Polyaxial locking assembly
RE049123 · 2022-07-05
Assignee
Inventors
Cpc classification
A61B17/8047
HUMAN NECESSITIES
A61B17/8038
HUMAN NECESSITIES
International classification
A61B17/80
HUMAN NECESSITIES
Abstract
A locking mechanism for a polyaxial locking screw is provided, together with a polyaxial locking assembly for locking a receiving member to a substrate. Also provided is a plating system for pelvic reconstruction.
Claims
1. A polyaxial locking assembly, comprising: a receiving member comprising at least one open cavity having a generally spherical inner surface; a .Iadd.one-piece .Iaddend.bushing with a generally spherical outer surface sized and shaped to fit within the cavity, .[.said.]. .Iadd.the outer surface engaging the inner surface of the at least one open cavity, and the .Iaddend.bushing comprising a hole aligned with an axis of the bushing, .[.said.]. .Iadd.the .Iaddend.hole further provided with .[.a.]. female .[.thread.]. .Iadd.threads.Iaddend.; a screw provided with .[.a.]. male .[.thread.]. .Iadd.threads .Iaddend.for engagement, in use, with the .Iadd.female threads of the .Iaddend.bushing.[.and the hole and thread thereof;.]., wherein the .Iadd.at least one .Iaddend.open cavity is provided with at least one radially outwardly protruding .Iadd.cavity .Iaddend.keyway; .Iadd.wherein .Iaddend.the bushing further .[.comprising.]. .Iadd.comprises .Iaddend.a .Iadd.bushing .Iaddend.groove aligned with .[.a.]. .Iadd.an outer .Iaddend.perimeter of the bushing, .[.said.]. .Iadd.the outer .Iaddend.perimeter being on a plane substantially orthogonal to the bushing axis, the bushing groove being shaped so that the bushing, at .[.a.]. .Iadd.an inner .Iaddend.perimeter of the .Iadd.bushing .Iaddend.groove and on .[.said.]. .Iadd.the .Iaddend.plane, .[.provides.]. .Iadd.defines .Iaddend.a cam.[., said cam.]. having at least one lobe; .[.there is further provided.]. an anti-rotation member that, in use, is positioned within the bushing groove between the cam and an inner surface of the cavity, the anti-rotation member further comprising a key for cooperative engagement with the cavity keyway such that the ability of the anti-rotation member to rotate within the cavity is restrained; .Iadd.wherein .Iaddend.the anti-rotation member further having a generally annular, open or closed geometry and having a radial thickness, and further being contoured such that at least one portion of the anti-rotation member has an effective radial thickness greater than that of at least one other portion; .Iadd.and .Iaddend. .[.such that.]. .Iadd.wherein .Iaddend.in use, the screw may be threaded into the bushing until it reaches a limit of travel, whereupon further rotation of the screw also rotates the bushing, forcing the effectively radially thicker portion of the anti-rotation member outwards so that the anti-rotation member engages with the inner surface of the cavity and causes a build up of friction between the cam, the anti-rotation member and the inner surface of the cavity, so as to lock the assembly in a desired orientation.
.Iadd.2. The polyaxial locking assembly of claim 1, wherein the anti-rotation member is closed and substantially circular. .Iaddend.
.Iadd.3. The polyaxial locking assembly of claim 1, wherein the anti-rotation member is open and generally c-shaped. .Iaddend.
.Iadd.4. The polyaxial locking assembly of claim 1, wherein the hole of the bushing is a blind hole. .Iaddend.
.Iadd.5. A polyaxial locking assembly, comprising: a receiving member comprising a cavity having an inner surface with a generally spherical profile with at least one outwardly-protruding keyway; a one-piece bushing having an outer profile, wherein a portion of which has a generally spherical outer surface configured to fit within the cavity, wherein the outer surface engages the inner surface of the cavity, the bushing further comprising a threaded hole defining a bushing axis and a perimeter groove located on a plane substantially orthogonal to the bushing axis, the perimeter groove having at least one outwardly-extending protrusion; and an anti-rotation member configured to be positioned within the bushing groove, the anti-rotation member having a key for engagement within the keyway, wherein the anti-rotation member has a first radial thickness and a portion with a second radial thickness effectively greater than that of the first radial thickness. .Iaddend.
.Iadd.6. The polyaxial locking assembly of claim 5, further comprising a screw adapted for operative engagement with threads of the threaded hole of the bushing, wherein rotation of the screw beyond a predetermined amount rotates the bushing which urges the portion of the anti-rotation member with the second radial thickness against the inner surface of the cavity. .Iaddend.
.Iadd.7. The polyaxial locking assembly of claim 5, wherein the anti-rotation member is closed and substantially circular. .Iaddend.
.Iadd.8. The polyaxial locking assembly of claim 5, wherein the anti-rotation member is open and generally c-shaped. .Iaddend.
.Iadd.9. The polyaxial locking assembly of claim 5, wherein the hole of the bushing is a blind hole. .Iaddend.
.Iadd.10. The polyaxial locking assembly of claim 5, wherein the perimeter groove does not extend the entire perimeter of the bushing. .Iaddend.
.Iadd.11. The polyaxial locking assembly of claim 5, wherein the cavity of the receiving member is a first cavity, and further comprising a second cavity configured to accept a second bushing comprising a threaded hole that defines a second bushing axis. .Iaddend.
.Iadd.12. The polyaxial locking assembly of claim 11, wherein the bushing axis of the first cavity and the second bushing axis are parallel. .Iaddend.
.Iadd.13. The polyaxial locking assembly of claim 11, wherein the bushing axis of the first cavity and the second bushing axis are not parallel. .Iaddend.
.Iadd.14. The polyaxial locking assembly of claim 5, wherein the cavity has a first beveled end associated with a first surface of the receiving member and a second beveled end associated with a second surface of the receiving member. .Iaddend.
.Iadd.15. The polyaxial locking assembly of claim 5, wherein the receiving member has tapered first and second ends. .Iaddend.
.Iadd.16. A polyaxial locking assembly, comprising: a receiving member comprising a hole extending therethrough with a generally cylindrical inner surface having at least one outwardly-extending portion with an outer dimension greater than a radius of the at least one hole; a one-piece bushing configured to fit within the hole and having an outer profile complementary to the inner surface of the hole, wherein the outer surface engages the inner surface of the hole, the bushing having a threaded hole defining a bushing axis, and wherein the outer profile comprises a perimeter groove located on a plane substantially orthogonal to the bushing axis, the perimeter groove having at least one outwardly-extending protrusion; and an anti-rotation member configured to be positioned within the bushing groove, the anti-rotation member further comprising an outwardly-extending finger for engagement within the outwardly-extending portion of the hole, the anti-rotation member having a first radial thickness and at least one portion with a second radial thickness that is effectively greater than that of the first radial thickness. .Iaddend.
.Iadd.17. The polyaxial locking assembly of claim 16, further comprising a screw adapted for operative engagement with the threaded hole of the bushing, wherein rotation of the screw beyond a predetermined amount rotates the bushing to urge the at least one portion with a second radial thickness against the inner surface at least one hole. .Iaddend.
.Iadd.18. The polyaxial locking assembly of claim 16, wherein the anti-rotation member is open and generally c-shaped. .Iaddend.
.Iadd.19. The polyaxial locking assembly of claim 1, wherein the bushing is a unitary structure. .Iaddend.
.Iadd.20. The polyaxial locking assembly of claim 16, wherein the bushing is a unitary structure. .Iaddend.
Description
(1) The present invention will now be described, by way of example only, with reference to the accompanying drawings in which:
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(20) Various polyaxial locking assemblies are known in the art. The present invention provides for a further alternative improved such assembly.
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(22) The cavity is designed to accept an assembly (
(23) The bushing (
(24) As shown in
(25) When assembled, the anti-rotation member is engaged within the groove of the bushing. The bushing/anti-rotation member assembly is installed in the cavity of the plate, with the location key of the anti-rotation member engaged within the keyway of the plate (
(26) Upon insertion of the locking screw, the initial threaded portion passes through the bushing from the upper side of the plate to the lower side of the plate and into the substrate in question—in a preferred embodiment such substrate being bone and the initial threaded portion 516 being a self-drilling, self-tapping and reverse cutting mechanism for insertion into said bone (
(27) In an alternative embodiment, the bushing may be provided with no threading in the hole, the hole having a tapered configuration, and a screw may be provided with a tapered section for cooperation with this tapered hole in the bushing. Provided a force is applied in the axial direction which drives the tapered section of the screw into the tapered section of the bushing, rotation of the screw will result in rotation of the bushing and the locking mechanism of the polyaxial assembly will activate. Such a force may for example be applied in the instance that the screw has a lower section 516 which is screwed into a substrate, resulting in a force which ‘pulls’ the upper tapered section of the screw into the tapered hole of the bushing. In such an embodiment, one or both surfaces of such unthreaded tapers—female tapered hole in bushing and male tapered section of screw—may be non-smooth so as to increase the amount of available friction. In yet further alternatives, a screw with an unthreaded section and a shoulder may engage with a mating surface in the bushing, or a screw with a head at its upper end may engage with the upper surface of the bushing.
(28) The person skilled in the art will recognise these simply as various methods of providing a means of transmitting torque from a screw to the bushing so as to rotate the bushing and activate the locking mechanism, and will also recognise that other means may be provided for this and that the screw may be replaced with a bolt or other item. In one further alternative, it would be possible to provide the bushing on its upper surface with a slot or slots for a flat-bladed or ‘phillips’ cross-bladed screwdriver. With the bushing/anti-rotation member assembly in position within the cavity of the receiving member, the bushing could then be rotated by means of a screwdriver until the cam of the groove cross-section engages with the anti-rotation member, so that the bushing/anti-rotation member ‘locks’ in place in desired orientation. Any screw or bolt or other item may then be attached to the bushing or driven through it with its axis in a particular desired orientation as then defined by the locked-in position of the bushing.
(29) The polyaxial assembly described above, comprising at least a bushing and anti-rotation member, cooperating with a generally spherical cavity with a keyway and optionally also including a screw, may be used in conjunction with the plating system for the anterior pelvic ring as described below; the polyaxial assembly being used in place of the locking mechanism also described below. It will of course be readily understood by those skilled in the art that the polyaxial assembly described may be used in any number of applications, indeed any application where a polyaxial screw with a locking mechanism is required. In particular, the assembly may be used in any of the applications typical in the field of orthopedics, where various types of plate or support systems require affixing to skeletal structures of the human or animal corpus.
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(31) The bushing 30 is annular and comprises an inner surface that has is part-spherical in cross section. On the outer surface is provided with a screw-thread 32. The bushing 30 is sized such that the screw-thread 32 on the outer surface can interface with the screw-thread 28 lining the opening 26 in the plate 20. The bushing 30 is also provided with a tab 34 that protrudes radially inwardly from the part-spherical inner surface of the bushing 30.
(32) The split grommet 40 has an outer surface 42 that has a part-spherical profile and an inner surface that is provided with a screw-thread 44 for engagement, in use, with a locking screw. The split grommet 40 is capable of rotation in the X- and Y-axes (as illustrated in
(33) One example of a locking insertable screw 50 for use with the locking mechanism 10 is shown in
(34) The provision of the part-spherical surfaces on the inner surfaces of the opening in the plate 20 and the bushing 30 and the outer surface of the grommet 40 ensure that there is a high contact area between the components.
(35) The use of square section threads provides a resistance to cross-threading and the capacity of the thread to cause radial expansion of the grommet as the taper of the locking screw engages.
(36) The finish of the contact area between the plate 20, the bushing 30 and the grommet 40 is profiled in such a way as to facilitate a high level of friction between the assembled components and thus a friction interference fit during the process of radial expansion. The tolerances of the component parts prior to engagement of the locking mechanism are such that low friction rotation of the grommet within the design arc is possible.
(37) Alignment of the locking mechanism with the drilled hole in bone is facilitated by means of a drill guide 60 which is provided with a male thread 62 at its distal end that engages the female tapered square-section locking thread of the grommet 40. The diameter of the drill is smaller than that of the core diameter of the cortical screw such that insertion of the screw causes radial expansion and impaction of the surrounding bone which improves pull-out resistance in cancellous bone.
(38) The plate 20, bushing 30 and grommet 40 are fabricated from titanium alloys, in particular, titanium alloys that include aluminium and vanadium. They may also be surface finished to improve the fatigue strength of the parts. In addition, the surface finishing may include electroplating enabling the parts to be colour coded to aid quick identification of the parts.
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(40) The symphyseal plate 20 is arcuate and is contoured to match the radius of the pelvic inlet at the symphysis pubis, extending into the superior pubic ramus. The maximal depth of the plate 20 is of the order of 5 mm which is similar to the dimensions of plates designed to resist fatigue failure in long bone fractures. Each end 29 of the plate 20 beyond the most laterally distant of the openings 26 is tapered in two planes to facilitate ease of passage under the soft tissues required of minimally invasive surgical approaches. The plate 20 is also wasted around each of the openings 26.
(41) The plate contains cylindrical bores to accommodate 2 mm K-wires which may be utilised for the temporary positioning and stabilisation of the plate and prior to insertion of the poly-axial locking screws.
(42) Although the example illustrated in
(43) In addition to the four- and six-locking mechanism configurations, other applications may provide for a plate with a greater number of locking mechanisms in a range of different configurations. Other applications may provide for a plate constructed of materials other than a titanium alloy in order to provide a closer matching of the modulus of elasticity for that of cancellous bone. Such materials may include carbon fibre reinforced poly-ethyl-ethyl-ketone (PEEK).
(44) An example of a posterior pelvic reconstruction system 70 is illustrated in
(45) The locking screws 50 may be cortical or cancellous. However, as the diameter of the core is increased, the resistance to fatigue failure also increases. Therefore, cortical screws may be used in preference over cancellous screws. Indeed, the screws used may have a larger than standard core diameter.
(46) The posterior pelvic reconstruction system 70 provides for a biomechanically optimised device which is specific to the complex anatomical configuration of the posterior pelvic ring and takes account of the fact that the sacrum is a transitional zone between the pelvic ring and the axial skeleton or spine. Fracture-dislocations of the posterior pelvic ring are subject to complex, cyclical loading patterns with six degrees of freedom in single leg stance and may be inclusive of or independent of axial skeletal stability. “H”-pattern fractures for example require extension of the internal reconstruction configuration into the L5 and L4 pedicles. Furthermore and by inference, stability of the axial skeleton or spine in the case of long segment spinal fusions which include the lumbar-sacral junction require stable fixation into the pelvic ring.
(47) The plates 20 are anatomically contoured to be applied to the medial surface of the posterior iliac crests which requires that the plates are right and left sided, i.e. the two plates 20 are substantially mirror images of one another. The plates 20 provide a stable platform for the internal fixation of adjacent anatomical structures which include the greater sciatic buttress of the right and left hemi-pelvis and the S1 pedicles. In order to achieve this fixation, each of the plates is provided with a plurality of locking mechanisms 10 which provide poly-axial fixation by virtue of the angular deviation between the fenestrations or openings 26 in the plates 20 and also by virtue of the three component locking mechanism 10 described above with reference to
(48) A female threaded section may provided at either end of the cannulated section for engagement with a right hand threaded compression bolt 81. Two compression bolts are provided of which only one is shown. The compression bolts configured to be passed, in use, through drill holes in the posterior iliac crests. As the bolts 81 are tightened, the tapered section engages the countersunk outer cortex of the iliac crest, providing compression between the iliac crest and the transverse rod 72 and thus resisting disengagement of the transverse rod 72 from the plates 20.
(49) One of the transverse rods 72, typically the uppermost rod, that links the left and right plates 20 may be cannulated. The transverse rods 72 are provided with textured longitudinal slots 64 which engage male threaded grub screws. These screws engage female threaded fenestrations 26 in the plate 20. This arrangement has a dual function. The friction fit of the grub screws with the textured surface of the slot 64 prevents disengagement of the transverse rods 72 from the plates 20. Furthermore, the grub screws, by engagement with the plates 20 and the slots 64 prevent rotational distortion of the trapezoid formed by the transverse rods 72 and the plates 20. The transverse rods 72 together with the left and right plates 20 provide a stable link between instrumentation of the right and left hemi-pelvis and thus completing the posterior pelvic ring. The trapezoidal shape created between the two plates 20 and the two rods 72 ensures this stability within the system.
(50) Further vertical stability may be gained in both pelvic and spinal instrumentation applications by means of extension into the L5 and L4 pedicles or beyond. This process requires hybridisation with generic spinal instrumentation systems and is facilitated by the hook assembly 74 applied to the transverse rod 72. The hook assembly 74 operates as a compression system comprising a rod holder 75; a grub screw 82 and an aperture restriction ring 73. The rod holder 75 has a C-shaped cross section hook sized to conform to the transverse rod and a split aperture that has a smooth interior surface that is sized to conform to a rod 68 that forms part of the spinal instrumentation system 76. In one of the extremities of the C-shape (at the top of the holder 75 as illustrated) there is provided an indented female thread into which the grub screw 82 may be introduced. The grub screw is typically an M8 grub screw, although other sizes may be used as appropriate. Initially, the rod holder 75 engages the transverse rod 72. The rod 68 from the spinal instrumentation system 76 can then be introduced into the split aperture. The split aperture is then secured by the aperture restriction ring 73. As a result of the configuration of the rod holder 75 the rod from the spinal instrumentation system 76 and the transverse rod 72 are engaged in a substantially orthogonal configuration. The grub screw 82 is introduced into the female thread the interior surface of the C-shape forms an interference fit with the transverse rod 72 thus holding the rod holder 75 in place.
(51) But for the novel configuration described above with reference to
(52) The hook assembly 74 described above with reference to
(53) In this manner, the hook assembly 74 links the proximal and, if necessary, the distal transverse rods 72 to a vertically disposed 5.5 mm spinal instrumentation rod 68 which forms part of the spinal instrumentation system. Whilst the example illustrated in
(54) The system 70 allows for the internal fixation of most dissociations of the pelvic ring and those of the pelvis and axial skeleton. The biomechanics of spinal-pelvic stabilisation requires that the instrumentation extends anterior to the “pivot point” which is defined as the osteo-ligamentous column at the level of the L5-S1 junction and corresponds to the coronal plane of the posterior longitudinal ligament.
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(56) Fracture-dislocations of the posterior pelvic ring are in general associated with fracture-dislocations of the anterior pelvic ring, thus the symphyseal plating system described with reference to
(57) Fractures of the pelvic ring comprising a diastasis of the symphysis pubis in association with fractures of either all or some of the pubic rami provide for a difficult clinical problem in respect of the choice of internal fixation with conventional devices. Typically, the symphyseal diastasis may be stabilised by means of a symphyseal plate and screws. Fractures of the pubic rami may be stabilised by means of anterior column screws. In the case of a fracture dislocation combining these patterns, the trajectories for the screws of one device are obstructed by those of the other. The commonly employed alternative of a symphyseal plate in combination with an external fixator device lacks biomechanical strength and there is an inherent risk of pin track infections from the external fixator device. A further procedure is then required to remove the external fixator device.
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