SYSTEM AND DEVICE FOR DISPENSING A PRODUCT

Description

[0001] The invention relates to a product distribution system, in particular a liquid product intended for introduction into a site within a subject. Furthermore, the invention relates to a distribution device comprising the distribution system.

[0002] The technology is already known: a drug dispensing device comprising a reservoir and a membrane sealing the reservoir. To allow the dispensing of the product contained in the reservoir, the membrane is deformable from a storage position to an assembly position where a needle causes the membrane to burst. Such a membrane is particularly thin, on the order of 0.1 to 0.2 mm, and is therefore difficult to manufacture and assemble because it requires great care and very precise positioning of the membrane. Furthermore, the membrane deformation is difficult to achieve reproducibly, given its thinness and the fact that it must be subjected to a relatively high differential pressure to ensure that it deforms sufficiently to actually make contact with the needle and cause it to burst.Relevant prior art documents can be found under references US 2002 / 004641 A1, US 2009 / 0234323 A1, US 2013 / 0237922 A1 and US 2015 / 0313798 A1.

[0003] The invention aims in particular to provide a product distribution device whose implementation is simplified, while preserving the sterility of the product contained in the reservoir, up until the product is distributed out of the reservoir.

[0004] To this end, the invention relates in particular to a product distribution device, comprising a product reservoir having a neck defining an opening, a membrane closing the opening and thus having an inner side oriented towards the reservoir and an outer side opposite the inner side, a ring for fixing the membrane to the neck, the membrane being bistable in that it is configured to switch from a first stable position, in which the membrane is domed in a first direction so that it protrudes inside the reservoir and closes the reservoir, to a second stable position, in which the membrane is domed in a second direction opposite to the first direction so as to be pierced by a needle disposed on the outer side of the membrane.

[0005] Therefore, it is proposed to use a bistable membrane which, when transitioning from the first stable position to the second stable position, passes through an unstable intermediate position that generates stresses within the membrane, pushing it towards the second stable position. Thus, the membrane "snaps" from the first stable position to the second stable position, ensuring that the needle pierces the membrane. This increases the reproducibility of the bistable membrane's deformation because the bistable membrane is not necessarily thin and its performance does not depend on an uncertain swelling capacity.Furthermore, such a dispensing device is remarkably simple to implement, requiring only a membrane-fixing ring on the neck. This design maintains the sterility of both the reservoir and the product within it, from the moment the reservoir is assembled into the dispensing device until the product is dispensed, as well as during and after the reservoir is filled. The dispensing device is further simplified by the fact that, thanks to the membrane-fixing ring on the reservoir, the reservoir can be a standard type, such as those commonly used in the pharmaceutical industry, without requiring any specific membrane-fixing mechanism. This fixing ring can, for example, be shaped like a ferrule.Finally, the membrane allows for a particularly simple assembly in that, preferably, its sole function is to switch between a storage and assembly position corresponding to the first stable position, and a perforated position corresponding to the second stable position, without any other additional function.

[0006] Depending on other optional features of the distribution device, taken alone or in combination: The dispensing device includes a needle designed to pierce the membrane when it is in its second stable position. In its first stable position, the membrane seals the reservoir, thus blocking the dispensing of the product. In its second stable position, the membrane is bulged in the opposite direction, protruding from the reservoir. The retaining ring is made of thermoplastic or metallic material, preferably aluminum. This ensures that the membrane is held onto the reservoir in a particularly economical manner. The reservoir is made of glass or thermoplastic material. This allows for a particularly simple and economical design. It can, in particular, be a standard glass reservoir, commonly used in the pharmaceutical industry and easy to sterilize. The reservoir has a syringe shape with a neck.Thus, the reservoir is constructed in a particularly simple manner. In another variant, the reservoir is cartridge-shaped with a neck. In yet another variant, the reservoir consists of a flexible pouch connected to a neck that is more rigid than the flexible pouch. The needle is a connecting needle for a product delivery line, preferably a connecting needle for a product delivery catheter. Alternatively, the needle is a product injection needle, which has one end for piercing the membrane and the opposite end for injecting the product into the patient's site. The opening is closed solely by the membrane. The delivery device is thus constructed in a particularly simple manner. The membrane is mounted directly or indirectly onto the neck of the reservoir, preferably directly. In particular, it is crimped directly onto the neck of the reservoir by the retaining ring.Thus, the dispensing device is remarkably simple. The diaphragm is convex in the first direction so that it protrudes into the neck of the tank. The diaphragm has a peripheral portion that is axially compressed between the retaining ring and the tank neck. The axial direction is defined with reference to a central axis of the tank. In other words, the peripheral portion of the diaphragm is sandwiched between the retaining ring and the tank neck. There is therefore contact, preferably direct contact, between the diaphragm and the retaining ring on one side, and between the diaphragm and the tank neck on the other. This is a particularly simple version of the dispensing device, especially when the diaphragm is directly sandwiched between the retaining ring and the tank neck, without any intermediate parts.The retaining ring is fixed directly around the neck of the reservoir, preferably crimped around it. This makes attaching the membrane particularly simple. The product is a liquid, preferably intended for injection into a subject. For example, the product is a medication. The membrane is made of an elastomeric material, preferably based on bromobutyl or chlorobutyl. This allows the membrane to be manufactured simply, economically, and without any chemical effect on the product contained in the reservoir. Furthermore, these materials offer advantages in terms of sealing properties and compatibility with pharmaceutical products and sterilization processes.The dispensing device includes a needle that connects to a product dispensing tube. The needle is configured to be separate from the membrane when the membrane is in its first stable position and to pass through the membrane when it is in its second stable position. Therefore, if the membrane shifts into its second stable position at the beginning of product dispensing, the product only comes into contact with the needle and dispensing tube during the actual dispensing process. This preserves the sterility of the product in the reservoir until it is dispensed from the reservoir. The needle is configured to allow product dispensing from the reservoir through the needle when it passes through the membrane in its second stable position. This simplifies product dispensing. The needle is fixed relative to the reservoir.The needle is fixedly mounted on the reservoir. This makes positioning the needle relative to the reservoir neck particularly easy and eliminates the need for complex assembly, resulting in a simple and reliable membrane piercing process when the membrane moves into its second stable position. It is understood that the needle is preferably mounted indirectly on the reservoir. The dispensing device includes a piercing element comprising: a needle receiving element to which the needle is attached, the needle advantageously being fitted into said receiving element; and a fastening element for the mounting ring and / or the reservoir neck. This simplifies the attachment of the receiving element, and thus the needle itself, to the reservoir, while also providing simple and reliable positioning of the needle relative to the reservoir neck.The piercing element is fixed to the reservoir in such a way as to create an airtight seal between the needle and the membrane. This further preserves the sterility of the product contained in the reservoir. The needle receiving element is fixed above the retaining ring so that the retaining ring includes at least one portion positioned between the needle receiving element and the membrane along a central axis of the reservoir. The needle receiving element is designed to form an airtight chamber with the membrane when it is convex in the first direction. The retaining element and / or the needle receiving element are made of thermoplastic material. This makes the piercing element simple and economical to manufacture. The piercing element includes a seal that bears against the retaining ring.Advantageously, the seal is positioned between the needle receiving element and the retaining ring and bears axially against the retaining ring. The retaining element has clip-on tabs that snap onto the retaining ring and / or the reservoir neck. This makes attaching the needle to the reservoir particularly simple. Furthermore, once assembled, intentional or accidental removal of the needle from the reservoir is prevented or rendered impossible without damaging the assembled components. Correct operation of the diaphragm and needle assembly is thus guaranteed.

[0007] Alternatively, the fastening element is shaped like a hose clamp, which has a clip-on tab that snaps into a loop. This makes attaching the needle to the reservoir particularly simple. Furthermore, once assembled, this prevents accidental or intentional disengagement of the needle from the reservoir, thus ensuring proper functioning of the diaphragm and needle assembly. In addition, the clip-on mechanism is tangential, preventing excessive compression that could deform the retaining ring. This consequently increases the accuracy of the needle's positioning relative to the reservoir, and therefore, its positioning relative to the diaphragm. The needle receiving element is a single unit with the fastening element. Alternatively, the needle receiving element is designed to be assembled with the fastening element. Both the needle receiving element and the fastening element include complementary means for assembling the needle receiving element to the fastening element. Advantageously, the needle receiving element includes a circumferential element, such as a groove or rib, designed to cooperate with a corresponding circumferential element, such as a rib or groove, of the fastening element. The needle receiving element comprises, along a central axis of the reservoir, a first end through which the needle passes and from which a piercing end of the needle projects, and a second end, opposite the first end, covered by a protective element such as a film or an insulating cap against the external environment.The needle receiving element includes a product dispensing channel opening at its second end and extending between the second end and the needle. The needle extends through the needle receiving element and includes a first end for piercing the membrane and a second end designed to be connected directly or indirectly to a product dispensing tube. The needle and the dispensing device are assembled in a housing such that the needle is contained within a dispensing member comprising one or more fastening elements designed to interact with the housing, thus securing the needle relative to the reservoir. This results in a simple assembly without constraints or direct connection between the needle and the reservoir or the fastening ring, thereby simplifying its production.The maximum distance between the first stable position and the second stable position is between 3 mm and 10 mm, preferably 5 mm. This ensures compact operation of the diaphragm. The "maximum distance between the first stable position and the second stable position" refers to the maximum travel distance between the two diaphragm positions. If the bistable diaphragm has a generally domed disc shape, the "maximum distance between the first stable position and the second stable position" is defined as the distance traveled by the center of the diaphragm between the first and second stable positions. The needle tip closest to the membrane is axially distant from the membrane when the membrane is in its first stable position by a distance less than or equal to the difference between the maximum distance between the first and second stable positions and the membrane thickness, this value being 2 to 7 mm, preferably less than 4 mm. This ensures that the needle pierces the membrane in the second stable position. The membrane comprises a deformable central portion between the first and second stable positions, the central portion having a thickness between 0.3 mm and 2.5 mm, preferably 1 mm. The peripheral portion has a thickness between 1 and 5 times the thickness of the central portion, preferably between 2 and 4 times the thickness of the central portion. This facilitates the attachment of the membrane using the retaining ring. The membrane is disc-shaped and has a diameter between 7 mm and 20 mm, preferably 13 mm. This results in a compact membrane. The central portion is disc-shaped and has a diameter between 5 mm and 16 mm, preferably 9 mm. This results in a membrane with a small contact surface with the product in the reservoir, thus improving the sterility of the product in the reservoir.The membrane is configured to switch from a first stable position to a second stable position when the differential pressure between the inner and outer sides of the membrane exceeds a predetermined threshold. Thus, switching from the first stable position to the second stable position can be achieved simply by varying the pressure applied to the membrane. The predetermined threshold is between 0.4 bar and 3 bar, preferably between 0.6 bar and 0.7 bar. Therefore, the differential pressure required to switch the membrane from the first stable position to the second stable position is relatively low, and advantageously lower than the differential pressure that would be required to cause a membrane to swell and burst.Thus, the membrane is pierced without the need to apply significant pressure, which is particularly advantageous when energy conservation is required or the tank is designed to withstand low pressure. The dispensing device comprises a pump and an electric motor to drive the pump. The pump is configured to move the membrane from the first stable position to the second stable position and to dispense the product from the tank through the needle when the membrane is in the second stable position. This results in a particularly simple membrane operation, as no additional actuation elements beyond those required for dispensing are necessary. The dispensing device includes a battery to power the electric motor.The pump is configured to compress the product in the reservoir, such as a pump driving a piston that slides within the reservoir. This makes the pump particularly simple to implement. Alternatively, the pump is a peristaltic pump acting on the dispensing tubing connected to the connecting needle. This allows the pump to draw the product out of the reservoir. This also makes the pump particularly simple to implement. The pump is configured to produce a differential pressure at least equal to the predetermined threshold between the inner and outer sides of the diaphragm. The dispensing device includes a diaphragm positioning system. This allows for monitoring the diaphragm's correct operation, for example, by ensuring that the diaphragm has not accidentally moved to its second stable position before dispensing is required.The diaphragm positioning system includes a measuring device for the current or torque of the electric motor driving the pump. This provides a particularly simple and reliable means of monitoring the diaphragm's operation. When the diaphragm moves from the first stable position to the second stable position, the pressure changes sharply and rapidly, a change that is detectable by the measuring device. The diaphragm positioning system includes a pressure sensor configured to measure pressure on the inner and / or outer side of the diaphragm, preferably configured to measure the differential pressure between the inner and outer sides. This provides a simple way to monitor the pressure and, consequently, the diaphragm's operation.Indeed, when the membrane moves from the first stable position to the second stable position, the pressure changes sharply and rapidly, which is detectable by the pressure sensor. The membrane position determination system includes a membrane position detection sensor, preferably one chosen from the group including an optical sensor, an electromagnetic sensor, an inductive sensor, a capacitive sensor, a rebound sensor, an ultrasonic sensor, and a contact sensor. Thus, a simple and standardized method is available for controlling the membrane position.

[0008] The invention also relates in particular to a product distribution system comprising a product distribution device as described above, and a product distribution unit.

[0009] Depending on other optional features of the distribution system, taken alone or in combination: The product delivery unit includes a needle insertion device for inserting and injecting a product to an adjustable depth to allow for different types of injection. The insertion device includes a needle holder on which the insertion needle is mounted. The needle holder is movable between different positions, including at least one insertion position. The insertion device includes a catheter movable relative to the needle and a catheter holder capable of moving the catheter with the needle as the needle holder moves to at least one insertion position, and of disengaging it from the needle so that the catheter remains locked in motion when the needle holder retracts from at least one insertion position.The insertion device includes an insertion needle, separate from the needle in the dispensing device, which allows for insertion at a specific site. The dispensing system is portable. This allows the user to move around and carry out simple activities while receiving the product, which may, for example, be a medical product as part of a therapeutic treatment.

[0010] The invention also relates in particular to an assembly kit for a product distribution system, comprising a distribution device as described above, and preferably a product distribution unit.

[0011] Depending on other optional features of the assembly kit, taken alone or in combination: The assembly kit comprises a first module containing the product dispensing device and a product dispensing unit, and a second module comprising means for adjusting the product dispensing unit and, optionally, means for controlling the product dispensing unit. The first module is removably mounted on the second module. The adjustment and / or control means are connected to the product dispensing device, preferably interacting with the membrane positioning system. The adjustment means include a knob or a screw-nut assembly accessible to a user. The adjustment means include electronic control means. The control means include at least one distance sensor and / or at least one displacement sensor.At least one distance sensor and / or at least one displacement sensor is an inductive, capacitive, optical, ultrasonic, microwave, or optoelectronic sensor. The assembly kit includes a pump configured to move the diaphragm from the first stable position to the second stable position and to dispense product from the reservoir through the connecting needle when the diaphragm is in the second stable position. The pump is directly integrated into the first or second module. A motor may be integrated into the first or second module. The motor drives the pump according to one embodiment. Optionally, the motor may also drive the product dispensing unit. Preferably, the motor is an electric motor.The first module of the assembly kit corresponds to a disposable part, and the second module corresponds to a reusable part.

[0012] Thus, we have an economical distribution system, in which expensive and reusable elements, for example a motor, are integrated into a reusable part, while preserving safety, because the elements in contact with the product, for example the distribution device, are not reusable and are grouped in the disposable part, which is quite separate from the reusable part.

[0013] The assembly kit allows, for example, medical staff or the patient to have all the elements available to carry out a treatment or to resupply medical staff or the patient with part of the elements needed for the distribution system of a product in a site, including one or more disposable parts. Brief description of the figures

[0014] The invention will be better understood upon reading the following description, given solely by way of example and made with reference to the accompanying drawings in which: [ Fig. 1 ] there figure 1 is a schematic cross-sectional view of a distribution device according to a first embodiment. Fig. 2 ] there figure 2 is a schematic cross-sectional view of a detail of the distribution device according to the first embodiment, in which the membrane is in its first stable position. Fig. 3 ] there figure 3 is a schematic cross-sectional view of a detail of the distribution device according to the first embodiment, in which the membrane is in its second stable position. Fig. 4 ] there figure 4 is a schematic perspective cross-sectional view of a detail of a distribution device according to a second embodiment. Fig. 5 ] there figure 5is a schematic perspective view of a detail of the distribution device according to the second embodiment. Detailed description

[0015] In all figures, the same reference numerals refer to the same elements. The following embodiments are examples. Although the description refers to one or more embodiments, this does not necessarily mean that each reference numeral relates to the same embodiment, or that the features apply only to a single embodiment. Simple features from different embodiments can also be combined to provide other embodiments.

[0016] We have represented on the figure 1 a distribution device according to a first embodiment, designated by the general reference 1.

[0017] The product dispensing device 1 includes a product P reservoir 3, a membrane 5, a fixing ring 7 and a needle 8. The dispensing device 1 is portable.

[0018] Reservoir 3 has a neck 9 defining an opening 11. More specifically, in this example, reservoir 3 has a syringe shape with the neck 9. Reservoir 3 is made of glass or thermoplastic material. The product P contained in reservoir 3 is, in this example, a liquid product, preferably intended for introduction into a subject, for example, a human patient. For example, product P is a drug. In a variant not shown, the reservoir has a cartridge shape with a neck. In another variant not shown, the reservoir has a flexible pouch connected to a neck that is more rigid than the flexible pouch, which allows the membrane to be fixed to the neck via the fixing ring 7.

[0019] Products, including pharmaceuticals, that may be used by the dispensing device include, for example, formulations containing at least one active ingredient such as peptides, proteins, hormones, active ingredients of biological origin, active ingredients based on nucleotides, such as DNA, RNA or oligonucleotides, active ingredients with a molecular weight of up to 1500 Da, polysaccharides, vaccines, enzymes, antibodies, nutritional formulas and other substances or mixtures thereof.

[0020] The products, including pharmaceuticals, that can be used by the distribution device may be used for the treatment and / or prevention of diabetes, thrombosis, cardiovascular diseases such as coronary syndrome, angina, myocardial infarction, cancers, macular degeneration, inflammations, atherosclerosis and / or rheumatoid arthritis.

[0021] These active ingredients may include, but are not limited to, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, C-peptide, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptides (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies such as monoclonal antibodies, and any therapeutic agent that can be delivered by the above-mentioned device, as well as a pharmaceutically acceptable salt and / or solvate and / or hydrate of the active ingredients listed above. The medicinal product as used in the device may be formulated with one or more excipients.

[0022] In particular, the product may include at least one peptide for the treatment and / or prevention of diabetes.

[0023] In particular, the product may include at least one human insulin or an insulin derivative or analogue such as, for example, glucagon-like peptide (GLP-1) or an analogue or derivative of GLP-1, or exedin-3, exedin-4 or one of their analogues or derivatives, or human Gly(A21), Arg(B31), Arg(B32) insulins; human Lys(B3), Glu(B29) insulins; human Lys(B28), Pro(B29) insulins; human Asp(B28) insulins; human B29-N-myristoyl-des(B30) insulins; human B29-N-palmitoyl-des(B30) insulins; human B29-N-myristoyl insulins; human B29-N-palmitoyl insulins; human B28-N-myristoyl LysB28ProB29 insulins; B28-N-palmitoyl-LysB28ProB29 human insulins; B30-N-myristoyl-ThrB29LysB30 human insulins; B30-N-palmitoyl-ThrB29LysB30 human insulins; B29-N-(N-palmitoyl-Y-glutamyl)-of(B30) human insulins; B29-N-(N-lithocholyl-Y-glutamyl)-of(B30) human insulins;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulins and B29-N-(ω-carboxyheptadecanoyl) human insulins and / or a pharmaceutically acceptable salt and / or solvate and / or hydrate of the insulins listed above.;

[0024] In particular the product may include at least one hormone such as, for example, pituitary or hypothalamic hormones such as gonadotropins (follitropins, lutropins, chorionic gonadotropins, menotropins), somatropins or somatotropins, desmopressins, terlipressins, gonadorelins, triptorelins, leuprorelins, buserelins, nafarelins, goserelins and / or a pharmaceutically acceptable salt and / or solvate and / or hydrate of the hormones listed above.

[0025] In particular the product may comprise at least one polysaccharide such as, for example, glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or a heparin derivative, a sulfated or polysulfated polysaccharide, and / or a pharmaceutically acceptable salt and / or solvate and / or hydrate of the polysaccharides listed above.

[0026] Pharmaceutically acceptable salts include, for example, acid addition salts, such as HCl or HBr salts, and basic salts, such as salts composed of an alkali cation like Na+, K+, or Ca2+, or an ammonium ion of the type N+(R1)(R2)(R3)(R4), where R1, R2, R3, and R4 independently represent: a hydrogen atom, an optionally substituted (C1-C6) alkyl group, an optionally substituted (C2-C6) alkenyl group, an optionally substituted (C6-C10) aryl group, or an optionally substituted (C6-C10) heteroaryl group. Other examples of pharmaceutically acceptable salts are well known to those skilled in the art.

[0027] The retaining ring 7 is used to secure the membrane 5 to the neck 9. In this example, the retaining ring 7 is fixed directly around the neck 9 of the reservoir 3. More precisely, the retaining ring 7 is crimped around the neck 9 of the reservoir 3, and has a narrowed diameter at its end far from the membrane so as to cooperate with the neck 9 and thus prevent its extraction from the neck 9. The retaining ring 7 is made of thermoplastic material or metallic material, preferably aluminum.

[0028] The membrane 5 closes the opening 11 and thus has an inner side 13 oriented towards the reservoir 3 and an outer side 15 opposite the inner side 13. The membrane 5 is a bistable membrane. Thus, the membrane 5 is configured to switch from a first stable position shown in detail on the figure 2, wherein the membrane 5 is convex in a first direction such that the membrane 5 protrudes inside the reservoir 3 and closes the reservoir 3, to a second stable position shown in detail on the figure 3in which the diaphragm 5 is convex in a second direction opposite to the first. More precisely, the diaphragm 5 pivots from the first stable position to the second stable position when the differential pressure between the inner side 13 and the outer side 15 of the diaphragm 5 exceeds a predetermined threshold. The predetermined threshold is between 0.4 bar and 3 bar, preferably between 0.6 bar and 0.7 bar. Thus, in this example, in its first stable position, the diaphragm 5 seals the reservoir 3 such that it blocks the distribution of product P, and in its second stable position, the diaphragm 5 is convex in the second direction such that it protrudes outside the reservoir 3. In this example, the opening 11 is closed solely by the diaphragm 5. The diaphragm 5 is mounted directly against the neck 9 of the reservoir 3, the diaphragm 5 being crimped directly onto the neck 9 of the reservoir 3 by the retaining ring 7.The membrane 5 has a disc shape and a diameter between 7 mm and 20 mm, preferably 13 mm. As shown in the figure. figure 2During assembly and storage, the membrane 5 is convex in the first direction so that it protrudes into the neck 9 of the reservoir 3, through the opening 11. The membrane 5 comprises a peripheral portion 19 and a central portion 17 that is deformable between the first stable position and the second stable position. The central portion 17 has a thickness between 0.3 mm and 2.5 mm, preferably 1 mm. The central portion 17 is disc-shaped and has a diameter between 5 mm and 16 mm, preferably 9 mm. The peripheral portion 19 is fixed, as it is axially compressed between the retaining ring 7 and the neck 9 of the reservoir 3. In its uncompressed state, the peripheral portion 19 has a thickness between 1 and 5 times the thickness of the central portion 17, preferably between 3 and 4 times the thickness of the central portion 17.The maximum distance between the first stable position and the second stable position is between 3 mm and 10 mm, preferably 5 mm. This maximum distance corresponds to the distance between the center of membrane 5 located on the central portion 17, which is convex in the first direction in the first stable position, and the center of membrane 5 located on the central portion 17, which is convex in the second direction in the second stable position. Membrane 5 is made of an elastomeric material, preferably bromobutyl or chlorobutyl-based. When membrane 5 tilts into its second stable position, it is convex in the second direction so that it can be pierced by the needle 8 located on the outer side 15 of membrane 5.

[0029] In this example, needle 8 is a connecting needle to a product P delivery line 21, preferably a connecting needle to a product delivery catheter. Needle 8 is made of metallic material, for example, stainless steel. In one embodiment, needle 8 is made of plastic material, preferably thermoplastic. For example, needle 8 is connected to an insertion device via the delivery line 21. This insertion device includes an insertion needle for inserting product P into a site within the reservoir 3 and dispensing it via needle 8 when the membrane 5 is in its second stable position. Advantageously, this insertion device may also include a needle holder on which the insertion needle is mounted, the needle holder being movable between different positions, including at least one insertion position.Preferably, the insertion device includes a movable catheter mounted relative to the insertion needle and a catheter holder capable of moving the catheter with the insertion needle as the needle holder moves to at least one insertion position, and of disengaging it from the insertion needle so that the catheter remains locked in motion when the needle holder retracts from at least one insertion position.

[0030] According to an unrepresented variant, the needle is a product injection needle, which has one end for piercing membrane 5 and an opposite end for injecting product into a site of a subject.

[0031] The needle 8 is separated from the membrane 5 when the membrane 5 is in its first stable position and passes through the membrane 5 when the membrane 5 is in its second stable position. Thus, the needle 8 allows the distribution of product P from the reservoir 3 through the needle 8 when it passes through the membrane 5 in its second stable position. The needle 8 is fixed relative to the reservoir 3. In this example, the needle 8 is fixed to the reservoir 3. For this purpose, the needle 8 is fitted into a drilling member 23, which includes a fastening element 25 for the retaining ring 7 and / or the neck 9 of the reservoir 3. The drilling member 23 is also called the fastening member and comprises the fastening element 25 and a receiving element 28 for the needle 8, into which the needle 8 is attached, advantageously fitted.The receiving element 28 of the needle 8 is fixed above the fixing ring 7 such that the fixing ring 7 includes at least a portion positioned between the receiving element 28 of the needle 8 and the membrane 5 along a central axis of the reservoir 3. The needle 8 extends through the receiving element 28 of the needle 8 and includes a first end for piercing the membrane 5 and a second end suitable for being connected directly or indirectly to the distribution tubing 21 of product P.

[0032] The needle 8's retaining element 25 and / or receiving element 28 are made of thermoplastic material. In this example, the piercing element 23 is also made of thermoplastic material. The piercing element 23 is fixed to the reservoir 3 such that an airtight seal is formed between the needle 8 and the diaphragm 5. Thus, the receiving element 28 of the needle 8 is able to form, with the diaphragm 5 when it is convex in the first direction, an airtight chamber. For this purpose, the piercing element 23 includes a seal 27 which bears against the retaining ring 7. In this example, the seal 27 is positioned between the receiving element 28 of the needle 8 and the retaining ring 7 and bears axially against the retaining ring 7.

[0033] The receiving element 28 for the needle 8 comprises, along a central axis of the reservoir, a first end through which the needle 8 passes and from which a piercing end of the needle 8 protrudes, and a second end, opposite the first end. The receiving element 28 for the needle 8 includes a product P distribution channel opening at its second end and extending between the second end and the needle 8. In one embodiment, the second end of the receiving element 28 for the needle 8 is covered by a protective element such as a film or an insulating cap against the external environment. The protective element is removed before connecting the second end of the needle 8 directly or indirectly to the product P distribution tubing 21.

[0034] In this example, the seal 27 is annular. The fastening element 25 has clipping tabs 29 that snap onto the retaining ring 7, around the neck 9, and / or onto the neck 9 of the reservoir 3. In this example, the fastening element 25 is formed as part of the drilling element 23. In other words, the needle receiving element 8 is a single piece with the fastening element. Alternatively, in one variant, the needle receiving element 8 is designed to be assembled with the fastening element. In this variant, the needle receiving element 8 and the fastening element include additional means for assembling the needle receiving element 8 to the fastening element. Advantageously, according to this variant, the receiving element of the needle 8 includes a circumferential element, such as a groove or a rib, adapted to cooperate with a corresponding circumferential element, such as a rib or a groove, of the fixing element.

[0035] The needle 8 is positioned to pierce the membrane 5 when the membrane 5 is in its second stable position. Thus, the dispensing device 1 includes the needle 8 designed to pierce the membrane 5 when the membrane 5 is in its second stable position. To achieve this, the end of the needle 8 closest to the membrane 5 is axially distant from the membrane 5, specifically opposite the outer edge 15 of the membrane 5, when the membrane 5 is in its first stable position. This distance is less than or equal to the difference between the maximum distance between the first and second stable positions and the thickness of the membrane 5, this value being between 2 and 7 mm, preferably less than 4 mm.

[0036] In order to allow the distribution of product P, the distribution device 1 in this example includes a pump 31, an electric motor 33 for driving the pump 31 and a battery 35 for powering the electric motor 33.

[0037] The pump 31 is configured to move the diaphragm 5 from the first stable position to the second stable position and to dispense product from the reservoir 3 through the needle 8 when the diaphragm 5 is in the second stable position. In this example, the pump 31 is configured to compress the product P contained in the reservoir 3. For example, the pump 31 drives a piston 37 sliding within the reservoir 3. According to a second, unshown variant, the pump 31 is a peristaltic pump acting on the dispensing tubing 21 connected to the needle 8.

[0038] The pump 31 is configured to produce a differential pressure at least equal to the predetermined threshold between the inner side 13 and the outer side 15 of the membrane 5. Thanks to this, the pump 31 ensures both the communication of the distribution tubing 21 and the reservoir 3 via the needle 8 when the membrane 5 switches from the first stable position to the second stable position, and then the effective distribution of the product P via the distribution tubing 21.

[0039] In order to control the operation of membrane 5, the distribution device 1 includes a system for determining the position of membrane 5. As shown in the figure 1The system for determining the position of the membrane 5 includes a measuring element 39 for the intensity or torque of the electric motor 33 driving the pump 31. The system for determining the position of the membrane also includes a pressure sensor 41 configured to measure a pressure on the inner side 13 and / or the outer side 15 of the membrane 5, preferably configured to measure a differential pressure between the inner side 13 and the outer side 15 of the membrane 5. The system for determining the position of the membrane 5 further includes a sensor 43 for detecting the position of the membrane 5, preferably a sensor selected from the group comprising an optical sensor, an electromagnetic sensor, an inductive sensor, a capacitive sensor, a rebound sensor, an ultrasonic sensor, a contact sensor.

[0040] To assemble a dispensing system comprising the dispensing device 1, a first module is constructed including the reservoir 3 containing product P, the retaining ring 7, the diaphragm 5, the needle 8, a first part of the system for determining the position of the diaphragm 5, and a product dispensing unit (not shown). A second module is also constructed including the pump 31 and the electric motor 33 for driving the pump 31, a second part of the system for determining the position of the diaphragm 5, and adjustment means (not shown) for the product dispensing unit. The pump 31 is configured to move the diaphragm 5 from the first stable position to the second stable position and to dispense product P from the reservoir 3 through the needle 8 when the diaphragm 5 is in the second stable position.The first and second modules together form an assembly kit, with the first module being single-use and the second module reusable in the described configuration. An assembly kit for a product distribution system is defined as a kit comprising separately arranged components—in this case, the first and second modules—which are intended to be assembled later to form a product distribution system. Thus, the assembly kit for a product distribution system includes a dispensing device (1) and a product dispensing unit.

[0041] We have represented on the Figures 4 and 5A detail of a dispensing device 1' according to a second embodiment. The dispensing device 1' according to this second embodiment differs from the dispensing device 1 according to the first embodiment in that the drilling member 23', also called the fastening member, has a fastening element 45 that is structurally different from the fastening element 25 of the first embodiment, but which performs the same function of fastening the needle 8 to the reservoir 3 in order to position it relative to the diaphragm 5. In this second embodiment, the fastening element 45 has the form of a clamp, which has a clipping tab 47 that snaps into a loop 49. The snapping is thus achieved tangentially. The fastening element 45 is, for example, made of thermoplastic material.During assembly, the drilling member 23' is pre-positioned relative to the reservoir 3, and the fastening element 45 is then attached and tightened onto both the drilling member 23' and the fastening ring 7 and / or the neck 9 of the reservoir 3. Tightening is achieved by snapping the clip 47 into the loop 49. In this embodiment, the drilling member 23 also includes an annular seal 27, which bears against the fastening ring 7 when the distribution device 1' is in the assembled state. In this example, the receiving element 28' of the needle 8 is designed to be assembled with the fastening element 45. Thus, the receiving element 28' of the needle 8 and the fastening element 45 include additional means for assembling the receiving element 28' of the needle 8 to the fastening element 45.Advantageously, the receiving element 28' of the needle 8 includes a circumferential element, such as a groove or a rib, adapted to cooperate with a corresponding circumferential element, such as a rib or a groove, of the fixing element 45.

[0042] The receiving element 28' for the needle 8 comprises, along a central axis of the reservoir, a first end through which the needle 8 passes and from which a piercing end of the needle 8 protrudes, and a second end, opposite the first end, covered by a protective element such as a film or an insulating cap against the external environment. The receiving element 28' for the needle 8 comprises a product distribution channel P opening at its second end and extending between the second end and the needle 8.

[0043] In the embodiment shown in the figures, the needle is a beveled needle whose membrane piercing end has an opening facing the membrane and designed to allow the product to pass through. During product dispensing, the product is then designed to pass through the needle from the piercing end to a dispensing end opposite the piercing end along a longitudinal axis of the needle. Alternatively, the needle is a pencil point needle having, between the membrane piercing end and a dispensing end opposite the piercing end along a longitudinal axis of the needle, a lateral opening designed to allow the product to pass through. During product dispensing, the product is then designed to pass through the needle from the lateral opening to the dispensing end.

[0044] The invention is not limited to the embodiments shown, and other embodiments will be obvious to those skilled in the art. In particular, it is possible to combine the embodiments with each other. List of references

[0045] 1, 1': Dispensing device 3: Reservoir 5: Diaphragm 7: Fixing ring 8: Needle 9: Neck 11: Opening 13: Inner side 15: Outer side 17: Central part 19: Peripheral part 21: Dispensing tube 23, 23': Piercing element 25: Fixing element 27: Seal 28, 28': Receiving element 29: Clipping tab 31: Pump 33: Electric motor 35: Battery 37: Piston 38: Rod 39: Measuring element 41: Pressure sensor 43: Detection sensor 45: Fixing element 47: Clipping tab 49: Loop P: Product

Claims

1. Dispensing device (1, 1') for dispensing a product (P), comprising: - a reservoir (3) of product (P) provided with a collar (9) delimiting an opening (11), - a membrane (5) closing the opening (11) and thus having an inner side (13) oriented towards the reservoir (3) and an outer side (15) away from the inner side (13), - a securing ring (7) for securing the membrane (5) to the collar (9), characterized in that the membrane (5) being bistable in that it is configured to flip from a first stable position, in which the membrane (5) bulges in a first direction such that it protrudes into the reservoir (3) and closes off the reservoir (3), into a second stable position, in which the membrane (5) bulges in a second direction opposite to the first direction so as to be pierced by a needle (8) disposed on the outer side (15) of the membrane (5).

2. Dispensing device (1, 1') according to the preceding claim, wherein the membrane (5) is made of elastomer material, preferably bromobutyl-based or chlorobutyl-based.

3. Dispensing device (1, 1') according to any one of the preceding claims, which comprises the needle (8) as needle for connecting to a product distribution tubing (21), the needle (8) being configured to be distant from the membrane (5) when the membrane (5) is in the first stable position and to cross through the membrane (5) when the membrane (5) is in the second stable position.

4. Dispensing device (1, 1') according to any one of the preceding claims, wherein the device comprises the needle (8) which is fixedly mounted with respect to the reservoir (3).

5. Dispensing device (1, 1') according to any one of the preceding claims, wherein the membrane (5) has a peripheral part (19) which is compressed axially between the securing ring (7) and the collar (9) of the reservoir (3).

6. Dispensing device (1, 1') according to any one of the preceding claims, wherein the membrane (5) comprises a central part (17) that is deformable between the first stable position and the second stable position, the thickness of the central part (17) being between 0.3 mm and 2.5 mm, preferably equal to 1 mm.

7. Dispensing device (1, 1') according to any one of the preceding claims, wherein the membrane (5) is configured to flip from a first stable position into a second stable position when the differential pressure between the inner side (13) and the outer side (15) of the membrane (5) is greater than a predetermined threshold.

8. Dispensing device (1, 1') according to the preceding claim, wherein the predetermined threshold is between 0.4 bar and 3 bar, preferably between 0.6 bar and 0.7 bar.

9. Dispensing device (1, 1') according to any one of the preceding claims, which comprises a pump (31) and an electric motor (33) to drive the pump (31), the pump (31) being configured to flip the membrane (5) from the first stable position into the second stable position and to dispense product (P) out of the reservoir (3) via the needle (8) when the membrane (5) is in the second stable position.

10. Dispensing device (1, 1') according to any one of the preceding claims, which comprises a system for determining the position of the membrane (5).

11. Dispensing device (1, 1') according to the preceding claim in its dependence on claim 9, wherein the system for determining the position of the membrane (5) comprises a member (39) for measuring the current or torque of the electric motor (33) driving the pump (31).

12. Dispensing device (1, 1') according to claim 10 or 11, wherein the system for determining the position of the membrane (5) comprises a pressure sensor (41) configured to measure a pressure on the inner side (13) and / or the outer side (15) of the membrane (5), preferably configured to measure a differential pressure between the inner side (13) and the outer side (15) of the membrane (5).

13. System for dispensing a product (P) comprising a dispensing device (1, 1') according to any one of the preceding claims and a product dispensing unit.

14. Assembly kit for a system for dispensing a product, comprising a dispensing device (1, 1') according to any one of claims 1 to 12 and a product dispensing unit.