WO2009007891A1

WO2009007891A1 - A dental implant and dental implant packaging

Info

Publication number: WO2009007891A1
Application number: PCT/IB2008/052696
Authority: WO
Inventors: Espedito Brescia
Original assignee: Apollonia & Fama Implant S.R.L.
Priority date: 2007-07-11
Filing date: 2008-07-04
Publication date: 2009-01-15
Also published as: ITFI20070155A1

Abstract

In a dental implant (1) comprising an endosseous body (11) elongated along an axis (X) ending with an apical portion (12), the apical portion comprises means (19, 19') for engaging the implant with an external support for supporting the same implant apically, that is on the apex of without touching the side surface of the implant. Preferably the engagement means (19) comprise a hole or seat formed on the apical portion coaxially with respect to said axis (X), for engagement with a projection provided for by a packaging of the implant.

Description

TITLE

A DENTAL IMPLANT AND DENTAL IMPLANT PACKAGING

DESCRIPTION

Technical field of the invention The present invention generally regards the field of dental implantology, and more precisely it concerns a dental implant whose characteristics are suitable for a new type of packaging.

Background of the invention As known, endosseous dental implants are inserted surgically in place of the natural root of a lost tooth. The implant is osseointegrated, creating the anchorage for the application of a prosthesis in form of a single artificial tooth or even a complex structure provided with a plurality of artificial teeth. The prosthesis is joined to the implant by means of a so-called abutment, fixed by means of a retention screw to the dental implant.

The endosseous dental implants must be provided with a protection casing in such a manner to permit both the transportation and the storage of the product, assuring the integrity and sterility requirements over a certain period of time (normally five years) . Then, the operator must remove the implant from the sterile packaging and insert it into the surgical site previously prepared, taking care in that the external surface of the implant does not come into contact with his hands or with other non-biocompatible and non-sterile substances in order to avoid a contamination of the product.

According to the prior art, the casing comprises a primary sterile shell (a vial or an ampoule, made of glass or plastic material, or a blister) , having a shape generally elongated according to an axis, in which the implant is received arranged in manner substantially coaxial with respect to the abovementioned axis. These known packagings can be classified according to two types.

A first type of packaging provides for the use of an abutment which is made integral, for example by means of a screw, with the upper end of the implant. The abutment thus serves to support the overhanging implant, holding it tightly in axis with the sterile casing. The abutment also realizes a transfer system for removing the implant from the packaging. This latter operation can be performed manually: the operator - wearing sterile gloves - holds the abutment (to which the implant is fixed) , transfers it to the implant site previously prepared, engages the implant for a few rotations, unscrews the abutment and finally screws the implant using an insertion tool which engages directly on the same implant. In other cases, the transfer is performed with the help of an insertion tool: the operator fixes such tool on a contra-angle handpiece, or on a special spanner, uses it to clasp the abutment, transfers the implant to the implant site previously prepared, screws the implant, and finally removes the abutment .

In order to assist the operator' s task of removing the implant from the packaging, and the task of inserting the implant into the implant site, solutions capable of eliminating the use of the abutment have been recently proposed. As a matter of fact, avoiding the use of the abutment implies getting rid of two operation steps in the implant insertion surgery procedure: unscrewing and removing the abutment. Given that the latter step often entails difficulties (for example the abutment gets stuck, thus complicating its removal, or the implant is not stable enough in the site and hence tends to come out upon the unscrewing of the abutment) , it is clear that the elimination of the abutment is well accepted by the operators . Thus, a second type of known packaging is abutment- free. The implant is simply closed in a seat defined by a titanium or glass sheath fittingly inserted into the sterile casing. In other cases, it is held firm by two titanium rings which, arranged coaxially with respect to the casing in a mutually spaced manner, contact the side surface of the implant. Then, the operator fixes one insertion tool on a contra-angle handpiece or on a special spanner, clasps the tool directly onto the implant, thus removing it from the packaging, transfers it to the implant site previously prepared and then proceeds to screw it into place.

However, the solutions of the second type have in turn a drawback. As a matter of fact, grasping the implant with an insertion tool is not easy given that the implant itself is not firmly held in position, due to the clearance between the sterile casing and the sheath or the rings, or between the latter (sheath or rings) and the implant .

Summary of the invention The object of the present invention is to provide a new type of implant and a relative packaging capable of avoiding the use of an auxiliary support abutment, thus ensuring less complicated transfer operations, and at the same time a firm holding of the implant inside the ampoule, without the side surface of the implant coming into contact with any part of the sterile package.

Such object is achieved with the implant and package according to the present invention, the essential characteristics of which are defined by the attached claims 1 and 7, respectively.

Brief description of the drawings The characteristics and advantages of the dental implant and packaging according to the present invention will be apparent from the following description of embodiments thereof, given for exemplifying and non- limiting purposes with reference to the attached drawings, in which: figure 1 represents an axonometric view of an implant according to a first embodiment of the invention; figure 2 is a bottom plan view of the implant of figure 1 ; - figure 3 is an axial sectional view of the implant taken along lines III-III of figure 2 ; figure 4 is a side view of an implant packaging according to the first embodiment of the invention; figure 5 is a side view, according to arrow V, of the packaging of figure 4; figure 6 is a further side view of the packaging, in partial section taken along lines VI-VI of figure 5; figure 7 shows, sectioned axially like in figure 3, an implant according to a second embodiment of the invention; figure 8 is a side view of an implant packaging according to a second embodiment of the invention; figure 9 is an axial sectional view of the packaging of figure 8, taken along lines IX-IX;

- figure 10 is a perspective view of a variant of the packaging according to the first embodiment of the invention; and

- figure 11 is a side view, analogous to the one of figure 4, of the packaging in the variant of figure 10.

Description of the preferred embodiments Referring to the above figures, a dental implant 1 is made up in the traditional manner of an elongated, axially symmetrical endosteal body 11, on which in particular one can distinguish three different portions in series with each other along the axis, indicated at X: an apical portion of tapered shape 12, a substantially cylindrical central portion 13 and a coronal portion 14, also having a tapered shape.

The coronal portion 14 of the endosteal body 11 has a partially threaded axial seat 15, in which a corresponding abutment can be housed (not shown in the figures) , of known type and for the support of a prosthesis .

Along the entire side surface of the body 11 there evolves a threading for the insertion and stabilisation into the implant site (maxillary or mandibular bone) . On the apical portion 12 and on the central portion 13, a first threading 16 with a common single thread of substantially trapezoidal section, while on the coronal portion 14 a second, double-start threading 17 is present. On the apical portion 12, which ends with an apex surface

12a mainly extending in a transverse direction with respect to the axis X and not affected by the threading, the threaded side surface has a conventional, drain flat notch 18. The coronal portion 14 in turn culminates with a coronal edge surface 14a, with conicity opposite with respect to the overall conicity of the same portion.

According to the invention, in the apex of the implant, defined in this case by the apex surface 12a of the apical portion 12, engagement means are formed for engaging the implant to an external support, specifically suitable for providing an apical support, that is without touching its side surface intended for osseointegration . In this embodiment such engagement means consist in a conical hole 19 formed coaxially with the axis X.

As shown in figures 4 to 6, the hole 19 serves for engagement with a conical pin 22a arranged at an end 24a of an arm 24 defined by an elastic framework 23, which forms the main component of a casing in which the implant 1 is intended to be packaged. The packaging is completed with a blister made of plastic material (not represented) into which the framework 23 is to be enclosed. In greater detail, the framework 23 has a configuration similar to a clothes-pin with two opposite first-class levers, made up of two arms 24, 25, arranged in a parallel fashion, spaced and joined at an intermediate position by a flexible bridge 21. The arms 24, 25 have a laminar structure and define respectively, on opposite sides with respect to the bridge 21, first ends 24a, 25a for fastening the implant 1 in axial direction between the apex and the coronal portion, and second ends 24b, 25b for being pressed manually, in the direction corresponding to a mutual approaching, to drive the rotation of the arms around the centre of the bridge 21 and mutually move the first ends 24a, 25a away from each other. The first and the second ends can thus be identified as, respectively, fastening ends and operation ends .

Two opposite projections 24c, 25c extend from the operation ends 24b, 25b, for abutting to each other and thus providing a stop for the mutual approach of the arms. Two threaded seats 27, 28 of different sizes are respectively formed in such projections, for possible engagement of two implant closure screws of different diameters (not shown) .

Turning back to the fastening ends 24a, 25a, it was already mentioned that a pin 22a projects from the end 24a, towards the corresponding end 25a of the opposite arm

25 for engagement with the hole 19 of the implant. More in detail, the pin 22a is part of a first support 22 fixed to the first end 24a and in turn having a conical side surface 22b culminating with the pin 22a. A second support

26 is connected with the other fastening end 25b, that is the one intended for engagement with the coronal portion of the implant. The second support 26 is ring-shaped, delimiting a cylindrical passage 26a through the external and the internal face of the arm 25. The passage 26a defines at the internal end, that is the one facing the implant 1, a flared surface 26b for coupling with the coronal edge surface 14a of the same implant.

The passage 26a, as mentioned, also opens on the external face of the arm 25, all this to allow the grasping of the implant by an insertion tool fixed on a contra-angle handpiece, or by a special spanner. In order to attain this objective, the second support 26 and, correspondingly, the end 25a of the arm 25, have cracks 26b, 25d radially exposing the passage 26a, in such a manner to allow the exit of the insertion tool engaged with the implant. It should thus be observed that, according to the invention, the implant 1 is held in its packaging without requiring the use of any abutment or stump, and simultaneously without the side surface coming into contact with any part of the packaging. The implant is suspended between the two fastening ends 24a, 25a of the two arms 24, 25 of the framework 23 with an effect that shows, even from a strictly visual point of view, the level of cleanliness and asepticity attained.

Concerning the operations of extracting the implant and fixing it on the implant site, the procedure is quite simple (absence of additional steps required when using the abutment) and safe, given that the apical blocking by means of the pin 22a, in cooperation with the fastening on the coronal edge surface, is firm and allows an easy grasping of the implant using an insertion tool. As a matter of fact, such grasping step is particularly simple, given that first it is possible to engage the insertion tool with the coronal portion 14a through the passage 26a using one hand, then use the other hand to press on the operation ends 24b, 25b and to "open" the framework, releasing the fastening on the implant by the fastening ends 24a, 25a, and finally release the tool and the implant from the framework due to an extraction movement allowed by the cracks 26b, 25d.

In an alternative embodiment, represented in figure 7 with reference numerals corresponding to the ones already used for the first embodiment, the implant 1' has an apical hole 19' which is threaded, instead of a smooth or conical one. Referring now also to figures 8 and 9, the hole 19' is fit for engagement with a corresponding threaded element 42, axially projecting from a base 43a of a cylinder 43 which is part of a casing 4 in which the implant 1' is intended to be packaged. In further detail, the casing or packaging 4 comprises a tubular cylindrical ampoule 41, closed at one end and open at the opposite end which is closed with a plug 44, blocked within the ampoule due to an interference coupling. The plug 44 can advantageously also include an implant closure screw 5, accommodated inside a sterile compartment 44a defined on the inner side of the plug, and in particular driven axially into a threaded seat 44b formed in the bottom of such compartment .

The cylinder 43 is then inserted in a sliding manner into the ampoule 41, with the base 43a holding the implant 1 ' , apically supported by means of the threaded element 42, facing inwards the ampoule itself. The cylinder enters into the ampoule totally, until it stops against a shoulder 41a specifically formed in such a manner to allow total entry of the cylinder while leaving space at the same time, on the external side, for the engagement of the plug 44 and, on the internal side, for accommodating the implant 1 without interference with the closed top of the ampoule . Also in this second embodiment, the use of an abutment is avoided, and the side surface of the implant, which is plesantly erected inside the ampoule, does not come into contact with the casing in any way whatsoever. Furthermore, operations of extracting the implant and fixing it on the implant site follow a simple and safe procedure. As a matter of fact, grasping is easily performed by removing the cylinder 43 and the implant 1' from the ampoule 41, then holding the cylinder 43 with one hand while, using the other hand, the implant is engaged by using the insertion tool.

Regardless of the illustrated embodiments, a casing with an implant held at the apex according to the invention can be provided through different constructions.

For example, in packagings making use of a vial or ampoule

(possibly having a prismatic or other suitable shape) , an implant according to the invention can simply provide for an axial non-threaded conical hole (or even a simple flat surface orthogonal to the axis X) formed on the apex, the implant being blocked by axial fastening between a projection directly extending from a plug (analogous to the plug 44), and a counterplug at the opposite end of the ampoule (tubular in this case, and open at both ends) . As a matter of fact, the counterplug can be provided with a frustoconical projection which is fittingly engaged with the coronal seat 15', or the coronal edge surface 14', so as to hold the implant in position. Also this solution is capable of attaining the pre-determined objects, and thus it falls within the scope of the present invention.

On the other hand, as far as clothes-pin packagings - as in the first embodiment - are concerned, figures 10 and 11 show an example of a possible variant, in which use is made of a U-shaped element 29 which extends between the operation ends 24b, 25b of the two arms 24, 25, forming an actual spring member which elastically hinders the opening movement of the framework, increasing the effort required for such opening and thus preventing the implant from being accidentally released.

As an additional contribution to the stiffening of the framework, ribs 32 integrally extend between the bridge 21 and the fastening ends 24a, 25a of the arms 24, 25. Furthermore, distributions of recesses 30 and reliefs 31 are formed in the arms 24, 25, in correspondence to the operation ends and the bridge 21, for making easier and firmer the manual handling of the framework. The scope of the invention thus comprises all the embodiments providing an apical support, possibly in cooperation with a coronal support (a pin or a ring-shaped member) , with the result of avoiding the use of an abutment to be removed through additional procedural steps, and leaving the endosseous side surface of the implant completely free from contact.

Therefore, the invention thus conceived is susceptible to various modifications and variants, all falling within the scope of the invention itself as defined by the appended claims; moreover, all details can be substituted with other technically equivalent elements, without departing from the scope of the invention.

In practice, the materials used, provided they are compatible with the specific use, alongside the size of the various components, may vary according to the needs and the state of art.

Where the characteristics and the techniques mentioned in any of the attached claims are followed by reference numerals, the same were included for exemplifying purposes, with the sole aim of enhancing the comprehension of the claims and hence they have no limiting effect on the interpretation of any element identified by them.

Claims

1. A dental implant (1) comprising an endosseous body (11) elongated along an axis (X) ending with an apical portion

(12), characterised in that said apical portion comprises engagement means (19, 19') for engaging the implant with an external support so as to provide for an apical support, that is on the apex of the implant without touching its side surface.

2. The implant according to claim 1, wherein said engagement means (19) comprise a hole or seat formed on said apical portion coaxially with respect to said axis (X), for engagement with a projection provided for by a packaging of the implant.

3. The implant according to claim 2, wherein said engagement means (19) comprises a smooth conical hole

(19), for engagement with a projection correspondingly shaped in said packaging.

4. The implant according to claim 3, wherein said elongated endosseous body has a coronal portion (14) culminating with a cone-shaped coronal edge surface (14a) with a diameter decreasing moving away from said apical portion (12), for engagement with a correspondingly shaped ring-member of said packaging.

5. The implant according to claim 2, wherein said engagement means (19) comprise a threaded hole (19) for engagement with a correspondingly threaded projection in said packaging.

6. The implant according to any of the previous claims, wherein said apical portion (12) comprises an apex surface (12a) mainly extending in a transverse manner with respect to said axis (X), said engagement means (19) being formed on said apex surface (12a) .

7. A packaging (1) for a dental implant, said implant comprising an endosseous body (11) elongated along an axis (X) ending with an apical portion (12), characterised in that it comprises engagement means (22a, 42) for engaging at least with said apical portion (12) of said implant so as to provide for an apical support, that is on the apex of the implant without touching its side surface.

8. The packaging according to claim 7, wherein said engagement means (22a, 42) comprise a projection (22a, 42) for engagement with a hole or seat (19) formed on said implant coaxially with respect to said axis (X) .

9. The packaging according to claim 8, wherein said projection (22a) is a pin (22a) for engagement with a smooth hole (19) formed on said apical portion of said implant (1) .

10. The packaging according to claim 9, wherein said pin

(22a) comprises a portion shaped in a substantially conical manner for engagement with a corresponding conical hole (19) of said implant (1), and it extends from an arm (24) of a framework (23), said framework further comprising a second arm (25) parallel and spaced apart with respect to said first arm (24), in such a manner that said arms (24, 25) are suitable for fastening, elastically and in the direction of the axis (X), said implant (1) between the apical portion (12) and a coronal edge surface (14a), the framework (23) further comprising arm operation means for controlling the disengagement between the arms and the implant.

11. The packaging according to claim 10, wherein said arms (24, 25) comprise respective first ends (24a, 25a) for engagement with said implant (1), said operation means comprising respective second ends (24b, 25b) of said arms, a flexible bridge (21) joining said arms (24, 25) in a position intermediate between said first and second ends, whereby by manually pressing said second ends (24b, 25b) one towards each other, a rotation of the arms around the centre of said bridge (21) is driven, and the first ends

(24a, 25a) are mutually away from each other to release said implant (1) .

12. The packaging according to claim 11, wherein opposite projections (24c, 25c) extend from said operation ends (24b, 25b) , for mutually abutting and providing a stop for the mutual approach of the arms.

13. The packaging according to claim 12, wherein a threaded seat (28) for the engagement of an implant closure screw is formed in at least one of said projections (24c, 25c).

14. The packaging according to any of the claims 11 to 13, comprising a U-shaped element (29) extended between said second ends (24b, 25b) of said arms (24, 25), forming a spring element which elastically hinders the opening movement of said framework (23) .

15. The packaging according to any of the claims 11 to 14, comprising stiffening ribs (32) which integrally extend between said bridge (21) and said first ends (24a, 25a) of said arms (24, 25) .

16. The packaging according to any of the claims 11 to 15, wherein said arms comprise recesses (30) and distributions of reliefs (31) for making easier and firmer the manual handling of the framework.

17. The packaging according to any of the claims 10 to 16, wherein said second arm comprise a second support (26) for engagement with said coronal edge surface (14a) of the implant (1), said support delimiting a passage (26a) between the external and the internal face of the arm (25) and defining a flared surface (26b) to be coupled with said coronal edge surface (14a).

18. The packaging according to claim 17, wherein said passage (26a) is such to allow the entry by an insertion tool for grasping the implant (1), the second support (26) and, correspondingly, the first end (25a) of the second arm (25) having cracks (26b, 25d) radially opening the passage (26a) for allowing the radial exit of the insertion tool grasping the implant.

19. The packaging according to any of the claims 10 to 18, wherein said pin (22a) is defined by a first support (22) fixed on the first end (24a) of said first arm and having a conical side surface (22b) culminating with the pin (22a) .

20. The packaging according to claim 8, wherein said projection (42) is threaded for engagement with a hole

(19') of said implant, correspondingly threaded.

21. The packaging according to claim 20, wherein said projection (42) extends axially from a cylinder (43) inserted in a sliding manner into a tubular ampoule (41) closed at one end, the packaging further comprising a plug (44) for closing the open end of said ampoule (41) .

22. The packaging according to claim 21, wherein said plug (44) is blocked inside said ampoule (41) due to an interference coupling and defines on the internal side a compartment (44a) for accommodating an implant closure screw (5) .

23. The packaging according to claims 21 or 22, wherein said cylinder (43) stops against a shoulder (41a) defined by said ampoule in such a manner to allow a total entry of the cylinder while leaving space, on the external side, for the engagement of the plug (44) and, on the internal side, for the accommodation of the implant (I¹) without interference with the closed end of the ampoule.