WO2005046490A1

WO2005046490A1 - Therapeutic and diagnostic inoculation device

Info

Publication number: WO2005046490A1
Application number: PCT/FR2004/002712
Authority: WO
Inventors: Gaetan Terrasse; Emile Loria; Yves Trehin
Original assignee: Gaetan Terrasse; Emile Loria; Yves Trehin
Priority date: 2003-10-24
Filing date: 2004-10-22
Publication date: 2005-05-26
Also published as: FR2861284B1; FR2861284A1

Abstract

The invention relates to a therapeutic and diagnostic inoculation device that is characterised in that it comprises at least one monopoint needle (8) that moves in translation into at least one well (3), and according to a preferred mode of embodiment, pierces at least one capsule containing a substance, in order to individually inoculate a single substance or to simultaneously inoculate a plurality of different substances, for therapeutic or diagnostic purposes, ensuring a constant penetration pressure of the monopoint needle in the dermis.

Description

THERAPEUTIC AND DIAGNOSTIC INOCULATION DEVICE

The present invention relates to the use of a device for inoculating a substance for therapeutic or diagnostic purposes, in adults or children.

Many medical practices require injecting a substance into the dermis.

Examples include the inoculation of tuberculin or the allergy tests performed by pric tests. Current means generally use a device comprising one or more points whose penetration into the dermis is made by the gesture of the doctor who performs manual pressure. This pressure is variable depending on the practitioner and the control of the penetration of the substance into the dermis is thus linked to the experience and manual skill of the doctor.

To ensure a constant result during an inoculation, it is necessary to ensure that the pressure applied by the practitioner to penetrate the point or points in the dermis is constant. It is the object of the present invention to provide a device by which whatever the pressure applied by a practitioner, the penetration pressure does not exceed a maximum value which is necessary and sufficient for the inoculation of the substance. In addition, the inoculation of a substance in order to test the reaction of the organism must often be associated with that of a neutral substance serving as a control. The case can also arise from the need to inoculate several reactive substances. It is then judicious to be able to simultaneously carry out these inoculations of different substances. The present invention thus aims to provide a device comprising one or more single-pointed needles in order to inoculate either unitarily a single substance or simultaneously several different substances, while ensuring a constant penetration pressure in the dermis.

This inoculation device intended for the use of general practitioners or specialists for inoculating one or more substances for therapeutic or diagnostic purposes, in particular in the field of allergy testing, is characterized in that it comprises:

- one or more cylindrical parts, comprising a groove on the periphery, terminated at the base by a single-pointed needle of prismatic shape and extended at the top by a part serving as a handle, the lower face of which has a flat surface,

- A plate comprising one or more wells in each of which is positioned the cylindrical part terminated by a single point needle. The upper part of the well is delimited by four legs also distributed around the periphery and the top of which is clipped into the groove formed around the periphery of the cylindrical part. The thickness of the four legs determines their spacing stiffness. When the pressure applied axially on the cylindrical part, by pressing on the handle, exceeds the stiffness coefficient of the four clip legs, the latter move apart and release the cylindrical part which descends until the flat underside of the integral handle comes into abutment on the upper part of the plate. By a judicious choice of the length of the cylindrical part, this allows the single-point needle to exceed the lower surface of the plate of the device by the correct length necessary to penetrate the dermis for inoculation of the substance.

- A flat strip of blister type fixed on the underside of the plate and completely closing the outlet of the well (s) made in the plate, and which can optionally constitute the lower part of one or more capsules containing one or more substances to be inoculated.

a thermoformed film positioned between the flat strip and the lower face of the plate, of planar shape on the part in contact with the lower surface of the plate and of hemispherical or cylindrical shape at the outlet of the well (s), and constituting the upper part of one or more capsules containing one or more substances to be inoculated. This thermoformed film is not optionally used only when the substance or substances to be inoculated are advantageously enclosed in a capsule.

- at least one therapeutic or diagnostic substance such as an allergenic composition, located in the lower volume of the well left free by the single-pointed needle when the cylindrical part is clipped by the four tabs housed in the throat; the substance which can be contained either directly in the well closed by the planar strip fixed on the lower face of the plate, or in the capsule whose upper wall is formed by the thermoformed film and the lower wall by the planar strip fixed on the face bottom of the plate.

According to one embodiment of the invention, the device comprises a single well receiving a single cylindrical part terminated by a single-pointed needle, in order to serve as a unitary inoculation device for a single substance.

According to a variant of the embodiment of the invention, the device comprises several wells; each receiving a single cylindrical part terminated by a single-pointed needle, in order to serve as a device for the simultaneous inoculation of several substances. The number of wells is then between 2 and 10 arranged in 1 or 2 alignments. In the case of a distribution made over 2 alignments, they each include the same number of wells when the total number of wells is even. When the total number of wells is odd, one of the two alignments includes an additional well compared to the other alignment. A preferred embodiment of the invention provides that the substance to be inoculated is enclosed in a capsule placed in the volume left free at the bottom of the well closed by the planar coverslip; the underside of the capsule being formed by the flat blister-type strip fixed on the entire lower surface of the plate of the device, the upper face of the capsule being constituted by the thermoformed film, and the single-point needle perforating the capsule before penetrate the dermis.

Preferably, the distance between the underside of the handle secured to the cylindrical part and the end of the single-point needle is between 0.8 and 1.4 centimeters, the distance between the underside of the handle secured to the cylindrical part and the upper limit of the groove is between 1.5 and 2.5 millimeters delimiting the stroke of the cylindrical part when, by a pressure greater than the spacing stiffness of the clips, the latter is released and descends into well.

According to a preferred embodiment of the invention, the clips have a thickness section of between 0.3 and 1.5 millimeters depending on the stiffness of spacing of the clips necessary to limit the penetration pressure of the single-point needle in the dermis.

According to one embodiment of the invention, the single-point needle is integral with the cylindrical part in a hollowed-out base allowing the substance to be inoculated to be retained by capillary action when it is in liquid or emulsion form in the volume left free at the bottom of the well closed by the flat blister-type strip, and when the thermoformed film is not used in the device.

A preferred embodiment of the invention provides that the single-pointed needle has a length of between 5 and 6 millimeters and that it is positioned in a recess in the base of the cylindrical part, the length of which is between 3.5 and 4.5 millimeters and the inside diameter between 1.5 and 2.5 millimeters.

According to a preferred embodiment of the invention, the single-pointed needle has a prismatic shape with a diamond-shaped section, the dimensions of which, in line with the base of the recess of the cylindrical part, are for the length between 0.5 and 1 millimeter and for the width between 0.2 and 0.6 millimeter. Preferably, the cylindrical part terminated by the single-pointed needle has an outside diameter of between 3 and 3.5 millimeters.

A preferred embodiment of the invention provides that the inoculation device consists of sterile single-use materials; the preferred material according to the invention being polymethacrylate. The invention will be better understood with the aid of the description, given below for purely explanatory purposes, of an embodiment of the invention, with reference to the appended figures: - Figure 1 is a view in vertical section of the device according to the invention with the cylindrical part clipped in the high position; - Figure 2 is a vertical sectional view of the device according to the invention with the cylindrical part unclipped in the low position; - Figure 3 is a vertical sectional view of the cylindrical part terminated by the single-point needle, - Figure 4 is a sectional view of the single-point needle, Figure 5 is a schematic sectional view of the capsule containing a substance to be inoculated, - Figure 6 is a schematic top view of the capsule containing a substance to be inoculated, - Figure 7 is a front view of the device in an embodiment of the invention with a unitary well, - the FIG. 8 is a front view of the device in an embodiment of the invention with several wells, - FIG. 9 is a side view of the device in an embodiment of the invention with a single alignment of wells, - Figure 10 is a side view of the device in an embodiment of the invention with two well alignments. Figure 1 shows an embodiment of the device according to the invention, which comprises a cylindrical part (1) positioned in a plate (2) in which are formed one or more wells (3) in each of which the cylindrical part (1 ) is locked in the high position by four clips (4) which are received in a groove (5). The cylindrical part is extended at its top by a part (6) serving as a single handle for the entire device and integral with the different cylindrical parts (1) when the device is produced according to a mode comprising several wells (3). This handle has a lower face (7) which will abut on the upper face (14) of the plate (2) after application of an axial pressure causing the unclipping and the descent of the cylindrical part (1), and limit thus the depth of penetration of the single-point needle (8) into the dermis.

2 shows an embodiment of the device according to the invention, which comprises a cylindrical part (1) positioned in a plate (2) in which are formed one or more wells (3) in each of which the cylindrical part (1 ) is lowered into the low position after the clips (4) have been moved, allowing the single-point needle (8) to exceed the lower face (9) of the plate (2) by the length of penetration into the dermis necessary for inoculation.

FIG. 3 represents a detail in vertical section of the embodiment of the device according to the invention which comprises a cylindrical part (1) terminated at the base by a prismatic single-pointed needle (8) housed in a recess (10), comprising a groove (5) on its periphery and extending at the top by a part (6) serving as a handle, the lower face (7) of which has a flat surface.

Figure 4 shows a detail from below of the embodiment of the device according to the invention, which comprises a single-point needle (8) of prismatic shape and whose section has a diamond shape.

FIG. 5 represents a detail in schematic section of an embodiment of the device according to the invention, which comprises a thermoformed film (11) positioned between the lower face (9) of the plate (2) and the planar strip (12 ) of blister type, and forming with the latter one or more capsules (13) of hemispherical or cylindrical shape containing the substance or substances to be inoculated.

FIG. 6 represents a detail in top view of an embodiment of the device according to the invention, which comprises a thermoformed film (11) positioned between the lower face (9) of the plate (2) and the flat strip ( 12) of blister type, and forming with the latter one or more capsules (13) of hemispherical or cylindrical shape containing the substance or substances to be inoculated.

FIG. 7 represents a front view of an embodiment of the device according to the invention, which comprises a single well (3) for the inoculation of a single substance.

FIG. 8 represents in front view an embodiment of the device according to the invention, which comprises several wells (3) for the simultaneous inoculation of several different substances.

Figure 9 shows a side view of an embodiment of the device according to the invention, which comprises one or more wells (3) arranged in a single alignment for the inoculation of a single substance or of several different substances simultaneously. Figure 10 shows a side view of an embodiment of the device according to the invention, which comprises several wells (3) arranged in two alignments for the simultaneous inoculation of several different substances.

The inoculation device according to the invention can be produced in two molded parts.

The procedure for using the device can be described as follows:

The practitioner applies the underside of the plate of the device to the skin of the patient and exerts pressure on the handle (6) sufficient to cause the spacing of the clips (4); the cylindrical part (s) (1) are thus released and descend according to a translational movement in the well (s) (3) until the lower face (7) of the handle (6) abuts on the upper face (14) of the plate (2). As a result of the translational movement of the cylindrical part (s) (1), the single-point needle (8) secured to the hollowed out base of each cylindrical part (I) pierces the capsule (13) through the upper face formed by the film thermoformed (11), is covered with the substance to be inoculated, pierces the underside of the capsule (13) constituted by the flat strip (12) of blister type, and penetrates the patient's dermis of a necessary depth limited by the stop of the lower face (7) of the handle (6) on the upper face of the plate (2) thus carrying out the inoculation.

A variant use of the device according to the invention does not make use of the thermoformed film (II). In this case of use, the practitioner can either practice as above where the single-pointed needle (8) pierces the strip (12) of blister type before penetrating the dermis covered with the substance to be inoculated contained in the volume (15 ) left free at the base of the well (3) when the cylindrical part (1) is clipped in the high position, either remove the blister-type coverslip (12) before applying the plate (2) to the patient's skin; the substance to be inoculated then being retained by capillarity in the recess (10) made at the base of the cylindrical part (1). The practitioner then proceeds as above by exerting pressure on the handle (6) leading to the unclipping of the cylindrical part (1), its descent into the well (3) and penetration the single-pointed needle (8) covered with the substance to be inoculated.

It will be recalled that: - the length of penetration of the single-pointed needle into the dermis is limited by abutment on the flat lower face (7) of the handle (6) on the upper face (14) of the plate (2) and by a distance between 1.5 and 2.5 millimeters separating the upper limit of the groove (5) from the flat underside (7) of the handle (6), by a distance between 0.8 and 1.4 centimeters separating the flat underside (7) of the handle (6) from the end of the single-point needle (8), by a distance of between 0.6 and 1.2 centimeters separating the bottom (9) and upper faces ( 14) of the plate (2). - The capsule (13) containing the substance to be inoculated consists of two faces welded together; an upper face formed by the thermoformed film (11) of hemispherical or cylindrical shape with a diameter of between 2 and 2.5 millimeters and a flat lower face constituted by the flat strip (12) of blister type.

Claims

1. Device for inoculating a medicinal substance for therapeutic or diagnostic purposes, and for the use of a general practitioner or specialist, characterized in that it comprises: at least one cylindrical part (1), the hollowed-out base (10) is integral with a single-pointed needle (8), the central zone of which has a groove (5) around the entire periphery and the top of which is integral with a single handle (6) having a flat lower face ( 7), a plate (2) comprising at least one well (3), the upper part of which consists of 4 clips (4) also distributed around the periphery and blocking the cylindrical part (1) in the high position; said clips deviating under an axial pressure imparted to the cylindrical part (1) via the handle (6) and allowing a translational movement of the cylindrical part (1) and thus the penetration of the single-point needle (8) in the dermis to a depth limited by the stop in the low position of the cylindrical part (1), a flat strip (12) of blister type fixed on the whole of the lower face (9) of the plate ( 2) and said strip (12) serving as the underside of a capsule (13) containing a substance to be inoculated housed in the volume (15) left free at the base of the well (3) when the cylindrical part (1) is clipped in high position, a thermoformed film (11) positioned between the flat strip (12) and the underside (9) of the plate (2), of flat shape on the part in contact with the lower surface (9) of the plate (2) and of hemispherical or cylindrical shape at the outlet of the well (s) (3), and constituting the upper part of one or more capsules (13) containing one or more substances to inoculate; this thermoformed film (11) being used only when the substance or substances to be inoculated are advantageously enclosed in a capsule.

2. Inoculation device according to claim 1, characterized in that the plate (2) comprises between 1 and 10 wells (3) arranged on 1 or 2 alignments; each of the wells receiving a cylindrical part (1) terminated by a single-point needle (8).

3. Inoculation device according to claim 1, characterized in that the pressure force necessary to make the single-pointed needle (8) penetrate into the dermis is limited to constant value by a mechanism of clips (4) located in part high of the well (3), being housed in a groove (5) formed on the periphery of the cylindrical part (1) and whose thickness varies between 0.3 and 1.5 millimeters depending on the desired stiffness,

4. Inoculation device according to claim 1, characterized in that the penetration length of the single-pointed needle into the dermis is limited by abutment of the flat lower face (7) of the handle (6) on the upper face ( 14) of the plate (2) and by a distance of between 1.5 and 2.5 millimeters separating the upper limit of the groove (5) from the flat underside (7) of the handle (6), by a distance of between 0.8 and 1.4 centimeters separating the flat underside (7) of the handle (6) from the end of the single-point needle (8), by a distance between 0.6 and 1.2 cm separating the lower (9) and upper (14) faces of the plate (2).

5. Inoculation device according to claim 1, characterized in that the distance between the flat lower face (7) and the end of the single-point needle (8) is between 0.8 cm and 1.4 cm, the distance between said flat lower face (7) and the upper limit (16) of the groove (5) is between 1.5 and 2.5 millimeters, the section of the clips (4) has a thickness between 0, 3 and 1.5 millimeters, the length of the single-point needle (8) is between 5 and 6 millimeters, the depth of the recess (10) is between 3.5 and 4.5 millimeters and its internal diameter is between 1.5 and 2.5 millimeters, the prismatic section of the single-pointed needle (8) in line with the base of the recess (10) has a diamond shape of length between 0.5 and 1 millimeter and of width between 0.2 and 0.6 millimeter, the cylindrical part (1) has an outside diameter between 3 and 3.5 millimeters.

6. Inoculation device according to any one of claims 1 to 5, characterized in that said single-pointed needle (8) is positioned at the base of the cylindrical part (1) in a recess (10) whose role is to '' ensure retention by capillarity of any substance to be inoculated in liquid, emulsion or suspension form, when said substance is not contained in a capsule (13) but directly contained in the volume (15) left free at the base of the well (3 ) closed by the flat strip (12) of blister type; the thermoformed film (11) then not being used.

7. Inoculation device according to claim 1, characterized in that said capsule

(13) containing the substance to be inoculated is constituted by two faces welded together; an upper face formed by the thermoformed film (11) of hemispherical or cylindrical shape with a diameter of between 2 and 2.5 millimeters and a flat lower face constituted by the flat strip (12) of blister type.

8. Inoculation device according to any one of claims 1 to 6, characterized in that it consists of sterile single-use materials, preferably of which polymethacrylate.

9. Inoculation device according to any one of claims 1 to 8, characterized in that it is for unitary use for the inoculation of a single substance or multiple for the simultaneous inoculation of several different substances.