Medical device for controlled drug delivery and cardiac monitoring and/or stimulation

• US 7,917,208 B2
• Filed: 10/06/2003
• Issued: 03/29/2011
• Est. Priority Date: 10/04/2002
• Status: Expired due to Fees

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Herman, Stephen J., Yomtov, Barry M.
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US10/679,772
• Publication Number:
  US 20040106953A1
• Time in Patent Office: 2,731 Days
• Field of Search: 607/3, 607/120
• US Class Current: 607/3
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

Medical device and methods are provided for controlled drug delivery in a cardiac patient. The device includes an implantable drug delivery module comprising reservoirs containing a drug and a control means for selectively releasing an effective amount of drug from each reservoir; one or more electrodes or sensors for cardiac monitoring, stimulation, or both; and a microcontroller for controlling operational interaction of the drug delivery module and the cardiac electrode. The electrodes may comprise ECG monitoring, cardioversion, or cardiac pacing electrodes. A medical device also is provided for controlled delivery of drug to a patient having congestive heart failure, which includes an implantable drug delivery module comprising a natriuretic peptide and a release mechanism for selectively releasing a pharmaceutically effective amount of the natriuretic peptide into the patient; and a microcontroller for controlling the release mechanism, for example, in response to one or more monitored patient parameters.

Claims

1. A medical device for controlled drug delivery in cardiac care in a patient comprising:

an implantable drug delivery module which comprises

a plurality of reservoirs,

a release system contained in each of the reservoirs, wherein the release system comprises at least one drug,

a plurality of discrete electrically conductive reservoir caps separating the release system from an environment outside of the reservoirs, and

a means for disintegrating one or more of the reservoir caps by electrothermal ablation to release the drug from one or more of the reservoirs;

one or more electrodes or sensors for operable engagement with a cardiac tissue of a patient, wherein the one or more electrodes or sensors are useful for cardiac monitoring, cardiac stimulation, or both; and

at least one microcontroller for controlling operational interaction of the drug delivery module and the cardiac electrode or sensor,

wherein the means for disintegrating by electrothermal ablation comprises (i) an electrical input lead and an electrical output lead which are in direct physical and electrical connection to at least one of said reservoir caps, (ii) a power source, and (iii) a control means for controlling application of an electric current from the power source through said at least one of the reservoir caps, via the input and output leads.

2. The device of claim 1, wherein the one or more electrodes or sensors comprise ECG monitoring electrodes.

3. The device of claim 1, wherein the one or more electrodes or sensors comprise cardioversion electrodes.

4. The device of claim 1, wherein the one or more electrodes or sensors comprise cardiac pacing electrodes.

5. The device of claim 1, wherein the microcontroller is adapted to initiate release of the drug from the drug delivery module immediately upon receiving a signal from the one or more electrodes, which signal is indicative of onset of an arrhythmia.

6. The device of claim 5, wherein the device is adapted to detect non-sustained ventricular tachycardias, changes in heart rate variability, or both.

7. The device of claim 1, further comprising a defibrillator for delivering a cardioversion shock.

8. The device of claim 7, wherein the drug comprises an anti-coagulant, an analgesic, or both.

9. The device of claim 8, wherein the microcontroller, upon receiving a signal from the one or more electrodes or sensors indicative of an atrial fibrillation, is adapted to release the drug and then after a predetermined delay to initiate the cardioversion shock, wherein the delay is of a duration effective to permit the drug to take effect.

10. The device of claim 9, the device is adapted to reconfirm the arrhythmia following the predetermined delay and, if detected, to deliver the cardioversion shock.

11. The device of claim 1, which is adapted to treat ventricular arrhythmias.

12. The device of claim 1, further comprising a pacemaker having electrodes for contacting the cardiac muscle for monitoring of a patient and transmission of pacing signals.

13. The device of claim 12, wherein the drug comprises an anti-arrhythmic drug, which, upon release, is effective to reduce the frequency of induced pacing activity.

14. The device of claim 12, wherein the drug is one which, upon release, is effective to increase the sensitivity of myocardial tissue to the pacemaker stimulation pulse to effectively reduce pacing thresholds.

15. The device of claim 1, comprising a cardioversion means which comprises a signal generator connected to at least two of the one or more electrodes, wherein the microcontroller controls the signal generator and the means for disintegrating one or more of the reservoir caps.

16. The device of claim 15, wherein the cardioversion means is implantable.

17. The device of claim 1, comprising an ECG monitor for monitoring for a change in heart rate variability.

18. The device of claim 17, wherein the drug is one which, upon release, is used to reduce heart transplant rejection and the monitor is adapted to measure heart rate variability on a daily basis.

19. The device of claim 17, wherein the drug is one which, upon release, is effective to prevent angina or myocardial infarction or both.

20. The device of claim 17, wherein the microcontroller is adapted to release the drug as a function of the changes in the ST segment measured by the ECG monitor.

21. The device of claim 1, further comprising a cardiac monitoring means for measuring electrogram signals from the heart, wherein the microcontroller is adapted to receive a signal from the cardiac monitoring means and to control the means for disintegrating one or more of the reservoir caps.

22. The device of claim 21, wherein the cardiac monitoring means is implantable.

23. The device of claim 1, wherein the one or more electrodes or sensors are on an outer surface of a hermetically sealed encasement containing the drug delivery module and the microcontroller.

24. The device of claim 1, further comprising a hermetically sealed encasement containing the drug delivery module and microcontroller, wherein the one or more electrodes or sensors extend a distance from the hermetically sealed encasement.

25. The device of claim 24, further comprising a flexible catheter connecting the one or more electrodes to the encasement.

26. The device of claim 1, further comprising telemetry components in operable communication with the microcontroller.

27. The device of claim 1, wherein the drug delivery module comprises a microchip drug delivery device.

28. The device of claim 1, further comprising one or more physiological sensors operable to deliver a signal to the microcontroller.

29. The device of claim 1, wherein the one or more electrodes or sensors monitor one or more patient parameters useful in treatment or management of congestive heart failure.

30. The device of claim 1, wherein the drug comprises a natriuretic peptide.

31. The device of claim 1, wherein the drug comprises an antiarrhythmic agent, an antianginal agent, an antithrombotic agent, or an fibrinolytic agent.

32. A medical device for drug delivery to a cardiac care patient comprising:

an implantable drug delivery module which comprises

a plurality of reservoirs,

a release system contained in each of the reservoirs, wherein the release system comprises at least one drug,

a plurality of discrete metal reservoir caps separating the release system from an environment outside of the reservoirs,

an electrical input lead and an electrical output lead which are in direct physical and electrical connection to each of the reservoir caps,

a power source, and

a microcontroller for controlling application of an electric current from the power source through said at least one of the reservoir caps, via the input and output leads, in an amount effective to disintegrate the reservoir cap by electrothermal ablation to release the at least one drug from one or more of the reservoirs; and

one or more electrodes or sensors for operable engagement with a cardiac tissue of a patient, wherein the one or more electrodes or sensors are useful for cardiac monitoring, cardiac stimulation, or both.

33. An implantable medical device comprising:

a body;

at least one reservoir in the body;

reservoir contents contained in the at least one reservoir, wherein the reservoir contents comprises a sensor for measuring or analyzing the presence, absence, or change in a chemical or ionic species indicative of cardiac health;

an electrically conductive reservoir cap covering the at least one reservoir to separate the reservoir contents from an environment outside of the reservoir;

conducting leads to and from the reservoir cap; and

a power source and a controller for selectively delivering an electric current through the reservoir cap effective to disintegrate the reservoir cap by electrothermal ablation to release or expose the reservoir contents;

wherein the reservoir cap and the conducting leads to and from the reservoir cap are configured to provide, upon the application of electrical current to the conducting leads, an increase in electrical current density in the reservoir cap relative to the current density in the conducting leads to and from the reservoir cap.

34. The device of claim 33, further comprising one or more electrodes for operable engagement with a cardiac tissue of a patient, wherein the one or more electrodes are useful for cardiac monitoring, cardiac stimulation, or both.

35. The device of claim 33, which comprises a plurality of discrete reservoirs, each of which are covered by an electrically conductive reservoir cap connected to a pair of conducting leads.

36. The device of claim 33, further comprising one or more active agent reservoirs that contain an antiarrhythmic agent, an antianginal agent, a natriuretic peptide, an antithrombotic agent, or an fibrinolytic agent, for controlled release.

37. The device of claim 34, further comprising at least one microcontroller for controlling operational interaction of the drug delivery module and the one or more electrodes or sensors.

38. The device of claim 33, wherein the material forming the reservoir cap has a different electrical resistivity, thermal diffusivity, and/or thermal conductivity, than the material forming the conducting leads to and from the reservoir cap.

39. The device of claim 33, wherein the material forming the reservoir cap has a lower melting temperature than the material forming the conducting leads to and from the reservoir cap.