A BOLT APPARATUS FOR VERTEBRAL FIXATION

Abstract

The present invention relates to a bolt apparatus for vertebral fixation. In particular, the apparatus finds utility as a bolt apparatus for fixation of bones of the vertebral column (or spine or backbone), each bone known as a vertebra. In certain embodiments, the bolt apparatus has a body comprising an expandable section and expanding means to displace the expandable section between a contracted position and an expanded position; and a cross-section of at least part of the body is non-circular.

Claims

1. A bolt apparatus for fixation of spinal bones, said bolt apparatus having a body, said body comprising: (a) an expandable section having respective ends, wherein said expandable section is operable between a contracted position and an expanded position; and (b) expanding means in operable association with said expandable section, to displace said expandable section between said contracted position and said expanded position by applying force to said respective ends of said expandable section, such that each of said respective ends of said expandable section is advanced toward an opposing respective end; wherein a cross-section of at least part of said body is non-circular.

2. The bolt apparatus according to claim 1, wherein said cross-section of at least part of said body is ovate.

3. The bolt apparatus according to claim 1, wherein said body has a first end and a second end, and said cross-section of said second end of said body is non-circular.

4. The bolt apparatus according to claim 3, wherein said (a) expandable section and said (b) expanding means are located at said first end of said body.

5. The bolt apparatus according to claim 3, wherein said bolt apparatus further comprises at least one fin, wherein said at least one fin projects from said body.

6. The bolt apparatus according to claim 5, wherein said at least one fin is located at said second end of said body.

7. The bolt apparatus according to claim 5, wherein said bolt apparatus comprises at least two fins.

8. The bolt apparatus according to claim 5, wherein said at least one fin is tapered toward said first end of said body with respect to a longitudinal axis of said body.

9. The bolt apparatus according to claim 1, wherein said expanding means displaces said expandable section between said contracted position and said expanded position by simultaneously applying force to said respective ends of said expandable section, such that each of said respective ends of said expandable section is advanced toward an opposing respective end.

10. The bolt apparatus according to claim 1, wherein said expanding means is in operable association with said expandable section, to displace said expandable section between said contracted position and said expanded position by applying force to said respective ends of said expandable section, such that each of said respective ends of said expandable section are independently advanced toward an opposing respective end.

11. The bolt apparatus according to claim 1, wherein said expanding means comprises a connecting means, and at least two bodies mountable to said connecting means.

12. The bolt apparatus according to claim 11, wherein said connecting means is a shaft.

13. The bolt apparatus according to claim 11, wherein said at least two bodies are threadably mountable to said connecting means.

14. The bolt apparatus according to claim 11, wherein said connecting means comprises first and second threaded portions, wherein said threads of said first portion are of reverse orientation to said threads of said second portion.

15. The bolt apparatus according to claim 1, wherein said expandable section comprises at least two expandable members that extend from a longitudinal axis of said bolt apparatus under mechanical pressure.

16. A method for vertebral fixation comprising the steps of: (a) creating a pathway into a vertebral bone; (b) inserting the bolt apparatus according to claim 1 into said pathway; and (c) displacing said expandable section between said contracted position and said expanded position by applying force to said respective ends of said expandable section, such that each of said respective ends of said expandable section is advanced toward an opposing respective end; thereby fixing said vertebral bone,

17. A method for vertebral fixation comprising the steps of: (a) creating a pathway into a vertebral bone; (b) inserting the bolt apparatus according to claim 5 into said pathway; (c) advancing said at least one fin into said vertebral bone; and (d) displacing said expandable section between said contracted position and said expanded position by applying force to said respective ends of said expandable section, such that each of said respective ends of said expandable section is advanced toward an opposing respective end; thereby fixing said vertebral bone.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings, in which:

[0053] FIG. 1A is a perspective view of a distal end of a bolt apparatus according to a first embodiment of the present invention;

[0054] FIG. 1B is a perspective view of a proximal end of the bolt apparatus of FIG. 1;

[0055] FIG. 2 is an exploded perspective view of the bolt apparatus of FIG. 1;

[0056] FIG. 3A is a perspective view of a bolt apparatus according to a second embodiment of the present invention with the expandable section in a contracted position; and

[0057] FIG. 3B is a perspective view of a bolt apparatus according to a second embodiment of the present invention with the expandable section in an expanded position.

[0058] In the drawings, similar reference numerals will be used to indicate like parts.

DETAILED DESCRIPTION OF THE INVENTION

[0059] Referring now to the drawings, there is shown a bolt apparatus 10 according to a preferred embodiment of the invention. The bolt apparatus 10 has a body 12.

[0060] The body 12 comprises an expandable section 14 operable between a contracted position and an expanded position; and expanding means 16 in operable association with the expandable section 14. The expanding means 16 can displace the expandable section 14 between the contracted position and the expanded position by applying force to the respective ends of the expandable section 14, such that each of the respective ends of the expandable section 14 are advanced toward the opposing respective end.

[0061] A cross-section of at least part of the body 12 is non-circular.

[0062] In this embodiment, the cross-section of at least part of the body 12 is ovate, but the cross-section of at least part of the body 12 can be elliptical or oviform. In another embodiment, the cross-section of at least part of the body 12 is obround.

[0063] In this embodiment, the body 12 has first 12a and second 12b opposing ends. The expandable section 14 and the expanding means 16 are located at a first end 12a of the body 12. The cross-section of the second end 12b of the body 12 is non-circular, in this embodiment ovate.

[0064] The bolt apparatus 10 further comprises at least one fin 18. Each of the at least one fins 18 projects from the body. Each of the at least one fins 18 is located at the second end 12b of the body 12. In this embodiment, the bolt apparatus further comprises a pair of fins 18a, 18b. Each fin 18a, 18b projects from the body 12 and is located at the second end 12b of the body 12. Although not essential, each fin 18a in the pair is located diametrically opposed to the other fin 18b in the pair. Each fin 18 is tapered, preferably tapered with respect to the longitudinal axis of the body 12. In this preferred embodiment, the at least one fin 18 is tapered toward the first end 12a of the body 12.

[0065] The expanding means 16 displaces the expandable section 14 between the contracted position and the expanded position by simultaneously applying force to the respective ends 14a, 14b of the expandable section 14, such that each respective end 14a of the expandable section 14 is advanced toward the opposing respective end 14b. Each opposing respective end 14a, 14b can be simultaneously displaced by the independent and simultaneous application of a force to each of the respective ends 14a, 14b of the expandable section 14.

[0066] Preferably, the expanding means 16 comprises a connecting means 20 and at least two bodies 22a, 22b mountable to the connecting means 20. The connecting means 20 can be a shaft 20, which comprises an elongate member, and which is generally cylindrical in shape. The connecting means 20 is adapted to allow reciprocal movement of the at least two bodies 22a, 22b relative to the connecting means 20. The at least two bodies 22, 22b can be threadably mountable to the connecting means 20 and arranged for displacement in response to rotation of the connecting means 20 to simultaneously and independently apply mechanical pressure to the respective ends 14a, 14b of the expandable section 14.

[0067] In the preferred embodiment, the connecting means 20 is a shaft 20, which comprises first 20a and second 20b threaded portions, wherein the threads of the first portion 20a are of reverse orientation to the threads of the second portion 20b. Preferably, the threaded portions 20a, 20b of the connecting means 20 are helically threaded portions.

[0068] Preferably, the first body 22a is mountable to the first threaded portion 20a of the connecting means 20, and the second body 22b is mountable to the second threaded portion 20a of the connecting means 20.

[0069] In this embodiment, the first 20a and second 20b threaded portions are located adjacent one end, for example a distal end, of the connecting means 20.

[0070] In this preferred embodiment, the body 12 comprises a tube, which is generally cylindrical in shape and is open at each end. The inner surface of the body 12 is generally circular in transverse cross-section. The internal diameter of the body 12 is generally of similar length to the external diameter of the shaft 20, whereby the shaft 20 can be located longitudinally and rotated coaxially within the body 12.

[0071] In this preferred embodiment, one of the first body 22a is integral to the body 12 and comprises a helical screw thread provided along a limited length of the inner surface of the body 12.

[0072] The helical screw thread provided along a limited length of the inner surface of the body 12 can engage with one of the screw threaded portions 20a, 20b of the shaft 20. Specifically, a first helical screw thread provided along a limited length of the inner surface of the body 12 engages with the first screw threaded portion 20a of the shaft 20.

[0073] The proximal end of the connecting means 20 can be dimensioned and arranged to receive a torque delivery device such as a screwdriver, or similar device, so as to provide means for delivering torque to the connecting means 20. In an alternative embodiment, the proximal end of the connecting means 20, for example the shaft 20 is dimensioned and arranged to allow rotation thereof by a hex key, or similar device. However, it will be appreciated that any shape of screw drive to deliver the required torque may be used.

[0074] One, both, or each of the at least two bodies 22a, 22b can be engaged with at least one of the respective ends 14a, 14b of the expandable section 14. In such an embodiment, the expandable section 14 can be reversibly expandable, for example under mechanical pressure. Additionally, the expandable section 14 can be collapsible along its longitudinal axis, for example the expandable section 14 can be radially inwardly collapsible.

[0075] The expandable section 14 comprises expandable members 24, for example deformable arms 24, which extend from the longitudinal axis of the apparatus 10 under mechanical pressure. The expandable member 24, for example a deformable arm 24, extends radially from the longitudinal axis of the apparatus under mechanical pressure. In a preferred embodiment, at least one point of folding 24a is provided along each deformable arm 24. Each point of folding 24a acts as a point of weakness, a hinge mechanism, or any such mechanism to facilitate the folding of the deformable arm 24 at a desired location. A point of weakness 24a can be provided at each of the respective ends of each deformable arm 24, where the deformable arm 24 is attached to the respective ends of the expandable section 14; and adjacent the centre point of the length of each deformable arm 24.

[0076] The cross-section of the expandable section 14 is circular. The expandable section 14 is located at the first end 12a of the body 12 in a preferred embodiment and the cross-section of the expandable section 14 is circular.

[0077] The assembly comprising the shaft 20 and the mountable bodies 22a, 22b is located coaxially within the body 12.

[0078] Once assembled, each of the mountable bodies 22a, 22b is located on a respective screw threaded portion 20a, 20b of the shaft 20. Each of the mountable bodies 22a, 22b is in tandem but opposite orientation relative to the other mountable body, and is located at each respective end of the expandable section 14. Each of the mountable bodies 22a, 22b can be attached to each respective end 14a, 14b of the expandable section 14 by an adherent means, such as an adhesive.

[0079] In the preferred embodiment, to assemble the bolt apparatus 10, the second mountable body 22b is located onto the second screw threaded portion 20b of the shaft 20. The shaft 20 is then inserted coaxially into the lumen of the body 12, and the first screw threaded portion 20a of the shaft 20 is engaged with a helical screw thread on the inner surface of the body 12, such that the second mountable body 22b is located coaxially within, and irreversibly engages with, the lumen of the body adjacent the distal end.

[0080] Rotation of the shaft 20 within the body 12 causes each of the mountable bodies 22a, 22b to respectively advance along the screw threaded portions 20a, 20b, respectively, of the shaft 20. This applies mechanical pressure to the respective ends 14a, 14b of the expandable section 14, wherein the respective ends 14a, 14b are bought sequentially into closer proximity relative to one another, causing the deformable arms 24 of the expandable section 14 to deform at each of the points of weakness 24a, and to expand radially from the longitudinal axis of the bolt assembly 10.

[0081] The second body 22b can be a set screw 26. The set screw 26 can comprise a helical screw thread provided along a limited length of the inner surface of the set screw 26. The helical screw thread provided along a limited length of the inner surface of the set screw 26 can be threadably mountable to the connecting means 20, for example, to the second threaded portion 20b of the connecting means 20. The set screw 26 can be irreversibly secured, for example welded to the body 12, for example the second or posterior end 12b of the body 12.

[0082] Rotation of the shaft 20 in the opposite direction can ultimately cause the deformable arms 24 to retract toward the longitudinal axis of the bolt assembly 10, thereby facilitating the removal of the device, if required.

[0083] The bolt apparatus 10 is preferably formed of a material that is suitable for sterilisation, such as an autoclavable material, so as to be provided in a sterile packaged state for use. The material can be surgical stainless steel, but it will be seen that any material that is suitable for sterilisation and can impart the required mechanical strength may be used.

[0084] In a method for vertebral fixation; the bolt apparatus 10, once assembled and with the expandable section 14 in a contracted position, is placed from the posterior aspect of the spine. After surgical exposure, the anatomical landmarks are identified. The posterior cortical crest of bone is removed, for example with a rongeur or burr, to expose the underlying cancellous bone. The entry point is prepared, preferably with an awl. Using a curved blunt probe, a pathway into the pedicle is created. The probe should follow a path of least resistance without violating the pedicle walls. If resistance is felt, the entry point and trajectory should be re-evaluated. At any stage, correct position can be confirmed, for example with fluoroscopy. Other instruments, such as a pedicle feeler or drilling tool (such as PediGuard® by SpineGuard) can also be used to assist positioning and/or trajectory.

[0085] The pathway in cancellous bone may be enlarged by use of successive reamers of increasing outer diameter, ensuring that the cortical bone of the pedicle or vertebral body is not breached. A starter cavity within the cancellous bone of the vertebral body may be prepared with an instrument such as a curette or a bone compactor, later into which the deformable arms 24 of the expandable section 14 of the body 12 of the bolt apparatus 10 will radially expand.

[0086] When the bone pathway has been prepared, the bolt apparatus 10, once assembled and with the expandable section 14 in a contracted position, is inserted from the posterior aspect of the vertebra, through the pedicle and into the vertebral body. The position of the fins 18 should be noted, keeping the fins 18 broadly within the superior-inferior (sagittal) plane. Position may be checked with an image intensifier, noting that the location of the expandable section 14 is appropriately placed within the vertebral body and not in the pedicle.

[0087] The bolt apparatus 10 may be advanced gradually by light hammering on the base (posterior end) of the bolt apparatus 10. This may help advance the fins 18 into the cancellous bone of the pedicle.

[0088] The deformable arms 24 of the expandable section 14 of the body 12 of the bolt apparatus 10 are radially expanded using, for example, a screwdriver inserted into, for example, a hex socket in the proximal end of the connecting means 20, for example the shaft 20, with counter rotation being resisted by an instrument, such as a spanner, placed at the posterior end 12b of the bolt apparatus 10. Expansion is continued until a mechanical stop is felt, or until the torque limiter of the screwdriver trips out, or from operator choice from visual feedback on the image intensifier.

[0089] Whilst the expandable section 14 is being expanded, the posterior end 12b of the bolt apparatus 10 will be pulled anteriorly, deeper into the cancellous bone. This will advance further the fins 18 into the cancellous bone of the pedicle in a controlled manner with ergonomic feedback to the user. The fins 18 provide additional fixation strength and rotational stability to the bolt apparatus 10. The fins 18 have the advantage of gaining additional fixation within the ovate pedicle that would otherwise not be utilised by a circular cross-sectioned screw.

[0090] Should undue resistance be felt via the screwdriver, or torque limit of the screwdriver tripped out, the user may reassess position of the bolt apparatus 10 in relation to the cortical bone of the pedicle and vertebral body. If necessary, the expansion may be reversed by counter-clockwise rotation of the screwdriver and the bolt apparatus 10, with the expandable section 14 in the contracted position, removed.

[0091] The bolt apparatus 10 has a posterior end 12b, which can be monoaxial, polyaxial or uniplanar, to facilitate the ease of, and appropriate connection with, posterior metal rods. The posterior end 12b of the bolt apparatus 10 can comprise a large U-shaped component 28 to engage with posterior spinal rods.