JP2002513655A - Percutaneous dosing device by iontophoresis - Google Patents

Abstract

(57) [Summary] This iontophoretic transdermal administration device comprises: an assembly (A) including at least an electrode and a counter electrode mounted on a reservoir (37) loaded with the drug; an electronic circuit; A battery (35), wherein the electronic circuitry allows for the generation of a therapeutic current from the energy provided by the battery, the current passing between the two electrodes and the reservoir and the patient's skin (41). ), When applied to them, wherein the electronic circuit communicates a time program of administration of the drug to the battery discharge versus time from a fully charged state to near depleted state of the battery. Means to fit the curve.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] The present invention relates to a transdermal administration device by iontophoresis.

[0002] A device of this type, in particular in the French patent specification 9604735 in the name of the Applicant, allows the application to painless patients and a fully dosed medical procedure. The latter feature is particularly important if the drug used can be harmful to the patient's health if overdosed.

Devices of the type described in the above mentioned documents are designed to be reused a certain number of times. For this purpose, for example, the device described in the above-mentioned document comprises a programmable electronic module for controlling the treatment duration of varying length for a given drug as required by the patient. Further, in this reference, the module can be separated from the drug assembly of the electrode containing the drug, and can be matched to the other assembly of the electrode containing the other drug.

In a certain number of standard treatments, for example in local anesthesia, a single transdermal administration of the drug by iontophoresis is sufficient. The duration of treatment, which is typically 15 to 90 minutes, is fixed for a given drug. At this time, all the above-mentioned possibilities of variable programming or changing the medicine are unnecessary.

[0005] For this type of procedure, a simpler device is therefore sufficient. this is,
In combination with the unique and isolated features of the procedure, it guides the consideration of devices that are to be destroyed after using, for example, conventional bandages.

In this context, it is important to manufacture the device cheaper, and it is therefore important to manufacture the electronic control means of the procedure and the structure of the device itself as simply as possible.

In particular, it is essential to remove the complexity of the means currently used to trigger and stop the procedure.

[0008] It is an object of the present invention to provide an arrangement for integrating these restrictions.

[0009] This object of the present invention will become apparent after reading the following, and is a device for transdermal administration by iontophoresis, comprising an electrode mounted on a reservoir loaded with said drug and a counter electrode. At least including an assembly, an electronic circuit, and a battery, wherein the electronic circuit allows for the generation of a therapeutic current from the energy provided by the battery, the current storing the therapeutic current between the two electrodes. Flow through the vessel and the patient's skin when applied to them, and the electronic circuitry programs the timed program of administration of the drug from the fully charged state to near exhaustion of the battery. This is achieved by using a device comprising means to fit the discharge versus time curve of

According to a feature of the invention, the means comprises a current generator powered by a cutting power supply and controlled by a voltage proportional to the voltage measured at the terminals of the battery.

[0011] These features allow the production of iontophoretic transdermal dosage devices intended for single use at a lower cost.

[0012] Other features and advantages of the present invention will become apparent after reading the following description of the accompanying drawings, given by way of example only.

FIGS. 1 and 2 show an electrode assembly A, which is intended to be provided in a device according to the invention. The body of this assembly is cut, for example, Bendflex or Kapton, to essentially form a strip 1 having a first rounded end 2 and a second rounded end 3. (
It is made of a flexible material such as Kapton®.

The strip comprises a fold line 4 transverse to its length, located at the junction of the first rounded part 2 with the rest of the strip.

According to a first embodiment of the treatment trigger means, said strip additionally has a junction of the second rounded portion 3 with the rest of the strip, shown in broken lines in FIGS. 1 and 2. A slit 5 traversing with respect to its length. The use of this slit will become clear in the rest of this description.

The strip 1 is provided with a double-sided printed circuit 6 manufactured, for example, by photolithography. On an essentially rectangular portion of the side A of the strip, opposite one side for contacting the patient's skin, the circuit 6 comprises a plurality of contact blocks 7 for receiving electronic components, The circuit 6 and the assembly of these components form the electronic circuit of the device according to the invention. The contact blocks 7 are connected to each other by conducting the tracks, some of the tracks 8 being arranged on the face A1 of the strip and the other tracks 9 being arranged on the face A2 of the strip. The metallized holes 10 make it possible to ensure an electrical contact between the tracks arranged in the plane A1 and the tracks arranged in the plane A2.

The two conducting tracks 11, 12 arranged on the face A 1 of the strip 1
The two contact pads 13, 14 were connected, and these two contact pads 13, 14 themselves were arranged on the plane A2 of the strip via two metallized holes (
(See FIG. 2) Connected to the electrode 15 and the counter electrode 16 respectively. For example, an electrode 15, which can have a circular profile, is centered with respect to the first rounded end 2 of the strip. For example, a counter electrode 16, which can have a rectangular outer shape, is arranged between the part of the surface A2 where the conducting tracks 9 are arranged and the second rounded end 3 of the strip. These two electrodes can be manufactured in a standard manner by the deposition of a conducting material by silkscreen.

A third conducting track 17 arranged along an edge 18 of the face A 1 of the strip 1
One of the contact blocks 7 is brought into contact with a metallized hole 19 located at the junction of the second rounded end 3 with the rest of the strip. In the plane A2 of the strip, the conducting track 20 is provided with a metallized hole 19 in the contact block 25.
And the contact block 25 itself is connected via a metallized hole to a contact pad 26 located at the face A1 of the strip and centered with respect to the second rounded end 3. The distance d1 between the contact pads 14 and 26 is essentially equal to twice the distance of the pad 26 at the junction of the second rounded end 3 with the rest of the strip.

FIG. 3 shows an adhesive support B for securing the electrode assembly A to the patient's skin.

The adhesive support is formed into a standard with a simple medical surface so as to essentially form a strip 27 with a first rounded end 28 and a second rounded end 29. Cut out from sticky material.

The width of the strip 27 is greater than or equal to the width of the strip 1, for example, twice the width of the strip 1. The length of the strip 27 is essentially equal to the length of the strip 1.

The strip 27 has a first transverse strip 30 and a second transverse strip 31, which traverse with respect to the length of the strip 27 and the rest of said strip at a second rounded end 28. Are essentially located at the junctions with the parts. Essentially equal to the width of the strip 1 and the distance d separating them
2 is slightly shorter than the distance d3 separating the fold line 4 from the counter electrode 16. Further, note that the first slit 30 is connected to the edge of the strip 27 by a fold line 32.

According to a first embodiment of the treatment trigger means, the strip 27 also comprises a third transverse slit 33, which traverses with respect to the length of the strip 27 and has a second rounded shape. And has a width similar to the width of the slit 5 formed in the strip 1. From the second slit 31 to the third slit 3
The distance d4 to 3 is essentially equal to half d1. As shown in FIG.
Is indicated by a broken line. The use of this slit 33 will become apparent in a subsequent part of the present invention.

FIG. 4 and FIG. 5, which shows the device according to the invention on the skin 41 of a patient, show how the electrode assembly A and the adhesive support B work together. . These figures also show a specific number of devices that must be described.

An electronic component 34 is mounted in the zone where the contact block 7 is located on the face A 1 of the electrode assembly.

The two terminals of the battery 35 are brought into contact with the pads 14 and 26, respectively, by creasing the second rounded end 3 of the strip 1 towards the inside of the plane A1. The proximity of the conducting track 17 to the edge 18 of the strip 1 prevents contact with the battery and thus eliminates any risk of a short circuit.

According to the first embodiment of the treatment trigger means, the blade 36 made of an insulating material
Is inserted between the battery 35 and the contact pad 26. This blade protrudes outwardly through the slit 5 of the strip 1.

FIGS. 4 and 5 comprise a first reservoir 37 and a second reservoir 38, which are mounted on the electrode 15 and the counter electrode 16, respectively. These reservoirs are, for example, loaded with a substance, i.e. a solution containing the drug to be administered for the reservoir mounted on the counter electrode, and a neutral solution such as NaCl for the reservoir mounted on the electrode. Layer. These reservoirs are removed from the patient's skin 41 by the permeable membranes 39, 40.
And protect them during storage by a shell (not shown).

The electrode assembly A prepared as described above is inserted into the slit 3 of the adhesive support B.
0 and 31 so that only the electrode component 34 appears on the side of the support B that is not covered with the adhesive.

The fold lines 4 and 32 coincide and, in the first embodiment of the treatment trigger, the blade 36 intersects the slit 33 of the adhesive support B.

FIG. 5 shows that only the perimeter of the adhesive support B is attached to the surface of the patient's skin, and in addition, this support comprises a face A 1 of the first rounded end 2 and a second rounded end. Attached to the surface A2 of the end 3 provided.

FIGS. 6 and 7 show the device according to the invention in a storage configuration.

The first rounded ends 6 and 7 of the electrode assembly A and the adhesive support B, which are connected together by gluing, are connected to the surface A 1 of the electrode assembly A with respect to the fold lines 4 and 32. And fold each one. In this way, the size of the device is reduced. Furthermore, the electronic circuit component 34 is protected in this way during storage and transport.

According to a first embodiment of the treatment trigger means not shown in FIGS. 6 and 7, the blade 36 points outwards and traverses the slits 5 and 33, as is evident in FIGS. .

According to a second embodiment of the treatment trigger means shown in FIGS. 6 and 7, a blade 45 of insulating material placed between the battery 35 and the contact pad 26 points directly towards the electronic component 34. . This blade is fixed to the adhesive surface of the first rounded end of the adhesive support 34, so that opening this rounded end always has the effect of moving the blade from its initial position, , So that electrical contact between the battery 35 and the pad 26 is achieved.

FIG. 8 is a diagram which makes it possible to understand the principle of operation of the electronic surface of the device according to the invention.

A battery 35 supplies power to this circuit from the time the blade 36 or 45 is removed.

The circuit essentially comprises a current generator 46 powered by a cutting power supply 47 and controlled by a midpoint 48 of a divider bridge 49 consisting of resistors 50 and 51. Both cutting power supply 47 and bridge 49 are powered by battery 35
From the voltage V _batt given by

The current generator 46 generates a “therapeutic” current I _th for flowing the patient's skin between the electrode 15 and the counter electrode 16.

The control voltage 46 of the current generator 46, which is proportional to the voltage V _batt at the terminal of the battery, is compared with a reference voltage using a comparator 42. If the control voltage drops below this threshold voltage, the comparator commands the shut down of the current generator and the procedure ends.

In addition, the threshold and comparator 52 may be connected, for example, to a signaling device comprising an electroluminescent diode, said signaling device indicating when the process has been completed.

The control overtime of the electronic circuit is ensured by discharging the battery 35 from a fully charged state to a state near exhaustion.

In standard practice, the voltage transmitted by battery 35 cannot exceed a few volts. However, transdermal dosing by iontophoresis often requires much higher voltages, on the order of tens of volts (typically on the order of 25-30 volts). Supplying such a voltage to the current generator 46 is the role of the cutting power supply.

The current generator 46 provides a therapeutic current I whose intensity is essentially a linear function of the control voltage V. _th Supply. According to the present invention, this control voltage is
The control voltage V itself is given by way of the battery, given at point 48.
Voltage V_battIs a fraction defined by the division ratio of the bridge 49.

Next, the voltage V changes over time according to a function V (t), and a graph of this function shows a characteristic V _batt representing the change over time of the voltage provided by the battery during continuous operation of the voltage. It is essentially parallel and consistent with the graph in (t).

Of course, the intensity I _{th of the} current supplied by the current generator 46 itself evolves with respect to time to follow the change with time of the voltage provided by the battery in continuous operation.

FIG. 9 allows a better understanding of this operating principle. This figure shows GOULD 6C
FIG. 4 represents the discharge characteristic curve of a battery of type 100, which is an example of a battery that can be used to power the electronics of the device according to the invention.

The horizontal axis gives time by hour and the vertical axis shows the voltage V at the terminals of the battery. _batt FIG. 9 shows that V_battDetermines how long it takes to reach a given value
To be able to

As can be seen, this curve consists of three distinctly separate parts. First part 5
3 shows a drop in V _batt of about 1 volt in 5 minutes, which corresponds to a transition of V _batt from the electromotive force at the time of exhaustion to the voltage at the time of charging.

The second part 54 of the curve, which lasts about 3 hours, has the shape of a plateau located at about 4.5V.

The third portion 55 of the curve, where V _batt falls relatively sharply, corresponds to a decrease in battery function.

This shape of the battery's discharge characteristics can also be seen in the change over time of the therapeutic current I _th supplied by the current generator 46 as shown by the graph I _th (t) in FIG. 10, the graph of FIG.
, 54 and 55, respectively.

Initially, the initial excess intensity, indicated by the portion 53 ′ of the curve, indicates a sharp decrease (within about 5 minutes) in the resistance of the patient's skin, and thus a topography suitable for the application of iontophoretic procedures. Enable preparation.

Next, the portion 54 ′ of the plateau corresponds to the application of said therapeutic current.

Finally, the portion 55 ′ of the curve corresponds to the end of the procedure, and a simultaneous decrease in V _batt will cause the threshold generator, such as the comparator 52, to stop the operation of the current generator 46. Bring.

As can be readily appreciated, the validity of the application of the therapeutic current to a patient can be completely pre-determined by selecting a drug / battery / threshold level combination that is appropriate for each particular case. Can be determined.

The procedure for using the device according to the invention follows directly from the above description.

First, the user removes the shell protecting the first reservoir 37 and the second reservoir 38, then opens the first rounded end 28 of the rounded support 27, and then Next, the device according to the invention is fixed to the skin of the patient by means of an adhesive strip 27, and then, in the case of the first embodiment of the device according to the invention, the blade 36 is removed (second embodiment of the device according to the invention). In this case, the blade 45 has already been removed while opening the first rounded end 28), and finally, when the end of the procedure is signaled, the user can remove the entire device from the patient's skin. And discard it.

Here, the above-described invention allows the manufacture of a transdermal dosage device by iontophoresis, whose design is greatly simplified, its manufacturing cost is therefore low and can be discarded after use. You can understand.

In addition, the use of this device is very simple, and one could envisage the possibility of being used by the patient himself.

Of course, the invention is not limited to the above-described embodiments shown here, given only by way of example. Therefore, for example, the control regarding the stop time of the electronic circuit can be performed by the timer.

[Brief description of the drawings]

FIG. 1 is a top view of an electrode assembly of the device according to the invention.

FIG. 2 is a bottom view of the assembled part of the electrode.

FIG. 3 is a top view of an adhesive support for securing an electrode assembly to a patient's skin.

FIG. 4 is a top view of the treatment trigger device according to a first embodiment of the electrode assembly located at the adhesive support, in a folded position.

FIG. 5 is a side view of the device shown in FIG. 4 on a patient's skin.

FIG. 6 is a top view according to a first embodiment of the treatment trigger device, in an open position, of the electrode assembly located on the adhesive support.

7 is a side view of the device shown in FIG.

FIG. 8 illustrates the operation of the electronic surface of the device according to the present invention.

FIG. 9 shows the discharge characteristics of a battery capable of supplying power to the electronic circuit of the device according to the claims.

FIG. 10 shows the change over time of the current applied to the patient's skin.

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Claims (8)

[Claims] A device for transdermal administration by iontophoresis, comprising at least an electrode (15) mounted on a reservoir (37) loaded with said drug and a counter electrode (16). And an electronic circuit, and a battery (35), wherein the electronic circuit enables the generation of a therapeutic current (I _th ) from the energy provided by the battery, the current _flowing between the two electrodes. The reservoir and the patient's skin (41)
In the device flowing through when applied to them, the electronic circuit may program the time program of the administration of the drug by discharging the battery from a fully charged state to a near-depleted state of the battery. Means for adapting to a time curve (46, 47, 49)
An apparatus comprising: 2. A device according to claim 1, wherein said means is powered by a cutting power supply (47) and is proportional to a voltage (V _batt ) measured at a terminal of said battery (35). V) A current generator controlled by V). 3. The apparatus according to claim 2, wherein the electronic circuit additionally operates the cutting power supply (47) when the control voltage (V) reaches a predetermined threshold. A device comprising a threshold device (52) for stopping. 4. Apparatus according to claim 1, 2 or 3, wherein the electronic circuit comprises a device for signaling the cessation of the procedure. 5. The device as claimed in claim 1, wherein the electrode assembly (A) is provided with a printed circuit and has a simple surface with an adhesive support (5).
A device characterized in that it comprises a sheet of flexible material for acting in cooperation with B). 6. The apparatus according to claim 5, wherein the electrode assembly (A) is an electrode assembly.
And the adhesive support (B) are cut to form essentially a first strip (1) and a second strip (27), wherein the lengths of these two strips are essentially equal Then, the width of the second strip (27) is adjusted to the first strip (1).
), And inserting said first strip (1) into two slits (30, 31) formed transversely to said second strip (27) with respect to its length;
The portion of the first strip (1) located between the two slits (30, 31) is located on the side of the second strip (27) that is not covered with the adhesive, and The first and second portions of the first strip (1) located outside (30, 31) are located on the side of the second strip (27) covered with the adhesive. Characteristic device. 7. The device according to claim 6, wherein said two slits (30, 3).
1) The portion of the first strip (1) located between the patient's skin (41)
A plurality of electronic components (34) connected to the printed circuit (6) by a plurality of contact blocks (7) on a surface (A1) opposite to a surface (A2) for making contact with the printed circuit (6) to form the electronic circuit; An apparatus comprising: 8. The device according to claim 6, wherein said two slits (3).
0, 31), the first and second portions of the first strip (1) are located on the surface (A2) for contacting the patient's skin (41) at the surface (A2). A device comprising a counter electrode (16).