BONE ANCHORING DEVICE

Abstract

A polyaxial bone anchoring device includes a bone anchoring element having a head and a shaft, a receiving part having a head receiving portion, a rod receiving portion, and a bore having a bore axis, and a pressure member movable in the bore and having a first surface for engaging the head, wherein the pressure member is movable to a first position where friction between the first surface and the head generates a preload on the head to maintain the shaft at a temporary angular position relative to the receiving part, and wherein the pressure member is configured to engage the receiving part to generate a holding force for holding the pressure member at the first position without a positive lock, and wherein the pressure member is movable in and out of the first position by applying an axial force on the pressure member greater than the holding force.

Claims

1. A polyaxial bone anchoring device comprising: a bone anchoring element having a head and a shaft for anchoring to a bone; a receiving part for coupling the bone anchoring element to a rod, the receiving part having a head receiving portion with an accommodation space for accommodating the head, and a rod receiving portion with a bore in communication with the accommodation space; and a pressure member movable in the bore and comprising a first surface for engaging the head and a second surface for engaging a rod; wherein when the bone anchoring element and the pressure member are in the receiving part, the pressure member is movable to a position where the head is locked relative to the receiving part.

2-6. (canceled)

7. The polyaxial bone anchoring device of claim 1, wherein the pressure member is substantially cylindrical.

8. The polyaxial bone anchoring device of claim 1, wherein the pressure member has a first end and a second end, and a recess at the second end with a spherical-segment shape corresponding to a spherical-segment shaped surface portion of the head of the bone anchoring element.

9. The polyaxial bone anchoring device of claim 1, further comprising a sleeve-like insert piece configured to be positioned around a spherical-segment shaped portion of the head, wherein the insert piece is configured to pivot in the accommodation space of the receiving part, and wherein when the insert piece is seated in the receiving part and has a central axis coaxial with the bore axis, a lower edge of the insert piece extends out of a lower opening of the receiving part.

10-11. (canceled)

12. A method of manufacturing a polyaxial bone anchoring device comprising a bone anchoring element having a head and a shaft for anchoring to a bone, a receiving part for coupling the bone anchoring element to a rod, the receiving part having a head receiving portion with an accommodation space for accommodating the head, and a rod receiving portion with a bore in communication with the accommodation space, and a pressure member comprising a first surface for engaging the head and a second surface for engaging a rod, wherein when the bone anchoring element and the pressure member are in the receiving part, the pressure member is movable to a position where the head is locked relative to the receiving part, the method comprising: inserting the head of the bone anchoring element in the receiving part; and inserting the pressure member in the receiving part.

13-16. (canceled)

17. A method for coupling a rod to a bone via a polyaxial bone anchoring device comprising a bone anchoring element having a head and a shaft for anchoring to a bone, a receiving part for coupling the bone anchoring element to a rod, the receiving part having a head receiving portion with an accommodation space for accommodating the head, and a rod receiving portion with a bore in communication with the accommodation space, and a pressure member movable in the bore and comprising a first surface for engaging the head and a second surface for engaging a rod, and a fixation element, the method comprising: inserting the bone anchoring element into a bone when the head and the pressure member are in the receiving part; adjusting an angular position of the shaft relative to the receiving part; inserting a rod into the rod receiving portion of the receiving part; and advancing the fixation element in the receiving part to advance the rod towards the head receiving portion, and to exert an axial force on the pressure member to advance the pressure member to a position to lock the head relative to the receiving part and to lock a position of the rod relative to the receiving part.

18. The method of claim 17, further comprising: inserting the head of the bone anchoring element into the accommodation space of the receiving part; and inserting the pressure member into the receiving part.

19-20. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings. In the drawings:

[0012] FIG. 1 shows a perspective exploded view of a polyaxial bone anchoring device with a spinal rod according to a first embodiment;

[0013] FIG. 2 shows a perspective view of the bone anchoring device of FIG. 1 in an assembled state;

[0014] FIG. 3a shows a cross-sectional front view of the bone anchoring device of FIGS. 1 and 2 in the assembled state without the rod and without a fixation screw;

[0015] FIG. 3b shows an enlarged portion of the cross-sectional front view of the bone anchoring device of FIG. 3a;

[0016] FIG. 4a shows a cross-sectional front view (i.e., rotated from FIG. 4a by 90°) of a receiving part according to a first embodiment;

[0017] FIG. 4b shows a cross-sectional side view of the receiving part according to the first embodiment;

[0018] FIG. 4c shows a top view of the receiving part according to the first embodiment;

[0019] FIG. 4d shows a perspective top view of the receiving part according to the first embodiment;

[0020] FIG. 4e shows a perspective bottom view of the receiving part according to the first embodiment;

[0021] FIG. 5a shows a cross-sectional front view of a pressure member according to a first embodiment;

[0022] FIG. 5b shows a side view of the pressure member according to the first embodiment;

[0023] FIG. 5c shows a top view of the pressure member according to the first embodiment;

[0024] FIG. 5d shows a perspective bottom view of the pressure member according to the first embodiment;

[0025] FIG. 5e shows a perspective top view of the pressure member according to the first embodiment;

[0026] FIG. 6a shows a cross-sectional front view of a sleeve-like insert;

[0027] FIG. 6b shows a perspective top view of the sleeve-like insert;

[0028] FIG. 6c shows a top view of the sleeve-like insert;

[0029] FIG. 6d shows a perspective bottom view of the sleeve-like insert;

[0030] FIGS. 7a to 7h show steps of assembling the sleeve-like insert, the receiving part, the bone anchoring element and the pressure member, according to one embodiment;

[0031] FIG. 8a shows a cross-sectional view of a bone anchoring device in an assembled state, without a rod or a fixation screw, according to a second embodiment, the cross-section taken perpendicular to an axis of a rod channel of the device;

[0032] FIG. 8b shows an enlarged portion of the cross-sectional view of the bone anchoring device of to FIG. 8a;

[0033] FIG. 9 shows a perspective view of a receiving part according to a second embodiment;

[0034] FIG. 10 shows a perspective view of a pressure member according to a second embodiment;

[0035] FIG. 11a shows a cross-sectional view of a bone anchoring device in an assembled state, without a rod or a fixation screw, according to a third embodiment, the cross-section taken perpendicular to an axis of a rod channel of the device;

[0036] FIG. 11b shows an enlarged portion of the cross-sectional view of the bone anchoring device of FIG. 11a;

[0037] FIG. 12 shows a perspective view of a receiving part according to a third embodiment;

[0038] FIG. 13 shows a perspective view of a pressure member according to a third embodiment;

[0039] FIG. 14 shows a cross-sectional view of a bone anchoring device in an assembled state, without a rod or a fixation screw, according to a fourth embodiment, the cross-section taken perpendicular to an axis of a rod channel of the device; and

[0040] FIG. 15 shows a cross-sectional view of a bone anchoring device in an assembled state, without a rod or a fixation screw according to a fifth embodiment, the cross-section taken perpendicular to an axis of a rod channel of the device.

DETAILED DESCRIPTION

[0041] As shown in FIGS. 1 to 3b, a polyaxial bone anchoring device according to a first embodiment includes a bone anchoring element 1 in the form of a bone screw having a threaded shaft 2 and a head 3. The head 3 typically has a spherically-shaped outer surface portion 3a and a recess 3b at its free end for engagement with a tool, e.g., a driver. The head 3 can be held in a receiving part 4 that couples the bone anchoring element 1 to a stabilization rod 100. In an assembled state, in the receiving part 4, a sleeve-like insert piece 5 providing a seat for the head 3 of the bone anchoring element 1 and a pressure member 6 for exerting pressure onto the head 3 can be arranged. Furthermore, a fixation element in the form of a fixation screw 7 is provided for securing and fixing the rod 100 in the receiving part 4. In some embodiments, a bone anchoring device without the sleeve-like insert piece 5 is also possible. In those cases, the seat for the head 3 may be provided in the receiving part directly.

[0042] As can be seen from FIGS. 1 to 4e the receiving part 4 has a top end 4a and a bottom end 4b, a central axis C, and a coaxial bore 41 extending from the top end 4a in the direction of the bottom end 4b. Adjacent to the top end 4a, a U-shaped recess 42 is provided that forms a channel for receiving the rod 100. By means of the U-shaped recess 42, two free legs are formed, which are provided with an internal thread 43 for cooperating with an outer thread of the fixation screw 7 in an assembled state (see, e.g., FIG. 2).

[0043] The coaxial bore 41 opens into an accommodation space 8 provided in a lower region of the receiving part 4. The accommodation space 8 has a lower opening 45 at the bottom end 4b of the receiving part 4. The accommodation space 8 further includes a seat portion 46 near the bottom end 4b of the receiving part 4, in which the sleeve-like insert piece 5 can be seated. The seat portion 46 has a spherical shape in order to provide a socket portion for a ball and socket joint formed between the sleeve-insert piece 5 and the receiving part 4. It should be noted that the seat portion 46 can alternatively be tapered or can have another shape that can be used to realize a ball and socket joint. A smallest inner diameter at the lower opening 45 is smaller than a largest inner diameter of the accommodation space 8. It shall be noted that an inner diameter of the coaxial bore 41 does not need to be constant between the top end 4a and the accommodation space 8. The bore 41 may have different portions with different diameters.

[0044] In order to allow the sleeve-like insert piece 5 to be introduced from the top end 4a, two opposed recesses 47a, 47b (see, e.g., FIGS. 4c-4e) are provided in the inner wall of the coaxial bore 41 and/or the accommodation space 8. The recesses 47a, 47b may be aligned with the U-shaped recess 42. They may extend from the bottom of the U-shaped recess 42 into the accommodation space 8. The size of the recesses 47a, 47b is such that the sleeve-like insert piece 5 can be introduced from the top end in a 90° tilted or vertical position, where a width of the recesses 47a, 47b is greater than a height of the sleeve-like insert piece 5 in its axial direction. The recesses 47a, 47b extend into the accommodation space 8 to such an extent that inserting of the sleeve-like insert piece 5 into the seat 46 in such a tilted position is facilitated.

[0045] The pressure member 6 is shown in particular in FIGS. 5a to 5e. The pressure member 6 is substantially cylindrical, with an outer diameter that allows the pressure member 6 to be moved within the coaxial bore 41 and the accommodation space 8, for example, by means of a tool. However, in some embodiments an outer diameter of the pressure member 6 is slightly larger than an inner diameter of the coaxial bore 41 to achieve an interference fit or press fit connection between the inner surface of the coaxial bore 41 and an outer surface 65 of the pressure member 6. It is also possible that in some embodiments, only parts of the mentioned surfaces form the interference fit. The pressure member 6 has an upper end 6a and a lower end 6b. Adjacent its lower end 6b, the pressure member 6 has a recess 61 with a spherical shape that matches the shape of the outer spherical surface portion 3a of the head 3. At the upper end 6a, the pressure member 6 has a cylindrical recess 63 for receiving the rod 100 therein. Furthermore, the pressure member 6 has a coaxial bore 64 for allowing access to the screw head 3 with a tool when the device is in an assembled state. By the coaxial bore 64 and the cylindrical recess 63, two legs are formed facing the top end 4a. The coaxial bore 64 is also configured to allow a portion of the head 3 to extend therethrough when the bone anchoring element 1 is in a pivoted condition.

[0046] The sleeve-like insert piece 5 is shown in particular in FIGS. 6a-6d. The sleeve-like insert piece 5 has an upper end 5a and a lower end 5b. Between the upper end 5a and the lower end 5b, the sleeve-like insert piece 5 has a spherical-shaped outer surface portion 51. A largest outer diameter of the sleeve-like insert piece 5 is greater than the smallest inner diameter of the lower opening 45 of the receiving part 4. Hence, the sleeve-like insert piece 5 cannot escape through the lower opening 45 when it is seated in the receiving part 4. The dimension of the outer spherical surface portion 51 corresponds to the spherical-shaped seat portion 46 of the receiving part 4 in such a way that the sleeve-like insert piece 5 can pivot and rotate in the receiving part 4 when it is seated in the seat portion 46. When the sleeve-like insert piece 5 rests in the seat portion 46 such that its central axis 5c is coaxial with a central axis C of the receiving part 4, the lower end 5b may project out of the lower opening 45. When the sleeve-like insert piece 5 is pivoted in the receiving part 4, at least a portion of the lower end 5b projects out of the lower opening 45.

[0047] The sleeve-like insert piece 5 is hollow and has a central inner portion 52 that is spherically-shaped with a radius corresponding to a radius of the spherically-shaped outer surface portion 3a of the head 3 of the bone anchoring element 1. A lower end of the central portion 52 forms a shoulder 53. The inner diameter of the shoulder 53 is smaller than a largest outer diameter of the spherical head 3 so that the head 3 can rotate and pivot in the central spherical portion 52 of the sleeve-like insert piece 5, similar to a ball and socket joint. Between the shoulder 53 and the lower end 5b, a tapered portion 54 is provided that tapers outwards to allow angulation of the bone anchoring element 1 until the shaft 2 comes into contact with the tapered portion 54 of the lower end 5b. Between the spherical central portion 52 and the upper end 5a, a tapered portion 55 is provided, which tapers outwards. An inner diameter of the tapered portion 55 and of the transition between the tapered portion 55 and the spherical central portion 52 is greater than the largest outer diameter of the head 3, so that the head 3 can be inserted from the upper end 5a into the sleeve-like insert piece 5. At the upper end 5a, a chamfered portion 56 may be provided that may serve as a stop for the pressure member 6.

[0048] Respective center points of the spherical central portion 52 and of the outer spherical portion 51 may be offset in such a way that the center point of the inner central spherical portion 52 is shifted in a direction towards the bottom end 4b (i.e., closer to lower end 5b than the center point of the outer spherical portion 51). By means of this, a range of angulation for the bone anchoring element 1 can be further increased. A height of the sleeve-like insert piece 5 in an axial direction is less than a height of the head 3 in an axial direction, such that when the head 3 is inserted into the sleeve-like insert piece 5, a portion of the spherical outer surface 3a of the head 3 projects from the upper end 5a of the sleeve-like insert piece 5, for example, as can be seen from FIG. 3a.

[0049] The sleeve-like insert piece 5 and the anchoring element 1 are independently pivotable when the shaft 2 of the anchoring element 1 and the lower end 5b of the sleeve-like insert piece 5 are out of contact. When the shaft 2 of the bone anchoring element 1 is pivoted and engages the lower end 5b of the sleeve-like insert piece 5, further pivoting of the bone anchoring element 1 in a direction corresponding to the contact causes the sleeve-like insert piece 5 to pivot together with the bone anchoring element 1. When the pressure member 6 is in contact with the head 3, there may be a gap between the pressure member 6 and the sleeve-like insert piece 5.

[0050] As indicated by arrows in FIGS. 3a, 3b, a force F which is provided from above in the figures is divided between frictional resistance (indicated by the two horizontal arrows in FIG. 3a) and a preload force (indicated by the small arrows in FIG. 3b), which holds the head with respect to the receiving part 4 in a desired angular orientation by friction. The frictional resistance results from the interference fit connection between the pressure member 6 and the receiving part 4, where the outer diameter of at least one portion of the pressure member 6 is slightly larger than the inner diameter of a corresponding portion of the receiving part 4. The preload force acting on the head 4 leads to a small elastic preload of the whole system.

[0051] The steps of pre-assembling the bone anchoring device according to the first embodiment are shown with respect to FIGS. 7a to 7h. The bone anchoring device according to the first embodiment may be pre-assembled in such a way that, first the sleeve-like insert piece 5 is tilted by 90° and inserted into the receiving part 4 at the position of the U-shaped recess 42, as can be seen in FIGS. 7a and 7b. As shown in FIG. 7b the sleeve-like insert piece 5 is moved downwards into the accommodation space 8. Since the largest outer diameter of the sleeve-like insert piece 5 is larger than the smallest inner diameter the lower opening 45 of the receiving part 4, the sleeve-like insert piece 5 cannot escape through the lower edge of the lower opening 45. Then, as shown in FIGS. 7c and 7d the sleeve-like insert piece 5 is tilted so that it is finally seated in the seat portion 46 of the receiving part 4, as shown in FIG. 7d.

[0052] Thereafter, the bone anchoring element 1 is inserted, for example, from the top end 4a of the receiving part 4 until the outer surface portion 3a of the head 3 engages the seat portion 52 of the sleeve-like insert piece 5, as can be seen in FIGS. 7e and 7f. Then, the pressure member 6 is inserted from the top end 4a, as can be seen in FIG. 7g, and a predefined force is applied from the top, as indicated by the arrow in FIG. 7h. The pressure member 6 is arranged in an aligned position, in which the cylindrical recess 63 is aligned with the U-shaped recess 42 of the receiving part 4 for receiving the rod 100. Dependent on the degree of the interference fit connection, it may be necessary to use a tool for pushing down the pressure member 6 into the receiving part 4. The predefined force from above may be generated manually or by a tool, for example, and may be constant and/or force-controlled or path-controlled.

[0053] The bone anchoring device as a whole or in parts is made of a bio-compatible material, such as a bio-compatible metal, for example titanium, stainless steel, of a bio-compatible alloy, such as nitinol, or of a bio-compatible plastic material, such as, for example, polyetheretherketone (PEEK).

[0054] FIGS. 8a to 10 show a second embodiment of a bone anchoring device. Parts and portions which are the same or similar to those of the first embodiment are designated with the same reference numerals, and the descriptions thereof may not be repeated. The bone anchoring device according to the second embodiment differs from the bone anchoring device of the first embodiment by the construction of the outer surface 65′ of the pressure member 6′ and of the corresponding inner surface of the coaxial bore 41′ of the receiving part 4′. All other parts are identical or similar to those of the first embodiment.

[0055] As can be seen, especially in FIG. 8b, the inner surface of the coaxial bore 41′ is structured, for example, is roughened or fluted or grooved or ridged. The outer surface 65′ of the pressure member 6′ may also be structured, for example, may also be roughened or fluted or grooved or ridged. The surface interaction of the two surfaces prevents or restricts the pressure member 6′ from inadvertently moving backwards towards the first end 4a′. Therefore, a holding function of the interference fit connection is further increased. It is also possible that only one of the surfaces is structured as described above.

[0056] FIGS. 11a to 13 show a third embodiment of a bone anchoring device. Parts and portions which are the same or similar to those of the first embodiment are designated with same reference numerals, and the descriptions thereof may not be repeated. The bone anchoring device according to the third embodiment differs from the bone anchoring device of the first embodiment by the construction of the pressure member 6″ and the corresponding portions of the receiving part 4″. All other parts are identical or similar to those of the first embodiment.

[0057] Referring to the outer surface 65″ of the pressure member 6″, which has an upper portion 65a″ and a lower portion 65b″ with slightly different outer diameters, an interference fit in this embodiment may only be present at the lower portion 65b″ of the outer surface of the pressure member 6″, which contacts the inner surface of the coaxial bore 41″ of the receiving part 4″. Therefore, in this embodiment, only the diameter of the lower portion 65b″ may be slightly larger than an inner diameter of the corresponding portion of the coaxial bore 41″. The diameter of the upper portion 65a″ may be the same or smaller than the diameter of the coaxial bore 41″. The upper portion 65a″ may further include two projections 67″ at the free ends of the legs of the pressure member 6″, where the projections 67″ extend radially outwards and can latch into an annular groove 48″ provided in the coaxial bore 41″ of the receiving part 4″ when the pressure member 6″ is inserted into the receiving part 4″. Due to the larger outer diameter of the projections 67″ with respect to the inner diameter of the rest of the coaxial bore 41″, the legs of the pressure member 6″ may be compressed towards each other and elastically expand when the projections 67″ snap into the grooves 48″.

[0058] Pre-assembling of the bone anchoring device according to the second and third embodiments corresponds or are similar to the pre-assembling according to the first embodiment.

[0059] FIG. 14 shows a fourth embodiment of a bone anchoring device. Parts and portions which are the same or similar to those of the first embodiment are designated with same reference numerals, and the descriptions thereof may not be repeated. The bone anchoring device according to the fourth embodiment differs from the bone anchoring device according to the first embodiment in that there is no interference fit connection between the receiving part 4′″ and the pressure member 6′″, where an outer diameter of at least one portion of the pressure member 6′″ is equal to or smaller than an inner diameter of the corresponding portions of the receiving part 4′″. Instead, a set screw 9′″ is provided which is screwed into a through bore 49′″ located in one leg of the receiving part 4′″ during assembly, for fixing the pressure member 6′″ relative to the receiving part 4′″. The set screw 9′″ has an engagement portion 92′″ for engagement with a tool and a flat bottom side 91′″ for cooperating with the outer surface 65′″ of the pressure member 6′″. All other parts are identical or similar to those of the first embodiment.

[0060] The first steps of pre-assembling the bone anchoring device according to the fourth embodiment correspond or are similar to the pre-assembling according to the first embodiment. A predefined force is applied on the pressure member 6′″ from above to define or determine a preload force acting on the head 3′″. After that, the pressure member 6′″ is frictionally fixed by screwing in the set screw 9′″. The set screw 9′″ only acts radially, or perpendicular to an axis C′″, onto the outer surface 65′″ of the pressure member 6′″, and the pressure member 6″ is thereby held in place. Therefore, the preload force acing on the head 3″ is maintained.

[0061] FIG. 15 shows a fifth embodiment of a bone anchoring device. Parts and portions which are the same or similar to those of the first embodiment are designated with same reference numerals, and the descriptions thereof may not be repeated. The bone anchoring device according to the fifth embodiment differs from the bone anchoring device according to the first embodiment in that there is no interference fit connection between the receiving part 4″ and the pressure member 6″, where an outer diameter of at least one portion of the pressure member 6″ is equal to or smaller than an inner diameter of the corresponding portions of the receiving part 4″. A crimping blind hole 10″″ is provided, which is located in one leg of the receiving part 4″. All other parts are identical or similar to those of the first embodiment.

[0062] The first steps of pre-assembling the bone anchoring device according to the fifth embodiment correspond or are similar to the pre-assembling according to the first embodiment. A predefined force is applied on the pressure member 6″ from above to define or determine a preload force acting on the head 3″. After that, the pressure member 6″ can be frictionally fixed by crimping, for example, by means of a crimping tool. Here, a deformable portion 10a″″ of the receiving part 4″ adjacent to the crimping blind hole 10″″ can be deformed, and the deformed material radially exerts a pressure force onto the outer surface 65″″ of the pressure member 6″, by which the pressure member 6″ is held in place. Therefore, the preload force acting on the head 3″ can be maintained.

[0063] Further modifications of the embodiments described are also conceivable. For example, for the bone anchoring element, various different kinds of anchoring elements can be used and combined with the receiving parts. Such bone anchoring elements may be, for example, screws of different lengths, screws with different diameters, cannulated screws, screws with different thread forms, nails, hooks, etc. In some embodiments, the head and the shaft of the anchoring element may also be separate parts that are connectable to each other.

[0064] Further modifications of the receiving part may include, for example, a recess for the rod that is inclined or open to the side, instead of a U-shaped recess which is perpendicular to a central axis of the receiving part. Other kinds of locking devices, including outer nuts, outer caps, bayonet locking devices, or various other devices, may also be utilized. In embodiments of the invention, an inner surface portion of the pressure member that contacts the head may not necessarily be spherical-shaped, and can have any other shape suitable for exerting pressure onto the head of the bone anchoring element.

[0065] In some embodiments, it is also possible to use a two-part locking device for separately fixing the rod and the head of the bone anchoring element relative to the receiving part.

[0066] In some embodiments, it is also possible that the pressure member can be prevented from rotation by additional crimping.

[0067] It shall further be noted that portions or features of the various different embodiments described above can be combined with one another.

[0068] 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.