CA2185093A1

CA2185093A1 - System for performing a cardiac procedure

Info

Publication number: CA2185093A1
Application number: CA002185093A
Authority: CA
Inventors: R. Machold Timothy; Wesley D. Sterman
Original assignee: R. Machold Timothy; Wesley D. Sterman; Heartport, Inc.
Current assignee: Heartport Inc
Priority date: 1994-03-16
Filing date: 1995-03-10
Publication date: 1995-09-21
Also published as: EP0808191B1; US5458574A; EP0808191A4; WO1995024940A1; DE69528712T2; EP0808191A1; AU1980895A; DE69528712D1; ATE226840T1; JPH10500587A; AU691893B2

Abstract

A system for accessing a patient's cardiac anatomy which includes an occlusion catheter (10) with a first expandable member (11) or balloon on a distal extremity of the catheter which when expanded within the patient's ascending aorta separates the heart and coronary blood vessels from the rest of the patient's arterial system, and a second expandable member (15), distal to the first, which when expanded will be seated within the left ventricle. A cardiopulmonary bypass system (18) is connected to a major vein, e.g., femoral (20), to withdraw blood, remove carbon dioxide, oxygenate the withdrawn blood, and then return the oxygenated blood to the patient's arterial system through a major artery (22). Preferably, the heart muscle or myocardium is paralyzed by the antegrade and/or retrograde delivery of a liquid containig cardioplegic material to the myocardium through patient's coronary arteries or coronary sinus. The cardiac accessing system is suitable for a wide variety of cardiac procedures including opened and closed chest procedures.

Description

2 1 85093 Wo s~/24940 r~ Y
SYSTFI~ FOR PF.RFOR~ITNG A CARnlAC PRO~nURF.
FIELD OF THE INVENTION
This invenuon relates to n catheter system which ~'acilitates perfomming cnrdiac prooedures dnd y.uLiuul.uly an aortic catheter clarnp which isolates the pntient's heart from the pauient's arterial system.
BACKGROUND OF THE INVENTION
1 0 When it is necessary to rerform surgery on a patient's heart. the surgery hac heretofore usually been d~ by a major open heart surgical procedure, requiring general anesthesia and full .,~ l; ~y '~, .. . y bypass. with complete cessation of ,,~ ii.,~ ' y acuvity. Such surgery usually includes about three weeks of nd months of ~ ume t'or the p~uent. The aver~Lge mortaliy 5 rate with this ype of procedure is about five to six percent. and the ~ l rate is ~ly higher. Decrrirrit)nc of open heart procedures can be found in Gihhon's ~ery of thP ChPct 5th Ed.. David C. Sabiston. Jr., M.D.. Frank D. Spencer, M.D.. 1990, Vol. II, Ch. 52. pp. 1566-1596, and Textbnok of Tr,l~. ~, ..~;.... ~I
C7lrtiit~ Y~ Eric J. Topol, 1990. Chs. 43-44, pp. 831-867.
2 0 In those cardiac procedures requiring u.. ~ , l,.. ,. y hypass. a lar~e clamp is applied to the exterior of the ascending aorta to close it off once , _ y bypass is pc~slhli chPri However, applicauon of such dn extemal clamp to a calcified aorta may release emboli into the l-loo~ Further. upon the removal of the aortic clamp at the end of the procedure. any debris or uhrombus 2 5 generated during Lhe procedure upstream of the clamp or by the cl tmp itself can tr~vel into the l.... ~ , the c~rotid. or the subclavi~n arteries, with serious resultssuch as strokes and the like. For example, in up to 6~ oi' the open-chest coronary bypass surgenes perl'ommed in the United States. Lhere is noticeable ~ l of the p ~ùent's ment~ culties following such sur~enes. This ~ ,. is commonly w0 95/24940 2 ~ 8 5 0 9 3 r~ Y
attributed to cerebral artenal blockzEe trom debris and emboli generated durinE the surgical procedure.
An c.~duv~ul~ system and procedure for performinE c~rdiac surgery has been described in copending .~ ;..,.c Serial No. 07n30,s59. filed on July 16, 1991, Serial No. 07/991,188, filed on December 15, 199~, and Serial No.
08/123,411, filed September 17, 1993, the disclosures of which are hereby u.-,u-~ ~ herein by reference. In these paUM ..~ ' an c~-duv~uul~ clamp is described which isolates the patient's heart from the patient's arteri~l system without the need for a Ll~u~u~ul..y. The .,.~duv~,uL clilmp is ;m elonEated intra-aortic catbeter I 0 which is imtroduced into the patient's femoral artery and which has an occlusive balloon on a distal portion of the catheter. In the procedure described. the catheter is advanced throuEh the pauent's femoral artery and aort;l until the occlusive balloon on the distal portion of the catheter is disposed within the patient's ascending aorta at a location between the coronaty artery ostia and the l .. ~ lir artery. The occlusive balloon 1 5 is inflated or otherwise expanded in this region to occlude the aortic ~ y and is maintained in the expanded condition until the completion of the procedure. The patient is placed on ..~..l;.... ~ , - ~ bypass to maintain circulation of u~,, ' blood.inpl~opir material is then introduced into the ~y~ -ll of the pauent's heart either , ' 1~, through one or both of the coronary arteries or ~ ut.,~d~l~ throuEh 2 0 the patient's coronary sinus or both. Following compleuon of the procedure. the region upstream trom the occlusion balloon including the ascendmg aorta and the patient's left ventricle may be bathed in irrigation fluid, e.g. saline solution. and the fluid and any debris or emboli in the region can be aspirated through an inner lumen of the catheter to the proximal end thereot which extends out of the pauent. When the '2 5 nortic re~ion and the left ventricle are free of debris. the balloon is detlated or otherwis~
contracoed and the c;3theter removed so that normal blood tlow can resum~.
In the short period dunn~ and nt`ter the occ~usion balloon is intlatcd. but before the ~ material paralyi!es the patient's hcart. signific~nt pressure pulses trom the beatinE heart ~nd the car~ rl~lnl~n~v hypass svstem are applietl to both ~nds WO ss/24940 2 ~ 8 5 0 9 3 r~ 779 o~` the inflated occlusion bnlloon. This m~y displ~ce the occlusion bnlloon trom its desired position within the ascending ~orta, c~using darnage to the ~ortic valve. or occluding the ostia of the coronary arteries. h~ artery or other artery.
What has been needed and heretofore u~ vu;l~l~ is a means to securely S position the occlusion balloon within the ascending aorta so that the pressure pulses received on the ends of the occlusion balloon do not displace the balloon lrom its desired position. The present mvention solves this and other problems.
The descriptive terms "du .. ~ ul~" and "upstrearn", when used herein in relation to the p~tient's v_ ' rel~te to the direction of normal blood flow and 1 0 to the direcuon opposite normal blood flow through a vessel l~ ly, i.e., "upstream" is closer to the heart in the arterial system and further from the he~rt in the venous system. The terms "proximal" ~nd "distal", when used herein in relation to used in a c~rdiac procedure, refer to direcuons closer ~nd iarther ~way l~liv~, y from that end of the instrument which is held or ~ ' ' by the 1 5 operator performing the procedure.
SUMMARY OF THE INVENTION
The present invenuon is directed to an ~,.lduv~u~ u method and system for preparing a p~tient's heart for c~rdiac procedures and ~ u ' 1~, for isolatin~ the 2 0 pauent's heart lrom the p~tient's arterial system.
Essenual to the invention is an ~ uv~,ul~u catbeter which has a catheter shaft with a proximal portion and a distal portion, an C~IJCUlLIClille occluding member on the distal portion of tbe catheter shaft, ~ distal port in the distal end of the catheter shaft and a first inner lumen extending within the catheter shaft from the distal 2 ~ port to the proximal portion of the c~theter shaft. The c~theter shaft is .1;"....~;.,...~.~ so that ~ p~rt of the distal portion of the c~theter shaft m~y be disposed within the patient's ascendin~ aorta ~nd the proximDI portion of the c~theter shaft extends out of the p~tient when tbe catheter is properly positioned within the p~uent. An expandable s~atin~
member is disposed on the distal portion of the c~tbeter sha~t ~t ~ loc~tion which is Wo s5/24s40 s s o 9 3 . ~ iil lY

spaced a sui~lcient distance distal to th~ expandnble occluding member so that when the occluding member is properly positioned between the coronary ostia and the h lir artery, the seating member may be expanded and seated within the left ventricle upstream from the patient's aortic valve.
Preferably, tbe occluding and seating members are imlatable members and are expanded by tbe; ~u~ of inflation fluid within their mteriors. Although the catheter shaft may be provided with only one inflation lumen to inflate both the occlusion and seating members. it is preferred to provide separate inflation lumens for each of these expandable members so that their inflation and deflation may be I 0 ; ~ . . ly controlled The catheter shaft preferably also has another inner lumen which extends from a location in the proximal catheter shaft section outside of the p~tient to a port in the catheter shaft locaoed between the occluding and seating members. In this manner when the expandable occluding and seating members are expanded to block the 1 5 ascending aorta and fix the catheter position therein, a diagnostic or therapeutic fluid may be introduced into the isolated region of the ascending aorta between the coronary ostia and the aortic valve through the port between the two balloons. This fluiddelivery is ~ , useful m delivering ~ fluid into tbe coronary arteries through the coronaty ostia. Tbe lumen may also be used to deliver irrigation tluid into 2 0 the blocked region between the expanded occlusion and seating members to facilitate removal of debris and emboli which may be forrned during the procedure before the occlusion balloon is deflated at tbe end of the procedure. In addition, the lumen may be used for i- - ~ u~ .., of i~ . ` devices into the aorta andlor coronary arteries to perform various diagnostic or illil.l i ...iUII~
2 5 The catheter is .1;, ,~ nd configured tO be introduced into the patient's arterial system through the t`emoral. brachial or cnrotid ~rtenes. ;md ~dvanced in a retrograde manner until the occludin~ member on the c~theter shaft is disposed within the pauent's ascending aorta and the se~tin~ member on the catheter shaft is disposed within the patient's left ventricle i--~ d;~ ndjacent th~ upstre~m side o~ the ~ W095124940 _ 5 _ 2~ 93 .~ Y
~ortic valve. In some l , ho~ f ~ the c~theter p}ofile may be too ltlrge ~o be ir~troduced i~ ~ ~ u---'y as in n Seldinget technique so a cut-down may be required.
The occlusion catheter should be positioned within the ascending aorta, duw~
from the coronary ostia and upstream from the 1 ~ ; artery so th~t when the 5 occluding member is expanded it does not block either of these arterial lumens.
When the catheter is properly positioned within the patient's ascending aorta, the distal end of the cntheter extends through the patient's aortic valve so that the seating member is disposed in the left ventricle. After the seating member is expanded, the catheter shaft may be pulled du .. to seat the seating member within the left 1 0 ventricle upstream of the aor~ic valYe. The occluding member may then be expanded to occlude the ascending aorta In this manner the catheter then becomes securely positioned within the aorta so that there is little or no movement of the occlusion balloon during the procedure, particul~rly when the heart is be~ting.
In most instances, the catheter of the present invention requires the use I 5 of a ~ r y bypass sysum to deliver u~t~ blood to the arterial system which has been isolated from the patient's heart. Particularly attractive features of the invention include preparation of the patient's heart for a surgical procedure without the use of an external clamp on the ascending aorta, and allowing for c..Juv~.ul~ orIl.., ~ . .~ .".; surgery and various other procedures on the hetut wiLhout the need for a 2 0 ~ acuiu~ . It should also be noted th~t, if, during a closed-chest endovtlscular cardiac proceduoe in accordance with the invention. it becomes necessary to perform a .,u..~. : ' open-chest proceduoe, the patient's heart is already fully prep~red for the procedure. All that is necessary is to perform a 11,~.. ,.r ul~ ....y to expose the pauent's hearL
2 5 In one presently preferred r.. ,hc.i;",~ .,r of the invention directed to uv~.,ul~ coronary procedures. the occlusion catheter of th~ invention may he used ~o deliver ill:>U Ull.~.l..S for the procedures through the inner lumen ;md out the distal porL In these procedures. the expanded occluding cmber on the distal portion ot` the W0 95/24940 2 1 8 5 0 9 3 r~ ! /Y ¦~

catheter sufticientdy secures the distal end of the catheter within the aorta lo allow for the accurate guidance of ill~ULL~ t~ to be used dunng the procedure.
By ~Li.iUllillg the arterial system with the catbeter in this manner, it has been found that ~ .lf ~:f fluid can be c~ ., .l ;.. ~ly introduced into the patient's S coronary arteries at very low ~ 50 that the heart can be maintained in a paralyzed state for long periods without serious damage to the beart muscles. Irrigation fluid can be introduced through the distal port in the distal end of the catheter shaft to facilitate imaging, e.g. ~ f observation, of the cardiac procedure. A continual flow of clear fluid may be directed to the surgical field in order to maintain fluid clarity I O sufficient t'or imaging the site during the procedure. The pressure of the body of irrigation fluid at the surgical site should be maintained at a level higher than the fluid pressure in the pntient's left atrium to ensure that the mitral valve remains closed during the procedure and thereby prevent the intrusion of blood from the left atrium into the left ventricle which can interfere with the imaging.
I 5 The left ventricle is preferably flf~ ~d by holding the pulmonary and tricuspid valves open by suitable means such as the cntheter described in U.S.
Patent 4,889,137 ~fKolobow) which is i..~,u.~u.,.~ herein by reference. The cntheter described therein is advanced through the patient's venous system, e.g. through the right internal jugular vein, tbe right atrium and the right ventricle into the pulmonary 2 0 trrink. As described in this patent, n spring is provided on the exterior of the c~theter ~t the locations where the catheter will extend through the pulmonary and tricuspid valves m order to hold open tbe valv~s and ~' . the left ventricie through the pulmonary capiriaries. ln the altemative, a pulmonary vent cntheter mny.)e ndvanced in essentially the same manner as thnt described by Kolobow nbove until the distal end of 2 5 tbe c~theter is within the pulmonnry trunk. The catheter may include nn inrl~table member near it distal which is ~ f ~1 so thnt upon inflntion it will hlock the pulmonary trunk. The trunk may then be vented throu~h an inner lumen of the catheter which extends throu~h the catheter from n port in its distal end to a port in its proximnl end. which is located outside of the pntient.

~I W0 95124940 2 1 ~ 5 0 9 3 ~ Y
The catheter of the invention wiLh an expandable occludin~ member on the distal portion and an vAu~ blv seating member distal to the occluding memberprovides an effective aorLic clamp and, coupled with ~ y bypass, infusion of carioplegic fluid and fl~ of the left venLriCIe, provides for a unique ~ul~ approach to a wide variety of cardiac procedures which do not require grossly invasive thoracic or abdominal surgery. Moreover, as mentioned, the system may even be employed in UUII~ IUll~l open-heart procedures should it be needed.
These and other advantages of the invention will become more apparent from the following detailed description of the invention when taken in ~ ~ . j, 1;.-, with the I O ~ ' V exemplary drawin~s.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. I ~ ly illustrates a cardiac access system emhodyin~
features of Lhe invention, 1 5 Fig. 2 is a partial 1~ ~, " ' cross-sectional view of the occlusion catbeter shown in hg. 1.
Fig. 3 is a transverse cross-sectional view of the catheter shnft of the occlusion catheter shown in Fig. 2 taken along the lines 3-3.
Flg. 4 is a tr;tnsverse cross-sectional view of the catheter shafL of the 2 0 occlusion catheter shown in Fig. 2 taken along the lines 4-4.
Figs. ~ and 6 are transverse cross-sectional views of an alternative catheter shaft for the occlusion catheter and taken at essenLially Lhe same locations as in Figs. 3 and 4. ~ vly.
Fig. 7 is an enlarged view, pnrLially in section~ of Lhe occlusion caLheter 2 5 shown in Fig. I disposed within the ascending aorta nnd Lhe left ventricle of a patient.
Fig. 8 is an enlarged elevational view, p~rtially in secLion. of the heart shown in Fig. I illustr~Lin~ in more deLail the ~ u~llu~illg Dnd pulmonary v~nting caLheters~

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DETAILED DESCRIPTION OF THE INVENTION
Reference is made to Flg. 1 which ~. l.. ;. ,.lly illustrates the overall cardiac accessing system inciuding the occlusion catheter 10 of the invention. The occlusion catbeter 10 has an expandable occluding member 11 on a distal ponion of the 5 catheter shaft 12 which, when inflated as best shown in Fig. 7, occludes the ascending aorta 13 to separate the patient's heart from the rest of the patient's arterial system do.. therefrom. An expnndable seating member 15 is disposed on the catheter sbaft 12 distal to the occludinE member 11 and when inflated within the left ventricle 14, seats within the aortic vestibule 16, usunlly on the upstream surface of the aortic 1 0 valve 17, not shown in Flg. 1, nnd securely positions the distal portion of the catheter shaft 12 within the ascending aorta 13. A ~, u~ - y hy-pass system 18 removes venous blood from the femoral vein 20 through blood withdrawal catheter 21 as shown, removes CO~ and oxygenates the blood and then retums the oxy~enated bloodto the patient's right femoral ariery 22 through return catheter 23 at su~Ecient pressure 1 5 so as to fiow throughout the patient's arterial system except for the portion isolated by the expanded occluding member 11 on the occlusion catheter 10. Altematively, retum catheter 23 arld occlusion catheter 10 both may be positioned in the same femoral ariery (either right or left) by, for example, introducing occlusion catheoer 10 through the interior lumen of retum cntheoer 23. ~s described in co-pending application Serini No 2 0 08/162.742. filed December 3. 1993, the complete disclosure of which is il~ ul!~ul.l~d herein by reference. Suitable .,~ ';~ _' y bypass systems, such as those described in U.S. Patent No. 4.447,590 and U.S. Patent No. 4,540.399. which are Ul~,UI~ ' beem by reference. are ~ n " - ": ~ly available from. for exnmple, Themmedics (Wobum. MA).
A It:UUi~lrUa;UII bnlloon cntheter 24 is disposed within the patient's venous sysoem with the distai end of cntheter 2~ extendinE into th~ coronary sinus 25 IO
deliver n tluid containin~ .~Ji~ mnoennl in n retroEMde manner tO the ~" in order to paMlyse the entire llyo~uJIulll. Amegrade delivery ot ~diu~lr,~ luids may be performed through the occlusion cntheter 1(). as will be WO 95/24940 2 1 8 5 0 9 3 r~ 779 described in more detail below. in addition to or insuad of retrograde delivery through the coronary sinus.
T.he proxim31 extremity 26 of the occlusion catheur 10 exoends out of the left femoral artery 27 through a cut down 28 and is provided with a multi-arm adapur 30. The adapur 30 has one arm 31 to receive an inflation device 32, a second arm 33 with a main access port 34 through which ih~ u...~ iocr~pc irrigation fluid and the like may be passed. and a third arm 35 to withdraw blood. irrigation fluid and the like and direct the withdrawn fluid to the blood r~ ,u.~,.y system 36 through lines 37 and 38. A suitable valve or stopcock 4() is provided to open and close 1 0 the bypass line 37 and direct the fluid p3ssing through the bypass line to a discharge line 41. A return line 42 may be provided to return any filtered blood. which will be described h~rl~in~firr, to the L~ U~ 1 ~- y bypass sysum 18.
The details of the occlusion catheter 10 are best illustrated in Figs. 2-7.
As shown therein, occlusion catheter 10 includes an elongated catheter sh3~t 12 which 1 5 has a main inner lumen 43 e%unding in fluid ~ ;, .. with the distal port 44 on the distal end of the shaft and with the main access port 34 in the second arm 33 of the adapter 30 on the proximal end of the shaft (Fig. I ). The main lumen 43 and the distal port 44 may be used ~o pass surgical il~il u...~,..L~. ~ ;. .~ . ,r, ~ irrigation and aspiration unes and the Itke into the ventricle region distai to the distal end of the catheur shaft 12.
2 0 A supporting coil (not shown) may provided in the dist31 portion of the m3in or first inner lumen 43 or embedded in the wall of shaft 12 3 round inner lumen 43 to prevent the distal portion of the catheter shaft 12 from kinking as it is advanced through the patient's aortic arch. The sh~ft 12 is also provided with a second inner lumen 46 which is in fluud: with the interior of the occluding member 11 through port 47 2 5 and the interior of the ~ hl~ seating member l5 through port 48. A third inner lumen 50 may be provided within the shatt 12 to direct lluids. e.~. ~.ud;u~ , orirri ation fluids~ to the region of the ascending aort3 hetween the occlusion ;md se3ting members 11 and 15 through ports 51 between occluding member 11 and sealing member 15. Inner lumen 51) 3nd porls 51 may also hL com;gured to allow W0 95124940 2 ~ 8 5 0 9 3 i ~ / IY

;llt~ iul~ll deviees such as nngioplasty or dlll.,~c~iollly c_theoers to be introdueed through lumen 50 and port 51 into the norta andlor coronRry ~teries.
Ocelusion catheter 10 will prefer;3bly be ~' ' and configured for ~ u,~ . into a femoral artery and ddvu.l~,.,.ll.,... to the ascending aor~a and left 5 ventricle of the heart through the iliac artery, descending aorta and aortic arch. This will generally require a length of at least abûut 80 cm, and usually abûut 90-100 em.
Aloernatively, the ocelusion eatheoer 10 may be adapoed for illhud~,~,hul~ into the braehial or carotid aroeries and a.lv through the l,. ~ aroery into the ascending aorta, wherein the enthetPr m~y be s~hc~ntiRlly shorter in length. e.g.. '20-60 10 em.
Oecluding member 11 is separ~oed from seating member 15 by a dist_nce selecoed to allow the occluding member to be positioned in the ~scending Rort_ between the coronary ostia and the 1., .~ _rtery when the se~ting member is expanded and seaoed adjacent the upstream side of the rtic valve within the left ventricle of the 1 5 heart. Usually, the distal end of occluding member 11 will be separaoed from the proximal end of seating member 15 by a distanee in the range of I em to 8 em, and preferably between 3 em and 5 em.
In one presently preferred Pmho~iimPnt shown in Figs. 5 and 6, hhe e~theoer shaft 12 has an additional inflation lumen 52 whieh allows for the ~ inllation 2 0 _nd deflation of the oceluding member 11 and the seating member 15.
The oeelusion catheoer 10 shaft 12 may be formed of eonventional materinls sueh a pol~,ùh~lc.,." polyvinyl ehloride _nd the like. The oceluding member 11 and seating member 15 likewise may be formed of uu--~.,.lhu,~ polymers sueh as puiJ~,II,vb,~l~,, pol~ P~rphthR~ a polyolefinie ionomer such ~s Surlyn, which 2 5 is available from E~.L DuPont, DeNemours & Co. or polyulc~ ,l.e.
FiE. 7 illustrates the e~theter 10 dispûsed witbin the patient's _ort~ 53 with the distal portion of the eRtheter disposed within the aseendinE aort~ 13. The occludinn member 11. shown in the in~lated condition. oeeludes the ~ E~,vv.ly through the _scending aorta 13 between the eoron_ry artenes 54 _nd 55 and the l ."~

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artery 56. The seating member 15 is inflated within the aortic Yestibule 16 ndjncent to the aortic valve 17. I~riinp-~ ^ markers 57 nnd 58 facilitate the l[luulu~cu~Jicobservalion of the ends of the occluding member 11 and the radiopaque marker 60 and 61 facilitate the nuv~u~culJic ul~c. va~iull of the eAds of the seating member 15.
To set up the cardiac access system as shown in Fig. 1. the patient is initially placed under a light general anesthesia. The withdrawal catheter 21 and the return catheter 23 of the cardio-pulmonary bypass system 18 are 1~ y introduced into the right femoral vein 20 and the right femoral artery 22, I.,.,~.,~
The operation of the cardio-pulmonary bypass system 18 is initiated to withdraw blood I O from the femoral vein 20 through catheter 21. remove C02 and oxygenate the blood and then pump the oxygenated blood through the return cathe~er 23 to the right ~`emoral artery 22. With the bypass system 18 nrPr,Atinnol a cut down 28 is made in the left groin to expose the left femornl artery 27. Occlusion catheter 10 is inserted into the left femoral arlcry through an incision therein and advanced upstream until the occluding 1 5 member 11 on the distal end of the occlusion catheter 10 is properly positioned in the ascending aorta 13 between the coronary ostia and the 1~ arteries. and the seating member 15 is within the patient's left ventricle 14 upstream of the . ortic valve.
The seating member 15 may then be expanded within the left ventricle 14. Once seating member 15 is expanded. occlusion catheter lU may be drawn in a du .. ~ UII direction 2 0 so as to seat seating member 15 within aortic vesubuie 16. usu~lly ~gainst the upstre. m surface of the aortic valve 17. The occluding member 11 may then be inflated to occlude the ascending aorta 13. causing blood which is pumped out of the left ventricle 14 (until the heart stops beating due to the c . ~ r tluid as discussed herein~t'ter) to flow through the distal port 44 imto the main inner lumen 43 of the occlusion catheter 2 5 10. During the period in which the he_rt remains beating. s~ting member 15 remains securely sented within the nortic vestibule 16, preventing occlusion cntheter 1() trom heing moved under the pressure of blood ~owing out ot- the henrt. The hlood tlows through the inner lumen 44 out the third nrm 35 of the ndnpter 3() into the bypass line 37 and then into tbe blood filter nnd hlood recovery ~ystem 36 through the valve 4~) and wo gs/24940 8 9 line 38. For blood and irrigation tluids conta ning debris. thrombi and the like, the position oif the valve 40 may be changed to direcs dhe fluid Ihrough the discharge line 41.
As shown in Fig. 8, dhe l~h U,u~,lrL~;>;V~I catheter 24 is l.f ~ ~ f u ~iy 5 irlserted by a suitable means, such as the Seldinger technique, into the interior jugular vein 62 and advanced into the right ah-ium 63 and guided through the ostium 64 in dhe coronary sinus 25. The balloon 65 on the distal extremity of dhe ~ u~,~,.ru~;u~ catheter 24 is inflated to occlude the coronary sinus 25, to anchor the catheter 24 within the coronary sinus 25, and to prevent fluid loss through the ostium 64. A liquid containing I O a ., u,' , ', agent, such as KCI, is directed d~rough dhe catheter 24 into the comnary sinus 25 and the pressure of the .~ i fluid wihhin the coronary sinus 21 is maintained sufficiendy high (e.g. 4f~) mm Hg) so that the I l; ~I.It ~ ;.. tluid will pass hhough the coronary v~ins and the capillary beds to the coronary ar~eries. C~rdioplegic fluid may also be in~used through inner lumen 50 and distal ports 51 of occlusion 1 5 catheter 10 to perfuse dhe Illy, ' through coronary arteries 54. 55 (Fig.7). Once the u ud;u~l~;u fluid passes d rough the capillary beds into the III,~U~ II.LUIII. the heart very quickly stops beatiltg. At that point, the Illyu, LIl ' is paralyæd and has very litde demand for oxygen and can be maintained in dhis stae for long periods of vme with essentially no permanent d~mage by ~ ~.uJhJ~le~ , fluid within the 2 0 111~ ~ The flow of .1;. .1,l f~;. tluid through hhe capil~ary beds is maintained durtng the procedure and it is preferably maintained at a very low i r . e.g. 40C, hO further reduce oxygen demand. Once the ~ L;' lluid flow through the Illyv~,~d;ul~l is erminated and essentially all residue of the u~.I;v~ ;., tluid has been flushed out with irrigation fluid such as saline. the heart will be~in to beat on its own.
'~ 5 To minimiæ the flow of oxygenated blood into the left atrium and ultimaely the left ventricle. the pulmonary trunk 66 is vented by advancing pulmonary ventin~ calheer 67 through the inernal ju~ular v~in 62. hhe n~ht atrium 63 and ri~ht ventricle 68 into the pulmonary trunk 66 The occlusion b~lloon 7() on th~ distal end ot the pulmonary v~nting catheer 67 is intlaled hy in~la~ton lluid tû block hh~ pulmon~ry WO 9S/24940 2 1 8 5 0 9 3 ~ Y

trunk 66 and vent blood therein through distal port 71 ~nd an inner lumen (not shown) extending the length of the catheter 67 to its proximal end where the blood is discharged through the proximal end of the catheter, which remains outside of the patient during the procedure. The venting of the pulmonary trunk 66 results in the df~ of 5 the left ventricle 14. In the alumative, the venting catheter 67 may he prvvided with mearls on the exurior thereof, such as expanded coils as described in U.S. Patent 4,889,137 (Kolobow), which hold open the pulmonary valve and perfomm the same function of ~ : g, the left ventricle 14. See also the article written by F. Rossi et al. in the Joumal of Thoracic CalJi~ v- ~ Surgery. I99~f);100 914-921, entitled 1 0 "Long-Tetm C aJ;v,uuL.Iu~ Bypass By Peripheral ~ nn~ rjr~n In A Model Of Total Heart Failure", which is ~ ' ;I herein in its entirety by reterence.
Inflation of the occluding member 11 on the distal end of the occlusion catheter 10 fixes the distal portion of the c~theur within the ~scending aorta 13 and isolaus the left ventricle 14 and part of the ~scending aorta including ~he ostia of 1 5 coronary arteries 54, 55 from the rest of the arterial system du .. ,11-. u.. trom the occluding member 11. Inflation of the seating member 15 fimmly secures the distal portion of the occlusion catheur 10 within the ascending aorta 13. The passage of any debris or emboli generated during a ~. uJ;u~,uLa procedure to regions du.... m,.un from the site would be precluded by the inflated occluding member 11 ;md/or seating 2 O member 15.
With the _ ''-r ' y by-pass system in operation. the heart compleuly paralyzed and not pumping, tbe left ventricle . Ir~ _~fl and the ascendmg aorta blocked by the inflaud occluding member 11 on the occlusion catheter 10, the heart is ready for a procedure to be perfommed. Procedures which may be 2 5 perfommed using the occlusion c~theur 1() of the invention include coronnry 3rtery by-pass grafting, heart vaive repair and . rlJ~ I septal dei`ect repair, trenument of nneurism, pulmonary surgery, Il~oau-~ l procedures. :md various other proceduresin which cardiac arrest and ~ , Y bypass are desirnble.

wo 95/24940 ~ ~Y

In a preferred tlspect of the invention, surgical ill~UUIII~.I.;~ m2y be introduced through inner lumen 43 o~` occlusion c~theter 10 into the left ventricle of the heart for performing cardiac procedures such as mitral valve repair and l rl l r. I .. . Il, septal defect repair arld the like. in the manner described in commonly-assigned co-pending application Serial No. 07/991,188, which has been iUl~UI~/Ul.lL.~d herein by re~'erence. For example, am angioscope may be introduced through lumen 43 for visualization within the left ventricle or other heart chambers. Cutters, forceps, aspiration and irrigafion tubes, suturing devices, heart valve prostheses and prosthesis il~LIudu~iull devices, as well as suturing, stapling or clip applying devices may be 1 0 introduced through lumen 43 for purposes of, for example, repl~cing or repairing a '' ' ' ,~ mitrai valve. Moreover, il~t~ Liu~al devices may be introduced through lumen 50 arld port 51 for peri'orming procedures such as ~.~;o~l~.y, ~ Lullly, or aortic valve repair or r~ . I 1 11 du II:~L-~..I of se~tting member 15.
During such ~... ' , it may be desirable to deflate se~ting member 15 to i'acilitate 1 5 access to the aortic valve 17 and/or aortic vestibule 16 to observe or perform a surgical procedure on these structures. After the procedure has been performed, seating member 15 may again be inflated to maint~in the postion of occlusion c~theter 10 as the heain is restarted. A.l~ . u ly, the invention provides an c...lu v ~,uL~ ~u~ ,w Ly to facilitate the ~ - -- r of such procedures without the need for ~ gross 2 0 Llwl.l-ulullly as is required using .u..., -' ' techniques.
Upon completion of the procedure, the ~udiu~ t;c fluid pumped through the Ir~.iu!~,-rll~;ull catheter 24 or through lumen 43 of occlusion catheter IU is changed to a compatible nuid, e.g. s~line, containing no . ,~ f ~i. a~ents in order to flush out all of the . - . l l; ~ E:r materials i'rom the ll-yu~.~ld;ul~. The pulmon~ry '2 5 ventinf~ catheter 67 may be removed ~t the s~me time. Shonly thereal'ter, the he~n begins to beat on its own ;md the blood coming into the nght hean is pumped throu~h the pulmon~ry trunk 66 to the lun~s where it is oxygen:l~ed in a normnl fashion Oxygen~ted blood is returned irom the lungs through the left atrium nnd into the left ventricle 14. Initially, the occludin ! member 11 ~nd seatin memher 15 ~re maintt~ined ~ W0 95124940 2 1 8 5 0 9 3 ~ Y

in the inflnted condition. forcing the blood pumped out of the left ventricle to p~ss through the main inner lumen 43 of the occlusion catheter 10 taking with it debris, emboli and the like which may have fommed during the prAvcedure. The blood p3ssing through inner lumen 43 may be directed through the third arm 35 of adapter 30, through the valve 40 and line 38 leading to blood recovery system 36 where the blood may be filtered and retumed to the patient throu~h the ~ ~ ' I ' y bypass system18. Altematively. the position of the valve 40 may be changed by means of arm 71 to discharge blood or other fluid containing tissue, embolism, debris and the like through discharge Iine 41. After sufficient time has elapsed to ensure that debris and embolism-I O free oxygenated blood is being pumped out of the left ventricle 14, the rs~r~ y bypass system 18 is shut down and the occluding member 11 3nd se3ting b31100n IS3re deflated to allow nalUr~l blood flow through the aorta.
The invention provides sever31 advantages, including the ability to perform c..~uv~._u;u. or lI",..~rf.~. u~ c3rdiac procedures while avoiding the need for 1 5 a riskier, more expensive and r . '' ' open-chest c3rdiac pr^vcedure. Further, even in those instances in which a tll~vlOUv~UIII,~ is necessary, the present invention . . . -: l, . ..l ,l~ reduces the risks involved. Additionally, the use of a se,qting member that is expandable within tbe left ventricle in ~, ,1 j -- l;- -, with an aortic occludmg memher greatly enhances the F~ ;i; ly of the occluding member 3nd its resist3nce to 2 0 movement from pressurc pulses while the he3n is be3ting.
Unless described otherwise. the various t---. of the catheter and accessmg system of the present invention c3n be ~'ormed of co~l~, i materials usmg ~UIIV.~.ILiUllUI procedures. T.he tl npn~ nc of the various ~ 3re selected so that they periomm their intended functions in their mtended ~... ~ ;I~/IIII-~ .IL. Moreover, '2 5 while the invention has been described in temms of cenain preferred ~mhoriimPntc it will be apparent to those of ordinary skill in the an that many mnr~ifi~tinn~ 3nd illlUlv ~ a~ c3n he m~de to the invention wilhout dep3rting from the scop~ thereo~ 3s defined on the ~ppended cl3ims.

Claims

WHAT IS CLAIMED IS:

1. An endovascular intra-aortic catheter for providing access to a patient's heart through an aortic passageway leading away from an aortic valve in the patient's heart while isolating the heart from the patient's arterial system, comprising:
a) an elongated catheter shaft which is advanceable through the aortic passageway leading away from the aortic valve of the patient's heart, which has a proximal portion adapted to extend out of the patient and a distal portion adapted to be disposed within the patient's ascending aorta and left ventricle, and which has a first inner lumen extending therein from a port in the distal portion of the catheter shaft to a location in the proximal portion;
b) a first expandable means on the distal portion of the catheter shaft spaced proximally from the port in the distal portion which is configured so that it occludes the aortic passageway within the ascending aorta when expanded; and c) a second expandable means on the distal portion of the catheter shaft located proximally of the port in the distal portion and distally to the first expandable means and which is configured so that it seats within the left ventricle when expanded to secure the catheter as to minimize catheter movement within the aortic passageway.

2. The catheter system of claim 1 wherein the first expandable member is an inflatable balloon having an interior which is in fluid communication with aninflation lumen extending within the catheter shaft from a location within the interior of the first expandable member to a location in the proximal portion which is adapted to extend out of the patient.

3. The catheter system of claim 1 wherein the second expandable member is an inflatable balloon having an interior in fluid communication with an inflation lumen extending within the catheter shaft from a location within the interior of the first expandable member to a location in the proximal portion which is adapted to extend out of the patient.

4. The catheter system of claim 1 wherein a second port is provided in the catheter shaft between the first and second expandable means and a fluid delivery lumen extends within the catheter shaft from the second port to a location within the proximal portion of the catheter shaft extending out of the patient.

5. The catheter system of claim 1 wherein the first and second expandable members are inflatable balloons having interiors, the catheter shaft further comprising an inflation lumen which is in fluid communication with the interiors of the first and second expandable members.

6. The catheter system of claim 5 wherein the inflation lumen extends to a location within the proximal shaft section which extends out of the patient.

7. An endovascular catheter system for providing access to a patient's heart through the patient's ascending aorta, comprising:
a) an elongated catheter shaft which has at least one inner lumen extending therein and which is dimensioned and configured to be advanceable through an aortic passageway leading away from the patient's heart through the ascending aorta;
b) a first expandable means on a distal portion of the catheter shaft which is configured to occlude the aortic passageway when expanded therein;
c) a second expandable means on the distal portion of the catheter shaft, distal to the first expandable means, which is configured to seat within the left ventricle adjacent to the aortic valve when expanded to minimize movement of thecatheter within the aortic passageway; and d) a port in the distal portion of the catheter shaft distal to the second expandable member in fluid communication with the inner lumen which is adapted to withdraw fluid outside of the catheter into the inner lumen.

8. The catheter system of claim 7 wherein the first expandable means is an inflatable balloon having an interior in fluid communication with an inflation lumen extending within the catheter shaft.

9. The catheter system of claim 7 wherein the second expandable means is an inflatable balloon having an interior in fluid communication with an inflation lumen extending within the catheter shaft.

10. The catheter system of claim 7 further comprising at least a second port in the catheter shaft between the first and second expandable means in communication with a second inner lumen extending within the catheter shaft and adapted to infuse a fluid into the aortic passageway between the first and second expandable members.

11. The catheter system of claim 7 wherein the first expandable means is an inflatable balloon having an interior in fluid communication with a first inflation lumen extending within the catheter shaft and the second expandable means is an inflatable balloon having an interior in fluid communication with a second inflation lumen extending within the catheter shaft, such that the first and second expandable members are independently expandable.

12. The catheter system of claim 7 wherein the first expandable means is separated from the second expandable means by a distance selected to allow the first expandable means to be positioned between the patient's coronary ostia and the patient's brachiocephalic artery when the second expandable means is seated adjacent an upstream side of the patient's aortic valve.

13. A method of accessing a patient's coronary anatomy comprising:
a) advancing to a location within a patient's ascending aorta and left ventricle an elongated catheter which has proximal and distal ends, which has an inner lumen extending therein to a port in the distal end and which has first and second expandable members on a distal portion thereof;
b) expanding the first expandable member within the patient's ascending aorta between the coronary ostia and brachiocephalic artery to block blood flow therethrough; and c) expanding the second expandable member within the patient's left ventricle to seat the expanded second member therein.

14. The method of claim 13 further comprising paralyzing the patient's myocardium.

15. The method of claim 14 wherein the step of paralyzing comprises infusing cardioplegic fluid into the ascending aorta through at least one port in the catheter between the first and second expandable members so as to perfuse the patient's myocardium with the cardioplegic fluid through at least one coronary artery.

16. The method of claim 13 further comprising withdrawing fluid through the port in the distal end of the catheter and through the inner lumen to a location outside of the patient's body.

17. The method of claim 13 further comprising passing surgical instruments through the inner lumen of the catheter to a location within the patient's left ventricle.

18. A method for performing an endovascular cardiac procedure on a patient, comprising:

a) advancing to a location within a patient's ascending aorta and left ventricle an elongated delivery catheter which has proximal and distal ends, which has an inner lumen extending therein to a port in the distal end and which has first and second an expandable members on a distal portion thereof;
b) expanding the first expandable member within the patient's ascending aorta between the coronary ostia and brachiocephalic artery to block blood flow therethrough; and c) expanding the second expandable member within the patient's left ventricle to seat the expanded second member therein;
c) withdrawing blood from the patient's venous system, oxygenating the withdrawn blood and returning the oxygenated blood to the patient's arterial system; and d) passing one or more instruments for performing the cardiac procedure through the inner lumen of the delivery catheter.

19. The method of claim 18 further comprising paralyzing the patient's myocardium.

20. The method of claim 19 wherein the step of paralyzing comprises infusing cardioplegic fluid into the ascending aorta through at least one port in the catheter between the first and second expandable members so as to perfuse the patient's myocardium through at least one coronary artery.

21. A system for preparing a patient for a cardiac procedure, comprising:
a) an elongated aortic occlusion catheter adapted to be advanced to a location within a patient's ascending aorta, having proximal and distal ends, having a first inner lumen extending therein to a port in the distal end of the catheter, having a first expandable member on a distal portion thereof which when expanded within the patient's ascending aorta occludes the aortic passageway, and having a second expandable member distal to the first expandable member which is configured so that it seats within the patient's left ventricle when expanded so as to minimize catheter movement within the aortic passageway;
b) a cardiopulmonary bypass system having means to withdraw blood from the patient's venous system, means to oxygenate the withdrawn blood and means to direct the oxygenated blood into the patient's arterial system; and c) means to deliver cardioplegic material to the patient's myocardium.

22. The system of claim 21 wherein the first expandable member on the elongated aorta occlusion catheter is an inflatable member.

23. The system of claim 22 wherein the elongated aortic occlusion catheter has a second inner lumen adapted to direct inflation fluid to the interior of the first expandable member.

24. The system of claim 21 wherein the second expandable member is an inflatable member.

25. The system of claim 24 wherein the elongated aortic occlusion catheter has a third inner lumen adapted to direct inflation fluid to the interior of the second expandable member.

26. The system of claim 21 wherein the elongated aortic occlusion catheter is adapted to withdraw blood from the left ventricle through the first inner lumen thereof and direct the withdrawn blood outside of the patient's body.

27. The system of claim 26 including means to return the withdrawn blood to the patient's vasculature.

28. The system of claim 21 wherein the means to deliver cardioplegic material comprises at least a second port between the first and second expandable members in communication with a second inner lumen in the catheter adapted to infuse cardioplegic fluid into the ascending aorta between the first and second expandable members.