Patent Application
20220304780
The present invention relates generally to devices and/or instruments for the controlled exertion of dental implants from the jawbone. More specifically, the invention relates to implant exertion devices which combine different energy sources to aid in demineralizing and loosening the implant-bone interface resulting in a rapid, minimally-invasive and non-traumatic retrieval of the integrated screw of the implant.
The present invention also refers to a method or system for the retrieval of an osseointegrated dental implant by using a combination of thermal energy and vibration energy.
Dental implants have changed the field of Dentistry. Dental implants are designed to be a permanent replacement for missing tooth or teeth and are a popular alternative to removable dentures or fixed bridges. Implants anchor artificial teeth directly into the jawbone (this is known as osseointegration) which makes them a more functional and aesthetically-pleasing restoration. Today, the use of dental implants is widespread. However implant success is controversial. 90%-95% has been reported as the success rate of implants over the 10 years. It's estimated that about 5 to 10 percent of dental implants fail, either shortly after a procedure or months or years later. In any case, according to the National Institutes of Health, there are over 100 million people with missing teeth, and the demand for implant dentistry is higher than ever. Indeed, at least several million dental implants are currently in the jaws of patients around the world, with an estimate of 2 million new implants being placed annually. Nonetheless, as explained above, their potential for clinical failure is yet a significant concern for both patients and dentists. As with any other surgical procedures, there is a variety of internal and external factors that cause complications or even total failure of the treatments, and dental implants are not an exception. As cited above, at least 5% to 10% of dental implants fail every year. This translates into around 200,000 to 500,000 failed implants annually. Over the time, this percentage of dental implants that fail is expected to increase, due to several biological and technical issues. Inevitably, clinicians will dedicate more time than before to deal with wrong-positioned and failing implants.
When a dental implant has to be removed, whether due to unsuccessful insertion, fracture or peri-implantitis (chronic cervical infection causing marginal bone loss and loss of control of infection around the dental implant), the surgeon faces with a lack of efficient tools designed to facilitate the unscrewing of the dental implant without destroying it or the neighboring teeth and tissues. Hence, the only way to remove them is by performing an open surgery. However, the major problem associated with this time- and cost-consuming operation is that tools strong enough to unscrew the dental implant are also not available. Thus, the surgeon is faced with the challenge of removing the dental implant with unsuited utensils (such as tools used for exodontias), thus assuming a considerable risk of overheating and/or inducing direct trauma. Alternatively, the surgeon has to grind away the jaw bone surrounding the dental implant in order to expose part of it and achieve a better grip on the dental implant so to release it from the surrounding bony structures. The latter procedure normally entails extensive bone loss, also bearing the additional risk of damaging neighboring vital structures.
Among the known methods for dental titanium implant removal which are available in the prior art are the following: counter-ratchet technique, reverse screw technique, piezo-tips, high-speed burs, elevators, forceps and trephine burs that remove peripheral bone. All of these techniques are considered to be invasive and traumatic for the patient, mainly due to the exertion of excessive and damaging mechanical forces and thermal energies. Moreover, these methods are associated with healthy bone sacrifice, thus requiring bone grafting procedures afterwards.
Therefore, there is an unmet medical need to find better solutions and devices for the safe, rapid and non-invasive retrieval of dental implants.
Precisely, the present invention is focused on solving the above cited problems by providing a device and a methodology which can be effectively and safety used in the controlled exertion of dental implants from the jawbone and that, at the same time, substantially reduce the injury risk caused by the over-heat and/or bone degeneration effects, which can even lead to mucosal and bone necrosis.
According to the present invention, a process and a device have been developed which allow a fast, effective, atraumatic, safe and one-piece removal of osseointegrated dental implants.
In a preferred embodiment, the process and the device of the invention are characterized by the combined, controlled and measured application of thermal energy with ultrasonic vibrations, in order to destroy the interface or bone-implant union with the minimum damage or injury for the peri-implant tissues.
According to the present invention, the methodology and the device of the invention will confer, among others, the following advantages:
It is thus an object of the present invention to provide a device and/or instrument capable to control the application of combined and safe energies (thermal and vibration energy) to aid in releasing the implant-bone interface (for example by means of the dissolution, demineralizing or breaking-down the implant-bone interface) resulting in a rapid, non-traumatic and sound retrieval of the osseointegrated screw from the jaw bone, with minimal removal torque and thus with minimal or diminished necrosis/loss of surrounding bone.
Said object is preferably achieved by means of a device for the retrieval of an osseointegrated dental implant comprising, at least:
The temperature sensor can be either i) connected to the application head or to the adapter (for measuring the temperature in the device, in the dental implant or the surrounding tissues thereof) or ii) being a wireless temperature sensor.
As a result, the device is capable of timely combining the minimum and safest possible temperature with a comfortable and effective ultrasonic vibration frequency for the shortest required time, in order to achieve non-traumatic and sound implant retrieval by using the minimum possible torque force.
In a preferred embodiment of the present invention, the first source for applying thermal energy comprises an electro-cautery unit.
In a preferred embodiment of the present invention, the second source for applying vibration energy is adapted to operate in the ultrasound frequency band.
In yet another preferred embodiment of the present invention, the application head and the adapter of the device are coupled through a threaded connection, being preferably internally connected to the application head.
In yet another preferred embodiment of the present invention, the head and the adapter comprise coincident central and connected channels, arranged so that the energy sources can be applied inside the dental implant. This results in a more focused and localized effect on the implant, thus optimizing the extraction processes thereof.
In yet another preferred embodiment of the present invention, the temperature sensor of the device is adapted for its insertion into the housings of the head. Therefore the internal structures of the device are optimized for housing connections to every external element thereof.
In yet another preferred embodiment of the present invention, the temperature sensor is coupled to the adapter by means of a side housing arranged in said adapter.
In yet another preferred embodiment of the present invention, the device further comprises an auxiliary application arm, adapted for providing support to the thermal and/or vibration sources when they are applied to the device. The auxiliary application arm can be used for improving stability and precision during the delivery of energy to the implant through the thermal/vibration first and second energy sources.
In yet another preferred embodiment of the present invention, the thermal and vibration energy sources are combined for their joint application through one of the housings of the device. More preferably, both sources of energy are coupled through a ceramic isolation element and applied to the head as a combined energy source.
A further object of the invention relates to a device according to any of the embodiments described in the present document, for use in the retrieval of an osseointegrated dental implant.
A further object of the invention relates to a system for the retrieval of an osseointegrated dental implant, comprising a device according to any of the embodiments described in the present document, combined with at least a first source of thermal energy and a second source of vibration energy.
A further object of the invention relates to a system according to any of the embodiments described in the present document, for use in the retrieval of an osseointegrated dental implant.
A further object of the invention relates to a method for preparing an artificial dental implant prior to its insertion in a jawbone, comprising the use of a device or a system according to any of the embodiments described in the present document, comprising the realization of at least the following steps:
In a preferred embodiment of the present invention, the method further comprises the application of thermal energy and vibration energy to the dental implant by means of the first thermal energy source and the second vibration energy source of the device.
The characteristics and advantages of this invention will be more apparent from the following detailed description, when read in conjunction with the accompanying drawings, in which:
In order to provide a better understanding of the technical features of the invention,
(4′)
(5′)
(8′)
In the following description, for purposes of explanation and not limitation, details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments that depart from these details and descriptions without departing from the spirit and scope of the invention. Certain embodiments will be described below with reference to the drawings wherein illustrative features are denoted by reference numerals.
As shown in
The adapter (2) is also connected to an application head (4) comprised in the device, which is equipped with a plurality of housings (5) configured to receive thermal and vibration energy (6, 7). The application head (4) and the adapter (2) can be coupled, for example, through a threaded connection (4′) (
The main mode of operation of the device of the invention is thus based on its fixation inside the dental implant (1), once its external elements (abutment and/or dental crown) have been removed therefrom. Once the device has been fixed to the implant (1), it is possible to subsequently apply the combination of thermal (6) and vibration (7) sources in the head (4) through the housings (5) arranged for this purpose. Said housings (5) preferably comprise connected channels (5′) (
In a preferred embodiment of the invention, the head (4) and the adapter (2) comprise coincident central channels (8, 8′), so that the energy sources (6, 7) can be applied inside the dental implant (1). This results in a more direct effect on the implant (1), thus optimizing the extraction processes thereof.
In a preferred embodiment of the invention, the device further comprises a temperature sensor (9) configured for its insertion into the housings (5) of the head (4), as shown in
In a further embodiment of the invention, the device can be equipped with an auxiliary application arm (11) (
In a further embodiment of the invention, the thermal (6) and vibration (7) energy sources can be combined for their joint application through one of the housings (5) of the device.
A further object of the invention refers to a system comprising a device according to any of the embodiments described herein, combined with at least a thermal energy source (6) and a vibration energy source (7).
In a preferred embodiment, the reception channels of the application head (5′), the central channel of the application head (8) and the central channel of the adapter (8′) are inter-connected (see
In a preferred embodiment, the adapter internal channel has a conical morphology or a rectangular morphology with two sections (the upper section is wider as compared with the bottom section) (see
This example has the purpose of characterizing the magnitude/distribution of thermal energy by using an electrosurgical unit or ultrasound individually on dental implants. In order to do this, the tip of the electrosurgical unit/ultrasound was placed in the center of the implant and the corresponding stimulus was applied for 5, 10 or 15 seconds (maximum allowed by the electrosurgical unit). The magnitude or distribution of thermal energy was recorded with a thermal camera.
Ultrasound: The ultrasound not only produced the desired vibrations, but also generated secondary thermal energy. The thermal energy was concentrated in the implant; generating a sudden increase of the temperature of the implant (20.53° C.-39.81° C. max) and the peri-implant bone at the cortical level (average 25.44° C. vs. basal 20.47° C.). The temperatures reached in the bone/implant interface are well below to those necessary to induce a desired effect.
Electrosurgical unit: The use of electrosurgical unit produced a slight increase in the temperature of the implant concentrated mainly at apical level (23° C.-28.5° C. max, delta T°=5.5° C.). The apical peri-implant bone reached a maximum temperature of only 26.9° C., which remains low to induce the desired effects.
Ultrasound: Again the generation of vibrations and secondary thermal energy was observed. The thermal energy was concentrated in the implant, generating an abrupt increase of the temperature of the implant (20.84° C.-33.97° C. max, delta of T°=13.13° C.) and of the peri-implant bone at the cortical level (27.91° C. average vs. 21.73° C. basal). The temperatures reached in the bone/implant interface are well below those necessary to induce effects with therapeutic potential.
Electrosurgical unit: The application of electrosurgical unit produced a slight increase in the temperature of the implant concentrated mainly at the apical level (24° C.-31.63° C. max). The increase in time from 5 seconds to 10 seconds generated a greater temperature (31.6° C. max-24° C.=7.6° C.), however it remains insignificant for potential clinical applications. The greatest effects continue to be seen mainly in the apical part with poor distribution to the rest of the bone/implant interface.
Ultrasound: The ultrasound not only produced the desired vibrations, but also generated secondary thermal energy. The thermal energy was concentrated in the implant; generating a sudden increase in the temperature of the implant and of the peri-implant bone mainly at the cortical level. Although sufficient temperatures were reached to induce bone necrosis, thermal energy was concentrated mainly in the marginal cortex; poorly propagating to the rest of the bone/implant interface (apex). Considering that the basal temperature at the time of application was 20.47° C. average, the temperature that could be reached in vivo in a bone at 37° C. is a concern. On the other hand, the fact that thermal energy is concentrated mainly at the cortical level and poorly diffuses to the rest of the bone/implant union reduces the therapeutic effect of its application.
Electrosurgical unit: In contrast, the use of the electrosurgical unit produced a greater dissipation/propagation of the thermal energy through the bone/implant junction, showing greater homogeneity in the temperatures registered in the cortex vs Apex. Despite of this, the temperatures reached are low enough to generate the desired effects (mainly due to the low power of the equipment and the limitation of the manufacturer in terms of the maximum application time of only 15 seconds). Higher power/time of application of the electrosurgical unit could increase the thermal energy to clinically useful values, however, it concerns the uncontrolled dissipation of thermal energy to the peri-implant tissues (given that in the case of monopolar electrosurgical unit the thermal energy diffuses from the active pole to the receiver).
The previous experiment was repeated using the device of the invention, but by applying individual energy. In this case it was decided to apply individually 15 seconds of ultrasound or electrosurgical unit since the intention was to generate the maximum thermal energy. The purpose was to characterize the magnitude/distribution of thermal energy by using electrosurgical unit or ultrasound individually through the device of the invention. The device of the invention allowed the free transmission of the ultrasonic vibrations from the ultrasound to the implant. The invention device controls or guides or focuses the propagation of the vibrational as well as heat beam cortical to apex. The device allowed the free transmission and dissipation/homogeneous propagation of the thermal energy of the electrosurgical unit (main source of thermal energy generation in this model) to the whole bone/implant interface (cortical vs. apex).
When the temperatures reached in the bone/implant interface are below to those necessary to induce a therapeutic effect, in a preferred embodiment both thermal and vibration energy are combined to reach the desired temperature.
The objective is to maintain at least 45° C. within the implant itself and throughout its length within the bone, for the longest time possible, as this accumulative temperature is safe and comfortable for the patient, and effective in demineralizing the bone-implant interface. Specifically the objective is to maintain said 45° C. until the titanium fixture/screw/implant is retrieved from the bone.
The specific protocol for reaching this temperature by combining thermal and ultrasound energies directly depend on different factors, for example the equipment used (brand, quality, efficiency, power, resiliency) in the clinical setting.
Nevertheless, just with the objective of proving one of the possible protocols for reaching the desired temperature, this example shows the serial and combined use of the electrosurgical unit and ultrasound in cycles of 10 to 20 seconds (preferably 15-second cycles) interrupted by 25 to 35 seconds of rest (preferably 30 seconds of rest). Given the limitations of the electrosurgical unit, it was decided to increase the thermal energy generated by a serial or stepped application strategy. To do this, the electrosurgical unit or ultrasound was applied in cycles (10 cycles, each of 15 seconds of application followed by 30 seconds of rest). The purpose was to characterize the magnitude/distribution of thermal energy when applying the device following this new application strategy.
The combined application of thermal energy and ultrasonic vibrations following a stepped or serial strategy with the device of the invention allowed the generation of enough thermal energy to induce temperatures with potential biological/therapeutic effect on the implant and peri-implant alveolar bone. The goal of maintaining at least 45° C. within the implant itself and throughout its length within the bone, for the longest time possible, was achieved.
According to the records of the internal thermocouple of the device of the invention, the temperature at implant level rose by 17.1° C. average. It is considered that in in vivo conditions the basal temperature of the bone will be of 37° C.; said increase of temperature will allow reaching temperatures above 45° C. but below 51.6° C., always in agreement with good clinical practices (GCP) in order to avoid bone tissue damage/necrosis. Regarding the distribution of this thermal energy, it is confirmed that the device of the invention allows concentrating and localizing the thermal energy in a homogeneous way in the bone/implanting interface, reducing the amount of thermal energy which is dissipated to neighboring tissues, and therefore increasing the safety of the protocol by decreasing the area of bone tissue exposed to thermal injury.
In conclusion, the use of the device of the invention to apply, in combination, ultrasounds and the electrosurgical unit gives rise to the following results:
| Number | Date | Country | Kind |
|---|---|---|---|
| 19187923.8 | Jul 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/056978 | 7/23/2020 | WO |
