U.S. patent application number 11/747075 was filed with the patent office on 2007-11-15 for percutaneous continual electro-acupuncture stimulation system for in vivo and in situ tissue engineering.
Invention is credited to Y. King Liu.
Application Number | 20070265680 11/747075 |
Document ID | / |
Family ID | 38686118 |
Filed Date | 2007-11-15 |
United States Patent
Application |
20070265680 |
Kind Code |
A1 |
Liu; Y. King |
November 15, 2007 |
PERCUTANEOUS CONTINUAL ELECTRO-ACUPUNCTURE STIMULATION SYSTEM FOR
IN VIVO AND IN SITU TISSUE ENGINEERING
Abstract
The invention includes an electro-acupuncture stimulation system
for in vivo and in situ analgesia and tissue repair and
regeneration. Electrodes, which can be acupuncture needles, are
percutaneously implanted that deliver a pulsed electrical current
that creates an electrical field, which envelopes the targeted
tissue and restores cell-generating homeostasis to the affected
tissue and thereby promotes analgesia and tissue re-growth in
otherwise debilitated or deteriorating tissue. Methods and
apparatuses are also disclosed that may include a needle locking
system and acupuncture-needle assemblies for long-term in situ
electrical stimulation.
Inventors: |
Liu; Y. King; (Petaluma,
CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET, FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
38686118 |
Appl. No.: |
11/747075 |
Filed: |
May 10, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60799263 |
May 10, 2006 |
|
|
|
Current U.S.
Class: |
607/46 ;
128/907 |
Current CPC
Class: |
A61N 1/36021 20130101;
A61N 1/0502 20130101; A61N 1/321 20130101; A61N 1/36017 20130101;
A61N 1/326 20130101 |
Class at
Publication: |
607/46 ;
128/907 |
International
Class: |
A61N 1/34 20060101
A61N001/34 |
Claims
1. A securable percutaneous acupunctural system comprising: At
least one needle comprising an elongate body, proximal end, and
distal end, the needle having a fastener component disposed on the
elongate body; and a needle-securing element configured to lock
said implanted needles in situ, wherein the needle is retained in a
desired anatomical point.
2. The system of claim 1, wherein the elongate body of the needle
comprises a male screw threaded portion.
3. The system of claim 1, wherein the needles have a diameter of
between about 30 to 34 gauge.
4. The system of claim 1, wherein the needles have a length of
between about 8 mm to 2.5 cm.
5. The system of claim 1, wherein said needle-securing element
comprising a female-threaded portion that is configured to
interface with the male threaded portion of the needle.
6. The system of claim 1, wherein the needle-securing element has a
press-fit outer surface.
7. The system of claim 1, further comprising a fixator cup sized to
at least partially cover the needle-securing element.
8. The system of claim 7, wherein the fixator cup includes a
press-fit inner surface configured to attach to the press-fit outer
surface of the needle-securing element.
9. The system of claim 8, wherein an outer surface of the cup is
tied or soldered with a ring, which is connected to an insulated
wire.
10. The system of claim 9, wherein the wire is connected to one of
the positive or negative leads of a jack, the jack having both the
positive and negative leads connected to it; the jack operably
connected to an output port of an electronic stimulator.
11. A method for treating a patient, comprising: providing a
plurality of needles; selecting one or more treatment sites on a
patient; inserting the needles percutaneously into the treatment
site of the patient; providing an electrical stimulator; connecting
the needles to the stimulator; and activating the stimulator;
wherein the needles remain percutaneously inserted in the treatment
site for at least 24 hours.
12. The method of claim 11, wherein activating the stimulator
involves increasing the power on the stimulator to a threshold
level of sensation by the patient, and decreasing the power until
it becomes sub-sensory to the patient.
13. The method of claim 11, wherein the treatment site is a
joint.
14. The method of claim 13, wherein the joint is a knee.
15. The method of claim 13, where the treatment site comprises one
or more acupuncture points selected from the group consisting of
Heting (S156), Spleen 10, Stomach 34, Bladder 40, Stomach 35, and
Hsiyen (S145).
16. The method of claim 11, wherein the needles remain
percutaneously inserted in the treatment site for at least 7
days.
17. The method of claim 11, wherein the needles are operably
connected to a needle-securing element configured to keep the
needle in its originally inserted position.
18. The method of claim 11, wherein the patient exhibits signs or
symptoms of osteoarthritis.
19. The method of claim 11, wherein the treatment sites comprise
Heting (S156), Spleen 10, Stomach 34, Bladder 40, Stomach 35, and
Hsiyen (S145) and the needles inserted into the treatment sites
Heting (S156), Spleen 10, and Stomach 34 serve as positive
electrodes while the needles inserted into treatment sites Bladder
40, Stomach 35, and Hsiyen (S145) serve as negative electrodes.
20. The method of claim 11, wherein the stimulator is activated for
at least about 4 hours per day.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. .sctn.119
to U.S. Provisional Application No. 60/799,263, filed May 10, 2006,
the disclosure of which is incorporated by reference herein in its
entirety.
BACKGROUND OF THE INVENTION
[0002] In China, the insertion of acupuncture needles into
acupuncture points to treat diseases has been practiced for at
least 2,000 years. The addition of electricity or
electro-acupuncture was documented in a French text as early as in
1825. Its author, Chevalier Solardiere, claimed that when static
electricity, generated by rubbing a silk scarf against ebony was
discharged into the inserted acupuncture needles, the electrical
discharge enhanced the therapeutic results of acupuncture. In the
1950's, Chinese acupuncture practitioners used an automobile
starter motor as a continuous source of electrical stimuli to
acupuncture needles to enhance the efficacy and efficiency of the
acupuncture therapeutic effects. Since that original motor-starter
stimulator, various electronic stimulators have been employed with
a plethora of therapeutic claims. The stimuli delivered by these
stimulators to the acupuncture points through the acupuncture
needles have varied in frequency, voltage, current, pulse shape and
duration. The duration of the electrical stimuli is generally very
brief, such as ranging from 10 to 60 minutes. One such system and
method can be found in U.S. Pat. No. 7,200,444 to Gavronsky et al.,
herein incorporated by reference in its entirety. To Applicants'
knowledge, none have sought to percutaneously implant the
acupuncture needles for a prolonged period of time. This invention
describes such a system.
FIELD OF THE INVENTION
[0003] This invention relates to electro-acupunctural stimulation
and more specifically to percutaneous nearly continual electrical
stimulation of appropriately inserted acupuncture needles to
specific known anatomical and acupuncture points to achieve certain
in vivo and in situ therapeutic effects on analgesia and tissue
regeneration and repair.
SUMMARY OF THE INVENTION
[0004] According to one embodiment of the invention, disclosed is
an electro-acupuncture system, in which the acupuncture needles are
percutaneously implanted through an acupuncture guide tube. The
shank of a specially designed and constructed acupuncture-needle is
a male screw thread. Once the needle is in place, a small hollow
cylinder with a corresponding female thread in the inside diameter
is used to fixate an antibacterial O-ring against the skin to
prevent infection. The O-ring is placed in a cutout at one end of
the hollow cylinder while the other end has a tapered section with
rings and longitudinal sections trisecting the rings
perpendicularly. A plastic winged butterfly fixture is molded to
consist of a bendable piece of soft plastic with pieces of wire
embedded as flexible reinforcement. Velcro is attached to one side
of the butterfly surface. Near the tail of the other side of the
butterfly is a metallic cup. The metallic cup has a slightly
tapered internal inside diameter so that the shank of the implanted
needle can be interference-fitted to the cup. A small wire is tied
and soldered solidly to the cup and is then connected to an
electrical stimulator. Both sides of the electrical stimulator are
fitted with Velcro. In this fashion, when all the needles are
fixated and in place, a double sided Velcro band is used to secure
all the plastic butterflies snugly. The electrical stimulators are
affixed to the first Velcro band. A one-sided Velcro band is then
wrapped around the first band to complete the installation.
[0005] In some embodiments, disclosed is a customized electrode
in-dwelling stimulation assembly. This assembly is embodied in an
expandable sleeve that form-fits over the knee and is secured with
Velcro fixations. The assembly includes a battery-powered miniature
electrical stimulator and is housed with butterfly snaps and wire
leads that attach to a set of pre-inserted electrodes that allow
the delivery of electrical stimulus, which envelopes joint
cartilage within a custom tissue repairing electromagnetic
field.
[0006] In one embodiment, disclosed is a securable percutaneous
electro-acupunctural system that includes at least one needle
comprising an elongate body, proximal end, and distal end, the
needle having a fastener component disposed on the elongate body;
and a needle-securing element configured to lock said implanted
needles in situ. The needle is preferably retained in a desired
anatomical landmark, such as an acupuncture point. In some
embodiments, the elongate body of the needle comprises a male screw
threaded portion. The needles can have a diameter of between about
30 to 34 gauge. The needles can have a length between about 8 mm to
2.5 cm. The needle-securing element can include a female-threaded
portion that is configured to interface with the male threaded
portion of the needle. The system can further include an O-ring at
a distal end of the needle-securing element. The O-ring can include
an antimicrobial agent. The needle-securing element can have a
press-fit outer surface. The system can further include a fixator
cup sized to at least partially cover the needle-securing element.
The fixator cup can also include a press-fit inner surface
configured to attach to the press-fit outer surface of the
needle-securing element. In some embodiments, the outside surface
of the cup is tied or soldered with a ring, which is connected to
an insulated wire. The wire is connected to one of the positive or
negative leads of a jack, the jack having both the positive and
negative leads connected to it; the jack operably connected to an
output port of an electronic stimulator. The system can also
include a skin overlaying component having a first side and a
second side, the skin overlaying component configured to fit over
the fixator cup and the contour of surrounding skin of a patient
over the first side of the skin overlaying component. The skin
overlaying component can include embedded flexible wires to
facilitate bending to fit the contour of the surrounding skin of a
patient. The second side of the skin overlaying component can
include fastener material. The system can also include an
electrical stimulator. The electrical stimulator can be at least
partially covered by a fastener material; the fastener material of
the electrical stimulator configured to attach to the fastener
material of the second side of the skin overlaying component. In
some embodiments, the system further includes a strap with a first
side and a second side; the first side of the strap comprising
fastener material configured to attach to the fastener material of
the electrical stimulator.
[0007] Also disclosed herein is a method of treating a patient. The
method includes the steps of providing a plurality of needles;
selecting one or more treatment sites on a patient; inserting the
needles percutaneously into the treatment site of the patient;
providing an electrical stimulator; connecting the needles to the
stimulator, and activating the stimulator; wherein the needles
remain percutaneously inserted in the treatment site for at least
24 hours. In some embodiments, the step of activating the
stimulator involves increasing the power on the stimulator to a
threshold level of sensation by the patient, and decreasing the
power until it becomes sub-sensory to the patient. The treatment
site can be a joint, such as a knee. In some embodiments, the
treatment site comprises one or more acupuncture points selected
from the group consisting of Heting (S156), Spleen 10, Stomach 34,
Bladder 40, Stomach 35, and Hsiyen (S145). In some embodiments, the
needles remain percutaneously inserted in the treatment site for at
least a twenty-four hour period. The needles can be operably
connected to a needle-securing element configured to keep the
needle in its originally inserted position. The patient may exhibit
signs and/or symptoms of osteoarthritis. The duration of the
percutaneous electrical stimulus is governed by the severity of the
osteoarthritis disease being treated. For example, Grade I
osteoarthritis, might include electrical stimulus over the course
of one week versus a treatment period of three or more weeks for
Grade III osteoarthritis. For all treatments, clinical judgment
will determine the duration of electrical stimulus period. In some
embodiments, the treatment sites include the points Heting (S156),
Spleen 10, Stomach 34, Bladder 40, Stomach 35, and Hsiyen (S145)
and the needles inserted into the treatment sites Heting (S156),
Spleen 10, and Stomach 34 serve as positive electrodes while the
needles inserted into treatment sites Bladder 40, Stomach 35, and
Hsiyen (S145) serve as negative electrodes. In some embodiments,
the stimulator is activated for at least about 4 hours per day.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The invention is further illustrated in the following
Figures.
[0009] FIGS. 1A-1B show an overview of the acupuncture-needle
assembly system applied to produce analgesia, repair and/or
regeneration of cartilage in the knee joint.
[0010] FIG. 2 illustrates how the percutaneous acupuncture-needle
assembly is fixated against the skin, according to some embodiments
of the invention.
[0011] FIG. 2A is an exploded view of an acupuncture needle
assembly, according to some embodiments of the invention.
[0012] FIGS. 3A-B further illustrates the inter-relationship
between the skin overlaying component and the fixator cup. In this
illustration, the skin overlaying component is bent so as to fit
the contours of the skin. This is also shown in FIG. 2.
[0013] FIGS. 4A-B illustrates how the Velcro strap is used to bind
the three acupuncture points: Bladder 40, Stomach 35 together with
the Special Point (S145), Hsiyen or "the Eye of the Knee". These
three acupuncture points are connected to the negative terminals of
the electronic stimulator.
[0014] FIGS. 5A-B illustrates how the Velcro strap is used to bind
the three acupuncture points: Spleen 10, Stomach 34 and the Special
Point (S156) Heting or "the Crown of the Crane". These three
acupuncture points are connected to the positive terminals of the
electronic stimulator.
[0015] FIG. 6 shows how the electronic stimulator is attached to
the double-sided Velcro by the one-sided Velcro.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0016] Disclosed herein are devices and methods for analgesia and
tissue repair and regeneration that does not require major surgery
or a research-intensive stem cell approach and, at the same time,
it is a minimally invasive fast-acting treatment. The disclosed
treatment is inexpensive when compared to surgical treatments and
faster acting than current non-invasive devices. This recent
biomedical breakthrough is a vast improvement over current
treatment modalities, whether measured by cost or by time-to-heal
effectiveness.
[0017] According to some embodiments of the invention, disclosed is
an externally implanted electrotherapeutic in-dwelling system for
treating osteoarthritis including pain, joint stiffness, limitation
of range of motion and limitation of overall function through the
use of percutaneous sub-sensory unidirectional voltage or current
pulses. The electrical stimulus can be applied, in one embodiment,
through six 30-34 gauge needle electrodes inserted into the
appropriate anatomical points of the patient such that it is close
to the cartilaginous surfaces of an osteoarthritic joint. The
electrotherapeutic stimulation restores the normal electromagnetic
field enveloping the joint. For the cartilage tissue, the field
stimulates chrondrocyte functioning, and increases synthesis of
proteoglycans and Type II collagen molecules in cartilage resulting
in the efficient and efficacious repair of damaged cartilage. The
devices and methods disclosed herein can be more efficient and
efficacious than, for example, transcutaneous electrical
stimulation through non-specifically placed surface electrodes.
Articular cartilage and fibrocartilage repair can potentially take
place after three to four weeks of continuous treatment.
[0018] Most current treatments for advanced arthritis, such as
osteoarthritis involve surgically invasive interventions, such as
total knee replacement or total hip replacement. These treatments
are costly and for some they can be quite perilous in terms of
patient morbidity and mortality. Post surgical recovery requires
significant time and total joint replacement surgery presents
complications or compromised functionality for about 10% of
patients. There are few alternative treatments that have shown
effectiveness compared to conservative as well as standard surgical
practices. Those that do exist require months of treatment. To the
contrary, the device and method shown can provide a fast-acting
minimally invasive alternative treatment that works continuously or
substantially continuously and, in most cases, will permit daily
patient ambulation, which will further patient rehabilitation.
[0019] FIGS. 1A-1B illustrate some non-limiting possible
advantageous locations to produce analgesia, repair and/or
regeneration of cartilage 9 in the knee joint 50. FIG. 1A is a
lateral schematic view of the knee 50 illustrating acupuncture
needles inserted into the "Hsiyen (S145) point", also known as "eye
of the knee" 8, "Heting point (S156)" 4, and "Bladder 40" 6. FIG.
1B is a frontal schematic view of the knee illustrating other
advantageous acupuncture points for knee analgesia, repair, and/or
regeneration of cartilage, such as "Hsiyen (S145) 8", "Spleen 10"
7, "Heting point (S156)" 4, "Stomach 34" 11, and "Stomach 35" 13.
These points can be located by one of ordinary skill in the art as
described below:
[0020] "Hsiyen (S145)" 8: Locate this point with knee flexed, at
the lower border of the patella in the depression lateral to the
patellar ligament.
[0021] "Stomach 34" 11: Locate this point with knee flexed, two
finger-widths (comparable to the patients fingers size) above the
mediosuperior border of the patella on the bulge of the medial
portion of the quadriceps femoris muscle.
[0022] "Stomach 35" 13: Locate this point in the depression, medial
to the patellar ligament, locating the point with the knee
flexed.
[0023] "Spleen 10" 7: Locate this point with the knee flexed,
measure two thumb widths (comparable to the patients thumb size)
above the laterosuperior border of the patella.
[0024] "Heting (S156)" 4: Locate this point at the depression of
the midpoint of the superior patellar border.
[0025] "Bladder 40" 6: Locate this point at the midpoint of the
transverse crease of the popliteal fossa, between the tendons of
the biceps femoris and semitendinosus muscles.
[0026] The nature and location of various points and meridians used
in Chinese acupuncture are described in many texts, such as the
following; the book "Acupuncture in Medical Practice", Louise O.
Wensel, M. D., published 1980 by Reston Publishing (A Prentice Hall
Company) is particularly noted; the book "Acupuncture, The Ancient
Chinese Art of Healing and How it Works Scientifically", Felix
Mann, M. B. published 1973 by Vintage Books, a division of Random
House, New York; the book "Chinese Acupuncture and Moxibustion"
Revised Edition, Chief Editor Cheng Xinnong published 1999 by
Foreign Languages Press, Beijing, and; the book "A Manual of
Acupuncture" by Peter Deadman et al. published 2001 by Journal of
Chinese Medicine Publications. All of these four texts are herein
incorporated by reference in their entirety. Appropriate
corresponding anatomical landmarks can be selected in order to
produce the desired clinical result.
[0027] An embodiment of the invention involves the fixation of an
acupuncture needle into the body of a patient through a
conventional guide tube. Some guide tubes usable with the present
invention are described in U.S. Pat. Nos. 5,792,171 to Burdenko et
al. and 6,231,584 to Gavronsky, which are incorporated by reference
herein in their entirety. One embodiment of an acupuncture needle
and system is illustrated schematically in FIG. 2. The needle 10
has a beveled distal tip 12 for ease of needle 10 insertion. The
body 14, also referred to herein as the shank portion 14 of the
needle 10, includes a locking element in some embodiments,
preferably disposed on the outer diameter of the needle 10. The
locking element is preferably a male screw thread. In other
embodiments, the needle can be a conventional acupuncture needle
with lengths and dimensions as known in the art or the needle can
be incorporated into a needle cap assembly within the fixator cup
22 that houses the electrical lead from the electrical stimulator
34 that attaches to the upper shank portion 14 in the needle cap
assembly within the fixator cup 22.
[0028] A practitioner will typically position a guide tube (not
shown) over the skin 24, and then insert the needle 10 into the
guide tube. There is typically about 3-5 mm clearance between the
upper end of the guide tube and the top (proximal end) of the
acupuncture needle 10, which protrudes above the tube, The
practitioner can then tap on the proximal end of the needle 10
downward with an index finger while supporting the tube with the
other fingers. The needle 10, which has been resting on the surface
of the patient's skin prior to insertion, is now inserted 3-5 mm
through the skin into the desired acupunctural anatomical point.
The acupuncture needle used may be of any length and diameter,
depending on the desired clinical result. In some embodiments, the
needle is preferably between about 8 mm to 2.5 cm in length and no
more than about 5 cm in length. The diameter of the needle is
preferably between about 20 to 40 gauge, more preferably between
about 28 to 36 gauge, more preferably between about 30 to 34
gauge.
[0029] As shown in FIG. 2, after insertion, with the help of the
guide tube, a needle-securing element 16 configured to interface
with the needle 10 is placed over the proximal end of the needle
10. In one embodiment, the needle-securing element 16 is a hollow
tubular body, which may be a relatively short shank, approximately
3-6 mm in length, with a female screw thread lining the inner
diameter of the needle-securing element 16. In other embodiments,
the needle-securing element 16 could be a molded element integrally
formed with the needle, an adhesive or other fastener, a lock,
ratchet, etc. The female screw thread 17 of needle-securing element
16 is most preferably adapted to accommodate the male screw thread
portion of the needle 10. The needle-securing element 16 also
includes an O-ring 18 at its distal end in some embodiments. The
needle-securing element 16 can be screwed in place and closed with
a locked nut, in between fixator cup and needle-securing element
16. In some embodiments, at least a portion of the O-ring 18, such
as the inner diameter portion can be coated or impregnated with an
antimicrobial agent that is preferably broad-spectrum and/or covers
skin organisms, in order to prevent infection of the needle
insertion site. The proximal end 19 of the needle-securing element
16 preferably has a press-fit outer surface. Fixator cup 22
preferably also includes a press-fit surface on its inner surface
configured to attach to the outer press-fit surface of the
needle-securing element 16, such as by friction. The press-fit
surfaces, in some embodiments, include criss-crossing shallow rings
and ribs that can be perpendicular to one another.
[0030] A skin overlaying component, which is also referred to as a
butterfly 26 fixture herein, can be preferably molded of a bendable
piece of soft plastic. In some embodiments, wires can be embedded
within the butterfly 26 as flexible reinforcement. The butterfly 26
can also be made of any biocompatible material known in the art,
such as neoprene, polyurethane or other polymers, ePTFE, PTFE,
Dacron, and the like.
[0031] FIG. 2A illustrates a schematic exploded view illustrating
the needle 10, including distal beveled portion 12 and needle body
with threaded outer diameter 14. O-ring 18, needle-securing element
16 with internal threaded portion 17, and fixator cup 22 are also
shown. Locked nut is not shown for clarity.
[0032] FIGS. 3A-B schematically highlight the interrelationship
between fixator cup 22 and skin overlaying component or butterfly
26. As shown in the cross-sectional schematic view of FIG. 3A, the
butterfly 26 has two sides: a first side 28 that overlays the skin
and fixator cup 22 and a second side 30 preferably configured for
attachment to another surface. In a preferred embodiment, the
second side 30 of the skin overlaying component 26 includes
hook-and-loop fastener material, such as Velcro. FIG. 3B is a view
as indicated from arrows 3A-3A shown in FIG. 3A. Fixator cup 22 and
skin overlaying component 26 are illustrated.
[0033] FIGS. 4A-B illustrate possible needle placements suitable
for analgesia, cartilage repair and regeneration in the knee joint
50. FIG. 4A is a schematic lateral view, while 4B is an
anterior-posterior view of the knee 50. The points may be selected
or modified according to the desired clinical result. The depicted
shaded band 36 represents a fastening element, which may be a strap
with hook-and-loop fastener material in some embodiments, that can
be used to bind the selected acupuncture points: "Bladder 40" 6,
"Stomach 35" 13 together with the Special Point "Hsiyen (S145)" or
"the Eye of the Knee" 8. These needles at the selected acupuncture
points can be connected to the electronic stimulator, such as at
the negative terminals.
[0034] FIG. 5A further illustrates that acupuncture needles are
inserted into the acupuncture points: "Stomach 34" 11, "Spleen 10"
7 and "Heting point (S156)" 4. As noted above, the exact anatomical
locations of these points will be apparent to those skilled in the
art. FIG. 5B illustrates a fastening strap 36 that can be used to
fix the system in place, as elaborated upon in FIG. 6. In another
embodiment, the system could be fixed in place by a custom designed
orthotic created by one skilled in the art.
[0035] FIG. 6 schematically illustrates a securable electrical
acupuncture system. Shown is a winged plastic or "butterfly" skin
overlaying component 26 with a preferably tapered fixation cup 22
on the first side 28 and hook-and-loop fastener material 31 on the
second side 30. The tapered fixation cup 22 is most preferably
press-fitted to the complementary reverse tapered end of the
needle-securing component 16 with female internal-threaded portion
19 while butterfly 26 is bent to conform to the contour of the skin
24 with the side 30 having fastener material, that is most
preferably hook-and-loop fastener material, exposed. A first strap
32 that preferably has hook-and-loop fastener material on both
sides of the first strap 32 can be wrapped around the skin
overlaying component 26 to snugly secure a portion of the system.
As shown, an electrical stimulator 34 is preferably at least
partially covered with fastener material, such as hook-and-loop
fastener material and is preferably positioned between the first
strap 32 with a double-sided hook-and-loop fastener material and a
second strap 36 that preferably has hook-and-loop fastener material
on a single side only. The entire system can be secured when the
second strap 36 with a single side of hook-and-loop fastener
material that securely positions the stimulator 34 between the
second strap 36 and the first strap 32.
[0036] One of ordinary skill in the art will readily appreciate
that a wide variety of fastening materials can be substituted for
hook-and-loop fastener material for any or all of the disclosed
components. Such fastening materials include, for example, snap
fasteners, button fasteners, adhesives, tapes, buckle fasteners,
locks, magnetic fasteners, custom made orthotics, and the like.
[0037] In some embodiments, the electrical stimulator 34 can have
the following settings: 0-5 milliamp current, 0-18V voltage, 1-100
Hz frequency, 1-99% duty cycle. The pulse waveform is preferably
square; however, other morphologies such as triangular, sinusoidal,
sawtooth, spike, j-spike, and the like can also be used depending
on the desired clinical result. The electrical stimulator 34 is
preferably battery powered; however, the stimulator 34 could also
be attached to AC or DC current in other embodiments. The battery
may be rechargeable. The electrical stimulator 34 preferably
includes a conduit 38 that is operably connected to the needles 10.
In other embodiments, the conduit 38 may be operably connected to
the fixator cup 22 or needle-securing element 16 as well in the
embodiments whether these are made of a material configured to
conduct electricity to the needles 10.
[0038] However, it is to be understood that the above construction
is only an idealization for ease of illustration, and in reality
any of the components could vary in any one or more or any
combination of size, shape, size distribution, shape distribution,
or other geometric or orthotic characteristics.
Methods and Method of Use
[0039] Disclosed herein is a method of treating a patient involving
the steps of providing a percutaneous acupuncture system that can
involve electrical stimulation or other electromagnetic forms for
stimulation. The system can include one, two, three, four, five,
six, seven, eight, or more needles, such as those needles described
herein, percutaneously implanting the needles at a desired clinical
anatomical location on the body, and securing the needles in place
using one or more fastening components. The method can also include
the steps of providing an electrical stimulator component, and
stimulating one or more needles to promote, for example, analgesia,
growth or healing of bone, cartilage, muscle, ligament, skin, or
other tissues or organs.
[0040] Although described primarily herein as needles, the
invention includes a variety of electrodes of various shapes that
can be implanted percutaneously. Any of a variety of electrodes
capable of delivering current to tissue can be used, for example,
disc electrodes, spherical electrodes, wire electrodes,
electrically conductive filaments or fibers that may be woven or
nonwoven, metals, electrically conductive polymers, and the like as
one of ordinary skill in the art would appreciate.
[0041] The metallic components of the system, e.g., the acupuncture
needle 10 with threaded shank 14, the needle-securing component
with threaded inside diameter 16 and the press-fit fixator cup 22
are made of biocompatible material, e.g., surgical stainless steel,
titanium, or Vitalium.RTM.. The method of acupuncture needle
insertion can be done manually without guide tube assistance,
through a guide tube, or by any other method known in the art. The
choice of the acupuncture point for needle fixation is at the
discretion of the clinician.
[0042] The electrodes can be implanted anywhere appropriate in the
body to any appropriate depth, depending on the desired clinical
result. In some embodiments, the electrodes can be implanted to a
depth of at least about 1, 2, 3, 4, 5, 7, 10, 15, 20, 25, 30, 40,
50, 60, 70, or more millimeters under the epidermis. The electrodes
can be implanted intradermally, subcutaneously, intramuscularly,
intraarticularly or other regions of the joint, into an organ, or
other location desired by the practitioner. In some embodiments,
the electrodes can be implanted in a desired location and then are
stimulated wirelessly using, for example, external RF energy.
[0043] The continual or nearly continual electro-acupunctural
stimulation system can be applicable to all joints, organ systems,
and tissues where acupuncture needle(s) and/or an electrical field
can be shown to produce analgesia, repair and/or regeneration of
cartilage, muscle, ligament, skin, or other tissues or organs. In
musculoskeletal diseases such as osteoarthritis of any joint, for
example, joints of the cervical, thoracic, lumbar, or sacral spine;
hip, knee, ankle, wrist, shoulder, hand, foot, temporomandibular,
or other joints with pain and/or cartilage deterioration this
methodology can be used for therapeutic effect. The systems
disclosed herein can also be used to treat various diseases
including acute and chronic musculoskeletal pain, rheumatoid
arthritis, systemic lupus erythematosus, neuropathic pain
disorders, fibromyalgia, dry macular degeneration, and the like.
The systems and methods can be used to specifically treat hip
osteoarthritis by providing analgesia and/or tissue regeneration
and repair; hand and foot osteoarthritis by providing analgesia
and/or tissue regeneration and repair; degenerative spinal disc
disease by providing analgesia and/or tissue regeneration and
repair; and eye tissue stabilization and repair (e.g., dry macular
degeneration).
[0044] In one embodiment, a patient with a disease to be treated,
such as osteoarthritis of the knee, is selected. A general overall
health assessment for electrotherapy, a focused gait examination,
and a Visual Analog Scale (VAS) pain assessment is conducted to
better assess the patient's pre-treatment pain. The patient can
receive diagnostic bi-planar X-rays and/or Tessler 7 magnetic
resonance imaging (MRI) exams with body weight preload. If the
patient is determined to be a suitable candidate, treatment is
commenced by inserting at least one needle into each of the
following six acupuncture points on the knee, for the treatment of
knee osteoarthritis: "Heting (S156)" 4, "Spleen 10" 7, "Stomach 34"
11, "Bladder 40" 6, "Stomach 35" 13, and "Hsiyen (S145)" 8, as
illustrated and discussed in connection with FIGS. 1A-1B. In one
embodiment, the needles at points "Heting (S1 56)" 4, "Spleen 10"
7, and "Stomach 34" 11 serve as positive electrodes. The needles at
points "Stomach 34" 11, "Bladder 40" 6, "Stomach 35" 13, and
"Hsiyen (S145)" 8 serve as negative electrodes.
[0045] The needles are operably connected to an electrical
stimulator 34. The power of the stimulator is then increased to a
threshold level of sensation by the patient, and then decreased to
a sub-sensory level for patient comfort, as well as potentially
advantageously promoting analgesia and cartilage regrowth and/or
remodeling. The practitioner will be able to determine with an
appropriate treatment duration depending on the desired clinical
result and patient progress through regular serial follow-up
visits, physical examinations, pain assessments, radiographs and/or
MRIs.
[0046] In other embodiments, any variety of combination or
subcombinations of the points "Heting (S156)" 4, "Spleen 10" 7,
"Stomach 34" 11, "Bladder 40" 6, "Stomach 35" 13, and "Hsiyen
(S145)" 8 can be used as electrode insertion sites, with either
negative or positive polarity depending on the desired clinical
result. For example, a system may include electrodes placed at the
aforementioned six points with one positive and five negative
electrodes, two positive and four negative electrodes, three
positive and three negative electrodes, four positive and two
negative electrodes, or five positive and one negative electrodes.
Furthermore, the method could include implanting electrodes at just
one, two, three, four, or five of these points. Moreover, the
method could include implanting electrodes at any number of these
points in addition to other anatomical points as would be
appreciated by one of ordinary skill in the art.
[0047] In some embodiments, such as in a monopolar system, one of
the electrode with a certain polarity, such as a negative polarity,
can be external to the skin, such as an externally conductive
plate, strip, or wire that is held against the patient's skin,
while one or more of the implanted electrodes with a different
polarity, such as a positive polarity, are percutaneously implanted
as described above.
[0048] In some embodiments, the energy parameters can be modified
from those disclosed in U.S. Pat. No. 5,273,033 to Hoffman or U.S.
Pat. No. 7,200,444 to Gavronsky et al., both of which are hereby
incorporated by reference in its entirety. In some embodiments, the
electrical stimulator power remains above a threshold sensory level
during treatment. In other embodiments, the stimulator power
remains sub-sensory throughout the time the needles are operably
connected to the stimulator. In still other embodiments, the
stimulator power can cycle between sensory and sub-sensory power
levels during treatment. Candidates for total joint replacement may
benefit by undergoing nearly continuous stimulation over an
extended period of time. In some embodiments, the system is left in
place for 2-5 weeks as a therapeutic trial before contemplating
more invasive surgical procedures. In some embodiments, the system
can be implanted percutaneously for at least about 1, 2, 3, 5, 7,
10, 14, 21, 28, 35, 42, 60, 90, 120 or more days depending upon the
desired clinical result. The various fastening mechanisms disclosed
herein can advantageously assist in providing secure implantation
of the system for extended periods of time
[0049] The electrical stimulator may be turned on continuously for
24 hours each day. However, in some embodiments, it may be
preferable that the electrical stimulator be only activated for
only a portion of each day, for example, at least about 1, 2, 3, 4,
6, 8, 10, 12, 14, 16, 18, 20 hours or more each day, and not be
active when the patient is more actively moving the area to be
treated in activities such as standing, walking, bathing, or the
like. In some embodiments, the electrical stimulator may have a
mercury switch automatically that turns off the stimulator when the
patient stands and resumes stimulation when the patient is seated
or in a recumbent position. In other embodiments, the stimulator
can be turned on or off manually.
[0050] In other embodiments, the system can be implanted without
the electrical stimulator component, to provide the benefits of
acupuncture without electrical stimulation, depending on the
desired clinical result.
[0051] While the present invention has been described herein with
respect to the exemplary embodiments and the best mode for
practicing the invention, it will be apparent to one of ordinary
skill in the art that many modifications, improvements and
subcombinations of the various embodiments, adaptations and
variations can be made to the invention without departing from the
spirit and scope thereof. For the disclosed methods, the steps need
not necessarily be performed sequentially.
* * * * *