This invention relates to electrodes for cardiac pacemakers, and particularly to transvenous electrodes suitable for atrial sensing and ventricular pacing, for A-V sequential pacing or bifocal pacing.
There are many occasions when it is desirable to control an artificial cardiac pacemaker by physiological methods, or to maintain physiological atrial-ventricular timing during pacing. Such instances include detection of activity from the sinus node or the atrium (right or left) using this activity to activate a cardiac pacemaker with subsequent delivery of a stimulus to the ventricle (right or left), or to another suitable pacing site. A delay may be incorporated between sensing the supraventricular impulse and delivery of the ventricular stimulating impulse.
Under other circumstances, it may be desirable to pace both the atrium and the ventricle, with or without any intervening delay.
Present techniques for reliable sensing of supraventricular impulses usually rely on attachment of a separate sensing electrode placed independently from the stimulating electrode. Dual electrodes for sensing the atrium and pacing the ventricle are so far unreliable. It is extremely difficult to pace the atrium or adjoining tissues, such as the sinus node, unless a separate electrode is attached so that A-V sequential pacing requires complicated electrode placement.
I have now developed a transvenous dual electrode suitable for the above applications and which can be reliably and simply placed in position.
According to the invention I provide a dual electrode for use in cardiac pacemaking to enable both ventricular and atrial electrical contact to be made, which comprises a catheter for insertion through a blood vessel to the heart and having at its distal end a ventricular electrode electrically-connected to the proximal end of the catheter, and, spaced apart from the ventricular electrode, at least one atrial electrode disposed in a plane transverse to the catheter and spaced radially apart therefrom, said at least one atrial electrode being supported in a material connected to said catheter which is sufficiently flexible and resilient to enable the atrial electrode(s) to be deformed out of said plane and pass through said blood vessel, said atrial electrode(s) being electrically-connected to the proximal end of the catheter.
The electrodes are preferably formed as prongs extending outwardly from the catheter. At least two, and preferably three such prongs are employed.
Preferred features of the present invention will now be described with reference to the accompanying drawing, given by way of example, wherein:
FIG. 1 is a cross-section through a dual electrode of the invention with the ventricular stimulating tip omitted; and
FIG. 2 is a section along the line X--X of FIG. 1.
FIG. 3 is a section, similar to FIG. 2, of the dual electrode of the invention with two atrial electrodes;
FIG. 4 is similar to FIG. 3 and illustrates one atrial electrode;
FIG. 5 is an axial section showing a flexible rod in place of the spring shown in FIG. 1;
FIG. 6 is a section similar to FIG. 1 in which a "filled" atrial electrode replaces the electrode of FIG. 1;
FIG. 7 is a section similar to FIG. 1 in which the electrode of FIG. 1 is replaced by a conductive coating on the sheath;
FIG. 8 is a section similar to FIG. 1 in which the sheath supporting the atrial electrode extends to the proximal end of the electrode and one of the conductors is outside the catheter;
FIG. 9 is a section similar to FIG. 1 in which the separate electrodes are replaced by a floppy disc with a single, continuous electrode circumscribing the catheter; and
FIG. 10 is a section similar to FIG. 1 in which the conductors connected to the electrodes are co-axial.
Referring to the drawing, the dual electrode illustrated has a ventricular stimulating tip electrode 16 at its distal end and three atrial electrodes 2. The ventricular tip electrode employed may be any of those currently in use, for example a screw-in or contact type, with a surface shape and area as desired. The atrial electrodes 2 are disposed approximately 13 to 17 cms back from the tip and are radially-disposed about a central catheter 4 of electrically-insulating flexible plastics tubing. An insulated electrical conductor 6 which makes connection with the ventricular tip electrode passes along catheter 4 to the proximal terminal of the electrode, as is conventional. Although three atrial electrodes are shown, it will be apparent that one or two of the electrodes 2 may be omitted. FIGS. 3 and 4 illustrate such embodiments.
An electrically-conductive metal ring 8 makes contact with and circumscribes catheter 4. Electrically connected to ring 8 and passing through the catheter wall is a second insulated electrical conductor 10. Also connected to ring 8 and extending radially outwardly therefrom are three electrically-conductive metal springs 12. The springs are respectively connected to an atrial electrode 2 and enable electrical connection between the atrial electrodes 2 and conductor 10 to be made. The conductor 10 passes along catheter 4 to the proximal terminal of the electrode.
The atrial electrodes 2 are maintained in a sheath of thin electrically-insulating flexible plastics material 14. The electrodes thus form three radially-disposed prongs biassed outwardly under the influence of springs 12. The radial length of each prong is typically from 0.5 to 1.5 cms. The sheath 14 is sealed to catheter 4 just beyond each side of the prongs.
The prongs are flexible and therefore allow the entire electrode to be introduced through a vein of suitable size such as the jugular subclavian or cephalic. The stimulating distal tip of the electrode can be positioned in the ideal position within the right ventricle and the prongs will then make contact with the lateral wall of the right atrium even although the course of the electrical conductors 6 and 10 lies within the cavity of the right atrium, away from the wall.
The prongs are of such flexibility as to make adequate contact with the right atrial wall at one or more points and the tips are conductive with small area electrodes. The stiffness of the prongs can be influenced by the sheath material chosen (such as silicone rubber), by the dimensions and shape of the prongs, or by the incorporation of central stiffness such as the springs illustrated or flexible rod of metal 12a shown in FIG. 5.
The contact tips of the prongs can be shaped with a small radius of curvature to provide a high current density and pacing will occur through whichever of the prongs is contacting the atrial wall.
The prongs can alternatively be made conducting themselves, for example, by "filling" the insulating material 14 with biocompatible conducting elements such as carbon, as illustrated in FIG. 6 or by surface coating with a flexible conducting layer of biocompatible material, such as gold, as illustrated by 15 in FIG. 7.
Various modifications to the dual electrode described are possible. For example, the sheath 14 might only be sealed to the catheter 4 on the distal side of the prongs. On the proximal side the sheath 14 could then extend to the proximal end of the electrode with the conductor 10 extending to the proximal end in the annular gap between catheter 4 and sheath 14. In this manner, catheter 4 need not be pierced to allow passage of conductor 10 therethrough and, indeed, the insulation of one or both of conductors 6 and 10 could be omitted if desired. Such embodiment is illustrated in FIG. 8.
The invention is not restricted to the use of three atrial electrodes and more, or less prongs could be employed if wished, although 3, in the configuration illustrated, is thought to be the optimum.
In place of separate, radially-extending electrodes a single continuous atrial electrode, spaced apart from and circumscribing catheter 4, may be employed. In this embodiment, illustrated in FIG. 9 the atrial electrode would be similar to a small floppy disc extending outwardly from catheter 4.
Furthermore, in place of separate conductors for the atrial and ventricular electrodes, a coaxial cable with twin coaxial conductors may be employed, as illustrated in FIG. 10, the conductor 10a being co-axial with the conductor 6a.