HU192218B - Method and device for testing the electrochemical effects shown by metal prothesis, implants in living organism - Google Patents

Abstract

A process and an equipment are used for examination of electro-chemical effects inducing inflammation and allergic symptoms in the living organism, which are induced by two or more metal replacements respectively by other, in the living organism implanted metal (implantation). During the procedure according to the invention at patients with inflammatory and/or allergic symptoms it is controlled by in vivo current-measuring near the approachable metal replacements (implantations), if the ion current - which is established on the effect of galvanic cell has been created by metal replacements - reaches the allergic symptoms or the critical value inducing inflammation, further on the values of electrode potentials measured on the implantations are compared to the anode-polarization curves given to the metal replacement alloys, and on the basis of it the conclusion is drawn on the measure of ion current developed between certain metal replacement pairs. The equipment according to the invention consists of an electronic unit (1) and probe (2, 3, 5) used for measuring current resp. electrode potential. In the electronic unit there is a current-voltage converter (11) sensing current to be measured, an instrumental amplifier (12) sensing voltage to be measured, a precision rectifier (13) connected by its input with the output of formers, and on the output of it a suitably logarithmic amplifier (14) is connected, and on the amplifier a voltage-current converter is connected, which drives a suitably analogous indicator, especially Deprez-instrument (16). For the sake of the simplier handling, the equipment can be supplied with sound and/or light-source, which give signal for the doctor in case of overflowing a given value (voltage or current) about the presence of pathological ion-migration.

Description

FIELD OF THE INVENTION The present invention relates to a method for testing the electrochemical effects of two or more metal substitutes in a living organism, and to an apparatus comprising an electronic unit and a voltage measuring probe.

It is known that, especially as a result of the steep rise in the price of dental noble alloys, there has been a growing need for the production and use of dental non-noble metal alloys in the richest countries over the last 15-20 years. Primarily, the number of nickel-based metal alloys is high (Ni content: 60-75%), which also contains a fairly high percentage of chromium and cobalt. Relevant literature, such as H. W. Gundlach, "Edelmetall-Dentallegieningen: Edelmetallfreie-Dentallegierungen". a, Dental-Labor, 30 321 (1982), Sonderdruck, or D. Hermann, "Allergische Reaktionen durch zahnárztliche Werkstoffe". According to ZM Fortbilding's 18/1981 publication, all three metals may exhibit allergic phenomena. This is probably because these metal alloys, when inserted into the mouth (possibly into other parts of the body, such as the chest in the case of a pacemaker), together with existing or alloyed metal alloys, can form galvanic cells (amalgam, bridle, bridge, sheet metal). This means that metal alloys can begin to migrate to living tissues at favorable temperature and pH of the mouth. At this temperature (~ 35 'C), emigrated ions can attach very easily to protein bodies, resulting in allergic reactions (e.g. local and distal mucosa and skin reactions such as eczema, dermatitis, dermatosis, etc.) in previously metal sensitized organisms. ). This will continue until the allergenic factor (eg dental metal alloy tooth replacement) is removed.

To date, known methods for detecting metal replacements that cause ionic fluxes and thus form allergic foci are based on in vivo measurement of voltage differences between already installed metal replacements, and complex in vitro pre to determine the expected ion flux by placing metal replacements as electrodes in an electrolyte that mimics tissue fluids, often in saliva from the patient's mouth. Ultimately, however, neither the in vivo tensions in the mouth nor the in vitro ionic currents provide satisfactory information to the diagnosing physician.

Dr. Gundlach (Bego) wrote in early 1983, “Precious Metal Alloys. In his Communication "Precious Metal Alloys", he is the first to deal in depth with the in vitro electrochemical phenomena associated with dental metal alloys.

In his study, he points out that each metal alloy only releases its ions beyond its typical voltage limit, up to this voltage limit it is protected by its passive oxide layer. Correspondingly, each metal can be made with the so-called so-called special metal. anode polarization curve, from which it is possible to determine exactly what voltage limit is called a. passive flow (when there is no flow) and from which voltage limit is active flow. This is well illustrated by Gundlach's figure. (Fig. 4) It follows from the passive flow phase and the non-linearity of the voltage-current curve that not all voltage differences cause ionic currents that cause allergic symptoms, so the ion differences in the mouth between the metal replacements cannot be clearly concluded.

The disadvantage of measuring ion flow in vitro is that the patient's body electrolyte cannot be replaced by saliva alone and, furthermore, only the initial stage of galvanic cell formation can be investigated by such methods when the oxide layer on the electrodes (metal replacements) prevents later hazardous ion flow.

SUMMARY OF THE INVENTION It is also an object of the present invention to provide a simple and reliable in vivo detection of ionic currents that cause allergic symptoms. The present invention also provides a method for diagnosing the cause of allergic symptoms in sensitized patients by measuring ionic currents, i.e., detecting metal replacements responsible for ion migration that can be healed by removing the patient.

It is also an object of the present invention to predict the effect of a given alloy metal replacement after implantation by applying a voltage measurement and to easily select an alloy that is not expected to have a harmful electrochemical effect on the living organism.

It is a further object of the present invention to provide an instrument that is capable of measuring and signaling undesired ion migration not only in vitro, but primarily in vivo, in a given subject and thus to determine whether implanted metal replacements are in an allergologically active or passive state- e.

The present invention is based on the discovery that by measuring in vivo ion current caused by implanted metal replacements, the disadvantages of in vitro current measurement can be eliminated, and in vivo voltage measurement can be extended for prognostic purposes, if the measured values are intended or intended for implantation. the electrical properties of the metal alloys are compared in advance.

The essence of the method according to the invention is, based on this discovery, to check, in patients with inflammatory and / or allergic symptoms, "in vivo" pricing of available metal replacements (implants) to determine whether the ionic current produced by the galvanic element produced by the metallic replacements reaches the allergic symptoms. or the critical value that triggers the inflammation.

For local complaints, such as oral mucositis, ion current measurement provides sufficient assistance to identify the allergen, while for distant, i.e., allergic complaints, current measurement may be complemented by a dermatological specific test. This test can help you determine exactly which metal component in your metal alloy is responsible for the allergy.

The steps of the procedure described so far are particularly useful for diagnostic tests, i.e., when metal replacements have been in the body for a long time and the treating physician should determine whether the metal replacements are responsible for causing inflammation and / or allergic symptoms, and if so, which metal replacement or within its alloy, which component is the allergen, that is, the substance to which the subject's body is sensitive.

According to the invention, the results of the "in vivo" voltage measurement between pairs of metal replacements are compared with the anode polarization curves given for the alloys of the metal substitutes and from this we can infer the magnitude of the ion current between each pair of metal substitutes. The expected electrical voltage difference of the new metal replacements for implantation compared to the existing one (or others), according to the invention, is also measured "in vivo" by contacting a specimen or specimens of the same metal replacement material with the receiving tissue and and the anode polarization curve of the alloy is determined to determine the magnitude of the ion current expected after implantation.

The use of specimens is primarily useful in prognostic studies, so in cases where the physician has to decide whether the implant to be implanted will be active or passive in the patient's body after implantation, or one of the possible alloys to be used. one that remains passive when implanted in the patient's body, i.e., under stress conditions that develop there, does not cause allergic symptoms or an ionic current that causes inflammation.

Accordingly, the apparatus for carrying out the process is provided with a specially designed combined probe for measuring current or voltage, which is wired to the electronic unit, and preferably with a series of test pieces made of commercially available metal replacement materials. Further, the most common embodiment of the electronic unit is a current-to-voltage converter receiving the current to be measured, an instrumentation amplifier for sensing the voltage to be measured, an input of a precision rectifier connected to the outputs of the former two circuits, optionally a logarithmic amplifier connected thereto, it is constructed of an analogue device driven by it, preferably an Deprez instrument.

Preferred embodiments of the apparatus according to the invention are those in which an input of a comparator for the acoustic and / or light signaling device is connected to the output of the logarithmic amplifier of the electronic unit. The other input of the comparator is connected to a reference voltage source.

A particularly advantageous embodiment of the device according to the invention, wherein the combined probe for measuring voltage or current consists of two parts consisting of a hollow insulating handle and a measuring tip also made of insulating material, is automatically operated when the measuring tips are joined or separated. The mode switch, preferably the REED relay, and the actuating counterpart thereof, preferably are magnetically arranged in pairs such that the mode switch and the actuating counterpart thereof are at the same height when the combined probe parts are assembled.

Another preferred embodiment of the apparatus comprises platinum hemispheres attached at the ends of the probes of the combined probe, which are connected via a mode switch to the electronic unit through a mode switch, and at least one of the probes receiving a probe receiving electrode. metal wire passed through a measuring tip.

Certain test specimens of the aforementioned series of test specimens made from the materials of commercially available metal replacements are provided with a pin which fits into at least one of the probes of the combined probe.

The invention will now be described in more detail by way of an exemplary embodiment, with reference to the accompanying drawings, in which:

Figure 1 by way of example! a block diagram of an apparatus according to the invention, a

Figure 2 is a cross-sectional view of the combined probe, a

Figure 3 is a partially sectional view of one of the probes of the combined probe and a

Figure 4 is an anode polarization curve for an alloy of metal substitution.

Diagnostic examination of a patient with localized complaints (inflammation) following the procedure of the present invention proceeds as follows:

In the vicinity of the suspicious metal replacement, preferably the gingiva (gingiva propria), the ionic current is measured in its assembled state as a combined probe current meter. Because the probe detects only a small portion of the tissue forming the current path at a time, the electronic unit will not indicate the total ion current flowing between the two active metal replacements, but only a small percentage thereof. However, clinical experience suggests that this is sufficient to make a diagnosis, since the partial current delivered by the probe to the electronic unit is in any case proportional to the total ion current. As a result of measurement and examination on large patient material, ion currents below 30 nA are still considered normal, whereas ion currents above 50 nA are considered abnormal in all cases. Note that if one member of the metal replacement pair constituting the galvanic cell is implanted in an inaccessible location (eg with a screw to fix broken bones), it is sufficient to measure near an accessible metal replacement (eg tooth replacement) since the ion current exiting one metal replacement entering another.

When measuring the mucosa in the mouth, care should be taken to measure the ionic current in the mucosal area where

The bioflows of the mucous membrane displaced by 192,218 muscle movements should not affect the result of the measurement. An example of such a location is the area of the gingiva directly adjacent to the gingiva (gingiva propria). The appropriate area of the gingiva propria and the electrodes at the tip of the probe should be air dried prior to measurement.

In case of local complaints (inflammation, gingivitis) no additional dermatological test is required, the patient can be treated by removing the active metal replacements found to be responsible for the inflammation or by implanting a suitable metal replacement.

When examining a patient with allergic (distant) complaints, we also supplement the above with a dermatological specific allergy test (cutan test), which indicates which metal component of the alloy is responsible for the allergy. By introducing the pathogen allergen metal into the disease, alloys containing the allergen metal can be excluded for the future.

During therapeutic treatment, metal replacement alloys containing metals that are allergenic on the patient's medical record are excluded from the selection at the time of implantation. If such an allergen is not detected in the syndrome, search for it by the in vivo ionic current measurement according to the invention or, if appropriate, by a dermatological test. After removing the removable member of a metal replacement pair found to be overly active by ion current measurement, a metal specimen closer to the residual electrochemical potential is selected and then inserted into one of the probe tips in a separate probe for use as a combined probe voltage gauge. mucosa. At the same time, voltage is applied to one side of the combined probe for one of the remaining (existing) metal replacements. the voltage measurement is repeated several times with fixed metal replacements. Preferably, the mucosal area of gingiva propria is still selected, and the selected mucosal area and specimen are air-dried prior to measurement. The result of the voltage measurement is compared with the anode polarization curve of the selected specimen and (if known) alloy of the fixed metal replacement, and on this basis we can infer the expected ion current after implantation. If the expected ion current is greater than 50 nA, the selected alloy should be excluded from the range of possible alloys for implantation. The implantable metal alloys should be the one that least changes the tension in the body and thus does not cause ionic migration, which means that it remains inactive after a long period of implantation.

A block diagram of an apparatus for carrying out the process of the present invention as described above is shown in Figure 1. The dashed part forms the electronic unit 1, which is integrated into a control box. This electronic unit may be fitted with a specially designed combined probe for measuring current or voltage, the cross - section of which is shown in Figure 2.

is shown. Finally, the apparatus also comes with a series of 28 specimens, each of which is configured as shown in Figure 3, but each made of a different type of metal replacement material. The combined probe consists of two parts 2 and 3 which are joined to one another by means of the connecting pins 10, which consist of a hollow insulating handle 7 and a measuring tip 4 also of insulating material. In the cavity 8 of the insulating handle 7, for example, the mode switches 23 and 33 realized by the REED relay and the magnets 22 and 32 actuating them are arranged such that the mode switches and counterparts actuating them are at the same height. In addition, the ferromagnetic plates placed in front of the magnets also secure the two parts. In other embodiments, the REED relay and magnet may, of course, be replaced by other switching means or fasteners. The combined probe is connected by a four-wire to the electronic unit 1, two wires are connected to the voltage sensor input and two are connected to the current meter input. The output of the current-to-voltage converter 11 of the electronic unit and an instrumentation amplifier 12 for measuring the voltage to be measured are connected to the input of a precision rectifier 13 having an output of a heat compensated logarithmic amplifier 14 and an output of an analog display voltage to current converter is connected. At the output of the logarithmic amplifier 14 is connected one of the inputs of a comparator controlling an audible and light signaling device, the other input of which is connected to a reference voltage source. At the ends of the probes 4 of the combined probe are attached platinum hemispheres 25 and 35, which are connected by a metallic filament 5 passed through the probes 4 via the mode switches 23 and 33 to the electronic unit gel 1. At one of the probes, there is provided a base 27 for receiving the specimen 28, which is in metallic contact with the metal fiber passed through the probe. The unit is powered by a 9 V voltage source 17, but can also be powered from the network using a suitable AC adapter.

After connecting the probe of the combined probe to the socket in the control box and turning on the power, the unit will be operational. Current measurement is possible when the combined probe is connected, and voltage measurement is possible when the probe is disconnected. Mode switches 23 and 33 provided in the probe ensure switching of the probes to the appropriate input of the instrument. The voltage at the input of the instrument is sensed by the instrumentation amplifier 12, and the current by the current-to-voltage converter II is also converted to a voltage. This voltage is applied to the input of the precision rectifier 13, which serves to provide polarity-independent measurement. The rectified voltage is supplied through a logarithmic amplifier 14 to the voltage drive converter 15 driving the display. The logarithmic amplifier 14 provides the measurement of currents and voltages to be measured in a single measuring range. This eliminates the need for cumbersome, manual, or more complex auto-41

192 218 mathematical range change. The 16 Deprez instrument is easier for the physician to read because sensing a change is more important than measuring the exact voltage or current value when measuring. By setting a reference voltage source connected to the comparator input 18, a value can be set which, when exceeded, alerts the physician by means of an acoustic and light signaling device connected to the comparator output. In particular, the acoustic signal helps the diagnostic doctor to focus his full attention on positioning the probe.

Advantageous effects of using the method and apparatus of the invention may be summarized as follows:

By this method, the ionic currents that cause allergic symptoms, the metal substitutes that cause them, and the metal component responsible for the allergy are detected more easily and reliably than previously known and used methods. Replacing an overly active metal replacement can quickly heal the patient, and eliminating an allergen metal component can eliminate allergy-causing metal alloys in the future. The device according to the invention is largely task-oriented, that is, it is adapted to the requirements of special medical tasks. Easy to operate, requires no measurement range or mode switching. A special advantage of the audible version is that, during use, the physician is not forced to focus his attention, but simply focuses on the proper placement of the probe.

Claims (9)

1. A method of examining the electrochemical effects of two or more metal replacements, or other metal (implants) implanted in a living organism, on the living organism to cause allergic symptoms and inflammation, wherein the electrical voltage difference between the implanted metal replacements is measured in pairs, In addition to measuring, the ion currents caused by these voltage differences in the surrounding body tissues are measured "in vivo" (in the living organism). Method according to claim 1, characterized in that the values of the voltage differences between the implants are compared with the anode polarization curves given for the alloys of the metal replacements and based on that the magnitude of the ion current between each pair of metal replacements is deduced. Method according to claim 1 or 2, characterized in that the electrical voltage differences between the metal replacements that are to be implanted and which are expected to interact electrochemically with each other and / or with the metal implants already implanted, are measured by: the specimen (s) of the same material as the metal replacements to be implanted are contacted with the receiving tissue, and the voltage difference between the exposed specimen and another identical or ⁵ implanted metal replacements is measured. 4. Apparatus, in particular the apparatus 1-3. The method of claim 1, further comprising an electronic unit and a voltage measuring probe, further comprising a specially configured voltage or current measuring device ¹⁰ having a combined probe (2, 3) wired to the electronic unit and the electronic unit (2, 3). 1) a current-to-voltage converter (11) for sensing the current to be measured, an instrumentation amplifier (12) for sensing the voltage to be measured and a precision rectifier (13) connected to an output of said input, optionally output from a logarithmic amplifier (14). then ²⁰ ZOT, in particular Deprez-instrument (16) drive voltage to current converter is connected to the latter is preferably an analog Dis (15). 5. Apparatus according to claim 4, characterized in that preferably a logarithmic amplifier (14) output from the electronic unit (l) in a ²⁵ volume indicator means (20) and / or light signaling means (21) control comparator (18) one input also is connected while the other input of the comparator (18) is connected to a reference voltage source (19). ³ θ Apparatus according to claim 4 or 5, characterized in that the combined probe for measuring voltage or current consists of two parts (2, 3) which are connected to each other by means of connecting pins (10) and a hollow insulating handle (7). synthesis (4) are ³⁵ Ten mérőcsúcsból insulating material (23, 33) preferably reed relay and the actuating counterpart, preferably magnets (22, 32) (8) mode switch of the insulating handle cavity arranged in pairs so that from the combined probe When the tines (2, 3) ^{40 are} joined, the mode switch and its counterpart are at the same height. Apparatus according to claim 6, characterized in that the probes of the combined probe At its 45 ends, platinum hemispheres (25, 35) are connected, which are connected by a metal fiber (5) guided through the probes (4) to the electronic unit (1) and a probe receiving at least one of the probes. There are 50 sockets (27) which are in metallic contact with the metal wire passed through the probe tip. 8. Apparatus according to any one of claims 1 to 5, characterized in that the test piece (28) made of materials of commercial metal substitutes is also provided with a so55 set. Apparatus according to claim 7, characterized in that the specimens (28) are provided with a pin (29) which can be inserted into at least one of the measuring tips (4) of the combined probe (2).