U.S. patent application number 11/333919 was filed with the patent office on 2007-07-26 for intervertebral prosthetic device for spinal stabilization and method of implanting same.
This patent application is currently assigned to SDGI Holdings, Inc.. Invention is credited to Kent M. Anderson, Aurelien Bruneau, Thomas Carls, Jonathan Dewey, Eric C. Lange, Fred J. IV Molz, Matthew M. Morrison.
Application Number | 20070173823 11/333919 |
Document ID | / |
Family ID | 37898607 |
Filed Date | 2007-07-26 |
United States Patent
Application |
20070173823 |
Kind Code |
A1 |
Dewey; Jonathan ; et
al. |
July 26, 2007 |
Intervertebral prosthetic device for spinal stabilization and
method of implanting same
Abstract
A prosthetic device and method, according to which a member of a
relatively flexible, soft material is connected with a member of a
relatively stiff material and the connected members are implanted
in a spinal column using a non-rigid and a rigid connection.
Inventors: |
Dewey; Jonathan; (Memphis,
TN) ; Molz; Fred J. IV; (Birmingham, AL) ;
Bruneau; Aurelien; (Memphis, TN) ; Lange; Eric
C.; (Collierville, TN) ; Morrison; Matthew M.;
(Cordova, TN) ; Carls; Thomas; (Memphis, TN)
; Anderson; Kent M.; (Memphis, TN) |
Correspondence
Address: |
HAYNES AND BOONE, LLP
901 MAIN STREET, SUITE 3100
DALLAS
TX
75202
US
|
Assignee: |
SDGI Holdings, Inc.
Wilmington
DE
|
Family ID: |
37898607 |
Appl. No.: |
11/333919 |
Filed: |
January 18, 2006 |
Current U.S.
Class: |
623/17.11 |
Current CPC
Class: |
A61B 17/7067
20130101 |
Class at
Publication: |
606/061 |
International
Class: |
A61F 2/30 20060101
A61F002/30 |
Claims
1. A prosthetic device for insertion in a spinal column, the device
comprising: a first member of a relatively flexible material; a
second member of a relatively stiff material connected to the first
member; means for providing a non-rigid connection of one of the
members to a vertebrae of the column; and means for providing a
rigid connection of one of the members to a vertebrae of the
column.
2. The device of claim 1 wherein the second member is supported by
the first member.
3. The device of claim 2 wherein the first member is a spacer and
the second member is an insert that extends in a channel formed in
the spacer.
4. The device of claim 3 wherein the means for providing the
non-rigid connection comprises two notches formed in the spacer for
engaging the respective spinous processes of two vertebrae.
5. The device of claim 1 wherein the spinous process of one
vertebrae of the column is removed and wherein the notches engage
the respective spinous processes of the vertebrae adjacent the one
vertebrae.
6. The device of claim 3 wherein the means for providing the rigid
connection comprises two screws extending through an opening in the
spacer and into the pedicles of a vertebrae.
7. The device of claim 1 wherein the second member has an opening
for receiving a tab on the first member to connect the members.
8. The device of claim 7 further comprising a third member having a
tab that also extends in the opening of the second member.
9. The device of claim 8 wherein the means for providing the
non-rigid connection comprises a notch formed in the first member
and in the third member for engaging the respective spinous
processes of two vertebrae.
10. The device of claim 9 wherein the spinous process of one
vertebrae of the column is removed and wherein the notches engage
the respective spinous processes of the vertebrae adjacent the one
vertebrae.
11. The device of claim 10 wherein the means for providing the
rigid connection comprises two screws extending openings in the
second member and into the pedicles of the one vertebrae.
12. The device of claim 1 further comprising means on one of the
members for receiving a cable to tether the latter member to a
vertebrae of the column.
13. A method of implanting a prosthetic device in a spinal column
to stabilize the spine, the method comprising: connecting a first
member of a relatively flexible material to a second member of a
relatively stiff material; establishing a non-rigid connection
between one of the members and a vertebrae; and establishing a
rigid connection between one of the members and a vertebrae of the
spinal column.
14. The method of claim 13 wherein the first-mentioned step of
connecting comprises supporting the second member by the first
member.
15. The method of claim 14 wherein the first-mentioned step of
connecting further comprises supporting the second member in a
channel in the first member.
16. The method of claim 13 wherein the step of establishing the
non-rigid connection comprises forming two notches in the one
member for engaging the respective spinous processes of two
vertebrae.
17. The method of claim 16 wherein the spinous process of one
vertebrae of the column is removed and wherein the notches engage
the respective spinous processes of the vertebrae adjacent the one
vertebrae.
18. The method of claim 17 wherein the step of establishing the
rigid connection comprises inserting at least one screw through a
corresponding opening in one of the members and into the
corresponding pedicle of the one vertebrae.
19. The method of claim 13 wherein the step of establishing the
rigid connection comprises inserting at least one screw through a
corresponding opening in one of the members and into the
corresponding pedicle of the vertebrae.
20. The method of claim 13 wherein the first-mentioned step of
connecting comprises inserting a tab on one of the members into an
opening in the other member.
21. The method of claim 20 further comprising inserting a tab on a
third member into the opening.
22. The method of claim 21 wherein the step of establishing the
non-rigid connection comprises forming a notch in the one member
and in the third member for engaging the respective spinous
processes of the vertebrae.
23. The method of claim 22 wherein the spinous process of one
vertebrae of the column is removed and wherein the notches engage
the respective spinous processes of the vertebrae adjacent the one
vertebrae.
24. The method of claim 23 wherein the step of establishing the
rigid connection comprises two screws extending through openings in
the one member and into the respective pedicles of the one
vertebrae.
25. The method of claim 13 wherein the step of establishing the
rigid connection comprises at least one screw extending through an
opening in the one member and into a pedicle of the vertebrae.
26. The method of claim 13 further comprising tethering one of the
members to a vertebrae of the column.
Description
BACKGROUND
[0001] The present invention relates to an intervertebral
prosthetic device for stabilizing the human spine, and a method of
implanting same. Spinal discs that extend between adjacent
vertebrae in vertebral columns of the human body provide critical
support between the adjacent vertebrae while permitting multiple
degrees of motion.
[0002] These discs can rupture, degenerate, and/or protrude by
injury, degradation, disease, or the like to such a degree that the
intervertebral space between adjacent vertebrae collapses as the
disc loses at least a part of its support function, which can cause
impingement of the nerve roots and severe pain.
[0003] In these cases, intervertebral prosthetic devices have been
designed that can be implanted between the adjacent vertebrae, both
anterior and posterior of the column and are supported by the
respective spinous processes of the vertebrae to prevent the
collapse of the intervertebral space between the adjacent vertebrae
and provide motion stabilization of the spine. Many of these
devices are supported between the spinous processes of the adjacent
vertebrae.
[0004] In some situations it is often necessary to remove the
laminae and the spinous process from at least one of the adjacent
vertebrae to get proper decompression. In other situations, the
defective disc is removed and two vertebral segments are fused
together to stop any motion between the segments and thus relieve
the pain. When two adjacent vertebrae are fused, the laminae and
the spinous process of at least one vertebrae are no longer needed
and are therefore often removed.
[0005] However, in both of the above situations involving removal
of a spinous process, it would be impossible to implant an
intervertebral prosthetic device of the above type since the device
requires support from both processes.
SUMMARY
[0006] According to an embodiment of the invention, an
intervertebral prosthetic device is provided that is implantable
between two adjacent vertebrae, at least one of which is void of a
spinous process, to provide motion stabilization.
[0007] Various embodiments of the invention may possess one or more
of the above features and advantages, or provide one or more
solutions to the above problems existing in the prior art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a side elevational view of an adult human
vertebral column.
[0009] FIG. 2 is a posterior elevational view of the column of FIG.
1.
[0010] FIG. 3 is an enlarged, front elevational view of one of the
vertebrae of the column of FIGS. 1 and 2.
[0011] FIG. 4 is an enlarged, partial, isometric view of a portion
of the column of FIGS. 1 and 2, including the lower three vertebrae
of the column, and depicting intervertebral prosthetic device
according to an embodiment of the invention implanted between two
adjacent vertebrae.
[0012] FIG. 5 is an enlarged, isometric, exploded view of the
prosthetic device of FIG. 4.
[0013] FIG. 6 is a cross-sectional view of the implanted device of
FIGS. 4 and 5.
[0014] FIG. 7 is an enlarged, isometric, exploded view of an
alternate embodiment of the prosthetic device of FIG. 5.
DETAILED DESCRIPTION
[0015] With reference to FIGS. 1 and 2, the reference numeral 10
refers, in general, to a human vertebral column 10. The lower
portion of the vertebral column 10 is shown and includes the lumbar
region 12, the vertebrae V6, and the coccyx 16. The flexible, soft
portion of the vertebral column 10, which includes the thoracic
region and the cervical region, is not shown.
[0016] The lumbar region 12 of the vertebral column 10 includes
five vertebrae V1, V2, V3, V4 and V5 separated by intervertebral
discs D1, D2, D3, and D4, with the disc D1 extending between the
vertebrae V1 and V2, the disc D2 extending between the. vertebrae
V2 and V3, the disc D3 extending between the vertebrae V3 and V4,
and the disc D4 extending between the vertebrae V4 and V5.
[0017] The vertebrae V6 includes five fused vertebrae, one of which
is a superior vertebrae V6 separated from the vertebrae V5 by a
disc D5. The other four fused vertebrae of the sacrum 14 are
referred to collectively as V7. A disc D6 separates the vertebrae
V6 from the coccyx 16 which includes four fused vertebrae (not
referenced).
[0018] With reference to FIG. 3, the vertebrae V5 includes two
laminae 20a and 20b extending to either side (as viewed in FIG. 2)
of a spinous process 22 that projects posteriorly from the juncture
of the two laminae. Two transverse processes 24a and 24b extend
laterally from the laminae 20a and 20b, respectively, and two
pedicles 26a and 26b extend inferiorly from the processes 24a and
24b to a vertebral body 28. Since the other vertebrae V1-V3 are
similar to the vertebrae V5 they will not be described in detail.
Also, V4 is similar to V5 with the exception that the spinous
process 22 of V4 has been removed for one or both of the reasons
set forth below.
[0019] Referring to FIG. 4, it will be assumed that, for one or
more of the reasons set forth above, the vertebrae V4 and V5 are
not being adequately supported by the disc D4 and that it is
therefore necessary to provide supplemental support and
stabilization of these vertebrae. As stated above, it will also be
assumed that the spinous process 22 of V4 has been removed.
[0020] An intervertebral disc prosthetic device 40 according to an
embodiment of the invention is provided which is adapted to be
implanted between the spinous processes 22 of the vertebrae V3 and
V5. The prosthetic device 40 is shown in detail in FIGS. 5 and 6
and includes a spacer 42 which is substantially rectangular in
shape with the exception that two curved notches 42a and 42b are
formed its respective end portions. A laterally extending channel
42c, having a substantially rectangular cross section, extends
through the entire width of the spacer 42 approximately midway
between the notches 42a and 42b.
[0021] An insert 44 is provided that is dimensioned so as to extend
in the channel 42c with minimum clearance. Tabs 46a and 46b extend
out from the respective ends of the insert 44 and elongated
openings 46c and 46d extend through the respective tabs. The length
of the insert 44 substantially corresponds to the length of the
channel 42c so that when the insert is inserted in the channel, the
tabs 46a and 46b project outwardly from the channel.
[0022] Two protrusions 48a and 48b extend from the sides of the tab
46a and two protrusions 48c and 48d extend from the sides of the
tab 46b. The protrusions are for the purpose of receiving tethers,
or the like, to tether the device 40 to the vertebrae V4 and/or
V5.
[0023] Since the spinous process of the vertebrae V4 has been
removed, the device 40 is implanted between the spinous process 22
of the vertebrae V3 and the spinous process 22 of the vertebrae V5.
In the implanted position shown in FIGS. 4 and 6, the spinous
process 22 of the vertebrae V3 extends in the notch 42a of the
spacer 42, and the spinous process 22 of the vertebrae V5 extends
in the notch 42b. The dimensions of the device 40 are such that,
when it is implanted in this manner, the elongated openings 46c and
46d extend over the pedicles 26a and 26b (FIG. 3) of the vertebrae
V4.
[0024] Then, two screws, one of which is referred to by the
reference numeral 49 in FIGS. 4 and 6, are inserted through the
elongated openings 42c and 42d, respectively, of the spacer 42.
Torque is applied to the screws 49 so that they are driven into the
pedicles 26a and 26b of the vertebrae V4. The elongated openings
46c and 46d in the tabs 46a and 46b, respectively, enable the
screws 49 to be adjusted laterally and to be angled towards the
pedicles 26a and 26b as necessary so that they can be driven into
the pedicles.
[0025] Although not shown in the drawing, tethers can be tied
between the protrusions 46a-46d and the vertebrae V3, V4, and/or V5
to provide additional support and resistance.
[0026] As examples of the materials making up the spacer 42 and the
insert 44, the spacer can be of a relatively soft material, such as
soft plastic, including silicone, while the insert can be of a
relatively stiff material, such as hard plastic or rubber. In the
latter context, the surgeon could be provided with several inserts
44 that vary in stiffness, and once the condition of the vertebrae
V4 and V5 (FIG. 4), and therefore the desired stiffness, is
determined, the proper insert 44 can be selected.
[0027] When the device 40 is implanted in the manner discussed
above, the relatively flexible, soft spacer 42 provides non-rigid
connections to the vertebrae V3 and V5 that readily conforms to the
processes 22 of the vertebrae V3 and V5 and provides excellent
shock absorption, while the insert 44 adds stiffness, compressive
strength and durability, and the screws 49 provide a rigid
connection to the vertebrae V4.
[0028] A prosthetic device 50 according to another embodiment is
shown in detail in FIG. 7 and includes a spacer 52 which is
substantially rectangular in shape with the exception that a curved
notch 52a, is formed in one end portion. A tab 52b projects from
the other end of the spacer 52 for reasons to be described.
[0029] A spacer 54 is also provided which is substantially
rectangular in shape with the exception that a curved notch 54a is
formed in one end portion and a tab 54 projects from the other end
of the spacer 52.
[0030] A connector 56 is designed to fit over the tabs 52b and 54b
of the spacers 52 and 54, respectively, to connect them. To this
end, the connector 56 has a through opening 56a with a cross
section slightly greater than the cross sections of the tabs 52b
and 54b.
[0031] Two tabs 56b and 56b extend out from the respective ends of
the connector 56, and elongated openings 56c and 56d extend through
the respective tabs for receiving screws, for reasons to be
described.
[0032] Two protrusions 58a and 58b extend from the sides of the tab
56b and two protrusions 58c and 58d extend from the sides of the
tab 56c. The protrusions are for the purpose of receiving tethers,
or the like, to tether the device 40 to the vertebrae V4 and/or
V5.
[0033] To connect the spacers 52 and 54, their respective tabs 52b
and 54b are inserted into the opening 56a of the connector 56 from
opposite ends of the opening until the corresponding shoulders of
the spacers 52 and 54 engage the corresponding ends of the
connector 56. The spacers 52 and 54 and the connector are sized so
that the tabs 52a and 54a engage the inner wall of the connector 56
in a friction fit so as to retain the spacers 52 and 54 in the
connector.
[0034] Since the spinous process of the vertebrae V4 has been
removed, the device 50 is implanted between the spinous process 22
of the vertebrae V3 and the spinous process 22 of the vertebrae V5.
In the implanted position, the spinous process 22 of the vertebrae
V3 extends in the notch 52a of the spacer 42, and the spinous
process 22 of the vertebrae V5 extends in the notch 52b. The
dimensions of the device 50 are such that, when it is implanted in
this manner, the elongated openings 56c and 56d extend over the
pedicles 26a and 26b (FIG. 3) of the vertebrae V4.
[0035] Although not shown in the drawing, tethers can be tied
between the protrusions 58a-58d and the vertebrae V3, V4, and/or V5
to provide additional support and resistance.
[0036] The spacers 52 and 54 could be fabricated from a relatively
soft material, such as soft plastic, including silicone, while the
connector 56 could be fabricated from a relatively stiff material,
such as hard plastic or rubber. In the latter context, the surgeon
could be provided with several connectors 56 that vary in
stiffness. Thus, once the surgeon ascertains the condition of the
vertebrae V3, V4, and V5 (FIG. 3) and determines the particular
stiffness that is needed, the proper connector 56 can be
selected.
[0037] Thus, when the device 50 is implanted between the processes
22 of the vertebrae V3 and V5 in the manner discussed above, the
relatively flexible, soft spacers 52 and 54 provide a non-rigid
connection to the vertebrae V3 and V5 that readily conforms to the
processes 22 of the vertebrae V3 and V5, and provides excellent
shock absorption. Also, the connector 56 adds stiffness,
compressive strength and durability, and the screws 49 provide a
rigid connection to the vertebrae V4.
[0038] It is understood that other variations may be made in the
foregoing without departing from the invention and examples of some
variations are as follows: [0039] Any conventional substance that
promotes bone growth, such as HA coating, BMP, or the like, can be
incorporated in the prosthetic device of the above embodiments.
[0040] One or more of the components of the above devices may have
through holes formed therein to improve integration of the bone
growth. [0041] The surfaces of the body member defining the notch
can be treated, such as by providing teeth, ridges, knurling, etc.,
to better grip the spinous processes and the adapters. [0042] The
body member can be fabricated of a permanently deformable material
thus providing a clamping action against the spinous process.
[0043] The spacers and associated components of one or more of the
above embodiments may vary in shape, size, composition, and
physical properties. [0044] Through openings can be provided
through one or more components of each of the above prosthetic
devices to receive tethers for attaching the devices to a vertebrae
or to a spinous process. [0045] The prosthetic device of each of
the above embodiments can be placed between two vertebrae in the
vertebral column 10 other than the ones described above. [0046] The
prosthetic device of each of the above embodiments can be
fabricated from materials other than those described above. [0047]
The relative stiff components described above could be made of a
resorbable material so that their stiffness would change over time.
[0048] The prosthesis of the above embodiments can be implanted
between body portions other than vertebrae. [0049] In the
embodiment of FIG. 7, the spacers 52 and 54 can be fabricated from
a relatively stiff material and the connector 56 from a relatively
soft, flexible material. [0050] The prostheses of the above
embodiments can be inserted between two vertebrae following a
discectemy in which a disc between the adjacent vertebrae is
removed, or a corpectomy in which at least one vertebrae is
removed. [0051] The spatial references made above, such as "under",
"over", "between", "flexible, soft", "lower", "top", "bottom", etc.
are for the purpose of illustration only and do not limit the
specific orientation or location of the structure described
above.
[0052] The preceding specific embodiments are illustrative of the
practice of the invention. It is to be understood, therefore, that
other expedients known to those skilled in the art or disclosed
herein, may be employed without departing from the invention or the
scope of the appended claims, as detailed above. In the claims,
means-plus-function clauses are intended to cover the structures
described herein as performing the recited function and not only
structural equivalents but also equivalent structures. Thus,
although a nail and a screw may not be structural equivalents in
that a nail employs a cylindrical surface to secure wooden parts
together, whereas a screw employs a helical surface, in the
environment of fastening wooden parts a nail and a screw are
equivalent structures.
* * * * *