CA1230386A - Atrio-ventricular cardiac pacing catheter - Google Patents
Atrio-ventricular cardiac pacing catheterInfo
- Publication number
- CA1230386A CA1230386A CA000438910A CA438910A CA1230386A CA 1230386 A CA1230386 A CA 1230386A CA 000438910 A CA000438910 A CA 000438910A CA 438910 A CA438910 A CA 438910A CA 1230386 A CA1230386 A CA 1230386A
- Authority
- CA
- Canada
- Prior art keywords
- lead
- catheter
- distal end
- ventricular
- atrial
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- 230000000747 cardiac effect Effects 0.000 title claims abstract description 6
- 230000001746 atrial effect Effects 0.000 claims abstract description 66
- 230000002861 ventricular Effects 0.000 claims abstract description 58
- 210000002837 heart atrium Anatomy 0.000 claims abstract description 23
- 210000000591 tricuspid valve Anatomy 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims 3
- 230000003144 traumatizing effect Effects 0.000 claims 1
- 210000005245 right atrium Anatomy 0.000 abstract description 8
- 210000005241 right ventricle Anatomy 0.000 description 14
- 210000001008 atrial appendage Anatomy 0.000 description 8
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- 241000518994 Conta Species 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 239000004568 cement Substances 0.000 description 2
- 210000003464 cuspid Anatomy 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 210000005246 left atrium Anatomy 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
- 239000002991 molded plastic Substances 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- KRTSDMXIXPKRQR-AATRIKPKSA-N monocrotophos Chemical compound CNC(=O)\C=C(/C)OP(=O)(OC)OC KRTSDMXIXPKRQR-AATRIKPKSA-N 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- BTFMCMVEUCGQDX-UHFFFAOYSA-N 1-[10-[3-[4-(2-hydroxyethyl)-1-piperidinyl]propyl]-2-phenothiazinyl]ethanone Chemical compound C12=CC(C(=O)C)=CC=C2SC2=CC=CC=C2N1CCCN1CCC(CCO)CC1 BTFMCMVEUCGQDX-UHFFFAOYSA-N 0.000 description 1
- 241001272567 Hominoidea Species 0.000 description 1
- 241001237728 Precis Species 0.000 description 1
- 240000004543 Vicia ervilia Species 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 210000001174 endocardium Anatomy 0.000 description 1
- 239000003000 extruded plastic Substances 0.000 description 1
- XUCNUKMRBVNAPB-UHFFFAOYSA-N fluoroethene Chemical group FC=C XUCNUKMRBVNAPB-UHFFFAOYSA-N 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
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- 239000002674 ointment Substances 0.000 description 1
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- 229960004265 piperacetazine Drugs 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
Abstract
ATRIO-VENTRICULAR CARDIAC PACING CATHETER
ABSTRACT OF THE DISCLOSURE
A cardiac pacing catheter system includes a main guiding catheter and a pair of electrical leads adapted to make direct electrical contact with the ventricle and the atrium of the patient's heart.
The main catheter has a pair of lumens which guide and contain the ventricular and atrial leads. Each of the leads can be advanced and manipulated separately and independently within the main catheter body. The lumen for the ventricular lead exits at a port at the distal end of the main catheter body. The lumen for the atrial lead exits along a port at the side of the catheter, at a location proximal of the distal end. The atrial lead is spring-like and is formed with a J-shaped curve at its distal end which, when it exits from the catheter lumen, will assume the J-shaped configuration so that it may be manipulated into direct contact with the more upwardly disposed roof regions of the atrium. In use the catheter is advanced, with the leads retracted, to the entry to the right atrium. The ventricular lead then is extended to the ventricular apex and secured. the atrial lead then is advanced, assumes its J-shaped configuration and is adjusted into position to contact the roof of the atrium.
ABSTRACT OF THE DISCLOSURE
A cardiac pacing catheter system includes a main guiding catheter and a pair of electrical leads adapted to make direct electrical contact with the ventricle and the atrium of the patient's heart.
The main catheter has a pair of lumens which guide and contain the ventricular and atrial leads. Each of the leads can be advanced and manipulated separately and independently within the main catheter body. The lumen for the ventricular lead exits at a port at the distal end of the main catheter body. The lumen for the atrial lead exits along a port at the side of the catheter, at a location proximal of the distal end. The atrial lead is spring-like and is formed with a J-shaped curve at its distal end which, when it exits from the catheter lumen, will assume the J-shaped configuration so that it may be manipulated into direct contact with the more upwardly disposed roof regions of the atrium. In use the catheter is advanced, with the leads retracted, to the entry to the right atrium. The ventricular lead then is extended to the ventricular apex and secured. the atrial lead then is advanced, assumes its J-shaped configuration and is adjusted into position to contact the roof of the atrium.
Description
BACRGROUND OF THE INVENTION
This invention relates to cardiac eatheters of the type used to ~ontrol a patient~ he~rt ~ctivity by providinq electrical pulses ts the heart to pace the heart rhy~hm, The us~ of ~uc~ ~atheters often may be reauired when heart rhYthm malfunctionsO By applyinq electrical pulses directly to the he~rt the rhythmic malfunction may be corrected, at teast temporarily, to reestablish more re~ular heart activity and stabilizP the patient in that condition. Such pacinq techniques are used most eommonly in emergency ~ituations dl~ring pos'c-operative care and in intensive care units for pre-operative as well ~s post-operative care.
Although a variety ~f ratheters with pacinq electro~e~ are av3ilable commercially and ~re in regular clinical use, they are not ~ree from difficulty~ For example, often it is important to establish electrical conta~t ~5 ~uickly ~s possible, ~uch as when trying to restore a functi~ninq heartbeat to a patient under emer~ency ~onditions. The prior devices, however, have not lent themselves to raPid and accurate placemen~ of the electrodes. In ~ome ~echniaues independent electrodes are placed ~eparately throuqh different veins t~ contact ~he ~rium and ventricle. Other device~ have bundled together ~ num~er of electrodes of different lenaths arranged ~o that the lon9er electrodes will reach into the right ventricle while the ~horter electrodes will reach into the right ~trium.
~ 3 -~a~
Still other devices have been ~u~gested, sllch as that in U.S~ patent 3,949,757 to Sabel in which atrial and ventricular leads are contained ~ithin ~ ~heath ~r,d ~n which ~he ~trial lead is slida~le ~ith respect to the sheath ~o that it may be projected into ~urface contact with the atrium wall after the ventricular lead is placed~ Althouqh the device described in the ~abel patent appears to be more conveniently used than the '-prior devi~es, it nevertheless fails to overcome a number of remaining difficulties4 ~or example, none of the prior devices, ~ncluding Sabel, makes for any provision by which the wide variation in heart sizes of varlous patients may be accommodated. In this regard it is desirable, or a numher of t reasons, to place the electrode(s) in direct cont~ct with the heart muccle. Moreover~ ~t is desirab~e that ~ertain regions of the ventricle Dnd atrium (fos example, the sino-atrial node) which are ~cutely sensitive to electrical stimulation, ~e contacted directly by the electrode~ ~owever, because of the wide vari~tion, from patient to patient, of ~he ~e of the heart, no practical device has been proposed which was ~apable of quick and ea~y pl~cement and adjust~ent ~o as to make direct con~act wi~h ~pecific portions of the hear~ muscle, regardlesE
of the size of the patient'~ heart.
It is desirable, when pacing a heart, to contaot the most electrically sensitive ~r*as (~uch as the ~no~atrial node) because that enables l~wer enerqy pulses to he used. The u~e of lower energy pul~es ls desir~ble becsuse it tends to create less in~erference an~ disruption wi~h ~ther electrically c~ntrolled functions ~f the heart. Until the Presen~
invention, precise ~nd reliable pl~cement of the leads in direct contact with s~le~ed p3rtions ~f the heart could not he _ achie~ed reliably and, as a result, it of~en was necessary to apply relatively high energy pulses. Often the lea~ might not a be ~n direct ~ntact with the heart wall ~t ~11, much less in contact with a particularly ~ensitive portion of ~he heart wall. As a result, the higher energy pulse is necessarY ~
overcome the impedance ~f the blood and the distance between the electrode and the heart wall. In addi~ion, aPplyinq a hiah energy pulse also may interere with the sensinq function which often is desirable when pacing. Pacemaking equipment often includes sensing ~ircuitry by which the electical ~ctivi~y ~d condition of the heart may be monitored by th2 electrodes in the intervals between pacing pulses. The conditions sensed can be used o control the nature and timing of the pulses 3pplied to the patient. If it is necessary to apply hi~h ener~y pulses, as has been ~ommon with ~ny of the pr~or devices, that tends to disrupt and interfere with the sensing function of the pacemaker.
Another important ~onsideration ~n rar~i~c pacinq is proper ~ynchroniz~ti~n of atri~l and ventricular functi~ning. Often it is desirable to pace the ~trium ~nd the ventricle in ProPer ~equence so as t~ achieve as near ~s normal heart function as possible. This, ln turn, mav reauire placement of ~n electrode in each of ~he ventricle and the atrium and proper and precise ~ontrol of the pulsinq so that ~hey operate in the~r nor~al 3~
~equence. In some types of rhy~hmic disorders, such as heart blo~k, ~equential pacing ~f both the ~rivm ~nd ventricl~ is es~ential.
Still another difficulty presented with the prior art device~ is the tendency for the electrode leads to become dislodged from their position in the heart as a resu~t of the repeated ~lexing sf the heart ~n its pumpinq action.
Dislodqem~nt or ~hiftin~ of an electrode from its ~ntended position disrupts the pulsing ~nd/or ~ensing ~n~tions with potentially ~erious ~onseouen~es.
It is among the primary objects ~P the invention to pr~vide an atrio-ventric~lar pacing ~atheter which overco~es the foregoing ~nd other difficult~es.
SU~ARY O~ T~E INVF,N~JON
:The present invention includes ~ catheter ~ssembly havin~
main catheter body which receives and provides a quide for a -ventricular lead ~nd an atrial le~d. ~ach of the ventric~ar and atri~l leads i~ slidable in an independent lu~en formed in the ca~heter ~ ~h~ ~he ven~r~u~r and ~r~l leads are ~lidable independently with respect to the catheter and to ea~h ~ther. The lumen for the ventri~ular le~d has an exit POrt ~t the most distal end of the main catheter. The lumen for the atrial lead has an exi~ Por~ lo~ated proximally of the most dis~al end of .he ~atheter.
~ ~23~
In accordan~e with one of the objects of the ~nvention, ~he device is arran~ed ~o that the ventricular lead may be advanced into ~onta~t ~ith the ventri~ular ~pex ~nd the atrial lead may be advanced into ~ntact with the ~tr~l appenda~e. The ventricular apex ~nd ~trial appendage each define ~o~ewhat L
concave surfaces within the heart ~nd Provide ~oncave surf~c~s which tend to provide ~n in~reased degree of stabili~y for an electrode which bears against that surface under a li~ht ~pring-like pres~ure. ~he atrial appendage i~ located in the ro~f region of the ~trium in close proximity to the electrically ~ensitive ~ino-atrial nodeO Because the ~ino-atrial node as well as the atrial appendage ~re in the r~of region of the atrium~ they ~re difficult to rea~h, it being amon~ the ~bjects of the invention 40 provide an imProved system which facilitates makin~ direct electri~al sontacL with those roof regions of the atriumO
When in use, the leads are positioned in the main ~atheter wlth their dist31 tips ~cated just inwardly of thelr respective exit port~ and the ~ssembly is advanced~ in that ~onfiguration~ thr~uqh the patient'~ vein ~the ~uperior vena cav~ until the di~tal end of the catheter is just ~ the entry to the right atrium. The ~atheter is ~ecured in that position. The ventricular lead then is ~dvan~ed through the catheter ~o that its distal tip may pass thr~ugh the ri~ht tri~uspid valve of the heart and into the right ventricle. The dist~l end of the ventricular lead is provided ~ith a balloon which, lf the pa~ent has any blood flow, may ~e inflate~ durinq 3~
the insertion procedure to help to advance the ventricular lead through the tricuspid valve and into the riqht ventricle with the blood flow. Once in the right ventricle the balloon is _ deflated ~o that the electrode at the distal tip of ~he ventricular lead can be urged into a stable position in contact with the ventricular apex. Ventricular pacinq may beqin immediately upon contact with the electrode(s) ~t the distal tip of the ventricular lead with the surface of the ventricle.
Once the ventricular lead is secured in place and is functioning to pace the patient~ ventricle~ the atrial leaæ
ay be placed. That is accomplished simply by manipulating the proximal end of the atrial lead to advance ~he atrial lead and cause tne distal end to Proiect DUt of the ~trial lumen. Jn the present invention the outlet for the atrisl lumen is located proximally of the outlet for the v~ntricular lead and the lumen is located offset from the center of the main catheter. As the atrial lead emerges from i~s exit port, i~s distal ~ip assumes a J-shape and it will be in a better position to rea~h and contact the roof reqion of ~he atrium and the concave urfa~e of the atrial appendaqe. The device is arranged so that the atrial leafl may be controllably manipu~ted from ~ts proximal end in longitudinal as well as ~otational directiGns. Thus, the invention provides a high deqree of control in the placement of the atrial lead. The proximal end of the atrial le3d is provided with suitable markinqs tv facilitate positioning. Means (~uehy-80rst ~ 3 ~
adapters) are provlded to ~ecure the leads in their respective positions with respect to the catheter~
It ~ amon~ the general object~ of the invention to provide an improved atrio-ventricular pacinq catheter system.
Another object of the invention i~ to provide an atrio~ventricular pacin~ catheter whi~h can be deployed and placed r~pidly.
A further obje~ of th~ invention is t~ provide ~n ~trio-ventricular catheter which facilitates pla~ement of the electrical leads in ~table p~sition~ in each of the ventricle ~nd atrium.
Another object of the invention is to provide an atrlo-ventricular pacing c~theter which assures direct conta~t with khe surface of the heart ~nd which reuuires a low level signal for pacing.
A further ~bject of the invention i~ to provide a devi~e of the type described which may be used with equal facility with wide range o~ heart ~izeæ.
Another object of the ~nvention is to provide a device of the type des~ribed which ~s easier to use than with previous devices.
~ till another ob~ect ~f the invention is to provide a device of ~he type ~escribed which requires minimal adiustment but, ~f ~djustment is zequired, it may be a~c~mpli~hed ~uickly ~nd easily a _9_ Yet another object of the invention is to provide a device for introducinq two ~eparately and independ~ntly manipula~le cardiac electrodes through a ~ingle introduction site therebY
reducinq the chance of ~nfection and minimi~in~ tr~uma to the pat~ent'~ v~culature.
DESCRIPTION OF T~ DR~wINGS
The fore~oing and other obje~ts and a~v~nta4es of the invention will be appreciated more fully fr~ the followin~
urther description there~f, with reference to the ~ccompanyina dra~ings wherein:
FIG. 1 i~ an illustration, p~rtly broken away, of the ~a heter assem~ly includin~ the catheter containing the ventricular and ~trial leads p~sitionPd as they would be when the ~ssembly i5 introduced to he patient:
F.IG. lA i~ ~ ~ectional illustration of the bifur~ati~n of the ~athe~er;
FI~. 2 ls a cros~-~ection of the ~atheter ~ssemhl~ ~s ~een along line 2~2 of ~IG. l;
~ IG. 3 is ~ plan illustration of the di~tal portion of the catheter as ~een ~long the line 3-3 of ~IG. i;
~ IG. 4 i6 an enlarged ~ectional ~llustration ~f the distal portion of ~he catheter as ~een alonq the line 4-4 of FIG. 3 and illus~r~ting the position~ of the dis~al ends of ~he ventr~cular and atrial leads when ~he ~ssembly i5 in~roduced into the patient:
FIG. 5 is ~ illustration of the ventricular lead showin~, ~n phant~m, a flo~ assist hal70~n ln ~t~ inflated ~onfiqur~iOn;
FI~. 6 is an enlarged illustration of ~he distal end of the ventricular lead;
FIG~ 7 is an illustration of the atrial lead;
~ IG. 7A is an 111ustrati~n of the proximal ~nd distal ends ~f the atrial lead showin~ the plane of the zelaxed ~urved distal end and its ~lignment with lndicia at ~he proximal end;
FIG. 8 is an enlar~ed illustration o the distal tiP cf the atrial lead;
FIGS. 9-16 illustrate di~gramatically p~rtions of u patient~s heart and the manner in which the present invention is used.
DESCRI PTION OF ~HE PREFER~D EMBODIM~I~T
. . .
As ~hown in FIG. 1 the catheter assembly-includes ~ main catheter 10 which may be extruded :Erom an appropriate plastic material ~uch ~ a fluoroethylene polymer, The main cath~ter 10 ls formed with a pair of lumens, including a ventr~eular lead lumen 12 and an atrial l~ad lumen 14. The ventricular lead lumen 12 i~ ger ~n di~meter than the atrial lead lumen 14 and i~ intended to receive the relatively larqer d;a~eter ventricular lead 16, The ~maller lumen 14 ~lidably receives the ~tri~l lead, $ndicated generally at 1~. The lumens 12, 14 are ~rrhn~ed side-by-~ide with ~t lea~t the ~trial lumen 1~
being displa~ed from the central ~xis of the main catheter ~00 Wll -3~3~
The ventricular lumen l? extends fully ~lonq the length of the main catheter 10 and terminates in an exit port 20 at the _ distal t~.p ~f the ~ain c~theter 1OA The atrial lead lumen 14 terminates in an exit port 22 which i~ spaced proxim~lly fr~m the di~tal end of the catheter 10. ~n the preferred emhodiment of the invention the exit port 22 for the atrial lead 18 is disposed ~pproximately one ~enti~eter proxim311y of the ventricular lead outlet 200 When the ~trial lead 18 is advanced through the lumen 14, it will emerge from exit port 22 before reaching the distal tip of the ~atheter ln and, as wi~l be described~ will assume a J-~haped configuration 3s it emerges from the exit port 220 The proximal portion of the main satheter ln ~s bifurca ed to include and define an atrial guide tube 24 and 3 ventricular guide tube 26. The ventricular guide tuhe 2~ may be defined hy a ~ontinuation of the main catheter 10 with the atrial le~d lumen 14 obstructedO The ~tria~ guide tube 24 may be formed rom a ~eparate tube whi~h i~ ~pli~ed to the main catheter 10 ~o that it communi~ates only with ~he atrial lead lumen 14 as ~uggested in FIG~ lA. The ~pliced region may be encapsulated in ~ molded plastic fitting 28. The distal portion 29 of the molded fitting 28 preferably i~ formed with a taper ~o th~t it may be deta~hably locked to corre~pondin~ fitting on a catheter intrsducer, ~s will be des~ribed in further det~
The proximal end ~f each of the atria3 and ventricular guide tubes 24, 26 preferably i~ provided with a ~tandard luer fitting 30. Ea~h ~f the luer fit~ings 30 preferably is - 1?-provided with a l~ckablet ~ealing fitting ~ndicated ~t 34, ~chas, for example, a ~uehy-Borst fitting. The ~ittinqs 34 enable an elemént, ~uch as he 3tri~1 ~r ventricular lead ~o ~e passed through the fitting ~nd then tightened to lock the le~ds 1~, 18 in place and effect a seal about the lead, as will be described in further detail.
The ventricular le~d 16 ~ shown ~n further det~il ln FIGS.
5 and 6. It i~ substantially longer than the auide catheter 10 and, fo~ ~xample, may be ~f the order of fifty centimeters long. The lead 16 may be formed from a ~lender tu~e 48 of extruded plastic with insulated electrical wires 40, 42 carried in the tube 48. As ~h~wn in ~urther detail in FIG. 6 the ventricular lead 16, in ~ccordance with the present invention, is bipolar, having a pair of ~pa~ed ring electrDdes 36, 38 at its distal end. Each of the electrodes 36, 38 i~ electrically conne~ted to lnsulated wires 40, 42 whi~h emerge at the proximal end of the lead ~nd terminate in ~onnectors 44, 4~
(see FIG~ 5). The tube 4B emerges ~t the proximal end of the ventricular lead ~nd 1~ ~onnected to ~ ~topcock 52. ~he tube 48 thus ~lso defines ~n lnflat~n lumen 53 for a balloon 54 whiEh is attached to the distal end of the lead, betw~en the ring electrodes 36, 3B~ ~he ventricular lead ~s provided with a molded plastic member 5~ at the trifurcated re~ion of the tube 48 ~nd wire~ 40, 42. A~ will be descri~ed in further detail, the balloon 5~ may be ~nflated tD f~cilitate quidance of the ventricular lead ~nto proper placement and advancement thrsugh the tricuspid valve ~nd lnto engagement with the ventricular ~pex. _ Th~ ~trial lead lB is illustrated ln FIGS. 7 and 8 and may be ~bout forty centimeter~ long. The lead 18 i~ illustrated as being monopolar and formed fr~m a wound ~;prinq wire 19 havinc~ a centr~l core ~re 21 ~imilar to conventional construction for d ~pring ~uide. The core wire, however, terminates appr~ximat~ly eight millimeters ~rom the distal tip of the lead so that the distal re~ion will be ~oft and flexibleO The proximal end ~f the atrial lead includes a connector plug 58 for ~ttach~ent to a pacemaker. The atrial lead 18 is covered, ~lonq i~s leriqth, with an in~ulative jacket 23 whi~h may ~e formed from ~
~hrinkable pla~t~c9 ~hrunk onto the ~prlng wound lead. ~he jacket 23 may be formed, for example, from TFE plastic and ~overs all of the lead except for the most distal ~ive millimeters which ~erves a~ the atrial electrode.
As shown in ~IG. 7 the distal end of the ~trial lead 18 ~s formed ~o that when in ~ relaxed ~tate it will assume somewhat of a J-shaped configuration having a curved seament ~0 and a ~ost distal ~t~aight ~egment 62. ~he curved ~egment 60 extends throuqh an arc of Dpproximately 1509. The diameter of the ~tr~al lead 18 i5 approximately 2 French (oO26n) ~nd, therefore, is flexible ~o that the ~trial lead lR can flex easily ~o n 6traight confi~uration ~o as t~ be ~ontained fully and be slidable easily within the atrial lead lu~en 14 of the main c~heter 1~.
The manner in which the invention ~ay be used is described with reference to FIGS. 9-16 which ~llustrate the human heart and the various positions ~f the di~tal portions of th~ main catheter 10 and leads 16, 180 As ~u~qested diaqramatically in FIG. 9, in a properly functionlng heart blood returns from the '.
venous 6ystem through the ~uperior vena cava (1dentified as SVC
in the drawings) and inferior vena cava (IVC) the righ~ atrium ~RA) of ~he heart. ~hen the right atrium ~ontra~ts it pumps blood through the one-way tri~uspid valve ~TCV) and into the ri~ht ventricle (RV). The right ventricle (RV) then contr~cts to close the tr ~cuspid valve (TCV) under pressure ~nd to pump blood through the pulmonary ~rteries (PA) to the lun~s where the blo~d is oxygenatea. The oxygenated bl~od ~hen flows through the pulmonary veins 'co the left atrium (LA), through the left tricuspid valve ~nd hen into lthe left ventricle (LV~. The left ventricle pumps b~ood throu~h ~he aor~ca (A) throu~hout the body ~nd then through the venous ~ystem to return the blood to the heart ~nd renew the ~ycle.
As will be des~ribed in fur~her det~il, one facet of he invention relates to the ~bility of the leads t~ ~e pla~ed in ~oncave pQrtions of the atrium ~nd ventricle which will tend to re~ain the electrodes ~n ~ ~table ~sltion ~o thst the electrodes will not become dislodged as ~he heart flexes and pumps repeatedly. ~o that end, the present inventi~n ~ontemplates engaging the ventricular lead with the ventricular apex at the lower most portion o~ the riqht ventri~le ~s indic3teZ ~t 64 in F~G. 9. The ventricular apex is ~oneave and ~15-., ~ , . . . . . . . . .
~ 3 i~
provides a ~table lDca~ion from which ~he electrodes a~ ~he end of the ventr~ular lead will no become dislodge~ from their contact with the hear wall. The ventri~ular ~pex 64 i~
conside~ed a ~atisfactory loc3tion in which to make electrical ~ontact between the ventricular lead both for pacing rlnd ~ensing functiDns., In ac~ordance with the present invention the por~ion Df the right at:rium whici- most desirably is con'cacted with the ~trial lead i~ 'che atrial appendage 6~, a portion of the hear ~7hich i~ located in the roof re~ion of the ~trium which defines concave surface; as would ~e ~een from within the atrium.
Although the atrial appendage 65 :1~ not as ~ensitiYe electrically as the ~ino-atr~D node, lindicate9 at 67 in FIG.
9) it i~ 3djacent ts:~ the ~ino-~trio node and, therefore, is close enough to it ~o as 'co provide ~ubs'cantially lc~w impedance for. 'che pacing and ~ensing ~ignals to be hlyhly efiEective. The atrial appendage 65 is a relat~vely delicate membran~ portion of the heaxt and it is imPortant, therefore~ that the ~stria~
lead be constru~ted to that it will maXe ~ntact in a very del icate manner .
Norn:ally the ~elf-regulating ele~trical activity sf the heart causes the right atrium RA ~nd right ventri~le RV to contract in ~equence, with the right ~trium RA contractin~
fir~t to pump bl~d thr~ugh the tr~cuspid ~alY2 TVC and into the rlght ventricle RV, with the right ventri~le RV ~ontr~ctinq ~fter 3 sh~rt delayO The delay in the c~ntractions ~f the right atrium RA ~nd right ventricle RV are ~ufficient to enable ~ ~ ~(3~ ~
the atrium to pump blood through the tricuspid vallJe T~V and into the right ventricle RV.
Various disorders can occur with respect to the electrical control of the heart's ~unction. Typically, when there is a disruption in the normal electrical activity of the heart, it is essential first to reestablish a regular rhythm in the right ventricle so as to maintain at least a sufficient flow of blood to the lungs so as to provide at least a minimally sufficient supply of oxygenated blood to the patient. It is 10 preferred, and in some instances it is necessary, also to establish a proper sequential rhythm for the atrium so as to maximize the pumping efficiency of the heart. Thus, as soon as possible after the ventricular lead has been pl~ced and pacing has begun, it is desirable to place and begin pacing 15 with the atrial lead.
The catheter 10 of the present invention is introduced intravenously, preferably through the in-ternal jugular or subclavian vein which leads to the superior vena cava SVC.
Any of a variety of well-known techniques may be employed, 20 such as inserting a catheter introducer percutaneously to provide access to the vein. The device is arranged so that the leads 16, 18 are within their respective lumens 12, 14, with their distal ends located just proximally of their openings 20, 22 (as suggested in ~IG. 4) in readiness 25 to be advanced. The assembly, with leads so positioned, is advanced through the catheter 10 introducer until the distal tip of the catheter is at the region of the juncture between the superior vena cava SVC and ~L~3~
the right atrium RA as illustrated in ~IG. 10. The procDdure preferably is monitored on ~ fl~oroscoPe ~rom which the positioning ~f the various elements can be verified. The assembly should be positioned ~o that ~he outlet p~rt 22 of the catheter 10, from whi~h the di~sl end of the a$rial lead ~ill emerge, $~ ~ufficiently ~l~se to or jus~ wi~hin ~he a~rium so as to ~sure that the ~trial lead will advance and ex~end properly into the uPper re~ion of the atrium, as will be described. ~hen the catheter 10 is positioned properly, it is secured in place by any of a number of means, ~uch as by tapin~
it firmly to the patient or by ~ecuring the tapered p~rtlvn 29 of fittin~ 28 to the convention~l fit~in~ at the proximal end of the introdu~er, or by a combination, Once the guide ~atheter 10 is placed, it will not have to be moved again, until it is to be removed.
~ he ventricular lead 16 then is advanced, the se21inq qland 34 first being released to free the ventri~ular lead for movement. If the balloon i~ to be ~nfl~ted, ~s ~ugqested ~n ~IG. 11, the ventricular lead 16 then is advan~ed ~ htly to project the balloon tip ~utwardly beyond the distal openinq 20. The ballo4n may be inflated with ~arb~n dioxide g~s by a ~yringe connected to the ~topc~ck S2. With the ~all~on ~nflated, the ventricular lead i~ advanced throuqh the main ~atheter 10. The balloonD when used, fl~ws with the blood flow and provides assured guidance that the ventri~u7ar lead 16 will flow to and through the tri~uspid valve TCV into the right ventricle RV instead ~ passing downwardly into the inferior vena cava IVC or at ~ome other angle. The balloon may be used with some effectiveness only when the heart has ~ome pumpinq function ~nd there i5 80me ~lood flow. ~hen there i~ no pumping function ~nd no blood flow the ~ystem may be used without inflating the balloon.
Once the distal end of the ven~ri~ul~r lead is in the right ventricle R~ (as ~uggested in phantom in F~G. 11~ the balloon is deflated (if it was previously infl~ted) and the distal end of the ~entricular lead i~ advanced into the pocket-like ventricular apex 64. The ventricular lead is ~dvanced to the position shown in ~I~. 12 in which it ig assured that its distal end has been bent ~o that both ring electrodes 3fi, 38 are in ~ontact with the heart mu~cle, in the re~ion of the 3pex 64 a~ shown in enlaraed det~il in FIG. 13. Proper e~ectrical contact with the ring electrodes 3~ 3~ can be as~ured ~y monitoring the electrical paoing device and sensinq feedback signals indi~ative of the proper electrical ~ontact. ~hen the surgeon i~ ~atisfied that the ventri~ular lead lfi is properly placed, ~ecurely contained within ~he po~ket defined by the ventrioular ~pex ~nd in good direc electrical contact with the heart, the ventri~ular le~d is lo~ked in place by fastening the ~uehy Bors~ ~dapter 340 ~ n the illustrative embadiment, the preferred electro~e config~ration for the ventr~cular lead is bip~l~r~ that is, there are two ring electrodes 369 38 which wlll contact electrically the ~urface of the heart ~uscle~ Dt the ventricular apex. By ~pply a pulse ~ross these two cl~sely ' -19-~paced *lectr~de~, only that portion of the heart which 1~ in f the resion of the ele~trodes i~ affe~ted ~y the pulse. Because electrical activity wlthin the heart muscle is very ~omplex it is desirable to apply pul~es only at ~ location and of an energy level ~hich will be ~uffi~ient to pace the heart but without disrupting any other electrical fun~tion of the heart.
~hu~7 w~th the bipol~r ventricular lead ~hown in the illustrative embodiment, ele~trl~al energy is ~pplied only to the heart in a ~mall localized region ~ufficient to pace ~nd to sense the activity of the riqht ventri~le and ~Ithout ~ffectinq other portio~s of the heart'~ electr~c~l ~ctivity.
After he ventricular lead 16 has been placed, the atrial lead 18 is placed. The ~ealing gland 34 ~ssoci~ted with the ~trial lead i~ unlo~ked and the atrial lead 18 is advanced go that its distal end emerges from the outlet port 220 As the ~trial lead emerges, the most distal straiqht ~egment 62 will emerge, paralleling the catheter 1OJ ~5 ~ug~ested in ~IG. 140 As advan~ement of the atrial lead continues, the ~ur~ed se~ment 60 begins to emerge from ~he outlet port 22 and the lead be~ins to assume its J-~h~pe as Isuggeslted in Fl(; 15. Before the ~trial lead expands co it~ normally relaxed, full J-~onfiguration, the dist~l tip will enga~e ~nd dr~g ~gainst the upperm~st roo~ surf~es r~ the right atrium ~A~ as ~ugclested in FIG. 16. Further a~vancement of the atri~l lead will project lt more distally out of the exit port 22 ~nd downwardly frc~n the ro~f of the atrium until it assume~ a fully rel~xed ~onfigur~tion. The surgeon then may c~ontrol the -2û-position of the atrial lead by manipulating i~ from its proximal en~, both longitudinally and rotationally, By ~ch m~nipulation the ~urgeon can place the electrode at the distal tip at preci~ely the location on the r~of reqion of the atrium as he desires. This enables the s~rgeon to place the atrial electrode precisely aqainst the concave atrial appendaqeO A~
described ~bove, the atrial appendage defines ~omewhat of a ~oncave socket which provides a ~table ~ocation f~r electFode ~ontact. The urgeon can verify that c~nt~ct has been made with the atri~l appendage by monitoring feedback of electri~al signals. ~hen the ~uryeon i5 ~atisfied that the atrial lead is ln proper contact, the Tuehy Borst adapter is tightened down about the atrial lead to ~ecure lt in position.
The foregoing description ~f the ~trial lead has related to a monopolar con~iguration, in which the distalmost tip defines a single electrodeO A qr~unding electrode for use with the mon~polar electr~de may be in the form of an externally applied electrode patch ~uch ~s the type commonly used {n electrocardiogram procedures. AlternatelyO the ~tr~al lead may be ~ormed so ~s to be bipolar, in ~imilar manner ko the biPolar configuration ~f the ventri~ul~r lead. Whether monopolar or bipolar, ~t is $~portant ~ha~ the distal ~ip ~ the ~trial lead be flexible nd resilient to ~s~ure avoidance of trauma to the delica~e memhranes $n the roof region of the ~trium.
~ i~h the main ~atheter 10 and b~th leads 16, 1~ ~ecured in position, and particularly when ~he ventricular and a~rial leads ~re in enga~ement with the ventr~cular apex 3nd atrial appendage, respectively~ the ~oncav2 contacting regions materially reduce the chances og the leads becoming dislodqed under ~he ~nfluen~e of the pump~ng action of the heart.
F~om the foregoing it will be appreciated that the present invention may be used with ~11 patients, regardless of variations in heart size, because each of the leads is positioned independently with respect ~o each other and also independently with re~pect to he ~atheter~
~ eans also are provided to fscilltate positioninq ~nd orientation ~f the ~trial lead by reference to the rel~tive positi~n of the proximal end of the lead ~s compared to the catheter 10~ To that end~ the proximal end of the atrial lead preferably is marked with indicia indicated at 6~ in ~IG. 7A to indicate the radial plane in which the distal end portions 6n, 62 of the atrial lead project. By comparin~ the portion of marking 66 with the position of the guide tube 24, or ~ome other ~ndicia indi~ting the side of the guide catheter 10 where the outlet port 22 ~s located~ the æur~eon can determine the rela~ive angul~r posi~ion ~f ~he dis~al end of the atrial lead with respect to the ~ain catheter and, therefore, with respect to the patient's heart. By u~in9 ~u~h reference points the surgeon will be able to direct the distal en~ of the atrial lead in~o close proximity, lf not pre~ise ~onta~t with the atrial appendage quickly ~nd ~ith minimal manipul~ti~n.
Also ~mong the features ~ the invention is the rel~tiYe locatiDn of the exit port 22 with xe~pect to the distal tip of the catheter 10. When the ~theter 10 is positioned so that 1~3(~
lts di~tal tip 20 is located ju~t a~ the juncture of ~he ~uper~or Yena ~ava Svc and th~ r~ght ~trium RA, the exit port 22 for the ~trial lead will ~e located somewhat within the _ superior vena cava. However, a~ the atrial lead emerges from the opening 22 it advances ~ubstantially along ~nd parallel to the catheter 10 ~nd begins to assume its curl just as the a electrode tip of the atri~l lead enters i~to the upper portion of the atrium. ~h~s, as the ~trial lead is ~dvanced it will begin ~t~ curl in close proximity to the roof of the atrium and will contact ~nd brush ~qainst the roof o the ~trium ~efore it assu~,es its fully opened J-sonfiguration. If the ~urgeon has ~dvanced the atrial lead in a rotative position which would cau~e the atrial electrode to contact the a~rial appendage directly, then the atrial lead may be se~ured in that position immediately. Otherwi~e, the atEial lead may be advanced fur~her into ~he atrium, to enable the J to expand fully, free of the ~trial wall, so that the ~urgeon ~an r~tate the atr~al lead to the desired ~ngular position ~nd then draw the lead proximally to br~ng it intc ~ontact w~th the ~trial ~ppendaqe.
~rom the foregoinq 1~ will be ~ppreciated that the present invention provides ~i~nificant advant~ges over the prior ~rt and the pre~ently employed ystems. The ~ystem c2n be used wi~h e~ual effectiveness on ~ny patient regardless of the ~i7e ~f the patien~' hear~. It enables rapid deploymen~ of the ventricular and a~rial leads in sequence. It enables both ventri~ular l~ad ~nd atria~ lead to c~ntact conoave regions of the ventricle and atrium respectivelyO and particularly ~he ~3-8~
~trial appendage of the right atrium to ~ssure the mechanicallY
stable positioning a~ both ~en~ricular ~nd atrial leads so that they will not likely be dislodged a~ a resul~ of pumping action of the heart. ~oreover, these advantaqes are achieved in a pacing/s~ensing ~atheter in ~hich the electrodes make direct contact with the endocardium thereby reducing the amount of power which must be applied to the leads and enablin~ more precise ~ontrol of the pacing ~nd sensinq functions.
It should be understood~ ho~ever, that the foregoing description of the invention i~ intended merely to be ~llustrative and that other embodiments and modifications may be ~pparent to tho~e skilled in the ~rt without departinq from its ~pirit.
Havinq thus described the invention ~hat T desire to claim and secure by letters paten~ is:
~24-
This invention relates to cardiac eatheters of the type used to ~ontrol a patient~ he~rt ~ctivity by providinq electrical pulses ts the heart to pace the heart rhy~hm, The us~ of ~uc~ ~atheters often may be reauired when heart rhYthm malfunctionsO By applyinq electrical pulses directly to the he~rt the rhythmic malfunction may be corrected, at teast temporarily, to reestablish more re~ular heart activity and stabilizP the patient in that condition. Such pacinq techniques are used most eommonly in emergency ~ituations dl~ring pos'c-operative care and in intensive care units for pre-operative as well ~s post-operative care.
Although a variety ~f ratheters with pacinq electro~e~ are av3ilable commercially and ~re in regular clinical use, they are not ~ree from difficulty~ For example, often it is important to establish electrical conta~t ~5 ~uickly ~s possible, ~uch as when trying to restore a functi~ninq heartbeat to a patient under emer~ency ~onditions. The prior devices, however, have not lent themselves to raPid and accurate placemen~ of the electrodes. In ~ome ~echniaues independent electrodes are placed ~eparately throuqh different veins t~ contact ~he ~rium and ventricle. Other device~ have bundled together ~ num~er of electrodes of different lenaths arranged ~o that the lon9er electrodes will reach into the right ventricle while the ~horter electrodes will reach into the right ~trium.
~ 3 -~a~
Still other devices have been ~u~gested, sllch as that in U.S~ patent 3,949,757 to Sabel in which atrial and ventricular leads are contained ~ithin ~ ~heath ~r,d ~n which ~he ~trial lead is slida~le ~ith respect to the sheath ~o that it may be projected into ~urface contact with the atrium wall after the ventricular lead is placed~ Althouqh the device described in the ~abel patent appears to be more conveniently used than the '-prior devi~es, it nevertheless fails to overcome a number of remaining difficulties4 ~or example, none of the prior devices, ~ncluding Sabel, makes for any provision by which the wide variation in heart sizes of varlous patients may be accommodated. In this regard it is desirable, or a numher of t reasons, to place the electrode(s) in direct cont~ct with the heart muccle. Moreover~ ~t is desirab~e that ~ertain regions of the ventricle Dnd atrium (fos example, the sino-atrial node) which are ~cutely sensitive to electrical stimulation, ~e contacted directly by the electrode~ ~owever, because of the wide vari~tion, from patient to patient, of ~he ~e of the heart, no practical device has been proposed which was ~apable of quick and ea~y pl~cement and adjust~ent ~o as to make direct con~act wi~h ~pecific portions of the hear~ muscle, regardlesE
of the size of the patient'~ heart.
It is desirable, when pacing a heart, to contaot the most electrically sensitive ~r*as (~uch as the ~no~atrial node) because that enables l~wer enerqy pulses to he used. The u~e of lower energy pul~es ls desir~ble becsuse it tends to create less in~erference an~ disruption wi~h ~ther electrically c~ntrolled functions ~f the heart. Until the Presen~
invention, precise ~nd reliable pl~cement of the leads in direct contact with s~le~ed p3rtions ~f the heart could not he _ achie~ed reliably and, as a result, it of~en was necessary to apply relatively high energy pulses. Often the lea~ might not a be ~n direct ~ntact with the heart wall ~t ~11, much less in contact with a particularly ~ensitive portion of ~he heart wall. As a result, the higher energy pulse is necessarY ~
overcome the impedance ~f the blood and the distance between the electrode and the heart wall. In addi~ion, aPplyinq a hiah energy pulse also may interere with the sensinq function which often is desirable when pacing. Pacemaking equipment often includes sensing ~ircuitry by which the electical ~ctivi~y ~d condition of the heart may be monitored by th2 electrodes in the intervals between pacing pulses. The conditions sensed can be used o control the nature and timing of the pulses 3pplied to the patient. If it is necessary to apply hi~h ener~y pulses, as has been ~ommon with ~ny of the pr~or devices, that tends to disrupt and interfere with the sensing function of the pacemaker.
Another important ~onsideration ~n rar~i~c pacinq is proper ~ynchroniz~ti~n of atri~l and ventricular functi~ning. Often it is desirable to pace the ~trium ~nd the ventricle in ProPer ~equence so as t~ achieve as near ~s normal heart function as possible. This, ln turn, mav reauire placement of ~n electrode in each of ~he ventricle and the atrium and proper and precise ~ontrol of the pulsinq so that ~hey operate in the~r nor~al 3~
~equence. In some types of rhy~hmic disorders, such as heart blo~k, ~equential pacing ~f both the ~rivm ~nd ventricl~ is es~ential.
Still another difficulty presented with the prior art device~ is the tendency for the electrode leads to become dislodged from their position in the heart as a resu~t of the repeated ~lexing sf the heart ~n its pumpinq action.
Dislodqem~nt or ~hiftin~ of an electrode from its ~ntended position disrupts the pulsing ~nd/or ~ensing ~n~tions with potentially ~erious ~onseouen~es.
It is among the primary objects ~P the invention to pr~vide an atrio-ventric~lar pacing ~atheter which overco~es the foregoing ~nd other difficult~es.
SU~ARY O~ T~E INVF,N~JON
:The present invention includes ~ catheter ~ssembly havin~
main catheter body which receives and provides a quide for a -ventricular lead ~nd an atrial le~d. ~ach of the ventric~ar and atri~l leads i~ slidable in an independent lu~en formed in the ca~heter ~ ~h~ ~he ven~r~u~r and ~r~l leads are ~lidable independently with respect to the catheter and to ea~h ~ther. The lumen for the ventri~ular le~d has an exit POrt ~t the most distal end of the main catheter. The lumen for the atrial lead has an exi~ Por~ lo~ated proximally of the most dis~al end of .he ~atheter.
~ ~23~
In accordan~e with one of the objects of the ~nvention, ~he device is arran~ed ~o that the ventricular lead may be advanced into ~onta~t ~ith the ventri~ular ~pex ~nd the atrial lead may be advanced into ~ntact with the ~tr~l appenda~e. The ventricular apex ~nd ~trial appendage each define ~o~ewhat L
concave surfaces within the heart ~nd Provide ~oncave surf~c~s which tend to provide ~n in~reased degree of stabili~y for an electrode which bears against that surface under a li~ht ~pring-like pres~ure. ~he atrial appendage i~ located in the ro~f region of the ~trium in close proximity to the electrically ~ensitive ~ino-atrial nodeO Because the ~ino-atrial node as well as the atrial appendage ~re in the r~of region of the atrium~ they ~re difficult to rea~h, it being amon~ the ~bjects of the invention 40 provide an imProved system which facilitates makin~ direct electri~al sontacL with those roof regions of the atriumO
When in use, the leads are positioned in the main ~atheter wlth their dist31 tips ~cated just inwardly of thelr respective exit port~ and the ~ssembly is advanced~ in that ~onfiguration~ thr~uqh the patient'~ vein ~the ~uperior vena cav~ until the di~tal end of the catheter is just ~ the entry to the right atrium. The ~atheter is ~ecured in that position. The ventricular lead then is ~dvan~ed through the catheter ~o that its distal tip may pass thr~ugh the ri~ht tri~uspid valve of the heart and into the right ventricle. The dist~l end of the ventricular lead is provided ~ith a balloon which, lf the pa~ent has any blood flow, may ~e inflate~ durinq 3~
the insertion procedure to help to advance the ventricular lead through the tricuspid valve and into the riqht ventricle with the blood flow. Once in the right ventricle the balloon is _ deflated ~o that the electrode at the distal tip of ~he ventricular lead can be urged into a stable position in contact with the ventricular apex. Ventricular pacinq may beqin immediately upon contact with the electrode(s) ~t the distal tip of the ventricular lead with the surface of the ventricle.
Once the ventricular lead is secured in place and is functioning to pace the patient~ ventricle~ the atrial leaæ
ay be placed. That is accomplished simply by manipulating the proximal end of the atrial lead to advance ~he atrial lead and cause tne distal end to Proiect DUt of the ~trial lumen. Jn the present invention the outlet for the atrisl lumen is located proximally of the outlet for the v~ntricular lead and the lumen is located offset from the center of the main catheter. As the atrial lead emerges from i~s exit port, i~s distal ~ip assumes a J-shape and it will be in a better position to rea~h and contact the roof reqion of ~he atrium and the concave urfa~e of the atrial appendaqe. The device is arranged so that the atrial leafl may be controllably manipu~ted from ~ts proximal end in longitudinal as well as ~otational directiGns. Thus, the invention provides a high deqree of control in the placement of the atrial lead. The proximal end of the atrial le3d is provided with suitable markinqs tv facilitate positioning. Means (~uehy-80rst ~ 3 ~
adapters) are provlded to ~ecure the leads in their respective positions with respect to the catheter~
It ~ amon~ the general object~ of the invention to provide an improved atrio-ventricular pacinq catheter system.
Another object of the invention i~ to provide an atrio~ventricular pacin~ catheter whi~h can be deployed and placed r~pidly.
A further obje~ of th~ invention is t~ provide ~n ~trio-ventricular catheter which facilitates pla~ement of the electrical leads in ~table p~sition~ in each of the ventricle ~nd atrium.
Another object of the invention is to provide an atrlo-ventricular pacing c~theter which assures direct conta~t with khe surface of the heart ~nd which reuuires a low level signal for pacing.
A further ~bject of the invention i~ to provide a devi~e of the type described which may be used with equal facility with wide range o~ heart ~izeæ.
Another object of the ~nvention is to provide a device of the type des~ribed which ~s easier to use than with previous devices.
~ till another ob~ect ~f the invention is to provide a device of ~he type ~escribed which requires minimal adiustment but, ~f ~djustment is zequired, it may be a~c~mpli~hed ~uickly ~nd easily a _9_ Yet another object of the invention is to provide a device for introducinq two ~eparately and independ~ntly manipula~le cardiac electrodes through a ~ingle introduction site therebY
reducinq the chance of ~nfection and minimi~in~ tr~uma to the pat~ent'~ v~culature.
DESCRIPTION OF T~ DR~wINGS
The fore~oing and other obje~ts and a~v~nta4es of the invention will be appreciated more fully fr~ the followin~
urther description there~f, with reference to the ~ccompanyina dra~ings wherein:
FIG. 1 i~ an illustration, p~rtly broken away, of the ~a heter assem~ly includin~ the catheter containing the ventricular and ~trial leads p~sitionPd as they would be when the ~ssembly i5 introduced to he patient:
F.IG. lA i~ ~ ~ectional illustration of the bifur~ati~n of the ~athe~er;
FI~. 2 ls a cros~-~ection of the ~atheter ~ssemhl~ ~s ~een along line 2~2 of ~IG. l;
~ IG. 3 is ~ plan illustration of the di~tal portion of the catheter as ~een ~long the line 3-3 of ~IG. i;
~ IG. 4 i6 an enlarged ~ectional ~llustration ~f the distal portion of ~he catheter as ~een alonq the line 4-4 of FIG. 3 and illus~r~ting the position~ of the dis~al ends of ~he ventr~cular and atrial leads when ~he ~ssembly i5 in~roduced into the patient:
FIG. 5 is ~ illustration of the ventricular lead showin~, ~n phant~m, a flo~ assist hal70~n ln ~t~ inflated ~onfiqur~iOn;
FI~. 6 is an enlarged illustration of ~he distal end of the ventricular lead;
FIG~ 7 is an illustration of the atrial lead;
~ IG. 7A is an 111ustrati~n of the proximal ~nd distal ends ~f the atrial lead showin~ the plane of the zelaxed ~urved distal end and its ~lignment with lndicia at ~he proximal end;
FIG. 8 is an enlar~ed illustration o the distal tiP cf the atrial lead;
FIGS. 9-16 illustrate di~gramatically p~rtions of u patient~s heart and the manner in which the present invention is used.
DESCRI PTION OF ~HE PREFER~D EMBODIM~I~T
. . .
As ~hown in FIG. 1 the catheter assembly-includes ~ main catheter 10 which may be extruded :Erom an appropriate plastic material ~uch ~ a fluoroethylene polymer, The main cath~ter 10 ls formed with a pair of lumens, including a ventr~eular lead lumen 12 and an atrial l~ad lumen 14. The ventricular lead lumen 12 i~ ger ~n di~meter than the atrial lead lumen 14 and i~ intended to receive the relatively larqer d;a~eter ventricular lead 16, The ~maller lumen 14 ~lidably receives the ~tri~l lead, $ndicated generally at 1~. The lumens 12, 14 are ~rrhn~ed side-by-~ide with ~t lea~t the ~trial lumen 1~
being displa~ed from the central ~xis of the main catheter ~00 Wll -3~3~
The ventricular lumen l? extends fully ~lonq the length of the main catheter 10 and terminates in an exit port 20 at the _ distal t~.p ~f the ~ain c~theter 1OA The atrial lead lumen 14 terminates in an exit port 22 which i~ spaced proxim~lly fr~m the di~tal end of the catheter 10. ~n the preferred emhodiment of the invention the exit port 22 for the atrial lead 18 is disposed ~pproximately one ~enti~eter proxim311y of the ventricular lead outlet 200 When the ~trial lead 18 is advanced through the lumen 14, it will emerge from exit port 22 before reaching the distal tip of the ~atheter ln and, as wi~l be described~ will assume a J-~haped configuration 3s it emerges from the exit port 220 The proximal portion of the main satheter ln ~s bifurca ed to include and define an atrial guide tube 24 and 3 ventricular guide tube 26. The ventricular guide tuhe 2~ may be defined hy a ~ontinuation of the main catheter 10 with the atrial le~d lumen 14 obstructedO The ~tria~ guide tube 24 may be formed rom a ~eparate tube whi~h i~ ~pli~ed to the main catheter 10 ~o that it communi~ates only with ~he atrial lead lumen 14 as ~uggested in FIG~ lA. The ~pliced region may be encapsulated in ~ molded plastic fitting 28. The distal portion 29 of the molded fitting 28 preferably i~ formed with a taper ~o th~t it may be deta~hably locked to corre~pondin~ fitting on a catheter intrsducer, ~s will be des~ribed in further det~
The proximal end ~f each of the atria3 and ventricular guide tubes 24, 26 preferably i~ provided with a ~tandard luer fitting 30. Ea~h ~f the luer fit~ings 30 preferably is - 1?-provided with a l~ckablet ~ealing fitting ~ndicated ~t 34, ~chas, for example, a ~uehy-Borst fitting. The ~ittinqs 34 enable an elemént, ~uch as he 3tri~1 ~r ventricular lead ~o ~e passed through the fitting ~nd then tightened to lock the le~ds 1~, 18 in place and effect a seal about the lead, as will be described in further detail.
The ventricular le~d 16 ~ shown ~n further det~il ln FIGS.
5 and 6. It i~ substantially longer than the auide catheter 10 and, fo~ ~xample, may be ~f the order of fifty centimeters long. The lead 16 may be formed from a ~lender tu~e 48 of extruded plastic with insulated electrical wires 40, 42 carried in the tube 48. As ~h~wn in ~urther detail in FIG. 6 the ventricular lead 16, in ~ccordance with the present invention, is bipolar, having a pair of ~pa~ed ring electrDdes 36, 38 at its distal end. Each of the electrodes 36, 38 i~ electrically conne~ted to lnsulated wires 40, 42 whi~h emerge at the proximal end of the lead ~nd terminate in ~onnectors 44, 4~
(see FIG~ 5). The tube 4B emerges ~t the proximal end of the ventricular lead ~nd 1~ ~onnected to ~ ~topcock 52. ~he tube 48 thus ~lso defines ~n lnflat~n lumen 53 for a balloon 54 whiEh is attached to the distal end of the lead, betw~en the ring electrodes 36, 3B~ ~he ventricular lead ~s provided with a molded plastic member 5~ at the trifurcated re~ion of the tube 48 ~nd wire~ 40, 42. A~ will be descri~ed in further detail, the balloon 5~ may be ~nflated tD f~cilitate quidance of the ventricular lead ~nto proper placement and advancement thrsugh the tricuspid valve ~nd lnto engagement with the ventricular ~pex. _ Th~ ~trial lead lB is illustrated ln FIGS. 7 and 8 and may be ~bout forty centimeter~ long. The lead 18 i~ illustrated as being monopolar and formed fr~m a wound ~;prinq wire 19 havinc~ a centr~l core ~re 21 ~imilar to conventional construction for d ~pring ~uide. The core wire, however, terminates appr~ximat~ly eight millimeters ~rom the distal tip of the lead so that the distal re~ion will be ~oft and flexibleO The proximal end ~f the atrial lead includes a connector plug 58 for ~ttach~ent to a pacemaker. The atrial lead 18 is covered, ~lonq i~s leriqth, with an in~ulative jacket 23 whi~h may ~e formed from ~
~hrinkable pla~t~c9 ~hrunk onto the ~prlng wound lead. ~he jacket 23 may be formed, for example, from TFE plastic and ~overs all of the lead except for the most distal ~ive millimeters which ~erves a~ the atrial electrode.
As shown in ~IG. 7 the distal end of the ~trial lead 18 ~s formed ~o that when in ~ relaxed ~tate it will assume somewhat of a J-shaped configuration having a curved seament ~0 and a ~ost distal ~t~aight ~egment 62. ~he curved ~egment 60 extends throuqh an arc of Dpproximately 1509. The diameter of the ~tr~al lead 18 i5 approximately 2 French (oO26n) ~nd, therefore, is flexible ~o that the ~trial lead lR can flex easily ~o n 6traight confi~uration ~o as t~ be ~ontained fully and be slidable easily within the atrial lead lu~en 14 of the main c~heter 1~.
The manner in which the invention ~ay be used is described with reference to FIGS. 9-16 which ~llustrate the human heart and the various positions ~f the di~tal portions of th~ main catheter 10 and leads 16, 180 As ~u~qested diaqramatically in FIG. 9, in a properly functionlng heart blood returns from the '.
venous 6ystem through the ~uperior vena cava (1dentified as SVC
in the drawings) and inferior vena cava (IVC) the righ~ atrium ~RA) of ~he heart. ~hen the right atrium ~ontra~ts it pumps blood through the one-way tri~uspid valve ~TCV) and into the ri~ht ventricle (RV). The right ventricle (RV) then contr~cts to close the tr ~cuspid valve (TCV) under pressure ~nd to pump blood through the pulmonary ~rteries (PA) to the lun~s where the blo~d is oxygenatea. The oxygenated bl~od ~hen flows through the pulmonary veins 'co the left atrium (LA), through the left tricuspid valve ~nd hen into lthe left ventricle (LV~. The left ventricle pumps b~ood throu~h ~he aor~ca (A) throu~hout the body ~nd then through the venous ~ystem to return the blood to the heart ~nd renew the ~ycle.
As will be des~ribed in fur~her det~il, one facet of he invention relates to the ~bility of the leads t~ ~e pla~ed in ~oncave pQrtions of the atrium ~nd ventricle which will tend to re~ain the electrodes ~n ~ ~table ~sltion ~o thst the electrodes will not become dislodged as ~he heart flexes and pumps repeatedly. ~o that end, the present inventi~n ~ontemplates engaging the ventricular lead with the ventricular apex at the lower most portion o~ the riqht ventri~le ~s indic3teZ ~t 64 in F~G. 9. The ventricular apex is ~oneave and ~15-., ~ , . . . . . . . . .
~ 3 i~
provides a ~table lDca~ion from which ~he electrodes a~ ~he end of the ventr~ular lead will no become dislodge~ from their contact with the hear wall. The ventri~ular ~pex 64 i~
conside~ed a ~atisfactory loc3tion in which to make electrical ~ontact between the ventricular lead both for pacing rlnd ~ensing functiDns., In ac~ordance with the present invention the por~ion Df the right at:rium whici- most desirably is con'cacted with the ~trial lead i~ 'che atrial appendage 6~, a portion of the hear ~7hich i~ located in the roof re~ion of the ~trium which defines concave surface; as would ~e ~een from within the atrium.
Although the atrial appendage 65 :1~ not as ~ensitiYe electrically as the ~ino-atr~D node, lindicate9 at 67 in FIG.
9) it i~ 3djacent ts:~ the ~ino-~trio node and, therefore, is close enough to it ~o as 'co provide ~ubs'cantially lc~w impedance for. 'che pacing and ~ensing ~ignals to be hlyhly efiEective. The atrial appendage 65 is a relat~vely delicate membran~ portion of the heaxt and it is imPortant, therefore~ that the ~stria~
lead be constru~ted to that it will maXe ~ntact in a very del icate manner .
Norn:ally the ~elf-regulating ele~trical activity sf the heart causes the right atrium RA ~nd right ventri~le RV to contract in ~equence, with the right ~trium RA contractin~
fir~t to pump bl~d thr~ugh the tr~cuspid ~alY2 TVC and into the rlght ventricle RV, with the right ventri~le RV ~ontr~ctinq ~fter 3 sh~rt delayO The delay in the c~ntractions ~f the right atrium RA ~nd right ventricle RV are ~ufficient to enable ~ ~ ~(3~ ~
the atrium to pump blood through the tricuspid vallJe T~V and into the right ventricle RV.
Various disorders can occur with respect to the electrical control of the heart's ~unction. Typically, when there is a disruption in the normal electrical activity of the heart, it is essential first to reestablish a regular rhythm in the right ventricle so as to maintain at least a sufficient flow of blood to the lungs so as to provide at least a minimally sufficient supply of oxygenated blood to the patient. It is 10 preferred, and in some instances it is necessary, also to establish a proper sequential rhythm for the atrium so as to maximize the pumping efficiency of the heart. Thus, as soon as possible after the ventricular lead has been pl~ced and pacing has begun, it is desirable to place and begin pacing 15 with the atrial lead.
The catheter 10 of the present invention is introduced intravenously, preferably through the in-ternal jugular or subclavian vein which leads to the superior vena cava SVC.
Any of a variety of well-known techniques may be employed, 20 such as inserting a catheter introducer percutaneously to provide access to the vein. The device is arranged so that the leads 16, 18 are within their respective lumens 12, 14, with their distal ends located just proximally of their openings 20, 22 (as suggested in ~IG. 4) in readiness 25 to be advanced. The assembly, with leads so positioned, is advanced through the catheter 10 introducer until the distal tip of the catheter is at the region of the juncture between the superior vena cava SVC and ~L~3~
the right atrium RA as illustrated in ~IG. 10. The procDdure preferably is monitored on ~ fl~oroscoPe ~rom which the positioning ~f the various elements can be verified. The assembly should be positioned ~o that ~he outlet p~rt 22 of the catheter 10, from whi~h the di~sl end of the a$rial lead ~ill emerge, $~ ~ufficiently ~l~se to or jus~ wi~hin ~he a~rium so as to ~sure that the ~trial lead will advance and ex~end properly into the uPper re~ion of the atrium, as will be described. ~hen the catheter 10 is positioned properly, it is secured in place by any of a number of means, ~uch as by tapin~
it firmly to the patient or by ~ecuring the tapered p~rtlvn 29 of fittin~ 28 to the convention~l fit~in~ at the proximal end of the introdu~er, or by a combination, Once the guide ~atheter 10 is placed, it will not have to be moved again, until it is to be removed.
~ he ventricular lead 16 then is advanced, the se21inq qland 34 first being released to free the ventri~ular lead for movement. If the balloon i~ to be ~nfl~ted, ~s ~ugqested ~n ~IG. 11, the ventricular lead 16 then is advan~ed ~ htly to project the balloon tip ~utwardly beyond the distal openinq 20. The ballo4n may be inflated with ~arb~n dioxide g~s by a ~yringe connected to the ~topc~ck S2. With the ~all~on ~nflated, the ventricular lead i~ advanced throuqh the main ~atheter 10. The balloonD when used, fl~ws with the blood flow and provides assured guidance that the ventri~u7ar lead 16 will flow to and through the tri~uspid valve TCV into the right ventricle RV instead ~ passing downwardly into the inferior vena cava IVC or at ~ome other angle. The balloon may be used with some effectiveness only when the heart has ~ome pumpinq function ~nd there i5 80me ~lood flow. ~hen there i~ no pumping function ~nd no blood flow the ~ystem may be used without inflating the balloon.
Once the distal end of the ven~ri~ul~r lead is in the right ventricle R~ (as ~uggested in phantom in F~G. 11~ the balloon is deflated (if it was previously infl~ted) and the distal end of the ~entricular lead i~ advanced into the pocket-like ventricular apex 64. The ventricular lead is ~dvanced to the position shown in ~I~. 12 in which it ig assured that its distal end has been bent ~o that both ring electrodes 3fi, 38 are in ~ontact with the heart mu~cle, in the re~ion of the 3pex 64 a~ shown in enlaraed det~il in FIG. 13. Proper e~ectrical contact with the ring electrodes 3~ 3~ can be as~ured ~y monitoring the electrical paoing device and sensinq feedback signals indi~ative of the proper electrical ~ontact. ~hen the surgeon i~ ~atisfied that the ventri~ular lead lfi is properly placed, ~ecurely contained within ~he po~ket defined by the ventrioular ~pex ~nd in good direc electrical contact with the heart, the ventri~ular le~d is lo~ked in place by fastening the ~uehy Bors~ ~dapter 340 ~ n the illustrative embadiment, the preferred electro~e config~ration for the ventr~cular lead is bip~l~r~ that is, there are two ring electrodes 369 38 which wlll contact electrically the ~urface of the heart ~uscle~ Dt the ventricular apex. By ~pply a pulse ~ross these two cl~sely ' -19-~paced *lectr~de~, only that portion of the heart which 1~ in f the resion of the ele~trodes i~ affe~ted ~y the pulse. Because electrical activity wlthin the heart muscle is very ~omplex it is desirable to apply pul~es only at ~ location and of an energy level ~hich will be ~uffi~ient to pace the heart but without disrupting any other electrical fun~tion of the heart.
~hu~7 w~th the bipol~r ventricular lead ~hown in the illustrative embodiment, ele~trl~al energy is ~pplied only to the heart in a ~mall localized region ~ufficient to pace ~nd to sense the activity of the riqht ventri~le and ~Ithout ~ffectinq other portio~s of the heart'~ electr~c~l ~ctivity.
After he ventricular lead 16 has been placed, the atrial lead 18 is placed. The ~ealing gland 34 ~ssoci~ted with the ~trial lead i~ unlo~ked and the atrial lead 18 is advanced go that its distal end emerges from the outlet port 220 As the ~trial lead emerges, the most distal straiqht ~egment 62 will emerge, paralleling the catheter 1OJ ~5 ~ug~ested in ~IG. 140 As advan~ement of the atrial lead continues, the ~ur~ed se~ment 60 begins to emerge from ~he outlet port 22 and the lead be~ins to assume its J-~h~pe as Isuggeslted in Fl(; 15. Before the ~trial lead expands co it~ normally relaxed, full J-~onfiguration, the dist~l tip will enga~e ~nd dr~g ~gainst the upperm~st roo~ surf~es r~ the right atrium ~A~ as ~ugclested in FIG. 16. Further a~vancement of the atri~l lead will project lt more distally out of the exit port 22 ~nd downwardly frc~n the ro~f of the atrium until it assume~ a fully rel~xed ~onfigur~tion. The surgeon then may c~ontrol the -2û-position of the atrial lead by manipulating i~ from its proximal en~, both longitudinally and rotationally, By ~ch m~nipulation the ~urgeon can place the electrode at the distal tip at preci~ely the location on the r~of reqion of the atrium as he desires. This enables the s~rgeon to place the atrial electrode precisely aqainst the concave atrial appendaqeO A~
described ~bove, the atrial appendage defines ~omewhat of a ~oncave socket which provides a ~table ~ocation f~r electFode ~ontact. The urgeon can verify that c~nt~ct has been made with the atri~l appendage by monitoring feedback of electri~al signals. ~hen the ~uryeon i5 ~atisfied that the atrial lead is ln proper contact, the Tuehy Borst adapter is tightened down about the atrial lead to ~ecure lt in position.
The foregoing description ~f the ~trial lead has related to a monopolar con~iguration, in which the distalmost tip defines a single electrodeO A qr~unding electrode for use with the mon~polar electr~de may be in the form of an externally applied electrode patch ~uch ~s the type commonly used {n electrocardiogram procedures. AlternatelyO the ~tr~al lead may be ~ormed so ~s to be bipolar, in ~imilar manner ko the biPolar configuration ~f the ventri~ul~r lead. Whether monopolar or bipolar, ~t is $~portant ~ha~ the distal ~ip ~ the ~trial lead be flexible nd resilient to ~s~ure avoidance of trauma to the delica~e memhranes $n the roof region of the ~trium.
~ i~h the main ~atheter 10 and b~th leads 16, 1~ ~ecured in position, and particularly when ~he ventricular and a~rial leads ~re in enga~ement with the ventr~cular apex 3nd atrial appendage, respectively~ the ~oncav2 contacting regions materially reduce the chances og the leads becoming dislodqed under ~he ~nfluen~e of the pump~ng action of the heart.
F~om the foregoing it will be appreciated that the present invention may be used with ~11 patients, regardless of variations in heart size, because each of the leads is positioned independently with respect ~o each other and also independently with re~pect to he ~atheter~
~ eans also are provided to fscilltate positioninq ~nd orientation ~f the ~trial lead by reference to the rel~tive positi~n of the proximal end of the lead ~s compared to the catheter 10~ To that end~ the proximal end of the atrial lead preferably is marked with indicia indicated at 6~ in ~IG. 7A to indicate the radial plane in which the distal end portions 6n, 62 of the atrial lead project. By comparin~ the portion of marking 66 with the position of the guide tube 24, or ~ome other ~ndicia indi~ting the side of the guide catheter 10 where the outlet port 22 ~s located~ the æur~eon can determine the rela~ive angul~r posi~ion ~f ~he dis~al end of the atrial lead with respect to the ~ain catheter and, therefore, with respect to the patient's heart. By u~in9 ~u~h reference points the surgeon will be able to direct the distal en~ of the atrial lead in~o close proximity, lf not pre~ise ~onta~t with the atrial appendage quickly ~nd ~ith minimal manipul~ti~n.
Also ~mong the features ~ the invention is the rel~tiYe locatiDn of the exit port 22 with xe~pect to the distal tip of the catheter 10. When the ~theter 10 is positioned so that 1~3(~
lts di~tal tip 20 is located ju~t a~ the juncture of ~he ~uper~or Yena ~ava Svc and th~ r~ght ~trium RA, the exit port 22 for the ~trial lead will ~e located somewhat within the _ superior vena cava. However, a~ the atrial lead emerges from the opening 22 it advances ~ubstantially along ~nd parallel to the catheter 10 ~nd begins to assume its curl just as the a electrode tip of the atri~l lead enters i~to the upper portion of the atrium. ~h~s, as the ~trial lead is ~dvanced it will begin ~t~ curl in close proximity to the roof of the atrium and will contact ~nd brush ~qainst the roof o the ~trium ~efore it assu~,es its fully opened J-sonfiguration. If the ~urgeon has ~dvanced the atrial lead in a rotative position which would cau~e the atrial electrode to contact the a~rial appendage directly, then the atrial lead may be se~ured in that position immediately. Otherwi~e, the atEial lead may be advanced fur~her into ~he atrium, to enable the J to expand fully, free of the ~trial wall, so that the ~urgeon ~an r~tate the atr~al lead to the desired ~ngular position ~nd then draw the lead proximally to br~ng it intc ~ontact w~th the ~trial ~ppendaqe.
~rom the foregoinq 1~ will be ~ppreciated that the present invention provides ~i~nificant advant~ges over the prior ~rt and the pre~ently employed ystems. The ~ystem c2n be used wi~h e~ual effectiveness on ~ny patient regardless of the ~i7e ~f the patien~' hear~. It enables rapid deploymen~ of the ventricular and a~rial leads in sequence. It enables both ventri~ular l~ad ~nd atria~ lead to c~ntact conoave regions of the ventricle and atrium respectivelyO and particularly ~he ~3-8~
~trial appendage of the right atrium to ~ssure the mechanicallY
stable positioning a~ both ~en~ricular ~nd atrial leads so that they will not likely be dislodged a~ a resul~ of pumping action of the heart. ~oreover, these advantaqes are achieved in a pacing/s~ensing ~atheter in ~hich the electrodes make direct contact with the endocardium thereby reducing the amount of power which must be applied to the leads and enablin~ more precise ~ontrol of the pacing ~nd sensinq functions.
It should be understood~ ho~ever, that the foregoing description of the invention i~ intended merely to be ~llustrative and that other embodiments and modifications may be ~pparent to tho~e skilled in the ~rt without departinq from its ~pirit.
Havinq thus described the invention ~hat T desire to claim and secure by letters paten~ is:
~24-
Claims (11)
1. A rapidly placeable, percutaneously insertable catheter assembly for temporary emergency atrio-ventricular pacing comprising, in combination:
a catheter having proximal and distal ends and having a first lumen with an outlet port at the distal end of the catheter and a second lumen having an outlet port at the distal region of the catheter, the outlet port of the second lumen being disposed proximally of the outlet port of the first lumen;
a ventricular lead having a proximal end and a distal end and being slidably received within the first lumen of the catheter, said ventricular lead being longer than said first lumen said ventricular lead having electrode means at its distal end;
an atrial lead slidably received within the second lumen, the atrial lead being longer than said second lumen and having a distal end which is shaped so that it will assume a predetermined curve when in a relaxed configuration; the dimensions and flexibility of the atrial lead being such as to enable the distal end of the atrial lead to straighten when withdrawn into the second lumen and to return to its curved shape when projected out of the second lumen;
each of said leads being individually positionable longitudinally with respect to the catheter and each other;
said curved configuration for the distal end of the atrial lead having a first, arcuate, segment circumscribing an arc of approximately 150° and a second, straight segment extending from the distal end of the arcuate segment, the second segment being approximately 15 millimeters in length, the distal portion of the second segment including an exposed electrode;
quick-releasable sealing and locking means associated with the proximal end of the catheter for gripping and locking said leads in selected positions and in sealed relation to the catheter and for releasing said gripping and sealing to permit repositioning of the leads;
said catheter assembly being constructed and arranged to enable the catheter with said ventricular and atrial leads in place in said lumens to be inserted percutaneously and rapidly as a unit into a patient's venous system.
a catheter having proximal and distal ends and having a first lumen with an outlet port at the distal end of the catheter and a second lumen having an outlet port at the distal region of the catheter, the outlet port of the second lumen being disposed proximally of the outlet port of the first lumen;
a ventricular lead having a proximal end and a distal end and being slidably received within the first lumen of the catheter, said ventricular lead being longer than said first lumen said ventricular lead having electrode means at its distal end;
an atrial lead slidably received within the second lumen, the atrial lead being longer than said second lumen and having a distal end which is shaped so that it will assume a predetermined curve when in a relaxed configuration; the dimensions and flexibility of the atrial lead being such as to enable the distal end of the atrial lead to straighten when withdrawn into the second lumen and to return to its curved shape when projected out of the second lumen;
each of said leads being individually positionable longitudinally with respect to the catheter and each other;
said curved configuration for the distal end of the atrial lead having a first, arcuate, segment circumscribing an arc of approximately 150° and a second, straight segment extending from the distal end of the arcuate segment, the second segment being approximately 15 millimeters in length, the distal portion of the second segment including an exposed electrode;
quick-releasable sealing and locking means associated with the proximal end of the catheter for gripping and locking said leads in selected positions and in sealed relation to the catheter and for releasing said gripping and sealing to permit repositioning of the leads;
said catheter assembly being constructed and arranged to enable the catheter with said ventricular and atrial leads in place in said lumens to be inserted percutaneously and rapidly as a unit into a patient's venous system.
2. A catheter assembly as defined in claim 1 wherein said second lumen is offset from the central axis of the catheter.
3. An assembly as defined in claim 1 further comprising:
the proximal end of the catheter being formed to define a bifurcation, said bifurcation including tubular guide means for communication with each of the first and second lumens;
said quick releasable sealing and locking means being associated with each of the tubular guide means.
the proximal end of the catheter being formed to define a bifurcation, said bifurcation including tubular guide means for communication with each of the first and second lumens;
said quick releasable sealing and locking means being associated with each of the tubular guide means.
4. A catheter assembly as defined in claim 1 wherein the most distal portion of the second segment is more flexible and resilient than the more proximal portions thereof.
5. A catheter assembly as defined in claim 1 wherein said ventricular lead further comprises:
a bipolar electrode having a pair of spaced electrodes at the distal end.
a bipolar electrode having a pair of spaced electrodes at the distal end.
6. A catheter assembly as defined in claim 5 further comprising:
an inflatable balloon at the distal end of the ventricular lead for flow assist purposes to guide the ventricular lead along the flow path through the tricuspid valve of the heart; and means in communication with the proximal end of the ventricular lead for inflating and deflating the balloon.
an inflatable balloon at the distal end of the ventricular lead for flow assist purposes to guide the ventricular lead along the flow path through the tricuspid valve of the heart; and means in communication with the proximal end of the ventricular lead for inflating and deflating the balloon.
7. A catheter assembly as defined in claim 1 wherein a curved configuration for the distal tip of the atrial lead comprises:
a first arcuate segment at the distal end of the atrial lead; and a second, straight segment, extending from the distal end of the arc segment, the second segment of a length no shorter than the distance between the outlet ports of said first and second lumens.
a first arcuate segment at the distal end of the atrial lead; and a second, straight segment, extending from the distal end of the arc segment, the second segment of a length no shorter than the distance between the outlet ports of said first and second lumens.
8. A catheter assembly as defined in claim 1 wherein the distal end of the atrial lead further comprises said straight segment being of a length no shorter than the distance between the outlet ports of said first and second lumens.
9. A catheter assembly as defined in claim 1 further comprising:
the atrial lead having proximal and distal ends and being constructed so that its predetermined curve at its distal end lies substantially in a plane, and indicia means at the proximal end of the atrial lead corresponding to and providing an indication of the rotational orientation of the curve.
the atrial lead having proximal and distal ends and being constructed so that its predetermined curve at its distal end lies substantially in a plane, and indicia means at the proximal end of the atrial lead corresponding to and providing an indication of the rotational orientation of the curve.
10. An atrial lead for use in temporary emergency cardiac pacing comprising:
an elongate flexible lead having electrode means at its distal end and connector means at its proximal end;
the distal end of the lead being formed to define a curved configuration in its relaxed state, said curved configuration including a first arcuate segment circumscribing approximately 150° and a more distal straight segment extending about 15 millimeters in length, the electrode means being formed on said distal straight segment, said electrode means including a highly flexible electrically conductive electrode at the tip of the distal straight segment;
said atrial lead being constructed so that it may be straightened in its entirety, including its distal tip end, whereby the lead may be advanced through a catheter, said lead being constructed and arranged so that its emergence of its distal end from the outlet port of a catheter will be in a sequence in which the most distal straight segment projects substantially straight out of the exit port and in which the distal end of the atrial lead does not begin to assume its curved configuration until the curved segment begins to advance out of the exit port;
said atrial lead being of a small diameter of approximately two French, the distal end of -the lead being constructed and arranged as to avoid trauma-tizing the atrium.
an elongate flexible lead having electrode means at its distal end and connector means at its proximal end;
the distal end of the lead being formed to define a curved configuration in its relaxed state, said curved configuration including a first arcuate segment circumscribing approximately 150° and a more distal straight segment extending about 15 millimeters in length, the electrode means being formed on said distal straight segment, said electrode means including a highly flexible electrically conductive electrode at the tip of the distal straight segment;
said atrial lead being constructed so that it may be straightened in its entirety, including its distal tip end, whereby the lead may be advanced through a catheter, said lead being constructed and arranged so that its emergence of its distal end from the outlet port of a catheter will be in a sequence in which the most distal straight segment projects substantially straight out of the exit port and in which the distal end of the atrial lead does not begin to assume its curved configuration until the curved segment begins to advance out of the exit port;
said atrial lead being of a small diameter of approximately two French, the distal end of -the lead being constructed and arranged as to avoid trauma-tizing the atrium.
11. A catheter assembly as defined in claim 1, wherein the atrial lead has a diameter of approxi-mately 2 French.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/450,215 US4602645A (en) | 1982-12-16 | 1982-12-16 | Atrio-ventricular pacing catheter |
| US450,215 | 1982-12-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1230386A true CA1230386A (en) | 1987-12-15 |
Family
ID=23787232
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000438910A Expired CA1230386A (en) | 1982-12-16 | 1983-10-13 | Atrio-ventricular cardiac pacing catheter |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US4602645A (en) |
| JP (1) | JPS59115056A (en) |
| CA (1) | CA1230386A (en) |
| DE (1) | DE3338838A1 (en) |
| FR (1) | FR2537874B1 (en) |
| GB (1) | GB2132895B (en) |
| MX (1) | MX154473A (en) |
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-
1982
- 1982-12-16 US US06/450,215 patent/US4602645A/en not_active Expired - Lifetime
-
1983
- 1983-10-13 CA CA000438910A patent/CA1230386A/en not_active Expired
- 1983-10-26 DE DE19833338838 patent/DE3338838A1/en not_active Withdrawn
- 1983-10-27 FR FR838317198A patent/FR2537874B1/en not_active Expired
- 1983-11-21 GB GB08331023A patent/GB2132895B/en not_active Expired
- 1983-12-01 JP JP58227798A patent/JPS59115056A/en active Pending
- 1983-12-07 MX MX199656A patent/MX154473A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| DE3338838A1 (en) | 1984-06-20 |
| GB2132895B (en) | 1986-08-28 |
| GB8331023D0 (en) | 1983-12-29 |
| FR2537874B1 (en) | 1989-05-05 |
| GB2132895A (en) | 1984-07-18 |
| JPS59115056A (en) | 1984-07-03 |
| MX154473A (en) | 1987-08-28 |
| FR2537874A1 (en) | 1984-06-22 |
| US4602645A (en) | 1986-07-29 |
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