DEFIBRILLATOR AND DEMAND PACER CATHETER AND METHOD

Abstract: Apparatus which combines a demand pacer (26) and a defibrillator lead (15) structure is adapted for implantation into a patients body intravenously with a single surgical procedure. The apparatus includes an elongated electrical conductor (15) terminating in a porous, large surface area, electrically-conductive terminal with an anchoring arrangement (13) adapted for connection to the septum (31) between the ventricles of a patient's heart. The terminal is suitable for the signals supplied by the demand pacer (26) also. The apparatus includes monitoring equipment (27) to track the heart's activity and to provide control signals to activate the demand pacer (26) or the defibrillator (25) controllably.

Description: DEFffiRIL ATOR AND DEMAND PACER CATHETER AND METHOD Field of the Invention This invention relates to medical instrumentation and more particularly to implantable demand pacer and defibrillator leads. Background of the Invention It is well known that a demand pacer is implanted into the human body by inserting catheters, with corkscrew-shaped ends, transvenously for attachment to the fibrous material at the bottom of a patients ventricle. The demand pacer is adapted to monitor heart activity and to compensate for missing signals for maintaining heart activity at acceptable levels. A defibrillator, on the other hand, normally is not intended for implantation. The defibrillator is designed primarily for emergency use to apply a high energy pulse to the heart of a patient to disrupt heart activity with the hope that a normal rhythm to the heart activity will result when the pulse terminates. When a defibrillator is implanted, the procedure now requires the chest wall of the patient to be opened and a large conductive patch to be sewn to the exposed surface of the heart in order to accommodate the high energy pulse. It is clear that the demand pacer and the defibrillator serve quite different functions and the implantation procedures in the two cases are quite different accordingly. United States Patent No. 3,857,398 issued December 31, 1974, describes a combination of demand pacer and a defibrillator available for automatic use in emergency situations. The apparatus is adapted to monitor a patient and to make the decision, automatically, as to the apparatus, demand pacer or defibrillator, to be used. The implantation of such apparatus now would require two separate surgical procedures, as just described, which in most instances would be too taxing on a patient to be undertaken. Brief Description of an Embodiment of this Invention Apparatus which is a combination of a demand pacer and a defibrillator is implanted in the human body with a single attachment to the heart requiring only a single surgical procedure and not requiring that the patients chest wall be opened. Instead, the apparatus is connected to the heart transvenously, employing electrodes of a unique design for delivering the high energy pulse needed for defibrillation. The electrodes are attached to the heart in a unique position different from the position to which demand pacer are normally attached. In one embodiment, the apparatus of the above-mentioned patent is connected to the heart of a patient transvenously employing a porous electrode anchored to the septum between the two ventricles of the heart. The septum is known to be highly electrically conductive and along with a porous (large surface area) electrode, properly anchored, is suitable for the delivery of the high energy defibrillator pulse and suitable for the signals from the demand pacer as well. Brief Description of the Drawing Figs. 1, 2, and 3 are schematic representations of an implantable demand pacer- defibrillator catheter for automatic operation in accordance with the principles of this invention; Fig. 4 is a schematic block diagram of the electronic circuitry for delivering pacing signals and defibrillator pulses via the catheter of figure 1; Fig. 5 is a schematic representation of a human heart showing the placement of the catheter of figure 1; Fig. 6 is an enlarged view of a portion of the catheter of figure 1; and Fig. 7 is a graph of the signals and pulses delivered through the catheter of figures 1 and 4. Fig. 8 is an enlarged, partially cross-sectional, view of one embodiment of a portion of the catheter. Detailed Description of an Illustrative Embodiment of this Invention Figure 1 shows a catheter 10 useful for the delivery of demand pacing signals and defibrillator pulses in accordance with the principles of this invention. The catheter includes distal electrodes 11, proximal electrodes 12, and a defibrillation electrode 13. Three leads protrude from the right end of the catheter as viewed in the drawing. Lead 15 is connected to all of the distal electrodes 11, the electrodes being connected electrically in parallel. Lead 16 is connected to all of the proximal electrodes 12, also electrically in parallel. Lead 17 is connected to the defibrillation electrode (13). In one embodiment, distal electrodes 11 are connected in series with electrode 13 and thus, lead 15 and lead 17 can be used to apply defibrillation pulses in different embodiments. The illustrative catheter of figure 1 is a modification of a defibrillator catheter of the type shown in the Proceedings of the fourth New England Bioengineering Conference, May 7-8, 1978, Yale University, New Haven, Conn., page 427 et seq., "Automatic Defibrillation and Pacing with a Transvenous Electrode" by L. Rubin et al. That publication discloses a catheter in which the most distal section of a set of distal ring electrodes is also connected to a separate electrode for delivering pacing signals. Thus, in this reference the most distal electrode serves as a section of a defibrillation electrode as well as a pacing electrode. The catheter was used experimentally to deliver defibrillation pulses applied between the distal electrodes and a paddle placed on the chest or the hip of a patient. Both unipolar and bipolar defibrillation pulses were employed experimentally. In accordance with the principles of the present invention, the pacing electrode and lead are separate from and insulated from the defibrillation electrodes and leads. Specifically, in one embodiment, a catheter similar to that disclosed in the above-mentioned publication includes a central lumen into which a defibrillation electrode and lead are inserted. Moreover, the electrode is, illustratively, in the form of a pointed helix so that, when twisted, the helix will enter and anchor itself into a target position of the heart wall. The catheter is designed for transvenous implantation at a position in the heart different from that at which prior art defibrillator catheters are positioned. Further, I have discovered that if, as in the prior art, the defibrillation electrode is not embedded into the myocardial muscle but instead is allowed to be substantially exposed to the blood in the heart chamber, the blood, due to its conductivity shunts the electric power meant for the myocardium thereby making defibrillation extremely difficult to achieve. In addition, the catheter of figure 1 includes an extra electrode 18, at the distal end of the catheter. Electrode 18 also is in the form of a ring and is connected to a separate lead wire 19. The catheter illustratively, also includes an aperture 21, at the termination of a lumen 22 shown dotted in the figure. The lumen and aperture are for access of an extra demand pacer for the Atrium of the heart if necessary, Electrode 18 is the demand pacing electrode. United States patent serial number 3857398 issued December 3, 1974, to the inventor of the present invention discloses an apparatus which is a combination of a defibrillator, a demand pacer, and an analyzer-control device for implantation into a human body. Implantation is carried out via a catheter with three leads which apply the requisite energy between a most distal reference electrode and between the closer and the more distal of the two other electrodes for pacing signals and defibrillation pulses, respectively. The electrodes and associated leads were implanted transvenously with the catheter extending into the heart via the subclavian vein and the Superior Vena Cava. The apparatus disclosed in that patent can be used herein by interconnection with leads 15, 16, 17 and 19 of figure 1 which are connected to electrodes 11, 12, 13 and 18, respectively, leads 15 and 17 are used in the alternative, lead 17 being used in embodiments where electrodes 11 and 13 are electrically in series. Accordingly, such apparatus is not described in any detail herein. Suffice it to say that defibrillation pulses are applied between leads 15 (or 17) and 16 of figure 1 and pacing signals are applied between leads 19 and 16, the proximal electrodes being the reference electrodes. The catheter of figure 1 is operative in several modes. In the first mode, the catheter is operative as a demand pacer. In this mode, pulses are applied via lead 19 to ring electrode 18, through the heart of the patient to ring electrodes 12 to lead 16 to ground. This operation is represented in figure 2 where the passage of electrical current through the heart is indicated by the dashed line. Another mode of operation is demonstrated in figure 3 where defibrillation pulses are applied to lead 15 via ring electrodes 11 to cork screw electrode 13. Current passes through the heart of the patient as indicated by the dashed line in figure 3, through ring electrodes 12 to lead 16 to ground. In an alternative defibrillation operation, electrodes 11 need not be used as indicated by the dashed bracket about electrodes 11 in the figure. In such as embodiment, lead 17, connected directly to cork screw electrode 13 is used as indicated by the broken arrow 23 in the figure. The alternative use of leads 15 and 17 in different embodiments is indicated by figure 1 by showing the terminus of lead 17 in phantom. Thus, only three leads are necessary in any embodiment of this invention. Figure 4 shows a block diagram of such apparatus 24. The apparatus includes a source of defibrillation pulses 25, a source of pacing signals 26, and a controller 27. Controller 27 is responsive to voltage signals from sensors attached to a patient signalling characteristics of the operation of the patient's heart. The controller analyzes the signals and activates the defibrillator 25 or the demand pacer 26 depending on the signals received from the sensors as described in that patient. The helical and ring electrodes of figure 1 are made with porous surfaces to provide a relatively large surface area for the electrodes. Porous-surface electrodes are described in the Journal of Thoracic and Cardiovascular Surgery, St. Louis, Vol. 78, No. 2, pages 281- 291, August 1979, C.V. Mosby company, David C. MacGregor et al. The porous surfaces are formed by coating a solid metal (Titanium or Platinum) substrate with a rigid metal porous layer that is bonded to the substrate. Metal particles are joined together to form an interconnecting network of pores distributed uniformly through the coating. The metal substrate surface is roughened and then coated with a binder to which the particles adhere. After drying, the coated substrate is sintered at high temperature in a reducing atmosphere to fuse the particles together and to the surface. Commercially available pacing electrodes are useful to provide the solid metal substrate. The ring electrodes are made by Platinum or Titanium and have widths of 5 mm. Three electrodes, as shown for each of the proximal and distal electrodes in figure 1, are suitable for applying pulses of between one half joule and fifty joules. Figure 5 shows a schematic representation of a heart 30. The heart includes a right and a left atrium and a right and a left ventricle separated by a ventricular septum 31. The septum is known to be highly conductive, the most highly conductive point on the septum being known as the bundle of HIS. Electrical connection to the septum is made at a point typically about 5 cms away from the bundle so as not to disrupt other body functions. As shown in Fig. 5, the catheter enters the right atrium of the heart transvenously and passes through the tricuspid valve and into the right ventricle. The connection to the septum is made by anchoring defibrillation electrode 13 to the septum. For the illustrative embodiment, this is accomplished by rotating lead 17 in order to advance helical (cork screw) electrode 13 into the septum. The position of electrode 13 is shown in figure 5. Figure 6 shows an enlarged view of the defibrillation electrode showing point 32 advancing from the distal end of the catheter. Alternatively, catheter 10 can be made with the defibrillation lead integral with the catheter rather than threaded through a lumen. In such an embodiment, the helical electrode is exposed at the distal end of the catheter and the catheter is introduced to the patients vascular system through an introducer, the entire catheter being rotated for inserting the electrode into the septum. In this embodiment also, the introducer is removed after the position of the catheter is secured. In embodiments of this type, fixed electrical connection can be made between ring electrodes 11 and the defibrillation electrodes for implementing a series circuit accessed by lead 15 as indicated in figure 3. Figure 7 shows a graph of the energy delivered via a porous electrode in response to a 500 volt, 6 millisecond pulse compared to the energy delivered via a more conventional Titanium mesh electrode as indicated by the dashed curves and by the solid curves in figure 7, respectively. It is clear from the graph that the energy delivered via an electrode in accordance with the principles of this invention is greater than that delivered via the prior art system. Of course, the catheter of figure 1 could be used as a defibrillator catheter only, in which case posing electrode 18 would be absent. Transvenous implantation in such an embodiment, would also position the catheter for attachment to the septum of a patient. Figure 8 is an enlarged view of a preferred embodiment of the helical electrode 13. The advantage of this embodiment is the reduction of the current applied to localized areas of myocardial tissue thereby reducing the chances of damaging the tissue during defibrillation due to burning caused by excessive electric current in a small area. This is accomplished by providing the helical electrode 13 with a continuous insulating surface 32 over the inner half of the helix. The insulating surface can be an insulating coating applied over the inner- half of the helix over the length of the helix. Alternatively, the helix can be made of an insulating material having a conductive coating applied over the outer half of the helix. In any event, the resulting member is insulating along its inner surface 32 so that no current passes therethrough into the myocardial tissue and conducting along the outer surface portion 34 of the helix so as to transmit current to the myocardium in contact with that outer surface, thereby limiting the total current applied to the myocardium over small regions of myocardial tissue. What is Claimed:

Claims: 1. Apparatus including a defibrillator, a demand pacer, and means for monitoring the activity of a patients heart, said means being operative to generate first or second control signals responsive to said electrical activity for activating said defibrillator or said demand pacer respectively, said apparatus including elongated electrical conductor means for reaching said heart transvenously, said electrical conductor means including a porous electrically-conductive terminus for connection to said heart, said terminus having a surface area sufficiently large for permitting the delivery of said high energy pulse from said defibrillator to said heart, said electrical conductor means also including an anchoring means for connecting said terminus to said heart. 2. Apparatus as set forth in claim 1 wherein said anchoring means is adapted for connection to the septum between the two ventricles of the patients heart. 3. Apparatus as set forth in claim 2 wherein said terminus comprises Platinum or Titanium and has a surface area of at least 1.2 square cms. 4. Apparatus as set forth in claim 3 wherein said terminus comprise porous Platinum or Titanium and has a cork screw shape. 5. A catheter for connection, to a living heart for the delivery of defibrillator pulses said catheter having a distal and a proximal end, said catheter, including an electrically conducting lead having extended from its distal end an anchorable, large area terminus, said terminus comprising a porous electrically conducting material having a surface area of at least about 1.2 square centimeters. 6. A catheter as set forth in claim 5, wherein said terminus has a helical shape, said catheter including a central lumen, said lead residing in said lumen and being free to rotate therein. 7. A catheter as set forth in claim 5 wherein said lead has a helical shape and is in a fixed position in said catheter with said terminus extending from its distal end, and means for rotating said catheter to anchor said terminus into body tissue. 8. A catheter as set forth in claim 6 also including a first set of ring electrodes, said ring electrodes also comprising a porous, electrically-conducting material, said ring electrodes being connected to one another, electrically in parallel and electrically in series with said terminus. 9. A catheter as set for the in claim 8 also including a pacing ring electrode, said pacing ring electrode being positioned at said distal end between said terminus and said first set of ring electrodes, and a pacing lead connected to said pacing electrode and extending from said proximal end. 10. A catheter as set forth in claim 9 also including a second set of ring electrodes, said second set being positioned between said first set and said proximal end, the electrodes of said second set being connected electrically in parallel, and a lead connected to said second set and extending from said proximal end. 11. A catheter as set forth in claim 10 also including a lumen extending from a position near said proximal end to an aperture in the wall of said catheter, said aperture being positioned at said second set of ring electrodes for accepting an Atrium demand pacer. 12. A method for implanting a defibrillator catheter into a human body transvenously, said catheter including an electrically-conducting lead having a helical terminus extending from the distal end thereof, said terminus comprising a porous, electrically-conducting material with a surface area of at least 1.2 square centimeters, said method comprising the steps of inserting the distal end into said body transvenously, threading said catheter through the right Atrium and into the right ventricle of the heart of said body, and anchoring said terminus into the ventricular septum of said heart at a distanc from the bundle of HIS. 13. A method as set forth in claim 12 also including the step of inserting an introducer into a vein of the body and inserting said catheter into said introducer, and removing said introducer once said catheter is anchored to said septum. 14. A catheter as set forth in claim 7 wherein the inner surface of the helical shaped lead is electrically insulating while the outer surface thereof is electrically conducting.

Inventors: RUBIN LEO, RUBIN, LEO
Applicants: BRITISH TECH GROUP USA, BRITISH TECHNOLOGY GROUP USA, INC.
Application year: 1992
Main classification: A61N1
IPC codes: A61M39, A61N1