Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-21
2002-03-26
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C128SDIG001, C128SDIG001
Reexamination Certificate
active
06361522
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to systems and methods for drug delivery and the therapeutic application of electrical stimulation to the heart for pacing and/or defibrillation. In particular, the invention relates to a system and method for combining these two modes of therapy.
BACKGROUND
Cardiac pacemakers are implantable devices that replace or supplement a heart's compromised ability to pace itself (i.e., bradycardia) due to chronotropic incompetence or a conduction system defect by delivering electrical pacing pulses to the heart. Implantable cardioverter/defibrillators (ICD's) are devices that deliver electrical energy to the heart in order to reverse excessively rapid heart rates (tachycardia) including life threatening cardiac arrhythmias such as ventricular fibrillation. Since some patients have conditions that necessitate pacing and also render them vulnerable to life-threatening arrhythmias, implantable cardiac devices have been developed that combine both functions in a single device.
Most pacemakers today are operated in some sort of synchronous mode where the pacing pulses are delivered in a manner that is dependent upon the intrinsic depolarizations of the heart as sensed by the pacemaker. ICD's must also sense the electrical activity of the heart in order to detect an arrhythmia that will trigger delivery of the shock pulse in an attempt to reverse the condition. Such sensing information could be used to initiate another mode of therapy, and efforts have been made in the past to combine automatic drug delivery with either pacemakers, ICD's, or both to treat cardiac arrhythmias. U.S. Pat. No. 5,269,301, for example, deals with a system for delivering multi-modal therapy at the patient's bedside in order to treat heart conditions in which pacing, defibrillation, and drug delivery are under the control of a central processor. U.S. Pat. No. 5,087,243 discusses a drug delivery device incorporated into an ICD for delivering an antiarrhythmic drug iontophoretically directly to the myocardium via the patch electrodes used for electrical defibrillation upon detection of an arrhythmia. U.S. Pat. No. 5,893,881 describes an ICD with an integrated drug delivery device for delivery of a pain medication just prior to the delivery of a defibrillation shock. That patent also contemplates a separate implantable drug delivery device that communicates with the ICD via low-frequency radio waves transmitted through the body using a method described in U.S. Pat. No. 4,897,987.
Implantable drug delivery systems suffer from a number of disadvantages, however. Although the drug reservoir of such a device can be replenished, it is difficult to change the drug once it is put into the reservoir, making patient management difficult in cases where a patient's condition either changes or otherwise requires a change of medication. In addition, drugs degrade over time. Finally, there is the risk of leakage from the reservoir, the consequences of which can range from an annoyance to a medical emergency.
SUMMARY OF THE INVENTION
The present invention is embodied by a drug delivery system incorporated into an cardiac device which may be, for example, an implantable cardioverter/defibrillator, cardiac pacemaker, or combination device. A dose of a drug is delivered by the system to a patient upon detection of a particular medical condition such as an arrhythmia. The drug delivery device is preferably an electrically modulated transdermal drug delivery device for delivering the drug transdermally in accordance with a signal received from the implantable cardiac device. The implantable cardiac device communicates via a radio frequency link with the external drug delivery device.
In one embodiment, an external drug delivery device is designed for external affixation to a patient. In the case of an electrically modulated transdermal drug delivery device, the device is affixed to the patient's skin surface at a suitable location. The electrically modulated transdermal delivery injector may have one electrode with a drug reservoir in contact with the skin, another electrode also contacting the skin, and a voltage source for imposing a voltage between the electrodes. The device also has a telemetry interface for receiving and transmitting radio frequency signals, circuitry for demodulating radio signals received from the implantable cardiac device or an external programmer to derive a command signal therefrom, and circuitry for controlling the delivery of the drug in accordance with the command signal.
The cardiac device has at least one sensing channel for sensing electrical activity occurring in a patient's heart and generating sensing signals indicative of the activity. Circuitry in the device extracts information from the sensing signals, which information can be used to detect a particular medical condition, and a command signal is generated if the medical condition is present. A telemetry interface for receiving and transmitting radio frequency signals to the drug delivery device is also provided, along with circuitry for modulating the radio frequency signals with information relating to the command signal.
In another aspect of the invention, an implantable cardiac device with an incorporated drug delivery system is used to detect cardiac ischemia from the sensed electrical activity as well as arrhythmias. Upon detection of a cardiac event correlated with ischemia, the device causes delivery of an appropriate agent such as a thrombolytic, anti-platelet agent, coronary vasodilator, anticoagulant, analgesic, or combination of such agents.
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Girouard Steven D.
Heil, Jr. Ronald W.
Herner Mark
Scheiner Avram
Cardiac Pacemakers Inc.
Mendez Manuel
Schwegman Lundberg Woessner & Kluth P.A.
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