An actively anchored electrode for electrode catheters

Abstract: The electrode comprises a point (3) sandwiched between a protective insulating sheath (2) and an enlarged end portion (6) of the selfsame sheath in such a way that the tip (3a) of the point projects from the distal end of the sheath, together with a stimulation head (7) disposed coaxially with the sheath and connected electrically to a spiral wound conductor (1); when the point (3) is corkscrewed into a cardiac muscle (5), a conductive spring (8) positioned between the head (7) and the conductor (1) allows a measured retraction of the head (7) back into the sheath (2), with the result that the head is maintained constantly in contact with the surface of the cardiac muscle (5) independently of the penetrating movement of the point (3).

Description: The present invention relates to actively anchored electrode catheters. Conventional electrode catheters as used currently with cardiac pacemakers, whether mono- bi- or tri- polar, are anchored by way of a distal electrode consisting substantially in a head or point of conductive material that is hooked into the cardiac muscle and associated directly (via a connection made internally of a protective insulating sheath) to a spiral wound conductive wire returning to one of the pacemaker terminals. During implantation of the catheter, the surgeon uses a special tool operated from the remote end of the spiral wound conductor to corkscrew the point into the cardiac muscle of the patient, where it remains permanently anchored. The principal drawback betrayed by these implanted elements stems in effect from the very embodiment of the electrode catheter, whereby the point, being connected directly and electrically to the spiral wound wire, also functions as a cardiac sensing and stimulation terminal; the surface area of such an electrode is therefore of generous proportions, so that the concentration of the stimulation current flowing through the lesion produced in the cardiac muscle by penetration of the point gives rise to a negative secondary phenomenon in the electrical activity of the heart, referred to in technical jargon as a "lesion wave". The European Patent EP-035959 discloses such kind of electrode catheter, in accordance with the preamble of claim 1. The catheter comprises an electrode with two retaining hooks, that are pointed and bent over through 90 degrees to lie parallel to the end face of the electrode, such end face has two raised part between which the hooks are situated. This geometry allows the catheter to be passed along a vein without the danger of causing the hooks to lodge in the vein wall, while when a frontal contact is established with the wall destined to afford an anchorage the hooks can be made penetrate by applying rotation. All the component parts of the electrode are fixed one in relation to the other, therefore is difficult to ensure both that the electrode is well anchored and a wide contact surface is provided for the stimulation. Another of such catheter is disclosed in the German Patent DE-2949782. In this case the catheter disclosed comprises a hollow case which is firmly connected to a conductor and in which is ensheathed a spiral wound wire that can be anchored positively in the cardiac muscle. When the surgeon turns by means of a cable the spiral wound wire, this moves forward through an opening by an amount limited by a plate in the cardiac tissue. Also in this catheter there are no elements which combine freedom of axial movement with a capacity for ensuring a generous contact surface and a firm anchorage. Accordingly, the object of the present invention is to overcome the drawback in question by providing an electrode catheter capable on the one hand of allowing a secure penetration and anchorage in muscle tissue, and on the other, of producing electrical contact by way of a conductive surface that is proportioned to the requirements of stimulation, devoid of any traumatizing effect and with a greater stimulation sensitivity, the combined effect of which being to eliminate the "lesion wave". The stated object is fully realized in an actively anchored electrode catheter as characterized by the appended claims. The invention will now be described in detail, by way of example, with the aid of the accompanying drawings, in which: fig 1 is the side elevation of an anchor electrode catheter according to the invention, seen in a non-operative configuration and with certain parts illustrated in section; fig 2 is a further side elevation illustrating the anchor electrode catheter of fig 1, seen in an operative configuration and with certain parts in section. With reference to the accompanying drawings, the actively anchored electrode catheter disclosed forms part of an indwelling electrode catheter comprising one or more spiral wound stimulation signal conductors 1; the number of conductors will depend naturally upon the type of electrode catheter in question (mono- or bi- or tri- polar), though the conductor with which the disclosure is concerned is that denoted 1 extending to the distal extremity of the catheter. The spiral wound conductor is clad in a protective tubular sheath 2 of insulating material and affords a metallic anchor terminal, or point 3, located at the free end of the catheter, which can be rotated through the agency of control means 4 consisting in a spindle 41, capable of rotation about its own axis and affording a slot 42 in the face offered to the conductor 1; inserting a surgical screwdriver into the slot and turning the spindle, the point 3 can be made to penetrate into the cardiac muscle 5 and thus anchored. More exactly, the anchor point 3 of the electrode catheter according to the invention forms part of a spiral wound element sandwiched (see fig 1) between the tubular sheath 2 and an enlarged terminal portion 6 of the sheath, likewise of insulating material, with the tip 3a lying substantially beyond the compass of the sheath 2. The anchor point 3 is rigidly associated with the control means 4 by way of a ring 9 crimped over the innermost end 3b of the sandwiched spiral element in a position coinciding with that occupied by the control means 4. In a non-operative position, the active or exposed coils of the point 3 encircle a stimulation element or head 7 disposed coaxially to the tubular sheath 2 and connected to the spiral wound conductor 1; similarly, in the non-operative position, the active surface of the stimulation head 7 is positioned substantially in alignment with the tip 3a of the anchor point 3. In the example illustrated, the stimulation head 7 consists in a pin of cylindrical shape which might be embodied in a variety of materials, typically platinum/iridium, carbon, titanium etc.. The connection between the stimulation head 7 and the spiral wound conductor 1 is achieved utilizing conductive elastic means 8 interposed between the two components; such means 8 consist effectively in a coil spring 10 of conductive material, positioned between the control spindle 41 and the stimulation head 7, of which the ends are secured by means of corresponding rings 11 and 12 crimped onto relative pins 13 and 14 associated with the spindle 41 and the head 7 respectively, over which the two ends of the spring 10 are coaxially seated. The function of the coil spring 10 is to allow a measured retraction of the stimulation head 7 back into the sheath 2 as the point 3 screws into the cardiac muscle 5, thereby ensuring that the contact induced between the head and the surface of the muscle is maintained constant independently of the penetrating movement of the point 3. An electrode catheter according to the present invention is positioned and anchored in the following manner: locating the point 3 against the cardiac muscle 5, the surgeon, using a special flexible screwdriver inserted through the tubular sheath 2 and located in the slot of the spindle 41, applies pressure and rotation (see arrows F and F1); given the position of the spindle 41 between the conductor 1 and the spring 10, the effect of such a manoeuvre is to carry both the head 7 and the point 3 forward. As the tip 3a enters into contact with the cardiac muscle 5 and begins to penetrate, the stimulation head 7 also engages the surface of the muscle, and through the agency of the spring 10 is held in this same position as the active coils of the point 3 and the corresponding extremity of the sheath 2 are carried forward until the sheath also enters into contact with the muscle (as in fig 2). Thus, an electrode catheter embodied in the manner described above ensures efficient anchorage of the electrode catheter as a whole, together with improved levels of sensitivity in monitoring and stimulating the cardiac muscle, achieved by virtue of the type of head 7 and the materials used in its construction. More important still is the fact that the anchor point and the spiral wound conductor are isolated one from the other: thus, with the electrically conductive surface area offered by the electrode to the cardiac muscle reduced in size, the lesion wave returned by the muscle (detectable with appropriate instruments) is almost completely eliminated.

Claims: An actively anchored electrode catheter comprising: a distal end; at least one spiral wound stimulation signal conductor (1) disposed internally of a protective insulating tubular sheath (2) provided with a free end at the distal end, the tubular sheath being surrounded at the distal end by an outer sheath forming an enlarged portion (6); an anchor terminal (3) positioned at the distal end of the electrode catheter and coaxially to the sheath (2) and provided by a tip (3a); a stimulation element or head (7), rotation control means (4) rigidly associated with the anchor terminal (3) for rotating the anchor terminal in such a way as to penetrate and anchor in a cardiac muscle (5) characterized in that it comprises conductive elastic means (8) interposed between the stimulation head (7) and the spiral wound conductor (1), the elastic means (8) having an end connected to the rotation control means, the length of said elastic means (8) and the position of the end of the elastic means connected to the rotation control means (4) being such that, in a non-operative configuration of the catheter, the anchor terminal (3) encircles the stimulation head (7) and the active surface of the latter is disposed in alignment at least with the tip (3a) of the anchor terminal (3) and both projecting from the sheath beyond the free end of the tubular sheath (2), and in an operative configuration of the catheter, i.e. as the anchor terminal (3) is made to penetrate the cardiac muscle (5), the stimulation head retracts back into the sheath (2) in such a way that the contact induced between the head and the surface of the cardiac muscle can be maintained constant independently of the penetrating movement of the anchor terminal (3); and in that the anchor terminal is connected stably to the protective tubular sheath (2) in a position corresponding with said enlarged end portion (6) of the sheath and is electrically isolated from the spiral wound conductor (1) and that the stimulation head is connected to the spiral wound conductor (1). An electrode catheter as in claim 1, wherein the anchor terminal (3) is sandwiched between the free end of the protective tubular sheath (2) and the outer sheath forming the enlarged end portion (6); said control means (4) are disposed coaxially between the spiral wound conductor (1) and the elastic means (8) by means of a ring (9) crimped to an innermost end (3b) of the anchor element in such a way that the innermost end (3b) remains secured to the tubular sheath (2) in a position coinciding with the control means (4). An electrode catheter as in claim 1, wherein the elastic means (8) consist in a conventional spring (10) of conductive material interposed between the rotation control means (4) and the stimulation head (7), of which the ends are secured by means of corresponding rings (11, 12) crimped onto relative pins (13, 14) associated with the rotation control mans (4) and the head (7) respectively, over which the two ends of the spring (10) are coaxially seated. An electrode catheter as in claim 1 wherein the stimulation head (7) consists in a cylindrical pin fashioned from platinum-iridium. An electrode catheter as in claim 1, wherein the stimulation head (7) consists in a cylindrical pin fashioned from titanium. An electrode catheter as in claim 1, wherein the stimulation head (7) consists in a cylindrical pin fashioned from carbon.

Inventors: BORGHI ENZO, BORGHI, ENZO
Applicants: BARD S P A, BARD S.P.A.
Application year: 1992
Main classification: A61N1
IPC codes: A61N1