U.S. patent application number 10/773508 was filed with the patent office on 2004-08-12 for apparatus and methods for treating spinal discs.
Invention is credited to Ginn, Richard S..
Application Number | 20040158248 10/773508 |
Document ID | / |
Family ID | 25486763 |
Filed Date | 2004-08-12 |
United States Patent
Application |
20040158248 |
Kind Code |
A1 |
Ginn, Richard S. |
August 12, 2004 |
Apparatus and methods for treating spinal discs
Abstract
A band of biocompatible and/or bioabsorbable material is
provided including threads on one or both of its ends. An area
adjacent a spinal disc is accessed, and the band of material is
wrapped around the disc to stabilize the disc and/or to facilitate
healing. An elongate member is inserted around a posterior region
of the disc, e.g., through tubular guide members. An end of the
band is connected to a distal end of the elongate member, and the
elongate member is pulled back around the disc to direct the band
around the disc. The band is secured around the disc overlapping
vertebrae adjacent the disc. Optionally, a relative location of the
vertebrae is adjusted relative to the disc before wrapping the band
around the disc, for example, using a fork member or traction.
Energy may also be applied to the disc to enhance healing.
Inventors: |
Ginn, Richard S.; (San Jose,
CA) |
Correspondence
Address: |
ORRICK, HERRINGTON & SUTCLIFFE, LLP
4 PARK PLAZA
SUITE 1600
IRVINE
CA
92614-2558
US
|
Family ID: |
25486763 |
Appl. No.: |
10/773508 |
Filed: |
February 5, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10773508 |
Feb 5, 2004 |
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09947785 |
Sep 6, 2001 |
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6736815 |
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Current U.S.
Class: |
606/279 ;
606/86A; 606/907; 606/908 |
Current CPC
Class: |
Y10S 606/908 20130101;
A61F 2002/4435 20130101; A61F 2002/30062 20130101; A61F 2/4611
20130101; A61F 2210/0004 20130101; Y10S 606/907 20130101 |
Class at
Publication: |
606/061 |
International
Class: |
A61B 017/58 |
Claims
What is claimed is:
1. A method for treating a ruptured or degenerated spinal disc of a
patient, comprising: accessing an area adjacent an exterior of a
spinal disc disposed between adjacent vertebrae; and wrapping a
band of material around the disc to stabilize the disc in a desired
position relative to surrounding anatomy.
2. The method of claim 1, wherein the band engages at least one of
the vertebrae when the band is wrapped around the disc to
substantially secure the disc relative to the at least one of the
vertebrae.
3. The method of claim 1, wherein the accessing step comprises
accessing an anterior region of the disc, and wherein the wrapping
step comprises: extending a distal end of an elongate member along
a first lateral region of the disc around a posterior region of the
disc to an opposite second lateral region of the disc; connecting a
first end of the band to the distal end of the elongate member;
pulling the elongate member back around the posterior region of the
disc, thereby directing the first end of the band around the
posterior region of the disc; and securing at least one of the
first end and a second end of the band to another portion of the
band, thereby securing the band around the disc.
4. The method of claim 1, further comprising adjusting a location
of at least one of the vertebrae relative to the disc.
5. The method of claim 4, wherein the adjusting step comprises:
engaging at least one of the vertebrae between tines of a fork
member; and manipulating the tines between the vertebrae to
increase a space between the vertebrae.
6. The method of claim 4, wherein the adjusting step comprises
subjecting the patient to traction.
7. The method of claim 1, further comprising placing an
extra-cellular matrix material between the band and the disc.
8. The method of claim 7, wherein the band comprises the
extra-cellular matrix material on an interior surface thereof, and
wherein the extra-cellular matrix material is placed when the band
is wrapped around the disc.
9. The method of claim 1, wherein the band comprises
healing-promoting material for enhancing healing of damage to an
annulus fibrosis of the disc.
10. The method of claim 1, wherein the band comprises nonporous
material, and wherein the band substantially seals any leaks in the
disc when the band is wrapped around the disc.
11. The method of claim 1, wherein the band comprises bioabsorbable
material that remains around the disc until absorbed by the
patient's body.
12. The method claim 1, further comprising applying energy to the
disc to enhance healing of the disc.
13. The method of claim 12, wherein at least a portion of the band
is electrically conductive, wherein the method further comprises
coupling a source of electrical energy to the electrically
conductive portion of the band, and wherein the applying energy
step comprises applying electrical energy to the disc via the
electrically conductive portion of the band.
14. The method of claim 12, wherein the applying energy step
comprises applying electrical energy directly to one or more
desired regions of the disc.
15. The method of claim 1, further comprising inserting a tubular
guide member around a portion of the exterior of the disc, and
wherein the wrapping step comprises directing the band through the
guide member to facilitate wrapping the band around a posterior
region of the disc.
16. The method of claim 1, further comprising inserting a pair of
opposite-hand tubular guide members around opposing lateral regions
of the exterior of the disc.
17. The method of claim 16, wherein the guide members are inserted
around the disc until distal ends of the guide members are disposed
adjacent a posterior region of the disc.
18. The method of claim 16, wherein the wrapping step comprises:
directing a distal end of an elongate member through lumens of the
guide members; connecting a first end of the band to the distal end
of the elongate member; and directing the distal end of the
elongate member back through the lumens of the guide members to
direct the band around the posterior region of the disc.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to treatment of
spinal discs, and more particularly to apparatus and methods for
treating ruptured or degenerated spinal discs using a band of
material wrapped around the spinal disc.
BACKGROUND
[0002] Various apparatus and methods have been suggested for
treating spinal discs when they rupture, degenerate, or otherwise
become injured. For example, spinal fixation, i.e., fixing the
vertebrae on either side of an injured disc relative to one
another, is a commonly used treatment. This may involve inserting
pedicle screws or other anchors into the vertebrae, and securing
rods, wires, plates, and the like between the vertebrae, thereby
substantially removing much of the forces acting on the disc during
subsequent activity by the patient. In addition, the injured disc
may be removed and a fixation system used to anchor the adjacent
vertebrae, while the vertebrae are fused to one another. Such
fixation and fusion procedures, however, may substantially impair
free movement by the patient, because relative movement of the
vertebrae is intentionally fixed.
[0003] In addition to fixation, an injured disc may be completely
removed and replaced with a prosthesis. Alternatively, a portion of
a disc may be removed, and a prosthesis used to fill the resulting
cavity, such as those disclosed in U.S. Pat. Nos. 5,549,679 and
5,571,189, issued to Kuslich. In a further alternative, "hybrid"
material may be implanted directly within a space created within a
spinal disc, as disclosed in U.S. Pat. No. 5,964,807, issued to Gan
et al., rather than removing the entire disc.
[0004] Accordingly, apparatus and methods for treating spinal discs
would be considered useful.
SUMMARY OF THE INVENTION
[0005] The present invention is directed to apparatus and methods
for treating spinal discs, and more particularly to apparatus and
methods for treating a ruptured or degenerated spinal disc using a
band of material wrapped around the spinal disc.
[0006] In accordance with one aspect of the present invention, an
apparatus is provided for treating a ruptured or degenerated spinal
disc that includes a band of material. The band of material, which
may be formed from biocompatible and/or bioabsorbable material, may
have a length sufficient to wrap around an exterior of a spinal
disc, and may have a width sufficient to cover a spinal disc and at
least partially cover at least one vertebra adjacent the spinal
disc. In addition, one or both ends of the band may include a
connector, e.g., threads, clips, and the like, for securing the
ends to one another or to another portion of the band.
[0007] The band may include healing-promoting material coated
thereon, impregnated therein or otherwise carried thereby. For
example, an extra-cellular matrix material may be carried on at
least one side of the band of material. Optionally, at least a
portion of the band may be electrically conductive, and a source of
electrical energy may be coupled to the electrically conductive
portion of the band.
[0008] Optionally, the apparatus may include an elongate member
that includes a proximal end including a handle thereon, and a
curved distal end including a connector element thereon. The band
may include a first end that is releasably connectable to the
connector element on the elongate member. In an exemplary
embodiment, the connector element includes a hook on the distal end
of the elongate member, and one end of the band includes an opening
for receiving the hook therein.
[0009] In addition, the apparatus may include a fork member
including proximal and distal ends defining an axis therebetween.
The distal end may include a pair of tines, each tine including a
transverse portion extending generally parallel to one another
transversely with respect to the axis. The transverse portion of
each tine may include a tip and a heel disposed proximal to the
tip. A length between the tip and the heel may be sufficient for
engaging a first vertebra with the tip and pivotally engaging a
second vertebra with the heel to adjust a distance between the
first and second vertebrae.
[0010] In another embodiment, the apparatus may include a guide
member including a proximal end and a curved distal end having a
radius of curvature corresponding substantially to an exterior
perimeter of a spinal disc. The guide member generally includes a
lumen extending between the proximal and distal ends, the lumen
having a size for receiving the band of material therethrough.
Preferably, the lumen through the guide member is a slot including
a height greater than a width of the band, the slot preferably
having a height that extends substantially perpendicularly to the
radius of curvature of the distal end. More preferably, the
apparatus includes a pair of such guide members that are opposite
hand from one another.
[0011] In accordance with another aspect of the present invention,
a method is provided for treating a ruptured or degenerated spinal
disc of a patient. Initially, an area adjacent an exterior of a
spinal disc disposed between adjacent vertebrae is accessed. A band
of material, such as that described above, may be wrapped around
the disc to stabilize the disc in a desired position relative to
surrounding anatomy. Preferably, the band engages at least one of
the vertebrae when the band is wrapped around the disc to
substantially secure the disc relative to the at least one of the
vertebrae.
[0012] In one embodiment, this may involve extending a distal end
of an elongate member along a first lateral region of the disc
around a posterior region of the disc to an opposite second lateral
region of the disc. A first end of the band may be connected to the
distal end of the elongate member, and the elongate member may be
pulled back around the posterior region of the disc, thereby
directing the first end of the band around the posterior region of
the disc. At least one of the first end and a second end of the
band may be secured to another portion of the band, thereby
securing the band around the disc.
[0013] In another embodiment, a tubular guide member may be
inserted around a portion of the exterior of the disc, and the band
may be inserted through the guide member to facilitate wrapping the
band around a posterior region of the disc. Preferably, a pair of
opposite-hand tubular guide members may be inserted around opposing
lateral regions of the exterior of the disc. The band may be
inserted directly through the guide members or may be directed
through the guide members using an elongate member previously
advanced through the guide members, which may be used to pull the
band through the guide members.
[0014] Optionally, a location of at least one of the vertebrae may
be adjusted relative to the disc before wrapping the band around
the disc. For example, at least one of the vertebrae may be engaged
between tines of a fork member, and the tines may be manipulated
between the vertebrae to increase a space between the vertebrae.
Alternatively, the patient may be subjected to traction.
[0015] If desired, an extra-cellular matrix material may be placed
between the band and the disc, e.g., to promote healing of the
disc. For example, one or more layers of extra-cellular matrix
material may be carried on an interior surface of the band such
that the extra-cellular matrix material is placed against the disc
when the band is wrapped around the disc.
[0016] In addition, energy may be applied to the disc to enhance
healing of the disc. For example, at least a portion of the band
may be electrically conductive, and a source of electrical energy
may be coupled to the electrically conductive portion of the band.
Electrical energy may be applied to the disc via the electrically
conductive portion of the band, or alternatively, energy may be
applied directly to the disc, e.g., using a separate energy
device.
[0017] In accordance with yet another aspect of the present
invention, a method is provided for treating a spinal region of a
patient. An area adjacent an anterior region of a spinal disc may
be accessed, for example, by creating an incision in a ligament
surrounding the disc to access an exterior of the disc. An
instrument may be inserted between the ligament and the exterior of
the disc, e.g., through the incision, in order to access a
posterior region of the disc. A diagnostic or therapeutic procedure
may be performed that involves accessing the posterior region of
the disc.
[0018] For example, a tubular guide member may be inserted around a
portion of the exterior of the disc, e.g., between the ligament and
the disc until a distal end of the instrument is disposed adjacent
the posterior region of the disc. One or more instruments may then
be introduced through the tubular guide member to access the
posterior region. For example, an imaging device, such as an
endoscope, may be inserted through the guide member or directly
between the ligament and the disc to the posterior region. The
imaging device may be used to observe the posterior region and/or
to otherwise assist in diagnosing a patient's condition.
[0019] In addition to or instead of imaging, a therapeutic
procedure may be performed at the posterior region of the disc. For
example, a discectomy or other procedure may be performed that
involves removing at least a portion of the disc from the posterior
region, e.g., nucleus pulposus material that has leaked from within
the disc. A therapeutic agent may be introduced into the posterior
region or surrounding tissue to promote healing, pain relief, and
the like. In addition, a band may be wrapped around the disc to
stabilize the disc in a desired position relative to surrounding
anatomy, as described above. In addition, tissue structures
adjacent the posterior region of the disc, such as a facet joint or
spinal cord, may be accessed from the posterior region to perform
an intervention involving the accessed structure. Thus, the
apparatus and methods of the present invention may provide a
minimally invasive approach for accessing the posterior region of a
spinal disc, while minimizing exposure of the disc and/or the
spinal column adjacent the disc.
[0020] Other objects and features of the present invention will
become apparent from consideration of the following description
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a perspective view of a first embodiment of a
system for treating spinal discs, in accordance with the present
invention.
[0022] FIGS. 2A-2D are perspective views of a portion of an exposed
spinal column, showing a method for treating a spinal disc using
the apparatus of FIG. 1.
[0023] FIGS. 3A and 3B are side views of a spinal column, showing a
band of material implanted to treat a spinal disc, in accordance
with the present invention.
[0024] FIGS. 4A and 4B are perspective views of a spinal disc,
showing a method for treating the spinal disc using another
embodiment of an apparatus, in accordance with the present
invention.
[0025] FIG. 5 is a cross-sectional view of a spinal disc of FIG.
4A, taken along line 5-5, and showing the anatomy surrounding the
disc.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0026] Turning now to the drawings, FIG. 1 shows a first embodiment
of an apparatus 10 for treating a spinal disc (not shown), in
accordance with the present invention. The apparatus 10 generally
includes a grasper 12, and a band of material 14 releasably
connected to the grasper 12. Optionally, the apparatus 10 may also
include a fork member 16, as shown, for adjusting adjacent
vertebrae (not shown).
[0027] The band of material 14 is an elongate panel of
biocompatible material having first and second ends 18, 20 defining
a length "L" therebetween and defining a width "W." Preferably, the
length "L" is sufficiently long such that the band 14 may be
wrapped around an exterior perimeter of a spinal disc (not shown)
and the ends 18, 20 overlapped or otherwise secured with one
another. The width "W" may be sufficiently wide to cover an entire
surface of a spinal disc, and preferably is sufficiently wide to
cover a spinal disc and at least partially cover one or both
vertebrae on either side of the spinal disc (not shown).
[0028] The band 14 may include one or more panels of substantially
nonporous material, or alternatively, of porous material. In the
exemplary embodiment shown, the band 14 includes a pair of spaced
apart strips or filaments 22 that extend between the first and
second ends 18, 20.. Webbing 24, e.g., made from one or more
fibers, extend between the strips 22. The strips 22 and/or webbing
may be formed from inelastic materials, or alternatively may be
formed from elastic materials, which may enhance stabilization of a
spinal disc about which the band 14 is wrapped, as explained
further below.
[0029] In a preferred embodiment, at least a portion of the band
14, and preferably all of the band 14, is bioabsorbable, such that
it may remain within a patient's body until absorbed through
natural excretion. In addition, the band 14 may include one or more
healing-promoting materials within the band 14 and/or otherwise
carried by the band 14. For example, an antibiotic, a steroid, an
nsaid, an autologous therapeutics agent, e.g., a concentrated
growth factor, or other therapeutic compounds, may be impregnated
within or coated over the strips 22 and/or webbing 24.
Alternatively, or in addition, the band 14 may carry one or more
layers of naturally occurring extra-cellular matrix material, such
as intestinal submucosa, stomach submucosa, bladder submucosa, and
the like, e.g., along one or both side surfaces of the band 14.
[0030] At least one of the first and'second ends 18, 20 of the band
14 may include a connector (not shown) for securing the ends 18, 20
to another portion of the band 14. For example, the first and
second ends 18, 20 may be secured to one another for securing the
band 14 around a spinal disc. Preferably, threads 26 extend from
one or both ends 18, 20 for tying the ends 18, 20 to one another or
to another portion of the band 14. Alternatively, one or more clips
(not shown) may be attached (or attachable) to one of the ends 18,
20 that may be engaged with the band 14 on or adjacent the other of
the ends 18, 20. In a further alternative, sutures or other threads
(not shown) may be stitched between the first and second ends 18,
20 and/or elsewhere through the band 14 to secure the band 14
around a spinal disc.
[0031] In an alternative embodiment, at least a portion of the band
14 may be electrically conductive. For example, the strips 22
and/or the webbing 24 may include insulated electrically conductive
pathways, e.g., wires, and/or electrically exposed areas, e.g.,
defining electrodes (not shown). A source of electrical energy,
such a radio frequency ("RF") generator (also not shown), may be
coupled to the conductive pathways, e.g., by coupling the energy
source to one or both ends 18, 20 of the band 14. Alternatively, a
separate device (not shown) may be provided that may be coupled to
a source of energy, such as an RF generator, a laser, and the like,
for applying energy directly to one or more regions of a spinal
disc. The device may include a handle on one end and an electrode,
lens, or other element on its other end for applying energy.
[0032] Returning to FIG. 1, the grasper 12 is an elongate member
including a proximal end 28 having a handle, and a curved distal
end 30 having a hook or other connector element 32 thereon. The
distal end 30 preferably terminates in a rounded distal tip 33 to
facilitate substantially atraumatic insertion of the distal end 30
between tissue structures. The hook 32 may be configured for
releasably connecting one of the ends 18, 20 of the band 14 to the
distal end 30 of the grasper 12. For example, the first end 18 of
the band 14 may include a hole, slot, pocket, or other aperture 34
for receiving the hook 28 therein. The grasper 12 may be formed
from a substantially rigid biocompatible material, such as
stainless steel, or may be semi-rigid such that the distal end 26
may be bent or otherwise formed based upon a specific anatomical
situation, as explained further below. In a further alternative,
the distal end 26 may be a flexible or semi-rigid wire that is
biased to a predetermined curvature corresponding to an exterior
perimeter of a spinal disc, but may be resiliently deflectable to
other configurations, e.g., a substantially straight configuration,
to facilitate insertion of the grasper 12 into a surgical site.
[0033] The fork member 16 includes proximal and distal ends 34, 36
defining an axis 38 therebetween. The distal end 36 includes a pair
of tines 40 that include transverse portions that extend generally
parallel to one another substantially transversely with respect to
the axis 38. The tines 40 may extend away from one another in a
curved configuration that defines a space therebetween
corresponding to a portion of a spinal disc. Preferably, each of
the tines 40 terminates in a distal tip 42 and includes a heel 44
disposed proximal to the tip 42, e.g., at a base of the transverse
portion of the respective tine 40. A height "H" between the tips 42
and the heels 44 may be sufficiently long to facilitate engaging
and/or manipulating adjacent vertebrae, as described further
below.
[0034] Turning to FIGS. 2A-2D, 3A, and 3B, the apparatus 10 may be
used to treat a spinal disc 90 that has ruptured, become
misaligned, and/or otherwise degenerated. Generally, the disc 90 is
disposed between first and second vertebrae 92, 94 with a spinal
cord 96 disposed adjacent the vertebrae 92, 94. For simplification,
only the body portions of the vertebrae 92, 94 are shown, and other
surrounding tissue structures, including the spinous process and
transverse process of the vertebrae, nerve bundles extending from
the spinal cord, and the like, have been eliminated.
[0035] Initially, the disc 90 may be accessed using conventional
surgical procedures. Preferably, a surgical field is opened
adjacent an exterior perimeter of the disc 90 that is exposed from
an anterior approach, i.e., from a chest side of the patient. An
anterior approach may be particularly useful for accessing and
treating discs between the cervical vertebrae, because of the
minimal amount of intervening tissue between the skin and the
spinal column. An anterior approach may also avoid having to work
around the spinous process and transverse process portions of the
vertebrae in order to gain access to the spinal disc 90.
[0036] A location of at least one of the vertebrae 92, 94 may be
adjusted relative to the disc 90 and/or relative to the other of
the vertebrae 92, 94, e.g., to allow adjustment of the disc 90 if
it has slipped or otherwise become misaligned. For example, as
shown in FIG. 2A, the fork member 16 may be inserted around the
disc 90, such that the tines 38 straddle the disc 90. The fork
member 16 may be adjusted until the heels 42 engage the first
vertebra 92 and the tips 40 engage the second vertebra 94. The fork
member 16 may then be pivoted with the heels 42 against the first
vertebra 92 such that the tips 40 move the second vertebra 94 away
from the first vertebra 92 to increase a space between the
vertebrae 92, 94, as shown in FIG. 2B.
[0037] The fork member 16 may then be stabilized, for example,
manually or by securing the proximal end 34 to a support, e.g.,
fixed to a surgical table (not shown). Alternatively, the patient
may be subjected to traction in order to increase the spacing
between and/or otherwise realign the vertebrae 92, 94, as is well
known in the art. If desired, the disc 90 may be adjusted, aligned,
or otherwise manipulated, e.g., to prevent the disc 90 from
impinging upon the spinal cord 96 or other nerves (not shown),
and/or to create a channel around the perimeter of the disc 90. In
addition, any nucleus pulposus (not shown) that has leaked through
fissures in the annulus fibrosis of the disc 90 may be removed.
[0038] Returning to FIG. 2B, the distal end 30 of the grasper 12
may then be inserted around one lateral region of the disc 90
towards the posterior region of the disc 90, i.e., between the disc
90 and the spinal cord 96. Because of the rounded distal tip 33,
the distal end 30 may be advanced around the disc 90 substantially
atraumatically until the distal tip 33 becomes accessible around
the opposite lateral region of the disc 90.
[0039] As shown in FIG. 2C, with the distal end 30 of the grasper
12 accessible, the first end 18 of the band 14 may be connected to
the distal end 30, for example, by receiving the hook 32 through
the hole 34 in the band 14. The grasper 12 may then be pulled back
around the disc 90, thereby directing the first end 18 of the band
14 around the posterior region of the disc 90, as shown in FIG.
2D.
[0040] Once the band 14 has been directed around the posterior
region of the disc 90, the fork member 16 may be removed, and the
band 14 secured tightly around the disc 90, as shown in FIGS. 3A
and 3B. To accomplish this, the first end 18 of the band 14 may be
released from the grasper 12, and the first and second ends 18, 20
of the band 14 may be secured to one another. For example, threads
26 (not shown, see FIG. 1) on the first and second ends 18, 20 may
be tied to one another. In this embodiment, the first and second
ends 18, 20 may not overlap one another, but may end in close
proximity to one another such that the threads 26 may be tied
together. Alternatively, one of the first and second ends 18, 20
may be lapped over the other, and the threads 26 on the overlying
end tied to an underlying portion of the band 14. In a further
alternative, one or more clips, sutures, or other mechanical
fasteners (not shown) may be used to secure the ends 18, 20 to one
another or to another portion of the band 14. In yet another
alternative, an adhesive may be used to secure the ends 18, 20,
and/or mere frictional contact between the overlying end and the
underlying portion may adequately secure the band 14 around the
disc 90.
[0041] Preferably, the band 14 is subjected to sufficient tension
when it is wrapped around the disc 90 to stabilize the disc 90
and/or to secure the disc 90 relative to one or both adjacent
vertebrae 92, 94. To enhance this tension, all or a portion of the
band 14 may be formed from elastic material, such that the band 14
may be stretched tightly around the exterior perimeter of the disc
90. If the band 14 is formed from elastic material, it may also
allow the fork member 16 to be removed after the band 14 has been
secured around the disc 90.
[0042] The band 14 may be sufficiently wide to cover the width of
the disc. 90 Preferably, the band 14 has a width "W" that is wider
than the disc 90 such that the band 14 overlaps one or both
adjacent vertebrae 92, 94, as shown in FIG. 3B. Thus, when the band
14 is tightened, the disc 90 may also be secured in substantial
alignment with the adjacent vertebrae 92, 94.
[0043] In the embodiment shown, the band 14 includes an open
webbing 24, and consequently is porous. Thus, the band 14 may
merely provide structural support for the underlying disc 90, e.g.,
to stabilize the disc 90 relative to the adjacent vertebrae 92, 94.
In addition, the band 14 may compress the disc 90, consequently
squeezing closed any fissures, holes, and the like that have
occurred in the annulus fibrosis of the disc 90. Alternatively, the
band 14 may be formed from a substantially nonporous panel of
material such that the band 14 may substantially seal any fissures
in the disc 90, thereby preventing nucleus pulposus material, and
the like from leaking through the annulus fibrosis.
[0044] In yet a further alternative, a substantially nonporous
material (not shown) may be provided between the band 14 and the
exterior of the disc 90. For example, one or more layers of
naturally occurring extra-cellular material, may be carried on an
interior surface of the band 14 such that the material may be
placed between the band 14 and the disc 90. In addition to sealing
any fissures, such material may also promote healing, as is well
known to those skilled in the art. Alternatively, or in addition,
other materials that promote healing may be coated on and/or
impregnated within the band 14.
[0045] If the band 14 is formed from bioabsorbable material, the
band 14 may remain around the disc 90 until it is absorbed by the
patient's body. Alternatively, the band 14 may be merely
biocompatible such that the band 14 may remain within the patient's
body indefinitely or until the disc 90 has sufficiently healed. In
the latter example, a follow-up procedure may be performed to
release the ends 18, 20 of the band 14 and pull the band 14 around
the disc 90 to remove it from the patient's body.
[0046] In another embodiment, energy may be applied to the disc 90
to enhance healing, to cause scarring, and/or to enhance sealing of
fissures or other leaks in the disc 90. For example, as described
above, at least a portion of the band 14 may be electrically
conductive. A source of electrical energy, e.g., an RF generator
(not shown), may be coupled to the electrically conductive portion
of the band 14. Once the band 14 is secured around the disc 90,
electrical energy may be applied to the disc via the electrically
conductive portion of the band 14. The power of the electrical
energy may be relatively low, e.g., merely to enhance healing of
the disc 90. Alternatively, the power may be relatively high,
thereby causing scarring of the annulus fibrosis of the disc 90,
which may seal fissures through which nucleus pulposus may
leak.
[0047] Turning to FIGS. 4A, 4B, and 5, another embodiment of an
apparatus 110 is shown for treating a spinal disc 90. Generally,
the apparatus 110 includes a grasper 12, and a band of material 14
that are substantially identical to the embodiment described above.
In addition, the apparatus 110 includes a pair of guide members 150
for guiding the grasper 12 and/or the band 14 around the posterior
region of the disc 90. Optionally, the apparatus 110 may also
include a fork member (not shown), similar to the previous
embodiment.
[0048] Each guide member 150 is a semi-rigid or substantially rigid
tubular body including a slotted lumen 152 extending between its
proximal and distal ends 154, 156. The proximal end 154 may be
substantially straight, defining a longitudinal axis 158, and may
include an enlarged proximal opening 157 (shown in FIG. 5). The
distal end 156 of the guide member 150 may be curved, preferably
having a radius of curvature similar to an exterior perimeter of
the disc 90. The guide member 150 also has a cross-section
including a height "h" (extending generally between the vertebrae
adjacent the disc 90) that is greater than its width "w" (extending
away from the exterior surface of the disc 90). Thus, the band 14
may be received within the lumen 152 such that the width "W" of the
band 14 is substantially less than the height "h" of the guide
member 150, thereby minimizing any folding or crumpling of the band
14 within the lumen 152. The distal end 156 of the guide member 150
terminates in a distal tip 160 that is disposed transversely and
preferably substantially perpendicular to the axis 158.
[0049] It will be appreciated that the distal end 30 of the grasper
12 has a shape that allows the distal end 30 to be directed easily
through the lumens 152 of the guide members 150. For example, the
distal end 30 of the grasper 12 may have a flat ribbon shape or may
have a generally round shape that is small enough to be inserted
through the lumens 152.
[0050] The apparatus 110 may be used to treat a spinal disc 90 that
has ruptured, become misaligned, and/or otherwise degenerated,
similar to the embodiment described above. Generally, the spinal
disc 90 is disposed between a first vertebra 92, best seen in FIG.
4B, and a second vertebra, which has been eliminated for
clarification. The vertebrae include spinous process 92a and
transverse process 92b defining a vertebral foramen 98, through
which a spinal cord 96 extends. The disc 90 generally includes
nucleus pulposus 90a surrounded by annulus fibrosis 90b, and is
surrounded by ligament 100, which may surround the entire spinal
column along its length.
[0051] Initially, the disc 90 may be accessed, preferably from an
anterior approach. This may involve creating incisions 102 in the
ligament 100 at locations corresponding to lateral regions of the
disc 90. The distal ends 156 of the guide members 150 may be
inserted through the respective incisions 102 and advanced around
an exterior surface of the disc 90 until the distal tips 160 are
disposed opposite one another adjacent a posterior region of the
disc 90. The distal ends 156 may be sufficiently flexible to
facilitate substantially atraumatic advancement of the guide
members 150 around the disc 90. Once the distal ends 156 are fully
inserted, the proximal ends 154 of the guide members 150 may extend
proximally from the incisions 102 generally parallel to one
another.
[0052] Optionally, a location of at least one of the vertebrae
adjacent the disc 90 may be adjusted, for example, using traction
or a fork member (not shown), before inserting the guide members
150, using a procedure similar to the embodiment described
above.
[0053] With particular reference to FIG. 4A, a distal end 30 of the
grasper 12 may be inserted into the lumen 152 of a first of the
guide members 150 and advanced distally until the distal end 30 of
the grasper 12 exits the distal end 156 of the first guide member
150 adjacent the posterior region of the disc 90. The grasper 12
may be manipulated further until the distal end 30 enters the lumen
152 at the distal end 156 of the second guide member 150, whereupon
the grasper 12 may be advanced further until the distal end 30
exits the proximal end 154 of the second guide member 150.
[0054] With the distal end 30 of the grasper 12 accessible, the
first end 18 of the band 14 may be connected to the distal end 30
of the grasper 12. The grasper 12 may then be pulled back through
the guide members 150, thereby directing the band 14 through the
lumens 152 of the guide members 150 and around the posterior region
of the disc 90, as shown in FIGS. 4A and 5. Once the first end 18
of the band 14 has been pulled out of the proximal end 154 of the
first guide member 150, the first end 18 of the band 14 may be
released from the distal end 30 of the grasper 12.
[0055] The guide members 150 may be withdrawn from the incisions
102, leaving the band 14 in place, as shown in FIG. 4B. Because of
the slotted lumens 152 of the guide members 150, the band 14 may
extend completely across a height of the disc 90 and preferably at
least partially covering one or both adjacent vertebrae 92. The
band 14 may then be secured tightly around the disc 90, as shown in
FIGS. 3A and 3B. For example, the first and second ends 18, 20 of
the band 14 may be secured to one another by threads (not shown),
similar to the embodiment described above. Optionally, if
necessary, one or both ends 18, 20 of the band 14 may be trimmed
before tightening and securing the band 14 around the disc 90.
[0056] If desired, energy may be applied to the disc 90 to enhance
healing, to cause scarring, and/or to enhance sealing of fissures
or other leaks in the disc 90. The energy may be applied directly
to one or more regions of the disc 90 or may be applied via
conductive regions of the band 14, similar to the embodiment
described above.
[0057] If the band 14 is formed from bioabsorbable material, the
band 14 may remain around the disc 90 until it is absorbed by the
patient's body, similar to the embodiment described above.
Alternatively, the band 14 may be merely biocompatible, such that
the band 14 may remain within the patient's body indefinitely or
until the disc 90 has sufficiently healed.
[0058] The apparatus and methods of the present invention may be
performed alone or in conjunction with other procedures used to
treat a spinal disc. For example, a band of material may be secured
around a spinal disc after performing a procedure within an
interior of a spinal disc, such as those disclosed in application
Ser. No. 09/828,039, filed Apr. 6, 2001, entitled "Apparatus and
Methods for Treating Spinal Discs," the disclosure of which is
expressly incorporated herein by reference.
[0059] In addition, one or more guide members in accordance with
the present invention may be used to access a posterior region of a
spinal disc in order to perform a diagnostic and/or therapeutic
procedure at the posterior region of the spinal disc. For example,
an imaging device, such as an endoscope (not shown), may be
inserted through the guide member to observe, monitor, or otherwise
image the posterior region and/or surrounding tissue
structures.
[0060] A therapeutic procedure may be performed at the posterior
region of the disc, e.g., following an imaging or diagnostic
procedure or concurrently with imaging (e.g., with multiple
instruments, not shown, being introduced through separate guide
members). A discectomy or other procedure may be performed that
involves removing at least a portion of the disc from the posterior
region (not shown). For example, nucleus pulposus material that has
leaked from within the disc may be removed. In addition or
alternatively, a prosthesis may be implanted within the disc from
the posterior region. A therapeutic agent may be introduced into
the posterior region or surrounding tissue to promote healing, pain
relief, and the like. In addition, a band may be wrapped around the
disc to stabilize the disc in a desired position relative to
surrounding anatomy, as described above.
[0061] In addition, access to the posterior region of a spinal disc
may be used to perform other interventions involving tissue
structures adjacent to or surrounding the disc, such as the spinal
cord or a spinal facet joint. Thus, instruments may be introduced
between the disc and surrounding ligament, e.g., through the guide
member, and directed to surrounding tissue structures in order to
complete other procedures while minimizing exposure of a patient's
spine.
[0062] While the invention is susceptible to various modifications,
and alternative forms, specific examples thereof have been shown in
the drawings and are herein described in detail. It should be
understood, however, that the invention is not to be limited to the
particular forms or methods disclosed, but to the contrary, the
invention is to cover all modifications, equivalents and
alternatives falling within the spirit and scope of the appended
claims.
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