US20160192965A1 - Polyaxial bone anchoring device with enlarged pivot angle - Google Patents
Polyaxial bone anchoring device with enlarged pivot angle Download PDFInfo
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- US20160192965A1 US20160192965A1 US14/987,437 US201614987437A US2016192965A1 US 20160192965 A1 US20160192965 A1 US 20160192965A1 US 201614987437 A US201614987437 A US 201614987437A US 2016192965 A1 US2016192965 A1 US 2016192965A1
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- United States
- Prior art keywords
- insert piece
- receiving part
- head
- bone anchoring
- anchoring element
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
- A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8605—Heads, i.e. proximal ends projecting from bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B2017/681—Alignment, compression, or distraction mechanisms
Definitions
- the invention relates to a polyaxial bone anchoring device with an enlarged pivot angle.
- the bone anchoring device includes a bone anchoring element for anchoring in a bone or a vertebra and a receiving part for coupling the bone anchoring element to a stabilization element such as a spinal rod, wherein the bone anchoring element is pivotable in the receiving part and can be pivoted with an enlarged pivot angle relative to a central axis of the receiving part.
- An orientation of the enlarged pivot angle can be selected for a range of 360° around the central axis and can be automatically achieved by pivoting the receiving part relative to the bone anchoring element.
- the polyaxial anchoring device is a modular device, wherein the receiving part and the bone anchoring element are connectable by introducing bone anchoring element, for example, from the bottom, into the receiving part.
- a polyaxial bone anchoring device with an enlarged pivot angle is described in U.S. Pat. No. 6,736,820.
- This bone anchoring device includes a bone screw and a receiving part with a seat for the head of the bone screw.
- the screw member can be pivoted to at least one side by an enlarged angle, because the edge bounding the free end of the receiving part is of asymmetric construction.
- an insert piece is provided, which has a spherical bottom as a seat for the head of the screw member.
- US 2007/0118123 A1 describes a polyaxial bone anchor with increased angulation.
- the polyaxial bone anchor has a locking element shaped and configured to allow an anchoring member, e.g. a screw or a hook, to polyaxially rotate at large angles about a central axis of the bone anchor before compression locking the anchoring member within an anchor head.
- an anchoring member e.g. a screw or a hook
- the bone anchoring device is a bottom loading polyaxial bone anchoring device, wherein an anchoring element can be inserted into a receiving part from a bottom of the receiving part.
- the bone anchoring device can be delivered by the manufacturer as a pre-assembled receiving part with a pressure member and, separate therefrom, one or more screw shanks or anchoring elements, some with pre-assembled or separate sleeve-like insert pieces.
- Such a polyaxial bone anchoring device can be assembled at any place and by anybody, in particular, by a surgeon or any personnel assisting him before or during surgery.
- Various shanks or anchoring elements with different diameter, thread form, length, or other features can be combined with a receiving part according to the actual clinical requirements in a particular clinical situation. This gives the surgeon a substantial choice of implants and reduces the number of parts that are including in an implant set or configuration.
- the polyaxial bone anchoring device has few parts, each of which are of simple design. Therefore, the bone anchoring device is cost-effective to manufacture. It provides safe fixation, since a pressure for locking an angular position of the anchoring element with respect to the receiving part is applied effectively in an axial direction. This enables the design of the bone anchoring device to have smaller dimensions and a low profile structure.
- the bone anchoring device may be devoid of any flexible parts or portions. Therefore, it may be more reliable, even if during adjustment of the angular position, the orientation of the enlarged pivot angle is changed several times.
- a maximum pivot angle of the bone anchoring element relative to the receiving part may be equal to or greater than 45° measured from a straight position. This renders the bone anchoring device particularly suitable for the application of lateral mass fixation, for example, in the cervical spine.
- a locking mechanism for locking the anchoring element and the sleeve-like insert piece provides for a high clamping force on a small surface. Therefore, the locking mechanism may be more efficient.
- an insert member may be arranged that needs space for placement, an upper position of the receiving part can still have a small size.
- FIG. 1 shows a perspective exploded view of a polyaxial bone anchoring device with a spinal rod 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 a cross-sectional view of the bone anchoring device of FIGS. 1 and 2 in the assembled state, without a rod or a fixation screw, the section taken along an axis of an inserted rod;
- FIG. 4 shows a cross-sectional view of the bone anchoring device of FIGS. 1 and 2 in the assembled state, with inserted rod and fixation screw, the section taken along the rod axis;
- FIG. 5 shows a perspective view from a bottom of a receiving part of the bone anchoring device according to FIGS. 1 to 4 ;
- FIG. 6 shows a cross-sectional view of the receiving part of FIG. 5 , the section taken perpendicular to the rod axis;
- FIG. 7 shows a side view of a sleeve-like insert piece according to a first embodiment
- FIG. 8 shows a perspective view from above of the sleeve-like insert piece of FIG. 7 ;
- FIG. 9 shows a cross-sectional view of the sleeve-like insert piece of FIGS. 7 and 8 , the section taken in a plane containing a central axis of the insert piece;
- FIG. 10 shows an enlarged portion of the sleeve-like insert piece of FIG. 9 ;
- FIG. 11 shows a perspective view of a pressure member of the polyaxial bone anchoring device according to an embodiment of the invention
- FIG. 12 shows a side view of the pressure member of FIG. 11 perpendicular to the rod axis
- FIG. 13 shows a side view of the pressure member of FIG. 11 along the rod axis
- FIG. 14 shows a top view of the pressure element of FIG. 11 ;
- FIG. 15 shows a perspective view from a bottom of another embodiment of a sleeve-like insert piece
- FIG. 16 shows a cross-sectional view of the sleeve-like insert piece of FIG. 15 , the section taken in a plane containing a central axis of the insert piece;
- FIGS. 17 to 28 show steps of assembling the polyaxial bone anchoring device according to an embodiment of the invention.
- FIGS. 29 to 32 show steps of adjusting an angle of the bone anchoring element with respect to the receiving part of the polyaxial bone anchoring device according to an embodiment of the invention
- FIG. 33 shows a perspective view of a modified receiving part with pressure member
- FIG. 34 shows a top view of the modified receiving part of FIG. 33 .
- a polyaxial bone anchoring device includes a bone anchoring element 1 in the form of, for example, a bone screw having a threaded shank 2 and a head 3 .
- the head 3 typically has a spherically-shaped outer surface portion 3 a and a recess 3 b at its free end for engagement with a driver or tool.
- the head 3 is configured to be held in a receiving part 4 that couples the bone anchoring element 1 to a stabilization rod 100 .
- 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.
- a fixation element in the form of, for example, a fixation screw 7 may be provided for securing and fixing the rod 100 in or relative to the receiving part 4 .
- the receiving part 4 has a top end 4 a and a bottom end 4 b , an axis C defining a central axis of the polyaxial bone anchoring device, and a coaxial bore 8 extending from the top end 4 a in a direction of the bottom end 4 b .
- a substantially U-shaped recess 9 Adjacent to the top end 4 a , a substantially U-shaped recess 9 is provided that forms a channel for receiving the rod 100 .
- two free legs are formed which are each provided with an internal thread 10 that cooperates with the fixation screw 7 .
- the coaxial bore 8 opens into an accommodation space 11 provided in a lower part of the receiving part 4 .
- the accommodation space 11 has a lower opening 12 at the bottom end 4 b of the receiving part 4 , and is shaped as a portion of a hollow sphere, including a largest inner diameter D.
- a seat for the sleeve-like insert piece 5 is provided, such that the seat and the sleeve-like insert piece 5 form a ball and socket joint.
- the seat can also be tapered, or can have any other shape that can be used to realize a ball and socket joint.
- An inner diameter of the lower opening 12 is slightly smaller than the largest inner diameter D of the accommodation space 11 .
- the receiving part 4 Adjacent the opening 12 , the receiving part 4 includes a threaded portion 13 with an internal thread.
- a height of the threaded portion 13 is such that it includes only a few thread turns, i.e., at least one thread turn and at a maximum just so many thread turns that the sleeve-like insert piece 5 can freely pivot in the accommodation space 11 once having passed the threaded portion 13 during insertion.
- the threaded portion 13 extends from the lower opening 12 to a distance from the portion of the accommodation space 11 having the largest inner diameter D.
- an inner diameter of the coaxial bore 8 does not need to be constant between the top end 4 a and the accommodation space 11 .
- the coaxial bore 8 may have different portions with different diameters.
- the sleeve-like insert piece 5 will be explained with reference to FIGS. 3, 4, and 7 to 10 .
- the sleeve-like insert piece 5 has an upper edge 5 a and a lower edge 5 b . Between the upper edge 5 a and the lower edge 5 b , a threaded outer surface portion 51 is provided.
- the thread corresponds to the thread of the threaded portion 13 of the receiving part 4 . Furthermore, the threaded outer surface portion 51 is spherically-shaped.
- Threaded outer surface portion 51 Dimensions of the threaded outer surface portion 51 are such that the sleeve-like insert piece 5 is insertable through the opening 12 by screwing, and once the insert piece 5 has passed the threaded portion 13 , the insert piece 5 can pivot and rotate in the receiving part 4 when the insert piece 5 is in the seat provided by the accommodation space 11 .
- the outer surface of the insert piece 5 can also be only partially threaded, with the threaded portion 51 including, for example, the portion of the insert piece 5 with the largest diameter.
- the sleeve-like insert piece 5 is hollow and includes a central portion 52 that is spherically-shaped, with a radius corresponding to a radius of the spherically-shaped outer surface portion 3 a of the head 3 of the anchoring element 1 .
- a lower end of this central portion 52 forms a shoulder 53 .
- An inner diameter of the shoulder 53 is smaller than a largest outer diameter of the spherical head 3 , such 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.
- a tapered portion 54 can be provided that tapers outward to allow angulation of an inserted bone anchoring element 1 until the shank 2 comes into contact with the lower edge 5 b .
- a tapered portion 55 is provided that 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 may be greater than the largest outer diameter of the head 3 , so that the head 3 can be inserted from the upper edge 5 a.
- Spherical center points of the spherical central portion 52 and of the outer spherical portion 51 may be offset from each other in such a way that the center point of the central spherical portion 52 is shifted towards the lower edge 5 b relative to the center point of the outer spherical portion 51 .
- a range of angulation of the bone anchoring element 1 can be further increased.
- a height of the sleeve-like insert piece 5 in an axial direction along the central axis C 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 3 a of the head 3 projects from the upper edge 5 a of the sleeve-like insert piece 5 , as shown in FIGS. 3 and 4 .
- An inner diameter of the central spherical portion 52 is dimensioned such that the head 3 can hold the sleeve-like insert piece 5 by a slight tension caused by a friction fit. By means of this, a torque necessary for screwing in of the anchoring element 1 with the sleeve-like insert piece 5 can be transferred from the anchoring element 1 to the sleeve-like insert piece 5 .
- the sleeve-like insert piece 5 is rigid, i.e., does not have any flexible portions such as, for example, slits that would render the insert piece 5 more flexible.
- the pressure member 6 is shown in particular in FIGS. 3, 4, and 11 to 14 .
- the pressure member 6 is substantially cylindrical with an outer diameter that allows it to move within the coaxial bore 8 and the accommodation space 11 of the receiving part 4 .
- the pressure member 6 it has an upper end 6 a and a lower edge 6 b . Adjacent its lower edge 6 b , a spherical recess 61 with a spherical shape that matches the spherical shape of the outer spherical surface portion 3 a of the head 3 is provided.
- 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 head 3 with a tool. The coaxial bore 64 is also configured to allow a portion of the head 3 to extend therethrough when the bone anchoring element is in a pivoted condition, as shown, for example, in FIG. 3 .
- a height of the pressure member 6 in an axial direction along the central axis C is such that when the fixation screw 7 is tightened, the fixation screw 7 presses onto the rod 100 , which then presses onto the pressure member 6 , which in turn acts onto the head 3 of the bone anchoring element 1 .
- each projection 65 has an upper surface 65 a facing the upper end 6 a having a spherical shape matching the hollow spherical shape of the accommodation space 11 .
- the projections 65 may be offset by 180° and may be located or oriented at a position perpendicular to the rod axis L as shown, for example, in FIGS. 12 and 13 .
- the projections 65 a may be located at a distance from the lower edge 6 b and at a distance from a bottom of the cylindrical recess 63 along central axis C.
- the recesses 66 are provided offset from each other by 180°.
- the recesses each have a portion 66 a extending into the spherical upper surface 65 a of the projections 65 .
- the recesses 66 provide a space for material of the inner wall of the receiving part 4 generated by crimping, as explained below.
- FIGS. 15 and 16 A further embodiment of the sleeve-like insert piece 5 ′ is shown in FIGS. 15 and 16 .
- the sleeve-like insert piece according to FIGS. 15 and 16 differs from the sleeve-like insert piece 5 described before by the additional provision of a drive feature for engagement with a tool to screw in the sleeve-like insert piece 5 ′ into the receiving part 4 .
- All other portions of the insert piece 5 ′ are the same as those in the first embodiment and are indicated by the same reference numerals. The descriptions thereof will therefore not be repeated.
- the sleeve-like insert piece 5 ′ has at its lower edge 5 b slits 56 that serve as an engagement portion for a tool.
- the slits 56 can have any shape that allows for engagement with a tool.
- a plurality of slits 56 may be provided in a circumferential direction.
- the head 3 may not need to be clamped in the sleeve-like insert piece 5 ′.
- the bone anchoring device as a whole or in part may be made of a bio-compatible material, such as a bio-compatible metal, for example titanium or stainless steel, a bio-compatible alloy, such as nickel-titanium alloys, for example, Nitinol, or of bio-compatible plastic materials, such as, for example, polyetheretherketone (PEEK).
- a bio-compatible material such as a bio-compatible metal, for example titanium or stainless steel, a bio-compatible alloy, such as nickel-titanium alloys, for example, Nitinol, or of bio-compatible plastic materials, such as, for example, polyetheretherketone (PEEK).
- a bio-compatible material such as a bio-compatible metal, for example titanium or stainless steel
- a bio-compatible alloy such as nickel-titanium alloys, for example, Nitinol
- PEEK polyetheretherketone
- FIG. 17 shows a side view of a first step of assembling the bone anchoring device.
- the pressure member 6 is introduced into the receiving part 4 through the lower opening 12 until its cylindrical recess 63 , as shown in FIG. 18 , projects slightly above the U-shaped recess 9 of the receiving part 4 , and is aligned therewith.
- the pressure member 6 may be mounted to or held in the receiving part 4 by crimping, wherein with a crimping tool the inner wall of the receiving part 4 is slightly deformed to form deformed portions 41 protruding into the recesses 66 .
- the pressure member 6 can move slightly within the receiving part 4 in an axial direction.
- the receiving part 4 and the pressure member 6 may be pre-assembled and delivered in such a pre-assembled state.
- the sleeve-like insert piece 5 is mounted to the bone anchoring element 1 , as shown in a side view in FIGS. 19 and 20 .
- the bone anchoring element 1 is introduced from the upper edge 5 a into the sleeve-like insert piece 5 until the spherical head 3 rests in the spherically-shaped central portion 52 and is slightly clamped therein in some embodiments.
- a large variety of bone anchoring elements, each with or without a mounted sleeve-like insert piece, may be provided.
- FIGS. 21 to 24 the bone anchoring element 1 with mounted sleeve-like insert piece 5 is introduced from the bottom end 4 b into the receiving part 4 .
- FIG. 21 shows a cross-sectional view of the polyaxial bone anchoring device with the section taken perpendicular to the rod axis.
- FIG. 22 shows a side view of the polyaxial bone anchoring device before assembling the bone anchoring element 1 with the receiving part 4 .
- FIG. 23 shows a cross-sectional view of the bone anchoring device and FIG. 24 a side view thereof, wherein the bone anchoring element 1 is introduced into the receiving part 4 through the lower opening 12 .
- the thread of the outer surface portion 51 of the sleeve-like insert piece 5 engages the threaded portion 13 of the receiving part 4 . Because the sleeve-like insert piece 5 is slightly clamped onto the head 3 of the bone anchoring element 1 , a torque applied to the shank 2 is transferred to the insert piece 5 to engage the threaded portion 13 . When the sleeve-like insert piece 5 ′ is used, a tool may be used to screw in the anchoring element 1 with the sleeve-like insert piece 5 ′.
- FIGS. 25 and 26 show a cross-sectional view and a corresponding side view of the polyaxial bone anchoring device, wherein the bone anchoring element 1 and the sleeve-like insert piece 5 have been completely inserted.
- the pressure member 6 is at its uppermost position, in which the upper spherical portions 65 a of the projections 65 abut against the inner wall of the accommodation space 11 .
- the head of the anchoring element 1 and the sleeve-like insert piece 5 are pivotable in the receiving part 4 .
- a suitable polyaxial bone anchoring device can be selected from a great variety of bone anchoring elements that can each be assembled with receiving parts on demand.
- the pressure member 6 may be further fixed by crimping.
- the pressure member 6 is moved downward relative to receiving part 4 until pressure member 6 slightly presses onto the head 3 with the spherical recess 61 to exert a preload or friction force onto the head 3 .
- deformed portions 42 are generated that hold the pressure member 6 in a predetermined preliminary position.
- the bone anchoring element 1 can then be pivoted only by overcoming the frictional force between the pressure member 6 and the head 3 .
- the assembly of the bone anchoring element 1 and the receiving part 4 with the second embodiment of the sleeve-like insert piece 5 ′ is carried out in the same manner as the first embodiment, except that a tool can be used for engaging the slits 56 and rotating the sleeve-like insert piece 5 ′.
- the steps of use of the bone anchoring device are shown by the cross-sectional views of FIGS. 29 to 32 .
- the fixation screw and the rod are omitted in these exemplary figures.
- the anchoring element 1 is inserted in a bone part or in a vertebra.
- several bone anchoring devices are needed to fix a stabilization rod 100 to the bone parts or the vertebrae to be stabilized.
- the receiving part 4 can be adjusted by pivoting and/or rotating, in order to be able to insert the stabilization rod 100 into the U-shaped recess 9 . In the condition shown in FIGS.
- both the sleeve-like insert piece 5 and the head 3 of the bone anchoring element 1 are independently and freely pivotable.
- the sleeve-like insert piece 5 is rotatable and pivotable in the receiving part 4 , and both are rotatable and pivotable with respect to the head 3 of the bone anchoring element 1 .
- the sleeve-like insert piece 5 provides for an enlarged range of angulation compared to devices where the head 3 is directly received in the receiving part 5 , because a distance between the shank 2 and the lower end 4 b of the receiving part 4 is greater.
- the sleeve-like insert piece 5 is rotatable and pivotable within the receiving part 4 , an enlarged range of angulation can be achieved at any position of the receiving part 4 with respect to the bone anchoring element 1 for 360° around the central axis C of the receiving part 4 . As shown in FIG. 30 , pivoting the receiving part 4 towards an opposite direction may also pivot the sleeve-like insert piece 5 .
- FIG. 31 a and in the enlarged representation of FIG. 31 b further pivoting the receiving part 4 may in some cases essentially maintain a position of the sleeve-like insert piece 5 .
- the shank 2 of the bone anchoring element 1 comes into contact with the lower edge 5 b of the sleeve-like insert piece 5 as shown in FIGS. 31 a and 31 b .
- the sleeve-like insert piece 5 will also be pivoted.
- the shank 2 pushes the insert piece 5 until the shank 2 abuts against an edge of the lower opening 12 of the receiving part 4 , as shown in FIG. 32 .
- the receiving part 4 is pivoted at a maximum pivot angle with respect to the bone anchoring element 1 .
- the maximum pivot angle to be achieved depends on the dimensions of the sleeve-like insert piece 5 , the receiving part 4 , and the bone anchoring element 1 , but is typically equal to or greater than 45° measured from a straight or zero angle position.
- FIGS. 29 to 32 While in FIGS. 29 to 32 , an example is shown in which pivoting is carried out in a plane that contains the rod axis, it should be noted that the same steps can be carried out at any other direction for 360° around the central axis C of the receiving part 4 .
- the sleeve-like insert piece 5 together with the bone anchoring element 1 cannot escape from the lower opening 12 because of the obstacle provided by the threaded portion 13 .
- the friction fit between the pressure member 6 and the head 3 of the anchoring element 1 has an effect where the receiving part 4 can be maintained provisionally at any position with respect to the bone anchoring element 1 .
- the rod 100 may be inserted and the inner screw 7 may be tightened to press the pressure element 6 onto the head 3 , to lock the head 3 and the sleeve-like insert piece 5 simultaneously.
- anchoring elements can be used and combined with the receiving part.
- Such anchoring elements may be, for example, screws of different length, with different diameters, canulated screws, screws with different thread forms, nails, hooks, etc.
- the head and the shank may also be separate parts that are connectable to each other.
- Modifications of the receiving part may include, instead of the U-shaped recess which is perpendicular to the central axis, having a recess for the rod which is inclined or open to the side or which is in the form of a closed channel.
- the receiving part 4 ′ has two opposed recesses 400 a , 400 b , along inner walls of coaxial bore 8 and accommodation space 11 .
- the recesses 400 a , 400 b are aligned with U-shaped recess 9 , and extend from a bottom of the U-shaped recess 9 into the accommodation space 11 .
- a size of the recesses 400 a , 400 b is such that the pressure member 6 can be introduced from the top end 4 a of the receiving part 4 ′ when projections 65 are positioned in or aligned with the U-shaped recess 9 .
- the pressure member 6 can be rotated, and a recess 63 of the pressure member 6 can be aligned with the U-shaped recess 9 of the receiving part 4 ′.
- the locking device can also be a two part locking device having one locking element that locks the head of the anchoring element and another locking element that locks the rod.
- the inner surface portion of the pressure member that contacts the head is not necessarily spherically-shaped.
- the inner surface portion can have any other shape that is suitable to exert pressure onto the head.
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Abstract
A polyaxial bone anchoring device includes an anchoring element having a shank and a head, a receiving part having a first end and a second end, a central axis, and an accommodation space for accommodating the head, the accommodation space having an opening at the second end, a sleeve-like insert piece configured to be arranged around a portion of the head and to be arranged in and to pivot in the accommodation space, and a pressure member including a portion configured to exert pressure onto the head, wherein the anchoring element and insert piece are pivotable with respect to the receiving part such that respective angles formed by a central axis of the insert piece with the central axis of the receiving part and a central axis of the anchoring element are adjustable, and can be locked by exerting pressure with the pressure member onto the head.
Description
- This application is a continuation of U.S. patent application Ser. No. 13/586,454, filed Aug. 15, 2012, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/525,092, filed Aug. 18, 2011, the contents of which are hereby incorporated by reference in their entirety, and claims priority to European
Patent Application EP 11 178 035.9, filed Aug. 18, 2011 the contents of which are hereby incorporated by reference in their entirety. - 1. Field of Invention
- The invention relates to a polyaxial bone anchoring device with an enlarged pivot angle. The bone anchoring device includes a bone anchoring element for anchoring in a bone or a vertebra and a receiving part for coupling the bone anchoring element to a stabilization element such as a spinal rod, wherein the bone anchoring element is pivotable in the receiving part and can be pivoted with an enlarged pivot angle relative to a central axis of the receiving part. An orientation of the enlarged pivot angle can be selected for a range of 360° around the central axis and can be automatically achieved by pivoting the receiving part relative to the bone anchoring element. The polyaxial anchoring device is a modular device, wherein the receiving part and the bone anchoring element are connectable by introducing bone anchoring element, for example, from the bottom, into the receiving part.
- 2. Description of Related Art
- A polyaxial bone anchoring device with an enlarged pivot angle is described in U.S. Pat. No. 6,736,820. This bone anchoring device includes a bone screw and a receiving part with a seat for the head of the bone screw. The screw member can be pivoted to at least one side by an enlarged angle, because the edge bounding the free end of the receiving part is of asymmetric construction. In a modified embodiment, an insert piece is provided, which has a spherical bottom as a seat for the head of the screw member.
- US 2007/0118123 A1 describes a polyaxial bone anchor with increased angulation. The polyaxial bone anchor has a locking element shaped and configured to allow an anchoring member, e.g. a screw or a hook, to polyaxially rotate at large angles about a central axis of the bone anchor before compression locking the anchoring member within an anchor head.
- Although the polyaxial bone anchoring devices in the related art described above provide for enlarged angulation in a desired orientation, there is still a need for an improved polyaxial bone anchoring device in terms of simplicity of design and greater variety of applications.
- It is an object of embodiments of the invention to provide a polyaxial bone anchoring device that allows adjustment of an orientation of an enlarged pivot angle, which has a simple design, and can be easily assembled, while also equally providing high efficiency or reliability of fixation.
- The bone anchoring device according to some embodiments of the invention is a bottom loading polyaxial bone anchoring device, wherein an anchoring element can be inserted into a receiving part from a bottom of the receiving part. The bone anchoring device can be delivered by the manufacturer as a pre-assembled receiving part with a pressure member and, separate therefrom, one or more screw shanks or anchoring elements, some with pre-assembled or separate sleeve-like insert pieces. Such a polyaxial bone anchoring device can be assembled at any place and by anybody, in particular, by a surgeon or any personnel assisting him before or during surgery. Various shanks or anchoring elements with different diameter, thread form, length, or other features can be combined with a receiving part according to the actual clinical requirements in a particular clinical situation. This gives the surgeon a substantial choice of implants and reduces the number of parts that are including in an implant set or configuration.
- By such modularity, costs of stock-holding can be lowered.
- The polyaxial bone anchoring device according to embodiments of the invention has few parts, each of which are of simple design. Therefore, the bone anchoring device is cost-effective to manufacture. It provides safe fixation, since a pressure for locking an angular position of the anchoring element with respect to the receiving part is applied effectively in an axial direction. This enables the design of the bone anchoring device to have smaller dimensions and a low profile structure. The bone anchoring device may be devoid of any flexible parts or portions. Therefore, it may be more reliable, even if during adjustment of the angular position, the orientation of the enlarged pivot angle is changed several times.
- A maximum pivot angle of the bone anchoring element relative to the receiving part may be equal to or greater than 45° measured from a straight position. This renders the bone anchoring device particularly suitable for the application of lateral mass fixation, for example, in the cervical spine.
- A locking mechanism for locking the anchoring element and the sleeve-like insert piece provides for a high clamping force on a small surface. Therefore, the locking mechanism may be more efficient.
- Meanwhile, although in a lower portion of the receiving part, an insert member may be arranged that needs space for placement, an upper position of the receiving part can still have a small size.
- 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 polyaxial bone anchoring device with a spinal rod according to an embodiment of the invention; -
FIG. 2 shows a perspective view of the bone anchoring device ofFIG. 1 in an assembled state; -
FIG. 3 shows a cross-sectional view of the bone anchoring device ofFIGS. 1 and 2 in the assembled state, without a rod or a fixation screw, the section taken along an axis of an inserted rod; -
FIG. 4 shows a cross-sectional view of the bone anchoring device ofFIGS. 1 and 2 in the assembled state, with inserted rod and fixation screw, the section taken along the rod axis; -
FIG. 5 shows a perspective view from a bottom of a receiving part of the bone anchoring device according toFIGS. 1 to 4 ; -
FIG. 6 shows a cross-sectional view of the receiving part ofFIG. 5 , the section taken perpendicular to the rod axis; -
FIG. 7 shows a side view of a sleeve-like insert piece according to a first embodiment; -
FIG. 8 shows a perspective view from above of the sleeve-like insert piece ofFIG. 7 ; -
FIG. 9 shows a cross-sectional view of the sleeve-like insert piece ofFIGS. 7 and 8 , the section taken in a plane containing a central axis of the insert piece; -
FIG. 10 shows an enlarged portion of the sleeve-like insert piece ofFIG. 9 ; -
FIG. 11 shows a perspective view of a pressure member of the polyaxial bone anchoring device according to an embodiment of the invention; -
FIG. 12 shows a side view of the pressure member ofFIG. 11 perpendicular to the rod axis; -
FIG. 13 shows a side view of the pressure member ofFIG. 11 along the rod axis; -
FIG. 14 shows a top view of the pressure element ofFIG. 11 ; -
FIG. 15 shows a perspective view from a bottom of another embodiment of a sleeve-like insert piece; -
FIG. 16 shows a cross-sectional view of the sleeve-like insert piece ofFIG. 15 , the section taken in a plane containing a central axis of the insert piece; -
FIGS. 17 to 28 show steps of assembling the polyaxial bone anchoring device according to an embodiment of the invention; -
FIGS. 29 to 32 show steps of adjusting an angle of the bone anchoring element with respect to the receiving part of the polyaxial bone anchoring device according to an embodiment of the invention; -
FIG. 33 shows a perspective view of a modified receiving part with pressure member; and -
FIG. 34 shows a top view of the modified receiving part ofFIG. 33 . - As shown in
FIGS. 1 to 4 , a polyaxial bone anchoring device according to a first embodiment includes abone anchoring element 1 in the form of, for example, a bone screw having a threadedshank 2 and ahead 3. Thehead 3 typically has a spherically-shapedouter surface portion 3 a and arecess 3 b at its free end for engagement with a driver or tool. Thehead 3 is configured to be held in a receivingpart 4 that couples thebone anchoring element 1 to astabilization rod 100. In the receivingpart 4, a sleeve-like insert piece 5 providing a seat for thehead 3 of thebone anchoring element 1 and apressure member 6 for exerting pressure onto thehead 3 can be arranged. Furthermore, a fixation element in the form of, for example, a fixation screw 7 may be provided for securing and fixing therod 100 in or relative to the receivingpart 4. - The receiving
part 4 has atop end 4 a and abottom end 4 b, an axis C defining a central axis of the polyaxial bone anchoring device, and a coaxial bore 8 extending from thetop end 4 a in a direction of thebottom end 4 b. Adjacent to thetop end 4 a, a substantiallyU-shaped recess 9 is provided that forms a channel for receiving therod 100. By means of therecess 9, two free legs are formed which are each provided with aninternal thread 10 that cooperates with the fixation screw 7. - The coaxial bore 8 opens into an
accommodation space 11 provided in a lower part of the receivingpart 4. Theaccommodation space 11 has alower opening 12 at thebottom end 4 b of the receivingpart 4, and is shaped as a portion of a hollow sphere, including a largest inner diameter D. By theaccommodation space 11, a seat for the sleeve-like insert piece 5 is provided, such that the seat and the sleeve-like insert piece 5 form a ball and socket joint. It should be noted that the seat can also be tapered, or can have any other shape that can be used to realize a ball and socket joint. An inner diameter of thelower opening 12 is slightly smaller than the largest inner diameter D of theaccommodation space 11. - Adjacent the
opening 12, the receivingpart 4 includes a threadedportion 13 with an internal thread. A height of the threadedportion 13 is such that it includes only a few thread turns, i.e., at least one thread turn and at a maximum just so many thread turns that the sleeve-like insert piece 5 can freely pivot in theaccommodation space 11 once having passed the threadedportion 13 during insertion. In any case, the threadedportion 13 extends from thelower opening 12 to a distance from the portion of theaccommodation space 11 having the largest inner diameter D. - It shall be further noted that an inner diameter of the coaxial bore 8 does not need to be constant between the
top end 4 a and theaccommodation space 11. The coaxial bore 8 may have different portions with different diameters. - The sleeve-
like insert piece 5 will be explained with reference toFIGS. 3, 4, and 7 to 10 . The sleeve-like insert piece 5 has anupper edge 5 a and alower edge 5 b. Between theupper edge 5 a and thelower edge 5 b, a threadedouter surface portion 51 is provided. The thread corresponds to the thread of the threadedportion 13 of the receivingpart 4. Furthermore, the threadedouter surface portion 51 is spherically-shaped. Dimensions of the threadedouter surface portion 51 are such that the sleeve-like insert piece 5 is insertable through theopening 12 by screwing, and once theinsert piece 5 has passed the threadedportion 13, theinsert piece 5 can pivot and rotate in the receivingpart 4 when theinsert piece 5 is in the seat provided by theaccommodation space 11. The outer surface of theinsert piece 5 can also be only partially threaded, with the threadedportion 51 including, for example, the portion of theinsert piece 5 with the largest diameter. - The sleeve-
like insert piece 5 is hollow and includes acentral portion 52 that is spherically-shaped, with a radius corresponding to a radius of the spherically-shapedouter surface portion 3 a of thehead 3 of theanchoring element 1. A lower end of thiscentral portion 52 forms ashoulder 53. An inner diameter of theshoulder 53 is smaller than a largest outer diameter of thespherical head 3, such that thehead 3 can rotate and pivot in the centralspherical portion 52 of the sleeve-like insert piece 5, similar to a ball and socket joint. Between theshoulder 53 and thelower edge 5 b, a taperedportion 54 can be provided that tapers outward to allow angulation of an insertedbone anchoring element 1 until theshank 2 comes into contact with thelower edge 5 b. Between the sphericalcentral portion 52 and theupper edge 5 a, a taperedportion 55 is provided that tapers outwards. An inner diameter of the taperedportion 55 and of the transition between the taperedportion 55 and the sphericalcentral portion 52 may be greater than the largest outer diameter of thehead 3, so that thehead 3 can be inserted from theupper edge 5 a. - Spherical center points of the spherical
central portion 52 and of the outerspherical portion 51 may be offset from each other in such a way that the center point of the centralspherical portion 52 is shifted towards thelower edge 5 b relative to the center point of the outerspherical portion 51. By means of this, a range of angulation of thebone anchoring element 1 can be further increased. A height of the sleeve-like insert piece 5 in an axial direction along the central axis C is less than a height of thehead 3 in an axial direction, such that when thehead 3 is inserted into the sleeve-like insert piece 5, a portion of the sphericalouter surface 3 a of thehead 3 projects from theupper edge 5 a of the sleeve-like insert piece 5, as shown inFIGS. 3 and 4 . An inner diameter of the centralspherical portion 52 is dimensioned such that thehead 3 can hold the sleeve-like insert piece 5 by a slight tension caused by a friction fit. By means of this, a torque necessary for screwing in of theanchoring element 1 with the sleeve-like insert piece 5 can be transferred from the anchoringelement 1 to the sleeve-like insert piece 5. - The sleeve-
like insert piece 5 is rigid, i.e., does not have any flexible portions such as, for example, slits that would render theinsert piece 5 more flexible. - The
pressure member 6 is shown in particular inFIGS. 3, 4, and 11 to 14 . Thepressure member 6 is substantially cylindrical with an outer diameter that allows it to move within the coaxial bore 8 and theaccommodation space 11 of the receivingpart 4. Thepressure member 6 it has anupper end 6 a and alower edge 6 b. Adjacent itslower edge 6 b, aspherical recess 61 with a spherical shape that matches the spherical shape of the outerspherical surface portion 3 a of thehead 3 is provided. - At the
upper end 6 a, thepressure member 6 has acylindrical recess 63 for receiving therod 100 therein. Furthermore, thepressure member 6 has acoaxial bore 64 for allowing access to thehead 3 with a tool. Thecoaxial bore 64 is also configured to allow a portion of thehead 3 to extend therethrough when the bone anchoring element is in a pivoted condition, as shown, for example, inFIG. 3 . A height of thepressure member 6 in an axial direction along the central axis C is such that when the fixation screw 7 is tightened, the fixation screw 7 presses onto therod 100, which then presses onto thepressure member 6, which in turn acts onto thehead 3 of thebone anchoring element 1. - At an outer surface of the
pressure member 6, two outwardly extendingprojections 65 that each extends over a length of thepressure member 6 in a circumferential direction, are provided. Eachprojection 65 has anupper surface 65 a facing theupper end 6 a having a spherical shape matching the hollow spherical shape of theaccommodation space 11. Theprojections 65 may be offset by 180° and may be located or oriented at a position perpendicular to the rod axis L as shown, for example, inFIGS. 12 and 13 . Theprojections 65 a may be located at a distance from thelower edge 6 b and at a distance from a bottom of thecylindrical recess 63 along central axis C. Above theprojections 65, tworecesses 66 are provided offset from each other by 180°. The recesses each have aportion 66 a extending into the sphericalupper surface 65 a of theprojections 65. Therecesses 66 provide a space for material of the inner wall of the receivingpart 4 generated by crimping, as explained below. - A further embodiment of the sleeve-
like insert piece 5′ is shown inFIGS. 15 and 16 . The sleeve-like insert piece according toFIGS. 15 and 16 differs from the sleeve-like insert piece 5 described before by the additional provision of a drive feature for engagement with a tool to screw in the sleeve-like insert piece 5′ into the receivingpart 4. All other portions of theinsert piece 5′ are the same as those in the first embodiment and are indicated by the same reference numerals. The descriptions thereof will therefore not be repeated. The sleeve-like insert piece 5′ has at itslower edge 5 b slits 56 that serve as an engagement portion for a tool. Theslits 56 can have any shape that allows for engagement with a tool. A plurality ofslits 56 may be provided in a circumferential direction. In embodiments where the sleeve-like insert piece 5′ is used, thehead 3 may not need to be clamped in the sleeve-like insert piece 5′. - The bone anchoring device as a whole or in part may be made of a bio-compatible material, such as a bio-compatible metal, for example titanium or stainless steel, a bio-compatible alloy, such as nickel-titanium alloys, for example, Nitinol, or of bio-compatible plastic materials, such as, for example, polyetheretherketone (PEEK).
- Steps of assembling the bone anchoring device according to embodiments of the invention will be explained with reference to
FIGS. 17 to 28 .FIG. 17 shows a side view of a first step of assembling the bone anchoring device. Thepressure member 6 is introduced into the receivingpart 4 through thelower opening 12 until itscylindrical recess 63, as shown inFIG. 18 , projects slightly above theU-shaped recess 9 of the receivingpart 4, and is aligned therewith. As shown in the sectional view according toFIG. 21 , thepressure member 6 may be mounted to or held in the receivingpart 4 by crimping, wherein with a crimping tool the inner wall of the receivingpart 4 is slightly deformed to formdeformed portions 41 protruding into therecesses 66. As therecesses 66 are larger in an axial direction than thedeformed portions 41 thepressure member 6 can move slightly within the receivingpart 4 in an axial direction. The receivingpart 4 and thepressure member 6 may be pre-assembled and delivered in such a pre-assembled state. - The sleeve-
like insert piece 5 is mounted to thebone anchoring element 1, as shown in a side view inFIGS. 19 and 20 . Thebone anchoring element 1 is introduced from theupper edge 5 a into the sleeve-like insert piece 5 until thespherical head 3 rests in the spherically-shapedcentral portion 52 and is slightly clamped therein in some embodiments. A large variety of bone anchoring elements, each with or without a mounted sleeve-like insert piece, may be provided. - As can be seen in
FIGS. 21 to 24 , thebone anchoring element 1 with mounted sleeve-like insert piece 5 is introduced from thebottom end 4 b into the receivingpart 4.FIG. 21 shows a cross-sectional view of the polyaxial bone anchoring device with the section taken perpendicular to the rod axis.FIG. 22 shows a side view of the polyaxial bone anchoring device before assembling thebone anchoring element 1 with the receivingpart 4.FIG. 23 shows a cross-sectional view of the bone anchoring device andFIG. 24 a side view thereof, wherein thebone anchoring element 1 is introduced into the receivingpart 4 through thelower opening 12. The thread of theouter surface portion 51 of the sleeve-like insert piece 5 engages the threadedportion 13 of the receivingpart 4. Because the sleeve-like insert piece 5 is slightly clamped onto thehead 3 of thebone anchoring element 1, a torque applied to theshank 2 is transferred to theinsert piece 5 to engage the threadedportion 13. When the sleeve-like insert piece 5′ is used, a tool may be used to screw in theanchoring element 1 with the sleeve-like insert piece 5′. -
FIGS. 25 and 26 show a cross-sectional view and a corresponding side view of the polyaxial bone anchoring device, wherein thebone anchoring element 1 and the sleeve-like insert piece 5 have been completely inserted. In this position, thepressure member 6 is at its uppermost position, in which the upperspherical portions 65 a of theprojections 65 abut against the inner wall of theaccommodation space 11. The head of theanchoring element 1 and the sleeve-like insert piece 5 are pivotable in the receivingpart 4. - The assembly steps shown in
FIGS. 19 to 26 can be performed by any person at any place. Therefore, a suitable polyaxial bone anchoring device can be selected from a great variety of bone anchoring elements that can each be assembled with receiving parts on demand. - In a final step shown in
FIGS. 27 and 28 , whereinFIG. 27 shows a cross-sectional view andFIG. 28 a corresponding side view of the polyaxial bone anchoring device, thepressure member 6 may be further fixed by crimping. Through further crimping, thepressure member 6 is moved downward relative to receivingpart 4 untilpressure member 6 slightly presses onto thehead 3 with thespherical recess 61 to exert a preload or friction force onto thehead 3. By this additional crimping step,deformed portions 42 are generated that hold thepressure member 6 in a predetermined preliminary position. By adjusting the force of the crimping operation, a defined friction fit is achieved between thehead 3 and thepressure member 6. Thebone anchoring element 1 can then be pivoted only by overcoming the frictional force between thepressure member 6 and thehead 3. - The assembly of the
bone anchoring element 1 and the receivingpart 4 with the second embodiment of the sleeve-like insert piece 5′ is carried out in the same manner as the first embodiment, except that a tool can be used for engaging theslits 56 and rotating the sleeve-like insert piece 5′. - The steps of use of the bone anchoring device are shown by the cross-sectional views of
FIGS. 29 to 32 . The fixation screw and the rod are omitted in these exemplary figures. First, the anchoringelement 1 is inserted in a bone part or in a vertebra. Usually, several bone anchoring devices are needed to fix astabilization rod 100 to the bone parts or the vertebrae to be stabilized. After thebone anchoring elements 1 are inserted, one example of which is shown inFIGS. 29 to 32 , the receivingpart 4 can be adjusted by pivoting and/or rotating, in order to be able to insert thestabilization rod 100 into theU-shaped recess 9. In the condition shown inFIGS. 29 to 32 , both the sleeve-like insert piece 5 and thehead 3 of thebone anchoring element 1 are independently and freely pivotable. The sleeve-like insert piece 5 is rotatable and pivotable in the receivingpart 4, and both are rotatable and pivotable with respect to thehead 3 of thebone anchoring element 1. The sleeve-like insert piece 5 provides for an enlarged range of angulation compared to devices where thehead 3 is directly received in the receivingpart 5, because a distance between theshank 2 and thelower end 4 b of the receivingpart 4 is greater. Because the sleeve-like insert piece 5 is rotatable and pivotable within the receivingpart 4, an enlarged range of angulation can be achieved at any position of the receivingpart 4 with respect to thebone anchoring element 1 for 360° around the central axis C of the receivingpart 4. As shown inFIG. 30 , pivoting the receivingpart 4 towards an opposite direction may also pivot the sleeve-like insert piece 5. - As shown in
FIG. 31a and in the enlarged representation ofFIG. 31b , further pivoting the receivingpart 4 may in some cases essentially maintain a position of the sleeve-like insert piece 5. As soon as theshank 2 of thebone anchoring element 1 comes into contact with thelower edge 5 b of the sleeve-like insert piece 5 as shown inFIGS. 31a and 31b , the sleeve-like insert piece 5 will also be pivoted. Theshank 2 pushes theinsert piece 5 until theshank 2 abuts against an edge of thelower opening 12 of the receivingpart 4, as shown inFIG. 32 . Hence, inFIG. 32 , the receivingpart 4 is pivoted at a maximum pivot angle with respect to thebone anchoring element 1. The maximum pivot angle to be achieved depends on the dimensions of the sleeve-like insert piece 5, the receivingpart 4, and thebone anchoring element 1, but is typically equal to or greater than 45° measured from a straight or zero angle position. - While in
FIGS. 29 to 32 , an example is shown in which pivoting is carried out in a plane that contains the rod axis, it should be noted that the same steps can be carried out at any other direction for 360° around the central axis C of the receivingpart 4. - The sleeve-
like insert piece 5 together with thebone anchoring element 1 cannot escape from thelower opening 12 because of the obstacle provided by the threadedportion 13. The friction fit between thepressure member 6 and thehead 3 of theanchoring element 1 has an effect where the receivingpart 4 can be maintained provisionally at any position with respect to thebone anchoring element 1. - Finally, the
rod 100 may be inserted and the inner screw 7 may be tightened to press thepressure element 6 onto thehead 3, to lock thehead 3 and the sleeve-like insert piece 5 simultaneously. - Further modifications of the embodiments described may also be conceivable. For example, for the bone anchoring element, all kinds of anchoring elements can be used and combined with the receiving part. Such anchoring elements may be, for example, screws of different length, with different diameters, canulated screws, screws with different thread forms, nails, hooks, etc. The head and the shank may also be separate parts that are connectable to each other.
- Modifications of the receiving part may include, instead of the U-shaped recess which is perpendicular to the central axis, having a recess for the rod which is inclined or open to the side or which is in the form of a closed channel.
- In another modified embodiment shown in
FIGS. 33 and 34 , in order to allow apressure member 6 to be inserted from atop end 4 a of a receivingpart 4′, the receivingpart 4′ has two opposedrecesses accommodation space 11. Therecesses U-shaped recess 9, and extend from a bottom of theU-shaped recess 9 into theaccommodation space 11. A size of therecesses pressure member 6 can be introduced from thetop end 4 a of the receivingpart 4′ whenprojections 65 are positioned in or aligned with theU-shaped recess 9. When theprojections 65 enter theaccommodation space 11, thepressure member 6 can be rotated, and arecess 63 of thepressure member 6 can be aligned with theU-shaped recess 9 of the receivingpart 4′. - Other kinds of locking devices including outer nuts, outer caps, bayonet locking devices, or others are also possible. The locking device can also be a two part locking device having one locking element that locks the head of the anchoring element and another locking element that locks the rod. In some embodiments, the inner surface portion of the pressure member that contacts the head is not necessarily spherically-shaped. The inner surface portion can have any other shape that is suitable to exert pressure onto the head.
- 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 (20)
1. A polyaxial bone anchoring device comprising:
an anchoring element having a shank for anchoring in a bone and a head having a spherically-shaped outer surface portion;
a receiving part having a first end and a second end, a central axis extending through the first end and the second end, a transverse channel at the first end for receiving a rod, and an accommodation space for accommodating the head, the accommodation space having an opening at the second end; and
a sleeve-like insert piece configured to be arranged around a portion of the head and to be arranged in and to pivot in the accommodation space of the receiving part;
wherein when the insert piece is arranged around the head, the insert piece is insertable into the accommodation space through the opening of the receiving part; and
wherein when the head and the insert piece are arranged in the receiving part, the anchoring element and insert piece are pivotable with respect to the receiving part, and can be locked by exerting pressure onto the head.
2. The polyaxial bone anchoring device of claim 1 , wherein the receiving part comprises a first engagement portion near the second end, and the insert piece comprises a second engagement portion for engaging the first engagement portion.
3. (canceled)
4. The polyaxial bone anchoring device of claim 2 , wherein the accommodation space has a portion with a largest diameter, and wherein the first engagement portion extends from the opening towards the portion of the accommodation space with the largest diameter.
5. The polyaxial bone anchoring device of claim 2 , wherein the second engagement portion extends over a full outer surface of the insert piece.
6. The polyaxial bone anchoring device of claim 2 , wherein the insert piece is insertable into the accommodation space by engaging the first engagement portion and the second engagement portion, and wherein when the insert piece is inserted in the accommodation space and the first engagement portion and the second engagement portion are disengaged, the insert piece is freely pivotable in the accommodation space.
7. The polyaxial bone anchoring device of claim 2 , wherein when the insert piece is in the receiving part, the first engagement portion and the second engagement portion form a stop to prevent the insert piece from being removed from the receiving part.
8. The polyaxial bone anchoring device of claim 1 , wherein the insert piece is configured to be held on the head by friction.
9. The polyaxial bone anchoring device of claim 1 , wherein the insert piece has a first edge and a second edge, and wherein an engagement portion is provided at the second edge for engaging a tool.
10. The polyaxial bone anchoring device of claim 1 , wherein the accommodation space defines a hollow spherically-shaped portion, and the insert piece has an outer spherically-shaped surface portion.
11. The polyaxial bone anchoring device of claim 1 , wherein when the insert piece is arranged around the head and inserted in the receiving part, the insert piece and the anchoring element are independently pivotable relative to the receiving part when the shank of the anchoring element and an edge of the insert piece are out of contact.
12. The polyaxial bone anchoring device of claim 11 , wherein when the shank of the anchoring element engages the edge of the insert piece, the anchoring element and the insert piece are pivotable together.
13. The polyaxial bone anchoring device of claim 1 , wherein the insert piece has an inner spherical surface portion that forms a seat for the head.
14. The polyaxial bone anchoring device of claim 1 , wherein the insert piece is rigid.
15. The polyaxial bone anchoring device of claim 1 , wherein when the head and the insert piece are in the receiving part, the bone anchoring device is configured to be held at a position where a preload is exerted onto the head to clamp the head by friction at a first adjustable position before final locking of an angular position of the anchoring element relative to the receiving part.
16. The polyaxial bone anchoring device of claim 1 , wherein the insert piece is rotationally symmetrical.
17. A method of coupling a rod to a bone or vertebra via a polyaxial bone anchoring device, the bone anchoring device comprising an anchoring element having a shank for anchoring in a bone and a head having a spherically-shaped outer surface portion, a receiving part having a first end and a second end, a central axis extending through the first end and the second end, a transverse channel at the first end for receiving a rod, and an accommodation space for accommodating the head, the accommodation space having an opening at the second end, a sleeve-like insert piece configured to be arranged around a portion of the head and to be arranged in and to pivot in the accommodation space of the receiving part, and a fixation element, the method comprising:
connecting the anchoring element to the receiving part by introducing the head with the insert piece arranged around the head through the opening and into the accommodation space of the receiving part, wherein the anchoring element and the insert piece are pivotable with respect to the receiving part;
inserting the anchoring element into a bone or vertebra;
pivoting the receiving part relative to the anchoring element;
inserting a rod into the channel of the receiving part; and
advancing the fixation element in the channel, such that the fixation element exerts pressure on the rod, to exert pressure onto the head of the anchoring element, to lock respective angular positions between the anchoring element, the insert piece, and the receiving part.
18. The method of claim 17 , further comprising attaching the insert piece to the head of the anchoring element prior to connecting the anchoring element to the receiving part.
19. (canceled)
20. The method of claim 17 , further comprising holding the bone anchoring device at a first position when the anchoring element is connected to the receiving part and the rod is not inserted into the channel, such that a frictional force is exerted on the head of the anchoring element to hold the angular position of the receiving part relative to the anchoring element, wherein said position is adjustable by applying a force greater than the frictional force on the receiving part or the anchoring element.
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US10610265B1 (en) | 2017-07-31 | 2020-04-07 | K2M, Inc. | Polyaxial bone screw with increased angulation |
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EP2757988A4 (en) | 2009-06-15 | 2015-08-19 | Jackson Roger P | Polyaxial bone anchor with pop-on shank and winged insert with friction fit compressive collet |
JP2013542774A (en) * | 2010-10-05 | 2013-11-28 | ダニエル エス. サベージ | Pedicle screw assembly and assembly method |
AU2011324058A1 (en) * | 2010-11-02 | 2013-06-20 | Roger P. Jackson | Polyaxial bone anchor with pop-on shank and pivotable retainer |
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-
2011
- 2011-08-18 ES ES11178035.9T patent/ES2504067T3/en active Active
- 2011-08-18 EP EP20110178035 patent/EP2559390B1/en active Active
-
2012
- 2012-08-15 CN CN201210289552.XA patent/CN102949231B/en not_active Expired - Fee Related
- 2012-08-15 TW TW101129445A patent/TW201309256A/en unknown
- 2012-08-15 US US13/586,454 patent/US9247965B2/en active Active
- 2012-08-15 JP JP2012180032A patent/JP6073597B2/en not_active Expired - Fee Related
- 2012-08-16 KR KR20120089699A patent/KR20130020610A/en not_active Application Discontinuation
-
2016
- 2016-01-04 US US14/987,437 patent/US20160192965A1/en not_active Abandoned
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US10610265B1 (en) | 2017-07-31 | 2020-04-07 | K2M, Inc. | Polyaxial bone screw with increased angulation |
US11229459B2 (en) | 2017-07-31 | 2022-01-25 | K2M, Inc. | Polyaxial bone screw with increased angulation |
Also Published As
Publication number | Publication date |
---|---|
KR20130020610A (en) | 2013-02-27 |
EP2559390B1 (en) | 2014-06-18 |
ES2504067T3 (en) | 2014-10-08 |
JP6073597B2 (en) | 2017-02-01 |
EP2559390A1 (en) | 2013-02-20 |
TW201309256A (en) | 2013-03-01 |
US20130096620A1 (en) | 2013-04-18 |
JP2013039369A (en) | 2013-02-28 |
US9247965B2 (en) | 2016-02-02 |
CN102949231B (en) | 2016-10-05 |
CN102949231A (en) | 2013-03-06 |
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