FR2734162A1 - ELECTRIC TRANSFER DEVICE FOR THE DELIVERY OF A MEDICINAL PRODUCT COMPRISING A REUSABLE CONTROL DEVICE - Google Patents

Abstract

An electrotransport system (10) includes a reusable controller (12) having a power source (20) and a separable disposable drug-containing unit (30) which contain both a donor electrode (32) and a counter electrode (34). A coupling means (26, 28, 36, 38) physically and electrically connects together the controller (12) and the drug unit (30) such that the controller (12) provides electrical current to the drug unit (30) for electrotransport delivery of the drug to a body surface (e.g., the skin) of a patient. The coupling means (26, 28, 36, 38) ensures correct polarity connection of the donor and counter electrodes (32, 34) to the outputs of the controller (12).

Description

 The present invention relates to drug delivery systems by electrical transfer, comprising an assembly containing a drug and a reusable control device comprising an electrically powered control circuit, the assembly and the control device being connected separately by a coupler which establishes an electrical connection between the assembly and the control device.

 The term "electrical transfer" (or "electrotransport") as used herein generally refers to the administration of an agent (for example a drug) through a membrane, such as the skin, a mucous membrane or nails. This administration is triggered or facilitated by the application of an electrical potential. For example, a beneficial therapeutic agent can be introduced into the systemic circulation of a human body by administration by electrical transfer through the skin. A widely used electrical transfer process, namely electromigration (also known as iontophoresis), involves the electrically induced transport of charged ions. Another type of electrical transport, namely electro-osmosis, involves the circulation of a liquid which contains the agent to be administered, under the influence of an electric field. Another type of electrical transfer process, called "electroporation", involves the formation of pores which exist transiently, in a biological membrane by means of the application of an electric field. An agent can be delivered through the pores either passively (i.e. without electrical assistance) or actively (i.e. under the influence of an electrical potential). However, in any given electrical transfer process, more than one of these processes can occur to some degree simultaneously.

This is why the expression "electric transfer", as it is used here, must be interpreted in its widest sense possible so as to include the transport or transfer induced or electrically improved by at least one agent, which may be charged or uncharged, or a mixture of a charged agent and an uncharged agent, regardless of the specific mechanism or mechanisms by which this agent is actually transported.

 In electrical transfer devices at least two electrodes are used which are in electrical contact with a certain part of the skin, nails, a mucous membrane or another surface of the body.

An electrode, usually referred to as a "donor" or "active" electrode, is the electrode from which the therapeutic agent is administered into the body. The other electrode, usually referred to as the "counter electrode" or "return" electrode, is used to close the electrical circuit through the body.

For example, if the agent to be administered is positively charged, i.e. a cation, then the anode is the active electrode or donor electrode, while the cathode serves to close the circuit. Otherwise, if an agent is negatively charged, i.e. an anion, the cathode is the donor electrode. In addition, both the anode and the cathode can be considered as donor electrodes if ions of both anionic and cationic agents or if uncharged or neutral charged agents are to be administered.

 In addition, electrical transfer delivery systems generally require at least one reservoir or source of the agent to be administered, which typically is in the form of a liquid solution or suspension. . Examples of such donor reservoirs include a sachet or cavity, a porous sponge or a porous pad and a hydrophilic polymer or a gel-forming matrix. Such donor reservoirs are electrically connected to the anode or the cathode and to the surface of the body and are positioned between the cathode or the anode and the surface of the body to form a stationary or regenerable source of one or more agents or drugs. Electrical transfer devices also include an electrical power source such as one or more batteries. Typically, one pole of the power source is electrically connected to the donor electrode, while the opposite pole is connected electrically at the counter electrode. In addition, certain electrical transfer devices include an electrical control device which controls the current applied via the electrodes, which makes it possible to adjust the rate of administration of the agent. In addition, passive flow control membranes, adhesives for keeping the device in contact with the surface of a body, insulating elements and impermeable support elements are other optional components of an electric transfer device.

All the devices for administering an agent by electrical transfer use an electrical circuit to electrically connect the energy source (for example a battery) and the electrodes. In very simple devices, such as those described by Ariura and others in US Patent 4,474,570, the "circuit" is simply an electrically conductive wire used to connect the battery to an electrode. In other devices, a variety of electrical components are used to control amplitude, polarity, timing, waveform configuration, etc. of the electric current delivered by the energy source. We will refer for example to the patent
US 5,047,007 to McNichols et al.

Hitherto, in commercial devices for transcutaneous administration of drugs by electrical transfer (for example the device designated by Phoresor, marketed by the company known as Iomed, Inc. of Salt Lake
City, UT; the so-called Dupel Iontophoresis System device sold by the company called Empi, Inc. of St Paul, MN; the device known as Webster Sweat Inducer, model 3600, marketed by the company known as Wescor, Inc. of Logan, UT) we used in general a unit for supplying electric power to the office and a couple of electrodes placed in contact with the skin. The donor electrode contains a solution of a drug, while the counter electrode contains a solution of a biocompatible electrolyte salt. The "satellite" electrodes are connected to the electrical energy supply unit by electrically conductive wires or cables of great length (for example 1-2 meters). Examples of office electrical power supply units, which use sets of "satellite" electrodes are described in US Pat. No. 4,141,359 in the name of Jacobsen et al. (See Figures 3 and 4), in the patent. US 5,006,108 filed in the name of LaPrade (see Figure 9), and in US Patent 5,254,081 filed in the name of Maurer et al. (See Figures 1 and 2). The power supply units in such devices include electrical controls for adjusting the intensity of the electrical current applied by means of the electrodes. Existing commercial electric transfer devices have been approved for use only by trained medical technicians.

An important point when connecting the "satellite" electrodes to the power supply unit is to make sure that the electrodes are connected with the correct polarity, i.e. a satellite electrode forming a donor which contains a cationic therapeutic agent, must be connected to the positive output of the control device, while a donor satellite electrode which contains an anionic therapeutic agent, must be connected to the negative part of the control device. To help the medical technician to make the connections with the correct polarity, two solutions were used. In the first solution, color coding was applied to the outputs of the control device, in relation to the appropriate satellite electrode. In the second solution (used in the device designated by
CF Indicator, marketed by the company known as SCandi
Pharm, Inc.), the controller is provided with electrodes in the form of metal plates (e.g. stainless steel), which are arranged on one side of the housing of the controller. The two electrode plates have different geometric shapes (that is to say one is square and the other circular). The donor gel containing the drug and the opposite gel containing the electrolyte have different shapes, which correspond to the shapes of the respective electrode plates to ensure that the donor gel and the opposite gel are placed in contact with the correct electrodes ( i.e. with the correct polarity).

More recently, small autonomous devices for administration by electrical transfer, capable of being worn on the skin, sometimes discreetly under a garment, for long periods of time have been proposed. The electrical components in such miniaturized electrical transfer drug delivery devices are also preferably miniaturized and can be either integrated circuits (i.e., chips) or small printed circuits. Electronic components, such as batteries, resistors, pulse generators, capacitors, etc., are electrically connected so as to form an electronic circuit which controls the amplitude, polarity, timing, configuration of the waveform, etc. electric current delivered by the energy source. Such small autonomous devices for administering drugs by electrical transfer are described for example in US Pat. No. 5,224,927 filed by
Tapper, in US patent 5,224,928 filed by Sibalis et al. And in US patent 5,246,418 filed by Haynes et al.

 Recently, suggestions have been made to use electrical transfer devices having a reusable controller, which is adapted for use with units containing multiple drugs. The medicine-containing units are simply disconnected from the control device when the medicine is used up, and a new medicine-containing unit is then connected to the control device, thereby making the relatively more expensive hardware components of the device (e.g. batteries , LEDs, hardware, etc.) can be accommodated in the reusable controller, and the relatively cheaper donor and opposing reservoir arrays can be accommodated in the disposable unit containing the drug, reducing the overall cost of administering a drug by electrical transfer. Examples of electrical transfer devices constituted by a reusable control device capable of being removably connected to a unit containing a drug, are described in US patent 5 320 597 filed in the name of Sage, Jr and others, in the U patent S 5,358,483 filed in the name of Sibalis, in US patent 5,135,479 filed in the name of Sibalis et al. (FIG. 12) and in the British patent application 2,239,803 filed in the name of Devane et al.

 Electric transfer devices which include reusable control devices and which are suitable for use with multi-drug units are particularly suitable for the administration of drugs to patients outside of clinic / clinic facilities. pharmacies of a doctor (for example for patients who need long-term medication). Unfortunately, the existing systems used to ensure that the drug reservoir of an electrical transfer device is connected to the electrode having the correct polarity are not completely safe. This poses an even greater problem in facilities outside the doctor's clinic / dispensary when the patient is expected to periodically replace the drug unit himself. charged in the event that the patient population tends to be older.

 One aspect of the present invention is to guarantee an electrical connection with the correct polarity between the medication reservoir of an assembly containing a medication and the reusable control device of an electrical transfer device comprising a reusable control device, capable of be used with a plurality of sets containing drugs.

 The object of the present invention is to guarantee electrical connections with correct polarity in an electrical transfer device comprising a reusable electronic control device, suitable for use with a plurality of single-use (for example disposable) units containing medicaments. . Once the medicine is used up in the medicine unit, disconnect this unit from the controller and discard it, then replace it with a new unit. The controller includes a bipolar power source (e.g. one or more batteries) and optionally a circuit for controlling timing, frequency, amplitude, etc. of the current applied by the device.

The drug-containing unit has first and second electrodes, at least one of which contains the therapeutic agent (i.e., the drug) to be administered.

 According to an embodiment of the present invention, the reusable control device is adapted to be electrically coupled to a unit containing a medicament, for more limited use (for example single use), by at least two snap connectors, electrically conductors. The snap connectors have different sizes and / or are arranged with different male / female parts in the respective respective units, so that the control device and the device containing the drug can be coupled in only one way, that is i.e. with connections with correct polarity.

 In another embodiment of the present invention, a projecting element is provided either on the control device or on the unit containing the medicament, while a hole of corresponding shape is arranged in the other unit. The positions of the protruding member and the correspondingly shaped hole are such that the control device and the unit containing the medicament can only be coupled in one way, that is to say with polarity connections. correct.

 More specifically, the invention relates to an electrical transfer device for administering a therapeutic agent through a surface of the body of a patient, this device comprising an assembly having first and second electrodes, of which the at least one contains the therapeutic agent to be administered, and a control device having a bipolar electric power source for applying an electric current to the electrodes, as well as a coupling device for electrically coupling and uncoupling the control device and the assembly, this device being characterized in that it comprises a coupling device which makes it possible to electrically connect the first electrode to a predetermined pole of the bipolar energy source and prevents the electrical connection of the first electrode to the other pole of the bipolar energy source.

 Furthermore, the invention also relates to a method for electrically coupling and uncoupling an assembly to a control device, the assembly comprising first and second electrodes and at least one of the electrodes containing a therapeutic agent to be administered, the control device comprising a bipolar electric power source for applying an electric current to the electrodes, which method comprises the electrical coupling and uncoupling of the control device and the assembly using a coupling device which allows electrically connecting the first electrode to a predetermined pole of the bipolar energy source and prevents the electrical connection of the first electrode to the other pole of the bipolar energy source.

Other characteristics and advantages of the present invention will emerge from the description given below, made with reference to the appended drawings, in which the identical elements are designated by the same reference numbers and among which
FIG. 1 is a perspective view of an electrical transfer device comprising a reusable control device and a separate unit containing a medicament, in the uncoupled state, the control device and the unit being able to be coupled in accordance with the present invention;
- Figure 2 shows a cross-sectional view of the device shown in Figure 1, which shows the control device and the unit containing the drug, in the coupled state;
- Figure 3 shows a perspective view of an electrical transfer device comprising a reusable control device and a separate unit containing a drug, in the uncoupled state, the control device and the unit containing the drug can be coupled in accordance with another embodiment of the present invention;
- Figure 4 shows a perspective view of an electrical transfer device comprising a reusable control device and a separate unit containing a drug, in the uncoupled state, the control device and the unit containing the drug can be coupled in accordance with yet another embodiment of the present invention;
- Figure 5 is a perspective view of another electrical transfer device in which the control device and the unit containing the medicament are in an uncoupled state, the unit containing the medicament being adapted to mesh by sliding with the control device;
- Figure 6 is a bottom view of the device of Figure 5, the control device and the unit containing the drug being in the coupled state;
- Figure 7 shows a cross-sectional view of the device shown in Figures 5 and 6, taken along line 7-7 in Figure 6 ;;
- Figure 8 is a perspective view of an electrical transfer device comprising a reusable control device and a separate unit containing a drug, in the uncoupled state, the control device and the unit containing the drug can be coupled in accordance with another embodiment of the present invention;
FIG. 9 is a plan view of a unit containing a medicament, according to another embodiment of the present invention;
- Figure 10 is a side elevational view of the drug-containing unit, shown in Figure 9;
- Figure 11 is a perspective view showing the coupling of a reusable control device to the unit containing the drug, shown in Figures 9 and 10;
- Figure 12 is a plan view of the coupled system shown in Figure 11 ;;
- Figure 13 is a plan view of a coupled electrical transfer system in accordance with another embodiment of the present invention;
- Figure 14 is a plan view of the drug-containing unit, shown in Figure 13;
- Figure 15 is a side elevational view of the drug-containing unit, shown in Figure 14, some parts being shown in section;
- Figure 16 is a plan view of another electrical transfer system according to the present invention;
- Figure 17 is a plan view of the drug-containing unit of the system shown in Figure 16; and
FIG. 18 is a perspective view showing the coupling of the reusable control device to the unit containing the medicament of the system shown in FIGS. 16 and 17.

 Figure 1 is a perspective view of an electrical transfer device 10 having a reusable electronic control device 12 which is adapted to be coupled to and uncoupled from a unit 30 containing a medicament. The control device 12 is reusable, that is to say it is suitable for use with a plurality of units 30 containing medicinal products, for example a series of identical and / or similar units 30 containing medication. On the other hand, the drug-containing unit 30 typically has a more limited lifespan and is capable of being discarded after use, i.e. when the drug contained in this unit has been administered or qu 'he's worn out.

 The controller 12 includes a housing 14, typically formed from a molded plastic.

Referring to FIG. 2, there is shown a sectional view of the device 10, the unit 30 of which containing the medicament is coupled to the control device 12. The control device 12 comprises a battery 20, for example a button battery, serving to supply power to the printed circuit board 22. The board 22 is conventionally formed and has conductive tracks structured so as to interconnect one or more components 24 located thereon. The electrical component (s) 24 control the amplitude, timing, frequency, configuration of the waveform, etc. of the electric current applied by the device 10. Although this is not critical for the present invention, the control device 12 comprises a push button switch 18, which can be used to start the operation of the device 10 and a device liquid crystal display (LCD) 16, which displays system information, such as magnitude of the current, dosage level, number of doses administered, elapsed time of application of the current, l intensity of the battery, etc., through a transparent lens 17.

 The drug-containing unit 30 is arranged to be detachably coupled to the control device 12, the upper part of the drug-containing unit 30 being adjacent to and facing the bottom of the control device 12. The part upper part of the unit 30 containing a medicament is equipped with the male parts of two connectors of the snap type, the male parts being studs 36 and 38 which extend upwards by pulling from the unit 30 containing the medicament. The bottom of the housing 14 is equipped with receptacles 26 and 28 (shown in FIG. 2), which are electrically connected to the outputs of the circuit located on the printed circuit board 22 by means of respective connectors 23 and 25 passing through the board. The receptacle 26 is positioned and dimensioned so as to receive the donor pad 36, and the receptacle 28 is positioned and dimensioned so as to receive the opposite pad 38. The receptacles 26, 28 and the pads 36, 38 are made of a material electrically conductor such as carbon or a metal (e.g. a metal such as silver, brass, stainless steel, platinum, gold, nickel, beryllium, copper, etc. or a metal-coated polymer (e.g. ABS with a silver coating). The donor pad 36 is electrically connected to the donor electrode 31, which, in turn, is electrically connected to the donor reservoir 32, which typically contains a solution of the therapeutic agent (e.g. a drug salt) The opposite pad 38 is electrically connected to the counter electrode 33 which, in turn, is electrically connected to the opposite reservoir 34, which typically contains a solution of a biocompatible electrolyte (e.g. a buffered saline solution ). The electrodes 31 and 33 are typically made of electrically conductive materials and are more preferably an anode electrode of silver (that is to say a silver foil or a polymer charged with silver powder) and a silver chloride cathode electrode. The reservoirs 32 and 34 typically comprise matrices formed of a hydrogel, which retain the solutions of the drug or electrolyte and are adapted to be placed in contact with the surface of the body (e.g. the skin) of a patient (not shown) in use. The electrodes 31, 33 and the reservoirs 32, 34 are isolated from each other by a membrane made of foam material 35. The lower surface (that is to say in contact with the patient) of the foam material element 35 is preferably covered with a skin contact adhesive. A removable coating 39 covers the surfaces which come into contact with the body, of the two reservoirs 32 and 34 and the surface covered with an adhesive of an element made of foam material 35 before the use of the unit 30. The removable coating 39 is preferably a polyester sheet coated with silicone. The removable coating 39 is removed when the device 10 is applied to the skin of a patient (not shown).

 Therefore, the donor pad 36 and the receptacle 26 include a snap-type connector, which electrically connects an output of the circuit located on the printed circuit board 22 and the donor electrode 32 and containing the drug. Similarly, the opposite stud 38 and the receptacle 28 include a snap-type connector, which electrically connects an output of the circuit located on the wafer 22 to the counter-electrode 34 containing the electrolyte. In addition to providing the electrical connections described above, the two snap-in connectors also provide a separable (that is to say non-permanent) mechanical connection between the unit 30 containing the medicament and the control device 12.

 The two circuit outputs located on the circuit board 22 have different polarities, that is to say that one output is positive and is adapted to be connected to the anode electrode in the unit 30 containing a drug, while the other output of the circuit is negative and is adapted to be connected to the cathode electrode in the unit 30 containing a drug. It is important to ensure that the connections of the two electrodes in the unit 30 containing a drug are connected to the outputs of the controller having the correct polarity, since if the connections were reversed (i.e. if the positive output of the circuit is connected to the cathode electrode and that the negative output of the circuit is connected to the anode electrode), a small amount of drug would be administered by electrical transfer, if any amount of drug is administered. The present invention ensures connections with correct polarity by making it essentially impossible to make connections with incorrect (i.e., reverse) polarity between the controller 12 and the drug-containing unit 30.

As is clearly shown in FIGS. 1 and 2, the diameter of the pad 36 is greater than the diameter of the pad 38. Similarly, the inside diameter of the receptacle 26 is greater than the inside diameter of the receptacle 28. Preferably, the inside diameter of the receptacle 28 is less than the diameter of the stud 36, so that it is impossible to insert the stud 36 in the receptacle 28.

 According to this embodiment of the present invention, the pads 36 and 38 have different dimensions. Those skilled in the art will note that apart from the fact that the dimensions (that is to say the diameter) of the studs 36, 38 are chosen to be different, the shapes (for example the shape in cross section) can be made sufficiently different or another form) of pads 36, 38 to ensure that only connections with correct polarity can be made between the controller 12 and the unit 30 containing a drug.

 Other means for ensuring connections with correct polarity between a drug-containing unit which has a donor electrode and a counter electrode and a controller are shown in Figure 3. A reusable controller 12 ' is adapted to be removably connected to one or more units 40 containing medicaments. The unit 40 containing a medicament comprises a donor pad 42 which performs a function similar to the donor pad 36 shown in FIGS. 1 and 2. However, unlike the unit 30 containing a medicament, the unit 40 containing a medicament comprises a receptacle 44 which is electrically connected to the counter electrode (not shown) in the unit 40 containing a medicament. The receptacle 44 is arranged so as to mesh with a stud (not shown) which extends from the underside of the control device 12 '. This is why the unit 40 containing a medicament contains both a male part (that is to say the stud 42) of a first snap connector and a female part (that is to say receptacle 44) of a second snap connector. The two snap-in connectors establish both an electrical coupling and a mechanical coupling of the unit 40 containing a medicament to the control device 12 ′.

Thanks to the presence of a male connector and a female connector both in the unit 40 containing a medicament and in the control device 12 ′, the coupling of the control device 12 ′ to the unit 40 containing a medicine can only be done in one way, that is, with connections with the correct polarity.

 Referring now to Figure 4, there is shown an electrical transfer device comprising a reusable electronic control device 12 "and a unit 50 containing a drug. Unlike the device 10 shown in Figures 1 and 2, the control device reusable 12 "has a third receptacle of the snap type, capable of receiving a third stud 56 located on the unit 50 containing a medicament. Consequently, the pads 52 and 54 assume essentially the same function as the pads 36, 38 in the device 10.

The positioning of the third stud 56 as well as the positioning of the receptacle (not shown) for the stud 56 in the bottom of the control device 12 "must not be equidistant from the studs 52 and 54, assuming that the studs and the receptacle all have the same dimensions and the same shape. By positioning the pad 56 closer to the pad 54 than to the pad 52, there is only one way of connecting the unit 50 containing the medicament to the control device 12 ", this i.e. with connections with correct polarity.

 Another way to ensure connections with correct polarity between a controller 62 and a drug-containing unit 80 is shown in Figures 5 to 7. The electrical transfer device 60 includes a reusable controller, which is adapted to be successively coupled to a plurality of identical or similar units 80 containing medicaments. The body of the control device 62, which is shown in section in FIG. 7, is shown in the form of a solid cross section to simplify the drawing. Those skilled in the art will note that the control device 62 contains a source of electrical energy and a current control circuit, similar to those shown in FIG. 2. The control device 62 has two circuit outputs 68 and 70, which must establish an electrical connection respectively with electrode contacts 82 and 84, in order to guarantee an electrical connection with correct polarity between the electrodes 88 and 90 and the control device 62. The control device 62 comprises a clasp 64. The unit 80 containing the medication can be inserted by sliding into the space between the clasp 64 and the body of the control device 62. A stud 66 engages in a notch 86 formed in the unit 80 containing the medication, when the unit 80 containing the medicament slides to be brought into position and blocks the position of the unit 80 containing the medicament relative to the control device 62 so that the output 68 of the circuit touches the contact of the electrode 82 and that the output 70 of the circuit touches the contact of the electrode 84. Apart from the meshing by sliding between the unit 80 containing the medicament and the control device 62, there is also provided a snap-type connector, which guarantees a secure, but removable mechanical connection between the unit 80 containing the medicament and the control device 62. The snap-in connector comprises a receptacle 72 located in the body of the control device 62 and a stud 92 located on the unit 80 containing the drug.

The stud 92 snaps into the receptacle 72 as is best represented in FIG. 7.

 Another means of guaranteeing connections with correct polarity between a control device 112 and a unit 130 containing the medicament is shown in FIG. 8. The electric transfer device 110 comprises a reusable control device 112, which is capable of being successively coupled to a plurality of identical or similar units 130 containing a medicament. The control device 112 contains a source of electrical energy and a current control circuit similar to the control device 12 in FIGS. 1 and 2. The control device 112 has two receptacles (not shown in FIG. 8) suitable for mesh with studs 136 and 138 in the unit 130 containing the medicament.

Unlike the device shown in Figures 1 and 2, the pads 136 and 138 have the same dimensions.

To ensure that the pads 136 and 138 are snapped into the correct receptacles at the underside of the control device 112, a protruding element 134 is provided on the surface of the unit 130 containing the drug, which is in abutment against the underside of the control device 112. As shown in FIG. 8, the projecting element 134 has a square shape which allows it to engage in a square-shaped hole (not shown in FIG. 8) on the underside of the control device 112. Those skilled in the art will note that the protruding element 134 can have any number of different shapes, such as a triangular, rectangular, circular shape, a crescent shape, etc. and should preferably protrude a sufficient distance from the surface of the drug-containing unit 130 to ensure that the stud 138 cannot engage the incorrect receptacle in the controller 112 in the event that the patient tries to couple the drug-containing unit 130 to the controller with connections of incorrect polarity. Preferably, the projecting element 134 is provided on a bar-shaped element 132 having increased rigidity. It is important that the projecting element 134 is placed on the bar 132 in a location other than the center between the two studs 136 and 138 so as to guarantee that only a polarity (that is to say correct) connection can be made between the unit 130 containing the medicament and the control device 112.

 Referring now to Figures 9 to 12, there is shown another embodiment of an electrical transfer device 210 comprising a control device 212 which is adapted to be successively coupled to a plurality of identical or similar units 230 containing medication. As is better visible in FIGS. 9 and 10, the unit 230 containing the medicament comprises a pair of studs 236, 238 adapted so as to engage in receptacles (not shown) formed in the underside of the control device 212. The studs 236, 238 are preferably arranged on an element in the form of a rigid bar 232. Similarly, a projecting element in the form of a wedge 234 is provided on the element in the form of a bar 232. As this is better visible on the Figures 11 and 12, the controller 212 has a wedge-shaped opening 235 having dimensions and a shape which are adapted for coupling with the wedge-shaped protruding member 234. The protruding member 234 and the opening 235 provide a visible latch and key mechanism, which visually guides the user in coupling the control device 212 to the unit 230 containing the drug, with the correct polarity connections in If it is necessary to have additional confirmation, the control device 212 can be made in such a way that the projecting element 234 meshes with and closes a switch contained in the control device 212, which makes it possible to closing a circuit path thereby allowing the device to apply electrical transfer control current to the patient.

When the protruding member 234 is removed from the opening 235, the switch is opened and administration of the drug by electrical transfer is not possible. Referring now to Figures 13 to 15, there is shown an electrical transfer device 310 comprising a reusable control device 312 adapted to be coupled to a series of identical or similar units 330 containing drugs. The drug containing unit 330 has a receptacle 334 which is adapted to receive and mesh with one end of the control device 312. The snap connections are provided in a position which ensures that the control device 312 can be coupled electrically to the unit 330 containing the medicament, only when one of the two ends of the control device 312 is inserted into the receptacle 334. Otherwise, the receptacle 334 can be dimensioned and / or shaped so as to accept only one from both ends of the control device 312.

Selective engagement of the control device 312 can be achieved by any number of known means including an appropriate modification of the dimensions and / or the shape of the respective ends of the control device 312 and / or by providing a certain type of suitable mechanism. with key (not shown). In this way, only one end of the control device 312 can be engaged in the receptacle 334, which guarantees connections with correct polarity between the control device 312 and the unit 330 containing the medicament, using the two snap-in connectors of the type described above.

 Referring now to Figures 16-18, there is shown another embodiment of the present invention. Like the system shown in FIGS. 13 to 15, the electrical transfer device 410 comprises a control device 412 which is adapted to be inserted in a single orientation inside the receptacle 434 provided on the unit 430 containing the medicament, due to the dissimilar shapes of the ends (one end is flat and the other is rounded) of the control device 412 and of the receptacle 434. By shaping the receptacle 434 so that it "adapts" to the shape of only 1 At one of the two ends of the control device 412, only a polarity (that is to say correct) connection can be established between the control device 412 and the unit 430 containing the medicament.

 According to an advantageous embodiment, the invention provides a device of the type described above, characterized in that the coupling device comprises a first coupler comprising male and female coupling elements, the first electrode being electrically connected to the a power source when the coupling elements of the first coupler are coupled, and a second coupler having male and female coupling elements; the second electrode being electrically connected to the power source when the coupling elements of the second coupler are coupled, and in that the female coupling element of the first coupler is positioned on the control device and the element d the female coupling of the second coupler is positioned on the assembly.

 According to another advantageous embodiment, the invention provides a device of the type described above, characterized in that the coupling device comprises a first coupler having male and female coupling elements, the first electrode being electrically connected to the energy source when the coupling elements of the first coupler are coupled, and a second coupler having male and female coupling elements, the second electrode being electrically connected to the energy source when the coupling elements of the second coupler are coupled, the coupling elements being positioned so as to obtain an overhanging orientation / without alignment of the control device relative to the assembly when the male coupling element of the first coupler is coupled to the element female coupling element of the second coupler and that the female coupling element of the first coupler r is coupled to the male coupling element of the second coupler.

 Although in the preceding detailed description, several embodiments have been described making it possible to guarantee a coupling with correct polarity of an electric transfer control device to a unit containing a medicament comprising a donor electrode and a counter electrode, it will be understood that the description given previously is given solely by way of illustration and has no limiting character for the invention described. It will be noted that it is possible for a specialist in the art to modify the materials, the dimensions, the type and the shape of the couplers described here or to include or eliminate different elements, while remaining within the scope of the present invention.

Claims (27)

 1. An electrical transfer device (10) for administering a therapeutic agent through a surface of the body of a patient, this device (10) comprising an assembly (30) having first and second electrodes (31,32 and 33,34), at least one of which contains the therapeutic agent to be administered, and a control device (12) having a bipolar electrical energy source (20) for applying an electric current to the electrodes (31, 32 and 33,34), as well as a coupling device (36,26 and 38,28) for electrically coupling and uncoupling the control device (12) and the assembly (30), this device being characterized in that '' It includes a coupling device which electrically connects the first electrode (31,32) to a predetermined pole of the bipolar energy source (20) and prevents the electrical connection of the first electrode (31,32) to the other pole of the bipolar energy source (20).  2. Device according to claim 1, characterized in that the coupling device allows the electrical connection of the second electrode (33,34) to the other pole of the bipolar energy source (20) and prevents the electrical connection of the second electrode (33,34) at the predetermined pole of the bipolar energy source (20).  3. Device according to claim 1 or 2, characterized in that the predetermined pole of the bipolar energy source (20) is a positive pole, the electrode electrically connected to the predetermined pole is an anode and the therapeutic agent is cationic .  4. Device according to claim 1 or 2, characterized in that the predetermined pole of the bipolar energy source (20) is a negative pole, the electrode electrically connected to the predetermined pole is a cathode and the therapeutic agent is anionic .  5. Device according to any one of claims 1 to 4, characterized in that the coupling device comprises at least one pair of snap-on connectors, electrically conductive (36,26 and 38,28).  6. Device according to claim 5, characterized in that the snap connectors (36,26 and 38,28) are made of a material chosen from the group comprising a metal and carbon.  7. Device according to claim 6, characterized in that the metal is chosen from the group comprising silver and stainless steel.  8. Device according to any one of claims 1 to 7, characterized in that the coupling device also establishes a mechanical coupling of the assembly (30) to the control device (12).  9. Device according to any one of claims 1 to 8, characterized in that the coupling device comprises a first coupler (36, 26) comprising a male coupling element (36) and a female coupling element (26 ), the first electrode (31,32) being electrically connected to the power source (20) when the coupling elements (32,26) of the first coupler are coupled, and a second coupler (38,28) having a male coupling element (38) and a female coupling element (28), the second electrode (33,34) being electrically connected to the power source (20) when the coupling elements (38,28) of the second coupler are coupled, and in that the male coupling element (36) of the first coupler cannot be coupled to the female coupling element (28) of the second coupler.  10. Device according to any one of claims 1 to 8, characterized in that the coupling device comprises a first coupler having first and second couples (52,54) of male and female coupling elements, the first electrode (31,32) being electrically connected to the power source (20) when the two pairs (52,54) of male and female coupling elements are coupled, and a second coupler comprising a third couple (56) d 'male and female coupling elements, the second electrode being electrically connected to the power source when the elements of the third pair of male and female coupling elements are coupled, and in that the positioning of the three pairs of male and female coupling elements only allow an electrical connection between the assembly (50) and the control device (12 ").  11. Device according to claim 10, characterized in that the first and second pairs of coupling elements must both be coupled to electrically connect the first electrode to the energy source.  12. Device according to claim 10, charac terized in that only the elements of the first pair of coupling elements must be coupled so as to electrically connect the first electrode to the power source, the second pair of elements d coupling establishing a mechanical coupling between the assembly and the control device.  13. Device according to any one of claims 1 to 8, characterized in that the coupling device comprises a first coupler (44) having male and female coupling elements, the first electrode (31,32) being electrically connected to the power source (20) when the coupling elements of the first coupler (44) are coupled, and a second coupler (42) having male and female coupling elements, the second electrode (33,34) being electrically connected to the power source (20) when the coupling elements of the second coupler (42) are coupled, and in that the male coupling element of the first coupler is positioned on the control device (12 ') and the male coupling element (42) of the second coupler is positioned on the assembly (40).  14. Device according to any one of claims 1 to 8, characterized in that the coupling device comprises a first coupler comprising male (42) and female coupling elements, the first electrode (31,32) being electrically connected at the power source (20) when the coupling elements of the first coupler are coupled, and a second coupler having male and female coupling elements (44); the second electrode (33,34) being electrically connected to the energy source (20) when the coupling elements of the second coupler are coupled, and in that the female coupling element of the first coupler is positioned on the control device (12 ') and the female coupling element (44) of the second coupler is positioned on the assembly (40).  15. Device according to any one of claims 1 to 8, characterized in that the coupling device comprises a first coupler having male (236) and female coupling elements, the first electrode (31,32) being electrically connected to the power source (20) when the coupling elements of the first coupler are coupled, and a second coupler having male (238) and female coupling elements, the second electrode (33,34) being electrically connected to the power source (20) when the coupling elements of the second coupler are coupled, the coupling elements being positioned so as to obtain an overhanging orientation / without alignment of the control device (212) relative to the assembly (230) when the male coupling element (236) of the first coupler is coupled to the female coupling element of the second coupler and the female coupling element of the pr The first coupler is coupled to the male coupling element (238) of the second coupler.  16. Device according to any one of claims 1 to 15, characterized in that the coupling device comprises a projecting element located either on the control device (112) or on the assembly (130).  17. Device according to claim 16, characterized in that the projecting element engages in an opening located on the other of the units, chosen between the assembly (130) and the control device (112), respectively.  18. Device according to any one of claims 1 to 17, characterized in that the coupling device comprises a receptacle (334,434) present in the assembly (330,430) and in that the control device (312,412) is adapted for engage in the receptacle (334,434) only in one orientation.  19. Device according to any one of claims 1 to 18, characterized in that the bipolar energy source (20) comprises a battery.  20. Device according to any one of claims 1 to 19, characterized in that the assembly (30) is designed to be discarded after a single use.  21. Device according to any one of claims 1 to 20, characterized in that the control device (12) is adapted to be successively coupled to a plurality of assemblies (30).  22. Method for electrically coupling and decoupling an assembly (30) to a control device (12), the assembly (30) comprising first and second electrodes (31,21 and 33,34) and at least one of electrodes containing a therapeutic agent to be administered, the control device (12) comprising a bipolar electrical energy source (20) for applying an electric current to the electrodes (31,32 and 33,34), which method comprises coupling and the electrical decoupling of the control device (12) and the assembly (30) using a coupling device (36, 26 and 38, 28) which makes it possible to electrically connect the first electrode (31, 32 ) to a predetermined pole of the bipolar energy source (20) and prevents the electrical connection of the first electrode (31,32) to the other pole of the bipolar energy source (20).  23. The method of claim 22, characterized in that the coupling of the control device (12) and the assembly (30) is obtained by means of an electrically conductive snap connector (36,26).  24. Method according to claim 22, characterized in that the coupling of the control device (12) and of the assembly (30) is carried out by means of a couple of electrically conductive snap connectors (36, 26 and 38, 28).  25. Method according to any one of claims 22 to 24, characterized in that the bipolar energy source (20) comprises a battery.  26. Method according to any one of claims 22 to 25, characterized in that the assembly (30) is discarded once the latter is decoupled from the control device (12).  27. Method according to any one of claims 22 to 26, characterized in that the control device (12) is coupled in turn to a plurality of assemblies (30).