U.S. patent application number 11/412272 was filed with the patent office on 2007-11-01 for devices, apparatus, and methods for bilateral approach to disc augmentation.
This patent application is currently assigned to SDGI Holdings, Inc.. Invention is credited to Hai H. Trieu.
Application Number | 20070255406 11/412272 |
Document ID | / |
Family ID | 38649263 |
Filed Date | 2007-11-01 |
United States Patent
Application |
20070255406 |
Kind Code |
A1 |
Trieu; Hai H. |
November 1, 2007 |
Devices, apparatus, and methods for bilateral approach to disc
augmentation
Abstract
A method of augmenting a nucleus pulposus of an intervertebral
disc comprises forming a first opening in an annulus of the
intervertebral disc and forming a second opening in the annulus of
the intervertebral disc. The method further comprises providing a
space creation instrument including an expandable spacing device
and introducing the spacing device through the first opening and
into the nucleus pulposus. The method further comprises introducing
a material delivery instrument through the second opening and into
the nucleus pulposus and expanding the spacing device to create a
space within the nucleus pulposus. The method also comprises
injecting a biocompatible material from the material delivery
instrument and into the space within the nucleus pulposus.
Inventors: |
Trieu; Hai H.; (Cordova,
TN) |
Correspondence
Address: |
HAYNES AND BOONE, LLP
901 MAIN ST
SUITE 3100
DALLAS
TX
75202
US
|
Assignee: |
SDGI Holdings, Inc.
Wilmington
DE
|
Family ID: |
38649263 |
Appl. No.: |
11/412272 |
Filed: |
April 27, 2006 |
Current U.S.
Class: |
623/17.11 ;
606/90 |
Current CPC
Class: |
A61F 2002/444 20130101;
A61F 2210/0004 20130101; A61F 2/4611 20130101; A61F 2002/30583
20130101; A61F 2002/4627 20130101; A61F 2002/30156 20130101; A61F
2002/467 20130101; A61F 2/442 20130101; A61F 2002/4435 20130101;
A61B 2017/0256 20130101; A61F 2002/30179 20130101; A61F 2002/30299
20130101; A61F 2230/0028 20130101; A61B 17/7097 20130101; A61F
2230/0023 20130101; A61F 2002/448 20130101; A61F 2/441 20130101;
A61F 2230/0093 20130101; A61F 2002/30146 20130101; A61F 2002/4495
20130101; A61F 2210/0085 20130101; A61F 2230/0017 20130101; A61F
2310/00365 20130101; A61F 2002/30677 20130101; A61F 2002/30062
20130101 |
Class at
Publication: |
623/017.11 ;
606/090 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A method of augmenting a nucleus pulposus of an intervertebral
disc, the method comprising: forming a first opening in an annulus
of the intervertebral disc; forming a second opening in the annulus
of the intervertebral disc; providing a space creation instrument
including an expandable spacing device; introducing the spacing
device through the first opening and into the nucleus pulposus;
introducing a material delivery instrument through the second
opening and into the nucleus pulposus; expanding the spacing device
to create a space within the nucleus pulposus; and injecting a
biocompatible material from the material delivery instrument and
into the space within the nucleus pulposus.
2. The method of claim 1 wherein none of the nucleus pulposus is
removed prior to expanding the spacing device.
3. The method of claim 1 further comprising expanding the spacing
device to dilate the annulus.
4. The method of claim 1 wherein the spacing device comprises an
inflatable balloon.
5. The method of claim 4 wherein the balloon comprises multiple
chambers.
6. The method of claim 1 wherein the spacing device is mechanically
actuated.
7. The method of claim 1 wherein the step of introducing the
spacing device further comprises introducing a guide member
adjacent to the spacing device.
8. The method of claim 1 wherein the step of introducing a material
delivery instrument further comprises guiding the introduction of
the material delivery instrument with an imaging system to direct
the material delivery instrument to the spacing device.
9. The method of claim 8 wherein the imaging system is
fluoroscopic.
10. The method of claim 1 wherein the step of expanding the spacing
device to create a space within the nucleus pulposus comprises
pressurizing an inflation medium.
11. The method of claim 1 wherein the step of expanding the space
creation device to create a space within the nucleus pulposus
comprises compressing the nucleus pulposus.
12. The method of claim 1 wherein the first and second openings are
bilateral posterior openings.
13. The method of claim 1 wherein the step of injecting a
biocompatible material from the material delivery instrument
further comprises monitoring the injection of the biocompatible
material with an imaging system to avoid overfilling the space.
14. The method of claim 1 wherein the step of expanding the spacing
device further comprises distracting a pair of vertebral endplates
adjacent to the intervertebral disc.
15. The method of claim 1 further comprising detaching the spacing
device from the space creation instrument within the space in the
nucleus pulposus.
16. The method of claim 15 wherein the step of injecting a
biocompatible material from the material delivery instrument
includes filling the spacing device within the space in the nucleus
pulposus.
17. The method of claim 1 further comprising collapsing the spacing
device as the biomaterial is injected into the space within the
nucleus pulposus.
18. The method of claim 1 further comprising withdrawing the
spacing device from the nucleus pulposus.
19. A system for augmenting a nucleus pulposus of an intervertebral
disc, the system comprising: a first cannula adapted for accessing
a nucleus pulposus of the intervertebral disc; a second cannula
adapted for accessing the nucleus pulposus of the intervertebral
disc; a space creation instrument adapted for passage through the
first cannula and including a spacing portion adapted to create a
space in the nucleus pulposus of the intervertebral disc; and a
material delivery instrument adapted for passage through the second
cannula and to carry a biocompatible material, wherein the space
created in the nucleus pulposus of the intervertebral disc with the
spacing portion receives the biocompatible material delivered by
the material delivery instrument through the second cannula.
20. The system of claim 19 wherein at least one of the cannulae is
directed through an annulus of the intervertebral disc to the
nucleus pulposus.
21. The system of claim 19 wherein at least one of the cannulae is
directed through an endplate of a vertebral body adjacent to the
intervertebral disc.
22. The system of claim 19 wherein none of the nucleus pulposus is
removed through the first or second cannulae.
23. The system of claim 19 further comprising an accessing
instrument adapted to pass through the first cannula to puncture an
annulus of the intervertebral disc.
24. The system of claim 19 further comprising a gauge for
monitoring pressure in the spacing portion.
25. A method for treating a nucleus pulposus of an intervertebral
disc, the method comprising: creating a first opening to access the
intervertebral disc; creating a second opening to access the
intervertebral disc; inserting a first space creation instrument
having a first spacing device through the first opening and into
the nucleus pulposus of the intervertebral disc; inserting a second
space creation instrument having a second spacing device through
the second opening to access the intervertebral disc; injecting a
first biomaterial into the first spacing device to expand the first
spacing device; and injecting a second biomaterial into the second
spacing device to expand the second spacing device, wherein the
expansion of the first and second spacing devices occur without
removing a portion of the nucleus pulposus.
26. The method of claim 25 wherein the first opening is in an
annulus of the intervertebral disc.
27. The method of claim 25 further comprising detaching the first
spacing device from the first space creation instrument.
28. The method of claim 25 wherein the first biomaterial is the
same as the second biomaterial.
29. The method of claim 25 wherein the first spacing device
conforms to an annulus of the intervertebral disc.
30. The method of claim 29 further comprising inserting a third
spacing device into the nucleus pulposus of the intervertebral disc
and expanding the third spacing device with a third biomaterial
31. The method of claim 30 wherein the third spacing device is
inserted through the first spacing device.
32. The method of claim 25 wherein at least one of the first or
second biomaterials is curable in situ.
33. The method of claim 25 further comprising inserting a material
delivery instrument through the first spacing device and injecting
a third biomaterial into the nucleus pulposus.
Description
BACKGROUND
[0001] Within the spine, the intervertebral disc functions to
stabilize and distribute forces between vertebral bodies. The
intervertebral disc comprises a nucleus pulposus which is
surrounded and confined by the annulus fibrosis. Intervertebral
discs are prone to injury and degeneration. For example, herniated
discs typically occur when normal wear, or exceptional strain,
causes a disc to rupture. Degenerative disc disease typically
results from the normal aging process, in which the tissue
gradually loses its natural water and elasticity, causing the
degenerated disc to shrink and possibly rupture.
[0002] Intervertebral disc injuries and degeneration are frequently
treated by replacing or augmenting the existing disc material.
Current methods and instrumentation used for treating the disc
require a relatively large hole to be cut in the disc annulus to
allow introduction of the implant. After the implantation, the
large hole in the annulus must be plugged, sewn closed, or other
wise blocked to avoid allowing the implant to be expelled from the
disc. Besides weakening the annular tissue, creation of the large
opening and the subsequent repair adds surgical time and cost. A
need exists for devices, instrumentation, and methods for
implanting an intervertebral implant using minimally invasive
surgical techniques.
SUMMARY
[0003] In one embodiment, a method of augmenting a nucleus pulposus
of an intervertebral disc comprises forming a first opening in an
annulus of the intervertebral disc and forming a second opening in
the annulus of the intervertebral disc. The method further
comprises providing a space creation instrument including an
expandable spacing device and introducing the spacing device
through the first opening and into the nucleus pulposus. The method
further comprises introducing a material delivery instrument
through the second opening and into the nucleus pulposus and
expanding the spacing device to create a space within the nucleus
pulposus. The method also comprises injecting a biocompatible
material from the material delivery instrument and into the space
within the nucleus pulposus.
[0004] In another embodiment, a system for augmenting a nucleus of
an intervertebral disc comprises a first cannula adapted for
accessing a nucleus pulposus of the intervertebral disc and a
second cannula adapted for accessing the nucleus pulposus of the
intervertebral disc. The system further comprises a space creation
instrument adapted to be received through the first cannula and
including a spacing portion adapted to create a space in the
nucleus pulposus of the intervertebral disc. The system further
comprises a material delivery instrument adapted to be received
through the second cannula and to carry a biocompatible material.
The space created in the nucleus pulposus of the intervertebral
disc with the space creation instrument is adapted to receive the
biomaterial delivered to the space by the material delivery
instrument through the second cannula.
[0005] In another embodiment, a method for treating a nucleus
pulposus of an intervertebral disc comprising creating a first
opening to access the intervertebral disc and creating a second
opening to access the intervertebral disc. The method further
comprises inserting a first space creation instrument having a
first spacing device through the first opening and into the nucleus
pulposus of the intervertebral disc and inserting a second space
creation instrument having a second spacing device through the
second opening to access the intervertebral disc. The method
further comprises injecting a first biomaterial into the first
spacing device to expand the first spacing device and injecting a
second biomaterial into the second spacing device to expand the
second spacing device. The expansion of the first and second
spacing devices occur without removing a portion of the nucleus
pulposus.
[0006] Additional embodiments are included in the attached drawings
and the description provided below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a sagittal view of a section of a vertebral
column.
[0008] FIGS. 2-5 are a sequence of views of an intervertebral disc
treatment including accessing the nucleus, inserting an expandable
device, expanding the expandable device to create a space, and
filling the space.
[0009] FIGS. 6-7 are sequence views of an intervertebral disc
treatment according to another embodiment of the present
disclosure.
[0010] FIGS. 8-9 are sequence views of an intervertebral disc
treatment according to another embodiment of the present
disclosure.
[0011] FIGS. 10-11 are alternative intervertebral disc treatments
according to other embodiments of the present disclosure.
[0012] FIGS. 12-13 are sequence views of an intervertebral disc
treatment according to another embodiment of the present
disclosure.
[0013] FIGS. 14-15 are sequence views of an intervertebral disc
treatment according to another embodiment of the present
disclosure.
[0014] FIGS. 16-17 are sequence views of an intervertebral disc
treatment according to another embodiment of the present
disclosure.
DETAILED DESCRIPTION
[0015] The present disclosure relates generally to devices, methods
and apparatus for augmenting an intervertebral disc, and more
particularly, to methods and instruments for minimally invasive
access procedures. For the purposes of promoting an understanding
of the principles of the invention, reference will now be made to
the embodiments, or examples, illustrated in the drawings 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. Any alterations and further
modifications in the described embodiments, and any further
applications of the principles of the invention as described herein
are contemplated as would normally occur to one skilled in the art
to which the invention relates.
[0016] Referring first to FIG. 1, the reference numeral 10 refers
to a vertebral joint section or a motion segment of a vertebral
column. The joint section 10 includes adjacent vertebral bodies 12,
14. The vertebral bodies 12, 14 include endplates 16, 18,
respectively. An intervertebral disc space 20 is located between
the endplates 16, 18, and an annulus 22 surrounds the space 20. In
a healthy joint, the space 20 contains a nucleus pulposus 24.
[0017] Referring now to FIGS. 2-5, in this embodiment, the nucleus
24 may be accessed by inserting a cannula 30 into the patient and
locating the cannula at or near the annulus 22. An accessing
instrument 32, such as a trocar needle or a K-wire is inserted
through the cannula 30 and used to penetrate the annulus 22,
creating an annular opening 33. This accessing procedure may be
repeated at another position on the annulus 22 using a cannula 34
to create an annular opening 35. With the openings 33, 35 created,
the accessing instrument 32 may be removed and the cannulae 30, 34
left in place to provide passageway for additional instruments.
[0018] In this embodiment, the nucleus is accessed using a
posterior bilateral approach. In alternative embodiments, the
annulus may be accessed with a lateral approach, an anterior
approach, a trans-pedicular/vertebral endplate approach or any
other suitable nucleus accessing approach. Although a bilateral
approach is described, a unilateral or multi-lateral approach may
be suitable. In another alternative embodiment, the nucleus 24 may
be accessed through one the of vertebral bodies 12, 14 and through
its respective endplate 16, 18. Thus, a suitable bilateral approach
to nucleus augmentation may involve a combination approach
including an annulus access opening and an endplate access
opening.
[0019] It is understood that any cannulated instrument including a
guide needle or a trocar sleeve may be used to guide the accessing
instrument.
[0020] In this embodiment, the natural nucleus, or what remains of
it after natural disease or degeneration, may remain intact with no
tissue removed. In alternative embodiments, partial or complete
nucleotomy procedures may be performed.
[0021] As shown in FIG. 3, a space creating device 36 having a
catheter portion 38 and a spacing portion 40 may be inserted
through the cannula 30 and the annular opening 33 into the nucleus
24. In this embodiment, the spacing portion 40 is an expandable
device such as a balloon which may be formed of elastic or
non-elastic materials. The balloon can be of various shapes
including conical, spherical, square, long conical, long spherical,
long square, tapered, stepped, dog bone, offset, or combinations
thereof. Balloons can be made of various polymeric materials such
as polyethylene terephthalates, polyolefins, polyurethanes, nylon,
polyvinyl chloride, silicone, polyetheretherketone, polylactide,
polyglycolide, poly(lactide-co-glycoli-de), poly(dioxanone),
poly(.epsilon.-caprolactone), poly(hydroxylbutyrate),
poly(hydroxylvalerate), tyrosine-based polycarbonate, polypropylene
fumarate or combinations thereof. Additionally, the expandable
device may be molded or woven.
[0022] In an alternative embodiment, the spacing portion may be
mechanical instrument such as a probe or a tamp. A mechanically
actuated deformable or expandable instrument which may deform via
hinges, springs, shape memory material, etc. may also be used as a
spacing portion. In some embodiments, the passage of the spacing
portion may be aided with a more rigid guide needle or cannula
which will accompany the spacing portion through the cannula and
the annulus opening. This guide may be removed after the spacing
portion is located within the nucleus 24.
[0023] As also shown in FIG. 3, a delivery instrument 42 may be
passed through the cannula 34, through the annular opening 35, and
into the nucleus 24. The delivery instrument 42 may be an injection
needle or other material delivery instrument and may be blunt to
avoid puncture or damage to the spacing portion 40.
[0024] Referring now to FIG. 4, an inflation medium 44 may be
pressurized and injected or otherwise passed through the catheter
portion 38 of the space creating device 36 to pressurize and
inflate the spacing portion 40. The inflation medium 44 may be a
saline and/or radiographic contrast medium such as sodium
diatrizoate solution sold under the trademark Hypaque.RTM. by
Amersham Health, a division of GE Healthcare (Amersham, UK). The
inflation medium 44 may be injected under pressure supplied by a
hand, electric, or other type of powered pressurization device. The
internal balloon pressure may be monitored with a well known
pressure gauge. The rate of inflation and the pattern, size, or
shape of the spacing portion 40 can be varied between patients
depending on disc condition. A control device for controlling
inflation and dispensing of material is described in further detail
in U.S. patent application Ser. No. ______, entitled "DEVICES,
APPARATUS, AND METHODS FOR IMPROVED DISC AUGMENTATION, (Attorney
Docket No. 31132.512) filed concurrently herewith and incorporated
by reference herein.
[0025] As the spacing portion 40 is gradually inflated, a space 46
is created in the nucleus tissue with the surrounding nucleus
tissue becoming displaced or stretched. The inflation may also
cause the intradiscal pressure to increase. Both the pressure
increase and the direct expansion of the portion 40 may cause the
endplates 16, 18 to distract. A pressure gauge and/or a pressure
limiter may be used to avoid over inflation or excessive
injection.
[0026] In an alternative embodiment, the space creating portion may
be disposed within the annular opening 33 such that as the space
creating portion is expanded, the opening becomes stretched or
dilated by the space creating device.
[0027] After the space 46 is created, the space creating portion 40
is deflated leaving the space 46 to be filled by a biocompatible
material 48 injected from the delivery instrument 42. The injection
of the material 48 may be facilitated by using a pressurization
device and monitoring gauge. The material 48 may be injected after
the space creating portion 40 has been deflated and removed or may
be injected while the space creating portion 40 is being deflated
and removed. For example, the biomaterial 48 may become
increasingly pressurized while the pressure in the space creating
portion 40 is lowered. In some procedures, the material 48 may be
injected before the space creating portion 40 is removed.
[0028] Examples of biocompatible materials 48 which may be used for
disc augmentation include natural or synthetic and resorbable or
non-resorbable materials. Natural materials include various forms
of collagen that are derived from collagen-rich or connective
tissues such as an intervertebral disc, fascia, ligament, tendon,
skin, or demineralized bone matrix. Material sources include
autograft, allograft, xenograft, or human-recombinant origin
materials. Natural materials also include various forms of
polysaccharides that are derived from animals or vegetation such as
hyaluronic acid, chitosan, cellulose, or agar. Other natural
materials include other proteins such as fibrin, albumin, silk,
elastin and keratin. Synthetic materials include various
implantable polymers or hydrogels such as silicone, polyurethane,
silicone-polyurethane copolymers, polyolefin, polyester,
polyacrylamide, polyacrylic acid, polyvinyl alcohol, polyethylene
oxide, polyethylene glycol, polylactide, polyglycolide,
poly(lactide-co-glycolide), poly(dioxanone),
poly(.epsilon.-caprolactone), poly(hydroxylbutyrate),
poly(hydroxylvalerate), tyrosine-based polycarbonate, polypropylene
fumarate or combinations thereof. Suitable hydrogels may include
poly(vinyl alcohol), poly(acrylic acids), poly(methacrylic acids),
copolymers of acrylic acid and methacrylic acid,
poly(acrylonitrile-acrylic acid), polyacrylamides,
poly(N-vinyl-2-pyrrolidone), polyethylene glycol,
polyethyleneoxide, polyacrylates, poly(2-hydroxy ethyl
methacrylate), copolymers of acrylates with N-vinyl pyrrolidone,
N-vinyl lactams, polyurethanes, polyphosphazenes,
poly(oxyethylene)-poly(oxypropylene) block polymers,
poly(oxyethylene)-poly(oxypropylene) block polymers of ethylene
diamine, poly(vinyl acetate), and sulfonated polymers,
polysaccharides, proteins, and combinations thereof.
[0029] The selected biocompatible material may be curable or
polymerizable in situ. The biocompatible material may transition
from a flowable to a non-flowable state shortly after injection.
One way to achieve this transition is by adding a crosslinking
agent to the biomaterial before, during, or after injection. The
biocompatible material in its final state may be load-bearing,
partially load-bearing, or simply tissue augmenting with minimal or
no load-bearing properties.
[0030] Proteoglycans may also be included in the injectable
biocompatible material 48 to attract and/or bind water to keep the
nucleus 24 hydrated. Regnerating agents may also be incorporated
into the biocompatible material. An exemplary regenerating agent
includes a growth factor. The growth factor can be generally suited
to promote the formation of tissues, especially of the type(s)
naturally occurring as components of an intervertebral disc. For
example, the growth factor can promote the growth or viability of
tissue or cell types occurring in the nucleus pulposus, such as
nucleus pulposus cells and chondrocytes, as well as space filling
cells, such as fibroblasts and connective tissue cells, such as
ligament and tendon cells. Alternatively or in addition, the growth
factor can promote the growth or viability of tissue types
occurring in the annulus fibrosis, as well as space filling cells,
such as fibroblasts and connective tissue cells, such as ligament
and tendon cells. An exemplary growth factor can include
transforming growth factor-.beta. (TGF-.beta.) or a member of the
TGF-.beta. superfamily, fibroblast growth factor (FGF) or a member
of the FGF family, platelet derived growth factor (PDGF) or a
member of the PDGF family, a member of the hedgehog family of
proteins, interleukin, insulin-like growth factor (IGF) or a member
of the IGF family, colony stimulating factor (CSF) or a member of
the CSF family, growth differentiation factor (GDF), cartilage
derived growth factor (CDGF), cartilage derived morphogenic
proteins (CDMP), bone morphogenetic protein (BMP), or any
combination thereof. In particular, an exemplary growth factor
includes transforming growth factor P protein, bone morphogenetic
protein, fibroblast growth factor, platelet-derived growth factor,
insulin-like growth factor, or any combination thereof.
[0031] Therapeutic or biological agents may also be incorporated
into the biomaterial. An exemplary therapeutic or biological agent
can include a soluble tumor necrosis factor .alpha.-receptor, a
pegylated soluble tumor necrosis factor .alpha.-receptor, a
monoclonal antibody, a polyclonal antibody, an antibody fragment, a
COX-2 inhibitor, a metalloprotease inhibitor, a glutamate
antagonist, a glial cell derived neurotrophic factor, a B2 receptor
antagonist, a substance P receptor (NK1) antagonist, a downstream
regulatory element antagonistic modulator (DREAM), iNOS, a
inhibitor of tetrodotoxin (TTX)-resistant Na+-channel receptor
subtypes PN3 and SNS2, an inhibitor of interleukin, a TNF binding
protein, a dominant-negative TNF variant, Nanobodies.TM., a kinase
inhibitor, or any combination thereof.
[0032] These regenerating, therapeutic, or biological agents may
promote healing, repair, regeneration and/or restoration of the
disc, and/or facilitate proper disc function. Additives appropriate
for use in the claimed invention are known to persons skilled in
the art, and may be selected without undue experimentation.
[0033] After the biocompatible material 48 is injected, the
delivery instrument 42 may be removed from the cannula 34. If the
selected biocompatible material 48 is curable in situ, the
instrument 42 may be removed during or after curing to minimize
leakage. The openings 33, 35 may be small enough, for example less
than 3 mm, that they will close or close sufficiently that the
injected biocompatible material 48 will remain within the annulus.
The use of an annulus closure device such as a suture, a plug, or a
material sealant is optional. The cannulae 30, 34 may be removed
and the minimally invasive surgical incision closed.
[0034] Any of the steps of the method including expansion of the
space creating portion 40 and filling the space 46 may be monitored
and guided with the aid of imaging methods such as fluoroscopy,
x-ray, computed tomography, magnetic resonance imaging, and/or
image guided surgical technology such as a Stealth Station.TM.
surgical navigation system (Medtronic, Inc., Minneapolis, Minn.) or
a BrainLab system (Heimstetten, Germany).
[0035] In an alternative embodiment, the space creating portion may
be detachable from the catheter portion and may remain in the
nucleus 24 as an implant. In this alternative, the biocompatible
material may be injected directly into the space creating
portion.
[0036] Referring now to FIGS. 6-7, in this embodiment, the nucleus
24 may be accessed by inserting a cannula 50 into the patient and
locating the cannula at or near the annulus 22. As described above,
an accessing instrument is inserted through the cannula 50 and used
to penetrate the annulus 22, creating an annular opening 53. This
accessing procedure may be repeated at another position on the
annulus 22 using a cannula 54 to create an annular opening 55. With
the openings 53, 55 created, the accessing instrument may be
removed and the cannulae 50, 54 left in place to provide bilateral
passageways for additional instruments. In this embodiment, the
natural nucleus, or what remains of it after natural disease or
degeneration, may remain intact with no tissue removed. In
alternative embodiments, partial or complete nucleotomy procedures
may be performed.
[0037] As shown in FIG. 6, a space creating device 56 having a
catheter portion 58 and a spacing portion 60 may be inserted
through the cannula 50 and the annular opening 53 into the nucleus
24. In this embodiment, the spacing portion is an expandable device
such as a balloon which may be formed of elastic or non-elastic
materials. The characteristics of the balloon may be the same or
similar to those described above. The spacing portion may be
inflated and removed as described in further detail in U.S. patent
application Ser. No. 10/314,396 ("the '396 application") which is
incorporated herein by reference. The space 61 created by the
spacing portion may be filled with a biocompatible material 62
using the cannula 54 through the bilateral opening 55 in a manner
similar to that described above for FIGS. 2-5 or alternatively,
using the same cannula 50 and the opening 53 in a manner similar to
that described in the '396 application. The procedure of creating a
space in the nucleus 24 may be repeated in another location of the
nucleus using the annular opening 55 to pass a space creating
device for creating a second space to be filled with a
biocompatible material. This procedure may be substantially similar
to that described above for creating and filling space 61.
[0038] Referring now to FIGS. 8-9, in this embodiment, the nucleus
24 may be accessed by inserting a cannula 70 into the patient and
locating the cannula at or near the annulus 22. As described above,
an accessing instrument is inserted through the cannula 70 and used
to penetrate the annulus 22, creating an annular opening 73. This
accessing procedure may be repeated at another position on the
annulus 22 using a cannula 74 to create an annular opening 75. With
the openings 73, 75 created, the accessing instrument may be
removed and the cannulae 70, 74 left in place to provide bilateral
passageways for additional instruments. In this embodiment, the
natural nucleus, or what remains of it after natural disease or
degeneration, may remain intact with no tissue removed. In
alternative embodiments, partial or complete nucleotomy procedures
may be performed.
[0039] As shown in FIG. 8, a space creating device 76 having a
catheter portion 78 and a spacing portion 80 may be inserted
through the cannula 70 and the annular opening 73 into the nucleus
24. In this embodiment, the spacing portion is an expandable device
such as a balloon which may be formed of elastic or non-elastic
materials. The characteristics of the balloon may be the same or
similar to those described above. The spacing portion 80 may be
pressurized and filled with a biocompatible material 82 as
described in further detail in the '396 application. In this
embodiment, the filled spacing portion 80 may be detached and left
within the nucleus pulposus 24 as an implant. The procedure of
creating a space in the nucleus 24 may be repeated in another
location of the nucleus using the annular opening 55 to pass a
spacing portion for creating a second space, filling the spacing
portion with a biocompatible material, and detaching the second
spacing portion. This procedure may be substantially similar to the
procedure for filling the spacing portion 80. In an alternative
embodiment, the spacing portion may be filled with a biocompatible
material using the cannula 74 and the bilateral opening 75 in a
manner similar to that described above for FIGS. 2-5. This delivery
of material through the bilateral opening 75 may occur either
before or after the spacing portion is detached from the catheter
portion of the space creating device.
[0040] Referring now to FIGS. 10 and 11, spacing portions similar
to those described in the previous embodiments may be preformed in
various shapes, such as triangular (FIG. 10) or capsular (FIG. 11),
to achieve patient-specific goals including compensating for unique
nucleus degradation or patient-tailored endplate distraction.
[0041] Referring now to FIGS. 12 and 13, in this embodiment, the
nucleus 24 may be accessed by inserting a cannula 90 into the
patient and locating the cannula at or near the annulus 22. As
described above, an accessing instrument is inserted through the
cannula 90 and used to penetrate the annulus 22, creating an
annular opening 93. This accessing procedure may be repeated at
another position on the annulus 22 using a cannula 94 to create an
annular opening 95. With the openings 93, 95 created, the accessing
instrument may be removed and the cannulae 90, 94 left in place to
provide bilateral passageways for additional instruments. In this
embodiment, the natural nucleus, or what remains of it after
natural disease or degeneration, may remain intact with no tissue
removed. In alternative embodiments, partial or complete nucleotomy
procedures may be performed.
[0042] As shown in FIG. 12, a space creating device 96 having a
catheter portion 98 and a spacing portion 100 may be inserted
through the cannula 90 and the annular opening 93 into the nucleus
24. In this embodiment, the spacing portion 100 is an expandable
device such as a balloon which may be formed of elastic or
non-elastic materials. The characteristics of the balloon may be
the same or similar to those described above. The balloon may be
shaped to fit along the inner contour of the annulus 22. The
spacing portion 100 may be pressurized, filled, and detached as
described above. The spacing portion 100 may be filled with a
biocompatible material 102 using the cannula 94 and the bilateral
opening 95 in a manner similar to that described above for FIGS.
2-5 or using the same cannula 90 and the opening 93 in a manner
similar to that described in the '396 application. The procedure of
creating a space in the nucleus 24 along the annulus 22 may be
repeated in another location of the nucleus using the annular
opening 55 to pass a space creating device for creating a second
implant to be filled with a biocompatible material. This procedure
may be substantially similar to that described above for creating
and filling spacing portion 100. The implant created by the filled
spacing portion 100 and its bilateral counterpart may be contoured
to fit along an interior segment of annulus 22. The resulting
implant may support a weakened annulus or reinforce a ruptured
annulus to reduce or prevent nucleus herniation. The biocompatible
material may be selected to optimize support and flexibility.
[0043] Referring now to FIGS. 14 and 15, in this embodiment, the
nucleus 24 may be accessed by inserting a cannula 110 into the
patient and locating the cannula at or near the annulus 22. As
described above, an accessing instrument is inserted through the
cannula 110 and used to penetrate the annulus 22, creating an
annular opening 113. This accessing procedure may be repeated at
another position on the annulus 22 using a cannula 114 to create an
annular opening 115. With the openings 113, 115 created, the
accessing instrument may be removed and the cannulae 110, 114 left
in place to provide bilateral passageways for additional
instruments. In this embodiment, the natural nucleus, or what
remains of it after natural disease or degeneration, may remain
intact with no tissue removed. In alternative embodiments, partial
or complete nucleotomy procedures may be performed.
[0044] As shown in FIG. 14, annulus contoured spacing portions 116,
118 may be inserted, detached, and filled as described above in
FIG. 12. The resulting implant may support a weakened annulus or
reinforce a ruptured annulus to reduce or prevent nucleus
herniation. The biocompatible filling material may be selected to
optimize support and flexibility. These annulus reinforcing spacing
portions 116, 118 may be used in conjunction with the more
centralized nucleus spacing procedures described in FIGS. 2-11. In
this embodiment, an additional spacing portion may be inserted
through the filled spacing portions 116, 118 and expanded within
the nucleus 24 to create a space 120. The space 120 may be filled
with a biomaterial 122. More spacing portions may be inserted to
create additional filled spaces in the nucleus 24. The use of
annular spacing portions in conjunction with more centralized
spacing portions may help to prevent the more centralized
biomaterial and the natural nucleus tissue from migrating through
annular defects or openings. The biomaterials selected for filling
the various spaces and spacing portions may be the same or
different depending upon the desired result.
[0045] In an alternative embodiment, a delivery instrument may be
inserted through the spacing portions 116, 118 to deposit a
biocompatible material directly into the nucleus 24 without
creating an additional space within the nucleus. In this
embodiment, the spacing portions serve to block migration or
expulsion of the biocompatible material through the annulus,
however the material may be more dispersed within the nucleus
rather than concentrated in a pre-formed space.
[0046] Referring now to FIGS. 16-17, in this embodiment, a
substantially similar method of nucleus augmentation as the
procedure described above for FIGS. 14-15 may be performed. In this
embodiment, however, as described in FIGS. 8-9, spacing portions
130, 132 for creating the more centralized nucleus spaces may be
detached to remain in the nucleus tissue as implants.
[0047] Although the instruments and implants described are suitable
for intervertebral applications, it is understood that the same
implants and instruments may be modified for use in other regions
including an interspinous region or a bone cavity. Furthermore, the
instruments and implants of this disclosure may be incorporated in
certain aspects into an intervertebral prosthesis device such as a
motion preserving artificial disc.
[0048] Although only a few exemplary embodiments have been
described in detail above, those skilled in the art will readily
appreciate that many modifications are possible in the exemplary
embodiments without materially departing from the novel teachings
and advantages of this disclosure. Accordingly, all such
modifications and alternative are intended to be included within
the scope of the invention as defined in the following claims.
Those skilled in the art should also realize that such
modifications and equivalent constructions or methods do not depart
from the spirit and scope of the present disclosure, and that they
may make various changes, substitutions, and alterations herein
without departing from the spirit and scope of the present
disclosure. It is understood that all spatial references, such as
"horizontal," "vertical," "top," "upper," "lower," "bottom,"
"left," "right," "anterior," "posterior," "superior," "inferior,"
"upper," and "lower" are for illustrative purposes only and can be
varied within the scope of the disclosure. In the claims,
means-plus-function clauses are intended to cover the elements
described herein as performing the recited function and not only
structural equivalents, but also equivalent elements.
* * * * *