Retaining element for an implant and ampoule for preserving...

Dentistry – Prosthodontics – Holding or positioning denture in mouth

Reexamination Certificate

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C433S201100

Reexamination Certificate

active

06261097

ABSTRACT:

APPLICATION AREA OF THE INVENTION
The present invention relates to a holding element for an implant, primarily in screw or cylinder form. A first type of implant which may be considered has a bore which at least in principle emerges axially on the implant head and has an internally threaded section. The mouth of the bore is surrounded by an implant shoulder, which forms the upper end of the implant. The second type of implant which is suitable has a segment which projects above the implant shoulder and has an internally threaded section. The segment has a predominantly polygonal or conical outer contour. Such implants are used, for example, in the dental sector or in bone surgery. The implant is intended to be inserted—i.e. screwed or pressed—into a receiving bore which has been prepared in the bone. This depends on whether the receiving bore has an internal screw thread or the implant has a self-tapping thread or the implant has no thread at all. Furthermore, the invention relates to an ampoule in which the implant is stored.
The holding element can be employed during a number of production phases of the implants in order to prepare them prior to the surgical intervention, and can also be employed directly during implantation. The primary application area of the invention is where the implants, for example for reasons of the sterile operating procedure required, must not be taken hold of at least directly with the hands, and where it is important to hold the implants secure.
The holding element can also be used inside a special ampoule which serves to transport and store the implant. During the surgical intervention, the implant can be removed from the ampoule under sterile conditions using an attached tool and then, by means of this tool, can be inserted into the receiving bore in the bone. To ensure a sterile operating procedure, the ampoule is stored in a secondary capsule until the start of the intervention.
PRIOR ART
The first type of implant mentioned is described, for example, in the monograph by SCHROEDER/SUTTER/BUSER/KREKELER: Oral Implantology, Georg Thieme Verlag Stuttgart and New York, 2nd Edn., 1996, pp 124-143, and in WO-A-96 19947. The second type of implant, having the outer segment which projects above the implant shoulder, is shown, for example, in WO-A-91 10410 and U.S. Pat. No. 5,538,428. Various manipulation members are used for handling these implants, the implants being taken hold of in a positively and/or non-positively locking manner.
The following situation exists with regard to ampoules where sterile conditions are to be maintained: in principle, the ampoules can also be divided into two types. In a first type, the implant stored in the ampoule is connected to the cover, which directly or indirectly functions at the same time as a screwing-in tool and is used at least to some extent to screw in the implant. According to U.S. Pat. No. 4,856,648, in its most simple form the cover has an extension with a non-rotationally symmetrical engagement contour which interacts with a complementary contour on the implant head. It is known from U.S. Pat. Nos. 5, 312,254 and 5,538,428 to introduce a connecting element between the cover and the implant, which connecting element transmits the rotational screwing movement. U.S. Pat. No. 5,062,800 has disclosed an ampoule where the cover represents the connecting element for the screwing-in tool. These ampoules are to some extent very expensive, as the tool components are generally only used once. Furthermore, handling these ampoules often requires a relatively large number of operations, and in addition external screwing-in tools are also required. Finally, it is doubtful whether the implants are gripped sufficiently reliably by the screw covers or the connecting elements.
In the case of the second type, the implant arranged in the ampoule has to be taken hold of and screwed in using an external tool. The present invention relates to this type of ampoule. EP-B-0 231 730 discloses a simple variant where the implant is positioned in a sleeve and the implant head projects above and closes off one end of the sleeve. The sleeve is fused into a glass ampoule, which has constrictions and an internal spring. The implant head is supported against the spring, and the sleeve is fixed inside the constrictions, one constriction at least partially closing off the bottom of the sleeve. Suitable external tools are used to grip the implant, while on the ampoule itself there are no means whatsoever which facilitate and make more reliable the removal of the implant from the ampoule and transportation to the site of implantation.
Such a type of ampoule with sterile conditions is also disclosed by SCHROEDER/SUTTER/BUSER/KREKELER, loc. cit., pp. 219-221. The capsule-like ampoule has a removable cover and a partition which extends perpendicular to the longitudinal axis, close to the cover. In this partition, there is an axial passage in which a bearing ring rests, in which the head of the implant is positioned, while the apical part of the implant projects into the ampoule. In order to take hold of the implant, a lockable screwing-in tool is attached, the threaded mandrel of which is screwed into the axial threaded bore, which is in the form of a blind bore and is present in the implant head. Having been screwed onto the screwing-in tool, the implant is then removed from the ampoule. The implant is then positioned in the hole in the bone, spanners being attached to the screwing-in tool. Finally, the lock between the implant and the screwing-in tool has to be released again, so that the screwing-in tool can be unscrewed. This handling method requires numerous operations, a plurality of instruments and particular care and skill on the part of the surgeon. The instruments attached while the implants are being introduced into the bone are unsuitable as manipulating members during the overall production process of the implants; separate holders have to be used for this purpose.
OBJECT OF THE INVENTION
In view of the abovementioned drawbacks of the devices which have been used to date to grip and hold implants of the two types mentioned above, the problem underlying the invention is that of perfecting such devices. It is desired to make the connection between the implant and the holding element more efficient in production terms, more widely usable, reliable and also, ultimately, able to be released without problems. In the preparatory phase of the surgical intervention and also during the intervention, it is necessary to ensure that the implants used can always be guided reliably, can in no way become loose and uncontrollable and that the sterility requirements are fulfilled. The holding element should significantly facilitate removal of the implant from the ampoule using the attached screwing-in tool and insertion of the implant into the bone. With regard to the ampoule, the object is to develop it further in such a manner that the implant is held reliably therein and can be removed in an uncomplicated manner and under sterile conditions using a screwing-in tool which is simple to attach. If the implant is removed from the ampoule correctly, it is intended that the risk of contact between implant and ampoule should in principle be ruled out, so as to avoid contamination or damage to the intra-ossal implant surface. It is to be envisaged that the ampoule can be inserted into a conventional external capsule for storage and transportation. Moreover, it should be possible to produce the ampoule as a disposable item in a material-saving and, overall, cost-effective manner.
OVERVIEW OF THE INVENTION
The holding element comprises a sleeve part and a rotatable screw which projects through the sleeve part and can move axially to a limited extent. The sleeve part has, at the bottom, a cylindrical shoulder part which ends with a mating shoulder which is directed downwards and is complementary to the implant shoulder. An upwardly directed external polygon segment extends above the shoulder part. An axial bore allowing the passage of the shaft of the screw

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