U.S. patent application number 13/329745 was filed with the patent office on 2012-04-19 for method for treating degenerative disc disease using noninvasive capacitively coupled electrical stimulation device.
Invention is credited to Jean C. Gan, Bruce J. Simon.
Application Number | 20120095522 13/329745 |
Document ID | / |
Family ID | 35758412 |
Filed Date | 2012-04-19 |
United States Patent
Application |
20120095522 |
Kind Code |
A1 |
Simon; Bruce J. ; et
al. |
April 19, 2012 |
METHOD FOR TREATING DEGENERATIVE DISC DISEASE USING NONINVASIVE
CAPACITIVELY COUPLED ELECTRICAL STIMULATION DEVICE
Abstract
A method for treatment of degenerative disc disease using
capacitively coupled electrical stimulation. In one embodiment, a
subject diagnosed as having degenerative disc disease is treated by
placing first and second electrodes on the subject's body at the
site of an identified disc in a state of degenerative disc disease,
and applying an electric field to the identified disc via the first
and second electrodes with the intent to treat the degenerative
disc disease. The electric field is created with an electrical
signal having a frequency within a range of 20 to 100 kHz and
having a symmetrical waveform with an amplitude within a range of
0.1 to 20 volts peak-to-peak, preferably a frequency of
approximately 60 kHz and an amplitude of approximately 5 volts
peak-to-peak.
Inventors: |
Simon; Bruce J.; (Mountain
Lakes, NJ) ; Gan; Jean C.; (Morris Township,
NJ) |
Family ID: |
35758412 |
Appl. No.: |
13/329745 |
Filed: |
December 19, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11176588 |
Jul 7, 2005 |
8082038 |
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13329745 |
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60586745 |
Jul 9, 2004 |
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Current U.S.
Class: |
607/43 |
Current CPC
Class: |
A61N 1/40 20130101 |
Class at
Publication: |
607/43 |
International
Class: |
A61N 1/32 20060101
A61N001/32 |
Claims
1. A nonsurgical method of treating degenerative disc disease,
comprising: identifying an unfused disc in a state of degenerative
disc disease in a subject; and nonsurgically treating the
degenerative disc disease by applying capacitively coupled
electrical stimulation to the identified unfused disc, intending to
promote generation of disc tissue as an alternative to spinal
fusion, the electrical stimulation characterized by an electric
field created with an electrical signal having a frequency within a
range of 20 to 100 kHz and having a symmetrical waveform with an
amplitude within a range of 0.1 to 20 volts peak-to-peak.
2. The method of claim 1, wherein said electrical signal has a
frequency of approximately 60 kHz and an amplitude of approximately
5 volts peak-to-peak.
3. The method of claim 2, wherein said electrical signal is a sine
wave.
4. The method of claim 2, wherein said electrical signal is a
bipolar DC signal with a square waveform.
5. The method of claim 2, wherein said electrical signal is a
bipolar DC signal with a triangular waveform.
6. A nonsurgical method of treating degenerative disc disease,
comprising: placing first and second electrodes on the body of a
subject at the site of a disc in a state of degenerative disc
disease; and applying an electric field to said disc noninvasively
via said first and second electrodes as an alternative, not an
adjunct, to spinal fusion.
7. The method of claim 6, wherein said electric field is created by
supplying a voltage across said electrodes at a frequency within a
range of 20 to 100 kHz and an amplitude within a range of 0.1 to 20
volts peak-to-peak.
8. The method of claim 7, wherein said frequency is approximately
60 kHz and said amplitude is approximately 5 volts
peak-to-peak.
9. The method of claim 8, wherein said voltage is sinusoidal.
10. The method of claim 8, wherein said voltage is a square
wave.
11. The method of claim 8, wherein said voltage is a triangular
wave.
12. A nonsurgical method of treating degenerative disc disease,
comprising applying capacitively coupled electrical stimulation to
a human intervertebral disc in a state of degenerative disc disease
untreated by spinal fusion surgery.
13. The method of claim 12, wherein said electrical stimulation is
characterized by an electric field created with an electrical
signal which has a frequency of approximately 60 kHz and an
amplitude of approximately 5 volts peak-to-peak.
14. The method of claim 13, wherein said electrical signal is a
sine wave.
15. The method of claim 13, wherein said electrical signal is a
bipolar DC signal with a square waveform.
16. The method of claim 13, wherein said electrical signal is a
bipolar DC signal with a triangular waveform.
17. A nonsurgical method of treating degenerative disc disease,
comprising applying capacitively coupled electrical stimulation to
a human intervertebral disc in a state of degenerative disc disease
between two adjacent vertebrae which are capable of substantially
normal relative motion.
18. A nonsurgical method of treating degenerative disc disease,
comprising applying capacitively coupled electrical stimulation to
a human intervertebral disc in a state of degenerative disc
disease, wherein said disc is in a structurally native state
between two adjacent vertebrae which are unconstrained by
orthopedic hardware.
19. A method of treating degenerative disc disease, comprising:
placing first and second electrodes on the body of a subject at the
site of an identified disc in a state of degenerative disc disease;
and applying an electric field to said disc via said first and
second electrodes, intending to promote generation of disc
tissue.
20. The method of claim 19, wherein said electric field is created
with an electrical signal having a frequency within a range of 20
to 100 kHz and an amplitude within a range of 0.1 to 20 volts
peak-to-peak.
21. The method of claim 20, wherein said frequency is approximately
60 kHz and said amplitude is approximately 5 volts
peak-to-peak.
22. A nonsurgical method of treatment for degenerative disc
disease, comprising providing a capacitively coupled electrical
stimulation device for application to a human intervertebral disc
in a state of degenerative disc for treatment thereof with
electrical stimulation as an alternative, not an adjunct, to spinal
fusion.
23. The method of claim 22, wherein said electrical stimulation is
characterized by an electric field created with an electrical
signal having a frequency within a range of 20 to 100 kHz and an
amplitude within a range of 0.1 to 20 volts peak-to-peak.
24. The method of claim 23, wherein said frequency is approximately
60 kHz and said amplitude is approximately 5 volts peak-to-peak.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
11/176,588, filed Jul. 7, 2005, now U.S. Pat. No. 8,082,038, issued
Dec. 20, 2011, which application claims the benefit of Provisional
Patent Application No. 60/586,745, filed Jul. 9, 2004, which
applications and patent are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] This invention relates to methods for treating degenerative
disc disease, and more particularly to methods for treating
degenerative disc disease noninvasively.
[0003] Degenerative disc disease (DDD), an irreversible process, is
the most common cause of back pain. The intervertebral disc
consists of a gelatinous nucleus pulposus encapsulated by a fibrous
annulus fibrosus and the end-plates. The nucleus pulposus plays an
important role in weight transmission. When this gel-like fluid is
subjected to load, the nucleus pulposus is pressurized deforming to
establish an equilibrating pressure between the annulus fibrosus
and vertebral end-plates. However, with maturation, the tissue
loses its gel-like properties becoming less hydrated and ultimately
more fibrous. It is thus less able to transmit the load by exerting
pressure on the annulus fibrosus. As a result, the annulus fibrosus
undergoes greater deformation, and a greater share of the vertical
load is borne directly by the annulus fibrosus. These changes
result in the development of cracks and cavities within the annulus
fibrosus leading to degeneration.
[0004] There are 3 therapeutic approaches to date:
[0005] 1) Anti-neuralgic and anti-inflammatory;
[0006] 2) Minimally invasive percutaneous treatments such as
discectomy, intradiscal electrothermy, nucleoplasty and
percutaneous radiofrequency application; and
[0007] 3) Major surgeries such as fusions, laminectomy and
nucleus/disc replacements.
[0008] Anti-neuralgic and anti-inflammatory methods treat the
symptoms but do not eliminate the problem. Minimally invasive
percutaneous treatments such as those identified above temporarily
improve the symptoms, but they do not prevent the progression of
DDD and may even accelerate it in the long term. Major surgeries
such as those identified above eliminate structures, risk nerve
injury during the operation, also risk morbidity, and may result in
accelerated disc degeneration at adjacent segments in the long
term.
SUMMARY OF THE INVENTION
[0009] The present invention provides for treatment of degenerative
disc disease as a new indication for capacitively coupled
electrical stimulation. According to one aspect of the present
invention, a subject diagnosed as having degenerative disc disease
is treated by placing first and second electrodes on the subject's
body at the site of an identified disc in a state of degenerative
disc disease, and applying an electric field to the identified disc
via the first and second electrodes with the intent to treat the
degenerative disc disease. The electric field is created with an
electrical signal having a frequency within a range of 20 to 100
kHz and having a symmetrical waveform with an amplitude within a
range of 0.1 to 20 volts peak-to-peak.
[0010] Treatment in accordance with the invention regenerates the
intervertebral disc or prevents further degeneration of the disc
and thus restores the mechanical properties of the spine or reduces
pain resulting from disc degeneration (e.g., discogenic pain). The
device may be used as an adjunct to other treatments such as
implantation of cells (e.g., stem cells from various sources and
intervertebral disc cells), biological factors (e.g., growth
factors, peptides), scaffolds or materials (e.g., collagen,
polymers, ceramics) and gene therapy.
[0011] Among other advantages of the present invention, it is a
noninvasive and simple approach to relieving pain associated with
the disc. It is simple to use, surgery is not required, the
treatment can be administered early to prevent further progression
of DDD, and it may regenerate the disc. Regeneration of the disc
restores the mechanical properties of the spine, and thus, unlike
other treatments such as spinal fusions, the present invention will
not cause accelerated disc degeneration at adjacent segments in the
long term.
[0012] These and other objects and advantages of the present
invention will be more apparent upon reading the following detailed
description in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a rear view of the lower torso of a human subject
with a pair of electrodes disposed on the skin proximate to the
spine for treatment of degenerative disc disease according to one
embodiment of the present invention.
[0014] FIG. 2 is a cross-sectional view of the portion of the spine
proximate to the skin electrodes of FIG. 1.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0015] For the purpose of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, such alterations and further modifications in the
illustrated device and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention
relates.
[0016] The present invention provides a new method of treating
degenerative disc disease (DDD) by using a noninvasive capacitively
coupled electrical stimulation device that is compact, light and
easy to use, and yet highly effective in operation. In the method
according to one aspect of the present invention, two or more
electrodes, e.g., electrodes 10 and 12 in FIGS. 1 and 2, are
applied noninvasively on the skin at the site of pain or location
of the intervertebral disc to be treated. For example, an electrode
may be placed on either side of the spine at the level of a disc to
be treated, with spacing of 4'' to 6'' between the electrodes.
Suitable electrodes include those used with the SpinalPak spinal
fusion stimulator, commercially available from EBI, L.P.
[0017] The electrodes are connected to a signal generator which
emits a signal with a frequency of 20 to 100 kHz and having a
symmetrical waveform with an amplitude of 0.1 to 20 volts
peak-to-peak. Examples of signals are described in patent
application Ser. No. 10/041,850, entitled Non-Invasive Capacitively
Coupled Electrical Stimulation Device For Treatment Of Soft Tissue
Wounds, filed Jan. 7, 2002 in the name of Jean C. Gan et al., which
application is assigned to the assignee of the present invention
and incorporated herein by reference. One preferred form of the
signal is a symmetrical sine wave with a frequency of approximately
60 kHz and an amplitude of approximately 5 volts peak-to-peak. A
bipolar DC signal with a symmetrical step or a triangular waveform
may be useful in certain applications of the present invention. The
signal is preferably applied intermittently but may be applied
continuously for a period of time.
[0018] While the invention is not limited to any one theory of
operation, it is believed that the invention promotes disc tissue
regeneration and/or inhibits further progression of DDD by
enhancing the proliferation and matrix synthesis of chondrocytes
and stimulating the production of inflammatory cytokine
antagonists, such as TGF-.beta.. As indicated above, the invention
may be used as an adjunct to other treatments such as implantation
of cells, biological factors, scaffolds or materials, and gene
therapy. The following additional patents and publications are
hereby incorporated by reference along with all references cited
therein: U.S. Pat. Nos. 4,467,808 and 4,535,775 to Brighton et al.;
International Application No. PCT/US01/05991 in the name of
Brighton et al.; Brighton Carl T., et al., "Treatment of
Castration-Induced Osteoporosis by a Capacitively Coupled
Electrical Signal in Rat Vertebrae," J. Bone and Joint Surg., 71-A:
228-236, 1989; Brighton, Carl T., et al., "Treatment of
Denervation/Disuse Osteoporosis in the Rat with a Capacitively
Coupled Electrical Signal: Effects on Bone Formation and Bone
Resorption," J. Orthop. Res., 6:676-684, 1988.
[0019] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only preferred embodiments have been shown
and described and that all changes and modifications that come
within the spirit of the invention are desired to be protected.
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