Device for administering a fluid substance

Abstract

The invention relates to a device and a method for assembling this device for administering a fluid substance. The device according to the invention comprises a housing (1) and a product container (2) which is accommodated in an axially fixed manner in the housing (1) and has a needle (2a), wherein the substance can be administered through the needle (2a). The device according to the invention further comprises an inwardly directed shoulder support (1a) which is provided on the housing (1) and on which the product container (2) bears with a distally arranged shoulder (2b), in order to prevent an axial relative movement between the product container (2) and the housing (1) in the distal direction.

Description

[0001] Device for administering a fluid substance

[0002] The invention relates to a device with a longitudinal axis (L) and a mounting of this device for administering a fluid substance, in particular a medicament.

[0003] The term "medicine" as used herein includes any flowable medicinal formulation suitable for controlled administration through a means such as a cannula or needle, for example, comprising a liquid, a solution, a gel, or a fine suspension containing one or more medicinally active ingredients. A medicament may be a composition with a single active ingredient or a premixed or co-formulated composition with multiple active ingredients from a single container. Medication includes drugs such as peptides (e.g.Insulins, insulin-containing medicines, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active ingredients, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances in solid (suspended) or liquid form, but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base, excipient and carrier substances.

[0004] Devices for administering a fluid substance are known from the prior art. EP2742962B1, for example, discloses an auto-injector comprising a housing and a syringe, wherein the syringe is axially fixedly received in a syringe holder. The syringe holder has a shoulder support, which serves to secure the syringe on a shoulder against movement along the longitudinal axis (L) in the distal direction relative to the syringe holder. In addition, the housing has a holding portion, which holds the shoulder support of the syringe holder in engagement with the shoulder of the syringe in order to secure the syringe in the auto-injector against movement along the longitudinal axis (L) in the distal direction.

[0005] The disadvantage of this auto-injector is that it has a complex structure.

[0006] It is an object of the invention to provide an alternative device and a mounting of this device for administering a fluid substance, which is constructed simply and safely.

[0007] In the following, the proximal direction in a device for administering a fluid substance means the direction towards the housing end and the distal direction in this device means the direction towards the needle end.

[0008] The device according to the invention with a longitudinal axis (L) for administering a fluid substance, in particular a medicament, has a housing. The housing is preferably elongated. The housing can preferably be sleeve-shaped and / or cylindrical, in particular circular-cylindrical. A product container is axially and firmly received in the housing. The product container contains the substance to be administered. The product container has a needle through which the substance can be administered. The product container can be designed as a syringe comprising a syringe body and a needle received at a distal end of the syringe body. Alternatively, the product container can be designed as a carpule with a carpule body and an attachable and removable needle unit.The needle or needle unit may include a removable needle shield to protect the needle from contamination and to keep the needle and the substance being administered sterile.

[0009] The device according to the invention further comprises an inwardly directed shoulder support provided on the housing, against which the product container is supported with a distally arranged shoulder in order to prevent axial relative movement between the product container and the housing in the distal direction. The shoulder of the product container is designed as a tapered section in the distal region of the product container, in particular in the distal region of the syringe body or the carpule body. The inwardly directed shoulder support of the housing is preferably elastic, in particular designed as an elastic holding arm or elastic snap arm. One or more holding arms or snap arms can be provided. The shoulder support is designed such that it can engage with the shoulder of the product container in order to prevent axial relative movement between the product container and the housing in the distal direction.The shoulder support of the housing is designed to be radially outwardly prestressed or radially deflectable. The needle of the product container is covered with the removable needle protection sleeve, wherein the inwardly directed shoulder support of the housing is snapped between a proximal end of the needle protection sleeve and the distal shoulder of the product container or engages when the product container is axially firmly received in the housing. When engaged, the shoulder support is relaxed or snapped in, wherein the shoulder of the product container is supported on the shoulder support of the housing. The shoulder support of the housing can preferably be formed as a single piece or integrally with the housing.This allows the device to be constructed with few components and at a low cost, since the use of the product container holder for holding and inserting the product container into the device housing is eliminated during assembly. Alternatively, the shoulder support and the housing can be formed in two parts or in two pieces, with the shoulder support being axially and rotationally fixed to the housing. This simplifies the assembly of the device.

[0010] Furthermore, the device according to the invention comprises a needle protection element for the needle, which can be displaced relative to the housing. The needle protection element can be sleeve-shaped and / or cylindrical, in particular circular-cylindrical. The needle protection element can serve to protect against puncture injuries caused by the needle, in particular by a distal tip of the needle. Furthermore, the device has a needle protection spring which is coupled to the needle protection element, wherein the needle protection element is axially movable from an initial position in which the distal tip of the needle is surrounded by the needle protection element, to a release position in which the distal tip of the needle is released by the needle protection element. From the initial position to the release position, the needle protection element moves in the proximal direction relative to the housing.

[0011] Furthermore, the device according to the invention comprises a drive device which is driven into a dispensing position by a dispensing spring in order to administer the substance from the product container. The dispensing spring provides the energy to effect the substance administration, in order to administer the substance from the product container through the needle. The device can be designed as an auto-injector. Auto-injectors are often referred to as devices which automatically dispense a substance to be administered to a patient after being triggered. Preferably, the drive device can be released or released by the axial movement of the needle protection element from the starting position to the trigger position in order to administer the substance from the product container.

[0012] The needle protection element preferably comprises a cam or a projection which, in the starting position of the needle protection element, engages with an opening in the housing or in a part fixed to the housing or abuts against a distal end of an opening in the housing or in a part fixed to the housing, wherein the cam or the projection is elastically arranged on the needle protection element. The cam or the projection can be arranged so as to be radially or tangentially deflectable. Alternatively, a cam or a projection can be provided on the housing or on a part fixed to the housing, which is engaged with an opening in the needle protection element or abuts against a distal end of an opening on the needle protection element, wherein the cam or the projection is elastically arranged on the housing or on a part fixed to the housing.This engagement or stop serves to create a trigger resistance between the needle guard and the housing or a part of the device fixed to the housing. When the needle guard moves from its initial position to the trigger position, a trigger resistance must be overcome, which at least makes unintentional triggering more difficult.

[0013] Alternatively, the device can be triggered by pressing a trigger button. The device can be designed to provide for manual or automatic insertion of the needle into the patient's skin and / or manual or automatic retraction of the needle into the device housing.

[0014] The needle protection spring and the dispensing spring can be designed as compression springs. Particularly preferably, the two springs are designed as spiral springs. However, other springs can also be provided. The needle protection spring and the dispensing spring are designed to be tensioned and relaxed. The force of the needle protection spring causes the needle protection element to move from the starting position to the dispensing position and back in the distal direction into a protective position. The force of the dispensing spring causes the dispensing spring to dispense the entire amount of the substance to be administered or a portion of the substance to be administered. The needle protection spring and the dispensing spring can preferably be made of metal. Other materials, such as plastic, can also be provided.

[0015] The device according to the invention further comprises a compensating spring provided on the housing, which is supported on a proximal end of the product container and via which the product container is elastically supported on the housing in and against the dispensing direction. The compensating spring can be designed as a single piece or as a single piece with the housing. This makes it possible to construct the device with few components and at a low cost, since the use of the compensating spring of the device can be omitted during assembly. Alternatively, the compensating spring and the housing can be designed as a two-piece or two-part unit, with the compensating spring and the housing being arranged axially and rotationally fixed to one another. This makes it possible to easily assemble the device. The compensating spring is designed so that it can be tensioned and relaxed.The compensating spring is designed such that it rests on the proximal end of the product container and elastically supports the product container against the housing, both in and against the discharge direction. This compensates for differences in the length of the product container that may arise due to manufacturing tolerances. Furthermore, it ensures that the product container sits securely on the shoulder support of the housing. The compensating spring is preferably made of plastic. Other materials, such as metal, can also be used.

[0016] The needle protection element can allow a radial outward pre-tensioning or a radial deflection of the shoulder support of the housing in a distal position and prevent a radial outward pre-tensioning or a radial deflection of the shoulder support of the housing in a proximal position. This allows, on the one hand, the product container to be pushed axially into the housing in the distal direction and, on the other hand, when the product container is axially firmly received in the housing, an axial relative movement between the product container and the housing in the distal direction can be prevented. The needle protection element holds the shoulder support of the housing in engagement with the shoulder of the product container in order to secure the product container in the device against movement along the longitudinal axis (L) in the distal direction. The needle protection element is sleeve-shaped.The needle protection element is preferably arranged radially between the product container and the housing. The needle protection element preferably has a wall thickness along the longitudinal axis (L). The wall thickness of the needle protection element can vary along the longitudinal axis (L). The wall thickness of the needle protection element is determined such that a radial deflection of the shoulder support is possible during one assembly step of the device and a radial deflection of the shoulder support is prevented during another assembly step of the device. The assembly position of the device depends on the axial relative position between the needle protection element and the housing. Particularly preferably, a distal region of the needle protection element has a greater wall thickness than a proximal region of the needle protection element. A proximal region of the needle protection element can have a thinner wall thickness than a distal region of the needle protection element.The needle protection element may comprise a distal and a proximal region which have different wall thicknesses.

[0017] The invention further relates to a method for assembling this device according to the invention. In a first step, a housing is provided with an inwardly directed shoulder support for receiving a product container. A needle protection element is pre-assembled in the housing. The needle protection element is positioned in a distal position relative to the housing. Furthermore, a product container with a distally arranged shoulder and a needle covered with a removable needle protection sleeve is provided. In a further step, the product container is displaced or inserted into the housing along a longitudinal axis (L) in a distal direction. During or during this axial relative movement between the product container and the housing, in particular during this displacement or during this insertion of the product container into the housing, the shoulder support of the housing is positioned in the proximal region of the needle protection element.The needle shield is arranged in the distal position relative to the housing. In the distal position of the needle shield, the proximal region of the needle shield is arranged radially offset relative to the shoulder support of the housing. In the distal position of the needle shield, the shoulder support of the housing can be preloaded radially outward or deflected radially. During or upon insertion of the product container into the housing, the inwardly directed shoulder support of the housing slides over an outer surface of the needle shield sleeve of the product container and is thereby preloaded radially outward or deflected radially.When the radially outwardly prestressed or radially deflected shoulder support of the housing reaches or is positioned between a proximal end of the needle protection sleeve and the distally arranged shoulder of the product container, the radially outwardly prestressed or radially deflected shoulder support can relax or snap into place between the proximal end of the needle protection sleeve and the distally arranged shoulder. The needle protection element can then be displaced relative to the housing in the proximal direction up to a proximal position. In the proximal position of the needle protection element, a renewed radial outward prestressing or a renewed radial deflection of the shoulder support of the housing is prevented by the needle protection element. In the proximal position of the needle protection element, the distal region of the needle protection element is arranged radially offset relative to the shoulder support of the housing.The proximal position of the needle protection element preferably forms the starting position of the needle protection element.

[0018] The advantage of this method is that few assembly steps are required to create the device according to the invention. During assembly, the provision of a product container holder for holding and inserting the product container into the device housing can be omitted. This allows for a cost-effective device according to the invention.

[0019] Furthermore, the housing of the device according to the invention can have a housing stop and the needle protection element can have a needle protection stop, wherein the needle protection element is in the stop position in the proximal position or a stop position of the device. The housing stop and / or the needle protection stop can be designed to be elastic. In the proximal position or stop position of the device, the needle protection element can no longer be pushed further relative to the housing and into the housing. This can ensure that radial outward pretensioning or radial deflection of the shoulder support of the housing is prevented. The product container is supported with the distally arranged shoulder on the inwardly directed shoulder support of the housing in order to prevent axial relative movement between the product container and the housing in the distal direction.

[0020] In a further step, a compensating spring, which rests on a proximal end of the product container and elastically supports the product container against the housing in and against the discharge direction, can be fixedly mounted in or to the housing. In an alternative embodiment, the housing already includes this compensating spring. The compensating spring serves to ensure the product container sits firmly on the shoulder support of the housing.

[0021] In order for the patient to use the device to administer the substance, the patient must first remove a cap that is detachably attached to the device. Removing the cap from the device removes the needle shield that is removably attached to the needle. The patient then presses the device against the skin, which moves the needle shield element proximal to the housing from its initial position to the release position.

[0022] If a certain threshold value of the force acting on the stop in the proximal direction is exceeded, the housing stop or the needle protection stop can be deflected radially or tangentially so that the needle protection element can be moved into the release position in which a distal tip of the needle is released.

[0023] Alternatively or additionally, if a certain threshold value of the force acting on the stop or engagement in the proximal direction is exceeded, the trigger resistance described above can be overcome. During or during the movement of the needle protection element into the trigger position, the needle is inserted into the patient's skin. The needle protection element moves from the starting position to the trigger position, releasing the drive device to administer the substance from the product container. The drive device is driven into the dispensing position by a dispensing spring to administer the substance from the product container. At the end of administration, the patient can remove the device from the skin. The force of the needle protection spring moves the needle protection element from the trigger position in the distal direction into the protective position.The home position and the protection position can be located at the same axial position or at different axial positions along the longitudinal axis (L) of the device. In the protection position, the needle shield can be locked, preventing further movement of the needle shield to the proximal position. The patient cannot retrigger the device.

[0024] The invention is described below with reference to several figures. The features disclosed herein advantageously further develop the invention, both individually and in combination. They show:

[0025] Figure 1 is a perspective longitudinal sectional view of an embodiment of the device according to the invention with a longitudinal axis (L) in a first assembly step.

[0026] Figure 2 is a perspective longitudinal sectional view of the device according to Figure 1 in a second assembly step.

[0027] Figure 3 is a perspective longitudinal sectional view of the device according to Figure 1 in a third assembly step.

[0028] Figure 1 shows a perspective longitudinal sectional view of an embodiment of the device according to the invention with a longitudinal axis (L) in a first assembly step. First, a housing (1) is provided with an inwardly directed shoulder support (1a) for receiving a product container (2). The inwardly directed shoulder support (1a) is designed to be elastic. The housing (1) and the inwardly directed shoulder support (1a) are formed in one piece or as a single piece. Furthermore, the product container (2) is provided with a distally arranged shoulder (2b) and a needle (2a) which is covered with a removable needle protection sleeve (2c). A needle protection element (3) is arranged radially between the product container (2) and the housing (1). The needle protection element (3) is arranged in a distal position. The needle protection element (3) has a different wall thickness along the longitudinal axis (L).The wall thickness of the needle protection element (3) is determined such that a radial deflection of the shoulder support (1a) is possible in one assembly step of the device and a radial deflection of the shoulder support (1a) is prevented in another assembly step of the device. A distal region of the needle protection element (3) has a greater wall thickness than a proximal region of the needle protection element (3). The proximal region of the needle protection element (3) has a thinner wall thickness than the distal region of the needle protection element (3). As can be seen in Figure 2, in a second assembly step, the product container (2) is displaced or inserted into the housing (1) along a longitudinal axis (L) in a distal direction. During this axial relative movement between the product container (2) and the housing (1), the inwardly directed shoulder support (1a) of the housing (1) slides over an outer surface of the needle protection sleeve (2c).The shoulder support (1a) of the housing (1) is prestressed radially outwards or deflected radially. The proximal region of the needle protection element (3) is arranged radially offset relative to the shoulder support (1a) of the housing (1), wherein the radial outwards prestressing or the radial deflection of the shoulder support (1a) of the housing (1) is possible. When the radially outwards prestressed or radially deflected shoulder support (1a) of the housing (1) reaches or is positioned between a proximal end of the needle protection sleeve (2c) and the distally arranged shoulder (2b) of the product container (2), the radially outwards prestressed or radially deflected shoulder support (1a) can relax or snap into place between the proximal end of the needle protection sleeve (2c) and the distally arranged shoulder (2b).When the shoulder support (1a) of the housing (1) is snapped between the proximal end of the needle protection sleeve (2c) and the distally arranged shoulder (2b) of the product container (2), the shoulder support (1a) of the housing (1) is released. The proximal region of the needle protection element (3) is arranged between the product container (2) and the housing (1).

[0029] As shown in Figure 3, in a third assembly step, the needle protection element (3) is displaced relative to the housing (1) and into the housing (1) in the proximal direction up to a proximal position of the needle protection element (3). In the proximal position of the needle protection element (3), a renewed radial outward pretensioning or a renewed radial deflection of the shoulder support (1a) of the housing (1) is prevented. The distal region of the needle protection element (3) is arranged radially offset relative to the shoulder support (1a) of the housing (1). In this position, a radial deflection or a radial pivoting out of the shoulder support (1a) of the housing (1) is prevented by the axial arrangement of the needle protection element (3). In the proximal position of the needle protection element (3), the needle protection element (3) holds the shoulder support (1a) of the housing (1) in engagement with the shoulder (2b) of the product container (2).A needle protection stop (3a) provided on the needle protection element (3) comes into contact with a housing stop (1b) attached to the housing (1). The stop forms and / or defines the stop position of the device and / or the proximal position of the needle protection element (3). The housing stop (1b) and / or the needle protection stop (3a) can be designed to be elastic. In the stop position of the device, the needle protection stop is in contact with the housing stop, so that the needle protection element can no longer be pushed further relative to the housing (1) and into the housing (1). The product container (2) is supported by the distally arranged shoulder (2b) on the inwardly directed shoulder support (1a) of the housing (1) in order to prevent an axial relative movement between the product container (2) and the housing (1) in the distal direction.In a further assembly step, a compensating spring, which rests on a proximal end of the product container (2) and via which the product container (2) is elastically supported on the housing (1) in and against the discharge direction, can be fixedly fastened in or to the housing (1). The compensating spring serves to ensure the secure fit of the product container (2) on the shoulder support (2b) of the housing (1).

[0030] In order for the patient to use the device to administer the substance, the patient must first remove a cap (4) detachably attached to the device. Removing the cap (4) from the device removes the needle protection sheath (2c) removably attached to the needle (2a). The patient then presses the device against the skin, whereby the needle protection element (3) is displaced from the distal position to the proximal position relative to the housing (1). If a certain threshold value of the force acting in the proximal direction is exceeded, in particular the force acting via the needle protection element (3) on the housing stop (1b) of the housing (1), the housing stop (1b) is deflected radially or tangentially, such that the needle protection element (3) is moved into a proximal position in which a distal tip of the needle (2a) is exposed.The needle shield (3) moves from the distal position to the proximal position, releasing a drive mechanism to dispense the substance from the product container (2). The drive mechanism is driven into a dispensing position by a dispensing spring to dispense the substance from the product container (2). At the end of administration, the patient can remove the device from the skin. The force of the needle shield spring moves the needle shield (3) in the proximal direction. This locks the needle shield (3), preventing further movement of the needle shield (3) in the proximal direction. The patient cannot trigger the procedure again.

[0031] Reference symbol:

[0032] 1 housing

[0033] 1a Shoulder rest 1b Housing stop

[0034] 2 product containers 2a needle

[0035] 2b shoulder

[0036] 2c Needle protection sleeve

[0037] 3 Needle protection element

[0038] 3a Needle guard stop

[0039] 4 cap

[0040] L Longitudinal axis

Claims

Patent claims 1 . Device for administering a fluid substance having a longitudinal axis (L) comprising: 1.1 a housing (1); 1.2 a product container (2) axially fixed in the housing (1) with a needle (2a), wherein the substance can be administered through the needle (2a); 1.3 an inwardly directed shoulder support (1 a) provided on the housing (1), on which the product container (2) is supported by a distally arranged shoulder (2 b) in order to prevent axial relative movement between the product container (2) and the housing (1 ) in the distal direction; 1.4 a needle protection element for the needle (2a) provided in the housing (1) and displaceable relative to the housing (1); 1.5 a needle protection spring which is coupled to the needle protection element (3), wherein the needle protection element is axially movable from an initial position in which the distal tip of the needle (2a) is surrounded by the needle protection element (3) and into a release position in which the distal tip of the needle (2a) is released from the needle protection element (3); 1.6 a drive device movably received in the housing (1) which is driven into a dispensing position by a dispensing spring in order to administer the substance from the product container (2); 1.7 a compensating spring provided on the housing (1), which is supported on a proximal end of the product container (2) and via which the product container (2) is elastically supported on the housing (1) in and against the dispensing direction.

2. Device according to claim 1, characterized in that the needle protection element (3) in a distal position prevents a radial outward pretensioning or radial deflection of the shoulder support (1 a), wherein a proximal region of the needle protection element (3) is arranged radially offset relative to the shoulder support (1 a) of the housing.

3. Device according to claim 1 or 2, characterized in that the needle protection element (3) in a proximal position prevents a radial outward pretensioning or a radial deflection of the shoulder support (1 a), wherein a distal region of the needle protection element (3) is arranged radially offset relative to the shoulder support (1 a) of the housing.

4. Device according to one of the preceding claims, characterized in that the drive device is released by the axial movement of the needle protection element (3) from the starting position to the triggering position in order to administer the substance from the product container (2).

5. Device according to one of the preceding claims, characterized in that the needle (2a) of the product container is covered with a removable needle protection sleeve (2c) and the inwardly directed shoulder support (1 a) of the housing (1) is snapped or engages between a proximal end of the needle protection sleeve (2c) and the distal shoulder (2b) of the product container (2).

6. Device according to one of the preceding claims, characterized in that the shoulder support is formed integrally with the housing.

7. A method for assembling a device for ejecting a substance according to any one of the preceding claims, comprising the following steps: -providing a housing (1) with an inwardly directed shoulder support (1 a) for receiving a product container (2), -providing a product container (2) with a distally arranged shoulder (2b) and a needle (1a) which is covered with a removable needle protection sleeve (2c), -Displacing or inserting the product container (2) into the housing (1) along a longitudinal axis (L) in a distal direction, wherein the inwardly directed shoulder support (1 a) slides over an outer surface of the needle protection sleeve (2c) and is thereby prestressed radially outwards or is deflected radially, - Relaxing or snapping the radially outwardly prestressed or radially deflected shoulder support (1 a) between a proximal end of the needle protection sleeve (2c) and the distally arranged shoulder (2b) of the product container (2), characterized by, -Displacing the needle protection element (3) relative to and into the housing (1) in the proximal direction up to a proximal position of the needle protection element (3) or a stop position of the device, in which a renewed radial outward pretensioning or a renewed radial deflection of the shoulder support (1 a) is prevented.

8. Method according to claim 7, characterized in that in the proximal position of the needle protection element (3) or in the stop position of the device, the needle protection element (3) is in abutment with a needle protection stop (3a) against a housing stop (1b) of the housing (1).

9. Method according to claim 8, characterized in that when a certain threshold value of the force acting in the proximal direction, in particular the force acting on the stop via the needle protection element (3), is exceeded, the housing stop (1b) or the needle protection stop (3a) is deflected radially, so that the needle protection element (3) can be moved into a release position in which a distal tip of the needle (2a) is released.

10. Method according to claim 9, characterized in that the needle protection element (3) is moved from the starting position into the triggering position, wherein the drive device is released in order to substance from the product container (2).

11. Method according to claim 10, characterized in that the drive device is driven by a discharge spring into a discharge position in order to eject the substance from the product container (2).

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