CA2188407A1

CA2188407A1 - Active perfusion dilatation catheter

Info

Publication number: CA2188407A1
Application number: CA002188407A
Authority: CA
Inventors: Ronald J. Solar
Original assignee: Individual
Current assignee: Individual
Priority date: 1994-04-20
Filing date: 1995-04-19
Publication date: 1995-11-02
Also published as: US5807331A; ZA953214B; AU2359395A; WO1995028983A1

Abstract

The invention relates to an active perfusion dilation catheter (1). More particularly, the invention relates to an active perfusion dilation catheter (1) comprising a catheter shaft (2) having proximal and distal portions and one or more inflation lumens (5) extending therethrough;
an inflatable dilatation balloon (3) positioned external to the distal portion of the catheter shaft (2) and in fluid communication with an inflation lumen (5); an occlusion balloon (4) positioned external to the distal portion of the catheter shaft (2) and proximal to the dilatation balloon (3) in fluid communication with an inflation lumen (5); and a perfusion lumen (6) at the distal portion of the catheter shaft (2), the perfusion lumen (6) having proximal (7) and distal (8) openings, the proximal opening (7) being located proximal to the occlusion balloon (4) and the distal opening (8) being located distal to the inflation balloon (3).

Description

2188~07 W0 93/28983 P~ r ACTIVE PFPIFUSION DILATATION CATI ~ ER
FI~T n OF ~J~ 1 h V 1: '- L ~
This invsntion relates to an active perfusion ..U~_LGL. More particularly, this invention relates to an actiVQ perfusion ` that u~ a dilatation 5 balloon to dilate ~trictures or st-- within the human body and allows perfusion of blood or other oAygen-bearing f luid distal to the stricture or stenosis during balloon inf lation.
R~t~'''~Ul~D OF T~T~ lhv~~
Durinq ~_,. - tr~ l ;n-l C-~LV~L2 An~1orlrty tPTCA), a I~LL~ or sL~I~o~ CVLV~CIL~
artery is enlarged by dilatation with a balloon c When the t1;lA~t1r~n bo.lloon i8 1nfl~ted during PTCA, the 15 artery i~ totally occl -'. Prolonged orrll~-irr ~G._..LD
blood c. LL~lng oxygen, from ~ n~ the heart muscle (myocardium), and may result in myoc~rdial; 'A.
GrUntzig et al., U.6. Patent No. 4,195,637, rirst ~1~r~ ' using a roller pump to perfuse blood through0 the lumen of a PTCA .-u. ~ to prevent myoc~rdi~l during a PTCA ~L~ .. Since then, others have de~cribed various w~ys to perfuse ~lood or other VA~ ~-Llng fluids during PTCA, either actively (using an ~D~-l pUllp ~eans) or p~Gsively (no pump).
For eAa~nple, H~_ t1 et al., U.S. Patent IJo.
4,771,777, sogard Qt al., V.S. Patent No. 4,944,745, Sahota, U.S. Patent No. 4,581,017, and Erbel et ~Ll., "New Balloon CCIU-_L~:L for Prolonged PTCA and Bypass flow in Ornl~ Vessels,~ C~U.~ lzation An~ oAr~ v~c~r~ r D1~nn~ , 12:116-123 (1986), each describe passive perfu~ion PTCA ~..U-_t6 D. Since th~se are passi~re perfusion deviees, each relie~ on the arterial blood ~L.- e5 of the patient to supply the driving forcQ to 2Ig~4~7 W0 9S/28983 ~ i X P~ C
push the blood through the catheter Each patient's blood ~, ~ ~ay vary, and as is often the case, this ~.. . ~ay be 1~ c-i~nt to provide ~ te y_ r~ irn to prevent i~ c _1~r~tions Activ~ perfusion PTCA LL_LG systems, ~uch as d~cribed by GrUntzig ~t al, as above, and Wi~ay, Qt al, ~ S Patent No 4,921,483, use various pump or plunger means to pump blood or other fluid through the lumen Or a PTCA cc~L~ t--. However, due to the l~mall ~ and long l~ngth reguired rOr PTCA ~L~_L ~, high driving ~L. ~1~ are 1~ y to pump the blood through the lumen Or thQ ~ This may result in high shear stress and hemolysis Or the blood cells Thus, th~re is a need for ~n active F- .r~ i~n balloon PTCA ~.~Lh~t e~ which would operate at lower driving yL
nR~ECTS OF q~r 1 h~
It is an ob~ct of the invention to provide an active pQL~ n dilatation It i8 also an ob~ect Or the invention to provide an active perfusion dilatation ~-~th~t~ wherein a l~1AtAt~rn b~lloon dilatcs strictures or iL 1~03an within the human body and blood or other VA~ lng f luid is F Ql a distal to the ~trictur~ or nL ;~ during balloon lnflAt ir.n It ~ a ~urther ob~ct Or thQ invention to providQ
an active perrusion ~lA~At~n c U-~L~ wh~ the ~L ~ ~ r ~ to pump the blood or other oAygQn-bearing rluid through the U - L~l is reducQd a~ ~d to known active perrusion dilatation c~ i L
It il~ a yet further ob~ect Or the invention to provide an active F_Lr~ i~n dilatation balloon ~clh~t wherein the length Or th blood perrusion lumen Or th~

2188~07 WO 9S/28983 r~
c~l ' 18 less than that Or the dilatation balloon inf lation lumen .
It is also an ob~ct Or the invention to provide a balloon dilA~Atinn perfuslon '' ' th~t has ~ lumen 5 positioned eYterior to th~ n, It is an additional ob~ect Or the invention to provide an active perruE~ion balloon ti~lAt~A~tlln ~ t-that is easy to ~ r~
These and other ob~ects Or the invention will become 10 more ~, ...~ rrOm the ~r~ tAn below.
~RTFF ~ U.. OF ~TF nRl~a Figure 1 i8 a ~_L~L_Live, partly ,.v_c E ' ;- -1 view of an . ' -~i t o~ the rAth~t~- Or the invention;
Figures 2 to 4 are each an alternative cro~-e ' ~ 1 vi~w Or the ~ shown in Fig. l;
Figure 5 i~ a ~ide elevational view Or anot~er ~i t of the c~ system Or the invention;
Ficsures 6, 8, and ll ,.~L.e_..~ side elevational 20 views o~ a distal portion Or a c..l' ' Or the invention a3 it i~ being f ormed;
Figur~s 7, 9, and lO ~ , alternative cross-~e ' ~ -l views o~ 'c, i~c~ ~rom which a c~ L of the i.-~. ' ;or can ~e ~ormed; and Figure 12 is a side levational view Or a rurth Or the ,~1` Or the invention.

2i88~07 WO 9sl28983 F~~
T~n ~ OF ~ l h V ~
Accordlng to the invention, a balloon dilatation is capable of active perfusion when the dilatation balloon i- { n-l r ' ' - The primary 5 dist~r~ut~ ng f~ature of the catheter Or the i..~. inn i8 that, unlilcQ other known active perfusion c~
ther~ ls a sQcond balloon proxiDal to the fl~ lA~rt~rn balloon. Th~ -t. ha~ a Dain ~haft, ~nnt-tntrg a first luDen which i- uned to inflate the hAllon~, and a 10 sRcond lumen u-ed ror the perrusion of blood, the length of the second lumen being c,~_l ~n~ tAl ly less than that Or the rirst luDQn. The distal balloon dilates blood vessel ~tricturus or ~t b , and the proxiDal balloon serves to occlude the annular ~pace forDed between thQ guiding :L5 . r and the Dain shart. ~ hub Deans at the proYiDal nd Or the ~ U~ItGL is in fluid _ tration with the inflation lumen ~md allow~ rnnn-~l tnn to an inflation device. The perfusion luDen is open at both its proxiDal and dibtal end~, and the proximal end of the perfu~ion 20 lumen is positioned proximal to the proximal, oC~ nn balloon while its distal end is di~tal to the distal fl~ lAtJ~ttnn ~Al l~nn.
In know.~ Active perfusion i~U~_tG~D a blood pump is c~ t~ to the ~L~ 1 end Or the perfusion lumen.
25 Th~ G r-quired to pump thQ blood through the lumen i~ proportional dir-ctly to length Or the lum-n And inversely to the fourth power o~ the lull~en ~lt~
Sinc~ 1 O Dust be long and hav~ a v~ry sDall llt. t to bG u~ed cltnir-lly~ the ~ require~ to 30 pump blood through the .;~U._LGl lumen, At a flow rate that will prevent t--h-n~! licrtions, is P~gn~c-ntly high. 8uch high ~ _~ Day result in h~moly~is and lead to U-- ~ic lt~ tions.
:~n this invention, blood is puDpe~ through the 35 guiding ~...;` . When the oC~ nn balloon of the invention i9 inflat~d, the di9tal segm-nt of th- guiding WO 95l28983 2 ~ 8 8 l 0 7 ~ c O is oc~ nd the blooa i_ dirocted through thc s~ortcr pQrrusion lumen Since the lumen o~ the guiding ' ' is much larger than that of the per~usion lumen, and _ince the distance the blood 3lust 5 trav~l through the ~maller 1;~ t~ r ;~r~ lumen i_ relatively short, the ~L ~ reguired to pump the blood 18 gr~atly roduced, as _ _ ~d to the ~ e reguired to pump blood through ~ perfusion lumen that ~ '-' to the proximal ~nd o~ th- guiding ~ ~Lh_L~l The inv~ntion can perhaps be bètter approciated by making rererence to the drawings In Fig 1, an active perrusion balloon, U_L5L 1 comprises a main ~-lh~t~Y
~haft 2 having dilatation balloon 3 and oc~ Q;^~ balloon 4. C~IU~Le~ sha~t 2 cnnt~nQ ~alloon inrlation lumen 5 The distal portion of sha~t 2 also cnn~ perru~ion lumen 6, where the proYimal opening 7 o~ lumen 6 is proYimal to oC~ o;nn balloon 4 ~nd the di_tal opening 8 o~ lumen 6 ifi distal to dilatlstion balloon 3 A Y-c~ 10 i8 positioned at the proYimal ~nd of guiding c ' 15 In u_e th active per~usion ~ t~t; ^n ~ is 1I~LL~ 1 d through a guiding C~ 15 Thu ~nd 16 of the guiding ~ -Ll.r~ 15 is - 1 in~1y ~
to Y _~ lO Blood or other ~A~ se Llng fluid ~rom a perfu_ion pump 19 is i LL~du~,_d through the Y-, - ~ 10 into th- annular spac- 17 betwuen the shaft

2 and the guiding ~ ' 15 The blood or other f luid travels distally to point proYimal to oc~l ~nn ~alloon 4 wher~ it QntQrs th- proYimal opening 7 of per~usion lumen 6 and travQls distal~y to distal opening 8 The DLLu~;LuL o~ the sha~t 2 where it ~n lumens 5 and 6 can vary Figures 2 to 4 are ~ach a ~L~ rl ~ -1 L~ n acro88 the distal portion of sha~t 2 between b-l 1 onnQ 3 and 4 . As shown ir Figures - 35 2 and 3, lumens 5 and 6 can be adjacent in the aYial 2188~07 1i~
direction. Alternatively, lum~n 5 could. be . ..- l lc to lu~n 6, a~ ~hown in Figure 4.
In the . ; t. of the i..~. ~nr~ ~hown in Fig~-rQ
1, tl-Q 1-~ ~ 3 and 4 ~r~ c_ lc to th~ ahaft 2.
5 According to nnothQr, pr-f-rred '; L o~ th~
inv~ntion, shown in Figrr 5, the dilr.t~ltion b~lloon 21 nd the o~rl ;rn balloon 22 are Qccuntric to ~ha~t 23.
8uch ~I con~$guration i- described in ~ore dQtail in co-pQnaing, co~monly Sl~;tJn~d ~J.S. patent ~Ipplicatiom~
Serial No. 07/969,887, filed October 30, 1992, for RAPID
r~T~rFD, SQrial No. 08/087,428, filed July 2, 1993, for RAPID WT~r'~ T. r~ru~FD, SQrial No.
07/969,946, filed October 30, 1992, for PREPARATION OF
BAPID ~Y~' '~9'U~R, ana Serial No. 08/111,304, filed 15 August 24, 1993, ~or DT~ v WIT. ~ C
'3AI~OON, ~11 of which are inC~LS~L~d herein by refer~nce. It i~ within tho ~;cope of t.'.e invention that one of hAllt - 21 and 22 could be c ~ lc to _~U.~t..
Ilh~ft 23 and the other onQ could be ~ :~ lc.
The ~Icc~mtric r~L , shown in Figl.re 5 has certain ~, ~ as - r_a to the c-- lc balloon hown in Figur~ 1. The prlmary ~
are ~asQ of ~ el~ lower ll r~ lng co~ts, higher r~l;Ah~l~ty, i.e., fewer part~ and ~ond3, facilitated steno~is ~;L~ ;n~--no balloon b~n~h;r~, and racilitatQd An~;r~pl~ty ~~ ;r~--focu-ed forcc.
It ~houla be further SSJ~JL~ 'r ~1~ that the perfusion uch a~ is ~hown in Fi~ur~ 5 can also contain ~LI~s~ L~ for a pu~hing wire or a guidHwir- or it F.ay be ~ _~ h~A for use in the ~lonorail ~e- ~,~ ~ when thQ
di8tal portion of the c ~ would b~ , ' over a guid~wire. A pUshing wirQ 25 is shoWn in PigurQ 5 in ~n OrL~ 1 lumen 26 that has been sealQd at the dist.~l portion 27 of pUshing wire 25 to grasp ~Aid distal portion 27. Alternatively, if portion 26 were not eal~d, thc .~l 20 could be ~ ed along a -Wo ss/28983 2 i 8 8 ~ 0 7 P~ c guidewire (not shown) that would extend through lumens 28 and 26. Also, as ;l~n~ above, the c~theter 20 could be ~ ~v~ d distally along a guidewire (not shown) n7 only through lumen 28.
In an additional alternative ~ t, the portion o~ lumen 29 proximal to balloon 22 could compris~ a L~,vL~, eithQr within the lumen 29 or in place of lumen 29. The ~t~ by such a hy~vLuL~ Yould make it ~ _ y to have a pushing wire, ., 'Ally ir monorail-type use over a guidewire were envisioned.
other sL ~.-,L~.l variations are within the scope o~
the invention. Por example, there could be a - ~t~
lumen ~YtPn~;n7 the entire length of Al l. I -1 1 or 20 rOr a guidewire, or Qach of dilatation balloon 3 or 21 and lS oc~ o~rn balloon 4 or 22 could have a _, ~t.l ~n~lA~n lumen.
The w~lls for lumens 5, 6, 28, and 29 can R~ch have a th;~ L of from about 0.3 to 20 mil., preferably rrOm about 0.5 to 10 mll. The wall for lum~n 6 or 28 will most likely b~ slightly thicker than wall ~or lumen 5 or 29, ~ ;vely.
The lumen walls are comprised of ~aterials conv~nt ~ ~nA 1 to balloon dilatation ~ D . Suitable materials include polyolefins such as polyethylene, polyethylene t~ lAte, pol~eL~.aneG, polyesters, and various copolymers therQor. Pushing wire 25 can be made ~rom any rigid, r- '~ - ~l ly a t. hl e materialB Buitable for such u~e, ;n~lt~n7~ but not limited to wires or v~ comprised of ~1-A;nl--q steel or othQr rigid materials.
The v.-_L~ ~ v ~ion according to the invention leads to flPY~h~l~ty in product design. For eYample, the choice Or a pushing wire allows the ~PeignAA~ to impart various re~ s to the CAL~. ~t~ in the form o various ~l~y~hll~ty and I -h~lity combinations. Also, a hollow ~188~07 wo g5n8983 ` ' ' P~
pulihing wire, or ~ 1 ;r>n or removal of the pushing wire, would ~acil$tate ;nt~l~Ri.~n Or fluids, drugs and/or C~ L<~6L neaia through thQ ~ t ~ into the di&tal va~culatur-. Further, it i_ within thQ scope of thQ
5 ln.. ' ;"T` th~t ,~I ~ 1 or 20 ~y havQ at l--ast one aaditional, ' iVQ lu Qn that would similarly t8 inru~ion of additional liquid_, drugs and/or ;~.-LL.~_L ~Qdia.
ThQ ~...t 1 or 20 may have vinual length -rlr~-10 along lts shart th~t would enable the, ~LLIL to prQdict when the c..U,~ L would exit the guiding .;~.U.~er into thQ vascul~turQ. Thi~ would r duce the rlu.,L ,, time.
The preferred design would put the ~~rl~ing~ dir~ctly on th- pushing wirQ 25 (h-at &hrink tubing rings, in~C&~
15 paint&, tc.). Since the pushing wire 25 iB ~ t-d within thQ second lumen 26, the ~r1r;ng~ would not be Ypo~ed to thQ patient (i.~., n~ would not come off, nnd ~aterial- which could be toxic if eYpos~d may be UR~d) .
~h- per~usion ~ 1 of the invention wherein the ~Allr - are c~ lc to the ~ ' shaft 2 can be ~L~, _d according to method~ well known to thosQ
skillsd in thQ art. l~ry ~-~ ~ arQ provided in GrUntzig Qt al., U.S. PatQnt No. 4,195,637, Simpson ~t al., U.S. Patent No. 4,323,071, and Leary, U.S. PatQnt llo. C,545,390, Qach of which is ir.~.vL~ ' herein by L .,r~-- .
ThQ ~ inn of a ~-U ~ - 20 according to thQ
invention i~ l~hown in FigurQ- 6 to 11. After a double lumen ~ ^ 40 i8 ~ aI~ the distal snd of thQ
i8 P -lir~ly clamped, and hQat and ;nQl~t~-n G are appliQ~ to cause thQ di~t~l portion Or lumQn 41 to eYpand to rorm thQ wall~ of ~-111- 21 and 22 ~na the distal portion of lumen 43 to exp~na to ~or~ lumen 28. The ~ocAt~on where hQat is applied can ~ vari~a to v~ry the L~ ' ive lengths of ~ 21 and 22 and _ _ Wo 95128983 2 1 ~ 8 ~ 0 7 p lumen 28. ~}eat sealing or application of suitable adhesive seals the distal portion of balloon 21. Opening 42 i~ cut into lumen 28, and opening 44 i5 r-; ntR; n-~A or created by trimming the distal portion of the _aU._L~:L.
5 Pushing wire 25 i8 then inserted into lumen 26, wherein either the ~ ; n; ng distal portion, or more, o~ lumen 2 6 i8 heat shrunk to cause pushing wire 25 to be pos~tively engaged by lumen 26. Alternatively, the distal portion of pushing wire 25 could be affixed by suitable means, 10 such a~ an adhesive or a plug, in lumen 26.
~ - 'c, i~e 40 can be ~ aI, d by methods well-]cnown to those skilled in the art. In a preferred method ._ '~ iece 40 can be LLe~a~d by blowing .:,.LLuded tubing 46, a ~L~ cLion of which i8 shown in Fig. 9.
In a preferred ';- L of the invention, catheter 20 can be ~Lc~ a~;e~ from ~,.LLude~ tubing 46 by blowing said tubing 46 under pLc~-~uLc and heating conditions ufricient to produce a catheter piece 47, a cross-~ection of which is shown in Fig. 10, wherein the 20 diameter~ of lumens 32 and 33 correspond substRnt ;Al ~y to the rinal ~ of balloon 21 and 22 and lume~ 28, respectively. The holes or op~n;n~ 34 and 35 in tubing 46 are not ~~ ~l ily the same, such that the ~ LD
of lumens 32 and 33 may also di~fer.
After an opening 37 (C~LL~ 1;ng to opening 36) is cut into lumen 33 at a point to define the length of the perfusion lumen 28, a pushing wire 25 i8 inserted into lumen 38. Pushing wire 25 extends the length Or lumen 38 to a point slightly distal of opening 37. Optionally a lubricious liner and/or a reinforcing coil or tube 60 i8 inserted into the distal end of lumen 33. Then, the distal end of lumen 32 is sealed, and, while lumen 32 is ~L~ uLized~ heat is applied to the distal portion of .~U.et~L piece 47 to cause lumen 33 to slightly shrink around liner or tube 60, which fixedly engages the distal end of pushing wire 2 5 . Next, the portions o~ catheter _g_ 2i88~7 ..
Wo 95/28983 r~
piQce 47 proximal to balloon 22 and between b7lloon~ 21 and 22, are heated to shrink lumen 32 to form the hAll~ and to shrink lumen 38 around pushing wire 25.
The balloon lengths are ~tDrm1 n~d by the exact locations 5 where heat is applied to lumen 32.
In an optional ' i- of the invention shown in Figure 12, lumen 26 of catheter 50 does not contain a pushing wire but is available in c~,..J ull~.Lion with lumen 28 to form a r~r~ y for a guidewire (not shown), ~or 10 example, 80 that the ~;c~U~_Ll:L of the invention could be eYrh~nq~-A rapidly, using a aL~r~daLd length guidewire.
Lumen 26 here is shortened as _ _ e ù to a similar lumen in Figure 8. The total length of lumen 26 plu8 lumen 28 in an ~ of Figure 12 would be about 20-30 cm versus a total length of about 120-150 cm for lumen 29.
An additional lumen 51 ~YtQn~l;n~ from the proximal end of the .-.th t~:L 50 to a point 52 proximal to the proximal ~nd 53 of lumen 26 can optionally contain a pu6hing wire 25 affixed by glue or other adhesive or by the heat 20 I;hrinking of lumen 51. The pushing wire 25 is particularly useful to impart st~fnP~q if catheter 50 is J~J~1 acro8g a guidewire (not shown). Alternatively, if lumen 29 proximal to balloon 22 cnnt~;n~ or is replaced by a l~ LuLe, lumen 51 and pushing wire 25 may 25 not be required.
When portions of the ~c.Ul~L~L are heated, the heating can be erfected by a point source of heat, where the point source is moved along the ~Y~ri or of the ;aUl~L or the catheter is moved across the point 30 source. Alternatively, the heat can be applied with n broader heat source, such as a hot water bath. The source of and/or t~rhni~ of heating will be aE,~a~-,.L
to those skilled in the art.
Also, in a pref erred : ' ~ '; - of the invention the 35 ~_ 's, iec e will optionally be cross-linked prior to working. Such cross-linking could be effected by 2i88~07 W0~ 3 IIOT TC BE TAKER IRT~ r~lD~E~lTloR FOR TRE PURPOSES OF 1 ~ ~ _

Claims

WE CLAIM:

1. An active perfusion dilatation catheter comprising:
a catheter shaft having proximal and distal portions and at least one inflation lumen extending longitudinally therethrough;
an inflatable dilatation balloon positioned external to the distal portion of the catheter shaft and in fluid communication with an inflation lumen;
an occlusion balloon positioned external to the distal portion of the catheter shaft and proximal to the dilatation balloon and in fluid communication with an inflation lumen; and a perfusion lumen at the distal portion of the catheter shaft, the perfusion lumen having proximal and distal openings, the proximal opening located proximal to the occlusion balloon and the distal opening located distal to the dilatation balloon.

2. The catheter of Claim 1, wherein the dilatation and occlusion balloons are eccentric to the catheter shaft.

3. The catheter of Claim 1, wherein the dilatation and occlusion balloons are concentric to the catheter shaft.

4. The catheter of Claim 1, wherein there is only one inflation lumen.

5. The catheter of Claim 1, wherein the dilatation and occlusion balloons are each in fluid communication with a separate inflation lumen.

6. The catheter of Claim 1, wherein there is another lumen containing a pushing wire, said lumen having a distal end that is proximal to the perfusion lumen.

7. The catheter of Claim 1, wherein there is an additional lumen proximal to and in fluid communication with the perfusion lumen such that said additional and perfusion lumens can form a passageway for a guidewire.

8. The catheter of Claim 7, wherein there is a second additional lumen extending from the proximal portion of the catheter to a point proximal to the proximal end of said additional lumen and said second additional lumen contains a pushing wire.

9. An active perfusion dilatation catheter system which comprises the catheter of Claim 1 and a guiding catheter.

10. In a method of perfusing blood or another oxygen-containing fluid during a balloon angioplasty procedure whereby a guiding catheter is introduced into a human body, a balloon dilatation catheter is then introduced through the guiding catheter, the dilatation balloon is positioned within a stenotic segment, and the dilatation balloon is inflated, the improvement wherein the balloon dilatation catheter contains an occlusion balloon located proximal to the dilatation balloon, a perfusion lumen extending from a point proximal to the occlusion balloon to a point distal to the dilatation balloon, the occlusion balloon is positioned within the guiding catheter and is inflated prior to or simultaneously with inflation of the dilatation balloon, and blood or other oxygen-bearing fluid is actively caused to flow distally through the annular space between the guiding catheter and the main shaft of the lumen and then through the perfusion lumen.

11. An active perfusion dilatation catheter comprising:
a catheter shaft having proximal and distal portions and at least one inflation lumen extending longitudinally therethrough;

an inflatable dilatation balloon positioned external to the distal portion of the catheter shaft and in fluid communication with an inflation lumen;
an occlusion balloon positioned external to the distal portion of the catheter shaft and proximal to the dilatation balloon and in fluid communication with an inflation lumen; and a perfusion lumen at the distal portion of the catheter shaft, the perfusion lumen having proximal and distal openings, the proximal opening being located proximal to the occlusion balloon and the distal opening being located distal to the dilatation balloon, wherein the dilatation and occlusion balloons are each in fluid communication with a separate inflation lumen and wherein the catheter shaft comprises an additional lumen containing a pushing wire, said additional lumen having a distal end that is proximal to the proximal opening of the perfusion balloon.