Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
  • A61C1/00—Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design
  • A61C1/08—Machine parts specially adapted for dentistry
  • A61C1/082—Positioning or guiding, e.g. of drills
  • A61C1/084—Positioning or guiding, e.g. of drills of implanting tools
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
  • A61C9/00—Impression cups, i.e. impression trays; Impression methods
  • A61C9/004—Means or methods for taking digitized impressions

Definitions

• the invention relates to a process for designing and manufacturing of an implantation guide in a suitable system, wherein as a part of the process the following steps are taken: an impression from the oral structures is made by a spoon with registration markers; the impression is digitized; the patient is digitized with the impression tray in place; the digitized images are registered together with a treatment planning software, then a treatment plan is designed; the digital model of the surgical guide is then made with a guide designing software based on the treatment plan; and on the basis of the digitized model of the implantation guide, the physical equivalent of the surgical guide is prepared.
• the invention furthermore relates to a system for designing and manufacturing of a surgical guide, which comprises an impression spoon equipped with registration markers; a computer equipped with a surgical treatment designing software for the registration and the preparation of the surgical plan; another computer equipped with a guide designing software for the planning and preparation of the surgical guide; a surgical tray in accordance with the surgical plan; and an implantation guide designed and prepared in line with the process according to the present invention.
• the implantation guides used in the framework of dental implantation processes are conventionally manufactured as follows. First of all, the so called radiographic guide must be prepared, which requires several steps. The operations in connection with this process are done by a dental technician.
• the positive copy of the organs in the oral cavity of the patient that is, a gypsum model is prepared in a device simulating the positions and movements of the jaws, in the articulator, using the dental impression of the patient.
• this gypsum model on the implantation area and its surroundings, the shape of the guide is elaborated using a kind of plastic. This represents the accomplishment of a longer set of operations manually, wherein as a first step, the planned border lines of the surgical guide must be determined on the gypsum model, then the guide must be elaborated, said guide meeting the determined border lines.
• the oral organs of the patient include so called undercuts (e.g. the areas under the cervix, or the gaps between the teeth), which, due to the rigid material of the surgical guide would prevent the perfect fit to the correct position in the surgery area. These parts are therefore filled in (blocked) by the dental technician using warmed wax in order to make the finalized radiographic guide applicable. This operation is definitely time consuming.
• the guide thus produced is then duplicated using the gypsum model, a silicone casting mould, and a self cross linking plastic material, and taking the required operational steps.
• the copy thus obtained is then further physically processed (chipping, polishing).
• radio dens markers or in other terms: registration markers
• the thus prepared radiographic guide is then placed in the mouth of the patient in such a manner that it perfectly fit on the organs of the oral cavity (with the help of bite registration using a kind of wax), and the necessary CT scan is then taken. Following this step, another CT scan of the guide is taken.
• dual scan or double scan
• the reason of preparing two images is that in CT scans used in dental applications (usually CBCT) only the hard structures (bones) give excellent images, however, the soft structures (such as, e.g. palate, tongue and the muscles) present only as grey spots. Thus, e.g. in case of a patient without teeth a single CT scan would be insufficient to decide, where the palate is located, to which the surgical guide is positioned.
• the dual scan protocol and CT guide together ensure that the position of the palate as compared to the bone or other oral structures can be determined.
• the necessary information relating to the hard structures and the soft structures may be obtained in such a manner that the two CT scans prepared are fitted onto each other, and are registered with the help of the registration markers used.
• the clinician will determine the size, location and position of the implants, that is the direction of the axis of the implants, based on which the metal sleeves serving the drive of the surgical devices are integrated into a guide prepared by the dental technician using the process described above, or into a guide made using a 3D printer based on the shape of said guide prepared by the dental technician.
• EP 1791491 European patent document discloses, among others, a process for the preparation of prosthesis, wherein said process comprises the step of fitting of two CT scans by a method implemented in a suitable computer programme, wherein the first image is taken of the jaw of the patient, while the second CT scan is taken of the gypsum model corresponding to the oral structures of the patient.
• the depth and direction of the implant is designed on the basis of the fitted CT scans, furthermore, the shape of the drill driver in the navigation device as well.
• the process according to the referred document requires the preparation of a radiographic guide, in contrast with the process according to the present invention.
• US2010105010 US patent document discloses the preparation of a prosthetic model, which may be used e.g. in the design and implementation of dental implantation surgeries.
• the process disclosed in the referred document comprises the following steps: a) digitized image is taken of the oral structures of the patient; b) the obtained digitized image is segmented on the basis of the teeth of the patient; c) the location of implantation is identified within the segmented image; d) the dimensions of the pilot drill are determined in the location of implantation; e) the study model with the pilot drill is made according to the design; f) the drilling sleeves are placed in the study model; then a transfer guide functioning as implantation guide is made from the thus obtained study model.
• the referred document uses design assisted by software, however, in order to prepare an implantation guide, preparation of a physical model is also necessary.
• W09426199 international patent publication document discloses a prosthetic spoon at least partially coated with a radio dens material and a process of using said spoon, for the implementation of prosthetic implantation.
• the spoon is inserted in the mouth of the patient, then a cross-sectional X-ray radiographs are taken of the lower jaw and the spoon; on the basis of the radiographs the optimal position of the implant is determined; the spoon is placed on a holder connected to an automatic system, where X-ray radiographs are taken of it; the records obtained are registered with the earlier records and the axis of the drills are determined, then the drills are prepared on the spoon using the automatic system. The spoon thus obtained is used as guide for inserting the implants into the lower jaw.
• US20040101803 US patent document discloses a highly complex spoon suitable for taking impression, which comprises, among others, a rigid framework split into two parts, and a membrane fixed to said framework, the strung of said membrane being controllable by a wire.
• a rigid framework split into two parts Prior to use the fit point of the two parts of the framework must be coated by a self-curing material, and a material suitable for taking impression must be used in both sides of the membrane, and it should be placed in the mouth of the patient this way.
• the wire is then removed, in order that the two parts of the framework be able to move independently from each other as a result of a bite.
• the application of the referred document seems to be rather cumbersome.
• WO2008057955 international patent publication document discloses, among others, a process for the preparation of a prosthetic implant, said process comprising the following steps: a) an impression is made from the implantation area; b) on the basis of the impression a physical model is prepared; c) a suitable dental implant is selected from the kit consisting of prefabricated dental shaped implants; d) the selected dental implant is fitted on the model; e) another impression is made from the model comprising the dental implant; f) a hole is drilled into the new impression thus obtained with the help of the dental model used earlier containing a hole, thus an implantation guide is obtained.
• the process according to the referred document requires time consuming, manual operations.
• a WO9932045 international patent publication document also discloses a process for the preparation of a prosthetic implant, where the patient typically lacks teeth.
• a 3D computed graphic model is prepared by imaging of the jaws and tissue structures positioning to the surface of the palate, wherein the imaging is made by X-ray or MRI technique.
• a radiographic guide is used, which fits the palate.
• the data of the holes of the implants are determined by the 3D model.
• the preparation of the body of the implant guide is not disclosed by the referred document, it is only disclosed that said element is formed in a physical model, then the holes in the thus obtained body of the guide are made using the data determined by the 3D model with the help of a CNC equipment.
• WO2010133326 international patent publication document discloses in detail the general process, which serves as a basis the already mentioned dual scan protocol, as well as the virtual designing of the craniofacial surgical operations. It is disclosed in the document that two sets of data is generated during the process. One set of data provides for data about surface structures, the other one about the structures under the surface, which are invisible; said data can visually be displayed. From the point of view of the prosthetic implantation, this corresponds to the imaging of the soft tissues and the bone tissues, respectively. The two sets of data thus generated are then unified.
• the disclosed process is suitable among others for the design of implantation guide, however, it is described that in case of imaging the teeth, soft tissues and locations without teeth, a radiographic guide is applied.
• US2013144422 US patent document also discloses a process and system for the preparation of a prosthetic implantation guide.
• a virtual model is generated on the basis of data obtained by CT and on the virtual equivalent of the designed implants.
• the referred document mentions the formation of the virtual model also requires a physical model, said model being prepared by conventional odontological laboratory techniques.
• the physical equivalent of the virtual model is prepared by a kind of rapid prototype-manufacturing process (e.g. 3D printing or milling).
• the body of the implantation guide is prepared on the thus obtained physical model by thermoshaping, then the excess parts are removed by physical operations, then the body of the guide is supplemented with metal sleeves.
• US2010240000 US patent document discloses a process similar to that disclosed in the above-mentioned document.
• the body of the implantation guide (negative guide body) is also prepared using a prefabricated physical model from a thermoplastic material by vacuum shaping.
• the oral structures of the patient are impressed (negative model), from which then a positive model is prepared, and this positive model is digitized.
• the invention relates to a process for the design and preparation of a prosthetic implant guide useful for the positioning of one or more dental implant in a system, wherein said system comprises a spoon suitable for taking impression, said spoon including in-built registration markers necessary for the dual scan protocol, and said spoon may be filled with a material suitable for taking impression, characterized in that the following steps are taken:
• a CT scan is prepared of the patient with the above-mentioned impression spoon, containing the impression, placed in the mouth of said patient in the suitable position, then the spoon is removed from the mouth of the patient and another CT scan is prepared of the separated impression spoon;
• the prosthetic implant surgery is designed using a surgical design software; 5) on the basis of the prosthetic implant surgery design the surgical guide is manufactured in the manner comprising the following steps:
• the border lines of the guide are defined on the digitized impression with the aid of a guide design software, then the thickness and shape of the guide are determined;
• the metal sleeves serving the drive of the implantation devices are fixed in the guide prepared by 3D printing, thus the finalized implantation guide is obtained;
• a preferred embodiment of the invention is the process according to point 1 , wherein the steps are performed on a patient, who, in the proximity of the prosthetic implantation surgical area, is in possession of anatomic structures, preferably one or more teeth, to which the location, position, and the direction of axis of the one or more implant designed in the course of the designing of said implant guide, can be positioned.
• a preferred embodiment of the invention is the process according to point 1 or 2, wherein the steps are taken in one place, and or within 48 hours, preferably within 24 hours, most preferably within 12 hours or even shorter period of time passed from the beginning of the operations.
• a preferred embodiment of the invention is the process according to any one of points 1 to 3, wherein the information needed for the design and preparation of the implant guide is transferred on-line between the CT laboratory, the dentist's office, and the place of manufacturing of the implant guide. 5.
• a preferred embodiment of the invention is the process according to any one of points 1 to 4, wherein in the course of manufacturing of the implant guide the product is touched with hands only during the supplementary works of the 3D printing, and the fixation of the metal sleeves in the guide.
• a preferred embodiment of the invention is the process according to any one of points 1 to 5, wherein said process further comprises the step of placing of the case identification sign on the product with the help of the above-mentioned guide design software, during the preparation of the implant guide, and/or the above- mentioned implantation surgical design is delivered to said guide design software using the Internet.
• Another aspect of the invention is a system for the design and preparation of a prosthetic implant guide, said system comprising the following elements:
• a) a spoon suitable for taking impression said spoon including in-built registration markers necessary for the dual scan protocol, and said spoon being suitable to be filled with a material suitable for taking impression; b) a computer equipped with a implantation surgical design software for the preparation of the implantation surgical design;
• a surgical tray defined in the implantation surgical design which comprises one, more or all devices selected from the group comprising: devices necessary for the fixation of the implant guide, drills necessary for the preparation of the hard structures, constrictor sleeves necessary for the precise driving of the surgical devices, devices necessary for the formation of pilot and universal hard structures, a device serving the checking of the precise position of the implant following its inserting;
• a preferred embodiment of the invention is the system according to point 7, said system transferring the information necessary for the design and preparation of the implant guide on-line between the CT laboratory, the dentist's office, and the place of manufacturing of the implant guide.
• a preferred embodiment of the invention is the system according to point 7 or 8, in which the surgical design software possesses one, more or all of the functions selected from the following group: 3D view, design view, panorama view, the designation and display of the nerve pathways, testing of the collision between the implants, fixing pins and sleeves, screening for the cases, the manufacturing of which is impossible, on-line order from the software.
• a preferred embodiment of the invention is the system according to points 7 to 9, in which the software for the guide design possesses one, more or all of the functions selected from the following group: the determination of the edge of the guide, the guaranteed insertability considering the undercut areas, check windows, generation of automatic surgery protocol, generation of automatic sleeving (manufacturing) guideline, guaranteed availability of the constrictor sleeve and manual piece, generation of sticking channels.
• Another aspect of the invention is the process according to any of points 1 to 6 or a system according to any of points 7 to 10, wherein said spoon suitable for taking impressions includes six to eight, inbuilt registration marker, necessary for the accomplishment of the dual CT protocol.
• Another aspect of the invention is the process according to any of points 1 to 6 or a system according to any of points 7 to 10, wherein said spoon suitable for taking impressions is made to be suitable to fit to the upper or lower jaw.
• Another aspect of the invention is the process according to any of points 1 to 6 or a system according to any of points 7 to 10, wherein the material suitable for taking impression is silicone or alginate.
• the dual scan protocol means the preparation of two CBCT records in such a manner that in the first record the patient is present with the impression spoon, containing the impression, placed in the mouth of said patient in the suitable position, while in the second record only the impression spoon with the markers and the impression placed therein is present.
• the registration marker in the framework of the present invention: is some kind of body giving an X-ray shade (in the present case gutta-percha), which is preferably of spheroid shape, of which more than one are placed in the impression spoon in a pre-determined number and location.
• X-ray shade in the present case gutta-percha
• the sleeve in the framework of the present invention: is an empty cylinder made from metal, which fits into the plastic guide tunnel prepared by three dimensional printer. Its role is the driving of the drills and other surgical devices.
• the invention relates to a process for the design and preparation of a prosthetic surgical guide in a suitable system wherein said system includes a spoon for taking impression, which is equipped with the inbuilt registration markers necessary for the dual scan protocol, said spoon being suitable to be filled with a material useful for taking impression.
• the process according to the present invention comprises that an impression is prepared of the structures of the oral cavity of the patient using the above-mentioned spoon.
• the first CT scan is prepared without removing the spoon from the mouth of the patient.
• the impression In case of a CT scanning prepared in a distant laboratory, the impression must be placed in the mouth of the patient again. Then the spoon is removed from the mouth of the patient, and a second CT scan is prepared of it.
• the preparation of the two CT scans corresponds to the dual scan protocol, however, there is no need here to make a gypsum model and radiographic guide made by a dental technician in advance.
• the impression made using the spoon disclosed in the present invention gives the negative copy of the structures in the oral cavity.
• the implantation surgery is designed with the help of a surgery design computer programme.
• the preparation of the implantation surgery design includes the selection of the type and size of the suitable implants, the determination of the location and position of the implants, and the selection of the surgical tray comprising the surgical devices necessary for the implantation.
• the implantation surgery design is delivered to a guide design computer programme through the Internet.
• the border lines of the guide are defined, the thickness and shape of the guide is determined using a guide design software. Accordingly, the dental technician uses a digitized negative impression to accomplish those operations, which, according to the state of the art, would be necessary to be made on a physical model, manually.
• the undercuts are removed in the predetermined direction.
• This solution is based on the discovery that if in the framework of the elaboration of the digitized model we presume a perfectly rigid material corresponding to the material of the final implant guide, then the undercuts may be determined in view of the given inserting direction of the guide, and by the removal of said undercuts it can be ensured that the final guide be in the perfect position and fit perfectly.
• the above- mentioned operation may be accomplished more simply and rapidly, even within a couple of seconds.
• the shape and size of the tunnels holding the metal sleeves serving the driving of the surgical devices are determined.
• the case identification sign is placed on the product.
• a guide-specific surgery (drilling) protocol is determined.
• the digitized model of the final implant guide is prepared, the physical equivalent of which is prepared by 3D printing. Then the metal sleeves serving the driving of the implantation devices are fixed in the guide prepared by 3D printing, thus the finalized guide is obtained.
• the surgical design software possesses, without limitation, the following functions: 3D view, design view, panorama view, the designation and display of the nerve pathways, testing of the collision between the implants, fixing pins and sleeves, screening for the cases, the manufacturing of which is impossible, on-line order from the software.
• the guide design software possesses, without limitation, the following functions: the determination of the edge of the guide, the guaranteed insertability considering the undercut areas, check windows, generation of automatic surgery protocol, generation of automatic sleeving (manufacturing) guideline, guaranteed availability of the constrictor sleeve and manual piece, generation of sticking channels.
• the process according to the present invention makes it possible to prepare an implant guide for the positioning of one or more dental implants, and/or the positioning of fixing pins.
• the process according to the present invention makes it possible to prepare guides with pilot or universal sleeves.
• the process according to the present invention makes it also possible to prepare an implant fitting to a tooth or soft tissues.
• the present invention relates to a process, wherein the above-mentioned steps are performed on a patient, who, in the proximity of the prosthetic implantation surgical area, is in possession of anatomic structures, preferably one or more teeth, to which the location, position, and the direction of axis of the one or more implant designed in the course of the designing of said implant guide, can be positioned.
• the process according to the present invention makes it possible that optionally at the first visit of the patient, the CT scans are prepared, thus the clinician may start designing of the implantation within short period of time. There is no need to accomplish the multi-step, time consuming (requiring even several days) and expensive work of the dental technician according to the state of the art, which has first of all been a burden on the patient. Therefore the present invention offers a more effective solution in terms of the practical accomplishment, time need and cost.
• the invention in its another aspect relates to a system for the design and preparation of an implantation guide, said system comprising the following:
• a spoon as disclosed in the present invention which is suitable for taking impression, said spoon including in-built registration markers necessary for the dual scan protocol, and said spoon being suitable to be filled with a material suitable for taking impression;
• a computer equipped with a implantation surgical design software (SMART Guide software) for the preparation of the implantation surgical design;
• a surgical tray defined in the above-mentioned implantation surgical design which comprises one, more or all devices selected from the group comprising: devices necessary for the fixation of the implant guide, drills necessary for the preparation of the hard structures, constrictor sleeves necessary for the precise driving of the surgical devices, devices necessary for the formation of pilot and universal hard structures, a device serving the checking of the precise position of the implant following its inserting; the implant guide designed and prepared according to the process according to the present invention.
• the process according to the present invention in the system suitable for the design of the implant guide makes it possible that the information necessary for the design and preparation of the implant guide is transferred on-line between the CT laboratory, the dentist's office, and the place of manufacturing of the implant guide.
• the process according to the present invention in the system suitable for the design of the implant guide makes it also possible that the implant guide as end product can be prepared by the least possible touch of human hands.
• the term "the least possible touch of human hands" in the context of the present invention is to be understood that during the preparation of the implant guide the product is touched by hands only at the supplementary works of the 3D printing, and the fixing of the metal sleeves into the guide.
• the SMART Guide spoon according to the present invention includes the registration markers necessary for the performance of the dual CT protocol, therefore there is no need to position said registration markers. There is no need to prepare a radiographic guide, when the SMART Guide spoon according to the present invention and the process according to the present invention.
• the spoon according to the invention having the suitable size, fitting the lower or upper jaw is selected;
• an impression is prepared of the implantation area using the spoon supplemented with the impression material
• a bite registration is made with a material suitable for bite checking, preferably with silicone or wax with the spoon including the cured impression material;
• the surface of the top of the jaw bone is filled with the impression material for bite registration, in order to keep the spoon in the optimal position;
• the undercuts are removed from the impression, and the testing of the spoon and bite registration is performed;
• the patient has the inserting of the spoon and bite practiced;
• CT1 patient with spoon
• CT2 spoon
• CT scans are made available for the computer equipped with the computer programme used in the present invention, which is responsible for the design
• CT scans are registered in the computer equipped with the surgical design programme, and the registered scans are made available for the computer equipped with the surgical design software, said computer being available for the clinician planning the surgery;
• the implantation surgery plan is prepared using the computer equipped with the surgical design programme;
• the finalized implantation guide is designed using the computer equipped with the manufacturing programme, and said guide is manufactured by 3D printing.
• the radiographic guide is prepared, and the registration markers are placed thereon;
• the removable prosthesis is supplemented with registration markers
• bite registration is performed
• CTl patient with complete removable prosthesis
• CT2 complete removable prosthesis
• the present invention offers a solution for the preparation of the implant guide in a simple, rapid, precise and cost effective manner.
• a radiographic guide for the process and system according to the present invention, said preparation of radiographic guide being a multi-step, requiring manual skill workflow, which is consequently time consuming and costly.
• the solution according to the present invention provides for support for the performance of all operations in a quick and simple way, which operations are necessary for the design and preparation of an implant guide. Consequently, the process and system according to the invention facilitate the scheduling of the operations to be made with implant guides in the daily dentist's office routine.

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• Health & Medical Sciences (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Dentistry (AREA)
• Epidemiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Surgical Instruments (AREA)

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• 2014
  • 2014-05-20 HU HU1400255A patent/HU230856B1/hu unknown
• 2015
  • 2015-05-20 EP EP15795808.3A patent/EP3145440A4/de not_active Ceased
  • 2015-05-20 WO PCT/HU2015/000047 patent/WO2015177579A2/en active Application Filing

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