Drug delivery system for implantable cardiac device

• US 7,201,733 B2
• Filed: 11/30/2001
• Issued: 04/10/2007
• Est. Priority Date: 10/21/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Girouard, Steven D., Scheiner, Avram, Heil, Ronald W. Jr., Herner, Mark
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/999,260
• Publication Number:
  US 20020099328A1
• Time in Patent Office: 1,957 Days
• Field of Search: 128/899, 128897-898, 128/903, 128/DIG.12, 128/DIG.13, 600/509, 600/300, 600/510, 607/9, 607/28, 604 50- 53, 604 65- 67
• US Class Current: 604/67
• 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 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A drug delivery system incorporated into a cardiac device for delivering a dose of a drug to a patient upon detection of a particular medical condition. The cardiac device may be, for example, an implantable cardioverter/defibrillator, cardiac pacemaker, or combination device that communicates via a radio frequency link with a drug delivery device. The drug delivery device is preferably an electrically modulated transdermal drug delivery device for delivering the drug transdermally in accordance with a signal received from the cardiac device.

Claims

1. A drug delivery system comprising:

an implantable cardiac device having incorporated therein a sensor for sensing a physiological variable in a patient, a first telemetry interface for transmitting radio frequency signals, and circuitry for modulating the radio frequency signals with a drug delivery command signal;

an external drug delivery device for affixation to a skin surface location on the patient, the drug delivery device having incorporated therein a second telemetry interface for receiving radio frequency signals, circuitry for demodulating radio signals to derive a drug delivery command signal therefrom, and circuitry for controlling the drug delivery device in order to deliver a drug upon receipt of a drug delivery command signal;

wherein the implantable cardiac device is programmed to transmit a drug delivery command signal to the external drug delivery device in response to the sensed physiological variable in a manner that attempts to control the sensed variable in a closed-loop fashion; and

,

wherein the system is programmed to maintain a downloadable log of the sensed physiological variable and of the amount of drug administered by the drug delivery device that can be used to formulate an optimum drug dosage schedule for the patient.

2. The system of claim 1, wherein the implantable cardiac device includes a cardioverter/defibrillator.

3. The system of claim 1, wherein the implantable cardiac device includes a pacemaker.

4. The system of claim 1, wherein the external drug delivery device is an electrically modulated transdermal injector comprising:

a first drug reservoir containing a first drug;

a first electrode, connected to the first drug reservoir, for contacting the patient'"'"'s skin;

a second electrode for contacting the patient'"'"'s skin; and

a controllable power source, connected to the first and second electrodes, to impose a voltage between the first and second electrodes.

5. The system of claim 4, wherein the transdermal injector further comprises a second drug reservoir containing a second drug, the second electrode is connected to the second drug reservoir, and the first and second drugs are simultaneously delivered, respectively from the first and second drug reservoirs.

6. The system of claim 5, wherein the pH of a solution containing the drug in each reservoir is separately adjusted in accordance with the polarity of the electrode to which the reservoir is connected.

7. The system of claim 1, wherein the drug delivered by the drug delivery device is a vasodilator.

8. The system of claim 1, wherein the drug delivered by the drug delivery device is a thrombolytic.

9. The system of claim 1, wherein the drug delivered by the drug delivery device is an anti-platelet agent.

10. The system of claim 1, wherein the drug delivered by the drug delivery device is an anti-arrhythmic.

11. A method for drug delivery comprising;

sensing a physiological variable in a patient with an implantable cardiac device;

generating a command signal with the implantable cardiac device in response to the sensed physiological variable in a manner that attempts to control the sensed variable in a closed-loop fashion;

transmitting the command signal with the implantable cardiac device to an external drug delivery device affixed to a skin surface location on the patient via a radio telemetry link;

receiving the command signal with the external drug delivery device;

delivering a drug with the external drug delivery device based on the command signal;

downloading a log of the sensed physiological variable and of the amount of drug administered by the drug delivery device; and

,

using the downloaded log to formulate an optimum drug dosage schedule for the patient.

12. The method of claim 11, wherein the implantable cardiac device includes a cardioverter/defibrillator.

13. The method of claim 11, wherein the implantable cardiac device includes a pacemaker.

14. The method of claim 11, further comprising delivering the drug by electrically modulated transdermal injection.

15. The method of claim 11, wherein the drug delivered by the drug delivery device is a vasodilator.

16. The method of claim 11, wherein the drug delivered by the drug delivery device is an anti-arrhythmic.

17. The method of claim 11, wherein the drug delivered by the drug delivery device is a thrombolytic.

18. The method of claim 11, wherein the drug delivered by the drug delivery device is an anti-platelet agent.