PLUG FOR USE IN HUMAN MEDICINE

Abstract: A magnetotherapeutic plug enables the treatment of rectal and vaginal inflammations especially haemorrhoids, by direct action on said tissue, and comprises magnetic ele­ ments (N S). The plug is adapted to the anatomic shape of rectal and vaginal cavities, so that it provides reliable contact with the tissue, without sharp edges that could damage the tissue during use, so that it is applied easily and simply and re­ mains in place without falling out during treatment. The magnetic flux density does not exceed 80 mT, pre­ ferably being from 20 mT to 40 mT.

Description: PLUG FOR USE IN HUMAN MEDICINE AND USE THEROF The present invention relates to a plug for insertion into a human bodily opening and comprising an elongate insertion member and an entry-limiting member at one end of the insertion member. The invention belongs to the field of magnetobiology, biomagnetism and magnetotherapy in the broader sense, and in a narrower sense to rectal and vaginal therapy - especially in cases of haemorrhoid treatment. Inflammatory processes in rectal and vaginal openings are treated classically by the aid of injections, liquid medicines, ointments or suppositories. In cases of haemorrhoids, surgical methods such as ligation,cauterization and others have been applied. The classical way of treatment is relatively long, and the proceedings are impeded owing to frequent resistance to medicines. History records controlled magnetotherapy as early as 200 B.C. Magnetism was used in healing various health disorders. The achieved success attributed to magnets the property of being a universal healer, as well as a guarantee of immortality. In ancient times, magnets were used to cure headaches, spasms, nerve disorders, ulcers, bleeding sicknesses Åand hydropsy. In spite of that, magnetic fields were long neglected and even forgotten in medicine. But in the second half of the XIX century mankind turned to magnetotherapy again. Nevertheless, the most valuable investigating results fall into the last decade (L. Hallagren: Inductive neural stimulator, IEEE Trans. on BME, 470-472, Nov. 1983., B. Beleslin, N. Dekleva, V. Manic: Some possibilities in electro-magnetic tissue stimulation, bioeng 80, London, 111-112, 1980). One of the fundamental investigation results of magnetobiological effect is the magnetic field action on leech ganglion cells giving electrical spike activity when subjected to magnetic fields (B. Beleslin, V. Majic: The effects of pulsed magnetic field on the nerve cells of leeches, Periodicum biologorum, 76, 39, 1974., V. Manic, B. Beleslin, B. Stamenovic, N. Dekleva: Biomagnetism and artificial magnetic stimulation of living structures, XXIX congress of International Astronautical Federation, Dubrovnik, 1-9, 1978). The influence of magnetic field on the heart action has been investigated, as well as spacial heart orientation in vitro according to the vector of magnetic flux density (B. Stamenovic, V. Majic: Heart function in magnetic field, Periodicum biologorum, 77, 57-61, 1975). Bactericidal action of magnetic field, bone healing in magnetic field, magnetotherapy in otorhinolaryngology, ophtalmology, and periodontal diseases have been known and accepted in clinical methods (S. Petronijevic, N. Dekleva, B. Beleslin, V. Majic: Magnetotherapy in otorhinolaryngology, World congress on medical physics and biomedical engineering, Hamburg, 12.22, 1982., B. Stefanovic, B. Beleslin, N. Dekleva, V. Maji6: Magnetostimulators in opthalmology, World congress on medical physics and biomedical engineering, Hamburg, 12.23, 1982., A. Skokljev, N. Dekleva, B. Beleslin, V. Majic: Magnetostimulators in periodontäl diseases treatment, Third Mediterranean Conference on Medical and Biological Engineering, Portoro2,.7.4, 1983). As far as is known, the field of haemorrhoid reaction to magnetic fields has not been investigated and is previously unknown. An object of the invention is to provide a simple and effective device for rectal and/or vaginal therapy. Another object of the invention is to provide a therapeutic plug for insertion into a human bodily opening. According to one aspect of the invention, there is provided a plug for insertion into a human bodily opening and comprising an elongate insertion member and an entrylimiting member at one end of the insertion member, characterized in that said insertion member comprises at least one permanent magnetic element According to another aspect of the invention, there is provided the use of the, plug according to said one aspect in rectal and/or vaginal therapy, e.g. treatment of haemorrhoids. For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which: Fig. 1 shows an end view (left) and a side view (right) of a plug according to one embodiment of the invention; Figs. 2 to 5 show configurations of plug according to four further embodiments of the invention; and Figs. 6 to 10 show five further embodiments of the invention having different arrangements of magnetic elements in a plug having the configuration shown in Fig. 1. Of course, the configurations of magnetic elements in Figs. 6 to 10 may also be employed; in the embodiments of Figs. 2 to 5. Referring to the Figures in more detail, each of Figures 1 to 5 shows a respective embodiment of magnetotherapeutic plug having an elongate insertion member 1a, 2a, 3a, 4a or 5a and an entry-limiting member 1d, 2d, 3d, 4d or 5d at one end thereof. The insertion member has in each case a rounded end 1c, 2c, 3c, 4c or 5c and is coated with biologically inactive material 1b, 2b, 3b, 3b or 5b. In Figure 1, the insertion member 1a is rod-like or cylindrical in form of circular or elliptical or oval cross-section, whilst Figure 2 shows a thickened end and tapening shank. Figure 3 shows an undulating surface, and Figure 5 shows a configuration approximating a dumbell or double ball shape. In Figure 4,"the insertion member 4a is similar to member 1a of Figure 1, but the limiting member 4d is separate and attached to member 4a by a thread 4e. Of course, the thread 4e should also be of biologically inactive material and preferably the entry-limiting member in each of Figures 1 to 10 is also coated with or made of biologically inactive material. Figures 6 to 10 show various configurations of permanent magnetic elements which may be employed. In these Figures, any outer coating of biologically inactive material is assumed to be removed to expose the permanent magnetic elements, which in each case are indicated by shading. The polarity of each elements is indicated by N (north pole) or S (south pole) as necessary. In Figures 6, 7, 9 and 10 a plurality of individual magnetic elements are provided, whilst in Figure 8 a continous helical element is provided. Figure 6 shows circular rings, Figure 7 shows longitudinal bands, Figure 9 shows small circular elements, and Figure 10 rectangular elements. The magnetic pole configuration may thus be axial, radial, helical, circular, rectangular or any other geometrical shape. The magnetic elements maybe of alnico alloy, of hard sintered or plastic ferrite material of barium or strontium type, or of metals from the rare-earth group. The magnetic flux density on the surface of the magnetically active part of the plug should not exceed 80 mT and is preferably in the range of from 20 mT to 40 mT. Now the use of the above described magnetotherapeutic plug will be explained. A magnetotherapeutic tool for healing, aimed for broad use, is provided by the magnetotherapeutic plug. The plug is to the insertion in a bodily opening such as the rectal or vaginal cavity. The most convenient shape of the magnetotherapeutic plug is a rod of circular, elliptical or any other crosssection and rounded edges, to avoid mechanical damage of the tissue. For that purpose, the outer plug surfaces may be coated by a smooth layer of non-magnetic and biologically inactive material, deposited by one of the usual procedures, or formed in the shape of a separate capsule in which the magnetic core is inserted. To provide the most suitable position of the plug in the rectal or vaginal opening (ostium), as well as easy extraction after use, one end of the plug is formed in the shape of a limiter, circular or any other shape, made of non-magnetic material. The body of the plug can also be of unequal thickness, with a frontal thickening or more thickenings with undulating shape, aimed at preventing unwanted falling out of the magnetotherapeutic plug from the rectal or vaginal opening during use. Besides the shape of a rod with a limiter, shown in Figures 1 and 2, the plug can have the shape of a small ball or capsule with a thread and the limiter on the other side. Another convenient shape has small double balls, the ball having the limiter, remaining out during the treatment. In our preliminary and prolonged clinical investigations, very good results have been obtained in the treatment of external and internal haemorrhoids by the aid of magnetotherapeutic plugs. After the second application, pain relief can be registered, and after the fourth one it vanishes. Besides, mucus discharge causing pruritus ani and faecal soiling also diminishes. Nevertheless, the procedure is repeated until the tenth treatment, lasting altogether ten days. Daily stimulation may last from one to four hours. The plugs can be delivered in sterile packing, in which case the plugs are discarded after use. But the patients with modest financial possibilities can use it repeatedly with compulsory washing after every use and in the same way the active clyster part is washed after use. The plugs should be washed with warm water and soap or mild detergent solution and rinsed afterwards. Before the application, the dry active part of the plug must be coated with medical petroleum jelly e.g. vaseline and after that squeezed into the rectal or vaginal opening till the limiter. The plug may be applied in a daily treatment of from 1 to 4 hours over a period of 7 to 14 days7 preferably 10 days. Plugs having differency geometric pole configurations may be used alternately. Twenty years at investigations and practical experience in the field of magnetobiology, biomagnetism and magnetotherapy lead the present inventors to feel justified in advocating use of electromagnets at clinics and hospitals as well as the use of permanent magnets in individual-home therapies, although the effect of varying electromagnetic field is stronger and faster. Electro-masnets are unsuitable for home use for safety reasons. Permanent magnets have no power supplies which, regardless of all the precaution, can provoke injuries, with even fatal results. However, in clinical practice, time varyina, pulse monopolar and bipolar magnetic fields, with or without pulsing with or without amplitude modulation and variously shaped signals have been used. But all magnetotherapies of this kind involve the use of electro-magnetic stimulators with internal or external power supplies. Therefore, the safest and simplest magnetotherapy to apply by nonprofessional people, suffering from haemorrhoids, is the one with magnetostimulators made of permanent magnets. Thus, by the aid of magnetic field, it is possible to attain soothing the inflammatory processes effectively and quickly. Magnetotherapy is performed by application of a plug, whose core is a magnetostimulator.

Claims: Claims: 1. A plug for insertion into a human bodily opening and comprising an elongate insertion member (1a, 2a, 3a, 4a, 5a) and an entry-limiting member (1d, 2c, 3d, 4d, 5d) at one end of the insertion member, characterized in that said insertion member comprises at least one permanent magnetic element (N, S). 2. A plug according to claim 1, characterized in that at least the insertion member is of biologically inactive material. 3. A plug according to claim 1, characterized in that the insertion member is at least partially coated with biologically inactive material (1b, 2b, 3b, 4b, 5b). 4. A plug according to any one of claims 1 to 3, characterized in that the entry-limiting member is attached to said insertion member by an elongate flexible element such as a thread (4e). 5. A plug according to any one of claims 1 to 4, characterized in that the outer surface of the insertion member is rounded and smooth. 6. A plug according to any one of claims 1 to 5, characterized in that the insertion member includes at least one portion of increased diameter (Figs. 2, 3 and 5). 7. A plug according to claim 6, characterized in that the insertion member comprises at least one substantially spherical portion (Fig. 5). 8. A plug according to any one of the preceding claims, characterized in that said at least one magnetic element is an elongate axial strip, a rectangular zone or a circular zone. 9. A plug according to any one of the preceding claims, characterized in that said at least one magnetic element is of alnico alloy, hard or plastic ferrite material of barium or strontium type or rare-earth metals. 10. A plug according to any one of the preceding claims, characterized in that the magnetic flux density in the insertion member is no greater than 80 mT, preferably in the range 20 mT to 40 mT. 11. For use in rectal and/or vaginal therapy, a plug according to any one of the preceding claims. 12. The use of a plug according to any one of claims 1 to 10 in rectal and/or vaginal therapy. 13. Use according to claim 11 or 12 in the treatment of haemorrhiods. 14. Magnetotherapeutic plug and the procedure for applic ation in human medicine, the plug being adapted to the anatomic shape of the rectal or vaginal cavity, made of biologically inactive material and having a magnetic core providing a constant magnetic field of desired configuration and intensity, for application in the cavity until satisfactory cumulative action on the diseased tissue is achieved.

Inventors: DEKLEVA, NIKOLA, PH.D., M.D., ANTIC, RADOSLAV, DIPL.-ING., BELESNIN, BOGDAN, PROF., PH.D., M.D., MAJIC, VIDAN, PH.D., DIPL.-ING.
Applicants: ANTIC, RADOSLAV, DIPL.-ING., BELESNIN, BOGDAN, PROF., PH.D., M.D., DEKLEVA, NIKOLA, PH.D., M.D., MAJIC, VIDAN, PH.D., DIPL.-ING.
Application year: 1984
Main classification: A61N2
IPC codes: A61N2