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

• US 20040106953A1
• Filed: 10/06/2003
• Published: 06/03/2004
• Est. Priority Date: 10/04/2002
• Status: Active Grant

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Herman, Stephen J., Yomtov, Barry M.
• Granted Patent: US 7,917,208 B2
• Time in Patent Office: Days
• 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, and a control means for selectively releasing a pharmaceutically effective amount of the drug from each 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.

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

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

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

5. The device of claim 1, wherein the drug, upon release, is effective to reduce the amount of energy required to cardiovert the heart.

6. The device of claim 1, wherein the drug, upon release, is effective to stabilize an arrhythmia.

7. The device of claim 6, wherein the microcontroller causes the drug to be released from the drug delivery module immediately upon receiving a signal from the one or more electrodes indicative of onset of an arrhythmia.

8. The device of claim 7, for detecting non-sustained ventricular tachycardias, changes in heart rate variability, or both.

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

10. The device of claim 9, which is useful in the treatment of atrial fibrillation, wherein the drug comprises an anti-coagulant, an analgesic, or both.

11. The device of claim 10, wherein the microcontroller, upon receiving a signal from the one or more electrodes or sensors indicative of an atrial fibrillation, releases the drug and then after a predetermined delay initiates the cardioversion shock, wherein the delay is of a duration effective to permit the drug to take effect.

12. The device of claim 10, wherein following the predetermined delay, the device reconfirms the arrhythmia and, if detected, delivers the cardioversion shock.

13. The device of claim 1, which is useful in the treatment of ventricular arrythmias.

14. 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.

15. The device of claim 14, wherein the drug comprises an anti-arrhythmic drug, which, upon release, is effective to reduce the frequency of induced pacing activity.

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

17. The device of claim 1, comprising a cardioversion means which comprises a signal generator connected to at least two of said electrodes, wherein the microcontroller controls the signal generator and the control means of the drug delivery module.

18. The device of claim 17, wherein the cardioversion means is implantable.

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

20. The device of claim 19, for use in a patient having a transplanted heart, wherein the drug, upon release, is used to reduce heart transplant rejection and the monitor measures heart rate variability on a daily basis, and if the variability increases, then a secondary drug or higher dose of drug is delivered to the patient.

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

22. The device of claim 19, wherein release of the drug is a function of the changes in the ST segment measured by the ECG monitor.

23. The device of claim 1, comprising a cardiac monitoring mean for measuring electrogram signals from the heart, wherein the microcontroller receives a signal from the cardiac monitoring means and controls the control means of the drug delivery module.

24. The device of claim 23, wherein the cardiac monitoring means is implantable.

25. The device of claim 1, further comprising a power source.

26. 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.

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

28. The device of claim 27, wherein a flexible catheter connects the one or more electrodes to the encasement.

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

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

31. The device of claim 1, wherein the control means for selectively releasing a pharmaceutically effective amount of the drug comprises a reservoir cap positioned over each reservoir and a means for actively disintegrating the reservoir cap.

32. The device of claim 31, wherein the reservoir cap is electrically conductive and the means for actively disintegrating the reservoir cap comprises an input lead and an output lead each connected to the reservoir cap and a power source for delivering an effective amount of electrical current through the reservoir cap, via the input lead and output lead, to heat and rupture the reservoir cap to release the drug.

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

34. 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.

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

44. A method of treating a patient in need of cardiotherapy comprising:

implanting into the patient the device of claim 1, so as to engage the one or more electrodes or sensors with cardiac tissue or blood flow in the patient;

monitoring one or more conditions of the heart with the electrodes or sensors, delivering electric stimulation to the heart with the electrodes, or both; and

releasing one or more drugs from the drug delivery module.

45. The method of claim 44, wherein one or more drugs are released based on ECG signals from the patient.

46. The method of claim 45, wherein the ECG signal is monitored for a change in heart rate variability which is indicative of an oncoming sudden cardiac death and one or more drugs are released, if and when needed, to prevent sudden cardiac death.

47. The method of claim 45, wherein the ECG signal is monitored for a change in heart rate variability which is indicative of rejection of a transplanted heart in the patient and one or more drugs are released, if and when needed, to prevent transplant rejection.

36. An implantable medical device for the controlled delivery of drug to a patient suffering from congestive heart failure comprising:

an implantable drug delivery module comprising a drug formulation which comprises a natriuretic peptide, and a release mechanism for selectively releasing a pharmaceutically effective amount of the natriuretic peptide into the patient; and

at least one microcontroller for controlling the release mechanism.

37. The device of claim 36, wherein the microcontroller operates in response to one or more monitored patient parameters.

38. The device of claim 37, further comprising an implantable monitoring module which monitors hemodynamic parameters, ECG parameters, or both, for use in determining the one or more patient parameters.

39. The device of claim 38, wherein interaction of the drug delivery module and the monitoring module is controlled by the at least one microcontroller.

40. The device of claim 37, wherein the microcontroller comprises telemetry components for receiving instructions for releasing the drug formulation, the instructions being based on the one or more monitored patient parameters.

41. The device of claim 40, wherein the patient parameters comprise external measurements.

42. The device of claim 37, wherein the monitored patient parameters are selected from the group consisting of blood pressures, cardiac electrical signals, tissue electrical impedance, blood oxygen, blood oxygen saturation, natriuretic peptide levels, and combinations thereof.

43. The device of claim 36, wherein the drug delivery module further comprises:

a second drug selected from the group consisting of diuretics, vasodilators, inotropic agents, anti-arrhythmic agents, Ca⁺ channel blocking agents, anti-adrenergics, sympatholytics, renin angiotensin system antagonists, and combinations thereof; and

a second release mechanism for selectively releasing a pharmaceutically effective amount of the second drug into the patient.

48. A method of treating a patient suffering from congestive heart failure comprising:

implanting a drug delivery module in a patient which can selectively release one or more drugs into the patient which are useful in the management or treatment of congestive heart failure; and

releasing the one or more drugs from the implanted module in response to the one or more monitored patient parameters.

49. The method of claim 48, further comprising monitoring one or more patient parameters with a monitoring module.

50. The method of claim 49, further comprising implanting the monitoring module in the patient.

51. The method of claim 50, wherein interaction of the drug delivery module and the monitoring module is controlled by at least one microcontroller.

52. The method of claim 48, wherein the one or more drugs comprises a natriuretic peptide.

53. The method of claim 48, wherein the monitored patient parameters are selected from the group consisting of blood pressure, cardiac electrical signals, tissue electrical impedance, blood oxygen, blood oxygen saturation, natriuretic peptide levels, body weight, and combinations thereof.