A METHOD AND APPARATUS FOR DISASSOCIATION OF CLOTS

Abstract: To disassociate and remove clots from blood vessels, a hand-held device (10 or 10') is employed to discharge negative electricity into the body near the clot. The device includes a patient-conforming electrode (36 or 36') mounted on a housing containing batteries (32, 32') which are connected between ground and a chopper (31) which feeds transformer to generate the desired negative current at electrode (36 or 36'). A switch (30) provides selective operation. In use, a slot is located and the device is placed on the skin and the switch (30) energized whereby the negative electricity is applied to electrode (36 or 36') and then discharged into the body surrounding the clot.

Description: A Method and Apparatus for Disassociation of Clots Background of the Invention There is little literature regarding the removal or disassociation by extra corporal means of obstructions, clots and the like, which are occasioned for whatever reason from time to time in the fluid systems of the body. There is a great deal written with regard to the mechanisms of hemostasis and of the fluid systems of the body and of natural lysis of clots and other such items under normal conditions. However, in the course of human intervention, little has been suggested, and even less implemented with regard to removal of said obstructions. At the present time, the only system being used clinically to remove obstructive clots of the blood system is the cannulized introduction of streptokinase or the like enzyme through the arterial system. This procedure is not without risk. In fact, the current guidelines suggests that this procedure be done only in medical centers where a team trained in this procedure is on duty at all times. The theory has been published by many investigators over several years. Basically, it has been demonstrated that in many experiments that a negative potential in vitro (glass) or in vivo (animal studies) discourages platelet aggregation and prevents clot formation. Further, after formation has occurred, reversal is possible for a period of time which seems to vary greatly from one investigation to another. In any case, it seems to be from a couple of hours to three days. In most cases, the experiments used wires to set up the field potential, both in vitro and in vivo, which would be invasive. The advantage of a non-invasive approach in human clinical work is obvious. Since the present approach is SUBSTITUTE SHEET virtually free of any negative side effects, the procedure can be utilized by persons with little skills or knowledge in this area of endeavor. Platelets are involved more in thrombosis of arteries than in veins, and their aggregation is the primary event in most heart attacks and brain strokes. Unless this plugging is prevented or reversed, permanent damage to the tissue will result. Current drug therapy fails short of the desired effect in reducing or reversing the obstruction in most cases. Summary of the Invention The present invention includes a non-invasive medical device for the purpose of removing and disassociating blood clots and other obstructions from a fixed location that prevent the normal flow of body fluid in the various vessel systems in living things. Preferably, an extra corporal electrical device is used to discharge a negative charge into the body tissue, penetrating to the area of obstruction, thereby negatively charging the molecules of said obstruction and thereby disassociating said obstruction from the fluid vessels. The means for i s a s s o c ia t ion of obstruction, clots and the like, which appear in the fluid systems of the body, for whatever reason, is a non-invasive device producing a negative electrical charge, which when penetrating the tissue to the area of the lesion, will charge the molecules of the said obstruction or clot at which time the said molecules that make up the clot shall in effect repel each other and disassociate into the body fluids. It is an object of this invention to provide a method of releasing of electrical energy from an extra SHEET corporal device in the form of negative field into a patients body to dislodge formed blood clots and the like that pre-fixed internally in the patient. Another object is to remove obstructions in any fluid system in the body by use of a negative charge applied extra corporally to the patient. It is an additional object of this invention to provide a compact extra corporal device to discharge blood clots. In accordance with these and other objects which will be apparent hereinafter, the instant invention will now be described with particular reference to the accompanying drawings. Brief Description of the Drawings In the drawings: Figure 1 is a side view partially in cross section of the disassociating blood clot device. Figure 2 is a side view partially in cross section of another embodiment of the dis ssociating blood clot device. Figure 3 is a front skeleton illustration of the positioning of the disassociating blood clot device over the heart of a patient. Figure 4 is a top view of Figure 3 showing the disassocia ing blood clot device in place. Figure 5 is a side elevation view of Figure 4 showing a portion of the patient. Figure 6 is a schematic drawing of an electrical system for the disassociating blood clot device. Description of the Preferred Embodiment The present invention is to method or SUB procedure for using an extra corporal device to disassociate obstructions and the like, to free fluid flow in the various vessel systems of the tissue of living things. The method uses a non-invasive medical device for the purpose of removing and disassocia ing clots and obstructions that prevent the normal flow of body fluid in the various vessel systems in living things. More specifically, - an extra corporal electrical device discharges a negative charge into the body tissue for penetrating to the area of the obstruction. The negative charged molecules of said obstruction disassociate said obstruction from the fixed position of the obstruction in a fluid vessel. The devices 10 and 10* shown in Figures 1 and 2 may consist of a biological electrode of a deformable nature. The electrode will follow the contours of the body to provide maximum contact with the skin of the patient. The electrode is made of a conducting material 36 or 36' such as chromium plates Mylar. This material may be disposed of after each treatment by removing the removable brackets 42-43 and 42'-43' that are normally connected by connectors to the body of the device 10 or 10'. The connectors, such as screws, are not shown. Backing positioned behind the electrode 36 or 36' is a dielectric capsule 38 or 38' of a flexible material such- as silicone. The body 20 shown in Figure 5 of the device 10 contains the power supply 32 and 32' and such circuitry, as shown in Figure 6, to achieve the appropriate aforementioned negative potential. The body 20 includes a handle 18. A switch 30 in the handle is used to activate said circuits. The electrical power may be internal in the form of batteries, or a piezo electric SUBSTITUTE SHEET crystal, or external in the form of alternating current usually found in most buildings. If a piezo electric crystal is used, a compression means not shown must be provided to compress the piezo electric crystal in order to provide a usable voltage and current. Referring now to Figure 1 showing a disassociating blood clot device 10 that may be placed on the patient 12, shown in Figures 3, 4, and 5, in the area of the blood clot in the heart 14, to disassociate the blood clot. The disassociating clot device 10 includes a handle 18 connected to the body 20 of the device with finger opening 16. The disassociating clot device provides a rather massive change to the desired area, preferably as a negative field, illustrated in Figure 4, to dislocate fixed blood clots from the inner heart wall. The pad of conductive material 36 is a current distributing, skin contacting layer. The pad of conductive material may provide a high resistance and is arranged to effectively limit and uniformly disperse the current from an electrical source through the skin area adjacent the desired area. The current distributing layer may be uniformly distributed in a nonconducting material . The pad of conductive material 36 is electrically conductive and is connected to the body 20 by metal brackets 42 and 42, shown in Figure 1, and likewise body by brackets 42' and 43' in Figure 2. The handle 30 and body 20 are connected together. The body may have a removable cover, not shown, to provide access to the batteries 32, 32' or 32" in Figures 1 and 2 for replacement and service. A gasket 40 or 40' may be placed between the pad of conductive SUBSTITUTE SHEET material 36 or 36* and the brackets. The materials 36 and 36' provide a low-impedance biological electrode device for establishing electrical connection between the human body without the use of conducting fluids, such as gels, pastes, and electrolytes. The electrically conducting connecting pad of conductive material 36 or 36' is placed in contact with the human body. Any of many well-known materials may be used. The material 38 or 38' may be a resilient material to provide comfort to the patient when the disassociated blood clot device 10 is used on a patient, especially if a piezo electric device is used and the user presses down on handle 18 to activate the piezo electric crystal. It should be noted that Figure 2 is another embodiment of the disassociated blood clot device 10 shown in Figure 1. The device in Figure 2 has a long body which allows the user to hold the disassociated blood clot device 10' as one would hold a flashlight. Openings 37 may be used to connect the device 10' to a recharger. The handle 18 of the device may include an activation switch 30 to allow discharge of the electrical energy into the patient to disassociate the blood clot from a particular location. The body of the disassociation device 10 as shown in Figures 1 and 2 includes a battery or batteries 32, 32' and 32" connectable to a circular transformer 34 or 34'. The batteries are placed into a battery compartment 60 or 60'. The batteries are electrically connected to the circular transformer 34 or 34' as illustrated in Figure 6. Transformers are used for stepping up or stepping down current and voltages. The principle underlying the operation of a transformer is closely associated with ET Faraday's law of induction. If the magnetix flux variation is produced by means of an electromagnet coil energized by winding, it will induce an electric current in the second coil secondary winding of the transformer. Any common type of transformer may be used. The transformer may be wound in concentric form, the primary winding being within the secondary. The iron core forms a double closed magnetic circuit and is laminated. For practical purposes, this is a more efficient design than the so-called toroidal transformer. The batteries such as 32, 32' or 32" shown in Figure 6 are connected to the circular electric transformer 34 or 34' and to the switch 30. When the switch is pressed the voltage and current in the secondary winding are connected by wire 64 to wires 66 and to the members 42 and 43 and 36 conductive material and into the chest area of the patient. The capacitor 33 may be used to hold the charge from the transformer 34 after it passes through diode 35 prior to passing the electrical energy to the conductive material. Regular household current may be connected to the transformer 34 or the batteries may be connected to a chopper 31 and then to the transformer to provide the input into the capacitor 33 that will store the electrical energy. A piezoelectric crystal may be used to replace batteries 34 or 34'. When the pizoelectric crystal is subject to a mechanical force it will automatically provide a pre-designed voltage and current to the capacitor for discharge into the patient through a pad 36. The instant invention has been shown and described herein in what is considered to be the most practical and preferred embodiment. It is recognized, however, that departures may be made therefrom within the scope of the invention and that obvious modifica ions may occur to a person skilled in the art. SUBSTITUTE SHEET

Claims: CLAIMS 1. A method of disassociating clots from a position in a patient by the steps of: locating a clot in a patient; creating a disassociating voltage and current outside of the patient; connecting said disassociating voltage and current to an epidermis area of a patient adjacent the located clot; discharging said disassociating voltage and current into the patient through said epidermis into the area of said clot; whereby said clot is dislodged into the body fluids . 2. A method as set forth in Claim 1, wherein: said voltage and current is for dis ssociating blood clot. 3. An extra corporal device for dislodging clots comprising : a body; an electrical discharge means in said body and connectable to a power source; said electrical discharge means for providing a clot disassoc iat ion voltage and current for disassociating clots internally in a patient; a connecting pad electrically connected to said discharge means for transmitting said clot d isa s so c iat ion voltage and current to an epidermis of the body of a patient and to the areas of the clot; SUBSTITUTE SHEET whereby a clot is disassociated from its resting place in the patient. 4. An extra corporal device as set forth in Claim 3, wherein: said voltage and current is for disassociating blood clots. T

Inventors: DE MONTFORT GERALD C, DE MONTFORT, GERALD, C.
Applicants: VASCULAR TECH INC, VASCULAR TECH, INC.
Application year: 1983
Main classification: A61N1
IPC codes: A61B17, A61N1