Atrial arrythmia sensor with drug and electrical therapy control apparatus

• US 5,925,066 A
• Filed: 09/15/1997
• Issued: 07/20/1999
• Est. Priority Date: 10/26/1995
• Status: Expired due to Term

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Kroll, Mark W., Kroll, Kai
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/931,233
• Time in Patent Office: 673 Days
• Field of Search: 607/3, 607/4, 607/5, 607/14, 607/120, 604/20, 604/21
• US Class Current: 607/3
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

An atrial arrythmia 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.

Claims

1. A method for controlling atrial fibrillation using antitachycardia pacing and drug injection into the heart of a patient to control atrial fibrillation comprising the steps of:

monitoring the atrial rate of a patient'"'"'s heart;

comparing the atrial rate to a threshold value to detect atrial fibrillation;

implementing anti-tachycardia pacing when the threshold atrial rate is exceeded; and

implementing a drug delivery regimen if said anti-tachycardia pacing is unable to control the atrial fibrillation.

2. The method according to claim 1 wherein said drug delivery regimen includes the step of applying an iontophoretic current to force drug discharge into the patient'"'"'s heart.

3. An atrial arrythmia sensing, therapy control and management apparatus having a memory implemented logic sequence in which operations of the apparatus in performing the desired functions include a set of instructions formed into each of a series of operational commands to be performed, the apparatus-implemented process comprising:

an initial atrial rate-regulating process that continuously regulates an atrial rate of a patient'"'"'s heart, the initial atrial rate-regulating process comprising;

continuous monitoring of the atrial rate;

determining if the monitored atrial rate is less than 60 BPM;

if the atrial rate is less than 60 BPM, implementing a first-type pacing process to increase said atrial rate to 60 BPM;

determining if the monitored atrial rate is greater than 60 BPM;

if the monitored atrial rate is greater than 60 BPM, ending the first-type pacing process;

determining if the monitored atrial rate is greater than 180 BPM;

if the atrial rate is greater than 180 BPM, implementing a second-type pacing process using anti-tachycardia pacing therapy to decrease the atrial rate to less than 180 BPM;

determining if the monitored atrial rate is less than 180 BPM;

if the monitored atrial rate is less than 180 BPM, ending the implementation of the second-type pacing process;

a second atrial rate-regulating process that implements a third-type pacing process to maintain the atrial rate at less than 180 BPM if the second-type pacing process fails to maintain the atrial rate under 180 BPM, the second atrial rate-regulating process comprising;

monitoring the second-type pacing process and comparing the second-type pacing process duration to a second-type pacing process threshold value;

if the second-type pacing process duration exceeds the second-type pacing process threshold value, injecting an amount of drug from a drug delivery system;

a therapy data management and comparison process in which the injections are monitored and timed so that drug injection dosages may be adjusted and so that a reversion to the initial atrial rate-regulating process is initiated if five injections are administered within 24 hours of the most recent initiation of the second atrial rate-regulating process;

determining if the monitored atrial rate is less than 180 BPM; and

if the monitored atrial rate is less than 180 BPM, ending the implementation of the third-type pacing process and reverting to the initial atrial rate-regulating process.

4. The apparatus of claim 3 wherein said third-type pacing process includes injecting drugs into the right atrium of the patient'"'"'s heart using an iontophoresis system.

5. The apparatus of claim 3 wherein said therapy data management includes storing patient therapy information compiled from digital electrograms from a plurality of sensing electrodes, analog electrograms from said sensing electrodes, atrial rhythm records, data of delivered drugs from said drug delivery system, data of pacing shocks administered from a cardiac pacer and an antitachycardia pacer, records of cardiac responses to preceding therapies and any combination thereof.

6. The apparatus of claim 3 wherein said third-type pacing process includes initiating a self-cleaning system using flushing means to clean drug delivery catheter(s) before and after drug delivery events.