FR2599976A1 - Therapeutic, portable, completely self-contained, transdermic device provided with at least one member forming a needle or tip which gets through the cutaneous barrier - Google Patents

Abstract

The invention relates to a transdermic therapeutic device. This device comprises an element 2 forming a reservoir for a therapeutic agent, provided with means 3 allowing the agent to be supplied over a prolonged period of time during extended application onto the dermis 4 of a living being, and is characterised in that the supply means 3 comprise at least one member 6 forming a needle or tip which large enough to get through the cutaneous barrier. This device makes it possible to convey any therapeutic agent, whatever its capacity for getting through the cutaneous barrier.

Description

Portable, completely autonomous transdermal therapeutic device, provided with at least one needle or tip-forming organ crossing the skin barrier.

 The present invention essentially relates to a portable, completely autonomous, transdermal therapeutic device provided with at least one organ forming a needle or point crossing the skin barrier.

 Numerous transdermal therapeutic devices are known for the supply over an extended period of time of at least one agent with therapeutic activity.

Known transdermal therapeutic devices comprise a reservoir element capable of means allowing the supply of said agent with therapeutic activity during the application of said device to the intact dermis of a living being. We can cite the documents ALZA FR-A-2'143 564; FR-A-2 508 318; FR-A2 158 201; FR-A-2 121 831; FR-A-2 299 853; FR-A-2 527 450
FR-A-2,545,357; EP-A1-0,010,876; EP-A3-0 033 615; EP-A2-O 052 916.

 All known devices are applied to the intact dermis and allow effective trans-dermal therapeutic treatment only for therapeutic agents in limited numbers which are capable of crossing the skin barrier.

 On the other hand, it is known from the applicant's prior patents FR-2 232 331; FR-2 309 242; FR-2 348 709 and FR-2 390 175, various devices suitable for loco-regional treatments (T.L.R.>.

These latter devices allow the skin barrier to be crossed by the use of # intradermal or even subcutaneous needles or points. These devices carry out an injection of the treatment substances # practically instantaneously or in a few seconds, this injection being carried out by the practitioner.

 The present inventors have now been able to observe that the action of these substances could be unexpectedly improved by the injection of these substances for an extended period of time of a few minutes, if possible a few hours, and even better for one or more days.

 Therefore, the present invention relates to a new technical problem consisting in the supply of a solution making it possible to provide a transdermal therapeutic device usable for any type of agent with therapeutic activity for an extended period of time, this device being portable by the patient in a completely autonomous way.

 This technical problem is solved for the first time by the present invention.

 Thus, the present invention provides a portable, completely autonomous, transdermal therapeutic device for the supply, for an extended period of time, of at least one agent with therapeutic activity, comprising a reservoir-forming element of said agent with therapeutic activity, provided with means allowing the supply of said agent for an extended period of time during the prolonged application of said device to the skin or dermis of a living being, characterized in that said supply means comprise at least one organ forming a needle or tip, full or hollow, of sufficient size to cross the skin barrier, thereby allowing the said therapeutic agent to be transported into the dermis or the hypodermis, whatever its own capacity to cross the skin barrier. This device therefore performs a subcutaneous injection or intradermal as is understandable to the practitioner.

 According to a preferred embodiment, this device comprises means of forced injection ensuring a forced injection, spread over time, in a continuous or discontinuous manner.

 According to a preferred embodiment, the forced injection means comprise a piston element whose movement is controlled by a control means such as atmospheric pressure or a mechanical, electromechanical or electronic system, with integrated, autonomous energy source , which can be supplied by a compressed spring, a reserve of compressed gas, a cell or battery without or with electronic input.

 Advantageously, this system is formed by a timing or timer system, which allows continuous or discontinuous injection.

 According to an advantageous embodiment, the device can be produced in the form of a patch or a strip of the type described in the aforementioned ALZA patents 2,143,564; 2,508,318 or 2,158,201, or 2,299,853 or 2,527,450.

 According to a particular variant embodiment, the reservoir can be made, at least in part, from a flexible deformable material, the aforementioned forced injection means then ensuring deformation of the reservoir. This reservoir may for example have the shape of a tube.

 According to another alternative embodiment, the reservoir may have any shape and include one or more opposite porous faces, so as to allow injection by capillarity.

 The means of forced injection can also act by compression of the under the action of an osmotic pressure applied by a particular osmotic pressure device.

 According to another alternative embodiment, it is possible to provide solid needles or points, advantageously grooved, or even hollow needles or points. These needles or points preferably have a dimension of the order of 4 mm, so as to ensure an intradermal injection.

 These needles or points can be of a smaller size for performing a subcutaneous injection, and can be inclined.

 The preferred use of the device according to the invention relates to loco-regional treatments (T.L.R.), also called mesotherapy.

The therapeutic agent must be incorporated into a solution composition sufficiently fluid to allow flow or injection.

 This device can be provided on a surface with an adhesive temporarily protected by a removable protective layer as is well known, in particular by the above-mentioned ALZA documents, in order to allow perfect adhesion to the skin or the dermis of a be alive. It will be observed that with the device according to the invention, the adhesive does not necessarily have to be permeable, unlike previously known devices which did not use needles ensuring the crossing of the skin barrier.

Other objects, characteristics and advantages of the invention will become apparent in the light of the explanatory description which will follow with reference to the appended drawings representing several embodiments of the invention given simply by way of illustration and which therefore cannot be no way limit the scope of the invention. In the drawings - Figure 1 is a very schematic cross-sectional view
enlarged view of a first embodiment of a device according to
the invention with a membrane, intended to be worn by a patient of
fully autonomous, - Figure 2 is a cross-sectional view also schematic
of another embodiment comprising a piston actuated by
an actuating device, - Figure 3 shows a third embodiment for a
tank with porous walls, the left part represents
a variant with straight tips and the right part a variant
with inclined points, again in a very enlarged manner.

 Referring to Figure 1, there is shown a first embodiment of a device according to the invention defined by the general reference number 1. This device comprises a reservoir element 2 of an agent with therapeutic activity and is provided means 3 allowing the supply of the agent for an extended period of time during the prolonged application of the device 1 on the skin or dermis 4 of a living being.

 According to the invention, the means 3 for supplying comprise at least one member 6 forming a needle or tip of sufficient size to cross the skin barrier, thereby allowing the therapeutic agent to be transported whatever its own capacities may be to cross the skin barrier and this even in the dermis or hypodermis in a completely autonomous way.

 According to a preferred embodiment, this device 1 also comprises means 8 of forced injection ensuring a forced injection, distributed over time, in a continuous or discontinuous manner.

 According to a preferred embodiment, these forced injection means comprise a piston element 10 whose movement is controlled by a control means 13 such as a mechanical system, as shown, or electromechanical or even electronic.

 According to the embodiment shown in Figure 1, the piston member 10 is constituted by a membrane dividing a cavity 12 formed in the device according to the invention, so as to subdivide it into two separate and non-communicating compartments 12a, 12b .

 The compartment 12b communicates with the needle or tip member 6 and therefore contains the therapeutic agent which is incorporated in a composition or solution sufficiently fluid to allow the flow or injection by this member 6.

 On the other hand, the vacuum has been created in the other compartment 12a and the external wall 2a of the device, opposite the element forming a needle or point 6 is provided with an orifice 14 which is sealed for communication with the atmosphere. by destruction of the cover 16.

 It is thus understood that when this device is applied to the dermis 4 or the skin of a living being so that the needle-forming organ or tip 6 penetrates subcutaneously or intradermally depending on the size of this needle or tip, by cutting the cover 16, the atmospheric air will penetrate into the sub-compartment 12 by applying pressure to the membrane 10 and thereby causing a progressive injection or flow of the composition or solution contained in the compartment 12 b, this flow or this injection being more or less slow depending on the flexibility or the rigidity of the membrane 10 used.

 It is thus possible to modulate at will the period of time necessary to inject or cause the solution containing the desired therapeutic agent to flow completely.

 Provision may be made for the face 2b of the device Z comprising the needle or point 6 to include a layer of adhesive 18 so as to be held with greater security on the skin of the living being thus treated.

This device can therefore be applied by the practitioner and be worn by the patient without any particular discomfort due to its reduced or miniaturized size and its completely autonomous operation.

 It can also be provided that this adhesive is temporarily protected by a removable protective layer, as is well known, in particular by the ALZA documents previously mentioned.

 Naturally, it is possible to provide a plurality of elements forming a point or needle 6. On the other hand, it will be observed that the thickness of the wall 2b is significantly greater than the thickness of the opposite wall 2a, since this allows securely hold the needle or tip member 6.

 This device is shown in Figure 1 and is made in a disposable form. It is advantageously produced in a sterile form.

 However, with reference to Figure 2, there is shown another embodiment of a device according to the invention of which only a part is disposable and is advantageously made sterile.

 According to this embodiment of FIG. 2, the device 30 comprises a disposable member 32 with a U-shaped cross section, the base of which comprises one or more members 34 forming needles or points and the lateral edges of which define a reserve cavity 36 of the agent with therapeutic action as such or incorporated into a solution or composition of sufficient fluidity. This cavity 36 is closed by a piston 38 mounted movable by sliding between the side walls 35a, 35b forming the branches of the U.

 This disposable member 32 is incorporated in an envelope 40 produced in two detachable parts 40a, 40b by which the member 32 can be securely blocked.

 The part 40b of the envelope 40, located above the piston 38 is advantageously provided with a means 46 for controlling the piston 38 constituted by a mechanical, electromechanical or electronic system.

Advantageously, this system is formed by a clock or timer system, which allows continuous or discontinuous injection of the therapeutic agent, thus allowing local regional treatments (LRT) over a particularly long period of time, from a day or even several days.

 The outer envelope may also be provided with a layer of adhesive 42 on the side of the needle or tip 34 and with a detachable layer 44 for protecting the adhesive. This adhesive then forms part of the device and is not in this case subjected to sterilization.

 According to an alternative embodiment, the adhesive is independent of the device, being for example formed by an adhesive strip 48, such as a band of adhesive plaster, applied over the device in a conventional manner.

 In this case, provision can also be made for the therapeutic agent to be distributed in a porous impregnation material 58.

 According to this embodiment, the injection or the flow is then done by capillary action.

 It is also possible to provide means of forced injection acting by compression or under the action of an osmotic pressure applied by a particular osmotic pressure device, as is well known from the state of the art previously cited.

 As previously mentioned, provision may be made for the use of needles or solid points which are advantageously grooved, or of needles or hollow points. These needles or points preferably have a dimension of the order of 4 mm, so as to ensure an intradermal injection. These needles or points may be of smaller size, so as to provide a subcutaneous injection, and in particular be inclined as shown in the right part of FIG. 3.

 We can always plan to pack the device according to the invention in a protective envelope 60 which is destroyed at the time of application.

 It is thus understood that the invention includes all the means constituting technical equivalents of the means described as well as their various combinations. In particular, the device according to the invention can have any shape and be in the form of a patch, strip or the like, which allows it to be given a portable, completely autonomous character. The tank can be filled before or after sterilization.

Claims (11)

1. Portable, totally autonomous transdermal therapeutic device for the supply for a prolonged period of time of at least one agent with therapeutic activity, comprising a reservoir-forming element (2) of said agent with therapeutic activity, provided with means (3) allowing the supply of said agent for an extended period of time during the prolonged application of said device to the skin or dermis of a living being, characterized in that said supply means (3) comprise at least one organ (6 ) forming a needle or tip, solid or hollow, of sufficient size to cross the skin barrier, thus allowing said therapeutic agent to be transported into the dermis or hypodermis whatever its own capacities may cross the skin barrier. 2. Device according to claim 1, characterized in that it comprises forced injection means (8,38) ensuring a forced injection, distributed over time, in a continuous or discontinuous manner. 3. Device according to claim 2, characterized in that the forced injection means (8,38) comprise a piston element (10,8) whose movement is controlled by a control means (13,46) such as the pressure atmospheric or a mechanical, electromechanical or electronic system, preferably a clock or timer system, with an integrated, autonomous energy source. 4. Device according to any one of claims 1 to 3, characterized in that the reservoir (2) is made at least in part from a flexible deformable material, the aforementioned forced injection means (8) then ensuring a deformation of the tank. 5. Device according to claim 4, characterized in that the reservoir (2) can have any shape and advantageously comprise one or more opposite porous faces (54,56) so as to allow an injection by capillarity. 6. Device according to claim 2, characterized in that the aforementioned forced injection means act by compression or under the action of an osmotic pressure applied by an osmotic pressure device. 7. Device according to any one of the preceding claims, characterized in that it comprises one or more needles or solid points, advantageously grooved. 8. Device according to claim 3, characterized in that the piston element is constituted by a membrane (10) dividing a cavity (12) formed in the device into two compartments (12a, 12b) distinct and non-communicating, a compartment (12b) communicates with the needle or tip member (6) and contains the therapeutic agent, the other compartment (12a) is under vacuum, the external wall (20) of the device, opposite the element ( 6) is provided with an orifice (14) sealed for communication with the atmosphere by destruction of the seal (16).  9. Device according to any one of the preceding claims, characterized in that it is produced in a sterile form and advantageously disposable, in whole or in part. 10. Device according to any one of the preceding claims, characterized in that it has the form of a patch or a strip, advantageously provided with an adhesive which may or may not be part of the device, to be held by adhesion on the skin or dermis of a living being. 11. Device according to claim 9, characterized in that the filling of the reservoir is carried out before or after the sterile packaging.