Device for administering a fluid substance

Abstract

The invention relates to a device for administering a fluid substance and to a method for assembling such a device. The device according to the invention comprises a housing (1) and a product container (2) with a needle (2a), which is axially fixedly received in the housing (1), wherein a substance can be administered through the needle (2a). Furthermore, the device according to the invention comprises an inwardly directed shoulder-like bearing (1a) arranged at the housing (1), on which the product container (2) is supported with a distally arranged shoulder (2b) in order to prevent an axial relative movement between the product container (2) and the housing (1) in distal direction.

Description

Technical Field

[0001] The present invention relates to a device having a longitudinal axis (L) for delivering fluid substances, particularly pharmaceuticals, and an assembly scheme for such a device. Background Technology

[0002] The term "medicine" herein includes every flowable medical formulation suitable for controlled delivery through devices such as cannulas or needles, comprising liquids, solutions, gels, or fine suspensions containing one or more therapeutically active substances. A medicine can be a composition having a single active substance or a premixed or co-formulated composition having multiple active substances from a single container. Medicines include pharmaceutical preparations such as peptides (e.g., insulin, insulin-containing drugs, preparations containing GLP-1 or its derivatives or similar), proteins and hormones, bio-derived or active active substances, hormone- or gene-based active substances, nutritional formulations, enzymes, and other substances, not only in solid (suspension) or liquid form, but also polysaccharides, vaccines, DNS or RNS or oligonucleotides, antibodies or portions of antibodies, and suitable matrix, adjuvants, and carrier substances.

[0003] Devices for dispensing fluid substances are known from the prior art. For example, EP2742962B1 discloses an autoinjector having a housing and an injector, wherein the injector is axially fixedly received in an injector holder. The injector holder has a shoulder-shaped support for securing the injector at the shoulder to prevent movement relative to the injector holder in the distal direction along the longitudinal axis (L). Furthermore, the housing has a retaining section that engages the shoulder-shaped support of the injector holder with the shoulder of the injector to secure the injector in the autoinjector to prevent movement in the distal direction along the longitudinal axis (L).

[0004] The disadvantage of this autoinjector is that it has a complex construction. Summary of the Invention

[0005] The object of the present invention is to provide an alternative device and an assembly scheme for such a device for conveying fluid substances, the device being simple and reliable in construction.

[0006] In the following text, in the device for conveying fluid substances, the proximal direction means the direction toward the end of the housing, while the distal direction in the device means the direction toward the end of the needle.

[0007] The device according to the invention for delivering fluid substances, particularly pharmaceuticals, having a longitudinal axis (L), has a housing. The housing is preferably constructed longitudinally. The housing is preferably constructed in a sleeve-like and / or cylindrical, particularly cylindrical, manner. A product container is axially fixedly received within the housing. The product container contains the substance to be delivered. The product container has a needle through which the substance can be delivered. The product container can be constructed as an injector, comprising an injector body and a needle received at the distal end of the injector body. Alternatively, the product container can be constructed as a Karpule, having a Karpule body and an mountable and removable needle unit. The needle or needle unit can have a removable needle protective sleeve to protect the needle from contamination and to keep the needle and the substance to be delivered sterile.

[0008] Furthermore, the device according to the invention includes an inwardly pointing shoulder-shaped support disposed on the housing, at which the product container is supported by a distally arranged shoulder to prevent axial relative movement between the product container and the housing in the distal direction. The shoulder of the product container is configured as a tapering section in the distal region of the product container, particularly in the distal region of the injector body or the carpoise bottle body. The inwardly pointing shoulder-shaped support of the housing is preferably resiliently constructed, particularly as a resilient retaining arm or a resilient engaging arm. One or more retaining arms or engaging arms can be provided. The shoulder-shaped support is configured such that it can engage with the shoulder of the product container to prevent axial relative movement between the product container and the housing in the distal direction. The shoulder-shaped support of the housing is configured to be preloaded radially outward or to be deflected radially. The needle of the product container is covered by a removable needle protector sleeve, wherein, when the product container is axially fixedly received in the housing, an inwardly pointing shoulder-shaped support of the housing engages or joins between the proximal end of the needle protector sleeve and the distal shoulder of the product container. During engagement, the shoulder-shaped support is entspannt or engaged, wherein the shoulder of the product container is supported at the shoulder-shaped support of the housing. The shoulder-shaped support of the housing is preferably constructed integrally with or as a single piece of the housing. This allows the device to be constructed with fewer components and at a lower cost, as a product container holder for holding and inserting the product container into the housing of the device can be omitted during assembly. Alternatively, the shoulder-shaped support and the housing can be constructed in two parts or as a single piece, wherein the shoulder-shaped support is axially fixed and anti-rotationally arranged relative to the housing. This simplifies the assembly of the device.

[0009] Furthermore, the device according to the invention includes a needle protection element for the needle, which is movable relative to the housing. The needle protection element can be constructed in a sleeve-like and / or cylindrical, particularly cylindrical, configuration. The needle protection element can be used to provide protection against puncture wounds caused by the needle, particularly by the distal tip of the needle. Additionally, the device has a needle protection spring coupled to the needle protection element, wherein the needle protection element is axially movable from a starting position (in which the distal tip of the needle is surrounded by the needle protection element) to a triggered position (in which the distal tip of the needle is released by the needle protection element). The needle protection element moves proximally relative to the housing from the starting position to the triggered position.

[0010] Furthermore, the device according to the invention has a drive mechanism that is driven to a discharge position by a discharge spring to dispense substance from the product container. The discharge spring provides energy to influence the delivery of the substance so that it is dispensed from the product container via a needle. The device can be configured as an autoinjector. An autoinjector is generally referred to as a device that automatically dispenses the substance to be administered to a patient upon triggering. Preferably, the drive mechanism can be released or disengaged by axial movement of the needle protection element from the starting position to the trigger position to dispense the substance from the product container.

[0011] Preferably, the needle protection element includes a protrusion or projection that engages with an opening in the housing or a component fixed to the housing in the initial position of the needle protection element, or forms a stop with the distal end of the opening in the housing or a component fixed to the housing, wherein the protrusion or projection is elastically arranged at the needle protection element. The protrusion or projection can be arranged in a manner that allows it to deflect radially or tangentially. Alternatively, the protrusion or projection can be provided at the housing or a component fixed to the housing, engaging with an opening in the needle protection element or forming a stop with the distal end of the opening at the needle protection element, wherein the protrusion or projection is elastically arranged at the housing or a component fixed to the housing. This engagement or stop serves to create a triggering resistance between the needle protection element and the housing or the component fixed to the housing of the device. Here, this triggering resistance must be overcome when the needle protection element moves from the initial position to the triggering position, which at least makes accidental triggering difficult.

[0012] Alternatively, the device can be triggered by manipulating a trigger button. The device can be configured to allow the needle to be inserted into the patient's skin manually or automatically, and / or to retract the needle into the device's housing manually or automatically.

[0013] The needle protection spring and the discharge spring can be constructed as compression springs. Particularly preferred are both springs constructed as helical springs. However, other springs can also be used. The needle protection spring and the discharge spring are configured to be tensioned and relaxed. The force of the needle protection spring causes the needle protection element to move from the initial position to the discharge position and back to the protection position in the distal direction. The force of the discharge spring causes the discharge spring to discharge the total amount or a portion of the material to be fed. The needle protection spring and the discharge spring are preferably made of metal. Other materials, such as plastic, can also be used.

[0014] Furthermore, the device according to the invention includes a balance spring disposed on the housing, the balance spring being supported at the proximal end of the product container, and the product container being elastically supported on the housing by the balance spring in both the discharge direction and the reverse discharge direction. The balance spring can be constructed integrally with the housing or as a single piece. This allows for the construction of the device with fewer components and lower cost, as the balance spring can be omitted during assembly. Alternatively, the balance spring and housing can be constructed in two parts or as two pieces, wherein the balance spring and housing are axially fixed and anti-rotationally arranged relative to each other. This allows for easy assembly of the device. The balance spring is configured to be tensioned and relaxed. The balance spring is constructed such that it is supported at the proximal end of the product container, and the product container is elastically supported on the housing by the balance spring in both the discharge direction and the reverse discharge direction. This compensates for possible length differences in the product container due to manufacturing tolerances. Furthermore, it ensures that the product container is securely positioned at the shoulder-shaped support of the housing. The balance spring is preferably made of plastic. Other materials, such as metal, can also be used.

[0015] The needle protection element allows the shoulder-shaped support of the housing to be pre-tightened or deflected radially outward in the distal position, and prevents the shoulder-shaped support of the housing from being pre-tightened or deflected radially outward in the proximal position. This allows the product container to be moved axially into the housing in the distal direction, and prevents axial relative movement between the product container and the housing in the distal direction within the axially fixed housing. The needle protection element engages the shoulder-shaped support of the housing with the shoulder of the product container to secure the product container in the device and prevent 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 be configured differently along the longitudinal axis (L). The wall thickness of the needle protection element is determined such that radial deflection of the shoulder-shaped support can be achieved during the assembly step of the device, and radial deflection of the shoulder-shaped support can be prevented during other assembly steps of the device. The assembly position of the device relates to the axial relative position between the needle protection element and the housing. Particularly preferably, the distal region of the needle protection element has a greater wall thickness than the proximal region. The proximal region of the needle protection element can have a thinner wall thickness than the distal region. The needle protection element can include distal and proximal regions with different wall thicknesses.

[0016] Furthermore, the present invention relates to a method for assembling such a device according to the invention. In a first step, a housing for receiving a product container is provided, the housing having an inwardly pointing shoulder-shaped support. 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 is provided, the product container having a distally arranged shoulder and a needle covered by a removable needle protection sleeve. In a further step, the product container is moved or inserted into the housing along a longitudinal axis (L) in a distal direction. During or in such axial relative movement between the product container and the housing, particularly during such movement or insertion of the product container into the housing, the shoulder-shaped support of the housing is positioned in the proximal region of the needle protection element. The needle protection element is positioned in a distal position relative to the housing. In the distal position of the needle protection element, the proximal region of the needle protection element is radially offset relative to the shoulder-shaped support of the housing. In the distal position of the needle protection element, the shoulder-shaped support of the housing can be pre-tightened radially outward or radially deflected. When or during the insertion of the product container into the housing, the inwardly pointing shoulder-shaped support of the housing slides across the outer surface of the needle protection sleeve of the product container, thereby pre-tightening or deflecting radially outward. When the radially pre-tightened or radially deflected shoulder-shaped support of the housing reaches or is positioned between the proximal end of the needle protection sleeve and the distally arranged shoulder of the product container, the radially pre-tightened or radially deflected shoulder-shaped support can relieve stress or engage between the proximal end of the needle protection sleeve and the distally arranged shoulder. Thereafter, the needle protection element can be moved proximal to a proximal position relative to the housing. In the proximal position of the needle protection element, the shoulder-shaped support of the housing is prevented from re-pre-tightening or re-deflecting radially. In the proximal position of the needle protection element, the distal region of the needle protection element is radially offset relative to the shoulder-shaped support of the housing. The proximal position of the needle protection element is preferably formed as the starting position of the needle protection element.

[0017] The advantage of this method is that it requires fewer assembly steps to manufacture the device according to the invention. During assembly, it eliminates the need to provide a product container support to hold and insert the product container into the device housing. This results in a low-cost device according to the invention.

[0018] 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 located in a proximal position or a stopped position of the device in the stop. The housing stop and / or the needle protection stop can be elastically constructed. In the proximal position or the stopped position of the device, the needle protection element can no longer move further relative to the housing and into the housing. This ensures that the shoulder-shaped support portion of the housing is prevented from being pre-tightened radially outward or deflected radially. The product container is supported at the inwardly pointing shoulder-shaped support portion of the housing by a distally arranged shoulder portion to prevent axial relative movement between the product container and the housing in the distal direction.

[0019] In a further step, the balance spring can be secured to or within the housing in a manner fixed to the housing, the balance spring supporting the product container at its proximal end, and the product container being elastically supported at the housing along and against the discharge direction by the balance spring. In an alternative embodiment, the housing already has the balance spring. The balance spring is used to ensure that the product container is securely positioned at the shoulder-shaped support of the housing.

[0020] To enable a patient to use this device for delivering substances, the patient must first remove the cap that is removably positioned on the device. Removing the cap causes the needle protector, which is removably attached to the needle, to be removed. The patient then presses the device against the skin, during which the needle protector moves proximally from the housing from its initial position to its trigger position.

[0021] When the force acting on the stop in the proximal direction exceeds a certain threshold, the housing stop or the needle protection stop can be deflected radially or tangentially, so that the needle protection element can move to the trigger position, in which the distal tip of the needle is released.

[0022] As an alternative or additional solution, when the force acting on the stop or joint in the proximal direction exceeds a certain threshold, the already described trigger resistance can be overcome.

[0023] The needle is inserted into the patient's skin while the needle protector is moving to or towards the trigger position. The needle protector moves from the initial position to the trigger position, where the drive mechanism is released to dispense material from the product container. The drive mechanism is driven to the discharge position by the discharge spring to dispense material from the product container. At the end of dispensing, the patient can remove the device from the skin. The needle protector moves from the trigger position distally to the protector position by the force of the needle protector spring. The initial and protector positions can be located at the same axial position or at different axial positions along the longitudinal axis (L) of the device. In the protector position, the needle protector can be locked, preventing re-movement of the needle protector towards the proximal position. The patient cannot re-trigger the device. Attached Figure Description

[0024] The invention will now be described with reference to the accompanying drawings. The features disclosed herein advantageously improve the invention, both individually and in combination. Wherein: Figure 1 A perspective longitudinal sectional view of an embodiment of the device according to the invention having a longitudinal axis (L) during a first assembly step is shown. Figure 2 It shows according to Figure 1 A three-dimensional longitudinal sectional view of the device in the second assembly step; Figure 3 It shows according to Figure 1 A three-dimensional longitudinal sectional view of the device in the third assembly step. Detailed Implementation

[0025] exist Figure 1In the image, a perspective longitudinal sectional view of an embodiment of the device according to the invention, having a longitudinal axis (L), is shown during the first assembly step. First, a housing (1) for receiving a product container (2) is provided, the housing having an inwardly pointing shoulder-shaped support (1a). The inwardly pointing shoulder-shaped support (1a) is elastically constructed. The housing (1) and the inwardly pointing shoulder-shaped support (1a) are constructed integrally or as a single piece. Furthermore, a product container (2) is provided, the product container having a distally arranged shoulder (2b) and a needle (2a) covered by a removable needle protection sleeve (2c). A needle protection element (3) is radially arranged 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 radial deflection of the shoulder support (1a) can be achieved in one assembly step of the device, and radial deflection of the shoulder support (1a) can be prevented in another assembly step of the device. The distal region of the needle protection element (3) has a greater wall thickness than the 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).

[0026] like Figure 2 As can be seen in the second assembly step, the product container (2) is moved or inserted into the housing (1) along the longitudinal axis (L) toward the distal end. During this axial relative movement between the product container (2) and the housing (1), the inwardly pointing shoulder-shaped support (1a) of the housing (1) slides across the outer surface of the needle protection sleeve (2c). Here, the shoulder-shaped support (1a) of the housing (1) is pre-tightened radially outward or deflected radially. The proximal region of the needle protection element (3) is arranged radially offset relative to the shoulder-shaped support (1a) of the housing (1), wherein the shoulder-shaped support (1a) of the housing (1) can be pre-tightened radially outward or deflected radially. When the radially outward pre-tightened or radially deflected shoulder-shaped support (1a) of the housing (1) reaches or is positioned between the proximal end of the needle protection sleeve (2c) and the shoulder (2b) arranged distally in the product container (2), the radially outward pre-tightened or radially deflected shoulder-shaped support (1a) can expand or engage between the proximal end of the needle protection sleeve (2c) and the distally arranged shoulder (2b). When the shoulder-shaped support (1a) of the housing (1) engages between the proximal end of the needle protection sleeve (2c) and the distally arranged shoulder (2b) of the product container (2), the shoulder-shaped support (1a) of the housing (1) expands. The proximal region of the needle protection element (3) is arranged between the product container (2) and the housing (1).

[0027] like Figure 3As shown, in the third assembly step, the needle protection element (3) moves relative to the housing (1) and moves towards the proximal end of the housing (1) to the proximal position of the needle protection element (3). In the proximal position of the needle protection element (3), the shoulder support (1a) of the housing (1) is prevented from being pre-tightened radially outward or deflected radially again. 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, the axial arrangement of the needle protection element (3) prevents the shoulder support (1a) of the housing (1) from deflecting radially or swinging radially outward. In the proximal position of the needle protection element (3), the needle protection element (3) keeps the shoulder support (1a) of the housing (1) engaged with the shoulder (2b) of the product container (2). Here, the needle protection stop (3a) provided at the needle protection element (3) and the housing stop (1b) installed at the housing (1) form a stop. This stop forms and / or defines the stopping 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 elastically constructed. In the stopping position of the device, the needle protection stop and the housing stop form a stop, such that the needle protection element can no longer move further relative to the housing (1) and into the housing (1). The product container (2) is supported by a distally arranged shoulder (2b) at an inwardly pointing shoulder-shaped support (1a) of the housing (1) to prevent axial relative movement between the product container (2) and the housing (1) in the distal direction.

[0028] In a further assembly step, the balance spring can be fastened to the housing (1) or to the housing (1) in a fixed manner. The balance spring is supported at the proximal end of the product container (2), and the product container (2) is elastically supported at the housing (1) along and against the discharge direction by the balance spring. The balance spring is used to ensure that the product container (2) is securely located at the shoulder support (2b) of the housing (1).

[0029] In order for a patient to use this device for delivering substances, the patient must first remove the cover (4) removably disposed at the device from the device. Removing the cover (4) from the device removes the needle protector (2c) that is removably attached to the needle (2a). Thereafter, the patient presses the device against the skin, wherein the needle protector (3) moves relative to the housing (1) from a distal position toward a proximal position. When the force acting in the proximal direction, particularly the force acting on the housing stop (1b) of the housing (1) through the needle protector (3) exceeds a certain threshold, the housing stop (1b) deflects radially or tangentially, causing the needle protector (3) to move toward the proximal position, in which the distal tip of the needle (2a) is released. The movement of the needle protector (3) from the distal position toward the proximal position releases the drive mechanism to deliver substances from the product container (2). The drive mechanism is driven into the discharge position by the discharge spring to deliver the substance from the product container (2). At the end of the delivery, the patient is able to remove the device from the skin. The needle protection element (3) moves proximally by the force of the needle protection spring. Here, the needle protection element (3) is locked, preventing the needle protection element (3) from moving proximally again. The patient cannot re-trigger the operation.

[0030] List of reference numerals in the attached diagram: 1. Shell 1a Shoulder-shaped support 1b Housing stop 2 Product Containers 2a needle 2b Shoulder 2c needle protective sleeve 3-pin protection element 3a pin protection stop 4. Cover L longitudinal axis

Claims

1. A device for feeding a fluid substance having a longitudinal axis (L), the device comprising: 1.1 Shell (1); 1.2 A product container (2) is axially fixedly received in the housing (1), the product container having a needle (2a) through which a substance can be delivered; 1.3 An inwardly pointing shoulder-shaped support (1a) provided at the housing (1), wherein the product container (2) is supported at the shoulder-shaped support by a distally arranged shoulder (2b) 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), the needle protection element being disposed in the housing (1) and movable relative to the housing (1); 1.5 A needle protection spring, the needle protection spring being coupled to the needle protection element (3), wherein the needle protection element is axially movable from a starting position to a trigger position, in the starting position, the distal tip of the needle (2a) is surrounded by the needle protection element (3), and in the trigger position, the distal tip of the needle (2a) is released by the needle protection element (3); 1.6 A drive mechanism movably received in the housing (1), the drive mechanism being driven to the discharge position by a discharge spring in order to feed the substance from the product container (2); 1.7 A balance spring provided at the housing (1), the balance spring being supported at the proximal end of the product container (2), and the product container (2) being elastically supported at the housing (1) by the balance spring along the discharge direction and against the discharge direction.

2. The apparatus according to claim 1, characterized in that, The needle protection element (3) prevents the shoulder support (1a) from being pre-tightened or deflected radially outward in the distal position, wherein the proximal region of the needle protection element (3) is arranged radially offset relative to the shoulder support (1a) of the housing.

3. The apparatus according to claim 1 or 2, characterized in that, The needle protection element (3) prevents the shoulder support (1a) from being pre-tightened or deflected radially in the proximal position, wherein the distal region of the needle protection element (3) is arranged radially offset relative to the shoulder support (1a) of the housing.

4. The apparatus according to any one of the preceding claims, characterized in that, The drive mechanism is released by the axial movement of the needle protection element (3) from the starting position to the trigger position, so as to feed the substance from the product container (2).

5. The apparatus according to any one of the preceding claims, characterized in that, The needle (2a) of the product container is covered by a removable needle protection sleeve (2c), and the inwardly pointing shoulder-shaped support (1a) of the housing (1) engages or joins between the proximal end of the needle protection sleeve (2c) and the distal shoulder (2b) of the product container (2).

6. The apparatus according to any one of the preceding claims, characterized in that, The shoulder-shaped support is constructed as a single piece with the housing.

7. A method for assembling a device for discharging a substance according to any one of the preceding claims, the method comprising the steps of: - Provide a housing (1) for receiving a product container (2), the housing having an inwardly pointing shoulder-shaped support (1a); - A product container (2) is provided with a shoulder (2b) and a needle (1a) arranged distally, the needle being covered by a removable needle protective sleeve (2c); - The product container (2) is moved or placed into the housing (1) along the longitudinal axis (L) in the distal direction, wherein, The inwardly pointing shoulder-shaped support (1a) slides across the outer surface of the needle protective sleeve (2c), and thereby pre-tightens radially outward or deflects radially; - The radially outwardly pre-tightened or radially deflected shoulder-shaped support (1a) relieves force or engages between the proximal end of the needle protection sleeve (2c) and the shoulder (2b) arranged at the distal end of the product container (2); characterized in that, - Move the needle protection element (3) relative to the housing (1) and into the housing (1) in a proximal direction to the proximal position of the needle protection element (3) or the stop position of the device, wherein the shoulder support (1a) is prevented from being pre-tightened radially outward or deflected radially again.

8. The 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) abuts against the housing stop (1b) of the housing (1) by means of the needle protection stop (3a).

9. The method according to claim 8, characterized in that, When the force acting in the proximal direction, especially the force acting on the stop through the needle protection element (3), exceeds a certain threshold, the housing stop (1b) or the needle protection stop (3a) deflects radially, so that the needle protection element (3) can move to the trigger position, in which the distal tip of the needle (2a) is released.

10. The method according to claim 9, characterized in that, The needle protection element (3) moves from the starting position to the trigger position, wherein the drive mechanism is released so as to discharge the substance from the product container (2).

11. The method according to claim 10, characterized in that, The drive mechanism is driven to the discharge position by a discharge spring so as to discharge the substance from the product container (2).

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