AU679019B2

AU679019B2 - Anchoring element for anchorage in bone tissue

Info

Publication number: AU679019B2
Application number: AU55827/94A
Authority: AU
Inventors: Per-Ingvar Branemark
Original assignee: Medevelop AB
Current assignee: Medevelop AB
Priority date: 1992-11-26
Filing date: 1993-11-24
Publication date: 1997-06-19
Anticipated expiration: 2013-11-24
Also published as: SE9303726D0; AU5582794A; WO1994017750A1

Description

la "Anchoring Element for Anchorage in Bone Tissue" The present invention relates to an implant anchoring element, preferably for bone tissue integration, consisting of a mainly rotation-symmetric body made of a biocompatible material and of which one end is designed for supporting of dental bridge constructions, artificial teeth etc. and which on its outer surface is provided with an external screw thread, as well as a method to apply such an anchoring element in the maxilla and the zygomatic bone for retention of a tooth prosthesis or a bridge construction.

BACKGROUND

In general, partially or completely edentolous upper jaws can be treated by drilling holes in the jawbone and 15 the consequent insertion of anchoring elements in these holes by the use of preferably cylindrical fixtures with an outer thread and to supply them with single-tooth or bridge prostheses in the latter case with more than one fixture to be applied in the bone in order to retain a 20 bridge construction.

In certain cases when the patient has been edentolous for a long time and for this reason the jawbone has been partly resorbed, the dimension and the retention force of the jawbone is inadequate for the anchoring of one or several fixtures. The patient may thus not be successfully treated with a desirable prosthetic appliance, or may not be willing to accept the risk which in such a case may be considerable, for losing the prosthesis or a fractured jawbone.

S:21804H 2 SUMMARY OF THE INVENTION The present invention provides a cylindric anchoring element provided with external threads and with support means arranged at its one supporting end for securing a dental prosthesis or bridge intended for substitution of one or several teeth in the upper jaw, characterised in that the anchoring element is of such length that it can be fixed with its portion proximal to the dental prosthesis or bridge in the maxilla and with its respective distal portion in the zygomatic bone and wherein the support means is adapced to hold the dental prosthesis or bridge at a constant angle with respect to a longitti.inal axis of the anchoring element.

0 Preferably, in at least preferred embodiments the a 15 present invention provides a fixture whereby artificial teeth or a tooth bridge construction can be successfully retained in an upper jaw with such properties that it ae *does not fulfil the dimensioned or retention force demands normally required for such a procedure.

20 Preferably, the anchoring element has substantially cylindrical shape and contralateral ends of different diameters, wherein the end portion with the smaller o il, diameter is intended to be inserted into the zygomatic Sd'Se@ bone and is at least partially threaded whereas the other end part with the larger diameter with its at least partly threaded portion is intended to be retained in the maxillar bone and both threaded parts having the same pitch.

Both threaded parts may suitably converge with each other to form a continuous outer thread with different diameters.

S:21804H I 3 According to a suitable embodiment of the invention the anchoring element can have a non-threaded middle zone between the threaded portions of the end parts.

According to a further embodiment of the invention, the anchoring element is designed to be retained by its tooth-adjacent part in the maxilla and its distal part (insertion part) in the zygomatic, whereby the stress forces in the maxilla are relieved.

In order to achieve this the length of the anchoring element is suitably dimensioned for retention in the maxilla with its tooth-adjacent part and in the zygomatic with its insertion part and is supplied with means of retention of prosthetic elements at its tooth-adjacent end.

15 It is preferred for the diameter of the fixture to be larger over a substantial extension from its proximal t end than over a substantial extension from its distal end, the outer diameter of the external threads in both portions being different but the distal and proximal external threads having the same pitch.

It is preferred for the fixation means to comprise a bore with internal threads and at least one abutment area •for the tooth prosthesis or bridge, and for the bore to be positioned at an angle in respect of the central axis.

It is furthermore preferred that the angle comprised between the central axis of the fixture and the bore axis of the fixation means is between 150 and 600, preferably S:21804H i I 4 about 45° or alternatively with a possibility for adjustment of this angle within a suitable range.

At its distal end the fixture according to the invention can be provided with a bore and through slits extending from the portion near the distal end or from that end in direction of the proximal end. It is also appropriate for the distal end to be somewhat bevelled. The threads can have self-tapping design.

According to another preferred aspect of the invention a non-treaded intermediate portion is arranged between the proximal and the distal external threads. It is preferred for the intermediate portion to have the same outer 15 diameter as the outer diameter of the distal threads. This intermediate portion preferably is somewhat smaller than the distance between the sides of the zygomatic bone and *a the upper jaw facing each other.

20 'According to a further embodiment a periosteal plate is i: placed around the gingival penetration area at the toothadjacent end ot the anchoring element, whereby this plate is porous and is having a thickness of between 0,1 0,3 mmu and suitably is supplied with a concentric hole with a diameter slightly larger than the gratest outer diameter of the anchoring.element.

0 The present invention also discloses a method for attaching an anchoring element to the jaw bone and the zygomatic bone, said anchoring element comprising a cylindric anchoring element having support means arranged at one, supporting end, for securing a dental prosthesis or bridge intended for substitution of one or several teeth in the upper jaw, the anchoring element being of such length that it can be fixed with its portion proximal to the dental prosthesis or bridge in the maxilla and with its respective distal portion in the zygomatic bone, the anchoring element having a first threaded portion proximate the distal end and a second S threaded portion proximate the proximal end, the diameter

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of the first threaded portion being less than the gee e 15 diameter of the second threaded portion, said method comprising: making a hole in the jaw bone, making a hole in the zygomatic bone in line with ee.

the hole in the jaw bone, the hole in the zygomatic bone being given a smaller diameter than the hole in the jaw bone, inserting said anchoring element with the first threaded end adapted to the diameter of the hole in the zygomatic bone, and second threaded end adapted to the diameter of the hole in the jaw bone, said first threaded end being inserted first, simultaneous screwing-on of the fixture into both holes, orienting the anchoring element by rotating it around its longitudinal axis to thereby position the support means at the supporting end of the fixture in a S:21804H -i I 5A tilted position with respect to the longitudinal axis of the fixture so as to allow anatomically correct mounting of the dental prosthesis or bridge, and mounting the dental prosthesis or the bridge on the supporting end of the anchoring element.

It is preferred for the screwing-on of the anchoring element to comprise self-tapping action.

Features and advantages of the invention will become apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, without being limited to the shown embodiments.

oS g o 555 e S:21804H WO 94/17750 PCT/SE93/01011 6 BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawing: Fig. 1 shows an anchoring element according to a first embodiment of the invention in a somewhat lateral side view, Fig. 2 shows a schematic view of the orientation of the anchoring element in relation to the maxilla and the zygomatic bone, in situ after operation, Fig. 3 shows an alternative embodiment of the anchoring element in situ after operation and supplied with a periosteal plate, and Fig. 4 a view of the plate shown in Fig. 3, DESCRIPTION OF PREFERRED EMBODIMENTS In principle the anchoring element shown in the figures is mainly cylindrical and at one end, the so called supporting end, supplied with supporting means to receive directly or indirectly after heeling into the bone, 6-ificl ji- c ernnts, tooth bridges, artificial teeth etc. Such anchoring elements are previously described, cp. US 5,064,425, showing the so called insertion end supplied with an outer thread, whereby the anchorirg element is screwed into a prefabrcated drilled hole with a slightly smaller diameter than the outer diameter of the thread on the anchoring element.

In this case the thread should preferably be self-tapping, as exemplified in US 5,064,425.

e- 7 9 0 *9 *3 6*e 9 09 ,a So 06 9S 6W 0 In order to achieve optimal healing and osseointegration with surrounding tissue, the surface of the anchoring element should preferably be formed with micropits within the size range of 10 1000 nm, as e.g.

described in US 4,330,891.

In the enclosed drawings, embodiments of a suggested anchoring element according to the invention is illustrated, for the retention of artificial teeth or bridge constructions in patients with different defects in the jawbone.

By the use of the suggested anchoring element the possibility exists of a double anchoring in the maxilla and the zygomatic bone.

The anchoring element shown in figure 1 is prepared in one piece of pure titanium and mainly built up of two adjacent and lined up cylinder-shaped segments.

The fixture shown in Fig. 1 is manufactured as a single piece of pure titanium and essentially composed of two cylindric segments 1, 2 bordering each other and being in alignment, wherein the segment proximal to the jaw and having a diameter larger than that of the segment distal to the jaw 2 is designated by 1.

The outside of the fixture is threaded, except for a mountfng portion extending from the proximal end of the fixture and connected to the cylindric proximal segment 1. The outer threads comprise first threads 4 on the proximal cylindric segment 1 and second threads 5 on the distal cylindric segment 2. The pitch is the same for both threads 6 099 9 9 9 S:21804H rr a r llls~ WO 94117750 PCT/SE93/01011 8 4, 5 merging at the border zone between the cylindric segments. The inner diameter of first threads 4 is somewhat but not much larger than the outer diameter of the second threads 5. Threads 4, 5 are self-tapping.

A symmetrically centred bore (not shown) extends from the distal end 6 and has an extension corresponding to about half the length of the proximal segment 2. Two through slits 7, 8 arranged symmetrically in segment 2 and in its longitudinal direction extend from a plane perpendicular to the central axis near the distal end 6 by a length of about three thread pitches. Slits 7, 8 establish communication between the outside of proximal segment 5 and the symmetrically centred bore arranged therein for transport of bone material removed by ablation. The outside of distal segment 2 is bevelled (bevelling 16) towards end 6.

The mounting section 3 is contained within a cylindric chamber with a diameter corresponding to the outer diameter of cylindric segment 1. The mounting segment 3 comprises a base portion 9 having the form of a cylindric body dissected by a plane at an angle of 450 i respect of the cylinder axis. The circular basis of base portion 9 is connected to the proximal end of proximal cylindric segment 1 with which it merges. Nearest to the proximal cylindric segment 1 base portion 9 has an annular flange 14 to which an annular groove 15 connects in direction of the proximal end. End face 10 of base portion 9 is defined by the aforementioned dissecting plane and, at its proximal zone, smoothly rounded joins the cylinder mantle of base section 9, the beading decreasing gradually towards the distal portion of the base section. Because of the bevelling the profile of end fane 10 is substantially circular. In its center end face 10 has a bore 12 running at an angle of in respect of longitudinal axis A for cylinder segments 1 and 2, for the fixture. At bore 12 base section 9 is L ~I se ~BI

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WO 94/17750 PCT/SE93/01011 9 extended under formation of a frustrum of a cone 11 tapering in direction away from base section 9. Mantle surface 13 of the cone frustrum 11 and the annular end face are designed for sealing abutment of a dental prosthesis or bridge (not shown) that can be mounted on the base portion by screw means.

The parts of the fixture according to the invention in contact with living bone tissue have a surface promoting integration, preferably a surface covered by micropits or similar surface irregularities in the order of 10 1,000 nm.

Implantation starts by providing in the maxilla a bore with a diameter corresponding to the inner diameter of threads 4 and at an angle deviating about 45° from the vertical (the longitudinal axis of the human body in an upright position), followed by a bore in the zygomatic bone having a diameter corresponding to the inner diameter of threads and in line with the first hole. Thereupon the fixture is inserted with its narrow end 6 into the hole in the upper jaw until, by means of its bevelled portion, it comes into engagement with the hole arranged in the zygomatic bone.

Thereupon the fixture is screwed on into the hole in the zygomatic bone in a self-taping manner and, after threads 4 having reached the jaw bone, also simultaneously into the latter in a self-taping manner. When attaining a sufficient insertion depth for the fixture, such depth being defined by the fixture's free end having the correct distance from the jaw bone, the screwing process is stopped. By fine tuning, that is, anti-clockwise or clockwise rotation around its longitudinal axis, bore 12 provided with internal threads is brought into correct position for mounting of the prosthesis, in a position in which bore 12 is substantially parallel with the longitudinal axis of the human body. The position for an implanted 81-~r~ L ~L 1 13~$ -q d ~IC~ WO 94117750 PCT/SE93/01011 fixture according to the invention is schematically shown in Fig. 2; the zygomatic bone has been designated by 0 and the maxilla by M.

The dental prosthesis or bridge can be mounted after surgery or after a healing period during which the fixture is progressively anchored in bone tissue.

The length of the fixture and cylindric sections 1 and 2 and the angle of bore 12 in base portion 9 are adapted to the anatomical requirements of the individual patient. A limited range of fixtures according to the invention, including fixtures of varied total length, varied ratio of length of the cylindric sections and varied angle of bore 12 in base section 9 in relation to the longitudinal axis of the fixture, will suffice for covering the needs of most patients.

It is also possible to produce the fixture in two parts, a separate base part 9 and a part 1, 2 provided with external threads. The base part and the part with external threads can be connected in various ways, for instance, by a symmetrically centred tap positioned on the end of base part 9 facing away from bore 12, said tap being arranged for screwing on into a threaded bore in the free end of part 1 provided with external threads, both parta otherwise having planar abutting surfaces (line B in Fig. 1 indicates their position) for abutment against each other.

In a second embodiment of the fixture according to the invention shown in Fig. 3 only the proximal portion of the proximal segment 1' has first external threads The rest of the proximal segment 1' has a polished surface, i.e., essentially the portion positioned upon implantation in the maxillary sinus 17 between the maxilla M and the-zygomatic bone Z. First external threads 4' thus have an extension WO 94/17750 PCT/SE93/01011 11 essentially corresponding to the depth of the through bore provided in the maxilla M in preparation for implantation.

The distal segment 2' is provided with corresponding second external threads As is also shown in Fig. 3 this second embodiment can be provided (as can the first embodiment shown in Fig. 1) with a periosteal plate or foil 20 for enhancement of integration of the implant with living tissue in an area where the distal end zone of distal portion 2' with mounting portion 3' emerges from the through bore in the maxilla M. The periosteal plate or foil 20 is a porous disc of thin pure titanium, preferably from about 0.1 to about 0.3 mm thick and having a concentric hole 21 with a diameter slightly larger than the largest outer diameter of the fixture allowing plate or foil 20 to be fitted like a collar around the part of the fixture protruding from the maxilla M. Periosteal plate or foil is fitted with its one side against outer surface 19 of the maxilla M after partial removal of the periosteum 18 (thickness of periosteum 18 is exaggerated in Fig. 3 for reasons of comprehensiveness) which is then folded back against the other side of the periosteal plate or foil The pores (not shown in Fig. 3 and 4) in the periosteal foil or plate 20 are through pores and provide for communication between both sides of foil or plate 20; it is preferred for the pores to have an average diameter of from about 0.1 to about 0.01 mm. The periosteal foil or plate promotes anchoring of the fixture around its proximal part and reduces the risk of communication between the oral cavity 22 and the maxillary sinus 17.

Claims

1. A cylindric anchoring element provided with external threads and with support means arranged at its one supporting end for securing a dental prosthesis or bridge intended for substitution of one or several teeth in the upper jaw, characterised in that the anchoring element is of such length that it can be fixed with its portion proximal to the dental prosthesis or bridge in the maxilla and with its respective distal portion in the zygomatic bone, and wherein the support means is adapted to hold the dental prosthesis or bridge at a constant 0• angle with respect to a longitudinal axis of the anchoring element. 0•

2. The anchoring element of claim 1, characterised S c. 15 in that the anchoring element over a substantial extension from its proximal end has a larger diameter than over a substantial extension from its distal end and that the external thread has different outer diameters but the same pitch at said portions. *e 20 3. The anchoring element of claim 1 or 2, characterised in that the supporting end of the anchoring element has at least one abutment area for the dental prosthesis or bridge and the support means comprises a bore extending at said angle and having internal threads 25 for engagement with the dental prosthesis or bridge to thereby secure the dental prosthesis or bridge to the anchoring element and hold the dental prosthesis or bridge at said angle.

4. Ehe anchoring element of claim 3, characterised in that the angle between its longitudinal axis and the bore is between 150 and 600, preferably about 450° S:21804H -e IIICI O 4. The anchoring element of claim 3, characterised in that the angle between its longitudinal axis and the bore is between 150 and 600, preferably about 450 The anchoring element of claim 1 to 4, characterised in that it is provided with an axial bore at its distal end and with through slits extending from the area adjacent to the distal end or from this end in the direction of the proximal end.

6. The anchoring element of any of claims 1 to characterised in that the distal thread portion and the proximal thread portion have the same pitch, and that the outer diameter of the distal thread portion is the same oe or smaller than the inner diameter of the proximal thread S. portion 15 7. The anchoring element of any of claims 1 to 6, characterised in that an intermediate portion free from threads is arranged between the proximal thread portion and the distal thread portion.

8. A method for attaching an anchoring element to S. 20 the jaw bone and the zygomatic bone, said anchoring Sow. element comprising a cylindric anchoring element having support means arranged at one, supporting end, for securing a dental prosthesis or bridge intended for substitution of one or several teeth in the upper jaw, the anchoring element being of such length that it can be fixed with its portion proximal to the dental prosthesis or bridge in the maxilla and with its respective distal portion in the zygomatic bone, the anchoring element having a first threaded portion proximate the distal end and a second threaded portion proximate the proximal end, S:21804H the diameter of the first threaded portion being less than the diameter of the second threaded portion, said method comprising: making a hole in the jaw bone, making a hole in the zygomatic bone in line with the hole in the jaw bone, the hole in the zygomatic bone being given a smaller diameter than the hole in the jaw bone, inserting said anchoring element with the first threaded end adapted to the diameter of the hole in the zygomatic bone, and second threaded end adapted to the diameter of the hole in the jaw bone, said first threaded end being inserted first, o simultaneous screwing-on of the fixture into both holes, 15 orienting the anchoring element by rotating it around its longitudinal axis to thereby position the support means at the supporting end of the fixture in a S tilted position with respect to the longitudinal axis of the fixture so as to allow anatomically correct mounting 20 of the dental prosthesis or bridge, and. *S@ mounting the dental prosthesis or the bridge on the supporting end of the anchoring element. A method according to claim 8, wherein the •support means comprises a bore with internal threads for engagement with the dental prosthesis or bridge to thereby secure the dental prosthesis or bridge to the anchoring element. An anchoring element, substantially as herein described with reference to the accompanying drawings. S:21804H K

11. A method of attaching an anchoring element to the jaw bone and the zygomatic bone, substantially as herein described with reference to the accompanying drawinas. Dated this 16th day of April 1997 MEDEVELOP AB By their Patent Attorneys GRIFFITH HACK Do: o et S. 0* 551b 0 S:21804H