WO1995005773A1 - Catheter de cartographie endocardique electrique - Google Patents

Catheter de cartographie endocardique electrique Download PDF

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Publication number
WO1995005773A1
WO1995005773A1 PCT/US1993/007881 US9307881W WO9505773A1 WO 1995005773 A1 WO1995005773 A1 WO 1995005773A1 US 9307881 W US9307881 W US 9307881W WO 9505773 A1 WO9505773 A1 WO 9505773A1
Authority
WO
WIPO (PCT)
Prior art keywords
probes
probe
catheter
guide
electrical
Prior art date
Application number
PCT/US1993/007881
Other languages
English (en)
Inventor
Lewis K. Waldman
Peng Sheng Chen
Original Assignee
Cardiac Pathways Corporation
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority to US07/833,746 priority Critical patent/US5237996A/en
Priority claimed from US07/833,746 external-priority patent/US5237996A/en
Application filed by Cardiac Pathways Corporation filed Critical Cardiac Pathways Corporation
Priority to AU50858/93A priority patent/AU5085893A/en
Priority to PCT/US1993/007881 priority patent/WO1995005773A1/fr
Publication of WO1995005773A1 publication Critical patent/WO1995005773A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6859—Catheters with multiple distal splines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]

Definitions

  • the present invention pertains generally to diagnostic catheters. More particularly, the present invention pertains to a catheter which individually and selectively positions a plurality of electrodes at separate locations on the endocardium of the left ventricle of a heart to simultaneously record the electrical responses from these locations during contraction of the heart muscle.
  • the present invention is particularly, but not exclusively, useful for the circumferential endocardial mapping of the left ventricle to locate the ectopic focus of an abnormally functioning heart muscle.
  • the heart muscle effectively acts as a pump which maintains the circulation of blood through the body. More particularly, the left ventricle is that portion of the heart which propels blood in systemic circulation through the body to supply the body tissues with nutrients. In lay terms, this pumping action results from contractions of the heart muscle which are more commonly referred to as the heart beat.
  • the ectopic focus of an arrhythmia is usually located in the endocardium. This mislocation of the initiation of contraction from the atrium to what is now the ectopic focus is what causes the arrhythmia. Since heart contractions result from the progression of an excitation wave of electrical impulses, location of the ectopic focus is merely a matter of identifying the point from where the abnormal excitation wave originates.
  • catheter electrodes have been proposed for this purpose. The following specifically cited references are representative of these catheters.
  • U.S. Patent No. 4,628,937 to Hess et al. for an invention entitled “Mapping Electrode Assembly” is an example of a device which is used for the epicardial or endocardial mapping of the electrical impulses from the heart.
  • the electrodes are symmetrically arrayed within a mounting cup that conforms to the organ being mapped. Consequently the electrodes of the Hess et al. device are set relative to each other and the efficacy of their displacement is dependent on the ability of the cup to conform to the particular surface.
  • Electrodes for an invention entitled “Intraventricular Multielectrode Cardial Mapping Probe and Method for using Same” discloses a device which positions the electrodes along wire assemblies which can be extended from a catheter to create an elliptical envelope. This envelope is then incrementally rotatable within the heart chamber while electrical potentials are measured and recorded at different points on the endocardium. For this device, all of the electrodes are symmetrically deployed as a unit. Thus, there is no individual control over the placement of any given electrode. Further, there is no assurance that all of the electrodes have, in fact, made contact with the surface of the endocardium.
  • U.S. Patent No. 4,522,212 to Gelinas et al. for an invention entitled “Endocardial Electrode” discloses a plurality of spring legs having insulated conductors which are connected to respective sets of spaced electrodes. In operation these spring legs of the Gelinas et al. device are allowed to extend apart to cause the electrodes to engage the wall tissue. Again, as with the other above cited references, there is no individual control over each of the separate electrodes. Consequently, there is no assurance that each electrode is properly placed, or that there is even contact between the electrode and the endocardium. None of the above examples either individually or collectively disclose the structure or the cooperation of structure which is used to accomplish the objects of the present invention.
  • an object of the present invention to provide an endocardial mapping catheter which has a plurality of electrode probes which can each be independently manipulated to achieve non-axisymmetric placement of the electrodes against the endocardium of the left ventricle.
  • Another object of the present invention is to provide an endocardial mapping catheter which establishes a favorable trajectory for each electrode during the placement process that directs the "electrode into contact with the endocardium from a direction that is substantially perpendicular to the endocardium.
  • Still another object of the present invention is to provide an endocardial mapping catheter which positions the plurality of electrodes circumferentially against the endocardium in a substantially coplanar arrangement.
  • Yet another object of the present invention is to provide an endocardial mapping catheter which can be positioned, and repositioned, within the left ventricle of a heart to make successive recordings of electrical impulses from the endocardium for use in preparing an isochronal map of these impulses.
  • Another object of the present invention is to provide an endocardial mapping catheter which is easy to use, relatively simple to manufacture, and comparatively cost effective.
  • a catheter for circumferentially mapping electrical responses from the left ventricle of the heart of a patient, includes a plurality of individually manipulable electrode probes which are structurally combined with an actuator assembly, a flexible support sheath and a probe guide.
  • the support sheath is a hollow elongated tube and the plurality of electrode probes are slidingly disposed inside the sheath.
  • the actuator assembly is attached to the proximal end of the support sheath, and a plurality of actuation levers are slidably mounted on the actuator assembly. In addition to being slidably mounted on the actuator assembly, each of these levers is fixedly attached to the proximal end of one of the electrode probes.
  • the probe guide which is formed with a plurality of flared passageways is mounted on the distal end of the support sheath, and the distal end of each electrode probe is positioned to slide through one of the passageways of the guide.
  • the guide at the distal tip of the catheter is inserted into the left ventricle and positioned therein as desired.
  • the operator then individually manipulates each actuation lever to move a respective electrode probe through the sheath in a distal direction.
  • This action sequentially deploys all of the electrode probes through the guide of the catheter and into the left ventricle.
  • the deployment of an electrode probe from the probe guide is accomplished along a favorable trajectory from the guide until the distal tip of the electrode probe contacts the endocardium.
  • this favorable trajectory extends from the probe guide and into a line which is substantially perpendicular to the surface of the endocardium. All of the electrode probes are thus sequentially deployed radially from the guide to circumferentially position their respective distal tips against the endocardium in a substantially coplanar arrangement.
  • the electrical responses resulting from heart muscle activity are recorded by electronic recording equipment associated with the catheter.
  • the electrode probes can be withdrawn and the guide at the distal tip of the catheter can be repositioned as desired. Additional data can thus be obtained from several locations of the catheter in the left ventricle and an isochronal map can be developed from the recorded data. With this map, the site of arrhythmogenesis or ectopic focus on the heart can be located.
  • Figure 1A is a perspective view of the endocardial electrical mapping catheter of the present invention
  • Figure IB is a perspective view of the probe guide portion of the catheter when the probes of the catheter are retracted;
  • Figure 2A is an exploded cross-sectional view of the guide of the catheter of the present invention as seen along the line 2-2 in Figure 1A;
  • Figure 2B is a cross-sectional view of the guide shown in Figure 2A when assembled and with probes extending therethrough;
  • Figure 3 is a perspective view of the heart of a patient with the catheter of the present invention inserted into the left ventricle, portions of the heart wall are removed for clarity and the guide is shown in phantom to indicate variations in the positioning of the guide inside the left ventricle of the heart;
  • Figure 4 is a cross-sectional view of the heart with inserted catheter as seen along the line 4-4 in Figure 3;
  • Figure 5 is a representative graph of timed responses from each of the probes of the catheter of the present invention during sequential cardiac cycles.
  • Figure 6 is a representation of three locations from the apex to the base of the left ventricle at which responses were recorded during a procedure using the catheter of the present invention.
  • an endocardial mapping catheter in accordance with the present invention is shown and is generally designated 10.
  • the catheter 10 includes a hollow elongated support sheath 12 which is formed with a lumen, and which is sufficiently flexible to be inserted through selected arteries of a body.
  • An actuator assembly 14 is attached to the proximal end of the sheath 12, and a probe guide 16 is attached to its distal end.
  • a plurality of individual electrode probes 18 a-h are disposed inside the hollow sheath 12 and extend therethrough from the actuator assembly 14 to the probe guide 16.
  • Electrode probes 18 there may be any number of electrode probes 18 desired by the operator, and there is no reason for limiting the catheter 10 to the use of only eight such electrode probes 18 a-h as shown in the Figures. For brevity, individual probes may be referred to hereinafter as a probe 18.
  • each electrode probe 18 has a tip 20 at its distal end.
  • the tip 20 is a bipolar electrode because electrical responses can be more clearly identified using a bipolar electrical structure.
  • a unipolar tip 20, however, is within the contemplation of the present invention.
  • the catheter 10 is used to deploy the tips 20 of electrode probes 18 a-h from the probe guide 16.
  • the electrode probes a-h be individually manipulable between a retracted configuration (shown in Figure IB) and a collectively deployed configuration (shown in Figure 1A) .
  • Figure 1A shows that a connector assembly 22 is used to join the actuator assembly 14 to the sheath 12.
  • a plurality of rigid spacer bars 24 are shown attached between the connector assembly 22 and a support disc 26.
  • a plurality of rigid guide rods 28 a-h connect and position a base plate 30 relative to the support disc 26.
  • the guide rods 28 a-h are flared outwardly in the proximal direction from the support disc 26 toward the base plate 30. This is done to facilitate the manipulability of catheter 10.
  • each of the actuation levers 32 a-h is fixedly attached to a respective electrode probe 18 a-h.
  • any manipulation of the actuation levers 32 a-h between the distal stops 34 and the proximal stops 36 will result in a corresponding distal or proximal movement of the electrode probes 18 a-h.
  • Figure 1A also shows that an electrical connector 38 a-h is attached to the distal end of a respective electrode probe 18 a-h.
  • the catheter 10 also includes a nozzle 40 that is connected to a hose 42 which extends through the actuator assembly 14 and which is connected in fluid communication with the lumen of hollow support sheath 12.
  • This nozzle 40 is attachable to a source of fluid (not shown) , such as a saline solution, which can be used to flush the catheter 10 through the sheath 12 and probe guide 16 to help maintain its operability.
  • a source of fluid such as a saline solution
  • the actuator assembly 14 is important and necessary for manipulating the individual deployment of the electrode probes 18 a-h from the catheter 10, the trajectory which is followed by each electrode probe 18 a-h when it is deployed is, at least, of equal importance.
  • the structure of catheter 10 which establishes the favorable trajectory of each electrode probe 18 is the probe guide 16. An understanding of the probe guide 16 will be best appreciated with reference to Figures 2A and 2B.
  • guide probe 16 includes a base 44, and a head 46 which is held on the base 44 by a screw 48. More specifically, the base 44 is formed with a plurality of channels 50 a-h. Also, the base 44 has a bracket 52 which is formed with a plurality of holes 54 a-h that communicate respectively with the channels 50 a-h. As shown, each of the channels 50 a-h has a curved end 56 a-h, and the bracket 52 is formed with a threaded orifice 58. In an alternate embodiment, the base 44 can be made without the channels 50 a-h.
  • the head 46 has a plurality of grooves 60 a-h which are formed to mate with the respective channels 50 a-h of the base 44 to create passageways 62 a-h (shown in Figure 2B) .
  • the screw 48 is inserted through the bore 64 of head 46 and threadably engaged with the threaded orifice 58 of base 44.
  • the sheath 12 can be joined to the detent 66 of base 44 by any means well known in the pertinent art, such as by solvent bonding.
  • the individual electrode probes 18 a-h are separately and individually extendable from the probe guide 16 along what is termed here, a favorable trajectory. Essentially, this is taken to mean that the tip 20 of any particular electrode probe 18 is deployed from the probe guide 16 along a path which approaches and contacts the endocardium 76 of the left ventricle 68 from a direction that is substantially perpendicular to the surface of the endocardium 76.
  • the benefits to be obtained from this cooperation of structure are two-fold. First, it allows the electrode probe 18 to contact the endocardium from a direction which has the optimal probability of establishing a good electrical contact between the electrode probe 18 and the endocardium 76. Second, it allows the individual electrode probe 18 to continue to be deployed from the catheter 10 until there is such contact. A specific example will be instructive.
  • FIG. 3 For the catheter 10 to be in the deployment pattern 74' as shown in Figure 3. Further, consider that Figure 4 corresponds to the positioning of the electrode probes 18 in deployment pattern 74'.
  • the electrode probes 18 a-h collectively, it can be appreciated that the deployed tips 20 a-h of the plurality of electrode probes 18 a-h are substantially coplanar when in contact with the endocardium 76.
  • a specific electrode probe 18 e.g. electrode probe 18d
  • the tip 20d of the electrode probe 18d contacts the endocardium 76 from a direction that is substantially perpendicular to the surface of the endocardium. Indeed, this is so for all electrode probes 18 a-h regardless of the topography of the endocardium 76 at the particular location where the tip 20 a-h makes its contact.
  • probe guide 16 in left ventricle 68 need not be established with precision for any particular deployment pattern 74, 74' or 74".
  • the probe guide 16 is not centered in the left ventricle 68.
  • the various electrode probes 18 a-h are each capable of being deployed from the catheter 10 and into contact with the endocardium 76.
  • the electrode probe 18e is not deployed from probe guide 16 as far as is the electrode probe 18h. Nevertheless, both probes I8e and l ⁇ h are in contact with the endocardium 76.
  • an operator can initially manipulate all of the actuation levers 32 a-h by drawing them proximally toward the proximal stops 36 a-h to withdraw the tips 20 of electrode probes 18 a-h into the retracted configuration for probe guide 16 shown in Figure IB.
  • the probe guide 16 at the distal end of support sheath 12 can then be inserted into the left ventricle 68 using any approved medical procedure.
  • the electrode probes 18 a-h can be individually deployed along favorable trajectories into a deployment pattern 74. Electronic responses from the heart 70 can then be recorded by the electronic device 72.
  • Figure 5 shows that the recorded electrical responses 78 a-h, as obtained through the respective electrode probe 18 a-h, occur at different times. It happens that, because an arrhythmia occurs as waves, the earliest recorded response is nearer the ectopic focus. Thus, Figure 5 indicates that for the particular contraction of heart 70 which caused the electrical responses 78 a-h, the electrode probes 18a and l ⁇ h were closest to the ectopic focus, and that the electrode probe 18d was farthest from the ectopic focus.
  • the subsequent set of recorded electrical responses 80 a-h which are obtained by catheter 10 in this same deployment pattern 74 is substantially similar.
  • Several such responses can be obtained, as desired by the operator.
  • these responses recorded (78, 80) one will be chosen for analysis.
  • the timing of the chosen activations relative to a selected reference time point, such as the onset of the QRS complex on the surface electrogram, will be assigned to one of the electrode locations shown in Figure 6 marked 78a/80a to 78h/80h.

Abstract

Un cathéter de cartographie endocardique (10) comporte un ensemble actuateur (14) d'où part une gaine de support creuse allongée (12). Plusieurs sondes électriques (18 a-h) sont disposées coulissantes en vue de permettre leur déplacement indépendant à travers la gaine (12), et chaque sonde (18) est fixée à l'ensemble actuateur (14) afin de permettre une manipulation individuelle. Un guide (16) est monté sur l'extrémité de la gaine (12) opposée à l'ensemble actuateur (14), en vue du déploiement radial de chaque sonde électrique (18) sur une trajectoire favorable séparée, à mesure que la sonde est manipulée. En service, les sondes (18) sont initialement rétractées dans la gaine (12). Une fois le guide (16) en position souhaitée, toutes les sondes (18) sont individuelement déployées jusqu'à ce qu'elles aient fait chacune contact avec l'endocarde du ventricule gauche. Des réponses cadencées par cycles sont obtenues des sondes (18), et une série de ces réponses provenant de diverses localisations du guide dans le ventricule gauche sont enregistrées pour effectuer une cartographie endocardique circonférentielle du c÷ur.
PCT/US1993/007881 1992-02-11 1993-08-23 Catheter de cartographie endocardique electrique WO1995005773A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US07/833,746 US5237996A (en) 1992-02-11 1992-02-11 Endocardial electrical mapping catheter
AU50858/93A AU5085893A (en) 1992-02-11 1993-08-23 Endocardial electrical mapping catheter
PCT/US1993/007881 WO1995005773A1 (fr) 1992-02-11 1993-08-23 Catheter de cartographie endocardique electrique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/833,746 US5237996A (en) 1992-02-11 1992-02-11 Endocardial electrical mapping catheter
PCT/US1993/007881 WO1995005773A1 (fr) 1992-02-11 1993-08-23 Catheter de cartographie endocardique electrique

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WO1995005773A1 true WO1995005773A1 (fr) 1995-03-02

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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6083170A (en) * 1996-05-17 2000-07-04 Biosense, Inc. Self-aligning catheter
US6203493B1 (en) 1996-02-15 2001-03-20 Biosense, Inc. Attachment with one or more sensors for precise position determination of endoscopes
US6211666B1 (en) 1996-02-27 2001-04-03 Biosense, Inc. Object location system and method using field actuation sequences having different field strengths
US6253770B1 (en) 1996-02-15 2001-07-03 Biosense, Inc. Catheter with lumen
US6266551B1 (en) 1996-02-15 2001-07-24 Biosense, Inc. Catheter calibration and usage monitoring system
US6285898B1 (en) 1993-07-20 2001-09-04 Biosense, Inc. Cardiac electromechanics
US6321109B2 (en) 1996-02-15 2001-11-20 Biosense, Inc. Catheter based surgery
US6332089B1 (en) 1996-02-15 2001-12-18 Biosense, Inc. Medical procedures and apparatus using intrabody probes
US6366799B1 (en) 1996-02-15 2002-04-02 Biosense, Inc. Movable transmit or receive coils for location system
US6453190B1 (en) 1996-02-15 2002-09-17 Biosense, Inc. Medical probes with field transducers
US6600948B2 (en) 1996-01-08 2003-07-29 Biosense, Inc. Method for velocity component vector mapping
US6618612B1 (en) 1996-02-15 2003-09-09 Biosense, Inc. Independently positionable transducers for location system
US6915149B2 (en) 1996-01-08 2005-07-05 Biosense, Inc. Method of pacing a heart using implantable device

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4289138A (en) * 1980-06-09 1981-09-15 Medical Testing Systems, Inc. Electrode assembly for temporary pacing and heart measurements
US4522212A (en) * 1983-11-14 1985-06-11 Mansfield Scientific, Inc. Endocardial electrode
US4602642A (en) * 1984-10-23 1986-07-29 Intelligent Medical Systems, Inc. Method and apparatus for measuring internal body temperature utilizing infrared emissions
US4699147A (en) * 1985-09-25 1987-10-13 Cordis Corporation Intraventricular multielectrode cardial mapping probe and method for using same
US4862887A (en) * 1987-05-29 1989-09-05 Gesellschaft Fuer Strahlen Und Umweltforschung (Gsf) Heart catheter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4289138A (en) * 1980-06-09 1981-09-15 Medical Testing Systems, Inc. Electrode assembly for temporary pacing and heart measurements
US4522212A (en) * 1983-11-14 1985-06-11 Mansfield Scientific, Inc. Endocardial electrode
US4602642A (en) * 1984-10-23 1986-07-29 Intelligent Medical Systems, Inc. Method and apparatus for measuring internal body temperature utilizing infrared emissions
US4699147A (en) * 1985-09-25 1987-10-13 Cordis Corporation Intraventricular multielectrode cardial mapping probe and method for using same
US4862887A (en) * 1987-05-29 1989-09-05 Gesellschaft Fuer Strahlen Und Umweltforschung (Gsf) Heart catheter

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6751492B2 (en) 1993-07-20 2004-06-15 Biosense, Inc. System for mapping a heart using catheters having ultrasonic position sensors
US6285898B1 (en) 1993-07-20 2001-09-04 Biosense, Inc. Cardiac electromechanics
US6600948B2 (en) 1996-01-08 2003-07-29 Biosense, Inc. Method for velocity component vector mapping
US6915149B2 (en) 1996-01-08 2005-07-05 Biosense, Inc. Method of pacing a heart using implantable device
EP1382293A3 (fr) * 1996-01-08 2004-01-28 Biosense Inc., State of Incorporation - Delaware, USA Catheter de cartograhpie
EP1382293A2 (fr) * 1996-01-08 2004-01-21 Biosense Inc., State of Incorporation - Delaware, USA Catheter de cartograhpie
US6266551B1 (en) 1996-02-15 2001-07-24 Biosense, Inc. Catheter calibration and usage monitoring system
US6332089B1 (en) 1996-02-15 2001-12-18 Biosense, Inc. Medical procedures and apparatus using intrabody probes
US6366799B1 (en) 1996-02-15 2002-04-02 Biosense, Inc. Movable transmit or receive coils for location system
US6453190B1 (en) 1996-02-15 2002-09-17 Biosense, Inc. Medical probes with field transducers
US6321109B2 (en) 1996-02-15 2001-11-20 Biosense, Inc. Catheter based surgery
US6618612B1 (en) 1996-02-15 2003-09-09 Biosense, Inc. Independently positionable transducers for location system
US6253770B1 (en) 1996-02-15 2001-07-03 Biosense, Inc. Catheter with lumen
US6203493B1 (en) 1996-02-15 2001-03-20 Biosense, Inc. Attachment with one or more sensors for precise position determination of endoscopes
US6211666B1 (en) 1996-02-27 2001-04-03 Biosense, Inc. Object location system and method using field actuation sequences having different field strengths
US6083170A (en) * 1996-05-17 2000-07-04 Biosense, Inc. Self-aligning catheter

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