APPARAl VS AiND METHOD FOR W OUλD ( ARE W ITH V LTRASOt ND AλD

PRESSURE THERAPY DEVICE

CROSS RFJFF-RCNCF. TO REf ATHD APPLICATION

I his application claims prioπn to U S Patent Application No. 1 1/46 ⁷ 225 filed August

25, 2006, the teachings of which aie hereby mcorpotated by ieference

BACKGROUND OF THE INVENTION

Field of the Im en lion

I he present invention is directed towards an apparatus and method of wound treatment combining ultrasound therap> and piessure therapy

Desc-iption of the Related Art

Chronic wounds in the extremities encountered m clinical practice can be slow to heal and difficult to manage. Such wounds are often seen in diabetics, the elderly, and individuals w jth compromised or diminished peripheral circulation. Such \\ ounds disable the patient, thereby i educing the patient ^' s quality of life. An unhealed wound's susceptibility to infection inci eases a patient ^' s morbidity and mortal itv Placing the patient in an eπviionment abundant in ditig rcsibtaitt infectious agents, such as hospital or institutional settings, fuithei inci eases the patient's morbidity and mortality. Treating such wounds, especially after a serious infection has set ui. burdens healthcare providers by increasing the time and resources that must be devoted to a single patient.

Maintaining a wound in a moist state, free of infections w ith a good blood supply and the coi rec t balance of anti-inflammatory drues is consideied to be the ideal treatment to

promote healing (Jones et a! 2005) Attempting to create Ae ideal treatment, medical device iπarmfactiues and inv entors have created a v aπety υf dev ices utilizing topical negativ e prcssute theiapy or ultrasound

Topical negativ e pje&sure fheiapy applies a conwolled negativ e pressure to the surface of 5 the wound General!} , the negativ e pressure is created by a vacuum pump or similar mechanism Represented dev ices are encompassed in Patent No 7,070,584 w Johnson et al , Patent No. 7.004,915 to Boynton et al.. Patent No. 6,994,702 to Johnson. Patent No. 6,695,823 to Lina et al .. and Patent No 6, 135, ! 16 to Vogel ct a! . Topical negaf K e pressure therapy dev ices been shown to increase the flow of positive healing elements, such as. but not 0 limited to. blood, nutrients, oxygen, and giowth factors, to the v. ound and the iate of granulation, oi tissue growth, while decreasing the levei of bacteria and inflammatory ageritb present Topical negath c pressure therapy , how c\ ct, lias sev eral limitations Ineffectiv c in treating sloughy oi grossly infected wounds, topical negative pressure therapy icet. arc only capable of promoting healing in clean and debπded wound beds. (Jones et al. 2005} S Furthermore negative picssure therapv is contraindicated o\er necrotic tissue (Jones et al 2005), the presence of which can hindei oi prevent healing, High rental costs and expensive silvcϊ dressings _* fuither limit the applicability of topical negative pressure de\ ices »i w ound caie. This is especially true in light of the fact that 4 to 6 weeks of continuous therapy is required, during which time the machine cannot be used on more than one patient,

Re-injuiJng the wound when the diessmgs ate changed furtbet hunts topical negative pressure therapy devices The dressings employed by such de\ ices are porous by necessity As the vv ound heals, new tissue grow s into the porous openings of the dressing W ben the dressing ϊS removed, healed tissue is removed w ith it.

Delivering ultrasonic energy through atomized liquid coupling mediums, ultrasonic 5 wound care de\ ices tteat wounds b> increasing the flow υf posim e healing elements to the wound Represented dev ices are encompassed in Patent No, 7,025,735 to Soring et al,; Patent No. , Patent No. 6,960, ! 73 to Babaev , Patent No 6,916,296 to Sυrmg, Patent No, 6J6J,729 to ; Patent No 6,723.064 to Babaev , Patent Mo 6,663,554 to , Patent No. 6,62 >,444 to Babaev , Patent No. 6,601 ,581 to Babauv ; Patent No. 6,569,0«

to . Patent No 6,533,803 to Babae\ , and Patent No 6.478754 to , Lacking relatively immediate contact w ith the target wound, these dex ices prov ide an inefficient transfet of ultrasound energy to the wound Consequently, the ability of these devices to clean the wound, remove necrotic tissue, or destroy infectious agents JS limned

5 Patent No 5,305,737 to Vago and Patent Ko. 5,665,141 to Vago discloses an ultrasound bath capable of treating an injmed anuria!. Immersing the animal in a degassed coupling medium (working fluid J and transmitting ultrasound energy to the animal thiough the degassed coupling medium the bath treats the injured animal Use of a degassed coupling medium prevents the formation of cavitations within the coupling medium.

I O in efforts to enhance the healing abilities of negative pressure therapy and nlti asGiind therapy, a dev ice for treating wounds utilizing ultrasound induced topical pressure therapy has been eioped by the author of the present application and disclosed m application 1 1/474,965 entitled "l ltrasound Wound Care Device and Method". L'ltrasonicalK inducing negative and positive piessure ci the surface of a w ound, ultrasound induced topical pressure therapy

15 assists wound healing Ultrasonic etiei»\ emitted into a treatment solution in contact w ith the wound induces cav itations within the treatment solution, leading to the formation of gas bubbles within the coupling medium. This phenomenon is simiiat to vvatei boiling but u> not the result of heating the ticatnicnt solution As gas bubbles form and dissipate against tlie surface of the w ound micro domains of topical positive and uegatπ e pressure aie cieated met the w ound's 0 surface The alternating pressure removes necrotic tissue and other contaminates from the woimci while inα casing the flow of positive healing elements to the wound

Increasing blood flow to the sue of the wound expedites healing by increasing the amount of positiv e heairag elements delrveied to the miur> . Negativ e pressure theiapv dev ices, those employing the healing benefits of ultrasound are only capable of increasing blood flow at 5 the mjury site. Circulation through the injured limb remains unaffected. Consequently, the amount of positive healmg factors available to the w ounded tissue is limited bv the amount of positiv e healing factors entci iπg the wound extremity Various devices and methods exist for increasing blood flow within the extremities (i e. arras, legs, feet, and hands). Applying alternating or fluctuating external piessiue to an extiemitj inci cases circulation within the

ex IT emits (hereafter referred to as "externa! pressure therapy"). Devices employing such external pressure therapy are represented by Patent No. 4,343302 to Dillon. Patent No, 4,269,175 to Dillon, and Patent No. 3,%l,e>25 to Dillon. Peripheral blood flow may also be enhanced by mechanical stimulation or agitation of the extremity as to work blood through the peripheral vascular system. Devices utilizing agitation to increase peripheral circulation are well known to the art. Though effective in increasing peripheral circulation, the mentioned devices are not capable of directly treating injuries or wounds located on the treated extremity .

Therefore, a need exists for a device and method capable of increasing the general circulation within a wounded extremity while simuitaneousU applying ultrasound induced topical pressure therapy to the wound.

SUMMARY Of' THR INVENTION

The present invention is directed towards a wound treatment device combining ultrasound therapy and pressure therapy. The device comprises an outer pressure chamber, ultrasonic transducers mounted on aud-'or within the sides of the pressure chamber, and a treatment chamber located within the pressure chamber. The treatment chamber applies ultrasound induced topical pressure therapy So an injured extremity as to clean the wound, increase the flow of positive healing elements to the wound, and or deliver various therapeutic compounds to the wound. Cleaning a wound refers to debriding the wound, remcπing necrotic tissue from the wound, ing contaminants from the wound, and or killing and removing bacteria, fungi, viruses, and/or othei infectious microorganisms within the wound. A treatment solution is held with.ni, and may be circulated through, the treatment chamber. The pressure chamber surrounding the treatment chamber applies externa! pressure therapy to the injured extremity as to increase circulation within injured extremity. The ultrasound transducers mounted on and or within the sides of the pressure chamber deliver therapeutic ultrasonic energy, through a coupling medium held within the pressure chamber, to the treatment chamber as to induce topical pressure therapy within the treatment chamber.

I he pressure chambei comprises a port or pluiality of ports through w hich a coupling medium raa> be injected and or evacuated Injecting coupling medium into the pressure chamber increases the pressure within the pressure chambei Inversely, evacuating coupling medium from the pressure chamber reduces the pressures within the pressure chamber The 5 coupling medium field within the piessure chamber may be any fluid capable of carrying ultrasound waves Injecting and/or evacuating the coupling medium mav be accomplished by a pump ot plurality of pump ⁵ , m communication with the ports Alternating the pressure within the piessure chamber by repetitively injecting and evacuating the coupling medium ma> create a pumping action within the vasculature of the treated extremity The induced pumping action 0 ma\ facilitate an increase in circulation within the treated extremity-, ϊ he incieased αiculation allows for the delivery of snore positive healing elements to the wounded extremity, consequently making more available to the wouml(s) being tteated

hi a possible alternative embodiment, the coupling medium ma> be injected into the piessure chamber thiough the porta of the pressure chambei as a presstuked stream, injecting S coupling medium as a pressurized stream allows direct pressure to be tatgeted to specific and oτ alternating regions of the exti entity being tieated Incorporating a noz/le tapeied at its distal end into the ports may be done as to bettei target and'Ot create a pressuri/ed sUeain of coupling medium To facilitate the selective targeting of such piessun/cd sa earns the ports may comprise means of opening and or closing the port, such as, but not limited to, v alves or solenoids, 0 incorporating a means of selectively opening and closing the ports such as, but not limited to a computer or control panel, into tie treatment device of the present invention would allow the uset to bettei direct pressurized streams of coupling medium as well as coiitiol the rate of pressure changes within the pressure chamber The ports may also incorporate ultis sound transducer

5 In another possible embodiment, the present invention may further comprise a manifold in communication with the poits possessing a vseries of \ ah es. solenoids and-oi similar means of mo\ ing and directing the flow of coupling medium to and or from various ports. The flow, of fluid through the manifold and ports may be controlled bv a compute! , coπttol panel, or similar means

ϊ he alternating positive and negative piessuie eieated within the pies&ute chamber by the sequential injection and ex acuation of coupling medium cieatcs an alternating negatnc and positøe piessuie w ithm the tieatment ehambei The tteatment chambet comprises pliable sides capable of expanding and contacting irt response to pies^itte changes w rfhm the pressuie 5 ehambei , thεreb) coupling the pleasure within the piessure chamber to that \\ uhm the Ueatment chamber 1 he negam e pressure created λλ ithiri the tieatment chamber as coupling medium is ev acuated fiom the piessuie chambet, cteates an em iioumerit similar to conventional negativ e piessure therap\ \ tieatment solution ma\ be circulated thiough the tieatment chambei as to irrigate the w ound while allowing for the evacuation of infectious mictoorgamsms mtlammatoi\ 0 agents, and oi \aπoυs contaminants removed fiom the \%ound out of the tieatment chamber

L iπa&onicalSy inducing topical piεssute therapλ o\er the outface of a wound, the present im cntion tteatt. \\ ounds and assists u ouiid healing L ltrasonic energv emitted fiom the ulttasound tians>duc«}>, located wuhin amioi upon the \\AK of the pies>suie chamber, induces ca\ ttatmns w ithm the treatment solution held in the treatment chambei , leading to the formation S of gat> hubbies within the tieatment SOUUJOπ This phenomenon is similar, to w ater boiling but is not the iesuh of heatmg the coupling niedumi λs uas bubbles form and dissipate against the sui face of the wound micio domams of topical positiv e and negative pressure are created o\er the w ound's s\u face The alternating ptesMue may clean the % ound

I he traatment solution u ithm the tieatment chamber iita) be liquid gel, or smniar fluid 0 medium DissoK ing or suspending diυgs v\ ithin the tieatment solution ma> be done to assist drug deln eι>< duung wound tieatment Liberating the dissoK ed or suspended drug from the coupling medium while inducing macio cavitations on the surface of the wound and micro ca\ itationb along \\ ith micro streaming u ithin the wound bed, the ultrasound wav es transport the drug into and aeioss the wound bed Hie solution within the treatment chambei ma\ also be *v capable of moistening the v\ ound

Within the wound, oltiasoutid wa\ es induce micro ca\ itation and mtcrostrcanuπg Killing bacteria and υthα mfcctious agents, the induced micio cav nation may disinfect the wound while cav itations vMthm the coupling medium leow e infectious agents fiurø the wound Inducing mierostiearaing « ithm the w ound bed, the dein eied uitiasoxind waves ma\ increase

blood to the w ound bed. therebv allowing tot the increased delivery of posftne healing elements {o the w ound and'oi the icrnox al of inflammatory agents ftom the w ound The fluctuating topical ptessiue mav also help w ith the of uifiammatoij agents Producing ov erlapping healing benefits the fluctuating topical piεssuϊe and deliveied ultrasound waves 5 mav exaggerate the actions of euhei when used alone thereb) αeatmg a synergistic healing action

I he piesent invention may contain a plural tt\ of ultrasound Langev m 01 eunbal tr ansdiicet s, pi ctct ablv c> mbal ts ansdυcei b I n such art an angcrnent, the selecti v e ac tn ation of a single transducer and/or collection ofuansducers would allow ulttasouiid energ\ to be taigeted 10 to the aica and 'or aieat> of the tieated extrenuty contamrng Incoφotatiiig a means of selectn elv \\ tthm {he tteatmcπt Mich as but not limited to, a computer oi control panel, allow s the us>« to better target or direct ultrasonic εneιg\ emitted Horn the trarii>duceis Io the wounds bought to treated

The de\ ice may iunher compπs>e a means of mechanic alh agitating or λ ibratmg the l *i injuied extremnv as to fiπther enhance of the therapeutic action of the externa! piessuie chai7iber and ot internal treatment chamber Agitating the ssstem by shaking vibrating gj iatmg, o&ci Hating υι mduerng Mmilai nwveraεm sn the piesbuie chamber and ot tredtment chamber ma> be done to induce a snnilai w ithiii the cxtrcmitλ being treated I he IϊIOλ ciiicnt imparted in the exiieinity may enhance healing by further ιncτ easing mcuktton u Uhin the 0 extreoutv being treated Healing ma> be further enhanced by the mdueUon of eddies oi other turbulences \\ ithm the treatment solution \\ ithm the treatment chambei ϊnduc ing eddies. \\ ithm the solution held m the treatment chamber mav mciease the flo and disbuisement of infectious microorgamstnsϊ, neciotic tissue, debus, contaminants, and 'or inflammatory agents aw av tϊom the wound being treated

5 Tteatiπg a \\ ound w ith the present m\ erition does not t equue tonttnoed use of (he deuce until the wound i& healed Rather the present invention mav be u ^cd to treat a pauent ^' i. wound Aftei a paiicπt has recened a tteatmcπt sesbion, the dev tee can be cleaned and sterilized and then used to treat other patients As to ieduee the amount of cleaning between tieatmcnt sessions uh dif Joient patients and to increase flic v ol the present mventiυn,

the treatment ehambei ma> be able and/oi disposable and aιiable in eial configurations matching the extremity to be treated

I hough the present invention is pnmanh intended fot the treatment of wounds one skilled in the att should be able to immedtateiv appieeiate its application to the improvement of peripheral cucutation m the absence of the wound caje and to the treatment of mjuied, strained, and'ot fatigued muscles, as wells as tiiμπed and at inflamed joints

One aspect of the pϊesent inv ention mav be to ticat xvouπds and assist w ound heahng

Another aspect of the present im ention mas be to remot e necrotic tissue infectious agents, and other contaminants fioin the wound

Aπothct aspect of the pioscnt raas be to dehx ci drugs to the wound

Another aspect of the present imention mas be to moisten the wound

Another aspect of the present j mention mas be to disinfect the wound h\ lulling bacteπa and othet infectious agents

Another aspect of the present invention mas be to increase the blood flow to the uound bed

λnothei aspect of the piesent im ention may be to increase the dein ery of nutuems to the wound

Another aspect of the present invention ma> be to iemos e inflammatory agents from the w ound

Another aspect of the present tm ention mav be to αeate miciodomains of fluctuating pressure the surface of the wound being tieated

Another aspect of the present un eiuion mas be to prov ide topical ptebsitre theπιp\

Another aspect of the present invention may be to alternate pressure from posith e to negathe or negative to positn e dming treatment.

Another aspect of the present invention may be to create a synergistic relationship between ultrasound therapy and topical pressure therapy.

Another aspect of the present invention may be to Hush out debris, necrotic tissue, bacteria!, and other contaminants from the wound

Another aspect of the present invention may be io allow for the simultaneous treatment of multiple patients with a single device.

Another aspect of the present invention may be to increase circulation to extremities.

Another aspect of the present invention may be to create a synergistic relationship between ultrasound therapy and external pressure therapy.

Another aspect of the present invention may be to create a synergistic relationship between ultiasυund enhanced negative pressuie thetapy and external pressuie. thetapy.

These and other aspects of the invention will become more apparent from the written descriptions and figures below.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure t depicts a cross-section view of a wound treatment device combining ultrasound therapy snά pressure therapy embodying the present invention.

Figure 2 depicts a cross sectional view of a possible alternative embodiment in which a coupling medium is injected into the pressure chamber through, the ports as a pressurized stream.

Figure 3 depicts possible embodiment of a port which injects coupling medium as a pressurized stream.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a wound treatment device combining ultrasound therapy and piessuie theiapy Preferred embodiments of the piesent invention in the context of a de\ ice are illustrated in the figures and described in detail below.

Figure 1 depicts a cross-section \ ιew of a wound treatment de^ ice combining ultrasound therap) and pressure therapy embodj ing the present h« ention The ice comprises a pressure chamber I ultrasonic nansducers 2 mounted on the stdes ( eeilmj., floor, and or walls) of the pressure chamber 2, and treatment chamber 3 located % ithm pressure chamber 1 The extremity to be treated 4 is mseited into treatment chambei 3 The treatment chamber 3 applies ultrasound induced topical pressure therapy to an injured extremity facilitated by the delήery of ultrasound energy, errmtcd fiom the ultrasonic transducers 2. thiough coupling medium 5 to treatment chambei 3

Iu keeping with figure I ₅ piessυre chamber 1 comprises a plurality of posts 6 through whsch coupling medium 5 mav be injected into and or evacuated from pressure chamber 3 injecting and OJ ev acuating the coupling medium raa) be accomplished by a pump or phuality of pumps (not show n) in communication with ports 6. Injecting coupling medium 5 into pressure chambei 1 inei eases the pressiue within pressure chamber ϊ. Inversely, evacuating coupling medium 5 i educes the pressuie within ptesM«e chamber 1 Coupling medium 5 held within the pressure chamber ma ^ be an> fluid capable of cam ing ultrasound \va\ es As depicted in Figure L coupling medium 5 may be injected and evacuated through different port? 6 λiternath eh\ coupling medium 5 may be injected and \\ ithdrawn through the same port($), In such an embodiment, a means of for selecmely injecting and/or extiactmg coupling medium 5 thiough port{s) 6 would be incorporated into the dc\ ice Such means for mo\ mg coupling medium mav include, bin ate not limned to, a reversible pump.

In keeping w ith Figure I- treatment chamber S comprises a pi tabic shell capable of expanding and contacting in response to pressuie changes within the piessure chamber, therein coupling the pressure withm the pressiπc chamber tυ that within the treatment chamber The tieatment chambei applies uhiasound induced topics! piessuie ϊheiapy to wounds on the

1 !

to be treated 4 I ' itrasøuud uansduceis 2 dehx ei therapeutic ultt asonic energy, thiough coupling medium 5 held w ithin the piessure chamber, tυ treatment chamber 3 as to induce topical pressure therapy within the treatment chamber. Alternating the pressure v, ithm treatment chamber 3 by repetitively injecting and evacuating coupling medium 5 from pressure chambei 1 creates a pumping action withm the vasculature of the treated extremity The induced pumping action fact I hates an increase in circulation w ithin the treated extremttt . The increased cuculatton allows fot the delivery of more posms e healing elements to the λV ounded extremity , consequently making more &\ ailable to the wound being tieated Treatment chamber 3 furthei comprises an opening at its apex through which the extremity to be treated 4 is inserted and a means of sealing the opening against the exrremiu to be treated 4 I he sealing means may be, but is not limited to, an elastic or rubber band that presses the opening against the extremity to be treated, an adhesn e that bonds the opening against the extremity to be treated, and oi a dπm string. The sealing means prevents treatment solution 7 held withm the treatment chamber 3 from escaping during the application of uitiasυund induced topical pressute therapy and external pressure theiapy treatment solution 7 u ithm the treatment chamber mav be iiquid, gel, oi similar fluid medium. Dissolving or suspending drugs withm the treatment solution may be done to assist diug delivery during wound treatment. Possibly liberating the dissoh ed or suspended drug ftoffl treatment solution 7 while inducing macro cavitations on the surface of the wound and micro es may transport the drug into and across the w ound bed. Treatment solution 7 ma\ be circulated through the treatment chamber 3 Circulating fieatmeot bolimon 7 enter^ the treatment chamber through mlct 8 and exits through outlet 9. Circulating treatment solution 7 through the treatment chambei may be accomplished by a pump oi plurality of pumps f not shown) in communication with the inlet 8 and/or outlet 9

I he treatment chamber depicted in Figure 1 possesses a configuration similar to that of a sock. Alternative!)', the treatment chamber may possess a configuration similar to a e. sleex e υi bout λ sleeve confirmation allows the treatment of a leg oτ aim without tteatment of the foot or hand respectively In a slee\ e embodiment of the present invention the treatment chambei would furthei comprise an opemng at its base sealed agamsi the extremity being treated. The treatment chamber ma\ also possess alterath e configuration, so long as the

confϊguiation chosen is capable of housing the extrenurv to be ueated I he neatmeπt chambet ina> be ά permanently attached to the present invention ot it m.rv be removable mid disposable λ disposable treatment chambei allow s the piesent invention to be used on sequential patients \\ ith minimal cleaning required between tieatments

In keeping w ith Figure 1, the present invention furthes corapuse an agitating mean* ^;

10 of mechanically agitating ot wbiating the injured ex tt emit} as tα faiihei enhance of the therapeutic action of the external piessuie chambei and'oi internal tteatment chambei Agitating means 10 may be coupled to an externa! surface of the pi ensure chamber 1 Alternatn eh , agitating means 10 ma\ be located within the piessuie chambei Agitating means 10 mav include a shaker pUufomn magnetic stπiet ot mechanical rimci and may agitate pies»itre chambei 1 and or tieatmeπt chambei 3

Figure 2 depicts a ciobs sccuoiial \ κv _* , of a possible alternative cnibodmient in which coupling medium 5 is injected into the piessuie chamber 1 thiough poit(s) 6 as a piesπut/ed stream 12 tϊnough a no// Ic 13 Injecting coupling medium as a piessuri/cd stteani allow > ditect piessure io be taiget to specific and oi altetnating iegions of the extremity being treated

Figure 3 depicts a possible embodiment of a pott u hich imects coupling medium as a pressurized stiearø comprising a nozzle 13, which may be tapeied at its distal end. a solenoid 14 allowing foi the selective opening and closing of the pott, and uitøasuund ttansducer opening \5 Nozzle 13 raa\ allow for better taigetmg and'Or creation of a piessuiized stieam of coupling medium Solenoid 14 facilitates the selectn e taigeting of such pressuπ/ed streams against a particular location of the extremity to be treated when multiple ports aie Selecuveh opening solenoid 14 of the port<s) emitting a stream at the desired icgion allow s the user of the ice to tax get the streams 1 ncoiporating a means of selectn eiy opening and closing the ports, (not shown) such as. but not limited to a computei \ ah e and or pump control panel into the treatment dev ice of the pieseiH sm enUon would allow the user to bettei direct prcsbuπzcd streams of coupling medium and 'or control the rate ot pressuie changes withui the piessuie chambei Incorpoiauon τrtd\ also enable the usci to cootdiπate the injection of pressurized streams fiom the port(s) enabling the cseation of \ anous spra\ patterns agam&i the cxtieniit^ to be treated

I he ultrasound wax es emitted ftorn transducer employed in the piesent ) m ention mav x with respect to frequency, approximately 15 kf l/ to 20 VtIi/ The prcfcπcd low-ftequeticy range is approximately 20 kH/ 100 kH?. The more preferred low -frequency range is approximately 25 kHz - 50 kHz The recommend low-frequency is approximately 30 kHz The preferred high-fiequency uiuasoimd range is appioxrmaieiy 0 7 MI i/ 20 MH/ 1 he more preferred high-frequency range is approximately 0 7 MHz 1 MHz I he lecøπvmend high- frequency i^ approximately 0.7 MH/ The likiasoimd v. as es empioyed may also \ ary v- iih respect to amplitude, approximately 1 rmcion and above The preferred ϊow-freqιιenc> amplitude is approximately 30 microns ~ 100 microns The recommended 1O\λ -frequency amplitude is approximately 100 microns T he high-frequency amplitude can be 1 micron and aboxc. The preferred high-frequency amplitude is approximately 5 microns. The recommended Ivigli-fiequency amplitude is appioximately 10 microns Frapiυying low fiequeπcj ultrasound V.9SCS is the preferred method of treatment.

Although specific embodiments have been iSkistrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement that is calculated to achiev c the same purpose may be substituted for the specific embodiments show n. It is to be understood that the above dcscπption is intended to be illustrative and not restrict e Combinations of the above embodiments and other embodiments xuli be apparem to tho^e hav ing skill in the an upon review of the present disclosure. The scope of the present should be determined with reference to the appended claims, along w «h the full scope of the equivalents to which such claims are entitled