mounted on the plate terminal wires which they orient and adjust in such a way as to illuminate the area to be treated and provide a visual control of the area involved with the treatment; or some LEDS or nano-emitters, at least a number of three, which are placed around the area to be treated and, if required, are detected from special cameras placed on two plate terminal wires which control and adjust the position of the terminal wires. In addition, the apparatus for the emission of a combined electromagnetic radiation and electron flow of the present invention may comprise a programmable timer placed on at least one of the two electric circuits for the emission of an intermittent flow, at adjustable programmed intervals. An apparatus for the emission of a combined flow of electrons and electromagnetic radiations having the characteristics mentioned before subparagraphs a) to c) is described in the patent of E.U.A. do not. 6, 397 103 and is used in the treatment of decubitus ulcers, scarring deficiency, cutaneous and venous ulcers and sports trauma. - According to a second purpose, the objective of the present invention is the use of the apparatus described in the above in the treatment and / or prevention of atheromatous disease which consists of orienting the two sets of elements of wires with tips of a directed and concentrated way towards the part of the body, isolated from the ground, which corresponds to the lesion to be treated and provide between the groups of pointed wires a direct current with a voltage comprised between 4,000 and 80,000 V and an intensity comprised between 0.05 and 0.5 mA. For the treatment of atheromatous disease with the apparatus of the present invention, the following operations are carried out: a chest x-ray is made of the patient and, by means of a coronary angiography examination, a map of the thoracic support is configured coronary tree, on which the vessels that are going to be treated are indicated; - the thoracic support is fixed to the patient's chest in such a way that the indicated vessels that are to be treated correspond to those of the patient; - the body corresponding to the lesion to be treated is isolated from the ground and exposed in correspondence to the two groups of pointed terminal wires, a group of which is connected to the output of a circuit of ~ corriHnte "" d? recta ~ "with" positive polarity (+) and the other group is connected to the output of a direct current circuit with a negative polarity (-); - the two sets of pointed terminal wires are oriented in such a way that their flows are directed simultaneously in a directed and concentrated manner to the vessels to be treated; the position and orientation of the pointed wire element groups is controlled and adjusted if required, so that the relevant flows are directed in a concentric and precisely directed manner towards the lesion to be treated, and - the part of the body 'is subjected to the action of a combined flow of electrons and electromagnetic radiations that are obtained by supplying a direct current with a voltage between 4,000 and 80,000 V and an intensity between 0.05 and 0.5 mA between the electric circuits. Each set of pointed wire elements can have a cross-sectional area comprised between 0.1 and 100 mm2, preferably between 1 and 10 mm2 and is formed by a number of wire elements comprised between 100 and 10,000. Each group can be divided into more groups of pointed wire elements and groups that form a set can also be 100. The combined flow of electrons and electromagnetic radiations emitted by the device is more significant and is distributed better. The greater the number of wire elements that are formed in each set. The pointed wire elements are preferably carbon fibers. Any kind of carbon fibers can be used; the fibers are made of carbon for at least 90% by weight and are generally obtained by carbonization of organic polymers similar to strands, such as acrylic fibers. BRIEF DESCRIPTION OF FI-GURAS The apparatus for the emission of a combined flow of electrons and electromagnetic radiations of the present.

The invention can be better understood from the following detailed description in which reference is made to the appended figures which represent a mode that is provided solely by way of illustrative and not limiting example, wherein: Figure 1 is an electrical schematic of this apparatus; Figure 2 is a schematic front view of this apparatus; Figure 3 is a front view of a set of. carbon fibers that are obtained through a microscope - scanning electron with an extension of x24.3; ~~ - Figure 4 is a schematic perspective view of a thoracic grid support for orientation- and centered in correspondence with the lesion to be treated, where. the two sets of pointed terminal wires of which one set is powered by direct current with positive polarity (+) and the other with direct current with negative polarity (-); Figures 5 and 6 are schematic perspective views of the articulated or flexible arms for supporting a plate terminal wire, respectively, with and without the plate terminal wire. DESCRIPTION OF THE PREFERRED MODALITY - -. .. .. The apparatus for the emission of a combined flow of electrons and electromagnetic radiations of the present invention comprises an electrical diagram shown in figure 1, which comprises two electric circuits (2, 2 ') fed by the same network ( 10) of alternating current distribution (for example 220V ac) through an outlet (3), a plug (5) and a switch (1). Each electrical circuit (2, 2 ') comprises an electrical or electronic device (7, 7') such as a transformer with rectifying diodes which can feed each output circuit (8, 8 ') with a direct current having polarity opposite each other, a high voltage and a low uy intensity. - - - - - --- In particular, said electrical or electronic devices (7, 7 ') supply the outputs (8, 8') with direct currents with a voltage of 4,000 - 80,000 V and an intensity of 0.05 - 0.5 A , one of which has a positive polarity (+) in one device (7) and the other has a negative polarity (-) -in the other device. { ! '). The outputs (8, 8 ') mentioned above are respectively connected to two plate wires (9, 9'). Each wire (9, 9 ') plate is provided with a set of fibers (11, 11 ') of carbon that act as - pointed wire elements. Each set (11, 11 ') can be divided into groups of carbon fibers, for example into three groups, as shown in Figure 1.

When the plate wires (9, 9 ') and the relevant carbon fibers (11, 11') are close to the part to be treated, the plug (5) is plugged into the outlet (3) and closed the switch (1), generates a flow of electrons and electromagnetic radiations that circulate in the direction of the arrow F in figure 1 is from the pole (-) negative to the positive (+). The flow of electrons and electromagnetic radiation can be continuous or intermittent; in case of intermittent flow the apparatus is provided with a programmable timer (14) that opens the circuit to "predefined intervals and in this way stops the passage of current." The plate wires (9, 9 ') are made of conductive materials such as copper, aluminum, etc. and the set of carbon fibers (11, 11') is fixed in each wire by any means of fastening ensuring the electrical connection between the plate wire (9, 9 ') and each fiber of the assembly (11, 11'). The plate wires (9, 9 ') can have any shape, square, rectangular, polygon, circular, elliptical, etc. The surface of the wires (9, 9 ') is not critical and depends on the surface of the damaged part to be treated. ') of the plate with the set of fibers (11, 11') of carbon fixed thereto can be protected with a removable cover (16, 16 ') made of a non-conductive insulating material The cover (16, 16') removable preferably it is bell-shaped, with the set of fibers fixed to the lower part formed by the wire (9, 5 9 ') The side wall of the cover (16, 16 ') can be perforated and can be provided with a transverse support at the free end. A removable separator (18, 18 ') can be connected to the transverse support, for example by means of a groove and tongue joint. 10 Both the cover (16, 16 ') and the separator (18, _. 1B) are preferably made of plastic material. The cover (16, 16 ') protects the carbon fibers from contact with the patient or the operator when the apparatus is used; the separator (18, 18 ') ensures that the plate wire (9, 9 ') or the carbon fibers are not in contact with the skin. The plate wires (9, 9 ') are connected to the apparatus by connecting cables (20, 20') with a plug. In addition, the apparatus may comprise a first outlet (21) for a cable with head for connection to the operator; a second outlet (23) for the cable to be connected to a removable head for connection to the patient and for each wire < 9, 9 ') of plate, a regulator (22, 22 ') of current and an ammeter (24, 24'). In addition, the The apparatus can be provided with a pilot light (25) for control during operation, with buttons (26, 26 ') for switching on the two circuits and with a timer (14) for the emission of an intermittent flow. Each wire (9, 9 ') of plate with the relevant cover (16, 16') can be fixed to articulated or flexible arms (27) that facilitate the orientation and application to the various parts of the human body, placing the fibers of coal near the same body and without contact with it; the spacers (18, 18 ') ensure that this contact is avoided. For_ accurate positioning and orientation; of the ~ wires - (9, -9 ') of plate and of the elements (11, 11') of wire with relevant tip towards the vessel to be treated, can be used, a thoracic support (30) which is fixed to the patient's body. The two plate wires (30) are oriented and fixed in this thoracic support (30) with precise measurements so that the flow of electrons and electromagnetic radiations that are generated between the sets (11, 11 ') are directed towards the coronary vessel which is going to be treated. For each patient, from the chest x-ray and coronary angiography, a map of the coronary tree is made by measuring the support (30) -thoracic on which the vessels are indicated. they will be treated together with the coordinates of the axis of the ordinates and the axis of the abscissas to establish the goniometric measurements. The patient is isolated from the floor by a dielectric element (13) which can be a chair, an armchair or a bed with legs of insulating plastic material. Before starting the treatment, a control must be carried out in order to ensure that the combined flow of electrons and electromagnetic radiation is directed and concentrated to the part to be treated; for this purpose, each plate (9, 9 ') is provided with a lighting means (40) and the arms (27) are adjusted and oriented in such a way that the area to be treated is illuminated with the light beams emitted by the lighting medium. In this way, it is possible to visually control the area of the body that is to be treated. The set of carbon fibers (11, 11 ') fastened on each plate wire (9, 9') can have a cross-sectional area comprised between 0.1 and 100 mm2, preferably between 1 and 10 mm2 and is constituted by a quantity of carbon fibers between 100 and 10,000. Each set can be divided into one or more groups of pointed wire elements and the groups form a set that can also be a number of 100. The apparatus has been used to treat atheromatous disease in patients with a stenosis - or with narrowing of arteries no greater than 75% of completion by non-invasive diagnostic techniques such as multilayered spiral computed tomography with quantification of calcium rating. According to clinical medicine, the inclusion in the study of patients was provided according to the following pathological classification: 1. coronary artery disease of one vessel, two vessels with stenosis of 60% in asymptomatic patients number of patients: 40 (38 men - 2 women, average age of 43 years old). 2. Coronary artery disease of one vessel, two vessels with stenosis greater than 60% and less than 75% in asymptomatic and symptomatic patients, number of patients: 38 (37 men - 1 woman, average age 53 years old). All patients are sent to a daily treatment of 45 minutes at the maximum intensity allowed by the device and a voltage of 40,000 V in the affected coronary vessel for 78 consecutive days, except on Sundays. The following results were obtained: - stenosis characterized by soft plaques (up to 60%) that show a hypoperfusion of the muscle tissue from the examination by chro- gygraphy all remitted after a negative final evaluation test; - calcified stenosis comprising between 60 and 75% shows a clear improvement in blood flow, particularly in cases of distal vessel pathology. Although the present invention has been described in the foregoing with reference to one embodiment, it is understood that many variations and changes may be made which will be apparent to a person skilled in the art, according to the description mentioned above. Therefore, it is intended that the present invention include all variants and changes that are within the spirit and scope of protection of the following claims. It is noted that in relation to this date, the best method known to the applicant -to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (12)

1. CLAIMS Having described the invention as above, the claim contained as claimed in the following claims: 1. An apparatus for the emission of a combined flow of electrons and electromagnetic radiation particularly suitable for the treatment of atheromatous disease, comprising: a. two electric circuits with opposite polarity, one circuit with positive polarity and the other with negative polarity fed by the same alternating current distribution network, each circuit comprises an electrical or electronic device that transforms the alternating current of the distribution network into direct current and it supplies a direct current with a voltage between 4,000 and 80,000 V and an intensity between 0.05 and 0.5 A; b. two outputs, one of which is connected to the circuit with positive polarity and the other connected to one with negative polarity, and c. two terminal wires on plate, each of them is provided with at least one set of wire elements with tip, one wire is connected to the output of the -circuit with positive polarity and the other wire is connected to the circuit output with negative polarity, characterized in that the apparatus is provided with a means suitable for the identification of the coronary vessel corresponding to the stenosis or lesion to be treated and with a means of controlling and driving the terminal wires on the plate in such a way that The combined flow of electrons and radiated electromagnetic radiation is directed in a concentric manner and directed precisely to the coronary vessel.
2. 2. The apparatus according to claim 1, characterized in that the means suitable for the identification of the coronary vessel to be treated are constituted by a thoracic support wherein a map of the coronary tree is formed which is obtained by an X-ray of the coronary vessel. thorax and an examination by coronarography and, when measuring the vessels that are going to be treated in the coordinates of the axis of the ordinates and the axis of the abscissa, the goniometric measurements are established.
3. The apparatus according to claim 1 or 2, characterized in that the means for teaching and driving the terminal wires in the plate are illumination means that are mounted on the plate terminal wires which they orient in such a way as to illuminate the area that is going to be treated and provide a visual control of the area involved with the treatment.
4. The apparatus according to claim 1 or 2, characterized in that the means for controlling and driving the terminal wires on the board are LEDS or nanoemitters, at least three in number, which are placed around the area that is to be to be treated, and if required, they are detected from special cameras placed on the two terminal wires on the plate.
5. The apparatus according to any of the preceding claims, characterized in that it comprises a programmable timer placed on at least one of the two electric circuits for the emission of an intermittent flow or at adjustable intervals. ^ _.
6. The apparatus according to one of the preceding claims, characterized in that the cross-sectional area of each set of 5 pointed wire elements is between 0.1 and 100 mm2.
7. The apparatus according to claim 6, characterized in that the cross-sectional area of each set of elements with tip 0 is comprised between 1 and 10 mm2.
8. The apparatus according to any of the preceding claims, characterized in that each set is constituted by a number of wire elements comprised between 100 and 10,000.
9. 9. The apparatus according to any of the preceding claims, characterized in that each set is divided into many groups of pointed wire elements and the groups form an assembly and can be of a number of up to 100. 5 10.
10. The apparatus according to any of the preceding claims, characterized in that the pointed wire elements are carbon fibers.
11. The apparatus according to any of the preceding claims from 1 to 10, characterized in that it is for use in the treatment and / or _ prevention of atheromatous disease, where the stenosis is not more than 75% consisting of orienting the two groups of pointed wire elements in a directed and concentrated manner towards the part of the body isolated from the earth, corresponding to The stenosis or lesion to be treated and supply between the sets a direct current that has a voltage between 4,000 and 80,000 V and an intensity between 0.05 and 0.5 mA.
12. 12. The apparatus according to claim 11, characterized in that the supply of the direct current is intermittent.