CA 02377441 2001-12-13
WO 00/76586 PCT/US00/16190
SELF-CONTAINED ULTRASOUND APPLICATOR
BACKGROUND OF THE INVENTION
1. Technical Field of the Invention
The present invention relates to an apparatus for therapeutically
treating injuries using ultrasound. More particularly, the present invention
relates
to a self-contained ultrasound applicator which may be mounted on a patient to
ultrasonically treat bone injuries, a variety of musculoskeletal injuries and
other
treatable injuries.
2. Description of the Related Art
The use of ultrasound to therapeutically treat and evaluate bone
injuries is known. Impinging ultrasonic pulses having appropriate parameters,
e.g.,
frequency, pulse repetition, and amplitude, for suitable periods of time and
at a
proper external location adjacent a bone injury has been determined to
accelerate the
natural healing of, for example, bone breaks and fractures. For patients with
reduced healing capacity, such as elderly persons with osteoporosis,
ultrasonic
therapy may promote healing of bone injuries that would otherwise require
prosthetic replacement or leave the patient permanently disabled.
U.S. Patent No. 4,530,360 to Duarte describes a basic non-invasive
therapeutic technique and apparatus for applying ultrasonic pulses from an
operative
surface placed on the skin at a location adjacent a bone injury. The
applicator
described in the ' 360 patent has a plastic tube which serves as a grip for
the
operator, an RF plug attached to the plastic tube for connection to an RF
source,
and internal calling connected to an ultrasonic transducer. To apply the
ultrasound
pulses during treatment, an operator must manually hold the applicator in
place until
the treatment is complete. As a result, the patient is, in effect, immobilized
during
treatment. The longer the treatment period, the more the patient is
inconvenienced.
The ' 360 patent also describes a range of RF signals for creating the
ultrasound,
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ultinsound power density levels, a range of duration for each ultrasonic
pulse, and a
range of ultrasoan~ic pulse fi~quencias.
U.S. Parent Nos. 5,003,965 and S,I $6,162, both to Talish et al., n,.latre
to an ultrasonic body treatment syatam having a body-applicator unit connected
to a
remote control unit by sheathed fiber optic lines. The signals controlling the
duration of u~asonic pulses and the pulse repetition fmqnancy are generated
apart
~m the body-applicator unit. Talish et al, also deaeribe a mounting ~xt<ue far
attaching the body-applicator unit to a patient so that the operative surface
is
adjacent the slan location.
U.S. Patent No. 5,55b,372, also to Talish at al., attempts to
improve upon the above ultrasonic body treatmem systems by providing an
ergonoxrrically constructed nltrasonie transducer treatment head module. The
main
operating unit is coasfrncted to fit within a pouch worn by the patieuut,
while the
transducer treatment head module is positioned adjacent the area of the
injury. The
apparatus dcscn'bed in the '372 patent therefore permits the patient to be
mobile
during treatment
While the systems described in the abavo pat~cnts relate; to therapeutic
methods and apparatus for ultrasonically treating injured bona, they do not
disclose
a self-comain~ed ultrasound applicator coafigmred to urgiagly bias the
transducer
toward a treatment site when mounted adjacent the trea>znent site.
PCT Publication WO 98/34578 relates to a lot of elements including
an ultrasonic generator, transducers with comtccting cables, sad a mesas for
locating the transducers over areas of the body containing cartilage, provided
with
the surgical instruments for post~surgical application to ultrasonically
stimulate the
cartilage gro'~rth, thus zelieving the effects of surgical intervention.
PCT Publication WO 97/33649 relates to an apparatus used for
therapeutically treating injuries using ultrasound. Tire appazatus includes an
ergonomically constructed uhrasonic transducer trcatatcnt head module is
positioned adjacent the area of the it~juty and excited for a predetermined
period of
timt. The apparatus includes means for positioning and hoidzng the treatment
head
module adjacent positions on tine torso of the body, such ss the clavicle, the
2
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' pelvrs, the hip and the spine.
PCT Publication WO 99/22b52 to methods and apparatus for
enabling sube~tially bloodless snrgcryand for st~~g hatnonhagiag using high
intensity focused nhrasound to form caubcrized tissue regions prior to
surgical
S incision.
It is t>tsrefore an objective of this imreation to provide a self
contained ultrasound applicator which is conf gnred to urgingly bias a
tra~nsaucex
toward a treatment site when mounted adjacent thereto.
SiTMMARY OF.T~ ri~Tt'EN~'IO1~T
it is an object of the present invention to provide a self-contained
ultrasound applicator having a main operating unit with an internal power
source, a
canh~ewer which is connected to and extends from the mnia operating unit, and
an
ultrasonic transducer which is connected ac~axnt a distal end of the
cantilever. The
self-contained ultrnsound applicator is preferably provided with a means for
attaching the applicator to a patient adjacent a treat'mant site. The
applicator
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WO 00/76586 3 PCT/US00/16190
attaching means advantageously provides a patient with virtually unlimited
mobility
and comfort during treatment.
It is a further object of this invention to provide a self-contained
ultrasound applicator having a cantilever which is configured to urgingly bias
the
transducer toward a treatment site when mounted adjacent the treatment site.
The
biasing feature of the cantilever configuration enhances the efficiency of the
therapeutic treatment administered by the ultrasonic transducer.
These and other objects, features and advantages of the present
invention will become apparent from the following detailed description of
illustrative embodiments, which is to be read in connection with the
accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
For a better understanding of the invention, reference is made to the
following description of exemplary embodiments thereof, and to the
accompanying
drawings wherein:
FIG. 1 is a perspective view of a self contained ultrasound applicator
in accordance with one embodiment of the present invention;
FIG. 2 is an end view of a self contained ultrasound applicator;
FIG. 3 is a top view of a self contained ultrasound applicator;
FIG. 4 is a side view of a self contained ultrasound applicator; and
FIG. S is a perspective view of a self contained ultrasound applicator
in accordance with another embodiment of the present invention.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
Referring initially to FIG. 1, there is shown a self-contained
ultrasound applicator 20 in accordance with one embodiment of the present
invention. The self contained ultrasound applicator 20 comprises a main
operating
unit 22 on a proximal end 24 thereof. Main operating unit 22 includes a
housing 23
which is typically constructed in two half sections joined together by screws,
ultrasonic welds or adhesives. Preferably, main operating unit 22 has an
internal
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WO 00/76586 4 PCT/US00/16190
power source for powering signal generator circuitry in an ultrasonic
transducer.
The internal power source typically comprises at least one lithium battery
positioned
in a battery compartment.
Signal generator circuitry, within the signal generator, generates and
controls the pulses transferred to an ultrasonic transducer assembly.
Preferably,
signal generator circuitry includes a processor having memory (e.g., RAM and
ROM) and stored programs (e.g., system and application) for controlling the
operation of the processor, as well as the transducer treatment head module. A
processor is typically coupled to a display and a keypad and is configured to
receive
data from the keypad and to transfer data to the display. The processor may
include
a microprocessor, such as the Intel~ 80/x86 family of microprocessors, or the
processor may be a microcontroller having internal memory. A communication
interface may be connected between a communication port and the processor to
communicate with, for example, an external computer. The communication
interface may be a serial interface, such as an RS-232 interface, a parallel
interface,
or a modem.
The processor is also utilized to control the treatment sequence, i.e.,
the start time and the stop time of the ultrasonic treatment. The processor
may be
preprogrammed. for treatment times and the user (e.g. the physician or
patient)
selects one of the treatment times via a keypad, or the processor may be
programmed by the user via the keypad to set the start and stop sequence.
Typical
treatment times may range between 1 and 55 minutes, although treatments in the
order of 10-20 minutes are common. Typical signal generator circuitry as is
known
to one of ordinary skill in the art may be used, for example, as disclosed in
U.S.
Patent No. 5,556,372 to Talish et al.
A cantilever 26 is connected to, and extends from, main operating
unit 22. Cantilever 26 has a proximal portion 28 and a distal portion 30. An
ultrasonic transducer 32 is connected adjacent a distal portion 30 of
cantilever 26.
It is known in the art that ultrasonic pulses attenuate rapidly in gases
such as air, and that, consequently, the operative surface of the ultrasonic
transducer
must be as flush against the treatment site as possible. It is also known in
the art.
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that, since it is olbea not poss~lo to pressthe operative surface completely
flush
against the tneamnent sits, ul6rasonically conductive coupling gel is need
between the
operative surface and the ~eatmmt site to ensure a continuous contact. To
further
enhance the continuity of contact between ulhaaonlc ucar 32 and a traatnneat
site, cantllevcr 26 is configared to urgiagly bias the transducer 32 toward
the
treatment site when the self-contained nhrasound applicator 20 is mounted
adjacent
the treatment site. Preferred con~tgurations of cantilever 26 are descn'bed
below.
Handles 34 era mouatcd on either side of the ~lfeontained
ultrasound applicator 20. Handles 34 are provided to connect a means for
attaching
applicator 20 adjaccat a treamiam site. Pno~eerably, the means for attaching
~e self
contained ultrasound applicator 20 to a treatment site comprises an adjustable
strap.
The adjustable strap is preferably in two sections and has a hook and loop
type
fastening assembly, such as Velcro, so that the two sections may be fastened
together and quickly unfastaned_ Other quick release fastening techaiquos are
also
contcmplatod.
FIGS. 2 and 3 illustrate end and top views of salfcontain~i
ultrasound applicator Z0, respectively. Handles 34 are apparaat oz; either
side of
self-contained ultrasound applicator 20. Cant~cvcr 26 is Shawn extaading
substantially orthogonal to main operating unit 22. Main operating unit 22
further
includes display 36 and keypads 38. I?isplay 3b may be, for example, a liquid
crystal type display or an LED type display suitable for displaying text arid
rrumerals. Display 36 and keypads 38 arc operably connected to a printed
circuit
board located within main opcratiag unit 2Z, as is known to ono sln'lled is
the art.
FTG. 4 is a side view of a self-contained ultrasound applicator which
ZS i7lustratcs a downwardly projecting configuration of cantilever 26. As
discussed
supra, to function properly, the operative surface of the transducer 32 must
be
co~aapletely flush against a treatment sits oa a patient to eliminate say air
gaps.The
ptefeaed eon$guration of cantilever 26 is designed to utgozgly bias the
operative
surface of transducer 32 toward a treatment site, thereby eahaacing the
co~inuity of
the contact area. As shown, cantilever 26 projects dowuwa<d as it eJCtends
from
rosin operating unit 22 to form a first predetermined angle 8 with a
horizontal plane
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parallel to a bottom surface of the main operating unit 22. The magnitude of
first
predetermined angle 0 is typically in a range of about one degree to about
fifteen
degrees. A preferred magnitude of first predetermined angle 0 is two degrees.
Also shown in FIG. 4 is a preferred configuration of transducer 32. Ultrasonic
transducer 32 is connected to a distal portion 30 of cantilever 26. Moreover,
in a
preferred embodiment, ultrasonic transducer 32 tilts downward to form a second
predetermined angle [3 with a horizontal plane parallel to a bottom surface of
main
operating unit 22. The magnitude of second predetermined angle ~3 is typically
in a
range of about one degree to about twenty degrees. A preferred magnitude of
second predetermined angle ~3 is five degrees.
Referring now to FIG. 5, there is shown a perspective view of
another embodiment of a self contained ultrasound applicator in accordance
with the
present invention. The self contained ultrasound applicator 60 comprises a
main
operating unit 62 on a proximal end 64 thereof. Main operating unit 62
includes a
housing which is typically constructed in two half-sections joined together by
screws, ultrasonic welds or adhesives. Preferably, main operating unit 62 has
an
internal power source for powering signal generator circuitry in an ultrasonic
transducer.
Main operating unit 62 also includes a display 84 and keypads 86.
Display 84 may be, for example, a liquid crystal type display or an LED type
display suitable for displaying text and numerals. Display 84 and keypads 86
are
operably connected to a printed circuit board located within main operating
unit 62,
as is known to one skilled in the art.
A cantilever 66 is slidably connected, and extends from, main
operating unit 62. In a preferred embodiment, a longitudinal slot 68 is
provided in
cantilever 66 for slidable engagement with main operating unit 62. Cantilever
66
has a proximal portion 70 and a distal portion 72. An ultrasonic transducer 74
is
connected adjacent a distal portion 72 of cantilever 66.
A means for attaching self contained ultrasound applicator 60
adjacent a treatment site is shown in a preferred embodiment comprising a
strap 76.
Strap 76 is preferably adjustable by means of a hook and loop type fastening
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assembly, such as Velao~, so that iwo sections of the strap may be fastened
together and quickly unfastened. Other quick release fastening techniques are
also
contemplated.
As discussed above, it is known in the art that ultcaaonic pulses
attcnuato rapidly in gases such as air, and that, consequently, the operative
suaface
of the ultrasoanic transducer must be as flush against the treatment site as
possible.
To enhance the peaformanae of ultrasonic transducer 74, a gal pad 78 is
typically
provided sad placed botweon ultixaonic tcauaducer 74 and a treamient sits. Oel
pad
78 prefexsbly contains an ultrasonically conductive coupling gel.
?o enhance the contact between ultrasonic transducer 74 and gel pad
78, a distal portion 7Z of cantilever 66 projects downward to foma a
predetoanincd
angle a. The downward projection of a distal portion 72 of cantilever 66
urgingly
biases ultrasonic transducer 74 in a direction toward gel pad 78, thereby
enhancing
the continuity of a contact area therebetwoen. The magnitude of the
px~etamined
1 S angle a is typically in a range of about one degree to about twenty
degrees.
During operation, a self-contained ultrasound applicator 60 is
typically attached to a cast 80 of a patient by means of a sl=ap 76. A cast 80
has a
hole 82 to iasertably receive a gel pad 78 and an ultrasonic transducer 74.
Hole 82 is
typically adjaoent a treatment site corresponding to an iqjury on or in a
patient's
body. The distance between strap 76 and ultrasonic t<ansdncez 74 may be
slidably
adjusted slang a longitudinal axis of slot 68 in ca~otr~ewer 66, to ensure a
pivper fit
between the self-contained ultrasound applicator 60 and a body of a patient by
moans of strap 76, and the proper contact between ultrasonic transducer 74 and
geI
pad 78 when insettably received in hole 82. Furthermore, the configuxation of
cantilever 66 forming predetermined angle a will urgingty bias ultrsasonic
t<ar'sducer
74 toward gel pad 78 in hole 82 of cast 8fl.
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various shapes and configurations of the self contained ultrasound applicator
components are contemplated, as well as various types of construction
materials.
All such changes and modifications are intended to be included within the
scope of
the invention as defined by the appended claims.
