U.S. patent application number 10/961726 was filed with the patent office on 2005-02-24 for facet arthroplasty devices and methods.
This patent application is currently assigned to Archus Orthopedics Inc.. Invention is credited to Reiley, Mark A..
Application Number | 20050043799 10/961726 |
Document ID | / |
Family ID | 46278786 |
Filed Date | 2005-02-24 |
United States Patent
Application |
20050043799 |
Kind Code |
A1 |
Reiley, Mark A. |
February 24, 2005 |
Facet arthroplasty devices and methods
Abstract
Surgically installed prostheses replace either the caudal
portion of a natural facet joint, the cephalad portion of a natural
facet joint, or both. The prostheses are readily attached to the
pedicles of a vertebral body and support at least one element that
defines an artificial facet joint structure. The caudal facet joint
structure is sized and located to articulate with the cephalad
facet joint structure. Together, the prostheses form a total facet
replacement system. The system is suitable for use in virtually all
levels of the spine.
Inventors: |
Reiley, Mark A.; (Piedmont,
CA) |
Correspondence
Address: |
RYAN KROMHOLZ & MANION, S.C.
POST OFFICE BOX 26618
MILWAUKEE
WI
53226
US
|
Assignee: |
Archus Orthopedics Inc.
|
Family ID: |
46278786 |
Appl. No.: |
10/961726 |
Filed: |
October 8, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10961726 |
Oct 8, 2004 |
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10067137 |
Feb 4, 2002 |
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6811567 |
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10067137 |
Feb 4, 2002 |
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09693272 |
Oct 20, 2000 |
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6610091 |
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60160891 |
Oct 22, 1999 |
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Current U.S.
Class: |
623/17.11 ;
606/247; 606/248 |
Current CPC
Class: |
A61F 2/4405 20130101;
A61F 2002/30873 20130101; A61F 2310/00604 20130101; A61F 2310/00179
20130101; A61B 17/1671 20130101; A61F 2002/30433 20130101; A61F
2310/00029 20130101; A61F 2002/30604 20130101; A61B 17/86 20130101;
A61F 2310/00329 20130101; A61F 2310/00634 20130101; A61F 2310/00131
20130101; A61F 2310/00017 20130101; A61F 2310/0097 20130101; A61F
2/28 20130101; A61F 2310/00976 20130101; A61F 2220/0025 20130101;
A61F 2002/30329 20130101; A61F 2310/00023 20130101; A61F 2002/449
20130101; A61F 2250/0004 20130101; A61F 2002/30537 20130101; A61F
2002/30387 20130101; A61F 2220/0041 20130101; A61F 2002/4631
20130101; A61F 2002/30777 20130101; A61F 2002/305 20130101 |
Class at
Publication: |
623/017.11 ;
606/061 |
International
Class: |
A61F 002/44 |
Claims
I claim:
1. A facet joint prosthesis to replace, on a vertebral body, a
cephalad portion of a natural facet joint, the prosthesis
comprising a component sized to be fixed to the vertebral body and
including an artificial facet joint structure adapted to replace
the cephalad portion of the natural facet joint after removal of
the cephalad portion of the natural facet joint from the vertebral
body.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 10/067,137, filed Feb. 4, 2002, which is a
continuation-in-part of U.S. patent application Ser. No.
09/693,272, filed Oct. 20, 2000, entitled "Facet Arthroplasty
Devices and Methods," now U.S. Pat. No. 6,610,091, which claims the
benefit of Provisional Patent Application Ser. No. 60/160,891,
filed Oct. 22, 1999, and entitled "Facet Arthroplasty Devices and
Methods," all of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention generally relates to devices and
surgical methods for the treatment of various types of spinal
pathologies. More specifically, the present invention is directed
to several different types of facet joint replacement prostheses,
surgical procedures for performing facet joint replacements, and
surgical instruments which may be used to perform the surgical
procedures.
BACKGROUND OF THE INVENTION
[0003] Back pain is a common human ailment. In fact, approximately
50% of persons who are over 60 years old suffer from lower back
pain. Although many incidences of back pain are due to sprains or
muscle strains which tend to be self-limited, some back pain is the
result of more chronic fibromuscular, osteoarthritic, or ankylosing
spondolytic processes of the lumbosacral area. Particularly in the
population of over 50 year olds, and most commonly in women,
degenerative spine diseases such as degenerative spondylolisthesis
(during which one vertebra slides forward over the top of another
vertebra) and spinal stenosis (during which the spinal canal
markedly narrows) occurs in a high percentage of the population.
Iida, et al, 1989.
[0004] Degenerative changes of the adult spine have traditionally
been determined to be the result of the interrelationship of the
three joint complex; the disk and the two facet joints.
Degenerative changes in the disc lead to arthritic changes in the
facet joint and vice versa. See Farfan and Sullivan, 1967; see also
Farfan, 1969; see also Farfan, 1980.
[0005] One cadaver study of nineteen cadavers with degenerative
spondylolisthesis showed that facet degeneration was more advanced
than disc degeneration in all but two cases. Farfan. In mild
spondylolisthetic cases, the slip appeared to be primarily the
result of predominantly unilateral facet subluxation. Other studies
into degenerative changes of the spine have revealed extensive
contribution of facet joint degeneration to degenerative spinal
pathologies such as degenerative spondylolisthesis, central and
lateral stenosis, degenerative scoliosis (i.e., curvature of the
spine to one side), and kypho-scoliosis, at all levels of the
lumbar spine. See Kirkaldy-Willis et al, 1978; see also Rosenberg,
1975.
[0006] It has been determined that facet joint degeneration
particularly contributes to degenerative spinal pathologies in
levels of the lumbar spine with sagittally oriented facet joints,
i.e. the L4-L5 level.
[0007] When intractable pain or other neurologic involvement
results from adult degenerative spine diseases, such as the ones
described above, surgical procedures may become necessary.
Traditionally, the surgical management of disease such as spinal
stenosis consisted of decompressive laminectomy alone. Herkowitz,
et al, The Diagnosis and Management of Degenerative Lumber
Spondylolisthesis, 1998. Wide decompressive laminectomies remove
the entire lamina, and the marginal osteophytes around the facet
joint. Because a lot of degenerative spine disease has been
demonstrated to be caused by facet joint degeneration or disease,
this procedure removes unnecessary bone from the lamina and
insufficient bone from the facet joint.
[0008] Furthermore, although patients with one or two levels of
spinal stenosis tend to do reasonably well with just a one to two
level wide decompressive laminectomy, patients whose spinal
stenosis is associated with degenerative spondylolisthesis have not
seen good results. Lombardi, 1985. Some studies reported a 65%
increase in degree of spondylolisthesis in patients treated with
wide decompressive laminectomy. See Johnson et al; see also White
and Wiltse. The increase in spinal slippage especially increased in
patients treated with three or more levels of decompression,
particularly in patients with radical laminectomies where all of
the facet joints were removed.
[0009] To reduce the occurrence of increased spondylolisthesis
resulting from decompressive laminectomy, surgeons have been
combining laminectomies, particularly in patients with three or
more levels of decompression, with multi-level arthrodesis, which
surgically fuses the facet joints to eliminate motion between
adjacent vertebrae. Although patients who undergo concomitant
arthrodesis do demonstrate a significantly better outcome with less
chance of further vertebral slippage after laminectomy, arthrodesis
poses problems of its own. Aside from the occurrence of further
spondylolisthesis in some patients, additional effects include
non-unions, slow rate of fusion even with autografts, and
significant morbidity at the graft donor site. Furthermore, even if
the fusion is successful, joint motion is totally eliminated at the
fusion site, creating additional stress on healthy segments of the
spine which can lead to disc degeneration, herniation, instability
spondylolysis, and facet joint arthritis in the healthy
segments.
[0010] An alternative to spinal fusion has been the use of an
invertebral disc prosthesis. There are at least 56 artificial disc
designs which have been patented or identified as being
investigated. McMillin C. R. and Steffee A. D., 20th Annual Meeting
of the Society for Biomaterials (abstract)(1994). Although
different designs achieve different levels of success with
patients, disc replacement mainly helps patients with injured or
diseased discs; disc replacement does not address spine pathologies
such as spondylolisthesis and spinal stenosis caused by facet joint
degeneration or disease.
SUMMARY OF THE INVENTION
[0011] There is a need in the field for prostheses and prosthetic
systems to replace injured and/or diseased facet joints, which
cause, or are a result of, various spinal diseases. There is also a
need for surgical methods to install such prostheses. There is also
a need for prostheses and prosthetic systems to replace spinal
fusion procedures.
[0012] The present invention overcomes the problems and
disadvantages associated with current strategies and designs in
various treatments for adult spine diseases. The present inventive
spinal arthroplastic systems avoid the problems of spine stiffness,
increased loads on unfused levels, and predictable failure rates
associated with spinal arthrodesis. The present invention pertains
to spinal prostheses designed to replace facet joints and/or part
of the lamina at virtually all spinal levels including L1-L2,
L2-L3, L3-L4, L4-L5, L5-S-1, T11-T12, and T12-L1. Various types of
joint replacement prostheses are described for treating different
types of spinal problems.
[0013] As will be described in greater detail later, a given
natural facet joint has a superior half and an inferior half. In
anatomical terms, the superior half of the joint is formed by the
vertebral level below the joint (which can thus be called the
caudal portion of the facet joint, i.e., because it is near the
feet). The inferior half of the joint is formed by the vertebral
level above the joint (which can thus be called the cephalad
portion of the facet joint, i.e., beacuse it is near the head). For
example, in the L4-L5 facet joint, the caudal portion of the joint
is formed by boney structure on the L-5 vertebra (e.g., a superior
articular suface and supporting bone on the L-5 vertebra), and the
cephalad portion of the joint is formed by boney structure on the
L-4 vertebra (e.g., an inferior articular surface and supporting
bone on the L-4 vertebra).
[0014] For the sake of description, the prostheses that embody the
features of the invention will be called either "cephalad" or
"caudad" with relation to the portion of a given facet joint they
replace. Thus, a prosthesis that, in use, replaces the caudal
portion of a facet joint (i.e., the superior half) will be called a
"caudal" prosthesis. Likewise, a prosthesis that, in use, replaces
the cephalad portion of a facet joint (i.e., the inferior half)
will be called a "cephalad" prosthesis.
[0015] One aspect of the invention provides a facet joint
prosthesis to replace, on a vertebral body, a caudal portion of a
natural facet joint (e.g., a superior articular surface and
supporting bone structure on the vertebral body). The caudal
prosthesis comprises a component sized to be fixed to the vertebral
body, e.g., on or near a pedicle. The caudal prosthesis includes an
artificial facet joint structure adapted to replace a caudal
portion of the natural facet joint after its removal from the
vertebral body. The removal of a caudal portion of the natural
facet joint and its total replacement by the artificial facet joint
structure of the caudal prosthesis frees the orientation of the
prosthesis from anatomic constraints imposed by a preexisting
articular configuration of the caudal portion of the natural facet
joint. Furthermore, the artificial facet joint structure of the
caudal prosthesis can comprise an artificial articular
configuration that is unlike the preexisting articular
configuration, so that a desired articulation or bony anatomy can
be restored to achieve a desired level of function.
[0016] This aspect of the invention also provides a method of
replacing, on a vertebral body, a caudal portion of a natural facet
joint. The method removes a caudal portion of the natural facet
joint from the vertebral body, and, in its place, fixes a component
to the vertebral body that includes an artificial facet joint
structure adapted to replace the removed caudal portion of the
natural facet joint. Desirably, the artificial facet joint
structure includes an artificial articular configuration unlike the
preexisting articular configuration of the removed caudal portion
of the natural facet joint.
[0017] Another aspect of the invention provides a facet joint
prosthesis to replace, on a vertebral body, a cephalad portion of a
natural facet joint (e.g., an inferior articular surface and
supporting bone structure on the vertebral body). The cephalad
prosthesis comprises a component sized to be fixed to the vertebral
body, e.g., on or near a pedicle, or on or near a lamina, or on or
near a spinous process, or combinations thereof. The cephalad
prosthesis includes an artificial facet joint structure adapted to
replace a cephalad portion of the natural facet joint after its
removal from the vertebral body. As with the removal and total
replacement of a caudal portion of the natural facet joint, the
removal of a cephalad portion of the natural facet joint and its
total replacement by the artificial facet joint structure of the
cephalad prosthesis makes possible the orientation of the
prosthesis free from anatomic constraints imposed by a preexisting
articular configuration of the cephalad portion of the natural
facet joint. Furthermore, like the caudal prosthesis, the
artificial facet joint structure of the cephalad prosthesis can
comprise an artificial articular configuration that is unlike the
preexisting articular configuration of the natural facet surface
(which is removed), so that a desired articulation or bony anatomy
can be totally restored.
[0018] This aspect of the invention also provides a method of
replacing, on a vertebral body, a cephalad portion of a natural
facet joint. The method removes a cephalad portion of the natural
facet joint from the vertebral body, and, in its place, fixes a
component to the vertebral body that includes an artificial facet
joint structure adapted to replace the removed cephalad portion of
the natural facet joint. Desirably, the artificial facet joint
structure includes an artificial articular configuration unlike the
preexisting articular configuration of the removed cephalad portion
of the natural facet joint.
[0019] Another aspect of the invention provides a prosthesis
assembly and related method for replacing a natural facet joint
between adjoining first vertebral body and a second vertebral
bodies. The assembly and method utilize a first component sized to
be fixed to the first vertebral body, which is superior to the
second vertebral body. The first component includes a first
artificial facet joint structure adapted to replace a cephalad
portion of the natural facet joint on the first vertebral body
after removal of the cephalad portion of the natural facet joint
from the first vertebral body. The assembly and method also
comprise a second component sized to be fixed to the second
vertebral body. The second component includes a second artificial
facet joint structure adapted to replace the caudad portion of the
natural facet joint of the second vertebral body after removal of
the caudad portion of the natural facet joint from the second
vertebral body. Together, the first and second artificial facet
joint structures comprise an artificial facet joint. The removal of
both cephalad and caudal portions of a natural facet joint and
their total replacement by the artificial facet joint structures of
the first and second components allows the artificial facet joint
to be installed without anatomic constraints imposed by a
preexisting articular configuration of the natural facet joint. The
removal of the natural facet joints also removes bone spurs
affecting the nerve roots adjacent the natural facet structures,
alleviating or eliminating pain. Furthermore, the artificial facet
joint structures of either the first or second components, or both,
can create an artificial articular configuration for the artificial
facet joint that is unlike the preexisting articular configuration
of the removed natural facet joint, so that a desired articulation
or bony anatomy can be completely restored. By restoring facet
joint articulation to a desired level of function, the incidence of
spondylolisthesis can be reduced or eliminated. Other features and
advantages of the inventions are set forth in the following
Description and Drawings, as well as in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is a lateral view of the L4 and L5 vertebrae;
[0021] FIG. 2 is a superior view of the L4 and L5 vertebrae in a
separated condition;
[0022] FIG. 3 is a superior section view of a vertebral body,
showing the fixation of a caudal prosthesis by pedicle screws to a
vertebral body, the prosthesis carrying facet joint structure
elements that create artificial facet surfaces for the superior
half of a facet joint replacement, the artificial facet joint
structure elements in FIG. 3 having a generally cup-shaped geometry
and being shown in positions medial of the typical anatomic
position of the superior half of the facet joint;
[0023] FIG. 4 is a superior section view of a vertebral body,
showing the fixation of a caudal prosthesis of the type shown in
FIG. 3, the length of the prosthesis spanning the pedicles being
adjustable, the cup-shaped artificial facet joint structure
elements in FIG. 4 being shown in alternative positions either
medial or lateral of the typical anatomic position of the superior
half of the facet joint;
[0024] FIG. 5 is a superior section view of a vertebral body,
showing the fixation of a caudal prosthesis of the type shown in
FIG. 3, the artificial facet joint structure elements in FIG. 5
having a generally ball-shaped geometry and being shown in
positions medial of the typical anatomic position of the superior
half of the facet joint;
[0025] FIG. 6 is an enlarged perspective view of a caudal
prosthesis of the type shown in FIG. 3, showing a mechanism that
allows movement of the artificial facet joint structure elements to
adjust their relative spaced-apart positions on the prosthesis;
[0026] FIG. 7 is a superior section view of a vertebral body,
showing the fixation of a caudal prosthesis by pedicle stems to a
vertebral body, the prosthesis carrying facet joint structure
elements that create artificial facet surfaces for the superior
half of a facet joint replacement, the artificial facet joint
structure elements in FIG. 7 having a generally cup-shaped geometry
and being shown in positions at or near the typical anatomic
position of the superior half of the facet joint;
[0027] FIG. 8 is a superior section view of a vertebral body,
showing the fixation of a caudal prosthesis of the type shown in
FIG. 7, the artificial facet joint structure elements in FIG. 8
having a generally ball-shaped geometry; and
[0028] FIG. 9 is a perspective posterior view of the spinal column,
showing the fixation of a cephalad prosthesis across the lamina of
a vertebral body, the cephalad prosthesis carrying facet joint
structure elements that create artificial facet surfaces for the
inferior half of a facet joint replacement, FIG. 9 also showing the
fixation of a caudal prosthesis of the type shown in FIG. 3
carrying facet joint structure elements that create artificial
facet surfaces for the superior half of a facet joint replacement,
the two prosthesis together created a total facet replacement
system.
[0029] The invention may be embodied in several forms without
departing from its spirit or essential characteristics. The scope
of the invention is defined in the appended claims, rather than in
the specific description preceding them. All embodiments that fall
within the meaning and range of equivalency of the claims are
therefore intended to be embraced by the claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0030] I. Anatomy of Lumbar Vertebrae
[0031] FIGS. 1 and 2 show the fourth and fifth lumbar vertebrae L4.
and L5, respectively, in a lateral view (while in anatomic
association) and in a superior view (separately). The lumbar
vertebrae (of which there are a total of five) are in the lower
back, also called the "small of the back."
[0032] As is typical with vertebrae, the vertebrae L4 and L5 are
separated by an intervertebral disk 25. The configuration of the
vertebrae L4 and L5 differ somewhat, but each (like vertebrae in
general) includes a vertebral body 10, which is the anterior,
massive part of bone that gives strength to the vertebral column
and supports body weight. The vertebral arch 12 is posterior to the
vertebral body 10 and is formed by the right and left pedicles 14
and lamina 16. The pedicles 14 are short, stout processes that join
the vertebral arch 12 to the vertebral body 10. The pedicles 14
project posteriorly to meet two broad flat plates of bone, called
the lamina 16.
[0033] Seven other processes arise from the vertebral arch. Three
processes--the spinous process 18 and two transverse 20
processes--project from the vertebral arch 12 and afford
attachments for back muscles, forming levers that help the muscles
move the vertebrae. The remaining four processes, called articular
processes, project superiorly from the vertebral arch (and are thus
called the superior articular processes 22) and inferiorly from the
vertebral arch (and are thus called the inferior articular
processes 24).
[0034] The superior and inferior articular processes 22 and 24 are
in opposition with corresponding opposite processes of vertebrae
superior and inferior adjacent to them, forming joints, called
zygapophysial joints or, in short hand, the facet joints or facets.
The facet joints permit gliding movement between the vertebrae L4
and L5. Facet joints are found between adjacent superior and
inferior articular processes along the spinal column.
[0035] The facet joints can deteriorate or otherwise become injured
or diseased, causing lack of support for the spinal column, pain,
and/or difficulty in movement.
[0036] As described in this Specification, a facet joint has a
superior half and an inferior half. The superior half of the joint
is formed by the vertebral level below the joint (which will
accordingly be called the caudal portion of the facet joint), and
the inferior half of the joint is formed by the vertebral level
above the joint (which will accordingly be called the cephalad
portion of the facet joint). For example, in the L4-L5 facet joint,
the caudal portion of the facet joint is formed by superior
articular surfaces and supporting boney structures on the L-5
vertebra, and the cephalad portion of the facet joint is formed by
inferior articular surfaces and supporting boney structures on the
L-4 vertebra.
[0037] II. Caudal Universal Facet Prosthesis
[0038] A. Structure
[0039] FIG. 3 shows a caudal facet joint replacement prosthesis 26
that embodies features of the invention. The prosthesis 26 is
designated "caudal" because it creates an artificial facet joint
structure 28 for the superior half of a facet joint replacement.
The caudal prosthesis 26 allows for the removal and replacement of
injured, diseased and/or deteriorating natural superior articular
surfaces and supporting boney structure on the vertebral body below
the facet joint, to provide improved support for the spinal
column.
[0040] The artificial facet joint structure 28 articulates with the
inferior half of the facet joint, which itself can comprise the
natural cephalad portions of the facet joint (i.e., inferior
articular surfaces and supporting boney structure on the vertebral
body above the facet joint), or an artificial facet joint structure
formed by a cephalad joint replacement prosthesis 48 (shown in
phantom lines in FIG. 3 and as will be described. later).
[0041] As will become apparent, the prosthesis 26 is particularly
well suited to double-sided procedures and/or for procedures
involving vertebral bodies that are not symmetrical.
[0042] As shown in FIG. 3, the prosthesis 26 comprises a bar
element 30. The bar element 30 is secured to a vertebral body 10 by
at least one fixation element 32. As also shown in FIG. 3, the bar
element 30 carries at least one facet joint structure element 34.
In FIG. 3, two fixation elements 32 (left and right) and two facet
joint structure elements 34 (left and right) are shown. The
prosthesis 26 thereby readily accommodates a double-sided (i.e.,
left and right) caudal facet joint replacement.
[0043] The bar element 30 is sized and shaped to span the distance
between left and right pedicles 14 of a vertebral body 10. The bar
element 30 may be formed of a material commonly used in the
prosthetic arts including, but not limited to, polyethylene,
rubber, titanium, chrome cobalt, surgical steel, bony in-growth
sintering, sintered glass, artificial bone, ceramics, or a
combination thereof.
[0044] As shown in FIG. 3, the spanning length of the bar element
30 may be fixed. Alternatively, as shown in FIG. 4, the spanning
length of the bar element 30 may be adjustable by the inclusion of
an intermediate sliding joint 36. The adjustment of the spanning
length of the bar element 30 may also be made, e.g., by use of a
turning gear wheel mechanism, or a ratchet mechanism, or the like.
A surgeon thereby has the capability to to size the bar element 30,
to custom-fit the prosthesis 26 during surgery.
[0045] In FIGS. 3 and 4, each end of the bar element includes an
opening 38. Each opening 38 accommodates passage of the fixation
element 32. In FIG. 1, the fixation elements 32 take the form of
pedicle screws or nails. The fixation elements 32 secure the left
and right ends of the bar element 30, respectively, to the left and
right pedicles 14 of the vertebral body 10.
[0046] One or both of the openings 38 could be elongated, either
along the superior-inferior axis of the vertebral body, or
transverse this axis, to allow for varying orientations and/or
sizes of the fixation elements 32. Passage of the fixation elements
32 through openings 38 provides straightforward and flexible
fixation of the bar element 30 to the vertebral body 10.
[0047] The bar element 30 shown in FIGS. 3 and 4 carries left and
right facet joint structure elements 34. The presence of the bar
element 30 spanning between the facet joint structure elements 34
lends overall stability to the prosthesis 26. Weight borne by the
left and right facet joint structure elements 34 is evenly
distributed by the bar element 30 between the left and right sides
of the vertebral body 10.
[0048] The facet joint structure elements 34 may be fixedly
attached to the bar element (e.g., by pre-welding, or by gluing
with a biocompatible adhesive) to provide a fixed, pre-ordained
spaced apart relationship between the facet surface elements 34.
The preordained, fixed position of and the spacing between the
facet joint structure elements 34 can vary, e.g., among prostheses
26 intended for children and adults, as well as for male and
females. The physician can also select the desired position of the
facet joint structure elements 34 based upon prior analysis of the
morphology of the targeted joint using, for example, plain film
x-ray, fluoroscopic x-ray, or MRI or CT scanning.
[0049] The facet joint structure elements 28 can be located at or
near the typical anatomic position of the caudal portion of the
facet joint, which would be generally aligned with the fixation
element 32 (as FIG. 7 shows in connection with another embodiment,
which will be described later). Alternatively, if desired, and as
shown in FIG. 3, the facet joint structure elements 34 can be fixed
within a range of pre-ordained locations medial of the typical
anatomic location. Still alternatively, and as shown in FIG. 4, one
or both of the facet joint structure elements 34 can be fixed
within a range of preordained positions lateral of the typical
anatomic position.
[0050] Alternatively, one or both of the facet joint structure
elements 34 can be carried by the bar element 30 for relative
movement, e.g., in a track 40 extending in the bar element (see
FIG. 5). In this arrangement, the position of the movable facet
joint structure element(s) 34 can be infinitely varied during
surgery to match the particular anatomy of the facet joint or
joints being replaced. In this arrangement, a set screw 42 or the
like can secure the position of the movable facet joint structure
element 34 along the track 40.
[0051] Whether one or more of the facet joint structure elements 34
are fixed or movable relative to the bar element 30, the prosthesis
26 can accommodate a variety of different symmetric or asymmetric
anatomic situations, e.g., where the caudal portion of the facet
joint on one side of a vertebral body 10 are differently spaced
from those on the other side of the same body 10. The prosthesis 26
can include adjustable facet joint structure elements 34, or,
alternatively, it can be pre-formed with various fixed relative
positions of left and right facet joint structure elements 34,
either symmetric and asymmetric; e.g., left and right typical; or
left and right medial; or left and right lateral; or left medial
and right lateral, or combinations thereof. The invention thereby
makes it possible for a surgeon to install a "custom" implant
during the surgical procedure.
[0052] The facet joint structure elements 34 may be made of a
biocompatible polymer (e.g., polyethylene or rubber) , or a
biocompatible ceramic, or bony in-growth surface, or sintered
glass, or artificial bone, or a combination thereof. The material
is selected to provide glide and cushioning ability for potential
contacting components. Desirably, these surface materials are, for
strength, backed by a biocompatible metal (e.g., titanium, titanium
alloys, chrome cobalt, or surgical steel).
[0053] The geometry of the caudal facet joint structure elements 34
can also vary, depending on the geometry of the matching cephalad
portions of a facet joint or facet joint replacement. As shown in
FIGS. 3 and 4, the caudal facet joint structure elements 34 may be
generally concave or cup-shaped, to thereby articulate with
generally convex or ball-shaped facet joint structures of the
cephalad portion of the facet joint or facet joint replacement.
Alternatively, as shown in FIG. 5, the caudal facet joint structure
elements 34 may be generally convex or ball-shaped, to thereby
articulate with generally concave or cup-shaped facet joint
structure of the cephalad portion of the facet joint
replacement.
[0054] The ball-shaped elements and the cup-shaped elements can
have various diameters and arcs of curvature. Preferably, the
ball-shaped element is elliptical or round.
[0055] The cup-shaped elements may be any appropriate shape
including, but not limited to, rectangular, disc shaped, trough
shaped, or cup shaped. The cup-shaped element is desirably sized
larger than the articulating ball-shaped half of the facet joint,
to allow for motion of the joint.
[0056] Regardless of geometry, the facet joint structure elements
34 can be fixedly attached or removably attached, e.g., by Morse
tapers 44 (see FIG. 5), or screws, slots, and the like.
[0057] In an alternative arrangement (see FIG. 7), the bar element
30 and facet joint structure elements 34 form a preformed unit, and
the fixation elements 34 comprise stems 46 secured to the vertebral
body 10. The stems 46 are secured by insertion into the pedicles 14
(e.g., by screwing or tapping). In FIG. 7, there are two stems 46
inserted, respectively, into the left and right pedicles 14.
[0058] In this arrangement, the bar element 30 and facet joint
structure elements 34 are desirably secured as a preformed unit
with compressive forces or friction to the stems 46, e.g., by Morse
tapers 44, to thereby enable their removal and replacement as a
unit. Alternatively, the bar element 30 and facet joint structure
elements 34 can be fixedly attached as a unit to the stem 46, e.g.,
by adhesive, screw, nail, or any means known in the art.
[0059] As FIGS. 7 and 8 show, the geometry of the caudal facet
joint structure elements 34 on the bar element 30 attached to the
stems 46 can vary, as previously described, depending on the
geometry of the matching cephalad portions of a facet joint or
facet joint replacement. As shown in FIG. 7, the caudal facet joint
structure elements 34 may be generally concave or cup-shaped, to
thereby articulate with generally convex or ball-shaped facet joint
structure of the cephalad portions of the facet joint or facet
joint replacement. Alternatively, as shown in FIG. 8, the caudal
facet joint structure elements may be generally convex or
ball-shaped, to thereby articulate with generally concave or
cup-shaped facet surfaces of the cephalad portions of the facet
joint replacement.
[0060] The caudal prosthesis 26 for the superior half of the facet
joint replacement described above may be used as a replacement for
the caudal portions of one or more of facet joints at any facet
joint at any level of the spine. In the preferred embodiment, the
prosthesis 26 is used to replace the caudal portion of one or more
facet joints. The prosthesis 26 is designed such that it has the
appropriate cephalad and caudad directions as well as the
appropriate medial/lateral angulation for the given level of the
spine where the implant occurs.
[0061] In further embodiments, one or more surfaces of a prosthesis
26 may be covered with various coatings such as antimicrobial,
antithrombotic, and osteoinductive agents, or a combination
thereof. See, e.g., U.S. Pat. No. 5,866,113, which is incorporated
herein by reference. These agents may further be carried in a
biodegradable carrier material with which the pores of the stem
and/or cup member of certain embodiments may be impregnated. See,
e.g., U.S. Pat. No. 5,947,893, which is also incorporated herein by
reference.
[0062] In still further embodiments of the present invention, the
prosthesis 26 may be attached to strengthened or fortified bone.
Vertebrae may be strengthened prior to or during fixation of the
prostheses using the methods, e.g., described in U.S. Pat. No.
5,827,289, which is incorporated herein by reference. This type of
bone strengthening is particularly suggested for osteoporotic
patients who wish to have facet replacement.
[0063] B. Surgical Method for Facet Replacement Using the Caudal
Prosthesis
[0064] A surgical procedure removes and replaces the caudal portion
of a facet joint with the caudal prosthesis 26 described above.
[0065] In one embodiment, the surgical procedure comprises exposing
the spinous process, lamina, and facet joints at a desired level of
the spine using any method common to those of skill in the medical
arts. Prominent bone of the caudal portion of the natural facet
joint natural, e.g., the superior articular process 22 and its
supporting bone, may rongeured using any means common in the field.
The caudal portion of the natural facet joint may also be trimmed
to decompress the adjacent nerve root. A reamer or any other
instrument that is useful for grinding or scraping bone, may be
used to ream the caudal portion of the facet joint into the
pedicle, to reach the geometry shown in FIG. 3, which is suitable
for receiving the caudal prosthesis 26.
[0066] The prosthesis can then directly screwed or tapped into the
vertebral body 10 using pedicle screws or other fixation elements.
Because the caudal portion of the natural facet joint has been
removed, the artificial facet joint structure of the caudal
prosthesis 26 can be installed in a desired position and
orientation, free of anatomic constraints imposed by the
preexisting articular configuration of the caudal portion of the
natural facet joint. Furthermore, the artificial facet joint
structure of the caudal prosthesis 26 can comprise an artificial
articular configuration that is unlike the preexisting articular
configuration of the natural facet surface (which is removed), so
that a desired articulation or bony anatomy can be totally
restored. Furthermore, decompression of the adjacent nerve root can
be maintained, eliminating pain at the same time a desired anatomy
is restored.
[0067] Further details of surgical procedures suitable for
installing the prosthesis 26 are described in co-pending U.S.
patent application Ser. No. 09/693,272, filed Oct. 20, 2000, and
entitled "Facet Arthroplasty Devices and Methods," which is
incorporated herein by reference.
[0068] III. Cephaled Prosthesis
[0069] A. Structure
[0070] FIG. 9 shows a cephalad facet joint replacement prosthesis
48 that embodies features of the invention. The prosthesis 48 is
designated "cephalad" because it provides an artificial facet joint
structure element 50 for the inferior half of a facet joint
replacement. The cephalad prosthesis 48 allows for the removal and
replacement of injured, diseased and/or deteriorating natural
inferior articular surfaces and supporting boney structure on the
vertebral body above the facet joint, to provide improved support
for the spinal column.
[0071] The artificial facet joint structure 50 articulates with the
superior half of the facet joint, which itself can comprise the
natural caudal portions of the facet joint (i.e., the natural
superior articular surfaces and supporting boney structure on the
vertebral body below the facet joint), or an artificial facet joint
structure formed by a caudal joint replacement prosthesis 28.
[0072] In FIG. 9, the superior half of the facet joint replacement
comprises the caudal facet joint structure 28 of the prosthesis 26
of the general type shown in FIGS. 3 and 4. In FIG. 9, the caudal
facet joint structure 28 comprise cup-shaped caudal facet joint
structure elements 34, which, in FIG. 9, are mutually located on
the bar element 30 in positions lateral of the typical anatomic
location. As shown in FIGS. 3 and 4, the relative position of the
cup-shaped caudal facet joint structure elements 34 can vary among
the typical anatomic position, a position medial of this position,
and a position lateral of this position, as has already been
explained. The cephalad facet joint structure elements 50 are
positioned to align with the caudal facet joint structure elements
34.
[0073] The cephalad prosthesis 48 shown in FIG. 9 desirably spans
the lamina 16 from the left side of a vertebral body 10 to the
right side of the vertebral body 10. The cephalad prosthesis 48
thereby makes possible the removal and replacement of injured,
diseased and/or deteriorating components along the cephalad
portions of both left and right facet joints, to provide improved
support for the spinal column. The cephalad prosthesis 48 allows
for replacement of diseased and deteriorating inferior portions of
the vertebra and partial replacement of lamina, which may be
pressing on the spinal nerves, to relieve pain. The cephalad
prosthesis 48 creates artificial facet joint structure elements 50
for the inferior half of facet joints in the spine, which provide
improved support for the spinal column.
[0074] Because the cephalad portion of the natural facet joint is
removed, the artificial facet joint structure element 50 of the
cephalad prosthesis 48 can be installed in a desired position and
orientation, free of anatomic constraints imposed by the
preexisting articular configuration of the cephalad portion of the
natural facet joint. Furthermore, the artificial facet joint
structure element 50 of the cephalad prosthesis 48 can comprise an
artificial articular configuration that is unlike the preexisting
articular configuration of the natural facet surface (which is
removed), so that a desired articulation or bony anatomy can be
totally restored. Furthermore, decompression of the adjacent nerve
root can be maintained, eliminating pain at the same time a desired
anatomy is restored.
[0075] As FIG. 9 shows, the caudal prosthesis 26, e.g., as
described above, may also be installed with the cephalad prosthesis
48, to replace both the caudal and cephalad portions of the natural
facet joint, after both caudal and cephalad portions of the natural
facet joint are surgically removed. Together, the caudal and
cephalad prostheses 26 and 48 form a total facet replacement system
52.
[0076] Because the system 52 entails removal of both the caudal and
cephalad portions of the natural facet joints, the placement of the
total facet replacement system 52 is not necessarily constrained by
normal anatomic considerations. To attain desired alignment and
load conditions, the artificial facet joint structures 28 and 48
can be positioned along, medial of, or lateral of the normal
anatomic locations of the facet joints. Likewise, the facet joint
structures 28 and 48 can be positioned at or slightly superior or
slightly inferior to the normal anatomic location of the facet
joints.
[0077] The system 52 can provide a succession of entirely
artificial facet joints along a length of the spinal column.
Alternatively, just the inferior half one or more facet joints, or
just the superior half of one or more facet joints, may be
replaced. The inferior and/or superior halves of facet joints may
be replaced on one side of a given vertebra (unilateral), on the
both sides of a given vertebra (bilateral), or a combination of
each along a length of the spinal column. At the same time a
desired bone anatomy is restored, decompression of the adjacent
nerve root can be maintained to eliminate pain.
[0078] In the embodiment shown in FIG. 9, the cephalad prosthesis
48 comprises three separate components--a central component 54 and
arm components 56 and 58 (left and right).
[0079] The central component 54 may be variously constructed. In
the illustrated embodiment, the central component 54 comprises a
spinous process chimney 60 and left and right lamina plates 62 and
64. The spinous process chimney 60 functions to surround and
stabilize the posterior aspect of the spinous process 18. If
desired, the spinous process 18 may be fixed between interior walls
of the spinous process chimney 60 with a trans-spinous process
screw 66.
[0080] The left and right lamina plates 62 and 64 contact the
lamina 16, to aid fixation of the central component 54 to the
vertebral body 10. The plates 62 and 64 can be secured to the
lamina 16 by various ways, e.g., poly(methylmethacrylate) bone
cement, hydroxyapatite, screws, nails, bolts, anchors, break-away
screws to facilitate any future removal of the prosthesis, or a
combination thereof, or any other means known in the art. Lamina
hooks 68 are also desirably used to push against the lamina 16,
thereby adding additional stability.
[0081] The left and right arm components 56 and 58 attach by a
coupling to medial sides of the left and right lamina plates 62 and
64. The coupling junction 70 between the arm components 56 and 58
and the lamina plates 62 and 64 may take a number of different
forms, including, e.g., a slotted joint between the plate 62/64 and
the respective arm 56/58. Alternatively, a screw attachment, a hook
attachment, or a snap-fit attachment can be used.
[0082] The left and right arm components 56 and 58 each include a
superior opening 72. Each opening 72 accommodates passage of a
fixation element 74. In FIG. 9, the fixation elements 74 take the
form of bilateral pedicle screws or nails, but other forms of
fixation can be used.
[0083] The fixation elements 74 secure the superior portions of the
left and right arm components 56 and 58, respectively, to the left
and right pedicles 14 of the vertebral body 10. One or both
openings 72 could be elongated, either along the superior-inferior
axis of the vertebral body 10 or transverse this axis, to allow for
varying orientations and/or sizes of the pedicle screw.
[0084] Passage of the pedicle screws through the openings 72
provides straightforward and flexible fixation of the left and
right arm components 56 and 58 to the vertebral body. Lamina hooks
68 are also desirably used to push against the lamina 16, thereby
adding additional stability.
[0085] The left and right arm components 56 and 58 also each
includes a depending cephalad facet joint structure element 76. The
facet joint structure elements 76 are sized and located for
articulation with a natural caudal portion of the facet joint or an
artificial caudal facet joint structure element.
[0086] The relative position and geometry of the cephalad facet
joint structure elements 76 can of course vary, depending on the
relative positions and geometry of the matching natural caudal
portion of the facet joint or an artificial caudal facet joint
structure element. As shown in FIG. 9, the cephalad facet joint
structure elements 76 may be generally convex or ball-shaped, to
thereby articulate with generally concave or cup-shaped facet joint
structure elements 34 of the caudal prosthesis. This articulation
is also shown in phantom lines in FIGS. 3 and 4, with the facet
joint structure elements 34 and 76 arranged at alternative,
different anatomic positions.
[0087] Alternatively, as shown in phantom lines in FIG. 5, the
cephalad facet joint structure elements 76 may be generally concave
or cup-shaped, to thereby articulate with generally convex or
ball-shaped facet joint structure elements 34 of the caudal
prosthesis.
[0088] As before explained, the ball-shaped joint structure
elements and the cup-shaped joint structure elements can have
various diameters and arcs of curvature.
[0089] Regardless of geometry, as with the caudal facet joint
structure elements 34, the cephalad facet joint structure elements
76 can be fixedly attached to the respective arm component 56 and
58. Alternatively, the cephalad facet joint structure elements 76
can be removably attached to the respective arm component 56 and
58, e.g., by Morse tapers 44, or screws, slots, and the like.
[0090] Regardless of geometry, the cephalad facet joint structure
elements 76 may be made of a biocompatible polymer (e.g.,
polyethylene or rubber), or a biocompatible ceramic, or bony
in-growth surface, or sintered glass, or artificial bone, or a
combinations thereof. Desirably, these surface materials are backed
by a biocompatible metal (e.g., titanium, titanium alloys, chrome
cobalt, or surgical steel).
[0091] The central component 54 and the left and right arm
components 62 may be made of material commonly used in the
prosthetic arts including, but not limited to, polyethylene,
rubber, titanium, chrome cobalt, surgical steel, bony in-growth
sintering, sintered glass, artificial bone, ceramics, or a
combination thereof.
[0092] In further embodiments, one or more surfaces of the cephalad
prosthesis 48 may be covered with various coatings such as
antimicrobial, antithrombotic, and osteoinductive agents, or a
combination thereof. See, e.g., U.S. Pat. No. 5,866,113, which is
incorporated herein by reference. These agents may further be
carried in a biodegradable carrier material with which the pores of
the base member and/or any screws, bolts, or nails of certain
embodiments may be impregnated. See, e.g., U.S. Pat. No. 5,947,893,
which is incorporated herein by reference.
[0093] In other arrangements, the cephalad prosthesis 48 may be
attached to strengthened or fortified bone. Vertebrae may be
strengthened prior to or during fixation of the prosthesis using
the methods described, e.g., in U.S. Pat. No. 5,827,289, which is
incorporated herein by reference. This type of bone strengthening
is particularly suggested for osteoporotic patients who wish to
have facet replacement.
[0094] B. Surgical Method for Lamina/Facet Replacement
[0095] Using the Cephalad Prosthesis
[0096] A surgical procedure removes and replaces the inferior
lamina 16 and the cephalad portion of the facet joint (e.g., the
articulated inferior processes 24 and its supporting bone of the
targeted vertebral body 10) with the cephalad prosthesis 48 as
described above.
[0097] In one embodiment, the surgical procedure exposes the
spinous process, lamina, and facet joints at a desired level of the
spine using any method common to those of skill in the medical
arts. The cephalad portion of the facet joint is cut at or near a
selected resection line. Most of the lamina 16 is desirably
preserved, as is the facet joint capsule, which may be opened and
folded back. The facet joint capsule may be cut perpendicular to
its direction. The cephalad portion of the facet joint may then be
retracted from the caudal portion. Once the facet joint 620 is
separated, the cut inferior bone of the upper joint (e.g., the cut
inferior portion of the L4 vertebra in the L4-L5 joint) may be
removed. Alternatively, it may be possible to remove the cut
inferior bone while simultaneously separating the facet joint.
[0098] The caudal prosthesis 26 can also be installed as previously
described, either before of after the inferior bone is removed or
even cut.
[0099] The cephalad prosthesis 48 as described above is placed over
the spinous process 18 over the lamina 16. The cephalad prosthesis
48 is attached as above described to the lamina 16 and to each
pedicle. The cephalad prosthesis 48 may also be further attached to
the spinous process 18 with a trans-spinous-process screw 66 to
provide additional stability, as also previously described.
[0100] Further details of surgical procedures suitable for
installing the prosthesis 48 are described in co-pending U.S.
patent application Ser. No. 09/693,272, filed Oct. 20, 2000, and
entitled "Facet Arthroplasty Devices and Methods," which is
incorporated herein by reference.
[0101] The size and shape of any prosthesis disclosed herein are
desirably selected by the physician, taking into account the
morphology and geometry of the site to be treated. The shape of the
joint, the bones and soft tissues involved, and the local
structures that could be harmed if move inappropriately, are
generally understood by medical professionals using textbooks of
human anatomy along with their knowledge of the site and its
disease and/or injury. The physician is also desirably able to
select the desired shape and size of the prosthesis and its
placement in and/or around the joint. based upon prior analysis of
the morphology of the targeted joint using, for example, plain film
x-ray, fluoroscopic x-ray, or MRI or CT scanning. The shape, size
and placement are desirably selected to optimize the strength and
ultimate bonding of the prosthesis to the surrounding bone and/or
tissue of the joint.
[0102] Other embodiments and uses of the invention will be apparent
to those skilled in the art from consideration of the specification
and practice of the invention disclosed herein. All documents
referenced herein are specifically and entirely incorporated by
reference. The specification and examples should be considered
exemplary only with the true scope and spirit of the invention
indicated by the following claims. As will be easily understood by
those of ordinary skill in the art, variations and modifications of
each of the disclosed embodiments can be easily made within the
scope of this invention as defined by the following claims.
* * * * *