Method and Apparatus for Treating Vascular Obstructions

BACKGROUND OF THE INVENTION Field _. of the Im en tion;

The present invention relates to method and appaiatυs foi treating vascular obstruct ions by using ultiasøund eneiu) in conjunction \\ ith cryogenic energy and/oi an expandable membet

Vascular lesions ha\e been traditionally treated by using percutaneous transluminal angioplasty (PTA) procedures, or more commonly known as -"balloon' ^' angioplasty This procedure imoKes inserting a catheter with an expanding balloon into a blood vessel and positioning the balloon o\ er the stenotic lesion to be treated The balloon is then inflated to treat the lesion by compressing the lesion or stretching the walk of the blood vessel. One drawback of this method is that it does not remove the lesion or plaque. Restenosis can occur wheie the blood \essel narrows once again, which would then tequire anothet treatment This technique can be used to treat both the coionaiy artery and other blood vessels. One problem with this procedure is that it relies on putting pressure on and possibls stretching the walls of the blood vessel This m turn can cause stress on the blood \ essel

Balloon angioplast> has ad\aneed into a method that also uses a otoplasty balloon. See, fbt example, V S Pat. Kos 5, 868,735 to ϊ al ^' ontame. 6,290,696 also to ϊ.aFontaine, and

6,290,696 to Joye. l hss method first uses balloon angioplasty treatment to compress the lesion.

After the angioplasty treatment, a cryoplasty balloon is inflated and filled with a cooling fluid.

The cooling fiuid then delivers coo! thermal energy through the ciyoplasty balloon to the treatment area The use of cryogenic energy to cool {he atea after tieatinenϊ helps prexenl restenosis m the blood \ essel Similar to the balloon angioplasty method described above, this method also relies on putting pressure on and possibly stretching the walls of the blood \essel.

Another method used to remove vascular lesions and blockages is ultrasonic angioplasty. This procedure imohes inserting an ultrasonic catheter so that the cathetei tip is positioned against the vascular blockage or lesion. The ultrasonic catheter is connected to m\

uStτasonic enetgv source via a tiansmission nierabei or guide wue Ultrasonic enejgy is delivered fiom the souice, along the aansπussion member or wire, and to the ultrasonic catheter The ultrasonic energy \ ibiates the ultrasonic catheter tip This \ ihration in the catheter tip ablates and removes the vascular blockage or lesion by mechanical impact and eav station Because the ultrasonic eneig) must tun el ovet a long distance, resulting m an attenuation of the energ}, a great amount of ultrasonic energy most be delivered from the ultrasonic sαuice This can iesult in the ultiasound tiansmission membei 01 wnε breaking OJ fiactuung dm ing use. \dditrønaik , the ultiasonjc energy must be deh\ eied at small inten als. generally through pulsed deliver) . because of the risk of tissue damage fiom the heat thermal energ} that is deh\ ered as a result of using ultrasonic energy.

I ' S Patent Ko 5,474,530 to I'avsafat et at and L S Patenϊ No 5,324,255 to Paasafai et al disclose a method that uses ultrasonic angioplasty with balloon angioplasty The ultrasound energy is used onlv to create a passage way through winch a balloon cathetei can travel if the opening in the blood \ essel is not wide enough for the balloon catheter Passafar ^' t. uses of ultrasound eneigj- is ouh to create a passage for the balloon, and theiefore still faces the drawback of the pressure on a blood \essel from an inflated balloon.

Current methods used to tieat vascular obstruction rel> on potting prcsbutc on a blood vessel or delivery heat theimal energy to the blood vessel 1 hese methods can iesiilt in stress on a blood \ essel or in tissue damage fϊom heat energy Theieibie. there is a need for a method and device that utilizes the benefits of uluasυnic enetg\ to remove vascular obstructions but that does not pose the risk of heat thermal damage to the blood vessel. There is an additional need foj a method and de\ see that can utilize ultrasonic energy ni conjunction w ith a balloon angioplasty de\ ice so that less pressure is exerted on the blood vessel from an Inflated balloon. Finally, there is a need for a method and device that can combine the benefits of balloon angioplasty, ultrasonic angioplasty . and cryoplasty.

Si:\iM ARY OF THE IKVCXTϊOX

The present invention is directed towards method and apparatus for ti eating vascular obstructions by using ultrasonic energv m conjunction with cryogenic energy and/or an expandable member. Method and apparatus in accordance with the present invention may meet

the abo\e-mentioned needs and also provide additional ad\ antages and improvements that v-ill be recognized b> those skilled in the art upon review of the ptcsent disclosure

The present invention comprises a specially designed ultrasound πansducer 1 he transducer is inserted into a blood vessel to treat \asculai obstructions. Examples of a x-asculai obstiuction include but are not limited to, plaque, lotion, thrombus, clot, tmd blockage

Freatment of a \ascular obstruction includes methods such as removal ablation, dilation, or other similar methods or combinations of methods The ttansducer delivers uhiasound erseig) to treat a vascular obstruction The ultrasound eneigy can be delivered diiectl) to temove a vascular obstruction through mechanical vibration. The ultrasound energy can also be delivered thiough the fluid iu the blood vessel to ϊemox e a vascular obstruction through cavitation

The present indention allows foi ultrasound energ) io be delivered in conjunction with cryogenic energy. The use of cryogenic energy, when used m conjunction with ultrasound energy, may have multiple benefits. First, the cryogenic energy may cooϊ the area to be treated in order to help loosen the obstruction that is being treated, which then may help the ultrasonic energy more easily, efficiently, and precisely tieat the vascular obstruction Second, the cr\ ogeπic energy may be used to piotect the blood \ essel Delrv ermg ultiasound energy can result in the deli vet y of heat cncigy to the blood \ essel The use of crj ogenic enetgy may pio\ ide a cooling effect to prevent damage to (he blood vessel that could result from the heat energy This cooling effect ma\ also allow for continuous deliv ers of uluascmic energy rather than pulsed delivery because these may be less concern with the generation of heat energy

Additionally, the cryogenic energy niay increase the effectiveness of the delivery of ultrasound energy. Finally, similar to its use v\ifh a balloon angioplasty de\ ice. the cryogenic energv may help prevent restenosis on the treated area

The present invention also permits ultrasound energy to be used in conjunction with an expandable member. The expandable memhei maj ha\e a srmilai effect in treating a vascular obstruction as a balloon angioplasty device. Lltrasound energy, when used in conjunction with an expandable member, max allow for a more effective compression of a vascular obstruction 1 lie use of ultiasound energy requites less pressure to be exerted from the expandable mernbei, thereby t educing the stress imposed on a blood \ essel Furthermore, the ultiasound energy may be able to treat a full vascular occlusion at the same time die expandable member and or

ultrasound energj treat a partial \ ascular occlusion, fhe expandable raembei may be in different formats including, but not limited to. a balloon at the eiκi of a transducer, a balloon inside a transducer, expandable tubing connecting the transducer to the proximal end. or a hinged transducer The hinged transducer may open outward so that it may be able to exert more pressiue on and ensure bettei contact with the obstruction being treated Additionally, a balloon m a> be positioned inside the hinged transducer so that the balloon may inflate when the hinged transducer opens or separates

The present imention finally permits ultrasound eπcrg\ to be used in conjunction with both cryogenic energy and an expandable member. This combination may utilize the beneficial aspects of each of these individual methods described abcne, and theiefoie it ma\ be more effectne because it combines the beneficial aspects of all these methods rather than using any of the methods cither individually or in pairs The expandable member maj again include, but is not limited to, a balloon at the end of the transducer, expandable cubing connecting the transducer to the proximal end of the ultrasound device, or a hinged transducer, The invention is related to method and apparatus to treat xascυiai obstructions by using ultrasonic eπergv in combination with cryogenic energy and/or an expandable member

One aspect of this imention may be to provide a method and device for more effecth e treatment of \ ascular obstructions

Another aspect of the imention may be to provide a method and de\ ice foi more efficient treatment of vascular obstructions.

Another aspect of the invention may be to provide a method and de\ ice that poses less risk of damage to blood \essels during the tieatment of vascular obstructions.

These and other aspects of the imention will become more apparent from the written descriptions and flguies below.

BRIEF DBSCRiPIlC)N OF THE DRAWINGS

The present Invention will be shown and described with reference to the drawings of preferred embodiments and clearly understood in details.

Figure 1. is a perspective view ultrasound apparatus with an ultrasonic transducer and elongated Figures 2a - 2ra are front cross-sectional views of variations of an elongated tube- Figure 3a — 3c are perspective views of the ultrasound energy as it emanates from the ultrasound transducer and ultrasound tip.

Figs. 4a-4d are open perspective views of variations of the ultrasound transducer with an elongated tube. Figs. 5a - 5b are perspective views of variations of a hinged transducer.

Figs, 6a - 6e are cross-sectional schematic views of an ultrasound apparatus with an expandable member.

Figs, 7a - 7b are embodiments of an ultrasound apparatus that has an internal power source.

DETAILED DESCRl PTK)N OF THE INVEN TION

The present invention is a method and apparatus for treating vascular obstructions by using ultrasonic energy in conjunction with cryogenic energy or an expandable member, or any combination thereof. Preferred embodiments of the present invention in the context of an apparatus and methods are illustrated in the figures and described in detail below.

Figure 1 is a perspective view of an ultrasound apparatus with an ultrasound transducer and an elongated tube/catheter for use according to the present invention. The apparatus is comprised of an ultrasound generator 1 that is connected to the transducer cable 2, This embodiment of the apparatus also comprises a cryogenic source 3 and a cryogenic tube 4. The transducer cable 2 and the cryogenic tube 4 are connected to the elongated tube 5. The elongated tube 5, which is connected to the ultrasound transducer 6, may serve as the delivery mechanism for the cryogenic energy from the cryogenic source 3 and for the electrical power from the ultrasound generator 1. The ultrasound transducer 6 is connected to the ultrasound tip 7. Other embodiments may be comprised of a fluid source instead of or in addition to the cryogenic source. A fluid such as saline or cryogenic energy may be used to enlarge an expandable member in the apparatus. Additionally, another embodiment could have neither a cryogenic source nor a fluid source.

Figures 2a - 2i« are from cross-sectional views of variations of the elongated tube 5 for use according to the present invention, Fig. 2a is an elongated tube 5 with electrical wires 8, a braided guide \\ ire 9, a fluid entry lumen 10, a fluid exit lumen IL inner tubing 12, and outer tubing 13. The electrical wires 8, positioned at the edges of the outer tubing 13 in this embodiment, act as the power source for the ultrasound transducer 6. The braided guide wire 9 is positioned in the center area of the elongated tube 5, Fig, 2b is an elongated tube 5 with electrical wires S, a fluid entry lumen iθ, a fluid exit lumen H, inner tubing 12, and outer tubing 13 _* and a solid guide wire 14, The braided guide wire 9 and the solid guide wire 14 may facilitate in the transmission of the elongated tube 5 through a blood vessel

Fig, 2c is an elongated tube 5 with electrical wires 8, bϊ asded guide \\ ire 9, a fluid entry lumen H), a fluid exit lumen 11. inner tubing 12, and outer tubing 13 The electncal w lies 8 in this embodiment are positioned along the same edge of the outer tubing 13

Fig. 2d is an elongated tube with electrical wires 8, a fluid entry lumen lθ. a fluid exit lumen 11 , inner tubing ϊ2, and outer tubing 13. The electrical wires 8 in this embodiment are located at the center area of the elongated tube 5 and act as a guide wit e

Fig. 2e is an elongated tube 5 with electrical \\ ires 8, braided guide \\ ire 9, outer tubing 13, and a single fluid lumen 15, The electrical wires 8 m this embodiment are located along the same edge of the outing tubing J 3, and the braided guide wire 9 is located at another edge of the outer tubing 13, There is a single fluid lumen IS that may allow for both the cntiy and the exit of a fluid

Fig. 2f is an elongated tube 5 with electrical wires 8 and a single fluid lumen 15. In this embodiment, the electrical wires 8 are located at the edges of the outer tubing 13 and act as a guide wire. Fig, 2g is an elongated tube with a braided guide wire 9 and a single fluid lumen 15. The braided guide λ\ iie 9 is located at the edges of the υutet tubing 13» This embodiment does not contain electrical w ires λn embodiment without electrical wires may be used w ith an ultrasound transducer that has an interna! power source rather than an external power source with connecting electrical wires Fig, 2h is an elongated tube 5 with electrical w ires 8 and a solid guide \\ ire 14. In this embodiment, theie arc multiple fluid lumens 16. These fluid lumens 16 may be used in any number combination as fluid entry and fluid exit lumens ^' 1 he fluid lumens 16 are di\ ϊded by inner tubing 12. The solid guide w ire 14 is located in the center area of the elongated tube, and the electrical wires 8 aie located at the edges of the outer tubing i3 Fig. 2i is an elongated tube 5 \\ ith electrical w ires S and a braided guide wire 9. In this embodiment, theie arc multiple fluid lumens 16. These fluid lumens 16 may be used in any nurabei combination as fluid entry and fluid exit lumens ^' 1 he fluid lumens 16 are di\ ϊded by- inner tubing 12, Flic electrical wires 8 and braided guide wire 9 are located at the edges of the outer tubma 13

Fig, 2j is an elongated tube 5 with electrical wires 8 and a solid guide \\ ire 14. In this embodiment, there are multiple fluid lumens 16. The multiple Iiυtd lumens 16 may be used in any number combination as fluid entry and fluid exit orifices The fluid lumens 16 are dh ided b> inner tubing 12. The solid guide wire 14 and the electrical wires 8 are located at the edges of the outer tubing 13

Fig. 2k is an elongated tube 5, with a braided guide wsre % a fluid emr> lumen 10, a fluid exit lumen 3 ϊ, inner tubing 12. and outer tubing 13. There are no electrical wires m this embodiment The biaided guide wire 9 is located in the center area of the elongated tube 5.

Fig. 21 is an elongated tube 5 with two braided guide wires 9 located along the edges of outer tubing 13. a fluid entry lumen 10, a fluid exit lumen 1 1, and inner tubing 12. There are no electrical \vire6 in this embodiment

Fig. 2m is an elongated tube 5 with two solid guide wires 14 located along the edges of outer tubing 13, and a single fluid lumen 15, There are no electrical wires in this embodiment.

Figures 2a - 2ra are only examples of \ aπations of the elongated tube 5 Other similar embodiments or combinations of these embodiments may also be utilized. An elongated tube may comprise no guide wire, a single guide w iie, or multiple guide wires. The tube may also comprise no electrical wiies, a single electrical w ire, or multiple electrical wires I he elongated tube may also comprise no lumen, a single lumen, or multiple lumens

Figure 3a - 3c are perspective Mews of the uitiasound eneigy as it emanates from the ultrasound transducer 6 and uitiasound tip 7 Fig. 3a shows ultrasound energy 17 as it emanates from the iadiai side of the uitiasound apparatus. The ultrasound energy 17 that emanates from the radial side of an ultrasound transducer and ultrasound tip are generally radsal waves. Fig. 3t> shows ultrasound energy 17 as it emanates from the distal end of the ultrasound apparatus. The ultrasound energy 17 that emanates from the distal end are geneially longitudinal wax es . Fig. 3c shows ultrasound etiergv 17 emanating from the ultrasound transducer d and ultrasound tip 7, Some sheai w a\es may emanate along with the longitudinal and iadial wax es

Figs, 4a-4d are open perspecth e \ Jews of vacations of the iiltiasoimd transducer 6 for use according to the present i mention Each of the embodiments show a in these \ aπations compϊise an elongated tube 5» which Ls computed of electrical wires 8, a biaided guide wire 9,

inner tubing 12, outei tubing 13, and an ultrasound tip 7 Fig. 4a is an open perspeeth e \ iew of an ultrasound apparatus comprised of an ultrasound transducci 6 that is compitsed of multiple piezoelectric disks ϊ8 Fig. 4b is an open perspecm e \ iew of an ultrasound appaiarus compπsed of an ultrasound transducer 6 that is comprised of two piezoelectric disks 19, Fig. 4c is an open perspective view of an ultrasound apparatus comprised of an ultrasound transducer 6 that is comprised of one single piezoelectric disk 20, Fig. 4d is an open perspective v iew of an ultrasound apparatus comprised of an ultrasound transducer 6 ihat is comprised of two hahes of piezoelectric disks 2ϊ [ ^" he two hah es of pie/oeiectuc disks 21 ma\ be bonded together or hinged together for use as a hinged transducer, or the two halves of piezoelectric disks 21 may be separable.

Figs, 5a and 5b are perspectπ e \ iew s of \ aπations of a hinged transducer 22. A hinged transducer 22 can be used as an expandable member according to the present invention. The hinged transducer 22 may open so that a balloon may expand from inside the transducer to contact the blood vessel Additionally, the hinged transducer 22 may expand to contact the blood vessel itself without a balloon expanding Tins direct contact may allow fot more effective treatment of a vascular obstruction because of v arious benefits that may include opening the blood \ essel, compressing an obstruction, and rnoie effective delnety of ultrasound energy Fig. 5a is a hinged ultrasound transducer 22. which is comprised of two separate halves of piezoelectric disks 21 that are connected via a thin mcmbiane 23 Fig. 5b is a hinged uhrasound transducer 22, which is comprised of two sepaiate hahes of piezoelectric disks 21 that are connected v ia a pivot point 24

Figs. 6a - 6e are cross-sectional schematic siews of an ultrasound apparatus with an expandable member. Fig. 6a is an ultrasound apparatus comprised of an ultrasound transducer 6 and an ultrasound tip 7. The elongated tube 5 is comprised of outer tubing 13, which is comprised of a thick section 25 and a narrow section 26, Hie thick section 25 is a certain thickness so that it remains a stable and is less expandable if a fluid flows through it The narrow section 26 ss thinnei than the thick section 25 so that it JS able to expand radial K 2? In tins embodiment, the narrow section 26 acts as an expandable member because it is able to expand iadialiy 27. The elongated tube 5 in this embodiment is compπsed of a single fluid lumen 14 as shown in fig, 2e and fig. 2f,

Fig, 6b is an ultrasound apparatus comprised of an ultiasound transduces 6 and an ultrasound tip 7 The outer tubing ϊ3 is comprised so that it can expand 28 if a fluid flows through it 1 here is also a proteethe sheath 28 o\er the outer tubing 13 so that only a portion of outer tubing ϊ3 is able to expand radially 27 Fig. 6v is an ultiasound apparatus comprised of an ultrasound ttansdueer 6 and an ultτasound tip 7 I he outei tubing 13 is comprised of a certain thickness so that it remains a stable si/e if a fluid flows through it. This embodiment is comprised of an expandable mernbes 29 is able to expand 30 at the distal end The expandable member 29 could be expandable tubing, an inflatable baϊfoon, or another similar expanding material. The elongated tube 5 in this embodiment is comprised of eiectiicai \\ ires 8 and a bt aided guide wiie 9 as shewn m fϊg. 2ϊI

Fig. 6d is an. ultrasound apparatus comprised of a hinged ultiasound transducer 22 and an ultrasound tip 6, The hinged transducer 22 is compπsed of two hakes of piezoelectric disks that are connected by a pnot point 24. The hinged ultrasound transducer 22 opens to alicm an expandable member to expand 31 The expandable member with a hinged transducer 22 may be an inflatable balloon positioned inside the hinged transducer 22 that may be inflated. The expandable member may also be the hinged transduce* 22 itself that opens to contact the walls of a blood vessel and/or a vascular obstruction.

Fig. 6e is an ultrasound apparatus comprised of an ultrasound oamducei 6 and an ultrasound tip 7, In this embodiment, the ultrasound transducer 6 is compπsed of two halves of piezoelectric disks 21 that arc unconnected. The piezoelectric disks separate to allow an expandable member to expand 32 The expandable member may be an inflatable balloon located inside the transducer 6.

Figs. 7a and 7b are embodiments of an ultiasound apparatus accoidiτ*g to the pteseπt in\ention that are comprised of an internal power source. FIg, 7a depicts an ultrasound transducer 6 and an ultiasound tip 33 that has an internal power source 34. The internal power source 34 may be used in lieu of the external ultiasound generator 1 shown in Fig. 1 This embodiment does not comprise an expandable membct Qyogenic enetgy may still be delixered through the elongated tube 5 in conjunction with the ultrasound energy Fig. 7b depicts an ultrasound transducer 6 and ultrasound tip 33 that has an internal ρm\ er source 34. The elongated tube 5 is comprised of outer tubing 13. which *s compπsed of a thick section 25 and a

nauow section 26, llie thick section 25 is a certain thickness so that it remains a stable and is lest expandable if a fluid Slows through u The nanυw section 26 a> thmnei than the {hick section 25 so that it is able to expand radraiiv 27 (o this embodiment, the naπow section 26 acts as an expandable member because it ss able to expand radially 27,

S The ultrasound apparatus shown m Fig. 1 dclners ultiasonnd enetgv to ttcat \astulai obstructions The pieseiu invention relates to a special iv designed υiti abound tiansducer I be tsamdiicer is nisei ted into a blood vessel to treat xasπilat obsttutttons Fxamples of v asculai ohsUuetiom indude, but are not limited to, plaques iesums tfciorabo.se:> clob and blockages Treatment of a vascular obstruction includes methods such as temos al ablation dilation, or 0 olhej similar methods oi combinations of methods I he transdutei dehv eis ultrasound energs to Ueat a \asculai obstiucuon Uie uitιasound eneι^> can be dein eied directly oi it can be delivered thsough tbe fluid m the blood \essel, theιcb\ remo\mg the ^ abcular obstruction tiiiough mechanical vibration oi cavitation I he ultiasound energy mav be deii\eied fiom the radial side of the ultiasound transducer and or ultrasound tip, horn the distal end of tbe S ultrasound tip, oi from the enlajgeabϊe meinbei, or anv coTubmation theieof I he uiltasouud tiansducet ma> also be powered b\ an external powet souice such as an ultiasound generatoi oi it im have an internal powei source as shown ni Fig. 7,

The pieseiu unention also ielates to a specialK designed elongated tube for use with the ultrasound traiisducei Tlie elongated lube is designed for inserting the «ltτji6θimd tπmsducer 0 uuo a blood \essel S lie tube πiav a Ku sene other functions that mav include, but ate not limited to delrv eπng the ultiasound pow er from the ultiasound geneiatoi to the transducer deli\eung L.r\ogeu!c eneigv dεln eπng fluid to enlaige au enlatgeable menibei oi expanding iadialK to sen c as> an enlaigcable member t itrasouαd etiergv mav be deliv ered m conjunction w ith civ ogemc eneig\ I he ^ ei v ogemc eneig) max be delneied to the \ astulai obstruction andoi to the blood vessel, the civ ogemc eneigv mav be delneied through the elongated tube tbe transducer the ultrasound tip oi an expandable membei ϊ he crvogemc enetgv may be delivered before during and oi aftei the deln eiv oi the ultrasonic enetgv

The use of ciyαgensc eneig> _s when used m conjunction with ultrasound energ\ ma\ 0 have multiple benefits _* I irsi the civ ogemc eneigv ma\ coo! tbe area to be tteated in order to

help loosen the obstruction that is being treated, which then niay help the ultrasonic energy more easily, efficiently, and precisely tieat the vascular obstruction Second, the cryogenic energy rna> be used to protect the blood \essel Delhering ultrasound energy can result in the delix er\ of heat energ> to the blood vessel. The use of cryogenic energy may pros iάe a cooling effect Lo pιe\ ent damage to the blood \ essel that could result ftortϊ the heat euergy fhis cooling effect may also allow for continuous delivers of ultrasonic energy rather than pulsed delners because there may be less concent with the generation of heat enetgy Additionally, the cryogenic energy may increase the effectn ersess of the delrvery of ultrasound energy. Finally, similar to its use with a balloon angioplasty dc\ ice, the cryogenic energy may help prevent restenosis on the treated area.

Ultrasound energy may be used m conjunction with an expandable member 1 be expandable member may have a similar effect in treating a vascular obstruction as a balloon angioplasty device Ultrasound energy, when used in conjunction with an expandable member may allow for a more effeeth c compression of a vascular obstruction. The use of ultrasound energy requhes less pressure to be exerted from the expandable member, thereby reducing the stress imposed on a blood vessel, t-urtheπnore, the ultrasound energy may be able to treat a full vascular occlusion at tiie same time the expandable member and or ultrasound energy treat a partial vascular occlusion. The expandable member may be in different formats including, but not limited to, a balloon at the end of a transducer, a balloon inside a transducer, expandable tubing connecting the transducer to the proximal end, or a hinged transducei ^' I he hinged transducer may open outward so that it may be able to exert more pressure on and ensure better contact with the obstruction being treated. Additionally, a balloon may be positioned inside the hinged ttarisdueer so that the balloon ma\ inflate when the hinged transducer opens or sepaiates

Finally, ultrasonic energy may be used in conjunction with both cryogenic energy and an expandable member This combination may utilize the beneficial aspects of each of these indh idual methods described above, and therefore it may be more effectn e because it combines the beneficial aspects of all these methods rather than using any of the methods either individually or in pairs. The expandable member may be comprised of a balloon at the end of the transducer, expandable tubing connecting the transducer to the proximal end, or a hinged transducer. Other expandable members may be similarly effective. The ultrasonic energy mas be deli\ered before, during, or after enlarging the expandable member, oi any combination

theieof TSie ultrasonic energy may also be delheted before, dunng. or after the delivery of cryogenic energy, 01 any combination thereof The cryogenic energy ina> also be delneted before, during, or after enlarging of the expandable member, or any combination thereof

The intensity of die ultrasound energy can be controlled through a \ ariatiou in the ultrasound pammeteis Mich as the frequency, the amplitude and the treatment time The frequency range for the ultrasound energy is 16 SdI/ to 40 MIk The tow -frequency ultrasound range is I fc kHz - 200 kll/, the preferred low~ftequeney ultrasound sange is 30 klϊ/ — !00 kl l/, and the recommend !ow-ftequenc\ ultiasυund value is 80 kl i/ The medium frequency ultrasound range is 200 kHz to 700 kHz, and the recommended medium frequency ultrasound \ alυe is 200 U 1/, The high-frequency ultrasound range is 0 7 MI 1/ 40 MI I/, the more preferred high-frequency uiuasøund iange ts 3 VUIz 5 MH/, and the recommend high- frequency ultrasound valise is 5MlIz. The amplitude of the ultrasound energj can be 1 micron and above, ϊhe preferred low -frequency ultrasound amplitude is in range of 2 microns to 250 microns, with the most preferred low-frequency amplitude to be m the range of 20 microns to 60 miαons. and the recommended low -frequency amplitude value is 20 30 microns The preferred amplitude range for of the high- frequency ultrasound is 1 micron to 10 microns, and tlie most preferred amplitude range for the high-fiequency ultiasound is 2 microns to 5 microns. The preferred method of treatment uses low-frequency ultrasound.

Although specific embodiments and methods υf use have been illustrated and desctibed net em, it \\ ill be appreciated by those of ordinal y skill in the art that any arrangement that is calculated to achieve the same purpose may be substituted for the specific embodiments and methods shown, it is to be understood that the abo\e description ss intended to be illusttatn e and not restrietn e. Combinations of the above embodiments and other embodiments as well as combinations of the abov e methods of use and other methods of use will be apparent to those ha\ ing skill in the art upon review of the present disclosure. The scope of the present imentioπ should be determined w ith reference to the appended claims, along with the full scope of equivalents to which such claims are entitled