U.S. patent application number 11/422222 was filed with the patent office on 2007-12-06 for intervertebral disc puncture and treatment system.
Invention is credited to Mohamed Attawia, Cynthia Lee, Michael O'Neil, Hassan Serhan.
Application Number | 20070282300 11/422222 |
Document ID | / |
Family ID | 38791242 |
Filed Date | 2007-12-06 |
United States Patent
Application |
20070282300 |
Kind Code |
A1 |
Attawia; Mohamed ; et
al. |
December 6, 2007 |
Intervertebral Disc Puncture and Treatment System
Abstract
A pre-assembled, telescoping needle system comprising an outer
needle surrounding a finer gauge needle which, after percutaneous
penetration by the outer needle, extends to penetrate the
intervertebral disc into which the injectable is to be
delivered.
Inventors: |
Attawia; Mohamed; (Canton,
MA) ; Lee; Cynthia; (Jamaica Plain, MA) ;
Serhan; Hassan; (South Easton, MA) ; O'Neil;
Michael; (West Barnstable, MA) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
38791242 |
Appl. No.: |
11/422222 |
Filed: |
June 5, 2006 |
Current U.S.
Class: |
604/506 |
Current CPC
Class: |
A61B 2017/00039
20130101; A61B 17/0218 20130101; A61F 2002/4627 20130101; A61B
2017/0262 20130101; A61F 2/4611 20130101; A61B 2017/00026 20130101;
A61B 17/3415 20130101; A61B 2017/00261 20130101; A61F 2002/444
20130101 |
Class at
Publication: |
604/506 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61M 31/00 20060101 A61M031/00 |
Claims
1. A method of delivering a therapeutic agent to a patient having
an intervertebral disc having an annulus fibrous and a nucleus
pulposus, comprising the steps of: a) providing a therapeutic
delivery system, comprising: i) an outer needle having a distal
end, and ii) an inner needle received within the outer needle and
having a distal end, b) inserting the outer needle into the patient
at a location dorsal of the intervertebral disc, c) advancing the
outer needle to abut the annulus fibrosus, and d) advancing only
the inner needle into the nucleus pulposus.
2. The method of claim 1 wherein the inner needle has an outer
surface having i) a first proximal outer diameter, and ii) a second
distal outer diameter, wherein the first proximal outer diameter is
greater than the second distal outer diameter.
3. The method of claim 1 wherein the delivery system further
comprises: iii) a syringe in fluid connection with the inner
needle, wherein the syringe contains a therapeutic agent.
4. The method of claim 3 further comprising the step of: e)
actuating the syringe to inject the therapeutic agent into the
nucleus pulposus.
5. The method of claim 3 further comprising the step of: e)
removing the inner needle from the outer needle, and f) inserting a
second inner needle into the outer needle.
6. A needle system for delivery of a therapeutic agent, comprising:
a) an outer needle having an outer surface having a transverse
throughhole, and a detent provided in the throughhole, the detent
having a projection extending inwardly, and b) an inner needle
having an outer surface having a plurality of axially spaced
grooves, wherein the projection of the detent is shaped to be
received in the plurality of axially spaced grooves.
7. The system of claim 6 wherein the outer surface of the inner
needle has a first proximal outer diameter upon which the grooves
are located and a second distal outer diameter, wherein the first
proximal outer diameter is greater than the second distal outer
diameter.
8. The system of claim 7 wherein the system further comprises: c)
an annular plug disposed within a distal end of the outer needle
and adapted to fit between the inner and outer needles.
9. The system of claim 6 further comprising: c) a syringe in fluid
connection with the inner needle, wherein the syringe contains a
therapeutic agent.
10. The system of claim 6 wherein the system is pre-assembled.
11. The system of claim 6 wherein the outer surface of the inner
needle has a plurality of depth markings.
12. A needle system for delivery of a therapeutic agent,
comprising: a) an outer needle having an inner surface having a
first thread, and b) an inner needle having an outer surface having
a second thread, wherein the first thread is adapted to mate with
the second thread.
13. The system of claim 12 wherein the outer surface of the inner
needle has a first proximal outer diameter upon which the second
thread is located and a second distal outer diameter, wherein the
first proximal outer diameter is greater than the second distal
outer diameter.
14. The system of claim 13 wherein the system further comprises: c)
an annular plug disposed within a distal end of the outer needle
and adapted to fit between the inner and outer needles.
15. The system of claim 12 further comprising: c) a syringe in
fluid connection with the inner needle, wherein the syringe
contains a therapeutic agent.
16. The system of claim 12 wherein the system is pre-assembled.
17. The system of claim 12 wherein the outer surface of the inner
needle has a plurality of depth markings.
18. A needle system for delivery of a therapeutic agent,
comprising: a) an outer needle having an inner surface, and b) an
inner needle having an outer surface, wherein one of the needles
has a tab extending from its surface, the other needle has a
channel in its surface, and wherein the tab is received in the
channel.
19. The needle system of claim 18 wherein the channel has a
plurality of alternating axial portions and lateral portions.
20. The needle system of claim 18 wherein the inner surface of the
outer needle has the tab and the outer surface of the inner needle
has the channel.
21. The needle system of claim 18 wherein the inner surface of the
outer needle has the channel and the outer surface of the inner
needle has the tab.
22. The system of claim 18 wherein the outer surface of the inner
needle has a first proximal outer diameter upon which the tab or
channel is located and a second distal outer diameter, wherein the
first proximal outer diameter is greater than the second distal
outer diameter.
23. The system of claim 22 wherein the system further comprises: c)
an annular plug disposed within a distal end of the outer needle
and adapted to fit between the inner and outer needles.
24. The system of claim 18 further comprising: c) a syringe in
fluid connection with the inner needle, wherein the syringe
contains a therapeutic agent.
25. The system of claim 18 wherein the system is pre-assembled.
26. The system of claim 18 wherein the outer surface of the inner
needle has a plurality of depth markings.
Description
BACKGROUND OF THE INVENTION
[0001] The natural intervertebral disc contains a jelly-like
nucleus pulposus surrounded by a fibrous annulus fibrosus. Under an
axial load, the nucleus pulposus compresses and radially transfers
that load to the annulus fibrosus. The laminated nature of the
annulus fibrosus provides it with a high tensile strength and so
allows it to expand radially in response to this transferred
load.
[0002] In a healthy intervertebral disc, cells within the nucleus
pulposus produce an extracellular matrix (ECM) containing a high
percentage of proteoglycans. These proteoglycans contain sulfated
functional groups that retain water, thereby providing the nucleus
pulposus with its cushioning qualities. These nucleus pulposus
cells may also secrete small amounts of cytokines as well as matrix
metalloproteinases ("MMPs"). These cytokines and MMPs help regulate
the metabolism of the nucleus pulposus cells.
[0003] In some instances of disc degeneration disease (DDD),
gradual degeneration of the intervertebral disc is caused by
mechanical instabilities in other portions of the spine. In these
instances, increased loads and pressures on the nucleus pulposus
cause the cells to emit larger than normal amounts of the
above-mentioned cytokines. In other instances of DDD, genetic
factors, such as programmed cell death, or apoptosis can also cause
the cells within the nucleus pulposus to emit toxic amounts of
these cytokines and MMPs. In some instances, the pumping action of
the disc may malfunction (due to, for example, a decrease in the
proteoglycan concentration within the nucleus pulposus), thereby
retarding the flow of nutrients into the disc as well as the flow
of waste products out of the disc. This reduced capacity to
eliminate waste may result in the accumulation of high levels of
toxins.
[0004] As DDD progresses, the toxic levels of the cytokines present
in the nucleus pulposus begin to degrade the extracellular matrix.
In particular, the MMPs (under mediation by the cytokines) begin
cleaving the water-retaining portions of the proteoglycans, thereby
reducing their water-retaining capabilities. This degradation leads
to a less flexible nucleus pulposus, and so changes the load
pattern within the disc, thereby possibly causing delamination of
the annulus fibrosus. These changes cause more mechanical
instability, thereby causing the cells to emit even more cytokines,
typically thereby upregulating MMPs. As this destructive cascade
continues and DDD further progresses, the disc begins to bulge ("a
herniated disc"), and then ultimately ruptures, causing the nucleus
pulposus to contact the spinal cord and produce pain.
[0005] US Published Patent Application 2004/0229878 discloses a
procedure for the intradiscal administration of therapeutics,
wherein an outer needle and an inner stylet are advanced to the
annulus fibrosus, the stylet is withdrawn and replaced with an
inner needle attached to a syringe, and the inner needle is
advanced to the nucleus pulposus for injection of the therapeutic
into the nucleus pulposus.
[0006] In other approaches, a single, fine gauge needle is used to
penetrate the skin and musculature approaching the intervertebral
disc. However, the drawbacks of this approach include the need for
a relatively sturdy needle and an increase in the risk of infection
to the disc (due to the fact that the needle that pierces the skin
is also the needle that enters the disc).
[0007] To reduce the risk of infection and subsequent discitis that
may result from percutaneous procedures, one common practice is to
use a double needle approach in which a larger gauge needle is used
to penetrate the skin and a second finer, gauge needle is passed
through the first needle and into the intervertebral disc. However,
this approach requires two separate needles and manual insertion of
the second needle inside of the first.
[0008] Some needle systems developed for use outside of the disc
area have dual needle designs. For example, in needle systems
unrelated to intradiscal delivery of therapeutics, various needle
systems and procedures are employed for aspirating body fluids, and
some of these employ concentric multi-gauge needles. Various access
needle systems designed to treat ailing tissue are made to allow a
second device to pass through an outer access needle. Various
extendable/retractable needle systems exist as safety devices to
prevent user injury by needle sticks.
[0009] U.S. Pat. Nos. 5,871,470 and 6,245,044 disclose a set of
interlocking concentric epidural-spinal needles for delivery of
medicaments into the epidural and subarachnoid spaces. However,
these systems contain two separate needles that the user must
assemble. Neither system is pre-assembled.
[0010] U.S. Pat. Nos. 6,497,686 and 6,695,822 disclose a method and
device for performing sterile endoluminal procedures using a needle
system that includes two concentric needles. However, these systems
do not allow for aspiration of the medicament into an attached
syringe. Moreover, the distal portion of the device is designed to
remain in place after the procedure is completed.
SUMMARY OF THE INVENTION
[0011] It is an object of the present invention to provide simple
and safe percutaneous access to the intervertebral disc for
intradiscal delivery of therapeutic agents to the disc.
[0012] The present inventors have developed a pre-assembled,
telescoping needle system comprising an outer needle surrounding a
finer gauge inner needle. After percutaneous penetration by the
outer needle and its advance to the annulus fibrosus, the inner
needle is moved distally to extend past the outer needle and
penetrate the intervertebral disc. A therapeutic agent may then be
delivered from a syringe through the inner needle and into the
nucleus pulposus.
[0013] The needle system of the present invention provides a number
of advantages over the conventional intradiscal needle systems.
[0014] First, the needle system is pre-assembled. This enables both
ease of use by the clinician and a reduced diameter of the inner
(injection) needle, as it is supported by the outer needle during
its insertion at the disc site.
[0015] Second, there is a reduced risk of discitis (intradiscal
infection). The inner injection needle is shielded by the outer
cannula from contact or exposure to the operative environment, skin
and soft inner tissues. This reduced exposure yields a reduced
infection potential.
[0016] Third, the invention provides a controlled discal injection
depth. The present invention allows for placement of the tip of the
outer needle at or upon the outer rim of the annulus fibrosus, and
subsequent advancement of the inner needle into the disc space.
Controlled and monitored advancement of the inner needle into the
disc space allows for pre-determination or measured determination
of intradiscal injection depths and associated location.
[0017] Therefore, in accordance with the present invention, there
is provided a method of delivering a therapeutic agent to an
intervertebral disc having an annulus fibrous and a nucleus
pulposus, comprising the steps of: [0018] a) providing a
therapeutic delivery system, comprising: [0019] i) an outer needle
having a distal end, and [0020] ii) an inner needle received within
the outer needle and having a distal end, [0021] b) inserting the
outer needle into the patient at a location dorsal of the
intervertebral disc, [0022] c) advancing the outer needle to abut
the annulus fibrosus, and then [0023] d) advancing only the inner
needle into the nucleus pulposus.
DESCRIPTION OF THE FIGURES
[0024] FIG. 1A discloses a cross section of the needle system of
the present invention having a ball detent locking mechanism, prior
to its deployment into an intervertebral disc.
[0025] FIG. 1B is an enlarged cross section of the locking
mechanism of FIG. 1Aa.
[0026] FIG. 2 discloses a cross section of the needle system of
FIG. 1A, after its deployment into an intervertebral disc.
[0027] FIG. 3A discloses a cross section of the needle system of
the present invention having a threaded locking mechanism, prior to
its deployment into an intervertebral disc.
[0028] FIG. 3B is an enlarged cross section of the locking
mechanism of FIG. 3A.
[0029] FIG. 4 discloses a cross section of the needle system of
FIG. 3A, after its deployment into an intervertebral disc.
[0030] FIG. 5A discloses a cross section of the needle system of
the present invention having a keyed locking mechanism, prior to
its deployment into an intervertebral disc.
[0031] FIG. 5B is an enlarged cross section of the locking
mechanism of FIG. 5A.
[0032] FIG. 5C is a perspective view of the inner needle of FIG. 5A
having a channel herein.
[0033] FIG. 6 discloses a cross section of the needle system of
FIG. 5A, after its deployment into an intervertebral disc.
[0034] FIGS. 7a-7b disclose cross sections of generalized needle
systems of the present invention.
[0035] FIGS. 8a-8b disclose cross sections of needle systems of the
present invention having threaded advancement.
[0036] FIGS. 9a-9d disclose cross sections of needle systems of the
present invention having keyed advancement.
DETAILED DESCRIPTION OF THE INVENTION
[0037] The present invention comprises a dual needle intradiscal
device comprising a larger gauge outer needle and a smaller gauge
inner needle. Preferably, the needles are sized for intradiscal
injection through a percutaneous approach.
[0038] The outer needle serves as the access needle, as it
functions to pierce and penetration the patient's skin and muscle
up to the annulus fibrosus. Further, it functions as a shield for
the inner needle prior to its entry into the disc, thereby
minimizing the chances of the inner needle infecting the disc and
subsequent discitis. Preferably, the outer needle has a sufficient
stiffness and length to penetrate the skin and underlying muscle,
and is more preferably between 10 gauge and 20 gauge in bore
diameter and between 8 cm and 20 cm in length.
[0039] The inner needle has a length sufficient to penetrate the
annulus fibrosus region of the disc, and is typically between 4 cm
and 10 cm longer than the outer needle. In order to minimize damage
to the intervertebral disc, the inner needle should be a fine gauge
needle, preferably between 22 gauge and 32 gauge. The proximal end
of the inner needle can attach to a standard syringe.
[0040] Preferably, the position of the outer needle can be advanced
and then fixed at various positions along the axis of the inner
needle according to the needs of the clinician. This is preferably
accomplished with a locking mechanism.
[0041] For example, in one embodiment, the inner needle is first
set in a first locked position to extend about 0.5 cm to 1 cm
beyond the outer needle so that medicament can be aspirated
proximally into the syringe through the distal end of the inner
needle. Once the medicament has been aspirated into the syringe,
the locking mechanism can be unlocked and the inner needle
retracted and fixed at a new position such it sits 0.5 cm to 1 cm
proximal to the distal end of the outer needle. In this second
locked position, the needle system can be inserted through the
patient's skin. When the outer needle has penetrated to a
sufficient depth (such as up to the annulus fibrosus), the locking
mechanism can again be unlocked and the inner needle can slide
distally relative to the outer needle and penetrate the disc.
[0042] In some preferred embodiments, the locking mechanism is
provided via a ball detent mechanism. Now referring to FIGS. 1A and
1B, in some embodiments, there is provided a needle system 1 for
intradiscal delivery of a therapeutic agent, comprising: [0043] a)
an outer needle 3 having an outer surface 5 having a transverse
throughhole 7, and a detent 9 provided in the throughhole, the
detent having a projection 11 extending inwardly, and [0044] b) an
inner needle 13 having an outer surface 15 having a plurality of
axially spaced grooves 17, wherein the projection of the detent is
shaped to be received in the plurality of axially spaced
grooves.
[0045] In some embodiments thereof, the outer surface of the outer
needle has a hole therein into which a pushbutton detent is
releasably provided. The outer surface of the inner needle contains
a plurality of grooves spaced at predetermined intervals. When the
push button of the outer needle is engaged with groove of the inner
needle, the needle system is locked and the relative axial
positions of the two needles are fixed. When the push button of the
outer needle is disengaged from a groove of the inner needle, the
system is unlocked and the inner needle may be moved forward or
backward relative to the outer needle (or vice versa). FIG. 2 shows
the distal movement of the inner needle 13 by a single stop
interval as compared to its position in FIG. 1A.
[0046] In some preferred embodiments, the locking mechanism is
provided via a pair of mating threads. In these embodiments, the
inner needle can be threadably connected to the outer needle and
advanced to a desired depth in the disc by rotation of the inner
needle within the outer needle. Now referring to FIGS. 3A and 3B,
in some embodiments, there is provided a needle system 21 for
intradiscal delivery of a therapeutic agent, comprising: [0047] a)
an outer needle 23 having an inner surface 25 having a first thread
27, and [0048] b) an inner needle 31 having an outer surface 33
having a second thread 35, wherein the first thread is adapted to
mate with the second thread.
[0049] When one of the needles is rotated in respect to the other
needle, the relative rotation of the engaged threads is such that
axial movement of the inner needle is accomplished.
[0050] FIG. 4 shows the distal movement of the inner needle
produced by relative rotation of the threads, as compared to its
position in FIG. 3A.
[0051] Now referring to FIG. 5A-5C, in some embodiments, the stops
are provided by a keyed mechanism. In FIGS. 5A-5C, there is
provided a needle system 51 for intradiscal delivery of a
therapeutic agent, comprising: [0052] a) an outer needle 61 having
an inner surface 63 having a tab 65 extending therefrom, and [0053]
b) an inner needle 71 having an outer surface 73 having a channel
75 therein, wherein the tab is received in the channel.
[0054] In preferred embodiments thereof, the inner diameter of the
outer needle has a tab extending therefrom, while the outer
diameter of the inner needle has a channel therein, wherein the
channel has alternating axial and lateral portions defining a
plurality of stop intervals. In use, the clinician moves the inner
needle distally until the tab of the outer needle abuts the lateral
portion of the inner needle. If the clinician desires to move the
inner needle distally again, the clinician rotates the inner needle
so that the tab moves along the lateral portion of the channel and
enters the next axial portion of the channel. The clinician then
moves the inner needle axially once again, with the channel of the
inner needle being guided by the tab, until the tab of the outer
needle abuts the next lateral portion of the inner needle.
[0055] FIG. 6 shows the distal movement of the inner needle
produced by movement of the tab in the channel, as compared to its
position in FIG. 5A.
[0056] In other embodiments using a keyed locking mechanism, the
inner surface of the outer needle has the channel and the outer
surface of the inner needle has the tab. In one preferred
embodiment, the keyed locking mechanism includes a simple
twist-lock mechanism such that in two predetermined rotational
positions (e.g., 0.degree. and either 45.degree., 90.degree.,
180.degree., or 270.degree.), the outer needle can slide relative
to the inner needle.
[0057] In some embodiments using a locking mechanism, and now
referring to FIG. 1A, the inner needle has a first proximal outer
diameter 81 and a second distal outer diameter 83, wherein the
first proximal outer diameter is greater than the second distal
outer diameter. This embodiment minimizes the diameter of the
portion of the needle that penetrates the annulus fibrosus, thereby
reducing injury to the annulus fibrosus. In some embodiments
thereof, the system further comprises an annular plug 85 disposed
within the distal end of the outer needle and adapted to fit
between the inner and outer needles. The annular plug prevents
fluid from entering the bore of the outer needle when the inner
needle has a reduced diameter and provides a guide for the distal
advance of the inner needle. In this embodiment, the first proximal
outer diameter is preferably sized to be slightly less than the
inner diameter of the outer needle, so that the locking mechanism
(whether it be a ball detent mechanism, a pair of threads, or a
keyed mechanism) possesses a snug fit.
[0058] In some embodiments, after the medicament is administered,
the locking mechanism can be re-engaged and the two needles can be
removed together from the patient. In other embodiments, after the
medicament is administered, the locking mechanism remains
disengaged and the two needles are removed independently.
[0059] In some embodiments wherein only the inner needle is
removed, a second needle can be inserted through the same outer
needle. In some embodiments thereof, this second inner needle may
be a standard needle that does not lock to the outer needle. In
other embodiments thereof, this second inner needle may comprise a
locking feature that is engageable with a locking feature of the
outer needle.
[0060] In some embodiments, depth markings can be provided to allow
the clinician to measure the depth of discal entry and location of
the treatment within the nucleus pulposus, and thereby control the
depth of discal entry and location of the treatment within the
nucleus pulposus.
[0061] The needle system of the present invention can be suitably
used to inject therapeutic agents into intravertebral disc and
synovial joints (such as facet joints, hip joints and knee joints).
It may be used in the aspiration of bone marrow or for biopsy
procedures.
[0062] In some embodiments, the therapuetic materials disclosed in
US Published Patent Application 2004/0229878, which is incorporated
by reference in its entirety, are injected into the disc.
[0063] FIGS. 7a and 7b depict the general concept of the
Intervertebral Puncture and Treatment System in its respective
pre-insertion and post-insertion modes. During pre-insertion, and
now referring to FIG. 7a, the tips of the outer cannula 101 and
inner needle 103 are aligned and advanced until disc contact is
observed. In some embodiments thereof, the outer cannula is about
18 gauge RW, with a 0.033 inch ID and a 0.050 inch OD, while the
inner delivery needle is about 22 gauge RW, with a 0.016 inch ID
and a 0.028 inch OD. Also shown is a generalized representation of
a depth control means 105 (that is enabled in subsequent figures by
threaded advancement and keyway stops). Depth control markings 107
correspond to the insertion depth (.times.mm) into the disc
following contact with the annular wall, as can be seen in the
post-insertion image FIG. 7b.
[0064] Now referring to FIG. 8a, there is provided a more detailed
embodiment depicted device orientation pre-insertion into the disc.
This device has a threaded advancement means 110 and a positive
depth stop 111 (as shown by ghost threads) at an insertion depth of
.times.mm. Handles 113 are provided on each of the outer cannula
115 and inner needle 117 to assist in threading the inner needle
into the outer cannula. Also shown in this FIG. 8a is the treatment
attachment location 119 (which may be, for example, a luer slip,
luer lock, or injection cap) at which the device is attached to a
treatment container 120 (which may be, for example, a syringe,
vial, bag, or pouch).
[0065] FIG. 8b discloses the threaded advancement device of FIG. 8a
following insertion into the disc. In this case, threaded
advancement of the inner needle has been stopped by the positive
depth stop 111 (provided by the end of the threads) at a
predetermined depth of .times.mm. Also shown in this figure are
handles 113, outer cannula 115, inner needle 117, and the treatment
container 120 attached to the inner needle 117 at treatment
attachment location 119 for dispensing at desired depth.
[0066] Now referring to FIGS. 9a and 9b, there is provided a device
having an outer cannula 121, an inner needle 123, advancement
handles 125, a treatment container 127 attached to the inner needle
at a treatment location 129, and keyed advancement means 131 in its
pre-insertion configuration. The key 133 is located on either the
outer and inner needle (shown here on the inner needle as a
protrusion) and is disposed within keyway 135. The distance between
the key and the keyway stop 137 will control the depth of
intradiscal insertion (2.times.mm) following contact with the
annulus.
[0067] Now referring to FIGS. 9c and 9d, there is provided the
device of FIGS. 9a and 9b in its post-insertion configuration. In
this case, inner needle 123 and its accompanying key 133 have been
advanced until the keyway stop is contacted (.times.mm). Additional
advancement of the inner needle (for example, 2.times.mm) may be
obtained by rotating the inner needle (for example, 90 degrees) and
applying an advancement force until the second key way stop is
contacted.
EXAMPLE I
[0068] This non-limiting prophetic example describes how to
transdiscally administer a formulation comprising a therapeutic
agent and saline into a nucleus pulposus of a degenerating
disc.
[0069] First, a clinician uses a diagnostic test to verify that a
particular disc within a patient has high levels of a particular
pro-inflammatory cytokine.
[0070] Next, the clinician provides a local anesthetic (such as 5
ml lidocaine) to the region dorsal of the disc of concern to reduce
subcutaneous pain.
[0071] Next, the clinician punctures the skin of the patient dorsal
the disc of concern with a relatively large (e.g., 18-19 gauge)
needle having a smaller gauge needle contained therein, and
advances the needle through subcutaneous fat and dorsal sacrolumbar
ligament and muscles to the outer edge of the intervertebral disc.
The proximal end opening of the smaller needle is fluidly connected
to a syringe. The barrel of the syringe contains the formulation of
the present invention. The formulation contains REMICADE.RTM.
infliximab, and has an infliximab concentration of between about 30
mg/ml and about 60 mg/ml.
[0072] Next, the physician advances the smaller needle co-axially
through the larger needle and past the distal end of the larger
needle, thereby puncturing the annulus fibrosus. The smaller needle
is then further advanced into the center of the nucleus pulposus.
Finally, the clincian depresses the plunger of the syringe, thereby
injecting between about 0.1 and 1 ml of the formulation into the
nucleus pulposus.
* * * * *