AU2002300149B2 - Method and apparatus for ultrasonic treatment of carpal tunnel syndrome - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 DIVISIONAL APPLICATION NAME OF APPLICANT(S): Exogen, Inc.

ADDRESS FOR SERVICE: DAVIES COLLISON CAVE Patent Attorneys 1 Little Collins Street Melbourne, 3000.

INVENTION TITLE: "Method and apparatus for ultrasonic treatment of carpal tunnel syndrome" The following statement is a full description of this invention, including the best method of performing it known to us/me: Q:\OPER\CAE\2002\JULY\2552522 DIV 198.DOC 16/7/02 PAOflRPH-fOSZ2f zmuspaI3uidckx-IMYTM4 lA- METHOD AND APPARATUS FOR ULTRASONIC TREATMENT OF CARPAL TUNNEL SYNDROME This application is a divisional of Australian Patent 752098 (Application No. 97957/98), the entire contents of which are incorporated herein by reference.

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 ultrasonic transducer configured to cooperate with a placement module or arm brace 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 described in the Durate 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 pluses 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 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 P;OPER\PHH\2552522 amspccisjul dc .OtMd4 -3injected 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 According to a first aspect of the present invention there is provided apparatus for ultrasonically treating carpal tunnel syndrome while maintaining patient mobility, comprising: at least one ultrasonic transducer; an arm brace; a conductive strip positioned on said arm brace and having a plurality of openings configured to receive said at least one ultrasonic transducer, said conductive strip being configured for placement with the arm brace along the patient's hand and/or wrist including the carpal tunnel; and a main operating unit having an internal power source electrically coupled to an ultrasonic signal generator, said ultrasonic signal generator being electrically coupled to the conductive strip on the arm brace by a conductor cable and said conductive strip being electrically coupled to said at least one ultrasonic transducer, whereby the at least one ultrasonic transducer can be excited by actuating said ultrasonic signal generator.

Preferably, the apparatus of the first aspect of the invention further comprises a second conductive strip positioned on said arm brace and having a plurality of openings configured to receive at least one further ultrasonic transducer, said second conductive strip being configured for placement along patient's hand and/or wrist including the carpal tunnel on the opposite side to the first-mentioned conductive strip, said ultrasonic signal generator being electrically coupled to the second conductive strip by a conductor cable and said second conductive strip being electrically coupled to the at least one further ultrasonic transducer, whereby said at least one further ultrasonic transducer can be excited by actuating said ultrasonic signal generator.

Also according to the first aspect of the present invention there is provided a method for ultrasonically treating carpal tunnel syndrome while maintaining patient mobility, comprising the following steps: releasably securing at least one ultrasonic transducer to a conductive strip whereby P.OPERPHI l52522 z.msppc5jul.doc.16074 -4the at least one ultrasonic transducer is electrically coupled to the conductive strip, said conductive strip being positioned on an arm brace and having a plurality of openings configured to receive said at least one ultrasonic transducer, said conductive strip being configured for placement with the arm brace along the patient's hand and/or wrist including the carpal tunnel; affixing the arm brace including said conductive strip on a patient's hand and/or wrist, such that said at least one transducer is in proximity to the carpal tunnel; electrically coupling said conductive strip to a signal generator; and exciting said at least one ultrasonic transducer by actuating said signal generator by means of a main operating unit having an internal power source electrically coupled to the ultrasonic signal generator to impinge ultrasonic waves to the carpal tunnel.

Preferably, the method of the first aspect of the invention includes the step of placing a gel-like substance between the at least one transducer and the patient's hand and/or wrist to minimize attenuation of said ultrasonic waves.

According to a third aspect of the present invention, there is provided apparatus for ultrasonically treating carpal tunnel syndrome or hand/wrist injury while maintaining patient mobility, comprising: at least one ultrasonic transducer; a placement module formed of electrically conductive material and having a plurality of openings configured to receive said at least one ultrasonic transducer and thereby electrically couple the at least one transducer to the placement module, said placement module being configured for placement on the patient's hand and/or wrist; and a main operating unit having an internal power source electrically coupled to an ultrasonic signal generator, said ultrasonic signal generator being electrically coupled to the at least one ultrasonic transducer, whereby the at least one ultrasonic transducer can be excited by actuating said ultrasonic signal generator.

Preferably, the main operating unit (MOU) has a display coupled to the signal generator to permit user operation and/or entry of data. The signal generator may include a processor, means for generating a pulsed control signal, and a switch coupled to 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 PAOPERPHH.2552522 ammspecl 5jul doc-16/07 4 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 may be provided to indicate to the user that the treatment time has expired. The alarm may be coupled to the processor such that when ultrasonic treatment is completed the processor activates the alarm and terminates ultrasonic generation.

Preferably, the MOU is fitted within a pouch which is releasably secured to a patient during treatment to permit portable operation thereof A MOU envisaged 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.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are described below, by way of example only, with reference to the drawings, which are described a follows: Fig. 1 is a perspective view with parts separated of a first embodiment of a portable ultrasonic treatment apparatus illustrating a main operating unit or controller and a placement module, as described and claimed in Patent 752098; 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; Fig. 5 is a block diagram of the circuitry for the ultrasonic transducer assembly; 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 placement module having a series of transducers, and including a modification in accordance with the present invention; Fig. 7 is a perspective view of a patient wearing the portable treatment apparatus of P'CPER'PHM2552S22 n usptl5jdL d -16 V7,4 -6- Fig. 6; Fig. 8 is a side view of a patient wearing the portable treatment apparatus of Fig. 6; Fig. 9 is a perspective view of a patient wearing a portable treatment apparatus 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 in accordance with the present invention, 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 described herein is used for the surgical noninvasive utlization 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. The apparatus includes an ergonomically constructed placement module or brace having a strap or other fastening means for being secured to a patient's hand and/or wrist. At least one ultrasonic transducer assembly is received within the placement module or brace and properly positioned in proximity to the carpal tunnel or hand/wrist injury to provide acoustic energy to the site of the 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. The apparatus also utilizes a portable, ergonomically constructed main operating unity (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.

PAOPEiMPH5h2S322 amSeI 5pzIAc-6UM -7- Turning to the figures, in particular Fig. 1, one embodiment of the portable ultrasonic treatment apparatus 10 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 25 for connecting the placement support 22 to the placement band 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 VELCROTM material and the end portion of the band is inserted into the 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 illustrated by Figs. 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 preferably multiconductor cables capable of transmitting relatively low frequency RF or optical signals, as well as digital signals. The cable 36 may include the coaxial cable or other types of suitable shielded cable.

Alternatively, the cables 36 may 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 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 PAOPERPHHf2552522 amntp L5juldc- 1607JD4 -9via driver 66 and 36. 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.

The main operating unit (MOU) has a display coupled to the signal generator to permit user operation and/or entry of data. The signal generator may include a processor, means for generating a pulsed control signal, and a switch coupled to 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 may be provided to indicate to the user that the treatment time has expired. The alarm may be coupled to the processor such that when ultrasonic treatment is completed the processor activates the alarm and terminates ultrasonic generation.

A second embodiment of the portable ultrasonic treatment apparatus 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.

In accordance with the present invention, it is envisaged that the placement module PAOPERWPHH2552522 amispcl 5ju1.doc.I6I7fl04 208 may be constructed from suitable conductive plastics, such as conductive ABS plastics with either carbon, stainless steel, nickel or aluminium 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 predetermined period of time to impinge ultrasonic waves to the carpal tunnel 100 or injured bone, as shown by Fig. A fourth embodiment of the portable ultrasonic treatment apparatus, in accordance with the invention and 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 each of two conductive strips 404 connected to an arm brace 406. Each transducer 402 is received in one of a plurality of openings through the brace and respective conductive strip. The conductive strips 404 are on opposite sides of the brace 406. Each strip 404 is aligned along a patient's carpal tunnel 100 once the arm brace 406 is secured to the patient's arm. Each conductive strip 404 is connected via a respective cable 408 to a MOU (not shown) which contains circuitry for exciting ultrasonic transducer 402 affixed to the conductive strip 404. Each conductive strip 404 is preferably constructed from suitable conductive plastics such as conductive ABS plastics with either carbon, stainless steel, nickel or aluminium fibers to forego the P; OPERPHS552522 a= ispoc5jut d MI6iT4 11 use of wires for electrically connecting more than one ultrasonic transducer to the conductive strip 404.

Each transducer 402 forms part of an ultrasonic transducer assembly which may correspond to the ultrasonic transducer assemblies 16, 206 and 306 described above.

Likewise, the MOU may correspond to the MOU 12 described above, which may be received in a pouch worn by the patient, also as described above.

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 or brace 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 otherwise, the word "comprise", and variations such as "comprises" and "comprising", 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 of suggestion that that prior art forms part of the common general knowledge in Australia.

Claims (1)

12- THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS: 1. Apparatus for ultrasonically treating carpal tunnel syndrome while maintaining patient mobility, comprising: at least one ultrasonic transducer; an arm brace; a conductive strip positioned on said arm brace and having a plurality of openings configured to receive said at least one ultrasonic transducer, said conductive strip being configured for placement with the arm brace along the patient's hand and/or wrist including the carpal tunnel; and a main operating unit having an internal power source electrically coupled to an ultrasonic signal generator, said ultrasonic signal generator being electrically coupled to the conductive strip on the arm brace by a conductor cable and said conductive strip being electrically coupled to said at least one ultrasonic transducer, whereby the at least one ultrasonic transducer can be excited by actuating said ultrasonic signal generator. 2. Apparatus according to claim 1, wherein said signal generator includes a processor, means for generating a pulsed signal, and a switch coupled to said processor for regulating said pulsed signal. 3. Apparatus according to claim I or 2, wherein said main operating unit is positioned within a pouch worn by the patient to permit portable operation thereof. 4. Apparatus according to any one of claims 1 to 3, further comprising a second conductive strip positioned on said arm brace and having a plurality of openings configured to receive at least one further ultrasonic transducer, said second conductive strip being configured for placement with the arm brace along the patient's hand and/or wrist including the carpal tunnel on the opposite side to the first-mentioned conductive strip, said ultrasonic signal generator being electrically coupled to the second conductive strip by a conductor cable and said second conductive strip being electrically coupled to the at least one further ultrasonic transducer, whereby said at least one further ultrasonic P:IOPERWIPHH2552522 mdeddiv .aimns 5jul do .16W7A04 -13- transducer can be excited by actuating said ultrasonic signal generator. A method for ultrasonically treating carpal tunnel syndrome while maintaining patient mobility, comprising the following steps: releasably securing at least one ultrasonic transducer to a conductive strip whereby the at least one ultrasonic transducer is electrically coupled to the conductive strip, said conductive strip being positioned on an arm brace and having a plurality of openings configured to receive said at least one ultrasonic transducer, said conductive strip being configured for placement with the arm brace along the patient's hand and/or wrist including the carpal tunnel; affixing the arm brace including said conductive strip on a patient's hand and/or wrist, such that said at least one transducer is in proximity to the carpal tunnel; electrically coupling said conductive strip to a signal generator; and exciting said at least one ultrasonic transducer by actuating said signal generator by means of a main operating unit having an internal power source electrically coupled to the ultrasonic signal generator to impinge ultrasonic waves to the carpal tunnel. 6. A method according to claim 5, wherein said main operating unit is positioned within a pouch worn by the patient to permit portable operation thereof 7. A method according to claim 5 or 6, further including the step of: placing a gel-like substance between the at least one transducer and the patient's hand and/or wrist to minimize attenuation of said ultrasonic waves. 8. Apparatus for ultrasonically treating carpal tunnel syndrome or hand/wrist injury while maintaining patient mobility, comprising: at least one ultrasonic transducer; a placement module formed of electrically conductive material and having a plurality of openings configured to receive said at least one ultrasonic transducer and thereby electrically couple the at least one transducer to the placement module, said placement module being configured for placement on the patient's hand and/or wrist; and P:OPERPH U 5I252 smwdeddiv claniiljul dO-16M7DTO -14- a main operating unit having an internal power source electrically coupled to an ultrasonic signal generator, said ultrasonic signal generator being electrically coupled to the at least one ultrasonic transducer, whereby the at least one ultrasonic transducer can be excited by actuating said ultrasonic signal generator. 9. Apparatus according to claim 8 and substantially as hereindescribed with reference to Figures 6 to 8 of the accompanying drawings. Apparatus for ultrasonically treating carpal tunnel syndrome substantially as herein described with reference to Figures 11 and 12 of the accompanying drawings. 11. A method for ultrasonically treating carpal tunnel syndrome substantially as herein described with reference to Figures 11 and 12 of the accompanying drawings. DATED this 16 th day of July, 2004 Exogen, Inc. by DAVIES COLLISON CAVE Patent Attorneys for the Applicant