Patent Application
20150150653
The present invention relates to a system and method for improving tissue regeneration at the cellular level. More particularly, the present invention relates to a system and method using electro magnetic fields for improving tissue regeneration at the cellular level.
In many varied fields of orthopedic and cosmetic procedures, lowering the period of healing of fractured bones and damaged tissues, as well as of the biointegration of implants, is a primary consideration.
The resorption of tissue and bone structure, affected by an implant or 5 otherwise, is a continuous process which takes time. The reason is a lowering of the local blood microcirculation and, in the particular field of dentistry for instance, results in dental mobility. The level of tissue integration depends firstly on the development rate of new cells in the region of surgical trauma. If the flow of these cells is high, a rapid neovascularization of the region is produced and the cells o can survive on the implanted material. The protoglycans layer may be reduced and the proportion of direct contact between bone and implant will increase in percentage. Normally, dead cells are immediately replaced by new progenitor cells, to be converted into osteoblast, cementoblast cells, etc, according to the specific character of that region.
Various technico-medical solutions have been developed for improving the biointegration of implants. The use of porous titanium, of zirconium oxide, the alloying of titanium with zirconium to obtain roxolid, are only a few known solutions for improving biocompatibility. Continuous research and development both in connected and in far removed fields of application have opened surprising avenues of further improvement in cellular regeneration.
In 1952, Doctor Winfried Otto Schumann of the Faculty of Science in Munich succeeded in demonstrating the theory that the terrestrial space comprised between the earth surface and ionosphere behaves as a wave guide and at the same time as a resonance box. The frequency spectrum of this space ranges approximately between 6 and 50 Hz, with the main average value of 7.83 Hz. As life on earth was created within this space, all that we call a living organism was adapted to this frequency. Vital functions of organisms deteriorate when not subjected to this frequency over extended periods of time. This explains why astronauts' bodies suffer important disturbances during extra-terrestrial flight, such as parodontopathy and osteoporosis. These conditions have since been at least partly prevented by artificially generating the 7.83 Hz frequency on board spaceships. Scientists have since discovered that, besides the basic frequency vital for each organism to function, the internal organs and cells constituting them also react favourably to other frequencies, some of them vital for their restoration when they have been subjected to lesions or when suffering from certain affections.
Further, James Oschman demonstrated that each normal or pathological event carried on within any organism, produces modifications of the electromagnetic field generated by said organism. Based on these principles, devices have been built for monitoring the heart, brain activity or to precisely determine an ovulation period. It was also Oschman who demonstrated that the muscle activity generates electromagnetic impulses that stimulate the cells regeneration, starting from the attraction of undifferentiated mesenchymal cells, and that any affection, such as a lesion caused by surgery, determines the modification of the magnetic field in the region of tissue trauma. In other words, the modification in the number of capillaries is accompanied by an increase of the magnetic “reluctance” of adjacent tissues. This increase is also determined both by the minerals included in the tophus extant in that region, and by any local metal implants that disturb or prevent the normal, regenerating magnetic field resulting from the Schumman magnetic frequencies and the biological cell oscillations. From the aspects presented above, a conclusion may be drawn that the bio-integrability of an implant, impeded by the increase of the magnetic reluctance in the region due to wounding the tissues, due to tophus, microbes extant in the region as well as the insertion of any metal implants, can nevertheless be hastened by bringing the regenerating magnetic field to normal values.
Sisken and Walker have demonstrated that the frequencies of 2 Hz, 25 Hz and 50 Hz stimulate nervous regeneration, which is useful in implantology if hypoesthesia occurs following a surgical procedure. Sisken and Walker have also demonstrated that a 7 Hz frequency stimulates osseous regeneration and that a 10 Hz frequency stimulates ligament regeneration, which is for instance useful in parodontology for lowering teeth mobility. Sisken and Walker have also demonstrated that the 15 Hz, 20 Hz and 72 Hz frequencies stimulate the reformation of capillaries, this action being necessary after any surgical intervention involving osseous or soft tissue graft. Herbert Frachlich demonstrated that an assembly of cells forming a tissue or organ has a specific frequency that regulates the physiology of said organ, and that if a large number of cells are affected, then the frequency cannot be emitted any longer and the disease or dysfunction occurs.
The prior art described above shows that a healthy organ contributes to maintaining the health in its neighbouring region, however a diseased organ cannot do this any longer and suitable steps should be taken to remedy the situation. Unfortunately, in the buccal cavity in particular, the natural regenerating field is reduced, since the microbes and minerals extant in the tophus composition “steal” from the regenerating field intensity in order to mineralise themselves. It is known that the phenomena of healing by magnetic oscillations occur at low amplitudes of the field, with a magnetic induction of about 10−9 to 10−1° Tesla.
International patent application WO 2009/04215 A1 discloses an electronic apparatus meant to hasten tissue healing in the knee region, by means of a low-frequency electromagnetic field. The apparatus belongs to a system meant to heal tissues and bones having different affections, and it is further provided with an electric circuit for magnetic field pulse control.
In order to solve the partial edentition problems there are known and applied a great variety of shapes of metal implants usually made of titanium, more or less alloyed, since this is sufficiently well tolerated by the human body, it is easily workable, has a good mechanical strength to compression, torsion and bending and, consequently, allows to achieve compound dental implants also called “in two surgical stages”, which have the advantage of giving the doctor the opportunity of selecting the prosthetic work type favourable to the subject, allow to comply with the hibernation period necessary for integrating the implant and favours the mounting of parallel prosthetic blunts for carrying on thereon dental crowns perfectly adapted to said case.
Subsequently, more researchers ascertained that the osteointegration time of an implant diminishes in case of carrying out the same from a ceramic material, more exactly zirconium oxide, since, in comparison with titanium for example, this is better tolerated by the organism and at the same time has the quality of not favouring the formation of electric cells even if combined with different other metals. Practically, there exist only few subjects allergic to this material, this material being both biocompatible and bioinert. Then, the zirconium is preferred also with regard to the thermal conductivity. It does not conduct heat so that the thermal variations are not transmitted to the alveolar bone. This is extremely important particularly when the implant shall be adjusted by grinding right in the subject's mouth. Moreover, even if it does not conduct heat, the zirconium oxide conducts the regenerating low frequency oscillations existing in the buccal cavity very well.
We shall also add here the fact that both titanium and zirconium, with their alloys, are used in implantology also for the reason that both have the characteristic of not inhibiting the growth of osteoblasts, which are essential cells for osteointegration.
Given the high qualities of zirconium oxide in respect of the osteointegration, it was tried to achieve compound implants, consequently implants to be inserted in two surgical stages and made of this material. Unfortunately, this was not yet possible due to low zirconium oxide workability, characteristic that has as effect that certain fineness operations, among which threading, cannot practically be carried out for the time being in an optimum way, such as in metals. Consequently, materials with increased biocompatibility, such as zirconium oxide and other ceramics, do not allow to obtain a self-threading region at the implant tip, nor the carrying out of an internal thread resisting in time, through which the connection between the prosthetic blunt and the implant proper can be made. As such, the implants made of zirconium oxide are usually carried out as a single item—reason for which they are also called one-piece implants—and the construction of the dental crown thereon is very difficult. This is due to the fact that on such implants only cemented works can be done, at the moment there being practically impossible to carry out threaded works.
It has not been possible so far to carry out viable implants which should combine workability and the mechanical qualities of the titanium with zirconium biocompatibility.
It is to be mentioned that the JP 2009254547 (A) patent application of 2009 Nov. 5 points out the fact that a composition comprising octacalcium phosphate can successfully contribute to osseous regeneration. Generalising, the researches carried out by numerous specialists demonstrated that there exist other mineral substances that help in normalising the cellular membrane level exchanges and enzymatic equilibrium regulating.
The patent application FR 2926460 of 22.012008, having Messers Gilles Gutierrez and Bogdan Vladila as authors, presents a first use of opal in dental surgery, with a view to accelerating the growth of osseous mass, disposed around an implant or around a tooth root. To this end, there is prepared a composition comprising natural or synthetic opal—in a ratio of 0.5 up to 20%, preferably between 1 and 10%—incorporated in a mass of easily polymerizable or fusible polymeric material. By the researches performed by the two authors, it has been ascertained that the existence of opal in this composition causes three times higher cell migration, particularly of osteoblasts, cementoblasts, fibroblasts or keratinocites, than in the default thereof. In other words, things happen as if opal would transmit a signal that calls said cells towards it. The solution can also be applied in the field of dental implants in order to succeed to improve the implant integration into the alveolar bone.
The same authors subsequently filed, on Jul. 10, 2008, also in France, with no. 0803921/FR 2933610 another patent application entitled “Opal based composition for the treatment of dental affections”. The composition includes an opal powder that is incorporated into the thermofusible polymer mass selected from polyolefins, such as polyethylenes or polypropylenes, alone or in admixture. From this mixture there is obtained a mould, customarized to each subject through a dental guard, with a view to periodontal regenerating. The obtained results mentioned by the authors within the application are very promising. It has to be added here that the application of the solution continues at present and the results are remarkable. The author of the present invention has treated more than 100 subjects so far by the use of such a guard.
The authors also demonstrated that the cell migration is carried out even if there does not exist a direct contact between opal—or a composition comprising opal—and the affected tissue. However, this migration is influenced by more factors, among which the subject's oral hygiene, age, material interposed between opal and the affected tissue and the opal concentration of a certain mixture. Then it was demonstrated that neither titanium nor zirconium hinder too much the signal transmitted by opal to the distance, signal that determines the cell migration. However, zirconium favors the transmission of this signal to a greater extent than the titanium. Even if, for a certain type of implant, the area occupied by the zirconium oxide cannot be too large, this is to be created, since zirconium is the one to favor the regenerating signal transmission better than any other metal. These experiments also reconfirmed the theory that the natural tooth itself seems to emit the signal which attacks towards it the progenitor cells with the purpose of regenerating what is destroyed due to the microbial activity. This regenerating signal intensity lowers with the age, and the tophus shields the transmission thereof. Unfortunately, the actual implants do not favor the transmission of this type of signal, reason for which they are more vulnerable in front of the mentioned degenerating agents.
It is well known the fact that the crystals resonating action increases between some limits also because of the increase of their temperature. The frequency normally generated whenever a subject drinks warmer liquids is consumed, a part for regenerating the parodontal tissue and another part for forming the tophus. Hence, the importance of periodically removing the formed dental tophus.
It is scientifically demonstrated by the researchers from the University of Gratz that salt crystals have a therapeutic action due to the vibrations generated. It is known that a positive effect is achieved by the vibrations present at the moment when a subject takes a bath in a tub wherein there is much natural salt at the constant temperature of 37[deg.]C. It is estimated that the water temperature shall be constant in order that the vibrations should have a constant frequency. This scientifically demonstrated thing is also applied in case of the buccal cavity where, salt crystals will favour these frequencies normalising the cell equilibrium affected due to the ion changes produced by the microbes that are electrically charged.
There are studies that show that the calcium ion resonate to a 33.3 Hz frequency. This ion is present in any dental and peridental tissues. These oscillations of the mineral particles can exist by the action thereon of some electromagnetic waves frequently issued by various artificial sources, said waves putting them in a synchronous oscillation condition, to specific beneficial biocompatible frequencies.
The experimental results to this effect were also obtained by K. Imamura in 1991 who, by placing plants into simple tap water and into tap water in which some minerals were put, has ascertained that after three weeks, the plant in the non-treated water dried, while the plant in the water with minerals was still green. It was concluded that the emission in infrared, within the wave length spectrum: 2,000-25,000 nm has beneficial vibratory effects on the ions at the cellular membrane level, balancing the ion exchange between the outside and inside of the cell and making the cellular membrane more permeable to nutritive substances, that lengthens the cell life. This effect is also manifested in animal and human tissue cells, as shown by the researches.
A system for increasing organic cell regeneration in a cellular medium, comprises:
an electromagnetic (EM) field generating device adapted to produce a constant EM field of less than 1 mT at a user-adjustable radiation frequency 7,69, 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.
According to an aspect of the present invention, the composition includes crystalline structure minerals with particle size 20-150 nm.
According to an aspect of the present invention, the composition includes human or animal tooth crystals.
According to an aspect of the present invention, composition is obtained of natural salt, volcanic rocks and/or animal horns, alone or in admixture.
According to an aspect of the present invention, 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.
According to an aspect of the present invention, the EM field is substantially 0.75 mT.
According to an aspect of the present invention, field is generated as a pulsed signal having a substantially rectangular waveform.
According to an aspect of the present invention, system is for increasing proliferation of the primary cell preferably maxillary bone and gums.
According to an aspect of the present invention, the may be as loose powder or pressed in the shape of teeth or implant cavity.
According to an aspect of the present invention, the device further including a polymer in admixture with the composition in the shape of area to be regenerated.
According to an aspect of the present invention, device further including coils excited to form an electronic device for generating biocompatible frequencies to harden bone and dentine.
According to an aspect of the present invention, the system is for slowing down the tissues resorption in preventive purposes and implicitly for accelerating their healing.
According to an aspect of the present invention, an implant is provided with activation coils excited by an electronic device generating regeneratives frequencies.
The system and method, according the invention presents the following main advantages:
it combines the biological qualities of some materials with low workability but high biocompatibility, with those of some materials with high workability and high mechanical strength, each of these materials being positioned in key regions and their combination being secure; for example it becomes possible to combine titanium so called grade 5 titanium, to make the self-threading head, with grade 2 titanium, with porous titanium, with zirconium oxide or roxolid elements at the outer shell level.
there also results a good primary stability of the implant due to the self-threading head combined with the biological qualities of the outer shell;
the adopted construction also allows to carry out pre-established elasticity implants by varying the ratio between the titanium elements mass and the zirconium elements mass that constitute the implant; thus, depending on the hardness of the bone portion where the implant is to be inserted, we could decide the type of implant adequate to said portion;
it allows the incorporation or attaching active substances favouring the restoration of affected cells and accelerates the osteointeg ration;
although it includes ceramic materials in a relatively high ratio, the implants permit however to carry out any prosthetic works, of the type possible only for metal implants, such as the screwed in works or rendering the prosthetic blunts parallel in the laboratory;
it is possible to change only the prosthetic blunt in case of fractures, implanting accidents etc, not being obliged to take out the whole implant; also, if there is an acute episode of periimplantite, the final blunt may be changed with a blunt with incorporated minerals, for example in acrylate or another high polarity polymer, for a more rapid regeneration;
there is not possible the formation of electric cells in case of combining zirconium oxide with titanium; nevertheless, some embodiments of an implant in compliance with the present invention are destined to be used in case of some extremely sensitive persons, since the only titanium element is disposed inside an implant body entirely made of zirconium, and the prosthetic blunt may be carried out only of zirconium oxide; also, if different devices generating electromagnetic waves are used, galvanism cannot occur, as the crown head of the implant is made of zirconium oxide;
possible contact regions between the component elements are located below the median third part of the implant, namely where it is no longer necessary to try to treat a possible periimplantite, but it is already demonstrated that the whole implant has to be replaced;
the use of prosthetic and/or healing blunts of a composition adapted to said case favours the osteointegration of the implant and reduction of the possibilities of post-surgery dehiscence and periimplantite occurrence. It is to be mentioned that said blunts may be used not only for the implant claimed by the invention but to any other types of implants already existing on the market;
while the dental implants are made in plants with homologated working conditions, the dental devices to be applied onto the implant may be made both in plants and in dental technique laboratories, there resulting pivots and incrustations, crowns and bridges, prosthetic and healing blunts made of materials with a high degree of polarity, acceptable physionomy and resistance, etc;
incorporating compositions in cements and materials for obturation ensures, besides the role of resonator for the regenerating frequencies, the improvement of the expansion coefficient, consequently, implicitly, a longer duration of resistance of the prosthetic work.
Other aspects are as set out in the claims herein. Brief Description of the Drawings For a better understanding of the invention and to show how the same may be carried into effect, there will now be described by way of example only, specific embodiments, methods and processes according to the present invention with reference to the accompanying drawings in which:
FIG. 1—a general axonometric view of a dental implant, according to the invention, in a first embodiment, having the healing blunt mounted;
FIG. 2—a general axonometric view, with partial axial section through the same implant, but without healing-cicatrising blunt;
a, b—a longitudinal section about the plane A-A through the implant
a, b, c—a longitudinal section about the plane C-C, through the central rod of the implant
FIG. 5—general axonometric view of the self-threading leading head;
FIG. 6—longitudinal section through the central frustoconically shaped shell, in the externally threaded version;
FIG. 7—longitudinal section through a hollow type active element made of a composition accelerating the osteointegration;
FIG. 8—longitudinal section through a healing blunt;
FIG. 9—general 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;
FIG. 11—general view of the central core of the implant;
FIG. 12—general view of the element for accelerating the osteointegration;
FIG. 13—general 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;
FIG. 14—longitudinal axial section, according to plane A-A in
FIG. 15—longitudinal axial section about the plane B-B of
FIG. 16—top view of the same implant presented in longitudinal section in
FIG. 17—general axonometric view of the implant shell/body, in the third embodiment, presented in
FIG. 18—general axonometric view, with partial section of an implant similar to the one in the third embodiment,
FIG. 19—general axonometric view of the prosthetic blunt, secured by screw;
FIGS. 20 to 23—general 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;
FIG. 24—version of the implant presented in
FIGS. 25 to 27—the 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;
FIGS. 28 to 31—other version of the implant of
FIGS. 32 to 34—version of implant of
FIGS. 35 to 37—version 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;
FIGS. 38 to 41—version 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;
FIGS. 42 to 47—version 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;
FIGS. 48 to 49—version 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;
FIGS. 50 to 54—version of the implant of
FIGS. 55 to 57—version of the implant of
FIG. 58—principle diagram of an electromagnetic field generating device, apt to generate frequencies biocompatible with the human body.
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.
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 a 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.
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.
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
The device was realised pursuant to the general structure shown in
The test protocol was as follows:
A tube containing 1.106 cells was defrosted then mixed in 29ml MCDB153.—Petri dishes were then primed with 5ml of the cell suspension, and placed in an incubator at constant 36.5[deg.]C, 5% CO2.
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.
2 petri dishes were placed at least 30 cm away from each device, to serve as a control for the testing.
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 (J4) days.
The cellular count on the fourth day of the test was as follows:
Control 1560000 cells
DM 1—1860000 cells
DM 2—2140000 cells
DM 3—2060000 cells
DM 4—2360000 cells
DM 5—1820000 cells
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%.
After three days of cultivation, with reference to Table 2 hereafter, a zone of confluence was 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.
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.
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 advantage—very important—can 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 of 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
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.
The special construction of the implant consequently allows the integration therein, even from the factory, of some 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,
After the implant insertion, the periimplantar healing passes through many 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 individualized response depending on the subject's reactivity and on the periimplantite occurring hazard.
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 from a ground human tooth cannot be provided in a large amount, it is recommended to use them intra-orally.
Also as a particular case, the 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.
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.
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.
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:
favor the production of the secondary biocompatible radiation;
determine the formation of a new dentine—called secondary dentine;
bring the thermal exansion factor of different materials close to the natural tooth coefficient, thereby avoiding fractures.
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.
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.
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 cells—treatments 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 biocornpatible 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 fields cosmetics, 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.
Other tests are conducted by the National Institute for Chemical-Pharmaceutical Research and Development—ICCF, 112 Vitan 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.
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.
The cellular model is based 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.
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.
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).
Results of exposure is shown below, in Tables 3, 4 Si 5
In conclusion, In the case of cells exposed both to minerals (topaz, aragonite and implants of zirconia) 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.
With reference to
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 working—for 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.
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.
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 of resonator for electromagnetic waves existing in the buccal cavity.
The dental implant with increased biocompatibility, as claimed by the invention, is made, in a first embodiment, presented in
The central rod 1 is provided—see FIG. 4—with a polygon-shaped or slightly frustoconical-shaped cylindrical head b1 lengthened by an polygon-shaped elongate portion b2 along which all the other items are to be mounted.
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 b1. 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, b3 also continuing axially with a relatively short threaded portion b4, as the prosthetic blunt is to be screwed in therein.
In the hexagonal cavity 3 of the upper end bi of the central rod 1 there may be first arranged a healing/cicatrising blunt 5—represented in FIG. 8—and 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.
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 b1 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 a corresponding hexagonal cavity—see
This type of implant can also be carried out without the inner space a4 destined to a composition for accelerating osteointegratlon, 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.
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 pin—see FIG. 13—and will entrain said shell in rotation motion upon implanting, also by means of a polygonal, for example hexagonal cavity.
The second implant embodiment represented in figures from 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 space c1 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 c2. The central core 7 is provided with some prominences c3 that may engage in channels c2. 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 c1. 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 c4 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 c4. 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 c6. 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.
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 d2, as in the first embodiment: The upper head, for exemplification, is provided with a hexagon-shaped machining d3 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 d4 for assembling with a prosthetic blunt by the process with Morse cone. Nothing prevents making a machining for assembling, with the 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 d2 is provided with two diametrically arranged lateral fins d5. These fins enter two recesses d6 made in correspondence, in body 10 presented in
Due to the existence of the two lateral fins d5 it is no longer necessary for the extension d2 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 d7 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 d9. 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.
Of the three given embodiments presented so far, only the first embodiment presents an implant provided with a leading head 2. We also give another embodiment, the forth one of the implant presented in
In
With reference to
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.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 201001010 | Oct 2010 | RO | national |
| PCT/RO2011/000004 | Feb 2011 | RO | national |
| 201100444 | May 2011 | RO | national |
| PCT/RO2011/000019 | Jul 2011 | RO | national |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13881627 | Apr 2013 | US |
| Child | 14538260 | US |
