Electronic transdermal drug delivery system

• US 5,405,614 A
• Filed: 01/11/1993
• Issued: 04/11/1995
• Est. Priority Date: 04/08/1992
• Status: Expired due to Fees

• Current Assignee: Americare Technology Incorporated
• Original Assignee: International Medical Associates, Inc.
• Inventors: D'Angelo, Joseph P., Schur, Henry
• Primary Examiner(s): Phelan, D. Gabrielle
• Application Number:
  US08/003,095
• Time in Patent Office: 820 Days
• Field of Search: 424/449, 602/41, 604/20, 128/419 R, 606/32
• US Class Current: 424/449
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A drug delivery system for transdermally delivering drugs through a given skin area is provided. The delivery system comprises a collapsible container for containing the drug. The container has a drug release opening. A displaceable member is in engagement with the container for expelling the drug from the container via the release opening. A driver is connected with said displaceable member so as to drive the same towards the collapsible container. Conduits are disposed between the release opening and the skin area for conducting the drug to the skin area. An ultrasonic transducer is disposed in the general conduit area for generating ultrasonic waves aimed at the skin area. An ultrasonic waveform generator drives the transducer and an electric control circuit is connected to the flow control for electrically activating the flow control.

Claims

1. An assembly for the transdermal administration of a drug to a patient, comprising:

a base unit having a timer and electrical connections for issuing electronic timing information from said timer;

a drug administration unit electrically connected to said base unit, said drug administration unit having a housing defining a space therein for receiving a drug and said housing having drug dispensing conduit means formed therein, a skin-contacting surface to be placed on a patient'"'"'s skin, dispensing means for selectively causing time-dependent dispensing of a drug from said space in said housing through said conduit means to said skin-contacting surface and to the patient'"'"'s skin, and means for generating pressure waves at said skin contacting surface for facilitating transdermal absorption of the drug dispensed to said skin contacting surface.

2. The assembly according to claim 1, wherein said dispensing means comprises valve means disposed in said conduit means for selectively closing and opening said conduit means.

3. The assembly according to claim 1, wherein said pressure wave generating means comprise a transducer disposed at said skin contacting surface, and circuit means operatively connected to said transducer for driving said transducer at a given frequency.

4. The assembly according to claim 3, wherein said circuit means comprises wave form generator means for generating an electronic signal formed of a square wave in a frequency range of between 20 KHz and 100 KHz and of a sine wave superimposed thereon in a frequency range of between 200 KHz and 1 MHz.

5. The assembly according to claim 1, wherein said pressure waves generating means include an ultrasonic transducer for generating ultrasonic waves aimed at the patient'"'"'s skin and an ultrasonic waveform generator drivingly connected to said transducer.

6. The assembly according to claim 1, including in said conduit means a skin area interface membrane for contacting the skin area, a layer of transfer gel in contact with said interface membrane, an open cell foam body having one side connected with said transfer gel, a medicament distribution chamber communicating at one side with said foam body and at an opposite side with said flow means.

7. The assembly according to claim 1, wherein said transducer is a planar piezo-electric disc electrically connected with said ultrasonic waveform generator.

8. The assembly according to claim 5, including in said ultrasonic waveform generator at least one sine wave generator, at least one square wave generator, a summing circuit having respective inputs connected to said sine wave generator and to said square wave generator for generating a superimposed signal of said sine wave and said square wave connected to said transducer.

9. The assembly according to claim 8, wherein said timing circuit is operative for activating said waveform generator in alternating on and off states in programmed sequence.

10. The assembly according to claim 9, including in said timing circuit EEPROM means for storing at least one timing program for timing said programmed sequence.

11. The assembly according to claim 10, including stored in said EEPROM means at least one basal timing sequence and at least one bolus timing sequence.

12. The assembly according to claim 11, including on said housing a plurality of control knobs connected to said electrical control circuit, wherein one of said control knobs is operative for activating said basal timing sequence, and a second one of said control knobs is operative for activating said bolus timing sequence.

13. The assembly according to claim 12, wherein said bolus sequence overrides said basal timing sequence.

14. The assembly according to claim 13, wherein said bolus timing sequence is time-limited.

15. The assembly according to claim 10, including an access port connected to said EEPROM means, said access port operative for accessing external programming means for entering timing programs into said EEPROM.

16. The assembly according to claim 1, including in said base unit an alarm system for generating an alarm in case of failure of said timer.

17. The assembly according to claim 16, including an audible alarm transmitter connected to said alarm system for generating an audible alarm in case of failure of said timer.