Remote control drug delivery device

• US 5,928,195 A
• Filed: 07/28/1998
• Issued: 07/27/1999
• Est. Priority Date: 01/31/1996
• Status: Expired due to Fees

• Current Assignee: Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Malamud, Daniel, Litt, Mitchell, Lewis, Benjamin L.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/123,299
• Time in Patent Office: 364 Days
• Field of Search: 604/891.1, 604/141, 604/131, 604/151, 604/890.1
• US Class Current: 604/141
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure

Abstract

A remotely controlled drug delivery device administers a dose of a drug, agent or microbicide using a gas pressure delivery system. The device stores multiple doses of the drug or agent. A toroid shaped housing includes three chambers, a gas chamber containing a pressurized gas, a drug storage chamber containing the drug or agent, and an expandable chamber for delivering the drug from the drug storage. The device includes an electronic controller for opening a valve connecting the gas chamber to the expandable chamber for a predetermined period of time in order to deliver a predetermined dose of the drug. The controller communicates with a remote control device via radio frequency. The remote control device sends a signal to the controller, which causes a dose to be delivered. The controller returns a signal to the remote control device indicating that the dose has been delivered and a signal indicating when the device needs to be removed for maintenance. The device may be used in any body cavity to deliver any desired type of drug.

Claims

1. A drug delivery system comprising:

a housing;

a drug storage chamber located within the housing and having at least one exit port, the drug storage chamber for holding at least one predetermined dose of a predetermined drug;

a drug delivery chamber disposed within the drug storage chamber;

a gas pressurized chamber located within the housing for holding a gas under pressure;

a valve connecting the gas pressurized chamber with the drug delivery chamber, the valve having an open position and a normally closed position, wherein in the open position, the gas is delivered through the valve to the drug delivery chamber;

a remotely activated control circuit electrically connected to the valve for receiving a remotely generated valve open signal and generating an electrical valve open signal therefrom, and providing the electrical valve open signal to the valve; and

a signaling device spaced from the control circuit for transmitting the remotely generated valve open signal to the control circuit, wherein upon receipt of the electrical valve open signal, the valve opens such that the gas in the gas pressurized chamber is released into the drug delivery chamber, thereby forcing a predetermined dose of the drug into the at least one exit port and out of the housing.

2. The drug delivery system of claim 1 wherein the housing is sized to fit within a cavity of a human body.

3. The drug delivery system of claim 2 wherein the housing is generally toroidal shaped.

4. The drug delivery system of claim 3 wherein the cavity comprises a vagina and an outer wall of the housing contacts the vaginal wall.

5. The drug delivery system of claim 4 wherein the housing has an outer diameter of about 40 mm to about 80 mm and an inner diameter of about 25 mm to about 75 mm.

6. The drug delivery system of claim 4 wherein the drug storage chamber contains a drug, wherein the drug comprises a microbicide.

7. The drug delivery system of claim 6 wherein the drug has an activity selected from the group comprising spermicidal, antiviral, antibacterial, antifungal, anticonceptive and antisexually transmitted disease activities, and mixtures thereof.

8. The drug delivery system of claim 7 wherein the drug comprises a compound comprising as a first component an alkyl-N-betaine surfactant and as a second compound an oxide selected from the group consisting of alkyl-N, N-dimethyl amine oxide, N-dihydroxyethylamine oxide, acylamino t-amine oxide and mixtures thereof.

9. The drug delivery system of claim 6 wherein the drug comprises a C31G.

10. The drug delivery system of claim 4 wherein a plurality of predetermined doses of the drug are stored in the drug storage chamber.

11. The drug delivery system of claim 10 wherein the plurality comprises at least ten.

12. The drug delivery system of claim 1 wherein the housing is constructed of a flexible, biocompatible material.

13. The drug delivery system of claim 1 wherein the pressurized gas is nontoxic.

14. The drug delivery system of claim 13 wherein the pressurized gas comprises air.

15. The drug delivery system of claim 1 wherein the gas pressure is about 1.2 atmospheres to about 2.5 atmospheres of absolute pressure.

16. The drug delivery system of claim 1 wherein the gas pressure chamber is rechargeable.

17. The drug delivery system of claim 1 wherein the drug delivery chamber comprises a collapsible membrane.

18. The drug delivery system of claim 1 wherein each one exit port comprises a slit in an outer surface of the housing and an inner surface of the drug storage chamber, wherein the drug passes through the slit only when the pressurized gas is released into the drug delivery chamber.

19. The drug delivery system of claim 1 wherein the valve comprises a solenoid valve.

20. The drug delivery system of claim 1 wherein the control circuit includes a timer circuit for maintaining the electrical valve open signal for a predetermined time period.

21. The drug delivery system of claim 20 wherein the electrical valve open signal is maintained for at least 3 msec.

22. The drug delivery system of claim 1 further comprising a pressure transducer disposed within the gas pressurized chamber and in communication with the control circuit, wherein the pressure transducer monitors the gas pressure within the gas pressurized chamber and transmits a gas pressure signal to the control circuit.

23. The drug delivery system of claim 22 wherein the control circuit further comprises:

means for generating a dose delivered signal; and

a control circuit transmitter for transmitting the dose delivered signal to the signaling device, wherein the signaling device includes means for displaying the transmitted dose delivered signal.

24. The drug delivery system of claim 23 wherein the control circuit further comprises:

means for generating a recharge signal, wherein the recharge signal is transmitted to the signaling device by the control circuit transmitter.

25. The drug delivery system of claim 24 wherein the signaling device includes means for displaying the transmitted recharge signal.

26. The drug delivery system of claim 24 wherein the recharge signal indicates a low gas pressure condition within the gas pressurized chamber.

27. The drug delivery system of claim 24 wherein the recharge signal indicates a low power condition of a control circuit power source.

28. The drug delivery system of claim 24 wherein the recharge signal indicates a low drug condition within the drug storage chamber.

29. The drug delivery system of claim 24 wherein the recharge signal indicates a low gas pressure condition within the gas pressurized chamber, a low power condition of a control circuit power source, and a low drug condition within the drug storage chamber.

30. A drug delivery system comprising:

a housing;

a drug storage chamber located within the housing having at least one exit port, the drug storage chamber adapted to hold at least one predetermined dose of a predetermined drug;

a drug delivery chamber disposed within the drug storage chamber;

a gas pressurized chamber located within the housing for holding a nontoxic gas under pressure;

a valve connecting the gas pressurized chamber with the drug delivery chamber, the valve having an open position and a closed position, wherein in the open position, the gas is delivered through the valve to the drug delivery chamber, thereby forcing one dose of the drug out of the exit port;

a pressure transducer located within the gas pressurized chamber for monitoring the gas pressure therein and generating a corresponding gas pressure signal;

a signaling device spaced from the housing for generating a valve open signal and transmitting the valve open signal at a predetermined radio frequency; and

a remotely activated control circuit located within the housing, the control circuit including a receiver circuit, a timer circuit, and a transmitter circuit, the receiver circuit for receiving the transmitted valve open signal, the timer circuit receiving the transmitted valve open signal from the receiver circuit, generating an electrical valve open signal, and providing the electrical valve open signal to the valve for a predetermined time period, and the transmitter circuit for receiving the gas pressure signal from the pressure transducer, generating a dose delivered signal therefrom, and transmitting the dose delivered signal to the signaling device, wherein the signaling device includes a display for displaying the dose delivered signal.

31. An intravaginal drug delivery device comprising:

a generally toroid shaped housing sized to fit within a human vagina;

a drug storage chamber located within the housing and having at least one exit port, the drug storage chamber for holding a plurality of predetermined doses of a predetermined drug;

a drug delivery chamber comprising a flexible membrane disposed within the drug storage chamber;

a gas pressurized chamber located within the housing for holding a nontoxic gas under pressure;

a valve connecting the gas pressurized chamber with the drug delivery chamber, the valve having an open position and a closed position, wherein in the open position, the gas is delivered through the valve to the drug delivery chamber;

a pressure transducer located within the gas pressurized chamber for monitoring the gas pressure therein and generating a corresponding gas pressure signal;

a signaling device spaced from the housing generating a valve open signal and transmitting the valve open signal at a predetermined radio frequency; and

a remotely activated control circuit located within the housing, the control circuit including a receiver circuit, a timer circuit, and a transmitter circuit, the receiver circuit for receiving the transmitted valve open signal, the timer circuit receiving the transmitted valve open signal from the receiver circuit, generating an electrical valve open signal, and providing the electrical valve open signal to the valve for a predetermined time period, and the transmitter circuit for receiving the gas pressure signal from the pressure transducer, generating a dose delivered signal therefrom, and transmitting the dose delivered signal to the signaling device, wherein the signaling device includes a display for displaying the dose delivered signal.