U.S. patent application number 10/085040 was filed with the patent office on 2002-08-15 for intervertebral disc annulus stent.
Invention is credited to Cauthen, Joseph C..
Application Number | 20020111688 10/085040 |
Document ID | / |
Family ID | 56290186 |
Filed Date | 2002-08-15 |
United States Patent
Application |
20020111688 |
Kind Code |
A1 |
Cauthen, Joseph C. |
August 15, 2002 |
Intervertebral disc annulus stent
Abstract
A surgical method of repair and reconstruction of the spinal
disc wall (annulus) after surgical invasion or pathologic rupture,
incorporating suture closure, or stent insertion and fixation,
designed to reduce the failure rate of conventional surgical
procedures on the spinal discs. The design of the spinal disc
annulus stent allows ingrowth of normal cells of healing in an
enhanced fashion strengthening the normal reparative process.
Inventors: |
Cauthen, Joseph C.;
(Gainesville, FL) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT &
DUNNER LLP
1300 I STREET, NW
WASHINGTON
DC
20005
US
|
Family ID: |
56290186 |
Appl. No.: |
10/085040 |
Filed: |
March 1, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10085040 |
Mar 1, 2002 |
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09947078 |
Sep 5, 2001 |
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09947078 |
Sep 5, 2001 |
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09484706 |
Jan 18, 2000 |
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60160710 |
Oct 20, 1999 |
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Current U.S.
Class: |
623/17.16 ;
623/17.11 |
Current CPC
Class: |
A61F 2002/2817 20130101;
A61B 2017/06176 20130101; A61F 2002/30092 20130101; A61F 2002/30784
20130101; A61F 2/441 20130101; A61B 2017/00004 20130101; A61F
2002/30299 20130101; A61F 2002/444 20130101; A61F 2/0063 20130101;
A61F 2210/0004 20130101; A61B 2017/0647 20130101; A61F 2230/0093
20130101; A61F 2/4611 20130101; A61B 2017/0648 20130101; A61B
17/06166 20130101; A61B 17/04 20130101; A61B 2017/0641 20130101;
A61F 2002/30777 20130101; A61F 2/30907 20130101; A61F 2002/4435
20130101; A61F 2002/30841 20130101; A61F 2310/00011 20130101; Y10S
606/907 20130101; A61F 2002/30579 20130101; A61F 2/4601 20130101;
A61F 2002/30062 20130101; A61B 17/86 20130101; A61F 2210/0019
20130101; A61F 2230/0026 20130101; A61F 2/442 20130101; A61B
17/0642 20130101; Y10S 623/902 20130101; A61F 2002/30158 20130101;
A61F 2002/4627 20130101 |
Class at
Publication: |
623/17.16 ;
623/17.11 |
International
Class: |
A61F 002/44 |
Claims
1. An annulus stent, for repair of an intervertebral disc annulus,
comprising an elongated centralized vertical extension, said
centralized vertical extension comprising a left and a right
lateral extension along said centralized vertical extension's
horizontal axis.
2. The annulus stent according to claim 1, wherein said vertical
extension further comprises a slot.
3. The annulus stent according to claim 1, wherein said vertical
extension is perforated.
4. The annulus stent according to claim 1, wherein said left and
right lateral extensions comprise an inside edge, an outside edge,
an upper surface and a lower surface, wherein said inside edge
joins said centralized vertical extension to form a horizontal
plane.
5. The annulus stent according to claim 4, wherein said upper
surface forms an angle of about 0 to 60 degrees below said
horizontal plane.
6. The annulus stent according to claim 4, wherein the length of
said inside edge is less than the length of said outside edge.
7. The annulus stent according to claim 4, wherein said inside edge
has a greater thickness than said outside edge.
8. The annulus stent according to claim 4, wherein said upper
surface is barbed.
9. The annulus stent according to claim 4, further comprising a
recess wherein said upper surface joins said centralized vertical
extension.
10. The annulus stent according to claim 4, wherein said lateral
extension further comprises a compressible core affixed to said
lower surface.
11. The annulus stent according to claim 10, wherein said
compressible core is made of a compressible biocompatible
material.
12. The annulus stent according to claim 10, wherein said
compressible core is made of a compressible bioreabsorbable
material.
13. The annulus stent according to claim 4, further comprising a
flexible bladder affixed to said lower surface of said left and
right lateral extensions.
14. The annulus stent according to claim 13, wherein said flexible
bladder comprises a membrane enclosing an internal cavity.
15. The annulus stent according to claim 14, wherein said internal
cavity is empty.
16. The annulus stent according to claim 14, wherein said membrane
comprises a thin flexible biocompatible material.
17. The annulus stent according to claim 16, wherein said membrane
further comprises a semi-permeable material.
18. The annulus stent according to claim 17, wherein said internal
cavity contains a biocompatible fluid.
19. The annulus stent according to claim 18, wherein said
biocompatible fluid is a hydrogel.
20. The annulus stent according to claim 16, wherein said membrane
further comprises an impermeable material.
21. The annulus stent according to claim 20, wherein said internal
cavity contains a biocompatible fluid.
22. The annulus stent according to claim 1, wherein said
centralized vertical extension is of a shape selected from the
group consisting of a trapezoid, circular and curved.
23. The annulus stent according to claim 1, wherein said annulus
stent is made from a material selected from the group consisting of
a biocompatible material, a bioactive material, and a
bioreabsorbable material.
24. The annulus stent according to claim 23, wherein said annulus
stent is made from a biocompatible fiber mesh.
25. The annulus stent according to claim 23, wherein said annulus
stent is made from a bioreabsorbable fiber mesh.
26. The annulus stent according to claim 23, wherein said annulus
stent is made from expandable polytetra fluoroethylyene.
27. The annulus stent according to claim 1, wherein said annulus
stent comprises a material to facilitate regeneration of disc
tissue.
28. The annulus stent according to claim 1, wherein said annulus
stent comprises a hygroscopic material.
29. An annulus patch, wherein said annulus patch is of the size and
shape for repair of a intervertebral disc annulus.
30. The annulus patch according to claim 29, wherein said annulus
patch is human muscle fascia, an autograft, an allograft or a
xenograft.
31. A method for repairing an intervertebral disc, wherein said
intervertebral disc comprises a disc nucleus and a disc annulus,
comprising the steps of; a) forming an aperture in said
intervertebral disc annulus; and b) securing across said aperture
to said intervertebral disc annulus an annulus patch.
32. The method for repairing an intervertebral disc according to
claim 31, wherein said annulus patch is human muscle fascia, an
autograft, an allograft, or a xenograft.
33. The method for repairing an intervertebral disc according to
claim 31, further comprising the step of preparing said
intervertebral disc, wherein said preparation step comprises the
steps; a) identifying a damaged section of said disc nucleus; and
b) removing said damaged section of said disc nucleus.
34. A method for repairing an intervertebral disc, wherein said
intervertebral disc comprises a disc nucleus and a disc annulus,
comprising the steps of; a) forming an aperture in said
intervertebral disc annulus; b) inserting an annulus stent into
said aperture, wherein said annulus stent comprises an elongated
centralized vertical extension, a left and a right lateral
extension along said centralized vertical extension's horizontal
axis; and c) securing said annulus stent to said intervertebral
disc annulus.
35. The method for repairing an intervertebral disc according to
claim 34, wherein said step of forming said aperture in said disc
annulus comprises the step of making a surgical incision into said
disc annulus.
36. The method for repairing an intervertebral disc according to
claim 34, wherein said step of inserting said annulus stent into
said aperture comprises the steps of; a) compressing said left and
right lateral extensions together; b) inserting said annulus stent
into said aperture, such that an upper surface of said left and
right lateral extensions conforms to an inside surface of said disc
annulus; and c) positioning said centralized vertical extension
within said aperture, such that said annulus stent may be secured
to said disc annulus.
37. The method for repairing an intervertebral disc according to
claim 34, wherein said step of inserting said annulus stent into
said aperture comprises the steps of; a) compressing said left and
right lateral extension together; b) rotating said annulus stent,
such that said annulus stent may be laterally inserted into said
intervertebral disc; c) inserting said annulus stent laterally
through said aperture into said intervertebral disc; d) rotating
said annulus stent within said intervertebral disc, such that an
upper surface of said left and right lateral extensions conforms to
an inside surface of said disc annulus; and e) positioning said
centralized vertical extension within said aperture, such that said
annulus stent may be secured to said disc annulus.
38. The method for repairing an intervertebral disc according to
claim 34, further comprising a step of preparing said
intervertebral disc, wherein said preparation step comprises the
steps of inserting a set surgical screws into a pair of adjacent
intervertebral, wherein said surgical screws comprise an eye hole
located at the top of said surgical screw.
39. The method for repairing an intervertebral disc according to
claim 38, wherein said step of securing said annulus stent to said
intervertebral disc comprises the steps of threading a surgical
suture through said eye hole on said surgical screw.
40. The method for repairing an intervertebral disc according to
claim 34, further comprising the step of preparing said
intervertebral disc, wherein said preparation step comprises the
steps; a) identifying a damaged section of said disc nucleus; and
b) removing said damaged section of said disc nucleus.
41. The method for repairing an intervertebral disc according to
claim 40, wherein said step of inserting said annulus stent into
said aperture comprises the steps of; a) compressing said left and
right lateral extensions together; b) inserting said annulus stent
into said aperture, such that an upper surface of said left and
right lateral extensions conforms to an inside surface of said disc
annulus; c) positioning said centralized vertical extension within
said aperture, such that said annulus stent may be secured to disc
annulus; and d) injecting a biocompatible fluid into said internal
cavity, through said annulus stent.
42. The method for repairing an intervertebral disc according to
claim 41, wherein said biocompatible fluid comprises a hygroscopic
material.
43. The method for repairing an intervertebral disc according to
claim 40, wherein said step inserting said annulus stent into said
aperture comprises the steps of; a) compressing said left and right
lateral extensions together; b) rotating said annulus stent, such
that said annulus stent may be laterally inserted into said
intervertebral disc; c) inserting said annulus stent laterally
through said aperture into said intervertebral disc; d) rotating
said annulus stent within said intervertebral disc, such that an
upper surface of said left and right lateral extensions conforms to
an inside surface of said disc annulus; e) positioning said
centralized vertical extension within said aperture, such that said
annulus stent may be secured to disc annulus; and f) inject a
biocompatible fluid into said internal cavity, through said annulus
stent.
44. The method for repairing an intervertebral disc according to
claim 43, wherein said biocompatible fluid comprises a hygroscopic
material.
Description
CROSS-REFERENCE TO A RELATED APPLICATION
[0001] This application is a continuation of U.S. Ser. No.
09/484,706, filed Jan. 18, 2000 which claims the benefit of U.S.
Provisional Application No. 60/160,710, filed Oct. 20, 1999.
FIELD OF THE INVENTION
[0002] The invention generally relates to a surgical method of
intervertebral disc wall reconstruction with a related annulus
stent augmenting the repair. The effects of said reconstruction are
restoration of disc wall integrity and reduction of the failure
rate (3-21%) of a common surgical procedure (disc fragment removal
or discectomy). This surgical procedure is performed about 390,000
times annually in the United States.
BACKGROUND OF THE INVENTION
[0003] The spinal column is formed from a number of vertebrae,
which in their normal state are separated from each other by
cartilaginous intervertebral discs. The intervertebral disc acts in
the spine as a crucial stabilizer, and as a mechanism for force
distribution between the vertebral bodies. Without the disc,
collapse of the intervertebral space occurs in conjunction with
abnormal joint mechanics and premature development of arthritic
changes.
[0004] The normal intervertebral disc has an outer ligamentous ring
called the annulus surrounding the nucleus pulposus. The annulus
binds the adjacent vertebrae together and is constituted of
collagen fibers that are attached to the vertebrae and cross each
other so that half of the individual fibers will tighten as the
vertebrae are rotated in either direction, thus resisting twisting
or torsional motion. The nucleus pulposus is constituted of loose
tissue, having about 85% water content, which moves about during
bending from front to back and from side to side.
[0005] As people age, the annulus tends to thicken, desicate, and
become more rigid. The nucleus pulposus, in turn, becomes more
viscous and less fluid and sometimes even dehydrates and contracts.
The annulus also becomes susceptible to fracturing or fissuring.
These fractures tend to occur all around the circumference of the
annulus and can extend from both the outside of the annulus
inwards, and the interior outward. Occasionally, a fissure from the
outside of the annulus meets a fissure from the inside and results
in a complete rent or tear through the annulus fibrosis. In
situations like these, the nucleus pulposus may extrude out through
the annulus wall. The extruded material, in turn, can impinge on
the spinal cord or on the spinal nerve rootlet as it exits through
the intervertebral disc foramen, resulting in a condition termed
ruptured disc or herniated disc
[0006] In the event of annulus rupture, the inner-nucleus component
migrates along the path of least resistance forcing the fissure to
open further, allowing migration of the nucleus pulposus through
the wall of the disc, with resultant nerve compression and leakage
of chemicals of inflammation into the space around the adjacent
nerve roots supplying the extremities, bladder, bowel and
genitalia. The usual effect of nerve compression and inflammation
is intolerable back or neck pain, radiating into the extremities,
with accompanying numbness, weakness, and in late stages, paralysis
and muscle atrophy, and/or bladder and bowel incontinence.
Additionally, injury, disease or other degenerative disorders may
cause one or more of the intervertebral discs to shrink, collapse,
deteriorate or become displaced, herniated, or otherwise
damaged.
[0007] The surgical standard of care for treatment of herniated,
displaced or ruptured intervertebral discs is fragment removal and
nerve decompression without a requirement to reconstruct the
annular wall. While results are currently acceptable, they are not
optimal. Various authors report 3.1-21% recurrent disc herniation,
representing a failure of the primary procedure and requiring
re-operation for the same condition. An estimated 10% recurrence
rate results in 39,000 re-operations in the United States each
year.
[0008] An additional method of relieving the symptoms is thermal
annuloplasty, involving the heating of sub-annular zones in the
non-herniated painful disc, seeking pain relief, but making no
claim of reconstruction of the ruptured, discontinuous annulus
wall.
[0009] There is currently no known method of annulus
reconstruction, either primarily or augmented with an annulus
stent.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention provides methods and related materials
for reconstruction of the disk wall in cases of displaced,
herniated, ruptured, or otherwise damaged intervertebral discs.
[0011] In a preferred form, one or more mild biodegradable surgical
sutures are placed at about equal distances along the sides of a
pathologic aperture in the ruptured disc wall (annulus) or along
the sides of a surgical incision in the weakened, thinned disc
annulus.
[0012] Sutures are then tied in such fashion as to draw together
the sides of the aperture, effecting reapproximation or closure of
the opening, to enhance natural healing and subsequent
reconstruction by natural tissue (fibroblasts) crossing the now
surgically narrowed gap in the disc annulus.
[0013] A 25-30% reduction in the rate of recurrence of disc nucleus
herniation through this aperture, has been achieved using this
method.
[0014] In another embodiment, the method can be augmented by
placement of a patch of human muscle fascia (the membrane covering
the muscle) or any other autograft or allograft acting as a bridge
in and across the aperture, providing a platform for traverse of
fibroblasts or other normal cells of repair existing in and around
the various layers of the disc annulus, prior to closure of the
aperture.
[0015] A 30-50% reduction in the rate of recurrence of disc
herniation has been achieved using the aforementioned fascial
augmentation with this embodiment.
[0016] Having demonstrated that human muscle fascia is adaptable
for annular reconstruction, other biocompatible membranes can be
employed as a bridge, stent, patch or barrier to subsequent
migration of the disc nucleus through the aperture. Such
biocompatible materials may be, for example, a medical grade
biocompatible fabric, biodegradable polymeric sheets, or form
fitting or non-form fitting fillers for the cavity created by
removal of a portion of the disc nucleus in the course of the disc
fragment removal or discectomy. The prosthetic material can be
placed in and around the intervertebral space, created by removal
of the degenerated disc fragments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 shows a perspective view of the annulus stent.
[0018] FIG. 2 shows a front view of the annulus stent.
[0019] FIG. 3 shows a side view of the annulus stent.
[0020] FIGS. 4A-4C show a front view of various alternative
embodiments of the annulus stent.
[0021] FIGS. 5A-5B shows the alternative embodiment of a pyramid
shaped annulus stent.
[0022] FIGS. 6A-6B shows the alternative embodiment of a coned
shaped annulus stent.
[0023] FIG. 7 shows the primary closure of the opening in the disc
annulus, without an intervertebral or subannular stent.
[0024] FIGS. 8A-8B shows the primary closure with a stent in
generic form.
[0025] FIG. 9 shows a method of suturing the annulus stent into the
disc annulus, utilizing sub-annular fixation points.
[0026] FIGS. 10A-10B show the annulus stent with flexible bladder
being expanded into the disc annulus.
[0027] FIGS. 11A-11D show the annulus stent being inserted into the
disc annulus.
[0028] FIGS. 12A-12B show the annulus stent with the flexible
bladder being expanded by injection.
DETAILED DESCRIPTION OF THE INVENTION
[0029] The present invention provides methods and related materials
for reconstruction of the disk wall in cases of displaced,
herniated, ruptured, or otherwise damaged intervertebral discs.
[0030] In one embodiment of the present invention, as shown in FIG.
7, a damaged annulus 42 is repaired by use of surgical sutures 40.
One or more surgical sutures 40 are placed at about equal distances
along the sides of a pathologic aperture 44 in the ruptured annulus
42. Reapproximation or closure of the aperture 44 is accomplished
by tying the sutures 40 in such a fashion that the sides of the
aperture 44 are drawn together. The reapproximation or closure of
the aperture 44 enhances the natural healing and subsequent
reconstruction by the natural tissue crossing the now surgically
narrowed gap in the annulus 42. Preferably, the surgical sutures 40
are biodegradable, but permanent non-biodegradable may be
utilized.
[0031] Additionally, to repair a weakened or thinned disc annulus
42, a surgical incision is made along the weakened or thinned
region of the annulus 42 and one or more surgical sutures 40 are
placed at about equal distances along the sides of the incision.
Reapproximation or closure of the incision is accomplished by tying
the sutures 40 in such a fashion that the sides of the incision are
drawn together. The reapproximation or closure of the incision
enhances the natural healing and subsequent reconstruction by the
natural tissue crossing the now surgically narrowed gap in the
annulus 42. Preferably, the surgical sutures 40 are biodegradable,
but permanent non-biodegradable materials may be utilized.
[0032] In an alternative embodiment, the method can be augmented by
the placement of a patch of human muscle fascia or any other
autograft, allograft or xenograft in and across the aperture 44.
The patch acts as a bridge in and across the aperture, providing a
platform for traverse of fibroblasts or other normal cells of
repair existing in and around the various layers of the disc
annulus, prior to closure of the aperture.
[0033] In a further embodiment, as shown in FIG. 8, a biocompatible
membrane can be employed as an annulus stent 10, being placed in
and across the aperture 44. The annulus stent 10 acts as a bridge
in and across the aperture 44, providing a platform for a traverse
of fibroblasts or other normal cells of repair existing in and
around the various layers of the disc annulus, prior to closure of
the aperture 44.
[0034] In a preferred embodiment, as shown in FIGS. 1-3, the
annulus stent 10 comprises a centralized vertical extension 12,
with an upper section 14 and a lower section 16. The centralized
vertical extension 12 can be trapezoid in shape through the width
and may be from about 8 mm-12 mm in length.
[0035] Additionally, the upper section 14 of the centralized
vertical extension 12 may be any number of different shapes, as
shown in FIGS. 4A and 4B, with the sides of the upper section 14
being curved or with the upper section 14 being circular in shape.
Furthermore, the annulus stent 10 may contain a recess between the
upper section 14 and the lower section 16, enabling the annulus
stent 10 to form a compatible fit with the edges of the aperture
44.
[0036] The upper section 14 of the centralized vertical extension
12 can comprise a slot 18, where the slot 18 forms an orifice
through the upper section 14. The slot 18 is positioned within the
upper section such that 14 it traverses the upper section's 14
longitudinal axis. The slot 18 is of such a size and shape that
sutures, tension bands, staples or any other type of fixation
device known in the art may be passed through, to affix the annulus
stent 10 to the disc annulus 44.
[0037] In an alternative embodiment, the upper section 14 of the
centralized vertical extension 12 may be perforated. The perforated
upper section 14 contains a plurality of holes which traverse the
upper section's 14 longitudinal axis. The perforations are of such
a size and shape that sutures, tension bands, staples or any other
type of fixation device known in the art may be passed through, to
affix the annulus stent 10 to the disc annulus 44.
[0038] The lower section 16 can comprise a pair of lateral
extensions, a left lateral extension 20 and a right lateral
extension 22. The lateral extensions 20 and 22 comprise an inside
edge 24, an outside edge 26, an upper surface 28, and a lower
surface 30. The lateral extensions 20 and 22 can have an
essentially constant thickness throughout. The inside edge 24 is
attached to the lower section 16 and is about the same length as
the lower section 16. The outside edge 26 can be about 8 mm-16 mm
in length. The inside edge 24 and the lower section 16 meet to form
a horizontal plane, essentially perpendicular to the centralized
vertical extension 12. The upper surface 28 of the lateral
extensions 20 and 22 can form an angle of about
0.degree.-60.degree. below the horizontal plane. The width of the
annulus stent 10 may be from about 3 mm-5 mm.
[0039] Additionally, the upper surface 28 of the lateral extensions
20 and 22 may be barbed for fixation to the inside surface of the
disc annulus 40 and to resist expulsion through the aperture
44.
[0040] In an alternative embodiment, as shown in FIG. 4B, the
lateral extensions 20 and 22 have a greater thickness at the inside
edge 24 than at the outside edge 26.
[0041] In a preferred embodiment, the annulus stent 10 is a solid
unit, formed from one or more of the flexible resilient
biocompatible or bioresorbable materials well know in the art.
[0042] For example, the annulus stent may be made from:
[0043] a porous matrix or mesh of biocompatible and bioresorbable
fibers acting as a scaffold to regenerate disc tissue and replace
annulus fibrosus as disclosed in, for example, U.S. Pat. Nos.
5,108,438 (Stone) and 5,258,043 (Stone);
[0044] a strong network of inert fibers intermingled with a
bioresorbable (or biosabsorable) material which attracts tissue
ingrowth as disclosed in, for example, U.S. Pat. No. 4,904,260 (Ray
et al.);
[0045] a biodegradable substrate as disclosed in, for example, U.S.
Pat. No. 5,964,807 (Gan at al.); or
[0046] a expandable polytetrafluoroethylene (ePTFE), as used for
conventional vascular grafts, such as those sold by W. L. Gore and
Associates, Inc. under the trademarks GORE-TEX and PRECLUDE, or by
Impra, Inc. under the trademark IMPRA.
[0047] Furthermore, the annulus stent 10, may contain hygroscopic
material for a controlled limited expansion of the annulus stent 10
to fill the evacuated disc space cavity.
[0048] Additionally, the annulus stent 10 may comprise materials to
facilitate regeneration of disc tissue, such as bioactive
silica-based materials which assist in regeneration of disc tissue
as disclosed in U.S. Pat. No. 5,849,331 (Ducheyne, et al.), or
other tissue growth factors well known in the art.
[0049] In further embodiments, as shown in FIGS. 5-6, the left and
right lateral extensions 20 and 22 join to form a solid pyramid or
cone. Additionally, the left and right lateral extensions 20 and 22
may form a solid trapezoid, wedge, or bullet shape. The solid
formation may be a solid biocompatible or bioresorbable flexible
material, allowing the lateral extensions 20 and 22 to be
compressed for insertion into aperture 44, then to expand
conforming to the shape of the annulus' 42 inner wall.
[0050] Alternatively, a compressible core may be attached to the
lower surface 30 of the lateral extensions 20 and 22, forming a
pyramid, cone, trapezoid, wedge, or bullet shape. The compressible
core may be made from one of the biocompatible or bioresorbable
resilient foams well known in the art. The compressible core allows
the lateral extensions 20 and 22 to be compressed for insertion
into aperture 44, then to expand conforming to the shape of the
annulus' 42 inner wall and to the cavity created by pathologic
extrusion or surgical removal of the disc fragment.
[0051] In a preferred method of use, as shown in FIGS. 10A-10D, the
lateral extensions 20 and 22 are compressed together for insertion
into the aperture 44 of the disc annulus 40. The annulus stent 10
is then inserted into the aperture 44, where the lateral extensions
20 and 22 expand, with the upper surface 28 contouring to the
inside surface of the disc annulus 40. The upper section 14 is
positioned within the aperture 44 so that the annulus stent 10 may
be secured to the disc annulus 40, using means well known in the
art.
[0052] In an alternative method, where the length of the aperture
44 is less than the length of the outside edge 26 of the annulus
stent 10, the annulus stent 10 must be inserted laterally into the
aperture 44. The lateral extensions 20 and 22 are compressed, and
the annulus stent 10 is laterally inserted into the aperture 44.
The annulus stent 10 is then rotated inside the disc annulus 40,
such that the upper section 14 is pulled back through the aperture
44. The lateral extensions 20 and 22 are then allowed to expand,
with the upper surface 28 contouring to the inside surface of the
disc annulus 40. The upper section 14 is positioned within the
aperture 44 such that the annulus stent 10 may be secured to the
disc annulus, using means well known in the art.
[0053] In an alternative method of securing the annulus stent 10 in
the aperture 44, as shown in FIG. 9, a first surgical screw 50 and
second surgical screw 52, with eye holes 53 located at the top of
the screws 50 and 52, are opposingly inserted into the adjacent
vertebrae 54 and 56 below the annulus stent 10. After insertion of
the annulus stent 10 into the aperture 44, a suture is passed down
though the disc annulus 40, adjacent to the aperture 44, through
the eye hole 53 on the first screw 50 then back up through the disc
annulus 40 and through the orifice 18 on the annulus stent 10. This
is repeated for the second screw 52, after which the suture is
secured. One or more surgical sutures 40 are placed at about equal
distances along the sides of the aperture 44 in the disc annulus
42. Reapproximation or closure of the aperture 44 is accomplished
by tying the sutures 40 in such a fashion that the sides of the
aperture 44 are drawn together. The reapproximation or closure of
the aperture 44 enhances the natural healing and subsequent
reconstruction by the natural tissue crossing the now surgically
narrowed gap in the annulus 42. Preferably, the surgical sutures 40
are biodegradable but permanent nonbiodegradable forms may be
utilized. This method should decrease the strain on the disc
annulus 40 adjacent to the aperture 44, precluding the tearing of
the sutures through the disc annulus 40.
[0054] It is anticipated that fibroblasts will engage the fibers of
the polymer or fabric of the intervertebral disc stent, forming a
strong wall duplicating the currently existing condition of healing
seen in the normal reparative process.
[0055] In an additional embodiment, as shown in FIGS. 10A-B, a
flexible bladder 60 is attached to the lower surface 30 of the
annulus stent 10. The flexible bladder 60 comprises an internal
cavity 62 surrounded by a membrane 64, where the membrane 64 is
made from a thin flexible biocompatible material. The flexible
bladder 60 is attached to the lower surface 28 of the annulus stent
10 in an unexpanded condition. The flexible bladder 60 is expanded
by injecting a biocompatible fluid or expansive foam, as known in
the art, into the internal cavity 62. The exact size of the
flexible bladder 60 can be varied for different individuals. The
typical size of an adult nucleus is 2 cm in the semi-minor axis, 4
cm in the semi-major axis and 1.2 cm in thickness.
[0056] In an alternative embodiment, the membrane 64 is made of a
semi-permeable biocompatible material.
[0057] In a preferred embodiment, a hydrogel is injected into the
internal cavity of the flexible bladder 28. A hydrogel is a
substance formed when an organic polymer (natural or synthetic) is
cross-linked via covalent, ionic, or hydrogen bonds to create a
three-dimensional open-lattice structure which entraps water
molecules to form a gel. The hydrogel may be used in either the
hydrated or dehydrated form.
[0058] In a method of use, where the annulus stent 10 has been
inserted into the aperture, as has been previously described and
shown in FIGS. 12 A-b, an injection instrument, as known in the
art, such as a syringe, is used to inject the biocompatible fluid
or expansive foam into the internal cavity 62 of the flexible
bladder 60. The biocompatible fluid or expansive foam is injected
through the annulus stent 10 into the internal cavity of the
flexible bladder 28. Sufficient material is injected into the
internal cavity 62 to expand the flexible bladder 60 to fill the
void in the intervertebral disc cavity. The use of the flexible
bladder 60 is particularly useful when it is required to remove all
or part of the intervertebral disc nucleus.
[0059] The surgical repair of an intervertebral disc may require
the removal of the entire disc nucleus, being replaced with an
implant, or the removal of a portion of the disc nucleus thereby
leaving a void in the intervertebral disc cavity. The flexible
bladder 60 allows for the removal of only the damaged section of
the disc nucleus, with the expanded flexible bladder 60 filling the
resultant void in the intervertebral disc cavity. A major advantage
of the annulus stent 10 with the flexible bladder 60 is that the
incision area in the annulus can be reduced in size as there is no
need for the insertion of an implant into the intervertebral disc
cavity.
[0060] In an alternative method of use, a dehydrated hydrogel is
injected into the internal cavity 28 of the flexible bladder 60.
Fluid, from the disc nucleus, passes through the semi-permeable
membrane 64 hydrating the dehydrated hydrogel. As the hydrogel
absorbs the fluid the flexible bladder expands 60, filling the void
in the intervertebral disc cavity.
[0061] All patents referred to or cited herein are incorporated by
reference in their entirety to the extent they are not inconsistent
with the explicit teachings of this specification, including; U.S.
Pat. No. 5,108,438 (Stone), U.S. Pat. No. 5,258,043 (Stone), U.S.
Pat. No. 4,904,260 (Ray et al.), U.S. Pat. No. 5,964,807 (Gan et
al.), U.S. Pat. No. 5,849,331 (Ducheyne et al.), U.S. Pat. No.
5,122,154 (Rhodes), U.S. Pat. No. 5,204,106 (Schepers at al.), U.S.
Pat. No. 5,888,220 (Felt et al.) and U.S. Pat. No. 5,376,120
(Sarver et al.):
[0062] It should be understood that the examples and embodiments
described herein are for illustrative purposes only and that
various modifications or changes in light thereof will be suggested
to persons skilled in the art and are to be included within the
spirit and preview of this application and the scope of the
appended claims.
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