USRE35880E - Endocardial electrical mapping catheter and method - Google Patents
Endocardial electrical mapping catheter and method Download PDFInfo
- Publication number
- USRE35880E USRE35880E US08/518,355 US51835595A USRE35880E US RE35880 E USRE35880 E US RE35880E US 51835595 A US51835595 A US 51835595A US RE35880 E USRE35880 E US RE35880E
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- United States
- Prior art keywords
- probes
- probe
- catheter
- endocardium
- sheath
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- 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 or 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.
- contractions of the heart muscle result from an excitation wave of electrical impulses which originate at the atrium, which propagate via the atrioventricular node to the ventricles, and which progress outwardly through conductive tissue in the endocardium.
- This is normal, and the rhythmic repetition of the heart beat is an indicator of good health. It happens, however, that for a diseased heart there are sometimes variations from the normal rhythm of the heart beat which are manifested as abnormal spontaneous contractions. These abnormalities are clinically referred to as arrhythmia, and they can cause numerous unwanted complications for a patient.
- arrhythmia it is desirable to locate the site of arrhythmogenesis or ectopic focus or an arrhythmia with the hope that medical intervention can cure the problem.
- the ectopic focus or 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. Pat. 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.
- 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 or 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 or 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.
- FIG. 1A is a perspective view of the endocardial electrical mapping catheter of the present invention.
- FIG. 1B is a perspective view of the probe guide portion of the catheter when the probes of the catheter are retracted;
- FIG. 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 FIG. 1A;
- FIG. 2B is a cross-sectional view of the guide shown in FIG. 2A when assembled and with probes extending therethrough;
- FIG. 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;
- FIG. 4 is a cross-sectional view of the heart with inserted catheter as seen along the line 4--4 in FIG. 3;
- FIG. 5 is a representative graph of timed responses from each of the probes of the catheter of the present invention during sequential cardiac cycles.
- FIG. 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 or 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.
- FIG. 1A also shows that 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 FIG. 1B) and a collectively deployed configuration (shown in FIG. 1A). The mechanics of how this is accomplished will be best appreciated by considering the actuator assembly 14 as it is shown in FIG. 1A.
- FIG. 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.
- the connector assembly 22, support disc 26 and base plate 30, together with their respective interconnecting spacer bars 24 and guide rods 28 a-h establish a rigid platform structure from which the individual electrode probes 18 of the catheter 10 can be manipulated.
- each guide rod 28 should have a cross section profile, such as a square or rectangle, which will prevent any rotation or the associated actuation lever 32 a-h about the longitudinal axis of the guide rod 28 a-h.
- each of the actuation levers 32 a-h is fixedly attached to a respective electrode probe 18 a-h.
- FIG. 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.
- 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 FIGS. 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 FIG. 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.
- FIG. 3 also shows the catheter 10 in its electrical connection with an electronic device 72.
- the electronic device 72 can be of any type well known in the pertinent art which is able to record the electrical signals from the heart 70 which are picked up by the various electrode probes 18 a-h.
- FIG. 3 further indicates that the probe guide 16 at the distal end of catheter 10 can be moved and repositioned within the left ventricle 68.
- FIG. 3 shows three different deployment patterns for the catheter 10 which are successively designated 74, 74' and 74".
- 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 or 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. 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". As shown in FIG. 4, the probe guide 16 is not centered in the left ventricle 68. Still, the various electrode probes 18 a-h are each capable of being deployed from the catheter 10 and into contact with the endocardium 76. For example, the electrode probe 18e is not deployed from probe guide 16 as far as is the electrode probe 18h. Nevertheless, both probes 18e and 18h 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 FIG. 1B.
- 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.
- the electrode probes 18 a-h can be withdrawn into their retracted configuration.
- the probe guide 16 can then be repositioned within the left ventricle 68 for reconfiguration into the deployment pattern 74' and, subsequently from deployment pattern 74', into the deployment pattern 74".
- the operator is able to individually manipulate an actuation lever 32 on the actuator assembly 14 to either retract or deploy the corresponding electrode probe 18.
- the particular electrode probe 18 is deployed along a favorable trajectory.
- FIG. 5 shows a representative time sequence of electrical responses resulting from contractions of the heart 70 as they would be received by the catheter 10 from the heart 70 during any particular deployment pattern 74.
- the catheter 10 is in the deployment pattern 74 shown in FIGS. 3 and 4.
- FIG. 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.
- FIG. 5 shows a representative time sequence of electrical responses resulting from contractions of the heart 70 as they would be received by the catheter 10 from the heart 70 during any particular deployment pattern 74.
- 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. Among these responses recorded (78, 80), one will be chosen for analysis. The timing or 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 FIG. 6 marked 78a/80a to 78h/80h.
- the electrical responses 78/80 a-h et seq. are plotted around the circumference designated to correspond with deployment pattern 74.
- Other circumferences are obtained corresponding to the deployment patterns 74' and 74", and the earliest responses are identified to locate the ectopic focus.
- as many deployment patterns may be accomplished as is deemed necessary by the operator to properly locate the site of arrhythmogenesis.
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Abstract
Description
Claims (19)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US08/518,355 USRE35880E (en) | 1992-02-11 | 1995-08-13 | Endocardial electrical mapping catheter and method |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US07/833,746 US5237996A (en) | 1992-02-11 | 1992-02-11 | Endocardial electrical mapping catheter |
US08/518,355 USRE35880E (en) | 1992-02-11 | 1995-08-13 | Endocardial electrical mapping catheter and method |
Related Parent Applications (1)
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US07/833,746 Reissue US5237996A (en) | 1992-02-11 | 1992-02-11 | Endocardial electrical mapping catheter |
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USRE35880E true USRE35880E (en) | 1998-08-25 |
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US07/833,746 Ceased US5237996A (en) | 1992-02-11 | 1992-02-11 | Endocardial electrical mapping catheter |
US08/518,355 Expired - Lifetime USRE35880E (en) | 1992-02-11 | 1995-08-13 | Endocardial electrical mapping catheter and method |
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US07/833,746 Ceased US5237996A (en) | 1992-02-11 | 1992-02-11 | Endocardial electrical mapping catheter |
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AU (1) | AU5085893A (en) |
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