1. Field of the Invention
The invention relates to a receiving part for receiving a rod for coupling the rod to a bone anchoring element, a bone anchoring device with such a receiving part, a method and a tool for assembling the bone anchoring device. The receiving part includes a receiving part body and a locking ring. The locking ring can assume a first position in which it is latched with respect to the receiving part body and in which a head of the bone anchoring element can be inserted, and a second position in which it is latched with respect to the receiving part body and in which the bone anchoring element is held in an adjustable angular position but is not fully locked. The bone anchoring device can be realized, for example, in the form of a polyaxial bone screw. The method of assembling includes the steps of providing the receiving part body and the locking ring in the first position, inserting the head and moving the locking ring to the second position. A tool is configured for the execution of the steps.
2. Description of Related Art
WO 2007/038350 A2 discloses an apparatus for connecting a bone anchor to a support rod, the apparatus including a connector body and a cap. The connector body has a socket for insertion, angulation and removal of a bone anchor. A sleeve is provided, which is configured to fit over the connector body in a temporary position, in which the sleeve permits insertion of the bone anchor, to move to a provisional locking position in which the sleeve permits angulation but prevents removal of the bone anchor, and to move to a locking position, in which the sleeve prevents both angulation and removal of the bone anchor.
If a head of an anchoring element is freely pivotable with respect to a receiving part, alignment of the receiving part and insertion of a rod may be difficult in more complex clinical applications, for example, when multiple bone anchors are to be connected to the rod.
In some instances, there is also a need to have a choice between different anchoring elements during surgery, to select the most appropriate anchoring elements for a specific clinical application.
It is the object of the invention to provide an improved receiving part for receiving a rod for coupling the rod to a bone anchoring element, a bone anchoring device with such a receiving part which provides for safer handling during surgery and which allows for selection of an appropriate bone anchoring element to assemble with the receiving part. Further objectives are to provide a method for assembling the bone anchoring device which can be easily carried out, and to provide a tool for assembly of the bone anchoring device.
The receiving part according to an exemplary embodiment of the invention allows the insertion of the head of the bone anchoring element into the receiving part body when the locking ring is in a first position which is an insertion position. In this position, the locking ring is latched with respect to the receiving part body. Therefore, the locking ring cannot be inadvertently moved to compress the head receiving portion of the receiving part body, in order to facilitate the insertion of the head.
In a second position, which is a pre-locking position, the locking ring is latched with respect to the receiving part body and the head receiving portion is compressed so that the bone anchoring element is held in an adjustable angular position but is not fully locked. This prevents inadvertent removal of the anchoring element and holds the receiving part body in an adjustable angular position with respect to the head of the bone anchoring element. Therefore, safe and convenient handling of the bone anchoring device during surgery can be assured.
In a third position, which is a locking position, the locking ring compresses the head receiving portion such that the bone anchoring element is fully locked and cannot pivot.
The receiving part body and the locking ring may be preassembled, and may be delivered after manufacture in a configuration in which the locking ring is latched in the first position to allow introduction of the head of the bone anchoring element. A suitable bone anchoring element, for example, a bone screw with a desired diameter and length, can be selected and inserted into the receiving part. Thereafter, the locking ring can be moved into the second position with respect to the receiving part, in which the head is pre-locked. The latching of the locking ring in the receiving part body in the second position is audible, so that a person who assembles the bone anchoring device can be sure of correct assembly of the bone anchoring element in the receiving part. In the pre-locked condition, the bone anchoring element may only be pivotable with respect to the receiving part by applying an additional force, to overcome the frictional force of the clamping of the head.
With the bone anchoring device according to embodiments of the invention, a modular system can be provided, which allows combinations of various anchoring elements with any suitable receiving part on demand, depending on the actual clinical requirements. This reduces costs associated with polyaxial screws, reduces inventory, and gives the surgeon a wide choice of implants.
The method of assembling the bone anchoring device can be carried out by any specialist, for example, by a surgeon or any personnel assisting him or her before or during surgery.
The tool is easy to handle and enables safer assembly.
Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings. In the drawings:
a shows a perspective view of the tool depicting a step of assembly, where the head of the bone anchoring element is going to be inserted into the receiving part;
b shows an enlarged view of a portion of
a shows a perspective view of the tool depicting another step of assembly, with the head of the bone anchoring element inserted into the receiving part.
b shows an enlarged portion of
a shows an insert for a first holder according to the second embodiment, in the form of a cylindrical section having several cylinder-shaped or U-shaped recesses;
b shows a first holder according to the second embodiment;
As shown in
The receiving part body 5 includes a rod receiving portion 9, which is substantially cylindrical and which has a first end 9a and a second end 9b opposite the first end 9a. A coaxial first bore 10 is provided at the second end 9b as shown in
As can be seen in
On an outer surface of the rod receiving portion 9, in the region of the legs 12a, 12b, a groove 16 is provided, which extends in a circumferential direction and serves for engagement with a portion of the locking ring 8. The groove 16 is asymmetric in such a way that it allows for disengagement between the locking ring 8 and the groove 16 when the locking ring 8 is shifted in one direction. The asymmetric shape of the groove 16 is realized by a downwardly inclined lower wall 16a and an upper wall 16b that is substantially perpendicular to an outer surface of the rod receiving portion 9.
At the side of the second end 9b the receiving part body 5 comprises a head receiving portion 17 providing an accommodation space for the head 3 of the bone anchoring element 1. A largest outer diameter of the head receiving portion 17 is smaller than a largest outer diameter of the rod receiving portion 9. An internal hollow section 18 forms a seat for the head 3 of the bone anchoring element 1, and is open via an opening 19 to a free end 17b of the head receiving portion 17. The hollow section 18 corresponds in its shape to the shape of the head 3. In the embodiment shown, the hollow section 18 is a spherical section to accommodate the spherical head 3. Furthermore, the hollow section 18 is configured to encompass the head 3 of the bone anchoring element 1 from the side, covering a region including the largest diameter of the head 3.
A plurality of slits 20 are provided in the head receiving portion 17, which are open to the free end 17b. The slits 20 make the head receiving portion 17 flexible so that it can be compressed to clamp and finally lock the head 3 in the hollow internal portion 18 by means of friction. The number and size of slits 20 is provided depending on the desired flexibility of the head receiving portion 17. The flexibility of the head receiving portion 17 is such that the head 3 of the anchoring element 1 can be inserted by expanding the head receiving portion 17, and the head 3 can be clamped by compressing the head receiving portion 17.
The outer surface of the head receiving portion 17 has a first section 21, with an outer diameter which increases towards free end 17b, for example, in an outwardly curved or conically widening manner. Adjacent to the first section 21, there is a circumferential groove 22, which is recessed with respect to the first section 21 and which serves for engagement with a corresponding portion of the locking ring 8. The groove 22 is asymmetric to allow for disengagement between the locking ring 8 and the groove 22 when moving the locking ring 8 in one direction. The asymmetric shape of the groove 22 is realized by a lower downwardly inclined wall 22a and an upper wall 22b that is substantially perpendicular to an outer surface of the head receiving portion 17.
Adjacent the groove 22 on a side opposite the first section 21, there is a third portion 23 of the head receiving portion 17 with a substantially cylindrical outer surface. The third portion 23 is configured to cooperate with a portion of the locking ring 8 to enhance the clamping effect of the locking ring 8.
The locking ring 8 will now be described with reference to
At the lower end 8b, the locking ring 8 includes an inwardly projecting edge 82, the inner diameter of which is smaller than the inner diameter of the other portions of the locking ring 8. The inwardly projecting edge 82 is configured to engage the groove 22 of the head receiving portion 17.
The locking ring 8 further has a third portion 83 with upwardly extending wall portions 83a, which are separated from each other by slits 84. The upwardly extending wall portions 83a are arranged at an outer circumference of an inner circumferential shoulder 85 of the locking ring 8, and render the third portion 83 of the locking ring flexible. The number and size of the slits 84 and the thickness of the wall portions 83a are configured such that a desired flexibility is realized. At the free ends of the wall portions 83a are engagement sections 83b which are shaped so as to engage the groove 16 provided on the outer surface of the rod receiving portion 9. The inner diameter of the third portion 83 of the locking ring 8 is only slightly larger than the outer diameter of the rod receiving portion 9, as can be seen in
The locking ring 8 is sized in such a way with respect to the head receiving portion 17, that the head receiving portion 17 can expand within the locking ring 8 to allow the introduction of the head 3 when the locking ring 8 is in the first position, as shown in
Two projections 86, which are located diametrically opposite to each other, are formed in the third portion 83 of the locking ring. The projections 86 have a height where they extend into the cut-outs 15 and project above the bottom of the substantially U-shaped recess 12 when the locking ring 8 is in a position in which the head 3 is not yet locked, as shown in
The flexibility of the head receiving portion 17 and the size of the head receiving portion 17 at the open end 17b allows for mounting of the locking ring 8 by assembling the locking ring 8 from the free end 17b onto the head receiving portion 17. Since the outer diameter of the head receiving portion is smaller than that of the rod receiving portion 9, the locking ring 8 may only project minimally beyond the rod receiving portion 9 in a radial direction.
The inner screw 7 has a thread corresponding to the internal thread 13 provided on the legs 12a, 12b. If a thread type which prevents the legs 12a, 12b from splaying is used, a single fixation element such as the inner screw 7 is sufficient. This reduces the size of the bone anchoring device in a radial direction. Other fixation elements such as, for example, an outer nut are also possible.
The receiving part body 5, the locking ring 8, the inner screw 7 and the bone anchoring element 1 are made of bio-compatible materials, for example, titanium or stainless steel or a bio-compatible alloy such as nitinol or a bio-compatible plastic material, such as polyether ether ketone (PEEK). The parts can be made of the same or of different materials.
The function of the locking ring 8 is now explained with referenced
When the locking ring 8 is in the first position, the head receiving portion 17 is not compressed. In this position, the introduction of the screw head 3 is possible as can be seen in
In the second position, as can be seen in particular in
A third position, which is the locking position, is shown in
The dimensions of the receiving part body 5 and the locking ring 8 are configured such that desired clamping forces can be achieved in the second position and in the third position, respectively.
The third position can be reached by shifting the locking ring 8 relative to the receiving part body 5 such that the engagement portions 83b and the inwardly projecting ring 82 slide along the lower inclined wall portions 16a and 22a of the grooves 16, 22, respectively.
The bone anchoring device is preassembled as follows. First, the locking ring 8 is mounted onto the receiving part body 5 from the free end 17b. This can be done, for example, by the manufacturer. Preferably, the locking ring 8 is in the first position in which it is latched by engagement or alignment of the inwardly projecting edge 82 with the groove 22.
Thereafter, the head 3 of the anchoring element 1 can be introduced from the free end 17b into the hollow internal portion 18 of the head receiving portion 17. Thereafter, the locking ring 8 is moved downwards relative to the receiving part body 5, so that the inwardly projecting ring 82 slides out of the groove 22 and the engagement portions 83b of the flexible wall portions 83a snap into groove 16, to reach the second position, in which the head 3 is pre-locked by frictional clamping.
A tool for assembling the bone anchoring device and its operation will now be described with reference to
The holder 103 for the receiving part is also supported on the frame 101. It has a substantially circular recess 103, for accommodating a portion of the receiving part. The orientation of the holder 103 with respect to the holder 102 is such that a central axis of the receiving part is configured to be positioned coaxial with the screw axis when the receiving part and the bone anchoring element are both inserted into their respective holders. The circular recess 103a can be adjusted to have two different depths. This may be realized by an insert 104 which is inserted in a corresponding slot provided in the holder 103 and which can be shifted in a direction transverse to the direction of the central axis of the recess 103a, to limit the depth of recess 103a. The insert 104 has one circular recess 142. In position 1, as shown in
The holder 102 for the bone anchoring element 1 is movable relative to the holder 103 for the receiving part body 5 in an axial direction. The holder 102 can be actuated via a lever 105 and a handle 106. It is to be understood that the lever 105 is only an example, and that movement of the holder 102 for the bone anchoring element 1 can be effected in many other ways.
The dimensions of the tool 100 are configured such that, by movement of the holder 102 for the bone anchoring element 1 with respect to the holder 103 in which a receiving part is inserted, a sufficient force can be exerted to introduce the head 3 of the bone anchoring element 1 into the head receiving portion 17, when the recess 103a is set to have the first depth 141 and the locking ring 8 is in the first position. It is further configured such that a sufficient force can be exerted onto the locking ring 8 when holder 102 is moved again relative to the holder 103 to move the locking ring 8 out of the first position into the second position, when the recess 103a is set to have the second depth 142.
The operation of the tool is shown in
In a next step, as shown in
Thereafter, as shown in
As shown in
Thereafter, the holder 102 is moved backward and the bone anchoring device is removed.
A further embodiment of a first holder 302 for the bone anchoring element will now be described with reference to
The first holder 302, shown in
a and
Referring to
The U-shaped recess 302a of the first holder 302 is provided for receiving the insert 320. The radius of the circular portion of the U-shaped recess 302a may be substantially the same as the radius of the insert 320.
As can be seen from
The orientation of the first holder 302 with respect to a second holder 103 is such that a central axis of a receiving part 5 is configured to be positioned coaxial with an axis of the bone anchoring element 1 when the receiving part 5 is inserted into the second holder 103 and the bone anchoring element 1 is inserted into the first holder 302 in one of the recesses 322a, 322b or 322c of the insert 320.
The three recesses 322a, 322b or 322c are adapted to receive different sized shanks of bone anchoring elements. With reference to
In other embodiments, a cylinder or insert having more or less than three recesses can be provided. With the second embodiment of the holder, a user can combine screws or bone anchoring elements with different shanks to a receiving part. Hence, a modular system is provided that gives the user a wider selection of implant combinations depending on the actual clinical situation.
The bone anchoring device can be preassembled either by the manufacturer or in the course of preparation of surgery or at any other time. Advantageously, the surgeon can select prior to surgery the desired receiving parts and bone anchoring elements according to the specific requirements of the particular clinical application. The design of the bone anchoring device allows for selection of the appropriate bone anchoring elements in terms of diameter, length and other features of the anchoring section. Hence, a modular system can be provided, which includes receiving parts and various bone anchoring elements, which then can be individually chosen and adapted.
In use during surgery, the preassembled bone anchoring device including the receiving part body 5, the bone anchoring element 1 and the locking ring 8 in the pre-locking position, is screwed into a bone. The recess 4 of the head 3 can be accessed with a screw tool through the first bore 10. To correctly align the receiving part body 5 with respect to the rod 6, to which it will be connected, an additional force can be exerted onto the receiving part, either manually or by application of an instrument. Once the correct position of the rod 6 with respect to other bone anchoring devices is also achieved, the inner screw 7 can be tightened for each bone anchoring device. Since the rod 6 abuts against the projections 86 of the locking ring 8, the locking ring 8 is shifted downward into the third position which is the locking position. When the locking ring 8 is moved towards the free end 17b of the head receiving portion 17, it compresses the head receiving portion 17, thereby locking a position of the head 3. Final tightening of the inner screw 7 locks the rod 6 and the head 3 simultaneously.
In the pre-locking condition, the head 3 remains clamped when the inner screw 7 is loosened. This allows further adjustments with respect to positioning of the rod 6.
Further modifications of the embodiment shown are possible. For example, the head of the bone anchoring element can have any other shape, for example, a cylindrical shape, whereby a monoaxial bone screw is provided, allowing rotation of the screw element with respect to the receiving part body around a single axis. The head can also be conically shaped or otherwise shaped, and the internal hollow section of the head receiving portion is adapted to correspond to this shape. In a further modification, the flexibility of the head receiving portion is based on properties of the material, for example, a plastic material, and the slits may be fully or partly omitted.
The projections of the locking ring which engage the rod can have another shape, for example, the surface of the free end can be flat or can be otherwise shaped. Alternatively, the projections can be omitted.
The head receiving portion can have an inclined open end, or can be otherwise asymmetric to allow for greater angulation of the head in one direction.
The outer surface of the head receiving portion and the inner surface of the locking ring can have other shapes which allow for compression of the locking ring by means of an increasing force when the locking ring is shifted downwards relative to the receiving part body.
With respect to the tool, variations are also possible. For example, the tool can be configured such that the screw axis and the central axis of the receiving part extend perpendicular to the surface on which the tool is placed or positioned. The holder for the receiving part body can be movable with respect to the holder for the bone anchoring element. In addition, instead of a manual actuation of the tool, it may also be possible to actuate the tool by means of a mechanically or electronically operated device.
While the present invention has been described in connection with certain exemplary embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but is instead intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims, and equivalents thereof.
Number | Date | Country | Kind |
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10 162 063.1 | May 2010 | EP | regional |
The present application claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 61/331,518, filed May 5, 2010, the contents of which are hereby incorporated by reference in their entirety, and claims priority from European Patent Application EP 10 162 063.1, filed May 5, 2010, the contents of which are hereby incorporated by reference in their entirety.
Number | Date | Country | |
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61331518 | May 2010 | US |