AU752098B2 - Method and apparatus for ultrasonic treatment of carpal tunnel syndrome - Google Patents

Description

METHOD AND APPARATUS FOR ULTRASONIC TREATMENT OF CARPAL TUNNEL SYNDROME BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and apparatus for therapeutically treating injuries using ultrasound. More particularly, the present invention relates to a method and apparatus which utilizes an ergonomically constructed ultrasonic transducer configured to cooperate with a placement module for placement in proximity to the wrist or hand for therapeutically treating carpal tunnel syndrome.

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 to a bone injury has been determined to accelerate the natural healing of, for example, bone breaks and fractures.

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 i: 20, described in the Duarte patent has a plastic tube which serves a grip for the operator, an RF plug attached to the plastic tube for connection to an RF source, and internal cabling connected to an ultrasonic transducer. To apply the ultrasound S pulses during treatment an operator must manually hold the applicator in place until WO 99/19876 PCTfUS98/21341 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 Duarte patent also describes a range of RF signal for creating the ultrasound, ultrasound power density levels, a range of duration for each ultrasonic pulse, and a range of ultrasonic pulse frequencies.

U.S. Patent No. 5,003,965 to Talish et al. relates to an ultrasonic body treatment system having a body-applicator unit connected to a remote control unit by sheathed fiber optic lines. The signal controlling the duration of ultrasonic pulses and the pulse repetition frequency are generated apart from the bodyapplicator unit. Talish et al. also describes a mounting fixture for attaching the body-applicator unit to a patient so that the operative surface is adjacent the skin location.

While the systems described in these patents relate to therapeutic methods and apparatus for ultrasonic treatment there is a need for ergonomically configured signal generators and transducers which permit patient mobility during the treatment of carpal tunnel syndrome or a variety of hand/wrist injuries and/or problems. Further, a need exists for an apparatus which optimizes the treatment of carpal tunnel syndrome or a variety of hand/wrist injuries while maintaining patient mobility.

Carpal tunnel syndrome is a condition that results from pressure on the median nerve where it passes into the hand via a gap (the "carpal tunnel") under a ligament at the front of the wrist. The median nerve carries sensory messages from the thumb and some fingers and also motor stimuli to the muscles in the hand; damage to the nerve causes sensory disturbances, particularly numbness or tingling, and weakness. Treatment typically entails resting the affected hand at night in a splint. If symptoms persist, a small quantity of a corticosteroid drug may be I -P:OPER\CAE2292232 rs2.d-. 18/06/02 3 injected under the ligament in the wrist. If this fails to help, surgical cutting of the ligament may be performed to relieve the pressure on the nerve.

SUMMARY OF THE INVENTION The ultrasonic treatment apparatus of the present invention is used for therapeutically treating carpal tunnel syndrome including hand/wrist injuries using ultrasound. The apparatus includes an ergonomically constructed placement module configured for mounting thereon at least one ultrasonic transducer assembly with an integral signal generator which provides excitation signals to ultrasonic transducers within the transducer assembly. Timing control circuitry as well as monitoring circuitry for the proper attachment and operation of the transducer assembly are housed within a portable main operating unit constructed to fit within a pouch worn by the patient. In operation, the placement module is positioned on a patient's hand and/or wrist such that at least one transducer is positioned in proximity to the carpal tunnel or hand/wrist injury. At least one transducer is then excited for a predetermined period of time.

i "'"According to a first aspect of the present invention there is provided an apparatus i. for ultrasonically treating carpal tunnel syndrome or hand/wrist injury, comprising: a main operating unit and an ultrasonic transducer assembly, said main operating o• unit having an internal power source coupled to the ultrasonic transducer assembly, said ultrasonic transducer assembly including at least one ultrasonic transducer, an ultrasonic signal generator and signal generator circuitry therein; and 0 placement module configured to receive said transducer assembly, said placement module including a placement support, at least two lateral supports and a pivotably adjustable connector connected to each lateral support, said adjustable connectors being configured for securing said placement module to a patient's hand and/or wrist such that said at least one ultrasonic transducer is positioned in proximity to the carpal tunnel or site of the hand/wrist injury.

ooo ~Preferably, the main operating unit has a display coupled to the signal generator circuitry to display treatment sequence data, a keypad coupled to the signal generator circuitry to permit user operation and/or entry of data. The signal generator circuitry ST% includes a processor, means for generating a pulsed control signal, and a switch coupled to -P:\OPER\CAE\2292232 rms2.doc-I8O06/02 4 the processor for regulating the pulsed control signal. A communication interface may be connected between a communication port and the processor to provide a communication link between the ultrasonic signal generator and an external computer or modem. Preferably, the communication interface is a serial communication interface, however, a parallel interface is also contemplated. An alarm is provided to indicate to the user that the treatment time has expired. The alarm is coupled to the processor such that when ultrasonic treatment is completed the processor activates the alarm and terminates ultrasound generation.

The present invention also provides a kit for ultrasonically treating carpal tunnel syndrome while maintaining patient mobility. The kit includes an ultrasonic transducer assembly having at least one ultrasonic transducer, a placement module configured to be worn by a patient adjacent to the carpal tunnel or hand/wrist injury and configured to receive the ultrasonic transducer assembly and including a placement module configured to be worn by a patient, said placement module being configured to receive said transducer assembly and including a placement support, at least two lateral supports and a pivotably adjustable connector connected to each lateral support, said adjustable connectors being configured for securing said placement module to a patient's hand and/or wrist such that said at least one ultrasonic transducer of the transducer assembly is in proximity to the carpal tunnel or site of the hand/wrist injury, an integrated ultrasonic signal generator located in said ultrasonic transducer assembly, a main operating unit (MOU) or controller and a pouch constructed to receive the MOU, said pouch including a belt so that said pouch can be worn by a patient during treatment thereby providing patient mobility.

Preferably, the MOU has an internal power source and is fitted within a pouch which is releasably secured to a patient during treatment thereby providing patient mobility. A 25 MOU envisioned for use with the present invention is described in U.S. Patent No.

5,556,372 issued to Talish et al. on September 17, 1996, the contents of which are hereby incorporated by reference.

The MOU is electrically coupled to at least one transducer secured to the placement module. The signal generator corresponding to each transducer is then activated so as the excite the ultrasonic transducers for impinging ultrasonic waves against the carpal tunnel Sor hand/wrist injury.

P:'OPERCAE2292232 r3.doc- 15/07/02 -4A- A method for ultrasonically treating carpal tunnel syndrome including hand/wrist injuries while maintaining patient mobility is also provided, comprising the following steps: providing a main operating unit and an ultrasonic transducer assembly, said main operating unit having an internal power source coupled to the ultrasonic transducer assembly, said ultrasonic transducer assembly including at least one ultrasonic transducer, an ultrasonic signal generator and signal generator circuitry therein; providing a placement module configured to receive said transducer assembly and said placement module including a placement support, at least two lateral supports and a pivotably adjustable connector connected to each lateral support, said adjustable connectors being configured for securing said placement module to a patient's hand and/or wrist such that said at least one ultrasonic transducer is positioned in proximity to the S"carpal tunnel or site of the hand/wrist injury; and exciting said at least one ultrasonic transducer to impinge ultrasonic waves at or S: 15 near the carpel tunnel or site of the hand/wrist injury.

the location of the carpal tunnel or hand/wrist injury is ascertained, a placement module containing an ultrasonic transducer assembly having at least one transducer and one signal generator is affixed to the patient's hand and/or wrist such that at least one transducer is adjacent the carpal tunnel or hand/wrist injury.

S 20 In an alternative embodiment, a series of transducers are attached to a placement module and are controlled by a MOU. In another embodiment, a placement module is p provided for securing a plurality of transducers thereto in a plurality of configurations.

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*oo Further, the present invention also provides a strip having at least one ultrasonic transducer secured thereto for placement along the hand directly above the carpal tunnel for the treatment of carpal tunnel syndrome.

BRIEF DESCRIPTION OF THE DRAWING Preferred embodiments of the invention are described below, by way of example only, with reference to the drawings, which are described as follows: Fig. 1 is a perspective view with parts separated of a first embodiment of a portable ultrasonic treatment apparatus according to the present invention, illustrating a main operating unit or controller and a placement module; Fig. 2 is a perspective view of a patient wearing the portable treatment apparatus of Fig. 1; Fig. 3 is a cross-sectional view along line 3-3 in Fig. 2 illustrating the transducer assembly impinging ultrasonic waves to a patient's carpal tunnel, where a gel-like substance is positioned between the transducer assembly and the patient's wrist; Fig. 4 is a perspective view of the transducer assembly impinging ultrasonic waves to a patient's carpal tunnel where an alternative embodiment for the placement module is used; ooo* .Fig. 5 is a block diagram of the circuitry for the ultrasonic transducer *assembly; 25 Fig. 6 is a perspective view of a second embodiment of the portable ultrasonic treatment apparatus, illustrating a main operating unit or controller and a o .placement module having a series of transducers; Fig. 7 is a perspective view of a patient wearing the portable treatment apparatus of Fig. 6; .o 30 Fig. 8 is a side view of a patient wearing the portable treatment apparatus of Fig. 6;

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WO 99/18876 PCT/US98/21341 Fig. 9 is a perspective view of a patient wearing a portable treatment apparatus of a third embodiment configured for mounting a plurality of transducers in a plurality of configurations in proximity to the patient's hand and/or wrist; Fig. 10 is a cross-sectional view along line 10-10 of Fig. 9; Fig. 11 is a perspective view of a patient wearing a portable treatment apparatus of a fourth embodiment configured for treating carpal tunnel syndrome and hand/wrist injuries; and Fig. 12 is a cross-sectional view along line 12-12 of Fig. 11.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The ultrasonic treatment apparatus of the present invention is used for the surgically non-invasive utilization of ultra high-frequency acoustic energy in the treatment of carpal tunnel syndrome including hand/wrist injuries, such as accelerating the healing of a wrist-fracture. The treatment of other musculoskeletal injuries including cranial and venous ulcers are also contemplated with the present invention. The apparatus includes an ergonomically constructed placement module having a strap or other fastening means for being secured to a patient's hand and/or wrist. At least one ultrasonic transducer assembly partially fabricated with a conductive plastic material is attached or imbedded within the placement module and properly positioned in proximity to the carpal tunnel or hand/wrist injury.

Different types of ultrasonic transducers can be provided, such as those described and schematically depicted in U.S. Patent No. 5,520,612 issued to Winder et al. on May 28, 1996, the contents of which are hereby incorporated by reference.

Particularly, the transducers and arrangements schematically depicted by Figs. 7-11 of the application in which at least one transducer is used to provide acoustic energy to the site of the injury. The apparatus also utilizes a portable, ergonomically constructed main operating unit (MOU) which is constructed to fit within a pouch worn by the patient using belt and shoulder strap and provides control signals to the ultrasonic transducers. The MOU which is utilized is preferably the one described in U.S. Patent No. 5,556,372 issued to Talish et al. on September 17, 1996, the contents of which are hereby incorporated by reference.

Turning to the figures, in particular Fig. 1, one embodiment of the portable ultrasonic treatment apparatus 10 of the present invention is shown. The ultrasonic treatment apparatus 10 includes a MOU 12, a placement module 14, an ultrasonic transducer assembly 16, and a pouch 18 for releasably securing the MOU 12 to the patient during treatment for providing patient mobility. The placement module 14 is comprised of a placement band 20 and a placement support 22. The placement support 22 includes a pocket 24 adapted for placement of the ultrasonic transducer assembly 16 therein. The placement support 22 further includes a base 25, a wrist rest 26 and two lateral supports 28 and an adjustable connector 31A, 31B pivotally connected to each lateral support. Each lateral support forms an opening 30 with respect to the base for connecting the placement support 22 to the placement band 20 via the adjustable connectors, thus providing a firm secure attachment of the placement support to the patient's wrist. A sponge-like material 32 lines the inner surface of the placement support 22 for providing comfort to the patient.

A fastener 34 on connector 31A is provided to the placement band 20 for strapping the placement module 14 to the patient's wrist. A portion of the placement band 20 is lined with VELCROT 2O material 35 and the end portion of the band is inserted into fastener 34 and back over itself to secure the velcro material together and to firmly secure the placement module 14 to the patient's wrist.

The transducer assembly 16 includes circuitry, schematically S. illustrated by Figs. 5 and 5A and described below, for exciting at least one transducer therein and is coupled to the MOU by cable 36. The cable 36 is 25 preferably multiconductor cables capable of transmitting relatively low frequency :'RF or optical signals, as well as digital signals. The cable 36 may include coaxial cable or other types of suitable shielded cable. Alternatively, the cables 36 may x include fiber optic cable for transmitting optical signals. The signals may be transmitted continuously or as a series of pulses.

In operation, the placement module 14 is positioned and secured to the patient's wrist as shown by Figs. 2 to 4, such that the transducer assemblies 16 lie over the carpal tunnel 100 or hand/wrist injury. The carpal tunnel 100 contains the median nerve 102, nine flexor tendons 104 and their flexor sheaths and four WO 99/18876 PCT/US98/21341 carpal bones, which includes the hamate 106, capitate 108, trapezoid 110, and trapezium 112 which are tightly bound together to form the dorsal, medial and lateral walls of the tunnel. A locating ring such as the one disclosed in U.S. Patent No. 5,556,372 may be used for determining the location of injured bone in the case of a hand/wrist injury before the placement module 14 is secured to the patient's hand. Once the placement module 14 is properly positioned, the transducer within each transducer assembly is excited for a pre-determined amount of time to impinge ultrasonic waves towards the carpal tunnel 100. An alternative embodiment of the placement module 14 is shown by Fig. 4. A gel-like substance 37 may be positioned between the transducer assembly 16 and the patient's wrist to prevent attenuation of the ultrasonic waves as they travel to the carpal tunnel or injured bone 40 as shown by Figs. 3 and 4.

The placement support 22 may be constructed of hard plastics which may be custom molded for a particular patient. The placement support 22 may also be constructed to encapsulate the patient's entire hand/wrist area or to only surround the carpal tunnel or injured or fractured bone areas.

With reference to Fig. 5, a block diagram of the ultrasonic transducer assembly circuitry is shown. The transducer assembly circuitry 17 includes a receiver 50 which receives the signals transferred by a signal generator within MOU 12 via cable 36. Receiver 50 is connected to transducer driver 52 which excites transducer 54. The transducer assembly circuitry 17 further includes an internal battery 60 which supplies power to the components within the transducer assembly 16. For example, battery 60 supplies power to signal monitoring circuit 62 and signal driver 66. The signal monitoring circuit 62 provides, preferably, a digital output signal 68 which represents the waveform characteristics of the output of transducer driver 52. These characteristics can be displayed on a digital display and may include, for example, the frequency, pulse repetition frequency, the pulse width and the average output power of the transducer 54. The output signal 68 of signal monitoring circuit 62 is transferred to the signal generator within MOU 12 WO 99/18876 PCT/US98/21341 via driver 66 and cable 36. The signal generator may include a processor and a switch for regulating the signal characteristics. Control signals from the MOU 12 are received by receiver 50 via cable 36. Safety or fixture interlock 70, which may include switches on the outer surface of the placement module 14 or transducer assembly 16, ensures that the placement module 14 is properly positioned before providing power to the internal components of the transducer assembly 16.

A second embodiment of the portable ultrasonic treatment apparatus of the present invention is illustrated by Figs. 6-8 and designated generally by numeral 200. The treatment apparatus 200 includes MOU 12 and a series of transducer assemblies 206 on a placement module 208. The transducer assemblies 206 can be placed within pockets 210 of the placement module 208 such that at least one transducer 212 lies over the location of the carpal tunnel 100 or hand/wrist injury. Each transducer 212 is connected to the MOU 12 via wires 214. The circuitry 17 for each transducer assembly 206 may be similar to that disclosed for the first and second embodiments and schematically illustrated by Fig. In operation, the placement module 208 is positioned and firmly secured to the patient's hand or wrist by VELCRO T M tabs 216 as shown by Figs. 7 and 8, such that the transducer assemblies 206 lie over the carpal tunnel 100 or hand/wrist injury. Once the placement module 208 is properly positioned the transducers within the transducer assemblies 206 are excited for a pre-determined period of time to impinge ultrasonic waves to the carpal tunnel 100 or injured bone, as shown by Fig. 8.

It is envisioned that the placement module 208 be constructed from suitable conductive plastics, such as conductive ABS plastics with either carbon, stainless steel, nickel or aluminum fibers to forego the use of wires 212 for connecting the transducer assemblies 206 to each other. In such an embodiment, the conductive placement module 208 would be used to electrically connect the transducer assemblies 206 to each other.

With reference to Figs. 9 and 10, a third embodiment of the portable ultrasonic treatment apparatus is illustrated. In this embodiment, the treatment apparatus 300 includes a MOU (not shown), a placement module 304, ultrasonic transducer assemblies 306, and a pouch (not shown) for providing patient mobility during treatment. The placement module 304 is comprised of a placement band 310 and a placement support 312. The under-side of the placement support 312 includes pockets 314 for placement of transducer assemblies 306 therein. The transducer assemblies 306 may be arranged in a plurality of configurations within pockets 314 such that they lie over the carpal tunnel 100 or location of the hand/wrist injury. Each transducer assembly 306 is connected to the MOU via wires 316. The circuitry 17 for each transducer assembly 306 may be similar to that disclosed for the first and second embodiments and schematically illustrated by Fig. In operation, transducers within transducer assemblies 306 are excited for a pre-determined period of time to impinge ultrasonic waves to the 2) carpal tunnel 100 or injured bone, as shown by Fig. A fourth embodiment of the portable ultrasonic treatment apparatus which is primarily suitable for the treatment of carpal tunnel syndrome is illustrated by Figs. .11 and 12. In this embodiment, the apparatus 400 includes at least one ultrasonic transducer 402 positioned on a conductive strip 404 connected to an arm brace 406. The strip 404 is aligned along a patient's carpal tunnel 100 once the arm brace 406 is secured to the patient's arm.

The conductive strip 404 is connected via a cable 408 to a MOU (not shown) which contains circuitry for exciting ultrasonic transducer 402 affixed to the conductive strip 404. The conductive strip 404 is preferably constructed from suitable 4:-39: conductive plastics such as conductive ABS plastics with either carbon, stainless steel, nickel or aluminum fibers to forego the use of wires for electrically connecting more than one ultrasonic transducer to the conductive strip 404.

In operation, the transducer 402 is excited to impinge ultrasonic waves at the site of the carpal tunnel. It is contemplated that during treatment a gel-like substance is positioned between the transducer 402 and the patient's hand to prevent attenuation of the ultrasonic waves.

It will be understood that various modifications can be made to the various embodiments of the present invention herein disclosed without departing from its spirit and scope. For example, various shapes of the pouch and signal generator are contemplated, as well as various types of construction materials.

Also, various modifications may be made in the structural configuration of the placement module and the configuration of the components used to excite the ultrasonic transducer. Therefore, the above description should not be construed as limiting the invention but merely as presenting preferred embodiments of the invention. Those skilled in the art will envision other modifications within the scope and spirit of the present invention as defined by the claims presented below.

Throughout this specification and the claims which follow, unless the context requires :1 otherwise, the word "comprise", and variations such as "comprises" and "comprising", oo o will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form or suggestion that that prior art forms part of the

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common general knowledge in Australia.

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Claims (9)

1. An apparatus for ultrasonically treating carpal tunnel syndrome or hand/wrist injury, comprising: a main operating unit and an ultrasonic transducer assembly, said main operating unit having an internal power source coupled to the ultrasonic transducer assembly, said ultrasonic transducer assembly including at least one ultrasonic transducer, an ultrasonic signal generator and signal generator circuitry therein; and a placement module configured to receive said transducer assembly, said placement module including a placement support, at least two lateral supports and a pivotably adjustable connector connected to each lateral support, said adjustable connectors being configured for securing said placement module to a patient's hand and/or wrist such that said at least one ultrasonic transducer is positioned in proximity to the carpal tunnel or site of the hand/wrist injury. :°oo2. The apparatus according to claim 1, wherein said main operating unit is positioned within a pouch worn by the patient to permit portable operation thereof S3. The apparatus according to claim 1 or 2, wherein the placement module is configured to receive a plurality of ultrasonic transducers.

4. The apparatus according to any one of the preceding claims, wherein the placement module is constructed from a conductive material and said at least one ultrasonic transducer provided on said placement module is electrically coupled to said main 25 operating unit via said conductive material. The apparatus according to any one of the preceding claims, wherein the placement S"module is custom molded for a particular patient.

6. The apparatus according to any one of the preceding claims wherein one of the R/,adjustable connectors includes a placement band secured thereto at one end of the band PAOPER\CA2292232 clainins ,2.do-t/06102 -13- and wherein the free end of the placement band is attached to a second adjustable connector, the attachment being such that the length of the placement band around the patient's hand or wrist is adjustable.

7. A kit for ultrasonically treating carpal tunnel syndrome or hand/wrist injury while maintaining patient mobility, which comprises: an ultrasonic transducer assembly, each assembly having at least one ultrasonic transducer; a placement module configured to be worn by a patient, said placement module being configured to receive said transducer assembly and including a placement support, at least two lateral supports and a pivotably adjustable connector connected to each lateral support, said adjustable connectors being configured for securing said placement module to a patient's hand and/or wrist such that said at least one ultrasonic transducer of the transducer assembly is in proximity to the carpal tunnel or site of the hand/wrist injury; an ultrasonic signal generator positioned in said ultrasonic transducer assembly; a main operating unit; and a pouch configured to receive said main operating unit, said pouch including a belt so that said pouch can be worn by a patient during treatment thereby providing patient mobility.

8. The kit according to claim 7 wherein the apparatus according to any one of the preceding claims wherein one of the adjustable connectors includes a placement band secured thereto at one end of the band and wherein the free end of the placement band is attached to a second adjustable connector, the attachment being such that the length of the 25 placement band around the patient's hand or wrist is adjustable.

9. The kit according to claim 7 or 8, wherein said ultrasonic signal generator includes signal generator circuitry and an internal power source connected to said signal generator circuitry, a display coupled to said signal generator circuitry to display treatment sequence K ata, and said signal generator circuitry including a processor and means for generating a Iaed RF signal. P:OPER\CAE\2292232 r-3.doc-107/02 -14- The kit according to any one of claims 7 to 9, further comprising safety interlock means to prevent inadvertent excitation of said at least one ultrasonic transducer.

11. A method for ultrasonically treating carpal tunnel syndrome or a hand/wrist injury, comprising the following steps: providing a main operating unit and an ultrasonic transducer assembly, said main operating unit having an internal power source coupled to the ultrasonic transducer assembly, said ultrasonic transducer assembly including at least one ultrasonic transducer, an ultrasonic signal generator and signal generator circuitry therein; providing a placement module configured to receive said transducer assembly and said placement module including a placement support, at least two lateral supports and a pivotably adjustable connector connected to each lateral support, said adjustable 'connectors being configured for securing said placement module to a patient's hand "and/or wrist such that said at least one ultrasonic transducer is positioned in proximity to 15 the carpal tunnel or site of the hand/wrist injury; and exciting said at least one ultrasonic transducer to impinge ultrasonic waves at or near the carpel tunnel or site of the hand/wrist injury.

12. An apparatus for ultrasonically treating carpal tunnel syndrome or hand/wrist 20 injury substantially as herein described with reference to accompanying figures 1 to 8. 0 .000 13. A kit for ultrasonically treating carpal tunnel syndrome or hand/wrist injury *substantially as herein described with reference to accompanying figures 1 to 8.

14. A method for ultrasonically treating carpal tunnel syndrome or hand/wrist injury substantially as herein described with reference to accompanying figures 1 to 8. DATED this 15 th day of July, 2002 Exogen, Inc. T 0 by DAVIES COLLISON CAVE /r Patent Attorneys for the Applicant(s)