Device for transcutaneous administration of medications using io

Details Device for transcutaneous administration of medications using io Device for transcutaneous administration of medications using io

1998-10-15

2000-12-26

Dawson, Glenn K.

Surgery

Means for introducing or removing material from body for...

Infrared, visible light, ultraviolet, x-ray or electrical...

604501, A61N 130

Patent

active

061673021

DESCRIPTION:

BRIEF SUMMARY
The present invention concerns a device for transdermal administration of medications by iontophoresis and, more particularly, a device of this kind including at least a) a set of electrodes including an electrode joined to a reservoir that can be charged with a medication and a counter-electrode and b) an electronic module that can be separably mounted on said set of electrodes to control the magnitude of an electrical current passing, between the two electrodes, through the reservoir and the skin of a patient pressed against said reservoir.
Devices of the above kind are known in themselves, in particular from international patent applications WO 94/27671, WO 94/28965 and from French patent application no. 2 656 223. They are designed, for example, to administer medication from three therapeutic categories: narcotic analgesics, anti-emetics and anti-migraine medication. The response of patients to narcotic analgesics such as fentanyl and its derivatives, for example, is highly variable. It follows that the treatment must be adapted to suit the patient by the doctor. Iontophoretic devices for administering medication are particularly well suited to this application, because they can execute extremely varied administration programmes that can be modified with great flexibility. All risk of error in the treatment must be avoided, especially in the case of extremely active analgesics such as fentanyl and its derivatives, which can be dangerous, or even fatal, if administered in doses that depart from those precisely determined by pharmacological studies. To this end it is necessary to assure that the medication contained in the reservoir is that chosen and that this medication will be administered in accordance with a controlled programme initiated by a competent person. It is therefore necessary for access to the means for configuring and modifying this programme to be reserved to a competent person to prevent unskilled intervention creating a hazard to the patient.
In this context, the previously mentioned French patent no. 2 656 223 proposes to load into the electronic module all of the medication administration programmes corresponding to the various sets of electrodes that it is able to receive, a particular programme being selected at the time of fitting a particular set of electrodes to the module by mechanical or electrical contact means disposed at the interface between the set and the module to select automatically a programme applicable to the medication contained in the reservoir of the set of electrodes. As an alternative to this, the previously mentioned French patent application proposes that the electronic module should read a bar code carried by the set of electrodes when the two components are assembled together. No means are provided to prevent the use of this device by an unauthorised person.
Furthermore, the use of a bar code restricts the amount of information that can be transferred from the set of electrodes to the electronic module. It necessitates the provision in the module of bar code reading means, which reading can be prevented by interposition of opaque materials in the reading beam. Furthermore, a bar code is readily reproducible by photocopying, which makes potentially dangerous falsifications possible.
The selection of a programme by mechanical means such as projections actuating electrical switches distributed in a particular configuration, or by purely electrical means, has the disadvantage of using fixed configurations of projections or of electrical contacts, which can be readily identified, copied or activated by unauthorised persons.
An aim of the present invention is to provide an iontophoretic device for administering medication designed to assure safe administration both with regard to the competence of the administrator and the selection of the product administered and the administration programme.
Another aim of the invention is to provide a device of the above kind that is nevertheless very versatile in terms of programming and possible reprogramming.
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REFERENCES:
patent: 4931046 (1990-06-01), Newman
patent: 5591123 (1997-01-01), Sibalis et al.
patent: 5603693 (1997-02-01), Frenkel et al.
patent: 5876368 (1999-03-01), Flower
patent: 5899875 (1999-05-01), Millot et al.

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