SYSTEM AND METHOD FOR INCREASING ORGANIC CELL REGENERATION IN A CELLULAR MEDIUM

Abstract

A system for increasing organic cell regeneration in a cellular medium includes an electromagnetic (EN) field generating device adapted to produce a constant EM field of less then 1 mT at a radiation frequency of substantially 7.69 Hz, which comprises at least one coil and is adapted to generate the EM field so that the cellular medium is substantially within the generated EM field. A resonance medium is also provided for locating substantially at or adjacent the cellular medium, wherein the resonance medium comprises a composition which is adapted to resonate at the frequency of The EM field generated by the device, wherein the composition is a biologically active composition containing at least a composition comprising crystalline structure minerals.

Claims

1. A system for increasing organic cell regeneration in a cellular medium, comprising: an electromagnetic (EM) field generating device adapted to produce a constant EM field of less than 1 mT at a radiation frequency of substantially 7.69 Hz, which comprises at least one coil and is adapted to generate the EM field so that the cellular medium is substantially within the generated EM field; and a resonance medium for locating substantially at or adjacent the cellular medium, wherein the resonance medium comprises a composition which is adapted to resonate at the frequency of the EM field generated by the device, wherein the composition is a biologically active composition containing at least a composition comprising crystalline structure minerals.

2. The system according to claim 1, wherein the composition includes crystalline structure minerals with particle size 20-150 nm.

3. The system according to claim 1, wherein the composition includes human or animal tooth crystals.

4. The system according claim 1, wherein composition is obtained of natural salt, volcanic rocks and/or animal horns, alone or in admixture.

5. The system according to claim 1, wherein the composition comprises one or a combination selected from the group comprising silicates, crystals, quartz, opal, orthorhombic calcium carbonate, octacalcium phosphate, natural salt crystals, volcanic rock, ground animal horns.

6. The system according to claim 1, wherein the EM field is substantially 0.75 mT.

7. The system according to claim 1, wherein the EM field is generated as a pulsed signal having a substantially rectangular waveform.

8. Use of the system according claim 1 for increasing proliferation of the primary cell preferably maxillary bone and gums.

9. A device made of the composition according to claim 5, wherein it may be as loose powder or pressed in the shape of teeth or implant cavity.

10. The device of claim 9, further including a polymer in admixture with the composition in the shape of area to be regenerated.

11. Device according to claim 3, further including coils excited to form an electronic device for generating biocompatible frequencies to harden bone and dentine.

12. Use of the system according to claim 1 for slowing down the tissues resorption in preventive purposes and implicitly for accenting their healing.

13. Use of the system according to claim 1, in which an implant is provided with activation coils excited by an electronic device generating regeneratives frequencies.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0053] There are given hereinafter more embodiments of the invention in connection with FIGS. 1 to 58 which represent:

[0054] FIG. 1a general axonometric view of a dental implant, according to the invention, in a first embodiment, having the healing blunt mounted;

[0055] FIG. 2a general axonometric view, with partial axial section through the same implant, but without healing-cicatrising blunt;

[0056] FIGS. 3a, ba longitudinal section about the plane A-A through the implant

[0057] FIG. 3a, and a top view

[0058] FIG. 3b;

[0059] FIGS. 4a, b, ca longitudinal section about the plane C-C, through the central rod of the implant

[0060] FIG. 4a, top view

[0061] FIG. 4b, axonometric viewFIG. 4c;

[0062] FIG. 5general axonometric view of the self-threading leading head;

[0063] FIG. 6longitudinal section through the central frustoconically shaped shell, in the externally threaded version;

[0064] FIG. 7longitudinal section through a hollow type active element made of a composition accelerating the osteointegration;

[0065] FIG. 8longitudinal section through a healing blunt;

[0066] FIG. 9general spatial view of a dental implant as claimed by the invention, in a second embodiment, with bayonete-type assembling of the core to the body;

[0067] FIG. 10 and FIG. 10Ageneral view 10, and longitudinal axial section, 10A through the body of implant in FIGS. 9 and 10, with the view of the securing channels of the central core;

[0068] FIG. 11general view of the central core of the implant;

[0069] FIG. 12general view of the element for accelerating the osteointegration;

[0070] FIG. 13general axonometric view, with partial section of an implant, as claimed by the invention, in a third embodiment, namely with the prosthetic blunt secured by Morse cone;

[0071] FIG. 14longitudinal axial section, according to plane A-A in FIG. 16, of an implant as claimed by the invention, in the third embodiment;

[0072] FIG. 15longitudinal axial section about the plane B-B of FIG. 16, of an implant, as claimed by the invention, in the third embodiment;

[0073] FIG. 16top view of the same implant presented in longitudinal section in FIGS. 14 and 15;

[0074] FIG. 17general axonometric view of the implant shell/body, in the third embodiment, presented in FIG. 13;

[0075] FIG. 18general axonometric view, with partial section of an implant similar to the one in the third embodiment, FIG. 13, but provided with prosthetic blunt and secured to the implant by means of a usual screw;

[0076] FIG. 19general axonometric view of the prosthetic blunt, secured by screw;

[0077] FIGS. 20 to 23general view with sections of another implant, as claimed by the invention, in a fourth embodiment, namely with the self-threading leading head provided with support rod and assembling the blunt to the implant body by screw;

[0078] FIG. 24version of the implant presented in FIGS. 20 to 23, wherein the upper head of implant is provided with a bottom wall separating the cavity for screwing in the prosthetic blunt to the cavity of the self-treading head rod; FIGS. 25 to 27the fifth embodiment of the implant, as claimed by the invention, wherein the upper head is provided with a threaded cavity for securing the prosthetic blunt therein and with rod for securing it in the body by means of a pin;

[0079] FIGS. 28 to 31other version of the implant of FIGS. 25 to 27, wherein the upper head of implant is secured to the shell by adequate adhering or welding;

[0080] FIGS. 32 to 34version of implant of FIGS. 1 to 6, wherein the self-threading leading head securing in position to the rod of implant upper head is made by a pin;

[0081] FIGS. 35 to 37version of the implant according to the invention, wherein the body thereof is closed at its lower side by means of a plug, to facilitate the introduction of the regenerating composition therein, and with inner hexagon for achieving the insertion thereof;

[0082] FIGS. 38 to 41version of the implant according to the invention, wherein its body is closed at the lower side by a plug, in order to facilitate the introduction of the regenerating composition therein, and with outer hexagon for achieving the insertion thereof;

[0083] FIGS. 42 to 47version of the implant as claimed by the invention wherein its body made of zirconium is provided to the inner side with a metal bush, for example made of titanium, adhered or welded thereto, for assembling the prosthetic blunt;

[0084] FIGS. 48 to 49version of the implant as claimed by the invention wherein its body is provided to the inner side with a bush, adhered or welded thereto, for assembling the prosthetic blunt, and at the lower end with a hexagonal machining for assembling therein the self-threading leading head;

[0085] FIGS. 50 to 54version of the implant of FIGS. 48 to 49, wherein the self-threading leading head is screwed in the inner bush, to ensure maintaining said inner bush in position;

[0086] FIGS. 55 to 57version of the implant of FIGS. 50 to 54, wherein the self-threading leading head was replaced by a simple cap screw to ensure the maintaining of the inner bush in position;

[0087] FIG. 58principle diagram of an electromagnetic field generating device, apt to generate frequencies biocompatible with the human body.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0088] There will now be described by way of example a specific mode contemplated by the inventors. In the following description numerous specific details are set forth in order to provide a thorough understanding. It will be apparent however, to one skilled in the art, that the present invention may be practiced without limitation to these specific details. In other instances, well-known methods and structures have not been described in detail so as not to unnecessarily obscure the description.

[0089] The beneficial action of relatively warm crystals upon the human body is well known. A first explanation is that various minerals or crystals, such as opal for example, activate electromagnetic fields more or less intense in a frequency range beneficial to the human or animal body. A resonance medium comprising a composition that includes at least one mineral or crystal will favour electromagnetic radiations, in a frequency range favourable to its functioning and restoration of the immediately adjacent tissues. It is clear that such device will also be beneficial to face skin, by generating an age prevention effect, as well as to sinuses, the eyes and still more. Subjects accustomed to one or more resonance media as mentioned above, realise that by wearing it they feel better in several respects. The simplest way of applying these frequencies in the organism is to ask the subject to wear the medium as long as possible, and mainly during the night, for instance as a resonance medium made of a material resonating with some low biocompatible frequencies.

[0090] In other words, it is no longer necessary to use only electronic devices 5 capable to emit electromagnetic frequencies beneficial to the human body, but it is also good to create and use static devices which include minerals capable of lowering the local reluctance to, and to resonate with, the biocompatible frequencies, by taking over from the body energy for their functioning. By way of analogy, the clay treatment consisting in applying clay on the gum of the teeth o affected by parodontopathy, though unpleasant under many aspects, gives highly positive results, apparently still incomprehensible. The explanation is that the silicates microparticles in the clay composition, activated by the heat in the mouth, amplify the electromagnetic radiations beneficial to the organism.

[0091] The resonance medium may be connected, for longer or shorter periods of time, as the case may be, by the subject, during pause or rest periods, to electromagnetic (EM) field generating devices for accelerating the integration. The block diagram of such a device is given in FIG. 58. A relevant device will be made up of two distinct elements: at least one excitation element, usually a o coil, which generates the user-adjustable electro-magnetic field frequency, and the low frequency generator that will have the dimensions of a battery, the subject using the system as an energy healing system. More exactly, the electronic equipment for generating very low frequency magnetic field in the resonance medium, for instance a dental implant or of the tooth region, consists of a 5 microgenerator of functions having an integrated microcircuit at the basis, for example XR2206. The assembly generates a user-adjustable frequency ranging from 0.9-75 Hz with various signal shapes, preferably a pulse shape having a substantially rectangular waveform. The circuit shall also meet an essential condition with regard to the output signal level. It is known that the o healing phenomena have at the basis magnetic inductions of 0.10 to 1 miliTesla (mT), and tests by the applicant have revealed an optimal frequency at substantially 7.69 Hz and a magnetic induction level of substantially 0.75 mT. In certain embodiment, the signal generator will be physically connected to the resonance medium through a very thin coaxial conductor. From the generator, through this conductor, there starts a variable current of the amplitude 5 and frequency decided by sampling the subject's cellular tissue in the region to be treated. Coils will be secured exactly where heating is desired to be accelerated, for example in front of the resonance medium. This device may increase the blood microcirculation both by the electromagnetic oscillation and by thermal way by slightly heating the region to be treated. It is not however imperative for the device generating the EM field signal to be physically connected to the resonance medium, and alternative embodiments consider electromagnetic field generating devices for use in close proximity to a region of a subject, that are adapted to emit an electromagnetic field onto the 5 region without any physical connection. Such an EM field generating device according to the present invention was tested with samples of gum cells GLAC08 cultivated in a medium MCDB153 in a growth medium BC023 over a period of four days.

[0092] The device was realised pursuant to the general structure shown in FIG. 58 and comprises two copper coils mounted opposite one another, in a configuration referred to as Helmholz coils, so as to create an constant, nearly uniform electromagnetic field of no more than 1 mT there-between, driven at set a 5 frequency in the range 7 Hz to 8 Hz. The device comprises two banks of dipswitches, one for setting the EM field frequency precisely and one for setting the EM field intensity precisely.

[0093] The test protocol was as follows:

[0094] A tube containing 1.10.sup.6 cells was defrosted then mixed in 29 ml MCDB153,Petri dishes were then primed with 5 ml of the cell suspension, and placed in an incubator at constant 36.5[deg.]C., 5% C02. [0095] 5 petri dishes were placed in respective devices DM1, DM2, DM3, DM4 and DM5 as described above, between the two copper coils, with each device set as a respective frequency within the described range, and all devices set with the same intensity. [0096] 2 petri dishes were placed at least 30 cm away from each device, to serve as a control for the testing.

[0097] Each device generated a constant electromagnetic field for the entire period of testing, whereby the cells were continually subjected to the electromagnetic field for 4 days. A morphological study of each sample was then performed on the third and fourth days by microscope. From the study, cellular counting was performed in order to determine any cellular proliferation generated by the devices. Table 1 hereafter shows microscope images corresponding to each sample tested with a respective test device DM1, DM2, DM3, DM4, DM5 and a control sample, respectively on the third (J3) and fourth (H4) days. The cellular count on the fourth day of the test was as follows:

[0098] Control 1560000 cells

[0099] DM 11860000 cells

[0100] DM 22140000 cells

[0101] DM 32060000 cells

[0102] DM 42360000 cells

[0103] DM 51820000 cells

[0104] The cellular count confirms that the increase in cell number is in the order of approximately 34% for the second DM2 and the third DM3 devices, however it reaches up to approximately 50% for the fourth DM4 device, which was set at 7.69 Hz, whereas the first DM1 and fifth DM5 devices only show an increase of approximately 18%.

[0105] After three days of cultivation, with reference to Table 2 hereafter, a zone of confluence observed in the petri dishes of corresponding to the third DM3 and fourth DM4 devices, which zones were not present in the other petri dishes. After four days of cultivation, there were still no zone of confluence in the control sample.

[0106] The above tests demonstrate that a device contructed according to the principles and parameters of the present invention demonstrably increase cellular growth, even in the absence of regulated water in the cellular Figure technical solution is presented in many embodiments, mostly in the field of dentistry, but has a same inventive concept equally applicable to very many fields of application far removed from dentistry, encompassing cosmetic treatments, which is the application of an eletromagnetic field onto a mineral, particularly crystalline, composition to favour cellular growth and development.

[0107] A first conclusion to be drawn is connected to the consistence or hardness of the bone where a certain type of implant is to be inserted. The higher elasticity implants will be used in the rear region where the bone is soft and elastic while in the front region, where the bone is hard, implants of lower elasticity will be chosen. Though maybe more rigid at the beginning, the elasticity of the implant models with rod will vary in time, due to the play occurring between the titanium head and the zirconium oxide body. And this is so because in time, the zirconium oxide will abrade the titanium rod. This adjustment in time of the implant elasticity is in compliance with the modification of the osseous structure. We can say that the implant is adapted to the elasticity modifications of the bone. Due to osteoporosis or even to physiological aging, the bone in time becomes spongious. In time, as the implant elasticity increases, it may adapt to the new situation. As a matter of fact, this advantagevery importantcan be found in most implants that are the subject-matter of the invention, except for the ones entirely made of zirconium oxide. The implant entirely made of zirconium oxide is recommended to be used in the front region of the jaws, combining the aesthetic advantage of achieving the cervical region of the implant of zirconium oxide with maintaining a high rigidity, synchronously with the modifications in time of the bones in the front region of the jaws. The implant elasticity may also vary in time depending on the metal the pin is made up of as well as on the position thereof along the rod, consequently implicitly depending on its length. A pin made of a more elastic metal may allow a higher elasticity a the implant. Then, a general criterion will consist in that in order to obtain an elasticity in compliance with the jaw portion where the implant is to be inserted, the ratio between the mass and number of elements in the metal alloy and mass and number of elements made of zirconium oxide may vary. In other words, implants that are the object of FIGS. 1, 2, 3, 13, 20, 21 have a higher elasticity, since in the construction thereof more alloyed titanium is incorporated, and the implants that are the object of FIGS. 35, 38, 42 are more rigid, since zirconium oxide predominates here.

[0108] Thus, in case of occurrence of periimplantar infection, it was demonstrated that it is possible to sterilize the region affected by infection, provided that in this portion of the implant there does not exist a connection between two components. Also, it was demonstrated that, in case of an implant where the periimplantite decreased below its upper third, the infection cannot be treated and the implant is recommended to be replaced. For this reason, as it can be seen, the implant claimed by the invention, does not have connections in its upper third, fact that confers on it a special mechanical strength.

[0109] The special construction of the implant consequently allows the integration therein, even from the factory, of sonic elements made up of an active composition, but also the temporary addition, for short periods of time, both intra-orally and to the outer side of some dental devices also made of this composition, or of a composition with the same biological characteristics, devices that also have the same role in slowing down the resorption of tissues affected by the o implant insertion.

[0110] After the implant insertion, the periimplantar healing passes through may stages well-known with regard to chronology and physiology. A stomatologist may reinvigourate this regenerating signals in the period between the implant insertion and the application of the final prosthetic blunt, and by applying some cicatrizing/healing blunts and a temporary prosthetic blunt which should contain the desired substances incorporated in plastics and which, could be connected or not to thermostat-controlled heating devices or to biocompatible wave generators. After the integration period, the final prosthetic blunt shall be mounted inside the o implant. The coexistence of signals permanently generated due to the substances incorporated with signals generated for certain periods of time due to the substances or coils inserted upon a practitionner's decision, will allow an individual response depending on the subject's reactivity and on the periimplantite occurring hazard.

[0111] The composition that is active biologically may be made up of any of the previously quoted minerals or substances which have the quality of lowering the local reluctance, and possibly, of resonator for very low frequencies favorable to tissues adjacent to implant; more exactly, it is about mineral compositions o including silicates, such as for example opal, or some substances, such as orthorhombic calcium carbonate, octacalcium phosphate, known and already applied at the moment in the world, or which will be developed subsequently. As a particular case, the composition may also be made by grinding a tooth of said subject, or even from another subject, up to particle dimensions in the range of 20 to 150 nm, said tooth having been previously extracted for various reasons. Since this type of compositions, particularly the ones obtained from a crystal or a ground human tooth cannot be provided in a large amount, it is recommended to use them intra-orally.

[0112] Also as a particular case, composition may also include ground natural salt crystals, including powder obtained from teeth, horns, human or animal bones, used separately or in admixture. This type of compositions is recommended to be used by external devices.

[0113] Also, the compositions meant to be used intra-orally may be employed alone or in admixture with one another and, where appropriate, they may be used as such or embedded in a polar polymer. This polymer is recommended to have a polarization higher than or at least equal to that of polyethylene. In the implant, in order to have a more powerful regenerating effect, the composition is employed, as a rule, simple, as powder, but it may also be employed pressed in the shape of the implant cavity.

[0114] The substance to be introduced inside the implant even from the factory and to remain there will be for example opal or calcium carbonate or ground human or animal bone, since it is known that they stimulate the formation of bone. The introduction into some devices of the coils connected to the electronic generator for the purpose of preventing the occurrence of periimplantite is encouraged since a tighter periimplantar ring will be formed that will prevent the occurrence of periimplantite.

[0115] Similarly, the intra-oral use composition will also be used as powder if it will be introduced into the space created after the devitalisation of a tooth or at the tooth root. These compositions may also be employed for preparing materials for radicular or coronary obturations since they simultaneously have three important advantages: [0116] favor the production of the secondary biocompatible radiation; [0117] determine the formation of a new dentinecalled secondary dentine; [0118] bring the thermal exansion factor of different materials close to the natural tooth coefficient, thereby avoiding fractures.

[0119] In the mixture of materials for obturation, there will be added up to 20% by weight of powder opal or human or animal tooth ground up to a particle size in the range of 20 to 150 nm.

[0120] The compositions, may also be used to carry out implant elements, for example, having the shape of granules, filaments or tubular or in the shape of a small bolt, depending on the inner implant space. By incorporating into polar polymer such as low or high density polyethylene or in other polymer with a better polymerization degree, the composition may also be used for making implant elements of bigger dimensions that we called intra-oral dental devices, such as healing and/or cicatrizing blunts or even temporary prosthetic blunts which are to be finally replaced by metal blunts made up of titanium or, preferably, zirconium oxide or roxolid. It is recommended to make these blunts by incorporating minerals into polymers of a polarity higher than polyethylene, and of higher durity, such as, for example acrylate, since the resistance thereof shall be higher, although they are not used for mastication. However, the repeated passing of the alimentary bolus on them causes the destruction thereof.

[0121] Rodicular pivots for dental roots, acrylic dental works such as prostheses or fixed works etc may also be made of acrylic material incorporating minerals. There may also be carried out various types of devices used supragingivally, such as for example guards or bars for immobilization of teeth and implants. Moreover, pillows for sleeping during the night or even various coverings for head and/or jaws may be made of compositions of similar qualities, such as, for example, natural salt, ground animal horns, volcanic rocks etc., for the ones that cannot adapt themselves to wearing a guard. It is to be noticed that the mechanism we described, relating to the treatment with salt is different from the mechanisms used in all other treatments with salt crystals, since the already described treatments are based on the salt contact with the cellstreatments that had an antiseptic effect and the pH adjustment. Our treatment means that the salt, namely other minerals, remains blocked inside the devices and we have no risk of excessive ingeration of salt in case of prolonged treatment compulsory for slowing down tissues resorption. For the inner works, such as guards or dental cements, silicate such as opal may be employed, the amounts of active substance will be less here. With regard to incorporating the composition in a polymer, the process is the following: the active crystals are mixed with granules of high polarity polymers at a temperature specific to that polymer, then they are regranulated by breaking the thus obtained block. The new granules are processed to the necessary shape by hot or cold die-pressing. For making guards and various prosthetic works said granules are hot pressed between two or more polar polymer sheets, thereby obtaining a sandwich-like product. The advantage of this technique is that the active minerals do not come into contact with the tissues and thus the risks of adverse effects are reduced. It is to be noticed that the temporary character blunts but provided with activating devices and namely with thermostat-controlled heating systems as well as/or coils excited from an electronic device for generating biocompatible frequencies will be connected to these devices for conducting the treatment, and the guards and outer devices such as pillows and head and jaw coverings may be connected to these devices by the subject. Preferably, all these devices will be carried out with compositions capable of reducing local reluctance and/or of resonating with biocompatible frequencies of 7 Hz if destined to osseous regeneration, 10 Hz if destined for ligament regeneration, 15, 20 and 72 Hz if meant to form new capillaries and 2 Hz, 25 Hz and 50 Hz if meant for nervous regeneration, or 33.3 Hz the calcium resonating frequency if meant to regenerate calcium in tissues. Though the subject-matter of the present invention is limited only to some problems of the oro-maxilo-facial region, we recommend the adoption of this method by using external devices also specially adapted for solving similar problems in other fieldscosmetics, orthopedic, rheumatology etc. We repeat to this effect the example given at the beginning. Decreasing the blood microcirculation has as an effect the occurrence of wrinkles on the old people face skin. The dead cells are no longer removed and replaced, but they remain in the region causing the occurrence of wrinkles.

[0122] Other tests are conducted by the National Institute for Chemical-Pharmaceutical Research and DevelopmentICCF, 112 Vitali St., Bucharest supporting the beneficial actions of warm crystals and low-intensity electromagnetic field on human body. The objective of this research was to investigate the influence on cell proliferation of different mineral compositions (aragonite, topaz, implants of zirconium) placed outside the cell culture plate, at the interface between a low-intensity electromagnetic field (EMF) generating device and culture dish. The beneficial effect is more remarkable as there is no direct contact with the target cells.

[0123] A resonance environment that includes at least one mineral crystal will support the transition of electromagnetic radiation in a favorable frequency range for repairing immediately adjacent tissue. Crystals can obsorb, store, convert, amplify, transduce and transmit vibrational energies that have biological effects. Such a device would be beneficial especially for facial skin/generating a counteracting effect on wrinkles, creating stability for dental implants and generally by stimulating the regenerative capacity of the entire body. According of this tests, in the case of cells exposed both to minerals and EMF the proliferation rate was higher (7-12%) and extreme statistically significant than in the case of cells exposed only to EMF (5-10%), compared to unexposed control. The benefit is even more obvious since there is no direct contact with the target tissue.

[0124] The cellular model is used on standardized cell line of human dermal fibroblasts Hs27 because they are the predominant cells that synthesize extracellular matrix of connective tissue and collagen, with special importance both in the medical and cosmetic fields.

[0125] The electronic apparatus used is based on a device for generating a frequency with precision and stability. The output of the machine consists of a constant current source which leads to high stability of the magnetic induction.

[0126] In the action area of EMF, above and below the plate culture were applied envelopes containing various types of mineral powders (topaz, aragonite and implants of zirconium). On the same culture plate, a control area was preserved, kept only under the influence of the electromagnetic field. Also, another control culture plate was prepared in the same conditions, but unexposed either to EMF or minerals influences. Fibroblasts were exposed to EMF and minerals for 3 days, 2 hours per day. After this, the cells viability was measured using MTS assay. All data are expressed as the mean+SD. Statistical analysis was done using system of the invention t-test (GraphPad software).

[0127] Results of exposure is shown below, in Tables 3, 4 i 5

TABLE-US-00001 TABLE 3 Proliferation values after 3 exposures of 2 hours (MTS assay) Optical P compared density to (490 nm) SD control Control (unexposed) 2.395 0.039 Cells exposed to EMF and topaz crystals 2.571 0.1 p < 0.0001 Cells exposed only to EMF 2.525 0.14 p < 0.0001 Cells exposed to EMF and 2.687 0.1 p < 0.0001 aragonite crystals Cells exposed only to EMF 2.646 0.2 p < 0.0001

TABLE-US-00002 TABLE 5 Proliferation values after exposure 2 hours for 7 days (4 days exposure, two days break, 3 days exposure) Viability index Optical compared to Control density SD P unexposed (%) Control unexposed 0.7314 0.07 Field of system 0.7748 0.07 p > 0.01 105.9 (implants of zirconia) 4 Field of system 0.7657 0.06 p > 0.1 104.6 (implants of zirconia)

[0128] In conclusion, In the case of cells exposed both to minerals (topaz, aragonite and implant zirconia) and EMF the proliferation rate as higher (7-12%) and extreme statistically significant than in the case of cells exposed only to EMF (5-10%), compared to unexposed control. The benefit is even obvious since there is no direct contact with the target tissue.

[0129] With reference to FIGS. 1 to 57, there now follows a detailed description of a plurality of embodiments of a resonance medium according to the invention for use in the specific field of dentistry, however it will be readily apparent to the skilled person, as previously noted, that the single inventive concept disclosed herein is capable of application in very many further fields indeed. An implant for use according to the invention shall meet the following technical requirements:

[0130] To allow the combination of the titanium and its alloys workability with the biocompatibility of zirconium. This means that the implant elements that will undergo mechanical workingfor example, thread of various shapes and dimensions shall be made of titanium and the remainder of the body with role of facilitating the osteointegration will be made of zirconium oxide. Considering things only under this aspect, the zirconium oxide to titanium ratio shall be as high as possible. Furthermore, if a subject proves very sensitive to the titanium presence in the implant, he may have the option of an implant which, though includes titanium in its body, this has to be only at its inner side and cannot come into contact with the surrounding tissues.

[0131] To be possible the correlation of implant characteristic of elasticity with the one of the jaw or mandible portion where it is to be inserted. This means that the stomatologist, depending on the concrete case to be solved, shall have the pos suability of choosing a more rigid or more elastic implant, depending on the place this is to be inserted.

[0132] In order to accelerate the restoration of tissues affected upon insertion of the implant and implicitly the osteointegration thereof, it shall allow the incorporation therein of one or more implant elements, and/or attaching one/some intra-oral devices made up of a composition known and accepted by the practitioners for the fact that it has a stimulative action on the progenitor cells and produces the restoration of all affected tissues, since it contributes to lowering the magnetic reluctance and/or has the role resonator for electromagnetic waves existing in the buccal cavity.

[0133] The dental implant with increased biocompatability, as claimed by the invention, is made, in a first embodiment, presented in FIGS. 1 to 8, as an assembly consisting of several items, each having a well established role in implantation itself, in increasing biocompatibility and accelerating osteointegration. This first embodiment includes a central rod with upper head 1, hereinafter called briefly only the central rod 1. It may be made of usual titanium alloysalloys that are known, per se and used at the moment, for example grade 5 titanium, being the most used. The implant may be made of the new type of titanium-zirconium alloy called roxolid. The central rod 1 has a multiple role. First, it has the role of taking over both the torsion stresses occurring during the implanting proper and the compression and bending stresses occurring during mastication. Then, at the lower end of the rod there may be arranged, as in the present case, a self-threading leading head 2 (see also FIG. 5), made of the same material as the rod in order to avoid the formation of an electrical cell 4 and at the same time for allowing a lasting adheringby any adequate processbetween the two components 1 and 2. This solution also allows the combination of grade 5 titaninm, recommended for making the self-threading head, with grade 2 titanium usable in the outer shell. The head 2 is provided for the same purpose with a cutting thread with one or more beginnings and some cutting teeth a.sub.1. Moreover, a self-threading head 2 made of titanium, provided with cutting teeth, has the advantage that it contributes to the increase of the primary degree of stability and will allow the insertion of a predominantly ceramic implant also ino regions with fragile bone, such as for example, immediately post-extraction. The third item of the assembly is a central body, or, in other words, a central shell 3 (see also FIG. 6), preferably made up only of zirconium oxide, in order to facilitate the implant integration into the mandible bone or into the jaw. However, it may also be made of porous titanium, grade 2 titanium or titanium-zirconium alloy, namely roxolid, that was already mentioned. To the outer side of the central body 3, we can add various compositions for increasing the biocompatibility, for example proteins or various minerals, solution known per se. This shell may have a cylindrical or slightly conical shape and preferably, it shall be threaded to the outer side or at least provided with a relief design a.sub.3 which should allow the o anchoring thereof inside the dental bone, or it may be smooth, if made of porous titanium. The central body 3 may surround, at a certain distance, the central rod, so that between it and the rod there exists a small empty space a.sub.4 wherein there may be introduced a composition for accelerating the implant biointegration, said composition being as a powder or, where appropriate, the fourth element of the assembly, namely a hollow part 4 may be introduced (see FIGS. 2, 3a and 7), said hollow part being made by pressing from said composition. For the role of part 4 in accelerating osteointegration we can call it active pastille. It is true that zirconium does not conduct heat, but the rod is made of titanium and titanium has a good thermal conductivity. Consequently, the heat in the mouth is also o transmitted by means of the rod to element 4 that has the role of resonator for the regenerating frequencies in the subject's mouth, activating it additionally. The transmission of these frequencies through the zirconium shell is very good, this being the major advantage of zirconium oxide. As a matter of fact, this is the basic mechanism for increasing our implant biointegration. From those mentioned above, it has been ascertained that we have an assembly of parts madein view of reaching the proposed purposeof different materials, fact that entitles us to call it a hybrid. After mounting them, the obtained assembly is stiffened through a process of adhering or welding the terminal end of the central rod 1 to the front part of the leading head 2. The joining may be made by a simple pin, not represented here, which diametrically penetrates through both parts. This version will be further presented within this paper. For avoiding the formation of an electrical cell, this pin will also have to be made up of a material identical to the material for parts 1 and 2. We mention here, if still necessary, that the ensuring of a joining of more parts through a pin is a process very used in techniques and it is practised in the top field of techniques, in building motor vehicles, in aviation, in armament industry etc. Said pin shall form with the parts it penetrates a tightening fit. It is introduced, for example, by pressing or by other process adequate to said case and may only be extracted by the application of a force at least equal to and of reverse sense.

[0134] The central rod 1 is providedsee FIG. 4with a polygon-shaped or slightly frustoconical-shaped cylindrical head b.sub.1 lengthened by an polygon-shaped elongate portion b.sub.2 along which all the other items are to be mounted.

[0135] The polygon shape of the elongate portion b[sum] is first necessary since the self-threading leading head 2 shall be entrained in rotary motion by rotating the rod and second because the leading head 2 and the central shell 3 are threaded externally and the two threads will preferably be arranged one in the extension of the other, which is made easier by rotating them, by 60 degrees about the sides of the elongate polygonal portion b.sub.1. The other end of the rod 1 has, as we have already said, the shape of a slightly frustoconical or even polygonal cylindrical body of a diameter approximately equal to the outside upper diameter of shell 3. To its inner side the head bi may be provided with an axial hexagonal cavity, b.sub.3 also continuing axially with a relatively short threaded portion b.sub.4, as the prosthetic blunt is to be screwed in therein.

[0136] In the hexagonal cavity 3 of the upper end bi of the central rod 1 there may be first arranged a healing/cicatrising blunt 5represented in FIG. 8and then, after cicatrising, a prosthetic blunt known per se, whereon the dental crown is to be carried out. They can be tightened on the desired position by means of a screw, solution that is also known. The hexagonal cavity i>3 helps both to insert the implant into the alveolar bone and to mount the prosthetic blunt into the most favourable position with regard to aligning the teeth.

[0137] As particular versions of this first embodiment of the implant claimed by the invention we can notice that we can also carry out the head b.sub.1 with a hexagonal shape to the outer side which serves both for inserting the implant into the alveolar bone or for mounting a prosthetic blunt provided itself with as corresponding hexagonal cavitysee FIGS. 38 to 41. At the same time, the shell 3 may be anchored to prevent twistingin case when its inside diameter is larger than the diameter of the circle inscribing the polygon of portion b.sub.1. The thing is carried out very easy by various details of shape such as hexagonal portions or by some fins as the ones represented in FIGS. 13 and 17 and then all the versions presented in FIGS. 20 to 34. This type of implant allows the stomatologist to select, depending on the subject's health condition, age etc an implant with or without the active cartridge 4.

[0138] This type of implant can also be carried out without the inner space a.sub.4 destined to a composition for accelerating osteointegration, in this case the shell 3 will be made slightly more voluminous. However, we state precisely that all the versions with central rod described here allow to insert therein a composition, only by creating a play between the central rod and the shell made up of zirconium or any other material.

[0139] In a similar construction thereof, the self-threading leading head 2 may be given up, wherein the outer shell can be closed at the bottom side and the rod 1 will also be ensured by a pinsee FIG. 13and will entrain said shell in rotation motion upon implanting, also by means of a polygonal, for example hexagonal cavity.

[0140] The second implant embodiment represented in figures from FIGS. 9 to 12, shows a glass-shaped hollow implant body 6, namely a body open only at the upper side and closed at the lower side, so that an empty apace c.sub.1 is created therein. In its lower side a central core 7 is introduced to be anchored in the implant body by a short simple twisting. For this purpose, the hollow body 6 is provided at the upper side with some short L-shaped channels c.sub.2. The central core 7 is provided with some prominences c.sub.3 that may engage in channels c.sub.2. It can be observed from the drawings that the core 7 is introduced axially into the hollow body 6 and is rotated shortly for anchoring the same in said body. The two components are assembled in an extremely simple way. The composition as powder or as a cylindrical active pastille 8 may be introduced into the created space c.sub.1. The core 7 is made of alloyed titanium or roxolid and is provided at its inner side with an oval or hexagon-shaped machining made in correspondence with the employed prosthetic blunt. In order to insert the implant into the alveolar bone, the hollow body 6 is provided at its extreme upper side with a hexagon-shaped machining c.sub.4 made on a small portion of its length. However, implanting into the dental bone may be made by using an inner key adequate for the machining c.sub.4. To the outer side, the body 6 is provided with a thread of a known shape a3. The core 7 is further provided at its lower side with a thread c.sub.6. This helps to secure the prosthetic blunt by means of a screw passing there through. If the prosthetic blunt is also made from zirconium oxide, this type of implant is recommended to persons with completely special sensitivity to metals. The hollow body 6 will be made up of zirconium oxide, roxolid or alloyed titanium. Substances to increase biocompatibility may be added or not to the outer side thereof. FIGS. 13 to 17 present the third embodiment of the dental implant as claimed by the invention. This implant also includes a central rod with upper head 9 to be introduced into the hollow body 10 that is closed at the lower side and open at the upper side where the rod is introduced.

[0141] The manner of carrying out allows assembling of the two elements to be made by means of a securing pin 11. The rod 9 may be made in the manner known from embodiment 1. In other words, it is provided with an upper head di wherein the prosthetic blunt is introduced, and with a polygon-shaped, for example a hexagon-shaped portion d.sub.2, as in the first embodiment. The upper bead, for exemplification, is provided with a hexagon-shaped machining d.sub.3 which helps both to insert the implant into the alveolar bone and to secure the prosthetic blunt in the correct position. It further includes a machining d.sub.4 for assembling with a prosthetic blunt by the process with Morse cone. Nothing prevents making a machining for assembling, with the pr prosthetic blunt, by a thread, exactly as in the first embodiment, as the body b of the rod in the first embodiment can be processed for assembling with a Morse cone. In the present case, in the rod it is new the fact that at its joining with the hollow body 10, the polygon extension d.sub.2 is provided with two diametrically arranged lateral fins d.sub.5. These fins enter two recesses d.sub.6 made in correspondence, in body 10 presented in FIG. 17. The assembling of rod 9 with the hollow body 10 will be more steadfast. The body 10 is provided, as it could be expected, with a closed axial cavity d.sub.7 in which either a powder composition or an active pastille similar to the one already mentioned in FIG. 12 will be introduced. We remind that the central rod 9 with the hollow body is assembled by means of a securing pin 11. To this effect, through the two items 9 and 10 there will be drilled a hole d.sub.8 perpendicular to the longitudinal axis of the implant or laterally, perpendicular to the axis plane, but median to the two fins. It is to be added here the fact that the rod elasticity is depending on the titanium degree of alloying. For example, the grade 5 titanium is more rigid than the grade 2 titanium.

[0142] Due to the existence of the two lateral fins d.sub.5 it is no longer necessary for the extension d.sub.2 of the rod to be polygonal. It may also be circular, as the two fins take over the twisting moment and the pin has only the role of positioning, stiffening and securing the assembly. It is the manufacturer's choice to make the rod 9 polygonal or not in the section perpendicular to its rotation axis, or round, a version easier to carry out, since the inner cavity d.sub.7 will also be circular. As we have already mentioned, to the outer side the two elements 9 and 10 of the implant may be provided with a thread d.sub.9. As construction materials, the rod 9 may be carried out of titanium with its alloys, and the hollow body 10 may be carried out of zirconium oxide, porous titanium or alloys of titanium with zirconium. Steps may be taken to increase biocompatibility of said hollow body by depositing to the outer side thereof, by the process already known, growth proteins, minerals or other biological stimulants for integration.

[0143] FIGS. 18 and 19 present a concrete example of assembling a prosthetic blunt with the implant itself. The explanation given on FIG. 18 are, we hope, sufficiently explanatory. There was chosen the system for securing the prosthetic blunt by means of a resilient bush tightened by means of a screw passing through the inner part of the prosthetic blunt provided with a longitudinal channel. If the inner core/central rod are provided with inner thread (b.sub.4, c.sub.6) there will also be used a screw and the same shape of blunt.

[0144] Of the three given embodiments presented so far, only the first embodiment presents an implant provided with a leading head Z. We also give another embodiment, the forth one of the implant presented in FIGS. 20 to 24. As against the first embodiment, here things are a little reversed. The implant is made of an upper hollow head 12 made of alloyed titanium, or roxolid, an intermediary hollow shell 13 made up of zirconium or porous titanium and zirconia with its alloys, a self-threading head 14 and an assembling pin 15. To the inner side of the hollow shell 13 an active pastille 16, represented only in FIG. 21 may be introduced. We state precisely, in order to avoid misunderstandings, that in FIG. 20 the shell 13 is secured directly to the rod. This is the situation where the stomatologist considers that for a certain subject it is not necessary to take additional steps for stimulating regeneration. In the new embodiment, the self-threading head 14 is provided with a shank e.sub.1 of polygon shapefor example hexagon shapedin the cross section. Being provided with a supporting shank the self-threading head 14 will be easier to carry out, since there will nor be necessary to create auxiliary devices for gripping the same for machining. The upper hollow head 12 with the self-threading head 14 are assembled by means of a securing pin 15. To this end, the head 12 is provided at its lower side, starting from the end of the inner securing thread of the prosthetic blunt with a polygon shaped hole e[sum] made in correspondence with the dimensions of rod ei of the self-threading head 14.

[0145] In FIG. 22 we give another embodiment of the hollow head 12 and of shell 13. We have already mentioned this before, when we presented FIG. 17, but in a reversed version, FIG. 13, namely when the upper head is provided with a rod. The head 12 is made here (FIG. 22) with two radially arranged lateral extensions entering two lateral recesses e4 machined in shell 13. In this case, the twisting of shell 13 around the shank e.sub.1 of head 14 is prevented when between the shell and the shank ran active pastille 16 is interposed.

[0146] With reference to FIGS. 20 and 21 the distance between the terminal part of the inner thread of the hollow head 12 and of the terminal head of rod e.sub.1 of the self-threading head 14 may be shorter or longer depending on their length so that a space e.sub.5 may be created there between for introducing any type of active composition therein. This composition may be changed during the healing of the place for insertion of the implant. If it is not desired to create this space, then instead thereof, them may be achieved a separating wall e as presented in FIG. 24.

[0147] We have presented in detail the embodiments so far, fact which will allow us, to present only the main differentiating elements in the following embodiments.

[0148] FIGS. 25 to 27 present the fifth embodiment of the implant according to the invention, where the upper head is provided with threaded cavity for securing the blunt and with red for securing the same in the shell/body by means of a pin. The rod may also be polygonal, and in this case the fins e.sub.3 may be given up. We recommend however to carry out the two diametrical fins, since this solution may also strengthen the portion where the inner thread b.sub.4 may be carried out. This solution also has as advantages the creation of a longer inner space as well as the fact that the whole body of the implant may be of zirconium.

[0149] FIG. 28 to 31 presents another embodiment of the implant of FIG. 25 to 27, where the upper head of the implant is joined to the shell by adequate adhering or welding. The implant is secured against twisting only by fins e.sub.3 which enter the cavities e.sub.4. In other words, if there is available an adhesive biocompatible to the human body, the head may be joined with the shell by adhering. Similarly, the may be joined by any welding process which does not cause incompatibilities from a biological viewpoint. In this way, an even longer inner space f will be created. Where appropriate, the thread base e.sub.6 cover will be given up.

[0150] FIGS. 32 to 34 present another embodiment of the implant of FIGS. 1 to 6, where the self-threading leading head 2 securing to rod b.sub.2 of the upper plant head is carried out by the same pin 15. Here there were also maintained the fins e.sub.3 since, as we already mentioned, the threaded hole b.sub.4 will be reinforced.

[0151] FIGS. 35 to 37 present a new embodiment of the implant according to the invention, namely one where the body 16 thereof is carried out entirely of the same material, for example titanium oxide or roxolid. At the same time, this body is closed at it lower side with a plug 17, with a view to introducing the regenerating composition easier and it is provided with an inner hexagon b.sub.3 for inserting the same into the dental bone and with thread b.sub.4 for securing the prosthetic blunt. Although we think that it is no longer necessary, we repeat that this body is provided to the outer-side with a relief design a.sub.3. This embodiment has a further advantage, namely the fact that the implant may be carried out easily, both to the inner side and outer side only by mechanical machining on high output automatic machines.

[0152] FIGS. 38 to 41 present a version of the previous implant in FIGS. 35 to 37, according to the invention, where its body 16 is closed at its lower side with the same plug 17 for introducing the regenerating composition easier, but provided with an outer hexagon g for carrying out the insertion thereof. In our opinion, the advantage of this version would consist in that it may increase the inner hollow volume f.

[0153] At the same time the upper end will have a smaller diameter so as to create easily an adequate prosthetic blunt. It will be sufficient for said prosthetic blunt to cover only one of the outer hexagon sides.

[0154] FIGS. 42 to 47 present a favourite version of the implant claimed by the invention where its body 18 is provided to the inner part with an inner bush 19 threaded to the inner part, but hexagonal to the outer partin other words, it is identical to a simple hexagonal nutadhered or welded thereon, for assembling the prosthetic blunt. The bush 19 is arranged completely to the inner side of body 18, the biocompatibility condition of the adhering solution not being so severe. On the other hand, this implant body may be entirely made of zirconium, since it does not undergo any complex technological machining, for example thread. It is to be noticed that it may also be provided with an inner plug through which the active substance may be filled or, possibly, the welding of the bush to the implant body may be carried out. The hexagonal bush is arranged inside the implant body by providing a hexagonal machining h at the upper side thereof, said hexagonal machining being carried out in compliance with the hexagonal bush dimensions.

[0155] FIGS. 48 and 49 present a version that is partially similar to the preceding embodiment of the implant claimed by the invention, wherein its body 18 is also provided to the inner side with an identical inner bush 19 attached to it by adhesive or welded for assembling the prosthetic blunt, but at the lower side it is provided with another hexagonal machining h wherein it is also secured by attaching with adhesive or adequate welding, a self-threading leading head 14 similar to the head 14, with the only difference that it has a much shorter shank or rod i.

[0156] FIGS. 50 to 54 also present a preferred version of the previous implants in FIGS. 42 to 49, wherein a body 18 is similar to the two previous ones, but made even simpler, namely without the hexagonal machining h. In this case, a self-threading leading head 14 is screwed in the inner bush, in order to ensure the bush being maintained in position. To this end, the leading head is provided with a shank threaded in compliance with the thread of bush 19. The solution is very simple and recommended by us, since we do not have to make any additional works to maintain the inner bush in position. All implants, from 48 to 54 also have the advantage that, by being provided with self-threading head they ensure a very good primary stability, even if they are of ceramics.

[0157] FIGS. 55 to 57, the version of the implant in FIGS. 50 to 54 wherein the self-threading leading head was substituted by a simple cap screw 20 that has only the role to ensure the maintaining of the inner bush 19 in position. In the specification the terms comprise, comprises, comprised and comprising or any variation thereof and the terms include, includes, included and including or any variation thereof are considered to be totally interchangeable and they should all be afforded the widest possible interpretation and vice versa. The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail.