Patent Application
20060085076
This application claims priority to Great Britain Patent Application No. 0422963.9 filed Oct. 15, 2004.
This invention relates to devices and surgical methods for the treatment of various types of lumbar spine pathologies. It is specifically directed to the different types of degenerative pathologies in the lumbar spine. It deals with the development of an artificial facet joint, and an artificial lumbar disc replacement that is specifically designed to be inserted from a posterior approach to the spine.
Back pain affects 40% of the population. Up to 20% of the population visit their family doctor requesting help with their back problem. Up to 30% of patients continue to complain of significant back pain at one year following the onset of their symptoms.
Although the majority of patients have minor sprains or strains which are self limiting, a significant number of patients go on to develop severe chronic mechanical lower back pain which is caused by inflammatory changes in the lumbar disc associated with degeneration.
Another group of patients with degenerative spine disease go on to develop degenerative spondylolisthesis and spinal stenosis. This is a narrowing of the spinal canal caused primarily by degenerative changes in the facet joint, combined with a loss of normal disc height and buckling of the ligamentum flavum.
Degeneration occurs in a spinal segment. The spinal segment consists of the lumbar disc anteriorly and two facet joints posteriorly. This is therefore called a three joint complex. Degenerative changes in the disc can lead to changes in the facet joint and vice versa. In patients with significant lumbar disc degeneration, the facet joints are also usually degenerate.
Pain occurs from all components of the three joint complex, including the facet joints and the disc. The facet joint is in fact a synovial joint and suffers from the problems that are known to affect other synovial joints in the body like the hip and the knee. The facet joint particularly contributes to degenerate spondylolisthesis and commonly occurs at levels where the facet joints are sagittally orientated, for example at the L4/5 level.
After failing all the conservative treatments available, a minority of patients with back pain or leg pain will go on to require surgical intervention. For patients with predominantly lower back pain who have a degenerative lumbar disc, some surgeon's consider the solution lies in removing the pain generator which is the disc and restoring normal loading across the disc by doing an inter-body stabilisation procedure.
The two types of inter-body stabilisation procedure currently available are an artificial disc replacement performed anteriorly and inter-body fusions performed anteriorly and/or posteriorly. These inter-body stabilisation procedures are often combined with decompression of the spinal canal and the nerve roots if there is nerve root impingement.
As far as inter-body fusions are concerned, there are two basic strategies that surgeons adopt. The first is to perform an anterior inter-body fusion combined with posterior stabilisation externally of the spinal canal. Anterior inter-body fusion on its own is still questioned because it does not provide a posterior tension band. An alternative strategy is a posterior lumbar inter-body fusion, where the entire inter-body fusion procedure is performed from behind and it is combined with neural decompression as well as removal of the degenerative facet joints. Posterior lumbar inter-body fusion also provides a posterior tension band. This strategy therefore deals with all three joint components which can generate possible pain at the disc level, including the lumbar disc, the neural structures and the facet joints.
When it comes to lumbar disc arthroplasty procedures, these are performed via an anterior lumbar approach. The disc is removed and an artificial lumbar disc is inserted into the space. This removes the pain generator and allows normal loading across the disc, as well as allowing some movement at this level. The advantage of this is to reduce the strains on the disc above and therefore reduce the chances of adjacent segment degeneration. Several studies have shown that adjacent segment degeneration can occur above a fused segment because of the increased loads being transmitted to this level.
One of the disadvantages of anterior lumbar arthroplasty is that the facet joints at this level continue to move and also continue to act as a pain generator. In addition, if there is any neural impingement, these symptoms can continue. The other disadvantage of anterior lumbar arthroplasty is that the majority of spine surgeons are not familiar with the anterior approach, and although complications are uncommon, they can be life and limb threatening when they do occur.
There is therefore a concern among researchers and the surgical community, that long term results of anterior lumbar disc arthroplasty may be compromised by progressive degeneration of the facet joint at the same level. In addition, after lumbar disc arthroplasty, several patients continue to complain of facet joint pain because of increased loads being placed on the facet joint as a result of the surgical procedure.
At present there is no posterior lumbar arthroplasty procedure available. It is therefore an aim of the present invention to provide an artificial lumbar disc that can be inserted posteriorly, thereby delivering the advantages of approaching the spine posteriorly and removing the disadvantages associated with approaching the spine anteriorly.
It is a further aim of the present invention to provide a facet joint replacement prosthesis.
It is a yet further aim of the present invention to provide a lumbar prosthetic system that deals with the painful disc, the neural impingement and the painful facet joints by providing a combination of a lumbar disc prosthesis and a facet joint prosthesis as a single unit.
According to a first aspect of the present invention there is provided a lumbar disc prosthesis, said lumbar disc prosthesis including a pair of disc members, the first member of said disc pair having a vertebral endplate contact surface and a recessed portion on an opposing surface thereof, the second member of said disc pair having a vertebral endplate contact surface and a protruding portion on an opposing surface thereof, the protruding portion of the second member engaging with the recessed portion of the first member in use, and wherein the spinal disc prosthesis includes a further pair of disc members, said further pair of disc members also including first and second members.
Preferably the disc pairs are mirror images of each other.
Thus, the present invention provides a lumbar disc prosthesis having two disc member pairs and thus two separate articulating portions, one articulating portion on each pair of disc members. The disc member pairs are each independently inserted into the disc space on either side of the dural sac in use through the trans-foraminal or posterior route bilaterally and are provided a spaced distance apart in use to allow accommodation in accordance with the anatomy of the lateral aspect of the disc space. Thus, the disc prosthesis can be inserted through the posterior route whilst taking into account the neural anatomy posteriorly.
The lumbar disc prosthesis of the present invention can be inserted at all levels between L2 and the sacrum, typically depending on the level of expertise of the operating surgeon.
Preferably the first members of each disc pair are provided in the left and right areas of the disc space respectively in use. The second members of each disc pair are also provided in the left and right areas of the disc space respectively in use. Thus, each pair of members constitutes a left and right lumbar disc prosthesis.
Preferably the recessed portion of the first member is substantially curved and the curvature of the medial part of said recessed portion is asymmetrical to the curvature of the lateral part of said recessed portion.
The purpose of this asymmetry in the medial-lateral plane is to allow “capture” of the protruding portion of the second member. such that when two pairs of disc prostheses are placed in the patient, the two vertebrae can move from side to side as well as anteriorly and posteriorly.
Preferably the lateral part of the recess has curvature corresponding to an arc of a circle which has a radius greater that of an arc of a circle corresponding to the curvature of the medial part of the recessed portion. Further preferably the radius of the lateral part is at least twice as big as the radius of the medial part.
Preferably an anterior part of the recessed portion is substantially symmetrical to a posterior part of the recessed portion.
The protrusion portion of the second member is typically of different shape and/or dimensions to the recessed portion of the first member. Thus, the protrusion portion is asymmetrical or forms an asymmetrical fit with the recessed portion.
Preferably the protrusion portion is substantially dome shaped and makes contact with only a part of the recessed portion when assembled. Preferably the recessed portion is substantially an inversed dome shape.
The protrusion portion is typically symmetrical in the anterior-posterior plane and in the medial to lateral plane. The curvature in the medial to lateral plane can be the same or different to that in the anterior to posterior plane.
Preferably the inner or opposing surfaces of each of the first and second disc members are provided with at least three sections; a middle section and at least two end sections, the recessed and protruding portions being provided in the middle section of the respective disc members.
Preferably the thickness or depth of the first disc member is less adjacent the middle section or recessed portion compared to the two end sections thereof.
The middle and end sections of each disc member are typically arranged transversally along the length thereof, i.e. the boundaries of adjacent sections are provided between the medial to lateral sides of the disc members.
Preferably one or both ends of the first and second disc members have a narrowing taper (i.e. the prosthesis as a whole has a narrowing taper). This narrowing taper is as a result of the outer or vertebral end plate contact surface of said first and/or second disc member being provided at an acute angle with respect to the horizontal at one or both ends. These angled surfaces are preferably substantially planar in form. For example, the outer or vertebral end plate contact surface of the first disc member slopes downwardly towards the ends of the disc member and/or the outer or vertebral end plate contact surface of the second disc member slopes upwardly towards the ends of the disc member. The narrowing taper of the prosthesis allows easy insertion of the prosthesis in the disc space via a posterior route.
In one embodiment, the narrowing taper is provided at an anterior end of the prosthesis. Thus, the outer surfaces or vertebral endplate contact surfaces of the disc member(s) slope towards the opposing surfaces thereof at the anterior end of the disc member(s). This provides a “lead in” feature which increases the ease with which the front of the prosthesis can be inserted via a posterior route into the disc space.
In one embodiment, a narrowing taper is provided at the posterior end of the prosthesis. Thus, the outer surfaces or vertebral endplate contact surfaces of the disc member(s) slope towards the opposing surfaces thereof at the posterior end of the disc member(s). The posterior angled surface allows the prosthesis in the neutral position to be placed such that the vertebral end plates are in lordosis.
The posterior end of the prosthesis typically slopes or tapers in an opposite direction to the anterior end.
Preferably the anterior end slope is substantially smaller than the posterior end slope.
Preferably one or both end sections of the inner or opposing surfaces of said first and/or second members are provided at an acute angle to the horizontal. For example, the inner end section surface of said first member can slope downwardly towards one or both ends of said member. The inner end section surface of said second member can slope downwardly towards the one or both ends of said member.
Further preferably the outer and inner surfaces of said second disc member form a narrowing taper towards one or both ends of said disc member.
Further preferably the outer and inner surface of said first disc member form a narrowing taper adjacent an end of said disc member in which attachment screws are to be located therethrough.
The geometry of the middle and end sections of the first and second disc members allow contact to be made between the recessed and protrusion portions thereof and for a gap to be formed adjacent the end sections of the disc members when the prosthesis is in a neutral position. When the prosthesis is in extension or flexion (i.e. the upper or first disc member moves towards the posterior or anterior end of the lower or second disc member), the gap between the end sections at the opposite end increases, thereby causing the annulus in which the disc prosthesis is located to tighten. Due to the geometry of the planar slopes within the prosthesis the annulus will tighten not only posteriorly in flexion but laterally as well.
Preferably the vertebral endplate contact surface of the first and/or second members of each disc pair is provided with attachment means for allowing attachment of the disc member to an adjacent disc in use.
The attachment means can include one or more apertures for the location of screws and/or any other suitable attachment device therewith, one or more tapered members or fins and/or any other conventional attachment apparatus.
The first and second members of each pair typically correspond to upper and lower disc members. The superior surface of the lower disc member has a protrusion thereon and the inferior surface of the upper disc member has a captive recess or socket thereon.
Preferably the recessed portion has two sloped surfaces associated therewith, typically corresponding to the end sections thereof, one surface leading anteriorly to the edge of the inferior surface and one surface leading posteriorly to the edge of the inferior surface. These sloping surfaces can be planar or can be slightly concave in form.
The lumbar disc prosthesis can be used in conjunction with a facet joint prosthesis also provided posteriorly to provide a system which can work together as a single unit to replace the painful disc, overcomes neural impingement and painful facet joints.
Preferably the facet joint prosthesis typically includes a first member for attachment to a first vertebra of a corresponding disc and a second member for attachment to a second vertebra of a corresponding disc in use, and wherein at least a part of said first member is telescopically mounted in at least a part of said second member in use.
Preferably the first and second members are elongate members and the provision of one telescopically mounted in the other allows the distance between parts of the first and second members to be increased and/or decreased as required.
The first vertebra is typically an upper vertebra and the second vertebra is typically a lower vertebra.
The facet joint prosthesis allows replacement of existing facet joints to be undertaken at all lumbar levels from T12 to the sacrum.
The interconnecting first and second members are formed such that they can articulate to allow flexion-extension, small degrees of rotation and side to side flexion.
Preferably securing means are provided for insertion of the first and second members into each of the vertebral bodies above and below the disc between which the facet joint prosthesis is to be located. The first and second members can then be secured to said securing means. A plurality of first and second members can be attached to the securing means if required to form a stack, thereby allowing facet joint replacement at multiple levels within the spine.
The securing means can include any suitable type of surgical securing device, such as a pedicle screw.
According to a second aspect of the present invention there is provided a lumbar disc prosthesis, said lumbar disc prosthesis including a pair of disc members, the first member of said disc pair having a vertebral endplate contact surface and a recessed portion on an opposing surface thereof, the second member of said disc pair having a vertebral endplate contact surface and a protruding portion on an opposing surface thereof, the protruding portion of the second member engaging with the recessed portion of the first member in use, and wherein the recessed portion of the first member is substantially curved and the curvature of the medial part of said recessed portion is asymmetrical to the curvature of the lateral part of said recessed portion.
According to a third aspect of the present invention there is provided a facet joint prosthesis, said prosthesis including a first member for attachment to a first lumbar disc in use and a second member for attachment to a second lumbar disc in use, and wherein at least a part of said first member is telescopically mounted in at least a part of said second member in use.
The facet joint prosthesis can be used alone or in combination with the lumbar disc prosthesis of the present invention or with any other lumbar disc prosthesis. The facet joint replacement procedure of the present invention alone will have a role in the treatment of patients with spinal stenosis and adjacent level disc disease, where some stability is required at the disc level without fusing a particular disc segment. The facet prosthesis can partially constraining certain degrees of motion.
According to further independent aspects of the present invention there is provided a prosthesis system including a lumbar disc prosthesis and a facet joint prosthesis as hereinbefore described; a first or upper disc member for inclusion in a lumbar disc prosthesis pair; a second or lower disc member for inclusion in a lumbar disc prosthesis; a method of insertion of a lumbar disc prosthesis in a patient via a posterior route; and a method of insertion of a facet joint replacement prosthesis in a patient via a posterior route.
Thus, the present invention overcomes the problems and disadvantages associated with current disc replacement strategies. It has all the benefits associated with posterior lumbar inter-body fusion surgery, but at the same time it allows movement at that level and reduces the strain on adjacent discs and the risks of adjacent segment disc failure. This invention also address all three pain generators at the lumbar disc level including the degenerative disc, the impingement of the neural structures, and the facet joint.
a-d illustrates a) a solid inverse representation of the recess portion shape on the inferior surface of the upper member of the prosthesis b) an axial view of the prosthesis c) a side view and d) a front view showing the medial/lateral asymmetry of the prosthesis;
a and 29b illustrate oblique views of the left and right lumbar prosthesis pairs in
a-30f show a) superior surfaces of the upper members of the left and right lumbar prosthesis pairs in
a-44d illustrate a side view, front view, perspective view from the rear and perspective view from the front of the facet joint replacement prosthesis in
a and 45b illustrate the ability of the male member to move within the female member and produce a flexion and extension movement of the vertebral body respectively;
a-48d show a side view, front view, perspective view from the rear and perspective view from the front of facet joint prostheses when stacked respectively;
Lumbar Disc Prosthesis
Referring firstly to
The disc prosthesis 2 includes two pairs of disc members, each pair including an upper disc member 4, 4′ and a lower disc member 6, 6′.(Use of a reference numeral with ′ thereafter refers to a second or further feature equivalent to the feature indicated by the reference numeral alone. Thus, disc member 4 refers to the first prosthesis pair upper member and disc member 4′ refers to the second prosthesis pair upper member). The upper and lower disc members 4, 6; 4′, 6′ of each pair constitute a left and right disc prosthesis respectively. These disc members are shaped and dimensioned such that they can be inserted into a lumbar disc space either side of the dural sac whilst taking into account the posterior neural anatomy.
Each upper disc member 4, 4′ includes a vertebral endplate contacting surface or superior surface 8, 8′ and an inferior surface 10, 10′. Each lower disc member 6, 6′ includes a superior surface 12, 12′ and a vertebral endplate contacting surface or inferior surface 14, 14′.
A dome shaped protrusion 16 is formed substantially centrally of superior surface 12 of lower disc member 6. Protrusion 16 is received in a substantially central recess 18 on inferior surface 10 of upper disc member 4 as will be described in more detail below.
Both the superior surface 20 of upper member 4 and the inferior surface 22 of lower member 6 are angled to provide the prosthesis with a “lead in” or narrowing tapered feature. This lead in feature allows the prosthesis to enter the posterior disc space which is narrower than the anterior disc space. In addition to the lead in feature which is provided at the anterior or front end 24 of the prosthesis members, each prosthesis pair has a lordosis or narrowing taper angle towards the posterior or rear end 26 of the prosthesis members between the inferior surface 14 of the lower disc member 6 and superior surface 8 of the upper member 4 of approximately 6 degrees (this angle or any other angle mentioned hereinafter is for exemplary purposes and does not limit the invention in any way), as shown in
With reference to
With the protrusion 16 on lower member 6 located in recess 18 of upper member 4 when the prosthesis is assembled, relative movement between the upper and lower members 4, 6 allows the prosthesis to undergo extension and flexion. The substantially dome shaped protrusion 16 contacts only a part of the recess 18 due to differences in symmetry and geometry. In the example illustrated, the upper member 4 can move with respect to the lower member 6 through approximately 10 degrees in a posterior direction to allow extension of the prosthesis, as shown in
The upper member 4 can also move with respect to lower member 6 through approximately 10 degrees in an anterior direction to allow flexion of the prosthesis, as shown in
Referring to
Referring to
The central section 44 is substantially curved and forms an asymmetrical inverse dome shaped recess 18. The curvature of the recess in the medial half (i.e. portion adjacent medial edge 32) of the central section differs to the curvature of the recess in the lateral half (i.e. portion adjacent the lateral edge 34) of the central section. More specifically, the medial half of the dome has a curvature corresponding to the arc of a circle having a radius of approximately 15 mm as shown by arrow 50, whereas the lateral half of the dome has a curvature corresponding to the arc of a circle having a radius of approximately 40 mm, as shown by arrow 52 in
The anterior and posterior end sections 46, 48 are provided at an acute angle to the horizontal, typically approximately 12-14 degrees as shown in
The curvature of the central section recess on the anterior to posterior axis corresponds to an arc of a circle having a radius of approximately 17 mm, as shown by arrow 56 in
The geometry of the inferior surface of the upper disc member is also designed to allow limited rotation of the right or left prosthesis pairs. This means that if the upper disc member of the right prosthesis pair moves anteriorly, the upper disc member on the left prosthesis pair moves posteriorly allowing limited rotation of the two vertebral members to occur.
The aim of the surgical procedure for the disc replacement is to insert the left and right prosthesis pairs as parallel to each other as possible within the disc space. However, even if there is medial tilt of between 0-25 degrees between the prosthesis pairs, anterior and posterior movement of the pairs will still be possible and the upper and lower disc members will remain articulated during this movement. Thus, one disc pair is located at one side of the disc space and the other disc pair is located at the opposite side of the disc space (i.e in the medial lateral plane).
According to a further embodiment of the present invention, alternative attachment means can be provided in the form of fin members 58 on the superior surface 8 of the upper disc member 4 and on the inferior surface 14 of the lower disc member 6, as shown in
Fins 58 are substantially triangular in shape and are provided longitudinally of the prosthesis (i.e. between the posterior and anterior ends) towards the medial edge 32 of the disc members, so as to avoid the exiting nerve root which goes across the disc laterally. More specifically, the fins are located adjacent posterior end 26 and end before the lead in feature 20, 22 at the anterior end to avoid the exiting lumbar nerve root above the disc on the lateral side (i.e. they extend for approximately two-thirds of the disc surface). The fin has a narrowing taper from posterior end 26 towards anterior end 24.
With the disc prosthesis pairs fitted, the upper disc members typically move substantially symmetrically on the lower disc members as the upper vertebral body moves forward on the lower vertebral body. The anterior and posterior translations of these upper disc members are limited by a tightening of the anterior and posterior annulus in flexion and extension. This is designed to reflect the physiological process by which the anterior and posterior annulus tightens in flexion and extension in a normal lumbar disc.
It is to be noted that the end parts of the lateral side 34 of the disc members are curved to accommodate the lateral aspect of the disc space which is similarly curved, thereby allowing better anatomical placement. Thus, the lateral side includes an intermediate substantially straight/linear/planar surface with the end portions either side thereof curving inwardly towards the posterior and anterior ends respectively. The medial side 32 of the disc members is substantially straight/linear/planar.
Apertures 60 are defined in the posterior end 26 of the upper and lower disc members of each prosthesis pair to allow engagement of an insertion tool therewith so that the prosthesis pairs can be inserted into the disc space. Apertures 60 are typically a spaced distance apart and the apertures on the upper disc member are substantially aligned with the apertures on the lower disc member.
Facet Joint Replacement Prothesis
Referring to
Prosthesis 102 includes a first member or male member 104 and a second member or female member 106. Both male and female members 104, 106 are substantially elongate in form. Male member 104 has a first end 108 with securing means in the form of an aperture 110 defined therein and a second end 112. End 108 is in the form of a flat or planar plate portion 113 and a curved arm portion 114 is provided between this plate portion 113 and end 112. Female member 106 has a first end 116 with securing means in the form of an aperture 118 defined therein and a second end 120. End 116 is in the form of a flat or plate portion 117 and a curved channel portion 122 is provided between this plate portion 117 and end 120.
The facet prosthesis 102 is inserted by removing the entire existing facet joint and placing pedicle screws 124 into the vertebral body above and below the disc. End 112 of male member 104 is inserted into end 120 of channel 122 of female member 106 and the ends of the pedicle screws 123 are threaded through apertures 118 and 110 and secured with a nut 126. The edge of plate portions 113 and 117 which define apertures 118 and 110 are tapered inwardly so as to allow a good fit with a tapered or conical shaped locking nut 126, as shown in
Male member 104 has a rear or posterior 128 and a front or anterior surface 130. The anterior surface 130 of arm portion 114 is typically substantially concave in shape and the posterior surface 128 of arm portion 114 is typically substantially convex in shape. As such, when member 104 is fitted to pedicle screw 124 in use, anterior surface 130 typically faces the vertebrae to which it is to be attached.
Female member 106 has a rear or posterior surface 132 and a front or anterior surface 134. The anterior surface 134 of channel portion 122 is typically substantially concave in shape and the posterior surface of channel portion 122 is typically substantially convex in shape. As such, when member 106 is fitted to pedicel screw 124 in use, anterior surface 134 typically faces the vertebrae to which it is to be attached.
Thus, with the female member interconnected to the male member, the prosthesis curves outwardly from the vertebrae and outwardly of the plate portions 117 and 113. Arm portion 114 of male member 104 is freely slidable or movable in channel portion 122 of female member 106. The curvature of the male and female members is substantially the same. The male member 104 is of slightly smaller dimensions than the interior dimensions of channel portion 122, such that there is a small gap therebetween to allow some sideways movement, as shown by arrows 150 in
End 120 of channel portion 122 has curved ends 136 and straight side walls 138 or side walls of less curvature than said curved ends to form a flattened oval shape, as shown in
The anterior surface 134 of channel portion 122 has a slot 144 provided longitudinally thereof. Slot 144 is of such a width that the channel portion encloses approximately 70% of the male member 104 when interconnected therewith and is provided to allow some lateral flexion and/or extension and rotation between the male and female members.
A left and right pair of facet joint prostheses are located between the disc on each side thereof. It is irrelevant whether the female or the male member is uppermost and thus the position of the members is interchangeable. In addition, the facet prosthesis can be used at two adjacent levels, and anchor into pedicle screws, as seen in
The prosthesis can be formed from any suitable material, such as for example, stainless steel, ceramics, titanium, carbide or other suitable metal alloys. The surface of the prosthesis can be provided slightly roughened so as to increase bonding of the same with bone and/or one or more surface coatings can be provided thereon, such as for example, hyroxyapitite or plasma spray.
Thus, it can be seen that in one aspect of the present invention, the two pairs of lumbar disc prosthesis and the two pairs of facet joint prosthesis can be used to form a system designed to allow an arthroplasty to be performed through the posterior route, allowing movement between the vertebral bodies as well as restoring stability between the two vertebral bodies by allowing normal load transmission across the disc, freeing up the neural structures and replacing the facet joints as well.
| Number | Date | Country | Kind |
|---|---|---|---|
| 0422963.9 | Oct 2004 | GB | national |
