Apparatus for detecting and treating ventricular arrhythmia
First Claim
1. A system for providing arrhythmia therapy to a patient comprising:
- an implantable pulse generator;
a sensing circuit coupled to the implantable pulse generator; and
a subcutaneous electrode array coupled to the implantable pulse generator to deliver electrical stimulation to the patient upon detection by the sensing circuit of an arrhythmia.
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Accused Products
Abstract
A system and method for long-term monitoring of cardiac conditions such as arrhythmias is disclosed. The invention includes a pulse generator including means for sensing an arrhythmia. The pulse generator is coupled to at least one subcutaneous electrode or electrode array for providing electrical stimulation such as cardioversion/defibrillation shocks and/or pacing pulses. The electrical stimulation may be provided between multiple subcutaneous electrodes, or between one or more such electrodes and the housing of the pulse generator. In one embodiment, the pulse generator includes one or more electrodes that are isolated from the can. These electrodes may be used to sense cardiac signals.
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Citations
118 Claims
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1. A system for providing arrhythmia therapy to a patient comprising:
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an implantable pulse generator;
a sensing circuit coupled to the implantable pulse generator; and
a subcutaneous electrode array coupled to the implantable pulse generator to deliver electrical stimulation to the patient upon detection by the sensing circuit of an arrhythmia. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for treating patient arrhythmias, including the methods of:
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a) providing a subcutaneous pulse generator;
b) providing a monitoring circuit to monitor the patient'"'"'s cardiac signals for arrhythmias; and
c) providing a subcutaneous electrode array to deliver electrical therapy to a patient.
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8. A method of using a subcutaneously-placed pulse generator to treat arrhythmias, including the methods of:
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a) detecting an arrhythmia; and
b) employing at least one subcutaneous electrode to deliver therapy based on the detected arrhythmia. - View Dependent Claims (9)
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10. A system for delivering electrical energy to the heart of a patient, the system comprising:
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a subcutaneous pulse generator;
at least one sensing electrode disposed on a surface of the pulse generator and positioned proximate to subcutaneous tissue; and
at least one electrode array coupled to the pulse generator and positioned subcutaneously on the patient.
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11. An apparatus for monitoring cardiac signals of a patient, comprising;
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a hermetically-sealed housing;
sensing means included within the housing; and
first and second electrode sets coupled to the sensing means, the first electrode set including at least one electrode adjacent to a surface of the housing positionable proximate subcutaneous tissue at a first location in the patient'"'"'s body, and the second electrode set coupled to a connector on the housing and forming an electrode array subcutaneously positionable in the patient'"'"'s body at a location different from the first location.
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12. A method of implanting a subcutaneous cardioverter-defibrillator in a patient for treating arrhythmias without a transvenous, intracardiac or epicardial electrode, comprising:
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making a skin incision in the patient'"'"'s body;
implanting an electrode subcutaneously in the patient;
placing an electrically active canister subcutaneously in the patient, wherein the canister contains a source of electrical energy and operational circuitry that senses the presence of potentially fatal heart rhythms and has means for delivering electrical cardioversion-defibrillation energy using the canister as either the anode or the cathode and using the electrode as the opposite electrode from the canister, and wherein the canister is electrically connected to the electrode; and
closing the skin incision. - View Dependent Claims (53, 54, 55, 56)
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13. A method for providing anti-arrhythmia therapy via a subcutaneous cardioverter-defibrillator and without a transvenous, intracardiac or epicardial electrode, comprising:
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implanting a canister comprising a biocompatible housing subcutaneously in a patient, the biocompatible housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
implanting an electrically inert lead subcutaneously, the electrically inert lead comprising a substantially pliant and directable cannula adaptably connected to the canister with a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced to the cardioversion-defibrillation circuitry; and
delivering an electrical therapy comprising an anti-arrhythmia waveform from the lead electrode to the at least one electrically conductive surface. - View Dependent Claims (57, 58)
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14. A subcutaneous implantable cardioverter-defibrillator comprising:
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an electrically active canister that serves as either an anode or a cathode of the cardioverter-defibrillator wherein the canister houses a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms;
a subcutaneous electrode that serves as the opposite electrode from the canister (either the anode or the cathode);
a lead system electrically attaching the electrode to the canister;
means for delivering electrical cardioversion-defibrillation energy when the operational circuitry senses a potentially fatal heart rhythm; and
the absence of a transvenous, intracardiac, or epicardial electrode. - View Dependent Claims (59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73)
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15. A cardioverter-defibrillator for subcutaneous implantation, comprising:
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a canister comprising a biocompatible housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
an electrically inert lead connected to the canister comprising a substantially pliant and directable cannula adaptably connected to the canister; and
a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced to the cardioversion-defibrillation circuitry to deliver an electrical therapy with the at least one electrically conductive surface to the heart of a patient without a transvenous, intracardiac or epicardial electrode. - View Dependent Claims (74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89)
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16. A subcutaneous cardioverter-defibrillator with electrically active canister for minimally invasive implantation, comprising:
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a subcutaneously implantable, canister comprising a sterilizable biocompatible housing enclosing and containing cardioversion-defibrillation circuitry interfaceable through the biocompatible housing via an electrically isolated connector block, the biocompatible housing defining at least one electrically conductive surface on the outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
an electrically inert lead comprising a substantially pliant and directable cannula enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block; and
a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy with the at least one electrically conductive surface to the heart of a patient without a transvenous, intracardiac or epicardial electrode. - View Dependent Claims (90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102)
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17. A cardioversion-defibrillation device with electrically conductive housing means for subcutaneous implantation, comprising:
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means for housing and hermetically containing cardioversion-defibrillation circuitry, the housing means comprising electrically isolated means for externally interfacing to the cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the housing means that is electrically connected to the cardioversion-defibrillation circuitry through internal interfacing means;
means for guiding and enclosing one or more conductors connected to the cardioversion-defibrillation circuitry via the external interfacing means, the enclosing means being substantially pliant and directable; and
means for delivering an electrical therapy to a patient'"'"'s heart between a distal end of the guiding means and the at least one electrically conductive surface without a transvenous, intracardiac or epicardial electrode, the electrical therapy delivering means being responsive to an autonomously detected arrhythmic condition and being electrically connected via the one or more conductors to the cardioversion-defibrillation circuitry. - View Dependent Claims (103, 104, 105, 106, 107, 108, 109, 110)
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18. An implantable subcutaneous cardioverter-defibrillator with electrically active canister, comprising:
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an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining a discrete electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert; and
a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode. - View Dependent Claims (111, 112, 113, 114, 115)
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19. An implantable subcutaneous cardioverter-defibrillator providing antiarrhythmia therapy, comprising:
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an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry, the cardioversion-defibrillation circuitry monitoring cardiac physiological conditions;
a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert; and
a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an anti-arrhythmic waveform responsive to an arrhythmic condition autonomously detected by the cardioversion-defibrillation circuitry without a transvenous, intracardiac or epicardial electrode. - View Dependent Claims (118)
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20. An implantable subcutaneous cardioverter-defibrillator monitoring cardiac physiological conditions, comprising:
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an implantable canister providing a housing enclosing and containing cardioversion defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert; and
a sensing electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to sensing circuitry within the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode; and
monitoring circuitry integral to the cardioversion-defibrillation circuitry and deriving cardiac physiological measures.
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21. An implantable subcutaneous cardioverter-defibrillator detecting cardiopulmonary physiological conditions, comprising:
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an implantable canister providing a housing enclosing and containing cardioversion defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert; and
a sensing electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to sensing circuitry within the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode; and
detection circuitry integral to the cardioversion-defibrillation circuitry and deriving physiological measures.
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22. A subcutaneous implantable cardioverter-defibrillator comprising:
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a housing including a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potential fatal heart rhythms;
at least one cardioversion/defibrillation electrode located on the housing;
means for delivering electrical cardioversion-defibrillation energy when the operational circuitry senses a potentially fatal heart rhythm; and
the absence of a transvenous, intracardiac, or epicardial electrode. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. A method of implanting an implantable subcutaneous cardioverter-defibrillator in a patient comprising:
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making a skin incision in the patient'"'"'s body;
implanting a subcutaneous cardioverter-defibrillator, the subcutaneous cardioverter-defibrillator including a housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrode electrically interfaced to the cardioversion-defibrillation circuitry to deliver an electrical therapy to the heart of a patient without a transvenous, intracardiac or epicardial electrode; and
closing the skin incision.
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36. A cardioverter-defibrillator for subcutaneous implantation, comprising:
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a canister comprising a biocompatible housing enclosing and containing cardioversion-defibrillation circuitry;
at least one electrode formed on the biocompatible housing and electrically interfaced to the cardioversion-defibrillation circuitry to deliver an electrical therapy to the heart of a patient; and
the absence of a transvenous, intracardiac, or epicardial electrode. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50)
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51. A method for providing anti-arrhythmia therapy via a subcutaneous cardioverter-defibrillator and without a transvenous, intracardiac or epicardial electrode, comprising:
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implanting a canister comprising a biocompatible housing subcutaneously in a patient, the biocompatible housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrode on the outer surface of the biocompatible housing that faces the heart and electrically connected to the cardioversion-defibrillation circuitry; and
delivering an electrical therapy comprising an anti-arrhythmia waveform to the heart of a patient from the at least one electrode. - View Dependent Claims (52)
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116. An implantable subcutaneous cardioverter-defibrillator with discrete electrically active canister, comprising:
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an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining a discrete electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry, the housing further defining an electrically insulated surface juxtaposed to the discrete electrically conductive surface and substantially interposed therefrom by an electrically insulated area;
a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert; and
a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode. - View Dependent Claims (117)
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Specification