US20110276098A1

US20110276098A1 - Receiving part for receiving a rod for coupling the rod to a bone anchoring element, bone anchoring device, method and tool for assembling the same

Info

Publication number: US20110276098A1
Application number: US13/101,989
Authority: US
Inventors: Lutz Biedermann; Berthold Dannecker
Original assignee: Biedermann Motech GmbH and Co KG
Current assignee: Biedermann Technologies GmbH and Co KG
Priority date: 2010-05-05
Filing date: 2011-05-05
Publication date: 2011-11-10
Also published as: EP2384710A1; US9381043B2; ES2435013T3; US8881358B2; JP6001825B2; CN102274068B; US20150074977A1; TW201138710A; CN102274068A; EP2384709B1; US20120124813A1; TW201143709A; EP2384710B1; JP2011235101A; CN102232862A; JP2013039347A; EP2455029A1; US20120283032A1; KR20110122793A; EP2455029B1

Abstract

A receiving part for receiving a rod for coupling the rod to a bone anchoring element includes a receiving part body with a first end and a second end; a rod receiving portion with a channel for receiving a rod, and a head receiving portion for accommodating a head of a bone anchoring element, the head receiving portion having an open end at the second end of the receiving part body and being flexible so as to allow introduction and clamping of the head; and a locking ring configured to be positioned around the head receiving portion, wherein the locking ring can assume a first position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the head receiving portion is expandable to facilitate insertion of a head of a bone anchoring element, and wherein the locking ring can assume a second position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the locking ring compresses the head receiving portion, such that when a bone anchoring element has a head inserted in the head receiving portion, the bone anchoring element is held adjustably at a first angular position relative to the receiving part. A method for assembling a bone anchoring device includes inserting the head of the bone anchoring element into the receiving part body; and moving the locking ring and the receiving part body relative to each other until the locking ring assumes the second position with respect to the receiving part body.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S)

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.

BACKGROUND

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.

SUMMARY

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.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings. In the drawings:

FIG. 1 shows a perspective exploded view of a bone anchoring device according to an embodiment of the invention;

FIG. 2 shows a perspective view of the bone anchoring device of FIG. 1 in an assembled state;

FIG. 3 shows an enlarged perspective view of a locking ring according to an embodiment of the invention;

FIG. 4 shows a cross-sectional view of the locking ring shown in FIG. 3 along line A-A in FIG. 3;

FIG. 5 shows a cross-sectional view of a bone anchoring device according to an embodiment of the invention in an assembled state, the section being taken perpendicular to a rod axis, where the locking ring is in a first position and is latched with respect to the receiving part body;

FIG. 6 shows a cross-sectional view of the bone anchoring device in an assembled state, the section being taken in a plane perpendicular to the rod axis, where the locking ring is in a second position and is latched with respect to the receiving part body;

FIG. 7 shows a cross-sectional view of the bone anchoring device in an assembled state, with a rod inserted and fixed, the section being taken in a plane perpendicular to the rod axis, and wherein the locking ring is in a third position;

FIG. 8 shows a cross-sectional view of a portion of the bone anchoring device in a first assembly step where a bone anchoring element is going to be inserted into the receiving part;

FIG. 9 shows a cross-sectional view of a portion of the bone anchoring device in a second assembly step where a head of the bone anchoring element has been introduced into the receiving part and is pre-locked;

FIG. 10 shows a cross-sectional view of a portion of the bone anchoring device, where the head is locked;

FIG. 11 shows an enlarged cross-sectional view of a portion of the receiving part, wherein the locking ring is in the first position and is latched with respect to the receiving part body to allow for introduction of the head;

FIG. 12 shows an enlarged cross-sectional view of a portion of the bone anchoring device in the final locked state where additional clamping is effected by means of the locking ring;

FIG. 13 shows a perspective view of a tool for assembling a bone anchoring device according to an embodiment of the invention;

FIG. 14 shows an enlarged perspective view of a portion of the tool with a bone anchoring element inserted into a holder;

FIG. 15 shows a perspective view of a portion of the tool with a receiving part to be inserted into the holder;

FIG. 16 shows a perspective view of a portion of the tool with the receiving part introduced into a holder;

FIG. 17 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;

FIG. 17 b shows an enlarged view of a portion of FIG. 17 a;

FIG. 18 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.

FIG. 18 b shows an enlarged portion of FIG. 18 a;

FIG. 19 shows an enlarged perspective view of a portion of the tool and the bone anchoring device after insertion of the head and before entering the pre-locking position;

FIG. 20 shows a perspective view of the tool with the bone anchoring device in the pre-locking position;

FIG. 21 shows a perspective view of an enlarged portion of the tool, where the locking ring of the bone anchoring device has assumed the pre-locking position and clamps the head;

FIG. 22 shows a perspective view of a tool according to a second embodiment of the invention, depicting a step of assembly where the head of the bone anchoring element is to be inserted into the receiving part;

FIG. 23 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;

FIG. 23 b shows a first holder according to the second embodiment;

FIG. 24 shows the first holder and the insert in an assembled state according to the second embodiment;

FIG. 25 shows a cross-sectional view of the insert according to the second embodiment; and

FIG. 26 shows a cross-sectional view of a frame, the first holder, and the insert, the assembly holding a screw according to the second embodiment.

DETAILED DESCRIPTION

As shown in FIGS. 1 to 7, a bone anchoring device according to an embodiment of the invention includes a bone anchoring element 1 in the form of a bone screw having a threaded shaft 2 and a head 3 with a curved surface portion. In this embodiment the head is spherical segment-shaped. The head 3 has a recess 4 for engagement with a tool. The bone anchoring device also includes a receiving part body 5 for receiving a rod 6 to connect it to the bone anchoring element 1. Further, a fixation element 7 in the form of an inner screw is provided for fixing the rod 6 in the receiving part body 5. The bone anchoring device also includes a locking ring 8 for locking the head 3 in the receiving part body 5.
The receiving part body 5 includes a rod receiving portion 9, which is substantially cylindrical and which has a first end 9 a and a second end 9 b opposite the first end 9 a. A coaxial first bore 10 is provided at the second end 9 b as shown in FIGS. 5 to 7. The diameter of the first bore 10 is smaller than the diameter of the head 3 of the bone anchoring element 1. The rod receiving portion 9 further has a coaxial second bore 11 extending from the first end 9 a to a distance from the second end 9 b. The diameter of the second bore 11 is larger than that of the first bore 10. A substantially U-shaped recess 12 extends from the first end 9 a in the direction of the second end 9 b in the rod receiving portion 9, the diameter of the recess 12 being slightly larger than the diameter of the rod 6 in such a way that the rod 6 can be placed in the recess 12 and can be guided therein. By means of the recess 12, two free legs 12 a, 12 b are fowled on which an internal thread 13 is provided. The internal thread 13 can be a metric thread, a flat thread, a negative angle thread, a saw-tooth thread, or any other type of thread. Preferably, a thread such as a flat thread or negative angle thread is used, which prevents splaying of the legs 12 a, 12 b when the inner screw 7 is screwed-in. The depth of the recess 12 is such that the rod 6 and the inner screw 7 can be inserted between the legs 12 a and 12 b.
As can be seen in FIG. 1, cut-outs 15 are provided in the rod receiving portion 9 on either end of the channel formed by the recess 12.
On an outer surface of the rod receiving portion 9, in the region of the legs 12 a, 12 b, 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 16 a and an upper wall 16 b that is substantially perpendicular to an outer surface of the rod receiving portion 9.
At the side of the second end 9 b 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 17 b 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 17 b. 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 17 b, 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 22 a and an upper wall 22 b 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 FIGS. 1 to 7. The locking ring 8 is substantially cylindrical and has an upper end 8 a and a lower end 8 b. In the mounted state the upper end 8 a is oriented in the direction of the first end 9 a of the rod receiving portion 9, while the lower end 8 b is oriented towards the free end 17 b of the head receiving portion 17. Near the lower end 8 b, a first portion 81 with an inner surface 81 a is provided which cooperates with the first outer surface portion 21 of the head receiving portion 17 to compress the head receiving portion 17. The outer surface of the first portion 81 may also be tapered to reduce an outer bottom diameter. The size of the first portion 81 is such that, for example, the tapered inner surface 81 a can engage the outer surface portion 21 of the head receiving portion 17 to exert a compression force onto the head receiving portion 17. The inner surface 81 a of the first portion 81 of the locking ring 8 can also be curved with a curvature directed towards a center of the locking ring.
At the lower end 8 b, 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 83 a, which are separated from each other by slits 84. The upwardly extending wall portions 83 a 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 83 a are configured such that a desired flexibility is realized. At the free ends of the wall portions 83 a are engagement sections 83 b 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 FIG. 5.
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 FIG. 5.
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 FIGS. 5 and 6. A free end surface 86 a of the projections 86 can be curved, particularly inwardly curved, with a curvature corresponding to an outer surface of the rod 6. The locking ring is arranged in such a manner around the head receiving portion 17 of the receiving part body 5, that the projections 86 are located at the positions of (e.g., are aligned with) the recess 12. Here, the projections 86 prevent the locking ring 8 from rotating when the rod 6 is not inserted.
The flexibility of the head receiving portion 17 and the size of the head receiving portion 17 at the open end 17 b allows for mounting of the locking ring 8 by assembling the locking ring 8 from the free end 17 b 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 12 a, 12 b. If a thread type which prevents the legs 12 a, 12 b 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 FIGS. 5 to 12. As shown in FIG. 5, the locking ring 8 is in a first position, which is an insertion position where the locking ring 8 is latched with respect to the receiving part body 5. In the first position, the inwardly projecting edge 82 of the locking ring 8 engages groove 22 on the outer surface of the head receiving portion 17. As can be seen in the figures, the inner diameter of the inwardly projecting edge 82 is larger than the outer diameter of the head receiving portion 17 at the position of the groove 22, so as to allow for expansion of the head receiving portion 17 when the head 3 is introduced. In the first position, the locking ring 8 is additionally held by a clamping force between the rod receiving portion 9 of the receiving part body 5 and the flexible wall portions 83 a of the locking ring 8, which are slightly bent outwards, as can be seen in particular in FIGS. 5, 8, and 11.
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 FIG. 8. In the first position, the locking ring 8 is prevented from moving upwards towards the first end 9 a of the rod receiving portion 9, since the shoulder 85 of the locking ring 8 abuts against the second end 9 b of the rod receiving portion 9 b, while the inwardly projecting edge 82 of the locking ring 8 abuts against the upper wall 22 b of groove 22. As shown in particular in FIG. 8, the abutment of the locking ring against the second end 9 b and against the upper wall of groove 22 holds the locking ring 8 in place against upward movement. The inclined lower wall 22 a of the groove 22 prevents inadvertent downward movement of the locking ring 8, but allows downward movement of the locking ring 8 upon exertion of an additional force. Since portions of the inner diameter of the locking ring 8 are larger than corresponding portions of the outer diameter of the head receiving portion 17 in a non-compressed state in the first position, an expansion of the head receiving portion 17 into the space between the locking ring 8 and the head receiving portion 17 is possible. In addition, in the first position, the head 3 can freely pivot.
FIGS. 6 and 9 illustrate the bone anchoring device in a second position in which the locking ring 8 is latched with respect to the receiving part body 5 in a pre-locking position. In the second position, the locking ring 8 has been shifted from the first position towards the free end 17 b of the head receiving portion 17 until the engagement portions 83 b of the flexible wall portions 83 a resiliently snap into the groove 16 provided on the rod receiving portion 9. Once in the second position, the free upper edge of the engagement portions 83 b abut against the upper wall 16 b of the groove 16, as shown in FIGS. 6 and 9, thereby preventing upward movement of the locking ring 8 out of the pre-locking position. On the other hand, the inclined lower wall surface 16 a of the groove 16 prevents inadvertent downward movement of the locking ring 8 towards the free end 17 b, but allows for downward movement upon exertion of an additional force.
In the second position, as can be seen in particular in FIGS. 6 and 9, the inner inclined surface 81 a of the locking ring 8 presses against the first outer surface portion 21 of the head receiving portion 17, so as to compress the head receiving portion 17 to clamp the head 3 within the hollow internal portion 18, without fully locking the head 3. In addition, the inwardly projecting edge 82 of the locking ring 8 presses against the third portion 23 of the head receiving portion 17, resulting in an additional clamping force. Therefore, clamping of the head 3 can be effected not only from above and/or the sides of the head 3 but also from a region around the lower portion of head 3. Pre-locking means that under conditions arising during surgery, the angular position of the bone anchoring element 1 with respect to the receiving part body 5 is maintained, and can be loosened only by exerting an additional force onto the receiving part body 5 and/or the bone anchoring element 1 of the bone anchoring device. In the pre-locked position, the bone anchoring element 1 cannot be removed from the receiving part 5. Hence, accidental or inadvertent removal of the head 3 is not possible. However, angulation of the bone anchoring device to be adjusted to a desired angle is still possible, for example, by manual adjustment.
A third position, which is the locking position, is shown in FIGS. 7, 10, and 12. The third position is defined as a position in which the screw head 3 is finally locked within the head receiving portion 17. The inner surface 81 a of the locking ring 8 engages the outer surface of the first portion 21 of the head receiving portion 17 in such a way that the head 3 is locked by compression of the head receiving portion 17. In addition, the inwardly projecting edge 82 of the locking ring 8 further compresses the head receiving portion 17 at the third portion 23, thereby enhancing the locking force.
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 83 b and the inwardly projecting ring 82 slide along the lower inclined wall portions 16 a and 22 a 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 17 b. 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 17 b 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 83 b of the flexible wall portions 83 a 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 FIGS. 13 to 21. The tool 100 includes a frame 101 with a first holder 102 for the bone anchoring element 1 and a second holder 103 for the receiving part (including, for example, the receiving part body 5 and the locking ring 8). The holders 102, 103 are oriented such that the screw axis is horizontal or parallel with respect to a surface on which the tool is placed or positioned. The holder 102 has a recess 102 a for the shank 2 of the bone anchoring element 1, which serves for holding and guiding the shank 2. The diameter of the recess 102 a is smaller than the diameter of the head 3 in the area of a free end of the holder 102 facing the second holder 103. Therefore, a free end surface 102 b of the holder 102 serves as an abutment for the head 3 of the bone anchoring element 1. The holder 102 is supported on the frame 101.
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 103 a 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 103 a, to limit the depth of recess 103 a. The insert 104 has one circular recess 142. In position 1, as shown in FIGS. 13 to 18, the insert limits the depth of the recess 103 a to a first depth 141, and thus provides an abutment for the first end 9 a of the receiving part body 5. In position 2 which is shown in FIGS. 19 to 21 the insert 104 is shifted such that its recess 142 forms or defines the bottom of the recess 103 a of the holder 103, the depth of which is greater than the depth 141 of the recess 103 a when the insert 104 is in the first position. As such, recess 142 effectively increases the length of the recess 103 a. The receiving part can therefore be inserted deeper into the recess 103 a until an outer surface 103 b of the holder 103 forms an abutment for the locking ring 8 as shown in FIGS. 19 to 21. The shape of the recess 103 a need not be circular, but can be otherwise shaped, and in particular, it can be adapted to correspond to the contour of the receiving part.
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 103 a 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 103 a is set to have the second depth 142.
The operation of the tool is shown in FIGS. 17 to 21. As shown in FIGS. 17 a and 17 b first, the bone anchoring element 1 is inserted into the holder 102 and the receiving part body 5, with mounted locking ring 8 in the first position, is mounted in the recess 103 a of the holder 103 when the recess 103 a is set to have the first depth 141.
In a next step, as shown in FIGS. 18 a and 18 b, the handle 106 is actuated to actuate the lever 105 so that screw head 3 is pushed into the hollow internal portion 18 of the head receiving portion 17. The bottom of the recess 103 a of the holder 103 serves as an abutment for the receiving part, so that the head receiving portion 17 can expand to allow the introduction of the head 3. The handle 106 is actuated until the head 3 of the bone anchoring element 1 is latched or inserted in the hollow internal portion 18. The latching may produce an audible sound.
Thereafter, as shown in FIGS. 19 to 21, the holder 102 for the bone anchoring element 1 is shifted backward and the insert 104 is moved to the second position, in which the circular recess 142 forms or defines the bottom of recess 103 a to provide and use outer surface 103 b of holder 103 as an abutment for the locking ring 8.
As shown in FIGS. 20 and 21, the handle 106 is then actuated to push the holder 102 towards the holder 103. By means of this, the head 3 with the receiving part body 5 is pushed farther into the recess 103 a, which has a depth where the free front surface 103 b of the holder 103 presses against the engagement portions 83 b of the flexible wall portions 83 a of the locking ring 8, thereby moving the locking ring 8 out of the first position into the second position, where the engagement portions 83 b are latched in the groove 16 on the rod receiving portion 9. When the engagement portions 83 b snap into the groove 16, the latching of the locking ring 8 with respect to the receiving part body 5 is audible, which indicates that the correct pre-locking position is reached.
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 FIGS. 22 to 26. The tool 100 shown in FIG. 22 can be the same tool 100 described above, except for the first holder 302 which replaces the first holder in the previous embodiment.
The first holder 302, shown in FIGS. 23 b and 24, has a longitudinal U-shaped recess 302 a which referring to FIG. 23 b, extends from one end towards another end in a longitudinal direction and from the side of the first holder 302 inwards. The diameter of the recess 302 a is smaller than the diameter of a head 3 of a bone anchoring element 1 in the area of a free end of the first holder 302 facing the second holder. Therefore, a free end surface 302 b of the first holder 302 serves as an abutment for the head 3 of the bone anchoring element 1. The first holder 302 is supported on the frame 101.
FIG. 23 a and FIG. 25 show an insert 320 for the first holder in the form of a cylindrical section having a plurality of longitudinally extending recesses 322 a, 322 b, 322 c that are arranged circumferentially around a central axis 323 of the insert 320. The recesses are sized and/or adapted for the insertion of screws or other bone anchoring elements with different shanks. In the embodiment shown the insert 320 has a first cylinder-shaped or U-shaped recess 322 a having a first radius, a second cylinder-shaped or U-shaped recess 322 b having a second radius and a third cylinder-shaped or U-shaped recess 322 c having a third radius, wherein the three radii may be different from each other. The three recesses 322 a, 322 b, 322 c may extend the length of the insert 320, as can be seen from FIG. 23 a. The insert 320 has a first end and a second end, wherein a first pin 321 a is provided on the first end and a second pin 321 b is provided on the second end. The pins 321 a, 321 b are in line with the central axis 323 of the insert 320.
Referring to FIG. 23 b, the first holder 302 has a first end and a second end, where on the first end a first slot 311 is provided and near the second end a second slot 312 is provided which both extend from a side of the first holder 302 inwards. The second end of the first holder 302 is configured to be connected to a lever 105 and a handle 106 of the tool, as can be seen in FIG. 22.
The U-shaped recess 302 a of the first holder 302 is provided for receiving the insert 320. The radius of the circular portion of the U-shaped recess 302 a may be substantially the same as the radius of the insert 320.
As can be seen from FIG. 24, in a mounted state, the first pin 321 a of the insert 320 fits into the first slot 311 of the first holder 302, and the second pin 321 b of the insert 320 fits into the second slot 312 of the first holder 302. The insert 320 is supported and guided by the pins 321 a, 321 b, and is also held by the U-shaped recess 302 a of the first holder 302 as can be seen in FIG. 26.
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 322 a, 322 b or 322 c of the insert 320.
The three recesses 322 a, 322 b or 322 c are adapted to receive different sized shanks of bone anchoring elements. With reference to FIGS. 22, 24, and 26, a particular recess 322 a, 322 b, 322 c which is in use will face outwards towards the opening of the U-shaped recess 302 a. In this embodiment of the insert 320, mounting of at least three different sized bone anchoring elements can be accommodated. For changing the recess 322 a, 322 b, 322 c which is in use, the insert 320 can be rotated around its axis 323.
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 17 b 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.

Claims

1. A receiving part for receiving a rod for coupling the rod to a bone anchoring element, the receiving part comprising:

a receiving part body with a first end and a second end, a rod receiving portion with a channel for receiving a rod, and a head receiving portion for accommodating a head of a bone anchoring element, the head receiving portion having an open end at the second end of the receiving part body and being flexible so as to allow introduction and clamping of the head; and

a locking ring configured to be positioned around the head receiving portion,

wherein the locking ring can assume a first position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the head receiving portion is expandable to facilitate insertion of a head of a bone anchoring element, and

wherein the locking ring can assume a second position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the locking ring compresses the head receiving portion, such that when a bone anchoring element has a head inserted in the head receiving portion, the bone anchoring element is held adjustably at a first angular position relative to the receiving part.

2. The receiving part of claim 1, wherein when the locking ring is in the second position, the locking ring provides a first compression force on the head receiving portion such that when a head of a bone anchoring element is inserted in the head receiving portion, the head is not fully locked.

3. The receiving part of claim 2, wherein the locking ring can assume a third position with respect to the receiving part body in which the locking ring compresses the head receiving portion with a second compression force greater than the first compression force, such that when a head of a bone anchoring element is inserted in the head receiving portion, the head is fully locked in the head receiving portion.

4. The receiving part of claim 1, wherein in the first position, the locking ring is prevented from moving in an axial direction towards the first end of the receiving part body, but is movable towards the second end of the receiving part body by application of a force.

5. The receiving part of claim 1, wherein the locking ring has a first projection or a first recess which is configured to cooperate with a corresponding first recess or first projection of the receiving part body to latch the locking ring in the first position.

6. The receiving part of claim 5, wherein the receiving part body has an asymmetric recess.

7. The receiving part of claim 1, wherein in the second position, the locking ring is prevented from moving in an axial direction towards the first end of the receiving part body, but is movable towards the second end of the receiving part body by application of a force.

8. The receiving part of claim 7, wherein the receiving part body has an asymmetric recess.

9. The receiving part of claim 1, wherein when the locking ring is positioned around the receiving part body, the locking ring has a first annular portion which is non-resilient and which is arranged to be closer to the second end of the receiving part body and a second annular portion which is resilient and which is arranged to be closer to the first end of the receiving part body.

10. The receiving part of claim 1, wherein the head receiving portion has an exterior surface with a tapered or curved portion and the locking ring has an interior surface with a correspondingly tapered or curved portion which are configured to cooperate with one another, such that when a head of a bone anchoring element is inserted in the head receiving portion, the head is clamped when the locking ring is moved towards the second end.

11. The receiving part of claim 10, wherein the locking ring further comprises an inwardly projecting edge at one end which cooperates with the head receiving portion near the second end of the receiving part body to provide additional clamping.

12. A bone anchoring device comprising:

a bone anchoring element comprising a shaft with a threaded portion and a head with a spherical outer surface portion; and

a receiving part for receiving a rod for coupling the rod to the bone anchoring element, the receiving part comprising:

a receiving part body with a first end and a second end, a rod receiving portion with a channel for receiving a rod, and a head receiving portion for accommodating the head of the bone anchoring element, the head receiving portion having an open end at the second end of the receiving part body and being flexible so as to allow introduction and clamping of the head; and

a locking ring configured to be positioned around the head receiving portion,

wherein the locking ring can assume a first position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the head receiving portion is expandable to facilitate insertion of the head, and

wherein the locking ring can assume a second position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the locking ring compresses the head receiving portion to compress the inserted head, such that the bone anchoring element is held adjustably at a first angular position relative to the receiving part.

13. A method for assembling a bone anchoring device, the bone anchoring device comprising a bone anchoring element comprising a shaft for anchoring in a bone and a head, and a receiving part for receiving a rod for coupling the rod to the bone anchoring element, the receiving part comprising a receiving part body for accommodating the head of the bone anchoring element in a polyaxial manner, and a locking ring, in a first position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position in which the head of the bone anchoring element can be introduced into the receiving part body and can freely pivot therein, the method comprising:

inserting the head of the bone anchoring element into the receiving part body; and

moving the locking ring and the receiving part body relative to each other until the locking ring assumes a second position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the locking ring compresses a portion of the receiving part body to compress the head, such that the bone anchoring element is held adjustably at a first angular position relative to the receiving part.

14. The method of claim 13, wherein the shaft of the bone anchoring element comprises a threaded portion and the head of the bone anchoring element comprises a spherical outer surface portion,

wherein the receiving part body has a first end and a second end, a rod receiving portion with a channel for receiving a rod, and a head receiving portion for accommodating the head of the bone anchoring element, the head receiving portion having an open end at the second end of the receiving part body and being flexible so as to allow introduction and clamping of the head, and

wherein the locking ring is configured to be positioned around the head receiving portion.

15. The method of claim 13, wherein a same tool is utilized for both the inserting of the head and the moving of the locking ring and the receiving part body relative to each other.

16. The method of claim 15, wherein a first holder of the tool holds the bone anchoring element and a second holder of the tool holds the receiving part, and wherein the first holder and the second holder are moved closer relative to one another for both the inserting of the head and the moving of the locking ring and the receiving part body relative to each other.

17. A tool for assembling a bone anchoring device, the bone anchoring device comprising a bone anchoring element with a head and a shaft to be anchored in a bone, and a receiving part for receiving a rod for coupling the rod to the bone anchoring element, the receiving part comprising a receiving part body with a head receiving portion for accommodating the head of the bone anchoring element and a locking ring configured to be positioned around the head receiving portion, the tool comprising:

a first holder for holding a bone anchoring element; and

a second holder for holding a receiving part,

wherein the first and second holders are movable relative to one another, such that when the first holder is holding a bone anchoring element and the second holder is holding a receiving part, the movement between the first and second holders is configured to press the bone anchoring element against the receiving part body or the locking ring, and

wherein the tool further comprises an abutment device which is adjustable between a first configuration to provide a first abutment for preventing movement of the receiving part body with respect to the second holder when the first holder is moved towards the second holder to engage the bone anchoring element with the receiving part body, and a second configuration to provide a second abutment for preventing movement of the locking ring with respect to the second holder when the first holder is moved further towards the second holder, such that the bone anchoring element with the engaged receiving part body is moved relative to the locking ring to adjust the locking ring from the first position to the second position.

18. The tool of claim 17, wherein the second holder has a recess for inserting the receiving part body, and wherein the abutment device is configured to adjust the depth of the recess between a first depth for the second holder to provide the first abutment and a second depth for the second holder to provide the second abutment.

19. A method for coupling a rod to a bone anchoring element via a receiving part, the bone anchoring element comprising a shaft and a head, and the receiving part comprising a receiving part body with a first end and a second end, a rod receiving portion with a channel for receiving a rod, and a head receiving portion for accommodating the head of the bone anchoring element, the head receiving portion having an open end at the second end of the receiving part body and being flexible so as to allow introduction and clamping of the head, and a locking ring around the head receiving portion in a first position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the head receiving portion is expandable and in which the head of the bone anchoring element can be introduced into the head receiving portion and can freely pivot therein, the method comprising:

inserting the bone anchoring element in a first holder of a tool, and inserting the receiving part in a second holder of the tool;

moving one of the first holder or the second holder towards the other one of the first holder or the second holder to insert the head of the bone anchoring element into the head receiving portion of the receiving part body;

adjusting the tool;

moving the one of the first holder or the second holder further towards the other one of the first holder or the second holder to move the locking ring and the receiving part body relative to each other until the locking ring assumes a second position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the locking ring compresses the head receiving portion to compress the head, such that the bone anchoring element is held adjustably at a first angular position relative to the receiving part; and

removing the attached bone anchoring element and receiving part from the tool.

20. The method of claim 19, further comprising:

inserting the shaft of the bone anchoring element into a bone;

applying a force on the receiving part to move the bone anchoring element to a second angular position relative to the receiving part, wherein in the second angular position the receiving part is aligned with a rod;

inserting the rod into the channel of the receiving part body; and

locking the rod in the receiving part and locking the receiving part at the second angular position relative to the bone anchoring element.

21. The method of claim 20, further comprising:

attaching at least one additional bone anchoring element and receiving part assembly to the same bone or a different bone;

aligning the receiving part of the at least one additional assembly with the rod; and

locking the rod in the receiving part and locking an angular position of the receiving part relative to the bone anchoring element for each of the at least one additional assembly.

22. A tool for assembling a bone anchoring device, the bone anchoring device comprising a bone anchoring element with a head and a shaft to be anchored in a bone, and a receiving part for receiving a rod for coupling the rod to the bone anchoring element, the receiving part comprising a receiving part body with a head receiving portion for accommodating the head of the bone anchoring element and a locking ring configured to be positioned around the head receiving portion, the tool comprising:

a first holder for holding a bone anchoring element; and

a second holder for holding a receiving part,

wherein the first and second holders are movable relative to one another, and

wherein at least one of the first holder or the second holder has a first abutment, a second abutment, and a recess, and wherein the first abutment is movable to adjust a depth of the recess independent from the movement between the first holder and the second holder.

23. The tool of claim 22, wherein the recess is on the second holder and is for inserting a receiving part body, and wherein the first abutment is configured to adjust the depth of the recess.

24. The tool of claim 23, wherein the second holder comprises an insert, the first abutment is defined by a wall of the insert, and the insert has a hole adjacent to the first abutment, and wherein the insert is movable between a first position where the first abutment is aligned with the recess and a second position where the hole is aligned with the recess.

25. The tool of claim 23, wherein the tool further comprises an insert for receiving the bone anchoring element, the insert configured to be inserted into the first holder.

26. The tool of claim 25, wherein the first holder has a recess configured to receive the insert.

27. The tool of claim 25, wherein the insert has at least two recesses.

28. The tool of claim 27, wherein the recesses on the insert are cylinder-shaped or U-shaped.

29. The tool of claim 27, wherein the recesses on the insert extend over the whole length of the insert.

30. The tool of claim 25, wherein the insert is rotatable while in the first holder.

31. The tool of claim 22, further comprising a handle and lever, wherein the first holder or the second holder is connected to the handle and lever and is configured to be moved towards the other one of the first holder or the second holder by actuation of the handle and lever.

32. The tool of claim 31, further comprising a frame, wherein a position of the other one of the first holder or the second holder is fixed with respect to the frame.

33. A receiving part for receiving a rod for coupling the rod to a bone anchoring element, the receiving part comprising:

a locking ring configured to be positioned around the head receiving portion,

wherein the locking ring can assume a first position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the head receiving portion is expandable,

wherein the locking ring can assume a second position with respect to the receiving part body in which the locking ring is latched to the receiving part body in a position where the locking ring compresses the head receiving portion inwardly towards a central axis of the receiving part body, and

wherein the locking ring can assume a third position with respect to the receiving part body where the locking ring compresses the head receiving portion inwardly closer towards the central axis of the receiving part body than when the locking ring is in the second position.