WO1999042062A1 - Zwischenwirbelimplantat - Google Patents

Zwischenwirbelimplantat Download PDF

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Publication number
WO1999042062A1
WO1999042062A1 PCT/EP1999/001099 EP9901099W WO9942062A1 WO 1999042062 A1 WO1999042062 A1 WO 1999042062A1 EP 9901099 W EP9901099 W EP 9901099W WO 9942062 A1 WO9942062 A1 WO 9942062A1
Authority
WO
WIPO (PCT)
Prior art keywords
intervertebral implant
wedge
implant according
elements
walls
Prior art date
Application number
PCT/EP1999/001099
Other languages
English (en)
French (fr)
Inventor
Jürgen Harms
Lutz Biedermann
Thomas Wichmann
Original Assignee
Biedermann Motech Gmbh
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
Application filed by Biedermann Motech Gmbh filed Critical Biedermann Motech Gmbh
Priority to JP54213899A priority Critical patent/JP3522288B2/ja
Priority to US09/403,125 priority patent/US6176882B1/en
Priority to AT99910246T priority patent/ATE232374T1/de
Priority to DE59904262T priority patent/DE59904262D1/de
Priority to EP99910246A priority patent/EP0977529B1/de
Publication of WO1999042062A1 publication Critical patent/WO1999042062A1/de

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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
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    • A61F2/447Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0082Three-dimensional shapes parallelepipedal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0006Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting angular orientation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Definitions

  • the invention relates to an intervertebral implant with two spaced-apart side walls, a front wall connecting them at one end, a rear wall connecting them at its opposite other end, and an opening in each case on the bottom and top surfaces extending transversely to the aforementioned walls.
  • Such an implant is inserted after the removal of an intervertebral disc in order to stabilize the intervertebral space until the bone material that has been introduced at the same time has led to bony enlargement and stiffening.
  • An intervertebral implant is known from DE 195 29 605 C2.
  • the implant has two hook-shaped sections which are initially bent back into a cavity and are moved outwards into a gripping position by screwing in a screw having a conical section after insertion of the implant between two vertebral bodies.
  • a disadvantage of this device is that the arms having the grippers do not move into their retracted position. - 2 - can be moved back, so that the operator cannot change the position of the implant after the gripper has been extended for the first time.
  • An intervertebral implant is known from DE 195 49 426 C2, in which two end sections of a hollow body are moved by inserting a screw having a frustoconical section from an initially contracted position into an expanded position. Prongs provided on the outside engage the adjacent vertebral bodies in the pressed-apart position.
  • a screw having a frustoconical section from an initially contracted position into an expanded position.
  • An intervertebral implant is known from US 5,522,899. This comprises a lower part made of a rectangular base with two side walls extending at right angles thereto, which are rectangular and each have a projecting tongue extending away from the base in their central region. Furthermore, an upper part is provided which has a corresponding rectangular base and two side walls which extend at right angles to the base and which each have a section for receiving the tongues of the lower part.
  • the sides of the floors facing each other are wedge segment-shaped and dimensioned such that a space is formed between the floors facing each other. In this free space two wedges are provided with their bases facing away from each other and having bores which are concentric with one another.
  • the bore of the first wedge is threadless and serves as a guide for a screw, while the bore of the second wedge has an internal thread which corresponds to the thread of the screw.
  • - 3 The length of the screw is selected so that it is screwed through the first wedge and screwed into the second part when the two wedges are at their greatest distance, in which the two wedge-shaped elements are arranged at their smallest distance from one another.
  • the second wedge is pulled towards the first wedge, so that the distance between the two wedge-shaped elements increases.
  • the free end of the screw emerges from the second wedge. Since the screw itself is not guided to the other elements in its position, the movement of the two parts relative to the other elements is also not predetermined in a force-locking or positive manner.
  • the object of the invention is to provide an improved intervertebral implant of the type described in the introduction.
  • the extension and retraction of the teeth which can be adjusted with regard to the stroke, enables individual adaptation to the respective anatomical shape of the vertebral end plates.
  • the distance between the vertebrae can be controlled by adjusting the tooth height.
  • Fig. 1 is a perspective view of a first
  • FIG. 4 Exemplary embodiment of an intervertebral implant in an exploded view
  • FIG. 4 shows a part of a spine with the inserted intervertebral implant in a side view.
  • FIG. 3 shows a detail from FIG. 2 on an enlarged scale
  • FIG. 5 shows a side view of the intervertebral implant
  • FIG. 6 shows an end view of the intervertebral implant
  • FIG. 7 is a sectional view through the intervertebral implant along the line IV-IV of FIG. 6 with the prongs in the retracted position;
  • FIG. 8 is a sectional view through the intervertebral implant along the line IV-IV of FIG. 6 with the prongs in the protruding position;
  • FIG. 9 is a sectional view corresponding to FIG. 7 of a second embodiment.
  • Fig. 10 is a sectional view corresponding to FIG. 8 of the second embodiment.
  • the implant has a first side wall 1, a second side wall 2 opposite this at a distance and a front wall 3 connecting the two side walls 1, 2 at one end and an opposite one Rear wall 4 for connecting the two side walls at their opposite ends.
  • the bottom and top surfaces are, as can best be seen from FIG. 1, open, so that the four walls enclose a cavity 5 which is open at the top and bottom.
  • the two side walls 1 and 2, as can best be seen from FIG. 5, have a plurality of over the - 5 - Wall surfaces distributed recesses 6, which are preferably rhomboid.
  • a bore 7, 7 1 aligned coaxially with the respective other bore is provided in the front wall 3 and the rear wall 4 in the middle between the side walls.
  • the center 8 of the bore 7, 7 1 is located at the same distance from the upper or lower edge 9, 9 'of the implant and thus in the center of the front or rear wall.
  • the bore 7, 7 ' has a first on the outside of the front or.
  • the second region 11 forms a shoulder.
  • Each side wall 1, 2 is arranged approximately centrally between the front and rear walls and bores 12, 13 and 12 ', 13' are provided at a distance from the upper and lower free edges 9, 9 'of the implant, with opposing holes in each case Bores 12, 12 'and 13, 13' of the side walls 1, 2 are coaxial with each other.
  • a threaded spindle 15 is inserted into the pair of coaxial bores 7, 7 ', as can best be seen from FIGS. 1 and 7 and 8.
  • the threaded spindle 15 has a first end 16 and a second end 17 opposite this. Between the first end 16 and the second end 17 there is a first threaded section 18 each extending from the first end 16 to just under the center 20 of the threaded spindle and one at a distance from the second end 17 to just under the center 20 Threaded spindle extending second threaded portion 19 is provided.
  • the thread pitch of the first thread section 18 is opposite to the thread pitch of the second thread section 19
  • the first end 16 and the second end 17 each have a first hexagon 21 and a second hexagon 22, respectively.
  • each end 16, 17 of the threaded spindle 15 is rotatably inserted into a corresponding bearing element (or a bearing journal) 25, 26, which in turn is rotatably supported in the bores 7, 7 'and whose outer surface with the front or The back wall is flush.
  • Each bearing element 25, 26 is formed as a part with a first cylindrical section 27, 27 'with a first outer diameter and an adjoining cylindrical second section 29, 29' with a second outer diameter, the second outer diameter being larger than the first outer diameter.
  • the second section 29, 29 'in each case forms an annular extension projecting beyond the first section 27, 27'.
  • the diameters of the first and second sections are selected so that the bearing element 25 or 26 can be inserted into the bore 7, 7 'of the front or rear wall, and that in the inserted state the extension of the bearing part formed by the second region on the Shoulder of the bore 7, 7 'rests.
  • the first section 27 or 27 'of the bearing part 25 or 26 has a hexagonal bore 34 or 34', which extends from the end opposite the second section 29 or 29 'into the interior of the cylindrical section 27 or 27', the The longitudinal dimension corresponds to the dimension of the end section 21 or 22 of the threaded spindle 15 and into which the end regions 21 or 22 of the threaded spindle 15 are also inserted with a precise fit.
  • This enables an operator to approach the implant from both sides and to adjust it.
  • the wedge-shaped element 45 and 46 is delimited by a front surface 47, 47 'and a rear surface 48, 48' with a rectangular cross section which run parallel to one another and perpendicular to the spindle axis, the front surface 47, 47 'having a smaller cross section than the rear surface 48, 48'.
  • the front surface and rear surface are connected via two mutually opposite trapezoidal side surfaces 49, 49 'and in each case a top or bottom surface 51, 51' or 52, 52 'with a rectangular cross-section, whereby a wedge is formed.
  • the wedge-shaped element 45 has a threaded bore 55, which in each case passes through the center of the front and rear surface, with an internal thread corresponding to the external thread of the threaded section 18 of the threaded spindle 15.
  • the wedge-shaped element 46 likewise has a threaded bore 55 which passes through the center of the front and rear surface and has an internal thread corresponding to the external thread of the threaded section 19 of the threaded spindle 15.
  • the wedge-shaped elements 45 and 46 are screwed onto the respective threaded sections 18 and 19 of the threaded spindle 15 in such a way that their respective cover surfaces 51, 51 'and their respective bottom surfaces 52, 52' are inclined towards one another.
  • each engagement part 60 or 61 has a surface with a rectangular outline.
  • each element has a parallel to the front or.
  • Rear wall 3 and perpendicular to the surface of the element extending U-shaped slot 67, the bottom of which is directed towards the underside of the element.
  • the surfaces have serrations 68, which are each arranged on the outline of a square, as can be seen in particular from FIGS. 1 and 4.
  • a pin 70, 71 which extends parallel to the front and rear walls and extends in the opposite side walls, extends at a predetermined distance from the bottom and top surfaces.
  • the diameter of the pins 70, 71 is slightly smaller than the diameter of the U-shaped slot 67.
  • the pin sits in the U-shaped slot 70, 71 and thus forms a guide for the movable elements and with its reason at the same time a stop to limit the movement of the elements outwards.
  • the arrangement of the pins 70, 71 and the depth of the U-shaped slots 70, 71 are coordinated with one another in such a way that the relative height of the pin and the depth of the slot determines the maximum height of the movement of the respective element beyond the bottom and top surfaces is.
  • the dimensions of the wedge-shaped elements 45, 46, the threaded sections 18, 19, the spindle 15 and the engaging parts 60, 61, and the pitch of the thread is selected so that the engaging parts 60, 61 from a first position, which is shown in FIG is shown, in which the teeth 68 are located below the edge 9, 9 ', and a second position, which is shown in FIG. 8, in which the teeth can protrude beyond the respective edge 9, 9' of the implant.
  • the implant is made of a body-friendly material such as titanium.
  • each engagement part 60, 61 is in its lowest position, in which the prongs 68 do not protrude beyond the edge of the implant. This means that the implant can be easily inserted into the space between the vertebrae and there is no risk of injury to the soft parts or the vertebral end plates.
  • the two wedge-shaped elements 45, 46 are moved towards one another by turning the threaded spindle 15 by means of a hexagonal screwdriver, whereby a force is exerted on the inclined surfaces 63 via the wedge-shaped inclined surfaces , 64 or 63 ', 64' of the respective engagement part is exerted and this is raised until the prongs 68 protrude beyond the edge of the implant and can thereby claw in the vertebral body, as is shown in particular in FIGS. 2 and 3 .
  • the extension of the engaging parts 60, 61 is limited by the stop formed by the rod 70, 71 to a lifting height shown in FIG. 8, in which the prongs 68 of the respective engaging part protrude beyond the edge of the implant.
  • the engagement parts 60, 61 can only be retracted by turning back by means of the instrument, the pressure exerted on the engagement parts by the vertebrae pressing them into the implant cavity 5. This allows the teeth to be released from the vertebral end plate.
  • the two wedge-shaped elements with their wedge angles and the two elements to be extended in each case with their wedge surfaces interacting therewith or their angles are matched to one another in such a way that the surfaces of the elements to be extended are always parallel to the floor. and top surface are aligned.
  • the embodiment can always be used well if the operation is carried out from the abdominal side because the distance between the adjacent vertebral bodies on the abdominal side is greater than on the back.
  • the embodiment shown in FIGS. 9 and 10 is provided in particular for those cases in which the element is to be inserted from the back between two adjacent vertebral bodies. For the further description corresponding parts are always identified with the same reference numerals as in the first embodiment.
  • the side walls are rectangular, with the result that the bottom and top surfaces extend parallel to one another.
  • the wedge-shaped elements 45, 46 are located in each case with the front wall or rear wall - 11 - screwed back until it stops.
  • the elements 60 and 61 are thereby arranged within the cavity enclosed by the side walls and front and rear walls, so that the cuboid, the height of which corresponds to the height of the gap between the adjacent vertebrae, can be inserted at its narrowest point.
  • the two spindle sections 18 ', 19' not only have opposite thread directions, but the thread pitch of the two sections is also different.
  • the thread pitch of section 19 ' is predetermined so much greater than the thread pitch of section 18' that in the stop position shown in Fig. 10, at which the pins 70, 71 at the bottom of the U-shaped slots are in contact, the elements 60, 61 form a wedge angle with one another with their surfaces, which arises from the fact that the wedge-shaped element 45 travels a greater distance than the wedge element 46 when the spindle rotates due to the larger thread pitch of the section 19 '.
  • the intervertebral implant inserted in the state shown in FIG. 9 as described above can be brought into the expanded position shown in FIG. 10 in the inserted state, so that the two elements 60 and 61 of the tendency to split between the two neighboring ones Vertebral bodies are spread accordingly and rest on the two vertebral bodies. It is not necessary that the spindle is rotated up to the stop of the elements on the pins 70, 71. Intermediate positions can also be selected.

Abstract

Es wird ein Zwischenwirbelimplantat mit zwei einen Abstand zueinander aufweisenden Seitenwänden (1, 2), einer diese an ihrem einen Ende verbindenden Vorderwand (3), einer diese an ihrem gegenüberliegenden anderen Ende verbindenden Rückwand (4) und je einer Öffnung auf den sich quer zu den vorgenannten Wänden erstreckenden Boden- und Deckflächen, und mit wenigstens einem in dem von den vorgenannten Wänden umschlossenen Raum (5) vorgesehenen Element (60, 61) mit einer zur Deckfläche bzw. Bodenfläche gerichteten Oberfläche, welches zwischen einer ersten Endstellung, in der die Oberfläche über die Boden- bzw. Deckfläche wenigstens teilweise nach außen hervorsteht und einer zweiten Endstellung, in der die Oberfläche nicht über die Boden- bzw. Deckfläche hervorsteht, hin- und herbewegbar ist, geschaffen.

Description

- 1 -
Zwischenwirbelimplantat
Die Erfindung betrifft ein Zwischenwirbelimplantat mit zwei einen Abstand zueinander aufweisenden Seitenwänden, einer diese an ihrem einen Ende verbindenden Vorderwand, einer diese an ihrem gegenüberliegenden anderen Ende verbindenden Rückwand und je einer Öffnung auf den sich quer zu den vorgenannten Wänden erstreckenden Boden- und Deckflächen.
Ein solches Implantat wird nach der Entfernung einer Bandscheibe eingesetzt, um den Zwischenwirbelraum zu stabilisieren, bis das gleichzeitig eingebrachte Knochenmaterial zu einer knöchernen Durchbauung und Versteifung geführt hat.
Ein Zwischenwirbelimplantat ist aus der DE 195 29 605 C2 bekannt. Das Implantat weist zwei zunächst in einen Hohlraum zurückgebogene hakenförmige Abschnitte auf, die durch Einschrauben einer einen kegelförmigen Abschnitt aufweisenden Schraube nach Einsetzen des Implantates zwischen zwei Wirbelkörper nach außen in eine GreifStellung bewegt werden. Ein Nachteil dieser Vorrichtung besteht darin, daß die die Greifer aufweisenden Arme nicht in ihre zurückgezogene Stellung zu- - 2 - rückbewegbar sind, so daß ein Verändern der Position des Implantates durch den Operateur nach dem ersten Ausfahren der Greifer nicht mehr möglich ist.
Aus der DE 195 49 426 C2 ist ein Zwischenwirbelimplantat bekannt, bei dem zwei Endabschnitte eines Hohlkörpers durch Einsetzen einer einen kegelstumpfförmigen Abschnitt aufweisenden Schraube diese aus einer zunächst zusammengebogenen Stellung in eine auseinandergedrückte Stellung bewegt werden. Auf der Außenseite vorgesehene Zacken greifen in der auseinandergedrückten Stellung in die benachbarten Wirbelkörper ein. Auch hier besteht der Nachteil, daß nach dem erstmaligen Auseinanderdrücken und Eingreifen der Zacken in die benachbarten Wirbelkörper keine Rückführung zum Ersetzen oder Nachjustieren möglich ist.
Aus der US 5,522,899 ist ein Zwischenwirbelimplantat bekannt. Dieses umfaßt ein Unterteil aus einem rechteckigen Boden mit sich dazu im rechten Winkel erstreckenden zwei Seitenwänden, die rechteckig ausgebildet sind und in ihrem mittleren Bereich jeweils eine vom Boden sich weg erstreckende hervorstehende Zunge aufweisen. Ferner ist ein Oberteil vorgesehen, welches einen entsprechenden rechteckigen Boden und zwei zu dem Unterteil hin sich im rechten Winkel zum Boden erstreckende Seitenwände aufweist, die jeweils einen Abschnitt zur Aufnahme der Zungen des Unterteiles aufweisen. Die jeweils einander zugewandten Seiten der Böden sind keilsegmentförmig ausgebildet und so bemessen, daß zwischen den einander zugewandten Böden ein Freiraum gebildet ist. In diesem Freiraum sind zwei mit ihrer Basis voneinander abgewandte Keile vorgesehen, die zueinander konzentrische Bohrungen aufweisen. Die Bohrung des ersten Keiles ist gewindelos und dient als Führung für eine Schraube, während die Bohrung des zweiten Keiles ein Innengewinde aufweist, welches dem Gewinde der Schraube entspricht. - 3 - Die Länge der Schraube ist so gewählt, daß sie durch den ersten Keil hindurchgeführt in den zweiten Teil eingeschraubt ist, wenn die beiden Keile sich in ihrem größten Abstand befinden, in dem die beiden keilförmigen Elemente in ihrem kleinsten Abstand voneinander angeordnet sind. Durch Drehen der Schraube wird der zweite Keil in Richtung zum ersten Keil gezogen, so daß dadurch der Abstand der beiden keilförmigen Elemente sich vergrößert. Als Ergebnis tritt aus dem zweiten Keil das freie Ende der Schraube heraus. Da die Schraube selbst in ihrer Lagen zu den übrigen Elementen nicht geführt ist, ist auch die Bewegung der beiden Teile relativ zu den übrigen Elementen nicht kraft- bzw. formschlüssig vorbestimmt.
Aufgabe der Erfindung ist es, ein verbessertes Zwischenwirbelimplantat der eingangs beschriebenen Art zu schaffen.
Diese Aufgabe wird durch das im Patentanspruch 1 gekennzeichnete Zwischenwirbelimplantat gelöst.
Weiterbildungen der Erfindung sind in den Unteransprüchen gekennzeichnet.
Das bezüglich des Hubes justierbare Ausfahren und Einfahren der Zacken ermöglicht ein individuelles Anpassen an die jeweilige anatomische Form der Wirbelendplatten. Zudem kann durch die Justierung der Zackenhöhe der Abstand der Wirbel zueinander kontrolliert werden.
Weitere Merkmale und Zweckmäßigkeiten der Erfindung ergeben sich aus der Beschreibung von Ausführungsbeispielen anhand der Figuren. Von den Figuren zeigen:
Fig. 1 eine perspektivische Ansicht eines ersten
Ausführungsbeispieles eines Zwischenwirbelim- plantates in Explosionsdarstellung; - 4 - Fig. 2 einen Teil einer Wirbelsäule mit dem eingesetzten Zwischenwirbelimplantat in Seitenansicht;
Fig. 3 ein Detail aus Fig. 2 in vergrößertem Maßstab;
Fig. 4 eine Draufsicht auf das Zwischenwirbelimplantat;
Fig. 5 eine Seitenansicht des Zwischenwirbelimplantats;
Fig. 6 eine stirnseitige Ansicht des Zwischenwirbelimplan- tats ;
Fig. 7 eine Schnittansicht durch das Zwischenwirbelimplantat entlang der Linie IV-IV von Fig. 6 mit den Zacken in zurückgezogener Position;
Fig. 8 eine Schnittansicht durch das Zwischenwirbelimplantat entlang der Linie IV-IV von Fig. 6 mit den Zacken in hervorstehender Position;
Fig. 9 eine der Fig. 7 entsprechende Schnittansicht einer zweiten Ausführungsform; und
Fig. 10 eine der Fig. 8 entsprechende Schnittdarstellung der zweiten Ausführungsform.
Wie am besten aus den Figuren 1 und 4 bis 6 ersichtlich ist, weist das Implantat eine erste Seitenwand 1, eine dieser in einem Abstand gegenüberliegende zweite Seitenwand 2 und eine die beiden Seitenwände 1,2 an ihrem einen Ende verbindende Vorderwand 3 sowie eine dieser gegenüberliegende Rückwand 4 zum Verbinden der beiden Seitenwände an ihren gegenüberliegenden Enden auf. Die Boden- und Deckflächen sind, wie am besten aus Fig. 1 ersichtlich ist, offen, so daß die vier Wände einen oben und unten offenen Hohlraum 5 umschließen. Die beiden Seitenwände 1 und 2 weisen, wie am besten aus Fig. 5 ersichtlich ist, eine Mehrzahl von über die - 5 - Wandflächen verteilte Ausnehmungen 6 auf, die vorzugsweise rhombenartig ausgeführt sind.
Wie am besten aus den Figuren 1 und 6 bis 8 ersichtlich ist, ist in der Vorderwand 3 und der Rückwand 4 in der Mitte zwischen den Seitenwänden jeweils eine koaxial zu der jeweils anderen Bohrung ausgerichtete Bohrung 7, 71 vorgesehen. Der Mittelpunkt 8 der Bohrung 7, 71 befindet sich jeweils in gleichem Abstand von dem oberen bzw. unteren Rand 9, 9 'des Implantats und somit im Zentrum der Vorder- bzw. Rückwand. Die Bohrung 7, 7' weist einen ersten an der Außenseite der Vorderbzw. Rückwand gelegenen Bereich 10 mit einem ersten Durchmesser auf und einen daran angrenzenden in den Hohlraum 5 mündenden zweiten Bereich 11 mit einem zweiten Durchmesser auf, wobei der zweite Durchmesser etwas kleiner ist als der erste Durchmesser. Dadurch bildet der zweite Bereich 11 eine Schulter .
Jede Seitenwand 1, 2 weist in etwa mittig zwischen der Vorder- und Rückwand angeordnet und in einem Abstand von dem oberen und unteren freien Rand 9 , 9 ' des Implantats vorgesehene Bohrungen 12, 13 bzw. 12', 13' auf, wobei jeweils gegenüberliegende Bohrungen 12, 12' bzw. 13, 13' der Seitenwände 1, 2 koaxial zueinander sind.
In das Paar koaxialer Bohrungen 7, 7' ist, wie am besten aus den Figuren 1 und 7 und 8 ersichtlich ist, eine Gewindespindel 15 eingesetzt. Die Gewindespindel 15 weist ein erstes Ende 16 und ein diesem gegenüberliegendes zweites Ende 17 auf. Zwischen dem ersten Ende 16 und dem zweiten Ende 17 ist ein sich jeweils von in einem Abstand von dem ersten Ende 16 bis knapp zur Mitte 20 der Gewindespindel erstreckender erster Gewindeabschnitt 18 und ein sich in einem Abstand vom zweiten Ende 17 bis knapp zur Mitte 20 der Gewindespindel erstreckender zweiter Gewindeabschnitt 19 vorgesehen. Die Gewindesteigung des ersten Gewindeabschnittes 18 ist entgegengesetzt zu der Gewindesteigung des zweiten Gewindeabschnittes 19. Angrenzend an - 6 - das erste Ende 16 bzw. das zweite Ende 17 weist die Gewindespindel jeweils einen ersten Sechskant 21 bzw. einen zweiten Sechskant 22 auf.
Wie insbesondere aus den Figuren 6 bis 8 ersichtlich ist, ist jedes Ende 16, 17 der Gewindespindel 15 in ein entsprechendes Lagerelement (bzw. einen Lagerzapfen) 25, 26 drehfest eingeführt, welches seinerseits jeweils in den Bohrungen 7, 7' drehbar gelagert ist und dessen Außenfläche mit der Vorderbzw. Rückwand bündig abschließt. Jedes Lagerelement 25, 26 ist als Teil mit einem ersten zylinderförmigen Abschnitt 27, 27' mit einem ersten Außendurchmesser und einem daran angrenzenden zylinderförmigen zweiten Abschnitt 29, 29' mit einem zweiten Außendurchmesser, wobei der zweite Außendurchmesser größer als der erste Außendurchmesser ist, ausgebildet. Dadurch bildet der zweite Abschnitt 29, 29' jeweils einen über den ersten Abschnitt 27, 27' hervorstehenden ringförmigen Ansatz. Die Durchmesser der ersten und zweiten Abschnitte sind so gewählt, daß das Lagerelement 25 bzw. 26 in die Bohrung 7, 7' der Vorder- bzw. Rückwand einschiebbar ist, und daß in eingeschobenem Zustand der durch den zweiten Bereich gebildete Ansatz des Lagerteils auf der Schulter der Bohrung 7, 7' aufliegt. Der erste Abschnitt 27 bzw. 27' des Lagerteiles 25 bzw. 26 weist eine sich von dem dem zweiten Abschnitt 29 bzw. 29 ' gegenüberliegenden Ende in das Innere des zylinderförmigen Abschnittes 27 bzw. 27' erstreckende Sechskantbohrung 34 bzw. 34' auf, deren Längsabmessung der Abmessung des Endabschnittes 21 bzw. 22 der Gewindespindel 15 entspricht und in die auch die Endbereiche 21 bzw. 22 der Gewindespindel 15 jeweils paßgenau eingeführt sind. Von dem jeweils gegenüberliegenden Ende eines jeden Lagerteils 25, 26 erstreckt sich eine koaxiale Sechskantbohrung 38, 38' in Richtung des ersten Abschnittes 27, 27' zum Ineingriff ringen mit einem Sechskant- Schraubendreher. Dadurch wird ermöglicht, daß ein Operateur von beiden Seiten an das Implantat herankommt und dieses justieren kann. - 7 - Wie insbesondere aus den Figuren 1, 7 und 8 ersichtlich ist, befindet sich auf jedem Gewindeabschnitt 18, 19 der Gewindespindel 15 ein keilförmiges Element 45 bzw. 46. Das keilförmige Element 45 bzw. 46 ist jeweils begrenzt von einer Vorderfläche 47, 47' und einer Rückfläche 48, 48' mit rechteckigem Querschnitt, die parallel zueinander und senkrecht zur Spindelachse verlaufen, wobei die Vorderfläche 47, 47' einen kleineren Querschnitt aufweist als die Rückfläche 48, 48'. Vorderfläche und Rückfläche sind über zwei einander gegenüberliegende trapezförmige Seitenflächen 49, 49' und jeweils eine Deck- bzw. Bodenfläche 51, 51' bzw. 52, 52' mit rechteckigem Querschnitt verbunden, wodurch ein Keil gebildet ist.
Das keilförmige Element 45 weist eine jeweils durch die Mitte der Vorder- und Rückfläche hindurchgehende Gewindebohrung 55 mit einem dem Außengewinde des Gewindeabschnitts 18 der Gewindespindel 15 entsprechenden Innengewinde auf. Das keilförmige Element 46 weist ebenfalls eine durch die Mitte der Vorder- und Rückfläche hindurchgehende Gewindebohrung 55 mit einem dem Außengewinde des Gewindeabschnitts 19 der Gewindespindel 15 entsprechenden Innengewinde auf. Die keilförmigen Elemente 45 und 46 sind so auf die jeweiligen Gewindeabschnitte 18 bzw. 19 der Gewindespindel 15 aufgeschraubt, daß ihre jeweiligen Deckflächen 51, 51' und ihre jeweiligen Bodenflächen 52, 52' gegeneinander zugeneigt sind.
Zwischen die gegeneinander geneigten Deckflächen 51. 51' bzw. zwischen die gegeneinander geneigten Bodenflächen 52, 52', im folgenden als Keilflächen bezeichnet, der keilförmigen Elemente 45, 46 ist jeweils ein Element 60 bzw. 61 eingesetzt, welches an seiner den keilförmigen Elementen zugewandten Unterseite in Form eines Dachgiebels mit zwei schräg aufeinander zulaufenden Flächen 63, 64 bzw. 63', 64' ausgebildet ist. Der Neigungswinkel der Flächen 63, 64 bzw. 63', 64' entspricht dem Keilwinkel der keilförmigen Elemente. An seiner der Gewindespindel 15 abgewandten Seite weist jedes Eingriffs- teil 60 bzw. 61 eine Oberfläche mit rechteckigem Umriß auf. In - 8 - Längsrichtung zwischen Vorder- und Rückwand 3 , 4 gesehen in der Mitte weist jedes Element einen sich parallel zur Vorderbzw. Rückwand 3 und senkrecht zur Oberfläche des Elementes erstreckenden U-förmigen Schlitz 67 auf, dessen Grund zur Unterseite des Elementes hin gerichtet ist. Die Oberflächen weisen Zacken 68 auf, die jeweils auf dem Umriß eines Quadrates angeordnet sind, wie insbesondere aus Fig. 1 und Fig. 4 ersichtlich ist. Zwischen den Zacken befindet sich jeweils eine in etwa kreisförmige Vertiefung 69, so daß die auf dem Umriß eines Quadrates angeordneten Zacken jeweils einen Zackenkranz bilden.
In der Mitte zwischen Vorder- und Rückwand 3 , 4 erstreckt sich jeweils in einem vorgegebenen Abstand von Boden- und Deckfläche ein parallel zur Vorder- und Rückwand sich erstreckender Stift 70, 71, der in den sich gegenüberliegenden Seitenwänden festgehalten ist. Der Durchmesser der Stifte 70, 71 ist etwas geringer als der Durchmesser des U-förmigen Schlitzes 67. Wie aus den Figuren ersichtlich ist, sitzt der Stift in dem U-förmigen Schlitz 70, 71 und bildet somit eine Führung für die bewegbaren Elemente und mit seinem Grund gleichzeitig einen Anschlag zur Begrenzung der Bewegung der Elemente nach außen. Die Anordnung der Stifte 70, 71 und die Tiefe der U-förmigen Schlitze 70, 71 sind so aufeinander abgestimmt, daß durch die relative Lage von Stift und Tiefe des Schlitzes die maximale Höhe des Herausfahrens des jeweiligen Elementes über die Boden- und Deckfläche hinaus bestimmt ist.
Die Abmessungen der keilförmigen Elemente 45, 46, der Gewindeabschnitte 18, 19, der Spindel 15 und der Eingriffsteile 60, 61, sowie die Steigung der Gewinde ist so gewählt, daß die Eingriffsteile 60, 61 von einer ersten Stellung, die in Fig. 7 dargestellt ist, in der sich die Zacken 68 unterhalb des Randes 9, 9' befinden, und einer zweiten Stellung, die in Fig. 8 gezeigt ist, in der die Zacken über den jeweiligen Rand 9, 9' des Implantats hinausragen bewegt werden können. - 9
Das Implantat ist aus einem körperfreundlichen Material wie beispielsweise Titan gefertigt.
Im Betrieb werden mit einem Sechskant-Schraubendreher zunächst die keilförmigen Elemente 45, 46 durch Drehen der Gewindespindel 15 in die in Fig. 7 gezeigte Stellung gebracht, bei der die Rückflächen 48 an der dem Hohlraum 5 zugewandten Seite der Vorder- bzw. Rückwand 3, 4 des Implantates anliegen. Dadurch befindet sich jedes Eingriffsteil 60, 61 in seiner tiefsten Stellung, in der die Zacken 68 nicht über den Rand des Implantates hinausragen. Damit ist das Implantat leicht in den Raum zwischen die Wirbel einführbar, und es besteht keine Gefahr von Verletzungen der Weichteile oder der Wirbelendplatten. Wenn das Implantat in seiner Stellung zwischen den Wirbeln richtig positioniert ist, werden durch Drehen der Gewindespindel 15 mittels eines Sechskant-Schraubendrehers die beiden keilförmigen Elemente 45, 46 aufeinander zu bewegt, wodurch über die keilförmig gegeneinander geneigten Flächen jeweils eine Kraft auf die schrägen Flächen 63, 64 bzw. 63', 64' des jeweiligen Eingriffsteiles ausgeübt wird und dieses angehoben wird, bis die Zacken 68 über den Rand des Implantates hervorstehen und sich dadurch in dem Wirbelkörper verkrallen können, wie insbesondere in Fig. 2 und Fig. 3 dargestellt ist. Das Ausfahren der Eingriffsteile 60, 61 ist durch den über den Stab 70, 71 gebildeten Anschlag auf eine in Fig. 8 dargestellte Hubhöhe begrenzt, in der die Zacken 68 des jeweiligen Eingriffsteiles über den Rand des Implantates hervorstehen.
Durch das Übersetzen der Drehbewegung des Werkzeugs mittels der Gewindespindel und den keilförmigen Elementen ist eine feindosierte Einstellung des Hubes der Eingriffsteile und damit ein individuelles Anpassen des Implantats an die anatomische Form der Wirbelendplatten des einzelnen Patienten möglich. - 10 - Die Ausbildung des Anschlages für die Eingriffsteile 60, 61 in Form des in die zylinderabschnittförmige Ausnehmung 67 eingreifenden Stabes 70, 71 sind die Eingriffsteile 60, 61 in ihrer obersten Stellung drehbar um den jeweilige Stab 70, 71 gelagert. Dies ermöglicht eine selbständige Zentrierung der Eingriffsteile, indem die mit Zacken 68 besetzte Oberfläche der anatomischen Form der jeweiligen Endplatte des Wirbelkörpers folgt. Ein selbständiges Lösen der Eingriffsteile ist aufgrund der Gewindespindel nicht möglich. Nur durch Zurückdrehen mittels des Instrumentes können die Eingriffsteile 60, 61 zurückgefahren werden, wobei der Druck, der von den Wirbeln auf die Eingriffsteile ausgeübt wird, diese in den Implantathohlraum 5 drückt. Damit können die Zacken wieder aus der Wir- belkörperendplatte gelöst werden.
Bei den in den Figuren 1 bis 8 gezeigten ersten Ausführungsbeispielen sind die beiden keilförmigen Elemente mit ihren Keilwinkeln und die beiden jeweils auszufahrenden Elemente mit ihren damit zusammenwirkenden Keilflächen bzw. deren Winkeln so aufeinander abgestimmt, daß die auszufahrenden Elemente mit ihren Oberflächen stets parallel zur Boden- und Deckfläche ausgerichtet sind. Die Ausführungsform ist immer dann gut einsetzbar, wenn die Operation von der Bauchseite her erfolgt, weil der Abstand der benachbarten Wirbelkörper auf der Bauchseite größer als auf der Rückseite ist. Die in den Figuren 9 und 10 gezeigte Ausführungsform ist insbesondere für diejenigen Fälle vorgesehen, bei denen das Element von Rücken her zwischen zwei benachbarte Wirbelkörper eingesetzt werden soll. Für die weitere Beschreibung sind einander entsprechende Teile stets mit dem gleichen Bezugszeichen wie in der ersten Ausführungsform gekennzeichnet.
Bei dem Ausführungsbeispiel sind die Seitenwände rechteckig ausgebildet mit der Folge, daß die Boden- und Deckfläche sich zueinander parallel erstrecken. Wie aus Fig. 9 ersichtlich ist, befinden sich in der Ausgangsstellung die keilförmigen Elemente 45, 46 in der jeweils zu der Vorderwand bzw. Rückwand - 11 - hin bis zum Anschlag zurückgeschraubten Stellung. Die Elemente 60 und 61 sind dadurch innerhalb des durch die Seitenwände und Vorder- und Rückwand umschlossenen Hohlraumes angeordnet, so daß der Quader, dessen Höhe gleich der Höhe des Spaltes zwischen den benachbarten Wirbeln an seiner engsten Stelle entspricht eingeschoben werden kann.
Abweichend von der ersten Ausführungsform haben die beiden Spindelabschnitte 18 ' , 19 ' nicht nur einander entgegengesetzte Gewinderichtungen, sondern die Gewindesteigung der beiden Abschnitte ist darüber hinaus unterschiedlich. Dabei ist, wie aus Fig. 10 ersichtlich ist, die Gewindesteigung des Abschnittes 19 ' um so viel größer vorbestimmt als die Gewindesteigung des Abschnittes 18', daß bei der in Fig. 10 gezeigten Anschlagstellung, an der die Stifte 70, 71 am Grund der U- förmigen Schlitze anliegen, die Elemente 60, 61 mit ihren Oberflächen einen Keilwinkel zueinander bilden, der dadurch entsteht, daß das keilförmige Element 45 aufgrund der größeren Gewindesteigung des Abschnittes 19 ' bei Drehen der Spindel einen größeren Weg zurücklegt als das Keilelement 46.
Dadurch wird erreicht, daß das in der oben beschriebenen Weise in dem in Fig. 9 gezeigten Zustand eingeschobene Zwischenwirbelimplantat im eingeschobenen Zustand in die in Fig. 10 gezeigte aufgespreizte Stellung bringbar ist, so daß die beiden Elemente 60 und 61 der Spaltneigung zwischen den beiden benachbarten Wirbelkörpern entsprechend aufgespreizt werden und an den beiden Wirbelkörpern anliegen. Dabei ist es nicht erforderlich, daß die Spindel jeweils bis zu Anschlag der Elemente an den Stifte 70, 71 gedreht wird. Auch Zwischenstellungen können gewählt werden.
Abwandlungen der Vorrichtung sind möglich. Beispielsweise können anstatt der Zacken 68 Spitzen oder jede andere Oberflächenstruktur, die ein Eingreifen in Knochenmaterial erlaubt, vorgesehen sein.

Claims

- 12 - PATENTANSPRÜCHE
1. Zwischenwirbelimplantat mit zwei einen Abstand zueinander aufweisenden Seitenwänden (1, 2) , einer diese an ihrem einen Ende verbindenden Vorderwand (3) und einer dieser gegenüberliegenden Rückwand (4) und je einer Öffnung auf den sich quer zu den vorgenannten Wänden erstreckenden Boden- und Deckflächen, wenigstens einem aus in dem von den vorgenannten Wänden umschlossenen Raum (5) vorgesehenen Element (60, 61) mit einer zur Deckfläche bzw. Bodenfläche gerichteten Oberfläche, und einem mit dem Element zusammenwirkenden Einstellelement, welches in der Vorderwand bzw. Rückwand gelagert ist, derart, daß das Element zwischen einer ersten Endstellung, in der die Oberfläche nicht über die Boden- bzw. Deckfläche hervorsteht, und einer zweiten Endstellung, in der die Oberfläche über die Boden- bzw. Deckfläche wenigstens teilweise nach außen hervorsteht, hin- und herbewegbar ist.
2. Zwischenwirbelimplantat nach Anspruch 1, dadurch gekennzeichnet, daß in dem von den Wänden umschlossenen Raum (5) eine Gewindespindel (15) mit zwei Abschnitten (18, 19) mit entgegengesetzter Gewindesteigung vorgesehen ist, die mit ihrem einen Ende (16) in der Vorderwand bzw. in der Rückwand drehbar gelagert ist und auf der zwei mit ihrer Basis voneinander abgewandte keilförmige Elemente (45, 46) derart gelagert sind, daß beim Drehen der Gewindespindel in eine Richtung die Elemente aufeinander zu bewegt werden und beim Drehen der Gewindespindel in eine entgegengesetzte Richtung die Keilflächen voneinander weg bewegt werden und diese Keilelemente auf das Element zum Bewegen desselben einwirken.
3. Zwischenwirbelimplantat nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß zwei Elemente (60, 61) vorgesehen sind.
4. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die Elemente an ihrer der Ober- - 13 - fläche abgewandten Seite jeweils zwei dachgiebelför ig sich schneidende Flächen (63, 64; 63', 64') aufweisen und daß die Keilelemente mit den schrägen Flächen des jeweiligen Elementes in Eingriff stehen.
5. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß die Oberfläche jedes Elementes Zacken (68) zum Eindringen in benachbartes Knochenmaterial aufweist.
6. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß ein Anschlag (70, 67; 71, 67') zum Begrenzen der Bewegung jedes Elementes nach außen vorgesehen ist.
7. Zwischenwirbelimplantat nach Anspruch 6, dadurch gekennzeichnet, daß der Anschlag durch einen sich im wesentlichen parallel zur Vorder- bzw. Rückwand erstreckenden und in den Seitenwänden getragenen Stift (70; 71) gebildet wird.
8. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß die Seitenwände (1, 2) trapezförmig ausgebildet sind, so daß ein keilabschnittsförmiger Körper gebildet ist.
9. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß die keilförmigen Elemente unterschiedliche Keilwinkel besitzen.
10. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, daß die beiden Spindelabschnitte unterschiedliche Gewindesteigungen aufweisen.
11. Zwischenwirbelimplantat nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß die Oberfläche der Elemente in ihrer zweiten Stellung eine gegenüber der Boden- bzw. Deckfläche geneigte Stellung aufweisen. 14 -
12. Zwischenwirbelimplantat nach einem der Ansprüche 7 bis 11, dadurch gekennzeichnet, daß die Elemente jeweils einen sich quer zu ihrer Oberfläche erstreckenden U-förmigen Schlitz aufweisen, in dem jeweils einer der Stifte geführt ist.
PCT/EP1999/001099 1998-02-20 1999-02-19 Zwischenwirbelimplantat WO1999042062A1 (de)

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JP54213899A JP3522288B2 (ja) 1998-02-20 1999-02-19 椎間インプラント
US09/403,125 US6176882B1 (en) 1998-02-20 1999-02-19 Intervertebral implant
AT99910246T ATE232374T1 (de) 1998-02-20 1999-02-19 Zwischenwirbelimplantat
DE59904262T DE59904262D1 (de) 1998-02-20 1999-02-19 Zwischenwirbelimplantat
EP99910246A EP0977529B1 (de) 1998-02-20 1999-02-19 Zwischenwirbelimplantat

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TW390200U (en) 2000-05-11
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CN1262607A (zh) 2000-08-09
EP0977529B1 (de) 2003-02-12
JP2000513263A (ja) 2000-10-10
ATE232374T1 (de) 2003-02-15
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US6176882B1 (en) 2001-01-23
DE19807236C2 (de) 2000-06-21

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