U.S. patent application number 14/249669 was filed with the patent office on 2014-08-28 for red light implant for treating the spine.
This patent application is currently assigned to DePuy Synthes Products, LLC. The applicant listed for this patent is Mohamed Attawia, Thomas M. DiMauro, Jeffrey K. Sutton. Invention is credited to Mohamed Attawia, Thomas M. DiMauro, Jeffrey K. Sutton.
Application Number | 20140243937 14/249669 |
Document ID | / |
Family ID | 37895170 |
Filed Date | 2014-08-28 |
United States Patent
Application |
20140243937 |
Kind Code |
A1 |
DiMauro; Thomas M. ; et
al. |
August 28, 2014 |
Red Light Implant for Treating the Spine
Abstract
Red light-emitting implants for treating a spine.
Inventors: |
DiMauro; Thomas M.;
(Southboro, MA) ; Attawia; Mohamed; (Eatontown,
NJ) ; Sutton; Jeffrey K.; (Medway, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DiMauro; Thomas M.
Attawia; Mohamed
Sutton; Jeffrey K. |
Southboro
Eatontown
Medway |
MA
NJ
MA |
US
US
US |
|
|
Assignee: |
DePuy Synthes Products, LLC
Raynham
MA
|
Family ID: |
37895170 |
Appl. No.: |
14/249669 |
Filed: |
April 10, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12117712 |
May 8, 2008 |
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14249669 |
|
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11235664 |
Sep 26, 2005 |
7465313 |
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12117712 |
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Current U.S.
Class: |
607/92 |
Current CPC
Class: |
A61N 2005/063 20130101;
A61N 5/0601 20130101; A61N 2005/0651 20130101; A61N 2005/0663
20130101; A61N 2005/0659 20130101 |
Class at
Publication: |
607/92 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. A method of treating a spine, comprising the steps of: a)
implanting into a vertebral body an implant comprising a light
source and an emission surface, b) powering the light source to
transmit light from the light source through the emission surface
and across a vertebral endplate.
2. The method of claim 1 further comprising the step of: c)
orienting the implant so that the emission surface faces the
vertebral endplate.
3. The method of claim 1 wherein the light source transmits light
having a wavelength of between about 650 nm and about 1000 nm.
Description
CONTINUING DATA
[0001] This continuation patent application claims priority from
co-pending U.S. Ser. No. 12/117,712, filed May 8, 2008, entitled
"Red Light Implant for Treating Degenerative Disc Disease", and
from U.S. Ser. No. 11/235,664, filed Sept. 26, 2005, entitled "Red
Light Implant for Treating Degenerative Disc Disease" (Now U.S.
Pat. No. 7,465,313), the specifications of which are incorporated
by reference herein in their entireties.
BACKGROUND OF THE INVENTION
[0002] 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.
[0003] 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.
[0004] 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.
[0005] 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.
SUMMARY OF THE INVENTION
[0006] The present inventors have noted that the literature reports
that low level laser therapy may be effective in cartilage repair.
As the intervertbeal disc consists essentially of cartilage, the
present inventors believe that red light irradiation of the
intervertebral disc may provide a useful therapy to DDD.
[0007] The literature has consistently reported that red light
irradiation of cartilage stimulates extracellular matrix
production. For example, Spivak, Arthroscopy, 1992, 8(1) 36-43
applied 51-127 J/cm.sup.2 of red light to full-thickness articular
cartilage explants maintained in organ culture, and found
stimulation of extracellular matrix synthesis at 6-7 days following
laser exposure. Herman, J. Rheumatol. 1988, Dec. 15(12), 1818-26
assessed the in vitro affect of red light laser on mature normal
bovine articular cartilage metabolism, and found that normal pulsed
mode delivery of defined energy levels could be shown to
consistently upregulate cartilage proteoglycan, collagen,
non-collagen protein and DNA synthesis. Herman concludes that red
light irradiation applied directly at surgery or via arthroscopy
may provide a potential means of effecting cartilage healing. Jia,
Lasers Surg. Medicine, 34, 323-328, 2004 examined the 1-6
J/cm.sup.2 red light irradiation of rabbit articular cartilage in
vitro, and found that irradiation produced considerably higher cell
proliferation activity, and that 4-5 J/cm.sup.2 irradiation
produced a positive effect on synthesis and secretion of
extracellular matrix. Jia concluded that low power laser
irradiation treatment is likely to achieve the repair of articular
cartilage in the clinic. Cho, In Vivo, 18, 585-92 (2004) examined
the effects of low power red light irradiation upon the
osteoarthritic knees of rabbits, and reported that regeneration of
articular cartilage was seen in gross observation of the 4-week
treatment group. Cho concluded that low power red light irradiation
was effective in treating chemically-induced osteoarthritis.
Because one of the hallmarks of DDD is the degeneration of the ECM
(leading to decreased disc flexibility), it is believed that red
light irradiation of the disc will help the disc regain its
flexibility.
[0008] Chondrocyte apoptosis is believed to play a major role in
DDD. Rannou, Am. J. Pathology, 164(3), Mar 2004, 915-924, and
Ariga, Spine, 28(14), 1528-33 (2003). The present inventors have
further noted that low level laser therapy has been found to be
effective in enhancing cell viability and preventing apoptosis.
Morrone, Artif. Cells Blood Substit. Immobil. Biotechnol. 2000,
Mar., 28(2) 193-201 examined the effects of 780 nm red light on
cartilage cells in vitro and reported that the data showed good
results in terms of cell viability and levels of calcium and
alkaline phosphate in the groups treated with laser biostimulation.
Torricelli, Biomed. Phamacother., 2001, Mar. 55(2) 117-20 evaluated
the effect of red light upon chondrocyte cultures derived from
rabbit and human cartilage, and found a positive biostimulation
effect on cell proliferation and an increase in cell viability.
Torricelli concluded that these results provide a basis for a
rational approach to the experimental and clinical use of red
light. Lin, Am. J. Phys. Med. Rehabil. 2004, Oct. 83(10), 758-65
evaluated the effect of red light irradiation upon stress proteins
in induced arthritis, found the irradiation enhanced stress protein
production in arthritic chondrocytes, and concluded that low power
laser has a therapeutic effect in preserving chondrocytes. Schultz,
Lasers Surg. Med. 1985, 5(6), 577-88 irradiated partial thickness
cartilage defects in guinea pigs with red light and found that the
knees exposed to 25-75 J demonstrated a reparative process with
chondral proliferation.
[0009] In addition, low level laser therapy has also been found to
prevent apoptosis in other non-cartilage systems as well. See
Shefer, J. Cell Science, 115, 1461-9(2002) (skeletal muscle
satellite cells) and Carnevalli, J. Clin. Laser. Med. Surg. 2003,
Aug. 21(4), 193-6 (Cho K-1 cell line). Wong-Riley, J. Biol. Chem.
2004, e-pub Nov. 22, reports that irradiating neurons with 670 nm
red light significantly reduced neuronal cell death induced by 300
mM KCN from 83.6% to 43.5%.
[0010] The literature has further reported that oxidative stress
plays a major role in the beginning stages of DDD. Borenstein,
Curr. Opin. Rheumatol., 1999, Mar 11(2) 151-7. Cho, In Vivo, 18,
585-92 (2004) examined the effects of low power red light
irradiation upon the osteoarthritic knees of rabbits, and reported
that anti-oxidant superoxide dismutase (SOD) activity increased
40%. Therefore, it appears that red light may be useful in treating
the oxidative stress component of DDD as well.
[0011] Without wishing to be tied to a theory, it is further
believed that the red light irradiation of cells upregulates
cytochrome c oxidase activity in those cells. Cytochrome c oxidase
(also known as complex IV) is a major photoacceptor. According to
Wong-Riley, Neuroreport, 12:3033-3037, 2001, in vivo, light close
to and in the near-infrared range is primarily absorbed by only two
compounds in the mammalian brain, cytochrome c oxidase and
hemoglobin. Cytochrome c oxidase is an important energy-generating
enzyme critical for the proper functioning of many cell lines. The
level of energy metabolism in cells is closely coupled to their
functional ability, and cytochrome c oxidase has proven to be a
sensitive and reliable marker of cellular activity.
[0012] By increasing the energetic activity of cytochrome oxidase,
the energy level associated with cellular metabolism may be
beneficially increased. Indeed, the literature reports that red
light reverses the inhibitory effects of toxins upon cytochrome
oxidase activity, leading to increased energy metabolism in neurons
functionally inactivated by toxins. Wong-Riley Neuroreport 12(14)
2001:3033-3037 and Wong-Riley, J. Biol. Chem.,e-pub, Nov. 22,
2004.
[0013] Accordingly, the present inventors have developed inventions
for treating DDD based upon low level laser therapy that take
advantage of this therapy's ability to induce cartilage repair and
prevent apoptosis.
[0014] Therefore, in accordance with the present invention, there
is provided a method of treating DDD, comprising the step of :
[0015] a) irradiating the intervertebral disc with an amount
effective red light.
DESCRIPTION OF THE FIGURES
[0016] FIG. 1 is a cross-section of a preferred red light implant
of the present invention.
[0017] FIG. 2 is a cross-section of the implant of FIG. 1 embedded
with a vertebral body.
[0018] FIG. 3 is a cross-section of the implant of the present
invention embedded with a vertebral body, wherein the implant has a
subcutaneous red light collector.
[0019] FIG. 4 is a cross-section of the implant of the present
invention embedded with a vertebral body, wherein the implant has a
subcutaneous Rf antenna.
[0020] FIG. 5 is a cross-section of the implant of the present
invention embedded with a vertebral body, wherein the implant has
an Rf antenna contained within the vertebral body.
[0021] FIG. 6 is representative circuitry that may be included in
the implants of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0022] In some preferred embodiments, the therapeutic red light is
delivered across the vertebral endplates adjacent the disc into the
disc, preferably into the nucleus pulposus. This mode of delivery
allows the clinician to avoid harming the disc. Such delivery can
be effected by implanting a red light LED into the adjacent
vertebral body, or by implanting a red light conduit into the
adjacent vertebral body.
[0023] In other preferred embodiments, the therapeutic red light is
delivered across the outside surface of the annulus fibrosus of the
disc and preferably into the nucleus pulposus. Such delivery can be
effected by anchoring a red light LED onto an outside surface of an
adjacent vertebral body, and intradiscally directing the red light
emitted by the LED.
[0024] In other preferred embodiments, the therapeutic red light is
delivered to the disc through an intradiscal implant having a red
light source.
[0025] Now referring to FIG. 1, there is provided an intraosteal
red light implant 1 for treating DDD, comprising: [0026] a) a
hollow tube 3 having a throughbore, a proximal end portion 5 and a
distal end portion 7, the distal end portion forming a sharp tip 9.
[0027] b) a red light translucent material 11 disposed within the
throughbore at the distal end of the tube and forming an emission
surface 17, [0028] c) a power source 13 disposed within the
throughbore at the proximal end portion, [0029] d) a red light LED
15 disposed between the power source and translucent material.
[0030] Now referring to FIG. 2, in one preferred embodiments, there
is provided a method of treating a degenerating disc comprising a
nucleus pulposus NP and an annulus fibrosus AF, comprising the
steps of: [0031] a) implanting into a vertebral body VB an implant
1 comprising a red light source 15 and an emission surface 17,
[0032] b) orienting the implant 1 so that the emission surface 17
faces the vertebral endplate EP (preferably, the center of the
vertebral endplate), and [0033] c) powering the red light source 15
to transmit red light from the red light source 15 through the
emission surface 17 and through the vertebral endplate EP to the
intervertebral disc.
[0034] The implantation of the implant is preferably achieved by
inserting the implant through the skin and soft tissue to contact
the vertebral body slightly above and lateral to the pedicle, then
puncturing the cortical rim of the vertebral body at that location
with the sharp tip of the implant, then advancing the implant
towards the center of the lower endplate of the punctured vertebral
body. Once the implant arrives at the lower endplate, the implant
is rotated to insure that the emission surface is essentially flush
with the lower endplate, preferably the center of the lower
endplate so that red light emitted from the implant crosses the
endplate and irradiates the nucleus pulposus.
[0035] The hollow tube of the implant may be made out of any number
of biocompatible materials, such as metal like titanium or CrCo,
and ceramics such as alumina. If the implant includes an antenna as
the power source, then it is preferred that the tube be a
ceramic.
[0036] Preferably, the distal end portion of the tube is filled
with a translucent material to form an emission surface. This
translucent material (which is preferably substantially transparent
to red light) acts as a conduit for red light emitted by the LED to
be emitted from the distal end of the tube. The provision of this
translucent material at the distal end also protects the red light
LED from direct contact with body fluids. In some embodiments, the
red light-translucent material comprises a red light translucent
polymer. In other embodiments, the red light-transmissible implant
comprises a UVB-translucent ceramic, such as glass. In preferred
embodiments, the translucent material is silica. The glass content
of the implant is preferably in the range of 20-40 volume percent
("v/o"). At higher glass contents, the implant becomes relatively
inelastic. At lower fractions, red light transmission is more
problematic. The red light translucent component of the implant may
be in the form of beads, long fibers or chopped fibers.
[0037] Preferably, the distal end portion of the tube is shaped to
form a sharp tip. This sharp tip provides two advantages. First, it
can be used to penetrate the cortical rim of the vertebral body.
Second, the angular nature of the tip produces an oval-shaped
opening at the distal end (which is filled by the translucent
material). The oval nature increases the surface area of the
emission of the red light from the tube, thereby increasing the
amount of tissue that can be therapeutically irradiated by the red
light.
[0038] In the middle of the implant 1 lies the red light LED.
Conventional red light LEDs that are commercially available may be
used as the red light LED of the present invention.
[0039] In order to protect the active elements of the device from
body fluids, in some embodiments, the red light LED is encased in a
casing. This casing both protects the LED components from body
fluids, and also prevents the LED components from elicting a
violent immune reaction In some embodiments, the casing is made of
a red light transparent material. The red light transparent
material may be placed adjacent the LED component so that red light
may be easily transmitted therethrough. In some embodiments, the
red light transparent casing is selected from the group consisting
of silica, alumina and sapphire. In some embodiments, the light
transmissible material is selected from the group consisting of a
ceramic and a polymer. Suitable red light-transmissible ceramics
include alumina, silica, CaF, titania and single crystal-sapphire.
Suitable red light transmissible polymers are preferably selected
from the group consisting of polypropylene and polyesters.
[0040] In the proximal portion of the implant lies the power
source. In some embodiments, the power source can be a battery. The
battery may be electrically coupled to a timer (not shown) that
provides periodic energizing of the LED. In other embodiments, the
power source can be an Rf antenna adapted to receive Rf energy for
an external Rf antenna.
[0041] In some embodiments, energy (such as Rf energy or red light)
is delivered transdermally and collected near the skin layer of the
patient. Such a configuration would allow light to be delivered
deep within the patient, or in or near critical organs or tissues,
and yet have the light source and associated components in a less
sensitive region. This configuration allows easier access to the
light/controller should the need arise for service or maintenance,
and also allows for more efficient transdermal energy transmission.
Moreover, by using a hollow tube with reflective internal surfaces,
light and therapeutic fluids could be delivered to the implanted
device. The light source/controller implanted near the patient's
skin could also be a simple, hollow chamber made to facilitate the
percutaneous access described above. The advantages and benefits of
this system include: [0042] a) further removal from the deep site
of the functional implant, thereby reducing risk of contamination
of the deeper site by percutaneous access; [0043] b) easier
precutaneous access by being closer to the skin surface and having
a larger surface area or target to access with the needle; [0044]
c) a larger volume could hold more therapeutic fluid to provide a
longer duration of activity; and [0045] d) a central reservoir
could provide therapy to multiple implants throughout the body.
[0046] In use, the surgeon implants the implant into the spine of
the patient so that the Rf receiving antenna is adjacent the
posterior portion of the vertebral body.
[0047] In some embodiments wherein the red light is delivered
transdermally, it may be advantageous to provide the red light
collection closer to the skin. Now referring to FIG. 3, there is
provided a first exemplary implant having an external light source.
The externally based-control device has a light source for
generating light within the device. The light generated by this
source is transmitted through fiber optic cable 103 through the
patient's skin to an internally-based light port 109. The light
port is adapted to be in light-communication with a fiber optic
cable 221 disposed upon the proximal surface 203 of the red light
implant 201. The implant, which may be simply a metal tube 205
filled with silica 207, receives the light and transmits the light
to the adjacent cancellous tissue.
[0048] Now referring to FIG. 4, there is provided a second
exemplary UV unit having an internal light source. Externally
based-control device 222 has an RF energy source 224 and an antenna
230 for transmitting signals to an internally-based antenna 232
provided on the prosthesis. These antennae 230, 232 may be
electro-magnetically coupled to each other. The internal antenna
232 sends electrical power to a light emitting diode (LED) 15
disposed internally on the implant in response to the transmitted
signal transmitted by the external antenna 230. The light generated
by the LED travels across the red light transparent layer 11,
across the endplate and into the disc.
[0049] In some embodiments, the implant having an internal light
source further contains an internal power source, such as a battery
(not shown). The battery, which could be re-chargeable, is
controlled by an internal receiver and has sufficient energy stored
therein to deliver electrical power to the light source in an
amount sufficient to cause the desired light output.
[0050] When the implant is coupled with external energy, power can
be transmitted into the internal device to re-charge the
battery.
[0051] In some embodiments, the light generated by the implant is
powered by wireless telemetry integrated onto or into the implant
itself Now referring to FIG. 5, the LED 15 may comprise a
radiofrequency-to-DC converter and modulator. When radiofrequency
signals are emitted by the external antenna 230 and picked up by
the internal antenna 18, these signals are then converted by the
receiver (not shown) into electrical current to activate the light
source of the red light unit.
[0052] In one embodiment, the implant may have an internal
processor adapted to intermittently activate the LED.
[0053] In some embodiments, the telemetry portion of the device is
provided by conventional, commercially-available components. For
example, the externally-based power control device can be any
conventional transmitter, preferably capable of transmitting at
least about 40 milliwatts of energy to the internally-based
antenna. Examples of such commercially available transmitters
include those available from Microstrain, Inc. Burlington, VT.
Likewise, the internally-based power antenna can be any
conventional antenna capable of producing at least about 40
milliwatts of energy in response to coupling with the
externally-generated Rf signal. Examples of such commercially
available antennae include those used in the Microstrain
Strainlink.TM. device. Conventional transmitter-receiver telemetry
is capable of transmitting up to about 500 milliwatts of energy to
the internally-based antenna.
[0054] In some embodiments, and now referring to FIG. 6, the
implant includes a light emitting diode (LED) 234 built upon a
portion 307 of the implant, along with the required components to
achieve trans-dermal activation and powering of the device. These
components can include, but are not limited to, RF coils 301,
control circuitry 303, a battery 305, and a capacitor. Such a
device could be capable of intermittent or sustained activation
without penetrating the skin, thereby avoiding trauma to the
patient and/or risk of infection from skin-borne bacteria. As shown
above, the accessory items needed to power and control the LED may
be embedded within the implant. However, they could also be located
on the surface(s) of the implant, or at a site adjacent to or near
the implant, and in communication with the implant.
[0055] Preferably, the red light of the present invention has a
wavelength of between about 650 nm and about 1000 nm. In some
embodiments, the wavelength of light is between 800 and 900 nm,
more preferably between 800 nm and 835 nm.
[0056] In some embodiments, the light source is situated to
irradiate the intervertebral disc tissue with between about 0.02
J/cm.sup.2 and 200 J/cm.sup.2 energy. In some embodiments, the
light source is situated to irradiate the intervertebral disc
tissue with between about 0.2 J/cm.sup.2 and 50 J/cm.sup.2 energy,
more preferably between about 1 J/cm.sup.2 and 10 J/cm.sup.2
energy. Because there is light-attenuating bony cortical tissue
interposed between the red light implant and the target disc
tissue, the energy exiting the emission surface of the implant is
preferably somewhat higher than the energy values provided
above.
[0057] It is expected that the bony endplate will also serve to
diffuse the red light so that it will irradiate a surface of the
disc that is greater than the surface area of the emission
surface.
[0058] In some embodiments, the light source is situated to produce
an energy intensity of between 0.1 watts/cm.sup.2 and 10
watts/cm.sup.2. In some embodiments, the light source is situated
to produce about 1 milliwatt/cm.sup.2.
[0059] Therefore, in some embodiments of the present invention, the
therapeutic dose of red light is provided on approximately a daily
basis, preferably no more than 3 times a day, more preferably no
more than twice a day, more preferably once a day.
[0060] In some embodiments, the implant of the present invention
comprises an intervertebral motion disc and a red light source.
* * * * *