Method and apparatus for dual chamber bi-ventricular pacing and defibrillation

• US 6,370,427 B1
• Filed: 07/23/1998
• Issued: 04/09/2002
• Est. Priority Date: 07/23/1998
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated
• Original Assignee: Intermedics Incorporated
• Inventors: Sanders, Richard, Stotts, Lawrence J., Alt, Eckhard
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/121,523
• Time in Patent Office: 1,356 Days
• Field of Search: 607/4, 607/5, 607/9, 607/122, 607/120, 607/121
• US Class Current: 607/4
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Device and method are disclosed in which leads with pacing and defibrillating electrodes are implanted into both the right and left ventricles of a patient'"'"'s heart to enable simultaneous pacing of both ventricles to reduce the width of the QRS complex of the patient'"'"'s cardiac activity to a more normal duration, and, when appropriate, to apply electrical shock waveforms to both ventricles simultaneously for lower energy defibrillation of the ventricles. In applying the defibrillation therapy, the defibrillating electrode in the left ventricle may be used as the anode and the defibrillating electrode in the right ventricle may be used as the cathode, or both ventricular defibrillating electrodes may be the anode and the metal case in which the shock waveform generator is implanted may be the cathode. Implanting a lead with pacing and defibrillating electrodes in the right atrium enables selective pacing and defibrillation of the atria, in which atrial fibrillation is treated by applying the shock waveform across the right atrial and left ventricular defibrillation electrodes.

Claims

1. An implantable medical interventional device adapted to provide therapy to a patient to treat cardiac dysrhythmias, said device comprising a pulse generator and a shock generator for providing a plurality of functions corresponding to different levels of therapy including pulse, low energy and high energy shock waveforms configured to terminate respective dysrhythmias;

said pulse generator adapted for pacing the patient'"'"'s heart by generating stimulating electrical pulses therefor; and

a pair of thin leads dimensioned for insertion respectively into the left and right ventricles of the patient'"'"'s heart when said device is implanted, said pair of thin leads being coupled to said pulse generator and said pulse generator being adapted to energize said pair of thin leads in unison for simultaneous application of said stimulating electrical pulses to the left and right ventricles when said pair of thin leads are inserted respectively therein, each of said leads including a respective electrode adapted to be positioned in stimulating relation to cardiac tissue in a respective one of said ventricles when said leads are inserted therein and, when said leads are energized in unison by said pulse generator, to simultaneously pace said left and right ventricles;

the lead dimensioned for insertion into the left ventricle having an insulative sheath composed of a material of low thrombogenicity and coated at least in part with a biodegradable material to inhibit thrombus formation on the respective lead.

2. The device of claim 1, wherein said material of low thrombogenicity is selected from the group consisting of silicone and polyurethane.

3. The device of claim 1, wherein said biodegradable material coating includes at least one platelet inhibitor incorporated therein for timed release during disintegration of said coating.

4. The device of claim 3, wherein said at least one platelet inhibitor is iloprost.

5. The device of claim 3, wherein said biodegradable material coating further includes a plasmatic coagulation inhibitor incorporated therein for timed release during disintegration of said coating.

6. The device of claim 5, wherein said plasmatic coagulation inhibitor is selected from the group consisting of heparin and hirudin.

7. An implantable medical interventional device adapted to provide therapy to a patient to treat cardiac dysrhythmias, said device comprising a pulse generator and a shock generator for providing a plurality of functions corresponding to different levels of therapy including pulse, low energy and high energy shock waveforms configured to terminate respective dysrhythmias;

said pulse generator adapted for pacing the patient'"'"'s heart by generating stimulating electrical pulses therefor; and

a pair of thin leads dimensioned for insertion respectively into the left and right ventricles of the patient'"'"'s heart when said device is implanted, said pair of thin leads being coupled to said pulse generator and said pulse generator being adapted to energize said pair of thin leads in unison for simultaneous application of said stimulating electrical pulses to the left and right ventricles when said pair of thin leads are inserted respectively therein, each of said leads including a respective electrode adapted to be positioned in stimulating relation to cardiac tissue in a respective one of said ventricles when said leads are inserted therein and, when said leads are energized in unison by said pulse generator, to simultaneously pace said left and right ventricles;

said shock generator being adapted for defibrillating the patient'"'"'s heart by generating higher voltage electrical shock waveforms therefor; and

each of said pair of leads further including a defibrillation coil coupled to said shock generator and adapted to be positioned within a respective one of said ventricles and, when energized by said shock generator, for applying an electrical shock waveform to establish a substantially homogeneous electric field of sufficient electrical energy in the ventricles for defibrillation thereof.

8. The device of claim 7, wherein the defibrillation coils on respective ones of said pair of leads constitute defibrillation poles adapted to be energized simultaneously with their respective leads so that the defibrillation coil on the lead adapted to be positioned in the left ventricle is the anode and the defibrillation coil on the lead adapted to be positioned in the right ventricle is the cathode.

9. The device of claim 7, including a metal case housing said function generator, and wherein the defibrillation coils on said pair of leads constitute a defibrillation pole adapted to be energized simultaneously with their respective leads to act as an anode, in conjunction with said case constituting a defibrillation pole adapted when energized together with said defibrillation coils to act as a cathode.

10. The device of claim 7, further including an atrial pacing lead coupled to said pulse generator, said atrial pacing lead including a right atrial defibrillation coil, said right atrial defibrillation coil being coupled to said shock generator for defibrillation of the atrial chambers.

11. An implantable defibrillator, comprising a shock generator for generating electrical shock waveforms, a right ventricular lead including a defibrillation electrode coupled to said shock generator and adapted to be positioned in the right ventricle of a patient'"'"'s heart for delivery of electrical shock waveforms thereto, a left ventricular lead including a defibrillation electrode coupled to said shock generator and adapted to be positioned in the left ventricle of the patient'"'"'s heart for delivery of electrical shock waveforms thereto, and means for selectively applying said electrical shock waveforms of predetermined energy content simultaneously to said right and left ventricular defibrillation electrodes to establish a substantially homogeneous electric field distribution in the ventricles for defibrillation thereof.

12. The defibrillator of claim 11, including a metal case for said shock generator, and wherein said selectively applying means is adapted to apply said electrical shock waveforms either between said right and left ventricular defibrillation electrodes as separate poles, or between said right and left ventricular defibrillation electrodes as one pole and said metal case as another pole, for defibrillation of the ventricles.

13. The defibrillator of claim 11, further comprising a metal case for said shock generator, a right atrial lead including a defibrillation electrode coupled to said shock generator and adapted to be positioned in the right atrium of the patient'"'"'s heart for delivery of electrical shock waveforms thereto, and wherein said selectively applying means is adapted to apply said electrical shock waveforms between said right atrial defibrillation electrode and one of said right ventricular defibrillation electrode, said left ventricular defibrillation electrode, and said metal case, for defibrillation of the atria.

14. The defibrillator of claim 11, further comprising a pacing pulse generator of stimulating pacing pulses, separate pacing electrodes on each of said right and left ventricular leads respectively coupled to said pulse generator and adapted to be positioned respectively in the right and left ventricles of the patient'"'"'s heart for selective delivery of stimulating pacing pulses simultaneously thereto, and an atrial pacing lead including an electrode coupled to said pulse generator and adapted to be positioned in the right atrium of the patient'"'"'s heart for selective delivery of stimulating pacing pulses thereto.

15. A device-implemented method of treating cardiac dysrhythmias with an implantable medical interventional device adapted to deliver therapy to an implant patient, wherein the device possesses the capability to provide at least pacing therapy to the patient'"'"'s heart, said method including the steps of:

sensing a need for ventricular pacing; and

responding to said sensed need by delivering pacing pulses simultaneously to both ventricles of the patient'"'"'s heart; and

wherein said device possesses the capability to provide a plurality of functions corresponding to different therapies for treatment of dysrhythmias, and further including the steps of;

sensing ventricular fibrillation; and

responding to said sensed ventricular fibrillation by delivering an electrical shock waveform simultaneously to both ventricles of the patient'"'"'s heart to establish an electric field of relatively uniform distribution and sufficient electrical energy simultaneously in the ventricles for defibrillation thereof.

16. The device-implemented method of claim 15, including

delivering sense signals indicative of ventricular fibrillation to said device from separate right and left ventricular leads coupled thereto, and

delivering electrical shock waveforms simultaneously to said right and left ventricular leads from a shock generator of said device.

17. The device-implemented method of claim 15, further including the steps of:

sensing atrial fibrillation; and

responding to said sensed atrial fibrillation by delivering an electrical shock waveform between the right atrium and selectively either of the right and left ventricles of the patient'"'"'s heart to establish an electric field of sufficient electrical energy through the atrium for defibrillation thereof.

18. The device-implemented method of claim 15, including

delivering sense signals indicative of ventricular fibrillation to said device from separate right and left ventricular leads coupled thereto,

delivering sense signals indicative of atrial fibrillation to said device from a right atrial lead coupled thereto, and

delivering electrical shock waveforms from a shock generator of said device to said right atrial lead and said right and left ventricular leads as necessary for defibrillation.

19. An implantable medical interventional device adapted to provide therapy to a patient to treat cardiac dysrhythmias, said device comprising therapy-providing apparatus responsive to different types of dysrhythmia for providing a level of therapy appropriate respectively thereto, including electrical pulse and shock waveforms of sufficiently high energy content to pace and defibrillate respectively;

and therapy-application apparatus for application of therapy simultaneously to both ventricles of the patient'"'"'s heart, including a right ventricular lead and a left ventricular lead each including a pacing electrode and a defibrillating electrode separately coupled to said therapy-providing apparatus.

20. A method for providing a patient with an implanted medical interventional device to treat cardiac dysrhythmias, wherein the device performs a plurality of functions corresponding to different levels of therapy for treatment of different types of dysrhythmias, and responds to each different type of dysrhythmia to generate any of a plurality of electrical waveform therapies, including at least electrical pulse and shock waveform therapies, appropriate to terminate the respective sensed dysrhythmia, the method comprising the steps of implanting said device in the patient, implanting an electrical lead in the patient that includes an electrode for delivering at least one of said pulse and shock waveform therapies from the device in each of the right and left ventricles of the patient'"'"'s heart, and electrically connecting each lead to said device to enable said electrode thereof to receive at least one of the therapies;

and prior to implanting the lead, the step of coating at least a portion of the electrical lead to be implanted in the left ventricle with a biodegradable carrier impregnated with a thrombus inhibitor adapted to be time-released into blood in the locality of said portion of the lead in the left ventricle during disintegration of said carrier, to avoid embolization of a thrombus thereat.

21. The method of claim 20, including the step of selecting the biodegradable carrier to degrade harmlessly in the blood with negligible systemic impact, and selecting the thrombus inhibitor from the group consisting of ticlopidine, aspirin, heparin, and hirudin.

22. The method of claim 21, including the step of selecting at least one physical parameter of the biodegradable carrier to fix complete disintegration thereof within a period of from about one month to about three months from the time of implanting the lead, for time-release of the thrombus inhibitor over said period.

23. A method for providing a patient with an implanted medical interventional device to treat cardiac dysrhythmias, wherein the device performs a plurality of functions corresponding to different levels of therapy for treatment of different types of dysrhythmias, and responds to each different type of dysrhythmia to generate any of a plurality of electrical waveform therapies, including at least electrical pulse and shock waveform therapies, appropriate to terminate the respective sensed dysrhythmia, the method comprising the steps of implanting said device in the patient, implanting an electrical lead that includes an electrode for delivering at least one of said pulse and shock waveform therapies from the device in each of the right and left ventricles of the patient'"'"'s heart, and electrically connecting each lead to said device to enable said electrode thereof to receive at least one of the therapies;

and, wherein the step of implanting the electrical lead in the left ventricle includes puncturing one of the subclavian and brachiocephalic arteries, inserting the lead through the puncture, and advancing the lead through the aortic valve into the left ventricle until said electrode is properly located therein.

24. The method of claim 23, wherein each said ventricular lead includes both a pacing electrode at the distal end of the lead and a defibrillating electrode proximal of the pacing electrode, and the step of advancing the lead through the aortic valve into the left ventricle includes placing the pacing electrode in proximity to excitable cardiac tissue of the left ventricle.

25. The method of claim 24, including the step of applying pulse therapy to the pacing electrodes of both the right and left ventricular leads for pacing the ventricles simultaneously, whereby to reduce the duration of the QRS complex of the patient'"'"'s electrocardiogram.

26. The method of claim 24, including the steps of sensing ventricular fibrillation and thereupon applying shock waveform therapy to the defibrillating electrodes of both the right and left ventricular leads simultaneously, whereby to improve uniformity of the electric field distribution through the ventricles to terminate the ventricular fibrillation.

27. The method of claim 26, wherein the step of applying said shock waveform therapy to the defibrillating electrodes of both the right and left ventricular leads simultaneously includes applying said shock waveform therapy to the defibrillating electrode in the left ventricle as the anode and to the defibrillating electrode in the right ventricle as the cathode.

28. The method of claim 26, wherein said device is implanted in a pectoral region of the patient, and the step of applying said shock waveform therapy to the defibrillating electrodes of both the right and left ventricular leads simultaneously includes applying said shock waveform therapy to said defibrillating electrodes in the ventricles as the anode and to an electrically conductive case in which the therapy generator of said device is housed as the cathode.

29. The method of claim 24, including the steps of implanting an electrical lead with a pacing electrode and a defibrillating electrode thereon in the right atrium of the patient'"'"'s heart, and applying said shock waveform therapy to the defibrillating electrodes of both the right atrial lead and the left ventricular lead simultaneously to terminate atrial fibrillation.

30. The method of claim 29, including the step of selecting leads to be implanted in the right atrium, right ventricle, and left ventricle of the patient'"'"'s heart which are covered with an insulating sheath selected from a group comprising silicone and polyurethane, and in which the sheath is coated with a material selected from the group consisting of iridium oxide and titanium nitrate.

31. The method of claim 24, including the steps of detecting the local ECG at the left and right ventricles, and comparing the characteristics of size and morphology thereof for diagnosis of cardiac activity from which to discriminate ventricular and supraventricular tachycardias from one another.

32. The method of claim 23, including the steps of administering a platelet inhibitor into the patient'"'"'s vascular system for a limited period of time to facilitate healing and a build-up of connective tissue on electrodes of the lead implanted in the left ventricle to avoid interference with operation of the aortic valve.

33. A method for providing therapy to a patient from a medical interventional device adapted to be implanted to treat cardiac dysrhythmias, comprising the steps of simultaneously stimulating the right and left ventricles of the patient'"'"'s heart to perform ventricular pacing for enhancing hemodynamics, and defibrillating the heart by applying electrical defibrillation shocks to a point in the left ventricle to terminate ventricular fibrillation.