Drug Delivery Methods and Systems

• US 20090326510A1
• Filed: 06/30/2008
• Published: 12/31/2009
• Est. Priority Date: 06/30/2008
• Status: Abandoned Application

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Haefner, Paul A., Moon, Loell Boyce
• Application Number:
  US12/165,328
• Publication Number:
  US 20090326510A1
• Time in Patent Office: Days
• US Class Current: 604/503
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Drug delivery methods and systems that include a determination of whether a cardiac condition is normal or abnormal, so that a drug may be administered in accordance with that determination. In one implementation, a drug delivery device may be controlled to reduce or stop the drug administration when a normal cardiac condition is detected. In another implementation, a patient monitoring device determines the duration that a cardiac condition is normal and provides an output indicative of the determination so that the patient may alter a therapy accordingly.

Claims

1. A method of regulating drug administration to a patient, comprising:

administering a drug at an initial dosage level to a patient via a drug delivery unit;

monitoring a cardiac signal using a cardiac monitoring unit; and

reducing to a reduced dosage level that is lower than the initial dosage level when the monitored cardiac signal indicates a healthy cardiac sinus rhythm is present for at least a predetermined amount of time.

2. The method of claim 1, wherein administering the drug is accomplished by the patient.

3. The method of claim 1, wherein administering the drug is accomplished by a drug delivery system.

4. The method of claim 3, wherein the drug delivery system is external to the patient.

5. The method of claim 3, wherein the drug delivery system is implanted in the patient.

6. The method of claim 1, wherein the cardiac monitoring unit is implanted in the patient.

7. The method of claim 1, wherein the drug comprises an anticoagulant.

8. The method of claim 1, wherein the drug comprises an antiarrhythmic drug.

9. The method of claim 1, wherein the initial dosage level is determined by a physician.

10. The method of claim 1, wherein the cardiac signal is an electrocardiogram signal.

11. The method of claim 1, wherein the cardiac signal is a blood flow signal.

12. The method of claim 1, wherein the cardiac signal is a blood pressure signal.

13. The method of claim 1, wherein the reduced dosage level is a predetermined minimum level for patient safety.

14. The method of claim 13, wherein the predetermined minimum dosage level is physician selectable.

15. The method of claim 1, further comprising factoring in the ability of blood to properly clot before reducing to the reduced dosage level.

16. The method of claim 15, wherein the ability of the blood to properly clot is represented by a lab-measured, device-measured or patient-measured International Normalization Ratio (INR).

17. The method of claim 16, further comprising determining a desired INR level by the amount of time that the patient is in a healthy sinus rhythm.

18. The method of claim 1, further comprising resuming the drug administration or increasing the drug dosage when the monitored cardiac signal indicates the absence of a healthy cardiac sinus rhythm for at least a predetermined period of time.

19. The method of claim 18, wherein the amount of drug dosage increase is determined by the amount of time the patient is in a healthy sinus rhythm.

20. The method of claim 18, wherein the increased dosage does not exceed the initial dosage level.

21. The method of claim 1, further comprising tracking the amount of the drug that has been administered to the patient.

22. The method of claim 21, further comprising providing an alert when the amount of the drug administered reaches a predetermined maximum dosage amount.

23. The method of claim 1, wherein the drug delivery unit and the cardiac monitoring unit are contained within a single housing.

24. The method of claim 1, wherein the drug delivery unit is contained within a first housing, and the cardiac monitoring unit is contained within a second housing different from the first housing.

25. A patient monitoring and notification system, comprising:

a cardiac monitoring system comprising a cardiac condition sensor and a processing unit adapted to receive cardiac signals sensed over a time period by the cardiac condition sensor;

determine from the received cardiac signals a time measure indicating a duration of the time period that a cardiac condition is normal; and

generate, from the determined duration of the normal cardiac condition, prescriptive information relevant to an on-going therapy being administered to the patient; and

a user notification device adapted to receive the prescriptive information from the cardiac monitoring system, and provide a user output adapted to inform the user as to how the therapy should be administered.

26. The patient monitoring and notification system of claim 25, wherein the cardiac monitoring system is an implantable subcutaneous ECG monitoring system comprising a first telemetry component to wirelessly transmit information indicative of the determined cardiac condition of normal or abnormal;

and the notification device is a component of external equipment comprising a second telemetry component to receive the wirelessly transmitted information indicative of the determined cardiac condition.

27. The patient monitoring and notification system of claim 26, wherein the cardiac monitoring system processes a monitored subcutaneous system to evaluate sinus rhythm, and determines a cardiac condition to be normal if a healthy sinus rhythm has been present for a predetermined amount of time.

28. The patient monitoring and notification system of claim 27, wherein the determination of the cardiac condition being normal or abnormal involves use of a ratio of an amount of time during which healthy sinus rhythm is present compared to overall time.

29. A drug infusion system comprising:

a cardiac monitoring unit adapted to sense, from a subject, cardiac signals from which a sinus rhythm condition is evidenced if present;

a drug delivery unit adapted to contain and deliver to the patient an anticoagulant drug; and

a processing and control unit adapted to receive the sensed cardiac signals, perform an assessment of sinus rhythm, and control delivery of the anticoagulant drug by the drug delivery unit based on the assessment of sinus rhythm.

30. The drug infusion system of claim 29, wherein the processing and control unit is programmable to provide an initial drug dosage level at which the anticoagulant drug is delivered to the patient.

31. The drug infusion system of claim 29, wherein the processing and control unit is adapted to cease delivery of the anticoagulant drug if the processing and control unit determines that the subject is in healthy sinus rhythm for a predetermined amount of time.

32. The drug infusion system of claim 29, wherein the processing and control unit is adapted to reduce the dosage level at which the anticoagulant drug is delivered if the processing and control unit assesses that a condition exists indicative of a reduced risk of blood clotting from atrial fibrillation.

33. The drug infusion system of claim 29, wherein the cardiac monitoring unit comprises a cardiac electrical activity sensor.

34. The drug infusion system of claim 29, wherein the cardiac monitoring unit comprises a hemodynamic sensor.

35. A method for providing anticoagulant therapy to a patient having an atrial fibrillation condition, the method comprising:

controlling, at a programmed initial dosage level, infusion of an anticoagulant drug from a drug delivery unit to a subject;

monitoring cardiac signals of the subject, and determining from the monitored cardiac signals if there is present an improved condition indicative of a reduced risk of blood clotting in the subject from atrial fibrillation; and

if the improved condition is determined to be present, controlling the infusion of the anticoagulant drug from the drug delivery unit at a reduced dosage level that is lower than the initial dosage level.

36. The method of claim 35, further comprising receiving an input providing the programmed initial dosage level.

37. The method of claim 35, wherein the reduced dosage level is zero if it is determined that the atrial fibrillation condition has ceased to exist in the subject.

38. The method of claim 35, wherein the sensed cardiac signals comprise electrical signals indicative of cardiac activity.

39. The method of claim 35, wherein the sensed cardiac signals comprise hemodynamic signals indicative of cardiac activity.