CA1261405A - Intravascular multiple electrode unitary catheter - Google Patents
Intravascular multiple electrode unitary catheterInfo
- Publication number
- CA1261405A CA1261405A CA000477271A CA477271A CA1261405A CA 1261405 A CA1261405 A CA 1261405A CA 000477271 A CA000477271 A CA 000477271A CA 477271 A CA477271 A CA 477271A CA 1261405 A CA1261405 A CA 1261405A
- Authority
- CA
- Canada
- Prior art keywords
- electrode
- catheter
- sensing
- electrodes
- pacing
- 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
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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
- A61N1/02—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
ABSTRACT
A multiple electrode unitary intravascular cardiac catheter comprising a distal electrode for sensing and pacing, an intermediate electrode for sensing, pacing and cardio-verting, and a proximal electrode for sensing and cardioverting. The catheter may also be employed in combination with an external patch electrode.
A multiple electrode unitary intravascular cardiac catheter comprising a distal electrode for sensing and pacing, an intermediate electrode for sensing, pacing and cardio-verting, and a proximal electrode for sensing and cardioverting. The catheter may also be employed in combination with an external patch electrode.
Description
The present invention is directed to a multiple electrode unit2ry intr2vascular catheter designed for use in a system which continually monitors heart function and, upon aetection of abnormal Cunction, provides either pacing enercv or cardioverting energy 25 required.
Durins the past sever21 decades, coron~ry he2r~
ci.ce2se h2s become the pri~zry cause of deatn in the develo~ed areas of the world. Close to 1.5 million Americans will suffer a heart attack this year, with nearly 350,000 of them dying suddenly following the myocardial infarction. Although the precise cause of sudden death in coronary heart disease has not yet been entirely clarified, the av2ilable evidence permits the medical field to ascribe death in the majority of sudden de2th cases to rapid ~isturbances in cardiac electrical activity known as tachyarrhythmia. Tachyarrhythmic heart conditions which may be lethal, are ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Atrial tachyarrhythmic conditions such as atrial tachycardia and fibrillation only become life threatening when they lead to rapid ventricular disturbance.
Excessively slow rhythm disturbances, known as bradyarrhythmias, are involved in a minority of cases.
Bradyarrhythmic condi~ions become serious when there is a defect in impulse formation or in the normal cardiac conauction system without adequate "escape" rhythm.
Within the hospital environment, recent eY.perienCe has demonstrated that tachyarrhythmic conditions are often reversible phenomena and may be corrected by applying relatively high energy electrical shocks to the heart.
~radyarrhythmic conditions, although not as often fatal, are often correctable by pacemaking pulses of very low energy. The correction of arrhythmic heart conditions by application of relatively hish energy electrical shock to the heart will, for the purposes of this invention, be referred to as "cardioversion".
In recent years, substantial progress has been made in the development of techniques for effectively terminating various tachyarrhythmias. Recent developments include implantable electronic standby defibrillators which, in response to the detection of an abnormally rapid cardiac rhythm, discharge sufficient energy via electrodes connected to the heart to depolarize and restore the heart to normal cardiac rhythm.
Considerable sophistication now exists with regard to techniques for reliably monitoring heart activity in order to determine whether cardioversion is necessary. Included among such technigues are those which monitor ventricular rate to determine the presence of fibrillation on the basis of a probability density function ~PDF), a technique described in commonly owned U.S. Patent Nos . 4 ,184, 493, issued on January 22, 1980 and 4,202,340, issued on September ~9, 1981, both of Langer et al, and a more recent system which is disclosed in commonly owned Canadian Patent 1,171,912 issued on July 31, 19~4! utilizing both the PDF
technique to determine the presence of an abnorlnal cardiac rhythm and a heart rate sensing circuit for distinguishing between ventricular fibrillation and high-rate tachycardia, on the one hand, and a normal sinus rhythm or low-rate tachycardia, on the other hand.
Commonly owned, Cana~ian Patent 1,223,643 issued cn June 30, 1987, discloses a cardioversion system incluàing an implznt2ble deCibrillator and an external non~invasive controller/monitor for altering the state and/or retrieving status information from the implanted defibrillator. The implantable defibrillator comprises a high-voltage inverter circuit with shunt-prevention means; a combination of a PDF circuit and.a heart-rate analysis circuit, each circuit detecting abnormal cardi~c rhythms and both circuits jointly activating the high-voltage inverter circuit;
a plurality of electrodes connected to the heart, inc~uding bipolar sensing electrodes, coupled with the he2rt-rate analysis circuit, for sensing ventricular activity;
high-voltage pulse delivery electrodes, coupled with the high-voltage inverter circuit; circuits for, respectively, delivering hiah-energy, defibrillating pulses, 2nd providins PDF information signals; a pulse counter/memory for counting and storing the number Oc defibrillating pulses issued by the inverter circuit; a piezoelectric speaker, coupled to the w211 of a case enclosing the defibrillator circuits, for generating audible tones indicative of the status of the defibrillator;
and means responsive to an external magnet for changing the state of the defibrillator.
Technology now exists for the development of implantable devices capable of both pacing and cardioverting, each in response to a sensing mechanism which is incorporated ~L~O~' in the implantable device. The electrodes for sensing cardiac electrical abnormalities, as well as for delivering electrical impulses to the heart, are an extremely important consideration in the entire pacing/cardioverting system. U.S. Patent No.
3,942,536 issued on March 9, 1976 to Mirowski et al discloses a single intravascular catheter electrode system which monitors heart function and provides the malfunctioning heart with electrical shocks of suf'icient amplitude to restore the heart to normal sinus rhythm.
U.S. Patent No. 4,030, 509, issued on June 21, 1977 to Heilman et al, discloses several embodiments of an electrode system for use in ventricular defibrillation wherein the electrodes are applied to the exterior surface of the heart.
U.S. Patent No. 4,161,952, issued on July 24, 1979 to Kinney et al, discloses a catheter electrode including a resilient, wound wire discharge electrode having proximal and distal ends. The proximal end of the lead is adapted for connection to a pulse generator. The lead is connected to the wound wire discharge electrode at the proximal and distal ends thereof, and the catheter electrode system is designed for positioning in the superior vena cava or in the coronary sinus, and preferably acts against an independent apex electrode.
Thus, the electrode system of Kinney et al is not of unitary design.
U.S. Patent No. 4,355,646, issued on October 26, 1982 to Kallok et al, discloses a lead having multiple electrodes which is intravenously implanted for use in patients having a high ris~
of ventricular fibrillation. The lead comprises four electrodes, the two distal electrodes being spaced for optimzl measurement of impedance changes due to mechanical contractions and used for mechanical sensing of norm21 cardiac activity.
The two proximal electrodes are spaced from the distal elec-trodes so as to ensure their placement within the superior vena cava; the two distal electrodes serve to deliver the defibrillation energy.
None of the prior art references noted above discloses an effective multiple electrode unit2ry intravascular catheter capable of sensing heart abnormality and delivering either defibrillating energy or pacing energy in response to the abnormality for restoring normal heart function.
Additionally, none of the prior art devices noted above is capable of delivering a high-enersy discharse through
Durins the past sever21 decades, coron~ry he2r~
ci.ce2se h2s become the pri~zry cause of deatn in the develo~ed areas of the world. Close to 1.5 million Americans will suffer a heart attack this year, with nearly 350,000 of them dying suddenly following the myocardial infarction. Although the precise cause of sudden death in coronary heart disease has not yet been entirely clarified, the av2ilable evidence permits the medical field to ascribe death in the majority of sudden de2th cases to rapid ~isturbances in cardiac electrical activity known as tachyarrhythmia. Tachyarrhythmic heart conditions which may be lethal, are ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Atrial tachyarrhythmic conditions such as atrial tachycardia and fibrillation only become life threatening when they lead to rapid ventricular disturbance.
Excessively slow rhythm disturbances, known as bradyarrhythmias, are involved in a minority of cases.
Bradyarrhythmic condi~ions become serious when there is a defect in impulse formation or in the normal cardiac conauction system without adequate "escape" rhythm.
Within the hospital environment, recent eY.perienCe has demonstrated that tachyarrhythmic conditions are often reversible phenomena and may be corrected by applying relatively high energy electrical shocks to the heart.
~radyarrhythmic conditions, although not as often fatal, are often correctable by pacemaking pulses of very low energy. The correction of arrhythmic heart conditions by application of relatively hish energy electrical shock to the heart will, for the purposes of this invention, be referred to as "cardioversion".
In recent years, substantial progress has been made in the development of techniques for effectively terminating various tachyarrhythmias. Recent developments include implantable electronic standby defibrillators which, in response to the detection of an abnormally rapid cardiac rhythm, discharge sufficient energy via electrodes connected to the heart to depolarize and restore the heart to normal cardiac rhythm.
Considerable sophistication now exists with regard to techniques for reliably monitoring heart activity in order to determine whether cardioversion is necessary. Included among such technigues are those which monitor ventricular rate to determine the presence of fibrillation on the basis of a probability density function ~PDF), a technique described in commonly owned U.S. Patent Nos . 4 ,184, 493, issued on January 22, 1980 and 4,202,340, issued on September ~9, 1981, both of Langer et al, and a more recent system which is disclosed in commonly owned Canadian Patent 1,171,912 issued on July 31, 19~4! utilizing both the PDF
technique to determine the presence of an abnorlnal cardiac rhythm and a heart rate sensing circuit for distinguishing between ventricular fibrillation and high-rate tachycardia, on the one hand, and a normal sinus rhythm or low-rate tachycardia, on the other hand.
Commonly owned, Cana~ian Patent 1,223,643 issued cn June 30, 1987, discloses a cardioversion system incluàing an implznt2ble deCibrillator and an external non~invasive controller/monitor for altering the state and/or retrieving status information from the implanted defibrillator. The implantable defibrillator comprises a high-voltage inverter circuit with shunt-prevention means; a combination of a PDF circuit and.a heart-rate analysis circuit, each circuit detecting abnormal cardi~c rhythms and both circuits jointly activating the high-voltage inverter circuit;
a plurality of electrodes connected to the heart, inc~uding bipolar sensing electrodes, coupled with the he2rt-rate analysis circuit, for sensing ventricular activity;
high-voltage pulse delivery electrodes, coupled with the high-voltage inverter circuit; circuits for, respectively, delivering hiah-energy, defibrillating pulses, 2nd providins PDF information signals; a pulse counter/memory for counting and storing the number Oc defibrillating pulses issued by the inverter circuit; a piezoelectric speaker, coupled to the w211 of a case enclosing the defibrillator circuits, for generating audible tones indicative of the status of the defibrillator;
and means responsive to an external magnet for changing the state of the defibrillator.
Technology now exists for the development of implantable devices capable of both pacing and cardioverting, each in response to a sensing mechanism which is incorporated ~L~O~' in the implantable device. The electrodes for sensing cardiac electrical abnormalities, as well as for delivering electrical impulses to the heart, are an extremely important consideration in the entire pacing/cardioverting system. U.S. Patent No.
3,942,536 issued on March 9, 1976 to Mirowski et al discloses a single intravascular catheter electrode system which monitors heart function and provides the malfunctioning heart with electrical shocks of suf'icient amplitude to restore the heart to normal sinus rhythm.
U.S. Patent No. 4,030, 509, issued on June 21, 1977 to Heilman et al, discloses several embodiments of an electrode system for use in ventricular defibrillation wherein the electrodes are applied to the exterior surface of the heart.
U.S. Patent No. 4,161,952, issued on July 24, 1979 to Kinney et al, discloses a catheter electrode including a resilient, wound wire discharge electrode having proximal and distal ends. The proximal end of the lead is adapted for connection to a pulse generator. The lead is connected to the wound wire discharge electrode at the proximal and distal ends thereof, and the catheter electrode system is designed for positioning in the superior vena cava or in the coronary sinus, and preferably acts against an independent apex electrode.
Thus, the electrode system of Kinney et al is not of unitary design.
U.S. Patent No. 4,355,646, issued on October 26, 1982 to Kallok et al, discloses a lead having multiple electrodes which is intravenously implanted for use in patients having a high ris~
of ventricular fibrillation. The lead comprises four electrodes, the two distal electrodes being spaced for optimzl measurement of impedance changes due to mechanical contractions and used for mechanical sensing of norm21 cardiac activity.
The two proximal electrodes are spaced from the distal elec-trodes so as to ensure their placement within the superior vena cava; the two distal electrodes serve to deliver the defibrillation energy.
None of the prior art references noted above discloses an effective multiple electrode unit2ry intravascular catheter capable of sensing heart abnormality and delivering either defibrillating energy or pacing energy in response to the abnormality for restoring normal heart function.
Additionally, none of the prior art devices noted above is capable of delivering a high-enersy discharse through
2 single catheter and immediately being able to effectively sense the heart's electrical activity through the sa~e catheter. Followins cardioversion, the tissue in the area immediately adjacent the discharge electrodes at least temporarily loses 2 substantial portion of its abil ty .o conduct electrical impulses due to the high electrical ener~y jus~ zpplied to the area. Full recovery most often results, but there is a time when electrical concuction suffers. This phenomenon dele~eriously impacts on the sensing cap2bility of the prior art devices which sense and cardio~ert from the szme two electrodesr at least at a time when sensing is of utmost importance.
Further, the prior art electrodes were somewhat limited in their capability for integration with other electrodes in the event that pacing, cardioverting, or sensing could more effectively be accomplished through alternate electrode configurations.
Thus, a need has continued to exist for a unitzry multiple electrode catheter capable of sensing, pacing and cardioverting the heart, with an improved sensing capability immediately following cardioversion, and having the flex~bility to permit integration with other elec~rodes in the event that a more ef'ective distribution of the electrical energy is attainable.
It is t~erefore an o~ject of thîs invention to provide a novel multiple electrode unitary catheter.
An i~travascular ~atheter eLectrode assembLy adapted t~
operate in a paoing, a cardioverting and a plurality of sensing modes comprising:
an elongated electrically insulated catheter body having a distal end;
a first electrode positioned on said distal end of said catheter body;
a second electrode positioned on said catheter body proximally of said first electrode and spaced a predetermined distance rom said first ~lectrode;
a third electrode positioned on said catheter body between and spaced from said first and second electrodes;
first connecting means having a ~irst pair of inputtoutput connectors for configuring said first and third electrodes as a pacing electrode pair durln~ said pacing mode and a first sen~ing electrode pair during ono of said plurality of sensing modes; and second connecting means having a second pair of input/output connectors for configuring said second and third electrodes as a second senslng electrode pair durin~ a second of said plurallty of sensing mode and a cardioverting electrode pair during said cardiovertln~ mode.
The instant catheter provides continued, accurate sensing of hear~ rate activity following cardioversion because it utilizes different electrodes and an advanced electrode placement; therefore, different hear~ tissue is involved in the rate sensing activity on the one hand and the cardioverting activity on the other hand.
Further, because the instant catheter is compact and yet ve-y versatile, it can be combined with other electrodes simply by changing a connection at the pulse generator.
These and other advantases of the invention will become more readily apparen~ ~-hen reference is made by way of exar.~ple only to the following descriptlon taken in conjunction with the accompan~ing drawings.
Figure 1 is a sice view of the multiple electrode unitary in.ravascular pacing, cardioverting, and sensing c2theter.
Figure la is an enlarged fragmentary cross section of thzt portion of Figure 1 between the distal tip and the line la-la. .
Figure lb is an enlarged fragmentary cross-sectionzl view of that portion cf Figure 1 between lines la-la and lb-lb.
Figure lc is an enlarged fragmentary cross-sectior.al view of that.portion of Figure 1 between.lines:l~-lb and lc-lc.
Figure ld is an enlarged fragment2ry view of that portion of Figure 1 between lines lc-lc and ld-ld. .
Figure le is an enlarged fragmentary cross-section21 view o' that portion of Figure 1 showing elements 80, 86 and 862.
Figure lf is an enlarged fragmentzry cross-sectior.21 view of that portion of Figure 1 showing element 102.
Figure lg is an enlarged frzgmentary cross-section ~iew of that portion of Figure 1 showing element 101.
Figure lh is an enlarged fragmentary cross-section21 view of that portion of Figure 1 showing element 91.
Figure li is an enlarged frasmentary cross-sectional view of that portion of Flgure 1 showing element 90.
Figure 2 is a cross-sectional view depicting the c~theter positioned in the heart.
Figure 3 is a cross-sectional view of an embodiment wherein the unitary intravascular catheter is used in conjunc-tion with an external patch electrode.
The following description refers to Figures 1 and la through li of the drawings, hereinafter referred to collectively 2S "Figure l", where there is illustrated a plan view Oc a multiple electrode unitary catheter for sensing, cardioverting, and pacing comprising 2. distzl electrode 10, an intermeci2te electrode 18, and a proximal electrode 48. Distal electrode 10 comprises a distal tip 12 and lead lg, said lead 14 providing electric~al conductivitv between àistal tip 12, through hezrt lead coil 98, and terminating at male plug 96. Distal tip 12 hzs a aiameter in the range of 2.0-Z.8 mm, a length in the rznge of 0.5-2.0 ~, and 2 curface area on the order of 2bout 10-20 mm2. Typically, the dist~l tip is constructed of z platinum, iridium alloy con.aining approximately 10% iridium. Distal electrode 10, in conjunc.ion with intermediate electrode 18, provides sensing and pacing f~nctions.
The electrical conductor 98 of lead 14 is encased by.
an insulating tubing such 2S of Silastic, said insulating tubing typically having 2n outside diameter of 1.07 mm and an inside diameter of 0.81 mm. Lead coil 98 terminates in ~ale plug 96, adapted for insertion into an implantable device, not shown.
Distal electrode 10 is separated from intermediate electrode 18 by tubing 16. Tubing 16 acts to hold the distal tip in place, to seal the internal catheter from the body fluiàs, to provide proper spacing between distal electrode 10 and intermedi~te electrode 18, and to electrically insulate distal electrode 10 fro~ intermediate electrode l~. Typically, tubing 16 takes the for~ of a suitable insulating tubins such as Silastic having a wall thickness defined by.an outside diameter in the range of 1.8-2.8 mm and an inside diameter in the range of 1.8-2.0 mm. One critical aspect in the electrode o' this invention lies in the spacing between distal electrode 10 and intermediate electrode 18. It is preferred that the specing between these two electrodes lies in the range of 1 to 10 mm. An optimal dist2nce between the two electrodes is 4 mm.
Intermediate electrode 18 co~prises le2d fittings 20 and 22, spring 23, said sprina 23 comprising an electrically conductive wound wire surface, two electrically conductive tubings 28 and 30, said t~o electrically conductive tubings 28 and 30 connected in par~llel, DBS wires 40, 92 and 100, and male plugs 94 and 104. Lead fittinss 20 and 22 and spring wire 23 comprise an electrically ccr,ductive material inert to body fluids. C. P. titanium or platinum coated C. P. titanium is a preferrea material for this utility. Lead fitti~g 20 provides electxical contact between electriczlly conductiYe surface 23 and electrically conductive tubing 28; lead fitting 22 provides electrical contact between electrically conductive surface 23 znd electrically conductive tubing 30.
Spring 23 has a length in the rznge of about 20 to 50 mm and a diameter in the range of abou~ 3.0 to 4.0 mm. This spring is close-wound, and is preferably wound to approximately 20 turns 2er inch. The close-wound spring provi~es a continuous electriczlly conductive surface which mzintains its flexibili.y while still lowering the impedance of the electrode and thus permitting more curren' to be delivered. Typiczlly, the surface area 'or intermeàiate electrode 18 is in the range Or zbout ,0 to S0 mm , with about 43 mm2 being the preferred surface area. Anothe. important aspect of the present invention involves the length o~ the intermediate electrode 18 as measured from the outside edges of lead fittings 20 ~nd 22.
It is preferred that this length be in the range of zbout 20 to 50 ~m, with about 38 mm being optimal. Insulztive tubing 36 typically comprises a sil2stic materizl, having an outside di2meter of about 2.8 mm and an inside diame.er of about 2.4 mm. Tubing 36 provides insulative sepzration between l{)S
conductive lead fittings 20 and 22 and, additionally, seals the internal catheter from body fluids Electrically conductive tubings 28 and 30 are made of an electrically conductive material, typically stainless steel, and provide electriczl contact between DBS wire 40 and lead fittings 20 and 22. DBS
wire 40 is drawn, brazed, stranded wire, typically a mixture of stainless steel and silver, and provides means for electrical tr2nsmission for intermediate electrode 18 Thus, intermediate electrode 18, acting through spring element 23, provides sensinq, pacing, and cardioverting capability, coacting with cistal electrode 10 to provide sensing and pacing and coacting ~ith proximal electrode 48 to provide sensing and cardioversion Tubing 46 is typically an insulating tubing, such as "
Silastic, typically having an outside diameter of 3 2 mm a~d an inside àizmeter of 2 0 mm and serves to electrically insulate intermediate electrode 18 from proximal elec~rode 48, sezl the internals of the catheter from body fluids, provide sufficien.
.lexibility in the cztheter to provide for proper insertion and ~!/ prevent perforation OL the heartO Additionally, tubing 46 provides for proper spacing between intermediate electrode 18 and proximal electrode 48 It is preferred that this dis~znce be in the range of about 8 to 14 centimeters, with about 11 centimeters being optimal Proximal electrode 48 (Figure lc) comprises lead fittings 50 and 52, spring 53, said spring 53 comprising an electrically conductive wound wire surface, electrically conductive tubings 58 and 60, tubing 56, DBS wire 68, DBS
wire 70, and male plug 108. Lead fittings 50 and 52, and spring 53 comprise electricelly conductive mate_ials which are inert to body fluids. Typically, these elements are made of C.
P. titanium, platinum, iridium, or platinum coated titanium.
Electrically conductive tubi~gs 58 and 60 are typically stainless steel and are connected in parallel by DBS wire 68.
It is contemplated ~hat proximal electrode 48, as measured from the outside ~dges of lead fi~tings 50 an~ 52, be in the range of about 5 to }0 cm, with approximately 7.5 cm being optimal, and have a diameter in the range of about 3.0 to 4.0 mm.
Proxim21 electrode 48, acting through spring 53 and male plug 108, and paired with intermediate electrode 18, provides ~.
c2rdioverting mezns as well as PDF sensing mezns. DBS wires 68 znd 70 are drawn, brazed, stranded wire, typically a mixture of stainless steel znd silver, and provide electrical connection be.ween male plug 108, adapted for insertion into an implantable electrical device for sensing pacing and cardioverting, and spring 53.
Elements 80, 86 and 86a are reinforcing members.
Element 82 is a splice and provides for integration of DBS
wire 92 and DBS wire 100. After integration, these two wires become DBS wire 40. Elements ~4a 2nd 84b are typically insul2ting tubing such as Silastic, typically hzving an outer di~meter of about 3 mm and an inner diameter of about 2 mm.
Elements 88a, 88b, 88c and 88d are typically insulating tubing such as Silastic, typically having an outer diameter of about 1.95 mm and an inner diameter of about 1.25 mm. Each of these tubing elements electrically insulates its respective lead and protects it from body fluids. Elements 90, 91, 101 and 102 are proximal boots and provide for adaptive insertion and sealing, respectively, of the male plugs 94, 96, 104 and 108 into the implantable electrical device. Similar devices are described in U.S. Patent No. 4,262,673 issued on April 21, 1981. One of the male plugs 94, 96, 104, and 108, in a manner known to the prior art, is hollow and thus adapted for insertion of a stylette, the stylette facilitating directional control of the catheter during its placement in the heart.
The three-electrode catheter represents a substantial advance over prior art catheters.
Because heart rate sensing and pacing are accomplished by the distal electrode in conjunction with the intermediate electrode while higher energy cardioversion is accomplished by the intermediate electrode in conjunction with the proximal electrode, the instant catheter maintains its capability for heart rate sensing and low threshold pacing following cardioversion. Because the at least temporary depolarization of heart tissue due to higher voltage cardioversion affects heart tissue different from that involved with the rate sensing and pacing functions, the catheter continues to perform its rate sensing and low threshold pacing on undamaged heart tissue.
~J~ 3~
Referring now to Fiaure 2, there is depicted one possible position of the catheter electrode system in a heart for effecting ventricular defibrillation. Distal electrode 10, comprising distal ~ip 12, and intermediate electrode 18 is wedged in the apex of the right ventricle. Proximal electrode 48 is in the right a~rium and superior vena cava, s.raddling their junction.
Figure 3 sho~s one embodiment wherein the intravascular catheter is positioned as in Pigure 2 and, additionally, the heart is fitted with an ex-ternal patch electrode.
In certain situations, the unitary catheter system will not function to provide the required czrdioverting energy znd an additional external patch electrode 120 is reauireà.
Typical external patch electrodes are described in commonly assigned U.S. Patent No. 3,~42,536. Patch electrode 120 comprises the patch 122, the patch leaZ 12~, said patch lead 124 terminating in a proximal boot 101' and male plug 104', male plug 104' insertable into the implantzble device in place of male plug 104.
In operation, it is contemplated that the znesthe-tized patient hzs the catheter system intrzvascularly inserted into the heart, for example, as in Figure 2. ~t this point, fibrillation is induced in order to tes, the functioning of the system and to provide nformation regarding threshold energy requirement levels. If the single catheter system is ~L~6~40~i insufficient, the patient is fitted with a patch electrode 120.
At the same time, male plug 104 is disengaged from the implantable device and sealed to prevent penetration by body fluids. Male plug 104' is inserted into the implantable device to provide bipolar defibrillation through patch electrode 120 and proximal electrode 48, inserted into the implantable unit ~hrough male plug 108. By disengaging and sealing male plug 104, only the defibrillatins characteristic of intermediate electrode 18 is affected. The pacing and sensing function of intermediate electrode 18 remains intact, connection to the implantable device occurring through male plugs 94 and 96.
~ aving now fully described the invention it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit and ~cope of the invention 25 set forth herein.
Further, the prior art electrodes were somewhat limited in their capability for integration with other electrodes in the event that pacing, cardioverting, or sensing could more effectively be accomplished through alternate electrode configurations.
Thus, a need has continued to exist for a unitzry multiple electrode catheter capable of sensing, pacing and cardioverting the heart, with an improved sensing capability immediately following cardioversion, and having the flex~bility to permit integration with other elec~rodes in the event that a more ef'ective distribution of the electrical energy is attainable.
It is t~erefore an o~ject of thîs invention to provide a novel multiple electrode unitary catheter.
An i~travascular ~atheter eLectrode assembLy adapted t~
operate in a paoing, a cardioverting and a plurality of sensing modes comprising:
an elongated electrically insulated catheter body having a distal end;
a first electrode positioned on said distal end of said catheter body;
a second electrode positioned on said catheter body proximally of said first electrode and spaced a predetermined distance rom said first ~lectrode;
a third electrode positioned on said catheter body between and spaced from said first and second electrodes;
first connecting means having a ~irst pair of inputtoutput connectors for configuring said first and third electrodes as a pacing electrode pair durln~ said pacing mode and a first sen~ing electrode pair during ono of said plurality of sensing modes; and second connecting means having a second pair of input/output connectors for configuring said second and third electrodes as a second senslng electrode pair durin~ a second of said plurallty of sensing mode and a cardioverting electrode pair during said cardiovertln~ mode.
The instant catheter provides continued, accurate sensing of hear~ rate activity following cardioversion because it utilizes different electrodes and an advanced electrode placement; therefore, different hear~ tissue is involved in the rate sensing activity on the one hand and the cardioverting activity on the other hand.
Further, because the instant catheter is compact and yet ve-y versatile, it can be combined with other electrodes simply by changing a connection at the pulse generator.
These and other advantases of the invention will become more readily apparen~ ~-hen reference is made by way of exar.~ple only to the following descriptlon taken in conjunction with the accompan~ing drawings.
Figure 1 is a sice view of the multiple electrode unitary in.ravascular pacing, cardioverting, and sensing c2theter.
Figure la is an enlarged fragmentary cross section of thzt portion of Figure 1 between the distal tip and the line la-la. .
Figure lb is an enlarged fragmentary cross-sectionzl view of that portion cf Figure 1 between lines la-la and lb-lb.
Figure lc is an enlarged fragmentary cross-sectior.al view of that.portion of Figure 1 between.lines:l~-lb and lc-lc.
Figure ld is an enlarged fragment2ry view of that portion of Figure 1 between lines lc-lc and ld-ld. .
Figure le is an enlarged fragmentary cross-section21 view o' that portion of Figure 1 showing elements 80, 86 and 862.
Figure lf is an enlarged fragmentzry cross-sectior.21 view of that portion of Figure 1 showing element 102.
Figure lg is an enlarged frzgmentary cross-section ~iew of that portion of Figure 1 showing element 101.
Figure lh is an enlarged fragmentary cross-section21 view of that portion of Figure 1 showing element 91.
Figure li is an enlarged frasmentary cross-sectional view of that portion of Flgure 1 showing element 90.
Figure 2 is a cross-sectional view depicting the c~theter positioned in the heart.
Figure 3 is a cross-sectional view of an embodiment wherein the unitary intravascular catheter is used in conjunc-tion with an external patch electrode.
The following description refers to Figures 1 and la through li of the drawings, hereinafter referred to collectively 2S "Figure l", where there is illustrated a plan view Oc a multiple electrode unitary catheter for sensing, cardioverting, and pacing comprising 2. distzl electrode 10, an intermeci2te electrode 18, and a proximal electrode 48. Distal electrode 10 comprises a distal tip 12 and lead lg, said lead 14 providing electric~al conductivitv between àistal tip 12, through hezrt lead coil 98, and terminating at male plug 96. Distal tip 12 hzs a aiameter in the range of 2.0-Z.8 mm, a length in the rznge of 0.5-2.0 ~, and 2 curface area on the order of 2bout 10-20 mm2. Typically, the dist~l tip is constructed of z platinum, iridium alloy con.aining approximately 10% iridium. Distal electrode 10, in conjunc.ion with intermediate electrode 18, provides sensing and pacing f~nctions.
The electrical conductor 98 of lead 14 is encased by.
an insulating tubing such 2S of Silastic, said insulating tubing typically having 2n outside diameter of 1.07 mm and an inside diameter of 0.81 mm. Lead coil 98 terminates in ~ale plug 96, adapted for insertion into an implantable device, not shown.
Distal electrode 10 is separated from intermediate electrode 18 by tubing 16. Tubing 16 acts to hold the distal tip in place, to seal the internal catheter from the body fluiàs, to provide proper spacing between distal electrode 10 and intermedi~te electrode 18, and to electrically insulate distal electrode 10 fro~ intermediate electrode l~. Typically, tubing 16 takes the for~ of a suitable insulating tubins such as Silastic having a wall thickness defined by.an outside diameter in the range of 1.8-2.8 mm and an inside diameter in the range of 1.8-2.0 mm. One critical aspect in the electrode o' this invention lies in the spacing between distal electrode 10 and intermediate electrode 18. It is preferred that the specing between these two electrodes lies in the range of 1 to 10 mm. An optimal dist2nce between the two electrodes is 4 mm.
Intermediate electrode 18 co~prises le2d fittings 20 and 22, spring 23, said sprina 23 comprising an electrically conductive wound wire surface, two electrically conductive tubings 28 and 30, said t~o electrically conductive tubings 28 and 30 connected in par~llel, DBS wires 40, 92 and 100, and male plugs 94 and 104. Lead fittinss 20 and 22 and spring wire 23 comprise an electrically ccr,ductive material inert to body fluids. C. P. titanium or platinum coated C. P. titanium is a preferrea material for this utility. Lead fitti~g 20 provides electxical contact between electriczlly conductiYe surface 23 and electrically conductive tubing 28; lead fitting 22 provides electrical contact between electrically conductive surface 23 znd electrically conductive tubing 30.
Spring 23 has a length in the rznge of about 20 to 50 mm and a diameter in the range of abou~ 3.0 to 4.0 mm. This spring is close-wound, and is preferably wound to approximately 20 turns 2er inch. The close-wound spring provi~es a continuous electriczlly conductive surface which mzintains its flexibili.y while still lowering the impedance of the electrode and thus permitting more curren' to be delivered. Typiczlly, the surface area 'or intermeàiate electrode 18 is in the range Or zbout ,0 to S0 mm , with about 43 mm2 being the preferred surface area. Anothe. important aspect of the present invention involves the length o~ the intermediate electrode 18 as measured from the outside edges of lead fittings 20 ~nd 22.
It is preferred that this length be in the range of zbout 20 to 50 ~m, with about 38 mm being optimal. Insulztive tubing 36 typically comprises a sil2stic materizl, having an outside di2meter of about 2.8 mm and an inside diame.er of about 2.4 mm. Tubing 36 provides insulative sepzration between l{)S
conductive lead fittings 20 and 22 and, additionally, seals the internal catheter from body fluids Electrically conductive tubings 28 and 30 are made of an electrically conductive material, typically stainless steel, and provide electriczl contact between DBS wire 40 and lead fittings 20 and 22. DBS
wire 40 is drawn, brazed, stranded wire, typically a mixture of stainless steel and silver, and provides means for electrical tr2nsmission for intermediate electrode 18 Thus, intermediate electrode 18, acting through spring element 23, provides sensinq, pacing, and cardioverting capability, coacting with cistal electrode 10 to provide sensing and pacing and coacting ~ith proximal electrode 48 to provide sensing and cardioversion Tubing 46 is typically an insulating tubing, such as "
Silastic, typically having an outside diameter of 3 2 mm a~d an inside àizmeter of 2 0 mm and serves to electrically insulate intermediate electrode 18 from proximal elec~rode 48, sezl the internals of the catheter from body fluids, provide sufficien.
.lexibility in the cztheter to provide for proper insertion and ~!/ prevent perforation OL the heartO Additionally, tubing 46 provides for proper spacing between intermediate electrode 18 and proximal electrode 48 It is preferred that this dis~znce be in the range of about 8 to 14 centimeters, with about 11 centimeters being optimal Proximal electrode 48 (Figure lc) comprises lead fittings 50 and 52, spring 53, said spring 53 comprising an electrically conductive wound wire surface, electrically conductive tubings 58 and 60, tubing 56, DBS wire 68, DBS
wire 70, and male plug 108. Lead fittings 50 and 52, and spring 53 comprise electricelly conductive mate_ials which are inert to body fluids. Typically, these elements are made of C.
P. titanium, platinum, iridium, or platinum coated titanium.
Electrically conductive tubi~gs 58 and 60 are typically stainless steel and are connected in parallel by DBS wire 68.
It is contemplated ~hat proximal electrode 48, as measured from the outside ~dges of lead fi~tings 50 an~ 52, be in the range of about 5 to }0 cm, with approximately 7.5 cm being optimal, and have a diameter in the range of about 3.0 to 4.0 mm.
Proxim21 electrode 48, acting through spring 53 and male plug 108, and paired with intermediate electrode 18, provides ~.
c2rdioverting mezns as well as PDF sensing mezns. DBS wires 68 znd 70 are drawn, brazed, stranded wire, typically a mixture of stainless steel znd silver, and provide electrical connection be.ween male plug 108, adapted for insertion into an implantable electrical device for sensing pacing and cardioverting, and spring 53.
Elements 80, 86 and 86a are reinforcing members.
Element 82 is a splice and provides for integration of DBS
wire 92 and DBS wire 100. After integration, these two wires become DBS wire 40. Elements ~4a 2nd 84b are typically insul2ting tubing such as Silastic, typically hzving an outer di~meter of about 3 mm and an inner diameter of about 2 mm.
Elements 88a, 88b, 88c and 88d are typically insulating tubing such as Silastic, typically having an outer diameter of about 1.95 mm and an inner diameter of about 1.25 mm. Each of these tubing elements electrically insulates its respective lead and protects it from body fluids. Elements 90, 91, 101 and 102 are proximal boots and provide for adaptive insertion and sealing, respectively, of the male plugs 94, 96, 104 and 108 into the implantable electrical device. Similar devices are described in U.S. Patent No. 4,262,673 issued on April 21, 1981. One of the male plugs 94, 96, 104, and 108, in a manner known to the prior art, is hollow and thus adapted for insertion of a stylette, the stylette facilitating directional control of the catheter during its placement in the heart.
The three-electrode catheter represents a substantial advance over prior art catheters.
Because heart rate sensing and pacing are accomplished by the distal electrode in conjunction with the intermediate electrode while higher energy cardioversion is accomplished by the intermediate electrode in conjunction with the proximal electrode, the instant catheter maintains its capability for heart rate sensing and low threshold pacing following cardioversion. Because the at least temporary depolarization of heart tissue due to higher voltage cardioversion affects heart tissue different from that involved with the rate sensing and pacing functions, the catheter continues to perform its rate sensing and low threshold pacing on undamaged heart tissue.
~J~ 3~
Referring now to Fiaure 2, there is depicted one possible position of the catheter electrode system in a heart for effecting ventricular defibrillation. Distal electrode 10, comprising distal ~ip 12, and intermediate electrode 18 is wedged in the apex of the right ventricle. Proximal electrode 48 is in the right a~rium and superior vena cava, s.raddling their junction.
Figure 3 sho~s one embodiment wherein the intravascular catheter is positioned as in Pigure 2 and, additionally, the heart is fitted with an ex-ternal patch electrode.
In certain situations, the unitary catheter system will not function to provide the required czrdioverting energy znd an additional external patch electrode 120 is reauireà.
Typical external patch electrodes are described in commonly assigned U.S. Patent No. 3,~42,536. Patch electrode 120 comprises the patch 122, the patch leaZ 12~, said patch lead 124 terminating in a proximal boot 101' and male plug 104', male plug 104' insertable into the implantzble device in place of male plug 104.
In operation, it is contemplated that the znesthe-tized patient hzs the catheter system intrzvascularly inserted into the heart, for example, as in Figure 2. ~t this point, fibrillation is induced in order to tes, the functioning of the system and to provide nformation regarding threshold energy requirement levels. If the single catheter system is ~L~6~40~i insufficient, the patient is fitted with a patch electrode 120.
At the same time, male plug 104 is disengaged from the implantable device and sealed to prevent penetration by body fluids. Male plug 104' is inserted into the implantable device to provide bipolar defibrillation through patch electrode 120 and proximal electrode 48, inserted into the implantable unit ~hrough male plug 108. By disengaging and sealing male plug 104, only the defibrillatins characteristic of intermediate electrode 18 is affected. The pacing and sensing function of intermediate electrode 18 remains intact, connection to the implantable device occurring through male plugs 94 and 96.
~ aving now fully described the invention it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit and ~cope of the invention 25 set forth herein.
Claims (10)
1. An intravascular catheter electrode assembly adapted to operate in a pacing, a cardioverting and a plurality of sensing modes comprising:
an elongated electrically insulated catheter body having a distal end;
a first electrode positioned on said distal end of said catheter body;
a second electrode positioned on said catheter body proximally of said first electrode and spaced a predetermined distance from said first electrode;
a third electrode positioned on said catheter body between and spaced from said first and second electrodes;
first connecting means having a first pair of input/output connectors for configuring said first and third electrodes as a pacing electrode pair during said pacing mode and a first sensing electrode pair during one of said plurality of sensing modes; and second connecting means having a second pair of input/output connectors for configuring said second and third electrodes as a second sensing electrode pair during another of said plurality of sensing modes and a cardioverting electrode pair during said cardioverting mode.
an elongated electrically insulated catheter body having a distal end;
a first electrode positioned on said distal end of said catheter body;
a second electrode positioned on said catheter body proximally of said first electrode and spaced a predetermined distance from said first electrode;
a third electrode positioned on said catheter body between and spaced from said first and second electrodes;
first connecting means having a first pair of input/output connectors for configuring said first and third electrodes as a pacing electrode pair during said pacing mode and a first sensing electrode pair during one of said plurality of sensing modes; and second connecting means having a second pair of input/output connectors for configuring said second and third electrodes as a second sensing electrode pair during another of said plurality of sensing modes and a cardioverting electrode pair during said cardioverting mode.
2. The electrode assembly of claim 1, wherein the distance between said first and third electrodes is substantially less than the distance between said second and third electrodes.
3. The catheter assembly of claim 1, wherein said catheter body, said second electrode and said third electrode are flexible.
4. The catheter assembly of claim 1, wherein said first and third electrodes are spaced apart such that the heart rate is sensed during said one of said plurality of sensing modes which utilizes said first sensing electrode pair.
5. The catheter assembly of claim 1, wherein said second and third electrodes are spaced apart such that the probability density function is sensed during said other of said plurality of sensing modes which utilizes said second electrode sensing pair.
6. The catheter of claim 1, wherein said first electrode is spaced apart from said third electrode by a distance of about 4 mm and said third electrode is spaced apart from said second electrode by a distance of about 11 centi-meters.
7. The catheter of claim 1, wherein said third electrode comprises a low impedance electrically conductive wound wire surface and said second electrode comprises a low impedance electrically conductive wound wire surface.
8. The catheter of claim 7, further comprising sealing means for providing electrical insulation between said first electrode and said third electrode, and between said third electrode and said second electrode.
9. The catheter of claim 8 wherein said sealing means also seals said catheter from body fluids.
10. An intravascular multiple electrode unitary catheter adapted to deliver pacing and cardioverting signals to the heart and adapted to carry a plurality of sensing signals from the heart comprising a flexible elongated body having a distal end and a proximal region, a distal electrode thereon for sensing and pacing, an intermediate electrode thereon for sensing, pacing and cardioverting, and a proximal electrode thereon for cardioverting and sensing, said intermediate and proximal electrodes each comprising an electrically conductive close wound wire surface approximating the low impedance of a continuous metal surface and still maintaining sufficient mechanical flexibility to provide ease of insertion, the catheter further comprising two pairs of input/output connectors, a first pair thereof coupled to said distal and said intermediate electrodes and adapted to deliver said pacing signals and carry one of said plurality of sensing signals from said heart, a second pair of said two pair of input/output connectors coupled to said intermediate and said proximal electrodes and adapted to deliver said cardioverting signals and carry a second one of said plurality of sensing signals from the heart.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/606,948 | 1984-05-04 | ||
| US06/606,948 US4603705A (en) | 1984-05-04 | 1984-05-04 | Intravascular multiple electrode unitary catheter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1261405A true CA1261405A (en) | 1989-09-26 |
Family
ID=24430190
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000477271A Expired CA1261405A (en) | 1984-05-04 | 1985-03-22 | Intravascular multiple electrode unitary catheter |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US4603705A (en) |
| JP (1) | JPS60249972A (en) |
| AU (1) | AU571404B2 (en) |
| CA (1) | CA1261405A (en) |
| DE (1) | DE3515984A1 (en) |
| FR (1) | FR2563736B1 (en) |
| GB (1) | GB2157954B (en) |
| IL (1) | IL74722A (en) |
| NL (1) | NL191671C (en) |
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1984
- 1984-05-04 US US06/606,948 patent/US4603705A/en not_active Expired - Lifetime
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1985
- 1985-03-21 GB GB08507324A patent/GB2157954B/en not_active Expired
- 1985-03-22 CA CA000477271A patent/CA1261405A/en not_active Expired
- 1985-03-26 IL IL74722A patent/IL74722A/en not_active IP Right Cessation
- 1985-05-02 JP JP60095332A patent/JPS60249972A/en active Granted
- 1985-05-02 FR FR858506670A patent/FR2563736B1/en not_active Expired - Lifetime
- 1985-05-03 NL NL8501260A patent/NL191671C/en not_active IP Right Cessation
- 1985-05-03 DE DE19853515984 patent/DE3515984A1/en active Granted
- 1985-05-03 AU AU41939/85A patent/AU571404B2/en not_active Expired
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| JPS60249972A (en) | 1985-12-10 |
| US4603705A (en) | 1986-08-05 |
| NL191671C (en) | 1996-02-05 |
| GB2157954A (en) | 1985-11-06 |
| AU571404B2 (en) | 1988-04-14 |
| FR2563736B1 (en) | 1990-08-17 |
| NL8501260A (en) | 1985-12-02 |
| IL74722A0 (en) | 1985-06-30 |
| IL74722A (en) | 1990-02-09 |
| AU4193985A (en) | 1985-11-07 |
| GB2157954B (en) | 1987-08-19 |
| NL191671B (en) | 1995-10-02 |
| FR2563736A1 (en) | 1985-11-08 |
| GB8507324D0 (en) | 1985-05-01 |
| DE3515984A1 (en) | 1985-11-07 |
| JPH0318469B2 (en) | 1991-03-12 |
| DE3515984C2 (en) | 1988-09-08 |
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