Device for administering a fluid substance

Abstract

This invention relates to a device for feeding or discharging a fluid substance. The device according to the invention includes a housing (1) and a retaining element (6; 6') fixed to the housing, in which an injection spring (5) is received. The retaining element (6; 6') is radially outwardly movable or radially deflectable between an engaged position and a triggered position, in which the retaining element (6; 6') is engaged with the injection spring (5), and in the triggered position, the retaining element (6; 6') is disengaged from the injection spring (5). The retaining element (6; 6') disengages from the injection spring (5) as the needle protection element (3) moves axially from a distal position to a proximal position, thereby feeding or discharging the substance through a needle (2b) from a product container (2).

Description

Technical Field

[0001] The present invention relates to a device having a longitudinal axis (L) for delivering or discharging fluid substances, particularly pharmaceuticals. Background Technology

[0002] The term "medicine" herein includes every flowable medical formulation suitable for controlled delivery or expulsion 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, adjuvant, and carrier substances.

[0003] Devices for delivering or discharging fluid substances are known from the prior art. For example, EP2742962B1 discloses an autoinjector having a retaining element movable in an axial direction, wherein the retaining element is capable of disengaging from a piston rod. Furthermore, the piston rod, received by an injection spring, is movable distally to act on the stopper of the syringe, thereby delivering or discharging the fluid substance.

[0004] The disadvantage of this type of autoinjector is that it is complex in construction and has many components. Summary of the Invention

[0005] The object of the present invention is to provide an apparatus for feeding or discharging fluid substances, the apparatus being easily constructed with fewer components.

[0006] Next, in a device for feeding or discharging fluid, the proximal direction means the direction toward the end of the housing, and in the same device, the distal direction means the direction toward the end of the needle or cannula.

[0007] The device according to the invention, having a longitudinal axis (L), for the delivery or discharge of fluid substances, particularly pharmaceuticals, has a housing. The housing is preferably constructed longitudinally. The housing can preferably be 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. Furthermore, a stopper is provided within the product container, the stopper being axially movable within the product container. Additionally, the product container has a needle or cannula through which the substance can be delivered or discharged. The stopper is preferably arranged within the product container in a manner capable of axially moving from the proximal end to the distal end of the product container, so as to deliver or discharge the substance disposed within the product container. The product container can serve as a syringe, the syringe comprising a syringe body and a needle or cannula fixedly or non-removably received at the distal end of the syringe body. Alternatively, the product container can be constructed as a Karpule, having a Karpule bottle body and a needle unit that can be installed and removed.

[0008] Furthermore, the device according to the invention includes a needle protection element movable relative to the housing for a needle or cannula. The needle protection element can be constructed in a sleeve-like and / or cylindrical, particularly cylindrical, manner. The needle protection element serves to provide protection against puncture wounds caused by the needle or the cannula, particularly by the distal tip of the needle or the distal tip of the cannula. Additionally, the device has a needle protection spring coupled to the needle protection element, wherein the needle protection element is axially movable from a distal position to a proximal position, in which the distal tip of the needle or cannula is surrounded by the needle protection element, and in which the distal tip of the needle or cannula is released by the needle protection element in the proximal position.

[0009] Furthermore, the device according to the invention has an injection spring that provides energy to influence the delivery of the substance, and the injection spring works in conjunction with the stopper to deliver or expel the substance from the product container via a needle or via a cannula. The device can be configured as an autoinjector. An autoinjector is generally referred to as a device that automatically delivers a substance to be administered to a patient upon triggering.

[0010] The needle protection spring and injection spring can be configured as compression springs. Particularly preferred are these two springs as helical springs, especially as helical springs with one or more coils. However, other springs can also be used. The needle protection spring and injection spring are preferably preloaded in the device according to the invention. The needle protection spring and injection spring are configured to be tensioned and relaxed. The force of the needle protection spring allows it to move the needle protection element from a distal position to a proximal position, and then back to a distal position or to a distal position different from the distal position. The force of the injection spring allows it to discharge or discharge the total amount or a portion of the substance to be fed.

[0011] Furthermore, the device according to the invention includes a retaining element arranged axially fixed relative to the housing, wherein an injection spring is particularly pre-tensioned and retractable and received within the retaining element. The retaining element is radially movable outward or radially deflectable between an engaged position and a triggered position, in which the retaining element engages with the injection spring, and in the triggered position, the retaining element disengages from the injection spring. The retaining element is preferably constructed longitudinally and preferably extends along a longitudinal axis (L). Particularly preferably, the retaining element includes a retaining arm and / or a retaining protrusion, which is radially movable outward or radially deflectable. Multiple retaining arms and / or retaining protrusions can be provided. The retaining arm of the retaining element preferably extends from a proximal end to a distal end, wherein the proximal end of the retaining arm is preferably axially fixed at the housing or at an element axially fixed relative to the housing. The retaining element, particularly the retaining arm and / or retaining protrusion, is preferably resiliently constructed. The retaining element, particularly the retaining arm and / or retaining protrusion, is preferably resiliently constructed such that it can move radially outward or deflect radially between an engaged position and a triggered position. In the engaged position, the retaining element, particularly the retaining arm and / or retaining protrusion, engages with the injection spring, particularly one or more coils of the injection spring. In the triggered position, the retaining element, particularly the retaining arm and / or retaining protrusion, disengages from the injection spring, particularly one or more coils of the injection spring. The retaining element, particularly the retaining arm and / or retaining protrusion, is constructed such that the injection spring, particularly one or more coils of the injection spring, can be preloaded and retained engaged.

[0012] Furthermore, as the needle protector moves axially from the distal to the proximal position, the retaining element, particularly the retaining arm of the retaining element, and especially preferably the retaining protrusion of the retaining arm of the retaining element, disengages from the injection spring to allow the substance to be fed or discharged from the product container through the needle or through the cannula. The needle protector can be configured such that, as the needle protector moves axially from the distal to the proximal position, the retaining element, particularly the retaining arm of the retaining element, and especially preferably the retaining protrusion of the retaining arm of the retaining element, disengages from the injection spring to allow the substance to be fed or discharged from the product container through the needle or through the cannula. The injection spring, pre-tensioned in the retaining element, allows the retaining element, particularly the retaining arm and / or the retaining protrusion, to move radially outward or deflect radially. Furthermore, when the retaining element, retaining arm, and / or retaining protrusion disengages from the injection spring, the injection spring can relax, thereby allowing the substance to be fed or discharged from the product container through the needle or through the cannula. The injection spring relaxes directly into the product container during the feeding or discharging of the fluid substance. The advantage of the device according to the invention is its compact size, especially its external dimensions. This optimization of the device according to the invention results in a device with fewer components. Furthermore, the device according to the invention is simple and robust in construction.

[0013] In other embodiments, the retaining element can have a different configuration, wherein the retaining element is arranged axially fixed relative to the housing of the device and is radially movable outward or radially deflectable between an engaged position and a triggered position, in which the retaining element engages with the injection spring, and in the triggered position, the retaining element disengages from the injection spring. The retaining element can hold the injection spring preloaded in the engaged position. Furthermore, the injection spring can relax in the triggered position, thereby enabling the delivery or discharge of material from the product container.

[0014] In one embodiment of the device according to the invention, for feeding or discharging a substance from a product container, an injection spring can act directly on a stopper in the product container. The injection spring relaxes directly into the product container during feeding or discharging of the fluid substance. This embodiment of the device according to the invention has the advantage of providing high feeding or discharging performance and a compact structure. The injection spring can include a distal portion and a proximal portion. The distal portion of the injection spring can be configured such that it functions as a damping element. When the injection spring impacts the stopper, the impact energy can be at least partially absorbed to prevent glass breakage. In the delivery state, the distal portion of the injection spring can be relaxed and only loaded or tensioned upon impact with the stopper. The proximal portion of the injection spring can be used to store discharging or feeding energy. In the delivery state, the proximal portion of the injection spring can be pre-tensioned or held engaged by a pre-tensioned retaining element. Thus, the engagement position of the retaining element relative to the axial direction of the injection spring can divide the injection spring into a distal portion and a proximal portion. The distal and proximal portions of an injection spring can be made of different materials or have different structures or stresses.

[0015] In an alternative embodiment of the device according to the invention, an adapter is provided between the injection spring and the stopper to deliver or discharge material. A retaining element is capable of pre-tensioning the injection spring in an engaged position, wherein, in a triggered position, the retaining element is disengaged from the injection spring. Thus, the injection spring acts on the stopper via the adapter to deliver or discharge material. This embodiment of the device according to the invention has the advantage that it allows for the assembly of injection springs and stoppers shaped in various ways, and despite this, a device with high delivery performance and a compact structure can still be provided. The adapter can be constructed longitudinally and extend along a longitudinal axis (L). The adapter can be constructed in a sleeve-like manner or constructed of a solid material. In one embodiment of the device according to the invention, the distal and proximal ends of the adapter can be constructed such that these ends can form a stop contact with the stopper of the product container on the one hand and a stop contact with the injection spring on the other hand. Furthermore, the adapter can be constructed as a damping element to reduce or correspondingly adapt the force of the injection spring. In addition, the adapter can have a guide for guiding the injection spring. The guide of the adapter can be provided on the outer surface of the adapter. The guide portion extends parallel to the spring axis of the injection spring. This prevents the injection spring from bending. In one embodiment of the device according to the invention, the distal end of the injection spring can be supported at a portion of the adapter, particularly the proximal or middle portion, and the proximal end of the injection spring can be supported at the proximal portion of the housing or at the proximal portion of the retaining element. In the device according to the invention, the injection spring relaxes directly into the product container during the feeding or discharging of fluid. This advantageously optimizes the structure of the device according to the invention. During this relaxation process, the energy released by the injection spring, particularly the energy released by the injection spring, can be applied to the stopper through the adapter to feed or discharge the substance from the product container.

[0016] In another embodiment of the device, an adapter is provided between the injection spring and the plug for feeding or discharging material. In this embodiment, the retaining element can be engaged or disengaged from the adapter, either additionally or solely. The retaining element, particularly the retaining arm or retaining protrusion of the retaining element, is constructed such that the adapter remains engaged, allowing the injection spring, particularly one or more coils of the injection spring, to be preloaded.

[0017] Furthermore, as the needle protection element moves axially from the distal to the proximal position, the retaining element, particularly the retaining arm, especially preferably the retaining arm, or the retaining protrusion of the retaining element, disengages from the adapter to allow material to be fed or discharged from the product container through the needle or cannula. The needle protection element can be configured such that, as the needle protection element moves axially from the distal to the proximal position, the retaining element, particularly the retaining arm, especially preferably the retaining arm, or the retaining protrusion of the retaining element, disengages from the adapter to allow material to be fed or discharged from the product container through the needle or cannula. A pre-tensioned injection spring in the retaining element allows the retaining element, particularly the retaining arm, especially preferably the retaining arm, or the retaining protrusion of the retaining element, to move radially outward or deflect radially. Furthermore, when the retaining element, particularly the retaining arm, especially preferably the retaining arm, or the retaining protrusion of the retaining element, disengages from the adapter, the injection spring can relax, thereby allowing material to be fed or discharged from the product container through the needle or cannula. During this expansion and contraction process, the energy released by the injection spring, in particular, can be applied to the stopper via an adapter to deliver or discharge the substance from the product container. The injection spring acts indirectly on the stopper to deliver or discharge the substance from the product container. The injection spring also expands directly into the product container during the delivery or discharge of the fluid substance.

[0018] The advantage of the device according to the invention is its compact size, especially its external dimensions. This optimization of the device according to the invention results in a device with fewer components. Furthermore, the device according to the invention is simple and robust in construction.

[0019] The term "directly" in this document means "directly" or "without gaps or separated by only small gaps." For example, in one embodiment of the device according to the invention, no component (e.g., no piston rod) is arranged between the injection spring and the stopper. For example, in one embodiment of the device according to the invention, the injection spring can act directly on the stopper. Furthermore, for example, no component (e.g., piston rod) is arranged between the injection spring and the product container, wherein there is only a small gap or no gap between the injection spring and the product container. Therefore, the term "directly" can be understood not only as "along the longitudinal axis (L)" but also as "transverse to the longitudinal axis (L)".

[0020] The term "indirectly" in this document means "indirectly" or "through an intermediate element." For example, in another embodiment of the device, a component (e.g., an adapter) is arranged between the injection spring and the stopper. For example, in another embodiment of the device, the injection spring can act indirectly on the stopper. The term "indirectly" can be understood as "along the longitudinal axis (L)" or "transverse to the longitudinal axis (L)."

[0021] Furthermore, during the feeding or discharging of material, the injection spring, particularly the coil of the injection spring, can relax relative to and through the retaining element to generate an acoustic, visual, and / or tactile discharge signal. The discharge signal can be generated through relative movement between the retaining element, particularly the retaining arm and / or the retaining protrusion of the retaining element, and the injection spring, particularly the coil of the injection spring. Specifically, the coil of the injection spring, relaxed during the discharge process, can slide through the retaining element and / or through the retaining arm and / or the retaining protrusion of the retaining arm or retaining element to generate the discharge signal. The acoustic signal can be, for example, an audible vibration or click, caused during the feeding or discharging of material by relative movement between the retaining element, particularly the retaining arm and / or the retaining protrusion of the retaining element, and the coil of the injection spring. The retaining element, retaining arm, or retaining protrusion can be configured as a click element. To achieve a visual signal, for example, a window can be provided in the housing of the device according to the invention, through which the relaxation of the coil of the injection spring can be seen. When the coil of the injection spring relaxes relative to the retaining element, especially the retaining arm of the retaining element and / or the retaining protrusion of the retaining arm or the retaining protrusion of the retaining element, the tactile signal can be, for example, a perceptible vibration.

[0022] In another embodiment of the device according to the invention, the discharge signal can be generated by an additional retaining element, particularly an additional retaining arm of the retaining element or an additional retaining protrusion of the retaining arm or retaining element. Therefore, the device according to the invention can have a first retaining element and a second retaining element, particularly a first retaining arm and a second retaining arm, and a first retaining protrusion and a second retaining protrusion. The first retaining element, particularly the first retaining arm or the first retaining protrusion, can be used to engage or disengage the injection spring, and the second retaining element, particularly the second retaining arm or the second retaining protrusion, can be used to generate the discharge signal. The second retaining element, the second retaining arm, or the second retaining protrusion can be configured as a click element. The second retaining element, particularly the second retaining arm or the second retaining protrusion, can be resiliently configured. The second retaining element, particularly the second retaining arm or the second retaining protrusion, can be resiliently disposed at the first retaining element or at an element fixed axially relative to the housing.

[0023] To generate a discharge signal, the holding element, its holding arm, or its holding protrusion is preferably configured such that the frequency of the perceptible discharge signal is reduced during the delivery or discharge process, in order to indicate to the patient that delivery or discharge is about to end. For this purpose, the frequency of audible vibrations or clicks during delivery or discharge can be reduced, for example. Furthermore, the visible spacing between the coils of the injection spring can be increased during delivery or discharge. Additionally, the frequency of perceptible vibrations during delivery or discharge can be reduced, for example. Thus, the patient can be indicated that delivery or discharge from the product container is about to end and / or has ended. Alternatively, the frequency of the perceptible discharge signal can be designed or has been designed to be constant or unchanging.

[0024] Furthermore, the device according to the invention can include a switching sleeve arranged along a longitudinal axis (L) between the needle protection spring and the needle protection element, wherein the switching sleeve is driven proximally by the needle protection element as the needle protection element moves from a distal position to a proximal position. Preferably, the switching sleeve arranged between the needle protection spring and the needle protection element is movable from a distal position to a proximal position and back to a distal position, or to a distal position different from the distal position. The switching sleeve is preferably longitudinally elongated and sleeve-shaped. The switching sleeve is preferably cylindrical, especially cylindrical.

[0025] Furthermore, the device according to the invention can have a locking sleeve arranged transversely to the longitudinal axis (L) between the switching sleeve and the retaining element, wherein, in the distal position of the needle protection element, the locking sleeve prevents the retaining element from disengaging from the engagement between the retaining element and the injection spring and moving radially outward or deflecting radially. The locking sleeve is arranged in a manner that allows it to move axially from the distal position to the proximal position. The proximal end of the needle protection spring can be supported at the proximal end of the locking sleeve. Furthermore, the locking sleeve can be axially movably arranged on or at the retaining element. In the distal position of the needle protection element, the locking sleeve can be in a detachable engagement with the retaining element. For this purpose, the locking sleeve can, for example, have a protrusion that can be in a detachable engagement with a recess at the retaining element. Alternatively, the protrusion of the locking sleeve can surround the distal end of the retaining element and thus form a detachable engagement.

[0026] In the proximal position of the needle protection element, the switching sleeve can release the locking sleeve, and the retaining element can be moved into the trigger position by the injection spring. The injection spring acts on the retaining element such that the retaining element disengages from the injection spring and moves radially outward or deflects radially. The locking sleeve disengages from the retaining element. Therefore, the force applied by the needle protection spring can cause the locking sleeve to move or move axially from the distal position toward the proximal position. The locking sleeve can move proximal relative to the retaining element fixed to the housing and can form a stop contact with the retaining element to generate an acoustic, visual, and / or tactile discharge initiation signal. Thus, it is possible to indicate to the patient that the delivery or discharge of material from the product container has begun. The acoustic signal can be designed, for example, as an audible stop contact between the locking sleeve and the retaining element. Furthermore, the housing of the device according to the invention can, for example, have a window to visually indicate the axial movement of the locking sleeve relative to the retaining element. During the axial movement between the locking sleeve and the retaining element, a perceptible vibration can be generated to generate a tactile discharge signal. The locking sleeve is preferably elongated and sleeve-shaped. The locking sleeve is preferably cylindrical, especially cylindrical.

[0027] Furthermore, the locking sleeve and switching sleeve can have a grooved guide, a locking stop, and a corresponding tensionable locking element. Preferably, the locking sleeve and switching sleeve are arranged in a manner that allows them to move axially relative to each other and rotate relative to each other. The locking stop can be constructed in a ramp shape, wherein the locking element can be radially deflected by the ramp of the locking stop during movement toward the distal end and can engage behind the shoulder of the ramp-shaped locking stop. The locking element is preferably constructed elastically. The locking element can be constructed as an elastic locking arm or an elastic locking engagement portion.

[0028] Preferably, during the proximal movement of the needle protection element, the locking sleeve and the switching sleeve are rotatable relative to each other via a grooved guide between them. The locking element is axially aligned with a locking stop to prevent the needle protection element from moving back to the proximal position. Therefore, the needle protection element is locked and can protect the patient from injury due to the needle or cannula, particularly the distal tip of the needle or cannula. Attached Figure Description

[0029] 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 longitudinal sectional view of a first embodiment of the device according to the invention, having a longitudinal axis (L), is shown in the delivery state; Figure 2The following is shown in the feeding or discharging state according to Figure 1 A longitudinal sectional view of the device; Figure 3 The following is shown in the locked state: Figure 1 A longitudinal sectional view of the device; Figure 4 A longitudinal sectional view of an embodiment of the device not according to the invention, having a longitudinal axis (L), is shown in the delivery state; Figure 5 The following is shown in the feeding or discharging state according to Figure 4 A longitudinal sectional view of the device; Figure 6 The following is shown in the locked state: Figure 4 A longitudinal sectional view of the device; Figure 7 A longitudinal sectional view of a second embodiment of the device according to the invention, having a longitudinal axis (L), is shown in the delivery state; Figure 8 The following is shown in the feeding or discharging state according to Figure 7 A longitudinal sectional view of the device; Figure 9 The following is shown in the locked state: Figure 7 A longitudinal sectional view of the device. Detailed Implementation

[0030] exist Figure 1The image shows a longitudinal sectional view of a first embodiment of the device according to the invention, in the form of an autoinjector, in a delivered state, the autoinjector having a longitudinal axis (L). The device is used to deliver or discharge fluid substances, particularly drugs. The device has a housing (1). The housing (1) can be constructed in a sleeve-like manner. A product container (2), together with the substance to be delivered, is axially fixedly received in the housing (1). A stopper (2a) is axially movable and received in the product container (2) to deliver or discharge the substance from the product container (2). The device includes a needle (2b) through which the substance can be delivered or discharged. The needle (2b) is disposed at the distal end of the product container (2). Furthermore, the device includes a needle protection element (3). The needle protection element (3) is used to protect against punctures caused by the needle (2b), particularly the distal tip of the needle (2b) of the product container (2). The needle protection element (3) can be constructed in a sleeve-like manner. Furthermore, the device has a needle protection spring (4) coupled to a needle protection element (3), wherein the needle protection element (3) is axially movable from a distal position to a proximal position, in which the distal tip of the needle (2b) is surrounded by the needle protection element (3), and in the proximal position, the distal tip of the needle (2b) is released by the needle protection element (3). Additionally, the device includes an injection spring (5) that provides energy for inducing the feeding or discharging of a substance, and the injection spring works in conjunction with the stopper (2a) to feed or discharge the substance through the needle (2b) from the product container. In the delivered state of the device, the needle protection spring (4) and the injection spring (5) are configured as pre-tensioned pressure springs. Furthermore, the device includes a retaining element (6) axially fixed relative to the housing (1), in which the injection spring (5) is received, particularly pre-tensioned and expandable. The retaining element (6) is capable of radially outward movement or radially deflection between an engaged position and a triggered position, in which the retaining element is engaged with the injection spring (5), and in the triggered position, the retaining element (6) is disengaged from the injection spring (5). The retaining element (6) includes a retaining arm (6a). Furthermore, the retaining arm (6a) includes a retaining protrusion (6b). The retaining arm (6a) and / or the retaining protrusion (6b) is capable of radially outward movement or radially deflection. The retaining arm (6a) of the retaining element (6) extends from a proximal end to a distal end, wherein the proximal end of the retaining element (6) or the proximal end of the retaining arm (6a) is axially fixedly arranged at the housing (1). The retaining element (6) and / or the retaining arm (6a) and / or the retaining protrusion of the retaining element (6) are elastically constructed.The retaining protrusion (6b) of the retaining element (6) is configured such that it can move radially outward or deflect radially between an engaged position and a triggered position. In the engaged position, the retaining protrusion (6b) is engaged with one or more coils of the injection spring (5), and in the triggered position, it is disengaged from one or more coils of the injection spring (5). In the delivered state of the device, the retaining protrusion (6b) of the retaining element (6) holds the injection spring (5) in a preloaded engagement. Furthermore, the device includes a switching sleeve (7) arranged along a longitudinal axis (L) between the needle protection spring (5) and the needle protection element (3). The switching sleeve (7) can be constructed in a sleeve-like shape. When the needle protection element (3) moves from the distal position to the proximal position, the switching sleeve (7) can be driven proximally by the needle protection element (3). Furthermore, the device has a locking sleeve (8) arranged transversely to the longitudinal axis (L) between the switching sleeve (7) and the retaining element (6). The locking sleeve (8) can be sleeve-shaped. The locking sleeve (8) is rotatably arranged relative to the switching sleeve (7). The switching sleeve (7) is anti-rotationally arranged relative to the housing (1). The locking sleeve (8) can prevent the retaining element (6), especially the retaining protrusion (6b) of the retaining element (6), from radially outward movement or radial deflection from the engagement between the retaining element (6) and the injection spring (5) in the distal position of the needle protection element (3). The proximal end of the needle protection spring (4) is supported at the proximal end of the locking sleeve (8). The locking sleeve (8) is axially movable on or at the retaining element (6). In the delivered state of the device, the locking sleeve (8) is in a detachable engagement with the retaining element (6). The locking sleeve (8) may have a protrusion (not shown) that is in a detachable engagement with a notch (not shown) at the retaining element (6). In order for a patient to use the device, particularly the autoinjector, for delivery or expulsion of the substance, the patient must first remove the cap (9) detachably disposed at the device. Removing the cap (9) from the device removes the needle protector cap (2c) detachably mounted at the needle (2a). Thereafter, the patient presses the device against the skin, wherein the needle protector (3) moves relative to the housing (1) from the distal position to the proximal position. Here, the needle (2b) is inserted into the patient's skin.Through this relative movement of the needle protection element (3) relative to the housing (1), the switching sleeve (7), loaded by the needle protection spring (4), moves proximally relative to the housing (1). In the proximally positioned position of the needle protection element (3), the switching sleeve (7) can release the locking sleeve (8). The retaining protrusion (6b) of the retaining element (6) can move radially outward or deflect radially based on the force of the injection spring (5), thereby disengaging the retaining protrusion (6b) of the retaining element (6) from the injection spring (5), particularly one or more of the coils of the injection spring (5). The protrusion (not shown) of the locking sleeve (8) disengages from the recess (not shown) of the retaining element (6). The protrusion (not shown) of the locking sleeve (8) moves radially outward or deflects radially and can form a groove guide. The groove guide of the protrusion (not shown) can engage with the groove guide provided at the switching sleeve (7). By the force applied by the needle protection spring (4), the locking sleeve (8) moves axially proximally relative to the switching sleeve (7) and relative to the retaining element (6) fixed to the housing, and forms a stop contact with the retaining element (6), wherein a discharge initiation signal is generated, in particular an audible stop. During the axial movement of the locking sleeve (8) proximally, the locking sleeve (8) rotates relative to the switching sleeve (7) based on the groove guide between the protrusion (not shown) of the locking sleeve (8) and the switching sleeve (7). By the relative movement between the locking sleeve (8) and the switching sleeve (8), the locking stop (not shown) provided at the locking sleeve (8) and the locking element (not shown) provided at the switching sleeve (7) are axially aligned. In an alternative embodiment of the device according to the invention, the locking sleeve may have a locking element and the switching sleeve may have a locking stop.

[0031] In a first embodiment of the device according to the invention, the injection spring (5) acts directly on the stopper (2a) of the product container (2). Furthermore, the injection spring (5) relaxes directly into the product container (2) during the delivery or discharge of fluid. This provides a device with high delivery or discharge performance and a compact structure. During the delivery or discharge of fluid from the product container (2), the coil of the injection spring (5) relaxes relative to the retaining element (6) and through the retaining protrusion (6b) of the retaining arm (6a) to generate a discharge signal, particularly an acoustic discharge signal in the form of an audible vibration or click. The retaining element (6) and / or the retaining arm (6a) and / or the second retaining protrusion (6b) are configured as click elements. Figure 2As shown, at the end of delivery or discharge, the acoustic discharge signal ceases to sound, indicating to the patient that delivery or discharge of the fluid substance from the product container (2) has ended and that the patient can remove the device from the skin. When the device is removed from the skin, the needle protection element (3) and the switching sleeve (7) move back from the proximal position to the distal position or to a distal position different from the proximal position based on the force of the needle protection spring (4).

[0032] The switching sleeve (7) preferably has a locking element (not shown), which is elastically constructed. The locking element (not shown) can be constructed in a radially deflectable manner. The locking sleeve (8) preferably has a locking stop (not shown). Based on the axial and rotational relative movement between the locking sleeve (8) and the switching sleeve (7), the locking stop (not shown) of the locking sleeve (8) is axially aligned with the locking element (not shown) of the switching sleeve (7). The locking stop (not shown) of the locking sleeve (8) can preferably be constructed with a shoulder (not shown) in a ramp shape, wherein the shoulder (not shown) can be disposed at the distal end of the locking stop (not shown).

[0033] During the movement of the needle protection element (3) and the switching sleeve (7) from the proximal position to the distal position or to a distal position different from the distal position, wherein the force of the needle protection spring (4) causes the switching sleeve (7) and the needle protection element (3) to move in the distal direction, the locking element (not shown) of the switching sleeve (7) slides through the ramp-shaped locking stop (not shown) of the locking sleeve (8). The locking element (not shown) of the switching sleeve (7) is capable of relaxing and / or engaging behind the shoulder (not shown) of the locking stop (not shown) of the locking sleeve (8). When the needle protection element (83) moves back in the proximal direction, the locking element (not shown), especially the relaxed locking element (not shown) of the switching sleeve (7), is capable of forming a stop contact with the locking stop (not shown), especially with the shoulder (not shown) of the locking element (not shown) of the locking sleeve (8). Therefore, the needle protection element (3) is locked and can protect the patient from injury due to the needle (2), especially due to the distal tip of the needle (2b). Figure 3 As shown, the device is in a locked state. Alternatively, the locking stop can be located at the switching sleeve (7), and the locking element can be located at the locking sleeve (8).

[0034] Figure 4 , Figure 5 and Figure 6An embodiment of a device for feeding or discharging fluid substances, not according to the invention, is shown, wherein... Figure 4 The device shown is in the delivery state. Figure 5 The device is shown in the state of feeding or discharging, and in Figure 6 The device is shown in a locked state. This embodiment differs from the first embodiment of the device in the presence of an additional adapter (10). Furthermore, the structure and function of this embodiment correspond to the first embodiment of the device described above. The adapter (10) is arranged between the injection spring (5) and the plug (2a) of the product container (2). The adapter (10) is axially arranged between the injection spring (5) and the plug (2a) of the product container (2). The injection spring (5) thus acts on the plug (2a) via the adapter (10) to deliver or discharge the substance. The retaining element (6) includes a retaining arm (6a) and a retaining protrusion (6b). The retaining element (6), particularly the retaining arm (6a) and / or the retaining protrusion (6b), is elastically constructed. In the delivered state of the device, the retaining protrusion (6b) can engage with the adapter and disengage from the adapter to deliver or discharge the substance. The retaining element (6) is capable of radially outward movement or radial deflection between an engaged position and a triggered position, in which the retaining element is engaged with the adapter (10), and in the triggered position, the retaining element (6) is disengaged from the adapter (10). The adapter (10) can be constructed in a sleeve-like manner. Therefore, injection springs (5) shaped in various ways and plugs (2a) shaped in various ways can be assembled. Furthermore, the adapter (10) can preferably be constructed as a damping element to reduce or correspondingly adapt the force of the injection spring (5). The injection spring (5) acts indirectly on the plug (2a) of the product container (2). In addition, the injection spring (5) relaxes directly into the product container (2) during the delivery or discharge of fluid. This provides a device with high delivery or discharge performance and a compact structure.

[0035] Figure 7 , Figure 8 and Figure 9 A second embodiment of the apparatus according to the invention for feeding or discharging fluid substances is shown, wherein, in Figure 7 The device is shown in the delivery state. Figure 8 The device is shown in the middle of being fed or discharged, and in Figure 9The device in the locked state is shown. The second embodiment of the device according to the invention differs from the first embodiment in the configuration of the retaining element (6') and the presence of an additional adapter (10'). The retaining element (6') has a first retaining arm (not shown) with a first retaining protrusion (not shown) capable of radially outward movement from an engaged position or radially deflected to a triggered position, in which the retaining protrusion (not shown) is engaged with one or more coils of the injection spring (5), and in the triggered position, the retaining protrusion (not shown) is disengaged from one or more coils of the injection spring (5). In the delivery state, the retaining protrusion (not shown) is capable of engaging with and disengaging from the injection spring to deliver or discharge the substance. The retaining element (6') also has a second retaining arm (6a') with a second retaining protrusion (6b'). The second retaining arm (6a') is longitudinally constructed and extends along a longitudinal axis (L). Alternatively, a second retaining element may be provided, which is axially fixedly connected to the housing or a component fixed to the housing. This second retaining element may include a second retaining arm (6a') and a second retaining protrusion (6b'). The second retaining arm (6a') and the second retaining protrusion (6b') are arranged in a manner that is radially offset by 90 degrees relative to the first retaining arm (not shown) and relative to the first retaining protrusion (not shown). The second retaining arm (6a'), and especially the second retaining protrusion (6b'), are constructed and used to generate a discharge signal, especially an acoustic discharge signal in the form of an audible vibration or click, when the substance is fed or discharged. When the injection spring (5) is relaxed, the retaining protrusion (6b') slides through the coil of the injection spring (5). During the feeding or discharging of the fluid substance from the product container (2), the coil of the injection spring (5) relaxes relative to the retaining element (6') and by the retaining protrusion (6b') of the retaining arm (6a') to generate a discharge signal, particularly an acoustic discharge signal in the form of an audible vibration or click. Figure 8As shown, at the end of delivery or discharge, the acoustic discharge signal specifically ceases to sound, indicating to the patient that delivery or discharge of the fluid substance from the product container (2) has ended. The retaining element (6') and / or the second retaining arm (6a') and / or the second retaining protrusion (6b') are configured as click elements. The retaining element (6') and / or the second retaining arm (6a') and / or the second retaining protrusion (6b') are elastically configured. Multiple first retaining arms (not shown) and / or second retaining arms (6a') with corresponding retaining protrusions (6b') can be provided at the retaining element (6'). The distal end of the injection spring is supported at the distal end of the adapter (10'), and the proximal end of the injection spring is supported at the proximal end of the retaining element (6'). In the delivered state of the device, the second retaining protrusion (6b') can be engaged with and disengaged from the adapter (10') to deliver or discharge the substance. The retaining protrusion (6b') is capable of radially outward movement or radially deflection between an engaged position and a triggered position, in which the retaining protrusion (6b') is engaged with the adapter (10'), and in the triggered position, the second retaining protrusion (6b') is disengaged from the adapter (10'). The adapter (10') can be constructed in a sleeve-like manner. Therefore, injection springs (5) shaped in various ways and plugs (2a) shaped in various ways can be assembled. Furthermore, the adapter (10') can preferably be constructed as a damping element to reduce or correspondingly adapt the force of the injection spring (5). The injection spring (5) acts indirectly on the plug (2a) of the product container (2). In addition, the injection spring (5) relaxes directly into the product container (2) during the delivery or discharge of the fluid substance. This provides a device with high delivery or discharge performance and a compact structure. The adapter (10') has a guide (10a). The guide portion (10') is disposed on the outer surface of the adapter (10') such that the injection spring (5) is guided when it relaxes. The guide portion (10a) extends parallel to the spring axis of the injection spring (5). This prevents the injection spring from bending.

[0036] In another embodiment of the device according to the invention, a sleeve (not shown) movable relative to the housing can be additionally provided. This sleeve is movable via a second retaining arm (6a') with a second retaining protrusion (6b') to generate a discharge signal, particularly an acoustic discharge signal in the form of an audible vibration or click. This sleeve (not shown) can be arranged concentrically with the longitudinal axis (L) between the injection spring (5) and the second retaining protrusion (6b''). This sleeve (not shown) can have one or more recesses and / or one or more protrusions that slide sequentially or ratchet through the second retaining protrusion (6b'') to generate a discharge signal. The plurality of recesses are arranged along the longitudinal axis (L). The plurality of recesses can be constructed in different sizes. If a plurality of second retaining arms (6a') and a plurality of second retaining protrusions (6b') are provided, corresponding recesses can be provided along the longitudinal axis (L), which, in conjunction with these second retaining protrusions (6b'), generate a discharge signal. These corresponding notches can be arranged offset from each other along the longitudinal axis (L) or arranged at the same axial position along the longitudinal axis (L).

[0037] List of reference numerals in the attached diagram: 1. Shell 2 Product Containers 2a Plug 2b needle 2c needle protective cover 3-pin protection element 4-pin protective spring 5. Injection Spring 6' Holding element 6a Holding Arm 6a' Second holding arm 6b Maintain the convex shape 6b' Second retaining protrusion 7. Switching sleeves 8 Locking Sleeve 9. Cover 10' Adapter 10a Guiding Section L longitudinal axis

Claims

1. A device for feeding or discharging a fluid substance having a longitudinal axis (L), the device comprising: 1.1 Shell (1); 1.2 A product container (2) is fixedly received in the housing (1) along the axial direction, the product container having a substance to be fed and a plug (2a) received in the product container (2) in a manner movable along the axial direction, and a needle (2b) provided at the product container for feeding or discharging the substance; 1.3 A needle protection element (3) for the needle (2b) that is movable relative to the housing (1); 1.4 Needle protection spring (4), the needle protection spring being coupled to the needle protection element (4), wherein the needle protection element (4) is axially movable from a distal position to a proximal position, in which the distal tip of the needle (2b) is surrounded by the needle protection element (3), and in which the distal tip of the needle (2b) is released by the needle protection element in the proximal position; 1.5 Injection spring (5), which provides energy for inducing the delivery of the substance and works in conjunction with the stopper (2a) to deliver or discharge the substance through the needle (2b) from the product container (2); 1.6 A retaining element (6; 6') is axially fixed relative to the housing (1), in which the injection spring (5) is received, and the retaining element (6; 6') is radially outwardly movable or radially deflectable between an engaged position and a triggered position, in which the retaining element (6; 6') is engaged with the injection spring (5), and in the triggered position, the retaining element (6; 6') is disengaged from the injection spring; 1.7 It is characterized by, As the needle protection element (3) moves axially from the distal position to the proximal position, the retaining element (6; 6') disengages from the injection spring (5) to allow the substance to be delivered or discharged from the product container (2) through the needle (2b).

2. The apparatus according to claim 1, characterized in that, The injection spring (5) acts directly on the plug (2a) to deliver or discharge the substance.

3. The apparatus according to claim 1, characterized in that, The injection spring (5) acts on the stopper (2a) via an adapter (10) to deliver or discharge the substance, the adapter being arranged along the longitudinal axis (L) between the injection spring (5) and the stopper (2a).

4. The apparatus according to any one of the preceding claims, characterized in that, The needle protection spring (4) and / or the injection spring (5) are constructed as helical springs.

5. The apparatus according to any one of the preceding claims, characterized in that, When the substance is delivered or discharged, the injection spring (5), in particular the coil of the injection spring, can relax relative to and through the retaining element (6; 6') to generate an acoustic, visual and / or tactile discharge signal.

6. The apparatus according to any one of the preceding claims, characterized in that... A switching sleeve (7) is arranged along a longitudinal axis (L) between the needle protection spring (4) and the needle protection element (3), wherein the switching sleeve (7) is driven by the needle protection element (3) in the proximal direction when the needle protection element (3) moves from the distal position to the proximal position.

7. The apparatus according to claim 6, characterized in that... A locking sleeve (8) is arranged transversely to the longitudinal axis (L) between the switching sleeve (7) and the retaining element (6; 6'), wherein the locking sleeve (8) in the distal position of the needle protection element (3) prevents the retaining element (6; 6') from disengaging from the engagement between the retaining element (6; 6') and the injection spring (5) and moving radially outward or deflecting radially.

8. The apparatus according to claims 6 and 7, characterized in that, The switching sleeve (7) releases the locking sleeve (8) in the proximal position of the needle protection element (3), and the retaining element (6; 6') enters the trigger position by means of the injection spring (5).

9. The apparatus according to claims 6 and 7, characterized in that, The locking sleeve (8) and the switching sleeve (7) have a groove guide, a locking stop and a corresponding locking element, wherein the locking sleeve (8) and the switching sleeve (7) are arranged in a manner that allows them to move axially and rotate relative to each other, and wherein, during the movement of the needle protection element (3) from the distal position to the proximal position, the locking element forms an axial alignment with the locking stop, and wherein, when the needle protection element (3) moves back towards the proximal direction, the locking element forms a stop contact with the locking stop in order to prevent the needle protection element (3) from moving back to the proximal position.

10. The apparatus according to any one of claims 7 to 9, characterized in that, The locking sleeve (8) is movable toward the proximal end relative to the retaining element (6; 6) and is able to form a stop contact with the retaining element (6; 6) to generate an acoustic, visual and / or tactile discharge initiation signal.

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