A device for monitoring the pressure or force of multiple jets generated at the outlet of a needleless injection device.

Abstract

The present invention relates to a device (1) for monitoring the pressure or jet force of a plurality of jets generated in a conduit (25a) at the outlet of a nozzle (25) of a needle-free injection device (2). The device (1) for monitoring the pressure or jet force comprises, for each jet generated at the outlet of the nozzle (25), a measuring element (10) for measuring the pressure or jet force of the corresponding jet. Each measuring element (10) for measuring the pressure or jet force has a jet-receiving surface (10a) oriented to receive the corresponding jet.

Description

Technical Field

[0001] The present invention relates to a monitoring device for the pressure or injection force of a plurality of jets generated by a conduit at the outlet of a nozzle of a needleless injection device.

Background Art

[0002] For example, needleless injection devices, pre-filled injection devices, and disposable injection devices that operate with an energy source such as a gas generator are known. These injection devices are used to inject active ingredients for human or veterinary medicine intradermally, subcutaneously, and intramuscularly.

[0003] The active ingredient may be composed of a viscous liquid, a liquid mixture, or a gel. The active ingredient may also be a solid dissolved in a suitable solvent for injection, or a powdered solid suspended in a suitable liquid at a certain concentration.

[0004] Such an injection device includes, as a known device such as, for example, French Patent Application Publication No. 2815544, a main body continuously having a gas generator, an expansion chamber, a container containing an active ingredient, and an injection system.

[0005] The container is sealed by an upstream plunger and a downstream plunger while being inserted into the tubular housing of the main body of the injection device. The free end on the lower side of the container cooperates with the injection system. The injection system includes an injection nozzle having several injection conduits extending along the axial direction of the injection axis. The diameter of the injection conduit corresponds to the particle diameter of the active ingredient so that the injection conduit is not blocked by the particles of the active ingredient.

[0006] To enable the injection of the active ingredient, the body of the injection device is mounted within a hollow cover that encloses the body of the injection device, sliding along a sliding axis from bottom to top, between a stationary position and a spray position. The injection device body is driven when the user presses the spray nozzle against their skin. The displacement of the injection device body within the cover activates the gas generator. The generated pressurized gas displaces the plunger, causing the active ingredient to be ejected through the spray nozzle and through the patient's skin.

[0007] At this injection position, the active ingredient is ejected from the nozzle conduit in the direction of injection as a jet with a predetermined injection pressure. This allows for more optimal injection so that the active ingredient penetrates the patient's skin to the desired depth. Therefore, the injection pressure of these jets determines the injection depth of the injected active ingredient into the skin.

[0008] Furthermore, to ensure successful injection, the jet at the nozzle outlet is supplied according to this injection pressure for a predetermined injection time. This guarantees the injection of the desired amount of active ingredient.

[0009] Of course, the magnitude of these injection pressures, or injection force and injection time, will vary depending on the active ingredient being injected.

[0010] Therefore, there is a need for a device that can accurately measure the pressure or force of the jet generated by a needle-free injection device and monitor the jet pressure or force. [Overview of the project]

[0011] Therefore, the present invention relates to a pressure or jet force monitoring device for multiple jets generated in a conduit at the nozzle outlet of a needleless injection device. The pressure or jet force monitoring device according to the present invention comprises an element for measuring the pressure or jet force of each jet generated at the nozzle outlet. It is noteworthy that each of the pressure or jet force measuring elements has a pressure-receiving surface oriented to receive the corresponding jet.

[0012] By independently measuring the pressure or force of each of these jets, it is possible to identify a fault in the injection conduit in a nozzle where the jet is not supplied according to a predetermined pressure or force. Identifying such faults allows for better assurance of the suitability of needleless injectors, for example, during batch production management.

[0013] According to one embodiment of the present invention, at least the pressure-receiving surface of the pressure or jet force measuring element is inclined with respect to a plane substantially perpendicular to the jet's ejection direction.

[0014] The inclination of the pressure-receiving surface of the pressure or jet force measuring element can limit the incidence of adjacent jets onto the pressure-receiving surface of the pressure or jet force measuring element.

[0015] Advantageously, each pressure-receiving surface of the pressure or jet force measuring element is inclined with respect to a plane substantially perpendicular to the direction of jet ejection.

[0016] Advantageously, the inclines of each pressure-receiving surface are oriented in different directions from one another.

[0017] According to one embodiment of the present invention, the inclination of the pressure-receiving surface of one or more pressure or injection force measuring elements is obtained by inclining the pressure or injection force measuring element corresponding to the plane substantially perpendicular to the injection direction according to the length of the measuring element.

[0018] Advantageously, the inclination of the pressure-receiving surface of each pressure or injection force measuring element is obtained by inclining the corresponding pressure or injection force measuring element with respect to the injection direction according to the length of the measuring element.

[0019] According to another embodiment of the present invention, one or more pressure or jet force measuring elements are formed by an assembly of a pressure or jet force sensor and an accessory having a pressure-receiving surface for receiving the corresponding jet.

[0020] Advantageously, the accessory comprises a mechanical transmission member that contacts a pressure or jet force measuring element. Advantageously, the mechanical transmission member enables the transmission of mechanical vibrations received by the accessory to the pressure or jet force measuring element.

[0021] Advantageously, the attached components are detachable from the pressure or jet force measuring element.

[0022] Advantageously, the pressure-receiving surface is the chamfered surface of the attached component.

[0023] In this latter configuration, for each of the pressure or jet force measuring elements, the pressure or jet force sensor extends substantially parallel to the direction of jet ejection.

[0024] It should be understood that each sensor extends in a direction coaxial with the axis of the conduit at the nozzle outlet from which the corresponding jet is emitted.

[0025] According to an alternative embodiment of the present invention, the pressure or jet force monitoring device comprises a support that more reliably supports each of the pressure or jet force measuring elements.

[0026] Advantageously, the support may include projections for aligning the pressure or jet force measuring element.

[0027] Advantageously, the alignment projections allow for radial and axial alignment of the attached components.

[0028] When the accessory parts are removable from the pressure or injection force measuring element, it should be understood that the removal of the accessory parts can be restricted by an alignment protrusion having alignment fingers provided for holding the accessory parts.

[0029] According to another variant, the accessory parts can be fixed to the pressure or injection force measuring element by adding liquid or viscous fixing elements such as wax, adhesive, resin, or by structural changes such as mechanical fixing by crimping.

[0030] According to another aspect of the present invention, the pressure or injection force monitoring device comprises a partition member that partitions the jets from each other.

[0031] The partition member can prevent the adjacent jets from entering the pressure receiving surface of the corresponding measuring element.

[0032] Advantageously, the partition member that partitions the jets may comprise a separation part that separates the pressure or injection force measuring elements from each other in order to prevent the adjacent jets from entering the pressure receiving surface of the corresponding pressure or injection force measuring element.

[0033] According to another variant of the present invention, the pressure or injection force monitoring device comprises an alignment member that aligns the conduit of the nozzle with respect to the pressure or injection force measuring element.

[0034] Advantageously, the alignment member may comprise a base for receiving the nozzle and two or more alignment ends for more reliably positioning the alignment member with respect to the pressure or injection force measuring element.

[0035] According to another variant of the present invention, the pressure or injection force monitoring device is composed of a force sensor or a pressure sensor and an interface.

[0036] The interface enables the acquisition and processing of electrical signals transmitted from the pressure or injection force measuring element.

[0037] The present invention also relates to an assembly for monitoring pressure or injection force, comprising a needleless injection device and a pressure or injection force monitoring device, as defined herein.

[0038] According to one embodiment of this assembly, the needleless injection device comprises a body having a gas generator, an expansion chamber, a container containing an active ingredient, and a spray system in sequence, the spray system having a spray nozzle.

[0039] Advantageously, the body of the needleless injection device is mounted within a hollow cover that encloses the body, and is slidable along a sliding axis between a stationary position and a spraying position.

[0040] Advantageously, the active ingredients contained in the container are the following: - Methotrexate - Adrenaline - Sumatriptan - Hydrocortisone -Naloxone - Midazolam - Apomorphine - Methylnaltrexone bromide - Phytomenadione - Chlorpromazine hydrochloride - Zuclopenthixol acetate - Danaparoid sodium - Enoxaparin sodium - Estradiol cypionate - Medroxyprogesterone acetate - Medroparin calcium - Methylprednisolone acetate - Heparin calcium - Terbutaline It can be selected from a group that includes this.

[0041] The present invention also relates to a method for monitoring the pressure or force of multiple jets generated by a conduit at the outlet of a nozzle of a needleless injection device. This method is performed using a pressure or force monitoring device as defined herein.

[0042] Methods for monitoring pressure or injection force are: A positioning step in which the conduit of the nozzle of the needleless injection device is positioned to face the pressure or injection force measuring element of the monitoring device, A step of measuring the pressure or force of each jet, which is measured independently of each other, It is attracting attention because it includes this. [Brief explanation of the drawing]

[0043] Other aspects, purposes, and advantages of the present invention are provided below as non-limiting examples and will be better understood in the detailed description of preferred embodiments, which will be made with reference to the accompanying drawings. [Figure 1] This is a perspective view of a pressure or injection force monitoring device according to the first embodiment of the present invention, which is compatible with needle-free injection devices. [Figure 2] Figure 1 is a diagram showing in detail a first embodiment of the pressure or injection force monitoring device. [Figure 3] This figure shows the monitoring device shown in Figure 1 installed at the base of the control unit. [Figure 4] This is a perspective view showing a pressure or injection force monitoring device according to a second embodiment of the present invention. [Figure 5] This is a perspective view showing a pressure or jet force monitoring device according to a third embodiment of the present invention, which shows that the pressure or jet force monitoring device is equipped with a partition member that partitions the jet. [Figure 6] This shows a perspective view of the alignment member for a needleless injection device relative to a pressure or injection force monitoring device. [Figure 7] This figure shows the alignment member in detail. [Modes for carrying out the invention]

[0044] Figures 1 to 3 show a pressure or jet force monitoring device 1 according to a first embodiment of the present invention. This device measures the pressure or jet force of each jet generated or ejected from the injection nozzle 25 of the needleless injection device 2 shown in Figure 1. The needleless injection device 2 and the pressure or jet force monitoring device 1 form an assembly specifically for monitoring pressure or jet force.

[0045] The illustrated needleless injection device 2 (needleless syringe) comprises a main body 20 which is operated by a gas generator 21, an expansion chamber 22, upstream and downstream plungers, and which has a container 23 containing an active ingredient and an active ingredient injection system 24 in sequence.

[0046] The injection system 24 has an injection nozzle 25 having a cylindrical shape around the main axis or injection direction O. The injection nozzle 25 is intended to work in conjunction with the main body 20. The injection nozzle 25 is provided with one or more conduits 25a (three conduits in Figure 1) oriented substantially parallel to the injection direction O.

[0047] When the spray nozzle 25 is pressed, the main body 20 slides between a stationary position and a spray position inside the hollow cover 26. As the main body 20 is displaced inside the cover 26, the gas generator 21 is activated and pressurized gas is generated, causing the plunger to displace and the active ingredient to be sprayed from the spray nozzle 25.

[0048] The propagation direction of these jets is approximately parallel to the injection direction O of the injection system 24.

[0049] To measure the pressure or force of each of these jets, the injection nozzle 25 of the needleless injection device 2 is positioned opposite the pressure or force monitoring device 1.

[0050] The pressure or jet force monitoring device 1 has a measuring element 10 specifically for measuring the pressure or jet force for each jet generated by the injection nozzle 25 of the needleless injection device 2. It should be understood that, as a result, the measurement of each jet is performed individually.

[0051] Each of the pressure or jet force measuring elements 10 is configured to be connected to a processing unit 100 that receives an electrical signal transmitted from the pressure or jet force measuring element 10. Advantageously, each of the pressure or jet force measuring elements 10 is connected to the processing unit 100 at its free end.

[0052] These electrical signals are preferably processed independently of each other.

[0053] Furthermore, the pressure or jet force monitoring device 1 includes a support body 11 that more reliably supports each of the pressure or jet force measuring elements 10. Advantageously, the pressure or jet force measuring elements 10 may be attached to the support body by screws, or they may be overmolded onto the support body. For example, the body of the pressure or jet force measuring element 10 may be tapped, and a threaded opening in the support body 11 may be intended to receive the pressure or jet force measuring element 10.

[0054] The support 11 for the pressure or jet force measuring elements 10 allows each of the pressure or jet force measuring elements 10 to be positioned relative to one another in a manner that allows it to receive the corresponding jet.

[0055] It should be understood that "corresponding jet" or "corresponding measuring element" refers to a jet related to a measuring element, or an element related to a jet.

[0056] To measure the pressure or force of each jet, each of the measuring elements 10 for the pressure or force of the corresponding jet is provided with a pressure-receiving surface 10a from which the corresponding jet is emitted.

[0057] To limit the incidence of adjacent jets onto the pressure-receiving surface 10a of the corresponding measuring element 10, each pressure-receiving surface 10a of the pressure or jet force measuring element 10 is inclined with respect to a plane substantially perpendicular to the jet's direction of ejection. The inclination of each pressure-receiving surface 10a is directed distinctly from one another.

[0058] In this first embodiment, each of the pressure or jet force measuring elements 10 is formed by an assembly of a pressure or jet force sensor 12 and an accessory 13 having a pressure-receiving surface 10a for receiving the corresponding jet.

[0059] The accessory part 13 is a complementary part to the pressure or jet force sensor 12. The pressure-receiving surface 10a of the measuring element 10 is the chamfered surface of the accessory part 13.

[0060] In the first embodiment of the present invention, each of the pressure-receiving surfaces 10a (in Figures 1 to 3, the chamfered surface of the pressure or injection force measuring element 10) is oriented radially outward with respect to the injection axis O, and the jet incident on the pressure-receiving surface 10a is then discharged radially outward with respect to the injection axis O.

[0061] Advantageously, the accessory 13 is intended to transmit the force received on the chamfered surface of the accessory 13 to the pressure or jet force sensor 12. For this purpose, for example, a mechanical transmission member may be provided. One end of the mechanical transmission member may be mechanically connected to the chamfered surface of the inner surface of the accessory 13. The other end of the mechanical transmission member may be mechanically connected to the surface of the pressure or jet force sensor 12, which is intended to be subjected to pressure or jet force for measurement. The mechanical transmission member may be formed by a substantially "Z" shaped blade, for example, the end face of the transmission member connecting the inner surface of the accessory 13 and the surface of the pressure or jet force sensor 12 as defined above.

[0062] Advantageously, the pressure or jet force sensor 12 may be a piezoelectric sensor sensitive to the mechanical changes when the pressure-receiving surface 10a receives the corresponding jet. When the jet is discharged from the conduit to the pressure-receiving surface 10a of the pressure or jet force measuring element 10, the pressure or jet force of this jet can be measured.

[0063] Advantageously, the pressure or jet force sensor 12 may be a pencil-type sensor that can be positioned opposite the conduit 25a of the injection nozzle 25, independently of the other pressure or jet force measuring elements 10. In other words, in the case of multiple conduits 25a, small-sized pencil-type sensors can be positioned opposite the conduits 25a of the injection nozzle 25 without contacting each other. This allows the pressure or jet force of each jet to be measured independently of each other.

[0064] Advantageously, the assembly of the pressure or jet force sensor 12 and the accessory part 13 having a chamfered surface allows the pressure or jet force sensor 12 to extend substantially parallel to the jet's direction of ejection, according to its length. Such a configuration facilitates the assembly of the measuring element 10 in the support 11. Furthermore, it facilitates the connection of the pressure or jet force monitoring device 1. In fact, when the pressure or jet force monitoring device is housed in the base 4 of the operating unit, the free end of the sensor 12 can be inserted into the corresponding plug.

[0065] The alignment projections 14 of the support 11 are provided for aligning the pressure or injection force measuring element 10. More specifically, advantageously, each alignment projection 14 allows for radial and axial alignment of its associated accessory 13. Each alignment projection 14 comprises a radial hole 14a opposite to the injection direction O and receives alignment fingers 14b for radial and axial alignment of each of the accessory 13, advantageously ensuring their orientation relative to one another.

[0066] Furthermore, it should be understood that by aligning the attached component 13 with the alignment projection 14, the signal-to-noise ratio of the information transmitted from the corresponding measuring element 10 can be limited, thereby improving the measurement of pressure or jet force.

[0067] Figure 4 shows a second embodiment of the present invention in which each of the pressure or jet force measuring elements 10 is integrally formed by a pressure or jet force sensor 15.

[0068] In this second embodiment, the inclination of the pressure-receiving surface 10a of each pressure or injection force measuring element 10 is obtained by an inclination of the corresponding measuring element 10 with respect to the injection direction O, according to the length of the measuring element.

[0069] Similar to the first embodiment, the pressure or jet force sensor 15 may be formed of a piezoelectric sensor that is sensitive to the mechanical changes when the pressure-receiving surface 10a receives the corresponding jet.

[0070] The pressure or jet force measuring element 10 may be attached to the support 11, as in the first embodiment.

[0071] The pressure or jet force sensor 15 may be pencil-shaped.

[0072] Figure 5 shows a third embodiment of the present invention, in which each of the pressure or injection force measuring elements 10 has a pressure-receiving surface 10a that is substantially perpendicular to the injection direction O.

[0073] Advantageously, in embodiments that can be combined with either this third embodiment or any one of the embodiments of the present invention, a partition member 3 is provided to separate the jets from each other. The partition member 3 is formed by a circular contour 30 from which separation portions 31, interconnected by a central portion 32 of the partition member 3, extend radially inward with respect to the injection direction O. Advantageously, the partition member 3 is attached to a foot portion 33 such that it is elevated relative to the support 11 of the pressure or injection force monitoring device 1. When the partition member 3 is attached to the support 11 or the base 4 of the operating unit, the separation portions 31 separate the measuring elements 10 from each other. More specifically, the separation portions 31 are positioned to separate the pressure or injection force measuring elements 10 while protruding from their pressure-receiving surfaces 10a in the direction of the injection direction O. In this way, the partition member 3 makes it possible to prevent adjacent jets from entering the pressure-receiving surfaces 10a of the corresponding measuring elements 10.

[0074] It should be understood that the partition member 3, which separates the jets, enables improved measurement accuracy for each jet.

[0075] Figures 6 and 7 show members 5 for aligning the conduit 25a of the injection nozzle 25 with respect to the pressure or injection force measuring element 10.

[0076] As shown in the diagram, the alignment member 5 is provided to be removably received in the opening 60 of the tray 6. In the operating section, the tray 6 is positioned such that the opening 60 provides access to the pressure or jet force monitoring device 1.

[0077] The alignment member 5 comprises a base portion 50 for receiving the injection nozzle 25 and two or more alignment ends 51 for more reliable positioning of the alignment member 5 with respect to the pressure or injection force measuring element 10.

[0078] The lever 53 of the alignment member 5 allows for rotational operation relative to the spray direction O. This enables the alignment end 51 to reach the final position where it is positioned corresponding to the complementary portion of the tray 6.

[0079] In this final position, the conduit 25a of the injection nozzle 25 is positioned opposite the pressure or injection force measuring element 10.

[0080] It should be understood that the alignment member 5 ensures more accurate discharge of each jet at the pressure-receiving surface 10a of the corresponding measuring element 10.

[0081] The pressure or jet force monitoring device 1 enables the implementation of a method for monitoring the pressure or jet force of multiple jets generated by the conduit 25a at the outlet of the injection nozzle 25 of the needleless injection device 2.

[0082] Of course, this method is carried out using a pressure or injection force monitoring device 1 according to any one embodiment of the present invention. This monitoring method includes at least, A positioning step in which the conduit 25a of the injection nozzle 25 of the needleless injection device 2 is positioned to face the pressure or injection force measuring element 10 of the pressure or injection force monitoring device, A step of measuring the pressure or force of each jet, which is measured independently of each other, Includes.

[0083] Advantageously, these jet measurements are performed by the processing unit 100.

[0084] Of course, the present invention is not limited to the embodiments described herein, and numerous modifications can be made to these embodiments without departing from the scope of the invention. In particular, different features, shapes, variations, and embodiments of the present invention can be related to one another in various combinations, to the extent that they are not incompatible or mutually exclusive. In particular, all the variations and embodiments described herein can be combined with one another.

Claims

1. A monitoring device (1) for the pressure or injection force of multiple jets generated by a conduit (25a) at the outlet of the nozzle (25) of a needleless injection device (2), The nozzle (25) is equipped with a plurality of pressure or jet force measuring elements (10) corresponding to each of the plurality of jets generated at the outlet, The plurality of pressure or jet force measuring elements (10) are located around a virtual axis extending along the jet's ejection direction. Each of the pressure or jet force measuring elements (10) has a pressure receiving surface (10a) that is oriented to receive the jet, At a minimum, the pressure-receiving surface (10a) of the pressure or jet force measuring element (10) is inclined with respect to a plane substantially perpendicular to the propagation direction of the jet, such that it faces outward in the radial direction with respect to the virtual axis. A device for monitoring pressure or injection force.

2. The pressure or jet force monitoring device according to claim 1, wherein one or more pressure or jet force measuring elements (10) are formed by an assembly of a pressure or jet force sensor (15) and an accessory component (13) that constitutes the pressure receiving surface (10a) for receiving the jet.

3. The pressure or jet force monitoring device according to claim 1 or 2, further comprising a support (11) for each of the measuring elements (10).

4. The pressure or jet force monitoring device according to claim 3, wherein the support (11) is provided with a projection (14) for aligning the measuring element (10).

5. A pressure or jet force monitoring device according to any one of claims 1 to 4, comprising a partition member (3) that separates the jets from each other.

6. The pressure or jet force monitoring device according to claim 5, wherein the partition member (3) includes a separation portion (31) that separates the measuring elements (10) from each other in order to prevent adjacent jets from entering the pressure or jet force measuring surface (10a) of the measuring element (10).

7. A pressure or jet force monitoring device according to any one of claims 1 to 6, further comprising an alignment member (5) for aligning the conduit (25a) of the nozzle (25) with respect to the measuring element (10).

8. The pressure or jet force monitoring device according to claim 7, wherein the alignment member (5) comprises a base (50) for receiving the nozzle (25) and two or more alignment ends (51) for positioning the alignment member (5) with respect to the measuring element (10).

9. An assembly for monitoring pressure or injection force, comprising a needleless injection device (2) and a pressure or injection force monitoring device (1) according to any one of claims 1 to 8.

10. A method for monitoring the pressure or jet force of multiple jets generated in a conduit (25a) at the outlet of a nozzle (25) of a needleless injection device (2), The monitoring method is performed using a pressure or injection force monitoring device (1) described in any one of claims 1 to 8. The aforementioned monitoring method is, A positioning step in which the conduit (25a) of the nozzle (25) of the needleless injection device (2) is positioned to face the pressure or injection force measuring element of the pressure or injection force monitoring device (1), A step of measuring each jet independently of the others in order to measure the pressure or force of the jet, A method for monitoring pressure or jet force, including the following.

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