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WO2024237814A1 - Implant endostéal à vis et procédé de production - Google Patents

Implant endostéal à vis et procédé de production Download PDF

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Publication number
WO2024237814A1
WO2024237814A1 PCT/RU2024/000148 RU2024000148W WO2024237814A1 WO 2024237814 A1 WO2024237814 A1 WO 2024237814A1 RU 2024000148 W RU2024000148 W RU 2024000148W WO 2024237814 A1 WO2024237814 A1 WO 2024237814A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
holder
threaded part
key
packaging
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/RU2024/000148
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English (en)
Russian (ru)
Inventor
Елизавета Михайловна ЧЕРНОВОЛ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from RU2023112248A external-priority patent/RU2830344C1/ru
Application filed by Individual filed Critical Individual
Publication of WO2024237814A1 publication Critical patent/WO2024237814A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools

Definitions

  • the invention relates to medical equipment, namely to surgical screw-type fastening devices.
  • the preferred areas of application of the technical solution are surgical dentistry and maxillofacial surgery, as well as surgical orthopedics of the musculoskeletal system.
  • a screw endosteal implant is known from patent document US 2021290345 A1 dated September 23, 2021, consisting of a working threaded part and a holder at the apical end of this part, designed to break off when removing the implant from the container during surgery.
  • the quality of the known implant is insufficient to ensure high success of engraftment due to the fact that the design of this implant does not imply the determinism of the relative position of the elements of the device.
  • a dental screw is known from US 11291548 B2 of 05.04.2022, the head of which is made with a chamfer.
  • the design of this screw is also not deterministic, since the said chamfer serves as an anti-rotation element of the design, but is not a key by which the relative position of the elements of the device is determined.
  • the geometry of the screw head is entirely arbitrary and is selected only from the condition of transmitting sufficient torque, that is, only on the basis of the mating of the screw head with the clamping technological devices in a certain position, when the protrusion of the clamping device corresponds to the chamfer, it is in principle impossible to know the position in space of other elements of the known screw.
  • a method for manufacturing a screw endosteal implant including the shaping processing of the implant blank, preparation of the implant surface and technical control, and only if all technological nuances are observed is the implant considered to be of high quality, and the success of implant engraftment is very high (Sudnev I., Mikhailov I., Goldstein E. "Dental implantation. New level of prosthetics" - St. Moscow: “MEDH”, 2007, p. 25).
  • the known method does not ensure acceptable quality of the implant, since it does not provide for measures to protect the prepared surface of the threaded part of the implant from contamination.
  • the mentioned patent document US 2021290345 A1 also discloses a method for packaging an implant made with a holder, which includes placing the implant in a package and sealing the package.
  • the potentially contaminated holder is located in the container, which creates a risk of contamination of the threaded parts of the implant body and causes a decrease in the biocompatibility of the product, due to which the success of engraftment of such an implant may be reduced.
  • the technical challenge is to achieve high technological and consumer quality of the screw endosteal implant.
  • the provided positive effects of the invention consist, in relation to the solutions known from the prior art, firstly, in the optimization of the geometric shape of the screw endosteal implant from the condition of increasing the determinism of the mutual arrangement of the structural elements of the said implant and the resulting simplification of the location of at least one such element by the position of the base, as well as an increase in the productivity and reliability of technical control of the screw endosteal implant during the production process, secondly, in increasing the purity of the working threaded part of the implant, and thirdly, in simplifying medical manipulations with the implant during a surgical operation.
  • a key chamfer is formed, the spatial position of which corresponds to the location of at least one structural element of the threaded part.
  • a chip groove is made on the top of the threaded part of the implant.
  • the tangential plane of the said groove is oriented in the same way, as well as the plane of the holder's chamfer-key.
  • the entry and/or exit of the retention thread lies (lie) in the geometric plane in which the holder's chamfer-key is located, or is (are) located in the immediate vicinity of the said plane of the chamfer-key.
  • the implant is made with an internal index element for the implant driver and/or abutment.
  • the index element has the form of a longitudinal recess, the front tangential plane of which is parallel to the plane of the holder key flat.
  • the method of manufacturing a screw endosteal implant includes the stages of shaping the implant blank, preparing the implant surface, its technical control and packaging. Moreover, during the process of preparing the implant surface, as well as control and packaging, the implant is moved by the holder, which is part of this implant.
  • the implant is moved exclusively by the holder.
  • the method of technical inspection of the said screw endosteal implant includes placing the screw endosteal implant in the inspection zone, wherein the axial position of the implant is set according to the key-flat of the holder from the condition of contact of at least one structural element of the threaded part of the implant with the working element of the inspection device, after which technical inspection of the said element of the implant is carried out.
  • the method of technical control includes fixing the implant relative to the control device.
  • the implant fixation device is preliminarily positioned relative to the control device.
  • the implant is secured in the fixation device by the implant holder.
  • a gap is provided between the threaded part of the implant and the inner surface of the packaging.
  • Fig. 1 General view of the screw endosteal implant.
  • Fig. 2 External cross-sections of the implant.
  • the presented endosteal implant is intended for surgical bone-jaw implantation as a supporting base for dental prosthetic components, in particular crowns.
  • the device comprises a working threaded part 1 and a technological holder 2 connected to the apical end of part 1 through a neck 3 (Fig. 1).
  • the threaded part 1 and the holder 2 with the neck 3 represent different sections of a single part having the shape of an elongated body of revolution.
  • the elements of the implant design are understood to be any parts of the implant body, including planes, projections, recesses, cutouts, holes, thread entry and exit, areas of increased roughness, etc., if they are implemented.
  • the threaded part 1 forms the main body of the implant of a straight shape with a rounded top.
  • an external screw thread with micro-roughness is made to increase the strength of the connection of the implant with the bone.
  • the thread occupies most of the surface of the threaded part 1.
  • a central shaft is made in the body of the implant in the form of a blind axial hole with an internal fastening thread for fixing the abutment and anti-rotational index elements 4 symmetrically located relative to the center, serving to fix the position of the head of the implant or superstructure.
  • Each index element 4 is an internal longitudinal recess with a tangential plane of the front wall facing the geometric axis of the threaded part 1.
  • At least one chip groove 5 is formed on the top of the threaded part of the implant for cutting and removing bone chips.
  • Groove 5 is made in the form of a cutout of a part of a quarter circle. This cutout is open both from the side of the apical end of part 1 and from the side of the implant top.
  • one of the two walls of the said groove, connected at a right angle, is characterized by a tangential plane, and the other wall has a rounded shape.
  • the holder 2 has a cylindrical shape, its longitudinal axis coincides with the longitudinal axis of the threaded part 1 or is predominantly parallel to it.
  • a chamfer-key 6 is made in the form of a flat tangential cut to the diameter on the cylindrical surface of the part.
  • the plane of the chamfer-key 6 is parallel to the longitudinal axis of the implant.
  • the shape of the holder 2 and the size of the said chamfer are selected from the condition that the chamfer clearly differs from other parts of the holder 2 and can perform the function of a key element, ensuring uniform mating of the holder 2 with technological devices in a strictly defined position, when the key element corresponds to the mating part.
  • the key-chamfer 6 imparts to the holder 2 the property of first-order axial symmetry, expressed in the symmetry of the shape of the body of the holder 2 relative to rotations exclusively at an angle of 360° around the longitudinal axis, due to which the holder 2 can be inserted into the tooling or grasped only at one angle without changing the position of the tool, which allows using the key-chamfer 6 as a base element.
  • the key-chamfer 6 is characterized by a working plane, and the surface of the body of the holder 2 opposite to the longitudinal axis is rounded (Fig.
  • the size of the plane of the key-chamfer 6 is many times greater than the size of the remaining planes on the body of the holder 2, when making this holder, for example, of a faceted shape.
  • the size of the neck 3 is selected from the condition of ensuring the possibility of breaking off the holder 2 from the apical end of the threaded part 1 by manual force.
  • the tangential plane of the chip groove 5 is oriented in the same way as the plane of the key flat 6 of the holder 2, that is, the indicated planes practically coincide (plane X-X in Fig. 2) or mutually parallel, depending on the design of the device.
  • the tangential plane of the front wall of the index element 4, facing the geometric axis of the threaded part 1 of the implant, is parallel to the plane of the chamfer-key 6 of the holder 2 (plane YY in Fig. 2). If the retention thread is cut starting from the side of the apical end, then the thread lead-in coincides with the tangential plane of the chip groove 5, and therefore the thread lead-in is located in the plane of the chamfer-key 6 or in the immediate vicinity of this plane.
  • the thread lead-out coincides with the tangential plane of the chip groove 5.
  • the thread lead-in or lead-out from the side of the crestal end is preferably performed in the immediate vicinity of the plane in which the chamfer-key 6 is located, or exactly in the specified plane.
  • the thread lead-in and/or lead-out lies in the plane of the chamfer-key 6 or is in the immediate vicinity of this plane.
  • the implant 1 has an optimal geometric shape due to the mutual correspondence of the arrangement of the key flat 6 of the holder 2, the entry and exit of the implant retention thread, as well as one of the index elements 4, which are among the most practically significant design elements of the threaded part 1 of the implant, the spatial arrangement of which is critically important for the doctor.
  • the shape of the implant is also optimized, although to a lesser extent, which is sufficient to simplify the finding of such an element by the position of the base, and therefore increases the productivity and reliability of control.
  • the angular orientation of the holder 2 relative to the longitudinal axis is always clearly known, which allows the key chamfer 6 to be adopted as the implant base. Due to the deterministic location of the thread and/or index elements 4 relative to the key chamfer 6, their spatial location is also known without additional calculations due to the correspondence to the position of the base element, which simplifies the location of the said structural elements, in particular when checking and orienting the implant inside the package, and facilitates work with the implant both during its manufacture and when used during a surgical operation.
  • the implementation of the holder 2 on the apical end of the threaded part 1 of the implant ensures the greatest approximation of the plane of the key chamfer 6 to the significant structural elements of the threaded part 1 of the implant (Fig. 2), which simplifies the location of any of the said deterministic structural elements by the position of the base key chamfer 6 and leads to an increase in the productivity and reliability of the technical control of the implant during the production process.
  • the method of manufacturing a dental implant includes a number of successive stages: shaping processing of the implant blank, primary technical quality control of the implant, preparation of the implant surface, repeated quality control of the implant and packaging.
  • a titanium rod of round cross-section preferably of Grade 4
  • Thread cutting is a difficult-to-control process, which determines the importance of information on the entry and exit points of the implant retention thread. Due to the tangential plane of the chip groove, the location of the beginning or end of the thread on the side of the implant apex is precisely known relative to the chamfer-key 6.
  • the entry or exit of the thread on the side of the cross end of the implant is preferably performed in the immediate vicinity of the plane in which the chamfer-key 6 is located, or exactly in the specified plane, which makes it possible to quite simply find the beginning and end of the retention thread by the position of the chamfer-key 6 during further manipulations.
  • the first stage of technical quality control of the implant is carried out, aimed at checking its geometric parameters.
  • this device is preliminarily placed in the working area of the control device, in particular, in the field of view of the microscope.
  • the implant is grasped by the tool by the holder 2 and transferred to the working area.
  • the implant is held by the holder 2 or, which is more preferable in practice, the holder 2 is fixed in the fixation device.
  • the axial position of the implant is set by the chamfer-key 6.
  • the chamfer-key 6 rests against the fixed jaw of the vice, taken as the starting point for spatial position of the implant base plane.
  • the implant fixation device is pre-positioned relative to the testing device and the implant is secured in the said fixation device by the implant holder, which will eliminate contamination of the surface during the work. In addition, this will increase the accuracy of measurements due to greater stability of the implant in the microscope's field of view. In addition, fixing the implant in the fixation device by the implant holder provides the possibility of highly productive automation of the testing process.
  • the specified control points and the associated elements of the implant structure are facing the microscope objective, which ensures, for example, that the data of the implant elements are controlled first at the control points, and then throughout the entire surface facing the microscope objective.
  • the implant is moved linearly in the field of view of the microscope, in particular, due to the mobility of the base of the precision vice, realized by rotating the lead screw, and then the head of the vice with the implant clamped in it is turned and another part of the implant surface is turned to the microscope objective, which allows for inspection of the entire surface of the implant, preferably in automatic mode according to a given program.
  • the implant surface preparation consists of sandblasting the implant followed by double acid etching, respectively in a sandblasting machine and an acid etching device intended for this purpose, in order to create a clean micro-roughness on the implant surface.
  • the surface preparation is completed by a cascade wash to remove traces of acid and other contaminants. Further contact of hands or a gripping tool with the threaded part 1 of the implant is not allowed, for which the implant is moved by the holder 2. Moving the implant during the production process exclusively by the holder 2 ensures not only high purity of the threaded part of the implant, but also leads to increased productivity and reliability of technical control.
  • a repeated quality control is carried out, similar to the primary control.
  • the main attention is paid to the compliance of the surface parameters of the threaded part 1 of the implant with the specified values characterizing the quality of the implant.
  • a selective comprehensive analysis of the purity of the implant surface is possible by scanning electron microscopy and energy-dispersive X-ray elementary analysis. Such analysis is carried out in order to exclude possible errors at the stage of surface cleaning.
  • the final stage of the production process for obtaining a finished implant includes actions to package a high-quality implant for further storage and transportation.
  • the packaging ensures protection of the clean implant from contact with any surfaces.
  • the packaging design is a container made of rigid plastic with an internal fastener for temporary fixation of the implant.
  • the container size is sufficient to accommodate the implant while ensuring an air gap between the threaded part 1 and the inner surface of the container.
  • the cavity of the packaging is pre-cleaned.
  • the implant that has successfully passed the test is placed inside the protective packaging by moving the implant by the holder 2 and securing it there, after which the packaging is hermetically sealed.
  • the implant is preferably secured in the packaging with support on the holder 2 or on a temporary abutment, which is pre-fixed in the central shaft of the implant, which ensures a stable absence of contact between the outer surface of the threaded part 1 and the inner surface of the packaging during the entire time the implant is inside the packaging.
  • the cleanliness of the working part of the implant is increased and a decrease in the quality of the implant during storage and transportation is prevented. It is also possible to secure the implant with support directly on the neck of the implant, but this type of connection is less reliable.
  • the holder 2 After fixing the implant with support on the temporary abutment, the holder 2 is disconnected by breaking off due to bending or rotation, and then removed for further disposal, together with the potential surface contamination formed during the implant manufacturing process. It is advisable to break off and remove the holder 2 at the packaging stage, since for many doctors the presence of the holder and the need to remove it are unusual and require an additional action that distracts attention during the surgical operation. In addition, during the storage and transportation of the implant, there is a risk of contamination from the holder 2 getting onto the main body of the implant.
  • the holder 2 Due to the implementation of the holder 2 on the apical end of the threaded part 1 of the implant, it is possible to break off the holder 2 from the main body of the implant after fixing with support on the temporary abutment or on the neck, which allows maintaining a high degree of purity of the threaded part 1 of the packaged implant for a long time due to the absence of a contaminated holder 2 in the cavity of the sealed package.
  • the implant When fixing the implant in the cavity of the package, the implant should be oriented at an angle along the longitudinal axis of the product, setting the position of the entry and exit of the implant retention thread, as well as the longitudinal recess of one of the index elements 4, and therefore all other index elements, according to the chamfer-key 6.
  • this implant was preferably moved exclusively by the holder, there was a risk of contamination of the threaded part 1 implant was minimal and this portion of the packaged implant was completely free of surface contamination.
  • the implant After storage and transportation, the implant is delivered to the doctor during a surgical operation.
  • the doctor or assistant opens the package and removes the implant without touching the clean surface of the threaded part 1 of the implant. Due to the high degree of determinism of the mutual arrangement of the implant's structural elements and its known orientation in the package by angle, the doctor immediately has an idea of the spatial position of the retention screw thread and internal index elements 4, which simplifies further treatment manipulations, in particular, setting the position of the future prosthetic structure, especially with a digital treatment protocol based on the use of software.
  • An implant driver is inserted into the central shaft of the implant and fixed relative to the anti-rotational index elements 4, after which the implant driver is set in motion and the implant is inserted into the patient's bone.
  • the proposed packaging method is suitable not only for screw endosteal implants, but also for any other implants made with a holder.
  • the optimal geometric shape of the implant and the end-to-end provision of cleanliness of the surface of the threaded part of the implant at all production stages give the implant high technological and consumer quality, which creates conditions for high success of implant engraftment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Orthopedic Medicine & 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)
  • Dental Prosthetics (AREA)

Abstract

L'invention concerne un implant endostéal à vis que l'on utilise dans le domaine de la chirurgie. Cet implant comprend une partie filetée (1) et un support (2) sur l'extrémité apicale de la partie filetée. Un méplat à clé (6) est formé sur le support (2). La disposition d'au moins un élément de la structure de la partie filetée (1) de l'implant correspond à la position dans l'espace du méplat à clé (6). Le procédé de production de l'implant comprend des étapes de traitement de mise en forme d'une ébauche d'implant, de préparation de la surface de l'implant, de contrôle technique de la qualité de l'implant et d'emballage de l'implant. Lors du processus de préparation de la surface, de contrôle et d'emballage, l'implant est déplacé avec le support (2). L'implant est placé dans une zone de contrôle. La position axiale de l'implant est définie en fonction du méplat à clé (6) du support (2). Au moins un élément de la structure de la partie filetée (1) de l'implant est orienté vers un organe de travail du dispositif de contrôle. Le contrôle se fait sur l'élément de la partie filetée (1) de l'implant. L'implant de qualité est placé dans un emballage avec le support (2). L'implant est fixé dans l'emballage avec un appui sur le support (2). Dans l'emballage, l'implant est orienté selon un certain angle par rapport au méplat à clé (6). Dans une autre variante, après la fixation de l'implant, ledit support (2) est cassé et éliminé. L'emballage est scéllé. On assure une optimisation de la forme de l'implant. On simplifie le positionnement de l'élément structurel par rapport à la position de l'élément de base. On augmente le rendement et la fiabilité du contrôle technique de l'implant. On augmente également la propreté de la surface de l'implant. On obtient ainsi une meilleure qualité de l'implant.
PCT/RU2024/000148 2023-05-12 2024-04-26 Implant endostéal à vis et procédé de production Pending WO2024237814A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2023112248 2023-05-12
RU2023112248A RU2830344C1 (ru) 2023-05-12 Винтовой эндостальный имплантат и способы его изготовления, технического контроля и упаковки

Publications (1)

Publication Number Publication Date
WO2024237814A1 true WO2024237814A1 (fr) 2024-11-21

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2024/000148 Pending WO2024237814A1 (fr) 2023-05-12 2024-04-26 Implant endostéal à vis et procédé de production

Country Status (1)

Country Link
WO (1) WO2024237814A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2125852C1 (ru) * 1998-04-20 1999-02-10 Малинин Михаил Валерьевич Универсальный слепочный трансфер для дентальных имплантатов
RU2246281C2 (ru) * 2003-04-10 2005-02-20 Кулаков Анатолий Алексеевич Стоматологический винтовой имплантат
US20160015483A1 (en) * 2014-04-30 2016-01-21 Osseodyne Surgical Solutions, LLC. Osseointegrative surgical implant
CN109152624A (zh) * 2016-06-02 2019-01-04 凯姆洛格生物科技股份有限公司 保持器、包装和保持器的组合件、手术装置用转接器以及带支承结构的手术装置用保持器
US20210290345A1 (en) * 2017-12-20 2021-09-23 Straumann Holding Ag Dental implant
US11291548B2 (en) * 2017-08-28 2022-04-05 botiss biomaterials GmbH Dental screw

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2125852C1 (ru) * 1998-04-20 1999-02-10 Малинин Михаил Валерьевич Универсальный слепочный трансфер для дентальных имплантатов
RU2246281C2 (ru) * 2003-04-10 2005-02-20 Кулаков Анатолий Алексеевич Стоматологический винтовой имплантат
US20160015483A1 (en) * 2014-04-30 2016-01-21 Osseodyne Surgical Solutions, LLC. Osseointegrative surgical implant
CN109152624A (zh) * 2016-06-02 2019-01-04 凯姆洛格生物科技股份有限公司 保持器、包装和保持器的组合件、手术装置用转接器以及带支承结构的手术装置用保持器
US11291548B2 (en) * 2017-08-28 2022-04-05 botiss biomaterials GmbH Dental screw
US20210290345A1 (en) * 2017-12-20 2021-09-23 Straumann Holding Ag Dental implant

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