CA1311980C

CA1311980C - Limacon geometry balloon angioplasty catheter systems and method of making same

Info

Publication number: CA1311980C
Application number: CA000565845A
Authority: CA
Inventors: G. David Jang
Original assignee: Individual
Current assignee: Individual
Priority date: 1987-05-06
Filing date: 1988-05-04
Publication date: 1992-12-29
Anticipated expiration: 2009-12-29
Also published as: ATE115418T1; US5304132A; EP0362268B1; US4958634A; AU1941888A; DE3852488T2; DE3852488D1; JPH02503276A; WO1988008727A1; EP0362268A4; AU614976B2; EP0362268A1

Abstract

LIMACON GEOMETRY BALLOON ANGIOPLASTY
CATHETER SYSTEMS AND METHOD OF MAKING SAME

Abstract of the Invention Disclosed in an angioplasty catheter comprising a catheter shaft having a distal end and at least one, and preferably two, angioplasty balloons on the distal end of the catheter shaft, wherein the distal end of the catheter and the balloons are formed from a single monolithic piece of polymer material. The distal end of the catheter may also include additional balloons formed from the same piece of polymer material. Each of the balloons is separately inflatable and deflatable by virtue of separate lumen running through the catheter shaft to the-balloon. Also disclosed is a method for making angioplasty balloons as described above, comprising the steps of forming from a single piece of polymer material the length of catheter shaft material having at least a first lumen therein, wherein each lumen has an outer wall and, if there are more than one lumen, each lumen has a common wall where the outer walls of at least two lumens converge, sealing the distal end of the first lumen to form a first sealed lumen, applying pressure to the proximal end of the first sealed lumen and heating the outer wall thereof to expand the outer wall of the first sealed lumen inside of first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of the die. Additional balloons may be formed on the catheter in the same manner.

WA-1322:dc3/rdt4

Description

131~ ~0 LI~ASO~ OE OMETR~ BALLOON A~GIOPLASTY
CAT~ETER SYSTEMS ~ND ~ETHOD OF ~A~ING SAME

Background of the Invention This invention relates to balloon angiopla6ty catheters having limacon geometry and a method of making same, and to angioplasty catheter systems utilizing multiple balloon6, and to angioplasty procedures utilizing those catheters.
Coronary angioplssty ha6 emerged ss the only viable present alternative to bypa~s surgery for revascularization of stenotic and occluded coronsry arteries. Although transluminal angioplasty has application in peripheral artery disease, it i8 most widely used in the treatment of coronary artery disesse.
Unlike bypass surgery, percutaneous angioplasty does not require general anesthesia, cutting of the chest wall, extracorporeal perfusion, or transfusion of blood.
Percutaneous coronary angioplasty is not only less lnvasive and less traumatic to the patient, it is also less expensive because the angioplasty patient will have a shorter hospital stay and shorter post-procedure recovery time.
Percutaneous transluminal angioplasty i~ performed by making a skin puncture with a specislly-designed needle in one of the groins, and then introducing a guiding catheter (typically 8 or 9 French size) into the aorta and coronary artery orifice. A smaller caliber catheter which has a built-in inflatable and deflatable balloon of predetermined size and diameter is passed through the guiding catheter which i8 positioned in the opening of a target artery. This balloon catheter (with the balloon totally deflated by negative pressure) is advanced inside the target artery toward the point of obstruction that needs to be d~lated. With the balloon portion of the catheter properly positioned inRide the obstructed segment i~,,,, ~.. ..

l~llg80 of the artery, under X-ray fluoroscopic observ~tion, the balloon is inflated by in3ecting contr~6t media mixed wlth fsaline at a prefssure cufflcient to overcome the ref~i6tance of the rtero6clerotic plaque of the ob6tructed ~egment S During the guiding catheter manipulation and especially while the balloon c-theter 1B belng adv~nced lnto the narrowed segment of the rtery, X-ray fluoroscopy 16 used cxten6ively However, bec~u6e one cannot ordin~r$1y ee the ~n~tomy of ~n rtery under X-r~y fluoroscopy, contrast -terial 16 used When contra6t media if3 ln3ected into an rtery, detail6 of the arterial natomy re brlefly vl6ible until the contr~st ~aterial flows way with the blood flow through the artery R~diographlc rterlogr ms re recorded durlng that brief lS moment of vi~uallzatlon lf the natomlc structure6 are complex ~nd ncgoti~tlng a partlcular ~rterl-l channel with ; the balloon catheter 18 difflcult, frequent contrast ln~ections durlng the procedure re necess-ry Nowever, thore ~re llmits to the mount of contrast materlal one ca~ u~- ln given p-tlent For ln~tance, the upper llmit of Renogr-fin-76 ln a nor~al lndlvldual lf~ pproxlmately 3 c c '~ per kllogr-m of body weight The toler-nce of a phy~lcally-lll lndlvldu l ay be ub~t-ntl-lly less Exco~lvo mount~ of contr-~t ~aterl-l c-n be toxlc to the 2S ~ldney~, llvcr nd br-in By lnfl-tlng the b-lloon ln the atenosls multiple tl e~ ov r perlod of between 20-30 econd,~ 0d one or two iDutes (-llowiDg blood flow between lnfl-tlons), the d-~ired dil-tlon of the ob~tructed ~egment of the rtery c-n be chleved When the de~ired re~ult-~h ve been obt~ln-d by b-lloon lnfl-tlons, the guldlng c-theter nd the b-lloon c-thet-r ~wlth the b-lloon co~plotely deflated ,~ wlth neg-tlve pr-~ure) re wlthdr-wn from the artery nd i~ ~ the procedure lo ~ucce~sfully t-rmln-ted ,~ 3S ~rtero~clerotlc coronary rtory di~ease i6 not ; ~ cur-blo Both byp~ urgery nd b-lloon nglopl-sty are i ~ ~

considered p~lliative treatments. Recurrence of dise~6e after byp~s~ surgery or coronRry angioplasty is prevAlent, ~nd repeat procedures are not uncommon due to the nature of the dise~se. A patient may initially develop single-vessel coronary artery di6ease and then slowly progressinto multiple-ves6el disease over the years. Medications, bypass surgery or angioplasty do help to relieve the symptoms, but they generslly cannot prevent a gr~dual progression of the diseage.
Because the cost of bypa6s surgery is 2 to 2.5 times the c06t of angiopla6ty, and because bypass 6urgery is more lnvasive and more traumatic, requiring longer hospital stays and longer post-operative recuper~tion, future demand for angioplasty is expected to grow as physician skill and equipment technology expands. It has been estimated th~t the number of coronary ~rtery sngioplasties performed in the United States will double or triple to 450,000 or 500,000 cases per year by the early to mid 1990'8. It al80 has been e6timated that the number of multiple-vessel angioplasty cases will be from 2 to 2.5 times the number of single-vessel angioplssty cases. Thls will be a dramatic change from the situation, in 1986 in which 70 to 80 percent of the coronary angioplasty cases are single-vessel dilstions. The expected future growth of multi-vessel coronary angioplasty has serious technical and patient care implications. Present-day coronary angioplasty technology is based on the original single balloon concept which was designed to tsckle single-vessel dieease and thus single-vessel dilations. However, the single balloon technologyis inadequate to meet the requirements of most multi-vessel disease situations.
During B typical coronary angioplssty, most of the procedure time iB Bpent in certain preliminary steps that are necessary before the balloon can be inflated inside the obstructed segment of a target ~rtery. In fact, the ,, . .
.

1 3 ~ 0 real 30b of dilating a ves6el take~ less than 20 percent of the total procedure time. The preliminary step6 include patient (aseptic) preparation, groin preparation and needle puncture, insertion of the guidewire into the artery to introduce the guiding catheter, arterial heparinization, manipulation of the guiding catheter to cannulate the target coronary orifice, prelim~nary arteriography using contrast media in~ection into the artery and taking radiographic cine. Moreover, the balloon catheter must be prepared before it can be introduced into the target artery through the lumen of the guiding catheter. Preparation of the balloon catheter takes a minimum of 15-20 minutes. X-ray fluoroQcopy and contrast media sre extensively used during the guiding catheter and balloon catheter manipulations, especially when the balloon tip is being manipulated through the insite of the artery toward an obstructed segment which needs to be reopened by the balloon tip. Sometimes, the ms~ority of the procedure time and the limits of the total allowable contrast volume are used up at this phase of a procedure. It is clear from the metical literature that the longer the proceture, the greater the risk of compllcations during cardiac catheterization. Likewise, the larger the volume of contrast material, the greater the chance of kitney failure or tissue toxicity, including brain ant/or liver tamage.
The size and diameter of the balloon to be used in a transluminal angioplasty should be approximately matched to the size ant native tiameter of the obstructed segment of the artery to be tilated. If the balloon size and di~meter iB emsller than the native artery, the results of b-lloon angioplasty are suboptimal, requiring a second dilation with ~ larger-sized balloon. In some cases, the result is a failed procedure, which may require either a ~econd separate angiopla6ty procedure (especially if too much contrast material was slready used~ or bypass ,~.. .

. ~

1311~80 surgery. If the b~lloon is oversized in relation to the obstructed segment of the native ves6el, the inner wall of the artery may dissect from the remainder of the artery and msy occlude the vessel completely, causing total cessation of blood flow to the target ares of the myocardium. This complication, except in rare occasion~, leads to acute myocardial infarction and nece66itates emergency bypass surgery. If the acute occlu6ion leads to a large infarction, death i6 a possibility.
The most common balloon diAmeters in dem~nd for coronary angioplasties are 2.0 mm, 2.5 mm, 3.0 mm and 3.5 mm. The 2.0 mm and 2.5 mm balloons are used in pstients w$th small caliber coronsry arterie6 or in the distal coronary branches of patients with otherwise normal-sized coronary arteries. However, a 1.5 mm balloon may al80 be desirable for certain spplications. The 3.0 mm and 3.5 mm balloons are generally used in the proximal and lsrger native coronary arteries. If a pstient has a eingle obstruction in the right or left coronary artery eystem, a single balloon catheter with a matching diameter and size will be selected for the intended dilation procedure. When the balloon is inflated inside the obstructed segment of the native artery, the balloon should maintsin the original preshaped configuration and dismeter under the maximum allowed pres~ure, which is generally up to 150 psi or more. Polymers such as PVC
(polyvinylchloride) and various derivatives of polyethylene have proved to be suitable $or making balloon catheters for coronary angioplasty. New polymer derivstives, including variations of Mylar material, are gaining popularity because of their high tensile strength and their potential for making very thin-walled dilation balloons.
In single lesion dilations, the choice of a properly-sized balloon cstheter is relatively simple, although there are instances in which the original selection of the .
?

- : ~
:
,:

1311~80 b~lloon cstheter i8 inadequate 80 that a second bslloon catheter is necessary to complete the procedure successfully However, in multi-vessel disesse, b~lloon cstheter selection becomes compounded and complex For S ex~mple, a pseient m~y h~ve three lesions in hi~ left ;coronary srtery, snd 811 three lesions msy be sppro~chable individu~lly for successful balloon sngioplssty But such lesions may be in veasels of different sizes, such as 8 3 0 mm lesion $n the proximsl portion of the left snterior descending srtery (LAD), 8 2 0 mm lesion in the distsl segment of the LAD, and a 2 5 mm lesion in the superior obtuse msrginsl srtery With currently avallable balloon catheters, angioplasty of these three differently-slzed lesions is not always imposs$ble, but $t $8 cumbersome and t5 $nefficient For each lesion, a mstch$ng balloon catheeer 18 exch-nged ant ~an$pulated into the target les$on under fluoroscopy with numerous contrast in~ections To do th$s three times in a row requires rougbly three t$mes the l~procodure time, three times the contrast amount, and a ;~20 ~lnl~um of three ~eparate balloon catheters and the$r accéssory devlces In llght of the forecsst thst pproxlmstoly two thirds of 450,000 to 500,000 patlents $n the 19908 will need multi-vesse} coronsry ngioplssty, $t is clesr thst there ~8~ a ne-d for -a ms~or advance in balloon angioplasty that will ~prov$de moFe effic$ent snd cost~effective ang$oplasty bslloon systems spec$flcslly deslgned (snd sulted) for ~ultl-vessel coronsry ngloplasty ~ ~
In multiballoon angioplasty procedures, the smoothness an~d flex~billty of ~the distal ont of the ngloplasty c-theter are extremely important Too ~uch ~tlffness or rigidity in the balloon section at the dlstal end of the catheter skes lnsert1on of the catheter more difficult S~oothness of the catheter 18 also desir-ble and, ln a 35~ multlple bslloon cathet-r,~lt will be important to provlde ooeh~tro-e~t10n ~ro-~balloon to b-lloon on the outslde - .

13~1~80 of the cAtheter.
Balloon fabrication technique~ heretofore employed have significant di~dvant~ges when it come6 to multiple bslloon cstheter~. Such difficult~es include the difficulty of providing A ~mooth tran~ition from b~lloon to balloon and difficulties in booding bslloon6 together in a lengthwise manner. Those difficulties are addressed by the pre6ent invention, which provides multiple b~lloon catheters atapted for use in multiple vessel di6ease.
Such catheters hQve not heretofore been available and the need for an angioplasty procedure suitable for u~e in multivessel disease is readily apparent.

Summary of the Invention The present balloon angioplasty catheter invention provides an angioplasty catheter having multiple balloon6 that are integrally formed with the catheter sh~ft itself from a single, monol~thic piece of polymer material. Thi~
provides for an extremely smooth transition from balloon to catheter shaft, and also minimizes the material present ln the balloon portion of the catheter, thus providing increased flexibility ~or the catheter itself. The method for making the catheters of the present invention is well adapted for making multiple balloon catheters, and circumvents many of the complications that would be experiencet in applying conventional balloon fabrication techniques heretofore used for single balloon catheters to multip~e balloon catheter manufacture.
The present invention is tesigned ior compatibility with existing and commercially available guidewires and guidlng catheters, requiring, at ost, minim~l modification of those existing systems.
The balloons utilized in the present invention must meet stringent requirements that are unique to angioplasty balloons. They are: (a) the balloon mu6t maintain its predetermined precise diameter and its original .
, :
-;
,. ;., .

configurstion under high inflation pre~sures (typicslly up to 150 psi or more) without significant or undue stretch or deformstfon; (b) the msterial used in construction of the balloon must h~ve 8 high tensile strength and not S rupture during inflation to the prescribed high pressure;
(c) the balloon must be indepentently inflstsble and de1atable under the external control of the operator; (d) the cross-sectional profile of the balloon should be low (G 90 mm to 1 20 mm or le~s in diameter) when it is 0 deflated with negative pressure ~o that it can pass through the lumen of a guiding catheter ant the tight and sometimes very hard internal lumen of the stenotic segment of a target artery; and (e) the material must be flexible as well as resilient 80 that the balloon catheter can lS negotiate the tortuous snd ~ometimes irregular artery by following or ~a~dvancing ow r a ~guldewire already placed in the artery ahead of the bslloon cstheter In all of the embodiments of the present invention, ~radiopaque ~arker~ may be provided on the catheter to mark ,!20 the longltudin-l loc-tion of any or all of the balloons on the catheter ~ For coronary angioplasty, it is preferred that none of Y~the balloons exceed bout 40 mm in length, and most pre~ferably none of the balloons exceed about 30 mm in ZS length For peripher-l angiopla6ty, it io preferred that none of~the balloons;exceed bout 100 mm in length, and they ost ~preferably do not exceed about 80 mm in length For coronary~angioplasty, it io further preferred that the m~ximum inflated diameter of each of the balloons 30 doe-~not exceed ~bout 4 5 _ For peripheral ngioplasty, lt~ is preferr0d that the maximum lnflated diameter of each o~the~balloons does not exceed about 15 m, although larger diameters may be required for ortic u~e Finally, for~w lvular angioplasty, it ie preferred thae none of the 3S~ balloons ~exceed about ~ 30~ ~m, prefer-bly 25 ~m, in dl- -t-r,~;-nd~th-t~th-y do~not e~ce d 65 _ , preferably 60 ,' : ' ~ , " :

'~: ' :

.~ : . . :., .' :

8 ~
_9_ mm, in length Thus, in accordance with one aspect of the present invention, there iB provided an angiopl~sty catheter, comprising a catheter shaft having a proxim~l end and a distal end, an angioplasty balloon on the distal end of the catheter sh~ft, the balloon having a balloon w~ nd a length, wherein the b~lloon and the distal end of the catheter are formed from a single monolithic piece of polymer material and wherein the balloon is eccentrically positioned with re6pect to the catheter shsft, and at least two lumens in the catheter shaft, one of the lumen~
in communic~tion with the interior of the balloon, and the other extenting through the balloon and being suitable for receiving a steerable guidewire In accordance with another aspect of the present ~-~ invention, there i- provided n ngioplasty catheter, ~ comprising a catheter shaft having a proximal end and a o~ distal ~end with ~at Ieast two lumens extending therethrough, nd an angioplasty balloon on the distal end of the catheter ohaft, wh-rein the balloon and the distal nt of the catheter shaft are formed from a single ~onolithic piece of polymer material by ~e~ling shut the di~tal ent of one of the lumens and heating the distal end of ~the catheter shaft, ~then ~internally pre--urizing the 2S~ oesled lumen to expand at ~least portion of~ the distal ent of the cath-ter h-fc into the balloon, wherein the balloon is eccentrlc~with respect~to~the catheter shaft In accordance wlth another embodiment of the present invention, theré i- provided -n angioplasty catheter, ~comprl~ing a catheter shaft having a proximal nd and a ~ dl~tal ond, at le-st two independently inflatable and ; ~ intepentently ~deflatable angioplasty balloono at the dlstal~end of the c-tbeter, each balloon havibg a balloon wall -nd having a length and~ ximum lnflated diameter, 3t ~ wherein thé balloons~ nd the dlstsl end of the catheter eh-ft~-ré~ form-d ~ fro- ~a slngle, monolithic piece of 1311~80 polymer material and wherein the balloon6 are eccentrically po6itioned with re6pect to each other. The balloons may advantageou61y also be eccentric with re6pect to the catheter shaft. Moreover, the wall of each balloon may be ~oined to either another of the balloons or to the catheter shaft along 6ubstantially the entire length of each balloon.
It is preferred that maximum inflated diameter of each balloon iB sub6tantially uniform over the length of the balloon when measured together with the thickne~s of any overlying, uninflated bslloon.
In one preferred embodiment, the balloons comprise a first balloon snd a second balloon, and the maximum inflated diameter of the first balloon is less than the maximum inflated diameter of the secont balloon. The first balloon may be at least partially inside the 6econd balloon, snd preferably at least 15~ but less than 85Z of the length of the first balloon is inside the second balloon. In an slternative embodiment, the first balloon is distal of the second balloon. The first balloon and the ~econd balloon are located on the same side of the catheter shaft, or on opposite sides.
In yet another embodiment of the invention, the balloons comprise a first balloon and the second balloon and further comprise a third balloon on the catheter shaft. Two bslloons may be on the same side of the cstheter shaft and the other balloon may be on the opposite side of the catheter shaft; altern~tively, the bslloons may all be on the ssme side of the catheter shaft.
In yet another embodiment of the invention, the catheter shaft extends through the balloons, ~nd the catheter shaft has a lumen extending the length of the catheter shaft for receiving a steersble guidewire.
35In still snother embodiment of the invention, the ~; catheter shaft includes at least a first lumen and a - - - - . ~.. . . - -~ .
., ~ ` - \
1 3 ~ 0 second lumen extending through the c~theter shaft, snd the b~lloons comprise ~ fir6t balloon and s ~econd balloon, wherein the fir6t lumen terminstes inside the f~rst balloon ~nd the second lumen terminates inside the second balloon. In this embodiment, the cstheter further comprises an axial torque guidewire extending through the first lumen and out of the di6tal end of the first balloon snd the cstheter, wherein the distal end of the first balloon i8 sesled to the guitewire. The walls of the first balloon may be formed by expsnding the walls of the first lumen snd the first bslloon m~y be substantially coaxi~l with the first lumen. Moreover, the walls of the second balloon msy be formed by expanding the w~lls of the second lumen and the second bslloon msy be eccentric with tS respect to the second lumen. The cstheter may still further comprise a third bslloon and the cstheter shaft may have a third lumen in communicstion with ~nt terminsting inside the third bslloon, wherein the third bslloon is eccentric with re6pect to the thirt lumen.
In sny of the catheters tisclosed herein, the walls of each balloon may be ~oined to a common line on the cstheter shaft along substsntially the entire length of esch balloon. Alternatively, the w~ll of the first bslloons may be ~oined to the cstheter shsft ~long s line extending substsntially the length of the first balloon and the wall of the second balloon may be ~oined to the wsll of the first balloon along s line extending slong the length of the first bslloon. Moreover, esch balloon hss a proximal end and B ti~tsl ent, snt the distal end of one of the bslloons may be ~oined to the wall of snother of the bslloons.
In accordance with snother sspect of the present invention, there is provided s method for making sngioplasty bslloons, comprising the steps of forming from a single piece of polymer material s length of catheter ~ shaft materisl having st lea6t a first lumen and s second ,::

;; . . . ' :~ .. ... .
, .

131~80 lumen therein, each lumen hsving sn outer wsll, each lumen hsving 8 proximsl end snd a distsl end, sesling the dist~l end of the first lumen to form 8 firfit sesled lumen, and applying pres6ure to the proximal end of the first sesled lumen snd hesting the outer wsll thereof to exp~nd the first sesled lumen inside 8 first die to expsnd the outer wall of the first sesled lumen to form~ a fir6t bslloon therefrom hsving dimensions determined by the dimensions of the interior of the die. The method msy further comprise the steps of sesling the distal end of the second lumen to form a secont sealed lumen, applying pressure to the proximsl end of the second sealed lumen ~nd hesting the outer wall thereof to expand the ~econd sesled lumen lnside a second die to form a second balloon therefrom hsving dimen~ions determined by the dimensions of the interior of the second die, wherein the first balloon and the second b~lloon are eccentric with respect to each other. The sealed end of the first lumen may be located dlstally of the eealed end of the second lumen 80 that the dlstal end of the flrst b~lloon 18 located distslly of the dlstal end of the eecond balloon. In one embodiment, the outer wall of the flrst lumen 18 locsted lnside the outer wall of the second lumen. In another embodiment, the flr~t balloon snd the second balloon are located on opposlte sides of the catheter. The forming step may adv~ntageously be a molding step or an extrusion step.
When the forming step is an extrusion step, the method msy further comprise the ~tep of shortening the second lumen prior to sealing the distal end thereof by removing 8 length of the outer wall of the second lumen at the dlstal-most end of the second lumen 80 that the dlstal end of the second lumen 18 located proximally of the distsl end of the first lumen.
In one embodiment of the method, the seallng step for 3S the second lumen comprises bondlng the outer wsll of the second lumen ~t the distal end thereof to the outer wall i: ~

~ ' ' .

.
:~ ~ ' " ' " " , ' ' ' 1311~80 of the first lumen.
In each embodiment of the method, the catheter sh~ft material may further have a third lumen therein, snd the method msy further comprise the steps of sealing the distal end of the third lumen to form s third sealed lumen, and applying pressure to the proximal end of the third 6ealed lumen and heating the outer wall thereof to expand the outer wall of the third sealed lumen inQide a die to form s third balloon therefrom having dimens~ons determined by the dimensions of the interior of the die.

Brief Description of the Drawings Figure 1 ie a side elevation of the distal end of a du~l-balloon steerable guidewire limacon geometry sngioplasty c~theter having balloons on the same side of ;~ the guidewire lumen showing the balloons snd connecting lumens in longitudinal~section and the guidewire lumen in psrtisl cross section.
Figure 2 iB B perspective view of the distal end of the cstheter of Figure 1, partially in cross section.
Figure 3 is s cross section of the catheter of Figure 2, tsken slong the line 3-3.
Figure 4 is s cross section of the catheter of Figure 2, t~ken ~long the line 4-4.
2S Figure 5 18 s cross section of the catheter of Figure 2, taken ~long the line S-5.
Figure 6 is a cross oection of the catheter of - Figure 2, taken slong the line 6-6.
Figure 7 18 s side elevation of the distsl end of a steersble guidewire tual b~lloon catheter of the present invention hsving bslloons on opposite sides of the ~; cstheter shsft, with bslloon lumens and bslloons shown in ~ longltudinsl section snd with the guidewire lumen shown in ,; ~ psrtisl cross section.
Figure 8 is a cross section of the catheter of Figure 7, tsken slong the line 8-8.

., ., . , : .. : : :

.: . , .:
: . , . - : :

., ~ .
, - , . , - . . , 13~1~80 Figure 9 i6 a cross section of the catheter of Figure 7, taken along the line 9-9 Figure 10 is a cro66 section of the catheter of Figure 7, taken along the line 10-10 SFigure 11 i8 a slde elevation of the distal end of a triple balloon steerable guidewire catheter of the present invention, having lntegrally-formed balloons on opposite sides of the guidewire lumen, with balloons~ shown in longitudinal section and with the guidewire lumen and the 10digtal balloon lumen shown in partisl section Figure 12 is a cross section of the catheter of Figure 11, taken along the line~ I2-12 Figure 13 is a cross section of the cstheter of Figure 11, taken along the line 13-13 - 15Figure 14 is a cross section of the~ c-theter of ~Figure 11, taken along the line 14 14 Figure 15 is a side elevstion~ of 8 triple balloon steerable guldewire catheter of the present lnvention, having two overlspplng balloons on one side of the 20gultewire lumen, nt another b-lloon on the opposite side of the guidowire lumen, with the- balloon lumons and balloon~ shown ln longitudinal soctlon Figure 16 18 a cross section of the cathetor of Flgure lS, taken -long the line 16-16 2SFlgure 17 ~i8 a cross section o the cathetor of Figure ~15 ? taken along the line 17-17 Flguro ~ 18 18~: a~;cross sectlon of the cathoter of Figure~lS, takon along the llno 18-18 Flgure 19 is a cro~s ~soctlon of the cathotor of ~- 30~ FIgure lS, t-ken~-long the line 19-19 Flgure 20 18 a slde elevatlon of the dlstal end of an xlal torque guidewire ~overlapplng double balloon catheter of ~the~pr-sent 1nv-ntlon, wlth the balloons and the catheter ~shaft shown ~in longltudinal sectlon 3S ~F~gure 21 18 a ~cross sectlon of the catheter of Flgu 2~ k n loog~ th Il-e 21-21 - . . . . . .
:
" ~. . , . . ~ .~ .
,. ~, . . :, .

1311~gO

Figure 22 is a cross section of the c~theter of Figure 20, taken along the line 22-22.
Figure 23 iB a cross section of the catheter of Figure 20, taken along the line 23-23.
S Figure 24 iB a side elevation of the tistal end of a tandem dual bslloon axial torque guidewire catheter of the present invention, showing the catheter shaft snd balloons in longitudinsl section.
- Figure 25 is a cross section of the catheter of Figure 24, taken slong the line 25-25.
Figure 26 i8 a cross section of the catheter of Figure 24, taken slong the Iine 26-26.
Figure 27 i8 a side elevation of a triple balloon axial torque guidewire cstheter of the present invention, - 15 with the balloons and catheter shaft shown in longitudinal section.
Figure 28 is a cross section of the catheter of Figure 27, tsken slong the line 28-28.
Figure 29~ i8 cross eection of the catheter of Figure 27, taken along the line 29-29.
Flgure 30 18 a cross section of the catheter of Figure~ 27, taken along the line 30-30.
Figure 31 is a ~ide elevstion of a portion of the i balIoon segmont of a catheter of the type illustrated in 2S Figure 2, 8howing one embodiment of 8 30int between two b~lloons .
Flgure 32 is a side elevation of a portion of the bslloon segment~ of a catheter of the type illustrated in F1gur-~ 2, ~showing another embodiment of a 30int between two balloons.
Figure 33 is a ~ide elevation of a portion of the balloon ~ogment of 8 cathetor of the typo illustratod in Figure 2, showing yet another embodiment of 6 30int between two b~lloons.
3S ~ ~ F1gure~ 34 is a disgram of the loft coronary srtery ptem.

~" ~ " ~, " . ,": ",, , ,, . , ,, " " ~ ', ':.. `' , : ~ :

, :. ,~ - . . . -: .

~^ ~ : . . - , . .: . -~3~80 D tailed Descriotion of the Invention The angiopl~6ty cstheter6 of the present invention fall into two broad, general categories: 6teerable guidewire type catheters and axial torque guidewire-type catheters. Both steerable guidewire catheters and axial torque guidewire catheters are known in the art. Briefly, a steerable guidewire-type catheter has a guidewire lumen extending the entire length of the catheter, from the proximal end to the distal end thereof, and the guidewire lumen extends through or pa6t all of the balloon~. A
guidewire can be threaded through the lumen and is rotatable through the lumen. An axial torque guidewire-type catheter, on the other hand, has a guitewire that extends through a lumen th~t terminates inside the di6tal-moet balloon, and the guidewire extends out from the distal end of the distal-most balloon. The distal-most end of the balloon iB bonded directly to the guidewire 80 that rotation of the proximal end of the guidewire about its axis rotates the guidewire tip to permit selection of a target vessel.
In general, the balloons of the present invention share a number of characterlstlcs ln common wlth conventlon~l angloplasty balloons. These characteristics 2S differentiate angioplasty balloons from other types of known catheter balloons. Angioplasty balloons are generally cylindrical snd have a predetermined m~ximum inflsted dlameter that remalns more or less constant over the range of worklng pressures to which the balloon is sub~ected. Modern balloon materials can be inflated with pressures of at least 100 psl, preferably at least 150 psl, ~nd often 200 psl. The balloon wall 18 not 1 reslllent, elastlc material, but lnstead 1B folded against j~ the catheter shaft ln lts deflated state and, upon inflation, assumes a predetermined shape. Even when l~- inflatlon pres~ures reach the high values discussed 1' ~, ,.. "4,,,.. ~, . -~:,~,; ~ - -131~0 herein, only a minor amount of ~tretching, ~f any, occur~.
The hard, non-el~stic balloon, when nflated, has the ability to compress sclerotic le6ions or stretch the n~rrowed segments in order to increa~e blood flow through S a diBeased blood vessel.
The angioplasty catheters of the present invention are suitable for coronary angiopla6ty, peripheral angioplasty, and val wlar angioplasty. The angioplasty balloons may be provided in different diameters snd lengths, depending on the intended use of the catheter. Balloon catheter shafts o$ size French 4.0 or less are preferred. For coronary ~ngioplssty, balloon diameter6 of from about 1.0 mm to about 4.0 mm and lengths from about 7 mm to about 30 mm are preferred. For periphersl vaecular angioplasty and valve angioplasty, the balloons may have diameters between about 3.0 mm and about 20 mm, with lengths between about 25 mm and about 60 mm.
Any of a number of materials may be used to make the balloon catheters of the present invention. At least the dlstal end of the catheter and the balloons are preferably formed from high-strength thermoplastic material, which may be the same as conventional sngioplasty balloon materials or may be other, advanced thermoplastic aterials. Balloon materials that have been used or are now in use include polyvinylchloride, polyethylene, polyethylene terephthalate (PET) mylar brand polyester materisl (made by du Pont). Other suitable film-forming materials capable of withstanding pressures of 100 p8i, preferably lSO psi or 200 psi, without bursting or significant stretching, may also be ueed to form the distal end of the catheter and the angioplasty balloons.
The catheters of the present invention are typified by the dual balloon catheter illustr~ted in Figures 1 snd 2.
To the extent that the catheters retain common or comparable elements from Figure to Figure, the same numbering will be applied to such elements, which will not ", ;~
,,~.. ' , ~- '- ' ' : '-. ,~ ' ' , . ' ' . , -., - . , - ', ' : .
. . . .
, , , ,:~ , ..
- . . , .
: ~ , , . ' ' . .

~lw~y6 be separ~tely expl~ined for e~ch Figure.
The catheter6 of the pre6ent invention are re~erred to as having "limacon" geometry becauRe of the resemblance of the crosR 6ection of the cstheter to s limacon. It will 5 be understood, however, thst the catheters of the present invention sre not required to exhibit true limacon geometry in cro~6 section.

I. Steerable Guidewire-Type Limscon Geometry Catheters With re~pect to Figures 1 and 2, a catheter 40 h~s at lea6t one bslloon, the first balloon 42 ~t the d~OEtal end 44 of the catheter 40. The catheter 40 al80 ha6 proxlmal end 46 which is indicated st the far left-hand side of Figure 2; however, it will be understood that the proximal end 46 of the catheter 40 i8 the end at the extreme opposlte end of the catheter 40 from the distsl end 44, snd that the true proximal end 46 i8 not shown in Figure 2. R~ther, Figure 2 illustrste~ only the distsl bslloon-besring portion of the cstheter 40, snd ~he 20 reference numeral 46 is provided only for purposes of indicsting the proximal direction.
The cstheter 40 slso hss s cstheter shsft 50 on which il s first balloon 42 is formed. As used herein, the cstheter shaft 50 shall refer to the lumens snd their 2S wslls in an expanded stste. The cstheter shaft 50 shsll not be considered to include outer walls of lumens which hsve been expsnded into balloons. The first balloon 42 has a first balloon wall 52. A first lumen 54 having an outer wsll 56 extends from the proximsl end 46 of the 30 cstheter 40 to the interior of the first bslloon 42, provlding a fluid passsgewsy between the proximal end 46 ,~ of the cstheter 40 snd the interior of the first balloon 42.
The catheter shaft 50 is slso provided with s 35 guidewire lumen 60 through which s steerable guidewire may be psssed. me guidewire lumen has an outer wall 68 snd ~ ~ , . ~ ." .,,. ,, .. , :
: '"' " , ' :
' , -1311~8~

extends from the proximal end 46 of the catheter shaft 50 to the distal end 44 of the catheter 40, and i6 large enough to receive a conventional steerable guidewire snd to further permit monitoring of blood pressure trough the S guidewire lumen 60. The guidewire lumen 60 and any guidewire placed therethrough extend beyond the d$~tal-most end of any of the balloon~, such a~ first balloon 52, on the catheter 40. The guidewire lumen 60 of the cat~eter 40 preferably has an ~nner dismeter of about .014 to about .016 inches, ~ust large enough to accommodate A
.012 or .014 inch conventional steerable guidewire inside and to monitor distal pre~sure through the lumen. The outside diameter of the catheter shaft 50 at the proximal end 46 of the catheter 40 should be size French 4.0 or less. In all of the steerable guidewire catheter6 of the present invention, holes communicating with the guidewire lumen 60 may be provided ~ust proximally of the balloons to permit blood flow through the guidewire lumen 60 and past the balloons 42, 62, to maintain coronary perfusion during balloon inflation.
A second balloon 62 having a wall 64 is also provided on the catheter shaft 50. A second lumen 66 having an outer wall 70 extends through the catheter shaft from the proximal end 46 thereof to the interior of the second balloon 62 to provide fluid communicatlon between the proximal end 46 of the catheter 40 and the second balloon 62.
Ae least the portion of the catheter 40 illu6trsted in Figure 2, rom a point ~ust proximally of the balloons 42, 62, inc~uding the catheter shaft 50, the walls 56, 70 of the lumens 54, 66, and the walls 52, 64 of the balloons 42S 62, is all formed $rom a ~ingle, monolithic piece of polymer material. Thus, the outer wall 56 of the first lumen 54 has been enlarged and streeched to form the wall 52 of the first balloon 42. Similarly, the outer wall 70 of the second lumen 66 has been enlarged and stretched to ~, . - , , .
. . ... . . .

. -~ .
.

1311~80 form the wsll 64 of the second bslloon 62. It should be understood that the thickness of the balloon w~ 52, 64 i8 generslly between sbout 0.01 mm and 0.10 mm, depending on the 6trength and flexibility of the m~terisl from which the bslloons 42, 62 sre formed. Thi8 thiCkneB8 iB greatly exsggerated in all of the figures for purposes of ~lluætration only. Moreover, the thickness of the o~tter walls 56, 70 of the lumens S4, 56 is substantially greater than the thickness of the balloon walls 52, 64. The outer walls 56, 70 of the lumen6 54, 66 Bre rigid enough to maintain their dimensions when negative pressure is applied to the proximal end of the lumens 54, 66. In contrast, the very thin balloon walls 52, 64 are i~exible and readily collapse when negative pressure i8 applied to the appropriate lumen for each balloon.
The guidewire lumen 60 has an outer wall 68. As lllustrated in Figure 3, each of the outer wall6 56, 68, 70 of the lumens 54, 60, 66 converge to 8 common point or llne lnto a common wall 72. Thus, the common wall 72 i8 a convergence polnt for outer lumen walls 56, 68, 70. The lumen wall~ 56, 68, 70, 72 in radial cross section~ as ~hown ln FLgure 3, sre arranged as eccentric circles, one within another, longitudinally ~oined together at the common lumen wall 72. The common lumen wall 72 is a line running the length of the catheter shaft 50.
The balloon srrsngement in the dual balloon limacon geometry catheter 40 of Figures l and 2 iB a psrtisl overlap teslgn. That is, the first balloon 42 is partially inside the second balloon 62. The distal end 74 of the first balloon 42 i~ ~oined to the outer wall 68 of the guldewire lumen 60. The distal ent 76 of the second balloon 62 18 ,~olned semlcircularly to the underlying wall 52 of the first balloon 42. The ~oints 77, 79 between the l~ distal ents 74, 76 of the first and second balloons 42, 62 35 and the underlying structure, sre formed using any suitable balloon ~oint bonding process, such ss hest ", -- :

^21-bonding, vulc~nization bonding, solvent bonding, ultr~sonic welding, lsser weld~ng, ~nd glue bonding These b~lloon ~oint6 ~re semicircular around the catheter sh~ft; thus, subst~ntially the entire distal endEs 74, 76 of the first and second balloons 42, 62 are closed The - ~oint itself in all of the balloon designs may lie in a plane normsl to the axis or length of the catheter shaft 50, or it may preferably lie in s plane st an acute angle to the length of the catheter shaft 50 10The first balloon 42 may be completely inside the second bslloon 62; however, it is preferred thst the first balloon 42 be only psrtially lneide the second balloon 62 - In a preferred embodiment, at le~st 15~ of the length of the firet ba}loon 42 is lnside the second bal}oon 52, but less than 85% of the length of the first balloon 42 is inside the second bslloon 62 It should be understood, however, that the design of Figure 2 may be modified to provide a tandem tual-bslloon limacon geometry catheter, ~ wherein the entire first balloon 42 is located distally of s~20 the ~econd balloon 62 In the tandem design, the first balloon 42 is completely outside the oecond balloon 62 ~-Unter ortinary contitions of use, when one of the balloons 42, 62 is inflatet, the other bslloon will be tei'lated ~(Both balloons 42, 62 are shown in the inflated Z5 ~ configuration simply for purposes of illustration ) lthough the wall 64 of the outer balloon 62 i~ very thin, it i~ nevertheless tangible In a preferred embodiment of the present invention, in order for the effective maximum inflated working dia-eter of the first balloon 42 to be ~uniform along substantially its entire length, the diamet-r of the portlon of the first balloon 42 that iB
inside the ~econd balIoon 62 is slightly less than the di meter of th portion of the first balloon 42 thst iB
outs~de the second balloon 62, with the difference in diameters betw en the two portions of the balloon 42 being approximately equ-l -to the thickness of the overlying, ., .,. :

~, . .
",:~: ' ' ' ' '~',' , :' ,'" ' '" ' , . .
: ~ ' ~ ' - .

` ~ ' ' ~ , ~31~ ~80 uninflated second balloon 62. In this way, the max~mum inflsted effective working di~meter of the first balloon 42, together with ~ny overlying uninflAted balloon walls, i8 gub~tantislly uniform along the entire length of the fir6t balloon 42.
In one slternative embodiment of the pre6ent invent~on which may be applied to any of the tesigns falling within the 6cope of the present invention, radiopaque marker6 78 may be provided on the catheter 6haft 50 60 the locstion of the catheter may be radiographically monitored.
The balloon con6truction may be more fully under6tood by comparison of the cros6-6ectional Figure6 3-6. In the cros6 section of the second balloon 62 and the catheter shaft 50 illu6trated in Figure 4, the firet lumen 54, its outer wall 56, the guidewire lumen 60, it6 outer wall 68, and the common wall 72 are 6ub6tantially the same aB in Figure 3. However, the outer wall 70 of the second lumen 66 ~hown in Figure 3, has, in Figure 4, become the wall 64 of the second balloon 62.
In F$gure 5, a cross section through the catheter shaft 50 and both the first bslloon 42 and the second bslloon 62, the common wall 72, the gui,dewire lumen 60, and its outer wall 68 are substantially the same as in Figures 3 ~nd 4. However, the outer wall 56 of the fir6t lumen 54 in Figures 3 and 4 has been expanded to form the wall 52 of the first balloon 42, and the outer wall 70 of the second lumen 66 in Figure 3 ha6 become the wall 64 of the second balloon 62.
In Figure 6, which is a cross section through only the first balloon 42 and the catheter 6haft 50, taken di6tally of the second balloon 62, only the guidewire lumen 60, it6 outer wall 68, snd the common wall 72 remain the 6ame a6 illustrated in Figure 3. The wall 52 of the fir6t balloon 42 convergeB with the outer wall 68 of the guidewire lumen 60 st the common wall 72, which common wall 72 run6 the entire length of the catheter 40. The wall 64 of the ~, ~ ~.. .

1311~80 second b,~lloon 62 (and/or the wall 70 of the eecond lumen from which it was formed) has been removed from the di~tal-mo~t end of the catheter 40, and is not present in Figure 6, the second balloon 62 h,aving terminated proximally of the line 6-6 The balloons 42, 62 in Figures l and 2 are eccentric with respect to each other and with respect to the catheter shaft 50 and the guidewire lumen 60 However, both the first balloon 42 and the oecond balloon 62 are locsted on the same side of the catheter shaft 50 The first balloon 42 has a maximum inflated diameter that is less than that of the eecond balloon 62 The maximum inflated diameter of the first balloon 42 is preferably about 1 5, 2 0, 2 5, or 3 0 mm The maximum inflated di,ameter of the larger, second balloon 62 i8 preferably 2 5 mm, 3 0 mm, 3 5 mm or 4 0 mm The lengths '~ of each o the balloons may advant,sgeously be between !'';ab,out 15 mm ,and about 40 mm, preferably ,about 20 mm to about 25 mm ,Another dual balloon limscon-geometry steerable guldewire angioplaoty catheter i8 illustrated in Figure 7 The catheter 40 has a first balloon 42 on one side of the c-theter shaft 50, and a oecond balloon 62 on the oppo",~ite oide of the catheter shaft 50 A guidewire lumen 2S 60 having an outer wall 68 on either side of common wall ~ 72 runs the length of the catheter 40 and completely i ~ through the two balloons 42, 62 The cath ter of Figure 7 differs from the catheter"3 of Flgures 1 and 2 because the balloon"~, 42, 62 are on ' ~ 30 oppooite sldes of the catheter ohaft 50 and the guidewire lumen 60 A first lumen 54 and a oecond lumen 66 ~sxtend from the proximal end 46 of the catheter 40 into the interior, r-~pectively, of the first balloon 42 and the second ~ balloon 62 for independent inflation and deflation of the , ~ balloons 42, 62 . ~

,: , 131~

The outer wall 56 of the first lumen 54 becomes the wall 52 of the first balloon 42, and the outer wall 70 of the second lumen 66 becomes the wall 64 of the second balloon 62.
5In Figure 8, which illustrates a cross section of the catheter shaft 50 of the catheter of Flgure 7 taken proximally of the balloon~ 42, 62, it can be seen that the outer wall 56 of the first lumen 54 merges with the outer walls 68 to form two common wall6 72. The outer wall 70 of the second lumen 66 merge6 with and i6 connected to the outer wall 56 of the fir6t lumen 54 at a point ~d~acent to the common wal 18 72.
In Figure 9, a cross section through both the fir6t balloon 42 and the second balloon 62, together with the 15guidewire lumen 60, the outer walls 56, 70 of the first and 8econd lumens 54, 66 have become the wall~ 52, 64 of the first and second bslloon6 42, 62. Only the guidewire lumen 60, its outer wall 68, and the common wall 72 remain the same a8 in Figure 8.
20In Figure 10, a cross section taken through the fir6t balloon 42 tistally of the distal end 76 of the first balloon 72, only the wall 52 of the first balloon 42 and the central lumen 60 ~nd its walls 68, 72 remain the same a8 in Figure 9.
25The diameters of the first and second balloons 42, 62 in Figure 7 may sdvantageously be about the same as the diameters of the first and second balloons 42, 62 in the catheter illustrated in Figure 2. However, in this design, the first balloon 42 is longer than the second 30balloon 62. Thus, although the proximal ents of the fir6t :; and second balloons 42, 62 are at substantially the same point along the length of the catheter 40, the distal end : 76 of the second balloon 62 ~8 located proximally of the ;~ ~ distal end 74 of the first balloon 42. The length of the 35first balloon 42 i8 preferably 25-45 mm, most preferably ~ : about 30 ~ , snd the len&th of the second balloon 62 is ':

, ~.

-25^

preferably 15-30 mm, preferably about 20 mm Thus, the length of the first balloon 42 is greater than the length of the second balloon 62 by about 10 mm When the second balloon 62 is deflated and the f irRt S balloon 42 is inflated, the msximum inflated diameter of the first balloon 42 distally of the distal end 76 of the second balloon 62 is slightly greater than the maximum inflated diameter of the first balloon 42 proximally of the distal end 76 of the second balloon 62 by an amount substantially equal to the thickness of the deflated balloon 62 In this way, the effective maximum inflated diameter of the fir~t balloon 42 is substantially uniform along the entire length of the first balloon 42, when ~, taken together with the thickness of the overlying deflated second balloon 62 The catheter ~illustrated in Figure 7~ has three effective working diameters The f$rst is the diameter of the first balloon 42, the second is the maximum inflated diameter of the second balloon 62, nd the third effective ~20 diameter of the catheter of F~gure 7 is achieved by Y ~ lnflatlng both the flrst balloon 42 nd the second balloon The catheter of Figure 11 1B a steerable guidewire catheter that has a flrst balloon 42 and a second balloon ~'r ,~ ~ ~ 2S 62 generally a8 descrlbed ln connection with Figure 7 However, unllke the oatheter of Flgure 7, the catheter of Flgure ll lncludes ~a separate, non-unltary third balloon 80 locatet~dlstally;of thè first balloon 42 nd the second b lloon 62 ~ The separate tbird balloon 80 1B separately ~ formed and connected to~the c-theter shaft 50; it i8 not formod fro- the ~ame monollthic plece of polymer material ;~ a8~ are the first nd second balloons 42, 62 and the c-theter ~haft 50 In~addition * ~the flr~t~ lumen 54, the second lumen 3S~ ~66, and the gu~dewire lumen 60 de~cribed in connection viCh ~Igur ~7 -nd Flgure 2, the c-theter of Figure 11 has .,~ ;~ , , - - -~: ' : -"~ : , 1311~gO

a third lumen 82 extending from the proximal end 46 of the catheter 40 to the interior of the third balloon 80 for independently inflsting and deflating the third balloon SIn the catheter of Figure 11, the first, second, and third balloon6 42, 62, 80 are eccentric with respect to each other and the first and second b~lloons 42, 62 are eccentric with respect to the cstheter shaft 50 Although in Figure 11 the proximal end of the first balloon 42 i8 located st the same point as the proximal end of the second balloon 62, it should be understood that the proximal end of the first balloon 42 may instead be located distally of the proximal end of the second balloon lSThe third balloon 80 is substantially coaxial with the catheter shaft 50 and is made from a tube of 6uitable b~alloon material ~which may be the same a8 or different from the~materi-l from which the flrst balloon 42 and the second balloon 62 are made The third~ balloon 80 i6 ~ 20 bonded to the catheter shaft 50 by any conventional means, q~ ~uch a~ hest bonding, RF bonding, laser bonding, solvent if ~';, welding, athosive bonding, heat-ehrink bonding, or other suitablee technique The ma~imum inflated diameter of the third balloon 80 is proferably less than the maxlmum inflated diameter of ~-~; the f}rst balloon 42 and the second balloon 62 For coronary angiopla~ty, the third balloon 80 may have a ~ ~aximum lnflated diameter of about 2 0 mm ant may be about ''f~ 12-25 ~m in length,~preferably about 17 mm, the first ~ 30balloon 42 may be from about 20 to about 30 ~m in length, t` ~ preferably about 25 mm, with a aximum inflated diameter of about 2 5 mm, and the second balloon 62 may be about 12-20~ _ in le~ngth, preferably about 17 mm, with a maximum inflated diameter of about 3 0 mm In another embodiment 35 ~ of thi~ s-me~cath ter, th-~aforementioned maxlmum inflated tiameters may each be increased or decreaqed by about 13~980 0.5 mm.
As shown in Figure 12, a cross section through both the first b~lloon 42, the second bslloon 62, ~nd the catheter shaft 50, sppears sub~t~ntially the s~me AS
Figure 9, except that a second lumen 82 i6 present.
Figure 13 similarly corresponds to Figure 10, differing from Figure 10 by the inclusion of the third lumen 82.
In Figure 14, a cro6s section through the third bslloon 80, only the central lumen 60, the outer wall 68 thereof, snd the third balloon 80 sre present.
Yet another catheter sccording to the present invention i8 illugtrated in Figure 15. This catheter is a triple bslloon steerable guidewire catheter in which all three balloons sre formed from the same monolithic piece of polymer material.
The cstheter of Figure 15 has a first balloon 42 and a second bslloon 62, with the fir6t balloon 42 partially ",inside the second balloon 42. The detailed description provided in connection with the catheter disclosed in l20 Flgure 2 will not be repeated with respect to Figure 15;
,,~only the etructure added to the catheter of Figure 2 will ~!be emphssized.
In ~ddition to the first balloon 42 and the second balloon 62 illustrated in Figure 2, the catheter of Figure 15 has a unitary third balloon 84 on the opposite side of the catheter from said first and second balloons 42, 62.
A third lumen 82 is provided in the cstheter shaft 50 in fluid communlcation with the inter$or of the third bslloon 84. The third lumen 84 has an outer wall 86 which, as illustrsted in cross section Figure 16, is attached to the outer wall 70 of the thirt lumen 66 at two wall-to-wall unctions 90. The wall-to-wall ~unctions 90 run from the pr~oximal end 46 of the catheter 40 to the distal end 92 of the third balloon 84.
~¦~ 35 ~ Th- proximal ends of the second balloon 62 and the ;; Shird balloon 84 are at roughly the same polnt slong the ., .~, , , : ~ :

~ ~ .
, 1311~80 length of the catheter shaft 50. The distsl ends 76, 92 of the second balloon 62 and the third b~lloon 84 may sl~o be located st roughly the ssme point along the length of the cstheter shaft 50; however, a slightly offset S relstionship a8 illu6trated in Figure 15 iB preferred.
The catheter will generslly be stiffer and/or bulkier at the distal end of a balloon because of the ~oint located - st that point. Therefore, a 6moother more flexible catheter results if the distal ends 76, 92 are slightly (or greatly) offset, rather thsn terminating at exactly the same point along the length of the catheterg. In Figure 15, two balloons 42, 62 sre on one side of the cstheter shsft 50 and one balloon 84 is on the other side of the catheter shaft 50.
lS Figure 17 differs from Figure 16 in that the outer wslls 70, 86 of the second and third lumens 66, 82 hsve been expanted to form the second bslloon 62 snd the third i bslloon 84. As were the lumen wslls 70, 86 from which they were formed, the second snd third bslloons 62, 84 are ~oinet together along their length st the wall-to-wall ~unctions 90, which extend to the distal ends 76, 92 of those bslloons 62, 84.
Figure 18, a cross section through all three balloons 42, 62, 84, differs from Figure 17 only in th~t the outer wsll 56 of the first lumen 54 has become the wall 52 of the first bslloon 42.
In Figure 19, a cross section through only the first bslloon 42, the cstheter at that point comprises only the wsll 52 of the flrst bslloon 42 and the centrsl lumen 60 with itB w~118 68 snd 72.
The first bslloon 42, the ~econd balloon 62, snd the third bslloon 84 may sdvsntsgeously be approximately the same length, prefersbly between sbout 12 mm snd sbout 25 mm, more prefersbly sbout 17 mm, with dismeters, respectively, of 2.0 mm, 2.5 mm snd 3.0 mm. In other embodiments of the invention, the respective diameters of ~, ~
~,., , . ~.. .....

.
.
'. . . :

the three balloon6 42, 62, 84 may be increased or decreased 0 5 mm II Axial Torque-Type Limacon Geometry Catheters S Figure 20 illustrate6 an ~xial torque-type limacon geometry multiple balloon catheter In the illustrated dual balloon model, the catheter 40 has a first balloon 42 near the distal end 44 of the cstheter 40 The catheter shaft 50 extends only to the proximsl end of the first balloon 42 A first lumen 54 exteDds from the proximal end 46 of the catheter 40 to the interior of the first balloon 42 to provide for independent inflation snd deflation of the first balloon 42 A eecond balloon 62 may be provided on one side of the catheter ehaft 50 and the first balloon 42 The second c~ ~ balloon 64 is connected to the~ proximal end 46 of the c-theter 40 by ~-econd lumen 66 Nnning from the proximal ~end 46 of the catheter to the~ interior of the second balloon 62 me distal end 76 of the eecond b~lloon 62 is 30ined to the wall 52 of the first balloon 42 An axial torque eteèl wire 94 runs the length of the catheter 40 from the proximal end 46 to the dlstal end 44 thereof The axial torque eteel wire 94 ie pre$erably tap-red from a proximal diameter of about 0 016 lnchee to 2S a dlameter t the distal tip thereof of about 0 008 inches The dietal nd 74 of the firet balloon 42 is bonded directly to the ~ xial torque wire 94 by conventional bonding means, such as dhesive bonding, heat N ~ bondlng,~heat-ehrink bonding, or other technique The tip ~of the torque wire;ie welded to a ehort guidewire at the di-t-l ond of the~catheter 40 No guidewire lumen 60 p-rate rom th first lu en 54 ie provided in this deeign 8ecause an~axial torque limacon catheter having dual 3;~ b-iloon-~-ay be m-de with ae few as two lumens, the catheter~shaft 50 may be of relatively em-ll tiameter -: : : - .

~ : -.

131~80 Moreover, because there i8 no c~theter shaft running through the fir~t balloon 42, the b~lloon csn collapse sgainst the axisl torque wire to provide 8 cstheter with sn extremely low profile snd good flex$bility at the S distAl end thereof. Thus, becauee~the collapfied balloon~
are not filled with the catheter 6haft 50, they can collapse to the fullest pos6ible degree.
The first balloon 42 is at least partially in6ide the second bslloon 62. The length6 of the respective balloons are a matter of choice. Thus, if de6ired, the second balloon 62 may be as long as or longer than the fir6t balloon 42, and may extend substantially to the di6tal end 74 of the fir6t balloon 42. However, as shown in Figure 20, it is preferred that the first balloon 42 extend digtally from the distsl end 76 of the second balloon 62 for at lea6t 15~ of the length of the first balloon 42, and preferably for at least about 30~ or 40~ of the length of the flrst balloon 42. The first balloon 42 is substantially coaxial with the catheter shaft 50 (or at 20least the first lumen 54 thereof), and the eecond balloon 62 1B eccentric with respect to the catheter shsft 50 and ~ the gultewire 94. Moreover, the first balloon 42 and the ; second balloon 62 are eccentric with respect to each other.
25AB shown in Figure 21, 8 cross section of the catheter shaft proximally of the balloons 42, 62, the first lumen 54 has an outer wall 56. The guidewire 94 extends through the first lumen 54. The second lumen 66 has an outer wsll 70 on the same side of the guidewire 94 a8 the outer wall 3056 of the flrst lumen 54. The outer walls 56, 70 of the first ~nd second lumens 54, 66 converge together and are ~oined at a common lumen wall 72 runnlng from the balloons 42, 62 to the proximal end 46 of the catheter 40.
Figure 22 is a cross section through both the fir6t 35and second balloons 42, 62. In this f~gure, the outer wall 56 of the first lumen 54 has been expanded to form ~- :
., ~

, .
, the wall 52 of the first balloon 42. The common lumen wall 72 ha6 also become part of the wall 52 of the first balloon 42. The outer w~ll 70 of the second lumen 66 h~s become the wall 64 of the secont balloon 62. The fir6t S balloon 42 and the second balloon 62 sre ~oined together st at lesst one wsll-to-wall ~unction 90. Two wall-to-w~ unctions 90 ~re lllu6trated in Figure 2.
In Figure 23, only the wall 52 of the first balloon 42 remsins, with the guidewire 94 extending therethrough.
The cstheter of Figure 24 is similar to the cstheter of Figure 20 in that it is a dusl balloon sxial torque limscon geometry sngiopIssty cstheter. However, instesd of overlspping, the first balloon 42 snd the second balloon 62 sre srr~nged on the cstheter shaft 50 in tsndem '15 relstionship. Thst is, the first bslloon 42;i6 locsted ! ~:distslly of the distsl end 76 of the second balloon 62.
, ~ ~As in the cstheter of Figure 20, the second bslloon 42 snd 'l the first bslloon 62 are eccentric with relstion to esch other, the 8econd balloon 62 iB eccentric with respect to the cathet-r hsft S0, and the flrst bslloon 42 18 generally coaxial with the guidewire 94, the first lumen 54, nd~the catheter shsft 50.
In~the cro~s ~ection of Figure 25, the outer wsll 70 of the secont lumen 66 has become the wall 64 of the ~ ~2S balloon 62, whlle ehe unexpsnded outer wa}l 56 of the J ~ ~~ first lumen 54 iB substantlally inside the second balloon 62. The wall 64 of the second b lloon 62 i8 ioined to the outer wall 56 of the flrst lu~en 54 st the common lumen 'wall 72. Flgure 26 is itenticsl to Figure 23 and will not 30~ be eparately tescrlbet.
The len&ths~ of the' iirst baIloon 42 nd the second balloon~62 m~y be simllar, snd are preferably in the range of~ ~fr w ~about 12 ~-m to about 25 mm for coronsry angloplssty-~ The dlameters of the first and second 35~ balloons 42,~62 ~ay respectively be about 2.0 mm and about 2.~5~ although~in~ialternative;embodlments, they may be ~r ~

- ~ : : : .
: ~ ', , :

increa6ed or decre~sed by sbout 0.5 mm.
A triple balloon ~xi~l torque guidewire limscon geometry angioplasty catheter iB illu~trsted in Figure 27. This embodiment has a first balloon 42 and a second S balloon 62 in tandem relationship in much the ~ame manner as described in connection with Figure 21. However, A
third balloon 84 is provided on the opposite side of the catheter 6haft S0 from the 6econd balloon 62 in much the same manner ~6 wa6 described in connection with Figure 15. The proximal end6 of the 6econd b~lloon 62 and the third balloon 84 are located at roughly the 6ame point along the length of the c~theter 6haft 50; however, the di6tal end 92 of the third balloon 84 i6 preferably : located proximally of the di6tal end 76 of the second balloon 62. The wall 64 of the second balloon 62 and the w~ll 88 of the thirt balloon 84 are ~oined together ~t w~ll-to-wall ~unctions 90 Nnning lengthwise for the length of the third balloon 84.
As illustrsted in Figure 29, a cross section taken through the ~econd b~lloon 62 between the third balloon 84 ~nd the first b~lloon 42, the wall 64 of the second balloon 62 surrounds the outer wall 56 of the first lumen 54 wlth the ~xi~l torque gu$dewire 94 running through the first lumen 54. The w~ll 64 of the secont bslloon 62 and ; 25 the outer w~ll 56 of the first lumen 54 are ~oined ' together ~t ~ co~mon w~ll 72.
Figure 30, ~ cross section through the first b~lloon, ; is the s~me a8 Figures 26 ~nd 23 and will not be sep~r~tely expl~ined.
The di~meter of the distsl first b~lloon 42 is ~' prefer~bly smaller th~n the diameter of the second b~lloon 62, which is in turn prefer~bly emaller th~n the diameter ' of the third b~lloon 84. The first s,nd third b~lloons 42, ' ~ 84 may be ~pproxim~tely the same length, in the r~nge of ; 35 from about 10 mm to about 20 mm, ~nd the second b~lloon 62 may be longer, in the r~nge of from ~bout 20 mm to about , , :: . .
.

.

1311~0 30 mm. The di~meter6 of the b~lloons 42, 62, 84 for coronary sng~opla6ty may respectively be 2.0 mm, 2.5 mm and 3.0 mm. The6e diameters msy each be lncreased or decreased about 0.5 mm in ~lternative embodiments.
S Figures 31-33 illustrste vsrious types of ~oints that msy be formed between the distal end of a balloon and the underlying structure. Although the illustrated joints 79 sre between the distsl end 76 of a second balloon 62 and sn underlying first bslloon 42, it should be understood that these ~oints may represent the 30int between any distsl end of a balloon snd the underlying structure, whether snother bslloon or the cstheter shsft 50.
In Figure 31, the ~oint 79 st the distal end 76 of the second bslloon 42 is not in a plsne perpendicular to the lS length of the cstheter shsft 50, but instesd lies in a plane tilted st sn scute angle wlth respect to the length of the cstheter shsft 50. This permits smoother and essier pssssge of the ~oint 79 through nsrrowed or tortuous portions or restricted eegments of a vessel.
~ 20 In Figure 32, the ~oint 79 descrlbes a wavy or ; sswtooth line. This type of ~oint is desir~ble for the ressons discussed in connection with Figure 31.
The ~oint 79 lllustrsted in Figure 33 1B slsnted ~t sn acute sngle with respect to the length of the catheter shsft 50, but it is slanted in the direction opposite the direction of the ~oint in Figure 31. As shown in phantom in Figure 33, the ~oint 79 on the side of the c~theter opposite the illustrated side msy slsnt in a direction opposite the direction of the ~oint 79 on the illustrated side. Alternatlvely, it may slant ln the same direction on both sldes.
Although specific embodiments have been de~cribed hereln, it wlll be understood thst the varlous bslloon structure~ dlsclosed may be comblned in a large vsriety of 3S wsys, all of whlch are consldered to be wlthin the scope of the present lnventlon. Addltionsl balloons may be ,, ~, ,:

1311~8~

~dded, to provide quadruple or other multiple balloon catheter6. Other lumen ~rrangements ay be used.
Moreover, the balloon diameter6 and lengths disclosed in connection with each of the specific illu~trsted embodiment~ ~re preferred coronary angioplssty dimensions. For peripheral ~nd valvular ~ngioplasty, balloon diameters prefer~bly range from ~bout 4 mm to ~bout 10 mm ~nd balloon lengths r~nge from ~bout 30 mm to sbout 100 mm. Appropriate modificstions for such ~ngioplasty ~re within the scope of the present invention.

III. Limacon B~lloon Manufacturing Method Unlike prior ~rt bslloon designs, which contemplste sep~rate extrusion of the cstheter shaft snd the balloon materifil, with subsequent att~chment of the bslloons to the catheter sh~ft, the present invention permits the balloons to be formed from the c~theter sh~ft material itself, elimin~ting m~ny of the ~oint~ snt fsilure points fount in prior srt ~ngioplssty catheters snt simplifying the fabrlcation of multiple bslloon cstheters. Moreover, - the f~brication technique is ~taptet for the manufacture of ~ngioplssty b~lloon cstheters hsving b~lloon6 eccentricslly positionet with respect to e~ch other. Thus, if e~ch balloon is considered to h~ve sn ~xis running 2S gener~lly through the middle thereof, the axes of the various b~lloons will not coincide.
In sccordsnce with the method of the present invention, st le~st the distal-most end of the c~theter is formed from a single, unitsry, monolithic piece of polymer m~terisl. Prefer~bly, the entire catheter, from proximal ent to distal end, is formed from such ~ single piece of polymer m~teri~l. The balloons ~re formed by exp~nding out the wslls of individu~l lumens Nnning through the cstheter ehaft st the dist~l end of the c~theter.
After selecting ~ suit~ble thermoplastic polymer, the ~ cstheter ~haft, complete with lumens (or ~t least the 'i' :' , ~ , , , ' 1311~80 di6tal-most end of the catheter shaft) i8 formed by molding or by extrusion. Extruslon processes are preferred, because extrusion is a continuous process and may be used to form long lengths of c~theter shaft material which may be cut into the appropriate length for individual catheters. The advantage of molding processes, on the other hand, are that they provide the prospect for combining all sealing or bonding steps into a single molding step, except for possibly the step of sealing a length of catheter shaft materisl to the molded distal end.
Molded pieces may be directly blown to form balloon6. Extruded pieces, on the other hand, require ~ome add$tional preparation. The extruded piece has a plurality of lumens therethrough having appropriate geometries, e.g., geometries as shown in Figures 3, 8, 16 or 21, or varistions and adaptations of those geometries sultable for making other balloon configurat1ons falling wlthin the ~cope of the present invention. In each of the de~lgn~, the outer walls of the lumens may be thinner than the common lumen walls to provide for adequate thinning when the balloons are blown therefrom. Moreover, any de~ired portion of the catheter shaft may be thinned and/or elongated by heating and longitudinally or axially 2Sstretching the catheter ~haft, either prior to proceeding with the oth*r fabrication oteps, or at any desired point in the process.~Such stretching, for example, may be used ',;, ' to reduce the~diameter of the catheter ~haft.
Next, the outer walls of the lumens are removed as 30ppropriaee fro- the polnt at which the distal end of each balloon is to be located and extending to the distal end `of the catheter. In other words, ~ome of the lumens may be ~hortened by removlng the outer wall thereof so the lumen doe~not extend all the way to the dist~l end of the ~ 3Scatheter. This removal step is preferably sccomplished by g~ cuteLng~ -w y~ tbe out-r ~lumen wall. With each lumen `:

1 3 1 ~ 0 terminating ~t the point where the end of the balloon formed from the outer wall of the lumen i6 to hsve it6 tiætal end, the open lumen ends are sealed to either the underlying catheter 6hsft or to the underlying lumen wall, as appropriate. In axial torque multiple balloon catheters, the distal end of at lea6t one of the lumens i6 6ealed to the axial torque wire it6elf either at this point or after blowing the balloons.
In both the extrusion proces6 and the molding process, the outer walls of the lumen6 adjacent to their 6ealed, di6tal end6 are then heated to soften the thermoplastic material to the point where it can be blown to form balloon6. The balloons may advantageou61y be blown one at a time inside a die having appropriate dimension6. The timensions of the finished balloon are determined by the dimen6ions of the interior of the die. A heated die i6 preferred. Measures well known in the art to prevent sticking of overlapping balloon layers and sticking of bslloon material to the die ~hould be employed. Moreover, while applylng pressure to one lumen to blow the outer wall thereof at the distal end thereof into a balloon, collapse of other lumens must be prevented, either by applying a lesser pressure to those lumens or by inserting a solid or particulate filler or a trochar into the lumen. Blowin~ of innermo6t balloons first i~ preferred, with an appropriate adhesion-prevention powder (such as talcum powder), if required, inside lumen6 overlying the balloon being blown. The overlying balloon6 are then blown in sequence from innermost to outermost.
In some instances and with some thermoplastic materials, stiffening of the catheter shaft itself may be desirable. This is particularly true with steerable guidewire-type catheters. Such stiffening may be accomplished in any of a number of ways, such as by iDserting a stiffening materisl, solid, tubular, or any other suitable geometry, into one of the lumens or t. . ~
, .
: ' ' . . . ' :, ', -:
.:

1311~80 incorporating the stiffening mater~al directly into the cstheter 6haft. Alternatively, the stiffen$ng material may be bonded to the out6ide of the catheter shaft or the cstheter shaft may be completely surrounded by the stiffening material.
The aforementioned technique, while de6cribed in terms of multiple-balloon catheter6, may al60 be used to fabricate steerable guidewire-type single balloon c~theter6.
IV. Surgical Procedure Utilizing Limacon Balloon CAtheters In connection with the new catheter de6ign6 set forth above, ~ surgical procedure util$zing those bslloons to permit multi-ves6el coronary or peripher~l angioplasty in a greatly reduced time as compared to current technique6 has been developed. This new percutaneous transluminal coron~ry angioplssty (PTCA) technique for multi-ve66el disease is explained below in connection with a schematic trawlng illustrating particular locations of zo c-rdiov~scular disease. Of course, it will be understood that the present technique can be utilized, in one form or another, with any of the multiballoon catheter de6ign6 discloset in the present application, and that utilization of the technique iB not limited to the particul~r disease loc~tions exemplified ~nd illustrsted in the following discussion and the accompanying figure.
A model of the left coronary system having multiple lesions in vessels of various diameter has been adopted for purposes of this description. The disgram used in this descript$on, Figure 34, represents a hypothetical but not unreallstic ca6e. It should be understood, of course, that the new surgical technique described herein can be used in either ehe left or the right coronary artery, or ln both arteries ~8 a part of the s~me surgical 3S procedure. What is critical for ~ucces~ful dilation of the lesions in que6tion iB that each dilation should be , 1311~gO

performed with ~ balloon h~ving a predetermined m~ximum inflsted dismeter mstching the native tismeter of the ~rterosclerotic vessel.
Figure 34 i6 a disgram of the left coron~ry srtèry sy6tem. The left main srtery 110 branche6 into the left anterior descending (LAD) srtery 112, in which two arterosclerotic lesions are illustrated. The first lesion 114 is loc~ted in the proximal portion of the LAD, in a vessel hsving a native dismeter of 3.0 mm. The second le~ion 116 is located in the distal LAD in a ve~sel h~ving a n~tive diameter of 2.0 mm. The circumflex artery 120 branches off of the left main artery 110. A third lesion 122 iB illustrated in the circumflex artery 120, in a vessel having a nstive diameter of 2.0 mm. Finally, the obtuse margin~l artery 124 (OMA) branches from the circumflex artery 120. A fourth lesion 126 is illustr~ted in the OMA 124 in a vessel hsving a native diameter of 2.5 mm.
With currently ~v~ilable PCTA techniques, three sep~r~te PCTA catheters would be needed to perform multi-vessel PTCA in this model. One of the c~theters required would h~ve a balloon of 3.0 mm, one a b~lloon of 2.5 mm, ~nd one a balloon of 2.0 mm. With the procedure of the present invention, only one specially designed PCTA
; 25 catheter iB needed A~ a result, the necessity for catheter exchange is eliminated, and the ~mount of X-rsy exposure, the smount of contrast material in~ected, and the length of the PCTA procedure ~re ~11 reduced.
The present invention msy be used in the left coronary artery system having the lesions illustr~ted in Figure 31 in the following way.
The p~tient is prepared and a conventional guiding catheter is inserted through the aorta into the left main artery 110. Any suitable triple ~lloon catheter (or a - 35 du~l b~lloon c~theter havin~ two psrti~lly-overlapping b~lloons on oppo6ite side6 of the catheter shaft) of the , .

' . ' ' ~ ~ .
' ' ' ' ' ' ' - : ~ ....... .

1311~0 type described previously herein is advanced through the guiding catheter and into the LAD 112. The triple bslloon catheter iB provided with ~ firet bslloon having a mAximum infl~ted di~meter of 2.0 mm, a second b~lloon having a S maximum inflated diameter of 2.S mm, and a th~rd balloon (or two combined balloons) having a maximum inflated di~meter of 3.0 mm. Of course, all three balloons have been deflated with negative pressure as the catheter is ~tvanced into the first lesion 114 $n the LAD 112.
When the 3.0 mm third balloon $8 properly pos$t$oned inside the first lesion 114, as verified by radiogrsphy showing the location of the rsdiopaque marker in6ide the third balloon, the th$rd balloon $~ selectively inflated while the other balloons rema$n collspsed. When proper lS dilstion of the lesion 114 has been sch$eved, the third bslloon is deflsted by spplying negstlve pressure to the , third lumen. The bslloon catheter $8 then sdv~nced to the - next target lesion with sll three balloons completely ~, deflsted.
The balloon catheter 18 next ~dvanced d$stally $nto the LAD 112 untll the 2.0 mm first bslloon i8 positloned lnslde the second leslon 116. Once the deflated 2.0 mm flrst bal}oon 18 centered in the secont leslon 116, the flrst balloon iB lnflated to dllate the second lesion 116.
2S When the leslon 116 hss been fully dilated by lnflstlon of the flrst bslloon, negatlve pressure 18 applled to fully deflste the first balloon. The catheter is then retrscted back to the left msln artery 110 snd, ;~ ~ through ùse ~of a oteersble guldewlre, 18 then threaded i~ 30 lnto~the obtuse marglnal artery 124. Becsuse the fourth -8 lon 126 in thé obtuse marglnsl artery 124 1B in a ; ve~-el~hsvlng s nstlve dlameter of 2.5 m, the second bslloon havlng B maximum lnflsted dlameter of 2.5 mm 1B
positioned inslde the fourth leslon 126. The second ~ b~lloon 1B then~ fully lnflsted to dilate the leslon 126, ~ snd~ then~oollapsed ss dlscussed ln connectlon w~th the '~:'~ ~ ,' ' :
: : , -, --`" 1311980 previou6 dilations. The c~theter is then withdrswn from the obtuse marginal artery 124 and iB inserted into the third lesion 122 in the circumflex artery 120. The third lesion 122, in a ve6sel having a native di~meter of 2.0 mm, is dilsted with the first balloon in the same manner as wss described in connection with the second lesion 116.
The bslloon catheter snd the guiding catheter are then withdrawn snd the procedure i8 completed in sccordance with standard PCTA techniques.
Although the technique has been de6cribed in connection with the left coronsry srtery system, it is equslly applicsble in PTCA of the right coronsry srtery system snd in vslvular periphersl sngioplasty.~
1S ~ Because both the right and the left coronary artery systems re equally susceptible to srterogclerotic disesse, often pa:tients will have disea6e in both coronsry ~srteries at the ssoe time. As long as the ~lesions re ~ccessible to b-lloon angioplasty, they may be convenlently ~nd efflciently dilated by the technique ; described herein using the ulti-balloon catheter. The a e Salloon catheter can be used in both arteries.
However, lt wlll typlcally be nocessary to exchange the guidlng catheter if tho procoduro involves a shift from 2S one ~loft) coronsry artory to the other (right) coronary artory. The principle ~of offective balloon catheter I
utlllz-tion 1- the me in the tvo arteries. However, in order to incresse ~efficiency, guiting cathotors changod from~ one artery to the oth r ghould be oved in such as ~ way 8 to void a return to a Yessel that ha~ previously b-en entered. This is bocause oach time tho procedure is hifted froo one artery to the other, it is necessary to oxch~ange the guiding catheter. ?
~f `~ The~ ~pres-nt invention permits full and effective 3S dllation of 80 e lesions that cannot effectively be dilated with a single~balloon cathetor. In ~ome csses of , ',` ' ` ' ' . . ; : ' , ,: . ~ ' , ' f'~ ~ ` , ' \

~dv~nced ~rterosclerotic dise~6e, a lesion mRy result in such a reduced di~meter thst sn sngiopls6ty balloon hsving a msximum inflsted dismeter the ssme ss the diameter of the nstlve vessel csnnot be stvsnced into the lesion. In S this csse, a multi-bslloon cstheter msde in sccord~nce with the present invention msy be used to good effect.
The low profile distal bslloon on the cstheter, h~ving An inflsted dismeter less thsn the nstive di~meter of the vessel, csn be advsnced into the lesion ~nd infl~ted to psrtislly dilste the lesion 80 thst the sppropri~tely-sized balloon can be placed inside the le6ion and the lesion can be fully dllated. Thus, tight lesions can be predilsted with s small bslloon first, 80 thst dilstion of the les$ons can be completed with the lsrger bslloon. It 1S is estimsted th~t 20-25% of the single lesion cases in which balloon sngiopl~sty is now performed currently require s second bslloon catheter becsuse the originslly-selected balloon catheter is too large to cross the lesion. With the present invention, these constricted single-lesion dilations can now be performed with a single ~ulti-bslloon catheter.
Thus, in ~ccordance with one aspect of the procedure of the present invention requires advsncing s multi-bslloon angioplssty catheter of the type described herein 2S hsving s plurslity of differently-sized balloons into the vessel to be dilsted, dilsting a first lesion w~th a balloon having a first dismeter, dilating a second lesion with a bslloon hsving s second dismeter, and, optionally, i dilBting 8 third lesion with a thlrd balloon (or two combined bslloons) hsving s predetermined third di~meter appropriate for the third lesion.
In sccord~nce with another aspect of the procedure of the present invention, a single lesion may be dilated with s multl-b~lloon catheter of the type described herein by , 35 advancing s first balloon havin~ s predetermined first - dismeter into the lesion, ~nd dilating the lesion with the . ~ :

,, , ~ , : , , .

~ ~ .

1311~80 first b~lloon, and then adv~ncing ~ second bslloon into the lesion, wherein the second bslloon hAs ~ m~ximum infl~ted diameter l~rger th~n the m~ximum infl~ted di~meter of the first b~lloon, ~nd then dilAting the S lesion with the second b~lloon.

., .
"

!

'';
: 30 ~'~

,:~

:

: ' , ~ - . , ~ , . . . .
~ ' ~ ~-' ' .. . .
, .

Claims

1. An angioplasty catheter, comprising:
a catheter shaft having a proximal end and a distal end with at least two lumens extending therethrough; and first and second angioplasty balloons on the distal end of said catheter shaft, wherein said balloons and said distal end of said catheter shaft are formed from a single monolithic piece of polymer material by sealing shut two of said lumens and heating the distal end of said catheter shaft, then internally pressurizing said sealed lumen to expand at least a portion of said distal end of said catheter shaft into said balloons, wherein said balloons are eccentric with respect to said catheter shaft and one of said balloons extends only in part along the same length of said catheter shaft as another of said balloons and has a different maximum inflated diameter than said other balloon.

2. The catheter of claim 1, wherein said balloons have respective longitudinal axes, and the longitudinal axes of said balloons are eccentric with respect to said catheter shaft.

3. The catheter of claim 2, wherein the wall of each balloon is connected to said catheter along substantially the entire length of each said balloon.

4. The catheter of claim 1, wherein the maximum inflated working diameter of each balloon is substantially uniform over the length of said balloon.

5. The catheter of claim 1, wherein said balloons comprise a first balloon and a second balloon and wherein the maximum inflated diameter of said first balloon is less than the maximum inflated diameter of said second balloon.

6. The catheter of claim 5, wherein said first balloon is at least partially inside said second balloon.

7. The catheter of claim 5, wherein at least a portion of said first balloon is distal of said second balloon.

8. The catheter of claim 5, wherein said first balloon and said second balloon are located on the same side of said catheter shaft.

9. The catheter of claim 3 or 5, wherein said balloons comprise a first balloon and a second balloon located on opposite sides of said catheter shaft.

10. The catheter of claim 3 or 5, wherein said balloons comprise a first balloon and a second balloon and further comprise a third balloon on said catheter shaft.

11. The catheter of claim 10, wherein said first balloon and said second balloon are on the same side of said catheter shaft and said third balloon is on the opposite side of said catheter shaft.

12. The catheter of claim 2, wherein said catheter shaft extends through said balloons, further comprising a lumen extending the length of said catheter for receiving a steerable guidewire.

13. The catheter of claim 1, wherein said catheter shaft includes at least a first lumen and a second lumen extending through said catheter shaft, and wherein said balloons comprise a first balloon and a second balloon, wherein said first lumen terminates inside said first balloon and said second lumen terminates inside said second balloon, further comprising:
an axial torque guidewire extending through said first lumen and out of the distal end of said first balloon and said catheter, wherein the distal end of said first balloon is sealed to said guidewire, wherein the walls of said first balloon have been formed by expanding the walls of said first lumen and wherein said first balloon is substan-tially coaxial with said first lumen, and wherein the walls of said second balloon have been formed by expanding the walls of said second lumen and wherein said second balloon is eccentric with respect to said second lumen.

14. The catheter of claim 13, wherein said balloons further comprise a third balloon and wherein said catheter shaft has a third lumen in communication with and terminating inside said third balloon, wherein said third balloon is eccentric with respect to said third lumen.

15. The catheter of claim 3, wherein said balloons comprise a first balloon and a second balloon and wherein the wall of said first balloon is joined to said catheter shaft along substantially the entire length of said first balloon and wherein the wall of said second balloon is joined to the wall of said first balloon along at least part of the length of said first balloon.

16. A method for making angioplasty balloons, comprising the steps of:
forming from a single piece of polymer material a length of catheter shaft material having at least a first lumen and a second lumen therein, each lumen having an outer wall, each lumen having a proximal end and a distal end, and each lumen having a common wall where the outer walls of at least two lumens converge;
sealing said first lumen to form a first sealed lumen;
applying pressure to the interior of said first sealed lumen and heating the outer wall thereof to expand a portion of the outer wall of said first sealed lumen inside a first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of said die.

17. The method of claim 16, further comprising the steps of :
sealing said second lumen to form a second sealed lumen;
applying pressure to the interior of said second sealed lumen and heating the outer wall thereof to expand a portion of the second sealed lumen inside a second die to form a second balloon therefrom having dimensions deter-mined by the dimensions of the interior of said second die, wherein said first balloon and said second balloon are eccentric with respect to each other.

18. The method of claim 16, wherein the distal end of said first balloon is located distally of the distal end of said second balloon.

19. The method of claim 16, wherein the outer wall of said first lumen is located inside the outer wall of said second lumen.

: 45

20. The method of claim 16, wherein said first balloon and said second balloon are located on opposite sides of said catheter.

21. The method of claim 16, wherein said forming step is an extrusion step, further comprising the step of:
shortening the second lumen prior to sealing the distal end thereof by removing a length of the outer wall of said second lumen at the distal-most end of said second lumen so that the distal end of said second lumen is located proximally of the distal end of said first lumen.

22. The method of claim 21, wherein said sealing step for said second lumen comprises bonding the outer wall of said second lumen at the distal end thereof to the outer wall of said first lumen.

23. The method of claim 21, wherein said sealing step for said second lumen comprises bonding the outer wall of said second lumen at the distal end thereof to said catheter shaft.

24. The method of any one of claims 17-23, wherein said catheter shaft material further has a third lumen therein, further comprising the steps of:
sealing said third lumen to form a third sealed lumen;
applying pressure to the interior of said third sealed lumen and heating the outer wall thereof to expand a portion of the outer wall of said third sealed lumen inside a die to form a third balloon therefrom having dimensions determined by the dimensions of the interior of said die.

25. An angioplasty catheter, comprising:
a catheter having a proximal end and a distal end;
first, second and third independently inflatable and independently deflatable angioplasty balloons at the distal end of said catheter, each said balloon having a balloon wall and having a length and a different maximum inflated diameter, wherein at least two of said balloons and said distal end of said catheter shaft comprise a single, integral monolithic piece of polymer material and wherein said balloons are eccentrically positioned with respect to each other, such that said first balloon and said second balloon are on the same side of said catheter shaft and said third balloon is on the opposite side of said catheter shaft.

26. An angioplasty catheter, comprising:
an elongate catheter shaft having a proximal end and a distal end with an axis extending the length of the catheter shaft;
a first generally cylindrical inextensible angioplasty balloon coaxially mounted on the distal end of said catheter shaft; and a second generally cylindrical inextensible angio-plasty balloon located proximally of said first balloon and eccentrically positioned on said catheter shaft so that the longitudinal axis of said second balloon and the axis of said catheter shaft are parallel.

27. An angioplasty catheter, comprising:
a catheter shaft having an axis, a distal end, and a proximal end;
a first independently inflatable angioplasty balloon on a first side of the distal end of said shaft;
a second independently inflatable angioplasty balloon on a second side of the distal end of said shaft, wherein said first balloon and said second balloon are only in part axially coextensive on said catheter shaft.

28. The catheter of claim 27, wherein said first and second balloons and said distal end of said catheter shaft comprise a single integral piece of polymer material.

29. The catheter of claim 27, wherein the distal end of said catheter has a first predetermined diameter when said first balloon is inflated, a different second predetermined diameter when said second balloon is inflated, and a different third predetermined diameter when said first and second balloons are both inflated.

30. The catheter of claim 27, wherein said first balloon and said second balloon are on opposite sides of said catheter shaft and wherein at least part of said first balloon is directly opposite at least part of said second balloon.

31. An angioplasty balloon catheter, comprising:
a catheter shaft having a proximal end and a distal end;
first and second angioplasty balloons on the distal end of said catheter shaft, wherein said balloons have dif-ferent predetermined maximum inflated diameters and are joined to said catheter shaft along the length of said balloons so that said catheter shaft forms a part of the wall of said balloons, wherein said balloons are only in part axially coextensive along said catheter shaft.

32. The catheter of claim 10, wherein said first balloon and said second balloon extend from opposite sides of said catheter shaft, so that at least part of said first balloon is directly opposite at least part of said second balloon.