U.S. patent application number 09/943441 was filed with the patent office on 2002-02-28 for intervertebral disc nucleus implants and methods.
Invention is credited to Trieu, Hai H..
Application Number | 20020026244 09/943441 |
Document ID | / |
Family ID | 25479671 |
Filed Date | 2002-02-28 |
United States Patent
Application |
20020026244 |
Kind Code |
A1 |
Trieu, Hai H. |
February 28, 2002 |
Intervertebral disc nucleus implants and methods
Abstract
Nucleus pulposus implants that are resistant to migration in
and/or expulsion from an intervertebral disc space are provided. In
one form of the invention, an implant includes a load bearing
elastic body surrounded in the disc space by an anchoring,
preferably resorbable, outer shell. In certain forms of the
invention, the elastic body is surrounded by a supporting member,
such as a band or jacket, and the supporting member is surrounded
by the outer shell. Kits for forming such implants are also
provided. In another form of the invention, an implant is provided
that has locking features and optional shape memory
characteristics. In yet another aspect of the invention, nucleus
pulposus implants are provided that have shape memory
characteristics and are configured to allow short-term manual, or
other deformation without permanent deformation, cracks, tears,
breakage or other damage. Methods of forming and implanting the
implants are also described, as are delivery devices and components
thereof for delivering the implants.
Inventors: |
Trieu, Hai H.; (Cordova,
TN) |
Correspondence
Address: |
Jason J. Schwartz
Woodard, Emhardt, Naughton, Moriarty and McNett
Bank One Center/Tower, Suite 3700
111 Monument Circle
Indianapolis
IN
46204-5137
US
|
Family ID: |
25479671 |
Appl. No.: |
09/943441 |
Filed: |
August 30, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09943441 |
Aug 30, 2001 |
|
|
|
09650525 |
Aug 30, 2000 |
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Current U.S.
Class: |
623/17.16 ;
623/908 |
Current CPC
Class: |
A61F 2002/30179
20130101; A61F 2/4611 20130101; A61F 2002/30677 20130101; A61F
2002/30906 20130101; A61F 2/442 20130101; A61F 2002/30224 20130101;
A61F 2002/4495 20130101; A61F 2230/0069 20130101; A61F 2/441
20130101; A61F 2002/30891 20130101; A61F 2002/30594 20130101; A61F
2002/30838 20130101; A61F 2230/0091 20130101; A61F 2002/30957
20130101; A61F 2002/30062 20130101; A61F 2002/4627 20130101; A61F
2230/0015 20130101; A61F 2002/4415 20130101; A61F 2002/30291
20130101; A61F 2002/30909 20130101; A61F 2230/0065 20130101; A61F
2002/444 20130101; A61F 2/30965 20130101; A61F 2002/30133 20130101;
A61F 2002/302 20130101; A61F 2230/0058 20130101; A61F 2210/0004
20130101; A61F 2002/30563 20130101; A61F 2002/30092 20130101; A61F
2002/30604 20130101; A61B 2017/0256 20130101; A61F 2210/0014
20130101; A61F 2002/2817 20130101; A61F 2002/30925 20130101 |
Class at
Publication: |
623/17.16 ;
623/908 |
International
Class: |
A61F 002/44 |
Claims
What is claimed is:
1. An intervertebral disc nucleus pulposus implant, comprising: a
load bearing elastic body sized for introduction into an
intervertebral disk space, said body surrounded by a resorbable
shell.
2. An intervertebral disc nucleus pulposus implant, comprising: a
load bearing elastic body sized for introduction into an
intervertebral disc space, said body surrounded by a supporting
member, said supporting member surrounded by a resorbable
shell.
3. An intervertebral disc nucleus pulposus implant, comprising: a
load bearing elastic body sized for placement into an
intervertebral disc space, said body having a first end, a second
end, a central portion, and a first configuration wherein said
first end and said second end are positioned adjacent to said
central portion to form at least one inner fold, said elastic body
configurable into a second, straightened configuration for
insertion through an opening in an intervertebral disc annulus
fibrosis, said body configurable back into said first configuration
after said insertion.
4. The implant of claim 3, wherein said inner fold defines an
aperture.
5. The implant of claim 3, wherein said elastic body is comprised
of a hydrogel material.
6. The implant of claim 3, wherein said elastic body is comprised
of an elastomer.
7. The implant of claim 6, wherein said elastomer is selected from
the group consisting of silicone, polyurethane, copolymers of
silicone and polyurethane, polyolefins, nitrile and combinations
thereof.
8. The implant of claim 4, wherein said inner fold has a surface
with projections, said projections extending into said
aperture.
9. The implant of claim 3, wherein said elastic body has an outer
surface, said outer surface having projections extending therefrom,
said projections configured for enhancing fixation of said body in
said intervertebral disc space.
10. The implant of claim 3, wherein the outer surface of said
elastic body is microtexturized.
11. The implant of claim 10, wherein said microtexturizing is
performed by a process selected from the group consisting of bead
blasting, plasma etching, chemical etching and combinations
thereof.
12. The implant of claim 3, wherein said body further comprises a
reinforcing material at said inner fold surface.
13. The implant of claim 12, wherein said reinforcing material
comprises fibers.
14. The implant of claim 3, wherein said elastic body is comprised
of a hydrogel material, said material having at least one growth
factor dispersed therein.
15. The implant of claim 14, wherein said growth factor is selected
from the group consisting of transforming growth factor .beta.,
bone morphogenetic proteins, fibroblast growth factors,
platelet-derived growth factors, insulin-like growth factors and
combinations thereof.
16. The implant of claim 14, wherein said growth factor comprises a
recombinant protein.
17. The implant of claim 16, wherein said recombinant protein is a
human protein.
18. The implant of claim 3, wherein said body has at least one
surface depression in its second configuration, said inner fold
formed from said surface depression.
19. The implant of claim 3, wherein said first end is formed from a
first arm, said second end is formed from a second arm and one of
said arms of said implant has a length greater than the other of
said arms.
20. The implant of claim 4, wherein said aperture has a
cross-sectional shape selected from the group consisting of
annular-shaped, elliptical-shaped, and star-shaped.
21. The implant of claim 3, wherein said body is substantially
elliptical- or ring-shaped in its folded configuration.
22. The implant of claim 3, wherein said body has a top surface for
contacting an upper vertebral endplate of an intervertebral disc
and a bottom surface for contacting a lower vertebral end plate of
an intervertebral disc, said top and bottom surface configured to
be complementary to the endplate they are in contact with.
23. The implant of claim 22, wherein said top and bottom surface of
said body are convex.
24. The implant of claim 3, wherein said first end and said second
end each have an inner edge and an outer edge, at least one of said
inner edges having a rounded configuration.
25. The implant of claim 3, wherein said body has a top surface for
contacting an upper vertebral endplate of an intervertebral disc, a
bottom surface for contacting a lower vertebral end plate of an
intervertebral disc, and an external side surface, said body having
at least one groove on said side surface, said groove extending
between said top surface and said bottom surface.
26. An intervertebral disc nucleus pulposus implant, comprising: a
load bearing elastic body sized for placement into an
intervertebral disc space, said body having a first end and a
second end, said first end and said second end configured for
mating engagement with each other, said elastic body having a first
configuration wherein said first end and said second end are
matingly engaged to each other, said elastic body configurable into
a second, straightened configuration for insertion through an
opening in an intervertebral disc annulus fibrosis, said body
configurable back into said first configuration after said
insertion.
27. A kit for forming an intervertebral disc nucleus pulposus
implant, comprising a load bearing elastic body sized for
introduction into an intervertebral disc space and a container of
material to form a resorbable shell around said body.
28. A kit for forming an intervertebral disc nucleus pulposus
implant, comprising a load bearing elastic body sized for
introduction into an intervertebral disc space, a supporting member
to surround said body and a container of material to form a
resorbable shell around said supporting member.
29. A method for implanting an intervertebral disc nucleus pulposus
implant in an intervertebral disc space, comprising: (a) preparing
said intervertebal disc space to receive said implant; and (b)
introducing a load bearing elastic body into said disc space, said
body surrounded in said disc space by a resorbable shell.
30. A method for implanting an intervertebral disc nucleus pulposus
implant in an intervertebral disc space, comprising: (a) preparing
said intervertebal disc space to receive said implant; and (b)
introducing a load bearing elastic body into said disc space, said
body surrounded by a supporting member, said supporting member
surrounded in said disc space by a resorbable shell.
31. A method for implanting an intervertebral disc nucleus pulposus
implant in an intervertebral disc space, comprising: (a) providing
a load bearing elastic body sized for placement into an
intervertebral disc space, said body having a first end, a second
end, a central portion, and a first configuration wherein said
first end and said second end are positioned adjacent to said
central portion to form at least one inner fold, said elastic body
configurable into a second, straightened configuration for
insertion through an opening in said annulus fibrosis, said body
configurable back into said first configuration after said
insertion; (b) preparing said intervertebal disc space to receive
said body; and (c) positioning said body into said intervertebral
disc space after said preparing step.
32. A method for implanting an intervertebral disc nucleus pulposus
implant in an intervertebral disc space, comprising: (a) providing
a load bearing elastic body sized for placement into an
intervertebral disc space, said body having a first end and a
second end, said first end and said second end configured for
mating engagement with each other, said elastic body having a first
configuration wherein said first end and said second end are
matingly engaged to each other, said elastic body configurable into
a second, straightened configuration for insertion through an
opening in an intervertebral disc annulus fibrosis, said body
configurable back into said first configuration after said
insertion; (b) preparing said intervertebal disc space to receive
said body; (c) positioning said body into said intervertebral disc
space after said preparing step.
33. A spinal disc implant delivery device tip, comprising: (a) a
base member having a proximal end, a distal end and a lumen
extending longitudinally therethrough; and (b) a plurality of
movable members, said movable members having a proximal end and a
distal end, said proximal end of said movable members abutting said
distal end of said base member, said movable members having a
closed configuration defining a cavity in communication with said
lumen of said base member, said members sized and configured for
passage into an aperture in an annulus fibrosis.
34. The tip of claim 33, wherein said lumen of said base member is
sized to receive a nucleus pulposus implant.
35. The tip of claim 33, wherein said movable members have an open
configuration wherein said movable members move radially.
36. A spinal disc implant delivery device, comprising: (a) a base
member having a proximal end, a distal end and a lumen extending
longitudinally therethrough; (b) a plurality of movable members,
said movable members having a proximal end and a distal end, said
proximal end of said movable members abutting said distal end of
said base member, said movable members having a closed
configuration defining a cavity in communication with said lumen of
said base member, said movable members sized and configured for
passage through an aperture in an annulus fibrosus; and (c) an
elongated housing member having a proximal end, a distal end and a
lumen extending longitudinally therethrough, said proximal end of
said base member matingly engaged to said distal end of said
elongated housing member.
37. The device of claim 36, wherein said movable members have an
open configuration when said movable members move radially.
38. The device of claim 36, wherein said lumen of said elongated
housing member is sized to receive a nucleus pulposus implant.
39. The device of claim 36, said device further comprising a
plunger member, said plunger member disposed in said lumen of said
elongated housing member.
40. A spinal disc implant delivery device, comprising: (a) an
elongated housing member having a proximal end, a distal end and a
lumen extending longitudinally therethrough; (b) a tip member, said
tip member having a top wall, a bottom wall, a first side wall, a
second side wall, a proximal end, and a distal end, said walls
defining a lumen extending longitudinally therethrough, said
proximal end of said tip member connected to said distal end of
said elongated housing member, said tip member sized and configured
for delivery of a spinal disc implant through an aperture in an
annulus fibrosus, said lumen of said tip member in communication
with said lumen of said elongated housing member.
41. The device of claim 40, said device further comprising a
plunger member, said plunger member disposed in said lumen of said
elongated housing member.
42. The device of claim 40, wherein said top wall and said bottom
wall both include an opening therethrough that extends from said
proximal end of said tip member to said distal end of said tip
member.
43. The device of claim 42, wherein at least one of said top wall
and said bottom wall has a surface that includes a surface
roughening.
44. The device of claim 43, wherein said surface roughening
comprises teeth.
45. The device of claim 42, wherein one of said side walls has a
length greater than the other of said side walls.
46. The device of claim 40, wherein at least one of said top wall
and said bottom wall has a surface that includes a surface
roughening.
46. The device of claim 40, wherein one of said side walls has a
length greater than the other of said side walls.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part, and claims the
benefit, of pending U.S. patent application Ser. No. 09/650,525,
filed Aug. 30, 2000, which is hereby incorporated by reference in
its entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to nucleus pulposus implants
and methods for their implantation.
[0003] The intervertebral disc functions to stabilize the spine and
to distribute forces between vertebral bodies. A normal disc
includes a gelatinous nucleus pulposus, an annulus fibrosis and two
vertebral end plates. The nucleus pulposus is surrounded and
confined by the annulus fibrosis.
[0004] Intervertebral discs may be displaced or damaged due to
trauma or disease. Disruption of the annulus fibrosis may allow the
nucleus pulposus to protrude into the vertebral canal, a condition
commonly referred to as a herniated or ruptured disc. The extruded
nucleus pulposus may press on a spinal nerve, which may result in
nerve damage, pain, numbness, muscle weakness and paralysis.
Intervertebral discs may also deteriorate due to the normal aging
process. As a disc dehydrates and hardens, the disc space height
will be reduced, leading to instability of the spine, decreased
mobility and pain.
[0005] One way to relieve the symptoms of these conditions is by
surgical removal of a portion or all of the intervertebral disc.
The removal of the damaged or unhealthy disc may allow the disc
space to collapse, which would lead to instability of the spine,
abnormal joint mechanics, nerve damage, as well as severe pain.
Therefore, after removal of the disc, adjacent vertebrae are
typically fused to preserve the disc space. Several devices exist
to fill an intervertebral space following removal of all or part of
the intervertebral disc in order to prevent disc space collapse and
to promote fusion of adjacent vertebrae surrounding the disc space.
Even though a certain degree of success with these devices has been
achieved, full motion is typically never regained after such
vertebral fusions. Attempts to overcome these problems have led to
the development of disc replacements. Many of these devices are
complicated, bulky and made of a combination of metallic and
elastomeric components. Thus, such devices require invasive
surgical procedures and typically never fully return the full range
of motion desired.
[0006] More recently, efforts have been directed to replacing the
nucleus pulposus of the disc with a similar gelatinous material,
such as a hydrogel. However, there exists a possibility of tearing
or otherwise damaging the hydrogel implant during implantation.
Moreover, once positioned in the disc space, many hydrogel implants
may migrate in the disc space and/or may be expelled from the disc
space through an annular defect, or other annular opening. A need
therefore exists for more durable implants, as well as implants
that are resistant to migration and/or expulsion through an opening
in the annulus fibrosis. The present invention addresses these
needs.
SUMMARY OF THE INVENTION
[0007] Nucleus pulposus implants that are resistant to migration in
and/or expulsion from an intervertebral disc space are provided.
Accordingly, in one aspect of the invention, nucleus pulposus
implants are provided that include a load bearing elastic body
sized for introduction into an intervertebral disc space and
surrounded by a resorbable shell that provides the initial fixation
for the elastic body within the disc space. The implant may include
various surface features on its outer surface, including surface
configurations or chemical modifications, that enhance the bonding
between the outer surface of the implants and the resorbable shell.
Kits for forming such implants are also provided. In other forms of
the invention, the elastic body may be surrounded by a supporting
member wherein the supporting member is surrounded by the
resorbable shell.
[0008] In yet another aspect of the invention, nucleus pulposus
implants are provided that have shape memory and are configured to
allow extensive short-term deformation without permanent
deformation, cracks, tears or other breakage. In one form of the
invention, an implant includes a load bearing elastic body sized
for placement into an intervertebral disc space. The body includes
a first end, a second end and a central portion wherein the first
end and second end are positioned, in a folded, relaxed
configuration, adjacent to the central portion to form at least one
inner fold. The inner fold preferably defines an aperture. The
elastic body is deformable into a second, straightened,
non-relaxed, unfolded configuration for insertion through an
opening in an intervertebral disc annulus fibrosis. The elastic
body is deformable automatically back into a folded configuration
after being placed in the intervertebral disc space.
Advantageously, where the implant having shape memory is formed of
a hydrogel material, or other hydrophilic material that may be
dehydrated, the implant may be fully or partially dehydrated prior
to insertion such that it may be inserted through a relatively
small opening in the annulus fibrosis. The opening may, for
example, be a pre-existing defect or may be made by making a small
incision.
[0009] In still other aspects of the invention, nucleus pulposus
implants having locking features and optionally having shape memory
are provided. In one embodiment, an implant includes a load bearing
elastic body having a first end and a second end that are
configured for mating engagement with each other. The implant has a
first, locked configuration wherein the first and second ends are
matingly engaged to each other. The implant may be configured into
a second, straightened configuration by application of external
force for insertion through an opening in an intervertebral disc
annulus fibrosis. When the implant includes shape memory
characteristics, it may be automatically configured, or otherwise
returned, back into its first, locked configuration after insertion
through the opening in the annulus fibrosis and after any external
force is removed, or may be placed into its locked configuration by
application of external force.
[0010] In other aspects of the invention, methods of implanting the
nucleus pulposus implants of the present invention are provided. In
one mode of carrying out the invention, a method includes providing
the appropriate implant, preparing the intervertebral disc space to
receive the implant and then placing the implant into the
intervertebral disc space. Where the implant includes a load
bearing elastic body and an outer resorbable shell, a preferred
method includes preparing the intervertebral disc space to receive
the implant, introducing the elastic body forming the core of the
implant into the disc space wherein the body is surrounded in the
disc space by a resorbable outer shell. The material forming the
resorbable shell may be placed in the disc space prior to, after,
or at the same time as insertion of the elastic body.
Alternatively, the elastic body may be surrounded by the outer
shell prior to introduction of the elastic body into the
intervertebral disc space.
[0011] In further aspects, a spinal disc implant delivery device is
provided. In one form, the device includes a base member having a
proximal end, a distal end and a lumen extending longitudinally
therethrough; a plurality of movable members having a proximal end
and a distal end; and an elongated member having a proximal end and
a distal end and a lumen extending longitudinally therethrough. The
proximal end of the movable members abut the distal end of the base
member. The proximal end of the base member is matingly engaged to
the distal end of the elongated member. Moreover, the movable
members have a closed configuration that defines a cavity in
communication with the lumen of the base member.
[0012] In further aspects of the invention, a spinal disc implant
delivery device tip is provided that includes a base member and
movable members as described above.
[0013] In other forms of the invention, a spinal disc implant
delivery device includes an elongated housing member having a
proximal end, a distal end and a lumen extending longitudinally
therethrough and a tip member. The tip member advantageously has a
top wall, a bottom wall, a first side wall, a second side wall, a
proximal end, and a distal end. The walls of the tip member
preferably define a lumen extending longitudinally therethrough.
The proximal end of the tip member may be connected to the distal
end of the elongated housing member. Additionally, the tip member
is sized and configured for delivery of a spinal disc implant
through an aperture in an annulus fibrosis. The lumen of the tip
member is preferably in fluid communication with the lumen of the
elongated housing member.
[0014] In other forms of the invention, the top wall and bottom
wall include an opening therethrough that extends from the proximal
end of the tip member to the distal end of the tip member.
[0015] It is an object of the invention to provide nucleus pulposus
implants, and kits for their formation, that are resistant to
migration in and/or explusion from an intervertebral disc
space.
[0016] It is a further object of the invention to provide nucleus
pulposus implants having shape memory that are configured to allow
extensive short term manual, or other deformation without permanent
deformation, cracks, tears, breakage or other damage.
[0017] It is yet another object of the present invention to provide
nucleus pulposus implants having locking features.
[0018] It is a further object of the present invention to provide
methods of forming and implanting the nucleus pulposus implants
described herein, as well as spinal implant delivery devices or
tools for implanting the implants.
[0019] These and other objects and advantages of the present
invention will be apparent from the description herein.
BRIEF DESCRIPTION OF THE FIGURES
[0020] FIG. 1 depicts a side view of a cross-section of a nucleus
pulposus implant, including an elastic body 15 surrounded by an
anchoring outer shell 30, implanted in the intervertebral disc
space of a disc.
[0021] FIG. 2 depicts a top, cross-sectional view of the nucleus
pulposus implant of FIG. 1.
[0022] FIG. 3 depicts a side view of a cross-section of the nucleus
pulposus implant of FIG. 1 after outer shell 30 has been resorbed
and replaced by fibrous scar tissue 33.
[0023] FIG. 4 shows a top, cross-sectional view of the nucleus
pulposus implant of FIG. 3.
[0024] FIG. 5 shows a side view of a cross-section of a nucleus
pulposus implant, including an elastic body 15 surrounded by a
supporting member 34, in the form of a band, wherein the supporting
member is surrounded by an anchoring outer shell 30, implanted in
the intervertebral disc space of a disc.
[0025] FIG. 6 depicts a side view of a cross-section of a nucleus
pulposus implant, including an elastic body 15 surrounded by a
supporting member 37, in the form of a jacket, wherein the
supporting member is surrounded by an anchoring outer shell 30,
implanted in the intervertebral disc space of a disc.
[0026] FIGS. 7A-7D depict various patterns of a supporting member
of the present invention.
[0027] FIG. 8 depicts a side view of a cross-section of a nucleus
pulposus implant including an elastic body 15 surrounded by a
supporting member 34, taking the form of a band, that is further
reinforced, or otherwise supported, by straps 420 and 430. The
implant is surrounded by an anchoring outer shell 30 and is shown
implanted in the intervertebral disc space of a disc.
[0028] FIG. 9 shows a top, cross-sectional view of the nucleus
pulposus implant of FIG. 8.
[0029] FIG. 10 depicts a side view of an alternative embodiment of
a nucleus pulposus implant of the present invention that includes
peripheral supporting band 34" and securing straps 520, 530, 540
and 550 and is surrounded by an anchoring outer shell 30 and
implanted in the intervertebral disc space of a disc.
[0030] FIG. 11 depicts a top, cross-sectional view of the nucleus
pulposus implant of FIG. 10.
[0031] FIG. 12 depicts a top view of an alternative embodiment of a
nucleus pulposus implant having shape memory.
[0032] FIG. 13 shows a side view of the implant shown in FIG.
12.
[0033] FIGS. 14A-14J depict portions of nucleus pulposus implants
with surface modifications. FIGS. 14A-14H show side views of top
portions of the implants, and FIG. 14I and FIG. 14J show top views
of the views shown in 14C and 14D, respectively.
[0034] FIGS. 15A-15N show top views of alternative embodiments of
nucleus pulposus implants having shape memory in folded, relaxed
configurations.
[0035] FIGS. 16A-16N depict top views of the implants shown in
FIGS. 15A-15N, respectively, in unfolded, non-relaxed
configurations.
[0036] FIG. 17 depicts a top view of an alternative embodiment of a
nucleus pulposus implant of the present invention having a
self-locking feature. The implant is shown in its locked, relaxed
configuration.
[0037] FIG. 18 depicts a side view of the implant of FIG. 17.
[0038] FIG. 19 depicts a side view of the implant of FIG. 18 in an
unfolded, non-locked, non-relaxed configuration.
[0039] FIG. 20 depicts one step in a method of implanting nucleus
pulposus implant 40 into intervertebral disc space 20 between
vertebrae 21 and 22 using a conventional implantation tool 310.
[0040] FIG. 21 depicts a top, cross-sectional view of a nucleus
pulposus implant 10 in its folded, relaxed configuration positioned
in intervertebral disc space 20.
[0041] FIGS. 22A-22Q show top views of alternative embodiments of
nucleus pulposus implants having shape memory in folded, relaxed
configurations.
[0042] FIGS. 23A-23Q depict top views of the implants shown in
FIGS. 22A-22Q, respectively, in unfolded, non-relaxed
configurations.
[0043] FIGS. 24, 25, 26 and 27 depict side views of the implants
shown in FIGS. 22I, 22J, 22K and 22N, respectively.
[0044] FIG. 28 depicts a side cross-sectional view of one
embodiment of a spinal disc implant delivery tool configured to
deliver the shape memory implants described herein.
[0045] FIG. 29 depicts a view of another embodiment of a spinal
disc implant delivery device showing features of the tip
portion.
[0046] FIGS. 30A-30J depict side views of surface features that may
be present on the surfaces of the tip portions of various spinal
disc implant delivery devices described herein.
[0047] FIG. 31 depicts a view of an alternative embodiment of a
spinal disc implant delivery device showing features of the tip
portion.
[0048] FIG. 32 depicts how the spinal disc implant delivery device
of FIG. 31 may be used to aid placement of a spinal disc
implant.
[0049] FIG. 33 depicts a view of yet a further alternative
embodiment of a spinal disc implant delivery device.
[0050] FIG. 34 depicts a view of yet a further alternative
embodiment of a spinal disc implant delivery device showing
features of the tip portion.
[0051] FIG. 35 shows a view of an alternative embodiment of a
spinal disc implant delivery device showing features of the tip
portion.
[0052] FIG. 36 shows a side view of an alternative embodiment of a
spinal implant delivery device.
[0053] FIG. 37A depicts an end view of the device of FIG. 36, taken
along line 37A-37A.
[0054] FIGS. 37B-37F depict end views of tip portions of the disc
implant delivery devices described herein. The tip portions are of
various shapes and have variously numbered movable members.
[0055] FIG. 38 depicts a step in the method of implanting the shape
memory implants described herein into an intervertebral disc
space.
[0056] FIG. 39-44 depict further steps in the method of FIG.
38.
[0057] FIG. 45-48 show top views of how selected spinal disc
implant delivery devices may be positioned in an intervertebral
disc space for delivery of a spinal implant.
[0058] FIG. 49 depicts an end view of the positioned spinal disc
implant delivery device of FIG. 45, taken along line 49-49.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0059] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to
preferred embodiments and specific language will be used to
describe the same. It will nevertheless be understood that no
limitation of the scope of the invention is thereby intended, such
alterations and further modifications of the invention, and such
further applications of the principles of the invention as
illustrated herein, being contemplated as would normally occur to
one skilled in the art to which the invention relates.
[0060] The present invention provides prosthetic intervertebral
disc nucleus pulposus implants that may fully or partially replace
the natural, or native, nucleus pulposus in mammals, including
humans and other animals. In one aspect of the invention, implants
are provided that are configured to resist expulsion or other
migration through a defect, or other opening, in the annulus
fibrosis and to resist excessive migration within an intervertebral
disc space. In certain forms, these implants combine the advantages
of an injectable/in-situ curing implant with a pre-formed implant.
For example, a nucleus pulposus implant may include a load bearing
elastic body surrounded by an outer, preferably resorbable or
otherwise temporary, shell. The outer shell advantageously anchors
the elastic body within the intervertebral disc space. The surface
of the elastic body may include various surface features, including
various macro-surface patterns, and chemical or physical
modifications as described herein to further enhance fixation of
the implant to the outer resorbable shell. The surface features,
such as the macro-surface patterns and physical modifications, for
example, are also expected to enhance fixation of the elastic body
to surrounding tissue such that, in certain forms of the invention,
no outer shell may be needed.
[0061] In other aspects of the invention, nucleus pulposus implants
having shape memory that are configured to allow extensive
short-term manual or other deformation without permanent
deformation, cracks, tears, breakage or other damage are provided.
In preferred forms of the invention wherein the implants are formed
from a hydrogel or other hydrophilic material, the implants can not
only pass through a relatively small incision in the annulus
fibrosis, but can also substantially fill and conform to the
intervertebral disc space. In one form of the invention, an implant
includes a load bearing elastic body with shape memory having first
and second ends that are positioned adjacent to a central portion
to form at least one inner fold. The inner fold desirably defines
an aperture or channel.
[0062] In other embodiments of the invention, the shape memory
implants are configured to form a spiral or other annular shape in
the disc space, and may also be configured to have ends that
matingly engage each other for further securing the implant in the
disc cavity. Methods of making and implanting the implants
described herein are also provided.
[0063] As disclosed above, in a first aspect of the invention, a
nucleus pulposus implant is provided that includes a load bearing
elastic body sized for introduction into an intervertebral disc
space and surrounded by an outer, preferably resorbable, shell.
Referring now to FIGS. 1 and 2, prosthetic implant 10 includes a
core load bearing elastic body 15 disposed in intervertebral disc
space 20, between vertebral body 21 and 22 and surrounded by an
outer shell 30. More specifically, elastic body 15 has an outer
surface 16 in contact with, and preferably bonded to, an outer
shell 30 that may advantageously be resorbable, or otherwise
temporary. Outer surface 31 of outer shell 30 preferably conforms
to the shape of the intervertebral disc space 20, being in contact
with annulus fibrosis 5, and may completely surround elastic body
15 as seen in FIGS. 1 and 2, although outer shell 30 may only
partially surround elastic body 15. As an example, upper, lower
and/or lateral voids surrounding elastic body 15 may be filled in
by outer shell 30, as long as the elastic body is in some way
anchored, or otherwise fixed in place, by the outer shell so as to
prevent its expulsion from, or excessive migration in, the disc
cavity. Thus, outer shell 30 may be configured to fill the
aforementioned voids. Additionally, inner surface 32 of outer shell
30 preferably conforms to the shape of elastic body 15, and
preferably bonds to outer surface 16 of elastic body 15 as
discussed below. In preferred embodiments, the elastic core and the
outer shell substantially fill the disc cavity as further discussed
below.
[0064] Outer shell 30 not only provides for a properly fit implant
10 within intervertebral disc space 20 for maximum load-bearing,
stress transfer, and bonding of the implant surface to the
surrounding disc tissues for fixation against excessive migration,
it also seals an annular defect 18 for further resistance to
migration and/or expulsion of the implant. Such sealing of the
annular defect may also provide additional physical and mechanical
support to the disc. Furthermore, the injectable outer shell
material may provide intra-operative flexibility in fitting the
core elastic body of implant 10 within the disc space as it may
compensate for the differences in geometry and size between the
disc space and the pre-formed core.
[0065] Outer shell 30 is preferably resorbable and, in such form,
is preferably replaced with tissue, such as fibrous tissue and
including fibrous scar tissue, that may aid in permanently
confining the load bearing elastic body within the disc space.
Referring now to FIGS. 3 and 4, tissue 33 has replaced outer shell
30, and thus surrounds elastic body 15. Although elastic body 15
may be confined within the disc space with the aid of tissue 33,
body 15 is expected to have some mobility for normal
biomechanics.
[0066] The dimensions of load bearing elastic body 15 may vary
depending on the particular case, but elastic body 15 is typically
sized for introduction into an intervertebral disc space. Moreover,
elastic body 15 is preferably wide enough to support adjacent
vertebrae and is of a height sufficient to separate the adjacent
vertebrae. In order to provide long-term mechanical support to the
intervertebral disc, the volume of elastic body 15 in the disc
space should be at least about 50%, preferably at least about 70%,
further preferably at least about 80% and more preferably at least
about 90% of the volume of the entire disc space, the remaining
volume occupied by outer shell 30. However, the volume of elastic
body 15 may be as large as about 99% of the volume of the
intervertebral disc space, and thus about 99% of the volume of
implant 10. Accordingly, the volume of outer shell 30 may be at
least about 1% of the volume of the implant, but may range from
about 1% to about 50%. The appropriate size of implant 10 desired
in a particular case may be determined by distracting the disc
space to a desired level after the desired portion of the natural
nucleus pulposus and any free disc fragments are removed, and
measuring the volume of the distracted space with an injectable
saline balloon. The disc volume can also be measured directly by
first filling the disc space with a known amount of the outer shell
precursor material.
[0067] Elastic body 15 may be fabricated in a wide variety of
shapes as desired, as long as the body can withstand spinal loads
and other spinal stresses. The non-degradable and preformed elastic
body 15 may be shaped, for example, as a cylinder, or a rectangular
block. The body may further be annular-shaped. For example, implant
10' in FIGS. 12 and 13 has a spiral, or otherwise coiled, shape.
The implant includes a first end 23 and a second end 24. Elastic
body 15 may also be shaped to generally conform to the shape of the
natural nucleus pulposus, or may be shaped as further described
below. Although elastic body 15 is shown as one piece in, for
example, FIGS. 1-4, it may be made from one or several pieces.
[0068] Elastic body 15 may be formed from a wide variety of
biocompatible polymeric materials, including elastic materials,
such as elastomeric materials, hydrogels or other hydrophilic
polymers, or composites thereof. Suitable elastomers include
silicone, polyurethane, copolymers of silicone and polyurethane,
polyolefins, such as polyisobutylene and polyisoprene, neoprene,
nitrile, vulcanized rubber and combinations thereof. The vulcanized
rubber described herein may be produced, for example, by a
vulcanization process utilizing a copolymer produced as described,
for example, in U.S. Pat. No. 5,245,098 to Summers et al. from
1-hexene and 5-methyl-1,4-hexadiene. Suitable hydrogels include
natural hydrogels, and those formed from polyvinyl alcohol,
acrylamides such as polyacrylic acid and poly(acrylonitrile-acrylic
acid), polyurethanes, polyethylene glycol,
poly(N-vinyl-2-pyrrolidone), acrylates such as poly(2-hydroxy ethyl
methacrylate) and copolymers of acrylates with N-vinyl pyrrolidone,
N-vinyl lactams, acrylamide, polyurethanes and polyacrylonitrile,
or may be other similar materials that form a hydrogel. The
hydrogel materials may further be cross-linked to provide further
strength to the implant. Examples of polyurethanes include
thermoplastic polyurethanes, aliphatic polyurethanes, segmented
polyurethanes, hydrophilic polyurethanes, polyether-urethane,
polycarbonate-urethane and silicone polyether-urethane. Other
suitable hydrophilic polymers include naturally-occurring materials
such as glucomannan gel, hyaluronic acid, polysaccharides, such as
cross-linked carboxyl-containing polysaccharides, and combinations
thereof. The nature of the materials employed to form the elastic
body should be selected so the formed implants have sufficient load
bearing capacity. In preferred embodiments, a compressive strength
of at least about 0.1 Mpa is desired, although compressive
strengths in the range of about 1 Mpa to about 20 Mpa are more
preferred.
[0069] Outer shell 30 may be formed from a wide variety of
biocompatible, preferably elastic, elastomeric or deformable
natural or synthetic materials, especially materials that are
compatible with elastic body 15. The outer shell materials
preferably remain in an uncured, deformable, or otherwise
configurable state during positioning of the elastic body in the
interverterbral disc space, and should preferably rapidly cure,
become harder or preferably solidify after being introduced into
the intervertebral disc space, or, in other embodiments, prior to
positioning of the elastic body in the intervertebral disc space.
In preferred embodiments, the outer shell materials may remain
deformable after they harden or otherwise solidify. Suitable
materials that may be used to form the outer shell include tissue
sealants or adhesives made from natural or synthetic materials,
including, for example, fibrin, albumin, collagen, elastin, silk
and other proteins, polyethylene oxide, cyanoacrylate, polyarylate,
polylactic acid, polyglycolic acid, polypropylene fumarate,
tyrosine-based polycarbonate and combinations thereof. Other
suitable materials include demineralized bone matrix. These
precursor materials may be supplied in liquid, solution or solid
form, including gel form.
[0070] Elastic body 15 may include a variety of surface features on
outer surface 16, including chemical modifications and surface
configurations, to provide surface features that advantageously
improve the bonding between outer surface 16 of the elastic body
and inner surface 32 of outer shell 30. In one form of the
invention, outer surface 16 is chemically modified utilizing, for
example, chemical groups that are compatible with the materials
used to form outer shell 30. Suitable chemical modifications
include, for example, surface grafting of reactive functional
groups, including hydroxyl, amino, carboxyl and organofunctional
silane groups. The groups may be grafted by methods known to the
skilled artisan. Other modifications include pre-coating with a
primer, preferably one that is compatible with the outer shell
material, such as a layer of adhesive, sealing or other materials
used for forming the outer shell described above.
[0071] In yet another form of the invention, elastic body 15 may
include a wide variety of surface configurations, such as
macro-surface patterns, or protuberances, as seen in FIGS. 14A-14J,
showing side views or top views of top portions of elastic bodies
with various surface features. Referring now to FIGS. 14A-14J, the
pattern may be a dove-tail pattern 200, a circular pattern 205, a
square pattern 210, a conical pattern 215, various wave patterns
220 and 225 and random, irregular patterns 230. In other
embodiments, a fiber 240 may be disposed in elastic body 241 and
may project from the surface 242 thereof to form a fibrous pattern
235. Fiber 240 may be disposed as a loop projecting from the
surface of the elastic body, its ends may project from the surface
of the elastic body, or the fiber may have a wide variety of other
appropriate configurations. The fiber may be a short, polymeric
fiber, such as one that is cut to less than about one inch. The
fiber may, alternatively, be a continuous polymeric fiber. The
fiber may further be braided, and may be woven or non-woven. The
macro-surface patterns are preferably formed during formation of
elastic body 15. However, outer surface 16 of elastic body 15 may
also be physically modified after formation of elastic body 15 by,
for example, laser drilling or thermal deformation. Physical
modifications include, for example, a microtexturized surface
formed by bead-blasting, plasma etching or chemical etching.
Procedures for modifying various surfaces in this manner are well
known in the art.
[0072] In certain forms of the invention, the implant may include
only elastic body 15 having one or more of the outer surface
features as described above, without the outer resorbable shell.
The surface features are expected to provide a certain level of
fixation to the surrounding tissues for improved resistance to
migration and/or expulsion.
[0073] In yet other forms of the invention, the implant may include
an elastic body that is surrounded by a supporting, or otherwise
constraining, member wherein the supporting member is surrounded by
a resorbable shell as described herein. Referring now to FIG. 5,
implant 400 includes a load bearing elastic body 15 that is
surrounded by a supporting member 34. In one form, supporting
member 34 may be a preferably flexible, peripheral supporting band
that is disposed circumferentially about elastic body 15 as seen in
FIG. 5, leaving upper and lower surfaces 35 and 36, respectively,
of elastic body 15 free from the supporting band.
[0074] As seen in FIG. 5, portions of upper and lower surfaces 35
and 36, respectively, of elastic body 15 are exposed to directly
contact outer shell 30. This exposure minimizes the amount of
material needed to construct the supporting member, yet still
effectively provides, for example, lateral support. Although the
amount of the upper and lower surfaces of elastic body 15 that are
exposed may vary, typically at least about 50%, preferably at least
about 70%, more preferably at least about 80% and most preferably
at least about 90% of the surfaces are exposed.
[0075] In yet another embodiment shown in FIG. 6, nucleus pulposus
implant 500, that includes elastic body 15 as described above, is
reinforced with supporting member 37, which takes the form of a
jacket. The jacket preferably completely surrounds elastic body
15.
[0076] Suitable supporting members, including reinforcing outer
bands, covers, or other jackets, may be formed from a wide variety
of biocompatible polymers, metallic materials, or combination of
materials that form a strong but flexible support to prevent
excessive deformation, including lateral (horizontal) deformation,
of the core under increasing compressive loading. Suitable
materials include non-woven, woven, braided, or fabric materials
made from polymeric fibers including cellulose, polyethylene,
polyester, polyvinyl alcohol, polyacrylonitrile, polyamide,
polytetrafluorethylene, polyparaphenylene terephthalamide, and
combinations thereof. Other suitable materials include
non-reinforced or fiber-reinforced elastomers such as silicone,
polyurethane, copolymers of silicone and polyurethane, polyolefins,
including polyisobutylene and polyisoprene, neoprene, nitrile,
vulcanized rubber, and combinations thereof. In a preferred form of
the invention, a combination, or blend, of silicone and
polyurethane is used. Furthermore, the vulcanized rubber is
preferably produced as described above for the nucleus pulposus
implants. Supporting members 34 and 37 are advantageously made from
a porous material, which, in the case of an elastic body made from
a hydrogel, or other hydrophilic material, allows fluid circulation
through the elastic core body to enhance pumping actions of the
intervertebral disc. Supporting members may further be formed from
carbon fiber yarns, ceramic fibers, metallic fibers or other
similar fibers as described, for example, in U.S. Pat. No.
5,674,295.
[0077] FIGS. 7A-7D show supporting bands of various patterns,
typically made from various braided materials (bands 25, 26 and
27), or porous materials (band 28), as described above. It is also
understood the jackets may also be formed of such patterns. It is
realized that the braided materials may also be porous.
[0078] Supporting members 34 and 37 preferably decrease lateral
deformation, compared to deformation of an implant without the
supporting member, as desired. Supporting members 34 and/or 37 may,
for example, decrease lateral deformation by at least about 20%,
preferably at least about 40%, more preferably by at least about
60% and most preferably by at least about 80%. An implant, such as
one that includes an elastic body, having such a supporting member
will be flexible and otherwise resilient to allow the natural
movements of the disc and provides shock absorption capability at
low to moderate applied stress, but will resist excessive
deformation for disc height maintenance under high loading
conditions. As described herein in the case of a lumbar disc, for
example, low applied stress includes a force of about 100 Newtons
to about 250 Newtons moderate stress includes a force of about 250
Newtons to about 700 Newtons, and high loading conditions, or high
stress, includes a force of above about 700 Newtons. In preferred
forms of the invention, the supporting member is flexible, in that
it may be folded, or otherwise deformed, but is substantially
inelastic, so that the implant is more fully reinforced or
otherwise supported.
[0079] The elastic body may be covered by the jacket supporting
member, or the band supporting member may be wrapped around the
circumference of the elastic body. In a form of the invention
wherein the elastic body is formed from a hydrogel, or similar
hydrophilic material, the hydrogel may be dehydrated a desired
amount prior to being covered by the jacket, or prior to wrapping
the band around the circumference of the hydrogel body. The
hydrogel elastic body may be exposed to saline outside of the body,
or may be inserted into the disc space wherein it will be exposed
to body fluids in situ, and the body will absorb water and swell.
In reference to the peripheral band supporting member, the swelling
or expansion of the hydrogel elastic body in the horizontal
direction is controlled by the amount of slack designed in the
band. After the limited allowable horizontal expansion is reached,
the elastic body is forced to expand mostly in the vertical
direction until reaching equilibrium swelling under the in vivo
load. As the upper and lower surfaces of the elastic body are not
substantially constrained, the vertical expansion is mainly
controlled by the applied stress and the behavior of the hydrogel
material.
[0080] In yet other forms of the invention, an implant reinforced
with a peripheral supporting band as described above that is
surrounded by a resorbable outer shell may be further reinforced
with one or more straps. The straps may be advantageous in
preventing the peripheral supporting band described herein from
slipping, or otherwise sliding off the implant. Referring now to
FIGS. 8 and 9, at least one strap 420 extends along upper surface
35 and at least one strap 430 extends along lower surface 36 of
elastic body 15 of implant 400. Ends 421 of strap 420 and ends 431
of strap 430 are each preferably connected, or otherwise attached,
to peripheral supporting band 34'. The point of attachment may be
any location that will secure the strap, including at the upper
margins 138 of the band, lower margins 139 of the band or any
region between the upper and lower margins. Although two straps 420
and 430 are shown extending along upper surface 35 and lower
surface 36, respectively, in FIGS. 8 and 9, one continuous strap
may be utilized that extends completely around the implant, or the
strap utilized may be in one, two or multiple pieces, as long as
the combination of straps are sufficient to prevent excessive
slipping and or sliding of the supporting band. Furthermore, more
than one strap may extend along upper surface 35 and more than one
strap may extend along lower surface 36 of elastic body 15, as
seen, for example, in FIGS. 10 and 11 of implant 500, wherein
straps 520, 530, 540 and 550 are shown attached, or otherwise
connect to supporting member 34". It is realized that the straps
may be present in one or more pieces. For example, straps 520 and
530 may form a single strap, as may straps 540 and 550, or may all
combine to form a single strap.
[0081] In other aspects of the invention, kits designed for forming
the intervertebral disc nucleus pulposus implants that include the
outer shell described above are provided. In one form, a kit may
include a load bearing elastic body as described above, along with
a container of material to form the outer, preferably resorbable,
shell. The material may be selected from the materials as described
above. Moreover, the container that houses the material that forms
the shell may be made from a wide variety of materials that are
compatible with the outer shell material, including glass and
plastic. The kit may further include a supporting member, such as a
supporting band, jacket or other outer cover as described above.
Generally, the kits include sterile packaging which secures the kit
components in spaced relation from one another sufficient to
prevent damage of the components during handling of the kit. For
example, one may utilize molded plastic articles known in the art
having multiple compartments, or other areas for holding the kit
components in spaced relation.
[0082] In a further aspect of the invention, nucleus pulposus
implants are provided having shape memory that are configured to
allow extensive short-term manual, or other, deformation without
permanent deformation, cracks, tears, breakage or other damage,
that may occur, for example, during placement of the implant into
an intervertebral disc space. Referring now to FIGS. 15A and 16A,
in one form of the invention, implant 40 includes a load bearing
elastic body 41 with shape memory and having a first end 42 and a
second end 43 that are positioned adjacent to a central portion 44
to form at least one inner fold 45. Inner fold 45 preferably
defines at least one aperture 46 which is advantageously arcuate.
The elastic body is deformable, or otherwise configurable,
manually, for example, from this first folded, or otherwise relaxed
configuration shown in FIG. 15A into a second, substantially
straightened, or otherwise non-relaxed configuration shown in FIG.
16A for placement into the intervertebral disc space. As elastic
body 41 has shape memory, it returns by itself, automatically, back
into the first folded, relaxed configuration once manual or other
force is no longer exerted on the body. These implants therefore
provide improved handling and manipulation characteristics in that
they may be deformed, configured and otherwise handled by an
individual without resulting in any breakage or other damage to the
implant.
[0083] Further describing the shape memory nucleus prosthesis
implant 40, implant 40 includes surface depressions 47, or other
surface irregularities as more fully described below, that form
inner fold 45 when the implant is in its relaxed configuration.
Ends 42 and 43 have end surfaces 42a and 43a, respectively, that
are generally flat, and substantially parallel, or perpendicular in
other forms, to an axis X passing through the width of the implant
in its relaxed configuration, wherein the ends may abut each other
as seen in FIGS. 15A, 15B and 15E-15N. The ends of the implant may
each alternatively abut the central portion of the implant, as
shown for implants 60 and 70 in FIGS. 15C and 15D, respectively, to
form a generally bi-lobed or binocular-shaped implant.
[0084] Alternatively, in other forms of the invention, one end of
the implant may be tapered, or otherwise specifically shaped, and
the other end may be shaped complementary to the tapered, or
otherwise shaped, end. Moreover, either one or both sides 96a and
96b of the ends of the nucleus pulposus implant may be tapered. For
example, and as seen in FIGS. 15F and 16F, both sides of end 93 of
implant 90 are tapered to form a pointed end, such as a generally
V-shaped end, that advantageously fits into a complementary-shaped
(e.g., V-shaped) depression 95 defined by end 92. An implant having
only one inner fold that defines one aperture and ends that are
similarly configured as ends 92 and 93 is shown in FIGS. 15J and
16J. As another example, one side of each of the ends of the
implant may be oppositely tapered as seen in FIGS. 15G and 16G.
That is, side 108a of end 102 of implant 100 and opposite side 109b
of end 103 are tapered as seen in FIG. 15G and 16G. End surfaces
102a and 102b of implant 100 are transverse to axis X when the
implant is in its relaxed configuration shown in FIG. 15G. In those
embodiments where the ends of the implants are tapered, or
otherwise shaped, it is preferred that, when the ends of the
implants contact each other or the central or other portion of the
implant, an implant is formed that is uniform along the length of
the implant through the region of contact.
[0085] Although the implant may assume a wide variety of shapes, it
is typically shaped, in its folded, relaxed configuration, to
conform to the shape of the natural nucleus pulposus. Thus, the
implants may be substantially elliptical when in their folded,
relaxed, configurations in some forms of the invention. In yet
further forms of the invention, the shape of the implants in their
folded configurations may be generally annular-shaped or otherwise
shaped as required to conform to the intervertebral disc cavity.
Moreover, when the implants are in their unfolded, non-relaxed,
configuration, such as their substantially straightened
configuration, they may also assume a wide variety of shapes, but
are most preferably generally elongated, and preferably generally
cylindrical, or other shape as described herein.
[0086] In yet other forms of the invention, the folding implant may
have a surface that includes surface projections that further aid
in allowing short-term deformation of the implant without permanent
deformation or other damage as described above. Referring now to
FIGS. 15D and 16D, implant 70 includes a load bearing elastic body
71 having a first end 72, a second end 73 and a central portion 74.
Inner fold 75 defines an aperture 76 and includes an inner fold
surface 77 having wrinkles, or projections 78 thereon. Projections
78 of inner fold surface 77 extend into aperture 76. These wrinkles
advantageously facilitate stretching of the implant without
deformation, cracking, tearing, breakage, or other damage when the
implant is straightened or elongated for insertion into the
intervertebral disc space. In the embodiment shown in FIGS. 15D and
16D, the wrinkles, or surface projections, extend along the entire
length of elastic body 71, including central portion 74. Other
implants having wrinkled inner fold surfaces are seen in FIGS. 15E
and 16E and other wrinkle configurations upon folding the implant
are seen in FIGS. 15K-15N and 16K-16N.
[0087] Other folding implants are shown in FIGS. 22A-22Q, 23A-23Q
and 24-27. Referring to these figures, implants 400-620 are shown
that have a plurality of inner folds, ranging from, for example,
two to about six. Moreover, these implants, as well as the
above-discussed folding implants, have first and second ends that
are formed from first and second arms, respectively, of the
implants. As seen in FIGS. 22A and 23A, for example, first end 402
of implant 400 is formed from a first arm 408 connected to, or
otherwise associated with, one end 404a of central portion 404.
Second end 403 is formed from a second arm 409 connected to, or
otherwise associated with, opposing end 404b of central portion
404. Surface depressions 405 or other surface irregularities define
inner folds 406 when the implant is in its relaxed
configuration.
[0088] In certain forms of the invention, each of the arms
connected to the central portions of the implant are the same
length, as seen in FIGS. 15A-15J, 15L-15N, 22A-22B, 23A-23B,
22D-22E, 23D-23E, 22G and 23G. In yet other forms of the invention,
one of the arms is shorter than the other arm. For example, as seen
in FIG. 22C, second arm 429 of implant 420 is shorter than first
arm 428, wherein each arm is connected to an end of central portion
424. Stated alternatively, in certain forms of the invention, the
ends of the implant abut each other along a plane extending along
axis X and passing through the width of the implant, resulting in a
center or central closure C of the implant as seen, for example, in
FIG. 22A. In other forms of the invention, the ends of the implant
abut each other along a plane extending parallel to a plane
extending along axis X and passing through the width of the
implant, resulting in an off-center closure C' of the implant as
seen, for example, in FIG. 22C. The differential length of the arms
of the implants can facilitate implantation and proper positioning
of the implants in the disc space as more fully described
below.
[0089] Moreover, some of the inner folds of the implants may be
formed when the first end and the second end of the implant
contact, or otherwise abut, each other, as seen, for example, in
FIG. 22C. In such forms of the invention, each end of the implant
may include a surface that has a surface depression, such as
surface depression 421 or 422, as seen in FIG. 23C, that forms a
portion of the inner fold such that when the ends of the implant
contact each other, an inner fold is formed from the combination of
surface depressions. Additionally, the apertures defined by the
inner folds may have a variety of cross-sectional shapes, including
substantially annular or otherwise ring-shaped, substantially oval
or otherwise elliptical-shaped, star-shaped or other various shapes
known to the skilled artisan. The star-shaped pattern includes a
plurality of finger-like or otherwise elongated projections 465 or
475 as seen, for example, in FIGS. 22G and 22H, respectively.
[0090] FIGS. 221, 231, 24, 22K, 23K and 26 show further details of
implants of the present invention. For example, apertures, or
channels, 486 and 506, can be seen in FIGS. 24 and 26,
respectively, showing implants 480 and 500, respectively. Turning
now to FIGS. 22J, 23J and 25, implant 490 is shown that includes
all of the features of the aforementioned implants, including a
load bearing body 491, a first arm 498 having a first end 492, a
second arm 499 having a second end 493, and surface depressions
497. Additionally, implant 490 includes a central portion 494 that
extends along the full width of implant 490 from one end of the
implant to an opposing edge of the implant. In such an embodiment,
end surfaces 492a and 493a abut, and are otherwise in contact with,
central portion 494 when implant 490 is in its folded configuration
as seen in FIG. 22J.
[0091] In one form of the invention, at least one end of the
implants may be curved, or otherwise arcuately-shaped or rounded.
Referring to implant 510 in FIGS. 22L and 23L, first end 512 and
second end 513 each have an inner edge 512b and 513b, and an outer
edge, 512a and 513a, respectively. Outer edges 512a and 513a are
shown as rounded and can facilitate implantation and proper
positioning of the implants in the disc space as more fully
described below.
[0092] For example, the rounded edges allow for better conformity
of the implant to the disc space. Although not being limited by
theory, it is believed that the dome-shaped, or otherwise
concave-shaped, endplates may lead to increased stress concentrated
at the edges of the implant. The rounded edges reduce such stress.
In this manner, there is a smaller likelihood of the implant
penetrating the endplate, and the durability of the implant is
improved. Bone remodeling based on the shape of the implant is also
reduced.
[0093] Referring to FIGS. 22M and 23M, implant 610 is shown wherein
both ends of the implants have edges that are curved or otherwise
rounded. Implant 610 includes body 611 having first arm 613 and
second arm 614. First arm 613 and second arm 614 include ends 613a
and 614a, respectively, which both preferably have rounded edges
613b and 614b, respectively, although only one of the ends may have
such a rounded, straight or other shaped edge. In this embodiment,
end 614a of second arm 614 is tapered, or otherwise has a decreased
diameter compared to end 613a of first arm 613. Additionally, first
arm 613 is shorter than second arm 614.
[0094] Referring to FIGS. 22N-22Q, 23N-23Q and FIG. 27, alternative
embodiments of the above-described folding implants are shown. As
with all of the implants, the bodies forming the implants have a
top surface T for contacting an upper vertebral endplate of an
intervertebral disc and a bottom surface B for contacting a lower
vertebral endplate of the intervertebral disc as seen, for example,
in FIG. 27. Additionally, the implants have an external side
surface E that includes at least one groove G extending along the
side surface that advantageously further relieves the compressive
force on the external side E of the implant when the implant is
deformed into a substantially straightened, or otherwise unfolded
configuration and thus further allows extensive short-term
deformation without permanent deformation, cracks, tears or other
breakage. For example, implant 620 shown in FIGS. 22N, 23N and 27
includes a load bearing body 621 that has a top surface T, a bottom
surface B, an internal side surface I and an external side surface
E. A plurality of grooves G are disposed along external side
surface E that typically extend from the top surface to the bottom
surface of the implant. When dividing the implant in half, thus
more easily viewing a first side S.sub.1 and a second side S.sub.2,
with a plane passing through the width of the implant along axis X,
it can be seen in FIG. 22N that four grooves G are present on first
side S.sub.1 and four grooves G are present on second side S.sub.2,
although more or less may be present depending on the case. It is
preferred that at least one groove is present on each side S.sub.1
and S.sub.2.
[0095] FIGS. 220 and 230 depict implant 570, which is similar to
implant 620, with the exception that implant 570 includes a second
arm 572 that is smaller than first arm 571, resulting in an
off-center closure C' as more fully described above. FIGS. 22P and
23P depict implant 610' and FIGS. 22Q and 23Q depict implant 490',
which are identical to implants 610 and 490, respectively, with the
exception that implants 490' and 600' both include external side
grooves G as described herein.
[0096] In yet other preferred forms of the invention, the top and
bottom contact surfaces of the implants are configured to be
complementary to the top and bottom endplates of an intervertebral
disc, respectively. For example, the top and bottom contact
surfaces of the implants may be convex, to conform to the
respective concave intervertebral disc endplates. Additionally,
although the implants are preferably one-piece implants, they may
also be composed of one or more pieces. For example, an implant may
be composed of a separate central portion and first and second
arms, wherein the arms are associated or otherwise attached to the
central portion as described herein.
[0097] In certain preferred forms of the invention, the apertures
defined by the inner folds of the implants described above have a
radius of at least about 1 mm. Moreover, in other preferred forms
of the invention, a reinforcing material may be included at the
inner fold surface to further improve the structural integrity of
the implant. The reinforcing material may be a fabric that is
either woven, or non-woven, and may be formed from braided fibers
for further strength. The reinforcing material may be positioned on
the inner fold surface, may project therefrom or may be entirely
embedded under the inner fold surface. The implant may be formed as
a single piece, or may be formed of more than one piece that is
connected to the other pieces that form the assembled implant by
fabric that may be made from braided or other fibers, or may be
connected by some other components or manner, such as by use of
adhesives, or other methods of connecting such components together.
Although these implants are designed to be used without an
anchoring outer shell, they, as well as all of the implants
described herein, may form the core elastic body of an implant that
includes the outer shell described herein.
[0098] The implants may obtain their shape memory characteristics
in a variety of ways. For example, the implants may be formed in a
mold into a desired final shape, and, when deformed from this final
shape by application of an external force, will return to the final
shape upon release of the force.
[0099] In yet another embodiment of the invention, a nucleus
pulposus implant is provided that has a locking feature, with
optional shape memory characteristics, and thus may also resist
being expelled from the disc cavity to some extent. In one form of
the invention as seen in FIGS. 17-19, an implant 300 includes a
load bearing elastic body 301 having a first end 302 and a second
end 303. The ends are typically configured for mating engagement
with each other. Elastic body 301 has a first, locked configuration
wherein first end 302 and second end 303 are matingly engaged to
each other as seen more particularly in FIG. 17. When elastic body
301 has shape memory characteristics, elastic body 301 is
deformable, manually, for example, into a second, substantially
straightened, non-relaxed configuration for insertion into an
intervertebral disc space, as seen in FIG. 19, and may
automatically be configured or otherwise returned back into the
first, locked, relaxed configuration after insertion due to its
shape memory characteristics. In those cases where the elastic body
does not have shape memory characteristics and the elastic body is
configurable into a locked and/or straightened configuration, and
in those cases where the elastic body has shape memory
characteristics, the elastic body may also be placed into its
locked configuration with the assistance of external force.
[0100] More particularly describing one form of the invention, end
302 defines an internal channel 304 as seen in FIG. 19 whereas end
303 is configured to conform to the shape of internal channel 304.
The channel may take the form of a wide variety of shapes, as long
as the ends of the elastic body may be matingly engaged to form a
locked configuration. As seen in FIG. 19, the channel is somewhat
hour-glass shaped. Manual, or other force, may be applied to end
303 so that it may be temporarily deformed, or configured,
sufficiently to pass through narrowed passage 305 within internal
channel 304. Once properly positioned, end 303 will be secured
within channel 304, as end edges 303a and 303b are braced against
channel edges 304a and 304b, respectively. Alternatively, one end
of an implant with a locking feature may be friction-fit within the
internal channel present in the other end of the implant. The
friction-fit may arise as a result of the relative size differences
between the inner diameter of the channel formed by one end and the
outer diameter of the other end of the implant. Additionally,
and/or alternatively, the outer surface of one end, and/or the
inner surface of the channel defined by the other end, may include
surface roughenings as described herein that aid in achieving the
friction-fit. The implant may also be constructed from the
biocompatible polymeric materials as described above.
[0101] When the implants are formed from an elastic material, such
as a hydrogel, or other similar hydrophilic material, or include
the resorbable outer shell, they may advantageously deliver desired
pharmacological agents. The pharmacological agent may be a growth
factor that may advantageously repair the endplates and/or the
annulus fibrosis. For example, the growth factor may include a bone
morphogenetic protein, transforming growth factory-.beta.
(TGF-.beta.), insulin-like growth factor, platelet-derived growth
factor, fibroblast growth factor or other similar growth factor or
combination thereof having the ability to repair the endplates
and/or the annulus fibrosis of an intervertebral disc.
[0102] The growth factors are typically included in the implants in
therapeutically effective amounts. For example, the growth factors
may be included in the implants in amounts effective in repairing
an intervertebral disc, including repairing the endplates and the
annulus fibrosis. Such amounts will depend on the specific case,
and may thus be determined by the skilled artisan, but such amounts
may typically include less than about 1% by weight of the growth
factor. The growth factors may be purchased commercially or may be
produced by methods known to the art. For example, the growth
factors may be produced by recombinant DNA technology, and may
preferably be derived from humans. As an example, recombinant human
bone morphogenetic proteins (rhBMPs), including rhBMP 2-14, and
especially rhBMP-2, rhBMP-7, rhBMP-12, rhBMP-13, and heterodimers
thereof may be used. However, any bone morphogenetic protein is
contemplated including bone morphogenetic proteins designated as
BMP-1 through BMP-18.
[0103] BMPs are available from Genetics Institute, Inc., Cambridge,
Mass. and may also be prepared by one skilled in the art as
described in U.S. Pat. No. 5,187,076 to Wozney et al.; U.S. Pat.
No. 5,366,875 to Wozney et al.; U.S. Pat. No. 4,877,864 to Wang et
al.; U.S. Pat. No. 5,108,922 to Wang et al.; U.S. Pat. No.
5,116,738 to Wang et al.; U.S. Pat. No. 5,013,649 to Wang et al.;
U.S. Pat. No. 5,106,748 to Wozney et al.; and PCT Pat. Nos.
W093/00432 to Wozney et al.; W094/26893 to Celeste et al.; and
W094/26892 to Celeste et al. All bone morphogenic proteins are
contemplated whether obtained as above or isolated from bone.
Methods for isolating bone morphogenetic protein from bone are
described, for example, in U.S. Pat. No. 4,294,753 to Urist and
Urist et al., 81 PNAS 371, 1984.
[0104] In other forms of the invention, the pharmacological agent
may be one used for treating various spinal conditions, including
degenerative disc disease, spinal arthritis, spinal infection,
spinal tumor and osteoporosis. Such agents include antibiotics,
analgesics, anti-inflammatory drugs, including steroids, and
combinations thereof. Other such agents are well known to the
skilled artisan. These agents are also used in therapeutically
effective amounts. Such amounts may be determined by the skilled
artisan depending on the specific case.
[0105] The pharmacological agents are preferably dispersed within
the hydrogel, or other hydrophilic, implant for in vivo release,
and/or, with respect to the implants with the resorbable outer
shell, may be dispersed in the outer shell. The hydrogel can be
cross-linked chemically, physically, or by a combination thereof,
in order to achieve the appropriate level of porosity to release
the pharmacological agents at a desired rate. The agents may be
released upon cyclic loading, and, in the case of implants
including a resorbable outer shell, upon resorption of the shell.
The pharmacological agents may be dispersed in the implants by
adding the agents to the solution used to form the implant, by
soaking the formed implant in an appropriate solution containing
the agent, or by other appropriate methods known to the skilled
artisan. In other forms of the invention, the pharmacological
agents may be chemically or otherwise associated with the implant.
For example, the agents may be chemically attached to the outer
surface of the implant.
[0106] The implants described herein may have embedded therein
small metal beads or wire for x-ray identification.
[0107] Methods of forming and implanting the nucleus pulposus
implants described herein are also provided. In one form of the
invention, with respect to implant 10 described above having the
anchorable outer shell 30, implant 10 may be formed by first
forming elastic body 15 and then forming the outer shell. Methods
of forming elastic body 15 are well known in the art.
[0108] For example, if the elastic body is made of elastomeric
materials, such as powdered elastomers including, for example,
styrene-ethylene/butylene block copolymers, the powdered elastomer
may be placed into an appropriate mold and may be compressed and
heated to melt the powder. The mold is then cooled to room
temperature. If the elastic body is made from a hydrogel, such as a
polyvinyl alcohol, the polyvinyl alcohol powder may be mixed with a
solvent, such as, for example, water or dimethylsulfoxide, or
combinations thereof, and heated and shaken until a uniform
solution is formed. The solution may then be poured into a mold,
such as a rubber mold, and may be cooled at an appropriate
temperature, such as about 0.degree. C. to about -80.degree. C.,
for several hours to allow for crystallization. After cooling, the
hydrogel can be partially or completely hydrated by soaking and
rinsing with water but, in certain preferred embodiments, may
remain dehydrated so that it may be inserted through a smaller
aperture in the annulus fibrosis.
[0109] Prior to positioning the implant in the interverterbral disc
space, an incision may be made in the annulus fibrosis, or one may
take advantage of a defect in the annulus, in order to remove the
natural nucleus pulposus and any free disc fragments within the
intervertebral disc space. The disc space is then distracted to a
desired level by distractors or other devices known to the skilled
artisan for such purposes. Once formed, and after preparing the
disc space for receiving the implant, elastic body 15 may be
implanted into the intervertebral disc space utilizing devices well
known in the art and as described in U.S. Pat. Nos. 5,800,549 and
5,716,416. If the outer shell precursor material was already placed
in the intervertebral disc space, excess precursor material may
flow out of the disc space. This excess material should be promptly
removed before it sets or otherwise cures. The outer shell material
may be injected, or otherwise introduced, into the disc space
utilizing devices that are well known in the art, such as syringes,
sealant/caulk guns, automatic liquid injectors, and applicators
that include, for example, two separate syringes which allow for
simultaneous mixing of the components in a static mixer and
delivery to the site, and may be injected either prior to or after
introduction of the implant into the disc space. Whether the outer
shell material is introduced prior to or after introduction of the
implant into the disc space, the distractor is then removed, any
excess precursor material seeping out of the disc space is removed
and the precursor material within the disc space is cured to form
the outer shell. It is noted that the elastic body may already be
surrounded by the outer shell, which may be in a partially or fully
hardened state but preferably remains deformable, prior to
introducing the elastic body into the intervertebral disc
space.
[0110] In further aspects of the invention, spinal disc implant
delivery devices, or tools, are provided to be used in preferred
methods of implanting the implants described herein, especially the
shape memory implants. In one form, the device preferably includes
an elongated member having a lumen extending longitudinally
therethrough for loading of the desired implant, a tip portion for
controlling passage of the implant out of the delivery tool and a
plunger or other elongated member or other device for pushing the
implant through the tool and into an intervertebral disc cavity.
The tip portion preferably includes a movable member that may be
moved from a first, closed position in which it blocks the passage
of a spinal disc implant through the lumen, and out of the distal
end, of the elongated member into which the spinal implant is
loaded and otherwise housed. The tip portion may also preferably be
moved to a second, open position, wherein egress of the spinal
implant is allowed.
[0111] Referring to FIG. 28, device 700 includes an elongated
member 701, such as a syringe housing 702 or other elongated
housing or barrel that defines a cavity, or lumen, 703 that extends
along its length, and has a proximal end 704 and a distal end 705.
Proximal end 704 defines a flange 704a. Inner surface 703a of
cavity, or lumen, 703 is preferably configured for passage of a
spinal nucleus pulposus implant. For example, inner surface 703a is
preferably smooth. Although elongated housing member 701 is shown
in FIG. 29 as having a square cross-sectional shape, the
cross-sectional shape of housing member 701 may vary along its
length and may be selected from a wide variety of geometric shapes,
including elliptical, circular, rectangular, hexagonal or other
multi-sided shape or a combination thereof. Device 700 further
includes a plunger 706, or elongated or other member. Plunger 706
includes an elongated member, or rod, 720 having proximal end 707
and distal end 709 that may be utilized to push a nucleus pulposus
implant that may be disposed in cavity 703 through the housing and
ultimately into an intervertebral disc space. Distal end 709 of
plunger 706 may include a plunger tip 721 that is configured to
contact an implant during extrusion. The cross-sectional shape of
plunger tip 721 is preferably similar to that of elongated housing
member 701. Proximal end 707 of plunger 706 includes a plunger
handle 722. Plunger 706 may include one or more components that may
facilitate extrusion of the implant by pneumatic, hydraulic or
mechanical force, or by manual pushing or impacted force. For
example, the plunger can be in the form of a pushing or impacted
plunger, a syringe plunger, a caulk gun plunger, or a screw-driven
plunger as known in the art.
[0112] Device 700 further includes component, or tip portion, 710
having a proximal end 713 and a distal end 712 wherein tip portion
710 may be integral or detachable. For example, proximal end 713 of
tip portion 710 may be matingly engageable to, or is otherwise
connected or associated with, distal end 705 of housing 702 of
member 701. In one form of the invention depicted in FIG. 29, tip
portion 710 may include a top wall 730, a bottom wall 735, a side
wall 740 and an opposing side wall 745. Tip portion 710 defines a
cavity, or lumen, 731 extending longitudinally therethrough wherein
lumen 731 is continuous, and otherwise in fluid communication, with
lumen 703 of elongated housing member 701.
[0113] The dimensions of tip portion 710, such as height H and
width W, may be configured to accommodate a spinal disc implant to
be delivered. Height H of tip portion 710 may have a height similar
to or larger than the disc space height depending on whether disc
space distraction is required. Additionally, length L of the tip
portion may be chosen so that tip portion 710 will preferably not
substantially extend past the inner wall of the annulus fibrosis as
described more fully below. Different dimensions of the tip portion
may be determined by the skilled artisan.
[0114] Tip portion 710 is preferably configured to enter an
aperture in an annulus fibrosis for delivery of a spinal nucleus
pulposus implant or other spinal implant. Although tip portion 710
is shown as a rectangular tube in FIG. 29, it may have a wide
variety of shapes, including cylindrical, square, hexagonal or
other multi-sided shape. Surface 732 of top wall 730 and surface
733 of bottom wall 735 contact the endplates during delivery of the
implant, and may have surface features 738 that help anchor, engage
or otherwise secure the tip to the opposing endplates. Examples of
such surface features, such as surface roughenings, are shown in
FIGS. 30A-30J and include teeth 738c-738g, in the form of
serrations or spikes (FIGS. 30C-30H), ridges 738i and 738j (FIGS.
30I and 30J) a textured surface 738b (FIG. 30B) or a non-textured
surface 738a (FIG. 30A). The teeth or ridges may be directional and
may restrict movement in a single direction, as seen in FIGS. 30D,
30E, 30F, and 30G for example.
[0115] In yet another form of the invention, one side wall may be
shorter than the other to aid delivery and placement of the spinal
disc implants described herein. Referring to FIG. 31, delivery
device 700a includes tip portion 710a having side wall 740a that is
shorter than side wall 745a. FIG. 32 shows one way in which
delivery of an implant 40 is aided. For example, as implant 40
exits the device, it veers to the shorter side wall and will
subsequently fold up in the disc space.
[0116] In a further form of the invention, the top and bottom walls
of the tip portion may be partially open to alleviate any possible
constriction of the implant as it exits the device and is delivered
into a disc space. For example, referring to FIG. 33, tip portion
710' of device 700' may include a top wall 730' having an opening
739 and a bottom wall 735' having an opening 741, wherein both
openings may extend from a proximal end 712' to a distal end 713'
of tip portion 710'. In such a fashion, tip portion 710' forms
opposing arms 736 and 737, each having an inner surface I and an
outer surface O. Inner surfaces I are preferably concave and
preferably accommodate a spinal disc implant.
[0117] Although both arms 736 and 737 of tip portion 710' are shown
in FIG. 33 as having the same length, one of the arms may be
shorter than the other to, for example, aid placement of the
folding implants described herein. For example, as seen in FIG. 34,
arm 736' of tip portion 710" of device 700" is shorter than arm
737".
[0118] In yet another embodiment of a spinal disc implant delivery
device, one of the arms of the tip portion may be movable and the
other non-movable or otherwise stationary. As seen in FIG. 35, for
example, arm 737" of tip portion 710'" of device 700'" is similar
in configuration as arm 737' and is preferably non-movable and
further preferably otherwise rigid. Arm 736" may also be
non-movable or otherwise rigid, but it may include both a
non-movable portion 736a" and a movable, flexible or otherwise
elastic portion 736b" so that arm 736" may move, or be bent, and
form a closed configuration. For example, by appropriately
positioning arm portion 736b", arm 736" may be bent, preferably at
an angle a of greater than about 30.degree., further preferably
between about 45.degree. to about 90.degree., and typically about
60.degree.. It is preferred, especially when the tip portion also
functions as a distractor, that the movable portion of the arm has
a height that is less than the height of a disc space, and/or the
height of the arm at its distal end is shorter than at its proximal
end, so that it may move freely. In the closed configuration, the
width W of distal end 713'" of tip portion 710'" is narrow, such as
about 2 mm to about 10 mm, which makes it easier to guide the tip
portion into a small annular opening. Additionally, the implant for
delivery will be blocked from exiting the delivery device by arm
736" in its closed configuration.
[0119] After the tip portion is inserted into the disc space,
movable arm 736" may be moved, radially, for example, to form an
open configuration, such as the configuration of arm 736 of device
700' of FIG. 33, under extrusion pressure to expand the annular
opening and to allow the implant to exit the device and enter the
disc space as described below. After the implant is delivered to
the disc space, the movable arm retracts, bends or otherwise moves
back to its closed configuration in order to decrease the expansion
of the annular opening. It is realized that both arms may also be
rigid, flexible or otherwise elastic as desired. Other tip portions
that have such open and closed configurations are described below.
In preferred embodiments of the spinal disc implant delivery
devices described herein, the tip portion has wall support for the
top, bottom and side surfaces of the spinal disc implants to be
delivered. It is further noted that lumens 703', 703", 703'" of
elongated members 701', 701" and 701'", respectively, are
continuous, and in fluid communication, with cavity 731', 731",
731'", respectively.
[0120] In yet another form of the invention, and referring to FIG.
36, a spinal disc implant delivery device 800 includes an elongated
member 801, such as a syringe housing 802 that defines a cavity
803, and has a proximal end 804 with a flange portion 804a and a
distal end 805. Device 800 further includes a plunger 806, or
elongated or other member, having proximal end 807 and distal end
809 that may be utilized to push a nucleus pulposus implant that
may be disposed in cavity 803 through the housing, out of the
distal end of the housing and ultimately into an intervertebral
disc space.
[0121] Device 800 further includes component, or tip portion, 810
having a proximal end 813 and a distal end 812, wherein proximal
end 813 is matingly engageable to, or is otherwise connected or
associated with, distal end 805 of housing 802 of member 801 which
is also seen in FIG. 36. Tip portion 810 preferably includes a base
member 850 which has a proximal end 851, a distal end 852, and a
lumen 853 extending longitudinally therethrough. Tip portion 810
further preferably includes at least one movable member that may
form a closed configuration as described herein. In preferred forms
of the invention, tip portion 810 includes a plurality of movable
members 880. Proximal end 881 of movable members 880 abut, or are
connected to or are otherwise associated with, distal end 852 of
base member 850.
[0122] Movable members 880 have a first, closed configuration
wherein they define a channel or cavity 883. The members may
further have a closed configuration which includes a narrowed
distal end. Lumen 853 of base member 850 and cavity 883 are
preferably in fluid communication. Lumen 853 of base member 850 and
cavity 803 of housing 802 are also preferably in fluid
communication when distal end 805 of housing 802 and proximal end
851 of base member 850 are matingly engaged. In their closed
configuration, movable members 880 preferably further define an
aperture 884, or other opening, at their distal end as best seen in
FIG. 37A. Aperture 884 is preferably sized and/or configured for
ease of insertion of the tip into an annular opening, preferably an
undersized or relatively small annular opening. For example, the
diameter of aperture 884 of movable members 880 may range from
about 2 mm to about 10 mm in its closed configuration.
[0123] Movable members 880 are preferably movable, flexible, or
otherwise elastic, but in certain forms of the invention may be
otherwise rigid, and further have an open configuration wherein
movable members 880 are moved, flexed or otherwise bent
sufficiently to enable passage of a spinal implant, such as a
nucleus pulposus implant described herein, through lumen 853 of
base member 850 and through an area circumscribed by the movable
members in their open configuration so that the spinal implant may
exit the delivery tool and may be inserted into or otherwise
positioned in an intervertebral disc space. Movable members 880 are
preferably placed in their open configuration when, for example, a
spinal implant is positioned in housing 802 of syringe 801 and
plunger 806, or other elongated or similar member, transmits a
force sufficient for translation of the spinal implant through
cavity 803 of housing 802, lumen 853 of base member 850 and cavity
884 defined by movable members 880. Contact of the inner surfaces
of movable members 880 with, and continued translation of, a spinal
implant toward distal end 812 of device 800 forces the radial
flexing, bending or movement of movable members 880 as more fully
described below.
[0124] Movable members 880 and base member 850 may be engaged,
connected or otherwise associated with each other in a variety of
ways, including use of an adhesive. Moreover, movable members 880
and base member 850 may be integral. Base member 850 may also be
integral with syringe housing 802, or may be attached by adhesive
or other manner of attachment described herein and/or known to the
skilled artisan. For example, base member 850 may have an inner
surface 854 defining lumen 853 that is tapered as desired to
varying degrees so that base member 850 may be associated with
syringe housing 802 by friction fit. Other mechanical interlocking
methods known to the art may also be utilized to couple proximal
end 851 of base member 850 to distal end 805 of housing 802 of
syringe 801.
[0125] Tip portion 810 may include a plurality of movable members
and may assume a wide variety of shapes. As seen in FIG. 37A, tip
portion 810 is round and includes 16 movable members 880, although
more or less may be present as desired. For example, the tip
portion may include 8 movable members 780b, 780c and 780d (tip
portion 810b-810d, respectively) as seen in FIGS. 37B-37D, 4
movable members 780e (tip portion 810e) as seen in FIG. 37E or 2
movable members 780f (tip portion 810f) as seen in FIG. 37F.
Additionally, the movable members may contact a neighboring movable
member or may be variously spaced apart. For example, FIGS. 37D,
37E and 37F show movable members, some of which are spaced apart by
space S. Furthermore, the tip portions may assume a wide variety of
cross-sectional shapes, including circular, elliptical, square,
rectangular or other multi-sided or geometric shape.
[0126] The housing members, plunger members and base members
described herein may be made from a variety of materials, including
metals known to the art, such as stainless steel and titanium
alloys, polymers known to the art, including polyethylene,
polypropylene, polyetheretherketone and polyacetal. Movable
members, such as movable members 880, may also be made from a
variety of materials, preferably those which are flexible or
otherwise elastic, and allow for flexing, bending or pivoting.
Movable members 880 may be made from the same materials as the
housing members, plunger members and base members described
herein.
[0127] In yet another form of the invention, a method for
implanting a prosthetic intervertebral disc having shape memory is
provided. In one embodiment, an implant including a load bearing
elastic body having a first end and a second end positioned
adjacent to a central portion to form at least one inner fold as
described above is provided. As mentioned previously herein, the
disc space may be distracted if necessary and all or a portion of
the nucleus pulposus may be removed. The implant 40, for example,
may be deformed by, for example, manual force into a substantially
straightened, non-relaxed configuration for insertion through an
aperture formed in the annular fibrosis as indicated in FIG. 20,
and as best seen in FIG. 21. The aperture may be formed through
deterioration or other injury to the annulus fibrosis, or may be
made by purposely incising the annulus. The implant may then be
positioned in a delivery tool 310 known in the art, such as that
described in U.S. Pat. No. 5,716,416, and inserted through aperture
18 in annulus 19, although utilization of the delivery devices or
tools described more fully herein is preferred. As the implant
enters the intervertebral space 20 and is no longer subject to
manual force, it deforms back into its relaxed, folded
configuration as seen in FIG. 21. A portion, or substantially all,
of the natural nucleus pulposus may be removed from the
intervertebral disc space, depending on the circumstances, prior to
introduction of the implant into the intervertebral disc space.
When implanting an implant that includes a locking feature, or
other implant with shape memory as described herein, a similar
protocol is followed. Additionally, with respect to an implant with
a locking feature, the implant may be placed into the locked
configuration with external force, imposed by, for example, medical
personnel. It is noted that, due to the symmetrical features of a
variety of the implants described herein, the implant may be
inserted into the disc space by a wide variety of approaches,
including anterior and posterior approaches.
[0128] In preferred forms of the invention, a method for implanting
a prosthetic intervertebral disc having shape memory is practiced
with the spinal disc implant delivery devices described herein. As
an example, the method may be practiced with device 800 as depicted
in FIGS. 38-44. After implant 40 is deformed by, for example,
manual force into a substantially straightened, non-relaxed,
unfolded, configuration for insertion through an aperture formed in
the annular fibrosis, it is loaded, or otherwise positioned in
cavity 803 of syringe housing 802. Alternatively, as seen in FIG.
38, implant 40 may be straightened as it is inserted into cavity
803 at proximal end 804 of housing 802. Distal end 809 of plunger
806 may then be inserted into cavity 803 from proximal end 804 of
housing 802. Device 800, loaded with implant 40, may then be
positioned adjacent aperture 18 in annulus 19 as seen in FIG. 40.
Distal end 882 of movable members 880 are preferably positioned
through aperture 18 in annulus 19 and preferably extend into
intervertebral disc space 20 surrounded by annulus 19, as seen in
FIG. 40. Force is applied to plunger 806, preferably at its
proximal end 807, to contact end 42 of implant 40 for translation
of the implant towards distal end 812 of delivery tool 800. The
force preferably will allow contact of distal end 809 of plunger
806 with an adjacent end of the implant and may be provided
manually, with a mechanical pressurization device, including a
caulk gun, or by other devices and methods known to the skilled
artisan, including the force generator described in U.S. Pat. No.
5,800,849, as well as other hydraulic, pneumatic, manual or
power-assisted hydraulic force generators. It is noted that, when
utilizing device 700, 700', 700" or 700'", the tip portion of these
devices may act as a distractor to distract the disc space,
although a distractor may also be used depending on the
circumstances and preference of the surgeon.
[0129] As implant 40 enters cavity 883 (cavity 883 being seen in
FIG. 36) defined by movable members 880 in their closed
configuration, movable members 880 begin to move radially, or
otherwise flex or bend radially, as seen in FIG. 41. Radial
movement of movable members 880 allows the movable members to
contact the surrounding annular tissue and press or otherwise push
the tissue such that the annular defect, or other opening such as
aperture 18, is dilated. This allows implant 40 to exit distal end
812 of delivery device 800 and enter intervertebral disc space 20
as seen in FIGS. 41-43, wherein movable members 880 are seen in
their open configuration.
[0130] As mentioned above, implants described herein having arms of
differential length can facilitate implantation and proper
positioning of the implants in the intervertebral disc space. For
example, such an implant having an off-center closure may prevent
possible excessive rolling of the implant during insertion so that
the implant will be positioned such that the length of the implant
extends substantially parallel to the coronal plane of a patient's
body.
[0131] It is noted here that distal end 809 of plunger 806 may
retain movable members 880 in their open configuration as end 42 of
implant 40 approaches distal end 812 of delivery device 800 prior
to completely exiting the device. After the plunger is translated a
sufficient amount distally to allow implant 40 to exit the device,
if necessary, the plunger is retracted, or translated in a proximal
direction to ensure the deforming members are in their closed
configuration as seen in FIG. 44. Delivery device 800 is then
removed. As seen in FIG. 44, implant 40 is properly positioned in
intervertebral disc space 20.
[0132] Referring now to FIGS. 45-48, placement of the spinal
implant delivery devices having tip portions 710, 710', 710" and
710'", respectively, in an intervertebral disc cavity 20, is shown.
As can be seen in the figures, the distal ends of the tip portions
preferably extend slightly, e.g., about 1 mm to about 10 mm, past
the inner face, or wall, I of annulus fibrosis 19. FIG. 49 is a
view along line 49-49 of FIG. 45 showing placement of tip portion
710.
[0133] The preferred delivery instrument, or device, and methods
described herein are compatible with Medtronic Sofamor Danek's
MetRX.TM. microdiscectomy system and surgical procedures.
[0134] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiment has been shown
and described and that all changes and modifications that come
within the spirit of the invention are desired to be protected. In
addition, all references cited herein are indicative of the level
of skill in the art and are hereby incorporated by reference in
their entirety.
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