Patent Application
20230263603
The present disclosure relates to an implantation system with an implant body, an add-on element, and a connection element.
Furthermore, the disclosure relates to an add-on element for an implantation system.
Dentists performing surgeries, oral surgeons, and maxillofacial surgeons are often faced with the challenge that bone has been lost in the oral cavity as a result of bone atrophy, accidents, periodontitis, or tooth extraction. The choice is then frequently made to use a dental implant to replace the missing tooth or missing teeth.
A dental implant is an “alloplastic, ready-made component” inserted into the jawbone. This area of dentistry, which is concerned with the insertion of dental implants into the jawbone, is referred to as implantology. Because dental implants can be used to support dental prostheses, they assume the function of artificial tooth roots.
For this purpose, they are either screwed or inserted into the jaw bone (endosseus implants) by means of a screw thread. Within three to six months, they bond with the surrounding bone to form a fixed, extremely resilient support unit (osseointegration).
The design of the implant dictates the surgical insertion technique. The production of the superstructure—of the tooth set to be integrated into the implants—results from the design of the abutment—of the implant part protruding from the jawbone.
Since the 1980s, dental implants have typically been made of titanium, but also of ceramic materials or plastic. Implant systems are either placed crestally (at bone level) or subcrestally (1 mm to 3 mm below bone level) so that the bone can grow over the implant shoulder.
Dental implants with a so-called conical implant-abutment connection are typically placed in a subcrestal position, i.e., the ideal positioning for this implant type is subcrestal positioning.
Moreover, a more or less pronounced recession in the bone usually occurs over the years, which is another reason why the majority of today's implant systems are placed slightly subcrestally (1 mm to 3 mm) below bone level in order to prevent the rough threads of the implant from emerging prematurely, which, in addition to aesthetic deficits, leads to the accumulation of plaque and thus to a high risk of infection and peri-implantitis.
In approximately 50% of cases, a bone deficit resulting from bone atrophy, accidents, periodontitis, or tooth extraction exists, which has to be reconstructed by building up the bone (augmentation) if dental implants are to be used. It is necessary to reconstruct these bone deficits prior to or at the same time as the placement of an implant so that the dental implants have a stable foundation and a stable support in the bone—especially in the case of subsequent loading.
Where bone is built up using bone shells, it is to be avoided that the implant shoulder come to rest in a purely cortical bone—especially in the case of avascular bone shell transplants, as they have to undergo remodeling or resorption processes afterwards. There should, therefore, be a gap of 0.5 mm to 1 mm between the implant shoulder and the avascular bone shell. The same rule also applies in the case of lateral augmentation, when a bone shell is built up laterally. In this case too, said bone shell should not be in direct contact with the implant shoulder.
In the case of a vertical build-up with associated implantation in the lower jaw, the shoulder of the implant should sit 2.5 mm deeper than bone level. In the case of a vertical build-up in the upper jaw, the implant shoulder should sit at least 1 mm below bone level.
When a tooth is implanted with simultaneous bone build-up, in most cases submerged healing is recommended, since open healing would mean that the built-up bone has contact with the oral cavity via a gap, which increases the risk of bacterial contamination and the risk of implant and bone loss.
It is, however, a problem that no suitable implant systems exist—particularly in cases of planned, subcrestal implant positioning with simultaneous bone build-up and subsequent submerged healing.
Several problems occur in alveolar ridge augmentation with simultaneous (subcrestal) implant positioning. In the current state of the art, implant systems cannot be positioned subcrestally in compromised anatomical bone situations (e.g., in the case of thin bone wall of 2 mm to 3 mm in the lateral region of the upper jaw, sinus region) without there being a risk of them becoming unstable due to lack of retention/friction in the local bone and being lost. Thus, typically, the bone first has to be built up (e.g., sinus lift), i.e., the bone build-up has to take place, and only in a second step (after four to six months) can the implant be inserted. This means a considerable loss of time. Moreover, bone easily grows over the subcrestally positioned implant during the healing phase. When the region of the implant is exposed again after the healing phase (after approximately three to six months), firstly, it is difficult to relocate the implant and, secondly, it is difficult to remove the bone over the implant without damaging the inner or outer surface of the implant.
The present disclosure is therefore based upon the object of specifying an implantation system which solves the problems described above—in particular, for subcrestal implant positioning with simultaneous bone build-up and subsequent submerged healing.
Furthermore, an add-on element for an implantation system is to be specified.
According to the present disclosure, an implantation system—preferably designed for submerged healing—has an implant body, designed in particular for subcrestal positioning, an add-on element, and a connection element, wherein the implant body has a connection inner profile or a connection outer profile, which cooperates with a connection outer profile or with a connection inner profile of the add-on element such that the add-on element can be connected to the implant body in a rotationally-fixed manner, and wherein the connection element can be screwed through an aperture of the add-on element into a thread of the implant body in order to detachably connect the add-on element to the implant body.
Ab add-on element is also claimed—in particular, for an implantation system—with a connection inner profile or with a connection outer profile for producing a rotationally-fixed connection to a connection outer profile or to a connection inner profile of an implant body and an aperture—in particular, for introducing a connection element.
It should be noted that the add-on element can have individual, and optionally all, features and advantages of the add-on element of the implantation system according to the description below.
It has been recognized in a manner according to the present disclosure that the combination of an implant body with an add-on element, which can be arranged on the implant body in a rotationally-fixed manner and can be held captively on the implant body via a connection element, enables an ideal, and in particular subcrestal, positioning of the implant body. The connection element ensures that a firm and gap-free bond is provided between the implant body and the add-on element. This is particularly advantageous in anatomically difficult situations in which the surgeon has only a minimal overview. In a further manner according to the present disclosure, the add-on element ensures that bone is prevented from growing over the implant body, such that the space is kept open for subsequent connection geometries. The implantation system according to the present disclosure thus makes it possible to insert the elements already connected to one another as a gap-free unit into the bone such that a correct seat is always ensured. For example, in the case of insertion into the sinus wall, the entire implantation system can be left in situ during the healing period. After healing, the add-on element can be removed in a simple manner, and supraconstruction can take place. The rotationally-fixed connection realized by the corresponding connection inner and connection outer profiles makes it possible for sufficient torque to be transmitted from the add-on element to the implant body such that they can be inserted together into the bone. It is conceivable that a torque transmission of at least 30 N·cm, in particular of at least 40 N·cm, and preferably of at least 50 N·cm, is achieved. A further advantage of the combination of the connection inner profile and connection outer profile is that indexing can be realized, i.e., the add-on element can be arranged in a defined position relative to the implant body. Furthermore, it is possible for further elements to be connected to the implant body after healing and removal of the add-on element—for example, a gingiva shaper or the like.
In the case of an insertion with bone build-up in the form of a shell, there are various variants. For example, the occlusal bone shell can first be screwed tightly using small osteosynthesis screws, then a borehole can be produced in the bone shell using a trephine drill, and then the implant body can, together with the add-on element arranged via the connection element, be fixed in an ideal subcrestal—position.
Furthermore, it is conceivable that the insertion of the unit consisting of implant body with the add-on element arranged over the connection element be first carried out. The shell is subsequently positioned thereover and perforated. In addition to the use of a trephine drill, the bone shell can subsequently also be perforated using a conical diamond drill.
In the context of this disclosure, the term “implant body” describes the actual implant which remains in the jawbone and supports the abutment or the suprastructure.
In the context of this disclosure, the term “subcrestal” describes a positioning of the implant body such that the upper edge of the implant body lies below bone level—for example, at least 1 mm below bone level.
In an advantageous manner, in the state connected to the implant body, and in particular in the completely inserted state, the add-on element can project out of the implant body, i.e., from the shoulder of the implant body, by 1.5 mm to 4.5 mm, in particular by 1.5 mm to 3.5 mm, and preferably by 2.0 mm to 2.5 mm, or protrude therefrom. This makes it possible for the add-on element in the implanted state to project out of the bone level—preferably by 0.5 mm to 1.0 mm—or protrude therefrom, in order to prevent overgrowth. At the same time, submerged healing is made possible. It is thus made possible, using structurally simple means, that contamination, e.g., with bacteria, be avoided due to the submerged healing, and moreover, despite a subcrestal implant positioning, that bone be prevented from growing over the implant during the healing phase.
In a particularly advantageous manner, the add-on element can have an external thread, at least in regions. This has an advantage that, during implantation into a thin bone layer, e.g., in the case of a sinus lift, the implant body can be inserted so deeply that its external thread no longer sufficiently catches in the bone; however, the entire unit is securely fixed in this position via the external thread of the add-on element such that safe healing is achieved. If sufficient bone is present for fixing the implant body, the add-on element can have a smooth surface, such that osseointegration is prevented, and the add-on element can be easily removed again after becoming ingrown. Alternatively or additionally, the outer wall of the add-on element can run conically or be designed as a straight cylinder. An at least slightly conical configuration has the advantage that a force acting on the implant body in the longitudinal direction is exerted, which force contributes to the stabilization of the implant body in the desired position. Particularly with implantation in the sinus region, a conical embodiment of the add-on element prevents the unit from being placed in the direction of the maxillary sinus. A further advantage is that the add-on element can be removed more easily after the healing period.
According to an advantageous embodiment, the add-on element can have an active profile for an active element, such that the unit consisting of implant body, connection element, and add-on element can be implanted in a particularly simple manner. Due to the rotationally-fixed connection between the implant body and the add-on element, the entire unit consisting of implant body, add-on element, and connection element can be implanted via a single active element, e.g., a tool, wherein said tool engages in the active profile. The active profile can, for example, be any drive profile—preferably a hexagon, star, multi-tooth, octagon, 3PG, etc. Active profiles that allow unambiguous indexing are particularly advantageous. The active profile can preferably be designed to ensure a torque transmission of at least 30 N·cm, in particular of at least 40 N·cm, and preferably of at least 50 N·cm. According to an advantageous embodiment, the width across flats of the active element, and particularly in the case of a hexagon, can be 1.6 mm to 2.5 mm, preferably 1.9 mm to 2.4 mm, and in particular 2.3 mm. Such a width across flats has the advantage that a sufficiently sufficient torque transmission is ensured and at the same time builds the structure to be as small as possible.
A closing element is advantageously arranged which can be connected to the add-on element in a form-fitting and/or force-fitting manner in order to close the aperture of the add-on element. The closing prevents germs from entering the implant and the surrounding bone. In a further advantageous manner, the closing element and the add-on element can be designed such that, when they are connected together with the implant body, and in particular completely screwed in in each case, a head of the closing element and a head of the add-on element project out of the implant body or from the implant shoulder together by less than 5 mm, in particular less than 4 mm, and preferably less than 2.8 mm, or protrude therefrom. Thus, when the implant body is positioned subcrestally, bone tissue is prevented from growing over the implant body, and at the same time submerged healing is made possible. When add-on element and closing element project out by less than 5 mm, submerged healing can take place, wherein the dimensioning is sufficiently large that the individual elements can easily be produced. A projection of less than 4 mm has the advantage that the surgeon can close the incision more easily. A projection of less than 3 mm has the advantage that the incision can be closed by the surgeon particularly easily and can heal well. A further advantage is that the patient perceives such a low height to be less bothersome. Specifically, the head of the closing element could have a height of less than 2.5 mm, in particular of less than 1.5 mm, and preferably of less than 0.5 mm.
According to an advantageous embodiment, a thread for the closing element is formed on the active profile of the add-on element. Due to this design measure, the entire device is extremely small, and at the same time a secure connection is ensured between the add-on element and the closing element. The closing element can also be fastened in another way—for example, via a bayonet connection, a plug connection, or latching connection.
Advantageously, the implant body is designed so as to be arranged below the bone level. A corresponding dimensioning has the advantage that an ideal subcrestal positioning of the implant body can be achieved in a particularly simple manner.
According to an advantageous embodiment, the connection inner profile of the implant body and the connection outer profile of the add-on element or the connection outer profile of the implant body and the connection inner profile of the add-on element can be designed such that a torque transmission of at least 30 Ncm, in particular of at least 40 Ncm, and preferably of at least 50 N·cm, is possible. If the connection inner and connection outer profile are correspondingly matched to one another, sufficient torque can be transmitted from the add-on element to the implant body such that they can be introduced together into the bone.
Advantageously, the connection inner profile of the implant body and the active profile of the add-on element are at least substantially identical. This has the advantage that the implant body and the add-on element can be actuated by the same tool.
According to an advantageous embodiment, an instrument, and in particular a hand instrument, is arranged, wherein the instrument has a shaft, and wherein an active element is formed at the distal end of the shaft, said active element corresponding to the active profile of the add-on element. The instrument can, for example, be configured in such a way that it can be connected to and optionally driven by an elbow. Furthermore, it is possible for the instrument to be implemented as a hand instrument. Since the instrument can engage on the add-on element, the add-on element, together with the implant body connected in a rotationally-fixed manner, can be inserted into the bone such that the instrument serves in this case as an insertion instrument. For this purpose, a ratchet mechanism could, advantageously, also be embodied. It is also conceivable, however, that the instrument serve only for handling the add-on element, in order to receive the latter, to transfer it to the implant body, and to insert it into said implant body or to place it thereon.
In an advantageous manner, the elongate shaft is tubular, wherein a rod can be arranged or is arranged movably within the shaft, and wherein an active geometry is formed at the distal end of the rod and corresponds to an engagement point of the connection element. This design measure makes it possible to receive the add-on element with the active element of the tubular shaft and to place it on the implant body, wherein the connection element also used can be driven by the active geometry of the rod, such that a fixed connection is produced between the add-on element and the implant body. In order to facilitate the decoupling of the shaft and the add-on element or of the rod and the connection element, the active geometry of the rod and the engagement point of the connection element can preferably be matched to one another in such a way that no force-fitting connection is produced, i.e., sticking is avoided. Specifically, the rod can be part of a further instrument, and preferably a hand instrument.
In a particularly advantageous manner, a release instrument with a release rod instrument can be arranged. In this case, set back from the distal end of the release rod, a release thread can be formed. The release instrument serves to remove the add-on element from the implant body as easily, non-destructively, and safely as possible after the healing period. This can sometimes be possible only with difficulty if the add-on element has grown into the tissue. For release, the distal end of the release rod is inserted into the aperture of the add-on element, and the release thread is screwed into a lower thread of the add-on element. Since the release thread is set back from the distal end of the release rod, it abuts against the base of the implant body such that, when the release rod is screwed in further, the add-on element is pulled off the implant body. In this case, sufficient force is exerted on the add-on element that it can even be lifted off when it is partially grown into surrounding tissue.
There are various possibilities for designing and developing the teaching of the present disclosure in an advantageous manner. To this end, reference is made to the following explanation of preferred exemplary embodiments of the present disclosure based upon the drawings. In connection with the explanation of the preferred exemplary embodiments of the disclosure based upon the drawings, generally preferred developments and further developments of the teaching are also explained. In the following:
Furthermore, an active profile 6 for an active element 7 (
The connection element 10 has a thread 12, via which it can be connected to the thread 13 of the implant body 1, wherein it engages thereby with the shoulder 8 behind the projection 9 of the add-on element 4.
It can also be seen in
The blind hole formed in the connection element 10, in which the engagement point 23 is arranged, has a geometry corresponding to the base. This makes it possible to realize the closing element 14 with an extremely low height and to screw it deeply into the add-on element 4, such that it protrudes as little as possible from the add-on element 4, in order to facilitate submerged healing. The conical base of the blind hole in the closing element 14 provides enough space that the profile 24 can be formed with a stamp in the blind hole, and material can be displaced accordingly.
Furthermore, it can be seen that the shaft 19 is tubular, such that the rod 21 shown in
It is apparent from
With regard to further advantageous embodiments of the device according to the present disclosure, reference is made to the general part of the description and to the appended claims in order to avoid repetitions.
Finally, it is expressly pointed out that the exemplary embodiments described above of the device according to the present disclosure serve only to explain the claimed teaching, but do not limit it to the exemplary embodiments.
The various embodiments described above can be combined to provide further embodiments. These and other changes can be made to the embodiments in light of the above detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2020 209 688.0 | Jul 2020 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/DE2021/200098 | 7/26/2021 | WO |
