Closed loop drug delivery system and remote management thereof

• US 6,453,195 B1
• Filed: 03/19/2001
• Issued: 09/17/2002
• Est. Priority Date: 03/19/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/811,685
• Publication Number:
  US 20020133196A1
• Time in Patent Office: 547 Days
• Field of Search: 604/20, 607/3, 607/4, 607/5, 607/9, 607/13
• US Class Current: 607/3
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A transdermal drug delivery device in communication with at least one IMD is externally mounted to deliver pain analgesics and/or threshold reduction medications prior to or contemporaneous with a shock associated with a pacer, a defibrillator and similar therapy device. The drug delivery device includes an attachable strip with a storage for medications and is epidermally mounted. The medications are released into the bloodstream in response to an indication that the IMD is about to deliver a shock. The drug delivery device is adapted for use with various drugs. Further, the delivery of drugs could be controlled by the patient to provide a semi-automatic use and/or to terminate delay shock. The transdermal drug delivery device and the IMD include system status indicators to provide real-time operational data of the drug delivery device and the IMD individually and in combination. The drug delivery device is also implemented with a CHF monitor to treat CHF patients.

Claims

1. A drug delivery strip in communication with an implantable medical device (IMD), the combination comprising:

means for monitoring at least one pretherapy event in the IMD;

means for communicating to the drug delivery strip that said at least one pretherapy event is imminent; and

means for activating the delivery of drugs from the drug delivery strip prior to or contemporaneous with a therapy resulting from said at least one pretherapy event.

2. The combination of claim 1 wherein said therapy event includes the delivery of cardioversion/defibrillation energy.

3. The combination of claim 1 wherein said therapy event includes the delivery of energy shock to the heart.

4. A transdermal drug delivery device in wireless communications with at least one implantable medical device (IMD) wherein the drug delivery device is adapted to be externally mounted to a patient to deliver pain analgesics and/or threshold reduction medications prior to a shock associated with a pacer, a defibrillator and similar therapy device, the drug delivery device comprising:

means for storing the medications;

means for mounting epidermally to a patient;

means for communicating with at least one IMD; and

means for releasing the medications transdermally responsive to at least one indication that the at least one IMD is about to deliver the shock.

5. A transdermal drug delivery device in combination with an implantable medical device (IMD) to deliver medications to a CHF patient, the combination comprising:

the drug delivery device adapted to be externally mounted on a patient;

the IMD being a CHF monitoring device; and

a communication system between the drug delivery device and the IMD to enable the delivery of the medications prior to or contemporaneous with CHF signals from the IMD.

6. The combination of claim 5 wherein said signals include parameters that lie outside a pre-selected range of cardiac events.

7. An external drug delivery device adapted to be mounted to the skin of a patient and in communication with an IMD to deliver specialty drugs responsive to signals from the IMD relating to cardiac conditions and/or therapy, the drug delivery device having storage for the specialty drugs, the drugs comprising:

opiates;

non-opiates;

defibrillation threshold reducing agents; and

agents for treatment of CHF.

8. The drug delivery device of claim 7 wherein said opiates include morphine sulfate and hydromorphine.

9. The drug delivery device of claim 7 wherein said non-opiates include alpha-2 adreneorgic agonists and neuron specific calcium channel blocking agents.

10. The drug delivery device of claim 7 wherein said defibrillation threshold reducing agents include D-salotol, Procainamade or Quinidine as alternatives or in combination with one or both said opiates and said non-opiates.

11. The drug delivery device of claim 7 wherein said agents for treatment of CHF includes captopril, enalapril, lisinopril and quinapril.

12. The drug delivery device of claim 7 wherein said specialty drugs include drugs designed to overcome pain and threshold associated with cardiac shock.

13. The drug delivery device of claim 7 wherein said specialty drugs include drug types designed to treat CHF conditions.

14. The drug delivery device of claim 13 wherein the drug types are suited to treat pain, threshold, and CHF conditions in combination thereof.

15. An external drug delivery device in communication with an implantable medical device (IMD) forming a system in which one or more drugs are discharged into a patient based on signals received from the IMD, the system comprising:

a communication link between the drug delivery device and the IMD;

automatic means for discharging the one or more drugs from the external drug delivery device into the patient when the signals are received from the IMD via said communication link; and

automatic means for terminating the discharge of the one or more drugs.

16. The system of claim 15 wherein a semi-automatic means for discharging is implemented to enable the patient to activate the drug discharge on an as-needed basis.

17. The system of claim 15 wherein a semi-automatic means for terminating the discharge is implemented to enable the patient to terminate the drug discharge on as needed basis.

18. The system of claim 15 wherein the communication link includes system status indicators.

19. The system of claim 15 wherein said system status indicators include visual displays.

20. The system of claim 15 wherein said system status indicators include audible signals.

21. The system of claim 15 wherein said system status indicators include tactile interfaces.

22. The system of claim 15 wherein the communication link includes override means to enable the patient to terminate or delay shock using the drug delivery device as a controller.

23. The system of claim 15 wherein the communication link includes remote monitoring and programing means to enable remote patient management.

24. A system for delivering cardioversion energy to at least one chamber of a patient'"'"'s heart in need of cardioversion and for aleviating pain attendant to delivery of cardioversion energy comprising:

a transdermal drug delivery device adapted to be applied to the patient'"'"'s body responsive to a drug delivery command for transdermally delivering a drug into the patient'"'"'s body when the chamber is determined to be in need of cardioversion, the drug comprising one or both of a cardioversion threshold reducing medication to reduce the cardioversion threshold and a pain alleviating medication to alleviate pain felt by the patient arising from the delivery of the cardioversion energy; and

an implantable cardioversion/defibrillation device adapted to be implanted in the patient'"'"'s body comprising;

detecting means for detecting activity of a chamber of the patient'"'"'s heart;

determining means responsive to the detecting means for determining when the chamber of the patient'"'"'s heart is in need of cardioversion;

means responsive to the detecting means for transmitting the drug delivery command to the transdermal drug delivery device when the chamber of the patient'"'"'s heart is in need of cardioversion; and

cardioverting means responsive to the determining means for delivering cardioversion energy to the chamber of the patient'"'"'s heart when the chamber is in need of cardioversion.

25. The system of claim 24 further comprising means for delaying delivery of the cardioversion energy by said cardioverting means from the delivery of the drug for a delay period sufficient to allow the drug to take effect.

26. The system of claim 25 wherein the means for delaying comprises means for timing out a delay period to allow the drug to take effect and further comprising:

means operale upon time-out of the delay period for timing out a time course during which the drug remains effective;

means responsive to the detecting means for determining whether the patient'"'"'s heart chamber continues to be in need of cardioversion at any time during the time course; and

means responsive to a determination that the patient'"'"'s heart activity indicates a need for cardioversion during the time course for triggering delivery of the cardioversion energy to the heart chamber.

27. The system of claim 24 further comprising means responsive to the determining means for generating a patient warning of the imminence of the delivery of the cardioversion energy.

28. A method of delivering cardioversion energy to at least one chamber of a patient'"'"'s heart in need of cardioversion comprising the steps of:

detecting activity of a chamber of the patient'"'"'s heart;

determining when the chamber of the patient'"'"'s heart is in need of cardioversion from the detected activity;

transdermally delivering a bolus of a drug into the patient'"'"'s body when the chamber is determined to be in need of cardioversion, the drug comprising one or both of a cardioversion threshold reducing medication to reduce the cardioversion threshold and a pain alleviating medication to alleviate pain felt by the patient arising from the delivery of the cardioversion energy; and

delivering cardioversion energy to the chamber of the patient'"'"'s heart when the chamber is determined to be in need of cardioversion.

29. The method of claim 28 further comprising delaying delivery of the cardioversion energy for a delay period sufficient to allow the drug to take effect.

30. The method of claim 29, wherein the step of delaying comprises timing out the delay period and further comprising:

at the time-out of the delay period, timing out a time course during which the drug remains effective;

determining whether the patient'"'"'s heart chamber continues to be in need of cardioversion during a time course of effectiveness of the drug following time-out of the delay period; and

triggering delivery of the cardioversion energy during the time course following the time-out of the delay period in response to a determination that the patient'"'"'s heart activity indicates a need for cardioversion of the heart chamber during the time course.

31. The method of claim 28 further comprising the step of generating a patient warning of the imminence of the delivery of the cardioversion energy.

32. A method of delivering cardioversion energy to at least one chamber of a patient'"'"'s heart in need of cardioversion comprising the steps of:

detecting activity of the at least one chamber of the patient'"'"'s heart;

determining from the detected activity when the at least one chamber of the patient'"'"'s heart is in need of cardioversion;

upon determining the need for cardioversion, transdermally delivering a drug into the patient'"'"'s body, the drug comprising one or both of a cardioversion threshold reducing medication to reduce the cardioversion threshold and a pain alleviating medication to alleviate pain in body tissue arising from the delivery of the cardioversion energy;

timing out a delay period from the determination of the need for cardioversion sufficient for the applied drug to take effect; and

delivering cardioversion energy to the at least one chamber of the patient'"'"'s heart following time-out of the delay period and during a time course of effectiveness of the delivered drug.

33. The method of claim 32, wherein the cardioversion delivering step further comprises:

determining whether the patient'"'"'s heart chamber continues to be in need of cardioversion during the time course of effectiveness of the delivered drug; and

initiating delivery of the cardioversion energy during the time course of effectiveness of the delivered drug only in response to a determination that the patient'"'"'s heart activity indicates a need for cardioversion of the heart chamber.

34. A system for delivering cardioversion energy to at least one chamber of a patient'"'"'s heart in need of cardioversion comprising:

means for detecting activity of the at least one chamber of the patient'"'"'s heart;

means for determining from the detected activity when the at least one chamber of the patient'"'"'s heart is in need of cardioversion;

transdermal drug delivery means operable upon determining the need for cardioversion for transdermally delivering a drug into the patient'"'"'s body, the drug comprising one or both of a cardioversion threshold reducing medication to reduce the cardioversion threshold and a pain alleviating medication to alleviate pain in body tissue arising from the delivery of the cardioversion energy;

means for timing out a delay period from the determination of the need for cardioversion sufficient for the applied drug to take effect; and

means for delivering cardioversion energy to the at least one chamber of the patient'"'"'s heart following time-out of the delay period and during a time course of effectiveness of the delivered drug.

35. The system of claim 34, wherein the cardioversion delivering means further comprises means for initiating delivery of the cardioversion energy during the time course of effectiveness of the delivered drug only in response to a determination by the determining means that the patient'"'"'s heart activity indicates a need for cardioversion of the heart chamber during the time course.

36. An atrial cardioversion system, comprising an implantable cardioverter adapted to be implanted in the patient'"'"'s body, an external drug delivery device adapted to attached to the patient'"'"'s body, and a patient operated external programmer for communication with the implantable cardioverter and the external drug delivery device wherein:

the external programmer comprises means operable by the patient for transmitting a patient activated command signal to initiate delivery of a drug and a cardioversion therapy when the patient experiences symptoms of atrial fibrillation;

the external drug delivery device comprises means responsive to the command signal transmitted from the external programmer for transdermally delivering a bolus of a drug into the patient'"'"'s body, the drug comprising one or both of a cardioversion threshold reducing medication to reduce the cardioversion threshold or a pain alleviating medication to alleviate pain felt by the patient arising from the delivery of the cardioversion energy;

the implantable cardioverter comprises;

means for receiving the command signal transmitted from the external programmer;

delaying means responsive to the command signal for timing a delay period sufficient for the delivered drug to take effect; and

cardioversion energy generator means for delivering atrial cardioversion energy to the patient'"'"'s atria upon time-out of the delay period in response to the command signal.

37. The system of claim 36 wherein the implantable cardioverter further comprises:

means operable upon time-out of the delay period for timing out a time course during which the drug remains effective;

detecting means for determining whether the patient'"'"'s atria continue to be in need of cardioversion at any time during the time course; and

cardioversion energy trigger means responsive to a determination that the patient'"'"'s heart activity indicates a need for cardioversion during the time course for triggering delivery of the cardioversion energy to the atria.

38. The system of claim 37 wherein the implantable cardioverter further comprises:

means for detecting a ventricular depolarization of the patient'"'"'s heart; and

the cardioversion energy trigger means triggers delivery of the cardioversion energy to the atria in timed relation to the detected ventricular depolarization.

39. The system of claim 36 wherein the implantable cardioverter further comprises means responsive to the determining means for generating a patient warning of the imminence of the delivery of the cardioversion energy.

40. A method of operating an atrial cardioversion system, comprising an implantable cardioverter adapted to be implanted in the patient'"'"'s body, an external drug delivery device adapted to attached to the patient'"'"'s body, and a patient operated external programmer that the patient employs to transmit a patient activated command signal to initiate delivery of a drug and a cardioversion therapy when the patient experiences symptoms of atrial fibrillation, comprising:

transdermally delivering a bolus of a drug into the patient'"'"'s body in response to the command signal transmitted from the external programmer, the drug comprising one or both of a cardioversion threshold reducing medication to reduce the cardioversion threshold or a pain alleviating medication to alleviate pain felt by the patient arising from the delivery of the cardioversion energy; and

within the implantable cardioverter,

receiving the command signal transmitted from the external programmer;

in response to the command signal, timing a delay period sufficient for the delivered drug to take effect; and

delivering atrial cardioversion energy to the patient'"'"'s atria upon time-out of the delay period.

41. The method of claim 40, further comprising the steps of the implantable cardioverter of:

upon time-out of the delay period, timing out a time course during which the drug remains effective;

determining whether the patient'"'"'s atria continue to be in need of cardioversion at any time during the time course; and

triggering delivery of the cardioversion energy to the atria only in response to a determination that the patient'"'"'s heart activity indicates a need for cardioversion of the atria during the time course.

42. The method of claim 40 further comprising the steps of the implantable cardioverter of:

upon time-out of the delay period, timing out a time course during which the drug remains effective;

determining whether the patient'"'"'s atria continue to be in need of cardioversion at any time during the time course;

detecting a ventricular depolarization of the patient'"'"'s heart; and

triggering delivery of the cardioversion energy to the atria in timed relation to the detected ventricular depolarization only in response to a determination that the patient'"'"'s heart activity indicates a need for cardioversion of the atria during the time course.

43. The method of claim 40 further comprising the step of the implantable cardioverter of generating a patient warning of the imminence of the delivery of the cardioversion energy.

44. An atrial cardioversion system, comprising an implantable cardioverter adapted to be implanted in the patient'"'"'s body, an external drug delivery device adapted to attached to the patient'"'"'s body, and a patient operated external programmer for communication with the implantable cardioverter wherein:

the external programmer comprises means operable by the patient for transmitting a patient activated command signal to initiate delivery of a cardioversion therapy when the patient experiences symptoms of atrial fibrillation;

the implantable cardioverter comprises;

means for receiving a request of the patient activated command signal;

means for timing a delay period; and

cardioversion energy generator means for delivering a cardioversion energy to the patient'"'"'s atria upon time-out of the delay period; and

the external drug delivery device comprises means responsive to a command from one of the patient, the external programmer or the implantable cardioverter for transdermally delivering one or both that takes effect during the timing out of the delay period.

45. The system of claim 44 wherein the implantable cardioverter further comprises:

means for determining whether the patient'"'"'s heart activity continues to indicate a need for atrial fibrillation substantially on time-out of the delay period; and

means responsive to a determination that the patient'"'"'s heart activity does not indicate a need for a trial fibrillation for inhibiting delivery of atrial cardioversion energy.

46. The system of claim 44 wherein the implantable cardioverter includes means for restarting the delay period in response to a request of the patient transmitted by the external programmer for delaying atrial cardioversion.