U.S. patent application number 09/803543 was filed with the patent office on 2001-07-26 for ultrasonic plantar fasciitis therapy : apparatus and method.
This patent application is currently assigned to Alessandro Chiabrera. Invention is credited to Chiabrera, Allessandro, Kaufman, Jonathan J., Strom, David.
Application Number | 20010009999 09/803543 |
Document ID | / |
Family ID | 23202337 |
Filed Date | 2001-07-26 |
United States Patent
Application |
20010009999 |
Kind Code |
A1 |
Kaufman, Jonathan J. ; et
al. |
July 26, 2001 |
Ultrasonic plantar fasciitis therapy : apparatus and method
Abstract
Non-invasive therapeutic treatment of plantar fasciitis in vivo
using ultrasound is performed by subjecting a foot locale to an
ultrasound signal supplied to an ultrasound transducer placed on
the skin, and involving a repetitive finite duration signal
consisting of plural frequencies that are in the ultrasonic range
to 10 MHz. The ultrasound transducer is reproducibly positioned
using an ultrasound fixture. The ultrasound signal is applied daily
at least twice per day for 40 minutes per treatment, and has a
power intensity (SATA) of 18 mW/cm.sup.2. In an alternative
embodiment, an orthotic device holds the foot in dorsiflexion
concomitant with ultrasound treatment.
Inventors: |
Kaufman, Jonathan J.;
(Brooklyn, NY) ; Chiabrera, Allessandro; (Genoa,
IT) ; Strom, David; (Castle Rock, CO) |
Correspondence
Address: |
RADER, FISHMAN & GRAUER PLLC
39533 WOODWARD AVENUE
SUITE 140
BLOOMFIELD HILLS
MI
48304-0610
US
|
Assignee: |
Alessandro Chiabrera
|
Family ID: |
23202337 |
Appl. No.: |
09/803543 |
Filed: |
March 9, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09803543 |
Mar 9, 2001 |
|
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|
09310401 |
May 12, 1999 |
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Current U.S.
Class: |
606/32 |
Current CPC
Class: |
A61N 7/00 20130101 |
Class at
Publication: |
606/32 |
International
Class: |
A61B 018/04 |
Claims
What is claimed is:
1. A method of non-invasively therapeutically treating plantar
fasciitis in a foot locale in a living body, using an ultrasound
transducer, and an ultrasound pulser, which method comprises the
steps of: (a) acoustically coupling said ultrasound transducer to
skin overlying said foot locale of said living body; (b) connecting
said ultrasound transducer to said ultrasound pulser; and (c)
energizing said ultrasound pulser for a prescribed time duration,
whereby to produce an ultrasound signal within said foot locale for
said prescribed time duration.
2. The method according to claim 1, wherein said ultrasound
transducer is reproducibly positioned on said foot locale with an
ultrasound fixture.
3. The method according to claim 2, wherein said ultrasound fixture
has at least one transverse segment and at least one longitudinal
segment.
4. The method according to claim 1, wherein said ultrasound
transducer has an area of at least 4 square centimeters.
5. The method according to claim 1, wherein said ultrasound signal
has a SATA power intensity of less than or equal to 250 milliwatts
per square centimeter.
6. The method according to claim 1, wherein said ultrasound signal
has a SATA power intensity of less than or equal to 20 milliwatts
per square centimeter.
7. The method according to claim 1, wherein said prescribed time
duration is more than 15 minutes.
8. The method according to claim 1, wherein said foot locale
contains a portion of a plantar fascia adjacent to a calcaneus.
9. The method according to claim 1, wherein said ultrasound signal
is a continuous sinusoid.
10. The method according to claim 1, wherein said ultrasound signal
is a pulsed sinusoid.
11. The method according to claim 1, wherein said ultrasound signal
is a broadband repetitive pulse.
12. The method according to claim 1, wherein said ultrasound signal
is an amplitude modulated sinusoid.
13. The method according to claim 1, wherein said ultrasound signal
is a frequency modulated sinusoid.
14. The method according to claim 1, further including the step of
injecting a local anesthetic into said foot locale, said injecting
being performed prior to step (a).
15. The method according to claim 1, further including the step of
applying a non-steroidal anti-inflammatory cream to said skin, said
applying being performed prior to step (a).
16. The method according to claim 1, further including the step of
injecting a cortico-steroid into said foot locale, said injecting
being performed prior to step (a).
17. The method according to claim 1, wherein steps (ac) are
performed a number of times per day.
18. The method according to claim 17, wherein said number of times
per day is greater than or equal to two.
19. A method of non-invasively therapeutically treating plantar
fasciitis in a locale of a foot in a living body, using an
ultrasound transducer, an ultrasound pulser, and an orthotic
device, which method comprises the steps of: (a) applying said
orthotic device to said foot whereby said foot is held in
dorsiflexion; (b) acoustically coupling said ultrasound transducer
to skin overlying said locale of said foot of said living body; (c)
connecting said ultrasound transducer to said ultrasound pulser;
and (d) energizing said ultrasound pulser for a prescribed time
duration, whereby to produce an ultrasound signal within said
locale of said foot for said prescribed time duration.
20. The method according to claim 19, wherein said ultrasound
transducer is reproducibly positioned on said locale of said foot
with an ultrasound fixture.
21. The method according to claim 20, wherein said ultrasound
fixture has at least one transverse segment and at least one
longitudinal segment.
22. The method according to claim 19, wherein said ultrasound
transducer has an area of at least 4 square centimeters.
23. The method according to claim 19, wherein said ultrasound
signal has a SATA power intensity of less than or equal to 250
milliwatts per square centimeter.
24. The method according to claim 19, wherein said ultrasound
signal has a SATA power intensity of less than or equal to 20
milliwatts per square centimeter.
25. The method according to claim 19, wherein said prescribed time
duration is more than 15 minutes.
26. The method according to claim 19, wherein steps (ad) are
performed a number of times per day.
27. The method according to claim 26, wherein said number of times
per day is greater than or equal to two.
28. The method according to claim 19, wherein said locale contains
a portion of a plantar fascia adjacent to a calcaneus.
29. The method according to claim 19, wherein said ultrasound
signal is a continuous sinusoid.
30. The method according to claim 19, wherein said ultrasound
signal is a pulsed sinusoid.
31. The method according to claim 19, wherein said ultrasound
signal is a broadband repetitive pulse.
32. The method according to claim 19, wherein said ultrasound
signal is an amplitude modulated sinusoid.
33. The method according to claim 19, wherein said ultrasound
signal is a frequency modulated sinusoid.
34. A method of non-invasively therapeutically treating
enthesopathy in a locale in a living body, using an ultrasound
transducer, and an ultrasound pulser, which method comprises the
steps of: (a) acoustically coupling said ultrasound transducer to
skin overlying said locale of said living body; (b) connecting said
ultrasound transducer to said ultrasound pulser; and (c) energizing
said ultrasound pulser for a prescribed time duration, whereby to
produce an ultrasound signal within said locale for said prescribed
time duration.
35. The method according to claim 34, wherein said enthesopathy is
Achilles tendinitis.
36. The method according to claim 34, wherein said enthesopathy is
lateral epicondylitis.
37. The method according to claim 34, wherein said enthesopathy is
patellar tendinitis.
38. The method according to claim 34, further including the step of
injecting a local anesthetic into said locale, said injecting being
performed prior to step (a).
39. The method according to claim 34, further including the step of
applying a non-steroidal anti-inflammatory cream to said skin, said
applying being performed prior to step (a).
40. The method according to claim 34, further including the step of
injecting a cortico-steroid into said locale, said injecting being
performed prior to step (a).
41. A method of non-invasively therapeutically treating heel pain
in a foot locale in a living body, using an ultrasound transducer,
and an ultrasound pulser, which method comprises the steps of: (a)
acoustically coupling said ultrasound transducer to skin overlying
said foot locale of said living body; (b) connecting said
ultrasound transducer to said ultrasound pulser; and (c) energizing
said ultrasound pulser for a prescribed time duration, whereby to
produce an ultrasound signal within said foot locale for said
prescribed time duration.
Description
FIELD OF THE INVENTION
[0001] The invention pertains generally to apparatus and method for
non-invasive at-home ultrasound treatment of enthesopathies in
vivo. In particular, the invention pertains to apparatus and method
for non-invasive at-home ultrasound treatment of plantar fasciitis
in vivo.
BACKGROUND OF THE INVENTION
[0002] In recent years, various attempts have been made to treat
plantar fasciitis. These approaches have not been particularly
successful, and as a consequence have resulted in patients
experiencing protracted periods of pain and discomfort. In
addition, because of the very limited success of the treatment
options available, physicians are unclear as to which option (for
example, surgical or non-surgical) to pursue.
[0003] Plantar fasciitis is an inflammation of the plantar fascia,
a ligament which is attached at one end to the inner tubercle of
the heel bone. The plantar fascia extends from the heel bone,
becoming broader and thinner as it runs longitudinally along the
bottom of the foot, eventually dividing into 5 processes which
connect to each of the five toes. There is no clear understanding
of the exact cause(s) of inflammation in the plantar fascia. Some
data point to the occurrence of heel spurs where the plantar fascia
is attached to the calcaneus (heel bone), which themselves may be
due to constant stretching of the fascia.
[0004] A number of issued patents disclose methods and apparatuses
to treat plantar fasciitis by using a biomechanical approach.
Generally speaking, the biomechanical methods attempt to position
the patient's foot and leg for some period of time (often at night
when the patient is asleep) in such a way so as to slightly stretch
the plantar fascia, as a means by which the plantar fasciitis may
eventually be relieved. For example, Bergmann et al. U.S. Pat. No.
5,776,090, disclose method and device for treating plantar
fasciitis by placing a splint on the dorsal aspect of a patient's
foot, ankle and foreleg, and holding the patient's foot, toes and
ankle in the dorsiflexed position. The inventors state that
stretching the patient's plantar fascia reduces symptoms over
time.
[0005] Stano, U.S. Pat. No. 5,799,659 discloses an ankle foot
orthosis night splint for treating plantar fasciitis. The disclosed
orthosis is a rigid, molded shell having a generally U-shaped
cross-sectional configuration and a flat foot bed. The orthosis is
covered by a soft-fabric, and uses a removable and interchangeable
foot bed wedge insert which permits the angle of dorsiflexion and
the amount of plantarflexion to be varied.
[0006] Shipstead, U.S. Pat. No. 5,799,659 discloses foot supporting
devices and methods to hold the wearer's foot and leg at a
predetermined angle for sufficient time to reduce foot fatigue or
pain, while the wearer is not on the feet.
[0007] Gleichner, U.S. Pat. No. 4,168,585 discloses a one-piece
heel cushion formed of homogeneous elastomeric material adapted to
conform to the insole of a wearer's shoe to relieve heel pain. The
cushion tapers toward its forward end and has an elongated cavity
in the lower surface extending directly under the heel bone.
[0008] Fisher et al., U.S. Pat. No. 5,611,153 disclose an insole
and a method for relieving bottom of heel pain (i.e., plantar heel
pain). The insole, which is removable, is comprised of a flexible,
shock-absorbing material, and is tapered downward from the arch
portion.
[0009] An excellent description of biomechanical and other
nonsurgical methods for treating plantar fasciitis can be found in
the published journal article entitled "Outcome of nonsurgical
treatment for plantar fasciitis," by LH Gill and GM Kiebzak,
appearing in Foot and Ankle Int, September 1996, Volume 17, Number
9, pages 527-532. The authors report on the use of short leg
walking cast, steroid injection, rest, ice, runner's shoe,
crepe-soled shoe, aspirin or non-steroidal anti-inflammatory drug,
heel cushion, low-profile plastic heel cup and heat, to treat
plantar fasciitis. They found that most of the treatments were
unpredictable or minimally effective.
[0010] Surgical treatments for plantar fasciitis have also been
proposed, usually as a last resort, as these methods can have
associated with them a variety of complications, including foot
numbness, protracted post-operative pain and discomfort, skin
incision problems or painful scars on the bottom of the foot.
Endoscopic surgery has also been described. For example, McNamara
et al., U.S. Pat. No. 5,429,117 disclose a method and system for
performing endoscopic surgery at locations where tissue inserts
into bone, as for example with the plantar fascia.
[0011] Physical therapy based on ultrasound methods have also been
used for treatment of plantar fasciitis, with the therapeutic
benefits assumed to result from the production of heat within the
body. An excellent reference for such techniques can be found in
the book Therapeutic Heat and Cold, Fourth Edition, edited by
Justus F. Lehmann and published by Williams and Wilkins of
Baltimore, Md. in 1990. Although ultrasound based physical therapy
is widely used, mostly for deep heating of muscles (to provide
relief from the effects associated with spasms) and for relief from
joint pain, it apparently has been utilized much less frequently
for the treatment of plantar fasciitis, and when it has, little
success has been achieved. When prescribed for the treatment of
plantar fasciitis, ultrasound therapy is applied by a physical
therapist to a patient in a relatively uncontrolled way (i.e., the
therapist applies the ultrasound in an ad hoc fashion), at
relatively high power intensities (e.g., at or above 1
Watt/cm.sup.2) for short periods (about 5 minutes) only 2-3 times
per week at most.
[0012] Numerous ultrasound therapy devices have been described. For
example, Cody, U.S. Pat. No. 5,611,153 discloses a therapeutic
ultrasonic device which transmits multiple ultrasonic frequencies
through a single ultrasound applicator. The applicator is hand-held
by a specially trained therapist during treatment of a patient at a
particular anatomical site, usually at ultrasound spatial-average
temporal-average (SATA) intensities of 1 Watt per square centimeter
or more. Because of the relatively high intensities used, a
"stroking" technique is almost always utilized. A similar device,
also applied by a physical therapist, is described by Pohl et al.,
U.S. Pat. No. 5,578,060, which discloses a reconfigurable physical
therapy apparatus and a method of providing operator-selected
stimuli to a patient.
[0013] Several other ultrasound methods and devices relating
primarily to bone growth and repair have also been described. For
example, Kaufman et al., U.S. Pat. No. 5,309,808 disclose apparatus
and method for therapeutically treating and/or quantitatively
evaluating bone tissue in vivo, by subjecting bone to an ultrasonic
signal pulse of finite duration, and involving a composite
sine-wave signal consisting of plural discrete frequencies. These
frequencies are spaced in the ultrasonic region to approximately 2
MHz; the excitation signal is repeated substantially in the range 1
to 1000 Hz. In a closely related patent, Kaufman et al., U.S. Pat.
No. 5,458,130, the same inventors extend the apparatus and method
to the treatment to musculoskeletal tissue in general. In another
patent by the same inventors, Kaufman et al., U.S. Pat. No.
5,547,459 disclose apparatus and method for therapeutically
treating bone tissue in vivo, by subjecting bone to an ultrasonic
sinusoidal signal pulse peculiarly modulated by a sinusoidal signal
with a frequency between about 0 Hz and 25 kHz.
[0014] Duarte, U.S. Pat. No. 4,530,360 discloses apparatus and a
method of using ultrasonic energy for therapeutic treatment of bone
tissue in vivo, using a pulsed sine wave at substantially a single
frequency within the range 1.3 to 2.0 MHz, and at a pulse
repetition rate of 100 to 1000 Hz.
[0015] Talish, U.S. Pat. No. 5,762,616 discloses apparatus for
ultrasonic treatment of sites corresponding to the torso. The
apparatus includes means for positioning and holding an ultrasound
treatment head module adjacent to positions of the body, such as
the clavicle, the pelvis and the spine.
[0016] The prior art, exemplified by the references that have been
briefly discussed, have used either biomechanical, ultrasonic or
surgical approaches, for treating plantar fasciitis. The surgical
option, while it can sometimes relieve patients of pain, has
associated with it various side effects as well as high costs, and
is generally chosen only as a last resort. Non-surgical approaches
have not as yet been very successful in treating plantar fasciitis.
However, the present inventors have discovered how to achieve much
greater success with use of a non-surgical method using ultrasound
in treating the pain and discomfort associated with plantar
fasciitis.
BRIEF STATEMENT OF THE INVENTION
[0017] It is accordingly an object of the invention to provide an
improved method and apparatus for therapeutically treating plantar
fasciitis, whereby to eliminate or significantly reduce the
associated pain and discomfort.
[0018] Another object is to meet the above object, such that
plantar fasciitis may be more efficiently and more effectively
treated than heretofore.
[0019] A further object is to demonstrate ultrasound treatment
signals and regimens whereby to achieve the indicated.
[0020] In the currently preferred embodiment, the ultrasonic signal
is generated by a waveform synthesizer to which the transducer is
connected via a power amplifier. The waveform synthesizer emits an
electrical signal which is a pulsed sine wave with a frequency of
about 3.5 MHz, the duration of the pulse on-time is 4.8
milliseconds, and the signal is repeated at a repetition rate of 15
Hz.
[0021] In the presently preferred embodiment of the invent-ion, the
transducer is rectangular in shape, having dimensions 8 cm by 4 cm,
and is mounted in a fixture which sits on the floor, and into which
the patient's foot to be treated is placed. An ultrasound gel is
used to efficiently acoustically couple the ultrasound signal from
the transducer into the foot. The foot is reproducibly positioned
by the fixture so that the same approximate anatomical region is
treated each time, and also to ensure that the affected portion of
the plantar fascia, particularly the region where it attaches to
the calcaneus, receives ultrasonic energy. The large area of the
transducer (in comparison to those currently utilized for any kind
of ultrasound therapy) which covers a large region of the foot, in
conjunction with a relatively low power intensity, relatively long
treatment time, and with multiple treatments repeated daily, as
well as reproducible repositioning of the ultrasound transducer,
all combine to offer significant and dramatic relief from the pain
and discomfort associated with plantar fasciitis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is an electrical-circuit diagram schematically
showing the interconnected relation of components of apparatus of
the invention, including the ultrasound transducer and ultrasound
pulser, in a currently preferred embodiment of the invention.
[0023] FIG. 2 is a diagram showing the ultrasound transducer placed
against the skin of the bottom of the foot, in a currently
preferred embodiment of the invention.
[0024] FIG. 3 is a diagram showing the ultrasound transducer,
ultrasound fixture and foot, in a currently preferred embodiment of
the invention.
[0025] FIG. 4 is a diagram showing an orthotic splint, used in one
of the alternative embodiments of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0026] The invention will be described in detail for a presently
preferred embodiment, in conjunction with the accompanying
drawings. The invention is shown in FIG. 1, FIG. 2 and FIG. 3, in
application to interconnected components for constructing apparatus
for performing methods of the invention, namely for therapeutically
treating plantar fasciitis in vivo, whereby to reduce inflammation
and associated pain and discomfort. These components are, in
general, commercially available from different sources and will be
identified before providing detailed description of their total
operation.
[0027] In FIG. 2, the foot locale 10 of a patient's foot 52 to be
treated is shown with skin 9 and to be placed next to an ultrasonic
transducer 12, and obtainable from Acoustic Imaging, Inc., Phoenix,
Ariz.; suitably, the transducer 12 may be comprised of a 4
centimeter by 8 centimeter rectangular air-backed PZT-5a
piezoelectric element, and having a front layer matched for soft
tissue, with a nominal center frequency of 3.5 MHz. As shown,
transducer 12 is used for signal launching, in which the launched
signal is transmitted through standard ultrasonic couplant, through
the skin and overlying soft tissue (not shown), and into the
plantar fascia (also not shown). The ultrasound couplant may
suitably be obtained from Parker Laboratories, Incorporated, of
Orange, N.J. In this way the ultrasound transducer may be
understood to be efficiently acoustically coupled to the skin
9.
[0028] Now, with reference to FIG. 1, basic operation is governed
by computer means 14, which may be a PC computer, such as the "500
MHz Pentium III" available from Gateway 2000, Inc., North Sioux
City, S.D.; as its designation suggests, this computer contains a
500 MHz clock-pulse generator, and an Intel Pentium III
microprocessor, with provision for keyboard instruction at 14'.
[0029] An electrical function-generator card 15 is relied upon to
generate an excitation signal which is supplied to the launch
transducer 12, via power amplifier means 17. The power amplifier is
suitably Model No. 240L, an RF power amplifier product of EIN,
Inc., Rochester, N.Y. This product provides a 50 dB gain, over the
range 20 kHz to 10 MHz. The excitation signal generated by card 15
is a pulsed sine wave signal, having a frequency of 3.5 MHz, a
pulse on time of 4.8 milliseconds, and a pulse repetition rate of
15 Hz; after input of this signal to power amplifier 17, the peak
value of the output signal from the power amplifier 17 is
approximately 24 volts. Card 15 may suitably be a waveform
synthesizer product of Quatech, Inc., Akron, Ohio, identified by
Quatech part No. WSB-100. This waveform synthesizer provides
generation of analog signals independent of the host computer 14,
allowing full processor power to be used for other tasks, including
calculation of waveform data; it has the capacity to generate an
output signal comprising literally thousands of points in the
indicated frequency range. The computer 14, card 15, and power
amplifier 17 may be understood to comprise an ultrasound pulser 44
(shown within the dashed line in FIG. 1); however its present
embodiment as described herein has much more flexibility than
conventional ultrasound pulsers because of the wide range of
electrical excitation signals that may be realized. (It should
nevertheless be understood that a more conventional ultrasound
pulser may also be utilized in alternative embodiments of the
present invention.)
[0030] With reference to FIG. 3, an ultrasound fixture 18 is also
shown and receives the patient's foot 52 and holds it next to
transducer 12. As may be seen, the foot 52 and transducer 12 are
jointly held so that foot locale 10 may reproducibly be both
re-positioned and ultrasonically treated. In the presently
preferred embodiment, this is achieved by including in the fixture
a transverse segment 23 upon which the posterior portion of the
heel can rest, while the bottom portion of the foot rests on a
longitudinal segment 24 of the fixture. The transducer 12 sits in a
cutout-portion of longitudinal segment 24. In the presently
preferred embodiment of the invention, the ultrasound fixture is
made of Plexiglas, suitably available (including fabrication) from
Industrial Plastic Supply Company, New York, N.Y. As may be seen,
the transducer 12 faces up towards the bottom of the foot locale 10
to be treated.
[0031] Finally, and again with additional reference to FIG. 1,
general signal-processing/display/storage software, for the signal
processing control and operation of the computer 14 is not shown
but will be understood to be a CD-ROM loaded at 19 into the
computer; this software is suitably MATLAB 5, available from The
MathWorks, Inc., Natick, Mass. Further software, also not shown
include the Signal Processing, Optimization and Statistics
Toolboxes, also available from MathWorks, as well as C++ Version 5,
available from the Microsoft Corporation, Bothell, Wash.
[0032] In the presently preferred embodiment of the invention and
with additional reference to FIG. 1, FIG. 2 and FIG. 3, a patient's
foot 52 is placed into ultrasound fixture 18. The ultrasound
transducer 12, connected to an ultrasound pulser 44, is placed
adjacent to foot locale 10 with surrounding soft tissue and skin 9,
with sufficient ultrasound gel to insure efficient acoustic
coupling. An ultrasound signal is transmitted from transducer 12,
passes through skin 9, soft tissue, and into the foot locale 10
containing the plantar fascia. The transmitted ultrasound signal is
generated by pulsing the transducer with a 4.8 millisecond duration
sine wave, repeating at 15 Hz. This produces an ultrasound signal
with a center frequency of about 3.5 MHz, and of about 4.8
millisecond in duration, repeating at a frequency of 15 Hz. The
power intensity (SATA) of the ultrasound signal impinging on the
skin surface is 18 mW/cm.sup.2.
[0033] In the presently preferred embodiment of the invention, the
foot is placed in such a manner that a major portion of the plantar
fascia receives ultrasound energy, including that portion which
joins to the calcaneus. Further, the fixture serves to ensure that
each treatment provides ultrasound stimulation to the same portion
of the foot. In the presently preferred embodiment, the ultrasound
signal is applied twice per day, once in the morning and once in
the evening, with each treatment lasting for 40 minutes, for a
number of days as required to resolve the pain and discomfort of
plantar fasciitis. In the presently preferred embodiment, many
cases resolve within 30 days of treatment as described
hereinabove.
[0034] The preceding description has proceeded on the basis that
ultrasound can heal the inflammation associated with plantar
fasciitis. While there have been prior attempts to treat plantar
fasciitis with ultrasound, they have not been successful. In
contrast to these previously disclosed but unsuccessful treatment
apparatuses and methods, the present invention relies on several
key features: (1) reproducible positioning of a transducer so that
the same region of the foot is treated each time; (2) large area
transducer covering a large area of tissue; (3) low power
intensity; (4) long treatment periods, in terms of minutes per
treatment; (5) multiple intra-day treatments; and (6) daily
treatments. These ultrasound treatment characteristics described
hereinabove are able to achieve what has not been possible
heretofore, namely the successful resolution of the inflammation,
pain and discomfort of plantar fasciitis.
[0035] It should be understood that the ultrasound fixture serves
not only as a convenient means to hold the transducer against the
foot, but also provides a way in which a patient may be
self-treated at home. Thus, the region to be treated cannot be
arbitrarily chosen by the patient, but is instead pre-specified and
pre-located by design. This, together with the relatively low power
intensity makes home use both safe and efficacious.
[0036] It should also be appreciated that the present invention can
be embodied with a variety of ultrasound signals, including
continuous sinusoid, pulsed sinusoid, broadband repetitive pulses,
frequency modulated sinusoids, and amplitude modulated sinusoids.
Notwithstanding the variety of signals which can be utilized in the
present invention, they should be applied relatively often (at
least once a day, but twice or more a day are preferable), at
relatively low power intensities (no more than 250 mW/cm.sup.2 but
18 mW/cm.sup.2 is preferable), with a relatively large transducer
(with area at least 4 cm.sup.2 but 32 cm.sup.2 is preferable) in a
fixture which ensures that the same region of the plantar fascia is
treated from one treatment to the next, and wherein such
positioning ensures that the portion of the plantar fascia which
joins to the calcaneus is included. The treatment regimen should be
repeated for as many days as necessary to achieve full healing.
[0037] In an alternative embodiment of the invention, ultrasound
therapy is applied concomitantly while the patient's foot is held
in dorsiflexion. In this alternative embodiment, and with
additional reference to FIG. 4, an orthotic device 26 is used to
keep the foot in a position so that the plantar fascia is slightly
extended. This slight extension, when combined with the ultrasound
treatment, leads to more effective healing compared to when
ultrasound is applied alone. A number of orthotic devices are known
in the art. For example, Bergmann et al. U.S. Pat. No. 5,776,090,
disclose a splint which is affixed on the dorsal aspect of a
patient's foot, ankle and foreleg, which holds the patient's foot,
toes and ankle in a dorsiflexed position, and which is incorporated
by reference hereinto. Stano, U.S. Pat. No. 5,799,659 discloses
another orthosis, which is incorporated by reference hereinto. Yet
another orthosis or splint is disclosed by Shipstead, U.S. Pat. No.
5,799,659, and which is incorporated by reference hereinto. It
should be appreciated that the present invention may include any
orthosis which is capable of maintaining a patient's foot in
dorsiflexion during ultrasound therapy. It should be further
recognized that the ultrasound transducer, pulser and fixture (not
shown in FIG. 4) may be combined with the orthosis into a single
structure, or may instead remain as separate structures. It should
also be understood that all of the variations with respect to
ultrasound signals and treatment regimens disclosed hereinabove
apply also to the embodiments of the invention which combine
orthotic and ultrasound treatments. It should lastly be understood
that the various embodiments of the invention disclosed herein may
be utilized so that the patient is treated in a variety of
positions, for example sitting or lying down. In each case,
modifications of the ultrasound fixture or orthotic device may be
necessary to permit the patient to have his or her required degree
of freedom.
[0038] In yet an additional embodiment of the present invention,
ultrasound treatment is combined with injection of a local
anesthetic. In a presently preferred alternative embodiment, the
local anesthetic is most suitably Marcaine, available from Schering
Corporation, located in Kentworth, N.J. In this embodiment of the
invention, 1 cc of Marcaine is injected into the origin of the
plantar fascia on the calcaneus. Treatment with local anesthetic is
combined with ultrasound according to the methods disclosed herein,
and has been found to greatly aid in the resolution of the pain and
discomfort associated with plantar fasciitis. In another embodiment
of the invention, a non-steroidal anti-inflammatory cream is
applied topically to the skin surface overlying the plantar fascia
on the bottom of the foot. In this alternative embodiment, the
non-steroidal anti-inflammatory cream is most suitably Ibuprofen
cream, available from ITC Corporation, located in Denver, Colo. It
should be understood that the cream is rubbed into the skin, and
ultrasound therapy, according to the methods disclosed herein, is
applied, preferably within 1 hour. The ultrasound, when used in
conjunction with the cream, has been found to dramatically enhance
the efficacy of either treatment acting alone. The enhancement in
efficacy is due to a number of factors, including the ability of
the ultrasound to propel the active ingredients in the cream
towards the site of inflammation, which is generally many
millimeters below the skin surface. It should be additionally
understood that a variety of creams and compounds may be utilized,
either by local injection or by topical skin application,
including, for example, cortico-steroids, local anesthetics or
non-steroidal anti-inflammatory creams. It should also be
appreciated that the creams may serve a dual purpose, that is to
reduce pain but also as a means to efficiently couple the
ultrasound signal into the body, obviating the need for a separate
application of an ultrasound coupling gel. It should lastly be
further appreciated that the use of the creams and other compounds
may be further combined not just with ultrasound, but with orthotic
treatment as well, to further enhance the beneficial effects
obtained.
[0039] Finally, it should be appreciated that while new methods and
apparatuses for therapeutically treating plantar fasciitis have
been disclosed herein, the treatments can be also applied to
similar conditions arising at other anatomical sites within the
body. Such similar conditions may be understood to fall under the
general category of enthesopathies, and may include, for example,
Achilles tendinitis, lateral epicondylitis and patellar tendinitis,
as well as plantar heel pain but not necessarily diagnosed
specifically as plantar fasciitis. Such conditions can also greatly
benefit from the ultrasound treatment (and combined orthotic and
anesthetic, non-steroidal anti-inflammatory creams or
cortico-steroids) regimens disclosed herein.
[0040] While several embodiments of the present invention have been
disclosed hereinabove, it is to be understood that these
embodiments are given by example only and not in a limiting sense.
Those skilled in the art may make various modifications and
additions to the preferred embodiments chosen to illustrate the
invention without departing from the spirit and scope of the
present contribution to the art. Accordingly, it is to be realized
that the patent protection sought and to be afforded hereby shall
be deemed to extend to the subject matter claimed and all
equivalence thereof fairly within the scope of the invention.
[0041] It will be seen that the described invention meets all
stated objectives as to therapeutic treatment in vivo of plantar
fasciitis specifically and heel pain and enthesopathies generally,
with specific advantages that include but are not limited to the
following:
[0042] (1) Significantly enhanced healing effects due to the
reproducible repositioning of a large ultrasound transducer, as
well as because of multiple treatments intra-day and low power
intensities utilized;
[0043] (2) Avoidance of the need for surgical intervention;
[0044] (3) Achievement of even more dramatic results when
ultrasound therapy is combined with use of an orthosis;
[0045] (4) Description of a specific ultrasound signal for
obtaining the desired therapeutic results;
[0046] (5) The convenience and practicality of a much more
effective method for therapeutically treating plantar fasciitis and
related disorders, allowing much quicker resolution of the pain and
discomfort, in comparison to other non-surgical methods;
[0047] (6) The ability to treat patients at home, which leads to
much greater acceptance by the medical and patient communities, and
also by third-party-payers; and
[0048] (7) The nature of the apparatus as described here serves
best the purposes of further exploration for obtaining maximally
effective signals and dosage regimens that can be correlated for
the indicated objectives. The embodiments of the invention as
described above can explore a wide range of experimental
configurations. Their use is expected to lead to the development of
even more compact and efficient apparatus for obtaining the
indicated objectives. For example, a compact electronic analog
implementation can easily be constructed if economy and simplicity
are the primary objectives. Other systems which rely on combined
analog and digital electronics are more expensive, yet can be more
flexible in terms of the range of applications which can be
addressed (e.g., systems for a single therapeutic application to
plantar fasciitis, versus systems for therapeutic applications to
other anatomical sites for general enthesopathies disorders).
Further, systems can either be built as a stand-alone unit or as
part of a PC-based system.
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