WO2008043899A2 - Endosseous implant provided with axially extending reliefs to promote its osseointegration, and method for obtaining such an endosseous implant - Google Patents

Endosseous implant provided with axially extending reliefs to promote its osseointegration, and method for obtaining such an endosseous implant Download PDF

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Publication number
WO2008043899A2
WO2008043899A2 PCT/FR2007/001627 FR2007001627W WO2008043899A2 WO 2008043899 A2 WO2008043899 A2 WO 2008043899A2 FR 2007001627 W FR2007001627 W FR 2007001627W WO 2008043899 A2 WO2008043899 A2 WO 2008043899A2
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WO
WIPO (PCT)
Prior art keywords
cavity
implant
anchoring means
endosseous
section
Prior art date
Application number
PCT/FR2007/001627
Other languages
French (fr)
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WO2008043899A3 (en
Inventor
Jean-Claude Yeung Wai Ping
Original Assignee
Jean-Claude Yeung Wai Ping
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 FR0608779A external-priority patent/FR2906705B1/en
Priority claimed from FR0609873A external-priority patent/FR2906708B1/en
Application filed by Jean-Claude Yeung Wai Ping filed Critical Jean-Claude Yeung Wai Ping
Publication of WO2008043899A2 publication Critical patent/WO2008043899A2/en
Publication of WO2008043899A3 publication Critical patent/WO2008043899A3/en
Priority to SM200900032T priority Critical patent/SMP200900032B/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0018Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0018Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
    • A61C8/0022Self-screwing

Definitions

  • Endo-osseous implant provided with axially extended reliefs promoting osteointegration, and method of obtaining such an endosseous implant.
  • the invention is in the field of bone surgery and more particularly endosseous implants intended to support a medical device, such as implants used in dental surgery, in reconstructive surgery and / or in ENT (otolaryngology) surgery. for example. It relates to such an endosseous implant, which is provided with reliefs to promote osseointegration. It also relates to a method of manufacturing such an endosseous implant.
  • Endosseous implants are used in surgery to implant a medical device in a patient, such as for example a prosthesis in the dental field.
  • Such implants are likely to be of intra-oral type for use in the dental field in particular, or of the extra-oral type for use in the field of reconstructive surgery and / or ENT surgery, for example.
  • These applications are given by way of example and are not restrictive as to the scope of the present invention.
  • These implants consist of an elongate body which has at its air end means for joining the medical device, and at its end endosseous means for anchoring inside a bone tissue, such as the bone of the jaw for a dental application for example.
  • the implant is placed inside a housing previously made in the bone by the practitioner, inside which housing is introduced the endosseous end of the bone. body.
  • the anchoring means combine mechanical anchoring means and histological anchoring means.
  • the mechanical anchoring means are in particular of the impaction type and / or of the screw type, preferably self-tapping.
  • these mechanical anchoring means implement fixing reliefs which are arranged to hold the implant in position inside the bone when it is put in place.
  • fixing reliefs consist for example of a thread and / or annular members such as alternating lips and grooves.
  • the endo-osseous end of the body is provided with histological anchoring means, which are intended to promote an osteotomy.
  • integration of the implant from an exploitation of bone cell development.
  • Reliefs specifically dedicated to osseointegration are therefore provided on the endosseous end of the body, to form niches for colonization by bone cells that develop after placement of the implant. These osseointegration reliefs are organized so that any spontaneous removal of the implant is prohibited because of the integration in intimate contact of the endosseous end of the body into the bone mass.
  • Such an organization of osseointegration reliefs axially extended at the periphery of the implant deserves to be improved to promote the histological anchoring of the implant.
  • Such improvements must not induce a complexity of the implant structure which consequently may make it difficult to obtain.
  • These improvements must not only relate to the robustness of the histological anchoring obtained, but also allow osseointegration of the implant as quickly as possible after installation in the bone material.
  • This speed of histological anchoring aims to avoid any risk of spontaneous removal of the implant during the period when it is only maintained in the bone by means of mechanical anchoring means.
  • the arrangement and the manufacturing methods on the body of both the mechanical anchoring means and the osseointegration means must allow an implementation of the implant which is easy and at a lower cost without affecting the qualities required for these different means.
  • the arrangement and the methods for producing the osteointegration means must optimize the histological taking of the implant by the bone tissues without affecting the efficiency of the mechanical anchoring means, must take into account the desired manufacturing tolerances. widest possible without affecting the quality of the overall anchoring of the implant in bone.
  • the procedure for manufacturing the implant must enable it to be obtained with the lowest possible production costs.
  • the purpose of the present invention is to provide an endosseous implant provided with mechanical anchoring means for its installation in the bone and histological anchoring means promoting its osteointegration, as well as a manufacturing method of such an implant that allows its obtaining at lower costs despite the improvements brought to promote its osteo-integration, both in robustness and speed.
  • the osteointegration means must be able to be easily formed on the body of the implant while promoting their effectiveness and the speed of the histological anchoring of the implant. It is therefore also the object of the present invention to provide a process for obtaining this implant. More particularly, another object of the present invention is to provide a method for obtaining an endosseous implant with axially extended osteointegration clearances, the implementation of which takes into account all the constraints that have been stated.
  • the endosseous implant of the present invention comprises an elongated body whose air end is provided with means for joining a medical device and whose endosseous end is provided with means for anchoring in the bone.
  • the anchoring means combine mechanical anchoring means for fixing the implant in the bone during implantation, and histological anchoring means for osseointegration of the implant.
  • the histological anchoring means comprise at least one cavity that extends longitudinally inside the body. This cavity opens out along its dimension of longitudinal extension, laterally at the periphery of the body for the formation of a longitudinal window of passage of the bone material to and inside the cavity. This cavity also opens through the end face of the endo-osseous end of the body.
  • the cross section of the cavity is more particularly defined by a circle, so that the transverse dimension of the window is defined by a cord of this circle.
  • the histological anchoring of the implant is done from a migration bone material inwardly of the body laterally to its axis of extension, by passing through the window which opens at its periphery.
  • the longitudinal extension of the cavity corresponds to the longitudinal extension of the body and its direction of implantation in the bone. This longitudinal extension is oriented parallel to the axis of general extension of the body, and the cavity extends radially offset relative to the axis of extension of the body to allow its lateral outlet at the periphery thereof.
  • such an endosseous implant is mainly recognizable in that the rope defining the transverse dimension of the window corresponds to a segment delimited by an angle of less than 180 °.
  • the transverse dimension of the window is smaller than the diameter defining the section of the cavity.
  • the longitudinal conformation of the cavity in circular section opening laterally on the body along a rope of dimension smaller than its diameter taken inside the body makes it possible to optimize the volume of the cavity relative to the overall volume of the end. endosseous implant, and consequently optimizes the amount of bone material that can nest inside the body for the osseointegration of the implant.
  • the edges of the window can be used to form impaction reliefs of the implant, and / or reliefs for collection and delivery of the bone material to the inside of the cavity during the placement of the implant. implant, especially in case of implantation of the body by screwing.
  • the position of the cavity in the vicinity of the periphery of the body does not prevent the possible passage of the means of joining the body with the medical device, which may be arranged axially inside the endo-osseous end of the body to less partially adjacent to the cavity.
  • the optimization of the volume of the cavity with regard to the overall volume of the endosseous end of the implant, and consequently the optimization of the amount of bone material that can nest inside the body in order to osteointegration of the implant are supported from optimizing the useful volume of the cavity and from the obstacle formed by the edges of the window for the bone material nested inside the cavity.
  • These provisions are intended to optimize the capacity of the cavity to receive bone material, while maintaining a satisfactory surface extension of the window for the passage of this bone material.
  • the angle defining the rope is preferably close to 180 °.
  • a satisfactory compromise resides in a cord corresponding to a segment delimited by an angle which is between 15 ° and 60 ° with respect to the diameter of the circular section of the cavity.
  • the cavity at least may be single, or be in even or odd number plurality. This cavity preferably extends parallel to the axis of extension of the body, but may also extend inclined with respect to this axis and / or helical. The at least one cavity may extend continuously or discontinuously along the body.
  • the plurality of cavities may be the same or different, being disposed symmetrically or asymmetrically on the body. Each cavity is likely to have a section conformation of its own.
  • the cavity is unique and has a section of the order of one-half, more or less 30% weighted, of the overall section of the endo-osseous end of the body taken in the same plane of section.
  • This variant embodiment is rather intended to be applied to a body of small diameter.
  • the cavities are in plurality being angularly distributed within the body. Such angular distribution is likely to be regular or not, and / or to be performed concentrically or not with respect to the axis of the cavity.
  • This variant embodiment is rather intended to be applied to a body of larger diameter than the previous one.
  • the connecting means equipping the body are likely to extend inside the endo-osseous end of the body, adjacent cavities.
  • the cavity is unique being formed in an area of the body located in extension of a receiving area of the means for joining the body with the medical device .
  • This cavity although unique, is radially offset from the general axis of extension of the body, to allow its lateral opening and the formation of the window.
  • the cavities are in plurality.
  • the cavities are three in angularly distributed regularly and concentrically at an angle of 120 °.
  • These provisions offer a compromise between the overall volume offered by the cavities for receiving the bone mass inside the body during osteointegration of the implant, and the size of these cavities with regard to the area.
  • the cavity comprises in particular secondary osteo-integration reliefs constituted by the threads of an internal thread which extends at least partly along the cavity.
  • the threads provide between them a plurality of successive chambers for retention of the bone mass during the osseointegration of the implant.
  • Such secondary reliefs of osseointegration are oriented transversely to the direction of longitudinal extension of the cavity and therefore transversely to the direction of insertion and extraction of the implant, to prevent removal of the implant after its osteointegration from the resistance offered by the bone material bearing axially against each of the threads of the anchoring relief.
  • Such osseointegration is rendered robust because of the lateral opening of the chambers on the periphery of the body towards the outside of the implant, and of the faculty offered a lateral migration of the bone material from the bone to the interior volume of the rooms delimited between two successive nets.
  • Each of the chambers is delimited by the wall of the cavity in the space between two successive threads, and opens out laterally around the endo-osseous end of the body.
  • Such internal threading of the cavity makes it possible to easily increase the overall surface of the implant that can be enveloped by the bone material during its osseointegration.
  • the lateral communication with the outside of the body of this internal thread through the window allows each of the nets to be placed in individual contact with the bone material, which can migrate simultaneously and individually to each of these nets during the osseointegration of the implant, according to a development of the bone material from the outside laterally to the implant with respect to its axis of extension, and consequently to occupy progressively and simultaneously all the successive chambers retention of bone mass during osseointegration of the implant.
  • the quality of the histological anchorage obtained makes the installation of the implant robust, reliable and durable, with the possibility of withstanding the long-term repeated and important forces, such as chewing forces in the case of use dental.
  • the internal threading of the cavity for the formation of secondary osteointegration reliefs may be completed by at least one anchoring relief of another nature, such as grooves and / or radial grooves and / or or perforations arranged radially through the body.
  • Such anchoring reliefs may be successively arranged along the longitudinal extension of the cavity, at least in part along its length.
  • the provisions of the invention relating to the organization of the means of anchoring by osseointegration make it possible to freely organize not only the connecting means inside the body, but also the mechanical anchoring means, thanks to the optimization of the internal volume of the cavities and the presence of secondary osteointegration reliefs formed inside the cavities.
  • Ways mechanical anchoring may be indifferently means for anchoring by screwing and / or impingement anchoring means.
  • the thread formed inside the cavity is indifferently arranged in the same direction and / or in the opposite direction of the thread direction of the mechanical anchoring means.
  • the pitch of the thread formed inside the cavity is indifferently the same and / or is different from the thread pitch of the mechanical anchoring means.
  • the connecting means are likely to be arbitrary.
  • the joining means consist of at least one connecting member, such as an internal thread, which is formed in the body extending in extension or inside the endo-osseous end .
  • the assembly member is an element that emerges at the air end of the body, and which is reported or integrated therewith. Several assembly members are likely to be associated.
  • the body has in particular a generally circular conformation section, possibly conical.
  • a conformation of the body is however not restrictive, the body being able to present in a similar way a polygonal conformation section, especially in case of implantation by impaction.
  • the body is preferably formed from a cylinder inside which are easily formed the cavity and the threading it comprises by drilling and tapping. Drilling operations of the cavity or cavities, and their possible tapping to form the thread constituting the secondary reliefs of osseointegration, are performed from the end face of the corresponding end of the cylinder. Then, the diameter of this cylinder is reduced until laterally open the cavity and accordingly to form the window.
  • a surface treatment such as by corrosion and / or sandblasting, or even a contribution of material such as by projection, can be applied to the surfaces of the cavity and / or anchoring reliefs for the formation of micro-reliefs on these surfaces to improve the osseointegration of the implant.
  • Such a method is mainly recognizable in that it consists, from a raw body of gross section S1 greater than a finite section S2 of a finite body, to carry out successively the following operations: *) forming by drilling the cavity on the raw body, from the end face of the endo-osseous end of the body so that the axis of the cavity is radially offset relative to the median axis of the body.
  • the raw section S1 and the raw body correspond to the characteristics of a blank from which is removed from the material for the formation of the anchoring means and the means of joining with the medical apparatus, and for obtaining the finished body of finished section S2 implantable in the bone material.
  • the formation of the cavity is performed before any step to obtain the finite section S2 of the finished body and to provide the mechanical anchoring means, to preserve the surfaces of the implant used for its implantation in the bone material and its mechanical retention. waiting for his osteo-integration. This preservation makes it possible to avoid any alteration of the finished body and mechanical anchoring means likely to affect the effectiveness of the positioning and reliable maintenance of the implant in bone prior to osseointegration.
  • the precision of the radial extension of the cavity is inexpensively and sufficiently obtained to guarantee the effectiveness of the osseointegration of the implant, while allowing the subsequent obtaining of the finite section S2 of the finished body and mechanical fixing relief with optimized precision. More precisely, a rigor of dimensional tolerances is only applied for the surfaces necessary for the installation of the implant in the bone material waiting for its osseointegration.
  • the recovery operations of the body are limited: the formation of the cavity, incidentally its tapping and the reduction of the raw section of the raw body can both be made from the same phase of holding the body on tooling, that is to say without removal of the body of this tool.
  • the formation of the cavity by drilling from the end face of the implant is performed without risk of bursting of the blank, despite the lateral opening of this cavity for the formation of the window, this lateral outlet being obtained at from a reduction in the diameter of the raw body. More particularly, the hole formed by drilling is non-emerging on the periphery of the body, then the window is obtained by reducing the gross section of the body. The precision of the emergent surface of this window at the periphery of the body is obtained easily and at lower cost, from a reduction of the section of the gross body achievable with imperatives of dimensional tolerances that are not very restrictive and easy to implement. .
  • a complementary operation consists in providing along the cavity secondary reliefs of osseointegration, this complementary operation being performed after the formation of the cavity and prior to the reduction of the raw section S1 of the raw body to avoid to alter the finite body.
  • the secondary reliefs of osseointegration are advantageously formed by tapping the cavity prior to the reduction of the gross section of the raw body. Such a tapping operation is likely to be operated simultaneously with the drilling operation by means of a self-tapping drill, or after the drilling operation by means of a specific tap.
  • the formation of secondary osteointegration reliefs is achieved by preserving the mechanical anchoring means and the finished body from any alteration, the tapping of the cavity being easily achieved prior to their obtaining.
  • the secondary reliefs of osseointegration are obtained with low production costs for optimized osteointegration faculties of the implant.
  • the method comprises an auxiliary operation of bevelling the axial edges of the radial outlet of the cavity.
  • This auxiliary operation is performed after the reduction of the gross body section, or even the formation of the mechanical anchoring means.
  • Such beveling aims to debur the edges of the window and to provide scraping organs of the bone material during the installation of the implant by screwing.
  • the method also comprises at least one terminal operation consisting of arranging on the finished body the junction means of the medical device.
  • This end operation comprises, where appropriate, a completion of the endosseous end of the body in the case in particular of an implant placed by impaction, this completion consisting in conferring on the endo-osseous end of the body a shape adapted to an impaction of the implant, such as a rounded conformation or other similar conformation.
  • the terminal operation is performed after the formation of the mechanical anchoring means.
  • the terminal operation may also comprise a precision operation consisting of providing a junction relief with an adherent surface for receiving a junction relief with adherent surface complementary to the medical device.
  • Such junction relief with adherent surface is in particular a relief of the type with Morse taper or similar relief.
  • junction relief for the connection between the implant and a medical device aims to prohibit any movement between the implant and the medical device, or to analogous way between the implant and an intermediate junction piece equipping the medical device.
  • At least one finishing operation is incidentally carried out, and consists of a surface treatment of the endo-osseous end of the body, such as by corrosion and / or sandblasting, or even by a contribution of material by projection in particular.
  • This finishing operation aims to provide micro-reliefs on the treated surfaces to improve the osseointegration of the implant, and is performed after the formation of the mechanical anchoring means and where appropriate prior to the operation of precision not to affect the adhesion of the junction relief surface.
  • Fig.1 to Fig.3 are illustrations of an endosseous implant according to a first embodiment of the present invention, respectively axially viewed from the side, axially front view and sectional view.
  • Fig.4 and Fig.5 are illustrations of an endosseous implant according to a second embodiment of the present invention, respectively axially viewed from the front and sectional view.
  • Fig.6 is a side illustration of an endosseous implant according to a third embodiment of the present invention.
  • Fig.7 to Fig.11 are axially oriented diagrams illustrating successively respective steps of a method for obtaining an endosseous implant according to a preferred embodiment of the present invention.
  • FIGS. 1 to 6 are illustrations of an end seen implant at different stages of the process of obtaining this implant respectively shown in Fig.7 to Fig.10.
  • an endo-osseous implant is used in surgery to supply a medical device to a patient, and more particularly to the exemplary embodiments illustrated, but not exclusively, is intended for a patient. dental use while carrying a prosthesis.
  • This implant is mainly constituted by an elongated body 1, whose aerial end 2 is intended to receive the medical device while the endo-osseous end 3 is intended to be anchored in the bone.
  • the aerial 2 and endo-osseous ends 3 of the body 1 will be located with regard to the axially opposite position of their respective end face in the longitudinal direction of extension of the body 1.
  • the aerial end 2 of the body 1 is provided with means junction 4 with the medical device, directly or through a specifically dedicated organ.
  • these joining means 4 consist of an axial thread formed in the body 1, raised by a nut.
  • the structure of the joining means 4 is indifferent with regard to the specific provisions of the present invention.
  • the endo-osseous end 3 of the body 1 is provided with means for anchoring in the patient's bone, associating mechanical anchoring means 5 used during the placement of the implant, and means for Histological anchoring 6 to strengthen the maintenance of the implant in the bone by osteointegration.
  • the mechanical anchoring means 5 are of the screw type, and consist of a thread formed at the periphery of the body 1.
  • the mechanical anchoring means 5 are of impaction type, and comprise rings formed on the body 1 successively in its longitudinal direction of extension.
  • the structure of the mechanical anchoring means 5 is indifferent with regard to the structure of the histological anchoring means 6 proposed by the present invention.
  • the histological anchoring means 6 consist mainly of at least one cavity 7 which extends longitudinally in the direction of extension of the body 1.
  • This cavity 7 at least is formed inside the body 1 by opening laterally to its periphery, so as to provide a window 8 longitudinally extended for the passage of bone during osteointegration of the implant.
  • This window 8 extends in particular along the direction of longitudinal extension of the body 1, to allow osseointegration of the implant which is fast and effective.
  • cavity 7 a clearance formed in the body 1 whose section, taken either individually for a single cavity 7, or cumulatively for a plurality of cavities 7, has a significant surface area in relation to the overall surface of the corresponding section endosseous end 3 of the body 1.
  • the cavity or cavities 7 are of circular section, being formed by drilling preferably supplemented by a tapping.
  • the axis A1 of any cavity 7 is radially offset relative to the axis A of the body 1 to open laterally at its periphery so as to form the window 8.
  • the conformation in moon portion of the section of the cavities 7 promotes homogeneous migration of bone cells during osseointegration of the implant.
  • the moon-shaped conformation of the cavity or cavities 7 promotes the collection of bone tissue during implant placement, the edges of the window forming tools for collecting and bringing bone tissue into the cavity 7 during rotation of the body.
  • the cavity or cavities 7 are formed by drilling from the end face of the endo-osseous end 3 of the body 1, and are threaded to provide in their wall secondary reliefs of osseointegration 9 which consist of the threads thus formed and which are successively arranged along the longitudinal extension of the body 1.
  • Such secondary reliefs of osseointegration 9 delimit successively between them inside the cavity 7 of the chambers which are intended to independently receive the bone material during the Osteo- integration of the implant. This independent reception of the bone material by the chambers is in particular obtained thanks to their individual lateral outlet to the outer periphery of the body 1.
  • the implant is of the small diameter type and has a single cavity 7.
  • the joining means 4 being formed axially inside the body 1 from its aerial end 2, the axial zone of the body 1 is occupied by these junction means 4.
  • a longitudinal adjacency of the junction means 4 and the cavity 7 being made difficult because of the small diameter of the body 1.
  • the connecting means 4 and the cavity 7 are arranged in extension of each other.
  • the longitudinal extension of the cavity 7 being further restricted because of the presence of the joining means 4, the surface of its section is optimized to represent a surface of the order of half of the overall surface of the section. of the endo-osseous end 3 of the body 1.
  • the transverse dimension of the window 8 corresponds to a cord 10 of the circle determining the section of the cavity 7, the segment of which is delimited by an open angle towards the outside of the body which is less than 180 °, so that the rope 10 defining the transverse dimension of the window is smaller than the diameter of the cavity 7.
  • the implant is of the large-diameter type, allowing an extension of a plurality of cavities 7 in longitudinal adjacency of the joining means 4.
  • These arrangements make it possible to increase the longitudinal extension of the cavities 7, whose individual diameter is reduced but the cumulative surfaces of the sections of the set of cavities 7 can provide a significant capacity for receiving the bone material during osseointegration of the implant.
  • the cavities 7 are three in number being angularly evenly distributed over the body at an angle of 120 °.
  • the conformation and the individual dimensions of the cavities 7 formed on the same body 1 are identical. However, these conformation and individual dimensions are likely to be different for cavities 7 formed on the same body 1. Moreover, the relative position of the various cavities 7 relative to the axis A of extension of the body 1 is likely to vary from one cavity 7 to another.
  • each of the windows 8 corresponds to a cord 10 of the circle defining the section of the cavities 7, the segment of which is delimited by angles of the order of 45.degree. to the diameter of the corresponding cavity 7, on either side of the transversely median axis of this cavity 7.
  • the capacity of the cavities 7 is optimized despite their restricted diameter, the transverse dimension of the window 8 being limited but sufficient.
  • the choice of the number of cavities 7, their diameter and the dimension of the chord segment defining the transverse dimension of the window 8, are chosen according to the type of implant, and in particular according to the diameter of the endo-osseous end 3 of the body 1, and as a function of the position and the arrangement of the joining means 4, so as to best satisfy the necessary compromise between an overall volume of the cavity 7 which is optimized and a transverse dimension of the window 8 which allows a rapid migration of the bone material to the secondary osteointegration reliefs 9 constituted by the threads of the internal threading which comprises the cavity or cavities 7.
  • the body 101 of the implant has at its air end junction means 102 with a medical device, and at its end endosseous means for anchoring within a bone tissue.
  • the joining means 102 combine a threaded hole 103 and a junction relief 104 with an adherent surface of the Morse taper type.
  • the aerial end of the implant also comprises a driving relief 105 of the implant in rotation, as shaped in a polygon, for placing the implant in the bone material by screwing.
  • the anchoring means comprise mechanical anchoring means 106 constituted by an external thread formed at the periphery of the body 101.
  • the mechanical anchoring means 106 are formed of peripheral rings for impaction implant placement of the implant.
  • a blank consisting of a blank body 110 of rough section S1 is placed on a tool for the formation of cavities 108 by drilling. This operation is carried out from the end face of the endo-osseous end of the raw body 110, and is completed by a bulging operation of the cavities 108 to form the internal thread constituting the secondary osteointegration reliefs 111.
  • the cavities 108 are formed in full material to preserve the raw body 110 from any risk of bursting.
  • the body 110 is machined to reduce its section S1 to a section S2 corresponding to the section of a finite body 112 implantable in the bone material.
  • This operation aims not only to adjust the section S2 of the finished body 112, but also to open the cavities 108 on the periphery of the body to spare the windows 109.
  • the mechanical anchoring means 106 are formed at the periphery of the finished body 112. An appendage bevel operation edges of the windows 109 is preferably made.
  • the mechanical anchoring means 106 consist of an external thread formed at the periphery of the finished body 112.
  • the mechanical anchoring means 106 are formed peripheral rings 113 which are formed concomitantly with the reduction of the section S1 of the raw body 110 to obtain the finished body 112.
  • the endo-osseous end 114 is completed by giving it a shape favoring the impaction of the implant, such as a rounded shape on the exemplary embodiment illustrated.
  • the implant is completed by a terminal operation of forming the junction means 112 of the implant with the medical device and if necessary the driving relief 115 in rotation of the implant.
  • a finishing operation is performed to achieve a surface treatment of the implant promotes its osteo-integration.
  • an end operation is optionally performed, to form the junction relief 114 with adherent surface.

Abstract

The invention relates to an endosseous implant comprising a body (1) provided with at least one peripheral longitudinal cavity (7) whose cross section is defined by a circle and whose lateral aperture forms a window (8) for passage of the bone substance for osseointegration of the implant. The transverse dimension of the window (8) is smaller than the diameter defining the cross section of the cavity (7), being defined by a chord (10) of the circle that corresponds to a segment delimited by an angle of less than 180°. The cavity (7) is formed by drilling the body (1) and then reducing the diameter of the body (1) until the lateral aperture of the cavity (7) forming the window (8) is obtained.

Description

Implant endo-osseux muni de reliefs axialement étendus favorisant son ostéo-intégration, et procédé d'obtention d'un tel implant endo-osseux. Endo-osseous implant provided with axially extended reliefs promoting osteointegration, and method of obtaining such an endosseous implant.
Domaine technique de l'invention.Technical Field of the Invention
L'invention est du domaine de la chirurgie osseuse et plus particulièrement des implants endo-osseux destinés à supporter un appareil médical, tels que des implants utilisés en chirurgie dentaire, en chirurgie réparatrice et/ou en chirurgie ORL (oto-rhino-laryngologie) par exemple. Elle a pour objet un tel implant endo- osseux, qui est muni de reliefs pour favoriser son ostéo-intégration. Elle a aussi pour objet un procédé de fabrication d'un tel implant endo-osseux.The invention is in the field of bone surgery and more particularly endosseous implants intended to support a medical device, such as implants used in dental surgery, in reconstructive surgery and / or in ENT (otolaryngology) surgery. for example. It relates to such an endosseous implant, which is provided with reliefs to promote osseointegration. It also relates to a method of manufacturing such an endosseous implant.
Etat de la technique.State of the art
Les implants endo-osseux sont utilisés en chirurgie pour implanter un appareil médical chez un patient, tel que par exemple une prothèse dans le domaine dentaire. De tels implants sont susceptibles d'être du type intra buccal pour une utilisation dans le domaine dentaire notamment, ou du type extra buccal pour une utilisation dans le domaine de la chirurgie réparatrice et/ou de la chirurgie ORL par exemple. Ces applications sont données à titre d'exemple et ne sont pas restrictives quant à la portée de la présente invention. Ces implants sont constitués d'un corps allongé qui comporte à son extrémité aérienne des moyens de jonction avec l'appareil médical, et à son extrémité endo-osseuse des moyens d'ancrage à l'intérieur d'un tissu osseux, tel que l'os de la mâchoire pour une application dentaire par exemple.Endosseous implants are used in surgery to implant a medical device in a patient, such as for example a prosthesis in the dental field. Such implants are likely to be of intra-oral type for use in the dental field in particular, or of the extra-oral type for use in the field of reconstructive surgery and / or ENT surgery, for example. These applications are given by way of example and are not restrictive as to the scope of the present invention. These implants consist of an elongate body which has at its air end means for joining the medical device, and at its end endosseous means for anchoring inside a bone tissue, such as the bone of the jaw for a dental application for example.
Se pose le problème de la qualité de l'ancrage de l'implant dans l'os. L'implant est mis en place à l'intérieur d'un logement préalablement ménagé dans l'os par le praticien, à l'intérieur duquel logement est introduite l'extrémité endo-osseuse du corps. Les moyens d'ancrage associent des moyens d'ancrage mécanique et des moyens d'ancrage histologique.There is the problem of the quality of the anchoring of the implant in the bone. The implant is placed inside a housing previously made in the bone by the practitioner, inside which housing is introduced the endosseous end of the bone. body. The anchoring means combine mechanical anchoring means and histological anchoring means.
Les moyens d'ancrage mécanique sont notamment du type par impaction et/ou du type par vissage préférentiellement auto-taraudant. D'une manière générale, ces moyens d'ancrage mécanique mettent en œuvre des reliefs de fixation qui sont agencés pour maintenir l'implant en position à l'intérieur de l'os lors de sa mise en place. De tels reliefs de fixation sont par exemple constitués d'un filetage et/ou d'organes annulaires tels que lèvres et gorges alternées. Pour favoriser l'ancrage mécanique de l'implant, il a par exemple été proposé par US2005/0164146The mechanical anchoring means are in particular of the impaction type and / or of the screw type, preferably self-tapping. In general, these mechanical anchoring means implement fixing reliefs which are arranged to hold the implant in position inside the bone when it is put in place. Such fixing reliefs consist for example of a thread and / or annular members such as alternating lips and grooves. To promote the mechanical anchoring of the implant, it has for example been proposed by US2005 / 0164146
(CANTOR STANTON R.) de doubler les filetages ménagés sur le corps, l'un étant un filetage intérieur et l'autre étant un filetage extérieur.(CANTOR STANTON R.) doubling the threads formed on the body, one being an internal thread and the other being an external thread.
Pour conforter l'ancrage mécanique de l'implant et interdire à l'usage son retrait spontané hors de l'os, l'extrémité endo-osseuse du corps est munie des moyens d'ancrage histologique, qui sont destinés à favoriser une ostéo-intégration de l'implant à partir d'une exploitation d'un développement des cellules osseuses. A cet effet, il est recherché d'accroître les surfaces de l'implant en contact avec les tissus osseux, en sus des surfaces déjà offertes par les moyens d'ancrage mécaniques. Des reliefs spécifiquement dédiés à l'ostéo-intégration sont donc ménagés sur l'extrémité endo-osseuse du corps, pour former des niches destinées à être colonisées par les cellules osseuses qui se développent après mise en place de l'implant. Ces reliefs d'ostéo-intégration sont organisés de sorte que tout retrait spontané de l'implant soit interdit en raison de l'intégration en contact intime de l'extrémité endo-osseuse du corps dans la masse osseuse.To reinforce the mechanical anchoring of the implant and to prohibit the use of its spontaneous removal from the bone, the endo-osseous end of the body is provided with histological anchoring means, which are intended to promote an osteotomy. integration of the implant from an exploitation of bone cell development. For this purpose, it is desired to increase the surfaces of the implant in contact with the bone tissue, in addition to the surfaces already offered by the mechanical anchoring means. Reliefs specifically dedicated to osseointegration are therefore provided on the endosseous end of the body, to form niches for colonization by bone cells that develop after placement of the implant. These osseointegration reliefs are organized so that any spontaneous removal of the implant is prohibited because of the integration in intimate contact of the endosseous end of the body into the bone mass.
Parmi ces reliefs d'ostéo-intégration, on connaît ceux qui sont agencés en cavités ménagées longitudinalement en périphérie du corps. Ces cavités débouchent latéralement en périphérie du corps pour former des fenêtres longitudinales qui s'étendent parallèlement à l'axe d'extension du corps, à travers lesquelles fenêtres la matière osseuse est apte à migrer pour l'ostéo-intégration de l'implant. On pourra se reporter aux documents EP0437401 (SOFAMOR), EP1057456 (BRESSMAN R.A. ; MEGERT D.) et WOOO/47127 (ASHMAN A. ; LINKOW L.) qui décrivent de tels reliefs d'ostéo-intégration.Among these reliefs of osseointegration, those are known which are arranged in cavities formed longitudinally on the periphery of the body. These cavities open laterally at the periphery of the body to form longitudinal windows that extend parallel to the axis of extension of the body, through which windows the bone material is able to migrate for osseointegration of the implant. We can refer to the documents EP0437401 (SOFAMOR), EP1057456 (BRESSMAN RA, MEGERT D.) and WO00 / 47127 (ASHMAN A. LINKOW L.) which describe such osteointegration reliefs.
Une telle organisation de reliefs d'ostéo-intégration axialement étendus en périphérie de l'implant mérite d'être améliorée pour favoriser l'ancrage histologique de l'implant. De telles améliorations ne doivent cependant pas induire une complexité de la structure de l'implant qui en conséquence risque de rendre difficile son obtention. Ces améliorations doivent non seulement porter sur la robustesse de l'ancrage histologique obtenu, mais aussi permettre une ostéo- intégration de l'implant la plus rapide possible après son installation dans la matière osseuse. Cette rapidité d'ancrage histologique vise à éviter tout risque de retrait spontané de l'implant pendant la période où il est seulement maintenu dans l'os par l'intermédiaire des moyens d'ancrage mécanique. L'agencement et les modalités de fabrication sur le corps tant des moyens d'ancrage mécanique que des moyens d'ostéo-intégration, doivent permettre une réalisation de l'implant qui soit aisée et à moindre coût sans affecter les qualités requises pour ces différents moyens.Such an organization of osseointegration reliefs axially extended at the periphery of the implant deserves to be improved to promote the histological anchoring of the implant. Such improvements, however, must not induce a complexity of the implant structure which consequently may make it difficult to obtain. These improvements must not only relate to the robustness of the histological anchoring obtained, but also allow osseointegration of the implant as quickly as possible after installation in the bone material. This speed of histological anchoring aims to avoid any risk of spontaneous removal of the implant during the period when it is only maintained in the bone by means of mechanical anchoring means. The arrangement and the manufacturing methods on the body of both the mechanical anchoring means and the osseointegration means, must allow an implementation of the implant which is easy and at a lower cost without affecting the qualities required for these different means.
L'agencement et les modalités de réalisation des moyens d'ostéo-intégration doivent optimiser la prise histologique de l'implant par les tissus osseux sans altérer l'efficacité des moyens d'ancrage mécanique, doivent prendre en compte des tolérances de fabrication souhaitées les plus larges possible sans affecter la qualité de l'ancrage global de l'implant dans la matière osseuse. Le mode opératoire pour la fabrication de l'implant doit permettre son obtention avec des coûts de production les plus faibles possibles.The arrangement and the methods for producing the osteointegration means must optimize the histological taking of the implant by the bone tissues without affecting the efficiency of the mechanical anchoring means, must take into account the desired manufacturing tolerances. widest possible without affecting the quality of the overall anchoring of the implant in bone. The procedure for manufacturing the implant must enable it to be obtained with the lowest possible production costs.
Objet de l'invention.Object of the invention
Le but de la présente invention est de proposer un implant endo-osseux muni de moyens d'ancrage mécanique pour son installation dans l'os et de moyens d'ancrage histologiques favorisant son ostéo-intégration, ainsi qu'un procédé de fabrication d'un tel implant qui permette son obtention à moindres coûts malgré les perfectionnement apportés pour favoriser son ostéo-intégration, tant en robustesse qu'en rapidité.The purpose of the present invention is to provide an endosseous implant provided with mechanical anchoring means for its installation in the bone and histological anchoring means promoting its osteointegration, as well as a manufacturing method of such an implant that allows its obtaining at lower costs despite the improvements brought to promote its osteo-integration, both in robustness and speed.
Il est plus particulièrement visé par la présente invention de proposer un tel implant dont l'agencement des moyens d'ostéo-intégration autorise leur exploitation avec de quelconques moyens d'ancrage mécanique, leur confère une efficacité fiable et pérenne, favorise une ostéo-intégration rapide, robuste, fiable et pérenne de l'implant, et permet une obtention à moindres coûts de l'implant à partir d'opérations de fabrication qui sont simples et aisées à mettre en œuvre. Les moyens d'ostéo-intégration doivent pouvoir être formés aisément sur le corps de l'implant tout en favorisant leur efficacité et la rapidité de l'ancrage histologique de l'implant. Il est donc aussi visé par la présente invention de proposer un procédé d'obtention de cet implant. Plus particulièrement, un autre but de la présente invention est de proposer un procédé d'obtention d'un implant endo- osseux comportant des dégagements d'ostéo-intégration qui sont axialement étendus, dont la mise en œuvre prend en compte l'ensemble des contraintes qui ont été énoncées.It is more particularly the object of the present invention to provide such an implant, the arrangement of which means of osseointegration allows their exploitation with any means of mechanical anchoring, gives them reliable and long-lasting efficiency, promotes osteointegration fast, robust, reliable and durable implant, and allows a lower cost of the implant from manufacturing operations that are simple and easy to implement. The osteointegration means must be able to be easily formed on the body of the implant while promoting their effectiveness and the speed of the histological anchoring of the implant. It is therefore also the object of the present invention to provide a process for obtaining this implant. More particularly, another object of the present invention is to provide a method for obtaining an endosseous implant with axially extended osteointegration clearances, the implementation of which takes into account all the constraints that have been stated.
L'implant endo-osseux de la présente invention comprend un corps allongé dont l'extrémité aérienne est munie de moyens de jonction avec un appareil médical et dont l'extrémité endo-osseuse est munie de moyens d'ancrage dans l'os. Les moyens d'ancrage associent des moyens d'ancrage mécanique pour fixer l'implant dans l'os lors de son implantation, et des moyens d'ancrage histologique pour une ostéo-intégration de l'implant. Les moyens d'ancrage histologique comprennent au moins une cavité qui s'étend longitudinalement à l'intérieur du corps. Cette cavité débouche suivant sa dimension d'extension longitudinale, latéralement en périphérie du corps pour la formation d'une fenêtre longitudinale de passage de la matière osseuse vers et à l'intérieur de la cavité. Cette cavité débouche aussi à travers la face de bout de l'extrémité endo-osseuse du corps. La section transversale de la cavité est plus particulièrement définie par un cercle, de sorte que la dimension transversale de la fenêtre est définie par une corde de ce cercle. L'ancrage histologique de l'implant est réalisé à partir d'une migration de la matière osseuse vers l'intérieur du corps latéralement à son axe d'extension, par passage à travers la fenêtre qui débouche à sa périphérie.The endosseous implant of the present invention comprises an elongated body whose air end is provided with means for joining a medical device and whose endosseous end is provided with means for anchoring in the bone. The anchoring means combine mechanical anchoring means for fixing the implant in the bone during implantation, and histological anchoring means for osseointegration of the implant. The histological anchoring means comprise at least one cavity that extends longitudinally inside the body. This cavity opens out along its dimension of longitudinal extension, laterally at the periphery of the body for the formation of a longitudinal window of passage of the bone material to and inside the cavity. This cavity also opens through the end face of the endo-osseous end of the body. The cross section of the cavity is more particularly defined by a circle, so that the transverse dimension of the window is defined by a cord of this circle. The histological anchoring of the implant is done from a migration bone material inwardly of the body laterally to its axis of extension, by passing through the window which opens at its periphery.
L'extension longitudinale de la cavité correspond à l'extension longitudinale du corps et à sa direction d'implantation dans l'os. Cette extension longitudinale est orientée parallèlement à l'axe d'extension générale du corps, et la cavité s'étend de manière radialement décalée par rapport à l'axe d'extension du corps pour permettre son débouché latéral en périphérie de celui-ci.The longitudinal extension of the cavity corresponds to the longitudinal extension of the body and its direction of implantation in the bone. This longitudinal extension is oriented parallel to the axis of general extension of the body, and the cavity extends radially offset relative to the axis of extension of the body to allow its lateral outlet at the periphery thereof.
Selon la présente invention, un tel implant endo-osseux est principalement reconnaissable en ce que la corde définissant la dimension transversale de la fenêtre correspond à un segment délimité par un angle inférieur à 180°. La dimension transversale de la fenêtre est inférieure au diamètre définissant la section de la cavité.According to the present invention, such an endosseous implant is mainly recognizable in that the rope defining the transverse dimension of the window corresponds to a segment delimited by an angle of less than 180 °. The transverse dimension of the window is smaller than the diameter defining the section of the cavity.
La conformation longitudinale de la cavité en section circulaire débouchant latéralement sur le corps suivant une corde de dimension inférieure à son diamètre pris à l'intérieur du corps, permet d'optimiser le volume de la cavité au regard du volume hors tout de l'extrémité endo-osseuse de l'implant, et en conséquence permet d'optimiser la quantité de matière osseuse pouvant se nicher à l'intérieur du corps en vue de l'ostéo-intégration de l'implant. Les bords de la fenêtre peuvent être exploitées pour former des reliefs d'impaction de l'implant, et/ou des reliefs de collecte et d'amenée de la matière osseuse vers l'intérieur de la cavité lors de la mise en place de l'implant, notamment en cas d'implantation du corps par vissage. La position de la cavité au voisinage de la périphérie du corps ne fait pas obstacle au passage éventuel des moyens de jonction du corps avec l'appareil médical, qui peuvent être ménagés axialement à l'intérieur de l'extrémité endo-osseuse du corps au moins partiellement en adjacence de la cavité. L'optimisation du volume de la cavité au regard du volume hors tout de l'extrémité endo-osseuse de l'implant, et en conséquence l'optimisation de la quantité de matière osseuse pouvant se nicher à l'intérieur du corps en vue de l'ostéo-intégration de l'implant, sont confortées à partir de l'optimisation du volume utile de la cavité et à partir de l'obstacle formé par les bords de la fenêtre pour la matière osseuse nichée à l'intérieur de la cavité. Ces dispositions visent à optimiser la capacité de la cavité à recevoir de la matière osseuse, tout en maintenant une surface satisfaisante d'extension de la fenêtre pour le passage de cette matière osseuse. Dans le cas où la cavité est unique, l'angle définissant la corde est de préférence proche de 180°. Pour une pluralité de cavités angulairement réparties sur le corps, un compromis satisfaisant réside dans une corde correspondante à un segment délimité par un angle qui est compris entre 15° et 60° par rapport au diamètre de la section circulaire de la cavité.The longitudinal conformation of the cavity in circular section opening laterally on the body along a rope of dimension smaller than its diameter taken inside the body, makes it possible to optimize the volume of the cavity relative to the overall volume of the end. endosseous implant, and consequently optimizes the amount of bone material that can nest inside the body for the osseointegration of the implant. The edges of the window can be used to form impaction reliefs of the implant, and / or reliefs for collection and delivery of the bone material to the inside of the cavity during the placement of the implant. implant, especially in case of implantation of the body by screwing. The position of the cavity in the vicinity of the periphery of the body does not prevent the possible passage of the means of joining the body with the medical device, which may be arranged axially inside the endo-osseous end of the body to less partially adjacent to the cavity. The optimization of the volume of the cavity with regard to the overall volume of the endosseous end of the implant, and consequently the optimization of the amount of bone material that can nest inside the body in order to osteointegration of the implant, are supported from optimizing the useful volume of the cavity and from the obstacle formed by the edges of the window for the bone material nested inside the cavity. These provisions are intended to optimize the capacity of the cavity to receive bone material, while maintaining a satisfactory surface extension of the window for the passage of this bone material. In the case where the cavity is single, the angle defining the rope is preferably close to 180 °. For a plurality of angularly distributed cavities on the body, a satisfactory compromise resides in a cord corresponding to a segment delimited by an angle which is between 15 ° and 60 ° with respect to the diameter of the circular section of the cavity.
La cavité au moins peut être unique, ou être en pluralité en nombre pair ou impair. Cette cavité s'étend de préférence parallèlement à l'axe d'extension du corps, mais peut aussi s'étendre de manière inclinée par rapport à cet axe et/ou en hélice. La cavité au moins peut s'étendre de manière continue ou discontinue le long du corps. Les cavités en pluralité peuvent être semblables ou différentes, en étant disposées sur le corps de manière symétrique ou asymétrique. Chaque cavité est susceptible de présenter une conformation de section qui lui est propre.The cavity at least may be single, or be in even or odd number plurality. This cavity preferably extends parallel to the axis of extension of the body, but may also extend inclined with respect to this axis and / or helical. The at least one cavity may extend continuously or discontinuously along the body. The plurality of cavities may be the same or different, being disposed symmetrically or asymmetrically on the body. Each cavity is likely to have a section conformation of its own.
Selon une variante de réalisation, la cavité est unique et présente une section de l'ordre de la moitié, pondérée à plus ou moins 30%, de la section globale de l'extrémité endo-osseuse du corps prise en un même plan de coupe. Cette variante de réalisation est plutôt destinée à être appliquée à un corps de petit diamètre.According to an alternative embodiment, the cavity is unique and has a section of the order of one-half, more or less 30% weighted, of the overall section of the endo-osseous end of the body taken in the same plane of section. . This variant embodiment is rather intended to be applied to a body of small diameter.
Selon une autre variante de réalisation, les cavités sont en pluralité en étant angulairement réparties à l'intérieur du corps. Une telle répartition angulaire est susceptible d'être régulière ou non, et/ou d'être réalisée de manière concentrique ou non par rapport à l'axe de la cavité. Cette variante de réalisation est plutôt destinée à être appliquée à un corps de diamètre plus important que le précédent. Dans ce cas, les moyens de jonction équipant du corps sont susceptibles de s'étendre à l'intérieur de l'extrémité endo-osseuse du corps, en adjacence des cavités.According to another embodiment, the cavities are in plurality being angularly distributed within the body. Such angular distribution is likely to be regular or not, and / or to be performed concentrically or not with respect to the axis of the cavity. This variant embodiment is rather intended to be applied to a body of larger diameter than the previous one. In this case, the connecting means equipping the body are likely to extend inside the endo-osseous end of the body, adjacent cavities.
Plus particulièrement, dans le cas d'un implant dont le corps est de faible diamètre, la cavité est unique en étant ménagée dans une zone du corps située en prolongement d'une zone de réception des moyens de jonction du corps avec l'appareil médical. Cette cavité, quoique unique, est radialement décalée par rapport à l'axe général d'extension du corps, pour permettre son débouché latéral et la formation de la fenêtre. Dans le cas où le diamètre du corps est suffisamment conséquent pour l'autoriser, les cavités sont en pluralité.More particularly, in the case of an implant whose body is of small diameter, the cavity is unique being formed in an area of the body located in extension of a receiving area of the means for joining the body with the medical device . This cavity, although unique, is radially offset from the general axis of extension of the body, to allow its lateral opening and the formation of the window. In the case where the diameter of the body is sufficiently large to allow it, the cavities are in plurality.
Par exemple, les cavités sont au nombre de trois en étant angulairement réparties régulièrement et de manière concentrique suivant un angle de 120°. Ces dispositions offrent un compromis entre le volume global offert par les cavités pour la réception de la masse osseuse à l'intérieur du corps lors de l'ostéo- intégration de l'implant, et l'encombrement de ces cavités au regard de la zone axiale du corps laissée disponible pour loger les moyens de jonction équipant le corps.For example, the cavities are three in angularly distributed regularly and concentrically at an angle of 120 °. These provisions offer a compromise between the overall volume offered by the cavities for receiving the bone mass inside the body during osteointegration of the implant, and the size of these cavities with regard to the area. axial body left available to house the connecting means equipping the body.
La cavité comporte notamment des reliefs secondaires d'ostéo-intégration constitués par les filets d'un filetage intérieur qui s'étend au moins en partie le long de la cavité. Les filets ménagent entre eux une pluralité de chambres successives de rétention de la masse osseuse lors de l'ostéo-intégration de l'implant.The cavity comprises in particular secondary osteo-integration reliefs constituted by the threads of an internal thread which extends at least partly along the cavity. The threads provide between them a plurality of successive chambers for retention of the bone mass during the osseointegration of the implant.
De tels reliefs secondaires d'ostéo-intégration sont orientés transversalement à la direction d'extension longitudinale de la cavité et donc transversalement au sens d'introduction et d'extraction de l'implant, pour faire obstacle à un retrait de l'implant après son ostéo-intégration à partir de la résistance offerte par la matière osseuse prenant appui axialement contre chacun des filets du relief d'ancrage. Une telle ostéo-intégration est rendue robuste en raison du débouché latéral des chambres en périphérie du corps vers l'extérieur de l'implant, et de la faculté offerte d'une migration latérale de la matière osseuse en provenance de l'os vers le volume intérieur des chambres délimité entre deux filets successifs.Such secondary reliefs of osseointegration are oriented transversely to the direction of longitudinal extension of the cavity and therefore transversely to the direction of insertion and extraction of the implant, to prevent removal of the implant after its osteointegration from the resistance offered by the bone material bearing axially against each of the threads of the anchoring relief. Such osseointegration is rendered robust because of the lateral opening of the chambers on the periphery of the body towards the outside of the implant, and of the faculty offered a lateral migration of the bone material from the bone to the interior volume of the rooms delimited between two successive nets.
Chacune des chambres est délimitée par la paroi de la cavité dans l'espace compris entre deux filets successifs, et débouche latéralement en périphérie de l'extrémité endo-osseuse du corps. Un tel filetage intérieur à la cavité permet d'accroître aisément la surface globale de l'implant susceptible d'être enveloppée par la matière osseuse lors de son ostéo-intégration. La mise en communication latérale avec l'extérieur du corps de ce filetage intérieur par l'intermédiaire de la fenêtre, permet de placer chacun des filets en contact individuel avec la matière osseuse, celle-ci pouvant migrer simultanément et individuellement vers chacun de ces filets lors de l'ostéo-intégration de l'implant, suivant un développement de la matière osseuse depuis l'extérieur latéralement à l'implant au regard de son axe d'extension, et en conséquence occuper progressivement et simultanément l'ensemble des chambres successives de rétention de la masse osseuse lors de l'ostéo-intégration de l'implant.Each of the chambers is delimited by the wall of the cavity in the space between two successive threads, and opens out laterally around the endo-osseous end of the body. Such internal threading of the cavity makes it possible to easily increase the overall surface of the implant that can be enveloped by the bone material during its osseointegration. The lateral communication with the outside of the body of this internal thread through the window, allows each of the nets to be placed in individual contact with the bone material, which can migrate simultaneously and individually to each of these nets during the osseointegration of the implant, according to a development of the bone material from the outside laterally to the implant with respect to its axis of extension, and consequently to occupy progressively and simultaneously all the successive chambers retention of bone mass during osseointegration of the implant.
La qualité de l'ancrage histologique obtenu rend l'installation de l'implant robuste, fiable et pérenne, avec la possibilité de résister à long terme à des forces répétées et importantes, telles que des forces de mastication dans le cas d'un usage dentaire. Le filetage intérieur que comporte la cavité pour la formation des reliefs secondaires d'ostéo-intégration est susceptible d'être complété par au moins un relief d'ancrage d'une autre nature, tels que des cannelures et/ou des rainures radiales et/ou encore des perforations ménagées radialement à travers le corps. De tels reliefs d'ancrage peuvent être successivement disposés le long de l'extension longitudinale de la cavité, au moins en partie sur sa longueur.The quality of the histological anchorage obtained makes the installation of the implant robust, reliable and durable, with the possibility of withstanding the long-term repeated and important forces, such as chewing forces in the case of use dental. The internal threading of the cavity for the formation of secondary osteointegration reliefs may be completed by at least one anchoring relief of another nature, such as grooves and / or radial grooves and / or or perforations arranged radially through the body. Such anchoring reliefs may be successively arranged along the longitudinal extension of the cavity, at least in part along its length.
Les dispositions de l'invention relatives à l'organisation des moyens d'ancrage par ostéo-intégration permettent d'organiser librement non seulement les moyens de jonction à l'intérieur du corps, mais aussi les moyens d'ancrage mécanique, grâce à l'optimisation du volume intérieur des cavités et la présence des reliefs secondaires d'ostéo-intégration ménagés à l'intérieur des cavités. Les moyens d'ancrage mécanique sont susceptibles d'être indifféremment des moyens d'ancrage par vissage et/ou des moyens d'ancrage par impaction.The provisions of the invention relating to the organization of the means of anchoring by osseointegration make it possible to freely organize not only the connecting means inside the body, but also the mechanical anchoring means, thanks to the optimization of the internal volume of the cavities and the presence of secondary osteointegration reliefs formed inside the cavities. Ways mechanical anchoring may be indifferently means for anchoring by screwing and / or impingement anchoring means.
Dans le cas où les moyens d'ancrage mécanique sont du type par vissage, le filetage ménagé à l'intérieur de la cavité est indifféremment ménagé dans le même sens et/ou en sens inversé du sens du filetage des moyens d'ancrage mécanique. De même, le pas du filetage ménagé à l'intérieur de la cavité est indifféremment le même et/ou est différent du pas du filetage des moyens d'ancrage mécanique.In the case where the mechanical anchoring means are of the screw type, the thread formed inside the cavity is indifferently arranged in the same direction and / or in the opposite direction of the thread direction of the mechanical anchoring means. Similarly, the pitch of the thread formed inside the cavity is indifferently the same and / or is different from the thread pitch of the mechanical anchoring means.
Les moyens de jonction sont susceptibles d'être quelconques. Par exemple, les moyens de jonction sont constitués d'au moins un organe d'assemblage, tel qu'un filetage intérieur, qui est ménagé dans le corps en s'étendant en prolongement ou à l'intérieur de l'extrémité endo-osseuse. Par exemple encore, l'organe d'assemblage est un élément qui émerge à l'extrémité aérienne du corps, et qui est rapporté ou intégré à celui-ci. Plusieurs organes d'assemblage sont susceptibles d'être associés.The connecting means are likely to be arbitrary. For example, the joining means consist of at least one connecting member, such as an internal thread, which is formed in the body extending in extension or inside the endo-osseous end . For example still, the assembly member is an element that emerges at the air end of the body, and which is reported or integrated therewith. Several assembly members are likely to be associated.
Le corps présente notamment une section de conformation globalement circulaire, éventuellement conique. Une telle conformation du corps n'est cependant pas restrictive, le corps étant susceptible de présenter de manière analogue une section de conformation polygonale, notamment en cas d'implantation par impaction.The body has in particular a generally circular conformation section, possibly conical. Such a conformation of the body is however not restrictive, the body being able to present in a similar way a polygonal conformation section, especially in case of implantation by impaction.
Le corps est de préférence formé à partir d'un cylindre à l'intérieur duquel sont aisément formés la cavité et le filetage qu'elle comporte par perçage et taraudage. Les opérations de perçage de la ou des cavités, et de leur taraudage éventuel visant à former le filetage constituant les reliefs secondaires d'ostéo-intégration, sont effectuées à partir de la face de bout de l'extrémité correspondante du cylindre. Puis, le diamètre de ce cylindre est réduit jusqu'à faire déboucher latéralement la cavité et en conséquence jusqu'à former la fenêtre. Ces modalités d'obtention des moyens d'ancrage histologique permettent une obtention aisée de l'implant à moindres coûts.The body is preferably formed from a cylinder inside which are easily formed the cavity and the threading it comprises by drilling and tapping. Drilling operations of the cavity or cavities, and their possible tapping to form the thread constituting the secondary reliefs of osseointegration, are performed from the end face of the corresponding end of the cylinder. Then, the diameter of this cylinder is reduced until laterally open the cavity and accordingly to form the window. These modalities obtaining histological anchoring means allow easy obtaining of the implant at lower costs.
Un traitement de surface d'appoint, tel que par corrosion et/ou par sablage, voire un apport de matière tel que par projection, peuvent être appliqués aux surfaces de la cavité et/ou des reliefs d'ancrage en vue de la formation de micro-reliefs sur ces surfaces pour améliorer l'ostéo-intégration de l'implant.A surface treatment, such as by corrosion and / or sandblasting, or even a contribution of material such as by projection, can be applied to the surfaces of the cavity and / or anchoring reliefs for the formation of micro-reliefs on these surfaces to improve the osseointegration of the implant.
Il est plus précisément proposé un procédé d'obtention d'un implant tel qu'il vient d'être décrit. Un tel procédé est principalement reconnaissable en ce qu'il consiste, à partir d'un corps brut de section brute S1 supérieure à une section finie S2 d'un corps fini, à effectuer successivement les opérations suivantes : *) former par perçage la cavité sur le corps brut, à partir de la face de bout de l'extrémité endo-osseuse du corps de sorte que l'axe de la cavité soit radialement décalée par rapport à l'axe médian du corps.It is more specifically proposed a method for obtaining an implant as just described. Such a method is mainly recognizable in that it consists, from a raw body of gross section S1 greater than a finite section S2 of a finite body, to carry out successively the following operations: *) forming by drilling the cavity on the raw body, from the end face of the endo-osseous end of the body so that the axis of the cavity is radially offset relative to the median axis of the body.
*) réduire la section brute S1 du corps brut à une section correspondante à la section finie S2 du corps fini, jusqu'à l'obtention d'un débouché radial de la cavité sur la périphérie du corps pour la formation de la fenêtre longitudinale de passage de la matière osseuse vers et à l'intérieur de la cavité. *) ménager en périphérie du corps fini les moyens d'ancrage mécanique.*) reduce the raw section S1 of the raw body to a section corresponding to the finite section S2 of the finished body, until a radial outlet of the cavity is obtained on the periphery of the body for the formation of the longitudinal window of passage of the bone material to and inside the cavity. *) to provide the periphery of the finished body mechanical anchoring means.
La section brute S1 et le corps brut correspondent aux caractéristiques d'une ébauche de laquelle est retirée de la matière pour la formation des moyens d'ancrage et des moyens de jonction avec l'appareil médical, et pour l'obtention du corps fini de section finie S2 implantable dans la matière osseuse.The raw section S1 and the raw body correspond to the characteristics of a blank from which is removed from the material for the formation of the anchoring means and the means of joining with the medical apparatus, and for obtaining the finished body of finished section S2 implantable in the bone material.
La formation de la cavité est réalisée avant toute étape visant à obtenir la section finie S2 du corps fini et à ménager les moyens d'ancrage mécanique, pour préserver les surfaces de l'implant exploitées pour son implantation dans la matière osseuse et son maintien mécanique en attente de son ostéo-intég ration. Cette préservation permet d'éviter toute altération du corps fini et des moyens d'ancrage mécanique susceptible de porter atteinte à l'efficacité du positionnement et du maintien fiable de l'implant dans la matière osseuse préalablement à son ostéo-intégration.The formation of the cavity is performed before any step to obtain the finite section S2 of the finished body and to provide the mechanical anchoring means, to preserve the surfaces of the implant used for its implantation in the bone material and its mechanical retention. waiting for his osteo-integration. This preservation makes it possible to avoid any alteration of the finished body and mechanical anchoring means likely to affect the effectiveness of the positioning and reliable maintenance of the implant in bone prior to osseointegration.
La précision de l'extension radiale de la cavité est obtenue de manière peu coûteuse et suffisante pour garantir l'efficacité de l'ostéo-intégration de l'implant, tout en permettant l'obtention ultérieure de la section finie S2 du corps fini et du relief de fixation mécanique avec une précision optimisée. Plus précisément, une rigueur de tolérances dimensionnelles est seulement appliquée pour les surfaces nécessaires à l'installation de l'implant dans la matière osseuse en attente de son ostéo-intégration. Les opérations de reprise du corps sont limitées : la formation de la cavité, accessoirement son taraudage et la réduction de la section brute du corps brut peuvent être l'une et l'autre effectuées à partir d'une même phase de tenue du corps sur un outillage, c'est-à-dire sans retrait du corps de cet outillage. La formation de la cavité par perçage à partir de la face de bout de l'implant est réalisée sans risque d'éclatement de l'ébauche, malgré le débouché latéral de cette cavité pour la formation de la fenêtre, ce débouché latéral étant obtenu à partir d'une réduction du diamètre du corps brut. Plus particulièrement, le trou formé par perçage est réalisé de manière non débouchante sur la périphérie du corps, puis la fenêtre est obtenue par réduction de la section brute du corps brut. La précision de la surface débouchante de cette fenêtre en périphérie du corps est obtenue de manière aisée et à moindres coûts, à partir d'une réduction de la section du corps brut réalisable avec des impératifs de tolérances dimensionnelles peu contraignants et aisés à mettre en œuvre.The precision of the radial extension of the cavity is inexpensively and sufficiently obtained to guarantee the effectiveness of the osseointegration of the implant, while allowing the subsequent obtaining of the finite section S2 of the finished body and mechanical fixing relief with optimized precision. More precisely, a rigor of dimensional tolerances is only applied for the surfaces necessary for the installation of the implant in the bone material waiting for its osseointegration. The recovery operations of the body are limited: the formation of the cavity, incidentally its tapping and the reduction of the raw section of the raw body can both be made from the same phase of holding the body on tooling, that is to say without removal of the body of this tool. The formation of the cavity by drilling from the end face of the implant is performed without risk of bursting of the blank, despite the lateral opening of this cavity for the formation of the window, this lateral outlet being obtained at from a reduction in the diameter of the raw body. More particularly, the hole formed by drilling is non-emerging on the periphery of the body, then the window is obtained by reducing the gross section of the body. The precision of the emergent surface of this window at the periphery of the body is obtained easily and at lower cost, from a reduction of the section of the gross body achievable with imperatives of dimensional tolerances that are not very restrictive and easy to implement. .
De préférence, une opération complémentaire consiste à ménager le long de la cavité des reliefs secondaires d'ostéo-intégration, cette opération complémentaire étant réalisée postérieurement à la formation de la cavité et antérieurement à la réduction de la section brute S1 du corps brut pour éviter d'altérer le corps fini.Preferably, a complementary operation consists in providing along the cavity secondary reliefs of osseointegration, this complementary operation being performed after the formation of the cavity and prior to the reduction of the raw section S1 of the raw body to avoid to alter the finite body.
Les reliefs secondaires d'ostéo-intégration sont avantageusement formés par taraudage de la cavité antérieurement à la réduction de la section brute du corps brut. Une telle opération de taraudage est susceptible d'être opérée simultanément à l'opération de perçage au moyen d'un foret autotaraudant, ou postérieurement à l'opération de perçage au moyen d'un taraud spécifique. La formation des reliefs d'ostéo-intégration secondaires est réalisée en préservant les moyens d'ancrage mécanique et le corps fini de toute altération, le taraudage de la cavité étant aisément réalisé préalablement à leur obtention. Les reliefs secondaires d'ostéo-intégration sont obtenus avec des faibles coûts de production pour des facultés offertes d'ostéo-intégration de l'implant qui sont optimisées.The secondary reliefs of osseointegration are advantageously formed by tapping the cavity prior to the reduction of the gross section of the raw body. Such a tapping operation is likely to be operated simultaneously with the drilling operation by means of a self-tapping drill, or after the drilling operation by means of a specific tap. The formation of secondary osteointegration reliefs is achieved by preserving the mechanical anchoring means and the finished body from any alteration, the tapping of the cavity being easily achieved prior to their obtaining. The secondary reliefs of osseointegration are obtained with low production costs for optimized osteointegration faculties of the implant.
Accessoirement, le procédé comprend une opération annexe de biseautage des bords axiaux du débouché radial de la cavité. Cette opération annexe est réalisée postérieurement à la réduction de la section brute du corps brut, voire aussi à la formation des moyens d'ancrage mécanique. Un tel biseautage vise à ébavurer les bords de la fenêtre et à ménager des organes de raclage de la matière osseuse lors de l'installation de l'implant par vissage.Incidentally, the method comprises an auxiliary operation of bevelling the axial edges of the radial outlet of the cavity. This auxiliary operation is performed after the reduction of the gross body section, or even the formation of the mechanical anchoring means. Such beveling aims to debur the edges of the window and to provide scraping organs of the bone material during the installation of the implant by screwing.
Le procédé comprend aussi au moins une opération terminale consistant à ménager sur le corps fini les moyens de jonction de l'appareil médical. Cette opération terminale comprend le cas échéant un achèvement de l'extrémité endo- osseuse du corps dans le cas notamment d'un implant mis en place par impaction, cet achèvement consistant à conférer à l'extrémité endo-osseuse du corps une forme adaptée pour une l'impaction de l'implant, telle qu'une conformation arrondie ou autre conformation analogue. L'opération terminale est réalisée postérieurement à la formation des moyens d'ancrage mécanique.The method also comprises at least one terminal operation consisting of arranging on the finished body the junction means of the medical device. This end operation comprises, where appropriate, a completion of the endosseous end of the body in the case in particular of an implant placed by impaction, this completion consisting in conferring on the endo-osseous end of the body a shape adapted to an impaction of the implant, such as a rounded conformation or other similar conformation. The terminal operation is performed after the formation of the mechanical anchoring means.
L'opération terminale peut aussi comprendre une opération de précision consistant à ménager un relief de jonction à surface adhérente pour la réception d'un relief de jonction à surface adhérente complémentaire de l'appareil médical. Un tel relief de jonction à surface adhérente est notamment un relief du type à cône morse ou relief analogue.The terminal operation may also comprise a precision operation consisting of providing a junction relief with an adherent surface for receiving a junction relief with adherent surface complementary to the medical device. Such junction relief with adherent surface is in particular a relief of the type with Morse taper or similar relief.
L'utilisation d'un tel relief de jonction pour la liaison entre l'implant et un appareil médical vise à interdire tout mouvement entre l'implant et l'appareil médical, ou de manière analogue entre l'implant et une pièce intermédiaire de jonction équipant l'appareil médical.The use of such a junction relief for the connection between the implant and a medical device aims to prohibit any movement between the implant and the medical device, or to analogous way between the implant and an intermediate junction piece equipping the medical device.
Au moins une opération de finition est accessoirement effectuée, et consiste en un traitement de surface de l'extrémité endo-osseuse du corps, tel que par corrosion et/ou par sablage, voire par un apport de matière par projection notamment. Cette opération de finition vise à ménager des micro-reliefs sur les surfaces traitées pour améliorer l'ostéo-intégration de l'implant, et est réalisée postérieurement à la formation des moyens d'ancrage mécanique et le cas échéant antérieurement à l'opération de précision pour ne pas affecter l'adhérence de la surface du relief de jonction.At least one finishing operation is incidentally carried out, and consists of a surface treatment of the endo-osseous end of the body, such as by corrosion and / or sandblasting, or even by a contribution of material by projection in particular. This finishing operation aims to provide micro-reliefs on the treated surfaces to improve the osseointegration of the implant, and is performed after the formation of the mechanical anchoring means and where appropriate prior to the operation of precision not to affect the adhesion of the junction relief surface.
Description des figures.Description of the figures.
La présente invention sera mieux comprise à la lecture de la description qui va être faite d'exemples de réalisation, en relation avec les figures des planches annexées, dans lesquelles :The present invention will be better understood on reading the description which will be given of exemplary embodiments, in relation to the figures of the attached plates, in which:
Les fig.1 à fig.3 sont des illustrations d'un implant endo-osseux selon une première variante de réalisation de la présente invention, respectivement vue axialement de côté, vue axialement de face et vue en coupe.Fig.1 to Fig.3 are illustrations of an endosseous implant according to a first embodiment of the present invention, respectively axially viewed from the side, axially front view and sectional view.
Les fig.4 et fig.5 sont des illustrations d'un implant endo-osseux selon une deuxième variante de réalisation de la présente invention, respectivement vue axialement de face et vue en coupe.Fig.4 and Fig.5 are illustrations of an endosseous implant according to a second embodiment of the present invention, respectively axially viewed from the front and sectional view.
La fig.6 est une illustration de côté d'un implant endo-osseux selon une troisième variante de réalisation de la présente invention.Fig.6 is a side illustration of an endosseous implant according to a third embodiment of the present invention.
Les fig.7 à fig.11 sont des schémas en vue axiale illustrant successivement des étapes respectives d'un procédé d'obtention d'un implant endo-osseux selon une forme préféré de réalisation de la présente invention.Fig.7 to Fig.11 are axially oriented diagrams illustrating successively respective steps of a method for obtaining an endosseous implant according to a preferred embodiment of the present invention.
Les fig.12 à fig.15 sont des illustrations d'un implant vu de bout aux différentes étapes du procédé d'obtention de cet implant respectivement représentées sur les fig.7 à fig.10. Sur les fig.1 à fig.6, un implant endo-osseux est utilisé en chirurgie pour l'apport d'un appareil médical chez un patient, et plus particulièrement sur les exemples de réalisation illustrés, mais pas exclusivement, est destiné à un usage dentaire en étant porteur d'une prothèse. Cet implant est principalement constitué d'un corps 1 allongé, dont l'extrémité aérienne 2 est destinée à recevoir l'appareil médical tandis que l'extrémité endo-osseuse 3 est destinée à être ancrée dans l'os. On repérera les extrémités aérienne 2 et endo-osseuse 3 du corps 1 au regard de la position axialement opposée de leur face de bout respective selon la direction longitudinale d'extension du corps 1. L'extrémité aérienne 2 du corps 1 est munie de moyens de jonction 4 avec l'appareil médical, directement ou par l'intermédiaire d'un organe spécifiquement dédié. Sur les exemples de réalisation illustrés, ces moyens de jonction 4 sont constitués d'un filetage axial ménagé dans le corps 1 , rehaussé d'un écrou. D'une manière générale, la structure des moyens de jonction 4 est indifférente au regard des dispositions spécifiques de la présente invention. L'extrémité endo-osseuse 3 du corps 1 est munie de moyens d'ancrage dans l'os du patient, associant des moyens d'ancrage mécanique 5 mis en œuvre lors de la mise en place de l'implant, et des moyens d'ancrage histologique 6 pour affermir le maintien de l'implant dans l'os par ostéo- intégration.Fig.12 to Fig.15 are illustrations of an end seen implant at different stages of the process of obtaining this implant respectively shown in Fig.7 to Fig.10. In FIGS. 1 to 6, an endo-osseous implant is used in surgery to supply a medical device to a patient, and more particularly to the exemplary embodiments illustrated, but not exclusively, is intended for a patient. dental use while carrying a prosthesis. This implant is mainly constituted by an elongated body 1, whose aerial end 2 is intended to receive the medical device while the endo-osseous end 3 is intended to be anchored in the bone. The aerial 2 and endo-osseous ends 3 of the body 1 will be located with regard to the axially opposite position of their respective end face in the longitudinal direction of extension of the body 1. The aerial end 2 of the body 1 is provided with means junction 4 with the medical device, directly or through a specifically dedicated organ. In the exemplary embodiments illustrated, these joining means 4 consist of an axial thread formed in the body 1, raised by a nut. In general, the structure of the joining means 4 is indifferent with regard to the specific provisions of the present invention. The endo-osseous end 3 of the body 1 is provided with means for anchoring in the patient's bone, associating mechanical anchoring means 5 used during the placement of the implant, and means for Histological anchoring 6 to strengthen the maintenance of the implant in the bone by osteointegration.
Sur les fig.1 à fig.5, les moyens d'ancrage mécanique 5 sont du type par vissage, et sont constitués d'un filetage ménagé à la périphérie du corps 1. Sur la fig.6, les moyens d'ancrage mécanique 5 sont du type par impaction, et comprennent des anneaux ménagés sur le corps 1 successivement suivant sa direction longitudinale d'extension. D'une manière générale, la structure des moyens d'ancrage mécanique 5 est indifférente au regard de la structure des moyens d'ancrage histologique 6 proposés par la présente invention.In FIGS. 1 to 5, the mechanical anchoring means 5 are of the screw type, and consist of a thread formed at the periphery of the body 1. In FIG. 6, the mechanical anchoring means 5 are of impaction type, and comprise rings formed on the body 1 successively in its longitudinal direction of extension. In general, the structure of the mechanical anchoring means 5 is indifferent with regard to the structure of the histological anchoring means 6 proposed by the present invention.
Les moyens d'ancrage histologique 6 sont principalement constitués d'au moins une cavité 7 qui s'étend longitudinalement suivant la direction d'extension du corps 1. Cette cavité 7 au moins est ménagée à l'intérieur du corps 1 en débouchant latéralement à sa périphérie, de manière à ménager une fenêtre 8 longitudinalement étendue pour le passage de la matière osseuse lors de i'ostéo- intégration de l'implant. Cette fenêtre 8 s'étend notamment suivant la direction d'extension longitudinale du corps 1, pour permettre une ostéo-intégration de l'implant qui est rapide et efficace.The histological anchoring means 6 consist mainly of at least one cavity 7 which extends longitudinally in the direction of extension of the body 1. This cavity 7 at least is formed inside the body 1 by opening laterally to its periphery, so as to provide a window 8 longitudinally extended for the passage of bone during osteointegration of the implant. This window 8 extends in particular along the direction of longitudinal extension of the body 1, to allow osseointegration of the implant which is fast and effective.
On comprendra par cavité 7 un dégagement ménagé dans le corps 1 dont la section, prise soit isolément pour une cavité 7 unique, soit en cumul pour une pluralité de cavités 7, présente une surface significativement conséquente au regard de la surface globale de la section correspondante de l'extrémité endo- osseuse 3 du corps 1.It will be understood by cavity 7 a clearance formed in the body 1 whose section, taken either individually for a single cavity 7, or cumulatively for a plurality of cavities 7, has a significant surface area in relation to the overall surface of the corresponding section endosseous end 3 of the body 1.
La ou les cavités 7 sont de section circulaire, en étant formées par perçage préférentiellement complété d'un taraudage. L'axe A1 d'une quelconque cavité 7 est radialement décalé par rapport à l'axe A du corps 1 pour déboucher latéralement à sa périphérie de manière à former la fenêtre 8. La conformation en portion de lune de la section des cavités 7 favorise une migration homogène des cellules osseuses lors de l'ostéo-intégration de l'implant. En outre, dans le cas préféré d'une organisation en filetage des moyens d'ancrage mécanique 5, la conformation en portion de lune de la ou des cavités 7 favorise la collecte de tissus osseux lors de la mise en place de l'implant, les bords de la fenêtre formant des outils de collecte et d'amenée des tissus osseux vers l'intérieur de la cavité 7 lors de la rotation du corps.The cavity or cavities 7 are of circular section, being formed by drilling preferably supplemented by a tapping. The axis A1 of any cavity 7 is radially offset relative to the axis A of the body 1 to open laterally at its periphery so as to form the window 8. The conformation in moon portion of the section of the cavities 7 promotes homogeneous migration of bone cells during osseointegration of the implant. In addition, in the preferred case of a threaded organization of the mechanical anchoring means 5, the moon-shaped conformation of the cavity or cavities 7 promotes the collection of bone tissue during implant placement, the edges of the window forming tools for collecting and bringing bone tissue into the cavity 7 during rotation of the body.
La ou les cavités 7 sont ménagées par perçage depuis la face de bout de l'extrémité endo-osseuse 3 du corps 1 , et sont taraudées pour ménager dans leur paroi des reliefs secondaires d'ostéo-intégration 9 qui sont constitués des filets ainsi formés et qui sont successivement disposés suivant l'extension longitudinale du corps 1. De tels reliefs secondaires d'ostéo-intégration 9 délimitent successivement entre eux à l'intérieur de la cavité 7 des chambres qui sont destinées à recevoir indépendamment la matière osseuse lors de l'ostéo- intégration de l'implant. Cette réception indépendante de la matière osseuse par les chambres est notamment obtenue grâce à leur débouché individuel latéral à la périphérie extérieure du corps 1.The cavity or cavities 7 are formed by drilling from the end face of the endo-osseous end 3 of the body 1, and are threaded to provide in their wall secondary reliefs of osseointegration 9 which consist of the threads thus formed and which are successively arranged along the longitudinal extension of the body 1. Such secondary reliefs of osseointegration 9 delimit successively between them inside the cavity 7 of the chambers which are intended to independently receive the bone material during the Osteo- integration of the implant. This independent reception of the bone material by the chambers is in particular obtained thanks to their individual lateral outlet to the outer periphery of the body 1.
Sur les fig.1 à fig.3, l'implant est du type à faible diamètre et comporte une cavité 7 unique. Les moyens de jonction 4 étant ménagés axialement à l'intérieur du corps 1 depuis son extrémité aérienne 2, la zone axiale du corps 1 est occupée par ces moyens de jonction 4. Une mise en adjacence longitudinale des moyens de jonction 4 et de la cavité 7 étant rendue difficile en raison du faible diamètre du corps 1. Dans ce cas, les moyens de jonction 4 et la cavité 7 sont disposés en prolongement les uns des autres. L'extension longitudinale de la cavité 7 étant en outre restreinte en raison de la présence des moyens de jonction 4, la surface de sa section est optimisée jusqu'à représenter une surface de l'ordre de la moitié de la surface globale de la section de l'extrémité endo-osseuse 3 du corps 1. La dimension transversale de la fenêtre 8 correspond à une corde 10 du cercle déterminant la section de la cavité 7, dont le segment est délimité par un angle ouvert vers l'extérieur du corps qui est inférieur à 180°, de sorte que la corde 10 définissant la dimension transversale de la fenêtre est inférieure au diamètre de la cavité 7.In Fig.1 to Fig.3, the implant is of the small diameter type and has a single cavity 7. The joining means 4 being formed axially inside the body 1 from its aerial end 2, the axial zone of the body 1 is occupied by these junction means 4. A longitudinal adjacency of the junction means 4 and the cavity 7 being made difficult because of the small diameter of the body 1. In this case, the connecting means 4 and the cavity 7 are arranged in extension of each other. The longitudinal extension of the cavity 7 being further restricted because of the presence of the joining means 4, the surface of its section is optimized to represent a surface of the order of half of the overall surface of the section. of the endo-osseous end 3 of the body 1. The transverse dimension of the window 8 corresponds to a cord 10 of the circle determining the section of the cavity 7, the segment of which is delimited by an open angle towards the outside of the body which is less than 180 °, so that the rope 10 defining the transverse dimension of the window is smaller than the diameter of the cavity 7.
Sur les fig.4 à fig.6, l'implant est du type à large diamètre, autorisant une extension d'une pluralité de cavités 7 en adjacence longitudinale des moyens de jonction 4. Ces dispositions permettent d'accroître l'extension longitudinale des cavités 7, dont le diamètre individuel est réduit mais dont les surfaces cumulées des sections de l'ensemble des cavités 7 permettent de ménager une capacité importante de réception de la matière osseuse lors de l'ostéo-intégration de l'implant. Sur les exemples de réalisation illustrés, les cavités 7 sont au nombre de trois en étant angulairement équiréparties sur le corps suivant un angle de 120°.In FIGS. 4 to 6, the implant is of the large-diameter type, allowing an extension of a plurality of cavities 7 in longitudinal adjacency of the joining means 4. These arrangements make it possible to increase the longitudinal extension of the cavities 7, whose individual diameter is reduced but the cumulative surfaces of the sections of the set of cavities 7 can provide a significant capacity for receiving the bone material during osseointegration of the implant. In the exemplary embodiments illustrated, the cavities 7 are three in number being angularly evenly distributed over the body at an angle of 120 °.
Sur les exemples de réalisation illustrés sur les fig.1 à fig.6, la conformation et les dimensions individuelles des cavités 7 ménagées sur un même corps 1 sont identiques. Cependant, ces conformation et dimensions individuelles sont susceptibles d'être différentes pour des cavités 7 ménagées sur un même corps 1. Par ailleurs, la position relative des différentes cavités 7 par rapport à l'axe A d'extension du corps 1 est susceptible de varier d'une cavité 7 à une autre.On the exemplary embodiments illustrated in Fig.1 to Fig.6, the conformation and the individual dimensions of the cavities 7 formed on the same body 1 are identical. However, these conformation and individual dimensions are likely to be different for cavities 7 formed on the same body 1. Moreover, the relative position of the various cavities 7 relative to the axis A of extension of the body 1 is likely to vary from one cavity 7 to another.
Sur les fig.4 et fig.5, la dimension transversale de chacune des fenêtres 8 correspond à une corde 10 du cercle déterminant la section des cavités 7, dont le segment est délimité par des angles de l'ordre de 45° pris par rapport au diamètre de la cavité 7 correspondante, de part et d'autre de l'axe transversalement médian de cette cavité 7. Selon cette variante de réalisation, la capacité des cavités 7 est optimisée malgré leur diamètre restreint, la dimension transversale de la fenêtre 8 étant limitée mais suffisante.In FIGS. 4 and 5, the transverse dimension of each of the windows 8 corresponds to a cord 10 of the circle defining the section of the cavities 7, the segment of which is delimited by angles of the order of 45.degree. to the diameter of the corresponding cavity 7, on either side of the transversely median axis of this cavity 7. According to this variant embodiment, the capacity of the cavities 7 is optimized despite their restricted diameter, the transverse dimension of the window 8 being limited but sufficient.
D'une manière générale, le choix du nombre de cavités 7, de leur diamètre et de la dimension du segment de corde définissant la dimension transversale de la fenêtre 8, sont choisis en fonction du type d'implant, et notamment en fonction du diamètre de l'extrémité endo-osseuse 3 du corps 1 , et en fonction de la position et de l'agencement des moyens de jonction 4, de manière à satisfaire au mieux au compromis nécessaire entre un volume global de la cavité 7 qui est optimisé et une dimension transversale de la fenêtre 8 qui permet une migration rapide de la matière osseuse vers les reliefs secondaires d'ostéo-intégration 9 constitués par les filets du filetage intérieur que comporte la ou les cavités 7.In general, the choice of the number of cavities 7, their diameter and the dimension of the chord segment defining the transverse dimension of the window 8, are chosen according to the type of implant, and in particular according to the diameter of the endo-osseous end 3 of the body 1, and as a function of the position and the arrangement of the joining means 4, so as to best satisfy the necessary compromise between an overall volume of the cavity 7 which is optimized and a transverse dimension of the window 8 which allows a rapid migration of the bone material to the secondary osteointegration reliefs 9 constituted by the threads of the internal threading which comprises the cavity or cavities 7.
Sur la fig.11 , le corps 101 de l'implant comporte à son extrémité aérienne des moyens de jonction 102 avec un appareil médical, et à son extrémité endo- osseuse des moyens d'ancrage à l'intérieur d'un tissu osseux. Sur l'exemple de réalisation illustré, les moyens de jonction 102 associent un trou fileté 103 et un relief de jonction 104 à surface adhérente du type à cône morse. L'extrémité aérienne de l'implant comporte aussi un relief d'entraînement 105 de l'implant en rotation, tel que conformé en polygone, pour la mise en place de l'implant dans la matière osseuse par vissage. Les moyens d'ancrage comprennent des moyens d'ancrage mécanique 106 constitués par un filetage extérieur ménagé à la périphérie du corps 101. Sur la variante de réalisation illustrée sur les fig.1O et fig.15, les moyens d'ancrage mécanique 106 sont formés d'anneaux périphériques pour une mise ne place de l'implant par impaction.In Fig.11, the body 101 of the implant has at its air end junction means 102 with a medical device, and at its end endosseous means for anchoring within a bone tissue. In the exemplary embodiment illustrated, the joining means 102 combine a threaded hole 103 and a junction relief 104 with an adherent surface of the Morse taper type. The aerial end of the implant also comprises a driving relief 105 of the implant in rotation, as shaped in a polygon, for placing the implant in the bone material by screwing. The anchoring means comprise mechanical anchoring means 106 constituted by an external thread formed at the periphery of the body 101. In the variant embodiment illustrated in FIGS. fig.15, the mechanical anchoring means 106 are formed of peripheral rings for impaction implant placement of the implant.
Sur les fig.7 et fig.12, une ébauche constituée d'un corps brut 110 de section brute S1 est placée sur un outillage en vue de la formation des cavités 108 par perçage. Cette opération est effectuée à partir de la face de bout de l'extrémité endo-osseuse du corps brut 110, et est complétée par une opération de tauraudage des cavités 108 pour former le filetage intérieur constitutif des reliefs secondaires d'osté-intégration 111. Les cavités 108 sont formées en pleine matière pour préserver le corps brut 110 de tout risque d'éclatement.In Fig.7 and Fig.12, a blank consisting of a blank body 110 of rough section S1 is placed on a tool for the formation of cavities 108 by drilling. This operation is carried out from the end face of the endo-osseous end of the raw body 110, and is completed by a bulging operation of the cavities 108 to form the internal thread constituting the secondary osteointegration reliefs 111. The cavities 108 are formed in full material to preserve the raw body 110 from any risk of bursting.
Sur les fig.8 et fig.13, le corps brut 110 est usiné pour réduire sa section S1 à une section S2 correspondante à la section d'un corps fini 112 implantable dans la matière osseuse. Cette opération vise non seulement à ajuster la section S2 du corps fini 112, mais aussi à faire déboucher les cavités 108 sur la périphérie du corps pour ménager les fenêtres 109.In Fig.8 and Fig.13, the body 110 is machined to reduce its section S1 to a section S2 corresponding to the section of a finite body 112 implantable in the bone material. This operation aims not only to adjust the section S2 of the finished body 112, but also to open the cavities 108 on the periphery of the body to spare the windows 109.
Sur les fig.9 et fig.14 d'une part, et sur les fig.10 et fig.15 d'autre part, les moyens d'ancrage mécanique 106 sont formés en périphérie du corps fini 112. Une opération annexe de biseautage des bords des fenêtres 109 est de préférence réalisée. Sur les fig.9 et fig.14, les moyens d'ancrage mécanique 106 sont constitués d'un filetage externe ménagé à la périphérie du corps fini 112. Sur les fig.10 et fig.15, les moyens d'ancrage mécanique 106 sont formés d'anneaux périphériques 113 qui sont ménagés concomitamment à la réduction de la section S1 du corps brut 110 pour l'obtention du corps fini 112. Dans ce cas, l'extrémité endo-osseuse 114 est achevée en lui conférant une forme favorisant l'impaction de l'implant, telle qu'une forme arrondie sur l'exemple de réalisation illustré.On fig.9 and fig.14 on the one hand, and on fig.10 and fig.15 on the other hand, the mechanical anchoring means 106 are formed at the periphery of the finished body 112. An appendage bevel operation edges of the windows 109 is preferably made. In FIGS. 9 and 14, the mechanical anchoring means 106 consist of an external thread formed at the periphery of the finished body 112. In FIGS. 10 and 15, the mechanical anchoring means 106 are formed peripheral rings 113 which are formed concomitantly with the reduction of the section S1 of the raw body 110 to obtain the finished body 112. In this case, the endo-osseous end 114 is completed by giving it a shape favoring the impaction of the implant, such as a rounded shape on the exemplary embodiment illustrated.
Sur la fig.11, l'implant est achevé par une opération terminale consistant à former les moyens de jonction 112 de l'implant avec l'appareil médical et le cas échéant le relief d'entraînement 115 en rotation de l'implant. Accessoirement, une opération de finition est effectuée pour réaliser un traitement de surface de l'implant favorisant son ostéo-intégration. Puis une opération terminale est le cas échéant réalisée, pour former le relief de jonction 114 à surface adhérente. In Fig.11, the implant is completed by a terminal operation of forming the junction means 112 of the implant with the medical device and if necessary the driving relief 115 in rotation of the implant. Incidentally, a finishing operation is performed to achieve a surface treatment of the implant promotes its osteo-integration. Then an end operation is optionally performed, to form the junction relief 114 with adherent surface.

Claims

Revendications claims
1.- Implant endo-osseux comprenant un corps (1) allongé dont l'extrémité aérienne (2) est munie de moyens de jonction (4) avec un appareil médical et dont l'extrémité endo-osseuse (3) est munie de moyens d'ancrage (5,6) dans l'os qui associent des moyens d'ancrage mécanique (5) pour fixer l'implant dans l'os lors de son implantation, et des moyens d'ancrage histologique (6) pour une ostéo-intégration de l'implant qui comprennent au moins une cavité (7) qui s'étend longitudinalement à l'intérieur du corps (1) et qui débouche, d'une part suivant sa dimension d'extension longitudinale latéralement en périphérie du corps (1) pour la formation d'une fenêtre (8) longitudinale de passage de la matière osseuse vers et à l'intérieur de la cavité, et d'autre part à travers la face de bout de l'extrémité endo-osseuse (3) du corps (1), la section transversale de la cavité (7) étant définie par un cercle de sorte que la dimension transversale de la fenêtre (8) est définie par une corde (10) de ce cercle, caractérisé en ce que la corde (10) correspond à un segment délimité par un angle inférieur à 180°, la dimension transversale de la fenêtre (8) étant inférieure au diamètre définissant la section de la cavité (7).1.- Endosseous implant comprising an elongated body (1) whose aerial end (2) is provided with connecting means (4) with a medical device and whose endosseous end (3) is provided with means anchoring means (5, 6) in the bone which combine mechanical anchoring means (5) to fix the implant in the bone during implantation, and histological anchoring means (6) for an osteo -integration of the implant which comprise at least one cavity (7) which extends longitudinally inside the body (1) and which opens, on the one hand according to its dimension of longitudinal extension laterally on the periphery of the body ( 1) for forming a longitudinal window (8) for passage of bone material to and within the cavity, and secondly through the end face of the endo-bone end (3) of the body (1), the cross section of the cavity (7) being defined by a circle so that the transverse dimension of the window (8) is deflected inie by a rope (10) of this circle, characterized in that the rope (10) corresponds to a segment defined by an angle less than 180 °, the transverse dimension of the window (8) being smaller than the diameter defining the section of the cavity (7).
2.- Implant endo-osseux selon la revendication 1 , caractérisé en ce que la cavité (7) comporte des reliefs secondaires d'ostéo-intégration (9) constitués des filets d'un filetage intérieur qui s'étend au moins en partie le long de la cavité (7), les filets ménageant entre eux une pluralité de chambres successives de rétention de la masse osseuse lors de l'ostéo-intégration de l'implant.2.- endosseous implant according to claim 1, characterized in that the cavity (7) comprises secondary reliefs of osseointegration (9) consisting of threads of an internal thread which extends at least in part the along the cavity (7), the threads between them a plurality of successive chambers of retention of bone mass during the osseointegration of the implant.
3.- Implant endo-osseux selon l'une quelconque des revendications précédentes, caractérisé en ce que les moyens d'ancrage mécanique (5) sont indifféremment des moyens d'ancrage par vissage et/ou des moyens d'ancrage par impaction. 3. Endo-osseous implant according to any one of the preceding claims, characterized in that the mechanical anchoring means (5) are indifferently means for anchoring by screwing and / or impingement anchoring means.
4.- Implant endo-osseux selon les revendications 2 et 3, caractérisé en ce que les moyens d'ancrage mécanique (5) étant du type par vissage, le filetage ménagé à l'intérieur de la cavité (7) est indifféremment dans le même sens et/ou en sens inversé du sens du filetage des moyens d'ancrage mécanique.4.- endo-osseous implant according to claims 2 and 3, characterized in that the mechanical anchoring means (5) being of the screw type, the thread formed inside the cavity (7) is indifferently in the same direction and / or in the opposite direction of the thread direction of the mechanical anchoring means.
5.- Implant endo-osseux selon les revendications 3 et 4, caractérisé en ce que les moyens d'ancrage mécanique (5) étant du type par vissage, le filetage ménagé à l'intérieur de la cavité (7) est indifféremment d'un même pas et/ou d'un pas différent du pas du filetage des moyens d'ancrage mécanique (5).5.- endo-osseous implant according to claims 3 and 4, characterized in that the mechanical anchoring means (5) being of the screw type, the thread formed inside the cavity (7) is indifferently to a same pitch and / or a pitch different from the thread pitch of the mechanical anchoring means (5).
6.- Procédé d'obtention d'un implant endo-osseux selon l'une quelconque des revendications 1 à 5, caractérisé en ce qu'il consiste à partir d'un corps brut (110) de section brute Sl supérieure à une section finie S2 d'un corps fini (112), à effectuer successivement les opérations suivantes : *) former par perçage la cavité (108) sur le corps brut (110), à partir de la face de bout de l'extrémité endo-osseuse du corps de sorte que l'axe de la cavité (108) soit radialement décalé par rapport à l'axe médian A du corps. *) réduire la section brute Sl du corps brut (110) à une section correspondante à la section finie S2 du corps fini (112), jusqu'à l'obtention d'un débouché radial de la cavité (108) sur la périphérie du corps (110) pour la formation d'une fenêtre longitudinale (109) de passage de la matière osseuse vers et à l'intérieur de la cavité (108).6. A process for obtaining an endosseous implant according to any one of claims 1 to 5, characterized in that it consists of a raw body (110) of gross section Sl greater than one section. Finite S2 of a finite body (112), to successively perform the following operations: *) Piercing the cavity (108) on the raw body (110), from the end face of the endo-osseous end of the body so that the axis of the cavity (108) is radially offset from the center axis A of the body. *) reducing the gross section Sl of the raw body (110) to a section corresponding to the finite section S2 of the finished body (112), until a radial outlet of the cavity (108) is obtained on the periphery of the body (110) for forming a longitudinal window (109) for passage of bone material to and within the cavity (108).
*) ménager en périphérie du corps fini (112) les moyens d'ancrage mécanique (106).*) to provide the periphery of the finished body (112) the mechanical anchoring means (106).
7.- Procédé d'obtention d'un implant endo-osseux selon la revendication 6, caractérisé en ce qu'il comprend l'opération complémentaire consistant à ménager le long de la cavité (108) des reliefs secondaires (111) d'ostéo- intégration, cette opération complémentaire étant réalisée postérieurement à la formation de la cavité (108) et antérieurement à la réduction de la section brute S_l du corps brut (110). 7. A method for obtaining an endosseous implant according to claim 6, characterized in that it comprises the complementary operation of providing along the cavity (108) secondary reliefs (111) osteo - Integration, this complementary operation being performed after the formation of the cavity (108) and prior to the reduction of the gross section S_l of the raw body (110).
8.- Procédé d'obtention d'un implant endo-osseux selon la revendication 7, caractérisé en ce que les reliefs secondaires (111) d'ostéo-intégration sont formés par taraudage de la cavité (108) antérieurement à la réduction de la section brute Sl du corps brut (110).8. A method for obtaining an endosseous implant according to claim 7, characterized in that the secondary reliefs (111) of osseointegration are formed by tapping the cavity (108) prior to the reduction of the raw section Sl of the raw body (110).
9.- Procédé d'obtention d'un implant endo-osseux selon l'une quelconque des revendications 6 à 8, caractérisé en ce qu'il comprend une opération annexe de biseautage des bords axiaux du débouché radial de la cavité (108), cette opération annexe étant réalisée postérieurement à la réduction de la section brute Sl du corps brut (110) et à la formation des moyens d'ancrage mécanique (106).9. A process for obtaining an endosseous implant according to any one of claims 6 to 8, characterized in that it comprises an auxiliary operation of bevelling the axial edges of the radial outlet of the cavity (108), this additional operation being performed subsequent to the reduction of the gross section Sl of the raw body (110) and the formation of the mechanical anchoring means (106).
10.- Procédé d'obtention d'un implant endo-osseux selon l'une quelconque des revendications 6 à 9, caractérisé en ce qu'il comprend au moins une opération terminale consistant à ménager sur le corps fini (112) les moyens de jonction (102) et le cas échéant à achever l'extrémité endo-osseuse (114) du corps (112), cette opération terminale étant réalisée postérieurement à la formation des moyens d'ancrage mécanique (106).10. A process for obtaining an endosseous implant according to any one of claims 6 to 9, characterized in that it comprises at least one terminal operation consisting in providing the finished body (112) with the means of junction (102) and where appropriate to complete the endosseous end (114) of the body (112), this terminal operation being performed after the formation of the mechanical anchoring means (106).
11.- Procédé d'obtention d'un implant endo-osseux selon la revendication 10, caractérisé en ce que l'opération terminale comprend une opération de précision consistant à ménager un relief de jonction (104) à surface adhérente pour la réception d'un relief de jonction à surface adhérente complémentaire de l'appareil médical.11. A process for obtaining an endosseous implant according to claim 10, characterized in that the terminal operation comprises a precision operation consisting in providing a junction relief (104) with an adherent surface for the reception of a junction relief with adherent surface complementary to the medical device.
12.- Procédé d'obtention d'un implant endo-osseux selon l'une quelconque des revendications précédente, caractérisé en ce qu'il comprend au moins une opération de finition consistant en un traitement de surface de l'extrémité endo-osseuse du corps (112), cette opération de finition étant réalisée postérieurement à la formation des moyens d'ancrage mécanique (106) et le cas échéant antérieurement à l'opération de précision. 12. A process for obtaining an endosseous implant according to any one of the preceding claims, characterized in that it comprises at least one finishing operation consisting of a surface treatment of the endosseous end of the body (112), this finishing operation being performed after the formation of the mechanical anchoring means (106) and if necessary prior to the precision operation.
PCT/FR2007/001627 2006-10-05 2007-10-04 Endosseous implant provided with axially extending reliefs to promote its osseointegration, and method for obtaining such an endosseous implant WO2008043899A2 (en)

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FR0608779 2006-10-05
FR0608779A FR2906705B1 (en) 2006-10-05 2006-10-05 ENDO-BONE IMPLANT WITH RELIEF PROMOTING ITS OSTEO-INTEGRATION.
FR0609873 2006-11-11
FR0609873A FR2906708B1 (en) 2006-10-05 2006-11-11 METHOD OF OBTAINING ENDO-BONE IMPLANT HAVING AXIALLY EXTENDED OSTEO-INTEGRATION CLEARANCES
FR0700500 2007-01-24
FR0700500A FR2906709B3 (en) 2006-10-05 2007-01-24 METHOD OF OBTAINING ENDO-BONE IMPLANT WITH AXIALLY EXTENDED OSTEO-INTEGRATION CLEARANCES

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FR2906709A3 (en) 2008-04-11
SMP200900032B (en) 2010-03-01
MA30863B1 (en) 2009-11-02
SMAP200900032A (en) 2009-07-14
FR2906709B3 (en) 2008-08-22
WO2008043899A3 (en) 2008-06-05

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