AU2013357235B2 - Intervertebral cage expandable step-by-step - Google Patents

Abstract

Intervertebral fusion implant for fusing two adjacent vertebrae, comprising a base piece (2) and a top piece (3), both of which are designed to come to rest against a facing end plate of one of the adjacent vertebrae. The top piece is vertically adjustable relative to the base piece, a ratchet device (4) being provided between the base piece (2) and the top piece (3), said ratchet device causing a step-by-step vertical adjustment and preventing a set height from being reduced due to restoring forces. Said implant allows for a defined expansion according to the number of actuations. The state of expansion can be controlled with precision in a purely haptic manner. Furthermore, the ratchet device allows the implant to remain in the set expanded state.

Description

Technical Field

The present invention relates to an intervertebral 5 fusion implant for fusion of two adjacent vertebrae, and an arrangement consisting of the intervertebral fusion implant and an actuation instrument for the intervertebral fusion implant.

Background Art

The intervertebral disks of the spinal column suffer degeneration as a result of wear or of pathological changes. If conservative treatment by indication and/or physiotherapy is ineffective, surgical treatment is sometimes indicated. In this connection, it is known for a movable or immovable implant to be inserted into the intervertebral space containing the degenerated intervertebral disk. These implants take over the support function of the degenerated intervertebral disk and to this extent restore a stable bearing between the adjacent vertebrae. Immovable implants are also referred to as cages.

Various surgical techniques are known for implanting the cages. A traditional surgical technique involves a ventral access route, in order thereby to avoid the danger of damaging the spinal cord in the vertebral column. However, this advantage is obtained at the price of a very long access route through the abdominal cavity or thoracic cavity of the patient. Since this can cause complications, an alternative access route has become established, namely from the dorsal direction. Although the latter affords the advantage of a short route, there is the danger of collision with or damage to the spinal cord. To minimize this danger, the operation is usually performed by minimally invasive surgery. Approaches of this kind directly from the

REPLACEMENT SHEET (RULE 26)

10496962_1 (GHMatters) P100346.AJ

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2013357235 27 Jul 2018 dorsal direction or more from the side are known as PLIF (posterior lumbar intervertebral fusion) or TLIF (transforaminal lumbar interbody fusion), in which the intervertebral disk is exposed from the posterior or lateral direction, respectively. Because of the small transverse incisions used in an approach by minimally invasive surgery, the size of the cage is of course greatly restricted.

For treatment using the PLIF or TLIF technique, very small cages are known. They afford the advantage of being able to be implanted by minimally invasive surgery thanks to their small size. However, an inherent disadvantage of their small size is that the support function is limited because of the small dimensions and is sometimes inadequate. Although a larger size of the cages would improve the support function, this is impractical because of the limits of minimally invasive surgery.

It is to be understood that, if any prior art is referred to herein, such reference does not constitute

an admission that	the prior	art	forms a	part of	the
common general knowledge in	the	art, in	Australia	or
25 any other country.
Summary
Disclosed is an	intervertebral	fusion	implant	for

fusion of two adjacent vertebrae, comprising a base 30 piece and a cover piece, which are each designed to bear on a facing end plate of one of the adjacent vertebrae, the cover piece is adjustable in height with respect to the base piece, a ratchet mechanism, provided between base piece and cover piece, effecting a stepped adjustment of height and secures an adopted height against reversal, wherein the intervertebral

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2013357235 27 Jul 2018 fusion implant further comprises a catch mechanism, which limits an adjustment movement of the cover piece, and a release mechanism for the ratchet mechanism, in order to reset the height adjustment.

The intervertebral fusion implant may provide a better supporting action while still using a small access cross section of the kind customary in minimally invasive surgery.

The ratchet mechanism may include the base piece having a bottom wall, for bearing on the lower vertebra, and a vertical wall rising from this bottom wall, and the cover piece has a cover wall, for bearing on the upper vertebra, and a side wall projecting downward from this cover wall, said vertical wall and side wall being parts of the ratchet mechanism. Here, the ratchet mechanism expediently has a plurality of locking teeth on the side wall and a corresponding flange on the vertical wall, or vice versa.

The fusion implant may be adjustable in height such that, at the time of implantation, it can be introduced in the compact state through the minimally invasive access route into the intervertebral space and can be expanded there in height. This is done by actuating a height adjustment mechanism, which is designed as a ratchet mechanism. In this way, a defined expansion can be achieved that depends on the number of actuations.

This allows the surgeon precise control of the state of expansion, specifically by purely haptic means. The disclosure is therefore free of limitations of the kind that would arise with purely visual control of the state of expansion (if appropriate by X-ray).

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Moreover, the expansion state that has been locked using the ratchet mechanism. The form ratchet mechanism provides protection inadvertent return movement, even under loading forces. This results in excellent specifically also immediately after the until complete fusion of the two adjacent bodies is finally achieved by bone growth.

set can be fit of the against very high stability, operation, vertebral

A double ratchet mechanism may be provided, which may include one on each lateral face of the implant. On the one hand, this provides secure support, even under loads that are not exerted centrally. On the other hand, a double ratchet mechanism of this kind makes it possible to give both sides different heights, which results in a defined tilting of the cover piece with respect to the base piece. In this way, an adaptation to curvatures in the spinal column can be made in the respective intervertebral space. For this purpose, provision can also be made that the two ratchet mechanisms are offset in height with respect to each other, in some forms by an offset of their respective locking teeth.

Two vertical walls may be provided laterally on the bottom wall, and the bottom wall is elastic. This permits a flexible, reversible spreading open of the two vertical walls, such that the expansion movement is made easier. At the same time, by purposeful spreading open of the two side walls, a resetting possibility can be made available for the cover piece. This permits testing of the fusion implant and resetting in the event of overexpansion. In an alternative variant, only the vertical walls are elastic, while the bottom wall is rigid. This avoids bulging of the bottom wall.

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The cover piece may be made of a less elastic material than the bottom piece. For example, the cover piece is composed of a cobalt/chromium alloy, while the base piece is composed of a more elastic titanium alloy. In this way, it is possible for taken up, especially at the ratchet mechanism.

a greater force to be locking teeth of the

The catch mechanism may prevent accidental overexpansion. The catch mechanism may be formed by a pawl that interacts with a shoulder projection. Harmful overexpansion may be thus prevented in a simple and efficient manner. In an alternative embodiment, the catch mechanism is formed by windows in the vertical walls and by a transverse pin which projects laterally from the side walls and engages in the windows. The transverse pin may be arranged at the bottom on the side walls. In this way, the locking teeth can run uninterrupted on the side walls, which improves the force transmission.

To permit fine adjustment in the case of double ratchet mechanisms, the locking teeth on one of the two ratchet mechanisms may be designed such that they have a spacing which is an integral multiple of the spacing of the locking teeth on the other of the two ratchet mechanisms. For example, the spacing on one ratchet mechanism is twice as great as the spacing on the other one. On the one hand, a rapid adjustment can thus be achieved by the greater spacing. On the other hand, a finer adjustment can be obtained using the ratchet mechanism with the smaller spacing, which may be an advantage in practice, in particular as regards adjustment of an angle of tilt between cover piece and base piece.

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A suitable size of the spacing of the locking teeth from one another is approximately 1.5 to 3.0 times their elevation (which is defined by the distance between tooth tip and tooth bottom).

In some forms, the locking teeth are advantageously designed asymmetrically, in some forms in a sawtooth shape. This allows a configuration which is such that only a low force is needed for the expansion, by virtue of favorable flank angles, whereas high retention forces are applied against return movement. It has proven suitable if the angle of a supporting flank is in the range of 5 to 35°, in some forms at about 10°. The supporting flank is understood as being the one that bears the load and thus counteracts a return movement. The sawtooth shape may be designed such that a tooth angle in the range of 45° to 70°, in some forms of approximately 60°, is obtained. In an embodiment, the locking teeth overlap one another in an imbricated manner, wherein the counter-flank may be oriented in the same direction as, but flatter than, the supporting flank. This configuration permits a particularly favorable adjustment of the force relationships between the actuating force during the expansion and the retention force with respect to return movement. This can be further increased if the corresponding flange engages with a form fit in the locking teeth, wherein the shape of the locking teeth may be adapted to the corresponding flange such that a self-securing effect is achieved. This provides maximum securing against undesired return movement, which is ultimately defined only by the load limits of the material with respect to fracture or shear.

In some forms, to maximize the self-securing effect, the interacting surfaces on locking teeth and the

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2013357235 27 Jul 2018 corresponding flange are not parallel, but instead oriented at an acute angle to each other. At an acute angle is understood here as meaning that the respective surfaces diverge from each other in the direction toward the bottom of the locking teeth. This configuration has the effect that, under a load, the corresponding flange draws further between the locking teeth. An undesired escape of the corresponding flange from the locking teeth is thus safely avoided. The securing effect is thus maximized.

An inner hollow space may be formed between cover piece and base piece. This permits introduction of bone substance, such as grafts or chips, in order thereby to promote inward growth of bone substance for stiffening. In order to promote introduction of bone substance, and in particular also inward growth from the direction of the two adjacent vertebrae, at least one aperture may be provided on the cover plate and/or bottom wall and is connected to the hollow space.

A blocking element may also be provided, which can be pushed into the hollow space. In this way, after implantation and expansion to the desired height, the cover piece can be fixed in its position. An additional securing effect is thus obtained. A plurality of blocking elements with different heights may be provided, such that a blocking element can be pushed in that is of the right fit for the expansion. In some forms, at least one additional aperture is provided on the blocking element and is flush with the aperture on the cover plate and/or bottom wall. Thus, growth of bone substance into the hollow space can be promoted even when the blocking element has been pushed in.

Moreover, the cover piece and/or base piece may have openings on their end faces. On the one hand, this

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2013357235 27 Jul 2018 further promotes inward growth, and, on the other hand, bone substance can be introduced into the hollow space through this end opening even after implantation.

The cover piece and/or base piece may be advantageously rounded at its end faces, and in some forms, at its

corners	. This makes	it	easier	to push	the	fusion
implant according intervertebral space.	to	the	disclosure	into	the
The top of the	face of the cover piece and/or the base piece may be structured. This is	bottom face understood

to mean that it has regular elevations or depressions. These may be fine grooves extending longitudinally, that is to say in the direction from end face to end face, and/or furrows extending transversely, that is to say from side wall to side wall. The grooves have a spacing of at least 0.2 mm to at most 1 mm, while the furrows have a width of at least 2 mm and in some forms not more than 5 mm. The fine grooves act like teeth and hold the intervertebral fusion implant in place. The furrows protect it from migration, in some forms, under the effect of a force, as often occurs when the patient stoops or bends down. Moreover, they initially secure the intervertebral fusion implant against slipping. Advantageously, the top face and/or bottom face are provided with a coating of titanium plasma spray, which promotes inward growth of bone substance. The titanium plasma spray may be finely particulate with a grain size of at most 90 pm, such that it does not even close fine structures such as said grooves. In some forms, the edge areas toward the end faces are smooth or are provided only with the grooves and not with the furrows . This ensures a greater load-bearing capacity for the cortical vertebral margin.

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The overall configuration of the intervertebral fusion implant may be generally box-shaped. This is favorable from the point of view of production technology and simplifies introduction of the implant in a straight line into the intervertebral space. However, it may also be desirable that the implantation does not take place in a straight line but instead in an arc shape. For this purpose, the intervertebral fusion implant may be curved in the shape of an arc of a circle. This simplifies implantation, particularly in the case of an access route obliquely from behind by means of the TLIF (transforaminal lumbar interbody fusion) technique. The intervertebral fusion implant can also be wedge-shaped, in such a way that one end wall is lower than the other. In some forms, wedge angles are in the range of approximately 3° to 15°. This may allow better adaptation to a curvature of the spinal column, in particular to a lordosis.

It may be expedient to return the already expanded intervertebral fusion implant to the compact size in which it is provided for implantation. This can be done of functionality or performed for test able to reset the after an extracorporeal test following an (over) expansion purposes. In order to be intervertebral fusion implant, a release mechanism for the ratchet mechanism is provided. In a simple case, it can be in the form of seats that are arranged at the free end of the vertical wall and/or side wall and are provided for a laterally acting spreading element. This spreads the vertical walls open, such that the locking teeth move out of the area of engagement of the corresponding flange, and the cover piece can be moved back again relative to the base piece. In an embodiment, seats are designed as holes at the upper end of the vertical wall, in some forms in the area of

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2013357235 27 Jul 2018 the pawl. This permits a simple resetting option, albeit only in a state outside the intervertebral space .

A suitable spreading element may be a forceps-like instrument which has grippers that engage in the seats.

Disclosed is an arrangement composed of an intervertebral fusion implant according to the above disclosure and an actuation instrument for the intervertebral fusion implant wherein the actuation instrument has a cross section which at most is as great as that of the intervertebral fusion implant, the actuation instrument has a display mechanism, which indicates a presentation proportional to the height adjustment of the intervertebral fusion implant. In some forms, the expansion using the actuation instrument may take place through the same small minimally invasive access route used for the actual insertion of the intervertebral fusion implant. A second separate access route may be therefore not needed. This may reduce the work involved and also places less strain on the patient.

The actuation instrument may be designed as a draw-key expander with two spreading jaws. The draw key may be arranged in the front area on the spreading jaws. By moving the draw key, an expansion of the spreading jaws can be effected, which spreading jaws in turn act from the inside on the cover piece or the base piece and thus expand these.

For the movement of the draw key, a tensioning member may be provided, which is routed rearward between the spreading jaws. Here, rearward means being routed outward away from the implant in the direction of the

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2013357235 27 Jul 2018 surgeon. In some forms, this allows the surgeon comfortable actuation from the outside via the minimally invasive access. The routing of the tensioning member between the spreading jaws permits a compact structure. Moreover, this permits good protection of the tensioning member against mechanical impairment. The tensioning member is advantageously designed as an actuation spindle. In some forms, this permits a precise adjustment and also allows reversible actuation by rotation in the opposite direction.

In an embodiment, the draw key is arranged at the front end of the actuation spindle, and an adjustment wheel is mounted at the rear outer end. This may permit a comfortable reversible actuation from the outside.

It may in principle also be sufficient for tactile feedback to give the surgeon an idea of the extent of the height adjustment. However, it may also be advantageous if the actuation instrument has a display mechanism, which indicates the attained height adjustment of the intervertebral fusion implant. For this purpose, the display mechanism has a presentation proportional to the attained height adjustment. This makes it easier for the surgeon to determine the expansion that has already been attained.

Alternatively, an actuation instrument can also be provided as a rotary lever plate. It comprises a guide part and a lever part guided pivotably in the latter, wherein seats for either the base piece or the cover piece are provided on both. It is expediently configured such that the base piece is mounted at a front end of the guide part, while the cover piece is mounted on the lever part so as to rotate therewith. For this purpose, a screw connection is expediently

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2013357235 27 Jul 2018 provided at the front end of the lever part and engages in a corresponding mating thread of an opening in the end face of the cover piece.

The lever part may have a toggle for actuation at its rear end. It is mounted in the guide part, which for this purpose is designed such that the lever part is mounted movably in the radial direction. This means that, by pivoting the toggle in the radial direction, the lever part correspondingly rotates.

The lever part also may have an axial bore through which a fastening spindle is fitted. It serves for the easily releasable fastening of the cover piece on the lever part. It has proven useful to provide, on the guide part, a bell with a recess for the toggle. Here, the recess is shaped such that, in the radial direction, it has a greater width than corresponds to a thickness of the toggle. The toggle is thus movable in the radial direction in the bell and can thus be moved to and fro. This reciprocating movement transfers to the cover piece firmly screwed on the front end, which cover piece accordingly tilts and thus migrates upward alternately on the two ratchet mechanisms by in each case one further locking tooth. A height adjustment is effected in this way. Moreover, if tilting is desired, a tilt can be adopted by means of an uneven number of actuation procedures.

A further alternative actuation instrument is designed as a parallel expander with cross lever. The cross lever forms a reverse kinematics system, as a result of which the expander spreads open when pressure is applied to the handle. This kinematics system is more expedient in use than simple forceps without a cross lever, where the handle would have to be spread open.

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Moreover, the parallel expander may have an adjustable limit stop device. With this, a maximum expansion can be fixed, which is then not exceeded. This is particularly advantageous in implantation where access conditions are difficult, surgeon, during the expansion procedure, no longer has situations since the to manually control the position attained. A rotary wheel with a plurality of predefined and inscribed positions is expediently provided. With this, the limit stop device is adjusted accordingly. The desired degree of expansion can therefore be easily adjusted.

The spreading jaws may be designed differently as regards the retention of base piece and cover piece.

Devices for form-fit connection may be arranged on only one of the spreading jaws, in some forms in the form of projections engaging in openings in the base piece. By means of the different design, a fail-safe coding is obtained in the sense that the intervertebral fusion implant can only be correctly received with one orientation by the actuation instrument. Errors caused by the implant being received the wrong way round are thus ruled out.

Brief Description of the Drawings

The disclosure is explained in more detail below with reference to the attached drawing and on the basis of advantageous illustrative embodiments. In the drawing:

Fig. 1 shows a view of an illustrative embodiment of an intervertebral fusion implant in the implanted state on vertebral bodies;

Fig. 2 shows perspective views of base piece and cover piece as per the embodiment shown in Fig. 1;

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Fig. 3 shows schematic views of the action of a ratchet mechanism;

Fig. 4 shows an enlarged view of teeth of the ratchet 5 mechanism as per Fig. 3;

Fig. 5 shows an example of a catch mechanism in a variant of the illustrative embodiment;

Fig. 6 shows views of a release mechanism in the locked position and the unlocked position;

Fig. 7 shows a perspective view and a cross-sectional view of a securing element in the dismantled state and the assembled state;

Fig. 8 shows a perspective view of a grip head for an actuation instrument;

Fig. 9 shows cross-sectional views of the actuation instrument as per Fig. 8 in the relaxed state and partially expanded state;

Fig. 10 shows a plan view and cross-sectional details of the actuation instrument;

Fig. 11 shows a perspective view of a second embodiment;

Fig. 12 shows a two-part actuation instrument for an intervertebral fusion prosthesis as per a third embodiment; and

Fig. 13 shows views of the second actuation instrument 35 in a partially assembled state and a fully assembled state;

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Fig. 14 shows a perspective view of a further illustrative embodiment of the intervertebral fusion implant;

	Fig .	15	shows	a sectional	view of Fig.	14;
	Fig .	16	shows	an enlarged	detail from	Fig .	14;
10	Fig .	17	shows	a side view	of a variant	. of	Fig .	14;
	Fig .	18	shows	a plan view	of a fourth	embodiment of
			actuation instrument;
15	Fig .	19	shows	an enlarged	detail from	Fig .	18;	and
	Fig .	20	shows	another enlarged detail	from	Fig .	. 18.

Detailed Description

In the following detailed description, reference is made to accompanying drawings which form a part of the detailed description. The illustrative embodiments described in the detailed description, depicted in the drawings and defined in the claims, are not intended to be limiting. Other embodiments may be utilised and other changes may be made without departing from the spirit or scope of the subject matter presented. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings can be arranged, substituted, combined, separated and designed in a wide variety of different configurations, all of which are contemplated in this disclosure.

An intervertebral fusion implant, designated in its entirety by reference number 1, is provided for

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2013357235 27 Jul 2018 implantation in an intervertebral space 91 between two immediately adjacent vertebral bodies 9, 9' . In a physiologically intact vertebral column, an intervertebral disk 90 is located in the intervertebral space between the vertebrae. This intervertebral disk 90 may undergo degeneration as a result of disease or wear, with the result that it has to be at least partially resected. In order to achieve sufficient support of the intervertebral space 91, despite the loss of intervertebral disk material, and to thereby prevent collapse of the vertebral column, the intervertebral fusion implant 1 is inserted into the intervertebral space 91. It provides a supporting action and thus facilitates fusion of the two adjacent vertebrae 9, 9' in a natural way through bone growth.

The intervertebral fusion implant 1 comprises a base piece 2, which bears on an upper end plate 92 of the lower adjacent vertebra 9. Moreover, it comprises a cover piece 3, which bears on a lower end plate 93 of the upper adjacent vertebra 9' . In order to ensure a secure bearing of the base piece 2 on the lower end plate 92, on the one hand, and of the cover piece 3 on the lower end plate 93 of the upper vertebra 9' , it is necessary to suitably adjust the height of the intervertebral fusion implant 1. It has to be expanded until the base piece 2 and the cover piece 3 bear firmly on the respective end plates 92, 93.

To permit a movement of base piece 2 and cover piece 3 away from each other in the sense of an expansion, a ratchet mechanism 4 is provided. The latter comprises a multiplicity of locking teeth 43 on the cover piece, which interact with a corresponding flange 42 on the base piece 2 .

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In order to keep the intervertebral fusion implant 1 according to the disclosure compact, and thus be able to implant it through an access prepared by minimally invasive surgery, while at the same time allowing it to exert a sufficient supporting action in the intervertebral space 91, the intervertebral fusion implant 1 according to the disclosure is adjustable in height. For this purpose, it has a base piece 2 and a cover piece 3, which is arranged to be movable in height relative to the base piece 2. The base piece 2 is substantially trough-shaped and comprises a bottom wall 22, which functions as a contact face on the end plate 92 of the lower of the adjacent vertebrae 9, and an upwardly projecting vertical wall 21 on each of the two lateral faces. The base piece 2 therefore has an overall U-shape in cross section. At the upper end of the vertical wall 21, the corresponding flange 42 is arranged as a part of the ratchet mechanism 4 . Moreover, approximately at the middle of an upper end of the vertical wall 21 there is a projection 52, which forms a part of a catch mechanism 5. In the bottom wall 22, there are a plurality of openings 24 via which a hollow space 10, in the interior of the trough-shaped configuration between the side walls 21, is connected to the space underneath the bottom wall 22. This

promotes the	growth of	bone into	the intervertebral
fusion implant	1.
Moreover, the	depicted	illustrative	embodiment	of	the
30 intervertebral	fusion	implant 1	according	to	the

disclosure comprises a cover piece 3. The latter has a generally box-shaped configuration, with a substantially plane top face 33, which functions as a contact face for the lower end plate 93 of the upper adjacent vertebra 9'. A side wall 31 is arranged projecting downward on each of the lateral faces. On

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2013357235 27 Jul 2018 their outward surface, these side walls 31 carry a plurality of locking teeth 43, which form a part of the ratchet mechanism 4 and interact with the corresponding flange 42 on the base piece 2. In the illustrative embodiment shown, an end wall 30 is provided on an end face. It is optional and can also be omitted. Moreover, a bearing shoulder 53 is also formed approximately at the middle on the side walls 31. Its dimensions are chosen such that it interacts with the projection 52 on the base piece 2. The arrangement of the bearing shoulder 53 is chosen here such that it comes to bear on the projection 52 in the position of maximum extension of the cover piece 3 relative to the base piece 2. A limit stop is thus obtained. The projection

52 and the bearing shoulder 53 thus interact as a catch mechanism 5. A plurality of apertures 34 are formed on the top face 33, in order to allow bone substance to grow into the interior of the cover piece.

For implantation, the cover piece 3 is fitted into the hollow space 10 of the trough-shaped base piece 2. The implant is thus in the state of minimal expansion, as is shown in the uppermost of the three views arranged above one another in Fig. 3a. In this state, the implant is introduced into the intervertebral space 91 until it more or less reaches the position shown in Fig. lb. In a next step, it can then be expanded until it is set to the height of the intervertebral space 91. This is done by the cover piece 3 being moved upward by means of an actuation instrument 8, wherein the corresponding flange 42 successively engages with different locking teeth 43 on the lateral faces 31 of the cover piece 3 and thereby secures the attained position of expansion. This expansion procedure is depicted in the three views in Fig. 3a.

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The locking teeth 43 are sawtooth-shaped. Each tooth 43 has two flanks 45, 47. Here, the shorter flank 45 is the load-bearing flank, which comes into engagement with the corresponding flange 42 in such a way as to transmit force. This load-bearing flank 45 is shaped facing downward and is thus oriented in the same direction as the other, non-load-bearing flank 47. This results in a certain degree of imbrication of the locking teeth 43 when viewed from the side. In the illustrative embodiment shown in Fig. 4, the angles a and β are chosen such that the angle a is about 60° and the angle β is 8°. The top face 46 of the corresponding flange 42 is inclined by said angle β. Thus, together with the downwardly facing orientation of the load15 bearing flank 45, this means that a loading force F results in an inwardly directed lateral force L, which draws the corresponding flange 42 into the teeth 43 and thus secures it against undesired escape from the locking teeth 43. A self-securing effect is thus obtained in the sense that the securing force L increases the greater the loading force F.

In order to prevent a situation in which the cover piece is moved too far up during the expansion and the corresponding flange 42 thus leaves the area of the locking teeth 43, a catch mechanism 5' as shown in Fig. 5 is alternatively provided. It comprises a projection 52' on each flange 42, specifically at the middle thereof. A downwardly facing stirrup 53' is arranged on the cover piece 3, underneath the locking teeth 43, its dimensions being chosen such as to enclose the projection 52' . When the maximum expansion is reached, the stirrup 53' engages under the projection 52' and prevents a further expansion movement.

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For the purpose of height adjustment, the expansion movement generally takes place uniformly on both sides of the ratchet mechanism 4, as is also depicted in Fig. 3a. However, it may also be desirable for the adjustment to be non-uniform in order to adopt a defined tilt angle. A desired tilt angle can be adopted in a defined manner depending on whether the adjustment on one side takes place across one or two extra locking teeth 43. For this purpose, the surgeon simply has to count off the number of clicks, i.e. the number of locking procedures in the ratchet mechanism 4 made by the engagement of the corresponding flange 42 in the different locking teeth 43. For a finer adjustment of the tilt, more finely stepped teeth 43' can also be provided, twice as many teeth 43' of half the size of the teeth 43. In some embodiments, only one of the two ratchet mechanisms is provided with the finer teeth, as is shown in Fig. 5. Optionally, the start points of the teeth 43, 43' are mutually offset between the two ratchet mechanisms.

It may be necessary to return the cover piece 3 from its expanded position to a less expanded position or to a position of no expansion at all, as is used for the implantation. For this purpose, a resetting mechanism 6 is expediently provided. This comprises an instrument with forceps-like grippers 61 which, with corresponding gripper tips 62 at their front end, engage in receiving openings 60 formed for this purpose on the top face of the vertical walls 21. By spreading the grippers 61 in a forceps-like movement, the two vertical walls 21 lying opposite each other are moved away from each other, as a result of which the corresponding flange 42 on the respective vertical wall 21 is no longer in engagement with the locking teeth 43 on the cover piece

3. The ratchet mechanism 4 is thereby released. The

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2013357235 27 Jul 2018 cover piece 3 can be freely moved downward and in this way reset. For this purpose, the material of the base piece 2 may be chosen such that it is able to deform elastically, in particular the bottom wall 22. This is shown in Fig. 6.

In order to achieve additional securing of the attained height adjustment after successful expansion, a separate blocking element 70 can be provided. It may be shaped such that it can be pushed with a good fit into the hollow space 10 between cover piece 3 and base piece 2, which hollow space 10 has been enlarged by the expansion. It will be appreciated that different blocking elements 70 have to be used depending on the expansion status. The blocking element 70 may have a central aperture 74, which is flush with the apertures 34 on the cover piece 3 and the apertures 24 on the base piece 2. In this way, the hollow space 10 can be more easily reached and accessible for the inward growth of bone substance. In the inserted state, the blocking element 70 secures the cover piece 3 against a reverse movement back into the base piece 2, as is shown in Fig. 7b.

For the height adjustment by means of expansion, an actuation instrument is provided. It is designed as a draw-key expander 8 with two spreading jaws 81. They are provided at their front end with seats 84, which engage with a form fit in the apertures 34 . At the front end, the spreading jaws 81 are indented in a Vshape, and a wedge-shaped draw key 82 is fitted into this indent. The draw key 82 is connected to a tensioning member 80, which extends along the longitudinal axis of the actuation instrument 8, over the entire length of the latter (see Fig. 10). It begins with its front end on the draw key 82 and

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2013357235 27 Jul 2018 terminates, at the rear end of the actuation instrument 8, in a handwheel 88, in which it is mounted via a spindle thread 89. When the handwheel 88 is turned, the tensioning member 80 is moved rearward by means of the spindle thread 89, as a result of which the draw key 82 retreats into the V-shaped depression between the two spreading jaws 81. The spreading jaws 81 are thereby driven apart from each other (see Fig. 9, where the top view shows the non-expanded initial state and the lower view shows an expanded state) . Depending on the pitch of the spindle thread 89, the surgeon can obtain a desired spreading action by means of a defined number of rotations of the handwheel 88, as a result of which the cover piece 3 is adjusted in height in relation to the base piece 2. For additional control of the attained state of expansion, a display mechanism 85 is provided. It comprises a scale 86 arranged on the spreading jaws 81, and an indicator pin 87 arranged on the tensioning member 80. The indicator pin 87 is drawn rearward together with the tensioning member during the spreading procedure, as a result of which its position relative to the scale 86 changes, and the state of expansion attained can thus be read off.

A second alternative illustrative embodiment of the intervertebral fusion implant 1' is shown in Fig. 11. Although it is substantially the same as the one in

Fig. 1, it rectilinearly substantially not designed is instead an arc of a differs in that it is in a box shape but curved in the shape of circle. As regards structure and function, the above description applies by analogy.

In a further embodiment, which is suitable in 35 particular for a transverse implantation (as is indicated in Fig. la by a broken line in the area of

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2013357235 27 Jul 2018 the intervertebral disk 90), a further embodiment of the intervertebral implant is provided. In the area of its end face 30, it has an opening in which a part of the actuation instrument can be screwed (see opening 38 indicated by broken lines in Fig. 2a) . The actuation instrument 7 provided therefor is shown in Figures 12 and 13. The actuation instrument comprises a lever part 71 and a guide part 73. Moreover, a threaded rod 72 is provided, which is to be fitted into an axial bore 75' arranged along the longitudinal axis of the lever part 71. At its rear end, the lever part 71 has a toggle 75 protruding radially to the side. At its front end, the lever part 71 has a gripping jaw 71', which is designed to grip the bottom wall 22 of the base piece 2. At its front end, the guide piece 73 has a second gripping jaw 73' , which is correspondingly designed to grip the cover wall 33 of the cover piece 3. At the rear end, the guide piece 73 has a guide bell 77, which is open on one side at the front and, at its rear, closed end, has a central handle 78. On its front edge surrounding the open end of the bell, it has a recess 79. The recess 79 is dimensioned such that, seen in the radial direction, it has a greater width than the toggle 75 of the lever piece 71.

For assembly, the threaded rod 72 is pushed through the axial bore 75' of the lever piece 71 and, with a thread 72' at its front end, is fastened in a screw thread of the opening 38 on the end face 30 of the cover piece 3.

It is screwed tightly using a knurled head 76 at the rear end of the threaded rod 72. The lever part 71, with the cover piece 3 fastened thereon, is then mounted on the guide piece 73, specifically in such a way that its toggle 75 engages in the recess 79. The base piece 2 is fitted onto the front end of the actuation piece 73. In this way, the implant is fitted

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2013357235 27 Jul 2018 onto the instrument 7 in its assembly position, i.e. non-expanded.

The expansion takes place by means of the cover piece 3 5 being successively tilted relative to the base piece 2, such that the corresponding flange 42 always jumps one locking tooth 43 further on one side. This alternate tilting takes place by means of the toggle 75 being pivoted to and fro in the recess 79 from one radial end position to the other radial end position, as shown in Fig. 13c by the double arrow. In this way, the cover piece 3 is successively tilted and thus at the same time expanded. The above description applies accordingly for the further description.

Another alternative embodiment of the intervertebral fusion implant is shown in Figures 14 to 17. It is based on the embodiment shown in Fig. 2, and similar components are provided with the same reference signs and therefore, to this extent, require no explanation. This embodiment has an alternative catch mechanism 5'. This comprises a transverse pin 52', which is arranged at the bottom on the side walls 31 and protrudes outward (see also the detailed view in Fig. 16) . The transverse pin 52' engages in a window-like cutout 53', which is formed in the vertical walls 21. By having a shape extending in the vertical direction, they permit a height adjustment of the cover piece 2, specifically until the transverse pin 52' finally abuts against the upper end of the window-like cutout 53' . A further movement is thus prevented. Arranging the transverse pin 52' at the bottom on the side walls 31 has the advantage that the teeth 43 can run uninterrupted on the side walls. The arrangement of teeth is therefore stiffer and stronger than the interrupted design in the alternative embodiment shown in Fig. 5.

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The embodiment shown in Fig. 14 is also provided with a structuring. On its top face 33 and also on its bottom face 22, it has furrows 29, which extend in the transverse direction from one side to the other. They are approximately 2 mm wide and serve for better anchoring of the intervertebral fusion implant on the end plates 92, 93 of the vertebrae 9. The edge area of the top face 33 and of the bottom face 22, which edge area later comes to lie in the anterior or posterior area, remains free of the furrows 29, so as not to adversely affect the load-bearing capacity in these areas. A large number of fine grooves 28 are formed in the longitudinal direction and extend from one end face to the other. They have a spacing of approximately 1 mm and likewise serve for better anchoring. Moreover, the top face 33 and also the bottom face 22 are provided with a coating of titanium spray 27 . This is finely particulate and, as a result, does not block the grooves 28. This coating promotes growth of bone substance onto and into the implant. It will be noted that the structuring or the coating is not limited only to this embodiment but instead can also be provided just as well in the other embodiments.

As can be seen from Fig. 17, the intervertebral fusion implant can have a wedge shape with a wedge angle y. It is therefore better suited for implantation between vertebrae that are arranged in a more strongly curved section of the spinal column. It will be noted that the wedge shape is not limited only to this embodiment but instead can also be provided just as well in the other embodiments .

A further embodiment of an actuation instrument 8' is shown in Figures 18 to 20. In terms of its front area,

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2013357235 27 Jul 2018 designed to receive the intervertebral fusion implant, it substantially corresponds to the instrument shown in Fig. 10. Similar components bear the same reference signs and therefore to this extent require no explanation. The instrument 8' is designed as a parallel expander. It is actuated like forceps, wherein the spreading jaws 81'', 81''' are moved rectilinearly away from each other. A particular feature is that the instrument 8' has, firstly, a cross lever 89', with which a reverse kinematics system is formed. Its function is such that, when the instrument 8' is pressed together in the rear area of the handle, the spreading jaws 81'', 81''' in the front area move away from each other. This greatly simplifies handling.

Secondly, a mechanism with a draw key 82 is provided for expansion, as is also the case in the instrument shown in Figures 9 and 10.

Moreover, the actuation instrument 8' has a limit stop device 87' . The latter limits the adjustment path of the draw key 82' and, consequently, the expansion stroke. For this purpose, a rotary wheel 88' is provided at the rear end of the instrument 8' and can be adjusted to predefined positions. Depending on the position, it forms a limit stop 87' that protrudes to a greater or lesser extent and that is provided for the pulling member 80, which is actuated via a trigger lever 80' . To obtain expansion of the implant after it has been inserted, the surgeon only needs to actuate the trigger lever 80', specifically until the rear end of the pulling member 80 bears on the limit stop 87 that is adjustable via the rotary wheel 88'. The implant is thus expanded in the desired manner. Markings 86' arranged on the rotary wheel indicate the respective adjustable expansion positions. By adjusting the handwheel 88' to the desired expansion position, it

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2013357235 27 Jul 2018 is automatically ensured that the actuation instrument 8' stops when this position is reached. The danger of overexpansion, with the resulting risks to the patient, is thus eliminated.

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word comprise or variations such as comprises or comprising is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention .

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Claims (28)

1. Claims

   1. An intervertebral fusion implant for fusion of two

   5 adjacent vertebrae, comprising a base piece and a cover piece, which are each designed to bear on a facing end plate of one of the adjacent vertebrae, the cover piece being adjustable in height with respect to the base piece, a ratchet mechanism,

   10 provided between base piece and cover piece, effecting a stepped adjustment of height and securing an adopted height against reversal, wherein the intervertebral fusion implant further comprises a catch mechanism, which limits an

   15 adjustment movement of the cover piece, and a release mechanism for the ratchet mechanism, in order to reset the height adjustment, the release mechanism being configured for actuation by a spreading instrument.
2. 2. The intervertebral fusion implant as claimed in claim 1, wherein the base piece has a bottom wall, for bearing on one of the adjacent vertebrae, and a vertical wall rising from this bottom wall, and

   25 the cover piece has a cover wall, for bearing on the other of the adjacent vertebrae, and a side wall projecting downward from this cover wall, said vertical wall and side wall being parts of the ratchet mechanism.
3. 3. The intervertebral fusion implant as claimed in claim 2, wherein the ratchet mechanism is a multipart mechanism and has a plurality of locking teeth on one of its parts, and a corresponding

   35 flange on another of its parts.

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4. 4 . The intervertebral fusion implant as claimed in claim 3, wherein the locking teeth are arranged on the side wall and the corresponding flange on the vertical wall, or vice versa.
5. 5. The intervertebral fusion implant as claimed in one of the preceding claims, wherein a double ratchet mechanism is provided, one on each lateral face of the implant.
6. 6. The intervertebral fusion implant as claimed in claim 5, wherein the two ratchet mechanisms are offset in height with respect to each other with an offset of their respective locking teeth.
7. 7 . The intervertebral fusion implant as claimed in either claim 5 or claim 6, wherein the locking teeth on one of the two ratchet mechanisms have a spacing which is an integer multiple of the

   20 spacing of the locking teeth on the other of the two ratchet mechanisms .
8. 8. The intervertebral fusion implant as claimed in one of the preceding claims, wherein two vertical

   25 walls are provided laterally on the bottom wall, and only the vertical walls are elastic and the bottom wall is rigid.
9. 9. The intervertebral fusion implant as claimed in

   30 any one of claims 3 through 8, wherein the locking teeth are designed asymmetrically in a sawtooth shape .
10. 10. The intervertebral fusion implant as claimed in

    35 any one of claims 3 to 9, wherein the spacing of

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    2013357235 27 Jul 2018 the locking teeth from one another is about 1.5 to

    3.0 times their elevation.
11. 11. The intervertebral fusion implant as claimed in 5 any one of claims 3 through 10, wherein an angle β of a supporting flank is in the range of 5 to 35°.
12. 12 . The intervertebral fusion implant as claimed in claim 11, wherein the locking teeth overlap one

    10 another in an imbricated manner, wherein a counter-flank is preferably oriented in the same direction as, but flatter than, the supporting flank.
13. 15 13. The intervertebral fusion implant as claimed in any one of claims 3 through 12, wherein the corresponding flange engages with a form fit in the locking teeth.

    20 14. The intervertebral fusion implant as claimed in claim 13, wherein the shape of the locking teeth being adapted to the flange in such a way that a self-securing effect is obtained.

    25 15. The intervertebral fusion implant as claimed in claim 14, wherein for the self-securing effect, the interacting surfaces on each locking tooth and corresponding flange are not parallel but instead oriented at an acute angle to each other.
14. 16. The intervertebral fusion implant as claimed in any one of the preceding claims, wherein the catch mechanism is formed by a pawl, which interacts with a shoulder projection, and/or by a transverse

    35 pin on the cover piece, which transverse pin engages in window-like cutouts on the base piece.

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15. 17 . The intervertebral fusion implant as claimed in any one of the preceding claims, wherein an inner hollow space is formed between cover piece and

    5 base piece.
16. 18 . The intervertebral fusion implant as claimed in claim 17, wherein at least one aperture is provided on the cover plate and/or bottom wall and

    10 is connected to the hollow space.
17. 19. The intervertebral fusion implant as claimed in claim 17, wherein a blocking element is provided, which can be pushed into the hollow space and

    15 secures the cover piece in its position.
18. 20 . The intervertebral fusion implant as claimed in claim 19, wherein at least one additional aperture is provided on the blocking element and is flush

    20 with the aperture on the cover plate and/or bottom wall.
19. 21 . The intervertebral fusion implant as claimed in any one of the preceding claims, wherein the cover 25 piece and/or the base piece is rounded at its end faces .
20. 22 . The intervertebral fusion implant as claimed in any one of the preceding claims, wherein the cover 30 piece and/or base piece has openings on its end faces .
21. 23 . The intervertebral fusion implant as claimed in any one of the preceding claims, wherein the 35 intervertebral fusion implant is designed

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    PCT/EP2013/076697 rectilinearly in a box shape or is preferably curved in the shape of an arc of a circle.

    2013357235 27 Jul 2018

    The intervertebral fusion claim 23, wherein the implant is curved in the circle .

    implant as claimed in intervertebral fusion shape of an arc of a
22. 25 . The intervertebral fusion implant as claimed in 10 claim 24, wherein seats for a laterally acting spreading element are formed at the free end of the vertical wall and/or side wall.
23. 26. The intervertebral fusion implant as claimed in 15 claim 25, wherein the seats are holes at the upper end of the vertical wall.
24. 27 . The intervertebral fusion implant as claimed in either claim 25 or claim 26, wherein the spreading

    20 element includes grippers engaging in the seats.
25. 28 . The intervertebral fusion implant as claimed in any one of the preceding claims, wherein the cover piece is composed of a less elastic material than

    25 the base piece. 29. The intervertebral fusion implant as claimed in any one of the preceding claims, wherein the intervertecral fusion implant is wedge-shaped, in 30 such a way that one end wall is lower than the other, with a wedge angle of 3° to 15°. 30 . The intervertebral fusion implant as claimed in any one of the preceding claims, wherein a top 35 face of the cover piece and/or a bottom face of

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    2013357235 27 Jul 2018 the base piece are structured in the form of grooves or furrows .
26. 31. The intervertebral fusion implant as claimed in 5 claim 30, wherein the edges of the top face and of the bottom face in the area of end walls are free of structuring, or at least free of furrows.
27. 32 . The intervertebral fusion implant as claimed in 10 one of the preceding claims, wherein at least the top face and/or the bottom face are coated with a titanium plasma spray.
28. 33. Arrangement composed of an intervertebral fusion 15 implant according to any one of claims 1 to 32 and of an actuation instrument for an expandable intervertebral fusion implant, wherein the actuation instrument has a cross section which at most is as great as that of the intervertebral

    20 fusion implant, the actuation instrument has a display mechanism, which indicates a presentation proportional to the height adjustment of the intervertebral fusion implant.

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