Device for delivering a pharmacologically active principle by electrolytic pumping

• US 5,135,499 A
• Filed: 03/11/1991
• Issued: 08/04/1992
• Est. Priority Date: 07/12/1989
• Status: Expired due to Term

• Current Assignee: Apcis
• Original Assignee: Apcis
• Inventors: Tafani, Jean-Pierre, Alexandre, Jean, Zeghal, Slim, Valter, Francis
• Primary Examiner(s): Wilson, John J.
• Assistant Examiner(s): Smith, Jeffrey A.
• Application Number:
  US07/659,409
• Time in Patent Office: 512 Days
• Field of Search: 604/141, 604/145, 604/140, 604/151, 604/153, 604/132, 604/890.1, 604/891.1, 604/892, 604/93
• US Class Current: 604/141
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: F16N 11/10 by pressure of another fluid

Abstract

The device includes an electrolysis cell (C) comprising: a closed variable volume first chamber (2) containing an electrolyte that gives off gas under the effect of an electrolysis voltage applied to electrodes (3, 4) in contact with the electrolyte, the gas given off causing the first chamber to expand; and a variable volume second chamber (7) containing the active principle, said second chamber opening out to the outside via an orifice (11) enabling the active principle to be delivered; the total volume of the two chambers (2, 7) being constant, such that expansion of the first chamber causes the volume of the second chamber to be reduced and gives rise to a corresponding controlled expulsion of the active principle contained therein. According to the invention, the two chambers (2, 7) are separated from each other by a flexible wall (6) uniformly subjected to the pressure resulting from gas being given off in such a manner as to reduce the volume of the second chamber (7) and expel the active principle; and the first chamber (2) contains a liquid electrolyte in which the electrodes (3, 4) that extend over the major portion of the length of said first chamber are immersed so that the electrodes are always at least in part in contact with the electrolyte regardless of the position of the device.

Claims

1. A device for delivering a pharmacologically active principle by electrolytic pumping, the device including an electrolysis cell (C) comprising:

a closed variable volume first chamber (2) containing a liquid electrolyte that gives off gas under the effect of an electrolysis voltage applied to a pair of electrodes (3,

     4) in contact with the electrolyte, the gas given off causing the first chamber to expand; and

a variable volume second chamber (7), said second chamber opening out to the outside of said second chamber via an orifice (11) enabling the active principle to be delivered;

the total volume of the two chambers (2,

     7) being constant, such that expansion of the first chamber causes the volume of the second chamber to be reduced and gives rise to a corresponding controlled expulsion of the active principle contained therein;

the two chambers (2,

     7) are separated from each other by a flexible wall (6) uniformly subjected to the pressure resulting from the gas being given off in such a manner as to reduce the volume of the second chamber (7) and expel the active principle; and

the first chamber (2) contains the liquid electrolyte in which the pair of electrodes (3,

     4) that extend over a major portion of the length of said first chamber are immersed in said liquid electrolyte so that the pair of electrodes are always at least in part in contact with the liquid electrolyte regardless of the position of the device.

2. The device of claim 1, in which the first chamber (2) is defined by a rigid tube (1) closed at a first end (5), the flexible wall of the tube forming a central flexible bag extending axially over a major portion of the length of the tube and defining the second chamber (7), with a rim of the bag being connected to the rigid tube at a second end (9) opposite to its closed end and being closed by a plug (10) including the orifice (11) through which the active principle is delivered.

3. The device of claim 2, in which the pair of electrodes (3, 4) are a pair of elongate electrodes disposed against an inside wall of the rigid tube (1) and extending over the major portion of the length thereof.

4. The device of claim 3, including a plurality of similar pairs of electrodes (3, 4) distributed circumferentially in pairs against the inside wall of the tube (1) with electrode polarity alternating from one electrode to the next.

5. The device of claim 1, including a resistor (50) in series with the electrolysis cell, the resistance of the resistor being significantly higher than the resistance of the electrolyte as measured between the electrodes.

6. The device of claim 1, in which the electrolysis voltage is applied to the electrodes intermittently so as to deliver the active principle in repeated predetermined doses which are administered at regular intervals.

7. The device of claim 6, including an electrolysis control circuit comprising:

a source of electrolysis voltage (+Vcc);

an oscillator (20) delivering a predetermined reference frequency;

first counter means (21, 22,

     23) receiving the predetermined reference frequency (fo) at a first input and delivering a periodic sequencing signal (P) at a first output defining a desired periodicity with which a dose of the active principle is administered;

second counter means (21,

     24) receiving the predetermined reference frequency (fo) at a second input and delivering a periodic activation signal (A) at a second output defining a desired length of time during which each of the repeated predetermined doses of the active principle is administered; and

a voltage control circuit (30-40) combining the periodic sequencing signal and the periodic activation signal in such a manner as to selectively control application of the electrolysis voltage (+Vcc) to the electrolysis cell (C) so as to cause the active principle to be delivered with the desired periodicity and for the desired length of time.

8. The device of claim 7, in which the electrolysis control circuit further includes a third counter means (21, 60) receiving the predetermined reference frequency (fo) at a third input and delivering an inhibit signal (I) at a third output, the inhibit signal corresponding to an end of administering any active principle, the voltage control circuit (30-40) preventing any application of the electrolysis voltage after the inhibit signal has appeared.

9. The device according to any one of claims 1 to 8, characterized in that the second chamber (7) comprises a first compartment having a first orifice and a second compartment having a second orifice, with each of the first and second orifices being capable of delivering the active principle.

10. The device according to claim 9, in which the electrolysis control circuit is common to two of the delivery devices for the purpose of enabling different active principles to be delivered alternately.