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Title:
MEDICAL REFERENCE KIT FOR DENTAL IMPLANTOLOGY AND PROCESS FOR PRODUCTION THEREOF
Document Type and Number:
WIPO Patent Application WO/2014/072919
Kind Code:
A1
Abstract:
A medical reference kit (1) for performing surgical operations of dental implantology, comprising a surgical reference bone or mucous-support template (2), at the dentist's disposal and suitable to be used by the dentist as a guide element in positioning a dental prosthetic implant in the mandible and/or jaw of the mouth of the patient, following a predetermined prosthetic operation strategy, and an auxiliary three-dimensional surgical reference model (3), at disposal of the dentist and having exactly the overall conformation of the mandible and/or the jaw of the mouth of the patient, suitable to be used by the dentist outside the mouth of the patient in order to allow the dentist to verify from the outside, constantly and accurately, the actual situation inside the mouth.

Inventors:
SARTORATO LUIGI (IT)
FACCIANI VALENTINO (IT)
Application Number:
PCT/IB2013/059951
Publication Date:
May 15, 2014
Filing Date:
November 06, 2013
Export Citation:
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Assignee:
SAFE & SIMPLE SRL (IT)
International Classes:
A61C13/34; A61C1/08
Foreign References:
US20050037320A12005-02-17
US20100128033A12010-05-27
Other References:
None
Attorney, Agent or Firm:
CONTADIN, Giorgio et al. (Via N. Tommaseo 76/D, Padova, IT)
Download PDF:
Claims:
CLAIMS

1. Medical reference kit (1) for performing surgical operations of dental implantology, comprising at least one surgical reference bone or mucous-support template (2), at the dentist's disposal and suitable to be used by said dentist as a guide element in positioning a dental prosthetic implant in the mandible and/or jaw of the mouth of the patient, following a predetermined prosthetic operation strategy, characterized in that it includes at least one auxiliary three-dimensional surgical reference model (3), at disposal of said dentist and having exactly the overall conformation of said mandible and/or said jaw of said mouth of said patient, suitable to be used by said dentist outside said mouth of said patient in order to allow said dentist to verify from the outside, constantly and accurately, the actual situation inside said mouth.

2. Kit (1) according to claim 1) characterized in that said surgical reference bone or mucous- support template (2) is removably coupled with said auxiliary three-dimensional surgical reference model (3) in order to allow said dentist, before starting said surgical operation of dental implantology, to carry out a preliminary verification of the accuracy of said auxiliary three-dimensional surgical reference model (3) with respect to said predetermined prosthetic operation strategy.

3. Kit (1) according to any of the preceding claims characterized in that said surgical reference bone or mucous-support template (2) is made of transparent resin and has a laminar structure.

4. Kit (1) according to any of the preceding claims characterized in that said auxiliary three- dimensional surgical reference model (3) is made of resin and is obtained by stereolithography.

5. Kit according to any of the preceding claims characterized in that said auxiliary three- dimensional surgical reference model is made of resin and is obtained by laser sintering.

6. Kit (1) according to any of the preceding claims characterized in that said auxiliary three- dimensional surgical reference model (3) has at least one housing hole (4) having an access mouth (5) facing outwardly and made, in function of said predetermined prosthetic operation strategy, in the horseshoe-shaped horizontal arc (7) of the main body (6) of said auxiliary three-dimensional surgical reference model (3), said horizontal arc corresponding to the upper edge or lower edge respectively of said mandible or said jaw of said mouth of said patient.

7. Kit (1) according to any of the preceding claims characterized in that it includes at least one precise working cutter, having a fixed length, and at least one precise reinforcement bush (8), having a fixed length and suitable to exclusively and only conjugate by precision in a specific housing site made through said precise working cutter and as a function of said predetermined prosthetic operation strategy, in the horseshoe-shaped upper edge or in the horseshoe-shaped lower edge of the main body, respectively of said mandible or said jaw of said mouth of said patient.

8. Kit (1) according to claim 7) when dependent on claim 6) characterized in that said precise working cutter and said precise reinforcement bush (8) are removably inserted into said housing hole (4) of said auxiliary three-dimensional surgical reference model (3) in order to allow said dentist, before starting said surgical operation of dental implantology, to carry out a preliminary verification of the accuracy of said precise working cutter and said precise reinforcement bush with respect to said predetermined prosthetic operation strategy.

9. Process for producing a medical reference kit (1) to be used by dentists in surgical operations of dental implantology comprising the steps of:

obtaining images of the mandible and/or jaw of the mouth of a patient;

- scanning said images in such a way as to make them viewable on a screen of a personal computer;

- virtually designing a prosthetic operation strategy on said patient based on said virtual images;

arranging at least one surgical reference bone or mucous-support template (2), suitable to be used by said dentist as a guide element in positioning a dental prosthetic implant in said mandible and/or in said jaw of said mouth of said patient, following said designed prosthetic operation strategy,

characterized in that it comprises the operation of producing at least one auxiliary three- dimensional surgical reference model (3), having exactly the overall conformation of said mandible and/or said jaw of said mouth of said patient and suitable to be made available to said dentist to be used outside said mouth and allow said dentist to verify with precision, from the outside, the actual situation inside said mouth and to exactly assess the position said surgical template (2) will take in the bone plane, by constantly observing said auxiliary three-dimensional surgical reference model (3), said operation of producing said auxiliary three-dimensional surgical reference model (3) being performed by directly and automatically processing said virtual images scanned and stored in said personal computer.

10. Process according to claim 9) characterized in that said images are obtained by any of the diagnostic investigation techniques selected from the group consisting of computerized axial tomography (CAT) and/or similar.

11. Process according to claim 9) or 10) characterized in that said step of producing said auxiliary three-dimensional surgical reference model (3) comprises any one of the industrial process selected from the group consisting of stereolithography, laser sintering (or selective laser sintering) and/or similar.

12. Process according to any of the claims from 9) to 11) characterized in that it includes the operation of practicing, as a function of said designed prosthetic operation strategy, at least one housing hole (4), having an access mouth (5) facing outwardly, in the horseshoe-shaped horizontal arc (7) of the main body (6) of said auxiliary three-dimensional surgical reference model (3), said horizontal arc (7) corresponding to the upper edge or lower edge respectively of said mandible or said jaw of said mouth of said patient.

13. Process according to claim 12) characterized in that it comprises the operation of removably inserting into said housing hole (4) of said auxiliary three-dimensional surgical reference model (3) a precise working cutter, suitable to be used by said dentist to derive a housing site in said mandible and/or in said jaw of said mouth of said patient for the application of said dental prosthetic implant, and a precise reinforcement bush (8), suitable to be inserted into said housing site as a component element of said dental prosthetic implant, in order to allow said dentist, before starting said surgical operation of dental implantology, to carry out a preliminary verification of the accuracy of said precise working cutter and said precise reinforcement bush (8) in respect to said designed prosthetic operation strategy.

Description:
MEDICAL REFERENCE KIT FOR DENTAL IMPLANTOLOGY AND PROCESS

FOR PRODUCTION THEREOF

DESCRIPTION

The present invention concerns a medical reference kit for performing surgical operations of dental implantology.

The present invention relates also to a process for producing such a medical reference kit which can be used by dentists before and/ or during the execution of dental implantology operations.

It is widely known that, in the context of dental implantology, the dentist, by means of specialized suppliers, performs and puts in place a series of necessary, basic and delicate preparatory operations, which come before the actual surgical operation with which he applies the dental prosthetic implant in the patient's mandible and/or jaw.

In particular, before the surgical dental implants operation it should necessary to get images - more properly, through a CAT (Computerized Axial Tomography) radiography - of the mandible and/or jaw, depending on which part of the mouth of the patient is concerned by the operation itself.

The images thus obtained are scanned in such a way as to make them viewable in a display of a personal computer and allow the dentist to design at a virtual level a prosthetic operation strategy on the patient, just on the basis of these virtual images at his disposal. Operating methodology currently followed in dental implantology provides therefore to arrange, by specialized supplying companies, a surgical reference bone or mucous-support template, suitable to be used by the dentist as a guide element in the positioning of the abovementioned dental prosthetic implant in the mandible and/or jaw of the mouth of the patient, following the prosthetic operation strategy anteriorly designed that takes into account, for example, the conformation of the mandible and/or jaw and of the relative position of the nerves and bones.

Traditionally, in the various constructive solutions in which it is available on the market, the aforesaid surgical reference template presents a very thin laminar structure and is made of transparent resin: its base is formed in such a way as to exactly duplicate or reproduce the shape of the surface of the impression of a dental prosthesis, by virtue of the fact of deriving directly from the images acquired with one of the diagnostic techniques available in the medical field.

The surgical template, customized according to the designed prosthetic operation strategy, presents one or more through holes, placed exactly where it is foreseen to run in the patient's mandible and/or jaw one or more corresponding housing sites suitable to house the dental prosthetic implant and useful for the development of the support stump of corresponding artificial teeth.

These through holes of the surgical template present the exact physical features - in size, position and orientation terms - that the dentist has decided to give to the dental prosthetic implant and according to which, through a proper machining cutter for dental applications, he will make in the patient's mandible and/or jaw the housing sites provided for the implant. During the execution of the operation of dental implantology on the patient, the surgical template is thus placed close to the mandible and/or jaw inside the mouth and used by the dentist as a reference guide in the implementation of the housing sites through the machining cutter, in order to limit the obvious danger of the operation that the dentist must still perform relying mainly on his own ability or experience.

However, despite the operative methodology just described, currently followed to perform surgical operations of dental implantology on patients and which leads, in particular, to the appropriate availability for the dentist of the aforesaid surgical reference bone or mucous- support template, some recognized drawbacks of general nature associated with these surgical operations, still remain.

Indeed, the dentist, while making use of the help of the surgical reference bone or mucous- support template mentioned above, it is still obliged to perform in not fully favourable conditions and having thus to largely rely on his own experience the incision or drilling operation of the patient's mandible and/or jaw, to make the housing sites of the prosthetic implant, with all the disadvantages that this entails in terms of precision of the running surgical operation.

The difficult conditions which the dentist, however, operates in during dental implantology operations are determined by the continuous development of blood during surgical operation and that, despite the reference given by the surgical template and use of common surgical suction devices resting on the bottom lip of the patient, prevents proper and/or optimal view of the situation inside the mouth by the dentist which, inevitably affects the full and absolute correctness of the surgical operation itself.

In essence, then, the operating technique currently adopted by a dentist to perform dental implantology operations is not able to prevent in absolute line that the prosthetic implant, once installed on the patient, suffers from a certain inaccuracy, with the obvious and evident negative consequences that this entails, and which can be summarized as:

• tiresome or even unbearable pains felt by the patient during the surgical operation of dental implantology as well as in situations following the operation itself;

• necessary replacement and/or repair surgical operations of the prosthetic implant, with consequent inconveniences not only for the patient (further permanence times at the dentist, further situations of temporary use of provisional implants) but also for the dentist (loss of credibility or reliability and, more generally, of professional image);

• economically burden replacement and/or repair surgical operations of the prosthetic implant, typically charged to the dentist;

· onerous economical reimbursements requested by the patient to the dentist, even by legal - extrajudicial and/or judicial - way according to the latest trends;

• tiresome need for the patient, especially under the psychological point of view, to turn to another dentist whom to establish a new relationship based on trust with, if he wishes to stop that one with the dentist liable for damages suffered by the patient, aspect which is not always so automatic and immediate for the patient who, aware of this, is discouraged and/or worried.

It should be not overlooked then the fact that the dentist, aware of the risks he may meet in case of not optimal or even botched dental implantology surgical operation, works with some concern of mood which surely is not positive for his state of health and does not help to improve the outcome of his professional activity.

All in all, as part of the dental implantology, therefore the need for the dentist to determine in advance a high level of accuracy and precision in the surgical operations of installing a dental prosthesis on the patient currently remains, in order to prevent or avert at best the costly and dangerous risks (if not even charges) of professional liability just mentioned and which result from surgical operations performed with even partial failure.

The present invention seeks, therefore, to remedy the drawbacks of the prior art just mentioned. In particular, main purpose of the present invention is to provide a medical reference kit for performing surgical operations of dental implantology that allows to increase accuracy, precision, quality and reliability with which the dentist performs its professional activity, in relation to the installation of dental prosthesis implants on patients.

In other words, primary purpose of the invention is to design a medical reference kit which allows the dentist to determine with the maximum possible predictability which are the correct and precise operations that he must implement to perform with the necessary and required accuracy surgical operations of dental implantology, in order to avoid or at least minimize the risks arising from a not optimal final result.

As part of this purpose, it is a first task of the invention to implement a medical reference kit for performing surgical operations of dental implantology which reduces the risk of professional liability that may be incurred by a dentist as a result of an operation not performed in a workmanlike manner.

It is a second task of the invention to give substance to a medical reference kit for performing surgical operations of dental implantology which compared with the known art increases the guarantee level of the good and correct success of his own professional work that the dentist is able in advance to ensure to the patient who intends to undergo such surgical operations. It is another task of the present invention to improve the physical conditions of the patient during surgical operations of dental implantology, reducing the pain possibly suffered. It is another task of the present invention to increase the level of the patient's satisfaction with the final result of the surgical operation of dental implantology which he is subjected to. It is a further task of the present invention to create a medical reference kit for performing surgical operations of dental implantology which eliminates or considerably reduces compared to the current state of the art the need for repair and/or replacement interventions due to defectiveness of dental prosthetic implants already installed on patients.

It is another further task of the present invention to avert more than the prior art the use of procedures, even of legal basis, claiming reimbursements brought by patients against dentists due to defectiveness of the dental prosthetic implant installed, thus improving the personal relationship between the dentist and the patient.

It is a last but not least purpose of the present invention to provide a medical reference kit for performing surgical operations of dental implantology which allows to improve, cheering it up, the mood which the dentist performs dental implantology operations with. The aforesaid purposes are achieved through a medical reference kit for performing surgical operations of dental implantology according to the attached claim 1 attached, as hereinafter referred for the sake of brevity.

Further technical features of detail of the medical reference kit of the invention are contained in the corresponding dependent claims.

Integral part of the present invention is also a process for producing a medical reference kit for performing surgical operations of dental implantology according to the attached claim 9, as still hereinafter referred for the sake of brevity of exposition.

Further applicative features of detail of the process for producing a medical reference kit of the invention are set forth in the respective dependent claims.

Advantageously, the medical reference kit is able to significantly improve compared to the known art the professional work of a dentist in performing surgical operations of dental implantology.

This is due to the fact of making available to the dentist an auxiliary three-dimensional surgical reference model, having exactly the overall shape of the mandible and/or jaw of the patient's mouth being produced by directly and automatically elaborating, for example by means of stereolithography or selective sintering (also known as Selective Laser Sintering - SLS) virtual images, for example, obtained by a CAT (Computerized Axial Tomography) radiography, of such a mandible and/or jaw and subsequently scanned and stored in a personal computer; the dentist thus controls with absolute precision what is the real situation inside the mouth on which he must operate by surgery, constantly and entirely observing without any difficulty, from a close position, such an auxiliary three-dimensional surgical reference model that he handles and directs comfortably at will with his own hands.

Still advantageously, the medical reference kit of the invention allows the dentist to evaluate and decide in advance the strategy of surgical operation for the application of a dental prosthetic implant, having already previously available the real overall shape of the mandible and/or jaw of the patient and not only a surgical reference bone or mucous-support template (presenting through holes, having the position, orientation and size of the housing sites to be obtained, by means of a machining cutter, in the mandible and/or jaw), as it happens in the prior art.

Equally advantageously, the invention thus allows to reduce the residence time of the patient in a dentist's surgery in order to undergo surgical operations of dental implantology. Further features and peculiarities of the invention will become apparent from the description which follows, relating to a preferred executive embodiment of the medical reference kit for performing surgical operations of dental implantology and a preferred applicative embodiment of the process for producing a medical reference kit for performing surgical operations of dental implantology, which the exclusive protection is required herein of, with reference to the accompanying drawings, in which:

- figure 1 is an assonometric view of the medical reference kit of the invention in a possible operating condition;

- figure 2 is an assonometric view of a first component of the medical kit of figure 1;

- figure 3 is an assonometric view of a second component of the medical kit of figure 1.

The medical reference kit for performing surgical operations of dental implantology on patients is shown in figure 1 where it is globally numbered with 1.

It should be observed that the medical reference kit 1 of the invention comprises a surgical reference bone or mucous-support template, overall indicated with 2 and visible apart in figure 3, at the dentist's disposal and suitable to be used by the dentist himself as guide element in positioning a dental prosthetic implant (not shown in the appended figures) in the mandible (or lower jaw) and/or of the mouth of the patient, following a predetermined prosthetic operation strategy.

According to the invention, the medical reference kit 1 includes an auxiliary three- dimensional surgical reference model, generally indicated with 3, at the dentist's disposal and having exactly the overall conformation of the mandible and/or jaw of the patient's mouth, which is used by the dentist outside the mouth of the patient (for example resting on the latter's chest during the surgical operation of dental implantology) to allow the dentist to verify from the outside, constantly and accurately, the actual situation inside the mouth and, in particular, the area of this on which he must surgically operate.

Preferably but not necessarily, the surgical reference bone or mucous-support template 2 is removably coupled with the auxiliary three-dimensional surgical reference model 3 in order to allow the dentist, before starting the surgical operation of dental implantology, to carry out already a preliminary verification of the accuracy of the auxiliary three-dimensional surgical reference model 3 with respect to predetermined prosthetic operation strategy that will in any case be confirmed when the dentist lays the surgical template 2 on the mandible and/or jaw of the patient's mouth. In particular, the surgical reference bone or mucous-support template 2 is of the type known per se to the man skilled in the art: it's made of transparent resin and has a laminar structure. According to the preferred embodiment described herein of the invention, the auxiliary three-dimensional surgical reference model 3 is made of resin and is obtained by stereolithography.

It is understood that in alternative embodiments of the invention, the aforesaid auxiliary three-dimensional surgical reference model could be obtained by laser sintering of powders of plastic material.

In preferred but not binding manner, the auxiliary three-dimensional surgical reference model 3 of the medical kit 1 of the invention presents in this specific case four housing holes 4, each of which having an access mouth 5 facing outwardly and made, depending on the predetermined prosthetic operation strategy, in the horseshoe-shaped horizontal arc 7 of the main body 6 of the auxiliary three-dimensional surgical reference model 3: such a horizontal arc 7 evidently corresponds to the upper edge or lower edge respectively of mandible or jaw of the mouth of the patient.

It is stated precisely that other embodiments of the medical reference kit of the invention, not shown, could provide that the auxiliary three-dimensional surgical reference model presents a number of housing holes different from that one described above, this number could vary from one in function of the predetermined prosthetic operation strategy.

Advantageously, the medical reference kit also includes a precise working cutter (not shown in the drawings that follow), having a fixed length (for example ranging in the values of 8÷15 mm), and a precise reinforcement bush 8, having a fixed length and suitable to exclusively and uniquely by precision mate into a specific housing site made, through the aforesaid precise working cutter and depending on strategy the predetermined prosthetic operation strategy, in the horseshoe-shaped upper edge or in the horseshoe-shaped lower edge of the main body respectively of the mandible or jaw of the patient's mouth.

Preferably, the precise working cutter and precise reinforcement bush 8 can be removably inserted into the housing site 4 of the auxiliary three-dimensional surgical reference model 3 in order to allow the dentist, before starting the surgical operation of dental implantology, to carry out a preliminary verification of the accuracy of the precise working cutter and precise reinforcement bush with respect to the predetermined and programmed prosthetic operation strategy for that patient. As said, the subject of the present invention is also a process for producing a medical reference kit which can be used by dentists in surgical operations of dental implantology. Such a process basically comprises the following steps:

obtaining images of the mandible and/or jaw of a patient's mouth;

- scanning the images in such a way as to make them viewable on a screen of a personal computer;

virtually designing a prosthetic operation strategy on the patient on the basis of what emerges or is deductible from the virtual images ;

arranging the surgical reference bone or mucous-support template 2, which is used by the dentist as a guide element in positioning of a dental prosthetic implant in the mandible and/or jaw of the mouth of the patient, following the abovementioned designed prosthetic operation strategy.

In accordance with the invention, the process comprises the operation of producing an auxiliary three-dimensional surgical reference model 3, having exactly the overall conformation of the mandible and/or jaw of the mouth of the patient and suitable to be made available to the dentist to be used outside the mouth and allow the dentist to accurately, from the outside, the actual situation inside the mouth and exactly assess the position the surgical template 2 will take in the bone plane, simply by constantly observing the auxiliary three-dimensional surgical reference model 3 outside the mouth; the operation of producing the auxiliary three-dimensional surgical reference model 3 is performed by directly and automatically processing the virtual images scanned and stored in the personal computer. More in detail, the images are got through any of the diagnostic investigation techniques selected from the group consisting of computerized axial tomography (CAT) and similar. According to the preferred applicative embodiment here described of the invention, the operation of arranging the auxiliary three-dimensional surgical reference model 3 comprises one of the industrial process selected from the group consisting of stereolithography (in its known applicative variants), laser sintering (or selective laser sintering, also known by the abbreviation SLS, acronym of the English term of Selective Laser Sintering) and similar. In particular way, the operation of arranging the auxiliary three-dimensional surgical reference model 3 is performed before the operation of arranging the surgical reference bone or mucous-support template 2 and/or before the operation of virtually designing the prosthetic operation strategy on the patient based on the captured images. In preferred but not exclusive manner, the process of the invention includes in this case the operation of practicing, depending on the designed prosthetic operation strategy, four housing holes 4, each of which having a mouth 5 facing outwardly, in the horseshoe-shaped horizontal arc 7 of the main body 6 of the auxiliary three-dimensional surgical reference model 3, the horizontal arc corresponding to the upper edge or lower edge respectively of the mandible or jaw of the patient's mouth.

It is reiterated, however, that in other applicative embodiments of the process of the invention, not shown in the attached tables, the number of housing holes that is obtained in the horseshoe-shaped horizontal arc of the main body of the auxiliary three-dimensional surgical reference model could be different from that one described above and could vary according to the implant needs starting from one.

Preferably, the process of the invention comprises the operation of removably inserting into the housing holes 4 of the auxiliary three-dimensional surgical reference model 3 the precise working cutter, suitable to be used by the dentist to derive a housing site in the mandible and/or jaw of the patient's mouth for the application of the dental prosthetic implant, and the precise reinforcement bush 8, suitable to be inserted into the corresponding housing site as component element (stump) of the dental prosthetic implant, in order to allow the dentist, before starting the surgical operation of dental implantology, to carry out a preliminary verification of the accuracy of the precise working cutter and precise reinforcement bush 8 with respect to the aforementioned designed prosthetic operation strategy.

On the basis of the description given above, it is understood, therefore, that the medical reference kit for performing surgical operations of dental implantology and the process for producing such a medical reference kit which can to be used by dentists in dental implantology, both object of the present invention, achieve the purposes and reach the advantages previously mentioned.

By using the medical reference kit of the present invention, therefore, the dentist always keeps on hand and constantly on his own look the morphological situation actually existing in the mandible and/or jaw of the mouth of the patient and, in particular, where he must operate with a delicate surgical operation of dental implantology and where, during the actual execution of the surgical operation itself, it is somewhat difficult to decipher with absolute precision the internal situation, due to the inevitable amount of blood that generates. In execution phase, changes could be made to the medical reference kit for performing surgical operations of dental implantology by dentists of the invention consisting, for example, in a number of auxiliary three-dimensional surgical reference models perfectly equal each other and, by return, in a number of surgical reference bone or mucous-support template perfectly equal each other greater than one.

It is, finally, clear that several other changes could be made to the medical reference kit and producing process concerned, without departing from the principle of novelty intrinsic in the inventive idea expressed herein, as it is clear that, in the practical implementation of the invention, materials, shapes and sizes of the illustrated details could be changed, as needed, and replaced with others technically equivalent.

Where the constructive features and techniques mentioned in the following claims are followed by reference numbers or signs, those reference signs have been introduced with the sole objective of increasing the intelligibility of the claims themselves and therefore they have no limiting effect on the interpretation of each element identified, by way of example only, by these reference signs.