U.S. patent application number 10/970091 was filed with the patent office on 2006-04-20 for posterior spinal arthroplasty-development of a new posteriorly inserted artificial disc and an artificial facet joint.
Invention is credited to Tai Friesen, Manoj Krishna.
Application Number | 20060085076 10/970091 |
Document ID | / |
Family ID | 37421057 |
Filed Date | 2006-04-20 |
United States Patent
Application |
20060085076 |
Kind Code |
A1 |
Krishna; Manoj ; et
al. |
April 20, 2006 |
Posterior spinal arthroplasty-development of a new posteriorly
inserted artificial disc and an artificial facet joint
Abstract
Lumbar disc and facet joint replacement prosthesis are provided.
The lumbar disc prosthesis includes first member having a vertebral
disc contact surface and a recessed portion on an opposing surface
thereof and a second member having a vertebral disc contact surface
and a protruding portion on an opposing surface thereof. The
protruding portion of the second member engages the recessed
portion of the first member in use. The first and second members
are provided with at least a middle section and two end sections.
The recessed and protruding portions are provided in the middle
section of the respective members and each end section has a
narrowing taper. The facet joint prosthesis includes a first member
for attachment to a first posterior lumbar disc and a second member
for attachment to a second posterior lumbar disc. At least a part
of the first member is telescopically mounted in at least a part of
the second member.
Inventors: |
Krishna; Manoj; (Yarm,
GB) ; Friesen; Tai; (Ingleby, GB) |
Correspondence
Address: |
Michael E. Sellers;Gable & Gotwals
10th Floor
100 W. 5th Street
Tulsa
OK
74103
US
|
Family ID: |
37421057 |
Appl. No.: |
10/970091 |
Filed: |
October 21, 2004 |
Current U.S.
Class: |
623/17.15 ;
606/247; 606/259; 606/279; 606/900; 623/17.11; 623/17.14 |
Current CPC
Class: |
A61F 2/4425 20130101;
A61B 17/7025 20130101; A61F 2230/0004 20130101; A61F 2002/30286
20130101; A61F 2002/30578 20130101; A61F 2002/30367 20130101; A61F
2310/00017 20130101; A61F 2002/30112 20130101; A61F 2002/3037
20130101; A61B 17/7011 20130101; A61F 2002/30156 20130101; A61F
2002/30331 20130101; A61F 2002/448 20130101; A61F 2/4405 20130101;
A61B 17/7064 20130101; A61F 2002/449 20130101; A61F 2002/3065
20130101; A61F 2310/00796 20130101; A61F 2002/30372 20130101; A61B
17/7007 20130101; A61F 2002/30841 20130101; A61F 2002/30884
20130101; A61F 2/30771 20130101; A61F 2002/30373 20130101; A61F
2310/00179 20130101; A61F 2220/0033 20130101; A61F 2002/30369
20130101; A61F 2/4611 20130101; A61F 2002/30507 20130101; A61B
17/7059 20130101; A61F 2230/0063 20130101; A61F 2002/30828
20130101; A61F 2230/0023 20130101; A61F 2310/00023 20130101; A61F
2002/30654 20130101; A61F 2002/30934 20130101; A61F 2002/30601
20130101; A61F 2220/0025 20130101 |
Class at
Publication: |
623/017.15 ;
623/017.14; 623/017.11; 606/061 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61B 17/70 20060101 A61B017/70 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 15, 2004 |
GB |
0422963.9 |
Claims
1. A lumbar disc prosthesis, said lumbar disc prosthesis including
a pair of disc members, a first member of said disc pair having a
vertebral endplate contact surface and a recessed portion on an
opposing surface thereof, a 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 in the recessed portion of the first member in use,
and wherein the prosthesis includes a further pair of disc members,
said further pair of disc members also including first and second
members.
2. A prosthesis according to claim 1 wherein the two pairs of disc
member are mirror images of each other.
3. A prosthesis according to claim 1 wherein the pairs of disc
members are inserted via a posterior route into a disc space in the
patient.
4. A prosthesis according to claim 1 wherein each pair of disc
members is independently inserted into the disc space in the
patient and is located on either side of the dural sac.
5. A prosthesis according to claim 1 wherein the recessed portion
of the first member is substantially curved and the curvature of a
medial part of said recessed portion is asymmetrical to the
curvature of a lateral part of said recessed portion.
6. A prosthesis according to claim 5 wherein the lateral part of
said recessed portion corresponds to an arc of a circle which has a
radius greater than that of an arc of a circle corresponding to the
curvature of the medial half of the recessed portion.
7. A prosthesis according to claim 1 wherein an anterior part of
the recessed portion is substantially symmetrical to a posterior
part of the recessed portion.
8. A prosthesis according to claim 1 wherein the recessed and
protrusion portions in each disc member pair are asymmetrical.
9. A prosthesis according to claim 1 wherein the protrusion portion
in a disc member pair makes contact with only a part of the
recessed portion of said disc member pair.
10. A prosthesis according to claim 1 wherein the protrusion
portion is symmetrical in the medial-lateral plane and the
anterior-posterior plane but the curvature in the medial to lateral
plane may be different to that in the anterior to posterior
plane.
11. A prosthesis according to claim 1 wherein one or both ends of
each prosthesis pair have a narrowing taper towards said end or
ends.
12. A prosthesis according to claim 1 wherein the vertebral
endplate contact surfaces at one or both ends of said first and/or
second member is provided at an acute angle to the horizontal such
that the surfaces slopes towards the ends of the disc
member(s).
13. A prosthesis according to claim 12 wherein the angled surface
or surfaces are substantially planar in form.
14. A prosthesis according to claim 12 wherein with the vertebral
endplate contact surfaces provided at an angle at both ends of said
first and/or second member, the angle of the surface towards an
anterior end is in an opposite direction to the angle of the
surface towards a posterior end.
15. A prosthesis according to claim 14 wherein the anterior end
angled surface is substantially smaller in dimensions that the
posterior end angled surface.
16. A prosthesis according to claim 1 wherein the vertebral
endplate contact surface of the first and/or second disc members
are provided with attachment means thereon to allow attachment of
the disc members to an adjacent vertebra in use.
17. A prosthesis according to claim 16 wherein the attachment means
includes one or more apertures thereon for the location of screws
or other attachment devices therewith.
18. A prosthesis according to claim 16 wherein the attachment means
are provided adjacent a posterior end of the first and/or second
disc members.
19. A prosthesis according to claim 16 wherein the attachment means
includes one or more tapered members protruding outwardly of the
vertebral endplate contact surface, the taper of said member
narrowing from a posterior end towards an anterior end of the disc
member.
20. A prosthesis according to claim 16 wherein the attachment means
are provided towards a medial side of the first and/or second disc
members.
21. A prosthesis according to claim 1 wherein the inner or opposing
surfaces of the first and/or second members in a disc pair are
divided into 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.
22. A prosthesis according to claim 21 wherein the depth of the
first disc member is less adjacent the middle section or recessed
portion compared to the two end sections thereof.
23. A prosthesis according to claim 21 wherein the boundaries of
the middle and end sections are arranged in the medial to lateral
plane of each disc member.
24. A prosthesis according to claim 21 wherein the middle section
is located substantially centrally of said first and/or second disc
members.
25. A prosthesis according to claim 21 wherein the middle and end
sections each comprise at least one third of a disc member
surface.
26. A prosthesis according to claim 21 wherein one or both end
sections of the opposing surfaces of the first and/or second disc
members are provided at an acute angle to the horizontal.
27. A prosthesis according to claim 26 wherein the angled surface
of one or both end sections of said first and/or second disc
members are substantially planar in form.
28. A prosthesis according to claim 16 wherein the end sections of
the opposing surface of said first disc member are mildly concave
in form.
29. A prosthesis according to claim 16 wherein when one of the disc
members moves towards an end of the prosthesis in extension or
flexion, a gap between the end sections of the disc members
increases at an opposite end of the prosthesis.
30. A prosthesis according to claim 1 wherein the vertebral
endplate contact surface and opposing surface of said second disc
member form a narrowing taper towards one or both ends of said disc
member.
31. A prosthesis according to claim 1 wherein the vertebral end
plate contact surface and opposing surface of said first disc
member form a narrowing taper towards one or both ends of said disc
member.
32. A prosthesis according to claim 1 wherein the protrusion
portion extends across substantially the whole of the second disc
member in the medial to lateral plane.
33. A prosthesis according to claim 1 wherein the lateral side of
the first and/or second disc members has one or more curved
sections whereas the medial side of the first and/or second disc
members is substantially straight or planar.
34. A prosthesis according to claim 1 wherein one or more apertures
are provided at or adjacent the posterior end of the disc
members.
35. A prosthesis according to claim 1 wherein said prosthesis is
used in conjunction with a facet joint prosthesis.
36. A facet joint prosthesis according to claim 35 wherein a first
member is provided for attachment to a first posterior lumbar disc
in use and a second member is provided for attachment to a second
posterior 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.
37. A facet joint prosthesis according to claim 36 wherein the
first and/or second members are provided with or are associated
with securing means for securing the members to a disc in use.
38. A facet joint prosthesis according to claim 37 wherein the
securing means includes one or more pedicle screws.
39. A facet joint prosthesis according to claim 36 wherein the
first member includes an elongate arm portion which is movably
located in an elongate channel portion on said second member.
40. A facet joint prosthesis according to claim 39 wherein the arm
portion and said channel portion are curved in form.
41. A facet joint prosthesis according to claim 39 wherein each of
said arm portion and said channel portion communicate with a plate
portion.
42. A facet joint prosthesis according to claim 36 wherein a slot
is provided longitudinally of said channel portion.
43. A facet joint prosthesis according to claim 42 wherein said
slot is of such a width to allow approximately 30% of the arm
portion to be visible therethrough.
44. A facet joint prosthesis according to claim 36 wherein the arm
portion is of slightly smaller dimensions than the interior
dimensions of said channel portion, such that a small gap is
provided therebetween to allow some movement between said arm
portion and said channel portion.
45. A facet joint prosthesis according to claim 36 wherein with the
arm portion located in the channel portion, the arm portion can
undergo limited rotation, side ways movement and sliding movement
to allow flexion and extension with respect to said channel
portion.
46. A facet joint prosthesis according to claim 36 wherein the end
of the arm portion engaging in said channel portion has curved end
walls and curved side walls, the curvature of said side walls being
less than the curvature of said end walls.
47. A facet joint prosthesis according to claim 36 wherein the open
end of the channel portion in which the arm portion engages has
curved end walls and curved side walls, the curvature of said side
walls being less than the curvature of said end walls.
48. A facet joint prosthesis according to claim 35 wherein a pair
of facet joint prosthesis are used for each disc.
49. A facet joint prosthesis according to claim 36 wherein a
plurality of first members can be attached to a second member and
vice versa to form stacking of said prosthesis.
50. A prosthesis system, said system including a lumbar disc
prosthesis and facet joint prosthesis as defined in claim 1.
51. A first disc member for use with a lumbar disc prosthesis
according to claim 1.
52. A second disc member for use with a lumbar disc prosthesis
according to claim 1.
53. A facet joint prosthesis, said facet joint prosthesis including
a first member for attachment to a first posterior lumbar disc in
use and a second member for attachment to a second posterior 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.
54. A prosthesis system, said system including a lumbar disc
prosthesis and facet joint prosthesis as defined in claim 53.
55. A method of attachment of a lumbar disc prosthesis in a
patient, said lumbar disc prosthesis including a pair of disc
members, a first member of said disc pair having a vertebral
endplate contact surface and a recessed portion on an opposing
surface thereof, a 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 in the recessed portion of the first member in use,
the prosthesis including a further pair of disc members, said
further pair of disc members also including first and second
members, said method including the steps inserting each pair of
disc members via a posterior route.
56. A method of attachment of a facet joint prosthesis in a
patient, said facet joint prosthesis including a first member and a
second member, at least a part of said first member is
telescopically mounted in at least a part of said second member in
use, said method including attaching a part of said first member to
one of an upper or lower vertebrae in use posteriorly and attaching
a part of said second member to the other of said upper or lower
vertebrae in use posteriorly.
Description
REFERENCE TO PENDING APPLICATIONS
[0001] This application claims priority to Great Britain Patent
Application No. 0422963.9 filed Oct. 15, 2004.
FIELD OF THE INVENTION
[0002] 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.
BACKGROUND OF THE INVENTION
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] It is a further aim of the present invention to provide a
facet joint replacement prosthesis.
[0016] 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.
BRIEF SUMMARY OF THE INVENTION
[0017] 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.
[0018] Preferably the disc pairs are mirror images of each
other.
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] Preferably an anterior part of the recessed portion is
substantially symmetrical to a posterior part of the recessed
portion.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] The posterior end of the prosthesis typically slopes or
tapers in an opposite direction to the anterior end.
[0036] Preferably the anterior end slope is substantially smaller
than the posterior end slope.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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.
[0042] 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.
[0043] 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] The first vertebra is typically an upper vertebra and the
second vertebra is typically a lower vertebra.
[0049] The facet joint prosthesis allows replacement of existing
facet joints to be undertaken at all lumbar levels from T12 to the
sacrum.
[0050] 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.
[0051] 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.
[0052] The securing means can include any suitable type of surgical
securing device, such as a pedicle screw.
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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.
[0057] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] FIGS. 1-30 relate to a lumbar disc prosthesis according to
embodiments of the present invention and FIGS. 31-50 relate to a
facet joint replacement prosthesis according to embodiments of the
present invention.
[0059] FIG. 1 is a side view of a lumbar disc prosthesis according
to one embodiment of the present invention;
[0060] FIGS. 2-4 show the prosthesis in FIG. 1 with the upper disc
member in extension, flexion and in a neutral position
respectively;
[0061] FIGS. 5 and 6 show the superior surfaces of the upper
members of the left and right lumbar prosthesis pairs
respectively;
[0062] FIGS. 7 and 8 show rear views of the left and right lumbar
prosthesis pairs respectively;
[0063] FIGS. 9 and 10 show front views of the left and right lumbar
prosthesis pairs respectively;
[0064] FIGS. 11 and 12 show oblique views of the left and right
lumbar prosthesis pairs respectively;
[0065] FIGS. 13 and 14 show the superior surfaces of the lower
members of the left and right lumbar prosthesis pairs
respectively;
[0066] FIGS. 15 and 16 show rear views of the lower members of the
left and right lumbar prosthesis pairs respectively;
[0067] FIG. 17 is a side view of the lower member of a lumbar
prosthesis;
[0068] FIGS. 18 and 19 show front views of the lower members of the
left and right lumbar prosthesis pairs respectively;
[0069] FIGS. 20 and 21 show oblique views of the lower members of
the left and right lumbar prosthesis pairs respectively;
[0070] FIG. 22 is a side view of an upper member of a lumbar
prosthesis pair to illustrate the angulations and geometry of the
inferior surface thereof;
[0071] FIG. 23 is a front view of the upper member of the lumbar
prosthesis pair to illustrate the radius in the medial and lateral
part of the curvature of the inferior surface;
[0072] FIG. 24 is an oblique view of the upper member of the lumbar
prosthesis pair to further illustrate the shape of the inferior
articulating surface thereof;
[0073] FIG. 25 shows a perspective view of the inferior surface of
the upper members of the left and right lumbar prosthesis pairs
respectively;
[0074] FIGS. 26a-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;
[0075] FIG. 27 is a cross section through the upper member of a
lumbar prosthesis pair showing the medial lateral curvature of the
articulating surface;
[0076] FIG. 28 show front views of the left and right lumbar
prosthesis pairs respectively in an alternative embodiment with the
screws replaced by fin members;
[0077] FIGS. 29a and 29b illustrate oblique views of the left and
right lumbar prosthesis pairs in FIG. 28 joined together and spaced
apart respectively;
[0078] FIGS. 30a-30f show a) superior surfaces of the upper members
of the left and right lumbar prosthesis pairs in FIG. 28 b) a side
view c) a front view d) a further side view e) inferior surfaces of
the lower members of the left and right lumbar prosthesis pairs and
f) oblique views of the pairs;
[0079] FIG. 31 is a side view of a facet joint replacement
prosthesis according to an embodiment of the present invention;
[0080] FIGS. 32-36 show a front view, end view, side view, rear
view and oblique view respectively of the second or female member
of the facet replacement prosthesis;
[0081] FIG. 37 is a cross sectional view of the second or female
member of the facet replacement prosthesis taken along the line
marked A-A in FIG. 34;
[0082] FIGS. 38-42 show a front view, end view, side view, rear
view and oblique view respectively of the first or male member of
the facet replacement prosthesis;
[0083] FIG. 43 is a cross sectional view of the first or male
member of the facet replacement prosthesis taken along the line
marked A-A in FIG. 40;
[0084] FIGS. 44a-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 FIG. 31;
[0085] FIGS. 45a 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;
[0086] FIG. 46 illustrates end views of the facet replacement
prosthesis showing the ability of the male and female components to
undergo limited relative rotational movement;
[0087] FIG. 47 illustrates front views of the facet replacement
prosthesis showing the ability of the male and/or female components
to undergo side to side flexion;
[0088] FIGS. 48a-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;
[0089] FIG. 49 is an enlarged view of the ends of the female and
male members of the facet joint prosthesis; and
[0090] FIG. 50 is a cross sectional view taken through a pedicle
screw attached to a female member of a facet joint prosthesis.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Lumbar Disc Prosthesis
[0091] Referring firstly to FIGS. 1-30, there is illustrated a
lumbar disc prosthesis 2 which can be inserted into a lumbar disc
space via a posterior route as a replacement for a diseased and/or
damaged lumbar disc.
[0092] 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.
[0093] 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'.
[0094] 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.
[0095] 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 FIG. 1. This makes the outer
surfaces of the disc prosthesis pairs at the posterior and anterior
ends substantially wedge shaped or tapered to allow ease of
insertion into the disc space. The taper or angle of the outer
surfaces at the posterior end is in an opposite direction to the
taper or angle of the outer surface at the anterior end.
[0096] With reference to FIGS. 1-27, the superior surface of upper
disc member 4 and the inferior surface of lower disc member 6 have
attachment means in the form of screws 28 to allow attachment of
the disc prosthesis to adjacent vertebrae when positioned in a
patient. Apertures 30 are provided on the inferior and superior
surfaces 10, 12 of the upper and lower disc members 4, 6
respectively of the prosthesis pairs to allow the insertion of
screws 28 through the prosthesis disc members. The screws are
typically fitted from the posterior end 26 and the screws and
interior walls defining apertures 30 are provided at an acute angle
to the vertical to allow ease of attachment. Apertures 30 and
screws 28 within each pair diverge outwardly away from each other
towards anterior end 24. The inferior surface on which these
apertures are provided on the upper disc member is angled such that
it slopes upwardly towards the superior surface of the upper disc
member. The superior surface on which these apertures are provided
on the lower disc member is angled such that it slopes downwardly
towards the inferior surface of the lower disc member, thereby
forming a narrowing taper at the posterior end of the lower disc
member. These angled surfaces typically form, at least in part, the
posterior end segments of the inferior and superior surfaces 48, 38
of the upper and lower disc members 4, 6 respectively. This feature
is to allow ease of insertion of screws or other attachment means
to anchor the prosthesis into the vertebra.
[0097] 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 FIG. 2. Due to the nature
of the inferior surface 10 of upper disc member 4, as the upper
member 4 goes into extension there is an increased distance
adjacent anterior end 24 between the upper and lower members 4, 6.
This results in a tightening of the annulus anteriorly, as is seen
in physiological extension in the disc.
[0098] 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 FIG. 3. Again, due
to the nature of inferior surface 10, as upper member goes into
flexion there is in an increased distance adjacent posterior end 26
between the upper and lower members 4, 6. This results in a
tightening of the annulus posteriorly and serves as a natural block
to further flexion.
[0099] Referring to FIGS. 13-21, there are shown more detailed
views of lower disc prosthesis member 6, 6'. The dome shaped
protrusion 16 is located in a central or intermediate section of
superior surface 12 in the anterior to posterior plane. The
anterior and posterior end sections 36, 38 either side of the dome
section 40, as shown by dotted lines 42, are provided at an acute
angle to the horizontal sloping downwardly from intermediate
section 40 towards ends 24, 26 respectively. The angled surfaces
36, 38 are typically substantially planar in form. This downwards
incline is to accommodate the flexion and extension of the upper
disc member 4 without impingement therewith. In the medial and
lateral plane, protrusion 16 extends substantially the entire
distance between the sides of the prosthesis member or from the
medial to the lateral edges 32, 34 respectively.
[0100] Referring to FIGS. 22-27, there is illustrated more detailed
views of upper disc member 4 showing in particular the curvature
and complex geometry of the inferior surface 10. The surface 10 is
divided into three distinct regions as with the superior surface of
lower disc member 6; a substantially central or intermediate
section 44 and anterior and posterior end sections 46, 48
respectively. Each section typically occupies approximately one
third of the inferior surface.
[0101] 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
FIG. 23. Thus, the curvature of the lateral half of the central
section corresponds to an arc of a circle having a radius at least
double that of the arc of a circle corresponding to the curvature
of the medial half of the central section. The purpose of this
asymmetry in the medial/lateral plane is to allow capture of the
"dome" shaped protrusion 16 of the lower disc member, but still
allow some medial and lateral movement of the disc members. This
contributes to stability and prevents dislocation of the upper and
lower disc members during movement. The shorter curvature of the
medial half of the central section relative to the lateral half
helps in the medial and lateral movement of the two vertebral
bodies on the right and left prosthesis.
[0102] 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 FIG. 22, and provide an incline sloping
downwardly from the central section 44 to the anterior and
posterior ends 24, 26 of the inferior surface respectively. The
surface of the anterior and posterior end sections that runs from
the central section to the edge of the anterior and posterior
sections, as seen in FIG. 25, is generally planar, although a mild
curvature or concavity to the surface can be provided. It is to be
noted that the slope of the anterior section 46, 46' ends before
the anterior end, thereby leaving a small planar surface 54
adjacent anterior end 46, 46'. In the lateral view, the edge of the
anterior and posterior surfaces is substantially planar, and does
not include a radius, so that the distance between the vertebrae
increases in flexion and extension.
[0103] 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 FIG. 22. This is
designed so that in combination with the other geometric features
of the prosthesis, anterior and posterior movement of the upper
disc member is allowed with respect to the lower disc member of
approximately 10 degrees, as previously described in relation to
FIGS. 2 and 3, even if the prosthesis pairs are not exactly
parallel to each other. This geometry is also designed to allow
limited sideways (medial/lateral plane) tilt of the upper disc
member on the lower disc member, allowing sideways movement of the
two disc members on each other, such that the right and the left
prosthesis move in tandem.
[0104] 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.
[0105] 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).
[0106] 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
FIGS. 28-30f. Fin members 58 anchor the disc prosthesis to adjacent
vertebrae.
[0107] 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.
[0108] 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.
[0109] 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.
[0110] 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
[0111] Referring to FIGS. 31-50, there is illustrated a facet joint
replacement prosthesis 102 according to an embodiment of the
present invention. Facet joint prosthesis 102 can be used alone, or
in combination with the lumbar disc prosthesis described above to
form a single unit system. It is designed to replace the entire
facet joint on both the right and the left side of the
vertebrae.
[0112] 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.
[0113] 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 FIG. 50. A further spacing or locking nut 127
can also be provided.
[0114] 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.
[0115] 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.
[0116] 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 FIG. 47, and
rotation of the male member in the female member, as shown by
arrows 152 in FIG. 46. The male member can also move longitudinally
in the female member to allow flexion and extension of the
prosthesis and thus the vertebral body, as shown by arrows 154 in
FIGS. 45a and 45b.
[0117] 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 FIG. 49.
Preferably side walls 138 form part of an arc, the radius of which
is larger than for the arc of the curved ends 136. End 112 of arm
portion 114 is substantially complementary in shape to end 120
having curved ends 140 and straight side walls 142 or side walls of
less curvature than said curved ends. Preferably side walls 142
form part of an arc, the radius of which is larger than for the arc
of the curved ends 140. The provision of the shaped ends allows a
small degree of rotation of the male component in the female
component.
[0118] 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.
[0119] 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 FIGS. 48a-48d. A middle pedicle screw 124' can be used to
accommodate two plate portions of the male and/or female members to
form a stack. Any number of members can be attached to a pedicle
screw as required.
[0120] 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.
[0121] 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.
* * * * *