Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2001-03-19
2002-09-17
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06453195
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to medical devices. Specifically, the invention relates to communication between an implanted medical device and an external drug delivery device in wireless data communication thereof. More specifically, the invention relates to a system that automatically delivers analgesic and/or threshold reduction medications prior to the application of cardiac shock or drug delivery for pulmonary hypertension, for example, using RV pressure. The release of the drug is coordinated between the implanted device and the external device via the wireless communication system. The invention also provides remote management of a patient wherein drug delivery data from the external device and therapy information from the implanted device are transferred to a remote location using various methods of data transfer to enable physicians and caregivers to remotely review and monitor the patient as needed. In one aspect of the present invention, the drug delivery dose and frequency of treatment are preferably controlled via parametric modifications and adjustments of the implanted medical device. In yet another embodiment, the external drug delivery device is directly programmed overriding communication signals that initiate and call for drug delivery from the implanted medical device.
BACKGROUND OF THE INVENTION
Current practice of implanting both a therapeutic medical device such as a cardiac pacemaker, defibrillator, etc., in conjunction with implantable drug pumps is cumbersome and expensive to manage. Further, for example, with a defibrillator and an implanted drug delivery device, one would need to run a catheter to deliver the drug in addition to leads for the defibrillator. Most implanted drug delivery devices known in the art, do not deliver drugs directly into the bloodstream.
The alleviation of cardioversion shock pain has been the subject of various patents in the prior art. Most of the pain-alleviating therapy, in conjunction with the delivery of cardioversion energy to the heart chamber is well known in the art. Further, the alleviation of pain through the operation of implantable drug dispensers for automatically, periodically, delivering a bolus of a pain-alleviating drug at the site in the body are also well known in the art. For example, U.S. Pat. Nos. 5,662,689 and 5,817,131 to Elsberry et al, disclose a methods and apparatus for alleviating cardioversion shock pain. The disclosures include an implantable cardioverter for providing cardioversion electrical energy to at least one chamber of a patient's heart in need of cardioversion and applying a pain alleviating therapy at an appropriate site in the patient's body prior to, or in conjunction with, the delivery of the cardioversion energy to the heart chamber to alleviate propagated pain perceived by the patient. The combined cardioversion and pain alleviating therapies are preferably realized in a single implantable, multi-programmable medical device or separate implantable cardioversion and pain control devices with means for communicating operating and status commands between the devices through the patient's body.
U.S. Pat. No. 5,893,881 issued to Elsberry et al discloses a method and apparatus for alleviating cardioversion shock pain by delivering a bolus of analgesic. Specifically, the invention discloses an implantable cardioverter for providing cardioversion electrical energy to at least one chamber of a patient's heart in need of cardioversion and applying a pain alleviating therapy at an appropriate site in the patient's body prior to or in conjunction with the delivery of the cardioversion energy to the heart chamber to alleviate propagated pain perceived by the patient. The combined cardioversion and pain alleviating therapies are preferably realized in a single implantable, multi-programmable medical device or separate implantable cardioversion and pain control devices with means for communicating operating and status commands between the devices through the patient's body.
U.S. Pat. No. 5,087,243 to Avitall discloses a myocardial iontophoresis device. An implantable iontophoretic delivery system for use in applying medicinal materials rapidly to specific subcutaneous tissue sites of interest in conjunction with an implanted defibrillator is disclosed which uses a subcutaneously situated pouch for supplying medication in conjunction with a pair of defibrillator electrodes connected to a power source. One of the electrodes is located proximately with respect to the tissue of interest and is designed to dispense the medication of interest utilizing controlled electrical pulses. The pouch is connected with the administering electrode of the electrode system via pumping mechanism.
U.S. Pat. No. 5,733,259 to Valcke et al discloses a method and apparatus for closed loop drug delivery. Specifically, a closed-loop drug delivery system uses patient response and rule based decision-making methods to achieve operator specified responses for diagnostic purposes. In the preferred embodiment, cardiac diagnosis is performed by pharmacologically stressing the heart by administration of an exercise simulating agent drug. In the preferred method, a protocol is defined, which preferably includes a target for a physiologic variable, such as heart rate, and a plan to achieve that target value. Preferably, the plan includes a specification of the desired rate of increase in that variable, such as the rate of increase in the heart rate per minute. The plan comprises the desired changes in the physiologic variable as a function of time.
U.S. Pat. No. 5,925,066 to Kroll et al discloses an atrial arrhythmia sensor with drug and electrical therapy control apparatus. The invention relates to an atrial arrhythmia sensor and drug-dispensing apparatus is disclosed. The apparatus comprises a multiphase, multistage intelligent system to monitor and treat atrial fibrillation. The apparatus includes atrial rate sensing means, cardiac pacing and antitachycardia pacing means, drug delivery means including a self-cleaning catheter line with multi-drug dispensing capability preferably operated using a dual pump arrangement and an iontophoretic device. The drug delivery system may also include a porous catheter to discharge drug into the atrium. The intelligent system includes a memory implemented logic (software) to continuously monitor the atrial rate and initiate a response of either cardiac pacing, antitachycardia pacing or drug dispensing based on preset cardiac activity parameters. The system also includes a medical history-recording feature.
U.S. Pat. No. 5,527,344 to Arzbaecher et al discloses a pharmacological atrial defibrillator and method. In this invention, a method and an implantable apparatus for automatically delivering a defibrillating drug to a patient upon detection of the onset of atrial fibrillation are disclosed. Atrial activity of a heart is detected and monitored. A delivery time is continuously computed and a delivery signal is emitted as a function of the monitored level of the atrial activity. When the delivery signal is emitted, an infusion pump discharges a defibrillating drug into the bloodstream of the patient. The atrial activity is also continuously monitored for computing a pacing time at which a pacing signal is emitted as a second function of the monitored level of atrial activity. When the pacing signal is emitted a pacer paces the atrium of the heart.
U.S. Pat. No. 5,135,480 to Bannon et al discloses a transdermal drug delivery device. More specifically, the invention relates to a transdermal device having a detachably mounted electrode with a first surface adapted for contact with human skin and through which a drug substance contained in the electrode passes to the skin under the influence of an iontophoretic or electro-osmotic force and a second surface which is electrically conducting, the electrode has a surface area in contact with the skin, in use, in the range 0.1 to 30 cm and a drug dissolved or dispersed in a hydrophilic
Getzow Scott M.
Medtronic Inc.
Wolde-Michael Girma
LandOfFree
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